The CDC in America says that there is 1 death from flu per 200,000 people.
( http://www.cdc.gov/nchs/fastats/flu.htm )
But even they admit that figure is likely to be very innacurate: "CDC does not know exactly how many people die from seasonal flu each year. There are several reasons for this. First, states are not required to report individual seasonal flu cases or deaths of people older than 18 years of age to CDC. Second, seasonal influenza is infrequently listed on death certificates of people who die from flu-related complications. Third, many seasonal flu-related deaths occur one or two weeks after a person’s initial infection, either because the person may develop a secondary bacterial co-infection (such as bacterial pneumonia) or because seasonal influenza can aggravate an existing chronic illness (such as congestive heart failure or chronic obstructive pulmonary disease)."
( http://www.cdc.gov/flu/about/disease/us_flu-related_deaths.htm )
So the reality is that even if someone 'dies of flu', it is most likely that is due to the fact that they already had another underlying condition, or because they had another infection like pneumonia.
But even if we use the CDC's stats we get a 0.0005% risk of death from flu. Personally I have to say that I have never heard of anyone dying of flu, nor have I ever heard of anyone really complaining about it or making a big deal over it until just a few years ago, when all of a sudden it is portrayed as some kind of major risk, which is blatantly untrue.
What about adverse reactions?
It is not uncommon for children to have FEBRILE SEIZURES from the seasonal Flu Vaccine. That means that the child is most probably permanently brain damaged as a result.
The CDC has a system for reporting adverse reactions called VAERS ( The Vaccine Adverse Event Reporting System)
You can search it here: https://wonder.cdc.gov/vaers.html
I just did quick search for all adverse reactions to the Flu4 Seasonal Injected Vaccine between Dec 2013 - Dec 2014 And 1019 events came up, please have a read below and see what horrific reactions children have had to this seasonal flu vaccine and ask yourself what is worse? A child having a brain seizure, vomiting and passing out? or a flu? How can anyone think the danger of a flu outweighs the risk of giving a child brain damage?
Another search for ALL types Flu vaccine adverse reactions gives 8,082 total events for Dec 2013 - Dec 2014 USA. So considering that approximately 139,000,000 people in USA get a Flu vaccine each year ( http://www.cdc.gov/nchs/fastats/flu.htm ) We can calculate the risk of an adverse reaction to be approximately: 0.006%
So according to the CDC's OWN DATA YOU ARE TEN TIMES MORE LIKELY TO GET AN ADVERSE REACTION THAN YOU ARE TO 'DIE OF FLU'.
( Personally I would estimate that the figure is more likely to be something like 100 or 1000 times more likely, seeing as the figures for flu deaths are exaggerated and also many adverse reactions go unreported. )
Adverse reactions to the Flu4 Vaccine between Dec 2013 - Dec 2014 (USA) 1019 results
( http://www.cdc.gov/nchs/fastats/flu.htm )
But even they admit that figure is likely to be very innacurate: "CDC does not know exactly how many people die from seasonal flu each year. There are several reasons for this. First, states are not required to report individual seasonal flu cases or deaths of people older than 18 years of age to CDC. Second, seasonal influenza is infrequently listed on death certificates of people who die from flu-related complications. Third, many seasonal flu-related deaths occur one or two weeks after a person’s initial infection, either because the person may develop a secondary bacterial co-infection (such as bacterial pneumonia) or because seasonal influenza can aggravate an existing chronic illness (such as congestive heart failure or chronic obstructive pulmonary disease)."
( http://www.cdc.gov/flu/about/disease/us_flu-related_deaths.htm )
So the reality is that even if someone 'dies of flu', it is most likely that is due to the fact that they already had another underlying condition, or because they had another infection like pneumonia.
But even if we use the CDC's stats we get a 0.0005% risk of death from flu. Personally I have to say that I have never heard of anyone dying of flu, nor have I ever heard of anyone really complaining about it or making a big deal over it until just a few years ago, when all of a sudden it is portrayed as some kind of major risk, which is blatantly untrue.
What about adverse reactions?
It is not uncommon for children to have FEBRILE SEIZURES from the seasonal Flu Vaccine. That means that the child is most probably permanently brain damaged as a result.
The CDC has a system for reporting adverse reactions called VAERS ( The Vaccine Adverse Event Reporting System)
You can search it here: https://wonder.cdc.gov/vaers.html
I just did quick search for all adverse reactions to the Flu4 Seasonal Injected Vaccine between Dec 2013 - Dec 2014 And 1019 events came up, please have a read below and see what horrific reactions children have had to this seasonal flu vaccine and ask yourself what is worse? A child having a brain seizure, vomiting and passing out? or a flu? How can anyone think the danger of a flu outweighs the risk of giving a child brain damage?
Another search for ALL types Flu vaccine adverse reactions gives 8,082 total events for Dec 2013 - Dec 2014 USA. So considering that approximately 139,000,000 people in USA get a Flu vaccine each year ( http://www.cdc.gov/nchs/fastats/flu.htm ) We can calculate the risk of an adverse reaction to be approximately: 0.006%
So according to the CDC's OWN DATA YOU ARE TEN TIMES MORE LIKELY TO GET AN ADVERSE REACTION THAN YOU ARE TO 'DIE OF FLU'.
( Personally I would estimate that the figure is more likely to be something like 100 or 1000 times more likely, seeing as the figures for flu deaths are exaggerated and also many adverse reactions go unreported. )
Adverse reactions to the Flu4 Vaccine between Dec 2013 - Dec 2014 (USA) 1019 results
"Notes" "Age" "Age Code" "VAERS ID" "VAERS ID Code" Adverse Event Description "6-11 months" "1" "517710-1" "517710-1" "None stated." "6-11 months" "1" "524415-1" "524415-1" "Reported fever of 104.5 by mom, 101.5 in office." "6-11 months" "1" "528075-1" "528075-1" "Crying non-stop since approximately 1 hour post injection (approximately 5:00 PM on 12/18/13) until ALTE at 4:00 AM on 12/19/13 (received the 5-in-1 immunization as well as flu immunization and oral rotavirus vaccine) in pediatrician's office. She had began to run a temperature (approximately 102) around 7:00 PM, was administered Tylenol for this. Around 9:00 PM, she vomited. She was given more Tylenol around 10:00 PM. She vomited around 4:00 AM on 12/19/13, then about 2 minutes later, went unresponsive, cyanotic around her lips, and apneic. CPR was performed for approximately 3-4 cycles by mother (who is a nurse) and EMS was dispatched. After about 4 cycles, she began moaning and having agonal breaths, which within 30 seconds became vigorous cries. She never had any seizure-like activity. She was admitted to Hospital for 2 days observation and discharged with the diagnosis of ALTE." "6-11 months" "1" "528749-1" "528749-1" "Influenza vaccine 6-35 month ordered, influenza vaccine 3+ given to patient. Dr. notified parent unaware attempted to contact parent after inceident. Will continue to try to contact parent." "6-11 months" "1" "544039-1" "544039-1" "Generalized seizure for approximately 1 minute. Temp 99" "6-11 months" "1" "547394-1" "547394-1" "Bloody diarrhea, fever, dehydration." "6-11 months" "1" "547458-1" "547458-1" "Febrile seizure with temp to 102.7 without other source for infection, normal CBC, U/A." "6-11 months" "1" "549676-1" "549676-1" "Child developed rash 1 day after influenza vaccine. Rash spread seen at ER. 10/12/14 diagnosed erythema multiforme : possible secondary to influenza vaccine." "6-11 months" "1" "549812-1" "549812-1" "Discomfort to her left upper arm, feels like a torn rotator cuff." "6-11 months" "1" "550142-1" "550142-1" "Onset severe chills, day two through six, temp 102-103 joint pain (hips) three days. Slept 18 hours per day. Duration 7 days." "6-11 months" "1" "551582-1" "551582-1" "Seizure, eyes rolled back and had convulsions for about 3min" "6-11 months" "1" "552900-1" "552900-1" "Vaccine given 11/6/14 about 9 AM, child was fussy that night mom gave TYLENOL about 10:30-11pm -> hives within 1/2 hour of TYLENOL. Mom also notes that she did have red spots around her mouth after the vaccine was given. Child was given BENADRYL about 12 am. No hives since (seen in the office 11/7/14 about 2:45 pm)." "6-11 months" "1" "553869-1" "553869-1" "2 days after vaccine developed fiver and fussiness, refusing to eat - brought to walk in and dxd with otitis media." "6-11 months" "1" "556216-1" "556216-1" "Patient abducted left arm up above head, turned head to left with eyes to left deviation, and start shaking in a tonic clonic fashion. The entire episode lasted about 2 minutes." "6-11 months" "1" "557100-1" "557100-1" "IIV 4 given right anterior lateral thigh 12/3/14 at 1600. 1800 that same day noted whelps on back. BENADRYL oral given. No respiratory problems. No feeding problems. Small erythema macular rash trunk, face persistent to 12/4/14. ATARAX 2 mg/kg/day q6hr, consult allergist." "1-2 years" "1-2" "516146-1" "516146-1" "12/9/13 lethargy, vomiting began 15-30 minutes after vaccines given." "1-2 years" "1-2" "516914-1" "516914-1" "Child became lethargic 12/12/13 in afternoon - had seizure - was unable to arouse baby - went to ER - transferred to another hospital by ambulance. Remained unable to arouse baby for total of 13 hours. Discharged 12/14/13." "1-2 years" "1-2" "517189-1" "517189-1" "No adverse event. Error in vaccine administration." "1-2 years" "1-2" "517509-1" "517509-1" "Shaking staring spell, fever -> febrile seizure." "1-2 years" "1-2" "518904-1" "518904-1" ""8 x 5 cm area of induration with 12 x 8 cm warmth and erythema area to lt upper thigh. Began x 1 day post 15 mo immunizations. Pt (+) ""scratching"" at area <2 ""small"" pink indurated areas also noted to rt upper thigh on exam. TX: BENADRYL every 6 hours prn warm, moist compress."" "1-2 years" "1-2" "519124-1" "519124-1" "Patient was given a Kinrix (DTaP/IPV) combination vaccine instead of the Daptacel (DTaP) vaccine. He was also given a Ipol (Polio) vaccine and Hepatitis A and Influenza vaccines. So, he received Kinrix off-license and also received a dose of polio vaccine. He did not have any adverse effects." "1-2 years" "1-2" "520478-1" "520478-1" "Developed fever of 103F on 1/19/14, fever then subsided and developed rash on 1/23/14, they then saw physician." "1-2 years" "1-2" "521516-1" "521516-1" "Febrile seizure 24 hours after vaccination." "1-2 years" "1-2" "521959-1" "521959-1" "One half hour after injections, pt was completely perspired. One hour later pt developed fever of 102 degrees ax. Fever reduced with alternating TYLENOL and ibuprofen a 3 hrs. Pt woke this am with prickly red rash all over body. Pt afebrile at visit. Mother advised to continue TYLENOL and ibuprofen. BENADRYL for rash prn." "1-2 years" "1-2" "522438-1" "522438-1" "Swelling of left knee and limping. Vaccine was administered in the left leg. She did have a cold at the onset of this as well." "1-2 years" "1-2" "522976-1" "522976-1" "Petechial rash all over face that occurred within 15 minutes of vaccine. No difficulty breathing, vomiting or wheezing. No rash on another part of the body other than rash that was present when she came in. Had normal respiratory rate and O2 sats of 98%, even after 20 minutes of observation." "1-2 years" "1-2" "524736-1" "524736-1" "Pox developed at injection site." "1-2 years" "1-2" "525980-1" "525980-1" "Child woke up at 5:00 AM and was crying and had a fever. Child threw up then was staring and had jerky movements and difficulty breathing. Ambulance called and was taken to medical center." "1-2 years" "1-2" "544672-1" "544672-1" "Large local reaction to left thigh with swelling of lymph node to right inguinal area." "1-2 years" "1-2" "545003-1" "545003-1" "Pt had GTC sz at 9:00 PM about 1 min and sz at 11:00 PM, went to ED. Pt was admitted for complex febrile sz follwing vaccines. Discussed the importance of preventing the fever from rising quickly, so when there is the first sign of a fever, mother should start measures to cool patient down. This includes providing antipyretics. Acetaminophen and ibuprofen can be alternated up to every 3 hours if fever does not subside." "1-2 years" "1-2" "545011-1" "545011-1" "Welt at site of varicella vaccine. Fever to 105 later that night; facial swelling." "1-2 years" "1-2" "545830-1" "545830-1" "Left thigh with warm 4cm x 1.5cm lesion slightly indurated, nontender, erythematous. Treatment: hydrocortisone, MOTRIN Q 6 hrs, BENADRYL Q 6 hrs, KEFLEX if erythema spreading beyond outline." "1-2 years" "1-2" "546439-1" "546439-1" "Fever of 104, seizure" "1-2 years" "1-2" "546669-1" "546669-1" "50 cent size red hot lump at injection site that evening. By morning thigh was red. He was still active and wasn't complaining of it. By today reaction site was improved." "1-2 years" "1-2" "547419-1" "547419-1" "MMR, Hib, Flu vaccine received 9/26/14. Admitted on 10/4/14 after having 2 febrile seizures. Had a 3rd brief seizure after admission. Discharged home on 10/6/14." "1-2 years" "1-2" "547788-1" "547788-1" "Seizure (unwitnessed) with fever < 1 minute. Dad reports unconscious when he arrived. Taken to ER by ambulance. Post ictal <10 minutes. No further treatment. +family history of seizure in paternal uncle." "1-2 years" "1-2" "548292-1" "548292-1" "Varicella." "1-2 years" "1-2" "548689-1" "548689-1" "Pt received 1.0ml of influenza vaccine. Progress call to parent on 9/19/14 - no fever and no sore arm, redness or swelling at site." "1-2 years" "1-2" "548819-1" "548819-1" "Circumferential erythema of left upper arm (from shoulder to mid arm) extending across clavicle, positive swelling, no punctate lesion, no drainage." "1-2 years" "1-2" "548832-1" "548832-1" "Hives only, given Benadryl." "1-2 years" "1-2" "548922-1" "548922-1" "Spiked fever of 102 F 20-25 minutes after vaccine. Complained of head hurting and moaning, become drowsy and fell asleep in arms for just 2-3 minutes and then woke up at 12:15 PM vomiting. At 12:30 PM developed hives on right side of face and left leg (site of injection), trunk not visualized at the time. Hives resolved within 10 minutes. Received ibuprofen 100 mg chewable tablet. Refused to take diphenhydramine. Fell asleep at 2 pm and napped until 4 pm. At 5 pm spiked fever again to 101-102 F and complained of eyes hurting. Received ibuprofen again at 6:15 pm. Woke up at 3 am sweaty (temperature not recorded), went back to sleep without medicine. Woke up at 8 am (10/19/14) and no further episodes of fever." "1-2 years" "1-2" "549151-1" "549151-1" "Fever and vomiting started the next day from when vaccine was given." "1-2 years" "1-2" "549196-1" "549196-1" "Mother notified physician that around 3:00 PM patient would become silent and start to roll eyes into the back of the head. She denied any fevers or shaking. Patient's eyes would roll into the back of the head a couple of times. Time between episodes was around 30 min. - 1 hour. Mother states it is noticeable between 3-6:00pm. This happened daily for the next 6 days. No treatment at home. Patient was referred to neurologist." "1-2 years" "1-2" "549313-1" "549313-1" "Febrile siezure 20 hours after immunization; seen in ER; follow-up in PCP office." "1-2 years" "1-2" "549515-1" "549515-1" "Area on lt lateral leg - red rough, non tender area - 3 cm x 1 1/4 - at site of varicella - onset 10/6/14. Followed by wide spread red, papular rash, temp - 102.4 - onset 10/5. Duration 4 days." "1-2 years" "1-2" "549778-1" "549778-1" "Pt was given FLUZONE/Hep A. Then broke out head to toe in a rash." "1-2 years" "1-2" "550140-1" "550140-1" "Pt became limp, drooling, cyanotic, unresponsive x2-3 min. Sx resolved by the time EMS arrived. Taken to local ER and given Motrin (did not require any benzodiazepines or other medications to break seizure)." "1-2 years" "1-2" "550380-1" "550380-1" "On 10-14-14 pt was given 0.5 ml of the quadrivalent influenza vaccine in the left deltoid. Patient was supposed to be given 0.25 ml of the influenza vaccine due to his age." "1-2 years" "1-2" "550627-1" "550627-1" "Marked localized swelling of left upper arm 24 hours after flu vaccine administered. ? arthus reaction." "1-2 years" "1-2" "550697-1" "550697-1" "None stated." "1-2 years" "1-2" "550779-1" "550779-1" "Fever 4 days after vaccinations, then again 10 days after vaccination up to 103 degrees rash that is macular 10 days after vaccination." "1-2 years" "1-2" "551067-1" "551067-1" "Mom states fussiness began evening of flu shot given. Discussed with dr. Suggested to mom to alternate ibuprofen and TYLENOL due to suspected soreness." "1-2 years" "1-2" "551214-1" "551214-1" "Wrong vaccine administered for age. No illnesses resulted." "1-2 years" "1-2" "551215-1" "551215-1" "Patient was given #5 Hepatitis B vaccine. Should have received #2 Hepatitis A vaccine." "1-2 years" "1-2" "551478-1" "551478-1" "Given decreased dose than recommended by manufacturer." "1-2 years" "1-2" "551507-1" "551507-1" "(R) deltoid has a 3 x 4 cm red, hot, hard lump. Increased temp 104." "1-2 years" "1-2" "551599-1" "551599-1" "16 month old female inadvertently given Fluarix Quadrivalent dose of Influenza vaccine." "1-2 years" "1-2" "551724-1" "551724-1" "Tiny macular rash over trunk; hives on thighs." "1-2 years" "1-2" "551841-1" "551841-1" "Worsening skin rash both cheeks." "1-2 years" "1-2" "551992-1" "551992-1" "Urticarial rash started on Left leg, and then moved to body and face. Pt had similar reaction after 4 month shots, so vaccines were spread out to determine cause, and has since done fine with vaccines." "1-2 years" "1-2" "552208-1" "552208-1" "Febrile Seizure." "1-2 years" "1-2" "552680-1" "552680-1" "10/21/2014 Patient had been ill and having hives for several weeks prior to immunizations." "1-2 years" "1-2" "552908-1" "552908-1" "10cm erythema to lt leg. redness, warm to touch." "1-2 years" "1-2" "553014-1" "553014-1" "Limping and favoring his right leg." "1-2 years" "1-2" "553999-1" "553999-1" "11/14/14 Developed scattered discrete blanching erythematous macular, papular rash on neck, face, stomach, (no petechiae, no hives) developed. Also has croupy cough, congestion, viral URI sx. Rash could be viral exanthem or rlt vaccines." "1-2 years" "1-2" "554313-1" "554313-1" "1/7/14-Started with rash (right leg with bump and redness in area of shots given) now with rash too. 1/15/14-Fever (102.8), brusing to injection site area, warm to touch, area firm/indurated." "1-2 years" "1-2" "554352-1" "554352-1" "11/08/2014 - 4AM, Vomiting. 11/08/2014 - 11/10/2014 - Fever (101). 11/09/2014 - 4PM, Hives." "1-2 years" "1-2" "554783-1" "554783-1" "N/A" "1-2 years" "1-2" "554792-1" "554792-1" "High fevers that began approx. 48 hrs after FLUZONE and Hep A vaccines that ranged between 104-105.2 rectally for 9 days including a 60-120 sec period of blue infant and non-responsiveness en route to hospital. No other cause for fevers found. My daughter had brief desats in hospital requiring blow by O2 for 10-15 minutes. She had complained of (L) thigh pain and abdominal pain with no other symptoms." "1-2 years" "1-2" "555051-1" "555051-1" "10 days after vaccine developed large 4 cm area of erythema and swelling at injection site, fever, one generalized papular rash." "1-2 years" "1-2" "555053-1" "555053-1" "10 days after vaccine developed large - 5cm area of erythema and swelling at injection site, fever, and generalized papular rash." "1-2 years" "1-2" "555722-1" "555722-1" "Guillain BarrT - Fisher Miller variant; tingling, paralyzation, speech, muscle movement, coordination, respiratory failure: nerve damage/myelin damage peripheral nervous system; IVIG - intraveinous immunoglobulin." "1-2 years" "1-2" "555779-1" "555779-1" "This case was reported by a other health professional and described the occurrence of inappropriate age at vaccine administration in a 29-month-old male patient who received FLUARIX QUADRIVALENT, the patient experienced inappropriate age at vaccine administration and wrong administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown. It was unknown if the reporter considered the inappropriate age at vaccine administration and wrong vaccine administered to be related to FLUARIX QUADRIVALENT. Additional information received on 26 September 2014: FLUARIX QIV was administered instead of another flu vaccine approved for that age." "1-2 years" "1-2" "555824-1" "555824-1" "Developed rash on leg, then edema to face and lips. Received 10 mg Benadryl by mouth." "1-2 years" "1-2" "556319-1" "556319-1" "Developed light rash to chest approximately 10 min after receiving flu vaccine. Total lesions approx 1 dozen to torso. No respiratory involvement. Gave 1/2 tsp of BENADRYL in office. Same reaction when child received flu vaccine Dec 2013. Gave BENADRYL then also. Rash resolved." "1-2 years" "1-2" "557092-1" "557092-1" "48 hours after vaccine pt in for urgent ov with increased redness, warmth and swelling of B thighs L>R left thigh." "1-2 years" "1-2" "557247-1" "557247-1" "Swelling, redness, Moderate." "1-2 years" "1-2" "557292-1" "557292-1" "Febrile seizure presenting in status 8 days after vaccines." "3-5 years" "3-5" "516873-1" "516873-1" "Rash on back, face, arms, abdomen and legs 2 days after flu shot." "3-5 years" "3-5" "517177-1" "517177-1" "Development of bilateral conjunctivitis within 3 hours of nasal flu vaccine." "3-5 years" "3-5" "517278-1" "517278-1" "Fever and lethargy. Reported 102 degrees fever per mom. No fever at 12/16/13 visit." "3-5 years" "3-5" "517506-1" "517506-1" "10.5 cm x 10 cm area of induration/cellulitis, warmth. Given 7 d of antibiotics and 3 days steroids." "3-5 years" "3-5" "518468-1" "518468-1" "7.5 x 9 cm area of erythema and induration on the left anterior thigh with warmth to touch, no central fluctuance appreciated." "3-5 years" "3-5" "518892-1" "518892-1" "Severe rash, peeling skin, red bumps. Areas affected: feet, hands, face, ears, neck, upper chest, knees, elbows." "3-5 years" "3-5" "518968-1" "518968-1" "Client spiked a fever of 101.3 Mother gave Ibuprofen to reduce temp. Advised to see PCP. 2nd Phone conversation @ 1:45pm Temp now reduced, mother states her son had previous Sx's last year but not associated with Flu vaccine. been slightly ill since returning to school this year. Advised to still seek PCP for evaluation." "3-5 years" "3-5" "519071-1" "519071-1" "Daughter woke up from sleeping at approx 4 Am on 1-11. She woke up screaming that there were spiders on her and to help her. She had no fever. I removed her from her bed and took her into family room where it took about 40 min to call her down. I though maybe she just had a nightmare until later on in the day while in her car seat on our way to the store she started screaming for me to help her, saying snails were on her. I pulled over to assure her she was fine and she was paralyzed with fear. Her hand and legs were very stiff and when I put my as out for her to come to me she didn't move. Almost like she was frozen. After about 10 min I called her down. We continued on to the store where inside the store she had another episode. Just out of now where she started saying, I scared...snails on me. Help me. She kept repeating that. I left my cart of groceries and we exited the store. It is now 01/13/2014 amd she is still having these hallucinations. We are very scared and don't know what to do." "3-5 years" "3-5" "520273-1" "520273-1" "Swelling to injection site." "3-5 years" "3-5" "521463-1" "521463-1" "(From the medical record) Patient received flu vaccine. In less than 5 minutes she started to cough and have perioral cyanosis. The nurse was in the room giving sibling vaccines and called me into the room immediately. She was placed on the bed, cool towel placed on forehead. Pulse ox placed, SaO2 was in 80's, oxygen given by face mask. An erythematous rash was noted on her face and chest. Benadryl 25 mg was given orally. Her oxygen saturation came up in the 90's, color returned. No LOC. Epi was at bedside, but not needed. Her head was slightly elevated, she was able to take sips of apple juice, the rash faded. The oxygen was withdrawn and sats remained in high 90's. She complained of a stomachache. No emesis. She was observed for 20 minutes after the oxygen was removed. No wheezing or difficult breathing. Able to swallow easily. No rash." "3-5 years" "3-5" "522037-1" "522037-1" "Bilateral eye swelling; difficulty breathing." "3-5 years" "3-5" "523479-1" "523479-1" "Child received a Td based on incorrect hx card provided. Td should not be given before age 7 yrs and client is only 5 yrs 11 mo." "3-5 years" "3-5" "524741-1" "524741-1" "Broke out in a rash, starting on arm and progessing to all of body." "3-5 years" "3-5" "525818-1" "525818-1" "This case was reported by a healthcare professional and described the occurrence of seizure in a 5-year-old female subject who was vaccinated with FLUARIX QUADRIVALENT (GlaxoSmithKline). Historic vaccination included FLUZONE (non-gsk); non-GSK manufacturer; unknown; unknown given on an unspecified date 2012-2013 season. On 4 March 2014 the subject recevied unspecified dose of FLUARIX QUADRIVALENT (unknown). On 4 March 2014, immediately after vaccination with FLURAIX QUADRIVALENT, the subject experienced seizure. The healthcare professional reported the subject experienced a seizure immediately after administration of FLUARIX QUADRIVANELT; no other information was provided. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the seizure was unspecified." "3-5 years" "3-5" "526865-1" "526865-1" "Left arm from shoulder to elbow warm to touch, red, and swollen. No fever." "3-5 years" "3-5" "528827-1" "528827-1" "There is no adverse event. Nurse gave client .25 cc dose of flu instead of .5 cc dose per child's age." "3-5 years" "3-5" "532135-1" "532135-1" "Initial report received from a healthcare professional on 22 May 2014. A five-year-old male patient, with a history of asthma, received an intramuscular left deltoid injection of INFLUENZA QUADRIVAL A-B VACCINE (lot number U4820BA) on 29 January 2014. Two days post-vaccination, on 31 January 2014, the patient developed a tic, with twitching and jerking of the arms, legs, and head. Symptoms not occur when the patient was sleeping, and worsened when the patient was tired or ill; they did not interfere with school or play. The patient was seen in the emergency room, where symptoms were documented on video. He had been seen by a neurologist and diagnosed with transient tic disorder of acute onset. Treatment included amoxicillin and ZITHROMAX with no improvement of symptoms. At the time of the report, the patient had not recovered. Documents held by sender: None." "3-5 years" "3-5" "544146-1" "544146-1" "DISTENDED STOMACH, BODY ACHE, FEVER, INJECTION SITE REACTION ERYTHEMA, SWELLING, WARMTH." "3-5 years" "3-5" "544190-1" "544190-1" "Patient was given the Varicella vaccine in right lower vastus lateralis subq. within 1-2 mins. after injection, complained of itch, red rash noted around injection site, given liquid BENADRYL for treatment." "3-5 years" "3-5" "544707-1" "544707-1" "2 weeks after flu vaccine, developed erythema multiforme-like rash, fever, joint swelling." "3-5 years" "3-5" "545308-1" "545308-1" "Local reaction to immunization - area outlines with marker - (L) deltoid with 7 x 8 cm pink, slightly warm, non-tender, area of mild induration." "3-5 years" "3-5" "545410-1" "545410-1" "Rash, hive like bumps, on right side of the trunk under ribs, progressing to left side over the day and round to the back resolved with application of hydrocrtisone cream." "3-5 years" "3-5" "545678-1" "545678-1" ""Mom called and said that pt had a ""welt"" and rashy area at injection site. Approx. 1 cm ""welt"" not itchy. No fever. No resp. issues. Happy playful. Discussed with Dr. Advised mom to give 12.5 mg Benadryl. If ""welt"" worsens or rash spreads call PCP to be seen. If respiratory issues or trouble swallowing go to ER. Called mom 9/30/14 pt had a good night. Rash is gone. Small raised area still on arm. Mom wondering now if it could even be a bug bite and not a reaction at all."" "3-5 years" "3-5" "545792-1" "545792-1" "FEVER 9/15. HIVES, FEVER 102 9/16. TYLENOL, ADVIL AND BENADRYL GIVEN. 9/17 RESOLVED FEW HIVES NO FEVER RESOLVED BY AFTERNOON." "3-5 years" "3-5" "546105-1" "546105-1" ""Site reaction: redness, ""fist sized"" swelling."" "3-5 years" "3-5" "546585-1" "546585-1" "Fever 103.6, vomiting." "3-5 years" "3-5" "546757-1" "546757-1" "Redness, swelling, pain, induration, erythema, vesicular lesions." "3-5 years" "3-5" "547353-1" "547353-1" "Patient received the flu immunization in the left thigh on 10/08/14 in the AM. In the PM there was a small bump. Today his leg is red, swollen, hard and warm to the touch. No breathing difficulties." "3-5 years" "3-5" "547647-1" "547647-1" "Fever 105.0." "3-5 years" "3-5" "547992-1" "547992-1" ""Patient is ex-23 weeker with hx of seizure disorder received influenza vaccine on 10/14 and approximately 1 hour later starting having a seizure; the seizure lasted 5 hours and persisted despite multiple AEDs (Ativan, fosphenytoin, phenobarbital, Diastat). The seizure was consistent with his previous seizures but had an additional element of ""whole body stiffening."" He normally seizes approximately once every 1-2 months. Was apparently afebrile at the outside hospital, though he developed a low-grade fever the day after the seizure."" "3-5 years" "3-5" "548243-1" "548243-1" "Red's 0.5 pre-filled quad flu shot at office clinic on 10-01-14. Afternoon of 10-02-13, LA at site with redness, edema, blotchiness; warmth. Afebrile 2-3 other small 'hive-like' spots also to (rt) upper arm, cheek and neck by 10-03-14. Seen for s/s 10-03-14. Tx with KEFLEX (250/5 (8 ml BID x 7d)." "3-5 years" "3-5" "548272-1" "548272-1" "Shot given 9/29/14. Noticed redness, left thigh swollen an warm on 10/1/14. Child seen in office on 10/2/14 because area gotten larger. Treated with ORAPRED. F/u on 10/3/14 child doing better -getting smaller." "3-5 years" "3-5" "548409-1" "548409-1" "Sudden onset abdominal pain with sudden pallor, sleepiness, bradycardia to 57 BPM. No LOC, no vomiting. Irregular heart beat. Patient slow to recover and required transport via EMS to ER." "3-5 years" "3-5" "548811-1" "548811-1" "Redness and swelling of upper arm to elbow with excoriated blister vs abrasion at shot site." "3-5 years" "3-5" "549191-1" "549191-1" "Patient had just been evaluated by FNP, and was diagnosed with a URI. Patient was given an influenza injection approximately at 2:30 pm by myself. Shortly after, around 3:00 pm, the patient's father was being evaluated by another provider, who observed patient experience a seizure in the exam room. Note: Patient in clinic w/ father (who was being seen as patient). Patient had just been evaluated by another provider in this clinic and given flu shot approx 30-45 minutes before seizure.No hx seizures per father. Child was happy/playful in exam room, suddenly fell onto floor hitting head w/ seizure. Father states he noticed that patient first stiffened before fall. I did not witness this, but first saw her on floor, seizure activity. Stiffened body posturing w/ dilated pupils, gray coloring, unable to open mouth, no response. Heart rate remained regular, breath sounds apparent. Immediately provided safe care, airway and called 911. Pediatrician called to exam room. After approx 1 minute, patient aroused, crying, recognizing father. No incontinence. O2 sats monitored during seizure and post-seizure, reamined over 95%. Temp 97.1. Transported to ER per ambulance." "3-5 years" "3-5" "549241-1" "549241-1" "About one hour after receving injectable Flu vaccine the patient developed a rash on her arms which spread to her thorax. No difficulty breathing was noted at that time. Patient was given 12.5 mg of diphenhydramine by mouth and monitored for an hour. After the observation time the rash started to fade. The patient did not have any respiratory distress or signs of discomfort throughout the observation time. Mother of the patient was instructed to continue giving the patient 12.5mg of diphenhydramine every 6-8 hours for 48 hours following the onset of the rash." "3-5 years" "3-5" "549302-1" "549302-1" "A couple of hours after receiving an injectable Flu vaccine the patient developed abdominal pain followed by episodes of vomiting and upward rolling of eyeballs and shaking of his extremities while at the grocery store with his mother. He was taken via EMS to Medical Center where he was kept for observation. According to the ER report was post ictal for 3-4 hours." "3-5 years" "3-5" "549640-1" "549640-1" "HIVES, NO TREATMENT." "3-5 years" "3-5" "549648-1" "549648-1" "See attached physician note." "3-5 years" "3-5" "549663-1" "549663-1" "Child had a flu vaccination on 10/15/2014 and leg became red, swollen and irritated. Child was diagnosed with cellulitis and put on AUGMENTIN for 10 days. Left thigh was flu shot." "3-5 years" "3-5" "549684-1" "549684-1" "Mom called our office the day after pt received Flu vaccination 10/17/14 pt developed the following sx: pt arm was swollen from shoulder to hand. Arm felt warm/hard per mom. Pt developed hives all over her face; etc." "3-5 years" "3-5" "549868-1" "549868-1" "(R) thigh reddened warm to touch alittle puffy area. No temp noted given BENADRYL. Cool compresses better in 48 hours." "3-5 years" "3-5" "550175-1" "550175-1" "Parents report 2 episodes within 24 hrs of seizure like activity. Body arched back and stiff, hands fisted. Episodes lasted a few seconds. Sent to ER, admit for obs. - everything negative. Did develop temp while in ER. Later seen by neuro - neg as well." "3-5 years" "3-5" "550606-1" "550606-1" "Pt rec'd vaccine on 10/2/14. Friday 10/3/14 site of vaccine was red and warm to touch. Patient was placed on Prednisone and Amoxicillin. Patient had allergic reaction to Flu vaccine per Dr." "3-5 years" "3-5" "550612-1" "550612-1" "Mother called 10-12-14 at 10:08 am. Patient's arm had a red warm hard lump size about 3 x 3. No fever." "3-5 years" "3-5" "550706-1" "550706-1" "Erythemia and swelling L upper arm 7x10 cm; mild right arm flat 1x2 cm; 1 purple, 1 red papule." "3-5 years" "3-5" "550975-1" "550975-1" "Itchy rash on trunk of body, on back and chest. No fever. Rash lasted longer than 24 hours." "3-5 years" "3-5" "551149-1" "551149-1" "Localized redness and swelling to right thigh. Mother gave patient Benadryl for 2 days. Lasted for 48 hours." "3-5 years" "3-5" "551441-1" "551441-1" "Left arm started swelling getting red, painful to touch and is itchy all started on 11-1-14 in the morning as the day progress the redddness started spreading up to neck and down arm. Patient instructed to start taking benadrly for itching to arm and ibuprofen for pain to left arm and can apply a cold compress to site to help easy swelling." "3-5 years" "3-5" "551463-1" "551463-1" "Given decreased dose than recommended by manufacturer." "3-5 years" "3-5" "551600-1" "551600-1" "10/21/14 @0930 - Assessed L arm parent concern for swelling. L arm swollen, not red. Told to give Tylenol/Motrin for discomfort and warm pack as tol. 10/22/14- Morning Clinic visit. Nurse was contacted of NP diagnosis of cellulitis/ as reaction to vaccine." "3-5 years" "3-5" "552006-1" "552006-1" "Patient's mom stated he had swelling of right arm - we didn't see patient in our office." "3-5 years" "3-5" "552094-1" "552094-1" "Pt. received MMR and Varicella vaccine in outer (R) thigh on 10/6/14. On day 1 after vaccine developed erythema, tenderness area 15 cm in diameter. Day 2 after vaccine given developed blistering lesion over both sites and temp of 102. Resolved by 10/10/14." "3-5 years" "3-5" "552103-1" "552103-1" "Large local reaction to flu vaccine left deltoid - slight warm to touch - scant elevated pink swelling to elbow - swelling to axilla and upper chest pink blotchy rash along (L) clavicle." "3-5 years" "3-5" "552253-1" "552253-1" "Pt developed high fever, refusal to walk and lower extremity dystonia which lasted a few hours, 2 days following admin of injectible flu vaccine." "3-5 years" "3-5" "552257-1" "552257-1" "Temp of 102 degrees (Temporal artery scan), started 5 hrs after (about 8 pm 10/27/14) the immunizations were administered and fluctuated for 24 hrs. Last temp 100.2 degrees (TA) at 7:30 pm 10/28/14. Vomited x 4 in 24 hrs from 10/28/14, 1:45 am to 10/28/14 5:30 am. No history of diarrhea. Fussy/cranky for 24-36 hrs, starting 5 hrs after imm." "3-5 years" "3-5" "552467-1" "552467-1" "Leg is red, warm to the touch and swollen. Not affected walking. Gave ibuprofen but no improvement." "3-5 years" "3-5" "552605-1" "552605-1" "He has recurrent vomiting, fever, decreased ability." "3-5 years" "3-5" "552699-1" "552699-1" "Left deltoid had 7 X 5 cm large local reaction." "3-5 years" "3-5" "552702-1" "552702-1" "Redness and swelling from elbow to shoulder in vaccinated arm. Started approx 36 hrs after injection. No fever tried cool compress which made symptoms worse." "3-5 years" "3-5" "552707-1" "552707-1" "Bullous local reaction with surrounding erythema." "3-5 years" "3-5" "552708-1" "552708-1" "Large localized hive like reaction. Seen by MD on 11/6, it was 5x5 inches." "3-5 years" "3-5" "553769-1" "553769-1" "Pt received flu shot on 11-11-14, noticed hives on Wed, 11-12-14 at approx 4:00pm. Hive were located on her vaginal area, buttock, trunk of body. Denies any on limps, neck, or face." "3-5 years" "3-5" "553872-1" "553872-1" "13x7 cm area of localized induration, mild tenderness L ant thigh. 2x3 cm area mild erythemia R thigh." "3-5 years" "3-5" "554335-1" "554335-1" "11/11/14 father noticed red, swollen area, about quarter size on (L) deltoid. Gave 5 mL BENADRYL at 8pm. 11/12/14 father notified office red, swollen from armpit to almost elbow. No fever or SOB." "3-5 years" "3-5" "554518-1" "554518-1" "Red, warm, and raised to Rt. thigh injection sites. On 11/19/2014 Dr. ordered antibiotic with office visit." "3-5 years" "3-5" "555276-1" "555276-1" "Influenza quadrivalent 3 yrs IM injection placed 11/10/14 developed red, swollen area from shoulder to elbow. No fever. Mom called office 11/19. Appt given. Dx cellulitis 5 cm x 5 cm erythema, DURICEF started." "3-5 years" "3-5" "555481-1" "555481-1" "Area where pt received vaccine was red, hot, blotchy and itchy. Pt was put on oral antibiotics." "3-5 years" "3-5" "557365-1" "557365-1" "Mom went to put in car seat and child went limp, brought back inside Health Dept, child pale, awake, feet elevated, B/P 80/58, ambulance called to check out child. Color improved when ambulance arrived. Evaluated child, did not go to hospital, will follow-up with pediatrician today." "3-5 years" "3-5" "557801-1" "557801-1" "Pt returned on 10/03/2014 with right arm hot, red and swollen." "3-5 years" "3-5" "557806-1" "557806-1" "Father was securing pt on lap during vaccine administration when pt freed arm and swatted at needle during shot. Injection was completed but as withdrawing needle pt hit hand near needle causing a scratch at injection site. Immediately made dad aware and show him what had happened and he was aware. Pt showed no adverse reaction during or after shot was given. Cleared to leave." "6-17 years" "6-17" "517600-1" "517600-1" "Hives, itching, sharp bumps, stinging. Treatment = BENADRYL, hydrocortisone cream. Notified our office on 12/17/13." "6-17 years" "6-17" "517850-1" "517850-1" "After receiving 4 vaccinations client vomited and had multiple syncopal episodes." "6-17 years" "6-17" "519059-1" "519059-1" "Nausae and vomiting symptoms morning following influenza vaccination." "6-17 years" "6-17" "519748-1" "519748-1" "A 3 inch area around injection site is very swollen, reddish and has a rash. Was given diphenhydramine HCI 25mg at 11:00 pm." "6-17 years" "6-17" "520012-1" "520012-1" "Left knee swelling ? reactive effusion." "6-17 years" "6-17" "520438-1" "520438-1" ""HPV given, after observing for 15 minutes. Pt got off exam table, walked out exam room door and complained of being ""a little dizzy"". Taken back into exam room. Lay back VS taken x 2. Dr examined pt."" "6-17 years" "6-17" "520494-1" "520494-1" "Influenza vaccination at 9:30 am. Patient noticed erythema and pain at noon (R) deltoid. Patient evaluated at 3 pm. He was noted to have a 9 cm x 6.5 cm of erythema and mild edema consistent with a local skin rxn. Pt was given 25 mg BENADRYL PO and a cool compress applied. VSS. Pt encouraged to monitor for worsening rxn, take OTC ZYRTEC and f/u dr needed." "6-17 years" "6-17" "520992-1" "520992-1" "Rec'd 0.5 Quad. flu injection at office 1/22/14. S/S began 1/23/14; seen in office for (+) light pink erythema area 12-15 cm and (+) pruritus at site. Afebrile. ((+) warmth to touch). Tx with ice packs, BENADRYL and to c/ office if fever or other s/s occur." "6-17 years" "6-17" "521200-1" "521200-1" "Child was given Adacel and Menveo in left deltoid IM and Fluarix and Gardasil in right deltoid IM, in that order. Immediately following the last vaccine administration she showed no change in affect. About 1 min following last vaccine admin she stated she had a headache. Shortly after that she began to appear increasingly lethargic and stated she was hot. She did not ever completely become non-responsive but became very drowsy, pale and listless. She was consistently able to answer questions correctly through entire episode. Over about 10 minutes time she would become more and less near syncopal but never completely lost consciousness. After about 10 min she begin to recover and did not relapse. She did continue to c/o headache." "6-17 years" "6-17" "521325-1" "521325-1" "MOTHER VOICES PATIENT NOTED WITH LARGE HIVE TO HAND AND UPON FURTHER ASSESSMENT NOTED HIVES TO BACK AND BILATERAL POSTERIOR LEGS. MOTHER DOSED CHILD WITH BENADRYL PO. APPROXIMATELY 1 HOUR LATER HIVES HAD DISAPPERED." "6-17 years" "6-17" "521749-1" "521749-1" ""Developed large red, swollen area approximately 4"" diam distal of injection site on arm."" "6-17 years" "6-17" "522020-1" "522020-1" "Child began to have erythema at injection site with rash noted by mother around 9:00PM on 2/4/2014. Mother brough child to the office at 1:00PM on 2/5/2014. Child had nodule noted under injection site on outer left deltoid. Left arm also had erythema present at the injection site and extended approximate 3 inches below the injection site." "6-17 years" "6-17" "522051-1" "522051-1" "Client had vasovagal response after vaccines were given which lasted a few seconds. 5-10 minutes later developed itchy red rash on arms, legs, and torso. Given 50mg BENADRYL by mouth observed client for 45 minutes. Rash resolved, no respiratory problems." "6-17 years" "6-17" "522310-1" "522310-1" ""Mother reports child's right arm became red and swollen approx 3"" diameter area on the day after injection - 2/8/14. Today (R) arm is nontender and no redness or swelling noted."" "6-17 years" "6-17" "522995-1" "522995-1" "PATIENT WAS SEEN IN THE CLINIC TODAY FOR CONSULTATION RELATED TO MENSTRUAL PERIOD FOR 2 MONTHS. MENSTRUAL PERIOD EVERY DAY FOR 2 MONTHS. SOMETIMES BLEEDING IS HEAVY REQUIRING 4 TO 5 PADS IN ONE DAY. SHE HAS FELT TIRED RECENTLY AND GETS SHORT OF BREATH RAPIDLY. PATIENT STATES THE SYMPOTMS WERE OF ACUTE ONSET. SHE INITIALLY WAS AWARE OF A PROBLEM APPROXIMATELY 1 MONTH AGO." "6-17 years" "6-17" "524744-1" "524744-1" "Patient with swelling, redness and tenderness to entire left deltoid area." "6-17 years" "6-17" "525575-1" "525575-1" "Erythematous, tender, warm area on (L) arm lower vaccine (9 x 4.5 cm) (PPV23) site of onset 12 hrs after injection; promptly resolved within 36 hrs upon onset of Prednisone." "6-17 years" "6-17" "530718-1" "530718-1" "Patient developed syncope episode immediately following administration of his immunization and while being prepared for blood drawing. Pt has a hx of syncope during blood drawings." "6-17 years" "6-17" "531367-1" "531367-1" "Pt had 9:30 AM appt, reports during sleep that night after 12:00 AM woke up with swollen upper lip and rash around jaw line. Denies any tongue, throat, or orbital edema. H/o seasonal allergies. Mom reports provided BENADRYL and symptoms resolved w/o sequelae. Pt. lives in shelter system. PPD administered same day, left forearm." "6-17 years" "6-17" "541400-1" "541400-1" "Left upper arm pain, redness, and swelling with progression down to elbow and underside of upper arm." "6-17 years" "6-17" "541789-1" "541789-1" "5 hours after flu injection, pt complained of headache. 2 hours later pt vomited x1. 15 min later pt. vomited again. Pt. immediately felt better afterwards. Pt is now fine." "6-17 years" "6-17" "541945-1" "541945-1" "Severe swelling with redness over most of left upper arm from shoulder to elbow. Warm to the touch & painful. Child did not alert mother to situation until late in the evening 8/26 & mother took child to ER where child was given an antibiotic & pain medication prescriptions." "6-17 years" "6-17" "542990-1" "542990-1" "Swollen, itchy a few hours after administration. Hydrocortisone and cetirizine." "6-17 years" "6-17" "543606-1" "543606-1" "Patient developed a bruise the took over her upper arm, starting at the site of injection." "6-17 years" "6-17" "543647-1" "543647-1" "Significant right arm redness swelling from injection sight inferior to just above elbow and extending superiorly to right shoulder, also next day developed right sided facial swelling. pt also developed fever. Fever lasted for less than 24 hours. Face swelling improved after less than 24 hours. Arm swelling also improved in 24 hours." "6-17 years" "6-17" "544750-1" "544750-1" "Reports injection site redness and swelling. Tender to the touch. Seen at urgent care 9/21/14 was treated with BACTRIM and MEDROL dose pak. 9/22/14 follow up for symptoms. (Symptoms improved today)." "6-17 years" "6-17" "545001-1" "545001-1" "Described as extreme upper lip swelling." "6-17 years" "6-17" "545338-1" "545338-1" "Dusky erythematous macular papular lesions at (B) lower legs." "6-17 years" "6-17" "545353-1" "545353-1" "Flu shot was administered in the tricep area intramuscularly broke out a large reaction from elbow all the way up to back of deltoid. MD rxed AUGMENTIN for reaction/infection." "6-17 years" "6-17" "545841-1" "545841-1" "Swelling of upper arm with erythema extending to upper 3rd of left arm with itching. (Local reaction). No fever." "6-17 years" "6-17" "545846-1" "545846-1" ""Pt received MENACTRA, flu and GARDASIL on 9-23-14. Mom states she woke in the night at 10:00 pm on 9-23-14 with red dots on her trunk and woke in the middle of the night with body aches and felt hot to the touch. Felt ""weak"", dizzy with malaise. Wheezing (per pt) on Wed. night rx with VENTOLIN."" "6-17 years" "6-17" "546493-1" "546493-1" "Started HPV series in December within one month developed amenorrhea and eating disorder, unclear if related." "6-17 years" "6-17" "546531-1" "546531-1" "Woke at 12 AM with cold sweats, dizziness, 101 fever, nausea, body aches, headache. Treated with fluids and 500 mg of Tylenol for fever/symptoms. Fever and symptoms sustained through 10/5/2014." "6-17 years" "6-17" "547084-1" "547084-1" "Pt received flu shot here and per mom within 15 minutes had 7 focal seizures in a row. Mom took pt to our local pediatric minor care and per them pt was hospitalized. Pt does have a history of convulsions but has received a flu vaccine every year per our records, did receive Flumist last year." "6-17 years" "6-17" "547401-1" "547401-1" "Shortness of breath, dizziness, fever, redness, swelling, warmth at injection site, fasciitis over left deltoid muscle, early myositis" "6-17 years" "6-17" "547564-1" "547564-1" "Within 5 min of administration to (R) glut (Quadrivalent IM Flu), pt c/o feeling dizzy. Seated pt - c/o stomach ache, then vomited. (+) pale -> recovered, VSS after 25-30 min. Sips of water." "6-17 years" "6-17" "547614-1" "547614-1" "Patient received his Hepatitis A vaccine then fainted after receiving his influenza injection. He has never fainted before. He did not eat breakfast this morning." "6-17 years" "6-17" "547678-1" "547678-1" "15x12 cm area of redness on his right thigh. Zyrtec and Benadryl for itching." "6-17 years" "6-17" "548055-1" "548055-1" ""Diaphoretic, trembled, stated, ""vision spotty"". Did not lose consciousness."" "6-17 years" "6-17" "548077-1" "548077-1" "PATIENT DEVELOPED VERY ITCHY URTICARIA - SMALL BUMPS BEHIND HIS ARMS, ON HIS BACK, TORSO, CHEEKS." "6-17 years" "6-17" "548160-1" "548160-1" "Fever 101 for 24 hrs, headache, sore throat, nausea, pain at injection site with swelling moderate spasms of arm vaccine given in." "6-17 years" "6-17" "548420-1" "548420-1" "Swollen, red, and warm to the touch. Patients PCP advised patient to take Benadryl and Motrin." "6-17 years" "6-17" "548472-1" "548472-1" "Hives, Tx: Claritin PRN per MD order." "6-17 years" "6-17" "548555-1" "548555-1" "Erythematous induration on the left deltoid area with tenderness distinct margins no axillary lymph node involvement no fever - no vomiting no respiratory distress. Treated with 10 day course of AUGMENTIN orally." "6-17 years" "6-17" "548580-1" "548580-1" "Child left vaccination area and according to other classmates passed out and hit the back of her head. Child was conscious after falling but didn't remember what happened. School nurse administered concussion testing (negative), parents notified and child returned to class." "6-17 years" "6-17" "548584-1" "548584-1" "Right arm swelling approx 45 minutes after vaccination of influenza and menveo. Ice applied to right deltoid area." "6-17 years" "6-17" "548926-1" "548926-1" "Presented with large area (about the size of an orange) of redness and swelling around injection sight of where the flu vaccine was injected." "6-17 years" "6-17" "548999-1" "548999-1" "Syncope. Patient fainted at the check-out counter. She was with her mother. She gained consciousness right away. She stayed for 15 minutes then walked out with her mother." "6-17 years" "6-17" "549019-1" "549019-1" "Patient developed acute ataxia, which was treated with Benadryl and one dose of Decadron. Symptoms resolved within 24 hours." "6-17 years" "6-17" "549040-1" "549040-1" "10/18- QUARTER SIZE REDNESS AND SWELLING ON BACK OF RIGHT ARM. 10/19 AND 10/20- REDNESS AND SWELLING CONTINUED TO GROW IN SIZE TO ABOUT 7 CM X 7CM IN DIAMETER. PT ALSO REPORTED ITCHING AND WARMTH AT SITE ON THESE DAYS." "6-17 years" "6-17" "549061-1" "549061-1" ""After receiving injection patient stated ""I feel dizzy"" lost consciousness for 30 seconds had seizure like movements stiffening of arms and legs and jerking motion, color pale, blue around lips transported to hospital."" "6-17 years" "6-17" "549075-1" "549075-1" "Pt was given adult dose Hepatitis A vaccine instead of peds/adolescent dose." "6-17 years" "6-17" "549116-1" "549116-1" "Leg pain, weakness." "6-17 years" "6-17" "549136-1" "549136-1" "Red with a sm bruise under injection site, with a raised area." "6-17 years" "6-17" "549158-1" "549158-1" "Syncope." "6-17 years" "6-17" "549228-1" "549228-1" "Received lower dose than recommended by manufacturer." "6-17 years" "6-17" "549239-1" "549239-1" "Left upper arm with erythema, warmth, induration, and minimal tenderness between deltoid and just above elbow consuming 25% of the arm's circumferance." "6-17 years" "6-17" "549246-1" "549246-1" "SWELLING, REDNESS, TENDERNESS, HEAT WELL BEYOND INJECTION SITE, ITCHING." "6-17 years" "6-17" "549411-1" "549411-1" "MCV4 and flu vaccines administered on 10-21-14 and patient started with redness, swelling and pain to injection site within 24 hrs." "6-17 years" "6-17" "549439-1" "549439-1" "Headache, body aches, shaking reported 10/23/14 AM, has not sought further treatment." "6-17 years" "6-17" "549604-1" "549604-1" "Bronchospasm, dizziness, flushing (required 2 albuterol and oral steroids). Placed on 5 days oral steroids afterwards." "6-17 years" "6-17" "549721-1" "549721-1" "Patient received flu shot on the morning of 10/13/14 and called our office on the evening of 10/14/14 after noting an area of erythema and induration on vaccine site. No fever or streaking but arm felt warm at time of discovery and affected arm was painful earlier in the day. She presented in the office the morning of 10/15 and her mother noted the area of erythema had gotten larger. Measured during the visit to be 9cm by 9cm and 6cm at narrowest portion. Warm to touch with no motor deficits or edema of LUE." "6-17 years" "6-17" "549833-1" "549833-1" "Slight redness at injection site. Swelling at injection site about the size of a lemon. Itchiness and puffiness underneath eyes. Vaccine administered 10/21/14 to right arm." "6-17 years" "6-17" "549935-1" "549935-1" "Fever 101 initially with nausea, severe headache, muscle pain. Fever elevated to 103 with chills on 10/18/14 with tennis ball sized reddened, raised, hot to touch. Treated with anti fever medications. 10/19/14 continued with fever up to 103, chills, headache, muscle aches. 10/20/14 to 10/23/14 some improvement in symptoms, but continues with chills, fatigue, headache, and muscle pain. unable to attend school. Flu vaccine was given on same day. Reddened area was to site of Pneumovax 23." "6-17 years" "6-17" "550075-1" "550075-1" "Redness and swelling of left arm; treated with cephalexin." "6-17 years" "6-17" "550103-1" "550103-1" "Some erythema around the injection site. He had no difficulty breathing. Patient did take some Benadryl last night. Also put some ice. This morning there was some more redness. He had a history of asthma. He never had any difficulty of breathing. He is not having much itching. Due to the fact that the erythema is a little bit more than yesterday, he was brought to the clinic. Again, no difficulty breathing, not much itching." "6-17 years" "6-17" "550195-1" "550195-1" "Patient received FLUARIX vaccine on 10/22/2014 at 4pm. By evening he began to have a red spot. Mom felt it was normal. Within 24 hours he had LARGE swelling, redness, warmth/blistering 17mm x 15mm." "6-17 years" "6-17" "550228-1" "550228-1" "Sweaty, felt faint." "6-17 years" "6-17" "550275-1" "550275-1" "Pt was given Flu vaccine in (L) deltoid on 10/9/14. On 10/11/14 went to ER was dx with cellulitis of (L) arm." "6-17 years" "6-17" "550541-1" "550541-1" "Approx 48 hours after admiin of FLUZONE vaccine, pt reported to ED with left deltoid redness, edema and blisters." "6-17 years" "6-17" "550645-1" "550645-1" "Complaints of warm, red and tight arm from slightly below shoulder to elbow. No itchiness or draining. Advised to use cool compress, Advil or Tylenol for discomfort and to check temperature of patient." "6-17 years" "6-17" "550776-1" "550776-1" "Received vaccine to left deltoid, developed immediate pain at injection site greater than typical for vaccines, then developed sudden blurred vision, lethargy, nausea, abdominal pain, chills, then fever to 100 degrees." "6-17 years" "6-17" "550796-1" "550796-1" "None stated." "6-17 years" "6-17" "550950-1" "550950-1" """"PIMPLE LOOKING"" ROUND AREAS ON FACE, TRUNK AREA WITH ITCHING."" "6-17 years" "6-17" "551190-1" "551190-1" "Rash developed on legs, arms, face. Redness, swelling and warmth around the eyebrows, nose and ears. Pt. medicated with po Benadryl in the clinic and observed." "6-17 years" "6-17" "551236-1" "551236-1" "GI illness nausea/vomiting started 10/3/14. Continued for 24 hrs. On 10/4/14 visiual disturbances and gait issues and headache. To ER, dx viral illness continued with symptoms Oct 4 and OCt 5. To clinic Monday the 6th. Concerned possible brain tumor, to another medical center and had MRI and CT done. Transferred to another facility, lumbar puncture and labs done ro meninigis and enterovirus. Ataxia and dipolpia continued 2 doses Immunoglobulin given." "6-17 years" "6-17" "551268-1" "551268-1" "Given decreased dose than recommended by manufacturer." "6-17 years" "6-17" "551284-1" "551284-1" ""Pt received flu vaccine, following day reported HA, weakness, ""falling down"" x 4 but no syncope or seizure."" "6-17 years" "6-17" "551299-1" "551299-1" "Given decreased dose than recommended by manufacturer." "6-17 years" "6-17" "551362-1" "551362-1" "Mom reports raised red area/rash and spreading on Saturday AM, Zyrtec taken. Sunday no rash noted, Monday 10/13/14 noted area slight reddness and raised rash, c/o of itchiness, but decreased throughout the day." "6-17 years" "6-17" "551472-1" "551472-1" "Given decreased dose than recommended by manufacturer" "6-17 years" "6-17" "551482-1" "551482-1" "Patient was given flu vaccine 10/16/14 waited 30 min with no reaction. Mom states overnight he broke out in a rash, had swelling of face, and injection site was red, sore to touch. (1st time for non-preserv. free). Hives, localized erythema. Has egg allergy but has had flu vaccine before 2012, 2013." "6-17 years" "6-17" "551511-1" "551511-1" "Left arm swollen and red. Shoulder edge to 2/3 lower lateral (L) upperarm. No nodes" "6-17 years" "6-17" "551548-1" "551548-1" "Within 2 hours of receiving vaccination, arm and hand became swollen. Hand reddish/purple. Went to school nurse. Color has since resolved, current complaint includes pain from shoulder to fingers. She can move her fingers. 10/22/14 Mom states patient had hives last night that responded to BENADRYL. Today arm is still swollen and warm." "6-17 years" "6-17" "551823-1" "551823-1" "Patient passed out after standing up and chipped two front teeth as a result." "6-17 years" "6-17" "551868-1" "551868-1" "Headache, extreme fatigue, fever, weakness, dizziness, loss of appetite, numbness of face, body aches. Treatment per ED visit- Prednisone 40mg x 4 days, steroid shot, Benadryl 25mg every 6 hours." "6-17 years" "6-17" "551947-1" "551947-1" "11-3-14 mom noticed pt left deltoid was red, swollen, itching, pain when scratching, warm to touch." "6-17 years" "6-17" "551948-1" "551948-1" "Mother reports symptoms started following day x 5 days; nausea, fatigue, loss of appetite, back pain." "6-17 years" "6-17" "551986-1" "551986-1" "10/31/14 came back into office c/o redness and pain at site on (R) arm. 11 x 6 cm erythematous patch. No bleeding or oozing. Skin warm and tenderness at palpation. Cellulitis vs reaction to vaccine advised to take BENADRYL for itching and Ibuprofen for pain. Started clindamycin HCl 300mg." "6-17 years" "6-17" "552019-1" "552019-1" "Red, hard, warm to touch and painful per pt on right thigh." "6-17 years" "6-17" "552024-1" "552024-1" "Within 5 minutes of administration of flu vaccine, patient complained of loss of vision. Patient fainted but was grabbed by mother so he didn't fall. Patient was pale, diaphoretic and sporadically unresponsive. After 45 minutes of laying flat and drinking fluids, patient recovered." "6-17 years" "6-17" "552135-1" "552135-1" "Hives, rash -> stomach, arms. Wheezing. Started about 630pm 10-14-14. BENADRYL 25mg 630pm -> to ER. Recieved epinephrine and BENADRYL 25 mg PO." "6-17 years" "6-17" "552523-1" "552523-1" "PAIN IN RIGHT ARM AND ITCHING. INCREASED PAIN AND SWELLING." "6-17 years" "6-17" "552576-1" "552576-1" "Patient's face appeared swollen (especially in cheeks) and red. Complained of feeling ill and throat pain 5 minutes after vaccination. She was evaluated by Dr. Dose of BENADRYL given in office. Vitals taken and monitored, were within normal limits. Patient and mother given teaching on EPIPEN Jr and received Rx for EPIPEN Jr. Patient was in office for 1 hour, left in good condition feeling well. Last set of vitals was BP 97/63, HR 84, RR 20." "6-17 years" "6-17" "552625-1" "552625-1" "Large (approximately softball size) red area, swollen and itchy at the injection site. Today 11/07/2014, red area slightly bigger, but not as bright red, and still itchy per mom." "6-17 years" "6-17" "552780-1" "552780-1" "After administration, patient stood up, and started walking away. Got 3 steps away, told mom that he couldn't see. Pharmacist immediately helped mom get patient over to bench. Quickly patient's coloring turned pallor, breathing abruptly slowed. Very shallow and difficulty breathing. Eyes rolled back in head. Sweat through entire shirt. Pharmacist used EpiPen JR to right thigh (Lot number4GN349, Exp 12/15). Called 911. Over the next 10 min, breathing returned, vision returned, ability to talk returned. Paramedics came and walked next to patient and mom." "6-17 years" "6-17" "552831-1" "552831-1" "Mother states 3 hours after flu vaccine, fever, shaking - calmed by Tytra blanket, dry heaves, tired/weak, still eating, walking normally." "6-17 years" "6-17" "552868-1" "552868-1" "Seen by PCP: Swollen, red injection site." "6-17 years" "6-17" "553519-1" "553519-1" "1:55 pt weak, dizzy, diaphoresis, pallor. 1:56 VSS, lie down - laying down 25 min all Sx resolved." "6-17 years" "6-17" "553580-1" "553580-1" "Left arm with large red raised lesion measuring approximately 11 cm x 12 cm. Tender, itchy. Has tried Benadryl cream with relief, Tylenol for tenderness." "6-17 years" "6-17" "553637-1" "553637-1" "Received HPV #2, Flu shot, MCV, fainted 2mins after administration, became stiff, eyed rolled back, didn't respond to verbal questions. She was assisted to the floor, became responsive after two mins, stated she felt she was out for an hour." "6-17 years" "6-17" "553740-1" "553740-1" "Left armpit/axillae swelling. No redness or warmth. Treatment: symptomatic." "6-17 years" "6-17" "553868-1" "553868-1" "Started with fever and vomting within 24 hours of getting vaccine and then started with sore throat. At 48 hours, temp 102.6 fever did not resolve until 10/21/14." "6-17 years" "6-17" "553932-1" "553932-1" "ITCHING, REDNESS AND SWELLING AT INJECTION SITRE STARTING 11/6/2014." "6-17 years" "6-17" "554084-1" "554084-1" "Patient reported a fever on 11/09/2014 and presented to physicians office on 11/10/2014 with a rash that was diagnosed as chicken pox to which the patient has not been vaccinated against per the mother." "6-17 years" "6-17" "554350-1" "554350-1" "Shortly after receiving the flu vaccine, she began having shooting pains in her arms, swelling around her eyes and abdominal pain." "6-17 years" "6-17" "554412-1" "554412-1" "Tdap vaccination date due 11-21-14. Given 11-12-14. Pt had no adverse reaction no treatment needed." "6-17 years" "6-17" "554967-1" "554967-1" "Left arm induration, red and warm to the touch. Instructed to give patient Benadryl and put cold packs." "6-17 years" "6-17" "555110-1" "555110-1" "Approximately 4-5 minutes post flu injection, patient became faint and stumbled into table. His mother caught him and helped him into a chair. Nurse provided ice pack to place on the back of his neck. Patient also layed down on a couch in the office. Patient's BP was 100/56. After approximately 20 minutes, patient drank some lemonade, regained the color in his face, and said he felt better. 2 days later, patient's mother reported to the writer that patient was lethargic and light-headed for the rest of the evening on the date of the injection but was fine the next day." "6-17 years" "6-17" "555193-1" "555193-1" "Sore throat, malaise, fatigue." "6-17 years" "6-17" "555297-1" "555297-1" "Local injection site reaction - redness, swelling, discomfort. Treated with cool compress and BENADRYL." "6-17 years" "6-17" "555630-1" "555630-1" "None stated." "6-17 years" "6-17" "555783-1" "555783-1" "Pt stated arm (L) was sore to where unable to sleep at noc on 11/24/14. Noticed today-11/25/14-that arm was red and swollen, and came straight to doctor office. Left arm 18x14cm induration and tenderness w/erythema 18x18xm. Denied n/v/d, fever, or any other symptoms. Rx'd-sml-tmp DS tablet x 10 day, abx cream daily." "6-17 years" "6-17" "555914-1" "555914-1" "Significant facial swelling less than 24 hours after vaccine given. Tx with epinephrine 1:1000/ml 0/4 ml. Prednisone 30 mg po and ZYRTEC 10mg po. Transferred to ER." "6-17 years" "6-17" "555919-1" "555919-1" "Pt was seen out of the provider's peripheral vision to start falling to the floor (vaccine was given while seated about 5 minutes previously). Pt was then seen on floor with seizure-like movements of head and upper limbs for 5-10 seconds. It is possible the patient struck his head when falling against fire extinguisher on the wall or the wall itself. Pt regained consciousness with no memory of event. Felt ill. Given 50mg Benadryl PO in case of allergic rxn. Had headache immediately after fall and felt nauseated but no vomiting. Vital signs were within normal limits following incident. Rescue was called and transported pt to hospital ER." "6-17 years" "6-17" "556292-1" "556292-1" "Mother called mid morning that patient was cool and diaphoretic. Went to ED found to have worsening heart failure. Admitted to PICU 10/17/14, CXR with pneumonia, respiratory virus panel neg x 2, placed on ECMO 10/19/14. Patient died 11/16/14 of heart failure while on ECMO." "6-17 years" "6-17" "556384-1" "556384-1" "Got sore throat and upper respiratory infection the day after vaccination, he ended up with bronchitis treated with amoxicillin and steroids in hospital, then diagnosed with serum syndrome. Still in hospital as of 10/2/14." "6-17 years" "6-17" "556817-1" "556817-1" "Erythema, edema at site of injection measuring 20 x 12 cm." "6-17 years" "6-17" "557400-1" "557400-1" "Pt. started fever, body ache and pain on urination and blood in the urine on 11/13/14. Pt. was seen at ER on 11/13/14 night and was admitted at hospital from 11/14/14-11/16/14. Pt. is still being followed up by Nephrologist. Pt. still has blood in the urine and now has bleeding from the nose - started on 12/6/2014." "6-17 years" "6-17" "557754-1" "557754-1" "Pt recieved 2 vaccinations. About 5 minutes later pt. felt sweaty and queasy. Walked across room to desk and passed out. Struck L side of head above L ear. Pt observed until 11:35 AM when pt. vomited and passed out again. Pt. sent to Hospital for further evaluation." "6-17 years" "6-17" "557989-1" "557989-1" "Patient came in with hives. One at injection site and multiple all over body. Given BENADRYL in office, treated with prednisolone and ranitidine for hives." "18-29 years" "18-29" "517064-1" "517064-1" "Burning feeling at site of injection at right deltoid, going down arm to hand, with tingling of hand. Rash noted 8 hours later from site of injection down to mid forearm; it looked like hives." "18-29 years" "18-29" "519444-1" "519444-1" "Pt received flu shot for the 1st time - no Hx of any allergies. After 5 min - pt almost passed out - looked very pale. Both extremities (hands) were red and cold - she felt hot on the skin, but felt dizzy - BP was very low - almost had syncope." "18-29 years" "18-29" "519762-1" "519762-1" "Severe stomach cramps, diarrhea, sweating, chills." "18-29 years" "18-29" "520010-1" "520010-1" "All normal." "18-29 years" "18-29" "520982-1" "520982-1" "None stated." "18-29 years" "18-29" "522975-1" "522975-1" "Itching all over body, numbness in lips, throat closing." "18-29 years" "18-29" "523085-1" "523085-1" "After flu shot was given, patient said he felt dizzy then fell off the chair unconscious. Patient was responsive after about 1 min. 911 team came and did further assessment. The emergency response team said he was ok and no further treatment was given." "18-29 years" "18-29" "525628-1" "525628-1" "Hives, wheezing, swelling of tongue and lips, all occurred within about 5 minutes of receiving vaccine (I am not sure what time his vaccine actually was, his appointment was at 3.45 pm). His pediatrician gave him a large dose of Benadryl. His pediatrician and an allergist confirmed that this was an anaphylactic reaction. We followed up with an intradermal skin test with an allergist today and he had a definitive reaction to Fluzone lot #UH953AB. He has had this vaccine at least 10 times before and has never had any trouble with this or any other vaccine." "18-29 years" "18-29" "526242-1" "526242-1" ""Diarrhea, headache, ""eyes feel puffy"" (though no visible swelling), fever of 100.0F, tired, generalized aches, stomach pain, nausea without vomiting, stiff neck, slight photophobia."" "18-29 years" "18-29" "528468-1" "528468-1" "Gave pt flu shot, walked out of immunizing room and was talking to her then she staggered and started to fall to floor. I caught her and carefully laid her down and got her talking and had her rest." "18-29 years" "18-29" "528668-1" "528668-1" "Patient began feeling hot and weak a couple minutes after vaccine was administered. EMS were called and while we waited her blood pressure was checked. It was 106/85." "18-29 years" "18-29" "530454-1" "530454-1" "Pain at Right armpit and R shoulder not controlled with 400 MG advil x 1 dose. Pain began in the evening and had continued the next day. Pain rated 6 on a 1-10 scale on 5-7-14 at 10:45 AM." "18-29 years" "18-29" "540851-1" "540851-1" "Pt states he passed out 1-2 min after inj. Clinician and doc were not in room at the time. Vitals, EKG, and doctor eval were done. Pt also given crackers and water as he stated he had not had lunch." "18-29 years" "18-29" "541838-1" "541838-1" "Patient received her a flu vaccine in the left deltoid area. After receiving the flu vaccine patient complained of an extreme sharp pain in her arm at the area of injection. Then later felt nerve related pain in her arm that traveled through her upper back/neck then eventually to the opposite arm. Her pain later turned to numbness in both arms and neck and has remained for 1 week with accompanying muscle spasms and numbness from left to right side of her upper back. No specific error in injection technique was described by either the intern or the patient during the administration of the flu vaccine." "18-29 years" "18-29" "541899-1" "541899-1" "Burning during injection, injection arm burning throughout day until reported, vomiting, tremor, pale, heavy but NOT difficult breathing." "18-29 years" "18-29" "542151-1" "542151-1" "DIZZINESS; NAUSEA; FEVERISH FEELING (TEMP NOT MEASURED); MINOR DIARRHEA; ONSET OF MIGRAINE HEADACHE, MINOR VISION DISTURBANCES." "18-29 years" "18-29" "542398-1" "542398-1" "Received annual influenza vaccine in L deltoid in the morning and by evening reported that she began to have tenderness and pain to L axilla that has progressively gotten worse." "18-29 years" "18-29" "542700-1" "542700-1" ""Recieved the flu vaccine on 09/03/14 and then noticed rash to chest and upper abdomen upon awakening on 09/05/14. Also reports ""achiness"" to upper chest and upper back area. Relates feels like she was running a fever but was noted afebrile."" "18-29 years" "18-29" "542726-1" "542726-1" "Localized redness and itching; tightness of the chest;" "18-29 years" "18-29" "542972-1" "542972-1" "Patient experienced swelling/pain in arm where injection occurred. Presented at hospital and received antibiotics." "18-29 years" "18-29" "543050-1" "543050-1" "Hive, burning, itching, redness, warmth in L arm from site of injection (L Deltoid) to L FA." "18-29 years" "18-29" "543435-1" "543435-1" "Patient received Fluarix vaccine at 5:10 PM. She stayed seated in vaccination area for 15 minutes and did not experience any initial adverse effects. Patient left the store and came back within 1-2 minutes and stated that she was experiencing numbness of her entire left arm in which vaccine was administered. She also was experiencing tightness in her throat, facial flushing, dizziness, shortness of breath, and involuntary tears from both eyes. I, the intern who adminstered the vaccine, immediately knew she was having an anaphylactic reaction. I immediately notified the pharmacist in charge and the pharmacy technician called 911. Epipen (adult dose) was administered to the patient within a minute of identifying anaphylactic reaction. Paramedics arrived shortly after and administered IV Benadryl 25 mg and took patient to the ER." "18-29 years" "18-29" "544515-1" "544515-1" "Bump on left arm, pink around site and warm to touch." "18-29 years" "18-29" "544662-1" "544662-1" "Swelling, redness, pain." "18-29 years" "18-29" "544691-1" "544691-1" "Body aches." "18-29 years" "18-29" "544759-1" "544759-1" "Left shoulder pain that radiated to her anterior neck. Patient states that it was sharp and burning. She was treated with Ibuprofen 600 mg three times daily and instructed to put ice on the area of discomfort three times a day." "18-29 years" "18-29" "544805-1" "544805-1" "R- arm/neck (R-side) stabbing pain and unable to grip anything with R-hand. Fingers went numb and tingly." "18-29 years" "18-29" "545022-1" "545022-1" "2 cm right axillary node noted by nurse practitioner who saw pt for physical for EMT class. No fever." "18-29 years" "18-29" "545023-1" "545023-1" "The day after immunization pt noted new pea sized left supraclavicular node on same side as flu shot the day before--verified on exam by nurse practitioner during a physical for EMT class 9/15/14. No fever." "18-29 years" "18-29" "545033-1" "545033-1" "Painful at time of injection - (Hasn't happened with previous flu vaccines). The next day she felt faint and almost passed out. It lasted about 15 min. splashed cold water on face and rested until feeling went away. Upper legs hurt and nausea. Severe pain." "18-29 years" "18-29" "545113-1" "545113-1" "Redness and swelling at injection site." "18-29 years" "18-29" "545195-1" "545195-1" "Red welt appoximately 2 inches wide. Warm to touch and painful to touch." "18-29 years" "18-29" "545328-1" "545328-1" "Redness and soreness on 9/22/14. Awoke on 9/23/14 was hot, swollen, and little itchy. Showed nurses 9/23/14 afternoon. Put ice pack to site and soaked in bath 9/23/14 evening. On 9/24/14, redness decreased and more itchy. Nurse measured 93mm hard induration at injection site on 9/23/14 at 14:40." "18-29 years" "18-29" "545392-1" "545392-1" "Dime size area surrounding injection site in which skin peeled off with burning and itching." "18-29 years" "18-29" "546049-1" "546049-1" ""Patient said that 2 hours after administration of vaccine had itchiness at area of injection (left arm). Took Allegra Monday night. Tuesday a.m. itchiness was now starting on right arm as well, and more profound, as well as ""small round pimple-like dermatitis"" from wrist to shoulder apparent on BOTH arms. Took Allegra again. By Wed a.m. itchiness partially had gone down, but rash was there."" "18-29 years" "18-29" "546065-1" "546065-1" "Patient collapsed to the floor and appeared to be in a seizure-like state (rigid arms and body, glazed eyes and unresponsive to verbal stimulus) at 6PM. State lasted approximately 3 to 5 minutes. Patient was confused when first coming out of seizure-like state and slowly over approximately 30 minutes regained cognition and was able to answer specific questions correctly. Patient was evaluated by EMS at pharmacy and refused to be taken to the emergency department for further evaluation." "18-29 years" "18-29" "546177-1" "546177-1" "Whole arm swollen after carrying child. Red, hard, hot from injection site to fingers (L) arm. Pt treated with ice and 400 mg MOTRIN PO, reaction resolved in approximately 15 min." "18-29 years" "18-29" "546245-1" "546245-1" "Patient states that friends and acquaintances told her that her face appeared swollen, patient states it was. By evening hours 10/01/2014 patient states she noted itchy rash to neck, and chest which has spread to body." "18-29 years" "18-29" "546454-1" "546454-1" "Rash on chest." "18-29 years" "18-29" "546576-1" "546576-1" "10/02/14 Received a call from patient's mother, that patient had received her flu vaccine on 9/20/14 and on Wednesday evening she had a 4 inch welt on her arm that was warm to touch, swollen, and painful to the touch and she had itchy eyes. Mom says they had applied warm compress's to her arm and the swelling has gone down, still some redness. She is wondering if this should be documented as a reaction, and maybe get FLUMIST in the future. She will have her continue to do warm compresses's and she is picking up BENADRYL for her as well. Any other recommendations, please advise, thanks." "18-29 years" "18-29" "546586-1" "546586-1" ""Within seconds of the injection she c/o itching and redness at the injection site followed by itching to the face and throat. She was given 50 mg Benadryl PO and a cool cloth was placed at the injection site. Within 5-10 minutes her throat was feeling ""tight"" as if there ""is something in my throat"". She was taken to the ER where she received, NS, Methylprednisolone, Pepsid, and Zofran. She was discharged with prescriptions for Prednisone and Pepcid. On 10/05 she woke up with itching to the face, Benadryl was taken and provided relief. Throughout the day she ran a fever up to 101.5 and intermittent facial itching. The injection site remains swollen with a ""knot"" and bruising."" "18-29 years" "18-29" "546742-1" "546742-1" "Developed almost immediate red, itchy swollen area at injection site. About 1 hour later developed chest tightness and several hours later developed hives. Seen by allergist who completed PFTs and diagnosed immediate type I hypersensitivty reaction. Treated with epinephrine, Ventolin and steroid dose pack." "18-29 years" "18-29" "546855-1" "546855-1" "Shoulder and chest area in lots of pain. Really stiff. Slept for 13 hr. From 4:30pm-6am next morning." "18-29 years" "18-29" "546931-1" "546931-1" "Rash developed on arms and upper chest accompanied by itching." "18-29 years" "18-29" "547080-1" "547080-1" "AFTER ADMINISTERING THE FLU MIST TO THE PATIENT, WITHIN 5 TO 10 MINUTES SHE PRESENTED A SLIGHT REACTION ON RIGHT SIDE OF THE CHEEK AND ON THE UPPER CHEST TOGETHER WITH ITCHING OF THE EYES. NO RESPIRATORY DISTRESS PRESENTED. PATIENT WAS ESCORTED TO PHYSICIAN WHICH AFTER PRESCRIBING PO PREDNISONE AND BENADRYL CLEARED THE PATIENT TO GO HOME FOR THE REMAINDER OF THE DAY. PATIENT WAS INSTRUCTED TO FOLLOW UP NEXT DAY." "18-29 years" "18-29" "547243-1" "547243-1" "10/5/2014 @ 4:34pm pt. called c/o fever & muscle aches onset 18 hours after receiving vaccines. Educated on vaccine reactions. 10/6/2014 @ 8:21am pt. called MD office c/o redness & swelling to injection site of pneumococcal vaccine approx. 5-6 inches in diameter and fever of 102.9 with body aches. Pt going to Urgent Care. At 2:43pm pt calls informing MD in ER and being admitted to hospital." "18-29 years" "18-29" "547322-1" "547322-1" "Patient fainted approximately 5 minutes post flu immunization." "18-29 years" "18-29" "547346-1" "547346-1" "L deltoid site red, hot, arm hurts, may have chills." "18-29 years" "18-29" "547487-1" "547487-1" "Vaccine administered high up on left deltoid. The nurse administering the vaccine met resistance and forcefully injected vaccine. For last two weeks, I have now had pain upon waking and severe pain with movement in my arm greater than 90 degrees. My provider diagnosed shoulder bursitis from the vaccine being administered incorrectly into the bursa. I have had no relief from pain since the administration and will be starting physical therapy this week." "18-29 years" "18-29" "547609-1" "547609-1" "Vomiting and diarrhea (see above). Lost day from work." "18-29 years" "18-29" "547690-1" "547690-1" "First started itching and the next day started hurting. The arm began to swell slightly and by Friday (10/10) it was hot and had a ring around it. It hurt to lift arm." "18-29 years" "18-29" "547696-1" "547696-1" "Localized redness, swelling (around 50mm in diameter), and itching." "18-29 years" "18-29" "547697-1" "547697-1" "Rash/Hives on both arms not relieved by oral Benadryl, that spread to chest and torso by the next day. RPh advised visit to MD for evaluation and possible steroid." "18-29 years" "18-29" "547703-1" "547703-1" "Redness, swelling, and warmth of injection site; vomiting." "18-29 years" "18-29" "547903-1" "547903-1" "Patient started itching and having swelling to her left deltoid approximately 30 minutes after injection. Cold compress was immediately put to area. Patient then started to have continued redness down into L) arm past elbow, down armpit, into L) side of abdomen, up into L) side of neck up into L) side of face and L) ear lobe. Patient was seen at approximately 5:00pm pm by a physician and was told to take prednisone and Zytrec. Patient went home and by 5:45pm patient has swelling in left elbow the size of a baseball. Patient took prednisone 20mg and Zytrec at 5:45pm, continued to have swelling, itching, numbness/tingling and c/o scratchy throat. Patient denied any SOB. Patient continued to have s/s through the night and this am at 10am patient still continues to have itch and golf ball sized edema around injection site." "18-29 years" "18-29" "548184-1" "548184-1" "Pain, nausea, vomiting, chills, weakness and numbness in arm." "18-29 years" "18-29" "548290-1" "548290-1" "Patient returned to nurse 20 minutes post flu vaccination complaining of light-headedness, nausea, and weakness in legs. Vitals taken by nurse - 126/62, Pulse 68 and respiration 20. Patient was oriented x3 and color was good. Patient instructed to sit down, drink water and stay in room with nurse. After 10 minutes, patient ambulated in hallway. Returned and said he was feeling much better." "18-29 years" "18-29" "548625-1" "548625-1" "Coughing, red itchy eyes, shortness of breath, swollen throat, cold/hot flashes." "18-29 years" "18-29" "548761-1" "548761-1" "Severe itching and systemic raised rash." "18-29 years" "18-29" "548798-1" "548798-1" ""Initial information received on 10 October 2014 from a healthcare provider. A 28 year old female patient was vaccinated intramuscularly on 07 October 2014 with Influenza Quadrival A-B Vaccine, batch number UI200AB, into the left deltoid. The patient had received ""TIV"", FLUZONE last year on an unspecified date, batch route and site not reported. The patient denied any illness at the time of vaccination, but has a history of allergies to NSAIDS and bee stings. The patient takes TYLENOL PRN and prenatal vitamins. The patient was not pregnant at the time of the report. On 08 October 2014, at 1:56 pm, the patient presented to the emergency room with abdominal pain, headache, generalized arthralgia, nausea and fever of 101.5F which the patient stated developed 1 hour post vaccination. The patient was treated with 3000 mL's of IV fluids, TYLENOL 1000 mg po, BENADRYL 25 mg po, morphine sulfate 6 mg IV, ZOFRAN 4 mg IV and 4 mg po. The patient was discharged at 6:51 pm with oral ZOFRAN and a diagnosis of viral syndrome. The patient returned to the emergency department on 08 October 2014 at 7:09 pm with the same symptoms along with ""SOB"", shortness of breath, swelling of the right ear to jaw, tingling of tongue and generalized sporadic raised red welts. The patient was treated with SOLU MEDROL 125 mg IV, PEPCID 20 mg IV, Doxycycline 200 mg po, ZOFRAN 4 mg IV and 1000 ml HSS IV. The patient was admitted to the hospital on 08 October 2014 at 11:20 pm with a diagnosis of acute allergic reactions. Laboratory tests were not reported. As of 10 October 2014, the patient remained in the hospital. The patient outcome is unknown. Documents held by sender: None."" "18-29 years" "18-29" "548859-1" "548859-1" "Left arm red post pneumovax 23 immunization, low grade fever, cellulitis left arm." "18-29 years" "18-29" "549105-1" "549105-1" ""Immediately sore at site (0815). By 1:15pm -> numbness down to hand. ""Numb""; ""felt heavy"". 10/8 - ""forearm and hand feel like lifted weights"", no pain at site, no redness or swelling."" "18-29 years" "18-29" "549149-1" "549149-1" ""Initial case received on 10 October 2014 from a consumer who is the patient. A 23 year old female patient with a history of wheat, gluten and latex allergy was vaccinated intramuscularly on 17 September 2014 with Influenza Quadrival A-B vaccine, batch number UI172AA into the left arm. On 09 September 2014, 30 minutes after the vaccination she experienced numbness and tingling in left side of her face and approximately 2 hours later also had numbness and tingling in her left arm. Two hours later it spread to right arm also and by midnight she called the Pharmacist because her entire torso was numb and tingly. She was advised to take two BENADRYL and a TYLENOL. She slept until 4 pm the next day. When she woke up, she had numbness and tingling in her arms and face and her tongue was numb. She was taken by her grandmother to an urgent care facility where she was given epinephrine. Her throat became tight and so she was sent to the emergency department next door. She was treated with SOLU MEDROL and was seen by a Neurologist. She was evaluated and had ""left sided deficient"" with a diagnosis of ""possible GBS"". She was placed on a 2-week neuro watch. The numbness and tingling started to fade away. The patient was treated with a Prednisone regime. She was seen by a primary care physician and a neuro evaluation was done on an unreported date. She was improving but was still very tired, sleeping 16 hours a day. On September 29, 2014 she developed a migraine headache and again was seen by the primary care physician on September 30, 2014. She was told to take IMITREX when she got home. About 30 minutes after taking IMITREX she experienced crushing chest pain and was ""diaphoric"". This lasted about 10 minutes, then went away. She was seen again by the physician on October 2, 2014 and was given TORADOL IV. She had numbness and tingling to left side of face and hand. She was sent to the ER and was given Dexamethasone, BENADRYL, and REGLAN IV. After about one hour, the treatment didn't help so she was given Morphine IV. The numbness and tingling were gone but the headache continued. She was seen by a neurologist on October 7, 2014. The reporter stated that the doctor ""suspects something in the Flu shot triggered the nervous system to react against her own body"". Her right optic nerve was inflamed- (occipital neuralgia) and she was given an unspecified nerve block for the migraine. She was in Dexamethasone orally and still has a few seconds of numbness in her face. At the time of the report she was still experiencing electrical shocks throughout her body which lasted a few seconds. She also had blurred vision. Laboratory tests were not reported. The patient outcome was unknown. Documents held by sender: None."" "18-29 years" "18-29" "549170-1" "549170-1" "This case was reported by a physician via sales rep and described the occurrence of arm pain in a 29-year-old female patient who received BOOSTRIX (batch number AC52B102AA, expiry date 19th March 2015). Co-suspect products included FLUARIX QUADRIVALENT (batch number 2KJ3T, expiry date 25th June 2015). Previously administered products included Flu vaccine (no reactions). Concomitant products included Birth Control Pill, levothyroxine and Muscle Relaxant. On 5th September 2014 11:30, the patient received the 1st dose of BOOSTRIX (unknown) .5 ml. On 5th September 2014, the patient received the 1st dose of FLUARIX QUADRIVALENT (unknown). On 6th September 2014, 1 days after receiving BOOSTRIX and FLUARIX QUADRIVALENT, the patient experienced arm pain (serious criteria disability and clinically significant/intervention required) and restricted movement in arm. The patient was treated with cortisone and ALEVE. On an unknown date, the outcome of the arm pain and restricted movement in arm were not recovered/not resolved. It was unknown if the reporter considered the arm pain and restricted movement in arm to be related to BOOSTRIX and FLUARIX QUADRIVALENT. Additional details: The patient had any relevant medical history and previous vaccinations went uncomplicated. The reporting physician stated the patient received the FLUARIX in the left arm, and the BOOSTRIX in the right. The patient reported the FLUARIX was given in the right, and BOOSTRIX in the left. Also, the physician has 2 practices within the same county. The AE was reported to the rep during a visit at the address listed above. It is not known at time of report which office the patient received the injections. The patient reports a Grade 2 level pain in the left arm, with restricted movement. The physician saw the patient on September 15th, and the patient was given a cortisone injection in the affected arm and told to take ALEVE twice a day. The reporter also mentioned that the patient received the injections using a 1 inch 22 gauge needle. Follow-up information received on 08 October 2014 from the physician: BOOSTRIX and FLUARIX QUADRIVALENT were given concomitantly in different arms. Less than a week after the vaccination with BOOSTRIX and FLUARIX QUADRIVALENT the patient experienced pain at injection site which prolonged to 30 days. The physician does not feel that the injection site pain was vaccine related but wanted to know of any case reports of subacromial bursitis or continued deltoid pain were received. No additional information provided." "18-29 years" "18-29" "549273-1" "549273-1" "Hi Dr., I wanted to let you know that Friday night after my appointment I came down with a fever, chills, and body aches that lasted until Sunday evening. I had one episode of emesis early Saturday morning. Since about mid Sunday afternoon I've had a headache that seems to be originating from my neck with rushes of pain when I sit up or stand up, also with turning my head. It seems to be resolving now, but turning my head still causes pain in my neck that seems to be from muscle tension. My best guess is that this may have been an adverse reaction to the Tdap, since I've never had trouble with flu shots before. All I did was take Tylenol to keep the fever under control (it peaked at 102.5). If there is anything else you think I should do, please let me know." "18-29 years" "18-29" "549327-1" "549327-1" "Given decreased dose than recommended by manufacturer." "18-29 years" "18-29" "549329-1" "549329-1" "Received lower dose than recommended by manufacturer." "18-29 years" "18-29" "549446-1" "549446-1" "Itching at injection site and a 4cm round red rash around injections site." "18-29 years" "18-29" "549521-1" "549521-1" ""Patient received flu shot. She got up and watch mother receive hers. Her and her mom walked out of pharmacy. Rph noticed they sat back down. Rph went to them. Daughter was hot and sweaty. She looked pale. She threw up in waste basket. Mother said she looked pale. Patient received flu shot around 12:00 pm. She got up. Her mother received hers. She watched mom get her flu shot immediately after hers. Her and her mom walked out of pharmacy. I (the Rph) noticed them sit back down. I went to them. Mom said daughter felt dizzy and was sweaty and pale. Daughter look pale and was ""pasty"". Daughter felt nauseous. Mom gave her a waste basket and she threw up. I felt her skin and it was cool and pasty. Injection site looked normal. After about 10-15 mins. daughter looked like she got her color back. I observed her until she felt better. Mom was confident she was ok and walked out with her. I called mom 2 hours later and daughter went to work and felt back to normal and ate something when she got home."" "18-29 years" "18-29" "549785-1" "549785-1" "I administered the vaccine at 12:35 patient called me at 7:00 said she was not feeling well her face was numb and she was very weak. She wanted to know if that was normal. I told her if she had someone to bring her in we could check her BP but I would not hesitate to go get checked out. Pt called ER and they told her they could not do anything. Through the night she said her face swelled, lips were numb and she felt weak the next day (10/15/14)." "18-29 years" "18-29" "549794-1" "549794-1" "Raised, red, hot, itchy area lasting 4 days." "18-29 years" "18-29" "549828-1" "549828-1" ""Pt was given flu shot in (R) deltoid, and immediately his muscles became tense and he felt he could barely breathe, he denies any seizure activity. He has had previous flu shots without any problems. Pt taken to Emergency Room. VS = BP 132/100 - P=132 - R=20 - T=99; HT=70""; WT=222; O2 sat=98%."" "18-29 years" "18-29" "550042-1" "550042-1" "Itching and some hives, patient took Benadryl and was fine the next morning." "18-29 years" "18-29" "550313-1" "550313-1" "PAINFUL/SORE SHOULDER, NUMBNESS AND TINGLING THROUGHOUT ARM AND HAND." "18-29 years" "18-29" "550506-1" "550506-1" "2 hours after receiving injection started hives. Spread over body and worse on scalp. Some fullness in throat. Took BENADRYL - seen at clinic 20 hours later. Symptoms resolved." "18-29 years" "18-29" "550642-1" "550642-1" "L deltoid erythremia 9.5 x 3.5 cm. Dx' d cellulitis and given antibiotics (ANCEF) by Dr. Denies any previous reactions." "18-29 years" "18-29" "550852-1" "550852-1" "This is a prospective pregnancy case. This 25-year-old female subject was enrolled in an open label study titled FLUARIX, FLULAVAL, FLUARIX QUADRIVALENT, FLULAVAL QUADRIVALENT Pregnancy Registry: a prospective, exploratory, cohort study to detect and describe any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with either FLUARIX OR FLUARIX QUADRIVALENT or FLULAVAL or FLULAVAL QUADRIVALENT during pregnancy or within 28 days preceding conception. On 26th September 2014, the subject received Flu Seasonal QIV Dresden .5 ml. The subject received Flu Seasonal QIV Dresden during the second trimester of pregnancy. On an unknown date, an unknown time after receiving Flu Seasonal QIV Dresden the subject developed vaccine exposure during pregnancy (non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. It was unknown if the investigator considered the vaccine exposure during pregnancy to be related to Flu Seasonal QIV Dresden. Pharmacist provided limited information. More specific gestational timing was not available. Minimum information collected for asymptomatic adverse event." "18-29 years" "18-29" "551025-1" "551025-1" "None stated." "18-29 years" "18-29" "551051-1" "551051-1" "Patient had redness and swelling at site next day but then 2 days after injection also experienced soreness and pain under arm hurts to move arm. Patients PCP was consulted and did not advise treatment." "18-29 years" "18-29" "551146-1" "551146-1" "Pt. describes swelling near collar bone on same side as the arm where shot was administered, with headache. Denies shortness of breath, denies egg allergies, denies trouble breathing, or swelling of facial area." "18-29 years" "18-29" "551264-1" "551264-1" "Given decreased dose than recommended by manufacturer" "18-29 years" "18-29" "551412-1" "551412-1" "Patient fainted right after Fluzone Quadrivalent was given." "18-29 years" "18-29" "551471-1" "551471-1" "Given decreased dose than recommended by manufacturer" "18-29 years" "18-29" "551476-1" "551476-1" "Given decreased dose than recommended by manufacturer." "18-29 years" "18-29" "551514-1" "551514-1" "Developed an anaphylactic reaction to flu shot. Administered Epipen and BENADRYL. Sent to ER for further monitoring." "18-29 years" "18-29" "551556-1" "551556-1" "States she awoke 10/29/2014 with very swollen face. Used Benadryl for the swelling. Face remained swollen until 10/30/2014 afternoon." "18-29 years" "18-29" "551760-1" "551760-1" "Whole body shaking uncontrollably, pulse 113, low grade temp, rapid shallow breathing - hard to catch breath, body aches, vomiting. Then at 4:30 AM: pulse 100, headache, stopped up nose, body aches, shallow breathing. Fever had broken by then and there was no more vomiting. Headache has continued through 11/04/2014." "18-29 years" "18-29" "551924-1" "551924-1" "Patient experienced redness and soreness at site but 3 days later developed pain under arm, it hurt to move arm. Pain lasted appx 24 hrs then resolved. Patient's PCP was consulted, she did not advise treatment." "18-29 years" "18-29" "551939-1" "551939-1" "Developed urticarial rash and scratchy throat approx. 45 min after receiving flu vaccine. Has never received flu vaccine in the past." "18-29 years" "18-29" "552048-1" "552048-1" "FLUZONE admin (R) del IM about 945a. C/O intense itching about 9:54am. Denies SOB/D/B. BP 104/76. BENADRYL 25mg IM about 9:58am. Expressed decreased itching about 10:04am. Monitored x 15 m. relays almost complete resolvement of itching 1015am. BP 110/70." "18-29 years" "18-29" "552189-1" "552189-1" "Patient states she has a rash and hives on palms and fingers. Patient refered to Urgent Care doctor as she does not have a primary care doctor." "18-29 years" "18-29" "552890-1" "552890-1" "Sore arm, pain, flu-like symptoms." "18-29 years" "18-29" "553038-1" "553038-1" "Woke with fever and hives over entire body. No respiratory or throat symptoms." "18-29 years" "18-29" "553050-1" "553050-1" "Patient reports she continues to have localized pain in left arm at administration site since receiving immunization on 10/3/14." "18-29 years" "18-29" "553311-1" "553311-1" ""I had an incidental interaction w/patient this AM at approx. 8:30 AM, following the monthly staff meeting where she asked me ""if she's supposed to tell me about a ""reaction"" she got from the flu vaccine"" (I confirmed she did receive the vax here on 10/14/14 at approx. 5 AM - as she recalls). I asked her if she reported it thru her PCP and she said she had called to report her symptoms but they did not want to see her - it is unclear to me when she placed this call to her MD office in response to her symptom development. She reports the following symptoms with the approximate time of presentation: - ""Itching"" - developed 1 hour (6AM) after flu vax given - did not report this to RN on duty - ""Hives"" - developed 2-3 hours (7-8 AM) after flu vax was given - did not report this to RN on duty - Weakness and Numbness in her Left Arm (site of injection) ""by the time she got home"" - she could hardly open the door to her vehicle"" - did not report to this nurse until 11/12/14 and is resolved. - Temp of 101 (I did not verify w/her that this was not 100.1, but 101) - developed at Midnight the following night after the vaccine was administered, while here at work. She states she reported this to her supervisor, and another staff RN gave her TYLENOL while here at work to treat the fever and she continued to work her shift. - She denies being sick the day of the injection; Denies allergy to eggs, egg products or chicken feathers, gelatin, or thimerosal. - She reports her only allergy as AUGMENTIN. Patient was asked to contact her PCP to assure that they hadn't followed up by completing VAERS reporting (based on her report, it was unsure to me if she actually spoke to the office, was seen by a provider or not) and to let me know if this was not reported, b/c of the need for follow up with VAERS. She agreed to do so and get back to me. She returned to my office approx. 20 minutes later and said she had called her Dr and per her ""they have no report in her file of her having called in to report these symptoms"". I did verify with her that she did NOT go any urgent care of ED for treatment of anaphylaxis. She states she did not. She does not admit to taking any medication post vaccination (Ex: BENADRYL to treat symptoms, only TYLENOL). She denied any long lasting adverse effects at this time and reports she is back to baseline."" "18-29 years" "18-29" "553380-1" "553380-1" "Received Influenza vaccine 10/24/14 4:07 pm. Had arm muscle pain after vaccine. Saturday at 10 am had numbness from shoulder to fingers lasting till 10/27/14 at 8AM. No meds, no ice/heat. Numbness went away but still with pain in upper. Takes 400mg Ibuprofen daily for migraines. Applying heat." "18-29 years" "18-29" "553805-1" "553805-1" "Over night started swelling and was really sore then started getting red and hot. The spot over a day started spreading across the shoulders area." "18-29 years" "18-29" "554085-1" "554085-1" "Patient called around 12:30pm saying her fingers were slightly tingly and was wondering if she should be concerned." "18-29 years" "18-29" "554311-1" "554311-1" "Next morning woke up with pain and discomfort on armpit as if pulled a muscle. It got worse over time. Then burning sensation started. Performed a tactile test and noticed nodules where the size of golf balls and tender to touch. No adverse event on immunization site. Went to doctor and lymph nodes size of apple and eventually increased to size of grapefruit. It is painful and tender to touch. Took ibuprofen and using cold/heat packs to see if it gets better. No improvement so far. Has taken flu shot yearly with no problems until this year." "18-29 years" "18-29" "554338-1" "554338-1" "After my flu shot I began getting hives on my left arm. Throughout the weeks, the hives got worse and appeared all over my body. I had to go to the ER on 10-18-14 b/c the hives were so bad and I was having breathing issues. Given steroids." "18-29 years" "18-29" "554382-1" "554382-1" "Sudden onset severe to profound sensorineural hearing loss in right ear." "18-29 years" "18-29" "554420-1" "554420-1" "Severe backpain left side." "18-29 years" "18-29" "554423-1" "554423-1" "Sharp pain-during elevation. Rash on abdominal area-pt took BENADRYL-5 day after 8-9 day it continue. Pt experiences pain on arm shot administer (11/7/14)." "18-29 years" "18-29" "555009-1" "555009-1" "After receiving Tdap patient had swelling at injection site which spread to shoulder/back. Reaction happened within 5 mins of receiving vaccine. Given 25 mg of BENADRYL. Sxs began to resolve while being monitored in office. Prednisone 40 mg given to hold in case of systemic reaction." "18-29 years" "18-29" "555087-1" "555087-1" "Nausea, vomiting, body aches-visit 11-10-2014. RX ZOFRAN. Cough, dizziness-persistent URI-sx-evaluated 11-17-2014-R/T vaccinations 11-20-14 - seen for sinus cough persistent cough x-rays neg RX CEFTIN given." "18-29 years" "18-29" "555112-1" "555112-1" ""Client reports left arm swelling at injection site sates now size of her palm and ""feels hot""."" "18-29 years" "18-29" "555192-1" "555192-1" "Unknown if attributed to vaccine. Patient had vaccination on 11/19/2014 symptoms of fever, dizziness, headache began next day. Patient demise time unclear may not be related however per process noting that vaccination had occurred in the previous 36 hours." "18-29 years" "18-29" "555451-1" "555451-1" "Employee complained of feeling nauseated, then became pale and fainted. Fell out of chair onto floor, sustaining abrasion to R upper cheekbone. Then arms turned inward and became rigid, unresponsive to verbal stimuli, stertorous breathing. Turned onto L side, 911 called. Employee then regained consciousness, but remained pale. Placed in supine position with legs elevated, BP 120/84, P 80, A&O x 3, skin warm and dry. EMS arrived who transported employee to ER where he was treated and released." "18-29 years" "18-29" "556791-1" "556791-1" "Patient came to the pharmacy, accompanied by his father, to request the quadrivalent flu vaccine. He mentioned that he does not fare well with needles but wanted the vaccine anyway. After the vaccine was administered, he was given a bottle of water and asked to sit for a few minutes to see how he feels. After sitting for a few minutes, he felt weak so he laid down on the floor with his feet up on the chair for a few minutes and then sat back up on the chair for a few more minutes until he felt he was okay to leave. After he left the pharmacy and crossed the street, he felt lightheaded and fainted. He came out of it quickly, took a couple steps and fainted again. He came out of it and continue to go home. He fainted again when he reached the front entrance of his building and injured his chin as a result of his fall. His father helped him into the lobby and called down his mother for help. He laid down and rested until he felt a little better. Then they took him to the hospital to treat his injuries. His mother called today (11/26/14) to report the event and said that he is now okay." "18-29 years" "18-29" "556965-1" "556965-1" "Patient received the quad vaccine in the afternoon. Within a couple of hours, her chronic pain level had increased from a 6 (on 1-10 scale) to a 9.5. She ran a slight fever (99.5 to 101 F) for about one week. The increase in pain significantly restricted her movements. Both of her wrists and left knee were swollen at the joint for 2 days. We followed up at our clinic one week later (next Wednesday) and, on the advice of the physician assistant we saw, the emergency room on the same day. At the emergency room she received a 60 mg shot of toradol which did nothing to alleviate her pain, along with some advice that her pain wasn't real. Today, 12/04/2014 is one month later and patient is still at a 9 to 9.5 for pain level. She is becoming permanently disabled by the continued increase of her chronic pain." "18-29 years" "18-29" "557170-1" "557170-1" "PT recieved three vaccines in accordance with his readiness report. At the time of administration, the patient denied having any drug, food or latex allergies (verified with online medical systems) patient received his vaccines along with his classmates, was then instructed to standby in the clinic lobby until his entire class was completed. Time spent waiting was approximately 20-30min. Patient stated that he did not have any reactions until after 5pm. PT states had a itchy red rash covering his middle torso, upper right chest and right side of the neck. He denied any trouble breathing, any numbness or tingling to his extremities or any other abnormal feelings of being ill. Patient reported after sick call hours to the medical clinic he recieved the vaccines, and stated that the rash has gotten better but is still present. Patient was evaluated by the medical staff and the duty flight surgeon. Patient was released without limitations." "18-29 years" "18-29" "557216-1" "557216-1" "Patient said he arm bruised immediatly after administration, site became painful later same day. Over next couple of days patient said bruising and redness got worse. Presented to pharmacy on 12/6/2014 and I referred her to urgent care. Diagnosed with cellulitis and prescribes 7 day course of Keflex." "18-29 years" "18-29" "557217-1" "557217-1" "Sharp shooting pains are injection site, recommended that patient see clinic." "18-29 years" "18-29" "557315-1" "557315-1" "This case was reported by a other health professional via call center representative and described the occurrence of injection site erythema in a 26-year-old female patient who received FLUARIX. Previously administered products included gentamicin (Patient has had a previous minor reaction to a gentamicin containing medication). Concurrent medical conditions included food allergy (Patient has multiple food allergies). In September 2014, the patient received FLUARIX (injection). On an unknown date, an unknown time after receiving FLUARIX, the patient experienced injection site erythema, injection site swelling, injection site pain, feels poorly nausea. On an unknown date, the outcome of the injection site erythema, injection site swelling, injection site pain feels poorly and nausea were recovered/resolved. The reporter considered the injection site erythema, injection site swelling, injection site pain, feels poorly and nausea to be probably related to FLUARIX. Additional information received: Clinic manager reports that a patient received FLUARIX 0.5 mL in September. She immediately experienced a moderate local reaction that consisted of pain, redness, and swelling. She also developed a systemic reaction of nausea and feeling poorly. These symptoms resolved 8 days after receiving the vaccine." "18-29 years" "18-29" "557336-1" "557336-1" "Complaint of redness, swelling on right deltoid at injection site started 10/16/2014." "18-29 years" "18-29" "557351-1" "557351-1" "Heaviness and soreness in central upper chest. No shortness of breath, wheezing, rash, or fever." "18-29 years" "18-29" "557483-1" "557483-1" "Started with headache, on 11/20/2014 afternoon, legs numb and tingly, on night of 20th, progressed to severe abdominal pain, unable to walk on morning of 11/21/2014 to ER 7 AM on 11/21/2014, transfered 11/21/2014 night, until 12/3/2014 when transfered again, remains hospitalized." "18-29 years" "18-29" "557765-1" "557765-1" "Pt fainted." "18-29 years" "18-29" "558094-1" "558094-1" "Swelling and redness at injection site." "18-29 years" "18-29" "558150-1" "558150-1" "I received an IM Fluarix Quadrivalent shot and there was much pain (6 out of 10 scale) in the right arm after administration. I developed a headache for 72 hours after the shot that went away; however, the pain (down to 3 out of 10) in my arm was continued for several weeks and interestingly I also felt pain in my left arm after 1 week of administration. Not sure why. It has been about 2 months and I feel muscle weakness and pain (currently 2 out of 10) in my right arm still. Not sure why this is continuing after the receiving the flu shot." "30-39 years" "30-39" "519880-1" "519880-1" "Dizziness 1st day; followed by upper arm redness/pain." "30-39 years" "30-39" "519933-1" "519933-1" "Injection site was sore and now extremely red. Soreness and redness is improving and patient does not think he needs to be seen by MD. I encouraged him to seek attention if needed and/or have it looked at by RPh." "30-39 years" "30-39" "521330-1" "521330-1" "Extreme soreness in upper left arm at injection site. Pain has gotten worse over the past few weeks. Pain when reaching above head, sleeping on arm, using muscle on arm." "30-39 years" "30-39" "522400-1" "522400-1" "Pt experiencing sharp pain in the muscle w/ stretching movements. Started at onset of flu shot and has continued since." "30-39 years" "30-39" "525620-1" "525620-1" ""Pt reports he has a rash that started on his abdomen and back. Within 1-2 hours spread to include some of his chest, possibly some on his inner arm bicep area (these later resolved) and also on his feet, ankles and up to his mid-calf area on both feet and legs. He reports he doesn't have any signs of fever, chills, itching, pain, discomfort. He feels ""ok"". Rash is described as small red dots that look like ""hair follicles"" but are not raised. I encouraged him to take some Benadryl and monitor closely. If sx worsen or rash spreads more, he should see Dr. ASAP. If he continues to feel okay and sx don't worsen we will monitor closely until Friday when he already has a Dr. apt scheduled."" "30-39 years" "30-39" "527394-1" "527394-1" "She received vaccine on 2/22/14 and is still reporting a very sore arm with pain radiating in whole arm (as of 3/18/14)." "30-39 years" "30-39" "528430-1" "528430-1" "Patient stated on 3-21-14 arm was still sore and numbness and tingling at times, on 3-24-14 employer of patient called stating pt had to go to ER due to she still was not feeling well. ER stated she had a infection at injection site." "30-39 years" "30-39" "539610-1" "539610-1" "Metallic tast in mouth and upper lip tingling." "30-39 years" "30-39" "542719-1" "542719-1" "Large area of redness and bruising at injection site." "30-39 years" "30-39" "542973-1" "542973-1" "Patient experienced cellulitis like reaction that required hospitalization (ICU) and numerous antibiotics. Patient received vaccine on 9/2/14. Patient discharged from hospital on 9/8/14." "30-39 years" "30-39" "542981-1" "542981-1" "Inflammation and swelling on 5 inch diameter surrounding injection site. Mild fever, chest tightness." "30-39 years" "30-39" "543619-1" "543619-1" "Area of injection became indurated with erythema. The area is about 3 inches in diameter. The are is warm to touch. There is no bruising or hematoma present." "30-39 years" "30-39" "543806-1" "543806-1" "fever (100.4 F), rhinitis, fatigue, HA, myalgia first time getting quadrivalent flu vaccine, had no previous reactions with trivalent" "30-39 years" "30-39" "543868-1" "543868-1" "After returning home from the clinic where the vaccines were administered, patient noted the left arm (site of vaccination) became painful, hot, red, and swollen. The patient developed fever (up to 103.8 F) and chills. Diagnosed as cellulitis and treated with antibiotics with improvement." "30-39 years" "30-39" "543899-1" "543899-1" "(L) arm burning and tingling and weakness progressive since flu vaccine 5 days ago. Radial nerve distribution. Unresponsive to NSAIDs. Dropping objects." "30-39 years" "30-39" "544021-1" "544021-1" "pain, swelling, redness at site of injection. Fever 102.3 with chills, glands in RT neck beginning to swell." "30-39 years" "30-39" "544173-1" "544173-1" "Severe headache, tingling in hands/wrist/forearms and around mouth, hot flashes, flushed face. No rash, no wheezing." "30-39 years" "30-39" "544576-1" "544576-1" "Initial onset was dull headache behind my left eye and remained unresponsive to 1000 mg doses of Tylenol for the next few days. The pain remained a fairly consistent dull ache, but on Friday, September 19 the pain became excruciating, and led to light headedness and vomiting. At this point, due to the non-responsiveness of the headache to OTC pain medications, I went to the ER." "30-39 years" "30-39" "544996-1" "544996-1" "Pt reports redness, hives, burning, and pain to anterior arm, joint, and axilla. Benadryl, Prednisone." "30-39 years" "30-39" "545115-1" "545115-1" "Pt called on 9/25 to report that on the evening of 9/22, she was experiencing allergic reaction: rash on arm and torso, fever, tingling lips. Went to the local ER for treatment." "30-39 years" "30-39" "545243-1" "545243-1" "Mild fever, malaise, myalgias lasting more than 16 hours, mostly responding to antipyretic medication (alternately taking acetaminophen and ibuprofen). Also tenderness and soreness with movement at the injection site (like most vaccinations)." "30-39 years" "30-39" "545313-1" "545313-1" "Itchy throat, nunny nose, hoarse voice, very reddened sclera." "30-39 years" "30-39" "545343-1" "545343-1" "The flu was administered at a school site. The patient reported to the school nurse on 9/18/14 that he had severe pain in his right arm going into his shoulder and neck ever since the injection. The nurse reported this information to me on 9/19/14 and that she advised him to see his physician. I contacted him on 9/22/14. He had not seen a doctor but the pain was not improved." "30-39 years" "30-39" "545673-1" "545673-1" "Woke up at 1:30am on 09/27/14 with hives, chills, diarrhea, and severe abdominal pain. Passed out twice at home, blood pressure performed by EMS at home was 80/52. Treated in ER with IV Benadryl, Demerol, and fluids on 9/27/14 at 3:30am. Discharged on 9/27/14 at 5:00am." "30-39 years" "30-39" "545765-1" "545765-1" ""Felt lightheaded and had headache that started about 20 min post injection. Got progressively worse. Began having chest pain around 11am. Took a dose of Benadryl. Did not subside. Went to ER and was given ""something for anxiety""."" "30-39 years" "30-39" "545795-1" "545795-1" "Hives on face, swelling of the face and throat, difficulty breathing. Epinephrine injection was administered. Events continued every 4-6 hours. Epinephrine injection was required again on 09/26/2014 at 3:15PM. On 09/27/2014 at 6:15 PM patient required emergency room visit again due to difficulty breathing." "30-39 years" "30-39" "545804-1" "545804-1" "Celluitis of the L arm. Pt presented with painful, red L arm along with fever and elevated blood glucose." "30-39 years" "30-39" "546034-1" "546034-1" "Patient complained that the redness and swelling started few hours after she received the flu vaccine. She reported it to me on 10/1/14 @ 1200 pm. The R deltoid area still had some redness and swelling (6.5 cm), slight warm to touch. NO other complaints." "30-39 years" "30-39" "546063-1" "546063-1" "Patient went to urgent care - soreness and swelling under left deltoid - ARNP gave prescription for ibuprofen 600 mg and to place hot compress on site - left axillary lymphadenitis." "30-39 years" "30-39" "546122-1" "546122-1" "Injection site swelling, bruising and warm to touch with red streaks going down right arm to wrist with sharp pain radiating to neck with right ear ringing." "30-39 years" "30-39" "546240-1" "546240-1" "Flu shot administered at her work site. Approximately 1 hour after the injection was given the patient reported generalized itching in her arm, neck and back. The nurse noted redness in these areas.The patient did not exhibit any signs/symptoms of respiratory distress. B/P 122/86, pulse 88, respiration 16. The patient denied any known allergies. The patient told the nurse that she was took 2 25mg Benadryl. The nurse instructed the patient to call her physician. The patient did so and went directly to his office. I followed up with the patient on 10/1/14. She was at work and stated the physician gave her a steroid injection and oral steroid and that she was not having any further problems." "30-39 years" "30-39" "546416-1" "546416-1" "Nausea occurred around 30 minutes post vaccine. Then headache, dizziness,raised red area, flushed face. Given Prednisone" "30-39 years" "30-39" "546448-1" "546448-1" ""Patient noticed 2 days after the shot that she had a large (approx 2-3"" in diameter) round bump where shot was administered. Patient reported that it was hot to the touch."" "30-39 years" "30-39" "546500-1" "546500-1" "Patient called about 2 hours after receiving the vaccination and complained of headache and sharp shooting pains down the arm." "30-39 years" "30-39" "546590-1" "546590-1" "I had a large, bright red patch surrounding the area where I had received my flu shot. The red area was also warm to the touch and tender. The area was light pink on the morning of 10/06." "30-39 years" "30-39" "546768-1" "546768-1" "SWELLING UNDER THE ARM OF INJECTION SITE. SLOWLY RESOLVED ON ITS OWN WITH NO MEDICAL INTERVENTION. PT STATES THIS HAPPENED ONCE BEFORE A COUPLE YEARS AGO BUT WAS WORSE THE LAST TIME." "30-39 years" "30-39" "546805-1" "546805-1" "Swelling, redness, heat, pain at vaccine site. Treatment ice and motrin. On 10/05/2015 symptoms increased and pain extending into right shoulder." "30-39 years" "30-39" "546837-1" "546837-1" "Hives and itching." "30-39 years" "30-39" "547004-1" "547004-1" "Employee denies fever, denies N/V/D. Reports sore throat, body aches, mouth hurts-more like dryness, head congestion and headache." "30-39 years" "30-39" "547045-1" "547045-1" "Metallic taste in mouth." "30-39 years" "30-39" "547076-1" "547076-1" "Redness, induration, warm-to-touch, soreness at vaccine administration site." "30-39 years" "30-39" "547358-1" "547358-1" "Vomiting; felt feverish; excess phlegm in the throat. IV fluid bolus, ondansetron, lab." "30-39 years" "30-39" "547396-1" "547396-1" "Patient described extreme muscle soreness, tingling in fingers, 1/2 grip strength, cannot lift arm or move across her body." "30-39 years" "30-39" "547403-1" "547403-1" "Pt reports feeling nausea and dizziness after vaccination, exercised with trainer at gym for a short time, unable to complete workout as she felt nauseated & dizzy. Started having cold chills, husband took pt to ER, had convulsions (?seizures), tachycardia, fever of 101. Treated in ER and released same day." "30-39 years" "30-39" "547422-1" "547422-1" ""Tolerated first every flu shot well, no problems after 15-20 min. After 2 hours returns, violently shivering, c/o feeling cold, breathing regularly but states his breathing felt ""wrong."" Extremely anxious, fingers of both hands extremely blanched, but hands above knuckles normal. Warm and diaphoretic on hands and arms. Went to nurses office where (I was told later) his BP was fine, O2 sat was in 80's until he breathed deeply and it ""shot up to 95"". Color returned to proximal fingers and seemed calmer when wife arrived, went to ED via 911 call by nurse."" "30-39 years" "30-39" "547482-1" "547482-1" ""On Tuesday, October 7th I had an immunization clinic. I had a 39 year old female that I immunized with the Pneumovax vaccine in the left arm and the Fluarix Quad in the right arm. The Pneumovax vaccine was indicated because she had asthma and had never received the pneumococcal vaccine before. She stated that her doctor recommended that she receive the vaccine. Patient describes that she developed a reaction in her left arm where she received the Pneumovax vaccine on the morning of Tuesday October 7, 2014. She began feeling ""bad"" that afternoon and started running fever. She states that it became very red and warm to the touch and became swollen to the size of a grapefruit at the injection site. On October 10, 2014, she decided to see a physician. At that time the physician prescribed her an antibiotic and ibuprofen. I spoke with her on the evening of October 10th and she stated that she felt ""much better."""" "30-39 years" "30-39" "547626-1" "547626-1" "Red swollen & hot around injection site by end of work day red swollen area extended down from right deltoid injection site to elbow (lasted 48 hours) low grade fever from 10/8/14 - present day 10/13/14 with highest temp being 100 on 10/8/14. Muscle aches, stiffness, headache, nausea and low grade fever of 99.5 ongoing symptoms today 10/13/2014." "30-39 years" "30-39" "547646-1" "547646-1" "Blotchy red rash the entire length of the left arm." "30-39 years" "30-39" "547731-1" "547731-1" "Fever up to 103.1 degrees Fahrenheit. About a 5 inch patch of erythema on upper arm where vaccine was administered. 2 blisters on the upper arm." "30-39 years" "30-39" "548054-1" "548054-1" "Injection site became very hot to the touch. Large palpable knot is present at site as well. Sore to touch." "30-39 years" "30-39" "548068-1" "548068-1" "Patient stated that she experienced right shoulder & neck pain. Went to emergency room. Received pain medication. Followed up with PCP & received more pain medication & steroids." "30-39 years" "30-39" "548075-1" "548075-1" "Red rash & itching over most of body; came to our office today for assessment; no shortness of breath, angioedema; treated with Medrol dose pack & hydroxyzine." "30-39 years" "30-39" "548579-1" "548579-1" "10:53 AM 10-14-14 reported a burning sensation with the injection. Later that day around 12:00 noon noticed a bruise at the injection site. Noticed around 1600 that area was red and warm to touch. woke up 10-15-14 with upper (L) arm swollen and hot to touch." "30-39 years" "30-39" "548581-1" "548581-1" "All over hives." "30-39 years" "30-39" "548586-1" "548586-1" "Noticed a pain in her arm approximately 4 hours after administration. Next day she woke with redness, swelling, and warmth at injection site. Taking over the counter Zyrtec and Benadryl." "30-39 years" "30-39" "548591-1" "548591-1" "Complaint of dizziness and weakness after administration. This morning she reports feeling better but not 100%. Denied wanting to see a physician for treatment." "30-39 years" "30-39" "548623-1" "548623-1" "Within approximately 15 min of recieving the vaccination the patient displayed hives, swollen tongue and was immediately taken to the emergency department for evaluation. She was given Decadron, Benadryl and a prednisone taper pack." "30-39 years" "30-39" "548735-1" "548735-1" "Muscle aches, low-grade fever (100 degrees F), sleeplessness, heart racing. Treatment consisted of 400mg Ibuprofen at 10:00 PM on 10/18/2014 and 3:30 AM on 10/19/2014." "30-39 years" "30-39" "548815-1" "548815-1" "Extreme pain at time of vaccine. 10x worse at least to any other flu shot I've ever gotten. Since then, without ceasing: extreme and crippling pain in shoulder/upper arm especially when moved certain ways; can barely do so at times and have loss of mobility, and stiffness (for over 3 wks now)." "30-39 years" "30-39" "548911-1" "548911-1" "Patient went to doctor after receiving flu shot. Tendonitis and bursitis was reported from flu shot. Pt recovered." "30-39 years" "30-39" "548919-1" "548919-1" "Severe headache and muscle pain when I woke up. By 10 am I started itching on my face, forehead, and back of neck. By evening the aches were much less, but I had hives on my face and neck. The aches subsided but the hives continued with itching in various areas on my body. The following day I had the hives and my lips would get itchy and numb intermittantly and I had some facial swelling. The following day I decided to go to urgent care since it was not responding to cortisone cream and antihistamines. I was given a cortisone injectone around 1100 am and continued antihistamines. The following day the rash is still present on my forehead and back of my neck but is less red and raised." "30-39 years" "30-39" "548955-1" "548955-1" "Sharp pain within 48 hours of injection. Pain subsided, but after 1 week patient started to notice more muscle pain during overhead movement or reaching behind. Pain getting worse until this day." "30-39 years" "30-39" "549016-1" "549016-1" ""PATIENT REPORTED TENDER, RED CIRCLE (1"" WIDE) AROUND THE INJECTION SITE ACCOMPANIED BY ITCHING AND PAIN. PATIENT ALSO REPORTED 2 RED, SWOLLEN SPOTS WHICH WERE TENDER TO TOUCH AROUND THE WAIST THAT LOOKED LIKE BUG BITES. Patient reported this morning that spot is less red and tender today. Appears to be getting better at injection site and spots on waist."" "30-39 years" "30-39" "549103-1" "549103-1" "Sore at site night of vaccination - also redness and swelling increased next day (10/8) with itching and warmth too. 10/9 - increased down arm to elbow - no induration. 10/10 - Swelling started to decrease. 10/13 - Back to normal." "30-39 years" "30-39" "549324-1" "549324-1" "Received lower dose than recommended by manufacturer." "30-39 years" "30-39" "549328-1" "549328-1" "Received lower dose than recommended by manufacturer." "30-39 years" "30-39" "549346-1" "549346-1" "Vertigo." "30-39 years" "30-39" "549360-1" "549360-1" "Swelling and pain of left upper arm and neck per provider visit note 10/17/2014." "30-39 years" "30-39" "549451-1" "549451-1" "The next day after receiving the flu vaccine, she noticed a bright red rash to her upper chest, numbness and tingling to her face, itchy eyes. No fever, no hives, no swelling, no shortness of breath/ difficulty breathing, no increased HR. She took BENADRYL and rash and itching subsided. Ibuprofen 40 mg x one day given by NP. She reported similar reactions in previous years. She was referred to PMD for follow-up." "30-39 years" "30-39" "549460-1" "549460-1" "Injection site became sore shortly after injection was given and has remained sore (22 days)." "30-39 years" "30-39" "549570-1" "549570-1" "Left arm, large raised red lump, 2x3 warm to touch, tender." "30-39 years" "30-39" "549647-1" "549647-1" "Very sore upper left arm hurts to move. No inflammation or redness." "30-39 years" "30-39" "549745-1" "549745-1" "Pt had 2 episodes of emesis after receiving the vaccine. Pt then developed fever, cough, runny nose, and malaise. Symptoms are improving with Nyquil." "30-39 years" "30-39" "549792-1" "549792-1" "Fever, red, hot raised area 13cm x 9cm lasting 5 days." "30-39 years" "30-39" "549875-1" "549875-1" "QUADRIVALENT vaccine administered at 10:24 a. Patient came back at 11:20 a c/o generalized itching and scratchy throat. No fever or redness. After 15 min it did not worsen. Pt told may try antihistamine and she agreed. Follow up 10/16. Pt said ok." "30-39 years" "30-39" "549899-1" "549899-1" "Event: Slight increase in temperature (99.1 C), Chills/sweating, headache, lethargy. Treatment: Ibuprofen (4 x tabs)." "30-39 years" "30-39" "550060-1" "550060-1" "Patient started experiencing vomiting, diarrhea, chills and facial soreness. She had a fever of 101 degrees F and symptoms persisted for about 36 hours." "30-39 years" "30-39" "550070-1" "550070-1" "Soreness in deltoid and axilla. Patient reported sleeping on injected arm overnight. Treatment with acetaminophen recommended." "30-39 years" "30-39" "550226-1" "550226-1" "Pt had an immediate inflammatory response at the injection site. Pt also became lightheaded, pale, slightly tight in his chest and BP dropped to low of 96 systolic. Pt was given epi 1:1000 1cc and Benadryl 50 mg IM. Pt did rebound and was able to be d/c to home." "30-39 years" "30-39" "550252-1" "550252-1" "Patient c/o SOB, chest tightness and swelling of hands and tongue. XOPENEX breathing treatment given and ZYRTEC 10 mg po." "30-39 years" "30-39" "550327-1" "550327-1" "Progressive numbness, tingling, burning, and pain in hands, legs, hips, back, right shoulder and feet. Difficulty walking. Developed bladder incontinence. Chest heaviness." "30-39 years" "30-39" "550368-1" "550368-1" "I am a nurse at the clinic and administered my own flu shot in my left VL. Within 10-15 minutes I developed itching and a red, raised area at the injection site. Within two hours of the injection, the area became significantly raised, red and aprox 6 inches in diameter. The skin of my neck and torso also became uniformly red and slightly itchy. I also developed very mild wheezing. I took loratidine 10mg and Benadryl 50mg orally. The wheezing and torso symptoms resolved with this treatment. The injection site symptoms are slowly resolving." "30-39 years" "30-39" "550399-1" "550399-1" "Pt's husband called 15 minutes after administration commented that pt was having allergic reaction at the time and to fill her prednisone Rx and he would be picking up shortly. Spoke to husband 10/27 - pt. ended up in ICU." "30-39 years" "30-39" "550504-1" "550504-1" "Patient started getting sore 2 hrs after, that night developed fever, insomnia, chills, nausea. Fever did not respond to ibuprofen or APAP. Patient's arm is red, swollen, not to touch and sensitive to touch." "30-39 years" "30-39" "550602-1" "550602-1" "PROJECTILE VOMITING, SPINNING, LEFT SIDE TINGLING AND WEAK." "30-39 years" "30-39" "550633-1" "550633-1" ""Initial stick ""felt"" high upon left arm. With injection of Flu Vaccine, a shooting pain was felt around shoulder and down arm. Rest and NSADIS x3 weeks with no improvement. Starting to lose ROM in shoulder. Pain continues to wake me at night - especially if I turn over on the left arm."" "30-39 years" "30-39" "550646-1" "550646-1" "Radiating neck pain, severe headache, dysphagia/tightness of throat, chest heaviness, difficulty taking deep breath, lower back ache, disorentation, overall weakness, tremors, febrile (101-103 degrees)." "30-39 years" "30-39" "550751-1" "550751-1" ""Almost immediately had headache, progressed through the evening. Became lethargic, nauseated. She went to bed at 9:30 after ""passing out"" on the couch. She was checking on son during the night at 1:30 am. She passed out, and had a seizure. Called Rescue Squad, taken to ED, given IV fluids. No cause found."" "30-39 years" "30-39" "550833-1" "550833-1" "This is a prospective pregnancy case. This 34-year-old female subject was enrolled in a study. On 15th October 2014, the subject received Flu Seasonal QIV Dresden .5 ml. On an unknown date, an unknown time after receiving Flu Seasonal QIV Dresden the subject developed exposure during pregnancy (Non-serious). The outcome of exposure during pregnancy was unknown. The pregnancy was ongoing. It was unknown if the investigator considered the exposure during pregnancy to be related to Flu Seasonal QIV Dresden." "30-39 years" "30-39" "550834-1" "550834-1" "This is a prospective pregnancy case. This 34-year-old female subject was enrolled in a study during pregnancy or within 28 days preceding conception. On 15 th October 2014, the subject received Flu QIV .5 ml. On an unknown date, an unknown time after receiving Flu QIV the subject developed exposure during pregnancy (non-serious). The outcome of exposure during pregnancy was unknown. The pregnancy was ongoing." "30-39 years" "30-39" "550847-1" "550847-1" "This is a prospective pregnancy case. This 33-year-old female subject was enrolled in a study. On 8th October 2014, the subject received the 1st dose of Flu Seasonal QIV Dresden (injection). Concomitant products included no therapy (None) and Vitamins. the subject's last menstrual period was on 22nd July 2014 and estimated date of delivery was 30th April 2015. The subject received Flu Seasonal QIV Dresden at week 11 of the pregnancy and during the first trimester of pregnancy. On 8th October 2014, an unknown time after received Flu Seasonal QIV Dresden the subject developed exposure during pregnancy (Non-serious). The outcome of exposure during pregnancy was unknown. The pregnancy was ongoing. It was unknown if the investigator considered the exposure during pregnancy to be related to Flu Seasonal QIV Dresden. Additional details: Caller stated she received the FLUARIX QUADRIVALENT vaccine last week at her job, it was administered by the Employee Health Department at her job. She doesn't know the dose that was given or the lot and expiration date of the product." "30-39 years" "30-39" "550851-1" "550851-1" "This is a prospective pregnancy case. This 31-year-old female subject was enrolled in a study during pregnancy or within 28 days preceding conception. On 15th October 2014, the subject received Flu QIV .5 ml. On an unknown date, an unknown time after receiving Flu QIV the subject developed exposure during pregnancy (Non-serious). The outcome of exposure during pregnancy was unknown. The pregnancy was ongoing. It was unknown if the investigator considered the exposure during pregnancy to be related to Flu QIV." "30-39 years" "30-39" "550917-1" "550917-1" "Flu-like symptoms (fever, headache, body aches, weak, knee joint-hot). had to stay home from work the next day." "30-39 years" "30-39" "550945-1" "550945-1" ""Circular 2"" x 1 1/4"" lot, firm induration at injection site. No visible signs of cellulitis or lymph node involvement. No fever."" "30-39 years" "30-39" "550946-1" "550946-1" "SOB, sweating and tongue swelling." "30-39 years" "30-39" "551003-1" "551003-1" "This is a prospective pregnancy case. This 32-year-old female subject was enrolled in an open label study titled FLUARIX, FLULAVAL, FLUARIX QUADRIVALENT, FLULAVAL QUADRIVALENT Pregnancy Registry: a prospective, exploratory, cohort study to detect and describe any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with either FLUARIX OR FLUARIX QUADRIVALENT or FLULAVAL or FLULAVAL QUADRIVALENT during pregnancy or within 28 days preceding conception. On 7th October 2014, the subject received Flu Seasonal QIV Dresden. The subjectÆs past medical history included miscarriage (around 5-6 week gestation in early July 2014). The subjectÆs last menstrual period was on 26th May 2014 and estimated date of delivery was 11th April 2015. The subject received FLUARIX at week 13 of the pregnancy and during the first trimester of pregnancy. On an unknown date, an unknown time after receiving FLUARIX the subject developed vaccine exposure during pregnancy (non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. It was unknown if the investigator considered the vaccine exposure during pregnancy to be related to FLUARIX. The patient received a FLUARIX vaccine while pregnant. Gestational age was 13 weeks. Last menstrual period 26 May 2014, but the patient experienced a miscarriage around 5-6 weeks gestation in early July 2014. This current pregnancy occurred before having another menstrual period. The patient had a twin pregnancy." "30-39 years" "30-39" "551011-1" "551011-1" "This is a prospective pregnancy case. This 32-year-old female subject was enrolled in an open label study titled FLUARIX, FLULAVAL, FLUARIX QUADRIVALENT, FLULAVAL QUADRIVALENT Pregnancy Registry: a prospective, exploratory, cohort study to detect and describe any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with either FLUARIX OR FLUARIX QUADRIVALENT or FLULAVAL or FLULAVAL QUADRIVALENT during pregnancy or within 28 days preceding conception. On 10th February 2014, the subject received Flu Seasonal QIV Dresden at week 9 of the pregnancy and during the first trimester of pregnancy. On an unknown date, an unknown time after receiving FLUARIX the subject developed vaccine exposure during pregnancy (non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. It was unknown if the investigator considered the vaccine exposure during pregnancy to be related to FLUARIX. Caller reported that she received a FLUARIX 2014-2015 season vaccine while she was pregnant. No AEs were reported." "30-39 years" "30-39" "551014-1" "551014-1" "This is a prospective pregnancy case. This 36-year-old female subject was enrolled in a study. On 15th October 2014, the subject received Flu Seasonal QIV Dresden (intramuscular) .5 ml. The subject's last menstrual period was on 18th April 2014 and estimated date of delivery was 23rd January 2015. The subject received Flu Seasonal QIV Dresden at week 26 of the pregnancy and during the second trimester of pregnancy. On an unknown date, an unknown time after receiving Flu Seasonal QIV Dresden the subject developed exposure during pregnancy (Non-serious). The outcome of exposure during pregnancy was unknown. The pregnancy was ongoing. It was unknown if the investigator considered the exposure during pregnancy to be related to Flu Seasonal QIV Dresden. Additional details: The dosage given was 0.5cc. She stated she is 26 weeks gestation. Reporter called to register in pregnancy registry." "30-39 years" "30-39" "551017-1" "551017-1" "Developed a shoulder strain - one week after her flu shot and now presents with a left deltoid muscle strain." "30-39 years" "30-39" "551033-1" "551033-1" "Began as a red rash on forearms. Progressed to lips swelling and shortness of breathe." "30-39 years" "30-39" "551104-1" "551104-1" "Shoulder and upper arm were tender and any movement was painful for three days post-shot (Oct. 21-23), then pain slightly improved. Oct. 28, shoulder and upper arm became progressively more painful to move with weakness related to pain." "30-39 years" "30-39" "551140-1" "551140-1" "Normal reaction, chills, headache but the headache and light sensitivity has never gone away." "30-39 years" "30-39" "551186-1" "551186-1" "PATIENT COMPLAINS OF HIVES AND RASH 4 HOURS POST VACCINATION, RECOVERED WITHIN 2 DAYS." "30-39 years" "30-39" "551304-1" "551304-1" "Given decreased dose than recommended by manufacturer." "30-39 years" "30-39" "551312-1" "551312-1" "Given decreased dose than recommended by manufacturer." "30-39 years" "30-39" "551464-1" "551464-1" "Given decreased dose than recommended by manufacturer." "30-39 years" "30-39" "551475-1" "551475-1" "Given decreased dose than recommended by manufacturer." "30-39 years" "30-39" "551477-1" "551477-1" "Given decreased dose than recommended by manufacturer." "30-39 years" "30-39" "551553-1" "551553-1" "Chills, fever, malaise, myalgia, weakness X 24 hours. Treated with ibuprofen and acetaminophen. Resulted in loss of 1 work day." "30-39 years" "30-39" "551716-1" "551716-1" "Approx 2 inches below where my flu vaccine was administered, I got a 2X3 inch area on my lower deltoid that was red, hot, swollen and painful. At the office, we drew a line around the edge of the redness to watch to see if the redness would get bigger. On Thursday, 10/30/14, the area spread outside the margins that were drawn. It increased in size on the bottom side increasing by an inch or so. The redness had completely faded on Saturday, November 1, but left a bruised looking area for the last two days. It is no longer painful, just irritated and itchy. I work in the clinic where the injection was administered, and one of the doctors watched the area through the day on Thursday." "30-39 years" "30-39" "551718-1" "551718-1" "I developed symptoms related to Bell's Palsy." "30-39 years" "30-39" "551757-1" "551757-1" "Experienced itching at injection site just a short time after receiving immunization. Over the course of the next day and a half, she developed a red, warm, raised area, oblong in shape and 2-3 inches in size. She will be calling her physician." "30-39 years" "30-39" "551774-1" "551774-1" "When raise arm above head, shooting pain down lt arm down through tricep/bicep seems to be nerve pain vs muscle pain. Arm gets limp and doesn't function." "30-39 years" "30-39" "551818-1" "551818-1" "L shoulder sore and stiff X 3 weeks, no response to ice and ibuprofen; no erythema or swelling now seeking PMD visit and physical therapy offered. Unknown if neuritis at this time." "30-39 years" "30-39" "551847-1" "551847-1" "Developed herpes zoster one day after receiving influenza vaccine. Concern for herpes zoster ophthalmicus. He presented for care 10/27/14." "30-39 years" "30-39" "551857-1" "551857-1" ""10/28 gave shot at 7 PM called back 8:30 PM throat and tongue felt ""thick"". Took BENADRYL told to seek ASAP medical help wanted to go to urgent care. I called ahead gave them allergies and vaccine name and lot. Nausea develop. Check on her that night 10 PM. Also next 3 days."" "30-39 years" "30-39" "552268-1" "552268-1" "I got flu shot yesterday at 1000. I was fine all day until when at the end of the day at around 5:00 pm, I noticed my eyes were itching, teary, and swollen, my hands & feet were swollen and itchy, the injection site was sore, and my throat was also itchy. I took Benadryl right away & fell asleep. When I woke up, my eyes are still swollen & itchy and my hands are swollen. My feet are fine. I was sent by charge nurse to Employee Health." "30-39 years" "30-39" "552497-1" "552497-1" "PT complained about a lot of pain about 30 Mins after receiving injection, which approx time given 2:15pm. She continued to have a lot of pain and then reported that she could not lift left arm. Provider on site evaluated her and states sh feels that the injection was given a little high. Pt was Sent to Occupational Health. Pt continues with decreased rom, pain and numbness and tingling in arm." "30-39 years" "30-39" "552700-1" "552700-1" "Developed hives 36 hours after getting 3 vaccines." "30-39 years" "30-39" "552832-1" "552832-1" "Rash on hands and swollen lymph nodes." "30-39 years" "30-39" "552904-1" "552904-1" "Constant left shoulder pain with radiation down arm. Unable to raise arm over shoulder. Stinging sensation in hand." "30-39 years" "30-39" "553001-1" "553001-1" "Pain in arm where injection was given as of 11-5-14." "30-39 years" "30-39" "553006-1" "553006-1" "Vaccine administered on 10/05/14, on 10/06/2014 hives started to appear on face only. Progressed to 10/07/2014 now covering whole face, hives with pustules. Patient reports itchy, hot sensation, and pain." "30-39 years" "30-39" "553039-1" "553039-1" ""10/8/14 Progressive weakness and parethesias in her hands and feet"". Unable to walk to the bathroom 10/9/14. 10/12/14 severe back pain, increased weakness, trouble swallowing. Intubated 10/14/14."" "30-39 years" "30-39" "553143-1" "553143-1" "Hives-10/31/2014, Fatigue and headache 11/01/2014-11/03/2014, as well as hives continued. 11/04/2014 Facial swelling and hives. 11/05/2014-11/11/2014- Hives. 11/12/2014- Facial swelling." "30-39 years" "30-39" "553857-1" "553857-1" "Bruising at the injection site that lasted 2 weeks after administration." "30-39 years" "30-39" "553989-1" "553989-1" ""Patient reported via email to me on 11/15/14-that ""24 hours after getting flu vax, she began w/migraines."" ""48 hours after flu vax, she began w/full body aches and fever 100.8 and extreme weakness."" ""Symptoms lasted 36 hours approx."""" "30-39 years" "30-39" "554260-1" "554260-1" "Complaint of bilateral armpit pain. Pain started the day after vaccine. Pain in R axilla actually was more sharp and the pain in the L axilla is more sore and achy. She denies any pain elsewhere of symptoms of systemic illness." "30-39 years" "30-39" "554380-1" "554380-1" "Cellulitis, arm was warm and inflamed. Pt reported that she got an antibiotic and Benadryl from urgent care." "30-39 years" "30-39" "554385-1" "554385-1" "Fever to 102.1; local swelling, erythema, pain." "30-39 years" "30-39" "554570-1" "554570-1" "Immediate left upper arm pain. As arm pain worsened she began having left neck and left upper back pain. Seen in ER on 10/25/14. Given Solu Medrol, pain meds, anti inflammatory meds and muscle relaxers. Has since been treated with Depo Medrol. Physical therapy has been ordered." "30-39 years" "30-39" "555170-1" "555170-1" "Numbness, tingling of right arm. Facial drooping on right side. Right upper lip numb. Severe headache." "30-39 years" "30-39" "555391-1" "555391-1" "This case was reported by a other health professional and described the occurrence of injection site swelling in a 34-year-old female patient who received FLULAVAL QUADRIVALENT (batch number 5ZT94 ?, expiry date 30th June 2014). Co-suspect products included MEDICATION UNKNOWN (VACCINE). Previously administered products included influenza vaccine with an associated reaction of pain in extremity and influenza vaccine with an associated reaction of nausea. On 6th November 2014, the patient received FLULAVAL QUADRIVALENT and VACCINE. On 6th November 2014, 0 min after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site swelling (serious criteria disability), injection site hardness, injection site warmth and musculoskeletal stiffness. On 7th November 2014, the patient experienced vomiting, chills, stomach upset, diarrhea and low grade temperature. The patient was treated with ibuprofen. On an unknown date, the outcome of the injection site swelling, injection site hardness, injection site warmth and musculoskeletal stiffness were recovering/resolving and the outcome of the vomiting, chills, stomach upset, diarrhea and low grade temperature were recovered/resolved. It was unknown if the reporter considered the injection site swelling, injection site hardness, injection site warmth, musculoskeletal stiffness, vomiting, chills, stomach upset, diarrhea and low grade temperature to be related to FLULAVAL QUADRIVALENT. The reporter considered the injection site swelling, injection site hardness, injection site warmth, musculoskeletal stiffness, vomiting, chills, stomach upset, diarrhea and low grade temperature to be not reported if related to FLULAVAL QUADRIVALENT. Additional information: The reporter (patient) was a physical therapy assistant. The patient had no known allergies. There was no concomitant medication. Injection site reaction occurred in the evening of 6 November 2014, neck and back stiffness during the night. On 7 November 2014, within 24 hours of vaccination, the patient experienced stomach upset with vomiting and diarrhea, chills and low grade temperature. As of the day she was recovered about 75% but she could not keep anything in her stomach. She could not do anything all day and took ibuprofen to get some sleep. Stomach upset with vomiting and diarrhea, chills and low grade temperature all lasted for 72 hours. She did not contact a health care professional. Refer to case US2014GSK023616 for tolerance to previous vaccination." "30-39 years" "30-39" "555567-1" "555567-1" "CLIENT ARRIVED 11/24/14 AT PUBLIC HEALTH CLINIC ASKING FOR ASSISTANCE RE VACCINE GIVEN AT SCHOOL ON 11/21/14. CLIENT CO'S OF DIZZINESS/NOT FEELING WELL AT BEDTIME ON 11/20/14. CLIENT STATES THAT ON THE NEXT DAY, SHE HAD RIGHT SORE ARM WITH REDNESS AND SWELLING, FATIGUE. SHE ALSO CO'S OF OCCASIONAL SOB, SORE THROAT, CHILLS. SHE DID NOT TAKE TEMP. TOOK IBUPROFEN ON SATURDAY AND YESTERDAY. FEELS SHE IS IMPROVING. 11 X 11 CM RED AREA WITH SWELLING AND TENDERNESS IS NOTED ON THE RIGHT ARM. COLD PACK APPLIED DURING VISIT. RECOMMENDED TO CONTACT MD (WRITTEN INFO GIVEN ON LOW COST MEDICAL FACILITIES) IF CONDITION DOES NOT IMPROVE, COLD PACK TO RIGHT ARM, AND USE OF IBUPROFEN/TYLENOL AS NEEDED. ENC TO TAKE FLUIDS AND MOVE ARM AS MUCH AS POSSIBLE." "30-39 years" "30-39" "556112-1" "556112-1" "Red hot sore arm, severe combined with radiating pain in arm then to joints - systemic. Developed aphthous ulcers oral and genital with fever. Elevated temp and aches 5 days later. Has had vaccines in the past with no known reactions. Saw MD - no cellulitis dx." "30-39 years" "30-39" "556532-1" "556532-1" "Employee received influenza vaccine 10/20/14. On 10/21/14 am left dentoid area red swollen and hot to touch. Area is 7 1/2 cm x 5 cm. Employee took 650 mg of TYLENOL prior to am work." "30-39 years" "30-39" "556708-1" "556708-1" "C/o not feeling well after flu vaccine. Feeling shaky. Visibly shaky. Blood pressure 138/92 Pulse 80 Respirations 20. Began to feel better after 5 minutes of rest. Stood up and took a few steps. Turned around and took another step. Then fell forward and began seizing." "30-39 years" "30-39" "556777-1" "556777-1" "Pain at site of injection, but also could feel pain in my humerus. The soreness eventually went away, but I continue to have stabbing pain in my shoulder with any movement overhead. It is painful to take my shirt off, get things out of cabinets. If I attempt to throw a ball with my son, my arm is so sore that I can barely use it for the rest of the day and into the next. I have tried applying heat to the site, but this only seems to make it worse." "30-39 years" "30-39" "557349-1" "557349-1" "Swelling, bruising, soreness in the arm, still do not have full range of motion left arm." "30-39 years" "30-39" "557433-1" "557433-1" "Erythema, swelling and tenderness at site. Temperature of 38 Celsius. Left axillary swelling and tenderness with motion. Numbness and swelling in sternal notch." "30-39 years" "30-39" "557809-1" "557809-1" "Pt describes arm pain and was referred to urgent care center who recommended ibuprofen as area was inflamed. Area not getting better and pt saw orthopedist who recommended additional 2 wks of antiinflammatory. Pt states arm still not better and cannot lift it past 90 degrees. Orthopedist now recommending physical therapy." "30-39 years" "30-39" "557847-1" "557847-1" "Patient recieved Pneumovax and influenza in left arm. Reports significant pain and hives of left arm x 1 week. History of influenza vaccine without incident." "30-39 years" "30-39" "558001-1" "558001-1" "Blisters and pain, went to hospital and doctor sait it was shingles caused from shot. Dr gave motrin and antiviral acyclovir and will pic up gabapentin today." "40-49 years" "40-49" "516137-1" "516137-1" "PATIENT CALLED THE CLINIC AT APPROXIMATELY 2:30 TO STATE THAT HER FACE WAS RED AND HER TONGUE FELT SWOLLEN. PATIENT WAS ADVISED TO SEEK IMMEDIATE MEDICAL ATTENTION FOR EVALUATION AND TREATMENT. PATIENT WAS SEEN AND TREATED IN URGENT CARE." "40-49 years" "40-49" "518048-1" "518048-1" "Hot pain at injection site; fever; fatigue; headache; muscle pain in arm and shoulder; decreased arm range of motion. Still have arm and shoulder pain and fatigue 10 days after injection." "40-49 years" "40-49" "518410-1" "518410-1" "Started having cough, sinus drip, and lost my voice completely, started having tingling in chest area with cough, fatigue, leg weakness, by Jan 2, was having serious cough, and called doctor. Symptoms stopped by Jan 4 with exception of voice." "40-49 years" "40-49" "518541-1" "518541-1" "Pt got 101 degrees fever, achy, especially legs that night." "40-49 years" "40-49" "518693-1" "518693-1" "Patient had temp of 101.5 degrees, left arm swollen 12cm in diameater, tender, pink, localized reaction." "40-49 years" "40-49" "518948-1" "518948-1" "Erythema at the site, local swelling to the site, pain that started approx 4 hours after vaccine was given. Patient treated herself with NSAIDs and warm compresses with little relief." "40-49 years" "40-49" "519050-1" "519050-1" "Patient had seizure (focal) after 2-5 minutes when vaccine given. Patient diagnosed with epilepsy last year. Has not had this with prior vaccines, he says this happens with Dental work. He was able to communicate and was alright. He sat 30 min - 1 hour, had some water, and said he was fully recovered as this happened before, patient not upset." "40-49 years" "40-49" "519145-1" "519145-1" "Initial report received from a healthcare professional on 06 January 2014. A 44-year-old patient had received a first dose of FLUZONE QIV (lot number: not reported, route of administration was not reported) in the left deltoid on 15 December 2013. The patient had a medical history of asthma and gluten allergy and the patient had received a flu vaccine in June (year not reported), and had no reaction. On 15 December 2013, few hours after vaccination, the patient became hot and red, had vomiting for several days, nausea, trouble breathing, shortness of breath, knees swelled up and had trouble walking and shaking, chest pain. The patient had similar episode which were unrelated to a vaccine in the past but the past time became blind briefly and the patient had to take prednisone which was diagnosed as allergic reaction. Laboratory investigation and corrective treatments were not reported. The patient had not recovered till the time of this report. Documents held by sender: none." "40-49 years" "40-49" "519391-1" "519391-1" ""This case was reported by a consumer's spouse and described the occurrence of seizure in a 42-year-old male subject who was vaccinated FLUARIX TRIVALENT or QUADRIVALENT (GlaxoSmithKline), influenza virus vaccine (unspecified). A physician or other health care professional has not verified this report. On 6 January 2014 at 12:00 the subject received a dose of FLUARIX TRIVALENT or QUADRIVALENT (unknown, left deltoid). On 6 January 2014, 3 hours after vaccination with FLUARIX, the subject experienced seizure, fatigue, muscle soreness, body pain, and partial seizure on side. The subject's wife reported that her husband experienced a mild ""paraseizure"" after being administered the FLUARIX vaccine. She was unsure if the vaccine was trivalent or quadrivalent. The subject's ""symptoms originated in his left cheek and extend dose his left arm, mostly in his left thumb and fore fingers"". The subject took ibuprofen following FLUARIX vaccination. At the time of the report all his symptoms have remained the same. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the seizure, fatigue, muscle soreness and body pain were unresolved. The spouse also reported that the subject experienced ""nothing beyond soreness at the site"" with previous flu shots; vaccination dates and details regarding the injection site soreness were not provided. The outcome of the injection site soreness was unspecified."" "40-49 years" "40-49" "519739-1" "519739-1" "Received call on 01/13/2014 from niece inquiring as to vaccines received by client. Stated client was hospitalized after she became disoriented on 01/08/2014 and developed seizures which have been uncontrollable. Remains in ICU (stable)." "40-49 years" "40-49" "520293-1" "520293-1" "Patient says she had shooting pain when vaccine was administered. She felt it in her neck and back. She still has some residual pain but it is now starting to get better." "40-49 years" "40-49" "520443-1" "520443-1" ""State night of 1/7/14, had high-grade fever, malaise. After several days went to ER was dehydrated and diagnosed with ""flu"" not covered by flu shot. Told ER received flu shot same day as ""got sick"". Received IV antibiotics in hospital. States hospital informed D/T egg allergy - should not have received and to let this nurse know of adverse event. Denies hives, chest tightness, throat swelling. States last ""a couple of weeks""."" "40-49 years" "40-49" "520987-1" "520987-1" "Pt received flu shot (FLULAVAL Quadrivalent) NDC# 19515-0895-11 on 1/13/14. Pt came to pharmacy on 1/21/14 to report ill effects 1 day following including loss of short term memory, loss of attention, feeling warm sensation in the head region, somewhat of a fever. To date, symptoms have not abated. Pt will f/u with her PCP." "40-49 years" "40-49" "522151-1" "522151-1" "Client experienced throat spasm for 1-2 seconds, dizziness, flushing, tingling, and back pain about 10 minutes after vaccination. Client immediately seated and cold rags applied. BP 116/76, pulse 60. Started feeling better within 5 minutes of onset of symptoms. Back pain and tingling resolved. Gave juice. About 20 minutes after incident client states symptoms resolved except mild headache." "40-49 years" "40-49" "523176-1" "523176-1" "States she received flu vaccine 2/4/14 and had pain in right arm during week. States pain started moving to right shoulder on 2//9/2014 - states when she moves right arm it hurts. Denies arm being puffy/swollen." "40-49 years" "40-49" "528522-1" "528522-1" "Swollen at site of injection. Area became red, itchy bump. Resolved on its own." "40-49 years" "40-49" "535170-1" "535170-1" ""This case was reported by a pharmacist (also subject) and described the occurrence of arm numbness in a 43-year-old female subject who was vaccinated with FLUARIX quadrivalent (GlaxoSmithKline). Concurrent medications included SYNTHROID. On 8 January 2014 at 16:00 the subject received a dose of FLUARIX quadrivalent (.5 ml, unknown route, right arm). On 8 January 2014, 15 minutes after vaccination with FLUARIX quadrivalent, the subject experienced arm numbness, tingling in cheek, feeling sleepiness, felt cold and shivering. On 8 January 2014, the events were resolved. The subject reported that she ""had to lay down and her symptoms resolved approximately 3 hours after administration"" of FLUARIX quadrivalent."" "40-49 years" "40-49" "540227-1" "540227-1" "SWOLLEN RED HOT ARM -- STARTED 8/15/2014 STILL REACTING AS OF 8/18/14 PT USING BENADRYL AND ICE PACKS TO REDUCE SWELLING AND STOP ITCHING." "40-49 years" "40-49" "541215-1" "541215-1" "Itching, hives. Family gave her Allegra for several days." "40-49 years" "40-49" "542108-1" "542108-1" "Itching and rash." "40-49 years" "40-49" "542911-1" "542911-1" "Pt had large hive present at vaccine site. Pt c/o generalized achiness; seen in office 9/5/14. BENADRYL, cold compress advised for tx." "40-49 years" "40-49" "543280-1" "543280-1" "Right lower extremity weakness started 2 days after vaccination and getting worse." "40-49 years" "40-49" "543290-1" "543290-1" "Patient returned to clinic after administration with swelling to injection site. Ice pack was applied. No erythema or hardness. Denies dizziness, nausea, headache or any other adverse effects. Swelling reduced with ice- advised to continue to ice site and take OTC analgesic if needed- stated understanding." "40-49 years" "40-49" "543440-1" "543440-1" "Fever, pain and swelling on injected arm which lasted for 4 days. MD prescribed antibiotic for possible cellulitis." "40-49 years" "40-49" "543717-1" "543717-1" "Patient said symptoms occurred right after shot. Fever, nausea, red eyes, very sore throat, skin sensitive to touch." "40-49 years" "40-49" "543788-1" "543788-1" "Erythema surrounding injection site and then on 9/13/14 erythema worsened and induration noted. Put ice on it immediately." "40-49 years" "40-49" "543818-1" "543818-1" "Patient asked if any reactions to Flu vaccine in past, she reported, flu symptoms, denies any allergies to eggs. 30 minutes after reports headache, dizziness - went to ED." "40-49 years" "40-49" "544340-1" "544340-1" "PT RECEIVED HIVES ON RIGHT ARM WHERE VACCINE WAS GIVEN AND SPREAD TO RIGH LEG. PT ALSO COMPLAINED OF ITCHINESS." "40-49 years" "40-49" "544455-1" "544455-1" "Pt received FLUARIX Quad 2014-15 yesterday (9-17) at approx 14:30. She called today (9-18) at 12:39 reporting vomiting, shivering, nausea and decreased appetite. She was going to f/u w/ MD." "40-49 years" "40-49" "544561-1" "544561-1" "Employee received injectable influenza vaccination on 17Sep14. Stated started feeling sore throat, congestion, nonproductive cough, tight chest, headaches, body aches, loss of appetite during the evening of 17Sep14. Unable to sleep during the night, reported feeling sweaty with chills. Currently still feeling the same symptoms as above also nausea with vomiting x 1 today (nausea started 18Sep14). Site of injection noted to have outline of band-aid, employee reported same reaction during April 2013 post-op with steri-strip and tegaderm. Possible sensitivity to adhesive. Employee reports site has improved since band-aid removed. Employee states took robitussin DM, pseudoephedrine, Motrin, Celebrex on 17Sep14 without relief." "40-49 years" "40-49" "544769-1" "544769-1" "Joint pain, temp of 100.5, dizziness and nausea, headache, asthma irritation/cough/tightness." "40-49 years" "40-49" "544841-1" "544841-1" "Had vaccine 11:30 AM 9/19/14. Developed burning of tongue shortly after. By 3:30, swelling of tongue; by evening hives. Did not seek med. attention." "40-49 years" "40-49" "545112-1" "545112-1" "Arm pain and shoulder pain. Physical therapy, acupuncture, pain medication, ice packs, heating pads, asper-cream. Multiple doctor visits and no diagnosis. Numerous calls to Dept. of Health and CDC with no prognosis." "40-49 years" "40-49" "545120-1" "545120-1" "More pain upon injection than usual. Noticed the site of injection became red and hot to the touch withing an hour/hour and a half from injection and continued to increase in size throughout the day. Placed a cold pack on it that night, 9/23/14, and again on 9/24/2014. Reported to a nurse at LPH department where vaccine was administered, on 9/24/14 and then to the Immunization Charge Nurse at LPH Dept. on 9/25/2014. When Immunization Charge nurse inspected site, noted by patient that size, pain and temperature had gone down significantly since previous day, 9/24/14, but were still more than just a local reaction. Site appeared to Immunization Charge nurse to be lower than the deltoid muscle and apperared by observation to be closer or in the tricep muscle." "40-49 years" "40-49" "545137-1" "545137-1" "PATIENT'S LEFT ARM BECAME VERY RED, SWOLLEN, AND TENDER." "40-49 years" "40-49" "545193-1" "545193-1" "Red welt appoximately 2 inches wide. Warm to touch and painful to touch." "40-49 years" "40-49" "545201-1" "545201-1" "Severe chills/shaking that resulted in fall. Unable to walk for 15 minutes. Severe fever, diaphoresis." "40-49 years" "40-49" "545404-1" "545404-1" "Patient fainted after receiving FLUZONE QUADRIVALENT." "40-49 years" "40-49" "545445-1" "545445-1" "Within 30 minutes patient developed nickle-sized red bump. By next day it was the size of a 50 cent piece. The next day if was larger and warm and sore to touch. She also had a low-grade fever. Visited family doctor on 9/25/14 and was diagnosed with local cellulitis and prescribed Augmentin 875mg twice a day for 10 days. By 9/27/14 the bump was resolving but not yet gone." "40-49 years" "40-49" "545645-1" "545645-1" "FEVER; PAIN." "40-49 years" "40-49" "545649-1" "545649-1" "FEVER; PAIN." "40-49 years" "40-49" "545654-1" "545654-1" "Extreme pain in arm from shoulder to fingers." "40-49 years" "40-49" "545766-1" "545766-1" "Swelling, pain, itching and redness to injection site. By the next morning patient had swollen ears and left eye and hives. Went to Urgent Care- tx: Benadryl and prednisone. By Sunday morning swelling increased to whole face, hives increased to whole body. Went to ER, tx: injection of Benadryl and Prednisone." "40-49 years" "40-49" "545904-1" "545904-1" "Pt experienced tingling sensation radiating from site of injection, at time of injection, radiated down to 2nd digit left hand. 9/30/14 pt reports weakness in left hand at 1st and 2nd digit, left wrist pain. Pt seen in the office 9/30/14, started on NSAID gel and antibiotic. 10/1/14 pt to schedule an appointment with a neurologist." "40-49 years" "40-49" "546218-1" "546218-1" "Flu shot administered by wellness nurse. The patient reported to her school nurse on 9/22/2014 that her left arm had been hurting since her injection and that it was not better. Followed up by phone with the patient on 9/23/2014 and she stated that her left arm still hurt and had not improved. Stated the arm bothered her worse at night when she turned on her left side in her sleep. Advised the patient to see her personal physician if symptoms did not improve." "40-49 years" "40-49" "546242-1" "546242-1" "TINGLING IN ARM, DIFFICULTY BREATHING. PT HAD TAKEN BENADRYL BEFORE IN RESPONSE TO A GRASS ALLERGY. ADMINISTERED EPIPEN TO PATIENT ONCE SHE WAS HAVING BREATHING DIFFICULTIES. THIS WAS NOT THE PT FIRST TIME HAVING ALLERGIC REACTION OR USING EPIPEN. AFTER EPIPEN ADMINISTRATION BLOOD PRESSURE AND PULSE WERE TAKEN AND WERE WITHIN NORMAL RANGE. EMS WAS CONTACTED AND ON SITE WITHIN 25 MINUTES. PT WAS NOT ADMITTED TO HOSPITAL BUT WAS SEEN BY A PHYSICIAN. ACCORDING TO PT, DR ADMINISTERED DIPHENYRAMINE AND A STEROID. PT WAS CONTACTED ON 10/2 AND SHE WAS AT HOME." "40-49 years" "40-49" "546408-1" "546408-1" ""She woke August 24, the morning after her YF shot, drenched and achy. Assumed it would go away but a few days later had back pain ""It locked"" and then developed problems in her knees, first one and then the other. Continued to have various problems with her knees and started to feel very tired,""Drained"" and both knees swelled. She tried OTC meds and cold packs, etc, as she is a runner and treats herself frequently for such things and didn't think it would last. She just muscled through because she has children and is very busy, but realized today that it all started after YF shot almost 6 weeks ago. Knee swelling and other sx are a little better and not gone. Has not sought any medical help."" "40-49 years" "40-49" "546643-1" "546643-1" "Redness, warmth, bruising adjacent to the injection site. Itching started 4 days post injection." "40-49 years" "40-49" "546648-1" "546648-1" "Localized rash and swelling at site of injection. Patient reports fever and night sweats over the weekend. Patient also reports soreness at site of injection, too." "40-49 years" "40-49" "546651-1" "546651-1" ""10 hours after flu shot c/o ""severe headache, severe joint aches, swollen glands in neck, entire back of neck very painful, intense temperature"" for 2 days. No reaction at all last year per patient."" "40-49 years" "40-49" "546671-1" "546671-1" "Itchy red rash on left and center of neck. Patient states she started BENADRYL Tues 9/23 and hydrocortisone. On 9/26 urgent care doctor told patient to use cetirizine, prednisone and famotidine." "40-49 years" "40-49" "546739-1" "546739-1" "Headache, running nose, coughing, sneezing, dizziness, weak, hard to breathe, etc. and lasted more than 4 days so far. Still suffering." "40-49 years" "40-49" "547276-1" "547276-1" "Near syncopal episodes twice in less than 24 hours from administration of vaccine." "40-49 years" "40-49" "547350-1" "547350-1" "Employee was treated in the ED. Symptoms: skin rash to Lt arm that was red, raised, macular, with hives, swelling, Lt arm erythema, itching and cough. Medication Prescribed: Medrol dose pak, Pepcid 20 mg, Benadryl." "40-49 years" "40-49" "547913-1" "547913-1" "Generalized rash, eyes itch, wheezing." "40-49 years" "40-49" "547938-1" "547938-1" "Pt diaphoretic, vomiting, hives and swelling to face." "40-49 years" "40-49" "548071-1" "548071-1" ""10/8/14 Redness/Swelling at injection site, hives and itching on body intermittently. 10/9/14 Increased swelling at injection site, left fingertip numbness, itching intermittently on body. 10/10/14 Facial numbness on left side of face, right/left side facial numbness in PM, tingling. 10/15/14 Facial numbness, scalp numbness intermittently, ""heaviness"" in arms bilaterally. Denies difficulty with speech, coordination. Reports reaction at age 21 after PPD test (Redness, burning, swelling, numbness)."" "40-49 years" "40-49" "548080-1" "548080-1" "PT NOTICED A WARM AND RED SPOT ABOUT THE SIZE OF A SILVER DOLLAR BUT HAD NOT SEEKED ANY MEDICAL ATTENTION. I ADVISED HER TO TRY BENADRYL AND TO HAVE IT CHECKED OUT IF IT DOES NOT IMPROVE." "40-49 years" "40-49" "548430-1" "548430-1" "Queasiness, shaking/jittery, blurry vision, dry mouth, racing heart." "40-49 years" "40-49" "548487-1" "548487-1" "Developed red, raised localized Rx 24 hours after shot given. At 47 hours area of (L) deltoid- Reaction worse red, raised inflamed area larger covering upper (L) deltoid. Seen and treated for cellulitis with antibiotics and topical steroids. Area improved after 24 hours of steroids." "40-49 years" "40-49" "548521-1" "548521-1" "Pain during administration of vaccine. No tingling or radiation down arm. Pain in shoulder joint of left arm and increased since time of vaccination. Range of motion decreased. Saw ortho MD 9/30/14 - had cortisone injection into shoulder area. To be seen again in 6 weeks, sooner if no improvement." "40-49 years" "40-49" "548594-1" "548594-1" "Nausea, chills times 6 hours in duration, fever of 102 degrees, vomiting x1. Client experienced chills after last yrs flu vaccine. On day 3 her fever is now absent but nausea and malaise persist." "40-49 years" "40-49" "548719-1" "548719-1" "Patient stated that he felt dizzy and strange. He was seated in a chair and after a minute or so his head went back, his eyes remained open, but he was completely unresponsive for 20-25 seconds. When he came out of it, he had no memory of the event and did not realize that he had been unresponsive." "40-49 years" "40-49" "548892-1" "548892-1" "Patient's arm is swollen at injection site, feverish, itching, painful to touch. She has been taking Benadryl and applying hydrocortisone 1% cream to help with itching." "40-49 years" "40-49" "548937-1" "548937-1" "Tuesday Oct 14 lips felt numb and tingling and burning. Had this 2 days. On Thurs Oct 16th entire left side of face became numb, burning and tingling, remains no change since then, saw Dr. 10/20 for these concerns, found to be related in time fashion to the flu shot received. Solu Medrol dose pack given." "40-49 years" "40-49" "548979-1" "548979-1" "She reports that she had numbness and tingling from elbow to shoulder within about 15 min of the injection, then it got worse by 45 min- 1 hour, then finally subsided by later that afternoon around 4:30PM." "40-49 years" "40-49" "549051-1" "549051-1" "This case was reported by a other health professional and described the occurrence of arm was sore in a 45-year-old female patient who received FLUARIX QUADRIVALENT (batch number 7LE2S, expiry date 30th June 2015). Previously administered products included influenza vaccine with an associated reaction of no adverse event. On 4th September 2014, the patient received FLUARIX QUADRIVALENT. On 4th September 2014, less than a day after receiving FLUARIX QUADRIVALENT, the patient experienced arm was sore (serious criteria disability), limited range of motion (serious criteria disability), waking up at night (serious criteria disability) and pain (serious criteria disability). On an unknown date, the outcome of the arm was sore, limited range of motion, waking up at night and pain were not recovered/not resolved. The reporter considered the arm was sore, limited range of motion, waking up at night and pain to be probably related to FLUARIX QUADRIVALENT. Additional information received: The reporter was a nursing student. She reported that her nursing class (a total of 30-35 students) received Flu vaccines at a local hospital about a month ago. About 5 of the students experienced adverse events. She reported that this patient received the vaccine and experienced pain, her arm was sore, is experiencing a limited range of motion, and wakes up at night from the pain. The reporter reported that this patient's events were worse." "40-49 years" "40-49" "549062-1" "549062-1" "Received FLUZONE vaccination on 10/9/2014. Developed hives to left arm approximately 12 hours post vaccine. Resolved spontaneously by 10/13/2014." "40-49 years" "40-49" "549078-1" "549078-1" ""Patient states he received vaccine at 11 AM and by 3 PM he was burning up with fever and hot chills, dizzy, body aches and pains - were ""on fire"". Went to bed and awoke at 9 PM - temp was 101F; took Tylenol and Advil. Feels better 10/17 - went to work but still achy joints."" "40-49 years" "40-49" "549108-1" "549108-1" "Large local reaction to (R) deltoid with itching. Redness 3.5 x 5 inches. Spoke to pt by phone. Dr advise eval and dose of BENADRYL." "40-49 years" "40-49" "549145-1" "549145-1" "10 minutes after receiving vaccine, had diffuse itchiness, sensation of dyspnea, diffuse erythema. Treated at ED with BENADRYL, SOLU-MEDROL, ZANTAC, d/c'd home with BENADRYL and prednisone x 3 days." "40-49 years" "40-49" "549237-1" "549237-1" "C/o numbness and tingling in R arm and hand. Stiffness in lower extremities. Flu vaccine was injected in left arm." "40-49 years" "40-49" "549242-1" "549242-1" "About an hour after the patient had flu shot she began itching but she said she didn't think anything about it because she itches alot due to the PSC. Then her lips began to swell and her eyes. She also had whelps all over her body. She went to urgent care and they put her on steroids and Atarax and told her to take OTC Zyrtec and Zantac (double dose twice a day). The whelps lingered for about 3-4 days." "40-49 years" "40-49" "549253-1" "549253-1" "Redness and itching at injection site." "40-49 years" "40-49" "549269-1" "549269-1" "Significant redness and swelling at injection site." "40-49 years" "40-49" "549312-1" "549312-1" "(L) deltoid area shot given. Pain and limited range of motion 1 month later." "40-49 years" "40-49" "549316-1" "549316-1" "Redness, swelling, induration and itch at site of injection (4 x 4 cm)." "40-49 years" "40-49" "549332-1" "549332-1" "24 hours after the injection, patient was afflicted with a dry itchy rash with red bumps at elbows and ankles." "40-49 years" "40-49" "549368-1" "549368-1" "Lip swelling followed by racing heart beat, some difficulty swallowing and shortness of breath. Lip quickly returned to normal and the other symptoms came in waves for about 2 hours. Went to urgent care and was given steroids." "40-49 years" "40-49" "549383-1" "549383-1" "States that he awoke this morning with his left eye swollen shut with bruising around his eye. His right eye swollen, his sinus feeling painful and full and his face appearing full. Also complains of equisite muscle and joint pain and local site injection redness, swelling and pain. Denies breathing difficulties / wheezing. Seeking care in ED this am." "40-49 years" "40-49" "549670-1" "549670-1" "Patient called at 6pm stating her flu shot given earlier today is giving her extreme muscle pain and radiating towards her neck, limiting her range of motion. We talked about how VIS -> rare but a serious reaction. I will call her PCP and she will as well and monitor. She thinks it may be b/c her shot was given higher on her arm (near shoulder) than she's used to." "40-49 years" "40-49" "549748-1" "549748-1" "Pt developed chills the next day." "40-49 years" "40-49" "549765-1" "549765-1" "Four to five hours after receiving influenza vaccine IM in left deltoid, developed scattered hives on left arm and left side of neck, had pruritis of scalp. She took a dose of BENADRYL and symptoms subsided." "40-49 years" "40-49" "549801-1" "549801-1" "Pt report unable to lift arm past a certain point. Dull pain in left arm. Has been taking Ibuprofen 200mg - Reports weakness. Dull aching pain that stays the same. Trouble putting on clothes." "40-49 years" "40-49" "549814-1" "549814-1" "Severe arm pain, redness and swelling, knot at injection site." "40-49 years" "40-49" "549903-1" "549903-1" "Had flu shot on Monday, woke up Tuesday morning with bilateral calf pain and pain of right thigh and knee. Pain continued and was more intense on Wednesday, so pt went to primary MD. He did labwork and ordered EMG. EMG done on Thursday, with negative results. Pt denies having any numbness or tingling during any of this time. Tried using Advil and soaking in warm tub to help relieve pain. Pt s/t she is finally feeling somewhat better today. S/t she has been massaging calves if she has to sit for extended periods and this seems to help." "40-49 years" "40-49" "550257-1" "550257-1" ""Patient reported back to Employee Health office at approx 15 min after vax. C/O lightheadedness, ""shaky"", nauseated, SOB, intense headache/head pressure and ""like I was having an anxiety attack"" vs checked and employee sent to occupational heatlh for evaluation; VS=98'-96-14 - 152/102 @ 100.5 deg (prior to leaving for work eval)."" "40-49 years" "40-49" "550271-1" "550271-1" "Approx. 4:55pm pt. came back to flu shot area and asked what was in shot. Stated hands were swelling and itching, SOB, chest tightness, rash around waist band." "40-49 years" "40-49" "550302-1" "550302-1" "Dull, aching pain in the left arm and shoulder." "40-49 years" "40-49" "550658-1" "550658-1" "Fever 101.7 F." "40-49 years" "40-49" "550737-1" "550737-1" ""Pt received FLUZONE Quad 10/13/14 and reported vomiting same night. Pt also had fever and ""felt terrible"" - aches and pains and run down/tired."" "40-49 years" "40-49" "550767-1" "550767-1" "Seeing white spots, sweats, rapid heartbeat, difficulty breathing, nausea (within one minute)." "40-49 years" "40-49" "550844-1" "550844-1" "Myalgia in upper arms, upper back, and neck. Slightly sore throat, slight light headedness began 10/28/2014 around 5PM. Generalized malaise and myalgia began 10/29/2014 around 6AM. Taking ibuprofen for discomfort." "40-49 years" "40-49" "550867-1" "550867-1" ""At the time of the needle stick (prior to the serum being injected) I stated to the nurse that she must have hit a nerve. She asked if I was in pain and I said, ""Not pain, but there is an achey feeling from my shoulder to my fingertips."" She continued with the injection and withdrew the needle and at that time asked if it was still hurting. I stated no, not at the time. Later that evening, the left shoulder and arm was in severe pain and I was not even able to lift my arm away from my body. I treated myself with over the counter Tylenol and was still in severe pain the next day so I sought treatment from the Occupational Health doctor on 10/7/2014. DX was Left deltoid pain after annual flu vaccination. I was told to ice as I could for 15 minutes at a time and to take Aleve as directed on the bottle. I returned on 10/9/14 for the scheduled follow up and was feeling better and range of motion was improving as I was using Aleve and ice to treat. I was told to follow up as needed. I never improved beyond that point and the following week the pain began to get worse. I called to see Dr. again on 10/21/14 and was told the next available appointment was on 10/23/14. I again saw Dr. that afternoon and was given the same instructions and was recommended therapy, which was denied by Workers Compensation. As of 10/29/14 I am still experiencing pain in my left shoulder and upper arm. I am scheduled to follow up on 11/6/14 if allowed by workers compensation."" "40-49 years" "40-49" "550871-1" "550871-1" "Client in for Hib and other IZ's due to asplenia and (+) HIV status. Opened new lot of what I thought was Hib vaccine but was actually PENTACEL. Drew up this vaccine with the other 3 vaccines listed below. Administered all IZ's and when done noted that PENTACEL was given in error. Client immed. notified. Info reports Hib is valid and DTaP counts as tetanus booster. Clients Primary Care Provider also notified. Med error report written." "40-49 years" "40-49" "551165-1" "551165-1" ""Initial report received from a health care professional (pharmacist) on 23 October 2014. A 43-years-old female patient, with no reported medical history, had received an intramuscular dose of FLUZONE QIV (batch number reported as U5196AE, which is not a valid lot number) in the left deltoid on 22 October 2014. She had none known allergies. On 22 October 2014, one hour post-vaccination, she experienced wheezing and hot flashes that lasted into the evening. At 6:30pm, the patient fainted and was taken to the Emergency room. It was stated that the ER diagnosis was ""viral syndrome"". She continued to experience fever and ""not feeling well"" on 23 October 2014. The patient had received vaccination through her employee health program, but vaccine was administered through the pharmacy which reported the events. It was not reported whether the patient had received any corrective or concomitant medications. At the time of the report, the patient was not recovered. Document held by sender: none."" "40-49 years" "40-49" "551237-1" "551237-1" ""Pt reports within an hour of receiving the vaccine she noticed tightness, tenderness and a knot developing in the muscle. Reports just ""felt bad"", restless all night and couldn't sleep. On 10/28/14, she noticed a large knot, redness, itching and tenderness at injection site. By 10/31/14 knot is smaller with occasional itching."" "40-49 years" "40-49" "551238-1" "551238-1" "On afternoon of receiving vaccine, pt noticed tenderness, redness and itching at the injection site. Also a knot developed at the injection site that continued to get larger for 2 days. Pt states the swelling and itching was unusual for her. By 10/31/14, improved but still reports itching and some swelling." "40-49 years" "40-49" "551253-1" "551253-1" "On evening of 10/27/14, pt reports injection site being very sore to touch. On 10/28/14 pt reports unusually large knot and redness at site. Reports symptoms gone by 10/31/14." "40-49 years" "40-49" "551267-1" "551267-1" "Given decreased dose than recommended by manufacturer." "40-49 years" "40-49" "551468-1" "551468-1" "Given decreased dose than recommended by manufacturer." "40-49 years" "40-49" "551469-1" "551469-1" "Given decreased dose than recommended by manufacturer." "40-49 years" "40-49" "551513-1" "551513-1" "Dr. started having a reaction at the injection site about 4 hours after receiving her Flu vaccination. It was very tender to the touch, raised wheal the size of a 50cent piece. The area around the raised wheal was very swollen. Dr took some Ibuprofen for the pain. Area is still swollen today 10/31/14." "40-49 years" "40-49" "551545-1" "551545-1" "Redness and swelling below injection site. Resolving with 3 days." "40-49 years" "40-49" "551593-1" "551593-1" "Pt complained arm very sore, hot red circle on left arm." "40-49 years" "40-49" "551680-1" "551680-1" "The client reported that since receiving the flu injection that she has had limited mobility in the left arm and pain from her biceps to the left elbow that has not been relieved by OTC medications. Reported that she was seeing her personal physician on 10/15/2014. Called client on 10/17/14 to follow up after her physician visit. She reported that the physician did lab work at the visit that indicated that she had inflammation in the left arm. He prescribed medication that she did not recall the name of but indicated that the pain in the arm was improving." "40-49 years" "40-49" "551682-1" "551682-1" "Swelling and discomfort in right axilla." "40-49 years" "40-49" "551928-1" "551928-1" "Pt received employee flu vaccine. Within 30 min inj site very red/swollen ice pack applied. 15' later entire upper body red/flushed/widespread itching. Epi 0.30 given IM then BENADRYL 25 mg PO and prednisone 20 mg PO. Symptoms resolved quickly." "40-49 years" "40-49" "551967-1" "551967-1" "Two hours after administering the flu vaccine, patient complained of headache. (throbbing). BP 140/90 mmHg at 3pm. BP 120/88 after 30 mins." "40-49 years" "40-49" "552001-1" "552001-1" ""Pain to right shoulder since the day I received the flu shot. Hurts to pull my arm across my body, hurts to remove my top ""shirts"" or put on."" "40-49 years" "40-49" "552012-1" "552012-1" "14 hrs after injection, skin burning over entire body from scalp to toes then turning very red. Dizziness, sweats and nausea followed for a short period. Intense burn turned to itching burn followed by chills. Took 2 BENADRYL which eased symptoms within an hour. Felt very hot, but temperature was 97.5." "40-49 years" "40-49" "552148-1" "552148-1" "Rt arm sore after few hours. About 8-9 hrs after injection started with headache, sweating, sharp pains throughout body. Vaccine given 10/14 in AM. Pt called 24 hours later to report events and stated she stil had HA and general achiness. Wasn't sure is she had fever. Arm not red or swollen." "40-49 years" "40-49" "552454-1" "552454-1" "After receiving the vaccine the pt's arm became sore, it then developed a small amount of induration and was tender to the touch." "40-49 years" "40-49" "552466-1" "552466-1" "It has been almost a month an the arm still aches. There has been no erythema, fevers or any other symptom. The only symptoms is pain at the injection site with certain ROM. Painful to abduct the arm to the side." "40-49 years" "40-49" "552472-1" "552472-1" "Seizure, seen in the Emergency Department. Dr requests to be reported as no other indications for seizure." "40-49 years" "40-49" "552626-1" "552626-1" "Fever, flu, today +influenza A 11/7/2014." "40-49 years" "40-49" "552738-1" "552738-1" "Left eye twitching and occasionally left cheek and above lip. Has occurred past three years after flu shot. Usually last about 1 month." "40-49 years" "40-49" "552807-1" "552807-1" "Approximately 30-45 minutes after receiving Flu vaccine patient began to experience difficulty breathing. Patient taken by EMS to emergency room. Received epinephrine in squad and received epinephrine and steroids in emergency room." "40-49 years" "40-49" "552899-1" "552899-1" "4 days after uneventful vaccine administration, client's left arm became painful from shoulder to hand, radiating to pectoral muscles and into axillary area." "40-49 years" "40-49" "553319-1" "553319-1" "Vaccine administered early afternoon. Patient reports start of not feeling well med evening time. She woke up in hives all over face, neck, trunk hands etc. Not breathing difficulties reported, did go to Clinic and get prednisone pack and steroid injection." "40-49 years" "40-49" "553366-1" "553366-1" "Pt stated had arm pain from vaccine received on 10/20/14. She went to PCP and said deltoid may have been bruised." "40-49 years" "40-49" "554263-1" "554263-1" "Developed hives on elbow and knee joints. Some shortness of breath. Treated with inhaler and Benadryl." "40-49 years" "40-49" "554310-1" "554310-1" "Received FLUZONE QUADRIVALENT Adult vaccine on 10/20/14. From 10/21-10/23 patient experienced headache, tiredness and difficulty with vision focus. On 10/24 rash appeared on one side of face. Rash worsened over 10/25 and 10/26. On 10/27 patient visited dermatologist and was diagnosed with shingles." "40-49 years" "40-49" "554358-1" "554358-1" "HEART PALPITATIONS FOR ABOUT 5 MINUTES ON SATURDAY AT 1:30 AM ALONG WITH HEADACHE FROM FRIDAY AT 10 PM AND DULLED WITH ALEVE, BUT HAS NOT GONE AWAY. GOT WORSE ON SUNDAY, BUT BETTER TODAY." "40-49 years" "40-49" "554769-1" "554769-1" "Patient woke up at midnight with chills and shivering. His right arm was sore and red where shot was administered, the redness was the size of a silver dollar. At 5 or 6 am he did take his temperature and it was 100.5 degrees Fahrenheit. He took Advil and stayed home from work. He stayed up until about 9 am and went back to bed. He woke up again at 1130 am wet with sweat and had a fever of 101.3 degrees Fahrenheit. He took Tylenol, stayed up, ate a something, watched TV and started to feel a little better by 3 PM. Next day no fever and did go to work." "40-49 years" "40-49" "554810-1" "554810-1" "Pain behind right ear and in shoulder and necke; AM 10/24/14 right side face drooping and some loss of taste. Sensitive hearing right hear loud noises hurt must drink through a straw cannot close eye right." "40-49 years" "40-49" "555042-1" "555042-1" "C/o pain and burning down arm and towards scapular and clavicular area. Saw MD on 11/11. Prescribed a course of prednisone and PRN FLEXERIL. Will be followed up by MD in December." "40-49 years" "40-49" "555199-1" "555199-1" "11/7/14 Pt reported sore arm at injection site with tolerable, periodic pain with movement. No redness, swelling, or inflammation. Pt was advised to use apap or ibu for pain if neccessary. 11/20 Pt states pain has stopped and has experienced no other complications." "40-49 years" "40-49" "555444-1" "555444-1" "Given 2015 flu vaccine, within 5 minutes compaint of numbness and tingling down arm into fingers, and up into shoulder area and left side of neck, c/o headache. Treated w/ NSAID, ice, gentle ROM exercise/limited use-rest of left arm. Has visit several times, report sx gradually decreasing. Last contact 11/24, some pain in shoulder and slight headaches." "40-49 years" "40-49" "555653-1" "555653-1" "11/19/2014 at 1120 pt. seen at clinic for allergic rhinitis at 1200 pt. receives flu vaccine. Pt. states around 1500 arm starts hurting. On 11/20/2014 at 0730 pt. notices red rash near injection site, cont. tenderness to area. On 11/21/2014 at 1525, pt contacts clinic and reports rash, warm to touch and tenderness. Pt advised to apply ice, ibuprofen and BENADRYL. Pt. reports had influenza vaccine in past and never had a reaction. Denied any angioedema. Pt. then went to urgent care on 11/21/2014 at 1800 for eval. Pt. notes received scanned in (HAIMS). Physician assessment indicated (+) tenderness to palpation of (L) deltoid - pain at injection site - (+) red rash in lateral mid-arm about 5 cm in diameter, well demarcated, warm to touch. Fine macular rash on (R) upper arm. Pt. diagnosed with cellulitis and instructed to use cold compresses and BENADRYL and F/U with PCM if no improvement. 11/24/2014 at 1400 pt. contacted to see how she is doing. Pt. states doing better, rash slowly fading." "40-49 years" "40-49" "555826-1" "555826-1" "C/o upset stomach, fatigue and red arm at site of injection. Wife is a doctor and talked to on-call provider at her place of employment, rx for abx given." "40-49 years" "40-49" "555949-1" "555949-1" "Pt developed redness in area, fever, unable to lift arm and joint pain. Patient went to ER 11/15/14 pm and was given antibiotic BACTRIM DS. Advised probably allergic reaction but could be infection." "40-49 years" "40-49" "556280-1" "556280-1" "Immediate pain in arm. Still having pain, can not lift arm above shoulder level, tingling in hand. Pain from shoulder to elbow. Can't sleep at night from pain." "40-49 years" "40-49" "556354-1" "556354-1" ""Immediately after administration the injection site began to swell. I removed the Band Aid to monitor. It looked red, swollen and ""knot-like"". I drew borders around it and watched it for about 20 mins. After 20 mins. no other symptoms appeared, pt felt fine and wanted to leave and the borders of the reaction had receded slightly. Pt refused BENADRYL due to work but took 2 with him just in case he needed it. It is unknown if pt ever took these."" "40-49 years" "40-49" "556451-1" "556451-1" "Patient is experience pain in the arm/shoulder of where injection was given after a Fluzone shot." "40-49 years" "40-49" "556679-1" "556679-1" "Rash/hives across chest at back (upper), back of neck, no itching, gone by next am." "40-49 years" "40-49" "556718-1" "556718-1" "Pt stated some pain in shoulder after vaccination administration. Pt declined evaluation." "40-49 years" "40-49" "556978-1" "556978-1" "On 11/26/14 patient still complains of sore and stiff arm where she can barely move her arm to lift." "40-49 years" "40-49" "556983-1" "556983-1" "Pain in Left side of neck (on side of vaccine) when turned both left and right (more pain when turned to left); pain in Left shoulder when reaching across and placing hand on right arm." "40-49 years" "40-49" "557181-1" "557181-1" "A headache 1 hour after vaccination that progressively got worse throughout the day." "40-49 years" "40-49" "557394-1" "557394-1" "Person could not lift arm after vaccine and is still experiencing pain 8 weeks later and is going to her HCP to follow up." "40-49 years" "40-49" "557473-1" "557473-1" "Vertigo, lost hearing temporarily in left ear. Tinnitus with dizziness occurred later that afternoon around 1:00 PM. Following day around 10:00 AM patient reports of tinnitus and dizziness." "40-49 years" "40-49" "557528-1" "557528-1" "Rash at injection site -> generalized rash with itch w/in 3 hrs." "40-49 years" "40-49" "557570-1" "557570-1" "Patient stated that she had arm pain and had difficulty lifting her arm above shoulder level." "40-49 years" "40-49" "557758-1" "557758-1" ""Client called at 10:25 am to say the arm that received the flu vaccine felt like ""extreme burning, hot coals"" inside her arm. No redness, swelling, or itching at the site. Encouraged client to come back to the clinic for further evaluation. She declined. Given Immunization Coordinator's contact information."" "40-49 years" "40-49" "557930-1" "557930-1" "Arm has been hurting since vaccination, especially during movement in certain angle." "40-49 years" "40-49" "558097-1" "558097-1" "Noticed swelling/ soft tissue mass on left arm developing over the last week. Denies any trauma and only significant event to the affected area was the flu shot administered on 10/27/14." "40-49 years" "40-49" "558132-1" "558132-1" "After I vaccinated the patient, she bruised instantley and her arms swelled where the injection was given. A hard knot formed underneath her skin where the bruise was. The patient, however, felt fine." "50-59 years" "50-59" "516237-1" "516237-1" "Red, raised 85 x 70 mm area (L) mid upper arm." "50-59 years" "50-59" "517724-1" "517724-1" "Migraine headache and vomiting for about 15 hrs.." "50-59 years" "50-59" "517728-1" "517728-1" "Pain and burning in left armpit and swelling right under armpit. Swelling at injection site in left arm. No redness at injection site or rash. In addition to above, one week later had pain all the way down into left wrist. Then two weeks later a rash in left crease of arm which lasted one day. To date still swollen at injection site and under arm with a burning pain not as severe, but still present. Went to doctor on 12/16/13 and received Prednisone 10 MG TAB take two one time. Didn't help. Then called doctor and on 12/20/13 was put on Cephalexin 500MG Capsules to take 3 times a day for five days. Took last dosage on 12/24/13. To date still swelling at injection site and under arm lymph nodes and slight burning under arm." "50-59 years" "50-59" "517731-1" "517731-1" "Patient reports severe muscle soreness at injection site, eight hours later could not touch site due to tenderness and pain. That night experienced one bout of loose bowels, large amount, felt bowels completely emptied, approximately 10 hours after receiving vaccine. Difficulty sleeping due to pain in arm. By next morning, patient observed swelling in left axillary and palpated nodules in same area, also felt swelling at left groin area. On the third day, nodule swelling at both sites, groin and axillary, had receded, no tenderness, but lateral deltoid muscle started to be tender that lead to a moderate-severe deep ache. Pain began in lateral deltoid, wrapped around lower arm to thumb and first two fingers. Client self medicated with ibupropen 600 mg and repeated this dose every four hours with little to no relief. On 12/23/2013, patient returned to Public Health Center to report his reactions to the PPSV23 vaccine and was on his way to the local clinic for help in achieving pain relief in his arm" "50-59 years" "50-59" "518034-1" "518034-1" "Patient vaccinated and later that evening felt that she was freezing and then vomited. Patient woke up the next morning feeling weak and had a tingly face." "50-59 years" "50-59" "518861-1" "518861-1" "Hot and red with large amount swelling at site. Skin on entire body with redness." "50-59 years" "50-59" "519704-1" "519704-1" "Unable to move left arm, can move fingers." "50-59 years" "50-59" "519995-1" "519995-1" "Initial redness and hard lump at injection site (quarter-sized) noted on 1/4/14. Redness, pain, heat radiating outward from injection site (fist sized) on 1/5/14. Diagnosed as staph infection 1/6/14 by general practitioner, area expanded to majority of upper arm. Initiated antibiotic therapy to treat." "50-59 years" "50-59" "520063-1" "520063-1" "Patient experiencing sharp pains down right arm - experienced after flu shot primarily at night. Pt was going to PCP following my recommendation." "50-59 years" "50-59" "520630-1" "520630-1" "Pain in shoulder (left) muscle after couple days of receiving vaccine. Has not taken any medication or has not put ice pack. Suggested to take NSAIDs put ice pak on site. Discussed about filing report (VAERS). He also started taking Atorvastatin. Not know if pain is due to the medication." "50-59 years" "50-59" "520680-1" "520680-1" "Face tingling withing 30 minutes of shot. Then burning, swelling and rash on face and neck withing 10 hours of shot. Then lip swelling, and throat itching withing 11 hours. Took Benadryl over the weekend." "50-59 years" "50-59" "521298-1" "521298-1" "Vaccine was administered on 01-13-14. Next day (01/14, 01/15) patient had soreness in arm. On Saturday 01/18 patient broke up in rash (red little needle-prick-like bumps) from waist down. On Sunday 01/19 rash spread to chest and patient went to the ER. Patient today 1-29-14 is reporting that after a course of prednisone she is doing well and rash has vanished." "50-59 years" "50-59" "521444-1" "521444-1" "Patient states she has a swollen, painful, pink lump approximately 1/2 apple in size at injection site." "50-59 years" "50-59" "521906-1" "521906-1" "Extreme shoulder soreness radiating down arm and up to neck. Its been 2 1/2 weeks and pain continues and at times is increasing making use of arm very painful." "50-59 years" "50-59" "522848-1" "522848-1" "Red, swollen area around injection site that same night. Next day fever 103 --> went to ER. Got TAMIFLU. That night spiked 105 degrees went to ER next day Sat. Spent 2 days in hospital. Diagnosis cellulitis. Pt concerned of RPh sterilization technique." "50-59 years" "50-59" "523409-1" "523409-1" "Pt. came in on 2/11/14 - said her arm was still very sore from flu shot given on 1/23/14. She said there was no swelling, rash or redness but her arm still hurts to move. Pt was told to let us know if she was still experiencing pain after a few more days. 2/14/14 pt returned said she took a muscle relaxant and her arm was feeling much better." "50-59 years" "50-59" "523864-1" "523864-1" "(L) facial droop 2/2/2014. Dry (L) eye. Resolved within 7 days. No treatment." "50-59 years" "50-59" "524670-1" "524670-1" "Slight bump (immediate). Larger bump (approximately 3 mins). Dizziness (approximately 4 mins). Diaphoresis (approximately 4 mins). Loss of consciousness (approximately 5 mins) for 15 sec. Confusion (approximately 5 mins) for 10 sec. Pt ok (approximately 7 mins)" "50-59 years" "50-59" "524740-1" "524740-1" "Rapid hearing loss, severely plugged ears, tinnitus. Audiogram on 01/13/2014 showed marked hearing loss. After 9 days with no improvement MD prescribed 8 day Prednisone treatment. After 6 weeks, no marked improvement except some of the plugged sensation resolved in right ear; left ear unchanged." "50-59 years" "50-59" "525296-1" "525296-1" "Pt reports 2 days after vaccine given, she woke up with a very sore arm - painful and numb at the same time - she had a hard time moving her left arm - she knew something was wrong. The next week she began frequent visits to the chiropractor who said there was a lot of inflammation. Pt states she is feeling better but her arm still hurts." "50-59 years" "50-59" "535168-1" "535168-1" ""This case was reported by a pharmacist and described the occurrence of bruise injection site in a 53-year-old female subject who was vaccinated with FLUARIX quadrivalent (GlaxoSmithKline). On 10 December 2013 the subject received 1st dose of FLUARIX quadrivalent (unknown, right arm). On 10 December 2013, less than one day after vaccination with FLUARIX quadrivalent, the subject experienced injection site bleeding. On 11 December 2013, one day after vaccination with FLUARIX quadrivalent, the subject experienced bruise injection site, described as bruising ""half-dollar size"". At the time of reporting the bruise injection site improved; the injection site bleeding resolved on 10 December 2013. The lot number was reported as ""5K4TZ"" from the reporter; however, based on a safety lot number review, the lot number was updated to 5K4TL."" "50-59 years" "50-59" "542859-1" "542859-1" "Employee received Influenza vaccine at approx. 1200 PM on 8/27/14 in the Employee Health Service office. He developed a swollen upper lip and mild itching sensation approx. 3 1/2-4 hrs after receiving the vaccination. He was treated with an antihistamine and given an ice pack." "50-59 years" "50-59" "542980-1" "542980-1" "Pt reported a very large red, hot and inflamed area at the injection site. Pt is also running fever. Pt was also given the influenza vaccine at the same time in a different arm." "50-59 years" "50-59" "543012-1" "543012-1" "Redness, swelling, warm to the touch at injection site." "50-59 years" "50-59" "543131-1" "543131-1" "Arm was slightly swollen, red, and hot with welps; did not report problems breathing." "50-59 years" "50-59" "543900-1" "543900-1" "Brachioplexopathy of (R) arm (injected side) lasting >2 weeks. Pain in median, radial and ulnar nerves." "50-59 years" "50-59" "543918-1" "543918-1" "Severe and movement limiting stiffness of entire body." "50-59 years" "50-59" "543928-1" "543928-1" "Cellulitis at injection site." "50-59 years" "50-59" "543956-1" "543956-1" "Woke up scratching my neck. It felt hot and itching. When I checked it was red with welts. Later I got a headache and nausea. I took fexafenadine twice that day, called the allergist that I go to on the 9/15. I was told not to come in for allergy shots for that week and to continue to take fexafenadine for the rest of the week. If it got worse come in to see a Doctor. I took two fexafenadine on 9/15 and dropped down to one one 9/16." "50-59 years" "50-59" "544154-1" "544154-1" "Dizziness, nausea, and shakes for about an hour until they stopped. Patient thought about going to the ER until it stopped." "50-59 years" "50-59" "544198-1" "544198-1" ""Patient' left arm (the arm in which she got the vaccine)started swelling and progressively got worse. It was swollen, red, and hot to the touch from the shoulder to the elbow. She called her family doctor two days later and was instructed to go to the ER. She went to the ER on 09/11/14 and was told it was a ""severe allergic reaction"" and was given Benadryl, Solu-medrol, and Pepcid in the ER and was given a prescription for antibiotics."" "50-59 years" "50-59" "544249-1" "544249-1" "Relates that around 1700 09/17/14 her L arm began to ache from the injection site all the way down her L arm to the L wrist. Them related that was awoke at midnight on 09/18/14 running a fever of 100.9 and arthralgia in all joints. Relates that all symptoms had resolved by the time she woke up the morning of 09/18/14." "50-59 years" "50-59" "544458-1" "544458-1" "1 1/2 hours after administration on 9/17/14 - pruritus began and blotchiness on entire body. Used OTC BENADRYL and had relief." "50-59 years" "50-59" "544526-1" "544526-1" "Severe headache, fever, 100 degrees, body aches, intractable nausea, inability to eat, chills, sweats." "50-59 years" "50-59" "544599-1" "544599-1" "Patient (pt) was not ill and was vaccinated 9/18/14 5PM with Pneumovax 23 INJ 25/0.5 MERCK and Fluzone QUAD14-15 INJ SAN. By 9/19 @ 9AM pt was complaining of general malaise. Timeline was a steady increase of deep muscle aches and pains beginning in neck and flowing steadily downward thru both arms, spine, ribs, to waistline, as the day progressed. Headache onset by 9/19 @ 3PM. Skin surfaces from waist up to neck progressively sensitive and painful with severe pain @ both injection sites. Pt took temp @ 5PM & 99.6. Treated with 1000mg Tylenol and ice packs on injection sites & joints. Fever increased over evening as did muscle pain accompanied by severe joint pain. On 9/20 pt unable to get out of bed, headache increased, fever increased to 100.5. A local inflammation reaction developed at both inj sites by noon 9/20. It was redness of several inches with pain. Skin treated with ice packs. By evening of 9/20 fever increased to 101.3. Treated with 1250 mg Tylenol. On morning of 9/21 the local reaction at the Quad flu vaccine site had diminished. The local reaction at the pneumovax site increased with severe redness and very hot to the touch. On 9/21 the fever decreased to 99.3 by evening but the pneumovax site persisted with increasing swelling, heat, redness, despite ice packs. That site began severe itching. On morning of 9/22 fever had decreased to 98.8, but the local reaction to Pneumovax continued and is approx. 5 inches long down the bicep and wraps completely around (encircles) the bicep. The lower portion (bottom) of the bicep appears to suffer from edema. Treated with Benadryl gel as it feels more like a local allergic reaction at this point than systemic. Overall, the administration of these two vaccines at the same time caused a significant systemic immune reaction that put a healthy 50 year old man in bed with a fever of 101, with a concern that this could be too much for some immunocompromised or elderly individuals." "50-59 years" "50-59" "544682-1" "544682-1" "Body aches, headache, fatigue with chest congestion for 3 days." "50-59 years" "50-59" "544906-1" "544906-1" "A RED RASH DEVELOPED ON RIGHT ARM BUT NOT IN THE AREA WHERE THE INJECTION WAS GIVEN." "50-59 years" "50-59" "544950-1" "544950-1" "Respiratory distress, runny nose and eyes hoarseness." "50-59 years" "50-59" "544966-1" "544966-1" "Pt reports to have to turned black and blue at injection site immediately after vaccine administration. Pt feels sore and achy since the vaccine has been administered. She will be calling her doctor." "50-59 years" "50-59" "545017-1" "545017-1" "Patient stated her arm swelled up from shoulder to elbow and swelling extended to breast. Patient stated that she did not seek any medical treatment." "50-59 years" "50-59" "545141-1" "545141-1" "SORE SHOULDER LIMITING USE OF MUSCLE LASTING GREATER THAN 1 WEEK." "50-59 years" "50-59" "545197-1" "545197-1" "Pt developed a sore red rash around administration site that was warm to the touch. Pt came back to pharmacy to show pharmist his arm on 9/24/2014. Pt was advised to take Benadryl and monitor for any signs that it is getting worse such as fever, rash spreading, or difficulty breathing." "50-59 years" "50-59" "545450-1" "545450-1" "Rash on entire body from face (including scalp) to ankle. Rash began on torso - entire torso is red. Rash went down both legs getting more diffuse below knee. Neck and arms are blotchy." "50-59 years" "50-59" "545494-1" "545494-1" "Pt states he has had pain at injection site since administered on 9/11/14. He reports burning sensation during administration, and achiness in the left deltoid. Pain continues to today." "50-59 years" "50-59" "545547-1" "545547-1" ""Rash/hive developed on ankles, legs first. Spread to waist, chest, by 9PM same day. 09/29/14 0500 AM - spread to arms, wrist and palm of hands. Red dots varying between 1/16"" and 1/4"" diameter. Itching accompanies rash/hives."" "50-59 years" "50-59" "545614-1" "545614-1" "Patient complaint of vertigo 24hr post vaccination. Complaint of not walking straight." "50-59 years" "50-59" "545644-1" "545644-1" "FEVER; PAIN." "50-59 years" "50-59" "545648-1" "545648-1" "FEVER; PAIN." "50-59 years" "50-59" "545909-1" "545909-1" "Patient states she had pain and swelling in left arm, headache, nausea and vomiting began Wed. morning (9/24/14) and visited P.A. and was prescribed an antibiotic and anti-inflammatory." "50-59 years" "50-59" "545951-1" "545951-1" "Started with body chills, headache, temp 102.8, nausea. Headache lasted 24 hours. Next day when temp went down started to have swelling in her R arm not where vaccines given, lower towards her bicep. Called Dr. office and spoke with nurse for Dr. who reported typical reaction in arm and to call back if worse. By Friday arm was twice the size, redness and hot to touch. Seen by PCP who did not think it was cellulitis, took pt she received 2 unnecessary vaccines and was not happy about pt receiving Flu and Pneumovax 23 in same right deltoid. Was told to take Benadryl and use ice packs. Pt unhappy with PCP response. She called allergist office and spoke with nurse. Not sure this is new allergy to eggs, pt reports eats eggs daily. Recommended that pt receive flu shot be given by allergist next year. Not sure if this is a true reaction to flu shot. Pt reports 20 years ago she had reaction to first flu shot, was dizzy for 3 days. Has had flu shot almost every year since and no problems. Pt will follow up with allergist." "50-59 years" "50-59" "546081-1" "546081-1" "Patient experienced altered mental status, fever, imbalance and lower extremity weakness. Was hospitalized from 9/24-9/26. Discharged 9/26." "50-59 years" "50-59" "546098-1" "546098-1" "Approximately 10 hours after vaccine, developed severe body aches, headache with fever 102 degrees oral. Persisted through 9/25/14; fever broke at 4:00 pm then returned that evening to 100.2 degrees. Seen by private doctor who indicated apparent reaction to influenza vaccine. Obtained lab work and chest x-ray (results not available to us as employer)." "50-59 years" "50-59" "546278-1" "546278-1" "PT SAID SHE HAD FEVER ON 9-29-2014 THEN IT INCREASED TO 100-102 DEGREES. INJECTION SITE HOT /HARD/BLOOD (SHE STATED BLOOD MAY HAVE BEEN THERE PREVIOUSLY) PT STATED CAN'T USE ARM." "50-59 years" "50-59" "546312-1" "546312-1" "Patient was given flu shot about 8:15 am. She then went to help a patient with breathing treatments in his room. She was masked and gloved. When she came out of his room face was red pus bumps, itching on entire face but worse under mask. Today 10/03/2014 went into same persons room and came out red again, itching down arms. sent to ER. Patient was given Solu Medrol in the ER. We are thinking most likely a reaction to patients med he is getting instead of influenza shot. do to after talking with other staff when they are in patients room they start coughing, SOB, watery eyes. But because of also getting flu shot prior wanted to report. Patients medication was a tube of Capsicum Oleoresine with 0.075% capsaicin." "50-59 years" "50-59" "546352-1" "546352-1" "Rash to chest, breast, and neck. Hives." "50-59 years" "50-59" "546449-1" "546449-1" "Angioedema severe, BENADRYL/steroids/Epi at urgent care, no prior hx of reaction to vaccine." "50-59 years" "50-59" "546516-1" "546516-1" "Pt states he experienced body aches and headache and diarrhea and backache a few hours after influenza vaccine was administered. Advised by provider to drink plenty of fluids and take TYLENOL or MOTRIN for body aches. Pt stated he did not plan to do this he will update provider with how he is feeling." "50-59 years" "50-59" "546526-1" "546526-1" "Injection site right arm pain radiating to and into anterior, medial and posterior shoulder joint, including arm pit, elbow and right neck." "50-59 years" "50-59" "546606-1" "546606-1" "Chills same day, next day rash L shoulder, L hand with some swelling, right thigh, right lower leg. Patient relates at this visit did have similar rash 3 years ago s/p flu vaccine." "50-59 years" "50-59" "546617-1" "546617-1" "Itching over entire body, beginning to have blotching/rash on arms and legs. MD notified. Diphenhydramine 50 mg po given with some relief. Sent to urgent care, given Pepcid 20mg po, released to return to work on 10/4/14." "50-59 years" "50-59" "546649-1" "546649-1" "Patient reports soreness at site of injection, fever, night sweats and localized rash to injection site." "50-59 years" "50-59" "546747-1" "546747-1" "Tingling in left arm. Flu Vaccine administered in Left deltoid. No treatment provided at time of report of symptoms. Instructed patient to seek medical attention if symptoms do not go away within 24 hours or get worse. Patient's provider aware as well. Patient reports symptoms resolving at 9:00 PM that same day." "50-59 years" "50-59" "546748-1" "546748-1" "A couple of days after the immunizaiton, the Right arm injection area became red and then itchy and a little blistered, and now has a scab on it. Patient denies any fever, generalized hives, or breathing difficulties. The injection site is at the Right deltoid, and it displays a 1 cm area of erythema, with a central area of dried exudate approx 4mm X 7mm in size. There is no active drainage from the site. There is a very mild amount of induration. There are no areas of redness or tenderness elsewhere on the arm." "50-59 years" "50-59" "546830-1" "546830-1" "3 cm erythema induration tenderness over deltoid injection site. Fever started 24 hrs after inject resolved after 5dys tx's w/ZYRTEC." "50-59 years" "50-59" "546927-1" "546927-1" ""Patient reports small rash that is boot shaped around injection site which is sore and itchy. Reported that when she ate imitation crab and tomato soup the site swelled and reddened more. She felt ""wiped out"" and called in sick to work. She did take Benadryl to help with itching which may contribute to her drowsiness. Reported feeling better today (10/07/2014) but still has a rash."" "50-59 years" "50-59" "546977-1" "546977-1" ""Vaccine ""felt thick"" to patient when injected. Reaction began with arm itching, progressed to all over itching, rash, and wheezing within 10 minutes of vaccination. Rec'd IM Benadryl in opposite arm."" "50-59 years" "50-59" "546990-1" "546990-1" ""Employee states she ""felt hot"", never did take temperature, felt dizzy, was nauseous but never did have emesis, got a headache-migraine like. Symptoms started a few hours after she received vaccine and continued through the next day. States she felt this way last year too after receiving vaccine at her previous employer."" "50-59 years" "50-59" "547092-1" "547092-1" "JUST A FEW SMALL BUMPS ACROSS BACK, THEN ITCHING, SWELLING/WELPS, BUMPS ABOVE SKIN BREAKING OPEN.....SEVERE ITCH. ALSO ACUTE KIDNEY FAILURE, 2 STONES. WENT WED TO ER LEFT HOSP. FRI. 29TH, BACK ON SUN. TIL WED." "50-59 years" "50-59" "547145-1" "547145-1" "Reaction: patient developed erythema, swelling and pain in left arm after injection of influenza and pneumococcal-23 vaccines. Other symptoms include patient reported fever of 102F, and scratchy throat. Management: the patient took diphenhydramine at home with no relief and acetaminophen for fever. The day following vaccination, patient reported to clinic for evaluation. Plan per clinic note to use ice, elevation, and diphenhydramine to treat local reaction. Patient instructed to present to emergency room if symptoms worsen." "50-59 years" "50-59" "547308-1" "547308-1" ""Pt received flu vaccine (FLUZONE Quad) and PNEUMOVAX 23 both same day same arm (1"" apart) 4 days later still had red mark, sore arm, slight raised area."" "50-59 years" "50-59" "547357-1" "547357-1" "Patient called to report that his arm hurts more, he feels like he has a fever and the left side of his face feels tingly." "50-59 years" "50-59" "547367-1" "547367-1" "Blisters at the site with f" "50-59 years" "50-59" "547421-1" "547421-1" "Shot well tolerated, no discomfort. After 30-60 minutes noticed her arm becoming sore at site and radiating down to elbow. Described as severe. Hx similar pain with fibromyalgia years ago, but has had flu shots since then without incident. By next day pain is resolving without treatment. Level 4 or 5 on scale of 10." "50-59 years" "50-59" "547569-1" "547569-1" "Redness, itchy and scaling rash on face only. She took Allegra every day since the reaction and states that rash is getting better." "50-59 years" "50-59" "547592-1" "547592-1" "Patient told physician she had headache, shortness of breath and diarrhea after flu shot." "50-59 years" "50-59" "547886-1" "547886-1" "Patient received Fluzone Influenza Vaccine on 9/25/2014 and 24 hours later developed progressive pain, stiffness and immobility in right arm including neuropathy described as tingling of entire right hand which is ongoing x 3 weeks." "50-59 years" "50-59" "547894-1" "547894-1" "5 hrs after vaccination, employee noted redness and swelling at site; next day redness and swelling continued and began extending down towards elbow. Mild itching and warmth noted. 10/8/14 mild swelling noted below elbow and warm to touch." "50-59 years" "50-59" "547989-1" "547989-1" "Next day patient reports fever of 102 degrees F resulting in the patient staying home in bed. Spot in the right deltoid where PPSV 23 vaccine was administered was reported by patient to be red, warm, sore and inflamed. 72 hours after injection, erythema expanded. Six days after injection, patient was seen by physician, and physician noted erythema with mildly increased warmth. Affected area was from the right deltoid down to the mid humerus for a total of about 18 cm long and 10 cm wide. Physician's recommendations included acetaminophen and cold compresses. Eight days after injection, patient reports symptoms to almost be resolved." "50-59 years" "50-59" "548043-1" "548043-1" "Within 5-10 min of vaccine, large red (pencil-eraser sized) bumps developed from left wrist to shoulder. Initially were flat, but became raised but did not itch. Vaccine site was red, hot, raised. Took diphenhydramine 25 mg po and ibuprofen 400 mg po. Throughout day, ran temp (100 degrees F) and experienced chills x 4-5 hours. Later in the evening rash changed to fine red rash from left shoulder to elbow and did itch. Resembled beat rash. Repeated diphenhydramine and ibuprofen. Rash improved on 10/4/14 -> BENADRYL gel applied and ibup 400 mg x 2. 10/5/14 pm about resolved." "50-59 years" "50-59" "548053-1" "548053-1" "Lymphedema right axilla with radiating pain. History of conjunctival hemorrhages previously." "50-59 years" "50-59" "548108-1" "548108-1" "Swelling occurred after taking flu vaccine in (L) arm. No redness and it's not tender to touch. Swelling under (L) arm and into the (L) side of chest into clavicle area." "50-59 years" "50-59" "548165-1" "548165-1" "Hives, itching began shortly after receiving flu vaccine on 10/1/14. Went to MD - took BENADRYL, received IM SOLU-MEDROL - later took dose pack steroids." "50-59 years" "50-59" "548186-1" "548186-1" "At 2:00 am 9/26/14 started with severe body pains generalized. Unable to move. Next day 7 am started to ease off. Pain continue Rt. leg. Next day 11:00 am symptoms started to ease. Continued with body aches less severe but is taking Ibuprofen q 12 hrs 800mg. Will see provider today 9/29/14." "50-59 years" "50-59" "548238-1" "548238-1" "48 hours - pain in upper arm, numbness lower arm and hand. Red raised site (golf ball) size, red-purple rash on entire upper arm. Headache, joints and body ached." "50-59 years" "50-59" "548418-1" "548418-1" "Pt received influenza vaccine 10/2/14. Called office 10/3 with c/o developing tight chest, red itchy eyes, then cough. Just wanted noted in chart 10/13 presented for office appt, c/o fever, chills, malaise, body ache and headache. Was hypotensive. Received TYLENOL, antiemetic, fluids, improved and sent home. Pt presented to hospital 10/13 in the evening critically ill, was intubated and on meds to maintain BP. She passed away 10/15/14 at 5P of multi-organ failure/septic shock." "50-59 years" "50-59" "548479-1" "548479-1" "Patient got flu shot and pneumonia shot on the same arm per patient's request. Her arm was sore, red and was painful for a couple days. She saw MD and was prescribed for antibiotics and improved. Do not know if that is caused by flu shot or pneumonia shot." "50-59 years" "50-59" "548501-1" "548501-1" "Had flu vaccine on 10-7. States upper lip started swelling about 8:00 pm-9:00 pm last night. No rash. LUA warm to touch. C/O slight headache. Took ASA. Had flu vaccine last 2 yrs. no reaction." "50-59 years" "50-59" "548596-1" "548596-1" """"Immediate burn sensation at site, rash and red below and to side of injection site started that day, some itchiness to rash, lymph nodes sore. Symptoms some better after 3 days without treatment."""" "50-59 years" "50-59" "548606-1" "548606-1" "Muscle aches, muscle weakness - hard time getting up/walking. Fatigue. Headaches. Shivering/chills. Facial swelling." "50-59 years" "50-59" "548734-1" "548734-1" "Patient was complaining that she was unable to walk, having a rapid heart beat and short of breath. Epinepherine was administered IM when patient started showing physical signs of SOB by the nurse practitioner." "50-59 years" "50-59" "548782-1" "548782-1" "Patient came into the pharmacy on Friday, 10/17/2014 at 11:00am to show the pharmacist on duty her left arm where she had received the Zostavax vaccine subcutaneously a week prior (10/10/2014 at 1:00pm). She said that on Monday, 10/13/14 or Tuesday, 10/14/14 she noticed that the site looked a little red and wasn't sure if she was having a reaction to the vaccine or if it could be caused from having the shingles previously. The pharmacist on duty on 10/17/14 looked at the injection site and noticed it there was a red spot about the size of a quarter with what possibly looked like a small blister underneath. There weren't any signs of swelling, puss, warmth, and the patient said she felt perfectly fine expect the site itched a litte. The pharmacy manager that administered the vaccine called the patient the night of 10/17/2014 and she said that the site wasn't spreading and that she thought the redness was starting to go down. She said she did not feel that she needed to seek medical attention and that she just wanted to continue to monitor it. The pharmacy manager called back on Sunday, 10/19/14 to follow up with the patient and she said that the redness was starting to go away and that it was not itching as much. On Monday, 10/20/2014 the patient said that the redness was almost completely gone and the site really didn't itch anymore and that she thought it was pretty much resolved. The pharmacy manager called the patients Doctor's office and spoke to R.N. to let them know about the possible adverse reaction and they said that they would make note of it and to instruct the patient to be seen if the redness doesn't go away, comes back, or gets worse." "50-59 years" "50-59" "548810-1" "548810-1" "One hour after arm achy, later in day feverish, dizzy and nauseated, weak feeling. Cold, sweaty." "50-59 years" "50-59" "548853-1" "548853-1" ""Fever, body aches, patient fainted and bruised lip on fall, next morning still had fever, body aches. Next morning still mild body aches from fall. October 20, felt ""awful"" and reported to employee health with symptoms of concussion."" "50-59 years" "50-59" "548881-1" "548881-1" "Hives all over body." "50-59 years" "50-59" "548912-1" "548912-1" ""Pt received flu shot and could not lift shoulder next day. Went to doctor. MD said shoulder ""bursa punctured"" and Rx steroids were given."" "50-59 years" "50-59" "548985-1" "548985-1" "Genital itching/irritation started 10/9. Treated with Benzocaine 5%/Resorcinol 2% topical ointment for 12 days. Subsequently developed sore throat and congestion starting 10/13. Developed fungal rash under breasts and band of itching/hives on scalp, ears and neck beginning 10/14. Seen by physician 10/15 and started on course of steroids (oral) and fungicide topical ointment. Responding to treatment (rash almost resolved) as of 10/21/14." "50-59 years" "50-59" "549077-1" "549077-1" """"I had a hard lump at the very site of the shot, very red and very hot to touch. Its now 10/21 and still like that but less. Its never happened before and IÆve had the shots before. It was a fairly hard lump and about 3 Inch diameterö."" "50-59 years" "50-59" "549104-1" "549104-1" "Pt. noticed itching, redness, swelling, soreness within 2 hours of vaccination. Iced area. Next day - induration at site with swelling and redness. By 10/10 -> all clear." "50-59 years" "50-59" "549110-1" "549110-1" "Pt developed a hoarse voice and sore throat as well as b/l redness of the sclera about 4 hours after being vaccinated." "50-59 years" "50-59" "549130-1" "549130-1" "Large, swollen red patch at injection site. Redness lasted 1 week. Still having residual mild pain and itching 2 weeks later." "50-59 years" "50-59" "549131-1" "549131-1" "Chills, achy fever of 103.8. Arm re swollen at injection sight." "50-59 years" "50-59" "549143-1" "549143-1" ""On 10/6 patient reported redness and swelling at ZOSTAVAX site. We followed up with the patient on 10/10 when she said she was feeling better but did have trouble breathing after injection. She also mentioned that she has ""a lot of allergies"" that she didn't report at time of vaccination."" "50-59 years" "50-59" "549192-1" "549192-1" ""Patient called stating that her arm where she received the injection has been sore for 3 weeks now. She stated ""I think they gave it to me in my muscle."" This vaccine (Fluarix) is an intramuscular vaccine."" "50-59 years" "50-59" "549226-1" "549226-1" "Received lower dose than recommended by manufacturer." "50-59 years" "50-59" "549304-1" "549304-1" "Pt reports moderate edema, erythema and warmth at site below where IZ was given. Tender but no painful. States less edema, erythema and warmth 10/22/14. Improved from 10/21/14." "50-59 years" "50-59" "549330-1" "549330-1" "Received lower dose than recommended by manufacturer." "50-59 years" "50-59" "549336-1" "549336-1" "Per provider her left arm (Pneumo vac) and right arm (Flu vac) swelled up and developed a rash." "50-59 years" "50-59" "549337-1" "549337-1" "Severe Shingles." "50-59 years" "50-59" "549495-1" "549495-1" "Redness on 10/20/2014. By 10/21/2014 patient had redness + swelling + itching." "50-59 years" "50-59" "549642-1" "549642-1" "10 minutes post flu vaccination, patient presented to nurse with a small hive behind his ear. Nurse provided 1 25 mg tablet of benadryl and advised patient to remain in the room where shots were being administered. After 15 minutes patient returned to his desk to work. When flu clinic ended for the day (5:30pm) nurse returned to patient to check in on him. He said he was fine. This writer contacted patient by phone the next day to follow-up. He said he was fine. Symptoms did not worsen." "50-59 years" "50-59" "549649-1" "549649-1" "Swelled upr arm turned red past elbow, fever, pain. ER doc treated with antibiotics." "50-59 years" "50-59" "549653-1" "549653-1" "Had fever, chills (temp 99.9 degrees F) 5 hours after getting vaccine. Had a splitting headache, sore throat. 3 days later, has symptoms of a cold (congestion, running nose). Other symptoms reduced significantly." "50-59 years" "50-59" "549654-1" "549654-1" "Rash beginning on arm starting below injection site spreading to other arm." "50-59 years" "50-59" "549722-1" "549722-1" "Pt. describes about 7 hrs after receiving vaccine developed chills, couldn't get warm, total body aches, fatigue felt as though she couldn't walk - lasted into next day, (Sat.) but did improve. States has never felt so terrible and has received many other vaccines including flu in the past." "50-59 years" "50-59" "549786-1" "549786-1" ""11 am - vaccine administered. 12 pm - dry ""barking"" cough, throat tickle, felt like ""swallowing razor blades"". 1 pm - throat ""on fire"", chills. 4 pm - unable to open eyes (applied warm cloth x 4 and it helped)."" "50-59 years" "50-59" "549938-1" "549938-1" "While getting vaccine, felt an electric like shock in left arm, with severe pain for 5 mins, and arm hanging limp. Pain resolved, with weakness, with symptoms improving for better daily." "50-59 years" "50-59" "549976-1" "549976-1" ""pt called today at approx. 3 pm and states. ""She"" Received a flu shot on 10/17/14 (afternoon) in the right arm."" She states her ""Right arm was hot to the touch and aches, redness and swelling about a hands with."" Fever of 99 degrees started that night."" She also states she had nausea and a severe headache. She called the doctor office on 10/20/14 - they told her to take BENADRYL - She took BENADRYL for 2 days. She also states that she ""had trouble breathing on Sunday morning (10/19/14) and Monday (10/20/14) till she took the BENADRYL"". ""The swelling in her arm went down Monday (10/20/14). She denied putting ice or heat on her arm. Patient called dr on 10/20/14 and reported the problems. Patient states the doctor told her she was allergic to the flu shot and to take BENADRYL. The patient denied going to the ER or doctor. Patient also states that she has received the flu shots every year since 2011 without incident."" "50-59 years" "50-59" "550048-1" "550048-1" "Hives and itching over most of his body." "50-59 years" "50-59" "550148-1" "550148-1" "Client reports her right arm began to swell and was painful to the touch on the evening of 10/24/14. She states she had fever but never checked with a thermometer. States it hurt so bad it woke her up that night. also reports headache. Began taking Motrin which does relieve the discomfort." "50-59 years" "50-59" "550157-1" "550157-1" "Pt was fine when left pharmacy. Woke up that night with whole upper left arm swollen and warm to touch. Also mild rash. Trouble moving arm." "50-59 years" "50-59" "550183-1" "550183-1" "Swelling under left arm and discomfort in entire arm." "50-59 years" "50-59" "550222-1" "550222-1" "Severe neck and arm pain on side of injection left. Went to ER for treatment on Sat. 10/25/2014 because severe arm and neck pain continued, steroid dose pack given." "50-59 years" "50-59" "550345-1" "550345-1" "Redness swelling and itching to site where vaccine given." "50-59 years" "50-59" "550404-1" "550404-1" "Pt described rash/blister-like on face, when assessed by Dr was diagnosed as shingles." "50-59 years" "50-59" "550463-1" "550463-1" "Light headed, tunnel vision, achy, lethargy. Temp 101.2 x 2 days. Red rash at injection site (3 days after)." "50-59 years" "50-59" "550502-1" "550502-1" "Patient started not feeling well Monday night, states no appetite, chills, arm is very swollen, red, hot to the touch and sore to touch. It has been 4 days and swelling has not gone down. Patient is taking BENADRYL and using ice to resolve swelling." "50-59 years" "50-59" "550524-1" "550524-1" "Patient fainted shortly after flu shot. Requested we call ambulance after resting for 30 minutes. Checked on patient that night and her sister confirmed the hospital said she passed out from not eating and being anxious." "50-59 years" "50-59" "550586-1" "550586-1" "Itching and swelling at injection site." "50-59 years" "50-59" "550660-1" "550660-1" "Swelling and induration with erythemia on the upper brachin reported 3 days after vaccination. Cold compresses, APAP, antihistamines, suggested. Patient resolution attained. (injection site Rxn)." "50-59 years" "50-59" "550687-1" "550687-1" "3 days after vaccine pt came in with redness from inj. site almost to elbow. Mild swelling and warmth. Says started day after administration." "50-59 years" "50-59" "550715-1" "550715-1" ""Approximately 2 days after receiving vaccine, patient noticed generalized rash at site of injection as well as opposite arm and torso. Dermatologist diagnosed him with vaccine related ""viral exanthem"". Not allergic reaction. No hives, no urticaria."" "50-59 years" "50-59" "550855-1" "550855-1" "This case was reported by a pharmacist and described the occurrence of injection site pain in a subject of unspecified age and gender who was vaccinated with FLUARIX Quadrivalent (.5 ml, unknown batch number, left arm). Within days of vaccination with FLUARIX Quadrivalent, the subject experienced pain and soreness at injection site. At the time of reporting, the outcome of the events were unspecified. Additional information received on 06 October 2014: The patient received 1st dose of FLUARIX Quadrivalent (batch number 2KJ3T, expiry date was unknown). On 4th September 2014, less than a day after receiving FLUARIX Quadrivalent, the patient experienced injection site pain and soreness. On 9th September 2014, the outcome of the events were resolved. The reporter considered the injection site pain and pain to be probably related to FLUARIX Quadrivalent." "50-59 years" "50-59" "550890-1" "550890-1" """"...felt like truck ran over me."" At 4 AM on 10/17""...felt my upper body on fire with pressure inside head and face. BS 322, took meds. At 7AM BS 176, felt ""horrible."" At 1300 woke up, shaky and weak BS 140. At 1800 felt normal."""" "50-59 years" "50-59" "550928-1" "550928-1" "Metallic taste, dizziness, nausea, chills, elevated BP 158/108, HR 85 all within 5 minutes." "50-59 years" "50-59" "550935-1" "550935-1" "Patient reported tingling in lower lip and tongue starting at 2:00 pm with subjective fever and joint pain in both knees. When he got home later in the day patient reported that his wife thought his face looked a little swollen. Woke up on 10/24/14 with hives on his back and scalp, but fever, tingling and swelling had resolved. Still has some pain in his knees. Patient then called Health Services to report his symptoms on 10/24/2014 at approx. 1:30 pm. Patient was referred to his private physician who treated him with Zyrtec with good effect. Hives completely resolved by 10/25/2014." "50-59 years" "50-59" "551153-1" "551153-1" "Initially joint pain, general malaise, low-grade fever. Progressed over 2 weeks to itchy rash. Pain most prominent in neck but also felt in hands and knees. Rash most prominent on trunk. Pain helped by ibuprofen by this lead to GI upset. One dose of Celebrex also relieved joint pain. Benadryl cream used at night allows her to sleep but she scratches in her sleep. Has open sores due to scratching. Planning to obtain Zyrtec as cannot tolerate oral Benadryl." "50-59 years" "50-59" "551170-1" "551170-1" "Saturday she felt like she had the flu all day and her arm was red and swollen and hurting." "50-59 years" "50-59" "551191-1" "551191-1" "Fever over 100 and extreme soreness in arm and lack of mobility in arm. Extreme weakness. Fever lasted 4 days, arm soreness is still present after a week. Antibiotic started after two days." "50-59 years" "50-59" "551251-1" "551251-1" "Pt reports within 2 hours of receiving injection, she noticed soreness at the injection site. By that evening, she noticed a hard knot with redness and heat that lasted a couple of days. by 10/31/14, pt continues to have a knot." "50-59 years" "50-59" "551265-1" "551265-1" "Given decreased dose than recommended by manufacturer." "50-59 years" "50-59" "551279-1" "551279-1" "Given decreased dose than recommended by manufacturer." "50-59 years" "50-59" "551280-1" "551280-1" "Approx. 30 minutes after injection developed 103 degree Fever, was weak and shakey. Next am woke with headache; temp was down to 99 degrees." "50-59 years" "50-59" "551292-1" "551292-1" "Started with coughing, then throat constricted, so difficulty breathing and swallowing, continued up the head w/nasal and sinus congestion, red, swollen, bloodshot eyes." "50-59 years" "50-59" "551466-1" "551466-1" "Given decreased dose than recommended by manufacturer." "50-59 years" "50-59" "551470-1" "551470-1" "Given decreased dose than recommended by manufacturer." "50-59 years" "50-59" "551473-1" "551473-1" "Given decreased dose than recommended by Manufacturer" "50-59 years" "50-59" "551493-1" "551493-1" "Itching and Hives on right arm, shoulder, and back - recommended that she seek medical attention and monitoring from a doctor due to her allergic reaction and concern that it could continue into a more severe allergic reaction." "50-59 years" "50-59" "551572-1" "551572-1" "Patient states that left arm was sore after shot (later that evening) the soreness spread down his arm and to his hips and shins over the next week and a half. Patient continues to have pain with increasing discomfort. He complains of no other symptoms and has no redness or swelling at the injection. Pt is also taking CRESTOR. Pt struggles to lift arm and is having difficulty walking." "50-59 years" "50-59" "551581-1" "551581-1" "About 4 hours after receiving vaccine, client developed a bad headache and felt tired. Around 7:30pm had pain, swelling, redness, heat @ injection site and developed a stiff neck. Pt. called physician. 10/28/14 symptoms continued with development of dizziness & fatigue. Redness was about 4.5 inches in diameter. Pt went home about 1:30. 10/29/14-no change. 10/30/14 pt woke up with hoarseness. Redness decreased to 4 inches. Injection site tender and warm to touch. 10/31/14 pt stayed home. 11/3/14 pt improving. Continues with hoarseness and tender to touch." "50-59 years" "50-59" "551687-1" "551687-1" "Left upper arm where pneumovax given area red, painful, and warm to palaption. Diagnosis of cellulitis. Treated with clindamycin for 7 days." "50-59 years" "50-59" "551695-1" "551695-1" "Reports rt shoulder pain following injection with subsequent increased pain and reduced mobility to right shoulder/trouble raising arm above head." "50-59 years" "50-59" "551881-1" "551881-1" "Sudden onset of lightheadedness, vomiting, chills. Followed by 101 temperature and severe whole body ache. Medicated in ER with Zofran, Tylenol and Toradol. Symptoms subsided except for fatique and headache for the next 18 hours." "50-59 years" "50-59" "552032-1" "552032-1" "Within approximately 5 min of receiving Flu shot the recipient felt drowsy and warm on face. Recipient had makeup on so didn't notice rash or skin color changes, nor swelling. At 5:30PM while driving to her home she noticed eyes and face swelling, burning in face and chest pressure." "50-59 years" "50-59" "552055-1" "552055-1" "Pt. received flu shot Sanofi UI 173AB on 10/9/14 and on 10/11/14 woke with swelling, redness and bruising in (L) deltoid area. Rx'd w/Prednisone 10mg x1, BENADRYL 50 mg, TYLENOL 750 mg" "50-59 years" "50-59" "552116-1" "552116-1" "Patient states on 10/17/14 he felt cold, freezing, and achy. Had a fever of 101.7. No appetite. Same symptoms on 10/18/2014. Went to emergency room on 10/19/14. Was admitted and given IV fluids and antibiotics. He states he was not given a diagnosis. Was discharged on 10/21/14." "50-59 years" "50-59" "552170-1" "552170-1" ""Pt received a Flu shot approx 10:20 at campus flu clinic at the law school. She returned to the room where shots were given at approx 10:55 with c/o ""funny breating"". She laid on the couch B/P 114/76 after 76 over."" "50-59 years" "50-59" "552460-1" "552460-1" "Brachial neuritis in right shoulder. Patient was seen by physician in corporate health and is currently receiving physical therapy." "50-59 years" "50-59" "552598-1" "552598-1" "The syringe broke when administering vaccine and spilled the vaccine on the arm of the patient." "50-59 years" "50-59" "553059-1" "553059-1" "Patient presented in the clinic complaining of fever and chills. Temperature reading was 100.8. Patient's right arm was swollen and hot, ANP ordered patient to have ibuprofen 800mg now and to go to ER if symptoms get worse. Pt also given Rx for Amoxicillin and ibuprofen." "50-59 years" "50-59" "553093-1" "553093-1" "9/26 = Left eye became sore to touch; 9/28 = Left eye vision loss; 9/29 = Primary eye MD referred her to ophthalmologist; 9/30 = ophthalmologist ordered MRI due to optic neuritis; 9/31 = MRI completed; 10/2 = Ophthalmologist ordered her to be admitted to hospital for further work-up. She received high doses of steroids and was admitted for 3 days; 11/4 = followed-up with neurologist. Outcome = optic neuritis has improved and she has regained most of her vision in the left eye." "50-59 years" "50-59" "553168-1" "553168-1" "Experienced pain at injection site almost immediately. Ibuprofen taken with some relief. Fever of 101.5 in afternoon of 10/28/2014. Pain radiates down arm when raising arm with burning sensation in lower arm." "50-59 years" "50-59" "553169-1" "553169-1" "Significant myalgias, fever, and increased dypnea requiring resumption of oxygen (had been tapered off the day before)." "50-59 years" "50-59" "553356-1" "553356-1" "Flushing, generalized itching, swelling of tongue. BENADRYL administered and brought to ED. ED observed and administered additional BENADRYL." "50-59 years" "50-59" "553358-1" "553358-1" "Guillain-Barre Syndrome." "50-59 years" "50-59" "553379-1" "553379-1" "Itching of face and neck at 1:20 pm itching of ear at 1:28 pm. Blood pressure 145/88 pulse 67 at 1:30 pm. Itching improved, but felt hot, flushed in face/neck. Took 25mg diphenhydramine, decreased itching. 4:00 pm felt fine and itching stopped." "50-59 years" "50-59" "553475-1" "553475-1" "Left shoulder pain and limited movement from flu shot on 10/27/2014. States that the pain started an hour after the flu shot was given and slowly and progressively increased at the left deltoid and shoulder." "50-59 years" "50-59" "553570-1" "553570-1" "Pt's wife called in AM saying pt had hives 1 day post vaccine - 11/10/14. She said pt will come in to ask for how to treat hives - pt came later and showed me his hives - per back of head -> toe, arms, body -> told pt to get BENADRYL and see MD in 2 days if Sx's not persisted." "50-59 years" "50-59" "553729-1" "553729-1" "Employee states he had severe pain at injection site in left deltoid and pain with raising his arm shortly after Flu shot administered. He did not report s/s for 2 weeks at which time s/s improved but remained painful. At 4 weeks Ee still complains of pain in deltoid and pain with raising arm. No swelling, redness, hematoma seen or palpated." "50-59 years" "50-59" "553768-1" "553768-1" "The patient was seen 10/12/14 in Emergency Room with a swollen red painful left upper arm. He had a pneumonia shot and a tetanus shot in that arm on 10/10/14. That evening he began having shaking chills and malaise. His wife said that 10/11/14, he sat under a blanket all day because he was so cold. He had no fever. There is an area of cellulitis extending from 4 cm below the injection site under the arm and up to the top of the shoulder. The area is red and warm and tender. CBC was normal, Rocephin administered, also instructed to continue with Bactrim (taking for R hand infection-unrelated). Follow-up exam with PCP the 10/13/14 - no change in treatment." "50-59 years" "50-59" "553885-1" "553885-1" "Red on entire back of upper arm, itchy, hot/warm to touch. Started 11/11/14 got gradually worse." "50-59 years" "50-59" "553907-1" "553907-1" ""Patient had pain upon admission of FLUZONE QUAD. A prefilled syringe was used with a 1"" needle. Pain and loss of arm function was reported. Patient saw her physician, 8 days after administration. She was diagnosed with SIRVA. She was treated with oral steroids and physical therapy. Pain is slowly getting better but still continues."" "50-59 years" "50-59" "554070-1" "554070-1" "C/O NAUSEA/VOMITING, STOMACH ACHE, COUGH, CHILLS. DEVELOPED SEVERE SORENESS AT INJECTION SITE BY 6:00AM. DENIES ERYTHEMA." "50-59 years" "50-59" "554073-1" "554073-1" "Pt had swelling, redness and tenderness around injection site. Area was warm to the touch. Arm is improving." "50-59 years" "50-59" "554233-1" "554233-1" "Pain in arm (left) day 2 was swollen no longer swollen, no redness. Pain continues." "50-59 years" "50-59" "554261-1" "554261-1" ""Starting feeling ""strange"". Itching all over, red splotchy areas over chest area. Lips itchings, throat sore. Treated with Benadryl 50 mg IM."" "50-59 years" "50-59" "554378-1" "554378-1" "At time of flu administration, patient states she felt a burning sensation going down her arm. 5 hours after getting the flu shot, she experienced a sudden onset of vomiti (1 episode) followed by lightheadedness, diaphoretic and low grade fever. She states she developed pain & a lump (size of half dollar) at the injection site. The pain radiated up & down her arm and was constant. She took Ibuprofen 6oomg BID with minimal result. She notified NP 11/04/14. She was advised to take Ibuprofen 800mg TID and call if no improvment. Patient was evaluated 11/14/14 after no improvement. Ultrasound was completed and results were no abnormalities. Recommend that she uses warm compresses to the area." "50-59 years" "50-59" "554782-1" "554782-1" "Pt reports red, raised itchy area at injection site where ZOSTAVAX given." "50-59 years" "50-59" "554794-1" "554794-1" "Pain radiating up and down left arm-arm of injection." "50-59 years" "50-59" "554939-1" "554939-1" "Patient called pharmacy on 11/5/14 (6 weeks after vaccine administered). She had no visible injection site reaction, but said she is having severe, sharp pain at injection site, especially when reaching back or applying pressure to site. Relieved by ibuprofen, but she refused doctor visit." "50-59 years" "50-59" "555020-1" "555020-1" "Patient complained of itching at the injection site. Redness was noted at the injection site. The event occurred approx 10 minutes after the patient received the vaccine. The MD evaluated the patient." "50-59 years" "50-59" "555071-1" "555071-1" "Received flu vaccine 9/8/14 developed chills, T. 100.2, low backache on 9/15/14 developed rash from knees down bilaterally and pain. Seen at ED on 9/15/14. Seen by PCP 9/16/14 referred to Derm 9/16/14 skin biopsy result vesicular rash. Seen by Rheumatology 9/17/14 blood work positive cryoprotein. Started on Prednisone final Dx autoimmune response to flu vaccine start Rituximab infusion 11/29/14." "50-59 years" "50-59" "555172-1" "555172-1" "Noted mildly raised, erythematous skin lesion at area of injection site of approximately 2-3 cm. + significant itching. No fluctuance. + improvement of itching with Benadryl. Recommend triamcinolone 0.1% lotion appy 2-3 times per day x 4-5 days." "50-59 years" "50-59" "555253-1" "555253-1" "Extreme, severe, acute chest pain. It started suddenly and I was in such distress that my husband had to rush me to the ER. Then I was transported to Hospital to the PCU." "50-59 years" "50-59" "555290-1" "555290-1" "Right arm swelling et itching-started 11/19/14. Tx-BENADRYL et warm compress." "50-59 years" "50-59" "555485-1" "555485-1" "Day after administration patient said she had a red, swollen, sore arm. Around 11/07/2014 she began to develop a rash on her trunk and legs. She called the office to notify us. Per Dr she was instructed verbally to use Benadryl and see if this helps. She then called back on 11/21/14 saying that it was not any better and spreading. We asked that she schedule an appointment but patient was unable to come in until 11/25/14. Therefore, Dr went ahead and called in Methylprednisolone. She came in for her appointment today and it is getting better." "50-59 years" "50-59" "555641-1" "555641-1" "11/7/14 Received flu vaccine in upper left deltoid. Shoulder pain decreased mobility has slowly increased. Unable to raise left arm over shoulder. Unable to step on left side." "50-59 years" "50-59" "555680-1" "555680-1" "Light raised red rash involving tops of thighs, elbows and knees - very itchy. This then progressed to systemic rash, initally itchy and dry, then very heavy skin flaked off entire body followed by 7 days of burning (on fire) skin condition. Now on 3 weeks of steroids." "50-59 years" "50-59" "555685-1" "555685-1" "Strong pain at injection site during the full injection. Continued pain still. Pain runs from injection site of front for arm down to left thumb, sometimes sharp pain. Have weakness and pain in shoulder, bicep and hand. Continues." "50-59 years" "50-59" "555775-1" "555775-1" "This case was reported by a consumer and described the occurrence of flu-like symptoms in a female patient who received FLULAVAL QUADRIVALENT(batch number XP4J2, expiry date 30th April 2015). Previously administered products included flu vaccination with an associated reaction of influenza like illness. Concurrent medical conditions included blood pressure high, lymphoma and drug allergy (allergy to Sulfa). Concomitant products included alprazolam and PNEUMOCOCCAL VACCINE. On 24th October 2014, the patient received FLULAVAL QUADRIVALENT. On 24th October 2014, 0 min after receiving FLULAVAL QUADRIVALENT and an unknown time after starting TYLENOL, the patient experienced flu-like symptoms, fever, dehydrated and woozy. The patient was treated with medication unknown (Fluid) and TYLENOL. On 27th October 2014, the outcome of the flu-like symptoms, fever and dehydrated were recovered/resolved. On an unknown date, the outcome of the woozy was unknown. The reporter considered the flu-like symptoms, fever, dehydrated, and woozy to be not reported if related to FLULAVAL QUADRIVALENT. It was unknown if the reporter considered the flu-like symptoms, fever, dehydrated and woozy to be related to FLULAVAL. Additional information: With her recent Lymphoma diagnosis, patient's physician recommended a flu shot. The concomitant pneumococcal vaccine was given on 24 October 2014. The patient indicated that on 24 October 2014 during the night or early in the morning she got up to go to bathroom and felt extremely dizzy. She felt like she could have had fever but she did not take her temperature at that time. She also felt woozy and went back to bed. When she got up next morning, she indicated that she felt like she had the flu and slept most of the day. She indicated that she felt a little better that night. The next morning, she still didn't feel right, got panicked and took her temperature (101.2 Deg F). Since she was recently diagnosed with lymphoma she called her oncologist. The oncologist advised for her to go to the emergency room. At the emergency room she was given fluid and TYLENOL and her fever was within the 100 Deg. F-range. She indicated she was very dehydrated, blood tests were run. She followed up with her oncologist the next day. Refer to case US2014GSK023485 for tolerance to previous vaccination." "50-59 years" "50-59" "555777-1" "555777-1" "This case was reported by a nurse and described the occurrence of hives in a 51-year-old female patient who received FLUARIX QUADRIVALENT (batch number 3JE9F, expiry date 30th June 2015). Concomitant products included NEXIUM. On 25th September 2014, the patient received FLUARIX QUADRIVALENT .5 ml. On 27th September 2014, 2 days after receiving FLUARIX QUADRIVALENT, the patient experienced hives. On 28th September 2014, the outcome of the hives was recovered/resolved. The reporter considered the hives to be possibly related to FLUARIX QUADRIVALENT. Additional information received on 30 September 2014: The patient had not known relevant medical history. She had already received previous vaccinations and previous fu shots but all without previous reactions. She did seek treatment at the emergency room. This is one of the 3 reports received by the sane reporter for the same vaccine." "50-59 years" "50-59" "555797-1" "555797-1" "After Flu vaccination, severe peripheral neuropathy developed within two days, requiring patient to be hospitalized for pain control, life monitoring, symptoms continue to progress, suspected CIDP or Guillain-Barre syndrome acquired." "50-59 years" "50-59" "556039-1" "556039-1" "First told pharmacy of pain in her Right shoulder on 11/9/14. She did not say when the pain initially started, but that she was in pain on 11/8/14. She said she had decreased range of motion. She asked her physician about it at a previously scheduled appointment. Her physician said to keep using her arm, it would feel better. She continued to complain of pain and decreased range of motion in her left arm. She went to see her doctor again due to level of pain and continued limited range of motion on 11/18/14. At this time, her physician referred her to an orthopedic doctor and told her to avoid using her arm and prescribed pain relievers. She saw the orthopedic doctor on 11/20/14. She received a shot in her arm from that doctor and was told to rest her arm and referred for outpatient physicial therapy." "50-59 years" "50-59" "556213-1" "556213-1" "Reports a few hours after receiving the flu shot noted pain in the joint. Rated the pain at a level of 6 (six) on a scale of 1-10 where 10 is the worst pain. Took Tylenol and took Ibuprofen a few hours after that. Reported medication helped but reported she experienced more weakness in her arm. Reported has an appointment to see MD on 12/02/2014. Reported pain comes and goes. Reports disconfort in the joint - points to shoulder joint in upper arm. Reports sometimes experiences weakness in hand." "50-59 years" "50-59" "556332-1" "556332-1" "Received flu vaccine at 10:00 A - no immediate reaction. Three hours later, fever spiked to 103.8 degrees. Severe body aches mid-torso and legs causing difficulty breathing and ambulating. Taken to emergency room for IV fluids and antipyretics." "50-59 years" "50-59" "556546-1" "556546-1" "Shivers, chills, shaking spells, episodes of feeling cold, fatigue, washed out, malaise for 2 days." "50-59 years" "50-59" "556789-1" "556789-1" "0905 immediately following the influenza vaccination he had an area of induration, warmth and erythema at the injection site. Given diphenhydramine 25mg. Within 7-10 minutes post injection he only had induration remaining." "50-59 years" "50-59" "556795-1" "556795-1" "This case was reported by a physician and described the occurrence of tremors in a 55-year-old female patient who received FLUARIX QUADRIVALENT (batch number GA22N, expiry date 30th June 2015). Previously administered products included influenza vaccine. Concurrent medical conditions included raised liver function tests, infectious mononucleosis and cytomegalovirus infection. On 17th October 2014 14:37, the patient received FLUARIX QUADRIVALENT. On 17th October 2014, 2 hrs after receiving FLUARIX QUADRIVALENT, the patient experienced tremors (serious criteria disability). On an unknown date, the outcome of the tremors was recovering/resolving. The reporter considered the tremors to be possibly related to FLUARIX QUADRIVALENT. Additional information: The subject didnÆt experience any events following previous vaccinations. Within 2 hours of vaccination, the patient experienced extreme tremors. She has therefore been out of work for 1 month. The patient consulted a neurologist and the reporting physician. At the time of reporting, the concurrent medical conditions were resolved and the liver function test was normal." "50-59 years" "50-59" "556811-1" "556811-1" "Patient called the evening of 12/3/14 and stated that she had an adverse reaction to the flu vaccine. She stated that her arm had been painful since the vaccine was administered making it difficult to sleep, wash her hair, and dress herself. She stated that she contacted her PCP who gave her some medication to reduce inflammation. She still has not had relief and stated she was going to have xray/CT/MRI later this week. We advised her that we would report the incident to the CDC and encouraged her to continue to follow up with her PCP and keep us informed of her condition." "50-59 years" "50-59" "556885-1" "556885-1" "(L) arm red swollen warm to touch about five inches long. Sore painful to touch. Took 10 days to totally feel better. Got a little better each day." "50-59 years" "50-59" "556988-1" "556988-1" "Myalgia, weaknrsss, unable to work." "50-59 years" "50-59" "557080-1" "557080-1" "Seen in our clinic 2 days after injection w/local redness, swelling and itchiness and injection site. Treated w/BENADRYL." "50-59 years" "50-59" "557198-1" "557198-1" "Redness, pain, itching, swelling at the injection site." "50-59 years" "50-59" "557266-1" "557266-1" "Sore left arm that improved briefly then started hurting and being somewhat weak. Got steroid injection which helped a little briefly. I am doing physical therapy but symptoms continue. Upper arm pain, muscle spasms, reduced ROM. Arm pit pain too." "50-59 years" "50-59" "557306-1" "557306-1" "Rash across the chest (collar bone) itchy, red, itchy all over the body from head to toe, muscle aches, irritated left arm." "50-59 years" "50-59" "557333-1" "557333-1" "Complains of redness, swelling right arm deltoid. Tender to touch, small red bumps; itchy area outside of injection and over deltoid area. Hard area at site of injection." "50-59 years" "50-59" "557435-1" "557435-1" "Cellulitis of left arm following administration of influenza vaccine and Tdap vaccine in left arm on 12/2/14. Treated with Keflex tid for 10 days on 12/5/14." "50-59 years" "50-59" "557760-1" "557760-1" "Patient experienced soreness and tenderness in the armpit on the same arm the vaccine was administered in the next morning. The swelling improved every day and is now gone." "50-59 years" "50-59" "558087-1" "558087-1" "Dizziness, nausea, sweating, headache, felt like she was going to consciousness." "50-59 years" "50-59" "558091-1" "558091-1" "Pain at injection site. Inflammation, pain in joints, loss of mobility, muscle wasting, weakness, extreme tiredness." "60-64 years" "60-64" "515880-1" "515880-1" "Redness of arm about 3 inch in diameter, hot." "60-64 years" "60-64" "516052-1" "516052-1" "10 minutes after vaccine patient complained of dizziness and feeling warm. Pt was shopping store when this occurred. I advised her to be seated and checked her BP (140/82 Pulse: 65). Husband came to pick her up." "60-64 years" "60-64" "519592-1" "519592-1" "Pain and rash on right side of upper back, axilla, and lateral right breast." "60-64 years" "60-64" "520075-1" "520075-1" "Upper left arm very sore; could not sleep on left side. 1/18/14 - (8:30 AM) body aching; muscle weakness. Symptoms progressively got worse. By noon time extreme nausea, chills, shivering; fever began and body pain intensifying. Fever up to 100.5 @ 4:30 pm. Migraine began. Did not medicate due to extreme nausea. Took Phenergan & 500 mg Aspirin. By 10:00 PM body pain worsening and nausea intensifying. Sun 1 AM 1/19/14 (1) phenergan & 500 mg more aspirin. Fever still 100.5. Fever broke during night with severe sweating. 1:10 PM 500 mg Aspirin & (1) Phenergan; 3:30 pm fever back up to 100.4; took (2) Pepto-Bismol caplets. 7:15 pm Body pain excruciating; 600 mg. Ibuprofen. 8:30 pm severe vertigo/dizziness occurred. Unable to move; broke out in cold, clammy sweat; duration - 5 mins. Mon 1:50 am 400 mg Ibuprofen and (1) Phenergan. Fever broke again during night. 10:55 AM Mon 1/20/14 400 mg. Ibuprofen. Severe muscle pain subsided." "60-64 years" "60-64" "521438-1" "521438-1" "Pt states arm is painful at all times and pain increases upon movement. The pain is not improving and the shot was given 18 days prior." "60-64 years" "60-64" "521636-1" "521636-1" "Vaccine administered 1/3/2014, within 96 hours patient experienced extreme vomiting, nausea and vomiting that lasted 7 days." "60-64 years" "60-64" "521637-1" "521637-1" "Vaccine (Quadrivalent flu vaccine) administered 1/6/14. Patient experienced severe nausea vomiting, diarrhea that lasted 6 to 7 day." "60-64 years" "60-64" "530537-1" "530537-1" "Patient reports her arm became red and swollen immediately after flu shot and within a few days her arm became stiff and almost frozen. She did not report problem until March 21." "60-64 years" "60-64" "539353-1" "539353-1" "Patient had severe nausea, vomiting, and diarrhea." "60-64 years" "60-64" "541830-1" "541830-1" "Fever (<102.8), chills, general body and head ache and soreness, lasting until morning of August 26. Fatigue gradually lessening as of 8/29." "60-64 years" "60-64" "543495-1" "543495-1" """"Awful muscle pain/aches/chills/fever for 48 hr period""."" "60-64 years" "60-64" "544132-1" "544132-1" "Pt called pharmacy on 9/17/2014 at 9:30am stating arm at injection site was swelling and inflammation at injection site. Told patient to apply a cold compress to site and recommend analgesic (i.e. APAP) and antihistamine if no contraindication or drug interaction and to also contact PCP. If it gets worse to seek medical attention. I contacted the PCP however office is closed on Wednesday. Will try again next day. Patient came in at 2:45pm to show arm. Arm was bruised and red around injection site. She did state she bruised easily." "60-64 years" "60-64" "544535-1" "544535-1" "Patient reported experiencing nausea/vomiting and hoarseness approximately 4 hours after receiving two immunizations. Hoarseness continued into following day." "60-64 years" "60-64" "544652-1" "544652-1" "(R) arm red area 4 1/4 in x 3 in, swollen area. Hot to touch, painful to touch. Arm sore to use, pain into neck causing headache, unable lay on (R) side." "60-64 years" "60-64" "544905-1" "544905-1" "Patient felt a tingling up and down her arm and into her fingers as soon as the shot was administered. Started feeling nauseous and light headed. Patient was given crackers and drink and she sat down for about 30 minutes. She started to feel better and said the tingling got better, then left." "60-64 years" "60-64" "544917-1" "544917-1" "Pt states has continued Left arm pain since recieving flu shot and vitamin B12 injections." "60-64 years" "60-64" "545202-1" "545202-1" "Patient developed a hard bump after vaccination. About the size of a golf ball. Patient did have a small dribble of blood after vaccination but nothing more than I have seen prior, but this is the first time that I noticed a large bump afterwards. Checked with the patient an hour later and bump was still present. Patient did not complain it hurt but I did mention to him that it will probably be black and blue and sore eventually." "60-64 years" "60-64" "545672-1" "545672-1" "Low grade fever, excessive mucus leading to vomiting and weakness, on going cough. I had to call in sick on 9-26-14 too weak to drive to work." "60-64 years" "60-64" "545868-1" "545868-1" "4 cm area red et warm adjacent to injection site." "60-64 years" "60-64" "546347-1" "546347-1" "Immediate swelling, bruising." "60-64 years" "60-64" "546409-1" "546409-1" "Immediately after the vaccine was administered, the patient's arm turned blue and purple. The discoloration spread and did not improve over the following 2 days. A knot formed under the skin where the injection entered the arm. There was also prolonged pain associated with the injection." "60-64 years" "60-64" "546589-1" "546589-1" "Patient c/o pain in left shoulder, and inability to raise arm above head." "60-64 years" "60-64" "546686-1" "546686-1" "Patient felt like passing out 9.30.14 dizzy - 9.30.14. Headache 10-1-14 in am. Not feeling well, foggy 10-1-14 am." "60-64 years" "60-64" "546764-1" "546764-1" "Swollen lymph nodes especially on the side that flu vaccine administered. Hard glands." "60-64 years" "60-64" "546827-1" "546827-1" "Migraine for 6 days, body aches, chills, sore throat, earache, anorexia, dizzy." "60-64 years" "60-64" "547001-1" "547001-1" "Rash on bilateral upper extremities, chest, back and neck. Took 50mg of Benadryl PO." "60-64 years" "60-64" "547148-1" "547148-1" "Reaction: patient developed flu-like symptoms (nausea, chills, diarrhea, headache, fatigue, dizziness, and body aches), injection site warmth and swelling approximately 6 hours after receiving the pneumococcal-23 and influenza vaccines in the same arm. Management: Patient refused appointment and therefore received care at home to manage symptoms. Instructed to seek urgent care if symptoms worsened." "60-64 years" "60-64" "547702-1" "547702-1" "Decreased range of motion in left arm." "60-64 years" "60-64" "547785-1" "547785-1" "NOTICE PINCHING PAIN IN LEFT SHOULDER AREA [NOT INJECTION SITE], FEELS LIKE A PULLED MUSCLE THAT MIGHT ERUPT IN PAIN, BECAME SHOCKING, STABBING, TAKE YOUR BREATHE AWAY PAIN THAT INVOLVES SHOULDER OVER TOP OF SCAPULA, RADIATES OVER CLAVICLE OVER TO ROTATOR CUFF..THE WHOLE AREA ERUPTS IN PAIN. CAN BARELY BEATHE. THIS HAS CONTINUED TP PRESENT, THOUGH THE PAIN LEVEL NOT ALWAYS 10/10. ALSO HAVE DISCOMFORT AT INJECTION SITE THAT I DESCRIBE AS DEEP ACHING AT SITE, DOWN OVER ELBOW AND DOWN OVER THE MUSCLE ON TOP OF FOREARM. THIS HAS BEEN A CONTINUOUS LEVEL 4-5/10 EVERY DAY SINCE I FIRST NOTICED IT ON 10/1/14. I SENSE A MUSCLE WEAKNESS THAT WAS NOT PRESENT BEFORE." "60-64 years" "60-64" "548045-1" "548045-1" "Developed infection. Cellulitis. (Also Diabetic). Incrased blood glucose. Missed 1 week work w/blood glucose probs (395 mg/DL)." "60-64 years" "60-64" "548064-1" "548064-1" "Extreme lethargy. Slept 8 hours during the day and another 9 hours that evening. this reaction is not life threatening but I thought I should report it anyway." "60-64 years" "60-64" "548291-1" "548291-1" "Employee states she woke with a swollen arm, with redness and warmth to the touch. She presented to Occupational Health Clinic and was referred to her MD who treats her lupus." "60-64 years" "60-64" "548328-1" "548328-1" "TOTAL BODY RASH-WITHIN 10 MINUTES. GETS FLU SHOT EVERY YEAR NO PROBLEM THIS YEAR GOT QUADRAVALENT." "60-64 years" "60-64" "548363-1" "548363-1" "Swelling at injection site after patient was fiven the Fluzone Quad injection. Swelling was immediate and about a quarter in size. Cold compress was applied at the injection site for about 15 minutes and patient was advised to take acetaminophen or a non-steroidal anti-inflammatory drug if swelling persisted or pain began. Patient said he had no pain at all at injection site. Also advised patient that he could apply a cold compress at home if needed." "60-64 years" "60-64" "548920-1" "548920-1" "Ringing in right ear. Slight loss of hearing. Pins and needles sensation on right side of face and scalp." "60-64 years" "60-64" "549097-1" "549097-1" "Arm became red, slightly swollen and hot and itchy near injection site. The reaction slowly went down the arm and cleared near the site over the course of about 2 weeks." "60-64 years" "60-64" "549317-1" "549317-1" "The patient is a 63-year-old female who was in her usual state of good health until 48 hours ago. On Friday 10/10, the patient received immunizations here at flu clinic. She received an influenza immunization in her left arm and received a pneumococcal immunization in her right arm. The patient qualified for a PNEUMOVAX-type immunization because of underlying respiratory problems, namely subglottic tracheal stenosis and remote history of TB. The day after immunization, the patient arose and attempted to walk her dog first thing in the morning She became quite weak. She was tachycardic. She just did not feel well. She returned home. Later that evening she noted the right arm (the site of the pneumonia immunization) was beginning to hurt. Then yesterday, 48 hours after immunization, the right upper arm became more red and tender. The patient was still quite weak and unable to get down the staircase in her home unless she stopped to rest. Her spouse called me last night and we arranged for her to be seen this morning. Her symptoms have not abated. She denies any cough. There is no chest pain, shortness of breath or bowel dysfunction. No irritative voiding symptoms or backache. She just feels weak and gets easily breathless." "60-64 years" "60-64" "549325-1" "549325-1" "Received lower dose than recommended by manufacturer." "60-64 years" "60-64" "549340-1" "549340-1" "Getting progressively weak and painful in left arm (arm where received flu shot). Hard to get arm above shoulder height without turning the arm. Had a similar experience with flu shot 2-3 years ago (didn't report that one)." "60-64 years" "60-64" "549674-1" "549674-1" ""Patient complained of severe arm pain, could not remove her work smock, high tolerance to pain (stated by patient), ""but this really hurts"", left arm."" "60-64 years" "60-64" "549766-1" "549766-1" "Swollen and red around injection to around front of the arm, painful, heat/hot to touch pain lasted 3 days and heat/inflamation for 5-6 days. (left arm) - patient did not report til 10/16/14. No treatment occurred." "60-64 years" "60-64" "549861-1" "549861-1" "Severe itching at injection site, that became generalized all over body - face became red and hot to the touch. Given IV BENADRYL and IV steroid to counter act." "60-64 years" "60-64" "549919-1" "549919-1" "General malaise escalated to painful body aches, fever, chills, weakness over the next 24 hours. Adverse events ended after 24 hours." "60-64 years" "60-64" "549979-1" "549979-1" "Fever (hot, no temperature taken). Arm achy, arm is itching. Circular, red, swelling around injection site. Signs/symptoms have escalated since date of injection 09/29/2014. No treatment - except aspirin 325 not scheduled dosing." "60-64 years" "60-64" "550065-1" "550065-1" "After 4 hours pain in shoulder which increased over time and radiated up to back of head. Physician diagnosed neuritis." "60-64 years" "60-64" "550067-1" "550067-1" "3 days 100-103 degrees temp fluctuating. Knot at site of flu vaccine." "60-64 years" "60-64" "550659-1" "550659-1" "Induration and swelling with erythremia on majority of inner upper Brachium L. Painful to touch. Advised cold compress, APAP, Antihistamine. Follow up post 8 days. Reduced swelling and erythremia. Resolving (injection site rxn)." "60-64 years" "60-64" "550663-1" "550663-1" "The next morning when I woke up I had Vertigo and Nystagmus." "60-64 years" "60-64" "550968-1" "550968-1" "About 7 hours after her injection she noticed a knot developed and pain at the base of her neck. It was the same side as the injection. She described the pain and knot as the same as she was feeling in her shoulder from the shot. Today she says the pain is resolved, however the knot is still mildly present. She did not seek medical treatment." "60-64 years" "60-64" "551078-1" "551078-1" "Right ear felt full, next day decreased hearing at 3000 Hertz noted and placed on Prednisone with complete resolution within two days." "60-64 years" "60-64" "551089-1" "551089-1" "Patient experienced a very sore arm even at rest, she was in discomfort." "60-64 years" "60-64" "551158-1" "551158-1" "Denies any flu-like symptoms or GI problems. Reports hoarsness but no sore throat. Reports progressive pain and swelling of joints of hands, knees and ankles. Initially just achiness but progressed to severe throbbing pain mostly in hands and wrists. Unable to make a fist at the worst point. Accompanied by burning and numbness of lower extemities and fatigue. Pain not relieved with advil alternating with Tylenol or by hot/cold. Improving with prednisone." "60-64 years" "60-64" "551233-1" "551233-1" "Pt noticed arm sore that evening. Next day, noticed unusual redness, swelling, tenderness and itchy that lasted 2 days. By 10/31/14, much improved." "60-64 years" "60-64" "551242-1" "551242-1" "Pt reports very painful injection. Pt states the injection site immediately felt sore. Within 2 hours, she noticed a large hard knot, redness and heat at injection site. On 10/28/14, area remained red (3 inch area), hot, tender to touch and hard knot. By 10/30/14, reports redness (about 1 1/2-2 inch area), tenderness and heat had decreased but still present." "60-64 years" "60-64" "551320-1" "551320-1" "12 hours after administration. Fever approx. 102 F, headache, chills, diarrhea, cold symptoms." "60-64 years" "60-64" "551467-1" "551467-1" "Given decreased dose than recommended by manufacturer." "60-64 years" "60-64" "551474-1" "551474-1" "Given decreased dose than recommended by manufacturer." "60-64 years" "60-64" "551479-1" "551479-1" "Given decreased dose than recommended by manufacturer." "60-64 years" "60-64" "551515-1" "551515-1" "7 hours after receiving vaccine was more sore than expected and next day it was worse. By 10/5 pain settled in shoulder and it was worsening. 10/6 went back to doctor, he was no sure what was wrong. TYLENOL did not help. 10/14 orthopedic doctor is not sure what is going on got an x-ray. Sent her to physical therapy." "60-64 years" "60-64" "551656-1" "551656-1" "Pain in deltoid muscle that radiates to upper shoulder, upper back and neck. Difficulty lifting arm. Symptoms present for 4 weeks. No signs of infection." "60-64 years" "60-64" "551830-1" "551830-1" "Pain in left arm upon movement and painful to touch, with reduced range of motion and weakness of the left shoulder and arm." "60-64 years" "60-64" "552008-1" "552008-1" "Patient received flu vaccine and shingles vaccine on 10/6/14. Patient reporting chills, fever, aching and nausea from 10/13/14 - 10/15/14." "60-64 years" "60-64" "552059-1" "552059-1" "As soon as she gave it felt burning in arm so took ibuprofen. Around 1pm arm was really hurting so took MOTRIN. Hurting through Sunday. Sunday night had temp because felt like if sweating. Both arms get numb and tingly which continued for 4 days. Hands ice cold when this happened. Went to employee care on Wednesday but was told it could not be related to vaccine. Still get back and forth tingling on arms but 10/7 joint and muscle pain started, also felt exhausted. Yesterday was first day without numbness and tingling but it came back today." "60-64 years" "60-64" "552217-1" "552217-1" "Decreased vision OD > OS related to optic neuropathy - likely optic neuritis." "60-64 years" "60-64" "552464-1" "552464-1" "Bell's palsy." "60-64 years" "60-64" "552578-1" "552578-1" "Pt called at 5:15 PM reported her arm hurt yesterday at injection site and now pain had settled in her spine." "60-64 years" "60-64" "552593-1" "552593-1" "Patient called the clinic and stated that on the 30th of October she had pain at the injection site, red sleepy eyes, red cheeks, ticklish cough, chills, Temp 102 and extreme fatigue. Adversely affected her brain, numb feet and a few seconds she couldn't recall but she fell from the toilet seat. She looked at her hands the next day and they looked unfamiliar to her. Took days for normal brain function to return." "60-64 years" "60-64" "552835-1" "552835-1" ""Approximately 24 hours post immunization, swelling, fever, redness measuring 4-6"" across injection site extreme pain at site (RA). Full body fever and sweat/chills the night before presented to immunization for follow up."" "60-64 years" "60-64" "552995-1" "552995-1" "Given FLUZONE Quadrivalent at 9:30 am 11/6/14. By afternoon: c/o hoarseness, dry cough, HA, red eyes. By evening: increased fatigue, scratchy throat, runny/stuffy nose and eyes which got red and crusty. Felt better evening of 11/6/14. 11/7/14: resolved." "60-64 years" "60-64" "553062-1" "553062-1" "Fever, Nausea for 4 days." "60-64 years" "60-64" "553094-1" "553094-1" "Day after Flu Vaccine was administered, patient's left arm became swollen, red and painful. 3-4 days later, a bumpy, itchy, red rash developed near the injection site and soon spread to right arm. On Nov 02, 2014, rash appeared on front and back of both legs. Patient saw dermatologist on November 2, 2014 and a biopsy was done. Patient received a diagnosis of eczema, acute hyperimmune reaction to the flu shot." "60-64 years" "60-64" "553167-1" "553167-1" "Patient expereinced redness/rash that covered a wide area." "60-64 years" "60-64" "553493-1" "553493-1" "The next day I realized I had difficulty sleeping on my left side as my arm up near the injection site was quite sore. This has continued since that time. I have difficulty raising my arm, lifting anything with that arm and cannot put any pressure on it like sleeping. it is worse during the night. This is continuing since I was given the Fluarix Quadrivalent injection. It was not placed intramuscularly but rather on the soft part of my arm. I have never had any reaction like this before. It is very debilitating. On 11/11/2014 I returned to pharmacy telling them how I was still in pain and asked them to report it. They said they would. I just want to know how much longer this pain will exist and why it happened." "60-64 years" "60-64" "553836-1" "553836-1" "Pt experienced a localized reaction at injection site (red, raised)." "60-64 years" "60-64" "554771-1" "554771-1" "Rash under arms and sides. No fever. No itching. No SOB." "60-64 years" "60-64" "554959-1" "554959-1" "Redness to area, warmth to area, fever, headache." "60-64 years" "60-64" "555424-1" "555424-1" ""Around 12:00 Noon 11/23/2014, patient started having ""severe needle pricking"" pain around the elbow up to 1/2 the distance to his shoulder and half the distance to his hand. His elbow swelled up and his hands swelled up about 5-10%. He took ibuprofen 400mg at 4:00 pm 11/23/2014 and then 600mg ibuprofen around bedtime. He used ice packs. He experienced sweating during the night. On 11/24/2014--the swelling was decreased. He saw his doctor at 1:00 PM 11/24/2014 and was instructed to take some Benadryl if needed."" "60-64 years" "60-64" "555508-1" "555508-1" "Received flu shot on 10-15-14 at 830 am. Around 300 pm began double vision in periphery (R) eye. Vision worsened next day. Saw ophthalmologist on 10-17-14. Dx vascular event. On 10-18-14 vision worsened. Went to ER. CT scan WNL. Double vision cont x 2 wks. At this time vision still not perfect." "60-64 years" "60-64" "555524-1" "555524-1" "Patient experiencing pain and weakness in arm area of vaccination that has not improved after 4 weeks. Patient had not been treated at this point." "60-64 years" "60-64" "555537-1" "555537-1" "The right side of body became almost numb after a day or two of taking shot. Most sensation reversed in few days but affects are still on right arm." "60-64 years" "60-64" "555796-1" "555796-1" "Injection given on right arm (1 am left-handed) way close to shoulder area. Injection site was never sore but pain and limited motion on right arm shoulder by 2nd day or so. Painful to lift arm and move pt carry things." "60-64 years" "60-64" "555912-1" "555912-1" "(L) deltoid area swelling, warmth, redness and itching about 1 hr after vaccination with flu. Pr. took BENADRYL and itchiness decreased. Call to pt next day-symptoms improving." "60-64 years" "60-64" "556340-1" "556340-1" ""She called me on 11/25/2014 to report adverse reaction to flu shot received 12 noon 11/21/2014 at a company flu shot clinic. She took Ibuprofen after her shot because it had been several years since her last flu shot. At 4 PM she started to feel headache and sl. nausea. She states she had rib pain ""crushing"" like she had been ""kicked"", some shortness of breath - she did not seek medical attention - she went home to bed had chills and was better in the morning when she woke up."" "60-64 years" "60-64" "556710-1" "556710-1" "2 days after received vaccine had localized rash at injection site, which progressivley spread to most of her entire body, had itching." "60-64 years" "60-64" "557313-1" "557313-1" "This case was reported by a pharmacist and described the occurrence of taste altered in a 63-year-old female who received FLUARIX Quadrivalent 2014-2015 season) (batch number 7S75Y, expiry date 30th June 2015). Previously administered products included FLUARIX Quadrivalent 2013-2014 season. On 12th September 2014, the patient received FLUARIX Quadrivalent 2014-2015 season (unknown). On 12th September 2014, less than a day after receiving FLUARIX Quadrivalent 2014-2015 season, the patient experienced taste altered and smell alteration. On 27th September 2014, the outcome of the taste altered and smell alteration were recovered/resolved. It was unknown if the reporter considered the taste altered and smell alteration to be related to FLUARIX Quadrivalent 2014-2015 season. Additional information: Patient shared she dealt with the odor for a week and then went to a doctor. Doctor told her she ha a slight touch of the Flu from the shot. He also tested her for Strep throat, which was negative. He gave her a Z-pack for 5 day therapy and the odor lasted another week." "60-64 years" "60-64" "557764-1" "557764-1" "Shot was given in left arm. Injection site seemed fine. Underarm seemed tender. This tenderness increased until I started to feel around under my arm. Discovered an enlarged, moveable lump right in the underarm area. As per my research this is called an axillary lymph node. Googled to see if this was considered a normal reaction. Saw some information indicating that some other people had complained of this. Was warned to." "60-64 years" "60-64" "557997-1" "557997-1" "Pt described fever and swelling of extremities for 2-3 days." "60-64 years" "60-64" "558092-1" "558092-1" "Dizziness, nausea, chilled, sweating, hot; though instructed to notify any nurse at shot clinic for any adverse reactions, patient did not report symptoms until following day; patient had been instructed to remain at clinic for a min of 15 minutes following vaccination since patient had never received a flu shot before." "60-64 years" "60-64" "558102-1" "558102-1" "Body aches, chills, nausea, vomiting, lip swelling, shortness of breath, throat swelling." "65+ years" "65+" "516064-1" "516064-1" "Patient called Saturday about 7 p.m. and said her right arm was sore. She was advised to ice area of vaccine. Sunday, 12-8, she called and said her arm was sore and swollen and she was going to emergency room for treatment." "65+ years" "65+" "517070-1" "517070-1" "Redness, pain, likely bruising left arm all the way to wrist. Felt poorly." "65+ years" "65+" "518940-1" "518940-1" "Patient states he went home and fainted from sitting position about 45 minutes after his immunization. Wife revived him after about 10 seconds by calling his name." "65+ years" "65+" "519202-1" "519202-1" "Complained of pain immediately - no visible redness or swelling. Saw PCP and was given MEDROL dose pak." "65+ years" "65+" "519378-1" "519378-1" "Developed 1 inch diam bruise at injection site on left arm; red raised itchy rash on both upper arms shoulder to elbow. No treatment." "65+ years" "65+" "519627-1" "519627-1" "Pain, inflammation, redness very sore." "65+ years" "65+" "519758-1" "519758-1" "Severe swelling & pain/ pain severe enough that arm could not be touched/ patient could not lift arm/ swelling spread over an area of 3 1/2 inches by 2 inches/ redness over same area and the area warm to the touch." "65+ years" "65+" "520900-1" "520900-1" "Left arm received immun. 1/9/14; on 1/10/14 pt experienced soreness, redness, swelling, and fever in the arm left arm by 1/11/14 pt could barely move arm and had a fever; symptoms improved by 1/13/14; received MEDROL DOSEPAK 1/14/14." "65+ years" "65+" "523125-1" "523125-1" "Nausea/Vomiting." "65+ years" "65+" "524813-1" "524813-1" "Injection site not healing, patient feeling pain and tingling sensation upon touch of the injection site - also complain of numbness of left hand occasional." "65+ years" "65+" "525529-1" "525529-1" ""Patient reported having increased production of phlegm in throat, resulting in the need to clear his throat ""500 times per day"" per patient. He states that he had/has a very hoarse voice and reports possible redness at back of throat. Saw his primary physician who then referred him to an ENT to be scoped. No diagnosis at this time. He takes Benadryl at night which seems to alleviate his symptoms. Air quality was listed as ""unsafe"" around that time. He may be experiencing severe allergy symptoms and states he is not sure whether or not any of this is related to the vaccine but wanted it reported."" "65+ years" "65+" "542752-1" "542752-1" "Moderate-severe muscle pain in deltoid evening after then pain subsided and soreness remains in bicep and warmth, redness and swelling seen in tricep area." "65+ years" "65+" "542938-1" "542938-1" "The patient was about to ride in the car to go home from the clinic, when she complained to the daughter/companion that she feels dizzy. She was brought back to the clinic. Initial VS were: BP 157/60 and HR 39. She was transferred to the UC via a wheelchair. At 10:50, at the UC, patient was placed at OBS room. Initial VS were: BP:160/69, HR: 46, O2 sat at 95% at Room Air. UC doctor was notified. Patient complained that her upper lip was sleeping and that her throat felt swollen. IV access was started with difficulty. Patient was given Solumedrol 125 mg/IV at 1110 AM, Benadryl 50 mg/IV at 1115 AM. At 1115, pulse was noted at 38. Patient was transferred to the ER via 911. At the ER, EKG was done and patient was given Pepcid 20 mg/IV and Solumedrol 125 mg/IV. Patient was discharged stable at 14:52." "65+ years" "65+" "543484-1" "543484-1" "Started as mild sore throat then advanced next day into considerable sinus drainage that in turn resulted in significant coughing. Temperature normal days one, two and three then rose to 100.1. Tylenol two doses reduced and by day four temperature gone and other symptoms gone. If this was sinus infection or cold it is one of the strangest I have had in my 73 years. Can only assume it was result of the Quad flu shot I received." "65+ years" "65+" "543620-1" "543620-1" "LEFT ARM PAIN. I CAN ONLY LIFT MY LEFT ARM A SMALL AMOUNT WITH OUT A LOT OF PAIN." "65+ years" "65+" "544145-1" "544145-1" "CHILLS, NAUSEA, HEADACHE, ACHY FEELING -BACK AND LEGS MORE SO THAN THE REST OF HER, INSOMNIA." "65+ years" "65+" "544510-1" "544510-1" "Low grade fever, and hives at administration site." "65+ years" "65+" "544532-1" "544532-1" "PAIN AND SWELLING AT INJECTION SITE LEFT DELTOID, DECREASED LIMB MOBILITY (PALM DOWN ELBOW LOCKED ARM LIFT TO APPROXIMATELY 45 DEGREES)." "65+ years" "65+" "544539-1" "544539-1" "Sudden onset of premature ventricular contractions (constant and multiple) a few hours after vaccination. Saw internist the next day and on 9/16. EKGs both days. He referred me to a cardiologist, who I saw on 9/17." "65+ years" "65+" "545409-1" "545409-1" "N/a" "65+ years" "65+" "545574-1" "545574-1" "Hives to left arm, neck, face." "65+ years" "65+" "545646-1" "545646-1" "FEVER; PAIN." "65+ years" "65+" "545760-1" "545760-1" "Pt had hematoma develop at injection site." "65+ years" "65+" "545849-1" "545849-1" "Developed throat tightness, periorbital edema, lower extremity weakness, pruritus and diaphoresis approximately 30-40 minutes after the vaccine - flu vaccine. EMS called and given IV access of NS; BENADRYL 50mg IV, given; EPIPEN on right thigh given; 50mg CORTEF 100mg IV given." "65+ years" "65+" "546023-1" "546023-1" "Pain, stinging, itch left uppper arm. Had requested to receive 2 vaccines in the same arm." "65+ years" "65+" "546033-1" "546033-1" "Adverse event started approximately two hours after flu shot - weakness, fever, increased bp, trouble breathing, chills, headache." "65+ years" "65+" "546176-1" "546176-1" "Infection at site. Patient showed arm (left) to Rph - very red in region of injection (2). Dr started abx but not sure of any other markers of infection. No pus/drainage." "65+ years" "65+" "546219-1" "546219-1" "PATIENT REPORTED A RASH UNDER ARMS AND AROUND WAIST AND ITCHING ALL OVER BODY. ADVISED HER TO GO TO ER. ER ADVISED PATIENT TO TAKE BENADRYL EVERY 6 HOURS AND RANITIDINE EVERY 12 HOURS UNTIL SYMPTOMS RESOLVED." "65+ years" "65+" "546333-1" "546333-1" "Aches, fever." "65+ years" "65+" "546940-1" "546940-1" "DIARRHEA, ITCHING ON LEGS/HANDS." "65+ years" "65+" "546983-1" "546983-1" "Redness, itching, and rash at injection site. Reported symptoms on 10/08/2014 @ 9:30 AM." "65+ years" "65+" "547079-1" "547079-1" ""Patient received both flu and pneumonia vaccines in the office on 10/7/14. One in each arm. Patient gave verbal consent to have one injection in each arm. Patient waited recommended time in the waiting room after vaccination with no adverse reactions. Patient called the office in the AM on 10/8/14. Patient stated that the previous night he felt ""crummy"" and ""had a fever - although did not check it with a thermometer."" Patient stated that left arm was swollen, red and warm. Offered a patient and appointment in the office. During the conversation patient stated that he ""just remembered"" that he had a Vantas implant in the left arm. Patient called back aproximately an hour later to schedule an office appointment. Patient was seen in the office at 1:45 pm. Patient upper left arm down to elbow was red, warm and swollen. At the injection site on the right arm, area was reddened, raised and warm. MD treated patient with Keflex for cellulitis."" "65+ years" "65+" "547086-1" "547086-1" ""Injection site (Left Deltoid) sore for a couple days, then developed redness at injection site, area warm to touch. Seen in office 10/06/14 and Dx: Cellulitis and given cephalexin and desloratadine as pt also had itchy throat which Dr felt was a reaction to the vaccine also. As of today 10/8/14 deltoid area is still red and warm but not as ""bright"" red as was before."" "65+ years" "65+" "547095-1" "547095-1" "Localized reaction around injection site including raised red ring and hot to touch." "65+ years" "65+" "547389-1" "547389-1" "Severe dizziness and severe ringing in ears. Unable to walking without holding on to something. Still ongoing after 15 hours. Taking meclizine for dizziness." "65+ years" "65+" "547692-1" "547692-1" "Redness at the site, slight swelling and itchiness." "65+ years" "65+" "547733-1" "547733-1" "BLACK & BLUE, HARD LUMP AT SITE OF INJECTION, RED STREAK FROM SITE TO ELBOW NO FEVER, NO STOMACH UPSET & NO DIARRHEA." "65+ years" "65+" "547784-1" "547784-1" "The next day her left arm was swollen from elbow to armpit. It was red, swollen, hot and very tender. Pt was unable to lift arm or have anything touch it. Pt had body aches and temp got to 102. Pt called today to report and arm is better. Arm is still tender, redness has gone down, swelling is down. Better today 10/14/14." "65+ years" "65+" "547840-1" "547840-1" "Swollen throat. Difficulty breathing. Bright red eyes." "65+ years" "65+" "547857-1" "547857-1" """"Incident"" or symptoms occurred 6 day after receiving FLUZONE Quadrivalent vaccination. Diagnosed as Bell's Palsy. Patient given Rx for steroids and antivirals and Abx."" "65+ years" "65+" "548074-1" "548074-1" "Chills, fever, headache, night sweats, shoulder pain, fever blister, tiredness, nausea." "65+ years" "65+" "548086-1" "548086-1" "Pain and inflammation at injection site for 2 days." "65+ years" "65+" "548331-1" "548331-1" "Patient stated she had shortness of breath, syncope and weakness in extremities during the night. Pt called us the next afternoon with mild syncope and weakness in extremities. Pt stated she felt better than last night. Pt was advised not to drive due to syncope and to seek medical care immediately." "65+ years" "65+" "548346-1" "548346-1" "Patient called the pharmacy reported that she has a red ring around her upper arm and it's swelling. She thinks it's the Pneumovax that she's allergic to." "65+ years" "65+" "548348-1" "548348-1" "Patient described warm feeling and slight pain around injection site. *pink reddish color*" "65+ years" "65+" "548470-1" "548470-1" "HA, sore arm for one month now." "65+ years" "65+" "548492-1" "548492-1" "Noticed hardness on 10/13/14 at 2pm. Erythema and swelling w/some streaking 3 days after the pneumonia shot on 10/16/14." "65+ years" "65+" "548520-1" "548520-1" "At midnight (Sun into Mon.), patient said she had vomiting and diarrhea. She then started having nerve pain from her butt down her legs, starting on her left side then down both sides of her body. Severe left arm pain at site of injection and left bicep. Very warm to the touch. At 6 a.m. she was brought to the ER, given morphine and TORADOL and discharged 3 hours later. She had chills throughout Mon. after and is still tired and has (L) arm pain." "65+ years" "65+" "548569-1" "548569-1" "Arm turned red and warm -> large area about 4 inches. Starting to fade as of 10/9/14. Pt went to the doctor, was told to wait." "65+ years" "65+" "548771-1" "548771-1" "Shoulder pain surrounding site of injection 5 days after injection." "65+ years" "65+" "548982-1" "548982-1" "Severe joint pain and nausea. The patient went to the ER. They found nothing. No treatment was given. Patient began to feel better." "65+ years" "65+" "549250-1" "549250-1" "Pt's left arm was bruised and painful from the left shoulder down to the elbow, black and blue." "65+ years" "65+" "549318-1" "549318-1" "Received shot 9/30/14. Next day achy/fever -> flu like symptoms. Daily progressively worse breathing harder, fever, and still achy. Pt declined visiting MD. Wanted reported to see if other people sick after quadrivalent shot." "65+ years" "65+" "549321-1" "549321-1" "Received lower dose than recommended by manufacturer." "65+ years" "65+" "549358-1" "549358-1" "Severe pain leading to decreased motion and inability to use arm in which vaccine was administered. Pain began one day after injection and continues one week after." "65+ years" "65+" "549435-1" "549435-1" "Itchy, pink blotches on both arms. No other complaints." "65+ years" "65+" "549472-1" "549472-1" "Redness left deltoid 4 x3 warm feeling and itch." "65+ years" "65+" "549513-1" "549513-1" "Swelling on the site of injection and redness traveling to the arm (whole arm)." "65+ years" "65+" "549525-1" "549525-1" "Redness 5 cm, soreness, swelling." "65+ years" "65+" "549629-1" "549629-1" "Patient had redness/rash beginning the morning after injection. Patient was seen by Dr. and there was concern for erysipelas. Patient was treated conservatively with Amoxicillin 500mg TID x 7 days." "65+ years" "65+" "549650-1" "549650-1" "Fever and very red/sore arm (per nurse). Patient did not return phone call to pharmacy. Nurse said patient already had pneumonia vaccine in 2012 but patient wasn't aware." "65+ years" "65+" "549655-1" "549655-1" "Pt c/o (L) arm pain. Unable to raise arm x 4 days. Pt notified doc office on 10/20/14 of reaction. Pt stated able to raise arm enough to put on deodorant today." "65+ years" "65+" "549808-1" "549808-1" "Left upper arm was red, swollen, and tender, pt. went to dermatologist and got prescription for MEDROL dose pak." "65+ years" "65+" "550453-1" "550453-1" "Patient states she has had pain (achy) and swelling in her left arm (injection arm, NOT injection site) since the shot. Painful after shot and states pain/swelling down whole arm ever since." "65+ years" "65+" "550816-1" "550816-1" "Redness and swelling noted to left deltoid 10/16/14 in AM. C/O itching. Shot flu received 10/15/14." "65+ years" "65+" "550868-1" "550868-1" "Had facial swelling especially of the lips. Respiratory Stridor - Respiratory difficulty. Redness of face and neck, explosive diarrhea. Respiratory Arrest - No pulse - Nonresponsive." "65+ years" "65+" "550874-1" "550874-1" "Phone call with report of signs and symptoms starting 8 hours after receiving IIV4 and PPSV23 to left arm. Fever 100.9 body aches, redness, swelling and hot to touch at injection site and approx. size of a large apple later swelling to arm to elbow. Area so itchy. Pt applied cold compress and took over the counter medication for fever and body aches. Also took BENADRYL. Did not seek medical care. 8-30 hrs. after was worst." "65+ years" "65+" "550876-1" "550876-1" "Patient received her flu shot and after 10 minutes she felt warmth and swelling in (R) arm (lump walnut size). She applied ice PRN. The next day there was bruising and on Thurs the bruise continued to her elbow. Bruise is resolving and no medical treatment was required." "65+ years" "65+" "551269-1" "551269-1" "Given decreased dose than recommended by manufacturer." "65+ years" "65+" "551288-1" "551288-1" "Given decreased dose than recommended by manufacturer." "65+ years" "65+" "551290-1" "551290-1" "Given decreased dose than recommended by manufacturer." "65+ years" "65+" "551301-1" "551301-1" "Given decreased dose than recommended by manufacturer." "65+ years" "65+" "551465-1" "551465-1" "Given decreased dose than recommended by manufacturer." "65+ years" "65+" "551547-1" "551547-1" "Rec'd flu shot 10 am, 10/10/14 - at 8 p.m. got severe headache and chest pains - heartbeat very fast - took 3 ADVIL for pain - sleepless night with fast heartbeat. Bedridden Friday night, all day and night Saturday. 80% better Sunday morning. (No fever but skin hurt to touch). Very scary." "65+ years" "65+" "551555-1" "551555-1" "Patient reported an itchy rash forming around the injection site on his RT arm." "65+ years" "65+" "551869-1" "551869-1" "Pat reported rash or redness around the injection site and spreading down the arm." "65+ years" "65+" "551913-1" "551913-1" "Pt reproted rash or redness around the injeciton site and spreading down the arm." "65+ years" "65+" "551917-1" "551917-1" "48 hours - high fever 102F for 2 days; 48 hours ore - swollen lymph node in neck; 24 hours more - shooting pain starting in neck, going over head to front of scalp. Given antiviral for shingles. MD changed mind and said it wasn't shingles. - 74 hours more and arm cannot be raised (vaccine arm)." "65+ years" "65+" "551941-1" "551941-1" "On 10/30/14 patient received two vaccinations: one was for the flu (Rx # 0504505 FLUZONE QUAD); and the other was for pneumonia (Rx # 0504506 PNEUMOVAX 23 vial). Early on 10/31/14 a red welt-like patch appeared at the site of the pneumonia injection. It got much worse, accompanied by fever. Went to the ER at Hospital and was admitted." "65+ years" "65+" "551960-1" "551960-1" "Left upper arm with area of erythema, warmth, tenderness. Treated with KEFLEX 11/4/14." "65+ years" "65+" "552035-1" "552035-1" "Pt stated swelling and heat at the injection site and that she developed a fever. Felt ill and stated arm was very swollen for 3 days." "65+ years" "65+" "552092-1" "552092-1" "Pt. rec'd vaccination Friday afternoon 10/10/14. Rash, hives developed Saturday afternoon. Pt was given injection of KENALOG and DECADRON and advised to take CLARITIN for next several days. Rash and hives present on arms and upper torso." "65+ years" "65+" "552499-1" "552499-1" "Pt received a second inactivated flu within 2 months, incidentally, without adverse reaction. CDC contacted to adverse event expected." "65+ years" "65+" "552798-1" "552798-1" "Extremely cold, headache, nausea and vomiting, diarrhea, weakness all through the night, took temp several times was in 96 range, chills, called Urgent Care but did not seek treatment, symptoms continued to Monday and then felt weakness and had loose stools for a week ending 11/10/14." "65+ years" "65+" "552879-1" "552879-1" "She had shot on 10/13/14. Friday 10/31/14 she called and said her both hands, both arms, up to shoulders are numbness and tingling. She did see her doctor. The doctor said that was side effect of flu vaccine and will go away." "65+ years" "65+" "552886-1" "552886-1" "Rash/spots/hives on upper torso." "65+ years" "65+" "552985-1" "552985-1" "Continuous pain (R) upper arm since Flu vaccine 9/23/14. Body aches x 3 weeks." "65+ years" "65+" "553060-1" "553060-1" "Patient developed rash and itching on trunk of body and arms the day following immunization. She applied ice and took diphenhydramine by mouth. Symptoms had resolved by 11/9/14 (3 days after vaccination)." "65+ years" "65+" "553219-1" "553219-1" "Initial soreness, overall achiness, severe indigestion, about 3 hrs, no tx sought as subsided." "65+ years" "65+" "553707-1" "553707-1" "Pt was given shot he turned back on spinal cord stimulator walked up hallway. Felt like passing out, when white, nose sneezing, running, nausea, light head, very hot, eyes very dry. Lasted about 15 minutes." "65+ years" "65+" "553862-1" "553862-1" "Pain exists from injection site down to elbow." "65+ years" "65+" "553906-1" "553906-1" "Inflammation of the arm in which the pneumonia vaccine (left arm) was injected. Fever. Facial swelling, headache, shivering." "65+ years" "65+" "554088-1" "554088-1" "Extreme chills, dizziness, general feeling of being sick with the flu." "65+ years" "65+" "554304-1" "554304-1" "Returned on 10-28-14 with large hematoma of left deltoid. Bruising of various colors in about 3-4 inch diameter of upper left deltoid. Noticed on 10-22-14 when woke up." "65+ years" "65+" "554312-1" "554312-1" "Pt had rash around inj site and around neck. Redness. Swelling and pt complaint of itching. Redness has subsided when I examined her." "65+ years" "65+" "555280-1" "555280-1" "Patient reported muscle pain at the left arm, where immunization was administered, after few months. Arm feels very weak, and something wrong w/ rotating cuff, pt claimed, told pt to have MD check." "65+ years" "65+" "555559-1" "555559-1" "After receiving these vaccine on 10/13/14 pt. stated that on or about November 1, 2014 he started to develop an itchy rash that spread over all his body; pt went to doctor on 11/14/14 and he was prescribed prednisone 10 mg po TID x 4 days afterwards pt was advised to us BENADRYL when itching. Finally, on November 24, 2014, pt stated most of rash had subsided." "65+ years" "65+" "555956-1" "555956-1" "This case was reported by a consumer and described the occurrence of left arm was swollen in a 83-year-old male patient who received FLUARIX QUADRIVALENT (batch number 7239G, expiry date June 2015). The patient's past medical history included blood clot in left leg (Patient takes warfarin because of the blood clot in his leg a few years ago). Concurrent medical conditions included no known drug allergy. Concomitant products included amlodipine, lisinopril, lovastatin, Pneumonia vaccine and warfarin. On 6th October 2014 13:00, the patient received FLUARIX QUADRIVALENT. On an unknown date, the dose was an unknown dose. On 7th October 2014, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced left arm was swollen, concentration difficulty, cannot drive, severe drive, severe allergic reaction, back pain, left arm pain, knee and leg pain, redness in arm, and difficultyto stand up. On an unknown date, the outcome of the left arm was swollen, concentration difficulty, cannot drive, severe allergic reaction, back pain, left arm pain, knee and leg pain and difficulty to stand up were not recovered/not resolved and the outcome of the redness in arm was recovering/resolving. It was unknown if the reporter considered the left arm was swollen, concentration difficulty, cannot drive, severe allergic reaction, back pain, left arm pain, knee and leg pain, redness in arm and difficulty to stand up to be related to FLUARIX QUADRIVALENT. Additional information: Patient reports that around 1:00pm Monday, October 6, 2014, he was administered a FLUARIX QUADRIVALENT vaccine and a pneumonia vaccine in his left arm. He reports that he was fine on Monday, but when he woke up on Tuesday October 6, 2014, he had symptoms of arm pain, redness, and swelling. He also had difficulty concentrating, and could not drive or get out of his chair. On Wednesday, October 8, 2014, the patient consulted with his pharmacist who advised if the reaction worsened that he should go to the ER. The patient went to his doctor on Thursday, October 8, 2014, and the doctor told him that he had a severe allergic reaction that was also neurological in nature to the FLUARIX QUADRIVALENT vaccine. The doctor told him that the reaction would not be from the pneumonia vaccine, and the he would not have gotten the reaction had he got the trivalent flu vaccine. The doctor told him that the reaction could persist for up to two weeks, and he told him to report the experience to the manufacturer. The patient has received flu vaccines yearly for the past 20 years, and he has never had symptoms before." "65+ years" "65+" "556256-1" "556256-1" "Flu-like symptoms for 48h after vaccination. Arm pain at site of injection with erythema and swelling. Remains painful to touch at 6d after injections. Flu and PNEUMOVAX given concurrently." "65+ years" "65+" "556295-1" "556295-1" "Received vaccine on 10/30/14 in (R) deltoid. Began to experience significant pain 5 days later. Patient complains of significant pain when moving/using her (R) arm. Situation has not improved as of today's date." "65+ years" "65+" "556356-1" "556356-1" "On third day my left hand swelled and turned red, was very sore, could not drive 1st day, in 2 days I could drive, gone in 4 days but on Wed. Nov 12, my teeth became very sensitive to cool and cold drinks, OK by Sunday 11-16-14." "65+ years" "65+" "556963-1" "556963-1" "Patient reports that his throat feels like it is closing and his eyes are itchy. The reaction is similar to a reaction he had when he ate shrimp, which he is allergic to. This started roughly 3 hours after his vaccine was given. Patient was instructed to seek immediate medical attention, either at the ER or a clinic. If this was not available to him, then we instructed him to go to a pharmacy to purchase Benadryl and take 25mg immediately." "65+ years" "65+" "557251-1" "557251-1" "Died from cardiac disease." "65+ years" "65+" "557253-1" "557253-1" "Died from ??UTI/Sepsis." "65+ years" "65+" "557294-1" "557294-1" "Client reports inside of hands and in between fingers are itching. She reports no changes other than got flu shot yesterday. She denies ever having allergies to vaccines or other allergies." "65+ years" "65+" "557300-1" "557300-1" "Received shingle shot 6-1-07. Received flu shot 11-14-07. Broke out shingle 11-20-14. Urgent care 11-23-14." "65+ years" "65+" "557485-1" "557485-1" "Flu shot given 10/30/14. Since then he is having clear nasal drainage if he moves from laying down or reclining position to a more upright position." "65+ years" "65+" "557565-1" "557565-1" "7 hours after flu shot and PNEUMOVAX in left upper arm pt got mild left medial arm swelling/redness and burning and 2 days later she is better." "65+ years" "65+" "557798-1" "557798-1" "Within 2 hours, injection site started swelling, looking red and became painful. Chest began to hurt and patient took nitrates. Diarrhea started, which she says was the worst she has ever experienced. Other symptoms have improved but is still experiencing some diarrhea." "Unknown" "U" "535076-1" "535076-1" "This case was reported by a pharmacy via a pharmacy claims management company and described the occurrence of adverse reaction in a subject of unspecified age and gender who was vaccinated with FLUARIX Quadrivalent (GlaxoSmithKline). On 29 January 2014 the subject received a dose of FLUARIX Quadrivalent (unknown). On an unspecified date in 2014, within months of vaccination with FLUARIX Quadrivalent, the subject experienced adverse reaction. At the time of reporting the outcome of the event was unspecified." "Unknown" "U" "544701-1" "544701-1" "Nausea, vomiting, chills and diarrhea." "Unknown" "U" "546623-1" "546623-1" "This case was reported by a healthcare professional and described the occurrence of swelling injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX QUADRIVALENT (GlaxoSmithKline). On 16 September 2014, the subject received unspecified dose of FLUARIX QUADRIVALENT (.5 ml, unknown arm and route). On 16 September 2014, immediately after vaccination with FLUARIX QUADRIVALENT, the subject experienced swelling, redness, bump, all at the injection site. The subject used a heavy duty Band-Aid for 10 minutes to cauterize the bleeding after the injection. At the time of reporting, the events were resolved. This case was associated to a product complaint. The reporter noted that the last 2 days, they had given 170 FLUARIX vaccine injections and they had seen a higher number of injection site reactions. This is one of the 7 cases reported by the same reporter for the same vaccine and same events. Follow-up information received 25 September 2014: QUAL number updated." "Unknown" "U" "546626-1" "546626-1" "This case was reported by a healthcare professional and described the occurrence of swelling injection site in a female subject of unspecified age who was vaccinated with FLUARIX QUADRIVALENT (GlaxoSmithKline). On 16 September 2014, the subject received unspecified dose of FLUARIX QUADRIVALENT (.5 ml, unknown arm and route). On 16 September 2014, immediately after vaccination with FLUARIX QUADRIVALENT, the subject experienced swelling, redness and bump, all at the injection site. The subject didn't use a heavy duty Band-Aid. At the time of reporting, the events were still unresolved. This case was associated to a product complaint. The reporter noted that the last 2 days, they had given 170 FLUARIX vaccine injections and they had seen a higher number of injection site reactions. This is one of the 7 cases reported by the same reporter for the same vaccine and same events. Follow-up information received on 25 September 2014: QUAL number updated." "Unknown" "U" "546629-1" "546629-1" "This case was reported by a healthcare professional and described the occurrence of swelling injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). On 16 Sep 2014, the subject received unspecified dose of FLUARIX (.5 ml, unknown arm and route). On 16 September 2014, immediately after vaccination with FLUARIX, the subject experienced swelling, redness, bump, all at the injection site. The subject used a heavy duty ban-aid for 10 minutes to cauterize the bleeding after the injection. At the time of reporting, the events were resolved. This case was associated to a product complaint. The reporter noted that the last 2 days, they had given 170 FLUARIX injections and they had seen a higher number of injection site reactions. This is one of 7 cases reported by the same reported for the same vaccine and same events. Follow-up information received on 25 September 2014: QUAL number updated." "Unknown" "U" "546630-1" "546630-1" "This case was reported by a healthcare professional and described the occurrence of swelling injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX QUADRIVALENT (GlaxoSmithKline). On 16 September 2014, the subject received unspecified dose of FLUARIX QUADRIVALENT (.5 ml, unknown arm and route). On 16 September 2014, immediately after vaccination with FLUARIX QUADRIVALENT, the subject experienced swelling, redness, bump, all at the injection site. The subject didn't use a heavy duty Band-Aid for 10 minutes to cauterize the bleeding after the injection. At the time of reporting, the events were resolved. This case was associated to a product complaint. The reporter noted that the last 2 days, they had given 170 FLUARIX vaccine injections and they had seen a higher number of injection site reactions. This is one of the 7 cases reported by the same reporter for the same vaccine and same events. Follow-up information received on 25 September 2014: QUAL number updated." "Unknown" "U" "546631-1" "546631-1" "This case was reported by a healthcare professional and described the occurrence of swelling injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX QUADRIVALENT (GlaxoSmithKline). On 16 September 2014, the subject received unspecified dose of FLUARIX QUADRIVALENT (.5 ml, unknown arm and route). On 16 September 2014, immediately after vaccination with FLUARIX QUADRIVALENT, the subject experienced swelling, redness, bump, all at the injection site. The subject used a heavy duty band-aid for 10 minutes to cauterize the bleeding after the injection. At the time of reporting, the events were resolved. This case was associated to a product complaint. The reporter noted that the last 2 days, they had given 170 FLUARIX vaccine injections and they had seen a higher number of injection site reactions. This is one of the 7 cases reported by the same reporter for the same vaccine and same events. Follow-up information received on 25 September 2014: QUAL number updated." "Unknown" "U" "546633-1" "546633-1" "This case was reported by a healthcare professional and described the occurrence of swelling injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX QUADRIVALENT (GlaxoSmithKline). On 16 September 2014, the subject received unspecified dose of FLUARIX QUADRIVALENT (.5 ml, unknown arm and route). On 16 September 2014, immediately after vaccination with FLUARIX QUADRIVALENT, the subject experienced swelling, redness, bump, all at the injection site. The subject used a heavy duty band-aid for 10 minutes to cauterize the bleeding after the injection. At the time of reporting, the events were resolved. This case was associated to a product complaint. The reporter noted that the last 2 days, they had given 170 FLUARIX vaccine injections and they had seen a higher number of injection site reactions. This is one of the 7 cases reported by the same reporter for the same vaccine and same events. Follow-up information received on 25 September 2014: QUAL number updated." "Unknown" "U" "548509-1" "548509-1" "Severe muscle soreness day of injection. Patient took MOTRIN to alleviate pain." "Unknown" "U" "549223-1" "549223-1" "This case was reported by a other health professional and described the occurrence of arm pain in a male patient who received FLUARIX QUADRIVALENT (batch number 7LE2S, expiry date 30th June 2015). On 4th September 2014, the patient received FLUARIX QUADRIVALENT. On 4th September 2014, less than a year after receiving FLUARIX QUADRIVALENT, the patient experienced arm pain (serious criteria disability), shoulder pain (serious criteria disability) and pain that radiated to his hands (serious criteria disability). On an unknown date, the outcome of the arm pain, shoulder pain and pain that radiated to his hands were not recovered/not resolved. It was not reported if the reporter considered the arm pain, shoulder pain and pain that radiated to his hands to be related to FLUARIX QUADRIVALENT. Additional information received: The caller was a nursing student. She reported that her class received flu vaccines at the local hospital. There were about 30-25 people in her class. She reported that her classmate experienced adverse events receiving the vaccine. He experienced arm pain, shoulder pain, and pain that radiated to his hand. As of right now, these events were not resolved. The caller did not know the lot number and expiration date of this patient's vaccine, but believed it was the same as the one she received. The lot number and expiration date of the vaccine she received was: 7LE2S, 30th June 2015." "Unknown" "U" "550735-1" "550735-1" "FLUZONE Quadrivalent administered approx. 4:00 p.m. Patient awakened at approx. 12:00 a.m. with numbness/tingling of tongue and lips. Symptoms resolved spontaneously after approx 1 hr." "Unknown" "U" "553091-1" "553091-1" "This case was reported by a nurse and described the occurrence of lesion on forehead in a unk patient who received FLUARIX QUADRIVALENT. On 30th September 2014, the patient received FLUARIX QUADRIVALENT (unknown). On 1st October 2014, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced lesion on forehead. On an unknown date, the outcome of the lesion on forehead was unknown. It was unknown if the reporter considered the lesion on forehead to be related to FLUARIX QUADRIVALENT. Additional information received: Nurse called to inquiry about a potential adverse event. She wanted to know if a forehead lesion has been reported after the use of FLUARIX QIV. She did not have the patient's name or any other information. The adverse event was left on her phone. She did not want to give her address, but she said she would call back after speaking to the patient. The vaccine was administered at a flu clinic the prior day." "Unknown" "U" "555025-1" "555025-1" "This case was reported by a nurse and described the occurrence of expired vaccine used in a female patient who received FLUARIX QUADRIVALENT (batch number XE294, expiry date 30th June 2014). On 30th September 2014, the patient received FLUARIX QUADRIVALENT. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. It was unknown if the reporter considered the expired vaccine used to be related to FLUARIX QUADRIVALENT. Additional information received: Nurse reported she gave 4 female adult patients an expired dose of flu vaccine. Additional information was either unavailable or not provided at time of report." "Unknown" "U" "555545-1" "555545-1" "This case was reported by a other health professional and described the occurrence of generalized body aches in a female patient who received FLUARIX QUADRIVALENT. On 22nd September 2014, the patient received FLUARIX QUADRIVALENT .5 ml. On 23rd September 2014, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced generalized body aches, low grade fever and skin soreness. On 26th September 2014, the outcome of the low grade fever was recovered/resolved. On an unknown date, the outcome of the generalized body aches and skin soreness were not recovered/not resolved. The reporter considered the generalized body aches and low grade fever to be probably related to FLUARIX QUADRIVALENT. The reporter considered the skin soreness to be possibly related to FLUARIX QUADRIVALENT. Additional information received: Patient began with low grade fever, generalized body aches and skin soreness 1 day after receiving FLUARIX QIV. HCP was unsure if symptoms are related to FLUARIX QIV 10 days post vaccination." "Unknown" "U" "555604-1" "555604-1" "This case was reported by a nurse and described the occurrence of expired vaccine used in a female patient who received FLUARIX QUADRIVALENT (batch number XE294, expiry date 30th June 2014). On 30th September 2014, the patient received FLUARIX QUADRIVALENT. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. It was unknown if the reporter considered the expired vaccine used to be related to FLUARIX QUADRIVALENT. Additional information received on 30 September 2014: Nurse reported she gave 4 female adult patients an expired dose of flu vaccine. Additional information was either unavailable or not provided at time of report. This is one of the 4 reports received from the same reporter for the same vaccine." "Unknown" "U" "556283-1" "556283-1" "This case was reported by a other health professional and described the occurrence of pain in arm in a adult female patient who received FLUARIX QUADRIVALENT (batch number 7LE2S, expiry date 30th June 2015). On 4th September 2014 14:00, the patient received FLUARIX QUADRIVALENT. On an unknown date, less than a month after receiving FLUARIX QUADRIVALENT, the patient experienced pain in arm and pain in shoulder. On an unknown date, the outcome of the pain in arm and pain in shoulder were unknown. The reporter considered the pain in arm and pain in shoulder to be probably related to FLUARIX QUADRIVALENT. Additional information received on 06 October 2014: The caller was a nursing student. Her nursing class received FLUARIX QUADRIVALENT vaccine on the same day about a month ago. A few of them experienced side effects subsequent to the vaccine." "Unknown" "U" "556284-1" "556284-1" "This case was reported by a other health professional and described the occurrence of stiffness in arm in a adult female patient who received FLUARIX QUADRIVALENT (batch number 7LE2S, expiry date 30th June 2015). On 4th September 2014 14:00, the patient received FLUARIX QUADRIVALENT. On 4th September 2014, less than a day after receiving FLUARIX QUADRIVALENT, the patient experienced stiffness in arm and mild pain in injected limb. On an unknown date, the outcome of the stiffness in arm and mild pain in injected limb were recovered/resolved. The reporter considered the stiffness in arm and mild pain in injected limb to be probably related to FLUARIX QUADRIVALENT. Additional information received on 06 October 2014: The caller was a nursing student. Her nursing class received Flu Vaccines about a month ago. They received the vaccines on the same day. This patient experienced side effects (stiffness and mild pain in the affected arm) subsequent to the vaccine. The nursing student reported that this patient pain has alleviated quite a bit. When she first received the vaccine she had some pain, then the pain alleviated a bit for a few days, and then it got worse, and now the pain is mostly better about a week and a half later. The caller reported that this patient gave herself some physical therapy (moved her arm around a bit) and the patient reported to her that the pain went away after this self-therapy." "Unknown" "U" "557066-1" "557066-1" ""This case was reported by a physician via sales rep and described the occurrence of generalized urticaria in a patient who received FLUARIX TETRA (batch number ZE4G7, expiry date 19th June 2015). On 7th October 2014, the patient experienced FLUARIX TETRA. On 8th October 2014, 1 days after receiving FLUARIX TETRA, the patient experienced generalized urticaria. The patient was treated with prednisone and ATARAX (nos). On an unknown date, the outcome of the generalized urticaria was unknown. The reporter considered the generalized urticaria to be possibly related to FLUARIX TETRA. Additional information received: A patient received FLUARIX QIV on 07 October 2014 and then developed local urticaria on 08 October 2014 in the arm the patient received the vaccination. It then gradually became a generalized urticaria, the patient went to emergency room on 12 October 2014 and was prescribed Prednisone, ATARAX and ""H2B""."" "---" "Dataset: The Vaccine Adverse Event Reporting System (VAERS)" "Query Parameters:" "Title:" "Adverse Event Description: All" "Adverse Events After Prior Vaccinations: All" "Age: All" "Current Illness: All" "Date Died: All, Before 1980 to Dec., 2014" "Date of Onset: All, Before 1980 to Dec., 2014" "Date Report Completed: All, Before 1990 to Dec., 2014" "Date Report Received: All, Jul., 1990 to Dec., 2014" "Date Vaccinated: Dec., 2013 to Dec., 2014" "Event Category: All" "Gender: All" "Grantee: All" "History: All" "Lab Data: All" "Medications At Time Of Vaccination: All" "Mfr/Imm Project Number: All" "Onset Interval: All" "Recovered: All" "Serious: All" "State / Territory: The United States, Territories, and Unknown" "Symptoms: All" "Vaccine Administered By: All" "Vaccine Dose: All" "Vaccine Lot: All" "Vaccine Manufacturer: All" "Vaccine Products: INFLUENZA VIRUS VACCINE, QUADRIVALENT (INJECTED) (FLU4(SEASONAL))" "Vaccine Purchased By: All" "VAERS ID: All" "Group By: Age, VAERS ID" "Show Totals: False" "Show Zero Values: Disabled" "---" "Help: See http://wonder.cdc.gov/wonder/help/vaers.html for more information." "---" "Query Date: Feb 4, 2015 2:23:20 AM" "---" "Suggested Citation: United States Department of Health and Human Services (DHHS), Public Health Service (PHS), Centers for" "Disease Control (CDC) / Food and Drug Administration (FDA), Vaccine Adverse Event Reporting System (VAERS) 1990 - last month," "CDC WONDER On-line Database Accessed at http://wonder.cdc.gov/vaers.html on Feb 4, 2015 2:23:20 AM" "---" Messages: "1. These results are for 1,106 total events." "2. When grouped by VAERS ID, results initially don't show Events Reported, Percent, or totals. Use Quick or More Options to" "restore them, if you wish." "3. Click on a VAERS ID to see a report containing detailed information for the event." "4. The full results are too long to be displayed, only non-zero rows are available." "---" Footnotes: "1. Submission of a VAERS report does not constitute admission that healthcare personnel or the vaccine caused or contributed to" "the event." "---" Caveats: "1. Some items may have more than 1 occurrence in any single event report, such as Symptoms, Vaccine Products, Manufacturers and" "Event Categories. If data are grouped by any of these items, then the number in the Events Reported column may exceed the total" "number of unique events. If percentages are shown, then the associated percentage of total unique event reports will exceed 100%" "in such cases. For example, the number of Symptoms mentioned is likely to exceed the number of events reported, because many" "reports include more than 1 Symptom. When more then 1 Symptom occurs in a single report, then the percentage of Symptoms to" "unique events is more than 100%. More information: http://wonder.cdc.gov/wonder/help/vaers.html#Suppress." "2. DISCLAIMER: Please note that VAERS staff follow-up on all serious and other selected adverse event reports to obtain" "additional medical, laboratory, and/or autopsy records to help understand the health concern raised. However, in general, coding" "terms in VAERS do not change based on the information received during the follow-up process. VAERS data on WONDER should be used" "with caution as numbers and conditions do not reflect data collected during follow-up. Note that information included in the" "VAERS data does not mean that the vaccine caused the adverse event. Review cautions in the interpretation of this data: More" "information: http://wonder.cdc.gov/wonder/help/vaers.html#Additional." "3. Data contains VAERS reports processed as of 12/14/2014. The VAERS data in WONDER are updated monthly, yet the VAERS system" "receives continuous updates including revisions and new reports for preceding time periods. More information:" "http://wonder.cdc.gov/wonder/help/vaers.html#Reporting."
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