chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Diarrhoea, Fatigue, Impaired work ability, Nausea, Paraesthesia
Clinical narrative: Low grade fever, nausea, and tingling in right fingers and right toes. Low grade temp is still going on at 99 today (11-3-09- tingling in fingers and toes have stopped).  Have had today 11-03-09 low grade temp (99), fatigue, diarrhea, nausea. Called doctors office, could not get someone to answer my question if this was a side effect of the H1N1 shot. Was too fatigued to drive 40 miles to doctors office. Treatment staying home from work until symptoms subside. If it gets worse I will go to ER since I am an insulin dependent diabetic.
Age: 59.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pyrexia
Clinical narrative: Low grade fever, nausea, and tingling in right fingers and right toes. Low grade temp is still going on at 99 today (11-3-09- tingling in fingers and toes have stopped).  Have had today 11-03-09 low grade temp (99), fatigue, diarrhea, nausea. Called doctors office, could not get someone to answer my question if this was a side effect of the H1N1 shot. Was too fatigued to drive 40 miles to doctors office. Treatment staying home from work until symptoms subside. If it gets worse I will go to ER since I am an insulin dependent diabetic.
Age: 4.0
Sex: M
Vaccine: FLU3, FLUN(H1N1)
Symptoms: Palpitations
Clinical narrative: palpitations
Age: 39.0
Sex: F
Vaccine: HEP, JEV1, RAB, TYP
Symptoms: Hypoaesthesia oral, Swollen tongue
Clinical narrative: Pt noticed numbness in her oral mucosa and felt as if her tongue was swollen.
Age: 89.0
Sex: M
Vaccine: FLU3
Symptoms: Gait disturbance, Muscle spasms, Musculoskeletal stiffness, Vomiting
Clinical narrative: Stiff lower back noted on brushing teeth over wash basin. Flew by air for FB Game arriving about 5 PM. Symptoms got progressively more severe with low back spasms accompanied by severe unsteady gait by 10/17/2009 requiring my son's arm support while walking, and part time wheelchair use on that date. I had no "cold", GI, Headache or neck pain symptoms, but vomited 20 min after eating one slice of pizza about 8PM which unaffected my 2 sons. I returned home by air on 10/18/09 and continued with slow improved gait for 5 days. Back spasms and stiffness slowly improved until today 11/3/09 is first that I did not require Tylenol.
Age: 60.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Nausea, headache, severe dizziness, very tired, low grade fever ... lasted two days.
Age: 6.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Oropharyngeal pain, Pyrexia, Wheezing
Clinical narrative: Fever, Wheezing, sore throat.
Age: 37.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Headache, Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Tingling and numbness, pain on left arm from shoulder to fingertips, headache.
Age: 22.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Headache, Nausea, Neuralgia, Pain
Clinical narrative: Headache, possible brain edema, nerve pain, nausea, body aches.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site induration, Injection site oedema
Clinical narrative: edema and induration of leg extending 6cm from injection site
Age: 25.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Corneal graft rejection, Discomfort, Eye inflammation, Eyelid oedema, Immediate post-injection reaction
Clinical narrative: Patient had bilateral rejection of her corneal transplants in the time period immediately following H1N1 vaccination. Topical steroid therapy was initiated which improved the inflammation in her left eye. Her right eye is still being monitored for clinical response. 11;20/09 Medical records receoved for DOS 10/23 -11/09 Final DX: PK (corneal inplant)  rejection.  1 day s/p vaccine. Eye pain, swollen lids, discomfort, photophobia s/p vaccine. Rejection of corneal implants. Edema OD. Decreased visual acuity. Redness, edema OD initially improved. then increased swelling, painful to move. HA. OS stable.
Age: 25.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Ophthalmological examination abnormal, Pain
Clinical narrative: Patient had bilateral rejection of her corneal transplants in the time period immediately following H1N1 vaccination. Topical steroid therapy was initiated which improved the inflammation in her left eye. Her right eye is still being monitored for clinical response. 11;20/09 Medical records receoved for DOS 10/23 -11/09 Final DX: PK (corneal inplant)  rejection.  1 day s/p vaccine. Eye pain, swollen lids, discomfort, photophobia s/p vaccine. Rejection of corneal implants. Edema OD. Decreased visual acuity. Redness, edema OD initially improved. then increased swelling, painful to move. HA. OS stable.
Age: 47.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Asthenia, Chest discomfort, Chills, Cough, Diarrhoea
Clinical narrative: Slight difficulty breathing.  Was trying to sleep (I work night shift).  Kept thinking to myself, "okay now breath",  I was a little scared to fall asleep, but I did.  Developed chills and headache around 2:30 pm.  General mild body aches.  Chills continued until 5 am, also had low grade fever (with antipyretics on board).  Felt like I was back to my normal self at 5 am on 10/28/09.   Then on 10/29/09 I developed diarrhea which continues through to this date.  On 10/30/09  had several hours of nausea, weakness & fatigue.  On 11/1/09 noticed tightness & occasional heaviness in chest with raw sensation when breath in.  Also developed mild cough 11/1/09, which continues.  Took Tylenol & Motrin evening of 10/27 & morning of 10/28/09.  Rested entire day of 10/30/09 with emesis basin nearby.  Have used my Albuterol inhaler at least daily since 11/1/09.
Age: 47.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Dyspnoea, Fatigue, Headache, Nausea, Pain
Clinical narrative: Slight difficulty breathing.  Was trying to sleep (I work night shift).  Kept thinking to myself, "okay now breath",  I was a little scared to fall asleep, but I did.  Developed chills and headache around 2:30 pm.  General mild body aches.  Chills continued until 5 am, also had low grade fever (with antipyretics on board).  Felt like I was back to my normal self at 5 am on 10/28/09.   Then on 10/29/09 I developed diarrhea which continues through to this date.  On 10/30/09  had several hours of nausea, weakness & fatigue.  On 11/1/09 noticed tightness & occasional heaviness in chest with raw sensation when breath in.  Also developed mild cough 11/1/09, which continues.  Took Tylenol & Motrin evening of 10/27 & morning of 10/28/09.  Rested entire day of 10/30/09 with emesis basin nearby.  Have used my Albuterol inhaler at least daily since 11/1/09.
Age: 47.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Pyrexia
Clinical narrative: Slight difficulty breathing.  Was trying to sleep (I work night shift).  Kept thinking to myself, "okay now breath",  I was a little scared to fall asleep, but I did.  Developed chills and headache around 2:30 pm.  General mild body aches.  Chills continued until 5 am, also had low grade fever (with antipyretics on board).  Felt like I was back to my normal self at 5 am on 10/28/09.   Then on 10/29/09 I developed diarrhea which continues through to this date.  On 10/30/09  had several hours of nausea, weakness & fatigue.  On 11/1/09 noticed tightness & occasional heaviness in chest with raw sensation when breath in.  Also developed mild cough 11/1/09, which continues.  Took Tylenol & Motrin evening of 10/27 & morning of 10/28/09.  Rested entire day of 10/30/09 with emesis basin nearby.  Have used my Albuterol inhaler at least daily since 11/1/09.
Age: 36.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Burning sensation, Headache, Musculoskeletal stiffness
Clinical narrative: Headache - lasting for 7 days, untreatable with aspirin, Tylenol, Ibuprofen.  Burning feelings in lungs - off and on for 7 days. Stiff neck and shoulders for 7 days.
Age: 22.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Headache, Injection site erythema, Injection site swelling, Myalgia, Vomiting
Clinical narrative: STARTED WITH A HEADACHE ABOUT 12:30 I TOOK A NAP AND AWOKE AROUND 4:30. INJECTION SITE WAS SWOLLEN AND RED WITH MUSCLE ACHES, AND VOMITING CONTINUING TILL 11/1/09 AT 09:00 PM. PERSISTANT HEADACHE EVER SINCE TAKEN TYLENOL, ADVIL, IBUPROPHEN, ALEVE, BENADRYL, CLARITIN, ICE PACKS, PLENTY OF WATER, DARK AND SILENCE WITH NO SIGNS OF HEADACHE RELIEF.
Age: 23.0
Sex: M
Vaccine: FLUX(H1N1)
Symptoms: Arthralgia, Cough, Fatigue, Pain, Pyrexia
Clinical narrative: Fever, aches in knees and lesser aches over entire body.  Tiredness, dry cough.
Age: 45.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Back pain, Neck pain, Tenderness
Clinical narrative: Severe neck & back pain.  Entire surface of back felt black & blue.  Couldn't tolerate touch.  Only lasted 24 hours.
Age: 5.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Abdominal pain, Epistaxis, Oropharyngeal pain, Pyrexia, Vomiting
Clinical narrative: Fever - 107F Abdominal Pain Vomiting Bloody Nose Sore Throat 11/09/09 HMO PCP and ED medical records received service dates 11/1/09 to 11/2/09. Assessment: Influenza like illness. Presents at ED. Parent reports child has fever, headache, dizziness. Also complained of abdominal pain and vomited. Sore throat. Next day parent states child running around happily.
Age: 4.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Cough, Headache, Pyrexia
Clinical narrative: Started with cough on 10/30/09, next day had cough and headache, then next day had fever and cough.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Dyspnoea, Eye discharge, Eye pruritus, Eye swelling
Clinical narrative: Immediately after seasonal influenza vaccine (preservative free) notice some tingling in lips - took 50 mg Benedryl gradually over next few hours eyes started feeling itchy and watery, some shortness of breath and some mild nausea. At 1:00 PM took another 50 mg Benedryl and by 1:30 PM went to Emergency Room due to increased shortness of breath, wheezing, nausea, light headedness, increased wateriness and mucous from eyes with puffiness and some puffiness and tingling of hands. Epinephrine given twice and Solumedrol given in ER. Discharged on Prednisone, Benedryl and Pepcid.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Immediate post-injection reaction, Lacrimation increased, Nausea, Paraesthesia, Paraesthesia oral
Clinical narrative: Immediately after seasonal influenza vaccine (preservative free) notice some tingling in lips - took 50 mg Benedryl gradually over next few hours eyes started feeling itchy and watery, some shortness of breath and some mild nausea. At 1:00 PM took another 50 mg Benedryl and by 1:30 PM went to Emergency Room due to increased shortness of breath, wheezing, nausea, light headedness, increased wateriness and mucous from eyes with puffiness and some puffiness and tingling of hands. Epinephrine given twice and Solumedrol given in ER. Discharged on Prednisone, Benedryl and Pepcid.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Wheezing
Clinical narrative: Immediately after seasonal influenza vaccine (preservative free) notice some tingling in lips - took 50 mg Benedryl gradually over next few hours eyes started feeling itchy and watery, some shortness of breath and some mild nausea. At 1:00 PM took another 50 mg Benedryl and by 1:30 PM went to Emergency Room due to increased shortness of breath, wheezing, nausea, light headedness, increased wateriness and mucous from eyes with puffiness and some puffiness and tingling of hands. Epinephrine given twice and Solumedrol given in ER. Discharged on Prednisone, Benedryl and Pepcid.
Age: 20.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Cough, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: I had sore throat about several hours later after I got the flu shot. Then I got a cough and catch a cold. And It's more and more serious athough I had eat medicine every day.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Asthenia, Dyspnoea, Hypoaesthesia facial, Hypoaesthesia oral
Clinical narrative: Dfficulty breathing, numbness of facial area especially mouth and tongue.weakness fainting, muscle weakness and joint pain
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Muscular weakness, Syncope
Clinical narrative: Dfficulty breathing, numbness of facial area especially mouth and tongue.weakness fainting, muscle weakness and joint pain
Age: 20.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Chills, Influenza serology negative, Pain in extremity, Pyrexia
Clinical narrative: Fever, chills, rigors, aches within legs flu 24 hours of vaccine (H1N1), R deltoid @ injection site w/no induration, no redness, non tender.
Age: 20.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Dyspnoea, Nausea, Pain
Clinical narrative: Fever, chills, rigors, aches within legs flu 24 hours of vaccine (H1N1), R deltoid @ injection site w/no induration, no redness, non tender.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Pain, Swelling, Wrong technique in drug usage process
Clinical narrative: NP called 10/30 to report patient had received flu shot in the joint space. Pt complained at visit that they would never have a flu shot again and how much it hurt. Told tech gave him his shot and there was a lot of chaos in the RxCu. Pt was injected twice after hitting bone. There is swelling/bulging. He is seeing a shoulder specialist (another problem exists). Will ask their opinion.
Age: 58.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pruritus, Urticaria
Clinical narrative: Itching and hives behind left ear and neck. Itching and hives both enter thigh area.
Age: 24.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Pt called to say he broke out in a localized rash. Pt later went to urgent care for steroids. He "felt better" on follow up.
Age: 6.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Fatigue, Headache
Clinical narrative: Mother states child c/o HA, feeling tired and dizziness in a.m. on 10-26-09. Received H1N1 vaccine @ approx 6:30 pm on 10-25-09. States child resolved sx by 10-27-09 0700. Did not seek medical attn or notify pediatrician. States called per nurse instruction to report sx of dizziness. States hx: migraine HA - sees neurologist.
Age: 18.0
Sex: M
Vaccine: FLUN3
Symptoms: Eye pain, Hypersensitivity, Ocular hyperaemia, Pruritus, Rash pustular
Clinical narrative: The day after receiving FLUMIST, noticed eye redness (mild) and itching. 6 days after vaccine, noticed tiny yellow pustules under eyes and continued to have pain and itching in eyes. He went to urgent care and diagnosed with allergic reaction, prescribed allergy eye drops.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Headache
Clinical narrative: Pt had headache that began 12 hours after her Flu shot. The headache lasted for 4 weeks.
Age: 0.19
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV1
Symptoms: Crying
Clinical narrative: Excessive crying >6 hrs after shots.
Sex: U
Vaccine: IPV, MMR, VARCEL
Symptoms: Erythema, Rash papular, Rash vesicular, Scab
Clinical narrative: Erythema papular 6-8 on abd 2-3 on shoulder 8-10 on thighs some sl. vesicular 1 or 2 with scabs.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Palpitations, Pyrexia
Clinical narrative: Fever, chills, weakness. Palpitations about 12 hours after vaccine admin.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 10/30/2009 Injection site is very hard, hot, swollen and burning. 11/1/09 went to urgent care clinic. Prescription given. Entire upper arm hard, swollen and burning hot.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Oval 2x4", swollen, hard, red, lump @ injection site itching was bothersome, used BENADRYL cream to treat seems to be getting smaller, less itching.
Age: 0.19
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: CSF culture negative, CSF glucose decreased, CSF protein increased, CSF white blood cell count increased, Enterovirus serology test positive
Clinical narrative: Pt presented to the local ER on 10/30/09 with fever and irritability. Work-up revealed aseptic meningitis. 12/29/09 DC summary and MR received for dates 10/31/09 to 11/3/09. DX: aseptic meningitis. SX: fever, irritable. Parent states pt was vaccinated recently.
Age: 0.19
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Irritability, Meningitis aseptic, Pyrexia, Red blood cells CSF positive
Clinical narrative: Pt presented to the local ER on 10/30/09 with fever and irritability. Work-up revealed aseptic meningitis. 12/29/09 DC summary and MR received for dates 10/31/09 to 11/3/09. DX: aseptic meningitis. SX: fever, irritable. Parent states pt was vaccinated recently.
Age: 2.0
Sex: M
Vaccine: UNK
Symptoms: Cough, Pyrexia, Rhinorrhoea
Clinical narrative: Runny nose started on the same day of vaccination then developed a bark like cough and now has a low-grade fever.
Age: 1.34
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Blood lead, Electroencephalogram, Eye rolling, Feeling abnormal, Full blood count
Clinical narrative: Within 24hr of vaccine patient began having episodes of turning head to right, eyes rolling back and "zoning out." Lasts 1-2 sec and patient recovers. Happening 2-3 times a day since. No previous problems.
Age: 1.34
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Metabolic function test, Posture abnormal, Vitamin D
Clinical narrative: Within 24hr of vaccine patient began having episodes of turning head to right, eyes rolling back and "zoning out." Lasts 1-2 sec and patient recovers. Happening 2-3 times a day since. No previous problems.
Age: 23.0
Sex: F
Vaccine: HEPAB
Symptoms: Injection site rash, Rash
Clinical narrative: Rash on both arms - onset L upper arm 1 hr after TWINRIX #2 dose. Spread down L arm to hand then to R arm.
Age: 1.85
Sex: M
Vaccine: HEP
Symptoms: Diarrhoea, Flatulence, Headache, Irritability, Photophobia
Clinical narrative: Fussy, diarrhea, gassy, c/o head hurting - Photophobia, temp 100 night of vaccine.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, IPV, PNC
Symptoms: Autism
Clinical narrative: Mom called requesting son's 12 record with manufacturer and lot number. Stated her son was DX and Autism and believes there is a link between immunizations provided and diagnosis. Stated she requested to have single antigens. Mom stated she would complete report herself.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Blister, Dysphonia, Injection site pain, Urticaria
Clinical narrative: 10/28/09 ~ 730 - 8 pm - Pain in upper arm above injection site. 10/29/09 AM - Pain continued. Also, hoarseness. PM - Hives on the arm - Patient took BENADRYL 25mg. 3-4 sacks of clear fluid under arm (small). 11/1/09 - All clear / still some minor soreness-improving.
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pruritus, Wrong drug administered
Clinical narrative: Injection site pruritus. Wrong drug administered. This case was reported by a healthcare professional and described the occurrence of injection site pruritus in female subject of unspecified age who was vaccinated with influenza vaccine trivalent (FLULAVAL, GalxoSmithKline) for prophylaxis. On 5 August 2009 at 16:00 the subject unspecified dose of FLULAVAL (unknown, left arm) instead of a TB test (wrong vaccine administered). On 5 August 2009, immediately after vaccination with FLULAVAL, the subject experienced injections site itching. At time of reporting the outcome of the injection site itching was unspecified.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pruritus
Clinical narrative: Pruritis, injection site pruritis. This case was reported by a healthcare professional and described the occurrence of itching in a subject of unspecified age and gender who was vaccinated with influenza vaccine trivalent (FLULAVAL, GSK). On September 15 2009 the subject received unspecified dose of DLULAVAL (unknown). On September 15 2009, almost immediately after vaccination with FLULAVAL, the subject experienced itching. The reporter stated a subject experienced itching from the inside out which began almost immediately after the shot was given. Specific information was not known. The reported stated that the batch of vaccine for lot number AFLLA261AA might be defective which caused the adverse event. The reported did not have specific information and is seeking advice on whether to continue giving injection with this lot. The reported did not have an expiration date. At the time of reporting the outcome of the events were unspecified. The reported stated three additional subjects experienced adverse events. Follow up was received from Sept 15 2009, via Quality assurance (QA). QA stated this is an Adverse Event and it will not be recorded as a complaint.  Follow-up was received on Sept 18 2009, via sales representative, who reported the 50 year old female subject received FluLaval on 14 September 2009. the onset of itchiness (described as skin crawling) at injection site was immediate following injection and lasted the rest of the day. Subject feeling well prior to vaccine, no fever, no other medications, no prior history of adverse events following flu vaccine. Subject was evaluated for rash and was negative. The events resolved on 14 September 2009 and was considered possibly related to FluLaval vaccination.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Hot flush, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a consumer and described the occurrence of swelling injection site in a 69-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included acid reflux, allergies, high blood pressure and high cholesterol. Concurrent medications included LOPID, LIPITOR, NEXIUM, PAXIL, XANAX, BENICAR, TOPROL, Nifedipine, CENTRUM SILVER, Vitamin B, ECOTRIN, ALLEGRA and NASACORT. On 3 September 2009 at 14:07, the subject received a dose of FLULAVAL (.5 ml, unknown, left arm). On 3 September 2009, at an unspecified time after vaccination with FLULAVAL, the subject experienced swelling injection site, hot flush, and fever. On 4 September 2009, at an unspecified time after vaccination with FLULAVAL, the subject experienced chills. At an unspecified time after vaccination with FLULAVAL, the subject experienced injection site pain. The subject was treated with EXTRA-STRENGTH TYLENOL. At the time of reporting the hot flushing, fever and chills were resolved and injection site swelling was unresolved. The outcome of injection site pain was unknown.Tthe subject is a retired physician. He took 500mg TYLENOL extra strength upon laying down to help with the pain at injection site on his left arm. He spiked a temperature at 102 that night and turned his air conditions to 62 degrees. He took a shower in cold water. This morning he had chills at about 5 am and covered up with sheet and to coverlets to keep him warm. He slept from 5 am until 2 pm. He feels better now in the afternoon, but not 100 percent.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of swelling injection site in a 69-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included acid reflux, allergies, high blood pressure and high cholesterol. Concurrent medications included LOPID, LIPITOR, NEXIUM, PAXIL, XANAX, BENICAR, TOPROL, Nifedipine, CENTRUM SILVER, Vitamin B, ECOTRIN, ALLEGRA and NASACORT. On 3 September 2009 at 14:07, the subject received a dose of FLULAVAL (.5 ml, unknown, left arm). On 3 September 2009, at an unspecified time after vaccination with FLULAVAL, the subject experienced swelling injection site, hot flush, and fever. On 4 September 2009, at an unspecified time after vaccination with FLULAVAL, the subject experienced chills. At an unspecified time after vaccination with FLULAVAL, the subject experienced injection site pain. The subject was treated with EXTRA-STRENGTH TYLENOL. At the time of reporting the hot flushing, fever and chills were resolved and injection site swelling was unresolved. The outcome of injection site pain was unknown.Tthe subject is a retired physician. He took 500mg TYLENOL extra strength upon laying down to help with the pain at injection site on his left arm. He spiked a temperature at 102 that night and turned his air conditions to 62 degrees. He took a shower in cold water. This morning he had chills at about 5 am and covered up with sheet and to coverlets to keep him warm. He slept from 5 am until 2 pm. He feels better now in the afternoon, but not 100 percent.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Bone pain, Pyrexia
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of fever in a female subject of unspecified age who was vaccinated with Influenza vaccine trivalent (Flulaval, GlaxoSmithKline). On 15 September 2009 at 15:00 the subject received unspecified dose of Flulaval (.5mL, unknown right arm). On 15 September 2009, less one day after vaccination with Flulaval, the subject experienced fever and bone pain. Subject received Flulaval dose yesterday and developed 104 fever and aching bones last night. This is unresolved as of 17 September 2009. At the time of reporting events were unresolved.
Age: 90.0
Sex: M
Vaccine: FLU3
Symptoms: Cognitive disorder, Fatigue, Hypersomnia, Hypotension, Unresponsive to stimuli
Clinical narrative: Cognitive disorder, fatigue, Hypersomnia, Hypertension. This case was reported by a healthcare professional and described the occurrence of difficulty responding in a 90-year-old male subject who was vaccinated with influenza vaccine trivalent (FLULAVAL, GlaxoSmithKline) for prophylaxis. Concurrent medical conditions included high blood pressure. Concurrent medications included Unknown (Unknown medication). On September 10 2009 at 10:00 the subject received unspecified dose of FLULAVAL (unknown, left arm). In September 2009, at an unspecified time after vaccination with FLULAVAL and an unspecified time after taking unknown blood pressure medication, the subject experienced difficulty responding, tiredness, sleep more than normal and low blood pressure. The reporter stated "cut blood pressure medication in half. Scheduled for a cardiogram today." At the time of reporting, low blood pressure had resolved. Follow-up received on 18 September 2009, via healthcare professional, reported an additional event of extreme fatigue. The subject was taking NORVASC. At the time of this report fatigue was worse.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Nausea, Pyrexia, Vertigo
Clinical narrative: This case was reported by healthcare professional and described the occurrence of vertigo in a 21-year-old female subject who was vaccinated with Flulaval, GlaxoSmithKline for prophylaxis. The subject's medical history included depression, gastroesophageal reflux disease, high cholesterol, reflux unspecified and seasonal allergy. Concurrent medications included Fluoxetine hydrochloride (Prozac), Clonazepam (Klonopin), Rosuvastatin calcium (Crestor), Flexofenadine hydrochloride (Allegra) and Omeprazole (Prilosec). In 2003, the subject received a dose of Flulaval (unknown). At an unspecified time after vaccination with Flulaval, the subject experienced nausea. The outcome was unknown. On 12 September 2009, the subject received a dose of Flulaval (.5 ml, unknown, left arm). On 12 September 2009 less than one day after vaccination with Flulaval, the subject experienced vertigo, low grade fever local swelling. The subject received the Flulaval vaccine. Shortly after receiving the injection, the subject developed a low-grade fever, local swelling and nausea that turned into vertigo. The reporter stated that as of now, the subject does not have a fever but the other symptoms have worsened. She says that the subject's blood pressure is fine. At the time of reporting, the fever resolved, while the swelling, nausea and vertigo were worse. The healthcare professional considered the events were probably related to vaccination with Flulaval.
Sex: U
Vaccine: FLU3
Symptoms: Lymphadenopathy
Clinical narrative: This case was reported by a pharmacist and described the occurrence of lymphnode swelling in a subject of unspecified age and gender who was vaccinated with influenza vaccine trivalent (Flulaval). On an unspecified date, the subject received a dose of Flulaval (unknown). One day, after vaccination with Flulaval, the subject experienced lymphnode swelling. The pharmacist reported a subject received Flulaval and one day later experienced "lymph node swelling in the subclavicular area". No other information was provided. At the time of reporting the outcome of the event was unspecified.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Pharyngeal oedema
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of throat closed in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline) for prophylaxis. On 15 September 2009, the subject received unspecified dose of FLULAVAL (unknown). on 15 September 2009, less that one day after vaccination with FLULAVAL, the subject experienced throat closure. The subject was seen in the emergency room and the event resolved. The reporter stated that the batch of vaccine for lot number AFLLA261AA might be defective which caused the adverse event. The reporter did not have specific information and is seeking advice on whether to continue giving injection with this lot. The reporter did not have an expiration date.  The reporter stated three additional subjects experienced adverse events; see cases A0807882A, A0807883A, and A0807884A. On 15 September 2009, the events were resolved. Follow-up was received on 18 September 2009, via sales representative, who reported the onset of symptoms were approximately a half hour, the subject was treated in the emergency room and discharged. Subject again visited emergency room that night, symptoms resolved. Subject reported feeling well prior to vaccine, no fever, no allergies to chicken feathers or eggs. Subject reported no previous allergy to flu vaccine, did report muscle aches and general symptoms following previous flu vaccine. No other concurrent medications. The event resolved on 16 September 2009 and was considered possibly related to vaccination with FLULAVAL.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pruritus
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of itching in a subject of unspecified age and gender who was vaccinated with influenza vaccine trivalent (Flulaval, GlaxoSmithKline). On 14 September 2009, the subject received unspecified dose of Flulaval (unknown). On 14 September 2009, almost immediately after vaccination with Flulaval, the subject experienced itching. The reporter stated a subject experiended itching from the inside out which began almost immediately after the shot was given. Specific informaotin was not known. The reporter stated that the batch of vaccine for lot number AFLLA261AA might be defective which caused the adverse event. The reporter did not have specific information and is seeking advice on whether to continue giving injection with this lot. The reporter did not have an expiration date. At the time of reporting the outcome of the events were unspecified. The reporter stated three additional subjects experienced adverse events; see cases A0807879A, A0807883A, and A0807884A. Follow-up was received from 15 September 2009, via Quality Assurance (QA). QA stated thsi is an adverse Event only and it will not be recorded as a compliant. Follow-up was received on 18 September 2009, via sales representative, who reported the 23-year old female subject received FLuLaval on 14 September 2009. The onset of itchiness (described as skin crawling) at injection site was immediately following injection; symptoms were not long lasting. Subject feeling well prior to vaccine, no fever, no other medications, nor prior history of adverse events following flu vaccine. Subject was evaluated for rash and was negative. The events resolved on 14 September 2009 and was considered possibly related to Flulaval vaccination.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Transient global amnesia
Clinical narrative: Global amnesia. This case was reported by a physician and described the occurrence of transient global amnesia in a 61 year old male subject who was vaccinated with influenza vaccine trivalent (FLULVAL, Glaxosmithkline). Concurrent medical conditions included diabetes, elevated cholesterol and high blood pressure. Concurrent medications included Diabetes medication, Blood pressure medication and Anti-hypercholesterolaemic (cholesterol reducing agent). On September 2009 the subject received unspecified dose of FLULAVAL (unknown, left arm). On September 30, 2009, 1 day after vaccination with FLULAVAL, the subject experienced transient global amnesia. On 30 September 2009, the event was resolved. The physician considered the transient global amnesia was unrelated to vaccination with FLULAVAL.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pruritus
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of itching in a subject of unspecified age and gender who was vaccinated with influenza vaccine trivalent (Flulaval). On 15 September 2009 the subject received unspecified dose of Flulaval (unknown). On 15 September 2009, almost immediately after vaccination with Flulaval, the subject experienced itching.  The reporter stated that subject experienced itching from the inside out which began almost immediately after the shot was given. Specific information was not known. The reporter stated that the batch of vaccine for lot number AFLLA261AA might be defective which caused the adverse event. The reporter did not have specific information and is seeking advice on whether to continue giving injection with this lot.  The reporter did not have an expiration date. At the time of reporting the outcome of the events were unspecified. The reporter stated three additional subjects experienced adverse events; see cases A08/07879A, A0807882A and A0807884A. Follow up was received from 15 September 2009, via quality assurance (QA). QA stated this is an adverse event only and it will not be recorded as a complaint. Follow up was received on 18 September 2009 via sales representative, who reported the 40-year old female subject received Flulaval on 14 September 2009. The onset of itchiness (described as skin crawling) at injection site was immediate following injection; symptoms were not long lasting. Subject feeling well prior to vaccine, no fever, no other medications, no prior history of adverse events following flu vaccine. Subject was evaluated for rash and was negative. The events resolved on 14 September 2009 and was considered possibly related to Flulaval vaccination.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Injection site swelling. Injection site pain. Injection site erythema. Incorrect route of drug administration. This case was reported by a healthcare professional and described the occurrence of swelling injection site in approximately 13 subjects of unspecified ages, and gender who were vaccinated with influenza vaccine trivalent (FLULAVAL, GlaxoSmithKline) for prophylaxis. On unspecified date the subjects received a dose of FLLAVAL (0.5ml, subcutaneous, unknown) and experienced inappropriate route of vaccination. One hour after vaccinations with FLULAVAL, the subjects experienced swelling injection site, injection site pain, and injection site redness. The reporter stat that there were approximately 13 subject who received FLULAVAL via subcutaneous route rather than deep intramuscular administration. The reporter did not know specifics for each subject. She reported that these subject experienced erythema, swelling and pain at the injection sites, which began approximately one hour after administration. At the time of reporting the outcome of the experienced swelling injection site, injection site pain, injection site redness and inappropriate route of vaccination were unspecified.
Age: 55.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Cough, Eye pruritus, Respiratory tract congestion, Rhinorrhoea, Throat tightness
Clinical narrative: Apporox. 10 min after injection she developed a cough, chest tightness, and difficultly taking a deep breath. She used her steroid inhaler and took an antihistamine.  Felt fine within 10 minutes.
Age: 55.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chest discomfort, Cough, Dyspnoea
Clinical narrative: Apporox. 10 min after injection she developed a cough, chest tightness, and difficultly taking a deep breath. She used her steroid inhaler and took an antihistamine.  Felt fine within 10 minutes.
Age: 27.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Convulsion, Immediate post-injection reaction
Clinical narrative: Seizure, lasted 15 seconds no treatment - resolved on its own.
Age: 27.0
Sex: M
Vaccine: TDAP, TDAP
Symptoms: Convulsion
Clinical narrative: Seizure, lasted 15 seconds no treatment - resolved on its own.
Age: 21.0
Sex: M
Vaccine: YF, YF
Symptoms: Febrile infection, Influenza serology negative, Malaise, Oropharyngeal pain, Pain
Clinical narrative: Received YF on Monday. That night felt a little feverish and ill. Then ok until Friday. Friday night felt very sick. States he felt "the sickest he has ever felt" and he had the "worst headache he has ever had". Fever around 100-103 with TYLENOL, chills, no appetite. Went to clinic Sat afternoon. Various testing done - all negative. Told to take ibuprofen and TYLENOL. No respiration symptoms. Felt much better by Monday. Went on Wed to attend training before going abroad.
Age: 21.0
Sex: M
Vaccine: YF, YF
Symptoms: Pyrexia, Streptococcal identification test negative
Clinical narrative: Received YF on Monday. That night felt a little feverish and ill. Then ok until Friday. Friday night felt very sick. States he felt "the sickest he has ever felt" and he had the "worst headache he has ever had". Fever around 100-103 with TYLENOL, chills, no appetite. Went to clinic Sat afternoon. Various testing done - all negative. Told to take ibuprofen and TYLENOL. No respiration symptoms. Felt much better by Monday. Went on Wed to attend training before going abroad.
Age: 21.0
Sex: M
Vaccine: YF, YF
Symptoms: Chills, Decreased appetite, Headache, Influenza serology negative, Malaise
Clinical narrative: Received YF on Monday. That night felt a little feverish and ill. Then ok until Friday. Friday night felt very sick. States he felt "the sickest he has ever felt" and he had the "worst headache he has ever had". Fever around 100-103 with TYLENOL, chills, no appetite. Went to clinic Sat afternoon. Various testing done - all negative. Told to take ibuprofen and TYLENOL. No respiration symptoms. Felt much better by Monday. Went on Wed to attend training before going abroad.
Age: 21.0
Sex: M
Vaccine: YF, YF
Symptoms: Mononucleosis heterophile test negative, Pyrexia, Streptococcal identification test negative
Clinical narrative: Received YF on Monday. That night felt a little feverish and ill. Then ok until Friday. Friday night felt very sick. States he felt "the sickest he has ever felt" and he had the "worst headache he has ever had". Fever around 100-103 with TYLENOL, chills, no appetite. Went to clinic Sat afternoon. Various testing done - all negative. Told to take ibuprofen and TYLENOL. No respiration symptoms. Felt much better by Monday. Went on Wed to attend training before going abroad.
Age: 6.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1), FLU(H1N1)
Symptoms: Abasia, Abdominal pain upper, Dizziness, Headache, Hypotonia
Clinical narrative: Received H1N1 vaccine at approximately 1:05 PM. Went to observation area to eat snack. School nurse noted cl't on floor-stated looked like "seizure activity". School nurse carried cl't to sick room. Cl't proceeded to vomit. BP 92/72, P-96, R-18. Alert, oriented, able to move all 4 extremities on command. Placed in reclining position with feet elevated. Parent arrived-cl't taken home. Alert, oriented and responding to questions and commands.
Age: 6.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1), FLU(H1N1)
Symptoms: Laboratory test normal, Pallor, Syncope, Vomiting
Clinical narrative: Received H1N1 vaccine at approximately 1:05 PM. Went to observation area to eat snack. School nurse noted cl't on floor-stated looked like "seizure activity". School nurse carried cl't to sick room. Cl't proceeded to vomit. BP 92/72, P-96, R-18. Alert, oriented, able to move all 4 extremities on command. Placed in reclining position with feet elevated. Parent arrived-cl't taken home. Alert, oriented and responding to questions and commands.
Age: 6.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1), FLU(H1N1)
Symptoms: Convulsion, Vomiting
Clinical narrative: Received H1N1 vaccine at approximately 1:05 PM. Went to observation area to eat snack. School nurse noted cl't on floor-stated looked like "seizure activity". School nurse carried cl't to sick room. Cl't proceeded to vomit. BP 92/72, P-96, R-18. Alert, oriented, able to move all 4 extremities on command. Placed in reclining position with feet elevated. Parent arrived-cl't taken home. Alert, oriented and responding to questions and commands.
Age: 78.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Blood test, C-reactive protein increased, Muscular weakness
Clinical narrative: My father received the flu shot on 10/05/2009 and on 10/6, he went from being independent, self care working, to very weak, with specific knee down and arm/hand weakness. He went to see his physician on 10/7 and was sent to see an orthoped on 10/9.  Unable to explain the acute onset of these symptoms, was places on a steroid dose pak. Symptoms improved slightly.  This week he is now unable to dress himself, can not feed himself. Had profound weakness, limited ambulation. Saw his MD on Wednesday, he ordered labs and chest x-ray and has an appointment to rheumatologist on Monday. He now has profound weakeness, my brother took the local ED.
Age: 78.0
Sex: M
Vaccine: FLU3, FLUX
Symptoms: Activities of daily living impaired, Asthenia, C-reactive protein increased, Gait disturbance, Muscular weakness
Clinical narrative: My father received the flu shot on 10/05/2009 and on 10/6, he went from being independent, self care working, to very weak, with specific knee down and arm/hand weakness. He went to see his physician on 10/7 and was sent to see an orthoped on 10/9.  Unable to explain the acute onset of these symptoms, was places on a steroid dose pak. Symptoms improved slightly.  This week he is now unable to dress himself, can not feed himself. Had profound weakness, limited ambulation. Saw his MD on Wednesday, he ordered labs and chest x-ray and has an appointment to rheumatologist on Monday. He now has profound weakeness, my brother took the local ED.
Age: 51.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Blood test normal, Computerised tomogram normal, Dizziness, Electrocardiogram normal, Fatigue
Clinical narrative: Dizziness, unable to walk straight, weak fatigue, right hand numbness, no fever
Age: 51.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Muscular weakness, Urine analysis normal
Clinical narrative: Dizziness, unable to walk straight, weak fatigue, right hand numbness, no fever
Age: 51.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Asthenia, Cardiac enzymes normal, Computerised tomogram normal, Dizziness, Fatigue
Clinical narrative: Dizziness, unable to walk straight, weak fatigue, right hand numbness, no fever
Age: 51.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Full blood count normal, Gait disturbance, Hypoaesthesia, Laboratory test normal, Oxygen saturation
Clinical narrative: Dizziness, unable to walk straight, weak fatigue, right hand numbness, no fever
Age: 51.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Red blood cell sedimentation rate normal, Urine analysis normal
Clinical narrative: Dizziness, unable to walk straight, weak fatigue, right hand numbness, no fever
Age: 13.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Erythema, Pain, Pruritus, Swelling, Urticaria
Clinical narrative: Hives over upper body parts, redness and swelling of skin and lumps on certain body parts, itching and soreness.
Age: 8.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Eye swelling, Lacrimation increased, Rash, Rhinorrhoea, Swelling face
Clinical narrative: Watery eyes, runny nose, swelling of face adn eyes, slight rash in between eyebrown doen dose and under chin.
Age: 9.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Chills, Cough, Pulmonary congestion, Pyrexia, Rhinorrhoea
Clinical narrative: Starting 10/31 evening runny nose and cough, continuing until 11/2 when High Fever (102 F with Tylenol), Chills, Chest Congestion, Runny Nose, Severe Cough
Age: 2.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Epistaxis
Clinical narrative: Patient received the H1N1 vaccination and woke up with a bloody nose, which occurred for about 5-7 minutes.
Age: 0.59
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Abdominal pain upper, Diarrhoea, Nausea, Pyrexia
Clinical narrative: Stomach pain, nausea, diarrhea, when she burped it smelled like rotting eggs and feels terrible. Had fever earlier in the day but not as of 2:49 AM on 11/04/2009 and no vomiting so far but still has nausea.  Been giving Tylenol and Motrin as needed.
Age: 4.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Grand mal convulsion, Pyrexia, Upper respiratory tract infection
Clinical narrative: Pt developed fever about 3 days after vaccine administration in getting of new URI sx. On 11/3/09 had witnessed GTC seizure taken to ER. Febrile 10 100.6 F. Sz x 2 min, self resolved, pt quickly back to baseline with nl exam.  11/9/09:  Vaccine record received, VAERS updated.  11/05/09 and 11/09/09 Medical records recieved.  FInal DX Febrile seizure. Three days s/p vacccine. Seizure while sleeping. Jerking arms and legs. ED visit s/p convulsion. Fever, cough. constipation. H/O febrile seizures. D/C to home.
Age: 1.08
Sex: F
Vaccine: HEPA, MMR
Symptoms: Decreased appetite, Irritability, Rash erythematous
Clinical narrative: Daughter was irritable, not drinking a full bottle and started to develop red bumps all over her torso. By morning it had further spread to the neck and face
Age: 3.0
Sex: F
Vaccine: FLU(H1N1), FLUX
Symptoms: Abdominal pain, Arthralgia, Haematuria, Henoch-Schonlein purpura, Skin lesion
Clinical narrative: Classic henoch-schonlein purpura with typical skin lesions, abd pain, joint pain and hematuria.  Normal BP 12/3/09 Medical records received for dates 11/3/09 to 11/16/09.  DX: henoch-schonlein purpura HSP. OV 11/3/09 presented w/ vomiting 2x in 24hrs. Pt had H1N1 vax 8 days ago, seasonal flu vax 5 days ago. Assessment: (+)vomit, (-)joint swelling, (+)urinary urgency. 11/4/09 Pt. parent placed call to MD stated has developed inflammation in middle of back/spines. OV: Pt parent states 2 day h/o rash, vomiting. Assessment: rash, red papules on back, (+)swelling. DX: rash secondary to h/o HSP. OV 11/16 DX: back ache.  Pt seen for c/o BA, SA. For f/u rash(+), back ache, same SA. Assessment: no blood in stool, UA(+)protein and blood, (-)blood in stool, (+)BA, (+)SA. Prev OV 9/27/09 for croupy cough.
Age: 5.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Pyrexia, Vomiting
Clinical narrative: 10/28/09-vomiting in evening. OK next day. 10/30/09-fever 103 degrees in evening-OK next day.