chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Abdominal pain upper, Headache, Malaise
Clinical narrative: Headache, stomach ache, general ill feeling.  Did not feel well enough to remain at school and went home.  Out of school on 12/8/09 and returned to school on 12/9/09.
Age: 20.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Decreased appetite, Pallor, Retching, Vomiting
Clinical narrative: Not wanting to eat or drink anything, dry heaves, paleness, severe vomiting from 9:00 pm through 3:00 am.
Age: 18.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Headache, Nausea, Throat irritation
Clinical narrative: Reported to school nurse that she developed headache, nausea, and throat "felt funny."  No medical evaluation.  Returned to school on 12/8/09.
Age: 2.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Gaze palsy, Listless, Pyrexia
Clinical narrative: Child became limp, eyes rolled back into his head. He was listless. Had a low fever (100 degrees). This lasted about 2 hours. We was back to his normal self by afternoon time.
Age: 29.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Abortion spontaneous, Drug exposure during pregnancy
Clinical narrative: Miscarriage. Exact time n dates is unknown. I have no previous history of miscarriage and I have a perfectly healthy 1yr old son from previous pregnancy unvaccinated.
Age: 1.6
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Convulsion, Cough, Diarrhoea, Laboratory test, Rhinorrhoea
Clinical narrative: Started having diarrhea, then vomiting, by 12/4 he had runny nose and cough as well, then on 12/5 he went into having seizures.
Age: 1.6
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Vomiting
Clinical narrative: Started having diarrhea, then vomiting, by 12/4 he had runny nose and cough as well, then on 12/5 he went into having seizures.
Age: 50.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Chills, Cough, Dry eye, Dyspnoea, Eye pruritus
Clinical narrative: Patient reports that when she returned home from receiving injection she developed red, itchy, dry eyes. She laid down and when she woke up she felt drugged and had fever and chills. Patient said she was having a little difficulty breathing and when she took a deep breath she would cough.  Patient took Benadryl but still has cough when deep breathing.
Age: 50.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Fatigue, Ocular hyperaemia, Pyrexia
Clinical narrative: Patient reports that when she returned home from receiving injection she developed red, itchy, dry eyes. She laid down and when she woke up she felt drugged and had fever and chills. Patient said she was having a little difficulty breathing and when she took a deep breath she would cough.  Patient took Benadryl but still has cough when deep breathing.
Age: 57.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Blood creatine phosphokinase normal, Blood magnesium normal, Differential white blood cell count normal, Full blood count, Metabolic function test normal
Clinical narrative: Client woke on 12/4/09 with severe pain in legs which worsened over time.  On 12/5/09, client could not bear weight on legs due to pain.  She & her husband were unsure if pain caused by H1N1 Vaccine or new med (Lamotrigine 25 mg hs started on 12/1/09.  Called neurologist who did not return call.  On 12/6/09, she stopped taking Lamotrigine.  Pain continued but decreased slightly.  On 12/8/09, husband reported symptoms to Dept. of Health, then made contact again with neurologist's office.  Went to ER later in day.  No cause for pain found.  Treatment prescribed:  stay off legs, elevate & apply heat & ice.  To follow up with Private Physician on 12/11/09.  No other symptoms or side effects.  No breathing difficulties.  No skin problems.  Pain localized in legs.
Age: 57.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Pain in extremity, Toxicologic test normal, Weight bearing difficulty
Clinical narrative: Client woke on 12/4/09 with severe pain in legs which worsened over time.  On 12/5/09, client could not bear weight on legs due to pain.  She & her husband were unsure if pain caused by H1N1 Vaccine or new med (Lamotrigine 25 mg hs started on 12/1/09.  Called neurologist who did not return call.  On 12/6/09, she stopped taking Lamotrigine.  Pain continued but decreased slightly.  On 12/8/09, husband reported symptoms to Dept. of Health, then made contact again with neurologist's office.  Went to ER later in day.  No cause for pain found.  Treatment prescribed:  stay off legs, elevate & apply heat & ice.  To follow up with Private Physician on 12/11/09.  No other symptoms or side effects.  No breathing difficulties.  No skin problems.  Pain localized in legs.
Age: 42.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Asthenia, Malaise, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, malaise, weakness.
Age: 1.6
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Blood test, Convulsion, Cough, Diarrhoea, Electroencephalogram
Clinical narrative: Started with runny nose and cough, then by 12/4 had diarrhea and vomiting, on the evening of 12/5 started having seizures, non breather, CPR administered, 911 called ambulance transported to Hospital. Continued to seize again and non breathe again .  12/14/09 DC summary and hospital records received for DOS 12/05/09-12/07/09 Pt presented to ED with 2 day hx. of cough, fever, diarrhea, emesis. Reports tonic-clonic seizure at home, another immediately before admission and a third seizure upon admission. EMS reported pt. apneic during seizure.  Received vaccine this week. Admitted for neuro evaluation and seizure management. Seizure activity resolved without requiring anti-epiletics and pt. was discharged home. DC DX: febile seizures secondary to an acute GI infection
Age: 1.6
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Lumbar puncture, Nuclear magnetic resonance imaging, Respiratory arrest, Resuscitation, Rhinorrhoea
Clinical narrative: Started with runny nose and cough, then by 12/4 had diarrhea and vomiting, on the evening of 12/5 started having seizures, non breather, CPR administered, 911 called ambulance transported to Hospital. Continued to seize again and non breathe again .  12/14/09 DC summary and hospital records received for DOS 12/05/09-12/07/09 Pt presented to ED with 2 day hx. of cough, fever, diarrhea, emesis. Reports tonic-clonic seizure at home, another immediately before admission and a third seizure upon admission. EMS reported pt. apneic during seizure.  Received vaccine this week. Admitted for neuro evaluation and seizure management. Seizure activity resolved without requiring anti-epiletics and pt. was discharged home. DC DX: febile seizures secondary to an acute GI infection
Age: 1.6
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Urine analysis, Vomiting
Clinical narrative: Started with runny nose and cough, then by 12/4 had diarrhea and vomiting, on the evening of 12/5 started having seizures, non breather, CPR administered, 911 called ambulance transported to Hospital. Continued to seize again and non breathe again .  12/14/09 DC summary and hospital records received for DOS 12/05/09-12/07/09 Pt presented to ED with 2 day hx. of cough, fever, diarrhea, emesis. Reports tonic-clonic seizure at home, another immediately before admission and a third seizure upon admission. EMS reported pt. apneic during seizure.  Received vaccine this week. Admitted for neuro evaluation and seizure management. Seizure activity resolved without requiring anti-epiletics and pt. was discharged home. DC DX: febile seizures secondary to an acute GI infection
Age: 15.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Malaise, Nausea, Vomiting
Clinical narrative: Nauseated.  Did not feel well enough to remain at school and was sent home.  Per father, started vomiting on 12/9/09 and he kept her home from school.  Father reports that he is uncertain if vaccine-related.  Pt has history of GERD and GI problems.  Was hospitalized last year because of problems with vomiting.
Age: 30.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Asthenia, Blood electrolytes decreased, Chest X-ray normal, Chest discomfort, Chest pain
Clinical narrative: Report received from a security administrator on 25-Nov-2009. A 30 year-old female patient received H1N1 vaccine, lot 005496118 by IM to the deltoid for immunization on 13-Nov-2009. The patient was not pregnant and has a history of 2 live births. Twenty minutes later, she couldn't breathe and EMS was called. She was admitted that day (13-Nov-2009) and was discharged on 15-Nov-2009 for a duration of 3 days. Her symptoms included trouble swallowing, heaviness in chest, twitching like PARKINSON'S. EMS (emergency medical service) was called again on 17-Nov-2009 due to complaints of not being able to breathe. She stayed in the ER (emergency room) for 1 day. The patient is currently undergoing diagnostic testing. She was seen by an allergist and neurologist. An MRI and EEG are anticipated. The female has lost 10 lbs. in less than a week and her electrolytes are low. She is weak and unable to eat a lot. No diagnosis has been provided as yet. The outcome is unknown; we await information from the reporter.
Age: 30.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Chills, Condition aggravated, Cough, Dizziness, Dysphagia
Clinical narrative: Report received from a security administrator on 25-Nov-2009. A 30 year-old female patient received H1N1 vaccine, lot 005496118 by IM to the deltoid for immunization on 13-Nov-2009. The patient was not pregnant and has a history of 2 live births. Twenty minutes later, she couldn't breathe and EMS was called. She was admitted that day (13-Nov-2009) and was discharged on 15-Nov-2009 for a duration of 3 days. Her symptoms included trouble swallowing, heaviness in chest, twitching like PARKINSON'S. EMS (emergency medical service) was called again on 17-Nov-2009 due to complaints of not being able to breathe. She stayed in the ER (emergency room) for 1 day. The patient is currently undergoing diagnostic testing. She was seen by an allergist and neurologist. An MRI and EEG are anticipated. The female has lost 10 lbs. in less than a week and her electrolytes are low. She is weak and unable to eat a lot. No diagnosis has been provided as yet. The outcome is unknown; we await information from the reporter.
Age: 30.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Dyspnoea, Electrocardiogram abnormal, Endoscopy abnormal, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: Report received from a security administrator on 25-Nov-2009. A 30 year-old female patient received H1N1 vaccine, lot 005496118 by IM to the deltoid for immunization on 13-Nov-2009. The patient was not pregnant and has a history of 2 live births. Twenty minutes later, she couldn't breathe and EMS was called. She was admitted that day (13-Nov-2009) and was discharged on 15-Nov-2009 for a duration of 3 days. Her symptoms included trouble swallowing, heaviness in chest, twitching like PARKINSON'S. EMS (emergency medical service) was called again on 17-Nov-2009 due to complaints of not being able to breathe. She stayed in the ER (emergency room) for 1 day. The patient is currently undergoing diagnostic testing. She was seen by an allergist and neurologist. An MRI and EEG are anticipated. The female has lost 10 lbs. in less than a week and her electrolytes are low. She is weak and unable to eat a lot. No diagnosis has been provided as yet. The outcome is unknown; we await information from the reporter.
Age: 30.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Hypersensitivity, Hypoaesthesia, Hypophagia, Oesophagogastroduodenoscopy, Oxygen saturation normal
Clinical narrative: Report received from a security administrator on 25-Nov-2009. A 30 year-old female patient received H1N1 vaccine, lot 005496118 by IM to the deltoid for immunization on 13-Nov-2009. The patient was not pregnant and has a history of 2 live births. Twenty minutes later, she couldn't breathe and EMS was called. She was admitted that day (13-Nov-2009) and was discharged on 15-Nov-2009 for a duration of 3 days. Her symptoms included trouble swallowing, heaviness in chest, twitching like PARKINSON'S. EMS (emergency medical service) was called again on 17-Nov-2009 due to complaints of not being able to breathe. She stayed in the ER (emergency room) for 1 day. The patient is currently undergoing diagnostic testing. She was seen by an allergist and neurologist. An MRI and EEG are anticipated. The female has lost 10 lbs. in less than a week and her electrolytes are low. She is weak and unable to eat a lot. No diagnosis has been provided as yet. The outcome is unknown; we await information from the reporter.
Age: 30.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Pulmonary function test abnormal, Red blood cell count decreased, Tachycardia, Throat tightness, Tremor
Clinical narrative: Report received from a security administrator on 25-Nov-2009. A 30 year-old female patient received H1N1 vaccine, lot 005496118 by IM to the deltoid for immunization on 13-Nov-2009. The patient was not pregnant and has a history of 2 live births. Twenty minutes later, she couldn't breathe and EMS was called. She was admitted that day (13-Nov-2009) and was discharged on 15-Nov-2009 for a duration of 3 days. Her symptoms included trouble swallowing, heaviness in chest, twitching like PARKINSON'S. EMS (emergency medical service) was called again on 17-Nov-2009 due to complaints of not being able to breathe. She stayed in the ER (emergency room) for 1 day. The patient is currently undergoing diagnostic testing. She was seen by an allergist and neurologist. An MRI and EEG are anticipated. The female has lost 10 lbs. in less than a week and her electrolytes are low. She is weak and unable to eat a lot. No diagnosis has been provided as yet. The outcome is unknown; we await information from the reporter.
Age: 30.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Ultrasound thyroid abnormal, Weight decreased, Wheezing, White blood cell count increased, X-ray normal
Clinical narrative: Report received from a security administrator on 25-Nov-2009. A 30 year-old female patient received H1N1 vaccine, lot 005496118 by IM to the deltoid for immunization on 13-Nov-2009. The patient was not pregnant and has a history of 2 live births. Twenty minutes later, she couldn't breathe and EMS was called. She was admitted that day (13-Nov-2009) and was discharged on 15-Nov-2009 for a duration of 3 days. Her symptoms included trouble swallowing, heaviness in chest, twitching like PARKINSON'S. EMS (emergency medical service) was called again on 17-Nov-2009 due to complaints of not being able to breathe. She stayed in the ER (emergency room) for 1 day. The patient is currently undergoing diagnostic testing. She was seen by an allergist and neurologist. An MRI and EEG are anticipated. The female has lost 10 lbs. in less than a week and her electrolytes are low. She is weak and unable to eat a lot. No diagnosis has been provided as yet. The outcome is unknown; we await information from the reporter.
Age: 30.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Chest discomfort, Dyspnoea, Eating disorder, Tachycardia, Tremor
Clinical narrative: Report received from a security administrator on 25-Nov-2009. A 30 year-old female patient received H1N1 vaccine, lot 005496118 by IM to the deltoid for immunization on 13-Nov-2009. The patient was not pregnant and has a history of 2 live births. Twenty minutes later, she couldn't breathe and EMS was called. She was admitted that day (13-Nov-2009) and was discharged on 15-Nov-2009 for a duration of 3 days. Her symptoms included trouble swallowing, heaviness in chest, twitching like PARKINSON'S. EMS (emergency medical service) was called again on 17-Nov-2009 due to complaints of not being able to breathe. She stayed in the ER (emergency room) for 1 day. The patient is currently undergoing diagnostic testing. She was seen by an allergist and neurologist. An MRI and EEG are anticipated. The female has lost 10 lbs. in less than a week and her electrolytes are low. She is weak and unable to eat a lot. No diagnosis has been provided as yet. The outcome is unknown; we await information from the reporter.
Age: 48.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: No reaction on previous exposure to drug, Pharyngeal oedema, Wheezing
Clinical narrative: Patient experience sensation of swelling of throat and wheezing within 5 minutes of vaccine administration.  Has NOT experienced similar reaction with the seasonal vaccine.  The sensation of throat swelling resolved within one hour of vaccination and the wheezing resolved by bedtime.  No intervention was necessary, however, patient did take her regularly scheduled cetirizine that evening.
Age: 4.0
Sex: M
Vaccine: FLU3, MMR, TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Unknown
Age: 55.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Bacterial infection, Eye discharge, Eye irritation, Eyelid oedema, Pruritus
Clinical narrative: Thirty minutes after receiving vaccine, developed white, thick, exudate from corners of both eyes, itching of eye lids and whole face, and minor swelling of eye lids.  No other skin problems, no leisons or blotching on face, neck, or body.  On 12/4/09, saw her optometrist who diagnoses bacterial infection.  Perscribed Ofloxacin 2 drops in each eye every 4 hrs.  Dischage from eyes resolved on 12/5/09 but minor itching of eye lids and face continued.  On 12/9/09, itching increased in eye lids & face and has burning in eyes.  Called optometrist again.  He advised her to report as possible reaction to H1N1 Vaccine.  To return to optometrist on 12/10/09.  No other symptoms or side effects.  No difficulty breathing.  No further skin problems.  No lesions or hives.
Age: 4.0
Sex: F
Vaccine: DTAP, FLUN(H1N1), MMR, VARCEL
Symptoms: Rash
Clinical narrative: "RASH ON LEGS, STOMACH, AND CHEEKS" PER MOTHER'S STATEMENT.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Injection site reaction, Pain in extremity, Skin hypertrophy
Clinical narrative: Initial case report received from a consumer on 25 NOV 2009. A 57 year old female was vaccinated with i.m. FLUVIRIN (batch no. 8788201) on 18 OCT 2008. On the same day, she experienced arm pain after injection. No other symptoms were noted at the time. The caller then stated that the pain got progressively worse and she was diagnosed with chronic bursitis in the area. She also developed a thickening around the injection area. These events were reported as bursitis, pain and skin hypertrophy. The patient's outcome was not reported.
Age: 61.0
Sex: U
Vaccine: FLU(H1N1)
Symptoms: Injection site nodule, Injection site pain, Pain
Clinical narrative: Soreness (pain!!!) when using left arm (where inj. site was)- esp. when using arm to pull, when crossing in front of chest, and when lifting arms to dress or undress. Inj. 11-19-09. Today is 12-9-09 also left upper shoulder 'Knots' in back.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cold compress therapy, Injection site erythema, Injection site mass, Injection site pruritus, Injection site warmth
Clinical narrative: Pt noted lump at injection site with warmth, redness & itching.  No other complaint/problem.  She applied topical Vaseline without relief.  Instructed to use ZYRTEC which she already has, apply cold compresses.  Site circled & instructed to observe, RTC if enlarges or further problem.
Age: 11.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Dizziness, Erythema, Heart rate increased, Rash macular
Clinical narrative: RAPID PULSE, DIZZY AND BLOTCHY RED SKIN (STUDENT CAME IN WITH BLOTCHY RED SKIN). AFTER VACCINE STUDENT RETURNED TO CLASS.
Age: 31.0
Sex: F
Vaccine: FLU(H1N1), FLUX
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Surgery, Ultrasound scan abnormal
Clinical narrative: I had a viable healthy pregnancy by ultrasound on 11/17/09 and I was 6 weeks and 1 day. I had the seasonal flu as well as the H1N1 vaccine on 12/2/09 and on 12/09/09 I had an ultrasound that my baby had died and resulted in a miscarriage. 12/10/09 Medical Records received for DOS 10/06/09. Pt. requesting IUD removal. Desires pregnancy.
Age: 87.0
Sex: M
Vaccine: FLU3
Symptoms: Vertigo
Clinical narrative: The patients daughter reported he had vertigo and was hospitalized.
Age: 14.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Chills, Full blood count, Headache, Lymphadenopathy, Mononucleosis heterophile test negative
Clinical narrative: Woke up with sore throat and pain and stiffness in back of neck in which she could not turn head to side positions or extend backwards. She developed an enlarged lymph node on lateral-posterior region of right neck that was painful to touch. Severe headaches not relieved by Tylenol, chills, fever peaking at 102.8 and only brought down with Tylenol which within 2 hours fever went back up. Seen by doctor 2 times within 3 days.
Age: 14.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Musculoskeletal stiffness, Neck pain, Oropharyngeal pain, Pyrexia, Streptococcal identification test negative
Clinical narrative: Woke up with sore throat and pain and stiffness in back of neck in which she could not turn head to side positions or extend backwards. She developed an enlarged lymph node on lateral-posterior region of right neck that was painful to touch. Severe headaches not relieved by Tylenol, chills, fever peaking at 102.8 and only brought down with Tylenol which within 2 hours fever went back up. Seen by doctor 2 times within 3 days.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Pruritus
Clinical narrative: onset over 2hr time period.  Developed 3" x 5" area of redness, induration, pain & itching at site of injection.  Itching spread to back, scalp.  Took about 40 mg po benadryl; then 5.5 hrs later took 25 mg benadryl.  Itching relieved.  On day 2 following onset, itching & redness but induration has improved.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Blood product transfusion, CSF protein increased, Dysstasia, Fatigue, Hypoaesthesia
Clinical narrative: On 10/25/09 weakness, pain and numbness began in lower extremities. By 11/1/09 spread to entire body paralyzed with extreme pain. Initiated IVIG (5) days moved to rehab hospital on 11/9 and discharged on 11/19/09 in a walker. Numbness, fatigue, weakness. Remain while unstable on feet. Treatment continues.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Lumbar puncture, Muscular weakness, Pain, Pain in extremity, Paralysis
Clinical narrative: On 10/25/09 weakness, pain and numbness began in lower extremities. By 11/1/09 spread to entire body paralyzed with extreme pain. Initiated IVIG (5) days moved to rehab hospital on 11/9 and discharged on 11/19/09 in a walker. Numbness, fatigue, weakness. Remain while unstable on feet. Treatment continues.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Walking aid user
Clinical narrative: On 10/25/09 weakness, pain and numbness began in lower extremities. By 11/1/09 spread to entire body paralyzed with extreme pain. Initiated IVIG (5) days moved to rehab hospital on 11/9 and discharged on 11/19/09 in a walker. Numbness, fatigue, weakness. Remain while unstable on feet. Treatment continues.
Age: 7.0
Sex: F
Vaccine: FLUN3
Symptoms: Abdominal pain upper, Malaise, Vomiting
Clinical narrative: Vomited x1 and c/o not feeling well and came to nurse/medical room and vomited twice. Also said she have no lunch and w/stomach ache, w/c per nurse student. Had sev. titers. Had CAT planned of. T=97.8. Given H2O to drink and to sx levitated.
Age: 46.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Discomfort, Rash erythematous, Swelling
Clinical narrative: c/o red raised rash at left shoulder at about 1:00 p.m. on 12/3/09.  Red rash spread to back and trunk that evening and continued until 12/3/09 when he called the Health Dept. Referred to physician. Was seen at clinic, who thought it resembled shingles, but it crossed over to other arm. Was given a Rx that reduced the swelling and discomfort.
Age: 15.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: 30 min after shot hand began to feel numb & tingly.  Went away.  No treatment.
Age: 18.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Laceration, Syncope, Unresponsive to stimuli
Clinical narrative: Student apparently fainted few minutes after recieving the vaccine.  He was unresponsive for a few seconds but later recovered.  He gave his name & place where he's at.  He sustained a small cut (R) cheek area.  Neuro signs OK.  911 was called at 10:06.  Father was notified by phone.  Student taken to Hospital via Fire Department ambulance around 10:25 AM.
Age: 14.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Hypoaesthesia, Injection site erythema
Clinical narrative: 1 hr after shot, felt numbness in right forearm.  Had redness around bandaid.  Numbness was from elbow down to fingertips then only from midarm to fingertips.
Age: 44.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Headache, Pain, Wheezing
Clinical narrative: PT CALLED COMPLAINING OF BODY ACHES AND HEADACHE, TOLD TO TAKE ADVIL OR TYLENOL FOR DISCOMFORT. LIE DOWN AND REST. PT STATED IF DIDN'T FEEL BETTER WOULD PROBABLY GO TO EMERGENCY ROOM
Age: 44.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Dyspnoea, Electrocardiogram, Headache, Heart rate increased, Pain
Clinical narrative: PT CALLED COMPLAINING OF BODY ACHES AND HEADACHE, TOLD TO TAKE ADVIL OR TYLENOL FOR DISCOMFORT. LIE DOWN AND REST. PT STATED IF DIDN'T FEEL BETTER WOULD PROBABLY GO TO EMERGENCY ROOM
Age: 44.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Pallor, Wheezing
Clinical narrative: PT CALLED COMPLAINING OF BODY ACHES AND HEADACHE, TOLD TO TAKE ADVIL OR TYLENOL FOR DISCOMFORT. LIE DOWN AND REST. PT STATED IF DIDN'T FEEL BETTER WOULD PROBABLY GO TO EMERGENCY ROOM
Age: 17.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Oedema peripheral, Pain in extremity, Rash
Clinical narrative: Next day both hands swelled & had rash on forearms.  Rash present second day.  Seen at doctor 12/2/09; given Benadryl.  On 12/3/09 reports pain in arm.
Age: 18.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Eye swelling, Headache, Immediate post-injection reaction, Pruritus generalised
Clinical narrative: Immediate headache, periorbital itching and swelling. c/o of itching all over. No localized reaction at injections site. Given Solu-medrol and Benadryl in ambulance.
Age: 2.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Urticaria
Clinical narrative: Urticaria
Age: 0.87
Sex: M
Vaccine: FLU(H1N1), FLUX
Symptoms: Blood culture negative, Convulsion, Culture urine negative, Influenza serology positive, Lethargy
Clinical narrative: Patient was taken to daycare following vaccine adminstration and about 1 hr. after arrival spiked a fever and experienced a seizure.  Patient was then brought in to clinic by father where his temp. was 102.4 and he was still somewhat lethargic/post-ictal.  Pt. was then transported to our Ped. ER wher blood and urine cultures were obtained and were eventually neg. A rapid flu test was also done and was neg. WBC was 23.4 K.  Pt. was given Rocephin and was followed up in our clinic the following day where a repeat flu test was positive. Pt. was afebrile then and had been afebrile for the previous 12 hrs. Pt. was then placed on Tamiflu. There was no further seizure activity and the febrile illness resolved.
Age: 0.87
Sex: M
Vaccine: FLU(H1N1), FLUX
Symptoms: Postictal state, Pyrexia, White blood cell count increased
Clinical narrative: Patient was taken to daycare following vaccine adminstration and about 1 hr. after arrival spiked a fever and experienced a seizure.  Patient was then brought in to clinic by father where his temp. was 102.4 and he was still somewhat lethargic/post-ictal.  Pt. was then transported to our Ped. ER wher blood and urine cultures were obtained and were eventually neg. A rapid flu test was also done and was neg. WBC was 23.4 K.  Pt. was given Rocephin and was followed up in our clinic the following day where a repeat flu test was positive. Pt. was afebrile then and had been afebrile for the previous 12 hrs. Pt. was then placed on Tamiflu. There was no further seizure activity and the febrile illness resolved.
Age: 60.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Asthenia, Blood product transfusion, Guillain-Barre syndrome, Lumbar puncture normal, Nerve conduction studies abnormal
Clinical narrative: Generalized weakness, tremor, numbness and tingling.  12/10/09 ED, hospital medical records received, orthopedic consultation, neurological consultation. Service dates 12/1/09 to 12/8/09. Assessment: Guillain-Barre Syndrome. Patient presents with acute onset generalized weakness including upper extremities. Can walk only 2-3 steps at a time. Legs tremble. Short of breath. Used walker or wheelchair. To admit to hospital. Numbness fingertips and toes. Depressed reflexes. Frequency of urination. IVIG administration.  12/16/09 Discharge summary, hospital records received. Service dates 12/1/09 to 12/9/09. Additional information abstracted. Assessment: Guillain-Barre syndrome following the H1N1 flu vaccine. Mild weakness throughout, more pronounced bilateral upper arms. Decreased vibratory, termperature, pinprick sensation extremities. Reflexes zero except for bilateral knee (trace). Extensive Candida intertrigo. IVIG administration followed by significant improvement. Discharge to home with out patient PT, OT.
Age: 60.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Paraesthesia
Clinical narrative: Generalized weakness, tremor, numbness and tingling.  12/10/09 ED, hospital medical records received, orthopedic consultation, neurological consultation. Service dates 12/1/09 to 12/8/09. Assessment: Guillain-Barre Syndrome. Patient presents with acute onset generalized weakness including upper extremities. Can walk only 2-3 steps at a time. Legs tremble. Short of breath. Used walker or wheelchair. To admit to hospital. Numbness fingertips and toes. Depressed reflexes. Frequency of urination. IVIG administration.  12/16/09 Discharge summary, hospital records received. Service dates 12/1/09 to 12/9/09. Additional information abstracted. Assessment: Guillain-Barre syndrome following the H1N1 flu vaccine. Mild weakness throughout, more pronounced bilateral upper arms. Decreased vibratory, termperature, pinprick sensation extremities. Reflexes zero except for bilateral knee (trace). Extensive Candida intertrigo. IVIG administration followed by significant improvement. Discharge to home with out patient PT, OT.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Gait disturbance, Insomnia, Pain in extremity
Clinical narrative: Friday morning (9/25) woke up w/ soreness from knees to feet. Pain increased until Saturday. Went to E.R. and followed up w/G.P. in N.J. is having trouble walking and sleeping w/pain in knees to feet.
Age: 1.97
Sex: M
Vaccine: FLU(H1N1), FLU3, HIBV
Symptoms: Diarrhoea haemorrhagic, Intussusception, Vomiting
Clinical narrative: Bloody diarrhea with vomiting. Hospitalized. Dx: Intussusception.
Age: 39.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Cellulitis
Clinical narrative: 1 wk after Mist developed cellulitis on nose.
Age: 53.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Unevaluable event
Clinical narrative: Patient has no symptoms or signs
Age: 25.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Unevaluable event
Clinical narrative: Patient has no symptoms or signs.
Age: 83.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Unevaluable event
Clinical narrative: Patient has no symptoms or signs
Age: 60.0
Sex: F
Vaccine: FLUN(H1N1), FLUX
Symptoms: No adverse event
Clinical narrative: Patient has no symptoms or signs.
Age: 5.0
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Erythema multiforme
Clinical narrative: erythema multiforme on hands, face starting 12/5/09.
Age: 2.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain Barre Syndrome, per medical records. Admitted to hospital 12/5/09.
Age: 0.27
Sex: M
Vaccine: FLU(H1N1)
Symptoms: Incorrect dose administered
Clinical narrative: 0.25 ml H1N1 vaccine administered to this patient (who is 3 months old).
Age: 51.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Antineutrophil cytoplasmic antibody negative, Antinuclear antibody negative, Blood creatine phosphokinase normal, Blood thyroid stimulating hormone normal, C-reactive protein normal
Clinical narrative: Swelling, numbness & tingling L shin & foot, then swelling R thigh, numbness/tingling R foot x 1 wk. Resolved in 1 wk. Then L shin/foot swelled w/numbness tingling along shin.
Age: 51.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Full blood count normal, Guillain-Barre syndrome, Hypoaesthesia, Myositis, Nerve conduction studies abnormal
Clinical narrative: Swelling, numbness & tingling L shin & foot, then swelling R thigh, numbness/tingling R foot x 1 wk. Resolved in 1 wk. Then L shin/foot swelled w/numbness tingling along shin.
Age: 51.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging normal, Oedema peripheral, Pain in extremity, Paraesthesia
Clinical narrative: Swelling, numbness & tingling L shin & foot, then swelling R thigh, numbness/tingling R foot x 1 wk. Resolved in 1 wk. Then L shin/foot swelled w/numbness tingling along shin.
Age: 51.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Red blood cell sedimentation rate increased, Rheumatoid factor negative, Swelling, Ultrasound Doppler, Ultrasound scan normal
Clinical narrative: Swelling, numbness & tingling L shin & foot, then swelling R thigh, numbness/tingling R foot x 1 wk. Resolved in 1 wk. Then L shin/foot swelled w/numbness tingling along shin.
Age: 63.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Orthostatic hypotension, Syncope
Clinical narrative: Orthostatic hypotension 10 min after H1N1 vaccine 11:15 resulted in new syncope. Initial pulse 60 after laying supine B/P 80/60 11:16 B/P 122/70 p-78 @ 11:20 - Pt remained supine for 20 min. was given 15 oz O.J. VS: orthostatic.
Age: 28.0
Sex: M
Vaccine: FLU(H1N1), FLUN3
Symptoms: Palpitations, Paraesthesia, Paraesthesia oral
Clinical narrative: Hx of anxiety. After receiving H1N1 shot and seasonal flu mist. Pt experienced perioper and digital paresthesia, palpitations. These were catecholamine driven/resolving over 20 min of onset.
Age: 32.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Dizziness, Headache, Hypoaesthesia, Injection site pain, Injection site swelling
Clinical narrative: Light-headedness, slight dizziness, slight numbness in arm that spread to hand then up neck and caused headache, tingling in lips and tip of tongue, later swelling and soreness at injection area in upper right arm.
Age: 32.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Paraesthesia oral
Clinical narrative: Light-headedness, slight dizziness, slight numbness in arm that spread to hand then up neck and caused headache, tingling in lips and tip of tongue, later swelling and soreness at injection area in upper right arm.
Age: 12.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Lip swelling
Clinical narrative: Swollen lips
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Severe redness,and swelling up all the way to the elbow area, severe pain, got worse for the last 12hrs. Tx: tylenol 500mg every 6hrs, started at 8:00pm 12/08/09
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Cough, Dyspnoea, Myalgia, Pain
Clinical narrative: dry cough, body aches, difficulty breathing, joint pain, muscle pain, fever
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Pyrexia
Clinical narrative: dry cough, body aches, difficulty breathing, joint pain, muscle pain, fever
Age: 6.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Conjunctivitis
Clinical narrative: Bilateral conjunctivitis, no treatment needed
Age: 58.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Rash
Clinical narrative: Facial rash with appearance of burst blood vessels
Age: 26.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Cough, Dyspnoea, Wheezing
Clinical narrative: Sudden onset of shortness of breath, weazie, difficulty breathing. This caused lots of coughing. This lasted until 11:40 pm that night. I tried taking a hot shower to help with my breathing, but that did not help. Then the symptoms then went away rather suddenly. I did have some peppermint tea to help sooth my throat. I did not call the doctor since it was so late.
Age: 18.0
Sex: M
Vaccine: FLU3
Symptoms: Electrocardiogram, Guillain-Barre syndrome, Nuclear magnetic resonance imaging
Clinical narrative: disgnosed GuillainBarre Syndrome
Age: 7.0
Sex: F
Vaccine: FLU(H1N1), FLU3
Symptoms: Abdominal pain, Vomiting
Clinical narrative: Vomitting, abdominal pain
Age: 28.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Muscle spasms, Vaginal haemorrhage
Clinical narrative: Patient was 5 weeks pregnant & started spotting blood. Patient experienced cramping & started spotting more heavily while at family doctor around 4:30 PM. The  doctor advised patient to go to the hospital. The physician at the hospital informed the patient that she was having a miscarriage.
Age: 20.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Injection site erythema, Injection site irritation, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 1710: Patient received H1N1 injection right deltoid. 1712: Patient complained of itching around site. Severe itching, irritation, some swelling, warmth and redness observed. 1714: Symptoms intensified to itching around mouth, left side of face and top of head. 1720: Patient transferred to ER for IV Benadryl; symptoms resolved.
Age: 20.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Oral pruritus, Pruritus
Clinical narrative: 1710: Patient received H1N1 injection right deltoid. 1712: Patient complained of itching around site. Severe itching, irritation, some swelling, warmth and redness observed. 1714: Symptoms intensified to itching around mouth, left side of face and top of head. 1720: Patient transferred to ER for IV Benadryl; symptoms resolved.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Injection site anaesthesia, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: By 3 PM my left upper outer arm was sore and swollen-approx 3" in diameter. I continued with low grade fever and called hospital to report this-was told to come in tomorrow.  By 5 PM area was swollen and red, twice the size-and hard to the touch.  Area continued to get larger, and lymph node left axilla swollen. Intermittent pain left neck, left arm and hand, numbness around area. I did go back to hospital this am-Dr.  did not see me, but after waiting a while told nurse to send me to my Primary MD-so I went upstairs and waited again, saw my doctor in hall and she said she didn't need to see me-could see my arm and redness-just said not to take shot again.  I was not examined by a doctor at all-but the nurses did give me info from vial-Merck and Co. PNEUMOCOCCAL VACCINE LOT 1296X. I guess I will cont. to watch areas and take Tylenol for discomfort.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Lymphadenopathy, Neck pain, Pain in extremity, Pyrexia
Clinical narrative: By 3 PM my left upper outer arm was sore and swollen-approx 3" in diameter. I continued with low grade fever and called hospital to report this-was told to come in tomorrow.  By 5 PM area was swollen and red, twice the size-and hard to the touch.  Area continued to get larger, and lymph node left axilla swollen. Intermittent pain left neck, left arm and hand, numbness around area. I did go back to hospital this am-Dr.  did not see me, but after waiting a while told nurse to send me to my Primary MD-so I went upstairs and waited again, saw my doctor in hall and she said she didn't need to see me-could see my arm and redness-just said not to take shot again.  I was not examined by a doctor at all-but the nurses did give me info from vial-Merck and Co. PNEUMOCOCCAL VACCINE LOT 1296X. I guess I will cont. to watch areas and take Tylenol for discomfort.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Bacterial infection, Blindness unilateral, Eye inflammation, Iris disorder, Migraine
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 18 year old female with no known medical history, she has been extremely healthy all her life and eats well and exercises daily, was vaccinated with a third dose of GARDASIL (lot# 663452/0671Y) in the right arm (route not reported) on 05-AUG-2009. Concomitant therapy included "birth control' (therapy unspecified) and tuberculin purified protein derivative (PPD) was administered on 05-AUG-2009. Since receiving the GARDASIL vaccination, the patient has suffered frequent migraine headaches, bloodshot eyes, and extreme sensitivity to light. Within a week or two of the third and final vaccination, eyes became extremely bloodshot. On 18-SEP-2009, the patient visit to team doctor for bloodshot eyes resulted in diagnosis of inflamed iris and two spots on the cornea. On 19-SEP-2009, when patient woke up in the morning, she was unable to see out of the left eye. She was taken to emergency room and was diagnosed with corneal ulcer and bacterial infection. She has been referred to cornea specialists for treatment. Treatment for past 9 days has involved hourly eyedrops and/or ointments applied to the eye, 24 hours a day. Doctor now concerned about thinning of cells and the surface of the eye being broken as a result of the bacteria attacking the cornea. These events have had an adverse number of effects on her life in addition to the medical concerns. Corneal ulcer and unknown bacterial infection caused loss of sight in left eye. The listing indicated that one or more of the events was considered to be immediately life-threatening. The originally reporting source was not provided. The VAER ID# is 358417. No further information is available. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all released specifications. The lot met the requirements of Center and was released.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Ocular hyperaemia, Photophobia, Ulcerative keratitis
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 18 year old female with no known medical history, she has been extremely healthy all her life and eats well and exercises daily, was vaccinated with a third dose of GARDASIL (lot# 663452/0671Y) in the right arm (route not reported) on 05-AUG-2009. Concomitant therapy included "birth control' (therapy unspecified) and tuberculin purified protein derivative (PPD) was administered on 05-AUG-2009. Since receiving the GARDASIL vaccination, the patient has suffered frequent migraine headaches, bloodshot eyes, and extreme sensitivity to light. Within a week or two of the third and final vaccination, eyes became extremely bloodshot. On 18-SEP-2009, the patient visit to team doctor for bloodshot eyes resulted in diagnosis of inflamed iris and two spots on the cornea. On 19-SEP-2009, when patient woke up in the morning, she was unable to see out of the left eye. She was taken to emergency room and was diagnosed with corneal ulcer and bacterial infection. She has been referred to cornea specialists for treatment. Treatment for past 9 days has involved hourly eyedrops and/or ointments applied to the eye, 24 hours a day. Doctor now concerned about thinning of cells and the surface of the eye being broken as a result of the bacteria attacking the cornea. These events have had an adverse number of effects on her life in addition to the medical concerns. Corneal ulcer and unknown bacterial infection caused loss of sight in left eye. The listing indicated that one or more of the events was considered to be immediately life-threatening. The originally reporting source was not provided. The VAER ID# is 358417. No further information is available. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all released specifications. The lot met the requirements of Center and was released.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Bacterial infection, Blindness unilateral, Iritis, Migraine, Ocular hyperaemia
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 18 year old female with no known medical history, she has been extremely healthy all her life and eats well and exercises daily, was vaccinated with a third dose of GARDASIL (lot# 663452/0671Y) in the right arm (route not reported) on 05-AUG-2009. Concomitant therapy included "birth control' (therapy unspecified) and tuberculin purified protein derivative (PPD) was administered on 05-AUG-2009. Since receiving the GARDASIL vaccination, the patient has suffered frequent migraine headaches, bloodshot eyes, and extreme sensitivity to light. Within a week or two of the third and final vaccination, eyes became extremely bloodshot. On 18-SEP-2009, the patient visit to team doctor for bloodshot eyes resulted in diagnosis of inflamed iris and two spots on the cornea. On 19-SEP-2009, when patient woke up in the morning, she was unable to see out of the left eye. She was taken to emergency room and was diagnosed with corneal ulcer and bacterial infection. She has been referred to cornea specialists for treatment. Treatment for past 9 days has involved hourly eyedrops and/or ointments applied to the eye, 24 hours a day. Doctor now concerned about thinning of cells and the surface of the eye being broken as a result of the bacteria attacking the cornea. These events have had an adverse number of effects on her life in addition to the medical concerns. Corneal ulcer and unknown bacterial infection caused loss of sight in left eye. The listing indicated that one or more of the events was considered to be immediately life-threatening. The originally reporting source was not provided. The VAER ID# is 358417. No further information is available. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all released specifications. The lot met the requirements of Center and was released.
Age: 18.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Photophobia, Ulcerative keratitis
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. An 18 year old female with no known medical history, she has been extremely healthy all her life and eats well and exercises daily, was vaccinated with a third dose of GARDASIL (lot# 663452/0671Y) in the right arm (route not reported) on 05-AUG-2009. Concomitant therapy included "birth control' (therapy unspecified) and tuberculin purified protein derivative (PPD) was administered on 05-AUG-2009. Since receiving the GARDASIL vaccination, the patient has suffered frequent migraine headaches, bloodshot eyes, and extreme sensitivity to light. Within a week or two of the third and final vaccination, eyes became extremely bloodshot. On 18-SEP-2009, the patient visit to team doctor for bloodshot eyes resulted in diagnosis of inflamed iris and two spots on the cornea. On 19-SEP-2009, when patient woke up in the morning, she was unable to see out of the left eye. She was taken to emergency room and was diagnosed with corneal ulcer and bacterial infection. She has been referred to cornea specialists for treatment. Treatment for past 9 days has involved hourly eyedrops and/or ointments applied to the eye, 24 hours a day. Doctor now concerned about thinning of cells and the surface of the eye being broken as a result of the bacteria attacking the cornea. These events have had an adverse number of effects on her life in addition to the medical concerns. Corneal ulcer and unknown bacterial infection caused loss of sight in left eye. The listing indicated that one or more of the events was considered to be immediately life-threatening. The originally reporting source was not provided. The VAER ID# is 358417. No further information is available. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all released specifications. The lot met the requirements of Center and was released.