chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Abortion spontaneous, Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received from a nurse, for the Pregnancy Registry for Gardasil, concerning a 17 year old female with drug hypersensitivity and penicillin allergy and a history of asthma. on 26-APR-2007 the patient was vaccinated with Gardasil (Lot#655205/1426F). Concomitant therapy included ADVAIR and MENACTRA. On 01-MAY-2007 the patient's mother notified the office that her daughter tested positive to a home pregnancy test. It was reported that the patient sought unspecified medical attention. No further information is available at this time. Follow up information received from the pediatrician, indicated that the patient had a spontaneous abortion, on/or at less than 20 weeks of gestation (date not specified). The outcome of spontaneous abortion was not specified. No further details were provided. Upon internal review, spontaneous abortion was considered to be serious as an other important medical event. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Drug exposure during pregnancy, Foetal disorder, Pregnancy test, Ultrasound scan abnormal
Clinical narrative: Information has been received through a Merck Pregnancy Registry and a 25 year old, female with no drug reactions/allergies and no medical history, who on 04-APR-2007 was vaccinated intramuscularly with the first, 0.5 mL dose of Gardasil. There was no concomitant medication. On 04-JUN-2007, the patient was vaccinated intramuscularly with the second, 0.5 mL dose of Gardasil. Since the vaccination the patient reported that she was eight weeks pregnant with an estimated date of delivery on 11-FEB-2008. The patient sought unspecified medical attention. The patient reported that she had a pregnancy test. The patient reported that she had not experienced any adverse reactions and could not provide the Gardasil lot numbers. In follow-up it was reported by the physician, that the date of the patient's last menstrual period was 08-MAY-2007 and estimated conception date was 21-MAY-2007. It was reported that on 05-JUN-2007, the patient was vaccinated intramuscularly with the second, 0.5 mL dose of Gardasil. Previously reported the patient was vaccinated with the second dose of Gardasil on 04-JUN-2007. The estimated delivery date was 12-FEB-2008. On 01-OCT-2007, the patient had prenatal testing, an ultrasound which revealed dilated bladder, posterior urethral valves. On 08-JAN-2008 the patient delivered a live born infant, male, 36 weeks from her last menstrual period (LMP). The infant was not normal. The infant had dilated bladder and ureters, posterior urethral valves. There was no complication during labor/delivery. At the time of the report, it was unknown if the infant recovered. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Syncope
Clinical narrative: Information has been received from a physician concerning a female who on unspecified date was vaccinated with a dose of Gardasil and fainted and then had seizure.  Subsequently, the patient recovered from the seizure and fainting.  Unspecified medical attention was sought.  No other information was provided.  Upon internal review the seizure was found to be an other important medical event.  Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: Pt had active case of Herpes Zoster when he received the Zostavax vaccine.  It appears that the active case worsened following administration of the Zostavax vaccine.
Age: 41.0
Sex: F
Vaccine: HEPA
Symptoms: Chest pain, Cough, Dizziness, Pruritus, Rash
Clinical narrative: Hepatitis A Vaccine and Tuberculosis Mantoux Skin test administered.  Patient developed dizziness, itching, rash on face, neck and chest; tachycardia; throat felt tight; slight cough, slight wheeze.  Epinephrine administered.  911 called.  Ambulance took patient to Hospital ER.  Patient was given IV Benadryl in ambulance.  Patient was observed in ER, given IV fluids and developed chest pain in ER.  Patient was admitted for overnight observation.  Discharged next morning.  No diagnosis.  2/12/08 Reviewed hospital medical records which reveal patient experienced chest pressure & pain s/p vax.  Immediately after vax, developed throat tightness, difficulty breathing, dizziness & macular erythematous rash.  Resolved w/epi but then developed chest pain.  Admitted 2/4-2/5/08.  BP elevated on admit 158/98 but normalized by next day.   FINAL DX: atypical chest pain; GERD.
Age: 41.0
Sex: F
Vaccine: HEPA
Symptoms: Tachycardia, Throat tightness, Wheezing
Clinical narrative: Hepatitis A Vaccine and Tuberculosis Mantoux Skin test administered.  Patient developed dizziness, itching, rash on face, neck and chest; tachycardia; throat felt tight; slight cough, slight wheeze.  Epinephrine administered.  911 called.  Ambulance took patient to Hospital ER.  Patient was given IV Benadryl in ambulance.  Patient was observed in ER, given IV fluids and developed chest pain in ER.  Patient was admitted for overnight observation.  Discharged next morning.  No diagnosis.  2/12/08 Reviewed hospital medical records which reveal patient experienced chest pressure & pain s/p vax.  Immediately after vax, developed throat tightness, difficulty breathing, dizziness & macular erythematous rash.  Resolved w/epi but then developed chest pain.  Admitted 2/4-2/5/08.  BP elevated on admit 158/98 but normalized by next day.   FINAL DX: atypical chest pain; GERD.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt was given pneumococcal 23 conjugate vaccine in right deltoid on the afternoon of 2/7/08, he subsequently developed erythema, swelling, pain and warmth to the touch at the site of injection.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Leukopenia, White blood cell count decreased
Clinical narrative: Lab results drawn 11.13.07 (day after vaccine given) showed critical values: WBC 2.6. Pathologist reviewed = leukopenia. Patient had stopped Simvastin 3 weeks prior but was taking Diazide (which has known although rare instances of leukopenia). Stopped Diazide 11.13.07, repeat lab 11.14.07 showed normalized WBC.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hypersomnia, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Vaccine given 11.5.07; by 11.5.07 night patient experiened shaking legs; she thinks she developed a fever; staying in bed all day Tues and Wed. Wed. night legs calmed down. There was swelling, redness and pain at injection site which showed improvement by 11.8.07 when she came in for appointment.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Tremor
Clinical narrative: Vaccine given 11.5.07; by 11.5.07 night patient experiened shaking legs; she thinks she developed a fever; staying in bed all day Tues and Wed. Wed. night legs calmed down. There was swelling, redness and pain at injection site which showed improvement by 11.8.07 when she came in for appointment.
Age: 1.04
Sex: M
Vaccine: HEPA, HIBV, MMRV, PNC
Symptoms: Herpes zoster, Rash
Clinical narrative: Shingles type rash center of low back and upper right buttocks. Rash occurred approx. 5 months after the Varicella vacine was given.  Dx. by family medical caregiver at Physicians office.  Treated with Acyclovir.  Rash occured about 2 weeks ago.  Mother reporting it today.
Age: 1.05
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Rash erythematous
Clinical narrative: Developed a moderate sized area of intense erythema and mild induration near site of MMR injection.  Also had a few erythematous macules scattered over body.
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Similar reaction on previous exposure to drug
Clinical narrative: Information has been received from a physician concerning a female (demographics not provided) who on unspecified date was vaccinated with her third dose of Gardasil (lot # not provided) and was hospitalized with abdominal pain.  It was reported that the patient also experienced unspecified adverse reactions post her first and second dose of Gardasil.  At the time of this report it was unknown if patient was discharged from the hospital or had recovered from the event.  No other information was provided.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Anorexia, Biopsy, Diarrhoea, Endoscopy
Clinical narrative: Information has been received from a physician concerning a 20 year old female who on 09-Aug-2007 was vaccinated intramuscularly with the first dose of Gardasil (658222/0927U).  Concomitant therapy included dicyclomine HC1 (BENTYL), citalopram hydrobromide (CELEXA) and lansoprazole (PREVACID).  In September 2007, the patient experienced diarrhea, nausea, pain on the left side of her abdomen, weight loss of 10 pounds within a week and general loss of appetite.  The patient went to the emergency room but was not admitted.  The patient's diarrhea and nausea and pain on the left side of her abdomen and weight loss of 10 pounds within a week and general loss of appetite persisted.  The diarrhea, nausea, pain on the left side of her abdomen, weight loss of 10 pounds within a week and general loss of appetite were considered to be disabling since the patient had to come home from college.  Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Weight decreased
Clinical narrative: Information has been received from a physician concerning a 20 year old female who on 09-Aug-2007 was vaccinated intramuscularly with the first dose of Gardasil (658222/0927U).  Concomitant therapy included dicyclomine HC1 (BENTYL), citalopram hydrobromide (CELEXA) and lansoprazole (PREVACID).  In September 2007, the patient experienced diarrhea, nausea, pain on the left side of her abdomen, weight loss of 10 pounds within a week and general loss of appetite.  The patient went to the emergency room but was not admitted.  The patient's diarrhea and nausea and pain on the left side of her abdomen and weight loss of 10 pounds within a week and general loss of appetite persisted.  The diarrhea, nausea, pain on the left side of her abdomen, weight loss of 10 pounds within a week and general loss of appetite were considered to be disabling since the patient had to come home from college.  Additional information has been requested.
Age: 2.0
Sex: M
Vaccine: FLUX
Symptoms: Allergy test positive, Blood immunoglobulin E, Cough, Food allergy, Hypersensitivity
Clinical narrative: Seriousness: Other-Medically Significant Information received on 24 January 2008 from the above reference journal article in which a 2-year-old male patient had received their first Influenza vaccine (manufacturer and lot number not provided) and shortly thereafter, developed a few hives scattered on his body with no respiratory symptoms. The hives appeared intermittently and were treated occasionally with diphenhydramine. The patient subsequently received his Influenza booster vaccination one month later and within ten minutes of vaccination, starting having coughing, wheezing and hives all over his body. he was treated acutely with diphenhydramine and nebulized albuterol. Epinephrine was not given. The patient was referred for evaluation of his allergic reaction to influenza vaccine. His physician examination at the time of follow-up for an allergy evaluation was normal. The patient had no known allergies and was up to date with their vaccinations with no prior adverse events. The patient had a positive history for developing perioral hives associated with eating gummy candy fruit snacks and Hot Tamale candies. The patient had been able to eat eggs with no problems. Follow up allergy testing included a skin prick test with the following results: histamine 6/30 mm, saline 0/0 mm, Knox gelatin (mixed with saline) 3/15, and liquefied gummy fruit snack (1:1 dilution in saline) 6/25 mm. Serum was sent for IgE to specific antigens with the following results: 1g# 127 ku/L with RAST to bovine gelatin 4.50 (class 3). A diagnosis of gelatin allergy was concluded based on his history and confirmatory skin and RAST testing. Since his initial episode, the patient had inadvertant gelatin exposure with ingestion of Frosted Mini-Wheat cereal, bacon and lunch meats with subsequent allergic reactions. No further information was provided in the report.
Age: 2.0
Sex: M
Vaccine: FLUX
Symptoms: Radioallergosorbent test, Similar reaction on previous exposure to drug, Urticaria, Wheezing
Clinical narrative: Seriousness: Other-Medically Significant Information received on 24 January 2008 from the above reference journal article in which a 2-year-old male patient had received their first Influenza vaccine (manufacturer and lot number not provided) and shortly thereafter, developed a few hives scattered on his body with no respiratory symptoms. The hives appeared intermittently and were treated occasionally with diphenhydramine. The patient subsequently received his Influenza booster vaccination one month later and within ten minutes of vaccination, starting having coughing, wheezing and hives all over his body. he was treated acutely with diphenhydramine and nebulized albuterol. Epinephrine was not given. The patient was referred for evaluation of his allergic reaction to influenza vaccine. His physician examination at the time of follow-up for an allergy evaluation was normal. The patient had no known allergies and was up to date with their vaccinations with no prior adverse events. The patient had a positive history for developing perioral hives associated with eating gummy candy fruit snacks and Hot Tamale candies. The patient had been able to eat eggs with no problems. Follow up allergy testing included a skin prick test with the following results: histamine 6/30 mm, saline 0/0 mm, Knox gelatin (mixed with saline) 3/15, and liquefied gummy fruit snack (1:1 dilution in saline) 6/25 mm. Serum was sent for IgE to specific antigens with the following results: 1g# 127 ku/L with RAST to bovine gelatin 4.50 (class 3). A diagnosis of gelatin allergy was concluded based on his history and confirmatory skin and RAST testing. Since his initial episode, the patient had inadvertant gelatin exposure with ingestion of Frosted Mini-Wheat cereal, bacon and lunch meats with subsequent allergic reactions. No further information was provided in the report.
Age: 0.8
Sex: M
Vaccine: MNQ
Symptoms: Inappropriate schedule of drug administration, Lumbar puncture abnormal, Respiratory syncytial virus infection, White blood cell count increased
Clinical narrative: Initial report received on 31 January 2008 from an investigator participating in the above-mentioned trial. An 11-month-old male subject, with concurrent illnesses of respiratory Syncytial virus symptoms, developed meningitis and was hospitalized 63 days after receiving a first, intramuscular, right thigh injection of Menactra (Lot number U2172AA) on 27 November 2007. Per the mother, on 29 January 2008, i.e., 63 days after receiving the study vaccine, the subject was taken to the pediatricians office for persistent symptoms post respiratory Syncytial virus diagnosis. The primary care physician admitted the subject to the hospital the same day, after results of laboratory work revealed elevated white blood cell count. A lumbar puncture test revealed the subject had meningitis. At the time of the report, the subject was being treated for the meningitis. The subject's continuation status in the trial was not provided. The investigator considered the event of meningitis as life threatening. According to the investigator, the event of meningitis was related to the study vaccine.  2/11/08 Received via email from manufacturer: This subject has another SAE of Respiratory Syncytial Virus on 26 January 2008 reported in case 2008-00317.  This case was reported in an 11-month-old MTA37 study participant (site #009 ; subject #00031), with a 4-day history of RSV infection.  We did contact the site and requested the investigator to provide further information.  The study coordinator explained that they have not received any document from the hospital yet. She has spoken with the attending physician who explained that they couldn't get cerebrospinal fluid because apparently the epidural space was full of pus.  She also mentioned that the child was being considered as having MRSA but was not sure from where.  The site will contact us and will send any follow-up information as soon as they receive them.  2/29/08 Received via email from manufacturer: Follow-up information was received from the investigator.  The diagnosis was amended from 'Meningitis'  to 'Methicillin Resistant Staphylococcus aureus' infection and the causal relationship was also reassessed by the investigator as unrelated.   No hospital records, however, were available at the time of this follow-up report.  Further information is being requested.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Pain in extremity, X-ray limb
Clinical narrative: Persistent deltoid pain despite AROM, ice and regular work including manual labor, also redness at injection site.
Age: 0.6
Sex: F
Vaccine: DTAP, FLUX, HEP, IPV, PPV
Symptoms: Chills, Inappropriate schedule of drug administration, Pyrexia, Vomiting
Clinical narrative: Fever, chills, vomiting, no coughing.
Age: 37.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Pruritus generalised
Clinical narrative: Approximately 15-20 minutes after vaccine administered red streak at injection site developed and patient had complained of itching all over.  Patient took Benadryl PO and signs and symptoms resolved.  No shortness of breath.
Age: 1.4
Sex: M
Vaccine: DTAP, FLU3
Symptoms: Immunisation reaction
Clinical narrative: Mild Immz. reaction to R upper thigh
Age: 0.1
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Body temperature increased, Irritability
Clinical narrative: Temperature 100.4.  Seen 11-26-07 in evening, fussy for 2 days, temperature 101.6.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Nausea
Clinical narrative: After receiving Gardasil vaccine pt became dizzy and nauseated. Symptoms subsided after about 10 mins.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Headache, Nausea, Vertigo
Clinical narrative: After receiving Gardasil vaccine - pt became nauseated, dizzy and c/o head swirling, severe headaches. Symptoms gone after about 15 mins.
Age: 1.1
Sex: F
Vaccine: HEPA, MMRV, PNC
Symptoms: Rash generalised, Rash maculo-papular
Clinical narrative: Localized rash, that spread to rest of body, face, neck, chest & a few on back, papulomacular, not confluent, not pruritic rash.  Pt does not appear to be bothered by rash.
Age: 3.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Pain in extremity
Clinical narrative: Leg pain to feet since vaccination
Age: 47.0
Sex: M
Vaccine: TDAP
Symptoms: Influenza like illness, Nasopharyngitis, Pyrexia
Clinical narrative: Flu like symptoms, cold, fever, sick.  Employee missed one day of work.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Chest pain
Clinical narrative: Intermittent pain center of chest lasting ~5 min since given injection 24 hours prior.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Blister, C-reactive protein, Full blood count, Pyrexia, Rash
Clinical narrative: Received vaccines 1/22/08, onset of fever 2/4/08 with onset of 4 macules 2/5/08.  Rash progressed to generalized chest/back on 2/7/08.  High temperature.  Macules with vesicles, no pruritus.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash macular, Streptococcal identification test
Clinical narrative: Received vaccines 1/22/08, onset of fever 2/4/08 with onset of 4 macules 2/5/08.  Rash progressed to generalized chest/back on 2/7/08.  High temperature.  Macules with vesicles, no pruritus.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Local reaction
Clinical narrative: R arm-localized reaction.  Rx: Medrol Dose Pak, ice, Omnicef.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Headache, Pain
Clinical narrative: Body aches, 101 degree temperature, headache.  Resolved with Aleve w/in 24 hrs.
Age: 0.4
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Erythema, Injection site erythema, Irritability, Oedema peripheral, Somnolence
Clinical narrative: Mother called 1-16-08, stating baby's leg was very red & swollen.  Child was sleeping more than normal & cranky.  No oozing or drainage from sites.  Both sites were the same & there was a small scratch by arm 1-17-08.  Swelling was subsiding & site remained red.
Age: 9.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Received varicella vaccine in right tricept SQ & within 24 hrs had "itchyness" and swelling at injection site.  48 hr later improved but still red 5x5 indurated area on R arm at site.
Age: 1.5
Sex: F
Vaccine: DTAP, HEPA, IPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Swelling & tenderness at site ~ 3cmx3cm at L thigh.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site pain, Injection site pruritus
Clinical narrative: Site of injection swelled up to an oval with a diameter of about 3 inches. It was hot, red, hard, sore and itchy for about a week. It started to swell about a day after the injection and the swelling started to dissipate about 5 days later. 3+ weeks later there is still a small, hard bump at the site.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Site of injection swelled up to an oval with a diameter of about 3 inches. It was hot, red, hard, sore and itchy for about a week. It started to swell about a day after the injection and the swelling started to dissipate about 5 days later. 3+ weeks later there is still a small, hard bump at the site.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, TD
Symptoms: Rash, Skin papilloma
Clinical narrative: Patient developed a rash, warty lesion on forehead.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site atrophy, Injection site erythema
Clinical narrative: PT. RECIEVED INFLUENZA VACCINATION 12 JAN 08. NOTICED ON 29 JAN 08 THAT THERE WAS A QUARTER SIZED INDENTATION AT THE SITE OF THE IMMUNIZATION, NO PAIN SWELLING, SOME REDNESS.
Age: 4.0
Sex: F
Vaccine: IPV, MMR
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Patient had 2 immunizations administered in right thigh, MMR and IPV.  Two days post administration Mom noticed redness, tenderness and swelling approximately the size of a quarter.  The next morning the area had significantly enlarged.  At her appointment time 10:40 on 2/08/2008 the size measured 3 inches by 2 1/2 inches.  Reaction as described was felt to be superficial with no muscle affected, no underlying induration.  Patient exhibited a normal gait.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Chronic obstructive pulmonary disease, Condition aggravated
Clinical narrative: Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized with a COPD exacerbation. Vaccination took place on 09/24/07 and hospital admission was 12/27/07.  Relationship to study treatment is 'None' according to physician.  We would be happy to forward the Study's SAE report form upon request.  2/11/08 Reviewed SAE which reveals patient experienced SOB & admitted for COPD exacerbation 12/27-1/7/08.  Was intubated in ICU.  Tx w/IV antibiotics & steroids. FINAL DX: COPD exacerbation.
Age: 1.63
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Crying, Irritability, Personality change
Clinical narrative: Child is reported by mother to be very out of character and fussy. Child wakes at night for hours at a time crying consolably. He is "just not acting himself."
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Breech delivery, Caesarean section, Drug exposure during pregnancy, Transfusion, Twin pregnancy
Clinical narrative: Information has been received from a physician for the Merck Pregnancy Registry for Gardasil concerning an 18 year old healthy female with an environmental allergy who on 21-JUN-2007 was vaccinated with a first dose of Gardasil (lot# 657868/0523U).  Concomitant therapy included on 21-JUN-2007 BACTRIM DS TABLETS BID for a UTI, on 06-JUL-2007, AUGMENTIN 875 mg BID for sinusitis, between 18-JUL-2007 to 22-AUG-2007 and ibuprofen 600 mg every 8 hours for back and rib pain.  On 21-AUG-2008 the patient was vaccinated with a second dose of Gardasil (lot#657006/0188U).  In October 2007 the patient had ciprofloxacin for UTI, ZYRTEC for allergies and on 26-OCT-2007 Z-PAK for sinusitis.  The patient's last menstrual period was approximately 24-FEB-2007 and became pregnant.  On 13-NOV-2007, the patient had an ultrasound and the results showed a twin pregnancy; the dates were too late to obtain.  The patient was unaware that she was pregnant.  On 01-DEC-2007 the patient delivered normal healthy twin boys weighing 5 pounds 1 ounce and a baby boy weighing 6 pounds 7 ounces.  The patient required a c-section because one of the twins was breech.  The patient also required a blood transfusion.  The babies were "fine".  On 24-DEC-2007 the patient was vaccinated with a third dose of Gardasil (lot# 658488/0930U).  At the time of reporting the patient had recovered.  Upon internal review breech delivery is considered to be an other medical event.  Additional information is not expected.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound abdomen abnormal
Clinical narrative: Information has been received from a physician for the Merck Pregnancy Registry for Gardasil concerning an 18 year old healthy female with an environmental allergy who on 21-JUN-2007 was vaccinated with a first dose of Gardasil (lot# 657868/0523U).  Concomitant therapy included on 21-JUN-2007 BACTRIM DS TABLETS BID for a UTI, on 06-JUL-2007, AUGMENTIN 875 mg BID for sinusitis, between 18-JUL-2007 to 22-AUG-2007 and ibuprofen 600 mg every 8 hours for back and rib pain.  On 21-AUG-2008 the patient was vaccinated with a second dose of Gardasil (lot#657006/0188U).  In October 2007 the patient had ciprofloxacin for UTI, ZYRTEC for allergies and on 26-OCT-2007 Z-PAK for sinusitis.  The patient's last menstrual period was approximately 24-FEB-2007 and became pregnant.  On 13-NOV-2007, the patient had an ultrasound and the results showed a twin pregnancy; the dates were too late to obtain.  The patient was unaware that she was pregnant.  On 01-DEC-2007 the patient delivered normal healthy twin boys weighing 5 pounds 1 ounce and a baby boy weighing 6 pounds 7 ounces.  The patient required a c-section because one of the twins was breech.  The patient also required a blood transfusion.  The babies were "fine".  On 24-DEC-2007 the patient was vaccinated with a third dose of Gardasil (lot# 658488/0930U).  At the time of reporting the patient had recovered.  Upon internal review breech delivery is considered to be an other medical event.  Additional information is not expected.
Age: 0.32
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Apnoea, Body temperature increased, Bradycardia
Clinical narrative: Increase Temps; Increased Apnea; Bradycardia  4/1/08 Reviewed hospital medical records for 2/7-2/10/08. FINAL DX: none provided, no d/c summary available.  ER admit dx: ALTE, apnea & bradycardia w/febrile illness in extremely preemie infant. Records reveal patient home from NICU approx 1 mo on home monitor.  Seen by PCP 2/6 for vax & experienced fever, cough, congestion, increased apnea, multiple episodes of bradycardia, cyanosis.  Tx w/IV antibiotics.  LP done.
Age: 13.0
Sex: F
Vaccine: FLU3, MNQ, TDAP, VARCEL
Symptoms: Erythema, Oedema peripheral, Skin warm, Tenderness
Clinical narrative: Redness, swelling, warmth, & tenderness L upper arm.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Red, feverish, swollen at site.  Swollen & raised area is 7.5cm x 9cm.  Pt doesn't c/o pain just itches.  Still getting larger also.  Told pt to use cold packs on site.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Anxiety, Chills, Dizziness, Headache, Hypotension
Clinical narrative: 2/7/08: After receiving Gardasil & Hep A => dizziness, pale, alot shivering.  98%; RR=24; BP=70/40; T=97 => Pt. given water/oxygen, reclined on examination table => Patient observed over 2 hour: BP=90/60; Pulse=70; RR=24 98%.  Pt was also given Benadryl & Prolone P.O.  This was questionable allergy vs vasovagal reaction.  10/30/07 Pt s/p flu & Gardasil => "felt throat closing in & rush of blood to head => O2 sat-100%, positive able to talk.  It was felt pt had an anxiety attack to vaccine during that visit.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Pallor, Respiratory rate increased, Throat tightness
Clinical narrative: 2/7/08: After receiving Gardasil & Hep A => dizziness, pale, alot shivering.  98%; RR=24; BP=70/40; T=97 => Pt. given water/oxygen, reclined on examination table => Patient observed over 2 hour: BP=90/60; Pulse=70; RR=24 98%.  Pt was also given Benadryl & Prolone P.O.  This was questionable allergy vs vasovagal reaction.  10/30/07 Pt s/p flu & Gardasil => "felt throat closing in & rush of blood to head => O2 sat-100%, positive able to talk.  It was felt pt had an anxiety attack to vaccine during that visit.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: Pt received Gardasil vaccine.  5 minutes post injection pt c/o dizziness.  No other symptoms lasting approx 5 min.  Discharged to home with no further c/o.
Age: 0.5
Sex: M
Vaccine: DTAP, IPV, PNC, RV5
Symptoms: Body temperature increased, Crying, Irritability, Oedema peripheral
Clinical narrative: Swollen left leg, extremely irritable, hysterical crying. Temp 103.8 at 1/31/08 visit.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Alopecia universalis, Eosinophil count increased, Full blood count, Haematocrit normal, Haemoglobin normal
Clinical narrative: Pt received Fluzone on 11-21-07. Started developing hair loss about 1 week later. Now with alopecia universalis.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Lymphocyte count increased, Monocyte count normal, Neutrophil count decreased, Platelet count normal
Clinical narrative: Pt received Fluzone on 11-21-07. Started developing hair loss about 1 week later. Now with alopecia universalis.
Age: 29.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral, Skin warm, Tenderness
Clinical narrative: Left deltoid hot to touch, very tender, swollen, red.  Swelling & redness measures approximately 3 1/2" X 4" 1:00pm when client came to clinic.  Called and made appointment with Dr. at 1:30pm today for evaluation & treatment if needed.
Age: 45.0
Sex: M
Vaccine: FLU3, HEP, PPV
Symptoms: Body temperature increased, Erythema, Oedema peripheral, Pain in extremity, Tenderness
Clinical narrative: Pts wife called on 2/7 reported (L) arm red, swollen and painful. Temperature of 102 on 2-5 and 2-6. Pt had hives as well. On 2/7 all symptoms resolved with exception of tenderness in arm.
Age: 45.0
Sex: M
Vaccine: FLU3, HEP, PPV
Symptoms: Urticaria
Clinical narrative: Pts wife called on 2/7 reported (L) arm red, swollen and painful. Temperature of 102 on 2-5 and 2-6. Pt had hives as well. On 2/7 all symptoms resolved with exception of tenderness in arm.
Age: 13.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Local reaction, Local swelling, Oedema, Tenderness
Clinical narrative: Excessive local reaction with redness, swelling and tenderness, peak extension of erythema and edema to 13x13.5 cm at 48 hours after vaccine.  No systemic symptoms.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral discomfort, Vomiting
Clinical narrative: 72 hours later experienced "violent" vomiting for 20 minutes, with "burning" in the mouth. Resolved by rinsing mouth with water for 10-15 minutes
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug hypersensitivity, Herpes zoster, Rash vesicular
Clinical narrative: Patient was given the Zostavax in the right tricep on 1/28/08 and on 1/29/08, she woke with approx 50 shingles-like lesions on her right buttocks. Patient was seen by a physician on 1/29/08 who confirmed non-injection site like zoster-like rash.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Fatigue, Headache, Pain, Skin warm
Clinical narrative: 3 inches redness, warmth across, 4 inches length, for 3 days, HA one day, using Advil for pain.  Wednesday tired, pain, tenderness.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Tenderness
Clinical narrative: 3 inches redness, warmth across, 4 inches length, for 3 days, HA one day, using Advil for pain.  Wednesday tired, pain, tenderness.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Activities of daily living impaired, Antinuclear antibody negative, Arthralgia, Culture throat negative, Dysgraphia
Clinical narrative: Sore throat, joint pain (hands, elbows) started 1/27/08.  Unable to write well with right hand.  Joint pain moderate.  Missed one day of school.  8/20/08-records received-presented to physician office 2/14/08 with C/O pain involving wrists and fingers began on 1/27/08 and on 1/29/08 pain in ankles, elbows and left TMJ with some swelling of right ankle and left knee, diffuse swelling of wrist and fingers, tenderness and morning stiffness. Pain interferes with sleep, unable to write. Fever, nausea and vomiting, abdominal pain. Erythema and pruritis, daily headaches, dry cough, diarrhea, occasional constipation. PE: full ROM, tenderness noted. Neuro exam normal. Impression: Marked myofascial pain with tenderness.  No additional visits to clinic.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Full blood count normal, Pharyngolaryngeal pain, Red blood cell sedimentation rate normal
Clinical narrative: Sore throat, joint pain (hands, elbows) started 1/27/08.  Unable to write well with right hand.  Joint pain moderate.  Missed one day of school.  8/20/08-records received-presented to physician office 2/14/08 with C/O pain involving wrists and fingers began on 1/27/08 and on 1/29/08 pain in ankles, elbows and left TMJ with some swelling of right ankle and left knee, diffuse swelling of wrist and fingers, tenderness and morning stiffness. Pain interferes with sleep, unable to write. Fever, nausea and vomiting, abdominal pain. Erythema and pruritis, daily headaches, dry cough, diarrhea, occasional constipation. PE: full ROM, tenderness noted. Neuro exam normal. Impression: Marked myofascial pain with tenderness.  No additional visits to clinic.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Activities of daily living impaired, Antinuclear antibody negative, Arthralgia, Full blood count normal, Joint swelling
Clinical narrative: Sore throat, joint pain (hands, elbows) started 1/27/08.  Unable to write well with right hand.  Joint pain moderate.  Missed one day of school.  8/20/08-records received-presented to physician office 2/14/08 with C/O pain involving wrists and fingers began on 1/27/08 and on 1/29/08 pain in ankles, elbows and left TMJ with some swelling of right ankle and left knee, diffuse swelling of wrist and fingers, tenderness and morning stiffness. Pain interferes with sleep, unable to write. Fever, nausea and vomiting, abdominal pain. Erythema and pruritis, daily headaches, dry cough, diarrhea, occasional constipation. PE: full ROM, tenderness noted. Neuro exam normal. Impression: Marked myofascial pain with tenderness.  No additional visits to clinic.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Oedema peripheral, Red blood cell sedimentation rate normal
Clinical narrative: Sore throat, joint pain (hands, elbows) started 1/27/08.  Unable to write well with right hand.  Joint pain moderate.  Missed one day of school.  8/20/08-records received-presented to physician office 2/14/08 with C/O pain involving wrists and fingers began on 1/27/08 and on 1/29/08 pain in ankles, elbows and left TMJ with some swelling of right ankle and left knee, diffuse swelling of wrist and fingers, tenderness and morning stiffness. Pain interferes with sleep, unable to write. Fever, nausea and vomiting, abdominal pain. Erythema and pruritis, daily headaches, dry cough, diarrhea, occasional constipation. PE: full ROM, tenderness noted. Neuro exam normal. Impression: Marked myofascial pain with tenderness.  No additional visits to clinic.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Arthralgia, Gait disturbance
Clinical narrative: Sore throat, joint pain (hands, elbows) started 1/27/08.  Unable to write well with right hand.  Joint pain moderate.  Missed one day of school.  8/20/08-records received-presented to physician office 2/14/08 with C/O pain involving wrists and fingers began on 1/27/08 and on 1/29/08 pain in ankles, elbows and left TMJ with some swelling of right ankle and left knee, diffuse swelling of wrist and fingers, tenderness and morning stiffness. Pain interferes with sleep, unable to write. Fever, nausea and vomiting, abdominal pain. Erythema and pruritis, daily headaches, dry cough, diarrhea, occasional constipation. PE: full ROM, tenderness noted. Neuro exam normal. Impression: Marked myofascial pain with tenderness.  No additional visits to clinic.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ, HPV4, MNQ, HPV4, MNQ, HPV4, MNQ
Symptoms: Arthralgia, Gait disturbance, Pain in extremity
Clinical narrative: Sore throat, joint pain (hands, elbows) started 1/27/08.  Unable to write well with right hand.  Joint pain moderate.  Missed one day of school.  8/20/08-records received-presented to physician office 2/14/08 with C/O pain involving wrists and fingers began on 1/27/08 and on 1/29/08 pain in ankles, elbows and left TMJ with some swelling of right ankle and left knee, diffuse swelling of wrist and fingers, tenderness and morning stiffness. Pain interferes with sleep, unable to write. Fever, nausea and vomiting, abdominal pain. Erythema and pruritis, daily headaches, dry cough, diarrhea, occasional constipation. PE: full ROM, tenderness noted. Neuro exam normal. Impression: Marked myofascial pain with tenderness.  No additional visits to clinic.
Age: 11.0
Sex: F
Vaccine: HPV4, TDAP, VARCEL
Symptoms: Dizziness, Immediate post-injection reaction, Urticaria
Clinical narrative: Patient had urticarial rash face, arms, upper torso and dizziness, immediately following administration of immunizations noted.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: 2-8-08 Pt called health dept and stated she has been diagnosed with shingles.  Pt placed on Tylenol with codeine and acyclovir 800 mg one 5x day x7 days.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Pt presented in office on 2/6/08 with rash starting 2/4/08 15-20 lesions
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash pustular
Clinical narrative: Pt presented with rash 1/30/08 approximately 15 pustules. Rash started 1/28/08.
Age: 9.0
Sex: M
Vaccine: HEPA, VARCEL
Symptoms: Erythema, Induration
Clinical narrative: Seen on 1-31-08, 50-60 mm induration with erythema.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Erythema, Local reaction, Oedema peripheral, Pruritus
Clinical narrative: Large local reaction involving (L) arm upper arm with redness, swelling, pruritus 2 days after injection
Age: 8.0
Sex: M
Vaccine: PPV
Symptoms: Full blood count, Injection site swelling, Laboratory test, Pyrexia, Urine analysis
Clinical narrative: Swelling-L deltoid area with fever x4 days.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Tenderness
Clinical narrative: Pneumovax given Rt deltoid 02/04/08.  Pt developed redness, swelling and tenderness posterior right arm 3x5cm.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Musculoskeletal pain
Clinical narrative: Pain in affected shoulder of injection erythema and edema proximal to injection site
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Chills, Headache, Pharyngolaryngeal pain, Pyrexia, Tonsillitis
Clinical narrative: 2 hours after receiving vaccine started fever, HA, chills and sore throat.  Was diagnosed with tonsillitis 2 days later and treated with Zithromax.
Age: 41.0
Sex: M
Vaccine: FLUN3, HEPAB
Symptoms: Fatigue, Headache, Oral pain, Pharyngolaryngeal pain, Sinus congestion
Clinical narrative: Headaches for 2 weeks tired for 2 weeks sinus congestion for 2 weeks left side of throat sore month.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Headache, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Nausea, vomiting, joint aches, muscle weakness, headache, mild fever around 100, 6cm very hot and tender swelling around injection site lasting 3 days (Benadryl applied), now just hard knot around site.  Physical symptoms occurred approx 24 hours after receiving vaccine.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth, Muscular weakness, Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea, vomiting, joint aches, muscle weakness, headache, mild fever around 100, 6cm very hot and tender swelling around injection site lasting 3 days (Benadryl applied), now just hard knot around site.  Physical symptoms occurred approx 24 hours after receiving vaccine.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Anxiety, Headache, Palpitations, Sleep disorder
Clinical narrative: Had vaccine at 4:15 pm on 02/05/08. Slept poorly, woke up Wednesday feeling anxious. Went to work felt like my blood pressure was really high (no ongoing history of high blood pressure) heart periodically raced throughout the day. Started getting a headache. Left work at noon. Took blood pressure at home - 120/85. Rested in afternoon. Headache came off and on for the rest of the day. Went to bed early and got up feeling fine on Thursday. Didn't occur to me to read the information sheet to connect symptoms to shot.
Age: 43.0
Sex: M
Vaccine: HEPA
Symptoms: Angiogram, Blood cholesterol, Blood pressure, Blood test, Body temperature
Clinical narrative: Fri 2/1 heart racing, tired  Sat. 2/2 achiness, fever, chills, sweating that soaked sheets.  Sun. 2/3  Dr. told me it wasn't a reaction to the vaccine--that it must be the flu.  Mon 2/4 stayed home from work, more flu-like symptoms.  Tues. 2/5 fever subsides but still cold hands and feet.  7 PM Heart Attack.  2/12/08 Reviewed medical records from 2nd hospital which reveal patient experienced flu like s/s including muscle aches, fever, chills, midsternal chest pressure w/SOB.  Seen at outlying ER, tx w/anti-clot med & transferred to higher level of care for emergent coronary angiography.  Admitted 2/5-2/8/2008. FINAL DX: acute coronary syndrome, unclear whether vasospasm or clot disolved.  2/14/08 Reviewed ER medical records of 2/5/08 which reveal patient experienced substernal chest pressure, heaviness & pain which radiated to both jaws with diaphoresis, nausea & flu-like symptoms x 3 days.  Tx w/meds including anti-clot med & transferred to higher level of care.  FINAL ER Dx: myocardial infarction.
Age: 43.0
Sex: M
Vaccine: HEPA
Symptoms: Chills, Fatigue, Hyperhidrosis, Influenza like illness, Myocardial infarction
Clinical narrative: Fri 2/1 heart racing, tired  Sat. 2/2 achiness, fever, chills, sweating that soaked sheets.  Sun. 2/3  Dr. told me it wasn't a reaction to the vaccine--that it must be the flu.  Mon 2/4 stayed home from work, more flu-like symptoms.  Tues. 2/5 fever subsides but still cold hands and feet.  7 PM Heart Attack.  2/12/08 Reviewed medical records from 2nd hospital which reveal patient experienced flu like s/s including muscle aches, fever, chills, midsternal chest pressure w/SOB.  Seen at outlying ER, tx w/anti-clot med & transferred to higher level of care for emergent coronary angiography.  Admitted 2/5-2/8/2008. FINAL DX: acute coronary syndrome, unclear whether vasospasm or clot disolved.  2/14/08 Reviewed ER medical records of 2/5/08 which reveal patient experienced substernal chest pressure, heaviness & pain which radiated to both jaws with diaphoresis, nausea & flu-like symptoms x 3 days.  Tx w/meds including anti-clot med & transferred to higher level of care.  FINAL ER Dx: myocardial infarction.
Age: 43.0
Sex: M
Vaccine: HEPA
Symptoms: Pain, Palpitations, Peripheral coldness, Pyrexia
Clinical narrative: Fri 2/1 heart racing, tired  Sat. 2/2 achiness, fever, chills, sweating that soaked sheets.  Sun. 2/3  Dr. told me it wasn't a reaction to the vaccine--that it must be the flu.  Mon 2/4 stayed home from work, more flu-like symptoms.  Tues. 2/5 fever subsides but still cold hands and feet.  7 PM Heart Attack.  2/12/08 Reviewed medical records from 2nd hospital which reveal patient experienced flu like s/s including muscle aches, fever, chills, midsternal chest pressure w/SOB.  Seen at outlying ER, tx w/anti-clot med & transferred to higher level of care for emergent coronary angiography.  Admitted 2/5-2/8/2008. FINAL DX: acute coronary syndrome, unclear whether vasospasm or clot disolved.  2/14/08 Reviewed ER medical records of 2/5/08 which reveal patient experienced substernal chest pressure, heaviness & pain which radiated to both jaws with diaphoresis, nausea & flu-like symptoms x 3 days.  Tx w/meds including anti-clot med & transferred to higher level of care.  FINAL ER Dx: myocardial infarction.
Age: 30.0
Sex: F
Vaccine: HEPA
Symptoms: Exposure to communicable disease, Hyperventilation, Lethargy, Pain
Clinical narrative: Hepatitis A Vacine administedred by Erie County DOH due to possible exposure from produce employe at Wegmans grocery store on Sheridan Dr in Williamsville, NY.  Vaccine administered at 6:30 PM with no immediate reaction.  Lethargy set in approximately 3 hours later.  By early morning it was difficult to take a deep breath, and had aches and pains similar to the flu.  No fever or nausea.  Benadryl provided some relief from difficult breathing.  Thus far no need for an ED visit.
Age: 31.0
Sex: M
Vaccine: ANTH
Symptoms: Amyotrophic lateral sclerosis, Full blood count, Muscle atrophy, Muscular weakness, Neuropsychological test
Clinical narrative: Amyotrophic Lateral Sclerosis.  2/19/08 Reviewed medical records which reveal patient initially seen in neuromuscular/MDA clinic 4/2007 referred for possible motor neuron disease.  Patient symptoms began 9/2005 w/decreased dexterity of left hand which worsened progressively.  Recently started w/right hand as well w/cramping & decreased dexterity.  Had 30# wt loss over past year.  Returned to clinic 5/2007 & started Rilutek for ALS & discussed clinical trials.  Returned to clinic 8/2007 with increased weakness of arms & hands.  Neuropsychology testing was done & found to be WNL.  Returned to clinic 11/2007 w/continued loss of dexterity of hands. Reported that hand cramping began in 1999-2000 while on board ship.  These were felt to represent initial stages of ALS.  Returned to clinic 2/2008 w/progression of weakness, fatigue & awkwardness.  Now w/weakness of ankles but respiratory function preserved.  Started on lithium & continued serial labs. FINAL DX: amyotrophic lateral sclerosis. Per 60 day follow up: Progressive weakness, muscle atrophy and paralysis dut to Amyotrophic Lateral Sclerosis; loss of motor neurons as defined in: http://www.springerlink.com/content/x457214811q62412/ Received shot 1-1/27/9999 FAV038, Shot 2-2/12/99 FAV038, Shot 3-2/24/99 FAV038, Shot 4-7/29/99 FAV038, Shot 5-1/27/2000 FAV031