chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: DTAP, IPV, PNC, RV5
Symptoms: Culture stool negative, Diarrhoea, Food intolerance, Sick relative
Clinical narrative: Information has been received from a physician concerning a male who is intolerant to regular formula and is on soy formula who on 26-JUL-2007 was vaccinated with a 2mL PO dose of Rotateq. Subsequently the patient experienced severe watery diarrhea after his feedings. The child's mother also has the same symptoms. The physician indicated that she will perform a stool culture test. The patient's severe watery diarrhea persisted. There was no product quality compliant. Additional information has been requested. Follow up information indicated that the patient's stool was negative for rotavirus and the culture showed normal flora. The outcome was recovered on 07-AUG-2007.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Hypotonia, Immediate post-injection reaction, Rash
Clinical narrative: Information has been received from a physician concerning a 9 week old male who "at the beginning of the year" in approximately January 2007, was vaccinated with Rotateq (Lot# not provided). Immediately post vaccination, the infant "went limp" and broke out in a rash. The infant was monitored at the office for approximately 45 minutes and recovered with no treatment. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Medication error
Clinical narrative: Information has been received from a health care provider concerning patients who were vaccinated with Rotateq. The health care provider reported that on an unspecified date multiple patients may have received Rotateq which had been improperly stored vaccine since FEB-2007. No problems reported. The patients sought unspecified medical attention. Additional information has been requested.
Age: 28.0
Sex: M
Vaccine: ANTH, SMALL, TYP, SMALL
Symptoms: Cellulitis
Clinical narrative: Redness, swelling around injection site, possible cellulitis.
Age: 28.0
Sex: M
Vaccine: ANTH, SMALL, TYP, SMALL
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Redness, swelling around injection site, possible cellulitis.
Age: 39.0
Sex: M
Vaccine: ANTH, SMALL, TYP, SMALL
Symptoms: Blister, Swelling
Clinical narrative: Large redness of area around immunization site, spreading to axilla - local reaction, possibly cellulitis.
Age: 39.0
Sex: M
Vaccine: ANTH, SMALL, TYP, SMALL
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: Large redness of area around immunization site, spreading to axilla - local reaction, possibly cellulitis.
Age: 25.0
Sex: M
Vaccine: TTOX
Symptoms: Erythema, Influenza like illness, Swelling
Clinical narrative: Moderate flu like symptoms 24hrs after receiving vaccine.  Red swollen area of approximately 5 inch diameter.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Anaphylactic reaction, Dyspnoea, Pharyngeal oedema, Urticaria
Clinical narrative: Initial report received from a health care professional on 28 August 2007. A 12-year-old male patient, with a history of pre-existing latex allergy, had received an injection of Menactra (route, site and lot number not reported) on 28 August 2007 and an unspecified period of time later experienced shortness of breath, hives, and throat swelling leading to an emergency room visit. The reporter stated that the patient had returned to the office with anaphylaxis. The patient's recovery status was unknown at the time of the report.
Age: 49.0
Sex: M
Vaccine: ANTH, FLUX, HEP
Symptoms: Blood cholesterol, Depression, Hypertension, Pain
Clinical narrative: Blood pressure - Lisinopril 20mg; Cholesterol - Simvastatin 40mg; Depression - Venlafaxine HCl 37.5 mg; Pain - Naproxen 550 mg.
Age: 1.0
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Blister, Pyrexia, Varicella
Clinical narrative: 8-13-07 - seen by MD. Varicella disease x 1 week - numerous vesicles over trunk and face; fever 102 oral. Zovirax tsp QID 200cc.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Syncopal episode
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Cellulitis, Lymphadenopathy
Clinical narrative: Local reaction - lymph node involvement. Early cellulitis possible.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Rash
Clinical narrative: Rash on left arm - post HPV vaccine
Age: 24.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Blood pressure increased, Dizziness, Feeling abnormal
Clinical narrative: Client complained of "feeling funny" after the shots were given. BP 154/100. Client observed x 30 min. No difficulty breathing or swallowing. BP returned to normal. Client drank some Coke. C/O feeling dizzy. Father came to drive her home.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Chest discomfort, Feeling hot, Injection site erythema, Pain, Pain in extremity
Clinical narrative: 8/21/07 AML Tdap given. PM - left arm and body aches. 8/22/07 -8/27/07 - Body aches and left arm sore. 8/24/07 - 1 PM Wheezing and chest tightness (but was around cats). 8/24/07 PM increased body aches, felt "hot", increased arm soreness, some redness. 8/25/07 AM increased arm redness - below injection site to elbow - splotches. 8/26/07 PM to ER dept.; given Keflex 500 mg 4x/day x 7 days. 8/28/07 - To PCP - given SoluMedrol injection. Improving since arm redness resolving.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Rash macular, Wheezing
Clinical narrative: 8/21/07 AML Tdap given. PM - left arm and body aches. 8/22/07 -8/27/07 - Body aches and left arm sore. 8/24/07 - 1 PM Wheezing and chest tightness (but was around cats). 8/24/07 PM increased body aches, felt "hot", increased arm soreness, some redness. 8/25/07 AM increased arm redness - below injection site to elbow - splotches. 8/26/07 PM to ER dept.; given Keflex 500 mg 4x/day x 7 days. 8/28/07 - To PCP - given SoluMedrol injection. Improving since arm redness resolving.
Age: 13.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis at injection site - Keflex.
Age: 22.0
Sex: M
Vaccine: TDAP
Symptoms: Chills, Myalgia, Pyrexia, Tremor, Vomiting
Clinical narrative: Vaccine given at 11 AM 8/27/07. At about 1130 pm he awoke shaking/shivering, fever 100.8, muscle aches, vomiting. Went to ER at 12 midnight. Given Solumedrol, Toradol, Ativan, Benadryl, Pepcid. Given Prednisone to take x 2 days. Feeling better today. Left ER at 3 AM.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular, Urticaria
Clinical narrative: (08-15-07 - 08-21-07 symptoms) Awoke with 3cm area right palm small poison-ivy looking area and large hive-looking raised irregular area near right ear and eye corner, day later 2 small red sores at right wrist, next day small hive left side of face just like right side, next day, 5-6 sores in breast cleavage mostly right few left. Next day small itchy area right ankle. Mostly right side some eruption left Varicella-like reaction.
Age: 17.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Hypersensitivity, Malaise
Clinical narrative: 8/15/07 - Pt received Tdap vaccine approx 8 AM. PC from mother reports pt "doesn't feel right". Informed to go to ER. 6/16/07 Spoke to mother; dx with allergic reaction to Tdap. On Atarax and steroids. TO see MD today. PC to mother - saw MD today, reports was to hospitalize but no beds available. (Some shortness of breath). 8/17/07 PC to mom. Reports signs and symptoms have improved. No SOB; on steroids and Atarax now.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Pyrexia
Clinical narrative: Patient, age 5, received vaccinations on 8/20/07. That night he complained his arm hurt and his parents gave Tylenol. The next morning, 8/21/07, his mother noticed his arm was red and swollen. He had a slight fever and the redness seemed to be spreading from his left shoulder to elbow. Child was brought back to the health department and advised to see their doctor. The mother provided a phone number for the health department to do a follow up call however both that # and the one given at the time of service are invalid. No contact has been made.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, MMRV
Symptoms: Oedema peripheral
Clinical narrative: Right arm swollen 2 times normal size. Antibiotic treatment started.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Injection site swelling, Pruritus generalised, Rash
Clinical narrative: Pt reports on 1/30/07 7 PM - was itching all over and had fine red raised rash on chest, both forearms, both thighs, denies fever. Rash and itching lasted 3-4 days - gone by 2/3/07. Also had localized swelling at injection site.
Age: 4.0
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Oedema peripheral, Skin warm
Clinical narrative: (R) thigh tenderness onset same day as vaccine. Morning after, parent noted significant swelling to right upper thigh. Seen in office and noted to have generalized swelling of right thigh from groin extending to and involving the right knee. No erythema or measured sign of reaction at injection site. Leg is warm to touch with uniform swelling to anterior and posterior thigh. Given Motrin and Benadryl, cold compress PRN.
Age: 33.0
Sex: F
Vaccine: MMR
Symptoms: Oedema peripheral, Pruritus, Rash
Clinical narrative: 2/23/2007 PC from pt. - was seen in ER 2/18/07 c/o rash - a "shot" was given. On 2/23/07, pt reports rash continues, hands are swollen and itching - referred to PMD. 2/26/2007 - Phone call - pt seen 2/23/07 by PMD - gave pt steroids and lotion. Reports is improving today.
Age: 27.0
Sex: F
Vaccine: DTAP
Symptoms: Oedema peripheral, Wheezing
Clinical narrative: Arm swelling started 8/27/07 and is improving. Wheezing started at night on 8/28/07; was seen on 8/30/07. Started Benadryl and Pepcid/Zantac, Albuterol.
Age: 12.0
Sex: M
Vaccine: HEPA
Symptoms: Cold compress therapy, Injection site erythema, Injection site rash
Clinical narrative: Pt. given Hep A #2 in (L) deltoid IM. Within 3 min., pt. had redness at site and developed raised rash around site, up over shoulder and near armpit. Also had two small areas on (R) side of neck. Cold compress applied. Breathing normal, no distress. Child said arm felt "funny" but moved it with assistance. After 20 min of cold, rash was less and not raised. Instructed mom to monitor carefully and I keep cold on it during trip home.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Body temperature increased, Crying, Screaming
Clinical narrative: Infant had vaccines at 9:00 am. At 12:00 PM, started screaming, mother unable to console. Screamed on and off x 3-4 hrs. Temp developed in the afternoon of 104.2 rectally. Has been given .8 dropper full of infant Tylenol every 6 hrs and cooling baths. Today temp is 102. No further screaming. Eating well.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Rash
Clinical narrative: Mom says that child had a rash on body since getting the Hep A.
Age: 4.0
Sex: F
Vaccine: DTAP, HEP, HEPA, VARCEL
Symptoms: Headache, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Redness and swelling at site of DTaP injection with a fever of 100 the day after receiving shots. She worsened the following day with a fever of 103; headache, and swelling up to 10 cm. Child was taken to Dr. whose plan was to monitor. She began to feel better the next day, July 19th, with less redness and a temp of 102. It was on this day that she returned to the clinic and the reaction was noted. The father was phoned the following day, July 20th, and he stated she was continuing to improve.
Age: 70.0
Sex: F
Vaccine: HEPAB, TYP
Symptoms: Angioedema, Lip swelling, Swelling face
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of angioedema in a 70-year-old female subject who was vaccinated with Twinrix, GlaxoSmithKline for prophylaxis. Concurrent medical conditions included hypertension. Concurrent vaccination included Salmonella typhi Vi capsular polysaccharide vaccine (oral) given on 17 April 2007; Twinrix 1st dose; GlaxoSmithKline given on 14 March 2007 in the right arm; live attenuated oral poliomyelitis vaccine (Sanofi) given on 14 March 2007; unspecified vaccine (Sanofi) given on 14 March 2007; yellow fever vaccine (Sanofi) given on 14 March 2007. Concurrent medications included Diovan and Risedronic acid (Actonel). On 17 April 2007 the subject received 2nd dose of Twinrix at 1.0 ml. In July 2007, after the 2nd vaccination with Twinrix, the subject experienced angioedema, swelling of cheek and lip swelling. The subject had three separate incidence of these events and was seen by two other physicians that related the event to her Diovan. Diovan was discontinued on 28 July 2007 and she was treated with Benadryl each time and the events resolved. The subject reported that two of the events occurred. At the time of reporting the events were resolved.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Dyspnoea, Wheezing
Clinical narrative: Shortness of breath, wheezing - seen in ER, given Albuterol, Prednisone. Admitted overnight for observation. Home on Albuterol/Prednisone.  9/7/07 Reviewed hospital medical records which reveal patient experienced congestion, cough, itchy eyes, lightheaded, HA, cough, sore throat & SOB on 8/23 which worsened & was admitted 8/24-8/25/07.  Tx w/tapering steroids, nebs, antihistamine.  Remained tachycardic & tachypneic but breathing improved by d/c.  Left upper arm injection site noted to be tender & swollen. FINAL DX: Reactive airway disease secondary to viral infection vs protracted anaphylaxis.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Abdominal pain upper, Dizziness, Fatigue, Gaze palsy, Headache
Clinical narrative: 2:00 PM gave Menactra and Tdap (R) arm; felt fine, no problems. Gave Gardasil (L) arm, felt pain at site, felt light headed. Stomach hurt, leaned back then eyes crossed, became stiff (body) and shook body for about 1 min then sat up asking - what is going on, then felt lightheaded and laid down on exam table. 2:04 PM 98/60, pulse 58. 2:13 Pulse Ox 99%. 2:20 PM 108/64, 71, Pulse Ox 99%, still feels nauseous. 2:28 PM Stated better, minor queasiness, feels tired. 2:30 PM C/O pain in tummy, leaned back, laid down. 2:44 PM Headache. 2:52 PM She got up and felt better, left office.
Age: 13.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site pain, Musculoskeletal stiffness, Nausea, Tremor
Clinical narrative: 2:00 PM gave Menactra and Tdap (R) arm; felt fine, no problems. Gave Gardasil (L) arm, felt pain at site, felt light headed. Stomach hurt, leaned back then eyes crossed, became stiff (body) and shook body for about 1 min then sat up asking - what is going on, then felt lightheaded and laid down on exam table. 2:04 PM 98/60, pulse 58. 2:13 Pulse Ox 99%. 2:20 PM 108/64, 71, Pulse Ox 99%, still feels nauseous. 2:28 PM Stated better, minor queasiness, feels tired. 2:30 PM C/O pain in tummy, leaned back, laid down. 2:44 PM Headache. 2:52 PM She got up and felt better, left office.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site rash
Clinical narrative: Red rash half way around injection site; noticed rash at home 9-1-07.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site pain, Myalgia
Clinical narrative: Pt given vaccine 6-12-07. Patient presented to office 8/17/07 for 2nd injection and c/o continued muscle soreness at injection site, especially when lifting arm up - c/o feeling of "pressure in muscle" when feeling on arm. No tenderness or palpation, no edema, nodules. Pt denies tingling, numbness, nerve s/s, 2nd injection withheld for now.
Sex: F
Vaccine: HEPA, HPV4, TDAP
Symptoms: Unevaluable event
Clinical narrative: As of 9/5/07, pt has had no adverse effects from administration of Hepatitis A on 8/30/07.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Rash
Clinical narrative: Pt. complained of a fine red rash to arms, abdomen, and chest approx 10 hrs after receiving Gardasil vaccine. Pt has been taking Benadryl, Claritin, and Medrol dose pack.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Chest X-ray, Lymphadenopathy, Vaccine positive rechallenge
Clinical narrative: Gardasil #1 = enlarged lymph node in (L) axillary area about 3 weeks after injection. Gardasil #2 = same as above, occurred 48 hours after injection (lymph node enlarged).
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Prodromal symp trigeminal nerve distribution day 7 after vaccination with rash development within 2 days. Valtrex 3 times daily initiated. Vital signs - T. 97.5, P. 80, BP 108/78.
Age: 1.6
Sex: M
Vaccine: TDAP
Symptoms: Diarrhoea, Wrong drug administered
Clinical narrative: 18 month old received Tdap instead of Dtap-developed diarrhea after 5 days
Age: 0.2
Sex: F
Vaccine: DTAPHEPBIP, RV5
Symptoms: Crying
Clinical narrative: Mother called provider office @ 3pm and reported baby had been crying uncontrollably for 2 1/2 hr. Office staff spoke with parent at "3:23pm", still crying; they advised giving baby Tylenol and to call back if continues to cry; No call back.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Cold compress therapy, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: (L) arm red, swollen hot to touch approx 4" x 5"; received 4 vaccines in same arm. Started on Orapred, Zyrtec, cool compresses
Age: 9.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Skin warm, Swelling
Clinical narrative: Vaccine given at 11 AM; starting swelling around 10 PM, worse in the morning. Heat at local reaction and itching. No pain. 80mm wheal.
Age: 1.3
Sex: M
Vaccine: PNC
Symptoms: Skin hypertrophy
Clinical narrative: Client received vaccine 4/3/07. End of April, mother noted a small dimple on (R) upper thigh; continued to get bigger throughout May. No redness or inflammation noted. Took child to PMD 6/8/07. PMD said it is a vaccine reaction. Has gotten bigger since 6/8/07. Indentation is about 1.25 inch cir.
Age: 61.0
Sex: F
Vaccine: TD
Symptoms: C-reactive protein increased, Spondyloarthropathy
Clinical narrative: Reactive seronegative spondyloarthropathy
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: fever, red and swollen @ site of injection
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Hyperaesthesia, Injection site erythema, Injection site swelling
Clinical narrative: Area of injection red and swollen, sore to touch.
Age: 1.1
Sex: F
Vaccine: MEA, RUB, VARCEL
Symptoms: Dysphonia, Wheezing
Clinical narrative: Wheezing and hoarseness.
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Rash
Clinical narrative: No fever. Child woke with "spots" on forehead (R) side and ant. neck and temple on 070707. More spots on 0712/07. Mother took child to doctor on 0712/07. TC from doctors office AM 0713/07 with above info. MD not sure if reaction from vaccines. TC to CDNS. Call mother to fill out VAERS and received more info. Mother state day 071307that spots have not increased. Denies any blisters> denies any fever. Mother states spots are barely raised.
Age: 1.0
Sex: M
Vaccine: MMRV, PNC
Symptoms: Blood amylase, Blood immunoglobulin G, Blood immunoglobulin M, Diarrhoea, Parotitis
Clinical narrative: Fever. Diarrhea, Rash, Parotitis
Age: 1.0
Sex: M
Vaccine: MMRV, PNC
Symptoms: Pyrexia, Rash, White blood cell count
Clinical narrative: Fever. Diarrhea, Rash, Parotitis
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Red raised area at site of MMR II injection
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Erythema, Eyelid oedema, Nasal congestion, Rhinorrhoea, Sneezing
Clinical narrative: Pt developed sneezing minutes after immunization. 1/2 hour later eyelids and mouth swollen, erythematous, and nose became runny, stuffy, red, had some urticaria trunk.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Pt developed sneezing minutes after immunization. 1/2 hour later eyelids and mouth swollen, erythematous, and nose became runny, stuffy, red, had some urticaria trunk.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, PNC
Symptoms: Abscess, Discomfort, Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: Received vaccine on 7/31/7 - she has a 4cm swollen, red, indurated but not fluctuant mass in her rt. upper thigh - this correlates with DTaP. No drainage. She has been using her leg well but with discomfort. This appears to be a sterile abscess associated with the DTaP. Use warm compresses and antipyretics.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, PNC
Symptoms: Injection site swelling
Clinical narrative: Received vaccine on 7/31/7 - she has a 4cm swollen, red, indurated but not fluctuant mass in her rt. upper thigh - this correlates with DTaP. No drainage. She has been using her leg well but with discomfort. This appears to be a sterile abscess associated with the DTaP. Use warm compresses and antipyretics.
Sex: F
Vaccine: DPP
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: recived injection on 7-25-2007 that afternoon began with nausea and vomiting and some dizziness, had no other reasons or new meds that would have caused this reaction, the next day still c/o dizziness but was much better, after the 3rd day was completely better.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Asthenia, Dizziness, Dyspnoea, Hypokinesia, Immediate post-injection reaction
Clinical narrative: Patient received Meningococcal Vaccine (Manactra) and immediately after experienced dizziness, difficulty breathing and weakness.  Later the same evening (approximately 2 hours after receiving the vaccine) patient experienced limb weakness of both arms and legs and was unable to lift anything or walk. Patient was taken to doctor visit to follow up on reaction.
Age: 8.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Patient brought in to Clinic on 8/29/2007.  Noted 3x3 cm induration with redness and itching to posterior aspect of right arm at injection site.  Per parent had gradually gotten worse over 24 hours.  Patient evaluated by Dr. and treated with Benadryl po and Keflex.  Upon follow up after 24 hours treatment, parents stated patient doing better.  Follow up after 5 days, completely resolved.
Age: 1.25
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Hypokinesia, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Large area of swelling and erythema in right thigh noted 2 days post adminstration.  Patient unable to bear weight.  Fever X 1 day.
Age: 14.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Abdominal pain, Computerised tomogram normal, Syncope, Tremor
Clinical narrative: severe abdominal pain, tremors, fainted twice. within 48 hours of vaccine receiving.  Also happened after having cajun foods.
Age: 14.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Abdominal pain lower, Computerised tomogram normal, Confusional state, Fatigue, Syncope
Clinical narrative: severe abdominal pain, tremors, fainted twice. within 48 hours of vaccine receiving.  Also happened after having cajun foods.
Age: 14.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Tremor
Clinical narrative: severe abdominal pain, tremors, fainted twice. within 48 hours of vaccine receiving.  Also happened after having cajun foods.
Age: 14.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Abdominal pain, Computerised tomogram normal, Syncope, Tremor
Clinical narrative: 15 hours after vaccine was administered (2:30am) patient awoke with severe lower abdominal pain.  Patient got up to go to the bathroom where patient fainted.  Patient's legs then began to tremor uncontrolably.  Patient's arms then began as well and we took patient by ambulance to the emergency room.  Patient was given Ativan and the tremors stopped.  Patient was also given a cat scan to look at her appendix but that was fine.  Patient was discharged by 7am, exhaused and confused.
Age: 14.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Abdominal pain lower, Computerised tomogram normal, Confusional state, Fatigue, Syncope
Clinical narrative: 15 hours after vaccine was administered (2:30am) patient awoke with severe lower abdominal pain.  Patient got up to go to the bathroom where patient fainted.  Patient's legs then began to tremor uncontrolably.  Patient's arms then began as well and we took patient by ambulance to the emergency room.  Patient was given Ativan and the tremors stopped.  Patient was also given a cat scan to look at her appendix but that was fine.  Patient was discharged by 7am, exhaused and confused.
Age: 14.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Tremor
Clinical narrative: 15 hours after vaccine was administered (2:30am) patient awoke with severe lower abdominal pain.  Patient got up to go to the bathroom where patient fainted.  Patient's legs then began to tremor uncontrolably.  Patient's arms then began as well and we took patient by ambulance to the emergency room.  Patient was given Ativan and the tremors stopped.  Patient was also given a cat scan to look at her appendix but that was fine.  Patient was discharged by 7am, exhaused and confused.
Age: 59.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Laboratory test
Clinical narrative: Patient had numbness in hands and feet.  Went to hospital, was diagnosed with Guillain Barre Syndrome.  Hospitalized for 3 weeks (21 days) then was admitted to inpatient rehab facility for 2 weeks.  Continues with outpatient rehab therapy.  Continues with numbness and difficulty walking.  9/18/07 Reviewed hospital medical records which reveal patient experienced decreased strength of legs x 4 days, trouble w/stairs, tingling of fingers & toes, taste changes, low back pain.  Exam revealed very unsteady gait & dramatically reduced DTRs of LEs which became absent on 2nd hospital day & UEs DTR were then reduced.  Admitted 7/27-8/6/2007.  Neuro consult done.  Patient refused EMG.  Tx w/IVIG x 5 days w/improvement.  D/C to inpatient rehab. FINAL DX: Guillain-Barre syndrome (recurrent).
Age: 59.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Patient had numbness in hands and feet.  Went to hospital, was diagnosed with Guillain Barre Syndrome.  Hospitalized for 3 weeks (21 days) then was admitted to inpatient rehab facility for 2 weeks.  Continues with outpatient rehab therapy.  Continues with numbness and difficulty walking.  9/18/07 Reviewed hospital medical records which reveal patient experienced decreased strength of legs x 4 days, trouble w/stairs, tingling of fingers & toes, taste changes, low back pain.  Exam revealed very unsteady gait & dramatically reduced DTRs of LEs which became absent on 2nd hospital day & UEs DTR were then reduced.  Admitted 7/27-8/6/2007.  Neuro consult done.  Patient refused EMG.  Tx w/IVIG x 5 days w/improvement.  D/C to inpatient rehab. FINAL DX: Guillain-Barre syndrome (recurrent).
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Immediate post-injection reaction, Pallor, Pruritus, Pyrexia, Rash generalised
Clinical narrative: Immediately after vaccination, patient became extremely pale (lips went white) and his arm itched "under my skin".  Six days after the vaccination, he developed a rash all over his body (face, trunk, back, genitals, legs, bottom).  He also ran a mild fever.  Gave him Benadryl for
Age: 64.0
Sex: M
Vaccine: PNC
Symptoms: Death
Clinical narrative: Subject in pneumococcal vaccine trial died approximately one month after vaccination alone in his home.  Cause unknown.  No autopsy. 1/18/08 Received death certificate which states COD as hypertensive cardiovascular disease & COPD as contributing factor.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Body temperature increased, Dizziness, Heart rate increased, Injection site pain, Myalgia
Clinical narrative: Patient presented to local Emergency Room on 9/1 at approximately 10:00 pm after receiving vaccine on 8/31, complaining of pain at injection site, localized muscle pain, dizziness, and a low grade fever. Patient had taken Advil and muscle pain was relieved. At time of presentation, patient vital signs were: Temperature 100.1, Pulse 87, Respirations 22, B/P 128/76, Oxygen saturation on room air 100%. ER MD recommended continuation of Ibuprofen as needed for fever and myalgia, fluids, and rest.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Oxygen saturation normal, Pyrexia, Respiratory rate increased
Clinical narrative: Patient presented to local Emergency Room on 9/1 at approximately 10:00 pm after receiving vaccine on 8/31, complaining of pain at injection site, localized muscle pain, dizziness, and a low grade fever. Patient had taken Advil and muscle pain was relieved. At time of presentation, patient vital signs were: Temperature 100.1, Pulse 87, Respirations 22, B/P 128/76, Oxygen saturation on room air 100%. ER MD recommended continuation of Ibuprofen as needed for fever and myalgia, fluids, and rest.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Malaise, Myalgia, Pyrexia
Clinical narrative: erythema and swelling at injection site, low grade fever, myalgia and malaise x 3 d after injection
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site induration, Injection site warmth, Nausea
Clinical narrative: redness, warmth, large enduration at injection site x 3+ wk, nausia, chills x 3d
Age: 22.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Fatigue, Headache, Rash erythematous, Rash generalised, Viral infection
Clinical narrative: Tdap & Hepatitis B vaccination given on 8/20/07. Developed a rash on neck, chest, abdomen, and back on 8/25/07. Noted red raised bumps approx 5mm in diameter, irregular shape, and non itchy. On 8/29 c/o mild HA and feeling little more tired than usual. Denies any fever or any other symtoms. Eval by MD and was diagnosed as viral. 9/1/07 Rash continue to spread over chest, neck,trunk,groin, and back....irregular shape red raised areas. Denies fever or itching. Evaluated by physician and was started on prednisone 10mg tab (2 tabs qd x3dys, 1tab qdx2dys, 1tab qod x2days).
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Blood creatine phosphokinase normal, Cardiac stress test normal, Chest X-ray normal, Coagulation test abnormal, Computerised tomogram abnormal
Clinical narrative: 9/5/07-Pt came into immunizations for Anthrax #3 immunization.  In my routine screening questions before giving an immunization pt. stated he had been hospitalized on 8/12/07 with an inflammation of the lining around his heart and was admitted to the Cornary Care Unit for 3 days.  He stated to me that approx. 7 to 8 days after his smallpox immunization he began to have shortness of breath and trouble breathing when he exercised.  These sypmptoms continued to worsen as the days progressed and he went to E.R. on 8/12/07.  He said they did all knds of lab tests, E.K.G., Echocardiogram, medicines and admitted him to an inpatient unit.  He said his blood test showed he had an inflammation of his heart muscle.  The M.D. called it pericarditis.  Pt was placed on low dose molecular weight heparin, low dose aspirin therapy and Indocin 25 mgm-po-tid while he was and in patient. Pt discharged on 8/14/07 with discharge instructions to continue Indocin 25 mgm-po-tid for 5 days.  Pt states he feels really good now.  09/10/2007 MR received for DOS 8/12-14/2007 for D/C DX of Chest Pain, probable Pericarditis and abnormal Troponin I Level. Pt presented to ER with a several day hx of substernal chest pain with radiation to the neck which is exertion related.  Shortness of breath and tingling of the arms also occur with minimal activity.  PE WNL. Treated with Indocin.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Dyspnoea, Dyspnoea exertional, Echocardiogram normal, Ejection fraction, Electrocardiogram normal
Clinical narrative: 9/5/07-Pt came into immunizations for Anthrax #3 immunization.  In my routine screening questions before giving an immunization pt. stated he had been hospitalized on 8/12/07 with an inflammation of the lining around his heart and was admitted to the Cornary Care Unit for 3 days.  He stated to me that approx. 7 to 8 days after his smallpox immunization he began to have shortness of breath and trouble breathing when he exercised.  These sypmptoms continued to worsen as the days progressed and he went to E.R. on 8/12/07.  He said they did all knds of lab tests, E.K.G., Echocardiogram, medicines and admitted him to an inpatient unit.  He said his blood test showed he had an inflammation of his heart muscle.  The M.D. called it pericarditis.  Pt was placed on low dose molecular weight heparin, low dose aspirin therapy and Indocin 25 mgm-po-tid while he was and in patient. Pt discharged on 8/14/07 with discharge instructions to continue Indocin 25 mgm-po-tid for 5 days.  Pt states he feels really good now.  09/10/2007 MR received for DOS 8/12-14/2007 for D/C DX of Chest Pain, probable Pericarditis and abnormal Troponin I Level. Pt presented to ER with a several day hx of substernal chest pain with radiation to the neck which is exertion related.  Shortness of breath and tingling of the arms also occur with minimal activity.  PE WNL. Treated with Indocin.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Full blood count normal, International normalised ratio, Laboratory test normal, Oxygen saturation normal, Pericarditis
Clinical narrative: 9/5/07-Pt came into immunizations for Anthrax #3 immunization.  In my routine screening questions before giving an immunization pt. stated he had been hospitalized on 8/12/07 with an inflammation of the lining around his heart and was admitted to the Cornary Care Unit for 3 days.  He stated to me that approx. 7 to 8 days after his smallpox immunization he began to have shortness of breath and trouble breathing when he exercised.  These sypmptoms continued to worsen as the days progressed and he went to E.R. on 8/12/07.  He said they did all knds of lab tests, E.K.G., Echocardiogram, medicines and admitted him to an inpatient unit.  He said his blood test showed he had an inflammation of his heart muscle.  The M.D. called it pericarditis.  Pt was placed on low dose molecular weight heparin, low dose aspirin therapy and Indocin 25 mgm-po-tid while he was and in patient. Pt discharged on 8/14/07 with discharge instructions to continue Indocin 25 mgm-po-tid for 5 days.  Pt states he feels really good now.  09/10/2007 MR received for DOS 8/12-14/2007 for D/C DX of Chest Pain, probable Pericarditis and abnormal Troponin I Level. Pt presented to ER with a several day hx of substernal chest pain with radiation to the neck which is exertion related.  Shortness of breath and tingling of the arms also occur with minimal activity.  PE WNL. Treated with Indocin.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Troponin I increased
Clinical narrative: 9/5/07-Pt came into immunizations for Anthrax #3 immunization.  In my routine screening questions before giving an immunization pt. stated he had been hospitalized on 8/12/07 with an inflammation of the lining around his heart and was admitted to the Cornary Care Unit for 3 days.  He stated to me that approx. 7 to 8 days after his smallpox immunization he began to have shortness of breath and trouble breathing when he exercised.  These sypmptoms continued to worsen as the days progressed and he went to E.R. on 8/12/07.  He said they did all knds of lab tests, E.K.G., Echocardiogram, medicines and admitted him to an inpatient unit.  He said his blood test showed he had an inflammation of his heart muscle.  The M.D. called it pericarditis.  Pt was placed on low dose molecular weight heparin, low dose aspirin therapy and Indocin 25 mgm-po-tid while he was and in patient. Pt discharged on 8/14/07 with discharge instructions to continue Indocin 25 mgm-po-tid for 5 days.  Pt states he feels really good now.  09/10/2007 MR received for DOS 8/12-14/2007 for D/C DX of Chest Pain, probable Pericarditis and abnormal Troponin I Level. Pt presented to ER with a several day hx of substernal chest pain with radiation to the neck which is exertion related.  Shortness of breath and tingling of the arms also occur with minimal activity.  PE WNL. Treated with Indocin.
Age: 20.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Arrhythmia, Atrial septal defect, Cardiac arrest, Cough, Nasopharyngitis
Clinical narrative: Information has been received from an agency concerning a 20 year old female who on 12-FEB-2007 was vaccinated intramuscularly into the right arm with a first dose of Gardasil (Lot #654389/0961F). Concomitant suspect therapy included Varivax (Lot #652550/1111R) subcutaneously into the right arm. The patient had no symptoms until 04-MAR-2007 when in the morning, the patient's mother noted that she had a cold/URI symptoms with cough. At 11am, the patient developed emesis after eating soup at 10am. The patient was napping at 3pm when her mother got home but she was difficult to arouse. The mother called 911 and started rescue breathing. The paramedics initially called in stable vital signs but required active CPR on the gurney by the time they came into the emergency department. The patient was in disorganized ventricular fibrillation in the emergency room and was resuscitated with PALS and cardiology was consulted for ECHO. The patient was hospitalized. The patient was cannulated for VA ECMO on full flow support after 1.5 hours. The heart was completely akinetic. The patient went to the catherization lab to get biopsies, CADs and assessment of integrity of heart with very poor tone/strength to heart muscle noted which was presumed to be acute viral myocarditis. The patient received IVIG. The patient neurologic function could not be assessed due to significant drug load. The patient currently remained with very disorganized rhythm. An EPS study was considered as well as the possibility of family inherited rhythm disturbances. The patient received ECMO support for cardiac arrest secondary to myocarditis. An endomyocardial biopsy showed acute lymphocytic myocarditis with scattered eosinophils. An echocardiogram revealed dilated right ventricle, severely decreased biventricular systolic function, mild tricupsid/mitral insufficiency, atrial septum bulges, and small right pleural effusion. The patient was discharged on 23-MAR-2007. At the time of this report, the outcome was unknown. Cough, emesis, cardiac arrhythmia, oxygen supplementation, acute viral myocarditis, respiratory arrest, cold/uri, difficult to arouse and cardiac arrest secondary to myocarditis were considered to be immediately life-threatening. 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 release specifications. The lot met the requirements and was released. No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Oxygen supplementation, Respiratory arrest, Somnolence, Urinary tract infection, Ventricular hypertrophy
Clinical narrative: Information has been received from an agency concerning a 20 year old female who on 12-FEB-2007 was vaccinated intramuscularly into the right arm with a first dose of Gardasil (Lot #654389/0961F). Concomitant suspect therapy included Varivax (Lot #652550/1111R) subcutaneously into the right arm. The patient had no symptoms until 04-MAR-2007 when in the morning, the patient's mother noted that she had a cold/URI symptoms with cough. At 11am, the patient developed emesis after eating soup at 10am. The patient was napping at 3pm when her mother got home but she was difficult to arouse. The mother called 911 and started rescue breathing. The paramedics initially called in stable vital signs but required active CPR on the gurney by the time they came into the emergency department. The patient was in disorganized ventricular fibrillation in the emergency room and was resuscitated with PALS and cardiology was consulted for ECHO. The patient was hospitalized. The patient was cannulated for VA ECMO on full flow support after 1.5 hours. The heart was completely akinetic. The patient went to the catherization lab to get biopsies, CADs and assessment of integrity of heart with very poor tone/strength to heart muscle noted which was presumed to be acute viral myocarditis. The patient received IVIG. The patient neurologic function could not be assessed due to significant drug load. The patient currently remained with very disorganized rhythm. An EPS study was considered as well as the possibility of family inherited rhythm disturbances. The patient received ECMO support for cardiac arrest secondary to myocarditis. An endomyocardial biopsy showed acute lymphocytic myocarditis with scattered eosinophils. An echocardiogram revealed dilated right ventricle, severely decreased biventricular systolic function, mild tricupsid/mitral insufficiency, atrial septum bulges, and small right pleural effusion. The patient was discharged on 23-MAR-2007. At the time of this report, the outcome was unknown. Cough, emesis, cardiac arrhythmia, oxygen supplementation, acute viral myocarditis, respiratory arrest, cold/uri, difficult to arouse and cardiac arrest secondary to myocarditis were considered to be immediately life-threatening. 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 release specifications. The lot met the requirements and was released. No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Viral myocarditis, Vomiting
Clinical narrative: Information has been received from an agency concerning a 20 year old female who on 12-FEB-2007 was vaccinated intramuscularly into the right arm with a first dose of Gardasil (Lot #654389/0961F). Concomitant suspect therapy included Varivax (Lot #652550/1111R) subcutaneously into the right arm. The patient had no symptoms until 04-MAR-2007 when in the morning, the patient's mother noted that she had a cold/URI symptoms with cough. At 11am, the patient developed emesis after eating soup at 10am. The patient was napping at 3pm when her mother got home but she was difficult to arouse. The mother called 911 and started rescue breathing. The paramedics initially called in stable vital signs but required active CPR on the gurney by the time they came into the emergency department. The patient was in disorganized ventricular fibrillation in the emergency room and was resuscitated with PALS and cardiology was consulted for ECHO. The patient was hospitalized. The patient was cannulated for VA ECMO on full flow support after 1.5 hours. The heart was completely akinetic. The patient went to the catherization lab to get biopsies, CADs and assessment of integrity of heart with very poor tone/strength to heart muscle noted which was presumed to be acute viral myocarditis. The patient received IVIG. The patient neurologic function could not be assessed due to significant drug load. The patient currently remained with very disorganized rhythm. An EPS study was considered as well as the possibility of family inherited rhythm disturbances. The patient received ECMO support for cardiac arrest secondary to myocarditis. An endomyocardial biopsy showed acute lymphocytic myocarditis with scattered eosinophils. An echocardiogram revealed dilated right ventricle, severely decreased biventricular systolic function, mild tricupsid/mitral insufficiency, atrial septum bulges, and small right pleural effusion. The patient was discharged on 23-MAR-2007. At the time of this report, the outcome was unknown. Cough, emesis, cardiac arrhythmia, oxygen supplementation, acute viral myocarditis, respiratory arrest, cold/uri, difficult to arouse and cardiac arrest secondary to myocarditis were considered to be immediately life-threatening. 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 release specifications. The lot met the requirements and was released. No further information is available.
Age: 20.0
Sex: F
Vaccine: HPV4, VARCEL, HPV4, VARCEL
Symptoms: Arrhythmia, Biopsy heart, Cardiac arrest, Cough, Depressed level of consciousness
Clinical narrative: Information has been received from an agency concerning a 20 year old female who on 12-FEB-2007 was vaccinated intramuscularly into the right arm with a first dose of Gardasil (Lot #654389/0961F). Concomitant suspect therapy included Varivax (Lot #652550/1111R) subcutaneously into the right arm. The patient had no symptoms until 04-MAR-2007 when in the morning, the patient's mother noted that she had a cold/URI symptoms with cough. At 11am, the patient developed emesis after eating soup at 10am. The patient was napping at 3pm when her mother got home but she was difficult to arouse. The mother called 911 and started rescue breathing. The paramedics initially called in stable vital signs but required active CPR on the gurney by the time they came into the emergency department. The patient was in disorganized ventricular fibrillation in the emergency room and was resuscitated with PALS and cardiology was consulted for ECHO. The patient was hospitalized. The patient was cannulated for VA ECMO on full flow support after 1.5 hours. The heart was completely akinetic. The patient went to the catherization lab to get biopsies, CADs and assessment of integrity of heart with very poor tone/strength to heart muscle noted which was presumed to be acute viral myocarditis. The patient received IVIG. The patient neurologic function could not be assessed due to significant drug load. The patient currently remained with very disorganized rhythm. An EPS study was considered as well as the possibility of family inherited rhythm disturbances. The patient received ECMO support for cardiac arrest secondary to myocarditis. An endomyocardial biopsy showed acute lymphocytic myocarditis with scattered eosinophils. An echocardiogram revealed dilated right ventricle, severely decreased biventricular systolic function, mild tricupsid/mitral insufficiency, atrial septum bulges, and small right pleural effusion. The patient was discharged on 23-MAR-2007. At the time of this report, the outcome was unknown. Cough, emesis, cardiac arrhythmia, oxygen supplementation, acute viral myocarditis, respiratory arrest, cold/uri, difficult to arouse and cardiac arrest secondary to myocarditis were considered to be immediately life-threatening. 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 release specifications. The lot met the requirements and was released. No further information is available.