chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.14
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC, RV5, RV5
Symptoms: Unevaluable event
Clinical narrative: Received 2 month shots on 8/31/06:  Pediarix, Prevnar, Acthib, and Rotateq. Office visit on 9/5/06 presenting with fever of unknown origin.  Family stated fever as high as 102.3 rectally.  At time of visit temp was 100.3 rectally post tylenol.  LP and CBC performed in office.  Admitted to Hospital.  10/13/06 Received D/C Summary from hospital which reveals the primary Dx as meningitis, cardiac arrest & seizures.  Patient had neurologic devastation s/p cardiac arrest, family requested palliative care & comfort measures.  Patient expired on 10/8/06
Sex: M
Vaccine: DTAP, IPV
Symptoms: Coma, Convulsion, Drooling, Eye movement disorder, High-pitched crying
Clinical narrative: DTaP #2 and IPV given right leg per private provider.  Child developed local redness x 5 days.  No elevation in temperature.  Child was "real lethargic" for 2 weeks following immunizations.  Approximately 2 weeks following immunizations, child became non-responsive, eyes rolled back, drooling.  Lasted approximately 3 minutes.  Mother did not take child to private provider at that time.  Mother did not take child to private provider until 5-7 days after the incident (of child becoming non-responsive, eyes rolled back).  According to the mother, the pediatrician stated that "it had nothing to do with the shots."  Mom then took child to a pediatric neurologist.  A 24 hour EEG was done and was "within normal limits".  The neurologist diagnosed seizure.  Mom states she did not mention to the neurologist the immunizations give approximately 2 weeks prior to the seizure.  According to mother, provider did not order anti-seizure medications and will not unless child has another seizure.  Mom states the child had high-pitched screaming after the seizure, was tired the rest of that evening, slept all night, and started feeling better and was less lethargic the next day.  No further seizure activity.  History of 1 brother diagnosed with autism at age 4.  History of 1 sister developed elevated temperature (103-104 F), large red spot on leg, lump size of hardball on leg, hospitalized x 2 days following 4 year-old immunizations.
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Lethargy
Clinical narrative: DTaP #2 and IPV given right leg per private provider.  Child developed local redness x 5 days.  No elevation in temperature.  Child was "real lethargic" for 2 weeks following immunizations.  Approximately 2 weeks following immunizations, child became non-responsive, eyes rolled back, drooling.  Lasted approximately 3 minutes.  Mother did not take child to private provider at that time.  Mother did not take child to private provider until 5-7 days after the incident (of child becoming non-responsive, eyes rolled back).  According to the mother, the pediatrician stated that "it had nothing to do with the shots."  Mom then took child to a pediatric neurologist.  A 24 hour EEG was done and was "within normal limits".  The neurologist diagnosed seizure.  Mom states she did not mention to the neurologist the immunizations give approximately 2 weeks prior to the seizure.  According to mother, provider did not order anti-seizure medications and will not unless child has another seizure.  Mom states the child had high-pitched screaming after the seizure, was tired the rest of that evening, slept all night, and started feeling better and was less lethargic the next day.  No further seizure activity.  History of 1 brother diagnosed with autism at age 4.  History of 1 sister developed elevated temperature (103-104 F), large red spot on leg, lump size of hardball on leg, hospitalized x 2 days following 4 year-old immunizations.
Age: 0.01
Sex: F
Vaccine: HEP
Symptoms: Coma, Convulsion, Dyspnoea, Laboratory test abnormal, Lethargy
Clinical narrative: Listlessness and lethargy progressing to uncontrollable seizures requiring hospitalization within 5 days of administration. Baby healthy and responsive during pediatric examination on 9/18/2006. Seizures, difficulty breathing, lack of responsiveness indicated. Potentially life threatening. Potential for neurological damage indicated.  10/5/06 Received provider clinic notes dated 9/18/06 which noted patient sleepy & decreased feeding.  Neuro tone was decreased compared to when seen 3 days prior.  Suck reflex was weak to absent & patient was mildly tachypneic.  Dx: consider infection.  Newborn metabolic screening was WNL.  Admitted patient to hospital NICU for septic w/u. 11/27/06 Received medical records from hospital which reveal patient experienced neonatal seizures with sepsis suspected but unproven.  Admitted 9/21/06 & d/c home on 10/02/06.  Patient was 7 days old upon admission with fussiness, poor feeding & increasing listlessness over the prior 24 hour period.  Just prior to LP, seizure activity was noted & continued to have intermittent seizures during admission.  Treated with meds & Vit B 6. Remained on Pb & off B6 on d/c to home.  Concerns remained re possible developmental delays.  Final DX: Neonatal seizures & suspected but unproven sepsis.
Age: 0.01
Sex: F
Vaccine: HEP
Symptoms: Listless, Sepsis
Clinical narrative: Listlessness and lethargy progressing to uncontrollable seizures requiring hospitalization within 5 days of administration. Baby healthy and responsive during pediatric examination on 9/18/2006. Seizures, difficulty breathing, lack of responsiveness indicated. Potentially life threatening. Potential for neurological damage indicated.  10/5/06 Received provider clinic notes dated 9/18/06 which noted patient sleepy & decreased feeding.  Neuro tone was decreased compared to when seen 3 days prior.  Suck reflex was weak to absent & patient was mildly tachypneic.  Dx: consider infection.  Newborn metabolic screening was WNL.  Admitted patient to hospital NICU for septic w/u. 11/27/06 Received medical records from hospital which reveal patient experienced neonatal seizures with sepsis suspected but unproven.  Admitted 9/21/06 & d/c home on 10/02/06.  Patient was 7 days old upon admission with fussiness, poor feeding & increasing listlessness over the prior 24 hour period.  Just prior to LP, seizure activity was noted & continued to have intermittent seizures during admission.  Treated with meds & Vit B 6. Remained on Pb & off B6 on d/c to home.  Concerns remained re possible developmental delays.  Final DX: Neonatal seizures & suspected but unproven sepsis.
Age: 23.0
Sex: F
Vaccine: HEP
Symptoms: Dyspnoea
Clinical narrative: After receiving injection approx. 4 hours later became short of breath.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Blood pressure increased, Convulsion, Laboratory test abnormal
Clinical narrative: Pt. upon receiving vaccines left the vaccine room with mother and was leaving the waiting area fell in the door way.  Mom reported that the child has a "seizure".  When PHN arrived the child was held by Mom and Phn had mom Lay Her in a reclining position with her feet up.  Child's eyes were half open  and another nurse was with pt. while  Phn Obtained aa blood pressure cuff and ammonia.  Pt. was crying when I returned.  BP was 120/80 RIGHT ARM.  Child remained in Clinic for approx. 30 min.  She was alert and drank some soda. Seen in ER due to an episode of unresponsiveness, while walking out of the health department after her Hib vaccine, she fell down face forward, her mother is not sure if she tripped or not, she was unconscious and arched her back, became stiff all over and had bilateral arms and legs extended, she also stopped breathing for "a few seconds" and turned blue but then regained consciousness. She lost urinary continence during the episode. While driving to ER she became weak.   Appeared to improve and was DC's from ER, while walking to car complained of nausea and became "weak in the knees" almost fell down twice, appeared drowsy. Returned to ER where she looked pale and diaphoretic. Patient stated she does not remember any of that episode. Small amount of yellow emesis.  No HX of fevers, rash, runny nose, vomiting prior to this episode.  Review of Systems: negative. Impression: new onset generalized seizure of unknown cause. No febrile seizure or concussion. Clinical picture does not suggest changed mental status, hypoxia, hypoglycemia, hyponatremia or hypernatremia. Clinical picture does not suggest volume depletion or urinary tract infection.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth, Pain
Clinical narrative: On Friday afternoon after child got off of school bus, around 3:30 pm, developed knot on upper right arm at area of injection. Had swelling, redness, and area is warm to touch. Pain and soreness extended up into neck.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Tenderness
Clinical narrative: LEFT ARM RED AT INJECTION SITE APPROXIMATELY THE SIZE OF A HALF A DOLLAR. THE AREA FEELS HOT TO THE TOUCH, VERY TENDER, AND SLIGHTLY RAISED. NOT ITCHY.
Age: 0.36
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Erythema, Swelling
Clinical narrative: Mom contacted office stating that her son had a local reaction from his vaccinations on 9/22/2006.  She stated that her son's right thigh was red and swollen when he woke up in the morning.  Mom stated that the child has no fever at this time.  The child's mother was encouraged to give him Motrin for swelling.  Will follow up in 3 days
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Pt received vaccination and developed severe swelling which was warm to the touch in vaccinated arm which resolved without MD intervention.
Age: 81.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: NOTED RIGHT UPPER ARM SWOLLEN AND SLIGHTLY WARM TO TOUCH, REDNESS DOWN ARM AND PUFFY IN BACK OF ARM ALMOST TO ELBOW, NO C/O ITCHING, PAIN AT THIS TIME. NO SHORTNESS OF BREATH, LUNGS CHECKS FOR BREATHING, TEMP. 96.1 MEASURED 13 1/2" CIRCUMFERENCE afebrile a+o amb non focal  redness ; swelling ; warmth ; intact skin Rt UE deltoid area at site of of  pneumococcal injection down to elbow ant > post area  pulses radial wnl  sensation intact  motor 5/5  no ax adenopathy chest cta no rrw  cor rrr  pv no edema   allergic reaction rt UE re to pneumococcal vaccine 08/15/06   Swelling resolved by 8/23/06
Age: 26.0
Sex: F
Vaccine: TD
Symptoms: Injection site hypersensitivity, Injection site mass, Pain, Pruritus, Throat tightness
Clinical narrative: Patient developed itching at site of injection and had "lump in throat" on evening of injection--resolved with no treatment.  Developed severe upper arm pain during that night.  Now arm feels better but is still tender.  Today (9/25/06) upper arm feels warm to touch and has palpable lump above area of injection.  B/P 108/80, no lymphadenopathy.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Apnoea, Convulsion, Cyanosis, Laboratory test abnormal
Clinical narrative: Within 24 hours after vaccination, pt developed perioral cyanosis and apnea CPR. Seizure like activity. No fever, witnessed desats in hospital D/C'd home with apnea monitor. 10/10/06-records received for DOS: 9/2-9/7/06 2 month old presented to ER with one episode of circum oral cyanosis of fingertips and toes turning blue and baby not breathing, mother administered CPR for 2-3 minutes with baby responding and breathing again. During apneic episode mother noted that baby was shaking and had eye twitches and eyes rolled back. Once baby awakened mother noted increased stiffness, unable to extend arms and stiff straight legs. On day of admission mother noted decreased responsiveness and increased sleeping. Also had congestion and cough. No fevers, decreased intake on day of admission. Urine output good, no vomiting no diarrhea. One sick contact with a 3 year old brother. IN ER PE WNL. UA: 10-20 protein, 300-500 glucose, negative nitrites, negative leukocyte esterase.  Hospital Course: Treated with Ampicillin and Cefotaxime. Initially had episodes of apnea and bradycardia with desaturations in 60s. One witnessed episode while patient was apneic and began having circum oral cyanosis and required stimulation and blow by O2. No further recorded episodes but was having respiratory rates as low at 10-12. DC with apena monitor.
Age: 1.02
Sex: F
Vaccine: HBHEPB, PNC
Symptoms: Convulsion, Laboratory test abnormal, Pyrexia
Clinical narrative: Fever to 102.5 followed by multiple tonic clonic seizures. 10/06/06-records received for DOS 9/21-9/22/06. DC DX: Seizure On 9/21/06-had blank stare, fever 101.5 (R), laboraded breathing, episode lasted 45 minutes, tonic clonic jerking movements of the right arm observed by paramedics along with 'strange eye movement'. RX with Valium. In ER temp 102.4, RX with Ativan secondary to persistant staring. No HX URI, no seizures in past, dad with possible URI. PMH: 1 previous ER visit 2 weeks ago for fever 103.5 DX as virus and RX with motrin and tylenol.  PE: awake, alert interactive. TM bilateral with erythema but non buldging. red raised macule 2cm right upper arm. DTR symmetrical, down going Babinski.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Pt fainted.
Age: 14.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Medication error
Clinical narrative: Client given adult dosage 1CC IM of Hep A vaccine instead of Pediatric dosage of 0.5 cc no adverse reaction noted at time of injection, no reactions reported at this time.
Age: 1.02
Sex: M
Vaccine: MMRV, PNC
Symptoms: Rash maculo-papular
Clinical narrative: Received ProQuad 1 and Prevnar 4 on 9/22/06 followed by generalized maculopapular rash 9/23/06.
Age: 34.0
Sex: F
Vaccine: TD
Symptoms: Unevaluable event
Clinical narrative: None Stated
Age: 1.01
Sex: F
Vaccine: HEP, HIBV, MMR
Symptoms: Blister
Clinical narrative: Multiple vesicles to to torso and a few to face.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site oedema
Clinical narrative: Swelling and redness on left deltoid area 2 days post immunization. Warm compress arm movement to affected site with Motrin PRN.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Tenderness
Clinical narrative: Red, warm, swollen arm, tender at injection site, had begun resolving by time pt contacted office Monday.
Age: 1.01
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Herpes zoster, Viral infection
Clinical narrative: Shingles
Age: 16.0
Sex: F
Vaccine: HEPA
Symptoms: Medication error
Clinical narrative: Client given adult dosage 1cc IM of Hep A vaccine instead of Ped dosage 0.5cc, no adverse reaction noted at time of injections, no reactions reported at this time.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Agitation, Crying, Superficial injury of eye
Clinical narrative: Crying inconsolable in almost 24 hour, excessive crying for 72 hours.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, HIBV
Symptoms: Erythema, Heart rate increased, Vomiting
Clinical narrative: Child received vaccine at 14:00, at 14:20, pt vomited and abd. and chest turned bright red. MD notified immediately and ordered Epi 0.05mg SC. P4's pulse was 130 prior to Epi 0.05mg SC to L thigh. HR at 144 after injection. Epi pl. well, and redness of trunk resolved. Offered other respiratory treatment but mom ///. Advised to go to ER if any problems.
Age: 0.21
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Constipation, Haematochezia, Intussusception, Irritability, Laboratory test abnormal
Clinical narrative: Information has been received from two physicians concerning an approx 17 week old male with no allergies and a history of jaundice at birth and eczema who on 5/23/06 and 8/4/06 was vaccinated PO with the first (lot 653754/0139F) and second (lot 653915/0389F) 2.0 ml doses, respectively, of Rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human Bovine). Concomitant vaccinations on 8/4/06 included the second dose in the right arm of Prevnar (lot B08655E), the second dose in the right thigh of IPOL (lot Y1051), the second dose in the left thigh of Hib conj vaccine (ActHib) (lot U8812AA) and the second dose in the left thigh of Dtap. There was no other concomitant therapy. Illness at the time of vaccination included an upper respiratory infection and congestion. On 9/5/06, at 26 weeks of age, the pt developed episodes of vomiting and was hospitalized as a diagnosis of intussusception was made via CT scan. An ultrasound was also performed (results not provided). The pt had two air contrast Barium enemas which were unsuccessful in reducing the intussusception. On 9/7/06, the pt underwent open reduction of the intussusception. It was noted that the pt did not lose any bowel as a result of the procedure. The pt was hospitalized for six days and was subsequently discharged at home. At the time of this report, the pt was noted to be recovering. Information received on 9/11/06 contained the following adverse experienced Bronchiolitis (July 2006), The physicians also considered intussusception to be an other important medical event (OMIC) ( surgery) and life threatening. Additional information has been requested.
Age: 0.21
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from two physicians concerning an approx 17 week old male with no allergies and a history of jaundice at birth and eczema who on 5/23/06 and 8/4/06 was vaccinated PO with the first (lot 653754/0139F) and second (lot 653915/0389F) 2.0 ml doses, respectively, of Rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human Bovine). Concomitant vaccinations on 8/4/06 included the second dose in the right arm of Prevnar (lot B08655E), the second dose in the right thigh of IPOL (lot Y1051), the second dose in the left thigh of Hib conj vaccine (ActHib) (lot U8812AA) and the second dose in the left thigh of Dtap. There was no other concomitant therapy. Illness at the time of vaccination included an upper respiratory infection and congestion. On 9/5/06, at 26 weeks of age, the pt developed episodes of vomiting and was hospitalized as a diagnosis of intussusception was made via CT scan. An ultrasound was also performed (results not provided). The pt had two air contrast Barium enemas which were unsuccessful in reducing the intussusception. On 9/7/06, the pt underwent open reduction of the intussusception. It was noted that the pt did not lose any bowel as a result of the procedure. The pt was hospitalized for six days and was subsequently discharged at home. At the time of this report, the pt was noted to be recovering. Information received on 9/11/06 contained the following adverse experienced Bronchiolitis (July 2006), The physicians also considered intussusception to be an other important medical event (OMIC) ( surgery) and life threatening. Additional information has been requested.
Age: 0.21
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Bronchiolitis, Intussusception, Vomiting
Clinical narrative: Information has been received from two physicians concerning an approx 17 week old male with no allergies and a history of jaundice at birth and eczema who on 5/23/06 and 8/4/06 was vaccinated PO with the first (lot 653754/0139F) and second (lot 653915/0389F) 2.0 ml doses, respectively, of Rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human Bovine). Concomitant vaccinations on 8/4/06 included the second dose in the right arm of Prevnar (lot B08655E), the second dose in the right thigh of IPOL (lot Y1051), the second dose in the left thigh of Hib conj vaccine (ActHib) (lot U8812AA) and the second dose in the left thigh of Dtap. There was no other concomitant therapy. Illness at the time of vaccination included an upper respiratory infection and congestion. On 9/5/06, at 26 weeks of age, the pt developed episodes of vomiting and was hospitalized as a diagnosis of intussusception was made via CT scan. An ultrasound was also performed (results not provided). The pt had two air contrast Barium enemas which were unsuccessful in reducing the intussusception. On 9/7/06, the pt underwent open reduction of the intussusception. It was noted that the pt did not lose any bowel as a result of the procedure. The pt was hospitalized for six days and was subsequently discharged at home. At the time of this report, the pt was noted to be recovering. Information received on 9/11/06 contained the following adverse experienced Bronchiolitis (July 2006), The physicians also considered intussusception to be an other important medical event (OMIC) ( surgery) and life threatening. Additional information has been requested.
Age: 0.21
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RV5, RV5, DTAP, HEP, HIBV, IPV, PNC, RV5
Symptoms: Intussusception, Vomiting
Clinical narrative: Information has been received from two physicians concerning an approx 17 week old male with no allergies and a history of jaundice at birth and eczema who on 5/23/06 and 8/4/06 was vaccinated PO with the first (lot 653754/0139F) and second (lot 653915/0389F) 2.0 ml doses, respectively, of Rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human Bovine). Concomitant vaccinations on 8/4/06 included the second dose in the right arm of Prevnar (lot B08655E), the second dose in the right thigh of IPOL (lot Y1051), the second dose in the left thigh of Hib conj vaccine (ActHib) (lot U8812AA) and the second dose in the left thigh of Dtap. There was no other concomitant therapy. Illness at the time of vaccination included an upper respiratory infection and congestion. On 9/5/06, at 26 weeks of age, the pt developed episodes of vomiting and was hospitalized as a diagnosis of intussusception was made via CT scan. An ultrasound was also performed (results not provided). The pt had two air contrast Barium enemas which were unsuccessful in reducing the intussusception. On 9/7/06, the pt underwent open reduction of the intussusception. It was noted that the pt did not lose any bowel as a result of the procedure. The pt was hospitalized for six days and was subsequently discharged at home. At the time of this report, the pt was noted to be recovering. Information received on 9/11/06 contained the following adverse experienced Bronchiolitis (July 2006), The physicians also considered intussusception to be an other important medical event (OMIC) ( surgery) and life threatening. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: UNK
Symptoms: Blister
Clinical narrative: Multiple vesicles
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Respiratory distress, Viral infection
Clinical narrative: Information has been received from a physician concerning a 2-3 month old pt who in 2006 was vaccinated PO with the first 2.0 ml dose of Rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human Bovine). the physician reported that on approximately 8/31/06, the pt was hospitalized in the ICU with respiratory distress and died. The physician also reported that the pt had tested positive for rotavirus. The physician also considered respiratory distress and rotavirus to be life threatening. The reporting physician, via a follow up telephone call, indicated that she was not the pts physician and did not have any additional information to provide. She did not have the pts name as this was reported to her second hand by an employee at a hospital. No further information is available.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Diplopia, Dizziness, Encephalitis, Headache, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: Information has been received from a pharmacist concerning her 9 year old son with no pertinent medical history and no drug reactions allergies who on 8/29/06 was vaccinated SC with a second booster dose of varicella virus vaccine live. It was noted that the pot was vaccinated with the first dose of varicella at 1 year old. Concomitant therapy included fluticasone propionate + salmeterol xinafoate (Advair). On 9/8/06, 10 days after vaccination, the pt experienced fever and dizziness. This continued the following day, and by 9/10/06, he experienced fever, increased dizziness, vomiting, and double vision. That evening he was admitted to the hospital where he stayed until 9/13/06, He was diagnosed with acute disseminated encephalomyelitis. An MRI revealed 4 lesions on the brain and spinal cord. Test including a spinal tap have rule out viral encephalitis. A CAT scan was also obtained. The mother reported that her son was fine at the time of the report, and occasionally experienced headaches and dizziness. No specimen was available. The outcome was recovering. There was no product quality complaint. The mother considered the event to be disabling. Additional information has been requested. 8/4/08-records received for DOS 9/11-9/13/06-DC DX: Acute demyelinating encephalomyelitis. Presented to ED with C/O 2 days of fevers and diplopia.
Age: 9.0
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Vomiting
Clinical narrative: Information has been received from a pharmacist concerning her 9 year old son with no pertinent medical history and no drug reactions allergies who on 8/29/06 was vaccinated SC with a second booster dose of varicella virus vaccine live. It was noted that the pot was vaccinated with the first dose of varicella at 1 year old. Concomitant therapy included fluticasone propionate + salmeterol xinafoate (Advair). On 9/8/06, 10 days after vaccination, the pt experienced fever and dizziness. This continued the following day, and by 9/10/06, he experienced fever, increased dizziness, vomiting, and double vision. That evening he was admitted to the hospital where he stayed until 9/13/06, He was diagnosed with acute disseminated encephalomyelitis. An MRI revealed 4 lesions on the brain and spinal cord. Test including a spinal tap have rule out viral encephalitis. A CAT scan was also obtained. The mother reported that her son was fine at the time of the report, and occasionally experienced headaches and dizziness. No specimen was available. The outcome was recovering. There was no product quality complaint. The mother considered the event to be disabling. Additional information has been requested. 8/4/08-records received for DOS 9/11-9/13/06-DC DX: Acute demyelinating encephalomyelitis. Presented to ED with C/O 2 days of fevers and diplopia.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Faeces discoloured, Haematochezia
Clinical narrative: Information has been received from a physician concerning an 8 week old male, with a family history of allergies, who on 8/24/06 was vaccinated with a 2ml oral dose of Rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human Bovine). On 9/5/06 the pt experienced orange stool and questionable blood and mucus in stool. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. The pts blood in stool was considered to be an other important medical event (OMIC). Additional information has been requested.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Erythema, Haematochezia, Vomiting
Clinical narrative: Information has been received from a physician concerning a 59 day old male, with no medical history and no allergies, who on 9/12/06 was vaccinated with a 2 ml oral dose of Rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human Bovine) (lot 653755/0319F). Concomitant vaccines administered on the same day included a dose of Pediarix, a dose of Hib conj vaccine (manufacturer unknown)  and a dose of Prevnar. The pt was seen in the office on 9/15/06 after experiencing bright red streaks of blood in his stool and vomiting the night before on 9/14/06. On examination the abdomen was soft and non tender, with no fever, and in no acute distress. The pt was sent to the hospital for X rays and blood tests. At the time of the report the pt had not recovered. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. The pts bright red streaks of blood in his stool was considered to be an other important medical event (OMIC). Additional information has been requested.
Age: 1.21
Sex: M
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received from a consumer concerning her approximately 15 month old son who has no known allergies or pertinent medical history, who 7 1/2 years ago, in approximately March 1999, was vaccinated SC with a 0.5 ml first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. There was no concomitant medication.  Subsequently, "around the same time" the vaccine was given, the patient started "showing signs" of autism. Medical attention was sought, a hearing test was performed and the patient's brain stem was "tested", results were not reported. At the time of the report the patient had not recovered. No further information was available. There was no product quality complaint involved. The patient's brother (WAES0609USA03020) also had an adverse experience after vaccination with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. Upon internal review, autism was considered to be an other important medical event (OMIC). Additional information has been requested.
Age: 0.96
Sex: M
Vaccine: MMR
Symptoms: Autism
Clinical narrative: Information has been received from a consumer concerning her approximately 12 month old son with no known allergies or pertinent medical history who, 6 1/2 years ago, in approximately March 2000, was vaccinated with a 0.5 ml dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. There was no concomitant medication. Subsequently, "around the same time" the vaccine was given, the patient started "showing signs" of autism. No tests were done, the patient was not hospitalized. At the time of the report the patient had not recovered. No further information was available. There was no product quality complaint involved. The patient's brother (WAES0609USA02487) also had an adverse experience after vaccination with measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. Upon internal review, autism was considered to be an other important medical event (OMIC). Additional information has been requested.
Age: 0.75
Sex: M
Vaccine: HEP, DTAP, DTAP, DTAP, HEP, HIBV, IPV
Symptoms: Anxiety, Autism, Insomnia, Laboratory test abnormal, Mental impairment
Clinical narrative: Information has been received from a consumer concerning her 7-year-old son who on 29-JAN-1999 and 29-SEP-1999 was vaccinated with his first, second and third doses of hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown).  Secondary suspect therapy included the first, second, third and fourth doses of Hib conj vaccine (manufacturer unspecified) given on 03-MAR-1999, 07-may-1999, 01-JUL-1999 and 19-APR-1999.  In August 2006, the patient was diagnosed with autism and Tourette's syndrome.  Another physician diagnosed her son with anxiety disorder and OCD obsessive compulsive disorder.  One of the physicians believed that the possible cause could be the thimerosal in the vaccines he received as an infant.  The mother reported that they cut out all dairy products, wheat and preservatives out of her son's diet with some noted improvement noted in his behavior.  He has difficulty making decisions and sleeping at night.  The following laboratory/diagnostic tests have been done,mercury level=0.001 ug/g, zinc 8.9 and magnesium level=41.  No further information was available at the time of this report.  The patient's vaccination history included: a dose of IVP, rotavirus vaccine (unspecified) given on 07-MAY-1999 and 01-JUL-1999, diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid given on 03-MAR-1999, 07-MAY-1999, 01-JUL-1999, 19-APR-2000 and 02-JAN-2003.  The patient's mother indicated that she wanted her pediatric office to "do a lot check".  Upon internal review, autism was determined to be an other important medical event.  Additional information has been requested. (OMIC)
Age: 0.75
Sex: M
Vaccine: HEP, DTAP, DTAP, DTAP, HEP, HIBV, IPV
Symptoms: Obsessive-compulsive disorder, Tourette's disorder
Clinical narrative: Information has been received from a consumer concerning her 7-year-old son who on 29-JAN-1999 and 29-SEP-1999 was vaccinated with his first, second and third doses of hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown).  Secondary suspect therapy included the first, second, third and fourth doses of Hib conj vaccine (manufacturer unspecified) given on 03-MAR-1999, 07-may-1999, 01-JUL-1999 and 19-APR-1999.  In August 2006, the patient was diagnosed with autism and Tourette's syndrome.  Another physician diagnosed her son with anxiety disorder and OCD obsessive compulsive disorder.  One of the physicians believed that the possible cause could be the thimerosal in the vaccines he received as an infant.  The mother reported that they cut out all dairy products, wheat and preservatives out of her son's diet with some noted improvement noted in his behavior.  He has difficulty making decisions and sleeping at night.  The following laboratory/diagnostic tests have been done,mercury level=0.001 ug/g, zinc 8.9 and magnesium level=41.  No further information was available at the time of this report.  The patient's vaccination history included: a dose of IVP, rotavirus vaccine (unspecified) given on 07-MAY-1999 and 01-JUL-1999, diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid given on 03-MAR-1999, 07-MAY-1999, 01-JUL-1999, 19-APR-2000 and 02-JAN-2003.  The patient's mother indicated that she wanted her pediatric office to "do a lot check".  Upon internal review, autism was determined to be an other important medical event.  Additional information has been requested. (OMIC)
Age: 0.75
Sex: M
Vaccine: HEP, DTAP, DTAP, DTAP, HEP, HIBV, IPV
Symptoms: Anxiety, Autism, Insomnia, Mental impairment, Obsessive-compulsive disorder
Clinical narrative: Information has been received from a consumer concerning her 7-year-old son who on 29-JAN-1999 and 29-SEP-1999 was vaccinated with his first, second and third doses of hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown).  Secondary suspect therapy included the first, second, third and fourth doses of Hib conj vaccine (manufacturer unspecified) given on 03-MAR-1999, 07-may-1999, 01-JUL-1999 and 19-APR-1999.  In August 2006, the patient was diagnosed with autism and Tourette's syndrome.  Another physician diagnosed her son with anxiety disorder and OCD obsessive compulsive disorder.  One of the physicians believed that the possible cause could be the thimerosal in the vaccines he received as an infant.  The mother reported that they cut out all dairy products, wheat and preservatives out of her son's diet with some noted improvement noted in his behavior.  He has difficulty making decisions and sleeping at night.  The following laboratory/diagnostic tests have been done,mercury level=0.001 ug/g, zinc 8.9 and magnesium level=41.  No further information was available at the time of this report.  The patient's vaccination history included: a dose of IVP, rotavirus vaccine (unspecified) given on 07-MAY-1999 and 01-JUL-1999, diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid given on 03-MAR-1999, 07-MAY-1999, 01-JUL-1999, 19-APR-2000 and 02-JAN-2003.  The patient's mother indicated that she wanted her pediatric office to "do a lot check".  Upon internal review, autism was determined to be an other important medical event.  Additional information has been requested. (OMIC)
Age: 0.75
Sex: M
Vaccine: HEP, DTAP, DTAP, DTAP, HEP, HIBV, IPV
Symptoms: Tourette's disorder
Clinical narrative: Information has been received from a consumer concerning her 7-year-old son who on 29-JAN-1999 and 29-SEP-1999 was vaccinated with his first, second and third doses of hepatitis B virus vaccine rHBsAg (yeast) (manufacturer unknown).  Secondary suspect therapy included the first, second, third and fourth doses of Hib conj vaccine (manufacturer unspecified) given on 03-MAR-1999, 07-may-1999, 01-JUL-1999 and 19-APR-1999.  In August 2006, the patient was diagnosed with autism and Tourette's syndrome.  Another physician diagnosed her son with anxiety disorder and OCD obsessive compulsive disorder.  One of the physicians believed that the possible cause could be the thimerosal in the vaccines he received as an infant.  The mother reported that they cut out all dairy products, wheat and preservatives out of her son's diet with some noted improvement noted in his behavior.  He has difficulty making decisions and sleeping at night.  The following laboratory/diagnostic tests have been done,mercury level=0.001 ug/g, zinc 8.9 and magnesium level=41.  No further information was available at the time of this report.  The patient's vaccination history included: a dose of IVP, rotavirus vaccine (unspecified) given on 07-MAY-1999 and 01-JUL-1999, diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid given on 03-MAR-1999, 07-MAY-1999, 01-JUL-1999, 19-APR-2000 and 02-JAN-2003.  The patient's mother indicated that she wanted her pediatric office to "do a lot check".  Upon internal review, autism was determined to be an other important medical event.  Additional information has been requested. (OMIC)
Age: 0.17
Sex: U
Vaccine: HIBV, RV5
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning a 2 month old pt who was vaccinated PO with a dose of Rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human Bovine). concomitant vaccinations included a dose of Hib conj vaccine (OMPC) and all routine 2 month immunizations. The physician reported that the pt subsequently developed a high fever. The physician also reported that the pt was admitted to the hospital for possible sepsis for an unknown length of time. The physician indicated that the pt did not have sepsis and the child recovered while hospitalized. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Pyrexia
Clinical narrative: Information has been received from a physician concerning a pt who was vaccinated PO with a dose of Rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human Bovine). concomitant vaccinations included standard routine immunizations. The physician reported that the pt subsequently developed a high fever. The physician also reported that the pt was admitted to the hospital for possible sepsis for an unknown length of time. The physician indicated that the pt did not have sepsis and the child recovered while hospitalized. Additional information has been requested.
Age: 0.25
Sex: F
Vaccine: RV5, DTAPHEPBIP, HIBV, MNQ, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: Death occurred at night in home, unwitnessed, possible SIDS, previously healthy with mild CER, autopsy performed, genetics involved second to strong family history of developmental delay and psychiatric d/o. Pt in phase III clinical trial of HibMency, received vaccine 8/9/06
Age: 0.25
Sex: F
Vaccine: RV5, DTAPHEPBIP, HIBV, MNQ, PNC
Symptoms: Unevaluable event
Clinical narrative: Death occurred at night in home, unwitnessed, possible SIDS, previously healthy with mild CER, autopsy performed, genetics involved second to strong family history of developmental delay and psychiatric d/o. Pt in phase III clinical trial of HibMency, received vaccine 8/9/06
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Laboratory test abnormal, Thrombocytopenic purpura
Clinical narrative: Idiopathic thrombocytopenic purpura and platelet count decrease to 1000.
Age: 1.28
Sex: M
Vaccine: MMR, DTAP, HIBV, IPV, MMR
Symptoms: Abnormal behaviour, Aggression, Antisocial behaviour, Asthma, Autism
Clinical narrative: Information has been received concerning a case in litigation, via medical records, concerning an approx 2 year old male with an unremarkable neonatal course and no known drug allergies with a family history of demyelinating process (brother)revealed via MRI who on 1/28/1989 was vaccinated with the first dose of MMR II 9lot 631641/0917J) was given on 9/3/1999. In approx Oct 1989, the pt was noted to have speech delay as he was no longer saying distinct words and could only be heard to utter jargon in a sing song manner. He was also noted to have stopped developing. In approx April 1990, a diagnosis of autism was made. on 5/10/1992 the pt was hospitalized in a pediatric ward for reactive air way disease, developmental delays and to rule out pervasive developmental delay. At that time, the pt was noted to have poor speech with a vocabulary of approx 15 words. He was evaluated by a developmental pediatrician who noted that the pt appeared to be showing very stereotypical behavior consistent with Pervasive developmental delay (PPD), in particular, autism, The physician noted that the pt had a severe verbal and non verbal communication disorder with some deviant social interactions. In additional, the pt had chromosomes which were also sent for fragile X, which were negative, High resolution chromosomes that were done revealed that the pt was a 46 xy normal male by chromosome appearance. The pt also had a normal EEG and audiological evaluation. A speech evaluation concluded that the pt had a severe speech delay pattern. Discharge diagnosis included PPD, probably moderate to severe mental retardation and reactive airway disease. On 7/10/1992, the pt was seen by a developmental pediatrician who confirmed a diagnosis of PPD, but was unclear of the specific etiology of the pts developmental difficulties. On 9/15/1992 and MRI of the brain was normal. On 3/19/2001, the pt developed a seizure disorder for which he was hospitalized. ON 3/20/01, a cranial CT scan was normal (no mass lesion and fluid space normal). The pt was also noted to have ADHD and neurobehavioral problems for which he was treated with multiple medications. As of 7/12/2001, the pt was becoming more violent, screaming all the time and hitting family members especially his mother, he had learned some single word slight vocabulary and spelling and numbers, but continued to converse in a single words at best and his verbal reasoning was rudimentary at best. The pt was currently taking lorazepam (Ativan) 4mg BID, divalproex NA (Depakote) 500 mg in the morning and clonidine 2 mg at night. Upon internal review, autism and moderate to severe mental retardation were determined to be an other important medical events (OMIC). Medical records received on 9/12/06 contained the following adverse experienced reactive airway disease requiring hospitalization. Ethmoideral and sphnoid sinus disease, revealed via cranial CT scan. No further information is available. All available medical records will be provided upon request.
Age: 1.28
Sex: M
Vaccine: MMR, DTAP, HIBV, IPV, MMR
Symptoms: Speech disorder
Clinical narrative: Information has been received concerning a case in litigation, via medical records, concerning an approx 2 year old male with an unremarkable neonatal course and no known drug allergies with a family history of demyelinating process (brother)revealed via MRI who on 1/28/1989 was vaccinated with the first dose of MMR II 9lot 631641/0917J) was given on 9/3/1999. In approx Oct 1989, the pt was noted to have speech delay as he was no longer saying distinct words and could only be heard to utter jargon in a sing song manner. He was also noted to have stopped developing. In approx April 1990, a diagnosis of autism was made. on 5/10/1992 the pt was hospitalized in a pediatric ward for reactive air way disease, developmental delays and to rule out pervasive developmental delay. At that time, the pt was noted to have poor speech with a vocabulary of approx 15 words. He was evaluated by a developmental pediatrician who noted that the pt appeared to be showing very stereotypical behavior consistent with Pervasive developmental delay (PPD), in particular, autism, The physician noted that the pt had a severe verbal and non verbal communication disorder with some deviant social interactions. In additional, the pt had chromosomes which were also sent for fragile X, which were negative, High resolution chromosomes that were done revealed that the pt was a 46 xy normal male by chromosome appearance. The pt also had a normal EEG and audiological evaluation. A speech evaluation concluded that the pt had a severe speech delay pattern. Discharge diagnosis included PPD, probably moderate to severe mental retardation and reactive airway disease. On 7/10/1992, the pt was seen by a developmental pediatrician who confirmed a diagnosis of PPD, but was unclear of the specific etiology of the pts developmental difficulties. On 9/15/1992 and MRI of the brain was normal. On 3/19/2001, the pt developed a seizure disorder for which he was hospitalized. ON 3/20/01, a cranial CT scan was normal (no mass lesion and fluid space normal). The pt was also noted to have ADHD and neurobehavioral problems for which he was treated with multiple medications. As of 7/12/2001, the pt was becoming more violent, screaming all the time and hitting family members especially his mother, he had learned some single word slight vocabulary and spelling and numbers, but continued to converse in a single words at best and his verbal reasoning was rudimentary at best. The pt was currently taking lorazepam (Ativan) 4mg BID, divalproex NA (Depakote) 500 mg in the morning and clonidine 2 mg at night. Upon internal review, autism and moderate to severe mental retardation were determined to be an other important medical events (OMIC). Medical records received on 9/12/06 contained the following adverse experienced reactive airway disease requiring hospitalization. Ethmoideral and sphnoid sinus disease, revealed via cranial CT scan. No further information is available. All available medical records will be provided upon request.