chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Beta haemolytic streptococcal infection, Bradycardia, CSF bacteria identified, Cerebral infarction, Convulsion
Clinical narrative: Former premature infant born at 28 weeks gestation & birthweight 697 gm received standard 2 month vaccinations (Pediarix, HIB, Prevnar) at 0550AM on 5/20/05.  Later that AM developed a fever to 102.1 and was given tylenol 15 mg/kg every 6 hr.  The patient continued to feed well and was clincally stable for the remainder of that day.  Pt had recurrent fever at 0600 5/21 & WBC 4.6 (2 bands, 16 seg). At 0900 5/21 pt developed abdominal distension and feedings were stopped & required oxygen.  Blood cultures were drawn & Vancomycin & gentamycin were started. Pt was intubated.  At 0015 5/22 pt had a seizure and fontanel became tense.  she received a loading dose of phenobarbital 20mg/kg and a blood transfusion.  Piperacillin/tazobactam IV given.  Pt transferred to hospital at 0300 5/22/05 for evaluation of ileus/surgical abdomen and Lumbar puncture to rule out meningitis.  Per annual follow up report: Pt had late onset group B Strep meningitis which resulted in static encephalopathy and neurodevelopmental delays.  Discharge summary states diabetes Insipidis, brain syndrome, chronic, cerebral infarct, bacterial infection, hypothyroid, bradicardia, thrombocytapenia, deaf. msv  This was a concurrent GBS meningitis case. Symptoms for the meningitis developed some time as the vaccination was given.  The polt vaccination fever may have raising appropieate concern when she  became febrile. She never recovered from the meningitis. The disease left her disabled developmentally delayed. She died close to a year of age when she received viral infection.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Deafness, Dementia, Diabetes insipidus, Encephalopathy, Endotracheal intubation
Clinical narrative: Former premature infant born at 28 weeks gestation & birthweight 697 gm received standard 2 month vaccinations (Pediarix, HIB, Prevnar) at 0550AM on 5/20/05.  Later that AM developed a fever to 102.1 and was given tylenol 15 mg/kg every 6 hr.  The patient continued to feed well and was clincally stable for the remainder of that day.  Pt had recurrent fever at 0600 5/21 & WBC 4.6 (2 bands, 16 seg). At 0900 5/21 pt developed abdominal distension and feedings were stopped & required oxygen.  Blood cultures were drawn & Vancomycin & gentamycin were started. Pt was intubated.  At 0015 5/22 pt had a seizure and fontanel became tense.  she received a loading dose of phenobarbital 20mg/kg and a blood transfusion.  Piperacillin/tazobactam IV given.  Pt transferred to hospital at 0300 5/22/05 for evaluation of ileus/surgical abdomen and Lumbar puncture to rule out meningitis.  Per annual follow up report: Pt had late onset group B Strep meningitis which resulted in static encephalopathy and neurodevelopmental delays.  Discharge summary states diabetes Insipidis, brain syndrome, chronic, cerebral infarct, bacterial infection, hypothyroid, bradicardia, thrombocytapenia, deaf. msv  This was a concurrent GBS meningitis case. Symptoms for the meningitis developed some time as the vaccination was given.  The polt vaccination fever may have raising appropieate concern when she  became febrile. She never recovered from the meningitis. The disease left her disabled developmentally delayed. She died close to a year of age when she received viral infection.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Fontanelle bulging, Guillain-Barre syndrome, Hypernatraemia, Hypothyroidism, Hypoxia
Clinical narrative: Former premature infant born at 28 weeks gestation & birthweight 697 gm received standard 2 month vaccinations (Pediarix, HIB, Prevnar) at 0550AM on 5/20/05.  Later that AM developed a fever to 102.1 and was given tylenol 15 mg/kg every 6 hr.  The patient continued to feed well and was clincally stable for the remainder of that day.  Pt had recurrent fever at 0600 5/21 & WBC 4.6 (2 bands, 16 seg). At 0900 5/21 pt developed abdominal distension and feedings were stopped & required oxygen.  Blood cultures were drawn & Vancomycin & gentamycin were started. Pt was intubated.  At 0015 5/22 pt had a seizure and fontanel became tense.  she received a loading dose of phenobarbital 20mg/kg and a blood transfusion.  Piperacillin/tazobactam IV given.  Pt transferred to hospital at 0300 5/22/05 for evaluation of ileus/surgical abdomen and Lumbar puncture to rule out meningitis.  Per annual follow up report: Pt had late onset group B Strep meningitis which resulted in static encephalopathy and neurodevelopmental delays.  Discharge summary states diabetes Insipidis, brain syndrome, chronic, cerebral infarct, bacterial infection, hypothyroid, bradicardia, thrombocytapenia, deaf. msv  This was a concurrent GBS meningitis case. Symptoms for the meningitis developed some time as the vaccination was given.  The polt vaccination fever may have raising appropieate concern when she  became febrile. She never recovered from the meningitis. The disease left her disabled developmentally delayed. She died close to a year of age when she received viral infection.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Ileus, Lumbar puncture, Meningitis, Neurodevelopmental disorder, Pyrexia
Clinical narrative: Former premature infant born at 28 weeks gestation & birthweight 697 gm received standard 2 month vaccinations (Pediarix, HIB, Prevnar) at 0550AM on 5/20/05.  Later that AM developed a fever to 102.1 and was given tylenol 15 mg/kg every 6 hr.  The patient continued to feed well and was clincally stable for the remainder of that day.  Pt had recurrent fever at 0600 5/21 & WBC 4.6 (2 bands, 16 seg). At 0900 5/21 pt developed abdominal distension and feedings were stopped & required oxygen.  Blood cultures were drawn & Vancomycin & gentamycin were started. Pt was intubated.  At 0015 5/22 pt had a seizure and fontanel became tense.  she received a loading dose of phenobarbital 20mg/kg and a blood transfusion.  Piperacillin/tazobactam IV given.  Pt transferred to hospital at 0300 5/22/05 for evaluation of ileus/surgical abdomen and Lumbar puncture to rule out meningitis.  Per annual follow up report: Pt had late onset group B Strep meningitis which resulted in static encephalopathy and neurodevelopmental delays.  Discharge summary states diabetes Insipidis, brain syndrome, chronic, cerebral infarct, bacterial infection, hypothyroid, bradicardia, thrombocytapenia, deaf. msv  This was a concurrent GBS meningitis case. Symptoms for the meningitis developed some time as the vaccination was given.  The polt vaccination fever may have raising appropieate concern when she  became febrile. She never recovered from the meningitis. The disease left her disabled developmentally delayed. She died close to a year of age when she received viral infection.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Thrombocytopenia, Transfusion
Clinical narrative: Former premature infant born at 28 weeks gestation & birthweight 697 gm received standard 2 month vaccinations (Pediarix, HIB, Prevnar) at 0550AM on 5/20/05.  Later that AM developed a fever to 102.1 and was given tylenol 15 mg/kg every 6 hr.  The patient continued to feed well and was clincally stable for the remainder of that day.  Pt had recurrent fever at 0600 5/21 & WBC 4.6 (2 bands, 16 seg). At 0900 5/21 pt developed abdominal distension and feedings were stopped & required oxygen.  Blood cultures were drawn & Vancomycin & gentamycin were started. Pt was intubated.  At 0015 5/22 pt had a seizure and fontanel became tense.  she received a loading dose of phenobarbital 20mg/kg and a blood transfusion.  Piperacillin/tazobactam IV given.  Pt transferred to hospital at 0300 5/22/05 for evaluation of ileus/surgical abdomen and Lumbar puncture to rule out meningitis.  Per annual follow up report: Pt had late onset group B Strep meningitis which resulted in static encephalopathy and neurodevelopmental delays.  Discharge summary states diabetes Insipidis, brain syndrome, chronic, cerebral infarct, bacterial infection, hypothyroid, bradicardia, thrombocytapenia, deaf. msv  This was a concurrent GBS meningitis case. Symptoms for the meningitis developed some time as the vaccination was given.  The polt vaccination fever may have raising appropieate concern when she  became febrile. She never recovered from the meningitis. The disease left her disabled developmentally delayed. She died close to a year of age when she received viral infection.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Feeling hot, Hypokinesia, Injection site abscess, Musculoskeletal stiffness, Pain
Clinical narrative: Had significant local reaction - sterile abscess/cellulitis occurring ~10 hours after administration. Seen next am with an 11x8.5 cm left lateral/deltoid area mass that was stiff, warm, painful with decreased mobility because of pain. recommended ice pack, Benadryl, ibuprofen. Resolved by day 4.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Pain
Clinical narrative: Vaccines given on 6/22/05 and mother called on 6/23/05 reporting patient's left upper arm in the deltoid area was very red, swollen and hard.  Instructed mom to use cold compresses and tylenol or Motrin for pain.  Called mother on 6/24/2005 and mom reported arm had gotten worse on the 23rd and was now swollen from the top of the shoulder down to the elbow and was hard in the whole area.  She said it did not seem to be getting any worse that day.  Parent called on 6/29 to follow up and mom reported that it was still swollen and painful until 6/27 but now all remains is a egg size hard area around the injection site.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Hyperaesthesia, Pain, Swelling
Clinical narrative: Reported by charge nurse the above patient return because of increase swelling and redness to left thigh.  Area very warm to touch and patient complaining of pain when touched.  Having symptoms for 48 hours now.  Examined by doctor per appt.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Injection site induration, Injection site warmth, Swelling
Clinical narrative: Pt received vaccines on 6/22/2005.  On 6/23/2005 mom called reporting severe swelling and redness to the left arm deltoid area. She reported that the swelling was warm, tight, and hard and extended down to elbow.  Instructed to use cold compresses and tylenol/motrin for discomfort. Mom was worried it would get tight to the point of weeping but it never did. Called on 6/24 and she reported the arm was some better.  By 6/29 the swelling was almost all gone just some hardness remained.
Age: 1.1
Sex: M
Vaccine: HIBV, MMR, PNC, VARCEL
Symptoms: Irritability, Pyrexia, Rash
Clinical narrative: fussy, rash was noticed 6/28/2005 that got worse that am and fever treatment observation fluids and motrin
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, PNC
Symptoms: Pain, Swelling
Clinical narrative: Right leg swelling, soreness, pain  treatment ice, rest, over the counter motrin and benadryl
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Cellulitis, Erythema, Swelling, Urticaria
Clinical narrative: Starting approximately 24 hours after shots he developed a red raised hives and swollen area on left thigh it measured 13cm in diameter with an area of 5 cm in diameter of slightly pale area around the DTaP site
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Bumps on stomach and back
Age: 1.4
Sex: F
Vaccine: DTAP, MMR
Symptoms: Swelling, Urticaria
Clinical narrative: Acute onset transient hives one hour after immunization.  Administered in left leg swelling for 24 hours benedryl and tylenol with relief
Age: 0.3
Sex: M
Vaccine: DTAP
Symptoms: Hypotonia, Listless, Pyrexia
Clinical narrative: low grade temperature 100.0 F, limp listless, EKA CT scan lab normal
Age: 18.0
Sex: F
Vaccine: HEP, HEPA, MNQ
Symptoms: Fatigue, Headache, Urticaria
Clinical narrative: Headache, fatigue, urticaria
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Nausea, Urticaria, Wheezing
Clinical narrative: wheezing, hives, nausea, 5 minutes after DTaP, IPV, MMR.  Treated with Benadryl, Albuterol, Nebulized, no known allergies
Age: 1.23
Sex: M
Vaccine: VARCEL
Symptoms: Convulsion, Sudden infant death syndrome
Clinical narrative: Information has been received from a RN concerning a male who in August 1998, at 15 months old, was vaccinated with a dose of Varivax. In August 1998, one week after vaccination, at 15 months old, the child experienced a seizure. No seizure was noted prior to vaccination. Approximately one month after the seizure, 5 weeks post vaccination, in September 1998, at 16 months old, the child was found dead in his crib. The autopsy stated the cause was SIDS. Unspecified medical attention was sought. There was no product quality complaint. The reporter considered the events to be life-threatening. No additional information is expected. As per autopsy report rec'd 07/18/2005 -- remove SIDS and add Reaction unevaluable.
Age: 1.6
Sex: M
Vaccine: VARCEL
Symptoms: Pharyngitis, Pruritus, Pyrexia, Rash, Rhinitis
Clinical narrative: Information has been received from a registered nurse concerning a 39 month old healthy male who on 10/20/03 was vaccinated with the first dose of varicella virus vaccine live (lot # 642676/0421M). On 6/18/05 the patient experienced cold symptoms, low grade fever, and greater than 400-500 lesions with itching. Unspecified medical attention was sought. He was treated with Acyclovir. As of 6/18/05, the patient was reported to be recovering. The registered nurse considered the adverse experiences to be other important medical events (OMIC). Additional information has been requested.
Age: 1.6
Sex: M
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: Information has been received from a registered nurse concerning a 39 month old healthy male who on 10/20/03 was vaccinated with the first dose of varicella virus vaccine live (lot # 642676/0421M). On 6/18/05 the patient experienced cold symptoms, low grade fever, and greater than 400-500 lesions with itching. Unspecified medical attention was sought. He was treated with Acyclovir. As of 6/18/05, the patient was reported to be recovering. The registered nurse considered the adverse experiences to be other important medical events (OMIC). Additional information has been requested.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Asthenia, Diabetes mellitus, Laboratory test abnormal, Polydipsia, Vision blurred
Clinical narrative: Symptom onset of polyuria in Nov 2004; later developed polydipsia, decreased energy level, and blurred vision. Diagnosed with Type 1 Diabetes in Feb 2005. Information from follow up sent on 08/29/2005: See Enclosed medical records.
Age: 38.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Arthritis, Blood bilirubin increased, Haematuria, Laboratory test abnormal
Clinical narrative: Patient experienced polyarthralgias following receipt of his fourth anthrax vaccine. He was diagnosed with Reactive Arthritis. Has been treated with Remicade, NSAIDS< Prednisone, and MTX. Symptom: Joint pain, multiple joints. Comment: affects toes, ankles, hips, shoulders, elbows, knees, and neck.
Age: 38.0
Sex: M
Vaccine: ANTH
Symptoms: Neck pain, Shoulder pain
Clinical narrative: Patient experienced polyarthralgias following receipt of his fourth anthrax vaccine. He was diagnosed with Reactive Arthritis. Has been treated with Remicade, NSAIDS< Prednisone, and MTX. Symptom: Joint pain, multiple joints. Comment: affects toes, ankles, hips, shoulders, elbows, knees, and neck.
Age: 0.5
Sex: F
Vaccine: DT, HIBV, PNC
Symptoms: Pyrexia
Clinical narrative: Patient experienced 103 fever the night after immunization.  Continuing to 101 for another 24 hours and then all resolved.  No other symptoms.  No other signs of illness
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, IPV, MMR, DTAPHEPBIP, IPV, MMR
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever 103 and vomiting 24 hours later. Fever for 48 hours. Resolved
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP, IPV, MMR, DTAPHEPBIP, IPV, MMR
Symptoms: Incorrect dose administered, Pyrexia, Vomiting
Clinical narrative: Fever 103 and vomiting 24 hours later. Fever for 48 hours. Resolved
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema
Clinical narrative: swelling and redness noted to left deltoid
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site induration
Clinical narrative: Had an area 7.5 cm by 6.5 cm of erythema, induration, and warmth at site of DTaP injection.  This began soon after injection and increased until the visit 48 hours later
Age: 44.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: pain, redness and swelling approximately silver dollar size at injection site.  4.5 by 7cm erythemia and induration
Age: 8.0
Sex: F
Vaccine: HEP
Symptoms: Anorexia, Dysphagia, Dyspnoea, Ear disorder, Eye swelling
Clinical narrative: About 13:00 body ached, eyes started to swell, then left arm swelling, hot to touch, fever (not taken with thermometer) ears swollen (lobes) mom gave her "painkiller" and stayed in bed for two days.  No appetite.  No one else ill.  second telephone call reported difficulty swallowing and breathing and rash also.
Age: 8.0
Sex: F
Vaccine: HEP
Symptoms: Injection site swelling, Injection site warmth, Pain, Pyrexia, Rash
Clinical narrative: About 13:00 body ached, eyes started to swell, then left arm swelling, hot to touch, fever (not taken with thermometer) ears swollen (lobes) mom gave her "painkiller" and stayed in bed for two days.  No appetite.  No one else ill.  second telephone call reported difficulty swallowing and breathing and rash also.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth, Oedema peripheral
Clinical narrative: hot red swollen arm from shoulder to elbow -- took antihistamine relief in two days.  Out of town could not see doctor
Age: 1.92
Sex: F
Vaccine: HIBV, PNC
Symptoms: Erythema, Oedema, Rash
Clinical narrative: Mother called states child's left arm has a rash. Also informed water that "both legs swollen and red." Advised mother to bring child and clinic now, but left almost immediately. Follow up phone call - mother states - "rash is gone."
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Erythema, Feeling hot, Oedema
Clinical narrative: Erythema, warmth, swelling left upper arm <24 hours after  dT administered.
Age: 17.0
Sex: F
Vaccine: YF
Symptoms: Malaise, Pruritus, Rash, Stomach discomfort, Urticaria
Clinical narrative: Rash started on chest the evening of 6/28/05, we applied topical Benedryl.  She had small rash symptoms morning of 6/29/05, during the day they became progressively worse and she had hives over her chest, arms and legs, she also felt sick to her stomach. We gave her two Benedryl tablets and applied more topical Benedryl.  The hives are very itchy and the welts are large.  This morning 6/30, she still has the hives and not feeling very well.
Age: 29.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Erythema, Feeling hot, Oedema, Skin nodule
Clinical narrative: Started 6-28-05 at 6:30PM Noticed swollen, red and warm to touch area on lt . Area hard approximately 2 1/2 "
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Face oedema, Pruritus, Swelling, Tongue oedema
Clinical narrative: Patient called 06-28-2005 stating her tongue was swollen.  She sought no medical treatment.  I spoke with patient on 6-30-2005; she stated in retrospect that there was some circumoral itching on 06-25-05 and then left facial and mouth swelling.  She took a Benadryl and the symptoms resolved.
Age: 1.03
Sex: M
Vaccine: HEP, IPV, MMR, VARCEL
Symptoms: Crying, Lethargy, Pain, Weight decreased
Clinical narrative: pt lethargic, not playful, crying excessively. not eating well has had a 1lb 8 oz weight loss since vaccine was administered.  pt is also holding his head as if he was in pain.
Age: 47.0
Sex: F
Vaccine: MMR
Symptoms: Difficulty in walking, Joint stiffness, Joint swelling, Lymphadenopathy, Rash morbilliform
Clinical narrative: My symptoms came 12 days after my shot from the MMR. I first had swelling in my neck glands, then had a Measles rash on my face and back. Swelling and stiffness in the joints on my legs, groin and wrist, I could hardly walk for two days. I went to the doctor and he confimed I had a reaction to the MMR shot, so he gave me a cortisone shot.
Age: 27.0
Sex: F
Vaccine: TD
Symptoms: Coordination abnormal, Dehydration, Dizziness
Clinical narrative: "Dizzy spells, loss of coordination had about a week after shot.  Had an I.V. for possible dehydration.  Had seizures and temp when a baby to a DTP vaccine." Per patient' written statement.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site swelling
Clinical narrative: Red raised area at right deltoid IM site that measured 6cmx6cm.
Age: 23.0
Sex: M
Vaccine: SMALL, TYP
Symptoms: Pericarditis
Clinical narrative: ACUTE PERICARDITIS, TRANSFERRED TO MEDICAL CENTER.
Age: 0.35
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Eye disorder, Lethargy, Pallor, Pyrexia, Somnolence
Clinical narrative: Pale, lethargic, eyes dysconjugate, fever in the first 6 hours and very quiet over the next 24 - 36 hours.
Age: 1.26
Sex: M
Vaccine: DTAPH, IPV
Symptoms: Abnormal behaviour, Antisocial behaviour, Autism, Drug toxicity, Speech disorder
Clinical narrative: At age 16 months (February 2003):  Had Rotovirus.  Lost all previously acquired speech.  Lost ability to point, clap hands, and wave goodbye.  Stopped referencing parents for cues.  Lost all joint attention skills.  Lost interest in peers.  Stopped responding to name.  Lost ability to maintain even minimal eye contact.  In months following this regression:  Began playing repetitively with toys (or parts of toys) and engaging in perseverative play.  Began arm/hand flapping.  Would "zone out" and not seem to hear, see, or notice the world around him.  Began to actively avoid peers.  Began having tantrums over slight changes in routine.  Began having difficulty adapting to new places.  Began early intervention with school district (speech and occupational therapy) at age 20 months.  To date (6/30/2005), the only one of the lost skills that has been reacquired is clapping.  The only maladaptive behavior that has diminished is arm/hand flapping.  PLEASE NOTE:  I do not believe it was only the last batch of vaccinations (1/14/2003) received prior to the onset of symptoms in February 2003 that caused the heavy metal toxicity, but rather a build up of all the thimerosal-containing vaccinations he'd received since birth building up to a toxic "tipping" point that occurred in February 2003.  Your form does not allow for entry of this phenomena, so I've done the best I could given your form's parameters. Diagnosis from Medical Record rec'd on 07/25/2005 is autism.
Age: 1.3
Sex: M
Vaccine: DTAP
Symptoms: Autism, Neurodevelopmental disorder
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of autism in a 2 year old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed vaccine for prophylaxis. The subject's medical history included some developmental delay. Previous and/or concurrent vaccination included Haemophilus influenzae type B vaccine; hepatitis B vaccine, inactivated poliomyelitis vaccine, MMR, varicella virus vaccine, and 7-valent conjugate pneumococcal vaccine. On 1/16/03, 3/17/03, 6/2/03, and 3/2/04, the subject received four doses of diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed vaccine. The following lot numbers were provided (lot DTaP57B9, DTaP583B2, and DTaP592A9); however no specific date of administration of each was provided. Approximately eight months later, on an unspecified date in November 2004, the subject was diagnosed with autism. This case was assessed as medically serious (OMIC). At the time of reporting the event was unresolved.
Age: 1.01
Sex: M
Vaccine: PNC, VARCEL
Symptoms: Pyrexia, Rash macular
Clinical narrative: Fever to 6 days after injection and blanchy macular rash.
Age: 4.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Injection site oedema, Injection site pain, Pyrexia
Clinical narrative: Left arm with local swelling, pain, high fever.
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Cyanosis, Lethargy, Pallor
Clinical narrative: Became gray with lips blue. Acted lethargic but not sloppy. Episode lasted about 5 minutes.
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, DTAPHEPBIP, HIBV, PNC
Symptoms: Cyanosis, Lethargy, Pallor, Vomiting
Clinical narrative: Became gray with lips blue. Acted lethargic but not sloppy. Episode lasted about 5 minutes.
Age: 1.03
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: Allergic reaction to vaccines given on 6/21/2005 (suspect Varivax). Office visit on 6/22/2005, red raised urticarial ring like rash bottom thighs, left arm where Varivax given.
Age: 15.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site reaction, Pruritus
Clinical narrative: According to pt, had edema, redness and itching at the site of vaccination.
Age: 0.7
Sex: F
Vaccine: DTAP, IPV, PNC
Symptoms: Hypokinesia, Irritability, Pyrexia
Clinical narrative: Fever all night, up to 104.7 Axillary, decreased activity level, cranky but consolable.
Age: 1.24
Sex: M
Vaccine: MMR, PNC, PNC
Symptoms: Abnormal behaviour, Autism, Diarrhoea, Laboratory test abnormal, Pyrexia
Clinical narrative: This case was considered medically important (OMIC). Information regarding Prevnar was received from a mother regarding her 4 year old son who experienced autism, child given 3 doses of vaccine at over 15 months of age. At 15 months of age, the patient received the first dose in January 2002. Relevant medical history was not provided. The indication for Prevnar was immunization. The product was administered in January 2002. Dose regimen was 1 dose 1 time per day (IM). Additional suspect medication included Comvax, Varicella Virus Vaccine Live, Poliomyelitis vaccine inactivated, and Diphtheria and Tetanus Toxoids and Pertussis, Hepatitis B Vaccine, and Haemophilus B conjugate vaccine.  Concomitant medications were not reported. In January 2002, at 15 months of age, the child received his first dose of Prevnar. Sometime that same month, the child began to show traits of autism. In April 2002, he received his second dose of Prevnar. According to the reporter, the child was medically diagnosed with autism in September 2002. In October 2002, a third dose of Prevnar was administered (inappropriate schedule of drug administration). Information regarding this report has been forwarded to the manufacturer of Comvax. No additional information was available at the time of this report.
Age: 1.24
Sex: M
Vaccine: MMR, PNC, PNC
Symptoms: Rash, Speech disorder, Viral infection
Clinical narrative: This case was considered medically important (OMIC). Information regarding Prevnar was received from a mother regarding her 4 year old son who experienced autism, child given 3 doses of vaccine at over 15 months of age. At 15 months of age, the patient received the first dose in January 2002. Relevant medical history was not provided. The indication for Prevnar was immunization. The product was administered in January 2002. Dose regimen was 1 dose 1 time per day (IM). Additional suspect medication included Comvax, Varicella Virus Vaccine Live, Poliomyelitis vaccine inactivated, and Diphtheria and Tetanus Toxoids and Pertussis, Hepatitis B Vaccine, and Haemophilus B conjugate vaccine.  Concomitant medications were not reported. In January 2002, at 15 months of age, the child received his first dose of Prevnar. Sometime that same month, the child began to show traits of autism. In April 2002, he received his second dose of Prevnar. According to the reporter, the child was medically diagnosed with autism in September 2002. In October 2002, a third dose of Prevnar was administered (inappropriate schedule of drug administration). Information regarding this report has been forwarded to the manufacturer of Comvax. No additional information was available at the time of this report.
Age: 1.24
Sex: M
Vaccine: MMR, PNC, PNC
Symptoms: Autism, Medication error, Overdose
Clinical narrative: This case was considered medically important (OMIC). Information regarding Prevnar was received from a mother regarding her 4 year old son who experienced autism, child given 3 doses of vaccine at over 15 months of age. At 15 months of age, the patient received the first dose in January 2002. Relevant medical history was not provided. The indication for Prevnar was immunization. The product was administered in January 2002. Dose regimen was 1 dose 1 time per day (IM). Additional suspect medication included Comvax, Varicella Virus Vaccine Live, Poliomyelitis vaccine inactivated, and Diphtheria and Tetanus Toxoids and Pertussis, Hepatitis B Vaccine, and Haemophilus B conjugate vaccine.  Concomitant medications were not reported. In January 2002, at 15 months of age, the child received his first dose of Prevnar. Sometime that same month, the child began to show traits of autism. In April 2002, he received his second dose of Prevnar. According to the reporter, the child was medically diagnosed with autism in September 2002. In October 2002, a third dose of Prevnar was administered (inappropriate schedule of drug administration). Information regarding this report has been forwarded to the manufacturer of Comvax. No additional information was available at the time of this report.
Age: 40.0
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Chills, Headache, Heart rate increased, Myalgia, Pyrexia
Clinical narrative: This case was reported by a nurse and described the occurrence of heart palpitations in a 40 year old male pt who received Twinrix injection. On 3/29/05, the pt received the 1st dose of Twinrix (lot AHABB012AA). At an unspecified time following the 1st administration of Twinrix, on 3/19/05, the pt experienced heart palpitation, chills and a fever of 102.5F. The immunization series with Twinrix was discontinued. The heart palpitations and chills resolved on an unspecified date on or before 4/1/05. The fever resolved on an unspecified date after 4/1/05 and on or before 5/4/05.
Age: 40.0
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Palpitations, Pyrexia, Weight decreased
Clinical narrative: This case was reported by a nurse and described the occurrence of heart palpitations in a 40 year old male pt who received Twinrix injection. On 3/29/05, the pt received the 1st dose of Twinrix (lot AHABB012AA). At an unspecified time following the 1st administration of Twinrix, on 3/19/05, the pt experienced heart palpitation, chills and a fever of 102.5F. The immunization series with Twinrix was discontinued. The heart palpitations and chills resolved on an unspecified date on or before 4/1/05. The fever resolved on an unspecified date after 4/1/05 and on or before 5/4/05.
Age: 30.0
Sex: F
Vaccine: HEPAB, MMR, TTOX, HEPAB, MMR, TTOX
Symptoms: Alopecia, Pruritus
Clinical narrative: This case was reported by a consumer and described the occurence of hair loss in a 30 year old female patient who received hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix).  The reporter is the patient.  A physician or other health care professional has not verified this report.  On 06/21/2004, the patient received the first dose of Twinrix.  On 06/21/2004, the patient also received injections of measles, mumps and rubella virus vaccine (MMR II, Merck) and tetanus toxoid absorbed.  Approximately seven days following the first administration of Twinrix, on 06/28/2004, the patient experienced hair loss and itching.  The patient was seen at a physician's office and was treated with corticosteroids and desloratadine.  The hair loss continued.  The itching improved.  On 07/23/2004, the patient received the second dose of Twinrix.  The patient reported that the hair loss continued following the second dose of Twinrix.  The patient declined to grant authority to GSK to contact her physician, therefore no further information will be available.
Age: 1.06
Sex: F
Vaccine: DTAP, MMR, VARCEL, DTAP, MMR, VARCEL
Symptoms: Periorbital oedema, Rash papular
Clinical narrative: Diffuse papular rash, peri-oral edema.
Age: 1.06
Sex: F
Vaccine: DTAP, MMR, VARCEL, DTAP, MMR, VARCEL
Symptoms: Oedema, Rash papular
Clinical narrative: Diffuse papular rash, peri-oral edema.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site oedema, Injection site pain
Clinical narrative: Pain, Swelling, and erythema 8cm.
Age: 0.15
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Discomfort, Injection site erythema
Clinical narrative: Child healthy with no complaints? 1: 06/27/2005 2  month vaccine provided. ? Started- fever and rest. all Redened over discomfort. No clinical TX.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site oedema, Pruritus
Clinical narrative: Swollen where the shot was given.  Redness appearing noted once yesterday.  Itche but not painful.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, DTAP, IPV, MMR
Symptoms: Erythema, Injection site swelling, Pruritus
Clinical narrative: Swollen where the shot was given.  Redness appearing noted once yesterday.  Itche but not painful.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site hypersensitivity, Injection site oedema
Clinical narrative: 06/17- 9:30 AM.  Swelling, redness (2-3) at injection site limited mobility, started ice, elevation and Advil. 06/17-8:00 swelling and redness worse (4-5") Started Benadryl. 06/18/05-12:00 PM Went to walk in clinic, swelling and redness worse measured 14x18cm. RX for Keflex 500mg 2 capsules BID and Zyrtec QD.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Headache, Malaise, Myalgia, Pyrexia
Clinical narrative: Febrile reaction 101.6 started 24 hr after injeciton. Required alternate of Tylenol and Ibuprofen x24 hours. Then 48 hours of Tylenol and Ibuprofen x 24 hours. Then 48 hours of malaise. 99.6 Sx Myalgia, mailaise, slight head ache.
Age: 18.0
Sex: M
Vaccine: MNQ, TD
Symptoms: Myalgia, Pyrexia
Clinical narrative: 24 hour Fever 101.8 max. Myalgia.
Age: 11.0
Sex: F
Vaccine: TD
Symptoms: Confusional state, Disorientation, Loss of consciousness, Musculoskeletal stiffness, Skin discolouration
Clinical narrative: Child fainted for 30 seconds and was stiff. No vomiting, did lose control of bladder in fact but she was pale and slightly disorientated, confused for 30 seconds.
Age: 11.0
Sex: F
Vaccine: TD
Symptoms: Urinary retention, Vomiting
Clinical narrative: Child fainted for 30 seconds and was stiff. No vomiting, did lose control of bladder in fact but she was pale and slightly disorientated, confused for 30 seconds.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Agitation, Anaemia, Apnoea, Autism, Cerebral ischaemia
Clinical narrative: Status epilepticus within 24 hrs of vaccines, coma 5 days, second episode of status epilepticus regressed to infantile state. Has fine motor skill impairment, speech delayed, he had to learn to walk again, was toilet trained. Per review of discharge summary on 7/28/05, additional symptoms included anoxic brain injury, nonpruritic rash, apnea, unable to talk, anemia, agitation, mild R eye ptosis, and poor visual tracking.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Coma, Convulsion, Encephalopathy, Epilepsy, Eyelid ptosis
Clinical narrative: Status epilepticus within 24 hrs of vaccines, coma 5 days, second episode of status epilepticus regressed to infantile state. Has fine motor skill impairment, speech delayed, he had to learn to walk again, was toilet trained. Per review of discharge summary on 7/28/05, additional symptoms included anoxic brain injury, nonpruritic rash, apnea, unable to talk, anemia, agitation, mild R eye ptosis, and poor visual tracking.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Hypokinesia, Mental retardation severity unspecified, Rash, Speech disorder, Visual disturbance
Clinical narrative: Status epilepticus within 24 hrs of vaccines, coma 5 days, second episode of status epilepticus regressed to infantile state. Has fine motor skill impairment, speech delayed, he had to learn to walk again, was toilet trained. Per review of discharge summary on 7/28/05, additional symptoms included anoxic brain injury, nonpruritic rash, apnea, unable to talk, anemia, agitation, mild R eye ptosis, and poor visual tracking.
Age: 2.0
Sex: M
Vaccine: HEP, MMR, VARCEL, HEP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site hypersensitivity, Urticaria
Clinical narrative: Immediate localized Rxc welts, at site, redness approximately 4" in diameter. Hep B also given in L leg IM no rxn. MMr given RL- slight redness at inject site. However, not as dramatic as varivax rxn.
Age: 2.0
Sex: M
Vaccine: HEP, MMR, VARCEL, HEP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: Immediate localized Rxc welts, at site, redness approximately 4" in diameter. Hep B also given in L leg IM no rxn. MMr given RL- slight redness at inject site. However, not as dramatic as varivax rxn.
Age: 8.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Erythema, Injection site induration
Clinical narrative: 8by7 cm area of erythema and slight induration in right thigh (large local reactions vs cellulitis)
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Arthritis, Rheumatoid arthritis
Clinical narrative: Diagnosed by husband (a physician) as acute inflammatory arthritis secondary to HBV.  Also seeing another physician.  Patient placed on Prednisone for seven days, felt better for several days.  Now back on Predisone as of 6/23/2005 due to pain in all fronts
Age: 6.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Feeling hot, Pruritus
Clinical narrative: Varivax given 06/09/2005 in left thigh.  Patient came in on 06/24/2005 still had a red spot on left thigh was itchy and warm seems to be resolving no other symptoms, no fever.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: Given IPOL vaccination in left thigh on 5/26 on 5/27 went to ER with redness warmth at site low grade fever symptoms resolved in 2 days
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Saturday 6/18/205 site became red, swollen, and warm to the touch - compresses were used
Age: 69.0
Sex: F
Vaccine: PPV, TD
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, pain, redness elbow to shoulder and 3-4 inches across upper back
Age: 5.0
Sex: M
Vaccine: DTAP, MEN
Symptoms: Cellulitis, Erythema, Injection site swelling, Pyrexia
Clinical narrative: Temperature to 104.9 despite tylenol and ibuprophen normal 98.9 post injection right anterior thigh swollen erythematus fever continued for second day cellulitis treated with Amoxicilin 250 TID 5 days
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Erythema, Injection site induration
Clinical narrative: 8.5 by 6cm of erythema and slight induration left anterior tigh (large local reaction)
Age: 0.4
Sex: F
Vaccine: PNC
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: fever 102, small bump and swelling to the site.  Home treatment - normal vaccine reaction
Age: 4.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: Raised red area around injection site 6 inches by 2 inches warm to touch, low grade fever (99.6)
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site warmth, Pyrexia
Clinical narrative: Left deltoid swollen, red and warm to touch.  No fever or any other symptoms.  Hard knot on the arm Patient taken to ER and ABTX prescribed.  Arm symptoms improved.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Feeling hot, Injection site erythema, Injection site swelling, Pain, Pyrexia
Clinical narrative: Adverse reaction in form of swelling, redness, warmth R upper deltoid and fever 102.2 oral. Inoculations given at 10:00 on 06/14/2005. Swelling, pain and temperature 7 hours later. Recovering. The Stanislaus Co Public Health Dept, Immunization Unit, received this report via mail from one of our county clinics. I am forwarding this to you for your review and consideration. Please disregard if your department has already received this report.
Age: 29.0
Sex: F
Vaccine: MMR
Symptoms: Lymphadenopathy, Rash
Clinical narrative: Received vaccine MMR 8/9/04. About 8/16/04 or 8/20/04 began to have rash on neck and swelling of glands back of neck. Now, does not want to take second MMR. Measles titer to be drawn. Never was checked by MD; took Claritin.
Age: 5.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Feeling hot, Injection site reaction
Clinical narrative: Local reaction to DTAP warm to touch. Benadryl dye free.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Feeling hot, Injection site erythema
Clinical narrative: Red and hot to touch on left leg. Treatment: Local care, warm soaks, Benadryl 1 tsp every 4-6 hours.
Age: 1.05
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Feeling hot, Rash
Clinical narrative: Pt received MMR,Varicella and PPD on 6/27/05. Pt grandmother called morning of 7/1/05 to report a rash over face of approximately 20 pin point/heat rash type bumps on face.  Felt warm on 6/29/05.  No treatment was necessary.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Right arm swelling noted about 40 hours after MMR vaccine administered subcutaneously.  Patient alsot received DTap and IPV in left (unaffected) arm.  Had fever to 102 day after vaccines, but now gone on day of evaluation.  Right upper extremity between antecub fossa and deltoid muscle noted to be red, warm, indurated, and slightly tender to touch.  No clear edge of erythema, no crust or exudate.  Patient with full range of motion of arm.  Clinically well appearing and playful.  Treated with Keflex liquid 375 mg TID for 7 days.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Tenderness
Clinical narrative: Right arm swelling noted about 40 hours after MMR vaccine administered subcutaneously.  Patient alsot received DTap and IPV in left (unaffected) arm.  Had fever to 102 day after vaccines, but now gone on day of evaluation.  Right upper extremity between antecub fossa and deltoid muscle noted to be red, warm, indurated, and slightly tender to touch.  No clear edge of erythema, no crust or exudate.  Patient with full range of motion of arm.  Clinically well appearing and playful.  Treated with Keflex liquid 375 mg TID for 7 days.
Sex: M
Vaccine: HIBV, PNC
Symptoms: Autism
Clinical narrative: This case was considered medically important (OMIC). Information regarding Prevnar was received from a healthcare professional via a manufacturer (A0560864A) regarding a 24 month old male patient who was diagnosed with autism. The patient received a dose in 2005. The patient previously experienced no reaction on previous exposure to drug while taking Engerix B. Indication for Prevnar was immunization. Product was administered in 2005. Dose regimen was 1 dose. Additional suspect medication included Haemophilus influenzae type B, Tripedia, Infanrix, and Engerix B. Concomitant medications were not reported. A physician reported that the patient was diagnosed with autism on an unspecified date in 2005 (on or before 5/26/05). No additional information was available at the time of this report.
Sex: M
Vaccine: HIBV
Symptoms: Autism
Clinical narrative: This case was considered medically important (OMIC). Information regarding Hib-Titer Vaccine was received from mother regarding an 18 month old son who experienced autism. The patient received the third dose on an unspecified date. Relevant medical history was not provided. Indication for Hib-Titer Vaccine was immunization. Product was administered on an unknown date. Dose regimen was 1 dose 1 time per day. Additional suspect medication included Acel-Imune Vaccine and Tetanus Toxoid Absorbed, Purogenated. Concomitant medications were not reported. The mother reported that her son was diagnosed with autism sometime in 2002 at 18 months of age. No additional information was available at the time of this report.
Age: 0.57
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Convulsion, Pyrexia
Clinical narrative: High fever/seizures. Transported to hospital.
Age: 1.14
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Joint range of motion decreased, Pruritus, Pyrexia, Rash
Clinical narrative: Low grade temp ever since immu 6/20. 6/23 developed       of ROM RDT, rash spread over R       , none on face or trunk plus pruritis           .
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Pyrexia
Clinical narrative: Fever on and off, up to 104 for 3 weeks. No localizing symptoms. Work-up pending. Referred to Peds.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: L arm swelling and redness on 6/15/05. Was very swollen and red and has been slowly getting better.
Age: 1.02
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pharyngitis, Rash vesicular, Rhinitis
Clinical narrative: Infant developed chicken pox rash on 6/29/05. Infant had cold-like symptoms prior to rash.
Age: 33.0
Sex: M
Vaccine: HEPAB
Symptoms: Rash
Clinical narrative: This case was reported by a physician and described the occurrence of rash in a 32 year old male patient who received hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix).  Concurrent medication included Clonazepam.  On 03/16/2004, the patient received the first dose of Twinrix (lot HAB016; incomplete lot number).  On 05/25/2004, the patient received the second dose of Twinrix (lot HAB306B6).  This represents an interval of 10 weeks between the first and second dose of Twinrix, rather than the recommended interval of one month.  Approximately 13 days after the administration of the second dose of Twinrix, on 06/07/2004, the patient experienced a rash.  The patient was treated with diphenhydramine hydrochloride and topical caladryl.  The outcome of the rash is unknown.  The immunization series with Twinrix was discontinued.  The reporting physician considered the events to possibly be related to vaccination with Twinrix.
Sex: U
Vaccine: HEPAB
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a physician to a sales representative and described a patient who did not respond to the Hepatitis A component of immunization with Hepatitis A inactivated and Hepatitis B recombinant vaccine (Twinrix).  The physician reported that approximately 30 patients did not respond to the Hepatitis A component of Twinrix, however, identifiers were not provided.  On an unspecified date, the patient completed the Twinrix immunization series.  Subsequently, on an unspecified date, a Hepatitis A antibody titer indicated that the patient was non-immune.
Sex: F
Vaccine: HEPAB
Symptoms: Drug ineffective
Clinical narrative: This case was reported by a nurse to a sales representative and described a female patient who received hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix) and subsequently tested positive for hepatitis A antibodies.  On an unspecified date in February 2004, the patient received the first dose of Twinrix.  Approximately one month after the administration of Twinrix, on an unspecified date in March 2004, the patient was anti-hepatitis A positive.
Age: 36.0
Sex: M
Vaccine: HEPAB
Symptoms: Alanine aminotransferase increased
Clinical narrative: This case was reported by a physician and described the occurrence of elevated serum glutamate pyruvate transaminase in a 36 year old male patient who received hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix).  The patient's medical history includes asthma.  On 09/10/2003 the patient received a dose of Twinrix (dose number one and lot number HAB239A4).  One year later, in September 2004, the patient experienced elevated serum glutamate pyruvate transaminase.  This case was assessed as medically serious by GSK.  the outcome of the event is unknown.