chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Laboratory test abnormal, Pyrexia, White blood cell count increased
Clinical narrative: A nurse reported that a 4 month old female received injections of Prevnar, Infanrix, Comvax and IPV vaccines on 11/28/01. The next day, the infant experienced a seizure and a fever of 105F. She was taken to the ER. As of 11/30/01, she was improving. The seizure was considered to be "Medically Important". Cancelled: This report has been determined to be a duplicate of report HQ9598719DEC2001. This case was reactivated upon receipt of follow-up info on 3/4/02. A physician reported that the infant may have had an infectious illness at the time of IZ's but was asymptomatic when the vaccines were administered. On 11/30/01, 2 days post vax, the infant experienced diarrhea, seizures, eye deviation and a fever of 104F. She was taken to the ER. She was treated with lorazepam, phenytoin and ceftriaxone. The infant was transferred to a tertiary care center where she was hospitalized for an unspecified period of time. All events resolved by 12/1/01. The immunizing physician considered these events to be possibly related to Infanrix administration and possibly related to the infectious illness. This is 1 of 2 infants from this facility who experienced a seizure and fever following receipt of Prevnar. See related report HQ9598719DEC2001.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Convulsion, Diarrhoea, Hypernatraemia, Hypoglycaemia, Laboratory test abnormal
Clinical narrative: A nurse reported that a 4 month old female received injections of Prevnar, Infanrix, Comvax and IPV vaccines on 11/28/01. The next day, the infant experienced a seizure and a fever of 105F. She was taken to the ER. As of 11/30/01, she was improving. The seizure was considered to be "Medically Important". Cancelled: This report has been determined to be a duplicate of report HQ9598719DEC2001. This case was reactivated upon receipt of follow-up info on 3/4/02. A physician reported that the infant may have had an infectious illness at the time of IZ's but was asymptomatic when the vaccines were administered. On 11/30/01, 2 days post vax, the infant experienced diarrhea, seizures, eye deviation and a fever of 104F. She was taken to the ER. She was treated with lorazepam, phenytoin and ceftriaxone. The infant was transferred to a tertiary care center where she was hospitalized for an unspecified period of time. All events resolved by 12/1/01. The immunizing physician considered these events to be possibly related to Infanrix administration and possibly related to the infectious illness. This is 1 of 2 infants from this facility who experienced a seizure and fever following receipt of Prevnar. See related report HQ9598719DEC2001.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Pyrexia, White blood cell count increased
Clinical narrative: A nurse reported that a 4 month old female received injections of Prevnar, Infanrix, Comvax and IPV vaccines on 11/28/01. The next day, the infant experienced a seizure and a fever of 105F. She was taken to the ER. As of 11/30/01, she was improving. The seizure was considered to be "Medically Important". Cancelled: This report has been determined to be a duplicate of report HQ9598719DEC2001. This case was reactivated upon receipt of follow-up info on 3/4/02. A physician reported that the infant may have had an infectious illness at the time of IZ's but was asymptomatic when the vaccines were administered. On 11/30/01, 2 days post vax, the infant experienced diarrhea, seizures, eye deviation and a fever of 104F. She was taken to the ER. She was treated with lorazepam, phenytoin and ceftriaxone. The infant was transferred to a tertiary care center where she was hospitalized for an unspecified period of time. All events resolved by 12/1/01. The immunizing physician considered these events to be possibly related to Infanrix administration and possibly related to the infectious illness. This is 1 of 2 infants from this facility who experienced a seizure and fever following receipt of Prevnar. See related report HQ9598719DEC2001.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Convulsion, Diarrhoea, Hypernatraemia, Hyperventilation, Hypoglycaemia
Clinical narrative: A nurse reported that a 4 month old female received injections of Prevnar, Infanrix, Comvax and IPV vaccines on 11/28/01. The next day, the infant experienced a seizure and a fever of 105F. She was taken to the ER. As of 11/30/01, she was improving. The seizure was considered to be "Medically Important". Cancelled: This report has been determined to be a duplicate of report HQ9598719DEC2001. This case was reactivated upon receipt of follow-up info on 3/4/02. A physician reported that the infant may have had an infectious illness at the time of IZ's but was asymptomatic when the vaccines were administered. On 11/30/01, 2 days post vax, the infant experienced diarrhea, seizures, eye deviation and a fever of 104F. She was taken to the ER. She was treated with lorazepam, phenytoin and ceftriaxone. The infant was transferred to a tertiary care center where she was hospitalized for an unspecified period of time. All events resolved by 12/1/01. The immunizing physician considered these events to be possibly related to Infanrix administration and possibly related to the infectious illness. This is 1 of 2 infants from this facility who experienced a seizure and fever following receipt of Prevnar. See related report HQ9598719DEC2001.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Hyponatraemia, Ketosis, Laboratory test abnormal, Pyrexia, Tachycardia
Clinical narrative: A nurse reported that a 4 month old female received injections of Prevnar, Infanrix, Comvax and IPV vaccines on 11/28/01. The next day, the infant experienced a seizure and a fever of 105F. She was taken to the ER. As of 11/30/01, she was improving. The seizure was considered to be "Medically Important". Cancelled: This report has been determined to be a duplicate of report HQ9598719DEC2001. This case was reactivated upon receipt of follow-up info on 3/4/02. A physician reported that the infant may have had an infectious illness at the time of IZ's but was asymptomatic when the vaccines were administered. On 11/30/01, 2 days post vax, the infant experienced diarrhea, seizures, eye deviation and a fever of 104F. She was taken to the ER. She was treated with lorazepam, phenytoin and ceftriaxone. The infant was transferred to a tertiary care center where she was hospitalized for an unspecified period of time. All events resolved by 12/1/01. The immunizing physician considered these events to be possibly related to Infanrix administration and possibly related to the infectious illness. This is 1 of 2 infants from this facility who experienced a seizure and fever following receipt of Prevnar. See related report HQ9598719DEC2001.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Vomiting, White blood cell count increased
Clinical narrative: A nurse reported that a 4 month old female received injections of Prevnar, Infanrix, Comvax and IPV vaccines on 11/28/01. The next day, the infant experienced a seizure and a fever of 105F. She was taken to the ER. As of 11/30/01, she was improving. The seizure was considered to be "Medically Important". Cancelled: This report has been determined to be a duplicate of report HQ9598719DEC2001. This case was reactivated upon receipt of follow-up info on 3/4/02. A physician reported that the infant may have had an infectious illness at the time of IZ's but was asymptomatic when the vaccines were administered. On 11/30/01, 2 days post vax, the infant experienced diarrhea, seizures, eye deviation and a fever of 104F. She was taken to the ER. She was treated with lorazepam, phenytoin and ceftriaxone. The infant was transferred to a tertiary care center where she was hospitalized for an unspecified period of time. All events resolved by 12/1/01. The immunizing physician considered these events to be possibly related to Infanrix administration and possibly related to the infectious illness. This is 1 of 2 infants from this facility who experienced a seizure and fever following receipt of Prevnar. See related report HQ9598719DEC2001.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Blood urea increased, Convulsion, Diarrhoea, Hyperchloraemia, Hypernatraemia
Clinical narrative: A nurse reported that a 4 month old female received injections of Prevnar, Infanrix, Comvax and IPV vaccines on 11/28/01. The next day, the infant experienced a seizure and a fever of 105F. She was taken to the ER. As of 11/30/01, she was improving. The seizure was considered to be "Medically Important". Cancelled: This report has been determined to be a duplicate of report HQ9598719DEC2001. This case was reactivated upon receipt of follow-up info on 3/4/02. A physician reported that the infant may have had an infectious illness at the time of IZ's but was asymptomatic when the vaccines were administered. On 11/30/01, 2 days post vax, the infant experienced diarrhea, seizures, eye deviation and a fever of 104F. She was taken to the ER. She was treated with lorazepam, phenytoin and ceftriaxone. The infant was transferred to a tertiary care center where she was hospitalized for an unspecified period of time. All events resolved by 12/1/01. The immunizing physician considered these events to be possibly related to Infanrix administration and possibly related to the infectious illness. This is 1 of 2 infants from this facility who experienced a seizure and fever following receipt of Prevnar. See related report HQ9598719DEC2001.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Hypoglycaemia, Platelet count increased, Pyrexia, Strabismus, White blood cell count increased
Clinical narrative: A nurse reported that a 4 month old female received injections of Prevnar, Infanrix, Comvax and IPV vaccines on 11/28/01. The next day, the infant experienced a seizure and a fever of 105F. She was taken to the ER. As of 11/30/01, she was improving. The seizure was considered to be "Medically Important". Cancelled: This report has been determined to be a duplicate of report HQ9598719DEC2001. This case was reactivated upon receipt of follow-up info on 3/4/02. A physician reported that the infant may have had an infectious illness at the time of IZ's but was asymptomatic when the vaccines were administered. On 11/30/01, 2 days post vax, the infant experienced diarrhea, seizures, eye deviation and a fever of 104F. She was taken to the ER. She was treated with lorazepam, phenytoin and ceftriaxone. The infant was transferred to a tertiary care center where she was hospitalized for an unspecified period of time. All events resolved by 12/1/01. The immunizing physician considered these events to be possibly related to Infanrix administration and possibly related to the infectious illness. This is 1 of 2 infants from this facility who experienced a seizure and fever following receipt of Prevnar. See related report HQ9598719DEC2001.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Convulsion, Dyskinesia, Eye movement disorder, Pyrexia
Clinical narrative: A nurse reported that a 4 month old female received injections of Prevnar, Infanrix, Comvax and IPV vaccines on 11/28/01. The next day, the infant experienced a seizure and a fever of 105F. She was taken to the ER. As of 11/30/01, she was improving. The seizure was considered to be "Medically Important". Cancelled: This report has been determined to be a duplicate of report HQ9598719DEC2001. This case was reactivated upon receipt of follow-up info on 3/4/02. A physician reported that the infant may have had an infectious illness at the time of IZ's but was asymptomatic when the vaccines were administered. On 11/30/01, 2 days post vax, the infant experienced diarrhea, seizures, eye deviation and a fever of 104F. She was taken to the ER. She was treated with lorazepam, phenytoin and ceftriaxone. The infant was transferred to a tertiary care center where she was hospitalized for an unspecified period of time. All events resolved by 12/1/01. The immunizing physician considered these events to be possibly related to Infanrix administration and possibly related to the infectious illness. This is 1 of 2 infants from this facility who experienced a seizure and fever following receipt of Prevnar. See related report HQ9598719DEC2001.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Convulsion, Diarrhoea, Dyskinesia, Eye movement disorder, Pyrexia
Clinical narrative: A nurse reported that a 4 month old female received injections of Prevnar, Infanrix, Comvax and IPV vaccines on 11/28/01. The next day, the infant experienced a seizure and a fever of 105F. She was taken to the ER. As of 11/30/01, she was improving. The seizure was considered to be "Medically Important". Cancelled: This report has been determined to be a duplicate of report HQ9598719DEC2001. This case was reactivated upon receipt of follow-up info on 3/4/02. A physician reported that the infant may have had an infectious illness at the time of IZ's but was asymptomatic when the vaccines were administered. On 11/30/01, 2 days post vax, the infant experienced diarrhea, seizures, eye deviation and a fever of 104F. She was taken to the ER. She was treated with lorazepam, phenytoin and ceftriaxone. The infant was transferred to a tertiary care center where she was hospitalized for an unspecified period of time. All events resolved by 12/1/01. The immunizing physician considered these events to be possibly related to Infanrix administration and possibly related to the infectious illness. This is 1 of 2 infants from this facility who experienced a seizure and fever following receipt of Prevnar. See related report HQ9598719DEC2001.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Dyskinesia, Eye movement disorder, Pyrexia
Clinical narrative: A nurse reported that a 4 month old female received injections of Prevnar, Infanrix, Comvax and IPV vaccines on 11/28/01. The next day, the infant experienced a seizure and a fever of 105F. She was taken to the ER. As of 11/30/01, she was improving. The seizure was considered to be "Medically Important". Cancelled: This report has been determined to be a duplicate of report HQ9598719DEC2001. This case was reactivated upon receipt of follow-up info on 3/4/02. A physician reported that the infant may have had an infectious illness at the time of IZ's but was asymptomatic when the vaccines were administered. On 11/30/01, 2 days post vax, the infant experienced diarrhea, seizures, eye deviation and a fever of 104F. She was taken to the ER. She was treated with lorazepam, phenytoin and ceftriaxone. The infant was transferred to a tertiary care center where she was hospitalized for an unspecified period of time. All events resolved by 12/1/01. The immunizing physician considered these events to be possibly related to Infanrix administration and possibly related to the infectious illness. This is 1 of 2 infants from this facility who experienced a seizure and fever following receipt of Prevnar. See related report HQ9598719DEC2001.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Convulsion, Pyrexia
Clinical narrative: A nurse reported that a 4 month old female received injections of Prevnar, Infanrix, Comvax and IPV vaccines on 11/28/01. The next day, the infant experienced a seizure and a fever of 105F. She was taken to the ER. As of 11/30/01, she was improving. The seizure was considered to be "Medically Important". Cancelled: This report has been determined to be a duplicate of report HQ9598719DEC2001. This case was reactivated upon receipt of follow-up info on 3/4/02. A physician reported that the infant may have had an infectious illness at the time of IZ's but was asymptomatic when the vaccines were administered. On 11/30/01, 2 days post vax, the infant experienced diarrhea, seizures, eye deviation and a fever of 104F. She was taken to the ER. She was treated with lorazepam, phenytoin and ceftriaxone. The infant was transferred to a tertiary care center where she was hospitalized for an unspecified period of time. All events resolved by 12/1/01. The immunizing physician considered these events to be possibly related to Infanrix administration and possibly related to the infectious illness. This is 1 of 2 infants from this facility who experienced a seizure and fever following receipt of Prevnar. See related report HQ9598719DEC2001.
Age: 12.0
Sex: M
Vaccine: HEP, HEP, HEP, HEP
Symptoms: Headache, Oedema, Pharyngolaryngeal pain, Rash erythematous
Clinical narrative: Information has been received regarding a 12 year old male from his mother. On 09/22/2001 the child was vaccinated with the third dose of hep B vaccine recombinant. On 09/22/2001, immediately after the vaccination, the pt experienced headaches, developed a rash on his entire upper body and swelling on his face and body. At the time of this report the pt was still experiencing the headaches and there was "a little bit of a rash." The pt sought unspecified medical attention. Additional info has been requested.
Age: 12.0
Sex: M
Vaccine: HEP, HEP, HEP, HEP
Symptoms: Headache, Oedema, Pallor, Rash
Clinical narrative: Information has been received regarding a 12 year old male from his mother. On 09/22/2001 the child was vaccinated with the third dose of hep B vaccine recombinant. On 09/22/2001, immediately after the vaccination, the pt experienced headaches, developed a rash on his entire upper body and swelling on his face and body. At the time of this report the pt was still experiencing the headaches and there was "a little bit of a rash." The pt sought unspecified medical attention. Additional info has been requested.
Age: 12.0
Sex: M
Vaccine: HEP, HEP, HEP, HEP
Symptoms: Unevaluable event
Clinical narrative: Information has been received regarding a 12 year old male from his mother. On 09/22/2001 the child was vaccinated with the third dose of hep B vaccine recombinant. On 09/22/2001, immediately after the vaccination, the pt experienced headaches, developed a rash on his entire upper body and swelling on his face and body. At the time of this report the pt was still experiencing the headaches and there was "a little bit of a rash." The pt sought unspecified medical attention. Additional info has been requested.
Age: 12.0
Sex: M
Vaccine: HEP, HEP, HEP, HEP
Symptoms: Face oedema, Headache, Rash, Swelling
Clinical narrative: Information has been received regarding a 12 year old male from his mother. On 09/22/2001 the child was vaccinated with the third dose of hep B vaccine recombinant. On 09/22/2001, immediately after the vaccination, the pt experienced headaches, developed a rash on his entire upper body and swelling on his face and body. At the time of this report the pt was still experiencing the headaches and there was "a little bit of a rash." The pt sought unspecified medical attention. Additional info has been requested.
Age: 1.33
Sex: M
Vaccine: DTAP, HBHEPB, IPV, MMR, DTAP, HBHEPB, IPV, MMR, DTAP, HBHEPB, IPV, MMR, DTAP, HBHEPB, IPV, MMR
Symptoms: Autism
Clinical narrative: This report is concerning an approx. 28 month old male (DOB 8/5/99) with no relevant medical history who on 12/12/00 was vaccinated with a 3rd dose of HIB (lot 634690/1977J). Concomitant therapy that same day included the 1st dose of Infanrix (lot 961A2), 3rd dose of IPOL and the 1st dose of MMRII (lot 630637/0162K) (also reported as (Pluserix). It was reported, "just recently" that the pt had received a dx of autism. As of 2/8/02, the pt's autism had not resolved. The pt's autism was considered as "Medically Serious". It was noted that the pt's vax history included; the 1st and 2nd dose of HIB + Hep-B on 10/27/99 (lot 629770/0610J) and 12/29/99 (lot 631247/0549J); the 1st and 2nd dose of IPOL on 10/27/99 and 12/29/99; 1st, 2nd and 3rd dose of alum, potassium + Tripedia on 10/27/99 (lot 7389AA), 12/29/99 (lot 7389AA) and 3/1/00 (lot 7387AA); 1st dose of HIB on 3/1/00. This report was originally reported by an RN. Follow-up information from an RN on 3/6/02, noted that the pt had been dx'd with autism "within the last 6 weeks", approx. 1/02. The mother of the child called the RN to obtain information on the thimerosal content within the vaccines that the child had received. Additional information has been requested. From folow up info from a woman in a physician's office noted that the pt did not receive the Haemophilus B conjuugate vaccine+hepatitis B vaccine recombinant at this office. Follow up info received on 3/28/02, from a registered nurse indicated that on 12/12/00 the pt was vaccinated with the fourth dose of Infanrix IM in the leg (961A2) (previously reported as the first dose). It was also reported that the vaccinations given on 12/12/00 were given by the following routes/sites: Infanrix IM leg, IPOL IM leg and MMR SC leg. The nurse reported that, according to the pt's mother, the child had been diagnosed with autism in the past few months. The reporter was unsure at what age the signs of autism occurred. Additional info has been requested. Follow-up information from a healthcare professional noted taht the patient did not receive any vaccine at their clinic. It was noted that the patient's parents are concerned because their child has autism and are investigating through their health department the correlation with HIB and Hep B. Additional information has been requested. Follow up info from a registered nurse noted that she did not have any additional info on this pt. The pt's family no longer lives in the county and he is not seen in this office. No further info is available.
Age: 1.33
Sex: M
Vaccine: DTAP, HBHEPB, IPV, MMR, DTAP, HBHEPB, IPV, MMR, DTAP, HBHEPB, IPV, MMR, DTAP, HBHEPB, IPV, MMR
Symptoms: Autism, Schizophreniform disorder
Clinical narrative: This report is concerning an approx. 28 month old male (DOB 8/5/99) with no relevant medical history who on 12/12/00 was vaccinated with a 3rd dose of HIB (lot 634690/1977J). Concomitant therapy that same day included the 1st dose of Infanrix (lot 961A2), 3rd dose of IPOL and the 1st dose of MMRII (lot 630637/0162K) (also reported as (Pluserix). It was reported, "just recently" that the pt had received a dx of autism. As of 2/8/02, the pt's autism had not resolved. The pt's autism was considered as "Medically Serious". It was noted that the pt's vax history included; the 1st and 2nd dose of HIB + Hep-B on 10/27/99 (lot 629770/0610J) and 12/29/99 (lot 631247/0549J); the 1st and 2nd dose of IPOL on 10/27/99 and 12/29/99; 1st, 2nd and 3rd dose of alum, potassium + Tripedia on 10/27/99 (lot 7389AA), 12/29/99 (lot 7389AA) and 3/1/00 (lot 7387AA); 1st dose of HIB on 3/1/00. This report was originally reported by an RN. Follow-up information from an RN on 3/6/02, noted that the pt had been dx'd with autism "within the last 6 weeks", approx. 1/02. The mother of the child called the RN to obtain information on the thimerosal content within the vaccines that the child had received. Additional information has been requested. From folow up info from a woman in a physician's office noted that the pt did not receive the Haemophilus B conjuugate vaccine+hepatitis B vaccine recombinant at this office. Follow up info received on 3/28/02, from a registered nurse indicated that on 12/12/00 the pt was vaccinated with the fourth dose of Infanrix IM in the leg (961A2) (previously reported as the first dose). It was also reported that the vaccinations given on 12/12/00 were given by the following routes/sites: Infanrix IM leg, IPOL IM leg and MMR SC leg. The nurse reported that, according to the pt's mother, the child had been diagnosed with autism in the past few months. The reporter was unsure at what age the signs of autism occurred. Additional info has been requested. Follow-up information from a healthcare professional noted taht the patient did not receive any vaccine at their clinic. It was noted that the patient's parents are concerned because their child has autism and are investigating through their health department the correlation with HIB and Hep B. Additional information has been requested. Follow up info from a registered nurse noted that she did not have any additional info on this pt. The pt's family no longer lives in the county and he is not seen in this office. No further info is available.
Age: 81.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Pneumonia
Clinical narrative: On 2/26/02, the pt received Engerix-B (lot ENG5242A4) and Havrix (lot VHA69A6). It was not known if she had received previous injections of Engerix-B or Havrix. On 2/27/02, 1 day post vax, the pt was hospitalized with a dx of pneumonia. The reporter indicated that the pt received Havrix (lot VHA69A6); however, this is not a valid lot number.
Age: 0.2
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Abnormal sleep-related event, Pulmonary congestion, Pulmonary oedema, Sudden infant death syndrome, Thymus hypertrophy
Clinical narrative: Information has been received from an investigator regarding a 2 month old male who received his 1st doses of Prevnar, Hib-Titer, Infanrix, IPV and Engerix-B vaccines on 12/28/01, as part of a post-marketing safety trial. On 1/10/02, at 02:00, the mother took the infant into her bed for breast-feeding and the infant remained in bed with her. At 06:00, the mother awoke to find the infant dead. The coroner reported the cause of death as SIDS. The investigator believes that SIDS (expected per package insert) was not related to vaccine administration. The medical monitor's assessment of relatedness is unknown. This report of a serious labeled event is being submitted in a 15-day time frame, as requested by the FDA. Per F/U 4/1/02: Date of death is reported as 1/9/02 on autopsy report. COD was reported as SIDS (bed-sharing context). There was pulmonary congestion and edema and thymus weight 37 grams (enlarged). Follow up on 01/28/04: "Follow up information received on 01/14/04 provided a change in the event date.  Information has been received from an investigator regarding a 2 month old male who received his first doses of Prevnar, Hib-Titer, Infanrix, IPV, and Engerix-B vaccines on 12/28/01 as part of a surveillance trial. On 01/09/02, at 03:00AM, the mother took the infant into her bed for breastfeeing and the infant remained in bed with her.  At 6:00AM, the mother awoke to find the infant dead.  The coroner reported the cause of death as Sudden Infant Death Syndrome. The investigator and the medical monitor agreed that SIDS (expected per package insert) was not related to vaccine administration.  This report of a serious, labeled event is being submitted in a 15-day time frame, as requested by the FDA."
Age: 0.75
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Apnoea, Lymphadenopathy, Ovarian cyst, Polyp, Pulmonary congestion
Clinical narrative: Information has been rec'd from an investigator regarding a pt who rec'd her 3rd doses of Prevnar, Infanrix, and ActHIB vaccines on 8/22/01 as part of a post marketing safety surveillance trial. On 10/30/01, at 9 months of age the infant was found not breathing. Emergency services were called and she was seen in an ER where resuscitation efforts were unsuccessful. The results of an autopsy revealed that the cause of death was Sudden Infant Death Syndrome. The investigator believed that SIDS (expected per package insert) was not related to vaccine administration. The medical monitor's assessment of relatedness is unknown. This report of a serious, labeled event is being submitted in a 15 day time frame as requested by the FDA. Per F/U 4/17/02: Autopsy states wholly liquified blood within the cardiovascular lumens, pulmonary congestion and a benign large tracheal polyp causing 50% occlusion of the tracheal lumen. The right ovary shows the presence of a cyst. There are enlarged lymph nodes.
Age: 0.75
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Pulmonary haemorrhage, Pulmonary oedema, Sudden infant death syndrome
Clinical narrative: Information has been rec'd from an investigator regarding a pt who rec'd her 3rd doses of Prevnar, Infanrix, and ActHIB vaccines on 8/22/01 as part of a post marketing safety surveillance trial. On 10/30/01, at 9 months of age the infant was found not breathing. Emergency services were called and she was seen in an ER where resuscitation efforts were unsuccessful. The results of an autopsy revealed that the cause of death was Sudden Infant Death Syndrome. The investigator believed that SIDS (expected per package insert) was not related to vaccine administration. The medical monitor's assessment of relatedness is unknown. This report of a serious, labeled event is being submitted in a 15 day time frame as requested by the FDA. Per F/U 4/17/02: Autopsy states wholly liquified blood within the cardiovascular lumens, pulmonary congestion and a benign large tracheal polyp causing 50% occlusion of the tracheal lumen. The right ovary shows the presence of a cyst. There are enlarged lymph nodes.
Age: 0.5
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Petechiae, Sudden infant death syndrome
Clinical narrative: Pt received shots on 3/11/02. Pt expired, during sleep, on 3/11/02. COD as per autopsy report: SIDS Per F/U 5/16/02 fo autopsy report: There are florid thymic petechiae.
Age: 0.5
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Sudden infant death syndrome
Clinical narrative: Pt received shots on 3/11/02. Pt expired, during sleep, on 3/11/02. COD as per autopsy report: SIDS Per F/U 5/16/02 fo autopsy report: There are florid thymic petechiae.
Age: 0.5
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Unevaluable event
Clinical narrative: Pt received shots on 3/11/02. Pt expired, during sleep, on 3/11/02. COD as per autopsy report: SIDS Per F/U 5/16/02 fo autopsy report: There are florid thymic petechiae.
Age: 22.0
Sex: F
Vaccine: ANTH
Symptoms: Abdominal pain upper, Anorexia, Arthralgia, Depression, Diarrhoea
Clinical narrative: Anthrax vaccine given in May, 2000, before she went overseas. Developed muscle ache, fatigue, diarrhea, severe RUQ abdominal pain, anorexia, joint pains, headache and folliculitis. Also fever, nausea & vomiting. Medical records indicate additional diagnoses of GERD and depression.
Age: 22.0
Sex: F
Vaccine: ANTH
Symptoms: Fatigue, Folliculitis, Gastrointestinal disorder, Headache, Myalgia
Clinical narrative: Anthrax vaccine given in May, 2000, before she went overseas. Developed muscle ache, fatigue, diarrhea, severe RUQ abdominal pain, anorexia, joint pains, headache and folliculitis. Also fever, nausea & vomiting. Medical records indicate additional diagnoses of GERD and depression.
Age: 22.0
Sex: F
Vaccine: ANTH
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: Anthrax vaccine given in May, 2000, before she went overseas. Developed muscle ache, fatigue, diarrhea, severe RUQ abdominal pain, anorexia, joint pains, headache and folliculitis. Also fever, nausea & vomiting. Medical records indicate additional diagnoses of GERD and depression.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PPV
Symptoms: Convulsion, Dyskinesia, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Developed fever, the evening the vaccines were given. Shrieking and screaming episodes of brief duration then the night with brief episodes of jerking of legs. Seen in office the next day. PE: remarkable for fever and 50 cent-sized area of redness and tenderness at the site of the DTAP. Went to ER for further evaluation. Developed seizure requiring Ativan, phosphenyton and phenobarbital to stop activity. Total seizure duration unknown. No further seizure X 2 hospital days. Discharged on phenobarbital. ER diagnoses included leukocytosis.
Age: 0.3
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PPV
Symptoms: Screaming
Clinical narrative: Developed fever, the evening the vaccines were given. Shrieking and screaming episodes of brief duration then the night with brief episodes of jerking of legs. Seen in office the next day. PE: remarkable for fever and 50 cent-sized area of redness and tenderness at the site of the DTAP. Went to ER for further evaluation. Developed seizure requiring Ativan, phosphenyton and phenobarbital to stop activity. Total seizure duration unknown. No further seizure X 2 hospital days. Discharged on phenobarbital. ER diagnoses included leukocytosis.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Lethargy, Oral intake reduced, Pallor, Pyrexia
Clinical narrative: Excessive sleepiness and lethargy, decreased appetite, low-grade fever and pale.
Age: 21.0
Sex: M
Vaccine: FLU3
Symptoms: Arrhythmia, Headache, Heart rate increased, Hot flush, Injection site reaction
Clinical narrative: Within 10 minutes of receiving flu shot, the pt experienced itching at the injection site and over abdomen. Approx. 2 hours later, the pt had a racing heart rate of 160 and hot flashes. Aid car was called and pt was transported to ER. He complained of pain and tingling on left side of head. Currently he is experiencing heart arrhythmia. He continued to experience cardiac arrhythmia.
Age: 21.0
Sex: M
Vaccine: FLU3
Symptoms: Paraesthesia, Pruritus
Clinical narrative: Within 10 minutes of receiving flu shot, the pt experienced itching at the injection site and over abdomen. Approx. 2 hours later, the pt had a racing heart rate of 160 and hot flashes. Aid car was called and pt was transported to ER. He complained of pain and tingling on left side of head. Currently he is experiencing heart arrhythmia. He continued to experience cardiac arrhythmia.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Somnolence
Clinical narrative: The pt was very sleepy X 10 hours, post vax. She slept through diaper changes and feedings.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Vaccines administered on 1/31/02. This morning, 2/1/02, mom called to report that the pt had a small localized, redness and rash around the Prevnar and Comvax IZ area, a low-grade temperature and no other symptoms.
Age: 0.2
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Hypotonia, Pallor, Stupor
Clinical narrative: Hypotonic-hyporesponsive, pallor episode, lasting minutes, within one hours of vaccines.
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV, PNC
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: Hives several hours, post vax. Also introduced Enfamil and oatmeal for the first time. Had rxn immediately after Enfamil.
Age: 35.0
Sex: F
Vaccine: ANTH
Symptoms: Abdominal distension, Acne, Amnesia, Anxiety, Arthralgia
Clinical narrative: Pt complained of joint pain in shoulders and hands; constipation; painful bloating; acne; weight gain. Anthrax #1 given 1/25/91; Anthrax #2 given 2/15/91 and gained 20 pounds over a few months. In 1993, she began having panic attacks and was dx'd with anxiety, adjustment and panic disorder; symptoms managed with therapy and stress management. In 1994, she had onset of constipation and short term memory loss. She did not have time to seek treatment at this point. Anthrax #3 given on 9/10/98; Anthrax #4 given 9/24/98 and had flu-like symptoms starting 3 days, post vax, with fatigue, muscle aches, excessive sleepiness and felt as though she were in a daze. She also experienced an unusual amount of crying. All symptoms lasted a week. Anthrax #5 given 10/8/98 and had same flu-like, fatigue, crying and withdrawal from family symptoms as with shot #4. Started 3 days, post vax, and lasted 2 weeks. During 6 month interval between shots #5 and #6, she had GI problems of constipation, bloating, lower abdominal pain and white mucous around stools increased. Anthrax #6 given 3/9/99; Anthrax #7 on 9/8/99 and tolerated both of these well. In 1/00, she began experiencing severe joint pain in her shoulders and left knee. Numbness radiates from the shoulders to the fingers. Anthrax #8 given on 3/6/00 and tolerated well. Symptoms that began after 7th Anthrax also included pain to the touch on the back of her neck and the medial aspects of both feet. She was dx'd with bursitis/arthritis, AC joint arthritis and impingement. She has tried both Celebrex and high dose Motrin with no relief. An orthopedic physician is currently managing her care. She began receiving cortisone shots every 6-8 weeks in 8/01. In 9/01, surgery was performed on her right shoulder and she received physical therapy from 10/01 to 1/02 and given a TENS machine for pain management (which she still uses daily). She was dx'd irritable bowel syndrome and prescribed a high fiber diet for the constipation. In 4/01 she began taking Paxil 20mg every day, which in conjunction with coping and stress management skills, is controlling her anxiety. She has not had a panic attack since 1993. Since 1991, she has been experiencing constant, painful acne on her face, lower legs and on the skin between her breasts. She has been on minocycline since 1991. Plan to refer to Rheumatology for joint pain, Dermatology for acne and refer to GI on symptoms of constipation.
Age: 35.0
Sex: F
Vaccine: ANTH
Symptoms: Arthritis, Bursitis, Constipation, Gastritis, Haemorrhoids
Clinical narrative: Pt complained of joint pain in shoulders and hands; constipation; painful bloating; acne; weight gain. Anthrax #1 given 1/25/91; Anthrax #2 given 2/15/91 and gained 20 pounds over a few months. In 1993, she began having panic attacks and was dx'd with anxiety, adjustment and panic disorder; symptoms managed with therapy and stress management. In 1994, she had onset of constipation and short term memory loss. She did not have time to seek treatment at this point. Anthrax #3 given on 9/10/98; Anthrax #4 given 9/24/98 and had flu-like symptoms starting 3 days, post vax, with fatigue, muscle aches, excessive sleepiness and felt as though she were in a daze. She also experienced an unusual amount of crying. All symptoms lasted a week. Anthrax #5 given 10/8/98 and had same flu-like, fatigue, crying and withdrawal from family symptoms as with shot #4. Started 3 days, post vax, and lasted 2 weeks. During 6 month interval between shots #5 and #6, she had GI problems of constipation, bloating, lower abdominal pain and white mucous around stools increased. Anthrax #6 given 3/9/99; Anthrax #7 on 9/8/99 and tolerated both of these well. In 1/00, she began experiencing severe joint pain in her shoulders and left knee. Numbness radiates from the shoulders to the fingers. Anthrax #8 given on 3/6/00 and tolerated well. Symptoms that began after 7th Anthrax also included pain to the touch on the back of her neck and the medial aspects of both feet. She was dx'd with bursitis/arthritis, AC joint arthritis and impingement. She has tried both Celebrex and high dose Motrin with no relief. An orthopedic physician is currently managing her care. She began receiving cortisone shots every 6-8 weeks in 8/01. In 9/01, surgery was performed on her right shoulder and she received physical therapy from 10/01 to 1/02 and given a TENS machine for pain management (which she still uses daily). She was dx'd irritable bowel syndrome and prescribed a high fiber diet for the constipation. In 4/01 she began taking Paxil 20mg every day, which in conjunction with coping and stress management skills, is controlling her anxiety. She has not had a panic attack since 1993. Since 1991, she has been experiencing constant, painful acne on her face, lower legs and on the skin between her breasts. She has been on minocycline since 1991. Plan to refer to Rheumatology for joint pain, Dermatology for acne and refer to GI on symptoms of constipation.
Age: 35.0
Sex: F
Vaccine: ANTH
Symptoms: Hypoaesthesia, Neck pain, Stomach discomfort, Weight increased
Clinical narrative: Pt complained of joint pain in shoulders and hands; constipation; painful bloating; acne; weight gain. Anthrax #1 given 1/25/91; Anthrax #2 given 2/15/91 and gained 20 pounds over a few months. In 1993, she began having panic attacks and was dx'd with anxiety, adjustment and panic disorder; symptoms managed with therapy and stress management. In 1994, she had onset of constipation and short term memory loss. She did not have time to seek treatment at this point. Anthrax #3 given on 9/10/98; Anthrax #4 given 9/24/98 and had flu-like symptoms starting 3 days, post vax, with fatigue, muscle aches, excessive sleepiness and felt as though she were in a daze. She also experienced an unusual amount of crying. All symptoms lasted a week. Anthrax #5 given 10/8/98 and had same flu-like, fatigue, crying and withdrawal from family symptoms as with shot #4. Started 3 days, post vax, and lasted 2 weeks. During 6 month interval between shots #5 and #6, she had GI problems of constipation, bloating, lower abdominal pain and white mucous around stools increased. Anthrax #6 given 3/9/99; Anthrax #7 on 9/8/99 and tolerated both of these well. In 1/00, she began experiencing severe joint pain in her shoulders and left knee. Numbness radiates from the shoulders to the fingers. Anthrax #8 given on 3/6/00 and tolerated well. Symptoms that began after 7th Anthrax also included pain to the touch on the back of her neck and the medial aspects of both feet. She was dx'd with bursitis/arthritis, AC joint arthritis and impingement. She has tried both Celebrex and high dose Motrin with no relief. An orthopedic physician is currently managing her care. She began receiving cortisone shots every 6-8 weeks in 8/01. In 9/01, surgery was performed on her right shoulder and she received physical therapy from 10/01 to 1/02 and given a TENS machine for pain management (which she still uses daily). She was dx'd irritable bowel syndrome and prescribed a high fiber diet for the constipation. In 4/01 she began taking Paxil 20mg every day, which in conjunction with coping and stress management skills, is controlling her anxiety. She has not had a panic attack since 1993. Since 1991, she has been experiencing constant, painful acne on her face, lower legs and on the skin between her breasts. She has been on minocycline since 1991. Plan to refer to Rheumatology for joint pain, Dermatology for acne and refer to GI on symptoms of constipation.
Age: 40.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site hypersensitivity, Pruritus, Rash papular
Clinical narrative: The patient received his first anthrax vaccination in 1990 while serving in Desert Storm. He received the shot in the right arm a few days after the vaccination, he noticed a pruritic papule at the site of injection, 5-8 mm in diameter and non-purulent. He did not seek medical treatment or use any topical steroids on the affected area the papule persisted for approximately one year at which time it spontaneously resolved. He has not received any additional anthrax vaccinations.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hypoaesthesia, Tremor
Clinical narrative: Light-headed, numbness all over shaky, patient monitored at office for about 2 hours, first time for flu vaccine
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, PNC
Symptoms: Injection site warmth, Rash erythematous
Clinical narrative: Child returned to clinic 34 hours after immunizations with right deltoid area red, swollen and warm to touch. Reddened area measured 7 cm X 7 cm-treated with Keflex,
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site hypersensitivity, Pruritus, Rash erythematous
Clinical narrative: Rash started with 1 small red spot on left arm, increased in size and pruritis developed. Over course of next 2 weeks, pinpoint size raised red rash developed into rash over entire body except neck and head. Rash consisted of vesicles and some rash areas 3 cm in size with dark scaly centers. Rash extremely pruritic. The patient was referred to MD. Placed on Zyrtec, Prednisone and cream for rash, but rash continued to progress and remained quite pruritic then saw dermatologist for skin bx 12/13. By 12/14/01, pruritis decreased and no further progression of rash.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Hypokinesia, Injection site warmth, Lymphadenopathy, Oedema, Pain
Clinical narrative: The morning after receiving vaccine, the injection site was warm but not red. Afebrile. Left axilla was edematous secondary to lymph nodes swollen and tender. Had sharp pains experienced in axilla on arm movement (non-radiating). Edema worsened and saw MD on 12/14/01. Placed on Relafen. MD dx'd rxn to the flu vaccine. Pain and edema resolving by 12/18/01.
Age: 1.25
Sex: F
Vaccine: PNC
Symptoms: Cold sweat, Dehydration, Listless, Pallor, Pyrexia
Clinical narrative: Temperature of 105F, listless, dehydrated, pale and "clammy", 5 days after each of 2 PCV7 doses. Treated with Motrin and antibiotics.
Age: 0.5
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Localized swelling and tenderness persisted. Now, 2 months later, induration and tenderness continue.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Drug ineffective, Infection
Clinical narrative: Varicella disease with over 50 pox.
Age: 16.0
Sex: F
Vaccine: HEP, HEPA, IPV, MMR, TD
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Parents reported that the client fainted and was unconscious. She had to be transported to ER via EMS and was hospitalized for 6 hours.
Age: 1.6
Sex: M
Vaccine: DTAP
Symptoms: Rash
Clinical narrative: Pt was in for shots at approx. 10:50. No adverse reaction noted after shots. At approx. 16:30, the mother called stating "my child has a rash on the back of his neck and stomach". I instructed her to take the child to an MD or ER for evaluation. Mother agreed to do so. On 2/23/02, mother called and stated that pt was fine but has started to break out again.
Age: 9.0
Sex: M
Vaccine: HEP
Symptoms: Pruritus, Urticaria
Clinical narrative: Generalized urticaria and pruritus.
Age: 1.3
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Right thigh was swollen and red.
Age: 24.0
Sex: F
Vaccine: MMR
Symptoms: Asthenia, Muscle twitching
Clinical narrative: Several hours, post vax, she noted weak sensation in extremities. Also, later with twitching of right shoulder (administered in left deltoid).