chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.25
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Coma, Myocarditis, Respiratory syncytial virus infection
Clinical narrative: Information has been received as a result of a FOIA request to VAERS on 7/21/01. Information regarding Prevnar was received regarding a 3 month old male patient who developed myocarditis. The patient received their second dose on 3/4/02. The patient also received the second dose of Tripedia, the second dose of Recombivax-HB, the second dose of IPOL, and the second dose of Act-Hib on 3/4/02. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 3/4/02. Dose regimen was 1 dose. Concomitant medications were not reported. On 3/14/02, the infant was found unresponsive at his residence. The autopsy determined that the cause of death was myocarditis. No additional information was available at the time of this report.
Age: 0.5
Sex: F
Vaccine: DTAP, HEP, IPV, PNC
Symptoms: Coma, Petechiae
Clinical narrative: Information has been received as a result of a FOIA request to VAERS on 7/21/01. Information regarding Prevnar was received from a regulatory authority regarding a 6 month old female patient who was found unresponsive. At 6 months of age, the patient received the second dose on 2/14/02. The patient also received the third dose of IPOL, the fourth dose of Engerix B, and the third dose of Infanrix on 2/14/02. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 2/14/02. Dose regimen was 1 dose (IM). Concomitant medications were not reported. On 2/15/02, the infant was found unresponsive in her crib in a supine position with a comforter covering her head. Autopsy results revealed thymic and pleural petechiae; no anatomic, metabolic, or toxicologic cause of death was found. No additional information was available at the time of this report.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Bronchitis, Cardiac arrest, Coma, Encephalitis, Encephalopathy
Clinical narrative: Information has been received as a result of a FOIA request to VAERS on 7/21/01. A healthcare professional reported that a 2 month old female received her first dose of Prevnar, Hib-Titer vaccine, Polio Vaccine, Infanrix, and second dose of Recombivax-HB on 4/18/01. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 4/18/01. Dose regimen was 1 dose. Concomitant therapy included Tylenol, Mylicon, and Topamax. On 4/27/01, the infant developed cold symptoms and fussiness. On 4/28/01, her symptoms worsened. On 4/30/01, she became extremely fussy and was eating very little. The following day, the infant started high pitched screaming and she developed a fever. The patient was hospitalized and diagnosed with viral meningoencephalitis with secondary status epilepticus. On 2/25/02, at approximately 12 months of age, the child developed a fever and cold symptoms. On 2/27/02, she was found unresponsive. Emergency services were called and noted that the child was asystolic and unresponsive to resuscitation. She was taken to an emergency room where she was pronounced dead. The cause of death was reported as global hypoxic-ischemic brain injury and respiratory syncytial virus bronchitis/bronchiolitis.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: High-pitched crying, Hypoxia, Infection, Irritability, Laboratory test abnormal
Clinical narrative: Information has been received as a result of a FOIA request to VAERS on 7/21/01. A healthcare professional reported that a 2 month old female received her first dose of Prevnar, Hib-Titer vaccine, Polio Vaccine, Infanrix, and second dose of Recombivax-HB on 4/18/01. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 4/18/01. Dose regimen was 1 dose. Concomitant therapy included Tylenol, Mylicon, and Topamax. On 4/27/01, the infant developed cold symptoms and fussiness. On 4/28/01, her symptoms worsened. On 4/30/01, she became extremely fussy and was eating very little. The following day, the infant started high pitched screaming and she developed a fever. The patient was hospitalized and diagnosed with viral meningoencephalitis with secondary status epilepticus. On 2/25/02, at approximately 12 months of age, the child developed a fever and cold symptoms. On 2/27/02, she was found unresponsive. Emergency services were called and noted that the child was asystolic and unresponsive to resuscitation. She was taken to an emergency room where she was pronounced dead. The cause of death was reported as global hypoxic-ischemic brain injury and respiratory syncytial virus bronchitis/bronchiolitis.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Oral intake reduced, Pharyngitis, Pyrexia, Respiratory syncytial virus infection, Rhinitis
Clinical narrative: Information has been received as a result of a FOIA request to VAERS on 7/21/01. A healthcare professional reported that a 2 month old female received her first dose of Prevnar, Hib-Titer vaccine, Polio Vaccine, Infanrix, and second dose of Recombivax-HB on 4/18/01. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 4/18/01. Dose regimen was 1 dose. Concomitant therapy included Tylenol, Mylicon, and Topamax. On 4/27/01, the infant developed cold symptoms and fussiness. On 4/28/01, her symptoms worsened. On 4/30/01, she became extremely fussy and was eating very little. The following day, the infant started high pitched screaming and she developed a fever. The patient was hospitalized and diagnosed with viral meningoencephalitis with secondary status epilepticus. On 2/25/02, at approximately 12 months of age, the child developed a fever and cold symptoms. On 2/27/02, she was found unresponsive. Emergency services were called and noted that the child was asystolic and unresponsive to resuscitation. She was taken to an emergency room where she was pronounced dead. The cause of death was reported as global hypoxic-ischemic brain injury and respiratory syncytial virus bronchitis/bronchiolitis.
Age: 0.2
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Status epilepticus, Viral infection
Clinical narrative: Information has been received as a result of a FOIA request to VAERS on 7/21/01. A healthcare professional reported that a 2 month old female received her first dose of Prevnar, Hib-Titer vaccine, Polio Vaccine, Infanrix, and second dose of Recombivax-HB on 4/18/01. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 4/18/01. Dose regimen was 1 dose. Concomitant therapy included Tylenol, Mylicon, and Topamax. On 4/27/01, the infant developed cold symptoms and fussiness. On 4/28/01, her symptoms worsened. On 4/30/01, she became extremely fussy and was eating very little. The following day, the infant started high pitched screaming and she developed a fever. The patient was hospitalized and diagnosed with viral meningoencephalitis with secondary status epilepticus. On 2/25/02, at approximately 12 months of age, the child developed a fever and cold symptoms. On 2/27/02, she was found unresponsive. Emergency services were called and noted that the child was asystolic and unresponsive to resuscitation. She was taken to an emergency room where she was pronounced dead. The cause of death was reported as global hypoxic-ischemic brain injury and respiratory syncytial virus bronchitis/bronchiolitis.
Age: 1.07
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Follow up information received on 10-APR-2003 from the physician provides test results and patient outcome (recovered). A nurse reported that a 12 month old female received a 4th dose of Prevnar (pneumococcal 7 valent conjugate vaccine) vaccine and a first dose of Varivax (varicella virus vaccine, live) (Merck) on 06-MAR-2003.  Within 24 hours of immunization, the child developed a fever of 102 deg F., which was treated with Tylenol (acetaminophen). On 10-MAR-2003, the child was brought to the physician's office with a rash on her torso. On 10-MAR-2003 a culture for Strep A was negative. The child recovered.
Age: 0.75
Sex: M
Vaccine: FLU3, HEP, PNC
Symptoms: Bacterial infection, Sepsis
Clinical narrative: Additional information received on 5/29/03 provided lab test results. Information has been received from a pediatrician regarding an 11 month old with a history of otitis media and an ENT surgery in 10/02. On 12/23/02, at 9 months of age, he received his third dose of Prevnar. The physician indicated that the infant received hepatitis B vaccine and Fluzone on an unspecified date. The pediatrician reported that he developed pneumococcal sepsis on an unspecified date and died on 3/6/03. Lab test results revealed a positive bacterial culture for S. pneumoniae serotype 35E.
Age: 0.4
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Face oedema, Mouth ulceration, Pyrexia, Rash
Clinical narrative: Follow-up information received 05/12/03 from the physician provided information on lab tests, other vaccinations given within 4 weeks of administration, past and concurrent medical history and events following prior vaccination in the pt or sibling.  A medical assistant reported that a 4 month old male received a dose of Prevnar (pneumococcal 7-valent conjugate vaccine) vaccine, diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (manufacturer unknown), polio vaccine (poliomyelitis vaccine inactivated) vaccine, and Act-Hib (Haemophilus b conjugate vaccine) vaccine on 03/11/03.  The next morning, the mother reported that her child had a fever of 102 deg. F, swollen lips, rash and ulcers in the mouth.  The pt had no symptoms at the time of this report.
Age: 1.0
Sex: F
Vaccine: PNC, VARCEL
Symptoms: Sneezing, Urticaria
Clinical narrative: A medical assistant reported that a 12 month old female received her fourth dose of Prevnar on 12-MAY-2003 along with her first dose of Varivax (Merck). "Immediately" after receiving the vaccines, the child began sneezing. Approximately, 20 minutes after leaving the physician's office, the child developed hives. When the child returned to the office that day, she was "covered from head to toe" with hives. Treatment medications included an injection of Benadryl (dephenhydramine). The reporter noted that this was the child's fourth dose of Prevnar, and the child never had a reaction like this before; however , it was the child's first dose of Varivax. No further information was available at the date of this report. Information regarding this event has been forwarded to Merck, manufacturer of Varivax.
Age: 1.58
Sex: M
Vaccine: PNC
Symptoms: Basophil percentage, Chest X-ray abnormal, Convulsion, Eosinophil percentage increased, Haematocrit normal
Clinical narrative: This case was serious since seizures were considered medically important. Follow-up information received 26-AUG-2003 provided patient details, laboraotry and radiology results and patient outcome (recovered). A nurse reported that a 19-month-old male received his 4th dose of PREVNAR on 04-AUG-2003. On 04-AUG-2003 and 05-AUG-2003, post immunization, the child experienced a fever of 102 deg. F. and also experienced seizures. Medical histoyr is significant for a fever and a seizure following the child's 3rd dose of PREVNAR on 15-APR-2003 (see related report HQWYE969108AUG03). The child's motehr did not report this event to the physician prior to administration of the 4th dose of PREVNR. Product was administered on 04-Aug-2003. Dose regimen was 1 dose of 0.5 mL (intramuscular). Concomitant medications were not reported. On 04-Aug-2003, post immunization, the patient developed a highf ever of 102 degree F. and experienced seizures. The child was seen at the hospital and treated with MOTRIN and TYLENOL. On 06-AUG-2003 his fever was down to 98.2 F. He recovered.
Age: 1.58
Sex: M
Vaccine: PNC
Symptoms: Lymphocyte percentage decreased, Mean cell haemoglobin concentration normal, Monocyte percentage increased, Neutrophil percentage increased, Platelet count increased
Clinical narrative: This case was serious since seizures were considered medically important. Follow-up information received 26-AUG-2003 provided patient details, laboraotry and radiology results and patient outcome (recovered). A nurse reported that a 19-month-old male received his 4th dose of PREVNAR on 04-AUG-2003. On 04-AUG-2003 and 05-AUG-2003, post immunization, the child experienced a fever of 102 deg. F. and also experienced seizures. Medical histoyr is significant for a fever and a seizure following the child's 3rd dose of PREVNAR on 15-APR-2003 (see related report HQWYE969108AUG03). The child's motehr did not report this event to the physician prior to administration of the 4th dose of PREVNR. Product was administered on 04-Aug-2003. Dose regimen was 1 dose of 0.5 mL (intramuscular). Concomitant medications were not reported. On 04-Aug-2003, post immunization, the patient developed a highf ever of 102 degree F. and experienced seizures. The child was seen at the hospital and treated with MOTRIN and TYLENOL. On 06-AUG-2003 his fever was down to 98.2 F. He recovered.
Age: 1.58
Sex: M
Vaccine: PNC
Symptoms: Pyrexia, Vaccine positive rechallenge, White blood cell count increased
Clinical narrative: This case was serious since seizures were considered medically important. Follow-up information received 26-AUG-2003 provided patient details, laboraotry and radiology results and patient outcome (recovered). A nurse reported that a 19-month-old male received his 4th dose of PREVNAR on 04-AUG-2003. On 04-AUG-2003 and 05-AUG-2003, post immunization, the child experienced a fever of 102 deg. F. and also experienced seizures. Medical histoyr is significant for a fever and a seizure following the child's 3rd dose of PREVNAR on 15-APR-2003 (see related report HQWYE969108AUG03). The child's motehr did not report this event to the physician prior to administration of the 4th dose of PREVNR. Product was administered on 04-Aug-2003. Dose regimen was 1 dose of 0.5 mL (intramuscular). Concomitant medications were not reported. On 04-Aug-2003, post immunization, the patient developed a highf ever of 102 degree F. and experienced seizures. The child was seen at the hospital and treated with MOTRIN and TYLENOL. On 06-AUG-2003 his fever was down to 98.2 F. He recovered.
Age: 0.6
Sex: M
Vaccine: DTAP, PNC
Symptoms: Erythema, Rash macular
Clinical narrative: Additional information was received on 12/15/03 from the reporter which provided additional vaccines that were administered on 11/14/03.  A health care professional reported that a 6 month old male pt received an injection of Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) on 11/07/03 and experienced a blotchy red face and neck.  The pt is reported to be healthy.  Indication for Prevnar was immunization.  Product was administered on 11/07/03.  Dose regimen was 1 dose.  Additional suspect medication included Tripedia.  Concomitant medications were not reported.  On 11/07/03, a 6 month old male pt experienced a blotchy red face and neck after receiving injections of Prevnar and Tripedia vaccines.  The reporter stated that the pt turned "blotchy red in face and neck area instantly".  At the time of the reaction, he was treated with Zyrtec (cetrizine hydrochloride) and was observed for 30 minutes.  The reporter indicated that blotchy areas were "completely cleared"  when the pt left the office.  On 11/14/03, the pt received injections of Comvax (Haemophilus b & Hepatitis B vaccine) and Ipol (poliovirus vaccine inactivated) and developed some red areas "on his head".  The event subsided spontaneously without treatment.
Age: 0.4
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, IPV, HBHEPB, PNC
Symptoms: Pallor, Pyrexia, Retching, Similar reaction on previous exposure to drug, Wheezing
Clinical narrative: Follow-up information received from the physician indicated that the infant had received one previous dose of each vaccine, and provided a revised address for the physician.  Information regarding Prevnar (pneumcococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a mother regarding her 4 month old daughter who developed a rhythmic grunt or sighing noise when exhaling, gagged a couple of times, became pale and had an axillary temperature of 102 deg. F.  At 4 months of age, the pt received the second dose on 11/07/03 along with the second doses of diptheria/tetanus toxoid/acellular pertussis (manufacturer unknown), Ipol, and Comvax vaccines.  The pt previously developed an injection site reaction characterized by a lump and redness following receipt of her first dose of Prevnar in 09/03.  Indication for Prevnar was immunization.  Product was administered on 11/07/03.  Dose regimen was 1 dose (IM).  On 11/07/03, between 9:00pm and 10:00pm the infant developed a "rhythmic grunt or sighing noise when exhaling," (grunting), gagged a couple of times (retching), and became pale (pallor).  The mother reported that these symptoms resolved without treatment in about an hour.  The infant also had an axillary temperature of 102 deg. F. (pyrexia) which was treated with a single dose of Tylenol (acetaminophen). No additional information was available at the date of this report.
Age: 0.4
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, IPV, HBHEPB, PNC
Symptoms: Grunting, Pallor, Pyrexia, Retching
Clinical narrative: Follow-up information received from the physician indicated that the infant had received one previous dose of each vaccine, and provided a revised address for the physician.  Information regarding Prevnar (pneumcococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a mother regarding her 4 month old daughter who developed a rhythmic grunt or sighing noise when exhaling, gagged a couple of times, became pale and had an axillary temperature of 102 deg. F.  At 4 months of age, the pt received the second dose on 11/07/03 along with the second doses of diptheria/tetanus toxoid/acellular pertussis (manufacturer unknown), Ipol, and Comvax vaccines.  The pt previously developed an injection site reaction characterized by a lump and redness following receipt of her first dose of Prevnar in 09/03.  Indication for Prevnar was immunization.  Product was administered on 11/07/03.  Dose regimen was 1 dose (IM).  On 11/07/03, between 9:00pm and 10:00pm the infant developed a "rhythmic grunt or sighing noise when exhaling," (grunting), gagged a couple of times (retching), and became pale (pallor).  The mother reported that these symptoms resolved without treatment in about an hour.  The infant also had an axillary temperature of 102 deg. F. (pyrexia) which was treated with a single dose of Tylenol (acetaminophen). No additional information was available at the date of this report.
Age: 0.4
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, IPV, HBHEPB, PNC
Symptoms: Dyspnoea, Pallor, Pyrexia, Respiratory disorder, Retching
Clinical narrative: Follow-up information received from the physician indicated that the infant had received one previous dose of each vaccine, and provided a revised address for the physician.  Information regarding Prevnar (pneumcococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a mother regarding her 4 month old daughter who developed a rhythmic grunt or sighing noise when exhaling, gagged a couple of times, became pale and had an axillary temperature of 102 deg. F.  At 4 months of age, the pt received the second dose on 11/07/03 along with the second doses of diptheria/tetanus toxoid/acellular pertussis (manufacturer unknown), Ipol, and Comvax vaccines.  The pt previously developed an injection site reaction characterized by a lump and redness following receipt of her first dose of Prevnar in 09/03.  Indication for Prevnar was immunization.  Product was administered on 11/07/03.  Dose regimen was 1 dose (IM).  On 11/07/03, between 9:00pm and 10:00pm the infant developed a "rhythmic grunt or sighing noise when exhaling," (grunting), gagged a couple of times (retching), and became pale (pallor).  The mother reported that these symptoms resolved without treatment in about an hour.  The infant also had an axillary temperature of 102 deg. F. (pyrexia) which was treated with a single dose of Tylenol (acetaminophen). No additional information was available at the date of this report.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC
Symptoms: Injection site induration, Rash erythematous, Rash maculo-papular
Clinical narrative: Follow up information received from the pediatrician on 03-JUN-2003 provided additional vaccination details, patient date of birth, and recovery status. A pediatrician reported that a female infant received her second doses of Prevnar , Tripedia (Aventis) , IPOL (Aventis) and Comvax (Merck) vaccines on 13-FEB-2003 at 4 months of age. Subsequently, the infant developed a generalized, erythematous, macular-papular rash that started in the infant's left thigh. She recovered The infant developed an injection site reaction characterized by a "knot" and a rash following receipt of her third dose of Prevnar at 6 months of age (see MCN HQWYE140209MAY03). The physician indicated that the infant experienced "no problems" following receipt of her first vaccine doses. Information regarding this event has been forwarded to Merck and Aventis, manufacturers of the concomitantly administered vaccines.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC
Symptoms: Pyrexia
Clinical narrative: Follow up information received 8/6/03 provided details on concomitant vaccines administered. A nurse reported via a company representative that a 9 month old male received his 1st dose of Prevnar on 10/01/02 at the age of 7 weeks. He also received Infanrix, Act-Hib, and Polio Vaccine at that visit. Medical history included premature delivery at 33 weeks gestation. On 10/2/02, one day post immunization, the child returned to the pediatrician with a fever of 99.1 axillary. Because the child was a preemie with a fever, he was hospitalized. Fever on admission was 100.6 axillary. Lab values included a full blood count with the following results: WBC 9000 and platelets 447,000. Blood culture showed no growth. No medications were given and the child became afebrile. On 10/3/02, he was discharged with a diagnosis of fever secondary to vaccination. He recovered. It was reported that the child's mother, after doing research, thinks Prevnar is responsible. The child has not received any additional doses of Prevnar at following exams. Information regarding these reports have been forwarded to the manufacturers of the concomitantly administered vaccines.
Age: 0.72
Sex: M
Vaccine: DTAPHEPBIP, DTAPHEPBIP, PNC, DTAPHEPBIP, PNC
Symptoms: Flatulence, Oedema peripheral, Pyrexia, Rash, Vomiting
Clinical narrative: A nurse reported that an 8 month old male patient received his third injection of Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protien)) on 22-OCT-2003, and experienced a fever, vomiting, gas pains, a rash on his left leg and swelling of leg. The patient also received the fist dose of Pediarix (diptheria/tetanus/acellular pertussis/hepatitis B/polio virus inactivated) vaccine on 22-OCT-2003. On 23-Oct-2003, one day post-immunization, a male patient developed a fever/pyrexia, vomiting, gas pains/flatulence, a rash on his left leg "which covered one fourth of his thigh", and swelling of leg. The patient's fever, vomiting and gas pains resolved on 24-OCT-2003. The outcome of leg rash and leg swelling were unknown. The nurse considered the leg rash and leg swelling to be "related" to vaccination with Pediarix and the fever, vomiting and gas pains to "possibly be related" to vaccination with Pediarix and Prevnar. No additional information was available at the time of this report.
Age: 0.72
Sex: M
Vaccine: DTAPHEPBIP, DTAPHEPBIP, PNC, DTAPHEPBIP, PNC
Symptoms: Erythema, Feeling hot, Injection site erythema, Injection site oedema, Injection site rash
Clinical narrative: A nurse reported that an 8 month old male patient received his third injection of Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protien)) on 22-OCT-2003, and experienced a fever, vomiting, gas pains, a rash on his left leg and swelling of leg. The patient also received the fist dose of Pediarix (diptheria/tetanus/acellular pertussis/hepatitis B/polio virus inactivated) vaccine on 22-OCT-2003. On 23-Oct-2003, one day post-immunization, a male patient developed a fever/pyrexia, vomiting, gas pains/flatulence, a rash on his left leg "which covered one fourth of his thigh", and swelling of leg. The patient's fever, vomiting and gas pains resolved on 24-OCT-2003. The outcome of leg rash and leg swelling were unknown. The nurse considered the leg rash and leg swelling to be "related" to vaccination with Pediarix and the fever, vomiting and gas pains to "possibly be related" to vaccination with Pediarix and Prevnar. No additional information was available at the time of this report.
Age: 0.72
Sex: M
Vaccine: DTAPHEPBIP, DTAPHEPBIP, PNC, DTAPHEPBIP, PNC
Symptoms: Pyrexia, Rash, Rash macular, Vomiting
Clinical narrative: A nurse reported that an 8 month old male patient received his third injection of Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protien)) on 22-OCT-2003, and experienced a fever, vomiting, gas pains, a rash on his left leg and swelling of leg. The patient also received the fist dose of Pediarix (diptheria/tetanus/acellular pertussis/hepatitis B/polio virus inactivated) vaccine on 22-OCT-2003. On 23-Oct-2003, one day post-immunization, a male patient developed a fever/pyrexia, vomiting, gas pains/flatulence, a rash on his left leg "which covered one fourth of his thigh", and swelling of leg. The patient's fever, vomiting and gas pains resolved on 24-OCT-2003. The outcome of leg rash and leg swelling were unknown. The nurse considered the leg rash and leg swelling to be "related" to vaccination with Pediarix and the fever, vomiting and gas pains to "possibly be related" to vaccination with Pediarix and Prevnar. No additional information was available at the time of this report.
Age: 0.72
Sex: M
Vaccine: DTAPHEPBIP, DTAPHEPBIP, PNC, DTAPHEPBIP, PNC
Symptoms: Flatulence, Injection site oedema, Injection site rash, Pyrexia, Vomiting
Clinical narrative: A nurse reported that an 8 month old male patient received his third injection of Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protien)) on 22-OCT-2003, and experienced a fever, vomiting, gas pains, a rash on his left leg and swelling of leg. The patient also received the fist dose of Pediarix (diptheria/tetanus/acellular pertussis/hepatitis B/polio virus inactivated) vaccine on 22-OCT-2003. On 23-Oct-2003, one day post-immunization, a male patient developed a fever/pyrexia, vomiting, gas pains/flatulence, a rash on his left leg "which covered one fourth of his thigh", and swelling of leg. The patient's fever, vomiting and gas pains resolved on 24-OCT-2003. The outcome of leg rash and leg swelling were unknown. The nurse considered the leg rash and leg swelling to be "related" to vaccination with Pediarix and the fever, vomiting and gas pains to "possibly be related" to vaccination with Pediarix and Prevnar. No additional information was available at the time of this report.
Age: 0.7
Sex: F
Vaccine: PNC, PNC
Symptoms: Unevaluable event, Vaccine positive rechallenge
Clinical narrative: Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diptheria crm197 protein) injection) was received from a mother regarding her 7 month old daughter who developed "funny breathing noises grunting or sighing," a croupy type cough, an upper respiratory virus infection, and a lot of phlegm.  At 7 months of age, the pt received the third dose on 01/28/04.  The pt previously experienced an injection site reaction characterized by a lump and redness following receipt of her first dose of Prevnar in 09/03, and grunting, gagging, pallor and pyrexia following receipt of her second dose of Prevnar along with diphtheria, tetanus, acellular pertussis (manufacturer unknown), IPOL, and Comvax vaccines on 11/07/03, at 4 months of age.  The pt had no other relevant medical history.  Indication for Prevnar was immunization.  Product was administered on 01/28/04.  Dose regimen was 1 dose (IM).  The reporter indicated that the infant received no other vaccinations on the same day as the Prevnar injection.  The infant was given Tylenol (acetaminophen) every four hours for three doses beginning before the vaccination.  On 01/29/03 at 01:00am, the pt developed "funny breathing noises grunting or sighing" (grunting).  The mother stated that the breathing noises were constant for about five hours, then intermittent for about two and a half hours before resolving without treatment.  The pt also developed an "infrequent croupy type cough" (cough) and a "full-fledged upper respiratory virus infection (viral upper respiratory tract infection) and a lot of phlegm (throat secretion increased)."  The mother indicated that the infant was given Tylenol (acetaminophen) every four hours for three doses beginning before the vaccination, therefore her temperature was not checked.  It is unknown if the pt had recovered.  See related cases: HQWYE824405FEB04 & HQWYE824505FEB04.  No additional information was available at the date of this report.
Age: 0.7
Sex: F
Vaccine: PNC, PNC
Symptoms: Cough, Injection site erythema, Injection site mass, Retching, Upper respiratory tract infection
Clinical narrative: Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diptheria crm197 protein) injection) was received from a mother regarding her 7 month old daughter who developed "funny breathing noises grunting or sighing," a croupy type cough, an upper respiratory virus infection, and a lot of phlegm.  At 7 months of age, the pt received the third dose on 01/28/04.  The pt previously experienced an injection site reaction characterized by a lump and redness following receipt of her first dose of Prevnar in 09/03, and grunting, gagging, pallor and pyrexia following receipt of her second dose of Prevnar along with diphtheria, tetanus, acellular pertussis (manufacturer unknown), IPOL, and Comvax vaccines on 11/07/03, at 4 months of age.  The pt had no other relevant medical history.  Indication for Prevnar was immunization.  Product was administered on 01/28/04.  Dose regimen was 1 dose (IM).  The reporter indicated that the infant received no other vaccinations on the same day as the Prevnar injection.  The infant was given Tylenol (acetaminophen) every four hours for three doses beginning before the vaccination.  On 01/29/03 at 01:00am, the pt developed "funny breathing noises grunting or sighing" (grunting).  The mother stated that the breathing noises were constant for about five hours, then intermittent for about two and a half hours before resolving without treatment.  The pt also developed an "infrequent croupy type cough" (cough) and a "full-fledged upper respiratory virus infection (viral upper respiratory tract infection) and a lot of phlegm (throat secretion increased)."  The mother indicated that the infant was given Tylenol (acetaminophen) every four hours for three doses beginning before the vaccination, therefore her temperature was not checked.  It is unknown if the pt had recovered.  See related cases: HQWYE824405FEB04 & HQWYE824505FEB04.  No additional information was available at the date of this report.
Age: 0.7
Sex: F
Vaccine: PNC, PNC
Symptoms: Wheezing
Clinical narrative: Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diptheria crm197 protein) injection) was received from a mother regarding her 7 month old daughter who developed "funny breathing noises grunting or sighing," a croupy type cough, an upper respiratory virus infection, and a lot of phlegm.  At 7 months of age, the pt received the third dose on 01/28/04.  The pt previously experienced an injection site reaction characterized by a lump and redness following receipt of her first dose of Prevnar in 09/03, and grunting, gagging, pallor and pyrexia following receipt of her second dose of Prevnar along with diphtheria, tetanus, acellular pertussis (manufacturer unknown), IPOL, and Comvax vaccines on 11/07/03, at 4 months of age.  The pt had no other relevant medical history.  Indication for Prevnar was immunization.  Product was administered on 01/28/04.  Dose regimen was 1 dose (IM).  The reporter indicated that the infant received no other vaccinations on the same day as the Prevnar injection.  The infant was given Tylenol (acetaminophen) every four hours for three doses beginning before the vaccination.  On 01/29/03 at 01:00am, the pt developed "funny breathing noises grunting or sighing" (grunting).  The mother stated that the breathing noises were constant for about five hours, then intermittent for about two and a half hours before resolving without treatment.  The pt also developed an "infrequent croupy type cough" (cough) and a "full-fledged upper respiratory virus infection (viral upper respiratory tract infection) and a lot of phlegm (throat secretion increased)."  The mother indicated that the infant was given Tylenol (acetaminophen) every four hours for three doses beginning before the vaccination, therefore her temperature was not checked.  It is unknown if the pt had recovered.  See related cases: HQWYE824405FEB04 & HQWYE824505FEB04.  No additional information was available at the date of this report.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Cough, Rhinorrhoea, Urticaria
Clinical narrative: Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 4 month old male infant who, during a well baby visit on 30-Jan-2004, received second doses of Prevnar, Daptacel (Aventis) (diphtheria and tetanus toxoids/acellular pertussis vaccine adsorbed), poliomyelitis vaccine inactivated, along with Act-Hib (Aventis) (haemophilus b conjugate vaccine (tetanus)). During a 4 month old well baby visit on 30-Jan-2004, a male infant received second doses of Prevnar, (urticaria) which resolved in four days. MANUFACTURER'S COMMENT: Information regarding this event has been forwarded to Aventis, manufacturer of the concomitantly administered vaccines. No additional information was available at the time of this report.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Urticaria
Clinical narrative: Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a healthcare professional regarding a 4 month old male infant who, during a well baby visit on 30-Jan-2004, received second doses of Prevnar, Daptacel (Aventis) (diphtheria and tetanus toxoids/acellular pertussis vaccine adsorbed), poliomyelitis vaccine inactivated, along with Act-Hib (Aventis) (haemophilus b conjugate vaccine (tetanus)). During a 4 month old well baby visit on 30-Jan-2004, a male infant received second doses of Prevnar, (urticaria) which resolved in four days. MANUFACTURER'S COMMENT: Information regarding this event has been forwarded to Aventis, manufacturer of the concomitantly administered vaccines. No additional information was available at the time of this report.
Age: 1.27
Sex: M
Vaccine: DTAP, HBHEPB, PNC, DTAP, HBHEPB, PNC, DTAP, HBHEPB, PNC, DTAP, HBHEPB, PNC
Symptoms: Cough, Crying, Febrile convulsion, Grand mal convulsion, High-pitched crying
Clinical narrative: This case was considered medically important. Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diptheria crm197 protein) injection) was received from a nurse regarding a 15-month-old male patient who experienced a seizure and a temperature of 101.4 deg. F. The patient received the third dose on 10-Feb-2004. The patient also received the third dose of Comvax (haemophillus b conjugate vaccine/hepatitis B vaccine) and a dose of Tripedia (diphtheria/ tetanus toxoid/accellular pertussis vaccine) on 10-Feb-2004. Medical history was not provided. Product Details: Indication for Prevnar was immunization. Product was administered on 10-Feb-2004. Dose regiment was 1 dose (intramuscular). Concomitant Therapy: Patient was not taking concomitant therapy. Event Details: On 15-Feb-2004, the patient was seen in an emergency room after experiencing a seizure (convulsion). One hour after the seizure, the child had a temperature of 101.4 deg F. (pyrexia). He was discharged from the emergency room. He recovered. Information regarding this event has been forwarded to manufacturers of the concomitantly administered vaccines. No additional information was available at the date of this report.
Age: 1.27
Sex: M
Vaccine: DTAP, HBHEPB, PNC, DTAP, HBHEPB, PNC, DTAP, HBHEPB, PNC, DTAP, HBHEPB, PNC
Symptoms: Hypersensitivity, Musculoskeletal stiffness, Oral intake reduced, Pallor, Rhinorrhoea
Clinical narrative: This case was considered medically important. Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diptheria crm197 protein) injection) was received from a nurse regarding a 15-month-old male patient who experienced a seizure and a temperature of 101.4 deg. F. The patient received the third dose on 10-Feb-2004. The patient also received the third dose of Comvax (haemophillus b conjugate vaccine/hepatitis B vaccine) and a dose of Tripedia (diphtheria/ tetanus toxoid/accellular pertussis vaccine) on 10-Feb-2004. Medical history was not provided. Product Details: Indication for Prevnar was immunization. Product was administered on 10-Feb-2004. Dose regiment was 1 dose (intramuscular). Concomitant Therapy: Patient was not taking concomitant therapy. Event Details: On 15-Feb-2004, the patient was seen in an emergency room after experiencing a seizure (convulsion). One hour after the seizure, the child had a temperature of 101.4 deg F. (pyrexia). He was discharged from the emergency room. He recovered. Information regarding this event has been forwarded to manufacturers of the concomitantly administered vaccines. No additional information was available at the date of this report.
Age: 1.27
Sex: M
Vaccine: DTAP, HBHEPB, PNC, DTAP, HBHEPB, PNC, DTAP, HBHEPB, PNC, DTAP, HBHEPB, PNC
Symptoms: Tonsillitis, Upper respiratory tract infection
Clinical narrative: This case was considered medically important. Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diptheria crm197 protein) injection) was received from a nurse regarding a 15-month-old male patient who experienced a seizure and a temperature of 101.4 deg. F. The patient received the third dose on 10-Feb-2004. The patient also received the third dose of Comvax (haemophillus b conjugate vaccine/hepatitis B vaccine) and a dose of Tripedia (diphtheria/ tetanus toxoid/accellular pertussis vaccine) on 10-Feb-2004. Medical history was not provided. Product Details: Indication for Prevnar was immunization. Product was administered on 10-Feb-2004. Dose regiment was 1 dose (intramuscular). Concomitant Therapy: Patient was not taking concomitant therapy. Event Details: On 15-Feb-2004, the patient was seen in an emergency room after experiencing a seizure (convulsion). One hour after the seizure, the child had a temperature of 101.4 deg F. (pyrexia). He was discharged from the emergency room. He recovered. Information regarding this event has been forwarded to manufacturers of the concomitantly administered vaccines. No additional information was available at the date of this report.
Age: 1.27
Sex: M
Vaccine: DTAP, HBHEPB, PNC, DTAP, HBHEPB, PNC, DTAP, HBHEPB, PNC, DTAP, HBHEPB, PNC
Symptoms: Convulsion, Cough, Cyst, Dehydration, Eye movement disorder
Clinical narrative: This case was considered medically important. Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diptheria crm197 protein) injection) was received from a nurse regarding a 15-month-old male patient who experienced a seizure and a temperature of 101.4 deg. F. The patient received the third dose on 10-Feb-2004. The patient also received the third dose of Comvax (haemophillus b conjugate vaccine/hepatitis B vaccine) and a dose of Tripedia (diphtheria/ tetanus toxoid/accellular pertussis vaccine) on 10-Feb-2004. Medical history was not provided. Product Details: Indication for Prevnar was immunization. Product was administered on 10-Feb-2004. Dose regiment was 1 dose (intramuscular). Concomitant Therapy: Patient was not taking concomitant therapy. Event Details: On 15-Feb-2004, the patient was seen in an emergency room after experiencing a seizure (convulsion). One hour after the seizure, the child had a temperature of 101.4 deg F. (pyrexia). He was discharged from the emergency room. He recovered. Information regarding this event has been forwarded to manufacturers of the concomitantly administered vaccines. No additional information was available at the date of this report.
Age: 1.27
Sex: M
Vaccine: DTAP, HBHEPB, PNC, DTAP, HBHEPB, PNC, DTAP, HBHEPB, PNC, DTAP, HBHEPB, PNC
Symptoms: Gastroenteritis, Hypoglycaemia, Laboratory test abnormal, Otitis media, Pharyngitis
Clinical narrative: This case was considered medically important. Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diptheria crm197 protein) injection) was received from a nurse regarding a 15-month-old male patient who experienced a seizure and a temperature of 101.4 deg. F. The patient received the third dose on 10-Feb-2004. The patient also received the third dose of Comvax (haemophillus b conjugate vaccine/hepatitis B vaccine) and a dose of Tripedia (diphtheria/ tetanus toxoid/accellular pertussis vaccine) on 10-Feb-2004. Medical history was not provided. Product Details: Indication for Prevnar was immunization. Product was administered on 10-Feb-2004. Dose regiment was 1 dose (intramuscular). Concomitant Therapy: Patient was not taking concomitant therapy. Event Details: On 15-Feb-2004, the patient was seen in an emergency room after experiencing a seizure (convulsion). One hour after the seizure, the child had a temperature of 101.4 deg F. (pyrexia). He was discharged from the emergency room. He recovered. Information regarding this event has been forwarded to manufacturers of the concomitantly administered vaccines. No additional information was available at the date of this report.
Age: 1.27
Sex: M
Vaccine: DTAP, HBHEPB, PNC, DTAP, HBHEPB, PNC, DTAP, HBHEPB, PNC, DTAP, HBHEPB, PNC
Symptoms: Postictal state, Pyrexia, Retching, Rhinitis, Viral infection
Clinical narrative: This case was considered medically important. Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diptheria crm197 protein) injection) was received from a nurse regarding a 15-month-old male patient who experienced a seizure and a temperature of 101.4 deg. F. The patient received the third dose on 10-Feb-2004. The patient also received the third dose of Comvax (haemophillus b conjugate vaccine/hepatitis B vaccine) and a dose of Tripedia (diphtheria/ tetanus toxoid/accellular pertussis vaccine) on 10-Feb-2004. Medical history was not provided. Product Details: Indication for Prevnar was immunization. Product was administered on 10-Feb-2004. Dose regiment was 1 dose (intramuscular). Concomitant Therapy: Patient was not taking concomitant therapy. Event Details: On 15-Feb-2004, the patient was seen in an emergency room after experiencing a seizure (convulsion). One hour after the seizure, the child had a temperature of 101.4 deg F. (pyrexia). He was discharged from the emergency room. He recovered. Information regarding this event has been forwarded to manufacturers of the concomitantly administered vaccines. No additional information was available at the date of this report.
Age: 1.27
Sex: M
Vaccine: DTAP, HBHEPB, PNC, DTAP, HBHEPB, PNC, DTAP, HBHEPB, PNC, DTAP, HBHEPB, PNC
Symptoms: Convulsion, Cyst, Febrile convulsion, Laboratory test abnormal, Muscle spasticity
Clinical narrative: This case was considered medically important. Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diptheria crm197 protein) injection) was received from a nurse regarding a 15-month-old male patient who experienced a seizure and a temperature of 101.4 deg. F. The patient received the third dose on 10-Feb-2004. The patient also received the third dose of Comvax (haemophillus b conjugate vaccine/hepatitis B vaccine) and a dose of Tripedia (diphtheria/ tetanus toxoid/accellular pertussis vaccine) on 10-Feb-2004. Medical history was not provided. Product Details: Indication for Prevnar was immunization. Product was administered on 10-Feb-2004. Dose regiment was 1 dose (intramuscular). Concomitant Therapy: Patient was not taking concomitant therapy. Event Details: On 15-Feb-2004, the patient was seen in an emergency room after experiencing a seizure (convulsion). One hour after the seizure, the child had a temperature of 101.4 deg F. (pyrexia). He was discharged from the emergency room. He recovered. Information regarding this event has been forwarded to manufacturers of the concomitantly administered vaccines. No additional information was available at the date of this report.
Age: 1.27
Sex: M
Vaccine: DTAP, HBHEPB, PNC, DTAP, HBHEPB, PNC, DTAP, HBHEPB, PNC, DTAP, HBHEPB, PNC
Symptoms: Otitis media, Pyrexia
Clinical narrative: This case was considered medically important. Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diptheria crm197 protein) injection) was received from a nurse regarding a 15-month-old male patient who experienced a seizure and a temperature of 101.4 deg. F. The patient received the third dose on 10-Feb-2004. The patient also received the third dose of Comvax (haemophillus b conjugate vaccine/hepatitis B vaccine) and a dose of Tripedia (diphtheria/ tetanus toxoid/accellular pertussis vaccine) on 10-Feb-2004. Medical history was not provided. Product Details: Indication for Prevnar was immunization. Product was administered on 10-Feb-2004. Dose regiment was 1 dose (intramuscular). Concomitant Therapy: Patient was not taking concomitant therapy. Event Details: On 15-Feb-2004, the patient was seen in an emergency room after experiencing a seizure (convulsion). One hour after the seizure, the child had a temperature of 101.4 deg F. (pyrexia). He was discharged from the emergency room. He recovered. Information regarding this event has been forwarded to manufacturers of the concomitantly administered vaccines. No additional information was available at the date of this report.
Age: 1.27
Sex: M
Vaccine: DTAP, HBHEPB, PNC, DTAP, HBHEPB, PNC, DTAP, HBHEPB, PNC, DTAP, HBHEPB, PNC
Symptoms: Convulsion, Pyrexia
Clinical narrative: This case was considered medically important. Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diptheria crm197 protein) injection) was received from a nurse regarding a 15-month-old male patient who experienced a seizure and a temperature of 101.4 deg. F. The patient received the third dose on 10-Feb-2004. The patient also received the third dose of Comvax (haemophillus b conjugate vaccine/hepatitis B vaccine) and a dose of Tripedia (diphtheria/ tetanus toxoid/accellular pertussis vaccine) on 10-Feb-2004. Medical history was not provided. Product Details: Indication for Prevnar was immunization. Product was administered on 10-Feb-2004. Dose regiment was 1 dose (intramuscular). Concomitant Therapy: Patient was not taking concomitant therapy. Event Details: On 15-Feb-2004, the patient was seen in an emergency room after experiencing a seizure (convulsion). One hour after the seizure, the child had a temperature of 101.4 deg F. (pyrexia). He was discharged from the emergency room. He recovered. Information regarding this event has been forwarded to manufacturers of the concomitantly administered vaccines. No additional information was available at the date of this report.