chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Feeling hot, Injection site erythema, Injection site hypersensitivity, Injection site oedema, Injection site reaction
Clinical narrative: DTap on 03/20/2002. Right thigh warm, red, swollen, tender on 03/22/2002. Pt afebrile.
Age: 1.6
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Induration on the anterior thigh, faint erythema at injection site.
Age: 1.25
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Rash vesicular
Clinical narrative: Varicella like rash 5-10 days post vaccine administration.
Age: 1.25
Sex: F
Vaccine: PNC
Symptoms: Pyrexia, Urticaria
Clinical narrative: A nurse reported that a 15 month old female received an injection of Prevnar on 07/03/2000. That day, she developed a "high" fever and a "hive like" body rash. No further info was available at the date of this report.
Age: 0.4
Sex: M
Vaccine: HIBV, PNC
Symptoms: Asthenia, Vomiting, White blood cell count increased
Clinical narrative: A healthcare professional reported that a male infant received Prevnar and Act-Hib vaccines on 03/23/2001 at 5 months of age and Tripedia and Recombivax-HB vaccines on 04/23/2001 at 6months of age. On 04/25/2001, the infant developed vomiting and weakness. On 04/26/2001 at 3am, he was taken to an ER. At 10:30 am the same day, he was transferred to the ER and operating room of another hospital. He died in the ER. The reporter noted that the pt's WBC count was 60,000 cells/cubic mm. "Non specific radiologies" were performed; however, the results were not reported. "Cause of death unknown."
Age: 0.5
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Colitis
Clinical narrative: On 6/12/01, the infant received injections of Infanrix and Act-Hib. It was not known if she had received previous injections of these vaccinations. On 6/14/01, the infant experienced colitis. As of 3/20/02, she had recovered. The adverse event "colitis" is considered to be "Medically Serious".
Age: 0.75
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC
Symptoms: Respiratory disorder, Somnolence
Clinical narrative: This report concerns a 9 month old male who received his first doses of Prevnar, Tripedia, ActHib and IPV as well as his second dose of Engerix-B on 10/24/2001. Immediately following immunization, he let out a sob, "had no breath," seemed to turn blue for 5 or 6 seconds, then seemed to start breathing again. The pt was very drowsy following this episode and slept for approximately 15 mins at the clinic and 1 1/2 hrs at home. As of the date of this report, no further info was available.
Age: 0.4
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, Hypernatraemia, Pyrexia
Clinical narrative: A nurse reported that a 4 month old female received injections of Prevnar, Infanrix, Comvax, and IPOL on 11/29/2001. On 11/30/2001, the day after vaccination, the pt experienced a seizure and a fever of 104 deg. F; she was taken to a local emergency facility. Treatment of the events was not specified. the patient was noted to be "improving" as of 11/30/01.the events were considered to be medically important FOLLOW-UP INFORMATION was received on 01/8/2002 from the original reporting nurse. Laboratory values were provided. A blood culture and urinalysis were negative; see laboratory data section for results. lot numbers were provided for the vaccine administered and it was noted that the patient had not received any other vaccine within 4 weeks of Prevnar (2nd dose) administration. She was not receiving any medications concomitnatly and she had no pre-existing illnesses at the time of vaccination. The patient recovered from the events. FOLLOW-UP INFORMATION was received on 01/15/01 from the physician. He indicated that the infant developed a fever of 105.4 deg F., her eyes rolled back, and her shoulders and chest jerked on and off for a period of 20 minutes. FOLLOW-UP INFORMATION was received on 02/01/02. The infant was reportedly hospitalized for this event.in addition to the seizure and fever, it was reported that the infant had developed diarrhea. FOLLOW-UP INFORMATION received provided a clarification that two 4 month old females fromthe same facility experienced seizures and fever following receipt of Prevnar (See related report HQ9598519DEC2001). The infant in this report did not develop diarrhea, hypernatremia, or hypoglycemia. She was not hospitlaized. She was seen in the emergency room and treated with ibuprofen and acetaminophen. The events resolved the same day. The immunizing physician considered considered these events to be moderate in severity  and "possibly related" to vaccine administration The seizure was considered medically important.
Age: 0.4
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, Eye disorder, Hypernatraemia, Hypoglycaemia
Clinical narrative: A nurse reported that a 4 month old female received injections of Prevnar, Infanrix, Comvax, and IPOL on 11/29/2001. On 11/30/2001, the day after vaccination, the pt experienced a seizure and a fever of 104 deg. F; she was taken to a local emergency facility. Treatment of the events was not specified. the patient was noted to be "improving" as of 11/30/01.the events were considered to be medically important FOLLOW-UP INFORMATION was received on 01/8/2002 from the original reporting nurse. Laboratory values were provided. A blood culture and urinalysis were negative; see laboratory data section for results. lot numbers were provided for the vaccine administered and it was noted that the patient had not received any other vaccine within 4 weeks of Prevnar (2nd dose) administration. She was not receiving any medications concomitnatly and she had no pre-existing illnesses at the time of vaccination. The patient recovered from the events. FOLLOW-UP INFORMATION was received on 01/15/01 from the physician. He indicated that the infant developed a fever of 105.4 deg F., her eyes rolled back, and her shoulders and chest jerked on and off for a period of 20 minutes. FOLLOW-UP INFORMATION was received on 02/01/02. The infant was reportedly hospitalized for this event.in addition to the seizure and fever, it was reported that the infant had developed diarrhea. FOLLOW-UP INFORMATION received provided a clarification that two 4 month old females fromthe same facility experienced seizures and fever following receipt of Prevnar (See related report HQ9598519DEC2001). The infant in this report did not develop diarrhea, hypernatremia, or hypoglycemia. She was not hospitlaized. She was seen in the emergency room and treated with ibuprofen and acetaminophen. The events resolved the same day. The immunizing physician considered considered these events to be moderate in severity  and "possibly related" to vaccine administration The seizure was considered medically important.
Age: 0.4
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 IPOL on 11/29/2001. On 11/30/2001, the day after vaccination, the pt experienced a seizure and a fever of 104 deg. F; she was taken to a local emergency facility. Treatment of the events was not specified. the patient was noted to be "improving" as of 11/30/01.the events were considered to be medically important FOLLOW-UP INFORMATION was received on 01/8/2002 from the original reporting nurse. Laboratory values were provided. A blood culture and urinalysis were negative; see laboratory data section for results. lot numbers were provided for the vaccine administered and it was noted that the patient had not received any other vaccine within 4 weeks of Prevnar (2nd dose) administration. She was not receiving any medications concomitnatly and she had no pre-existing illnesses at the time of vaccination. The patient recovered from the events. FOLLOW-UP INFORMATION was received on 01/15/01 from the physician. He indicated that the infant developed a fever of 105.4 deg F., her eyes rolled back, and her shoulders and chest jerked on and off for a period of 20 minutes. FOLLOW-UP INFORMATION was received on 02/01/02. The infant was reportedly hospitalized for this event.in addition to the seizure and fever, it was reported that the infant had developed diarrhea. FOLLOW-UP INFORMATION received provided a clarification that two 4 month old females fromthe same facility experienced seizures and fever following receipt of Prevnar (See related report HQ9598519DEC2001). The infant in this report did not develop diarrhea, hypernatremia, or hypoglycemia. She was not hospitlaized. She was seen in the emergency room and treated with ibuprofen and acetaminophen. The events resolved the same day. The immunizing physician considered considered these events to be moderate in severity  and "possibly related" to vaccine administration The seizure was considered medically important.
Age: 0.4
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 IPOL on 11/29/2001. On 11/30/2001, the day after vaccination, the pt experienced a seizure and a fever of 104 deg. F; she was taken to a local emergency facility. Treatment of the events was not specified. the patient was noted to be "improving" as of 11/30/01.the events were considered to be medically important FOLLOW-UP INFORMATION was received on 01/8/2002 from the original reporting nurse. Laboratory values were provided. A blood culture and urinalysis were negative; see laboratory data section for results. lot numbers were provided for the vaccine administered and it was noted that the patient had not received any other vaccine within 4 weeks of Prevnar (2nd dose) administration. She was not receiving any medications concomitnatly and she had no pre-existing illnesses at the time of vaccination. The patient recovered from the events. FOLLOW-UP INFORMATION was received on 01/15/01 from the physician. He indicated that the infant developed a fever of 105.4 deg F., her eyes rolled back, and her shoulders and chest jerked on and off for a period of 20 minutes. FOLLOW-UP INFORMATION was received on 02/01/02. The infant was reportedly hospitalized for this event.in addition to the seizure and fever, it was reported that the infant had developed diarrhea. FOLLOW-UP INFORMATION received provided a clarification that two 4 month old females fromthe same facility experienced seizures and fever following receipt of Prevnar (See related report HQ9598519DEC2001). The infant in this report did not develop diarrhea, hypernatremia, or hypoglycemia. She was not hospitlaized. She was seen in the emergency room and treated with ibuprofen and acetaminophen. The events resolved the same day. The immunizing physician considered considered these events to be moderate in severity  and "possibly related" to vaccine administration The seizure was considered medically important.
Age: 0.4
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 IPOL on 11/29/2001. On 11/30/2001, the day after vaccination, the pt experienced a seizure and a fever of 104 deg. F; she was taken to a local emergency facility. Treatment of the events was not specified. the patient was noted to be "improving" as of 11/30/01.the events were considered to be medically important FOLLOW-UP INFORMATION was received on 01/8/2002 from the original reporting nurse. Laboratory values were provided. A blood culture and urinalysis were negative; see laboratory data section for results. lot numbers were provided for the vaccine administered and it was noted that the patient had not received any other vaccine within 4 weeks of Prevnar (2nd dose) administration. She was not receiving any medications concomitnatly and she had no pre-existing illnesses at the time of vaccination. The patient recovered from the events. FOLLOW-UP INFORMATION was received on 01/15/01 from the physician. He indicated that the infant developed a fever of 105.4 deg F., her eyes rolled back, and her shoulders and chest jerked on and off for a period of 20 minutes. FOLLOW-UP INFORMATION was received on 02/01/02. The infant was reportedly hospitalized for this event.in addition to the seizure and fever, it was reported that the infant had developed diarrhea. FOLLOW-UP INFORMATION received provided a clarification that two 4 month old females fromthe same facility experienced seizures and fever following receipt of Prevnar (See related report HQ9598519DEC2001). The infant in this report did not develop diarrhea, hypernatremia, or hypoglycemia. She was not hospitlaized. She was seen in the emergency room and treated with ibuprofen and acetaminophen. The events resolved the same day. The immunizing physician considered considered these events to be moderate in severity  and "possibly related" to vaccine administration The seizure was considered medically important.
Age: 0.4
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 IPOL on 11/29/2001. On 11/30/2001, the day after vaccination, the pt experienced a seizure and a fever of 104 deg. F; she was taken to a local emergency facility. Treatment of the events was not specified. the patient was noted to be "improving" as of 11/30/01.the events were considered to be medically important FOLLOW-UP INFORMATION was received on 01/8/2002 from the original reporting nurse. Laboratory values were provided. A blood culture and urinalysis were negative; see laboratory data section for results. lot numbers were provided for the vaccine administered and it was noted that the patient had not received any other vaccine within 4 weeks of Prevnar (2nd dose) administration. She was not receiving any medications concomitnatly and she had no pre-existing illnesses at the time of vaccination. The patient recovered from the events. FOLLOW-UP INFORMATION was received on 01/15/01 from the physician. He indicated that the infant developed a fever of 105.4 deg F., her eyes rolled back, and her shoulders and chest jerked on and off for a period of 20 minutes. FOLLOW-UP INFORMATION was received on 02/01/02. The infant was reportedly hospitalized for this event.in addition to the seizure and fever, it was reported that the infant had developed diarrhea. FOLLOW-UP INFORMATION received provided a clarification that two 4 month old females fromthe same facility experienced seizures and fever following receipt of Prevnar (See related report HQ9598519DEC2001). The infant in this report did not develop diarrhea, hypernatremia, or hypoglycemia. She was not hospitlaized. She was seen in the emergency room and treated with ibuprofen and acetaminophen. The events resolved the same day. The immunizing physician considered considered these events to be moderate in severity  and "possibly related" to vaccine administration The seizure was considered medically important.
Age: 0.4
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 IPOL on 11/29/2001. On 11/30/2001, the day after vaccination, the pt experienced a seizure and a fever of 104 deg. F; she was taken to a local emergency facility. Treatment of the events was not specified. the patient was noted to be "improving" as of 11/30/01.the events were considered to be medically important FOLLOW-UP INFORMATION was received on 01/8/2002 from the original reporting nurse. Laboratory values were provided. A blood culture and urinalysis were negative; see laboratory data section for results. lot numbers were provided for the vaccine administered and it was noted that the patient had not received any other vaccine within 4 weeks of Prevnar (2nd dose) administration. She was not receiving any medications concomitnatly and she had no pre-existing illnesses at the time of vaccination. The patient recovered from the events. FOLLOW-UP INFORMATION was received on 01/15/01 from the physician. He indicated that the infant developed a fever of 105.4 deg F., her eyes rolled back, and her shoulders and chest jerked on and off for a period of 20 minutes. FOLLOW-UP INFORMATION was received on 02/01/02. The infant was reportedly hospitalized for this event.in addition to the seizure and fever, it was reported that the infant had developed diarrhea. FOLLOW-UP INFORMATION received provided a clarification that two 4 month old females fromthe same facility experienced seizures and fever following receipt of Prevnar (See related report HQ9598519DEC2001). The infant in this report did not develop diarrhea, hypernatremia, or hypoglycemia. She was not hospitlaized. She was seen in the emergency room and treated with ibuprofen and acetaminophen. The events resolved the same day. The immunizing physician considered considered these events to be moderate in severity  and "possibly related" to vaccine administration The seizure was considered medically important.
Age: 0.4
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 IPOL on 11/29/2001. On 11/30/2001, the day after vaccination, the pt experienced a seizure and a fever of 104 deg. F; she was taken to a local emergency facility. Treatment of the events was not specified. the patient was noted to be "improving" as of 11/30/01.the events were considered to be medically important FOLLOW-UP INFORMATION was received on 01/8/2002 from the original reporting nurse. Laboratory values were provided. A blood culture and urinalysis were negative; see laboratory data section for results. lot numbers were provided for the vaccine administered and it was noted that the patient had not received any other vaccine within 4 weeks of Prevnar (2nd dose) administration. She was not receiving any medications concomitnatly and she had no pre-existing illnesses at the time of vaccination. The patient recovered from the events. FOLLOW-UP INFORMATION was received on 01/15/01 from the physician. He indicated that the infant developed a fever of 105.4 deg F., her eyes rolled back, and her shoulders and chest jerked on and off for a period of 20 minutes. FOLLOW-UP INFORMATION was received on 02/01/02. The infant was reportedly hospitalized for this event.in addition to the seizure and fever, it was reported that the infant had developed diarrhea. FOLLOW-UP INFORMATION received provided a clarification that two 4 month old females fromthe same facility experienced seizures and fever following receipt of Prevnar (See related report HQ9598519DEC2001). The infant in this report did not develop diarrhea, hypernatremia, or hypoglycemia. She was not hospitlaized. She was seen in the emergency room and treated with ibuprofen and acetaminophen. The events resolved the same day. The immunizing physician considered considered these events to be moderate in severity  and "possibly related" to vaccine administration The seizure was considered medically important.
Age: 0.4
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 IPOL on 11/29/2001. On 11/30/2001, the day after vaccination, the pt experienced a seizure and a fever of 104 deg. F; she was taken to a local emergency facility. Treatment of the events was not specified. the patient was noted to be "improving" as of 11/30/01.the events were considered to be medically important FOLLOW-UP INFORMATION was received on 01/8/2002 from the original reporting nurse. Laboratory values were provided. A blood culture and urinalysis were negative; see laboratory data section for results. lot numbers were provided for the vaccine administered and it was noted that the patient had not received any other vaccine within 4 weeks of Prevnar (2nd dose) administration. She was not receiving any medications concomitnatly and she had no pre-existing illnesses at the time of vaccination. The patient recovered from the events. FOLLOW-UP INFORMATION was received on 01/15/01 from the physician. He indicated that the infant developed a fever of 105.4 deg F., her eyes rolled back, and her shoulders and chest jerked on and off for a period of 20 minutes. FOLLOW-UP INFORMATION was received on 02/01/02. The infant was reportedly hospitalized for this event.in addition to the seizure and fever, it was reported that the infant had developed diarrhea. FOLLOW-UP INFORMATION received provided a clarification that two 4 month old females fromthe same facility experienced seizures and fever following receipt of Prevnar (See related report HQ9598519DEC2001). The infant in this report did not develop diarrhea, hypernatremia, or hypoglycemia. She was not hospitlaized. She was seen in the emergency room and treated with ibuprofen and acetaminophen. The events resolved the same day. The immunizing physician considered considered these events to be moderate in severity  and "possibly related" to vaccine administration The seizure was considered medically important.
Age: 0.4
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 IPOL on 11/29/2001. On 11/30/2001, the day after vaccination, the pt experienced a seizure and a fever of 104 deg. F; she was taken to a local emergency facility. Treatment of the events was not specified. the patient was noted to be "improving" as of 11/30/01.the events were considered to be medically important FOLLOW-UP INFORMATION was received on 01/8/2002 from the original reporting nurse. Laboratory values were provided. A blood culture and urinalysis were negative; see laboratory data section for results. lot numbers were provided for the vaccine administered and it was noted that the patient had not received any other vaccine within 4 weeks of Prevnar (2nd dose) administration. She was not receiving any medications concomitnatly and she had no pre-existing illnesses at the time of vaccination. The patient recovered from the events. FOLLOW-UP INFORMATION was received on 01/15/01 from the physician. He indicated that the infant developed a fever of 105.4 deg F., her eyes rolled back, and her shoulders and chest jerked on and off for a period of 20 minutes. FOLLOW-UP INFORMATION was received on 02/01/02. The infant was reportedly hospitalized for this event.in addition to the seizure and fever, it was reported that the infant had developed diarrhea. FOLLOW-UP INFORMATION received provided a clarification that two 4 month old females fromthe same facility experienced seizures and fever following receipt of Prevnar (See related report HQ9598519DEC2001). The infant in this report did not develop diarrhea, hypernatremia, or hypoglycemia. She was not hospitlaized. She was seen in the emergency room and treated with ibuprofen and acetaminophen. The events resolved the same day. The immunizing physician considered considered these events to be moderate in severity  and "possibly related" to vaccine administration The seizure was considered medically important.
Age: 0.4
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 IPOL on 11/29/2001. On 11/30/2001, the day after vaccination, the pt experienced a seizure and a fever of 104 deg. F; she was taken to a local emergency facility. Treatment of the events was not specified. the patient was noted to be "improving" as of 11/30/01.the events were considered to be medically important FOLLOW-UP INFORMATION was received on 01/8/2002 from the original reporting nurse. Laboratory values were provided. A blood culture and urinalysis were negative; see laboratory data section for results. lot numbers were provided for the vaccine administered and it was noted that the patient had not received any other vaccine within 4 weeks of Prevnar (2nd dose) administration. She was not receiving any medications concomitnatly and she had no pre-existing illnesses at the time of vaccination. The patient recovered from the events. FOLLOW-UP INFORMATION was received on 01/15/01 from the physician. He indicated that the infant developed a fever of 105.4 deg F., her eyes rolled back, and her shoulders and chest jerked on and off for a period of 20 minutes. FOLLOW-UP INFORMATION was received on 02/01/02. The infant was reportedly hospitalized for this event.in addition to the seizure and fever, it was reported that the infant had developed diarrhea. FOLLOW-UP INFORMATION received provided a clarification that two 4 month old females fromthe same facility experienced seizures and fever following receipt of Prevnar (See related report HQ9598519DEC2001). The infant in this report did not develop diarrhea, hypernatremia, or hypoglycemia. She was not hospitlaized. She was seen in the emergency room and treated with ibuprofen and acetaminophen. The events resolved the same day. The immunizing physician considered considered these events to be moderate in severity  and "possibly related" to vaccine administration The seizure was considered medically important.
Age: 0.4
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 IPOL on 11/29/2001. On 11/30/2001, the day after vaccination, the pt experienced a seizure and a fever of 104 deg. F; she was taken to a local emergency facility. Treatment of the events was not specified. the patient was noted to be "improving" as of 11/30/01.the events were considered to be medically important FOLLOW-UP INFORMATION was received on 01/8/2002 from the original reporting nurse. Laboratory values were provided. A blood culture and urinalysis were negative; see laboratory data section for results. lot numbers were provided for the vaccine administered and it was noted that the patient had not received any other vaccine within 4 weeks of Prevnar (2nd dose) administration. She was not receiving any medications concomitnatly and she had no pre-existing illnesses at the time of vaccination. The patient recovered from the events. FOLLOW-UP INFORMATION was received on 01/15/01 from the physician. He indicated that the infant developed a fever of 105.4 deg F., her eyes rolled back, and her shoulders and chest jerked on and off for a period of 20 minutes. FOLLOW-UP INFORMATION was received on 02/01/02. The infant was reportedly hospitalized for this event.in addition to the seizure and fever, it was reported that the infant had developed diarrhea. FOLLOW-UP INFORMATION received provided a clarification that two 4 month old females fromthe same facility experienced seizures and fever following receipt of Prevnar (See related report HQ9598519DEC2001). The infant in this report did not develop diarrhea, hypernatremia, or hypoglycemia. She was not hospitlaized. She was seen in the emergency room and treated with ibuprofen and acetaminophen. The events resolved the same day. The immunizing physician considered considered these events to be moderate in severity  and "possibly related" to vaccine administration The seizure was considered medically important.
Age: 0.4
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 IPOL on 11/29/2001. On 11/30/2001, the day after vaccination, the pt experienced a seizure and a fever of 104 deg. F; she was taken to a local emergency facility. Treatment of the events was not specified. the patient was noted to be "improving" as of 11/30/01.the events were considered to be medically important FOLLOW-UP INFORMATION was received on 01/8/2002 from the original reporting nurse. Laboratory values were provided. A blood culture and urinalysis were negative; see laboratory data section for results. lot numbers were provided for the vaccine administered and it was noted that the patient had not received any other vaccine within 4 weeks of Prevnar (2nd dose) administration. She was not receiving any medications concomitnatly and she had no pre-existing illnesses at the time of vaccination. The patient recovered from the events. FOLLOW-UP INFORMATION was received on 01/15/01 from the physician. He indicated that the infant developed a fever of 105.4 deg F., her eyes rolled back, and her shoulders and chest jerked on and off for a period of 20 minutes. FOLLOW-UP INFORMATION was received on 02/01/02. The infant was reportedly hospitalized for this event.in addition to the seizure and fever, it was reported that the infant had developed diarrhea. FOLLOW-UP INFORMATION received provided a clarification that two 4 month old females fromthe same facility experienced seizures and fever following receipt of Prevnar (See related report HQ9598519DEC2001). The infant in this report did not develop diarrhea, hypernatremia, or hypoglycemia. She was not hospitlaized. She was seen in the emergency room and treated with ibuprofen and acetaminophen. The events resolved the same day. The immunizing physician considered considered these events to be moderate in severity  and "possibly related" to vaccine administration The seizure was considered medically important.
Age: 0.4
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 IPOL on 11/29/2001. On 11/30/2001, the day after vaccination, the pt experienced a seizure and a fever of 104 deg. F; she was taken to a local emergency facility. Treatment of the events was not specified. the patient was noted to be "improving" as of 11/30/01.the events were considered to be medically important FOLLOW-UP INFORMATION was received on 01/8/2002 from the original reporting nurse. Laboratory values were provided. A blood culture and urinalysis were negative; see laboratory data section for results. lot numbers were provided for the vaccine administered and it was noted that the patient had not received any other vaccine within 4 weeks of Prevnar (2nd dose) administration. She was not receiving any medications concomitnatly and she had no pre-existing illnesses at the time of vaccination. The patient recovered from the events. FOLLOW-UP INFORMATION was received on 01/15/01 from the physician. He indicated that the infant developed a fever of 105.4 deg F., her eyes rolled back, and her shoulders and chest jerked on and off for a period of 20 minutes. FOLLOW-UP INFORMATION was received on 02/01/02. The infant was reportedly hospitalized for this event.in addition to the seizure and fever, it was reported that the infant had developed diarrhea. FOLLOW-UP INFORMATION received provided a clarification that two 4 month old females fromthe same facility experienced seizures and fever following receipt of Prevnar (See related report HQ9598519DEC2001). The infant in this report did not develop diarrhea, hypernatremia, or hypoglycemia. She was not hospitlaized. She was seen in the emergency room and treated with ibuprofen and acetaminophen. The events resolved the same day. The immunizing physician considered considered these events to be moderate in severity  and "possibly related" to vaccine administration The seizure was considered medically important.
Age: 0.75
Sex: M
Vaccine: PNC, PNC
Symptoms: Pyrexia, Rash
Clinical narrative: A nurse reported that a 9 month old male received his first dose of Prevnar in December 2001. Shortly thereafter, the infant developed a "generalized flat red body rash" as well as a fever. The infant was seen in a clinic and was subsequently referred to a physician, who diagnosed a "vaccine reaction." The infant was treated with Benadryl. As of 12/31/2001, the infant was "well" the reporter indicated that the rash resolved 5 days following vaccine administration. No further info was available at the date of this report.
Age: 0.3
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC, DTAP, HIBV, IPV, PNC
Symptoms: Pyrexia, Urticaria
Clinical narrative: A registered nurse reported that a 4 month old male received a 2nd dose of Prevnar, Infanrix, IPOL, and a 1st dose of Pedvax-Hib on 01/03/2002. Concomitant therapy included Synagis. The pt has a past history of meconium aspiration and was treated in the neonatal intensive care unit. On 01/03/2002, eight hours post immunization, the infant developed hives and fever. Following pt's 1st Prevanr immunization on 10/31/2001, he developed hives, fever and viral syndrome and was hospitalized. Follow up info received on 02/05/2002 from the registered nurse contained pt's address and name of the nurse who administered vaccine.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Pyrexia, Urticaria, Viral infection
Clinical narrative: An RN reported that a 7 week old male received a 1st dose of Prevnar, Infanrix and Polio vaccines on 10/31/01. Concomitant therapy included Tylenol, Synagis and Comvax vaccine. The pt has a past history of meconium aspiration and was treated in the neonatal ICU on ECHO for 9 days. On 10/31/01, 8 hours post vax, the infant developed generalized hives and fever of 101F to 103F. The infant was admitted to the hospital on 11/1/01. He was dx'd with "viral syndrome". The pt was observed and treated with diphenhydramine (Benadryl). On 11/2/01, the child was discharged from the hospital. On 11/5/01, the infant was seen for follow-up by his HCP and he recovered. No additional information was available as of the date of this report. Follow-up information received on 2/5/02, states that the pt was seen by Allergist on 12/4/01 for issue of urticaria. The Allergist stated that the "vaccines do not appear to have caused any of his reactions...the time frame is not correct". In the opinion of the Allergist, "...the only potential reactive agent in his reactions could have been thimerosal with some of his vaccines; but, thimerosal vaccines do not cause urticaria as described by the parents". The pt received skin testing and had an "indeterminate reaction to milk and egg". Skin tests will be repeated in 3-6 months. No additional information was available as of the date of this report.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Hypersensitivity, Pyrexia, Urticaria, Viral infection
Clinical narrative: An RN reported that a 7 week old male received a 1st dose of Prevnar, Infanrix and Polio vaccines on 10/31/01. Concomitant therapy included Tylenol, Synagis and Comvax vaccine. The pt has a past history of meconium aspiration and was treated in the neonatal ICU on ECHO for 9 days. On 10/31/01, 8 hours post vax, the infant developed generalized hives and fever of 101F to 103F. The infant was admitted to the hospital on 11/1/01. He was dx'd with "viral syndrome". The pt was observed and treated with diphenhydramine (Benadryl). On 11/2/01, the child was discharged from the hospital. On 11/5/01, the infant was seen for follow-up by his HCP and he recovered. No additional information was available as of the date of this report. Follow-up information received on 2/5/02, states that the pt was seen by Allergist on 12/4/01 for issue of urticaria. The Allergist stated that the "vaccines do not appear to have caused any of his reactions...the time frame is not correct". In the opinion of the Allergist, "...the only potential reactive agent in his reactions could have been thimerosal with some of his vaccines; but, thimerosal vaccines do not cause urticaria as described by the parents". The pt received skin testing and had an "indeterminate reaction to milk and egg". Skin tests will be repeated in 3-6 months. No additional information was available as of the date of this report.
Age: 0.2
Sex: M
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Hypersensitivity, Lactose intolerance, Pyrexia, Urticaria, Viral infection
Clinical narrative: An RN reported that a 7 week old male received a 1st dose of Prevnar, Infanrix and Polio vaccines on 10/31/01. Concomitant therapy included Tylenol, Synagis and Comvax vaccine. The pt has a past history of meconium aspiration and was treated in the neonatal ICU on ECHO for 9 days. On 10/31/01, 8 hours post vax, the infant developed generalized hives and fever of 101F to 103F. The infant was admitted to the hospital on 11/1/01. He was dx'd with "viral syndrome". The pt was observed and treated with diphenhydramine (Benadryl). On 11/2/01, the child was discharged from the hospital. On 11/5/01, the infant was seen for follow-up by his HCP and he recovered. No additional information was available as of the date of this report. Follow-up information received on 2/5/02, states that the pt was seen by Allergist on 12/4/01 for issue of urticaria. The Allergist stated that the "vaccines do not appear to have caused any of his reactions...the time frame is not correct". In the opinion of the Allergist, "...the only potential reactive agent in his reactions could have been thimerosal with some of his vaccines; but, thimerosal vaccines do not cause urticaria as described by the parents". The pt received skin testing and had an "indeterminate reaction to milk and egg". Skin tests will be repeated in 3-6 months. No additional information was available as of the date of this report.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Injection site inflammation, Injection site swelling
Clinical narrative: A nurse reported that a 4 month old female received injections of Prevnar, Comvax, Tripedia and IPV on 01/17/2002. That day, she developed a hard knot and redness at Prevnar injection site. This is 1 of 3 patient from this facility who experienced this event following receipt of 2 different lotss of Prevnar. FOLLOW-UP information received on 03/18/02 indicated that she recovered.
Age: 0.3
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, DTAP, HBHEPB, IPV, PNC
Symptoms: Injection site erythema, Injection site induration, Injection site reaction
Clinical narrative: A nurse reported that a 4 month old female received injections of Prevnar, Comvax, Tripedia and IPV on 01/17/2002. That day, she developed a hard knot and redness at Prevnar injection site. This is 1 of 3 patient from this facility who experienced this event following receipt of 2 different lotss of Prevnar. FOLLOW-UP information received on 03/18/02 indicated that she recovered.
Age: 0.5
Sex: F
Vaccine: DTAP, PNC, DTAP, IPV, PNC
Symptoms: Injection site inflammation, Injection site swelling
Clinical narrative: A nurse reported that a 6-month -old female received injections of Prevnar, tripedia (aventis Pasteur INC), ands IPV (Aventis Pasteur SA) on 03-Jan-2002. That day, she developed a hard knot and redness at Prevnar injection site. This is 1 of 3 patient from this facility who experienced this event following receipt of 2 different lots of Prevnar. FOLLOW-UP information received on 03/19/02 indicated that the infant recovered/
Age: 0.5
Sex: F
Vaccine: DTAP, PNC, DTAP, IPV, PNC
Symptoms: Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: A nurse reported that a 6-month -old female received injections of Prevnar, tripedia (aventis Pasteur INC), ands IPV (Aventis Pasteur SA) on 03-Jan-2002. That day, she developed a hard knot and redness at Prevnar injection site. This is 1 of 3 patient from this facility who experienced this event following receipt of 2 different lots of Prevnar. FOLLOW-UP information received on 03/19/02 indicated that the infant recovered/
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, PNC
Symptoms: Injection site inflammation, Injection site swelling
Clinical narrative: A nurse reported that a 2 month old female received an injection of Prevnar on 01/09/2002. That day, she developed a hard knot and redness at Prevnar injection site. Per F/U 7/2/02: This is 1 of 3 pts from this facility who experienced this event following receipt of 2 different lots of Prevnar. Additional info received from the reporter on 3/19/02, indicated that the pt recovered.
Age: 0.2
Sex: F
Vaccine: DTAP, HBHEPB, IPV, PNC, PNC
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: A nurse reported that a 2 month old female received an injection of Prevnar on 01/09/2002. That day, she developed a hard knot and redness at Prevnar injection site. Per F/U 7/2/02: This is 1 of 3 pts from this facility who experienced this event following receipt of 2 different lots of Prevnar. Additional info received from the reporter on 3/19/02, indicated that the pt recovered.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, PNC, DTAP, IPV, MMR, PNC, DTP, IPV, MMR, PNC
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: A sales representative reported that a 4 year old child received Prevnar, Infanrix, MMR, and IPOL vaccines on 12/17/2001. The pt subsequently developed redness over the body, including the eyes. The child was brought to the hospital but was not admitted. No additional info was available as of the date of this report. Additional info received on 02/04/2002, from the physician via sales representative. On 12/18/2001, the pt developed two injection site reactions characterized by induration, redness and warmth. The area of the reactions measured 5cm x 6cm each and were located on the thighs.  Reported on 06/04/2003: "This report was received at an assigned manufacturer with the control number HQ0475104FEB2001.  This report was originally reported by a physician concerning a Hispanic 4-year-old male patient who on 12/17/2001, in the am, was vaccinated with a dose (Lot # 640964/1096L) of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation).  ON 12/18/2001 the patient developed an injection site reaction.  It was not reported if the patient sought medical attention.  Follow-up information received from a medical assistant indicated that the patient was also vaccinated on 12/17/2001 with concomitant doses of Streptococcus pneumoniae vaccine (PREVNAR) diphtheria toxoid/pertussis vaccine/tetanus toxoid (manufacturer not reported) and poliovirus vaccine (IPOL).  She reported that she did not know the recovery status of the patient.  No additional information is expected.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, PNC, DTAP, IPV, MMR, PNC, DTP, IPV, MMR, PNC
Symptoms: Erythema, Feeling hot, Injection site erythema, Injection site induration, Ocular hyperaemia
Clinical narrative: A sales representative reported that a 4 year old child received Prevnar, Infanrix, MMR, and IPOL vaccines on 12/17/2001. The pt subsequently developed redness over the body, including the eyes. The child was brought to the hospital but was not admitted. No additional info was available as of the date of this report. Additional info received on 02/04/2002, from the physician via sales representative. On 12/18/2001, the pt developed two injection site reactions characterized by induration, redness and warmth. The area of the reactions measured 5cm x 6cm each and were located on the thighs.  Reported on 06/04/2003: "This report was received at an assigned manufacturer with the control number HQ0475104FEB2001.  This report was originally reported by a physician concerning a Hispanic 4-year-old male patient who on 12/17/2001, in the am, was vaccinated with a dose (Lot # 640964/1096L) of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation).  ON 12/18/2001 the patient developed an injection site reaction.  It was not reported if the patient sought medical attention.  Follow-up information received from a medical assistant indicated that the patient was also vaccinated on 12/17/2001 with concomitant doses of Streptococcus pneumoniae vaccine (PREVNAR) diphtheria toxoid/pertussis vaccine/tetanus toxoid (manufacturer not reported) and poliovirus vaccine (IPOL).  She reported that she did not know the recovery status of the patient.  No additional information is expected.