chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.57
Sex: M
Vaccine: VARCEL
Symptoms: Cyst, Drug ineffective, Pyrexia, Rash papular, Skin ulcer
Clinical narrative: Information has been received from a healthcare worker concerning a 7-year-old Filipino and Portuguese male who on 22-Jan-1998 at 13:16 was vaccinated in the left arm with a first dose of varicella virus vaccine live (Oka/Merck) (lot/ #E). There was no concomitant medication. There was no illness at the time of vaccination. The reporter indicated that on 18-Mar-2004, the patient developed varicella break through. Symptoms included lesions, white and red bumps, and a fever. The patient was staying home from school. Unspecified medical attention was sought and no treatment was required. At the time of the report, the patient had not recovered. A product quality complaint was not involved. Follow-up information was received from the healthcare worker who indicated that on 22-Mar-2004 at 11:30 a.m., the patient acquired chickenpox and had a low grade temperature. The symptoms lasted for "eight days." Symptoms included vomiting and red sores on the torso and face. He was given acetaminophen (Tylenol) on the first day only. No diagnostic laboratory tests were performed. The patient recovered on 23-Mar-2004. It was also indicated that an omentum cyst was discovered "about three years later." It was noted that the patient had no adverse events following prior vaccination. Follow-up information received on 03-May-2004 contained the following adverse experience: omentum cyst (onset unknown). No further information is expected.
Age: 1.57
Sex: M
Vaccine: VARCEL
Symptoms: Viral infection, Vomiting
Clinical narrative: Information has been received from a healthcare worker concerning a 7-year-old Filipino and Portuguese male who on 22-Jan-1998 at 13:16 was vaccinated in the left arm with a first dose of varicella virus vaccine live (Oka/Merck) (lot/ #E). There was no concomitant medication. There was no illness at the time of vaccination. The reporter indicated that on 18-Mar-2004, the patient developed varicella break through. Symptoms included lesions, white and red bumps, and a fever. The patient was staying home from school. Unspecified medical attention was sought and no treatment was required. At the time of the report, the patient had not recovered. A product quality complaint was not involved. Follow-up information was received from the healthcare worker who indicated that on 22-Mar-2004 at 11:30 a.m., the patient acquired chickenpox and had a low grade temperature. The symptoms lasted for "eight days." Symptoms included vomiting and red sores on the torso and face. He was given acetaminophen (Tylenol) on the first day only. No diagnostic laboratory tests were performed. The patient recovered on 23-Mar-2004. It was also indicated that an omentum cyst was discovered "about three years later." It was noted that the patient had no adverse events following prior vaccination. Follow-up information received on 03-May-2004 contained the following adverse experience: omentum cyst (onset unknown). No further information is expected.
Age: 2.0
Sex: M
Vaccine: PNC, PNC, PNC, PNC
Symptoms: Apnoea, Coma, Drooling, Electrocardiogram abnormal, Electroencephalogram abnormal
Clinical narrative: This case was considered medically important (OMIC). Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a mother of a 30 month old male pt who experienced two seizure episodes and was found in an unresponsive state with eyes open, lightly fluttery.  At 27 months of age, the pt received the third dose on 13Jan05. History of seizure episode (reported occurring on 16Jan05 and 26Jan05); no trauma or injury. Indication for Prevnar was immunization. Product was administered on 13Jan05. Dose regimen was 1 dose. Pt was not taking concomitant therapy. On 11Apr05, the reporter stated that her son had a seizure episode (convulsion). She awoke at approx 6:30AM with her son next to her in an unresponsive state with his eyes open and slightly fluttery (blepharospasm). The child was not convulsing. This episode lasted about 2 minutes. The child was seen in the ER. A blood level drawn revealed his Depakote level low at 48. The pt was subsequently discharged to home. The mother reported that later in the day, about 1PM, he had another one in his car seat. She additionally noted that the child was exhausted and had not napped. The morning dose of Depakote had not been given as instructed in preparation for another blood level to be drawn. The reporter commented that her son's seizures seem to happen when he is coming out of sleep. She is to follow up with his neurologist on 13May05. The child remained on Depakote (divalproex sodium) 250mg twice daily.  See related cases: HQWYE688812MAY05 and HQWYE743816MAY05. No additional information was available at the time of this report.
Age: 2.0
Sex: M
Vaccine: PNC, PNC, PNC, PNC
Symptoms: Hypoventilation, Staring
Clinical narrative: This case was considered medically important (OMIC). Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a mother of a 30 month old male pt who experienced two seizure episodes and was found in an unresponsive state with eyes open, lightly fluttery.  At 27 months of age, the pt received the third dose on 13Jan05. History of seizure episode (reported occurring on 16Jan05 and 26Jan05); no trauma or injury. Indication for Prevnar was immunization. Product was administered on 13Jan05. Dose regimen was 1 dose. Pt was not taking concomitant therapy. On 11Apr05, the reporter stated that her son had a seizure episode (convulsion). She awoke at approx 6:30AM with her son next to her in an unresponsive state with his eyes open and slightly fluttery (blepharospasm). The child was not convulsing. This episode lasted about 2 minutes. The child was seen in the ER. A blood level drawn revealed his Depakote level low at 48. The pt was subsequently discharged to home. The mother reported that later in the day, about 1PM, he had another one in his car seat. She additionally noted that the child was exhausted and had not napped. The morning dose of Depakote had not been given as instructed in preparation for another blood level to be drawn. The reporter commented that her son's seizures seem to happen when he is coming out of sleep. She is to follow up with his neurologist on 13May05. The child remained on Depakote (divalproex sodium) 250mg twice daily.  See related cases: HQWYE688812MAY05 and HQWYE743816MAY05. No additional information was available at the time of this report.
Age: 2.0
Sex: M
Vaccine: PNC, PNC, PNC, PNC
Symptoms: Blepharospasm, Coma, Convulsion, Fatigue, Gaze palsy
Clinical narrative: This case was considered medically important (OMIC). Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a mother of a 30 month old male pt who experienced two seizure episodes and was found in an unresponsive state with eyes open, lightly fluttery.  At 27 months of age, the pt received the third dose on 13Jan05. History of seizure episode (reported occurring on 16Jan05 and 26Jan05); no trauma or injury. Indication for Prevnar was immunization. Product was administered on 13Jan05. Dose regimen was 1 dose. Pt was not taking concomitant therapy. On 11Apr05, the reporter stated that her son had a seizure episode (convulsion). She awoke at approx 6:30AM with her son next to her in an unresponsive state with his eyes open and slightly fluttery (blepharospasm). The child was not convulsing. This episode lasted about 2 minutes. The child was seen in the ER. A blood level drawn revealed his Depakote level low at 48. The pt was subsequently discharged to home. The mother reported that later in the day, about 1PM, he had another one in his car seat. She additionally noted that the child was exhausted and had not napped. The morning dose of Depakote had not been given as instructed in preparation for another blood level to be drawn. The reporter commented that her son's seizures seem to happen when he is coming out of sleep. She is to follow up with his neurologist on 13May05. The child remained on Depakote (divalproex sodium) 250mg twice daily.  See related cases: HQWYE688812MAY05 and HQWYE743816MAY05. No additional information was available at the time of this report.
Age: 2.0
Sex: M
Vaccine: PNC, PNC, PNC, PNC
Symptoms: Laboratory test abnormal
Clinical narrative: This case was considered medically important (OMIC). Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a mother of a 30 month old male pt who experienced two seizure episodes and was found in an unresponsive state with eyes open, lightly fluttery.  At 27 months of age, the pt received the third dose on 13Jan05. History of seizure episode (reported occurring on 16Jan05 and 26Jan05); no trauma or injury. Indication for Prevnar was immunization. Product was administered on 13Jan05. Dose regimen was 1 dose. Pt was not taking concomitant therapy. On 11Apr05, the reporter stated that her son had a seizure episode (convulsion). She awoke at approx 6:30AM with her son next to her in an unresponsive state with his eyes open and slightly fluttery (blepharospasm). The child was not convulsing. This episode lasted about 2 minutes. The child was seen in the ER. A blood level drawn revealed his Depakote level low at 48. The pt was subsequently discharged to home. The mother reported that later in the day, about 1PM, he had another one in his car seat. She additionally noted that the child was exhausted and had not napped. The morning dose of Depakote had not been given as instructed in preparation for another blood level to be drawn. The reporter commented that her son's seizures seem to happen when he is coming out of sleep. She is to follow up with his neurologist on 13May05. The child remained on Depakote (divalproex sodium) 250mg twice daily.  See related cases: HQWYE688812MAY05 and HQWYE743816MAY05. No additional information was available at the time of this report.
Age: 2.0
Sex: M
Vaccine: PNC, PNC, PNC, PNC
Symptoms: Catatonia, Convulsion, Cyanosis, Hypotonia
Clinical narrative: This case was considered medically important (OMIC). Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a mother of a 30 month old male pt who experienced two seizure episodes and was found in an unresponsive state with eyes open, lightly fluttery.  At 27 months of age, the pt received the third dose on 13Jan05. History of seizure episode (reported occurring on 16Jan05 and 26Jan05); no trauma or injury. Indication for Prevnar was immunization. Product was administered on 13Jan05. Dose regimen was 1 dose. Pt was not taking concomitant therapy. On 11Apr05, the reporter stated that her son had a seizure episode (convulsion). She awoke at approx 6:30AM with her son next to her in an unresponsive state with his eyes open and slightly fluttery (blepharospasm). The child was not convulsing. This episode lasted about 2 minutes. The child was seen in the ER. A blood level drawn revealed his Depakote level low at 48. The pt was subsequently discharged to home. The mother reported that later in the day, about 1PM, he had another one in his car seat. She additionally noted that the child was exhausted and had not napped. The morning dose of Depakote had not been given as instructed in preparation for another blood level to be drawn. The reporter commented that her son's seizures seem to happen when he is coming out of sleep. She is to follow up with his neurologist on 13May05. The child remained on Depakote (divalproex sodium) 250mg twice daily.  See related cases: HQWYE688812MAY05 and HQWYE743816MAY05. No additional information was available at the time of this report.
Age: 2.0
Sex: M
Vaccine: PNC, PNC, PNC, PNC
Symptoms: Catatonia, Coma, Convulsion, Crying, Cyanosis
Clinical narrative: This case was considered medically important (OMIC). Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a mother of a 30 month old male pt who experienced two seizure episodes and was found in an unresponsive state with eyes open, lightly fluttery.  At 27 months of age, the pt received the third dose on 13Jan05. History of seizure episode (reported occurring on 16Jan05 and 26Jan05); no trauma or injury. Indication for Prevnar was immunization. Product was administered on 13Jan05. Dose regimen was 1 dose. Pt was not taking concomitant therapy. On 11Apr05, the reporter stated that her son had a seizure episode (convulsion). She awoke at approx 6:30AM with her son next to her in an unresponsive state with his eyes open and slightly fluttery (blepharospasm). The child was not convulsing. This episode lasted about 2 minutes. The child was seen in the ER. A blood level drawn revealed his Depakote level low at 48. The pt was subsequently discharged to home. The mother reported that later in the day, about 1PM, he had another one in his car seat. She additionally noted that the child was exhausted and had not napped. The morning dose of Depakote had not been given as instructed in preparation for another blood level to be drawn. The reporter commented that her son's seizures seem to happen when he is coming out of sleep. She is to follow up with his neurologist on 13May05. The child remained on Depakote (divalproex sodium) 250mg twice daily.  See related cases: HQWYE688812MAY05 and HQWYE743816MAY05. No additional information was available at the time of this report.
Age: 2.0
Sex: M
Vaccine: PNC, PNC, PNC, PNC
Symptoms: Drooling, Feeling abnormal, Gaze palsy, Hypotonia, Hypoventilation
Clinical narrative: This case was considered medically important (OMIC). Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a mother of a 30 month old male pt who experienced two seizure episodes and was found in an unresponsive state with eyes open, lightly fluttery.  At 27 months of age, the pt received the third dose on 13Jan05. History of seizure episode (reported occurring on 16Jan05 and 26Jan05); no trauma or injury. Indication for Prevnar was immunization. Product was administered on 13Jan05. Dose regimen was 1 dose. Pt was not taking concomitant therapy. On 11Apr05, the reporter stated that her son had a seizure episode (convulsion). She awoke at approx 6:30AM with her son next to her in an unresponsive state with his eyes open and slightly fluttery (blepharospasm). The child was not convulsing. This episode lasted about 2 minutes. The child was seen in the ER. A blood level drawn revealed his Depakote level low at 48. The pt was subsequently discharged to home. The mother reported that later in the day, about 1PM, he had another one in his car seat. She additionally noted that the child was exhausted and had not napped. The morning dose of Depakote had not been given as instructed in preparation for another blood level to be drawn. The reporter commented that her son's seizures seem to happen when he is coming out of sleep. She is to follow up with his neurologist on 13May05. The child remained on Depakote (divalproex sodium) 250mg twice daily.  See related cases: HQWYE688812MAY05 and HQWYE743816MAY05. No additional information was available at the time of this report.
Age: 2.0
Sex: M
Vaccine: PNC, PNC, PNC, PNC
Symptoms: Screaming
Clinical narrative: This case was considered medically important (OMIC). Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a mother of a 30 month old male pt who experienced two seizure episodes and was found in an unresponsive state with eyes open, lightly fluttery.  At 27 months of age, the pt received the third dose on 13Jan05. History of seizure episode (reported occurring on 16Jan05 and 26Jan05); no trauma or injury. Indication for Prevnar was immunization. Product was administered on 13Jan05. Dose regimen was 1 dose. Pt was not taking concomitant therapy. On 11Apr05, the reporter stated that her son had a seizure episode (convulsion). She awoke at approx 6:30AM with her son next to her in an unresponsive state with his eyes open and slightly fluttery (blepharospasm). The child was not convulsing. This episode lasted about 2 minutes. The child was seen in the ER. A blood level drawn revealed his Depakote level low at 48. The pt was subsequently discharged to home. The mother reported that later in the day, about 1PM, he had another one in his car seat. She additionally noted that the child was exhausted and had not napped. The morning dose of Depakote had not been given as instructed in preparation for another blood level to be drawn. The reporter commented that her son's seizures seem to happen when he is coming out of sleep. She is to follow up with his neurologist on 13May05. The child remained on Depakote (divalproex sodium) 250mg twice daily.  See related cases: HQWYE688812MAY05 and HQWYE743816MAY05. No additional information was available at the time of this report.
Age: 2.0
Sex: M
Vaccine: PNC, PNC, PNC, PNC
Symptoms: Apnoea, Coma, Drooling, Electrocardiogram abnormal, Electroencephalogram abnormal
Clinical narrative: Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a mother of a 27 month old male pt who was found limp, cyanotic, catatonic, and experienced generalized seizures. At 27 months of age, the pt received a dose on 13Jan05. History of seizure episode (reported occurring on 16Jan05) lasting 45 minutes; no trauma or injury. Indication for Prevnar was immunization. Product was administered on 13Jan05. Dose regimen was 1 dose. Pt was not taking concomitant therapy.  Early in the morning on 26Jan05, the reporter found the pt limp. He became cyanotic and catatonic. The pt  was hospitalized for evaluation. He was started on Depakote sprinkles (divalproex sodium) 150mg twice daily, which was later increased to 250mg twice daily. It was reported that the pt's EEG results showed "spikes indicative of generalized seizures/convulsion). The mother stated that the doctors seemed perplexed and that the pt was referred to as not a typical case by a neurologist. The pt remained hospitalized for 2 days; no other treatment was given. See related cases: HQWYE688812MAY05 and HQWYE743916MAY05. No additional information was available at the time of this report.
Age: 2.0
Sex: M
Vaccine: PNC, PNC, PNC, PNC
Symptoms: Hypoventilation, Staring
Clinical narrative: Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a mother of a 27 month old male pt who was found limp, cyanotic, catatonic, and experienced generalized seizures. At 27 months of age, the pt received a dose on 13Jan05. History of seizure episode (reported occurring on 16Jan05) lasting 45 minutes; no trauma or injury. Indication for Prevnar was immunization. Product was administered on 13Jan05. Dose regimen was 1 dose. Pt was not taking concomitant therapy.  Early in the morning on 26Jan05, the reporter found the pt limp. He became cyanotic and catatonic. The pt  was hospitalized for evaluation. He was started on Depakote sprinkles (divalproex sodium) 150mg twice daily, which was later increased to 250mg twice daily. It was reported that the pt's EEG results showed "spikes indicative of generalized seizures/convulsion). The mother stated that the doctors seemed perplexed and that the pt was referred to as not a typical case by a neurologist. The pt remained hospitalized for 2 days; no other treatment was given. See related cases: HQWYE688812MAY05 and HQWYE743916MAY05. No additional information was available at the time of this report.
Age: 2.0
Sex: M
Vaccine: PNC, PNC, PNC, PNC
Symptoms: Blepharospasm, Coma, Convulsion, Fatigue, Gaze palsy
Clinical narrative: Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a mother of a 27 month old male pt who was found limp, cyanotic, catatonic, and experienced generalized seizures. At 27 months of age, the pt received a dose on 13Jan05. History of seizure episode (reported occurring on 16Jan05) lasting 45 minutes; no trauma or injury. Indication for Prevnar was immunization. Product was administered on 13Jan05. Dose regimen was 1 dose. Pt was not taking concomitant therapy.  Early in the morning on 26Jan05, the reporter found the pt limp. He became cyanotic and catatonic. The pt  was hospitalized for evaluation. He was started on Depakote sprinkles (divalproex sodium) 150mg twice daily, which was later increased to 250mg twice daily. It was reported that the pt's EEG results showed "spikes indicative of generalized seizures/convulsion). The mother stated that the doctors seemed perplexed and that the pt was referred to as not a typical case by a neurologist. The pt remained hospitalized for 2 days; no other treatment was given. See related cases: HQWYE688812MAY05 and HQWYE743916MAY05. No additional information was available at the time of this report.
Age: 2.0
Sex: M
Vaccine: PNC, PNC, PNC, PNC
Symptoms: Laboratory test abnormal
Clinical narrative: Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a mother of a 27 month old male pt who was found limp, cyanotic, catatonic, and experienced generalized seizures. At 27 months of age, the pt received a dose on 13Jan05. History of seizure episode (reported occurring on 16Jan05) lasting 45 minutes; no trauma or injury. Indication for Prevnar was immunization. Product was administered on 13Jan05. Dose regimen was 1 dose. Pt was not taking concomitant therapy.  Early in the morning on 26Jan05, the reporter found the pt limp. He became cyanotic and catatonic. The pt  was hospitalized for evaluation. He was started on Depakote sprinkles (divalproex sodium) 150mg twice daily, which was later increased to 250mg twice daily. It was reported that the pt's EEG results showed "spikes indicative of generalized seizures/convulsion). The mother stated that the doctors seemed perplexed and that the pt was referred to as not a typical case by a neurologist. The pt remained hospitalized for 2 days; no other treatment was given. See related cases: HQWYE688812MAY05 and HQWYE743916MAY05. No additional information was available at the time of this report.
Age: 2.0
Sex: M
Vaccine: PNC, PNC, PNC, PNC
Symptoms: Catatonia, Convulsion, Cyanosis, Hypotonia
Clinical narrative: Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a mother of a 27 month old male pt who was found limp, cyanotic, catatonic, and experienced generalized seizures. At 27 months of age, the pt received a dose on 13Jan05. History of seizure episode (reported occurring on 16Jan05) lasting 45 minutes; no trauma or injury. Indication for Prevnar was immunization. Product was administered on 13Jan05. Dose regimen was 1 dose. Pt was not taking concomitant therapy.  Early in the morning on 26Jan05, the reporter found the pt limp. He became cyanotic and catatonic. The pt  was hospitalized for evaluation. He was started on Depakote sprinkles (divalproex sodium) 150mg twice daily, which was later increased to 250mg twice daily. It was reported that the pt's EEG results showed "spikes indicative of generalized seizures/convulsion). The mother stated that the doctors seemed perplexed and that the pt was referred to as not a typical case by a neurologist. The pt remained hospitalized for 2 days; no other treatment was given. See related cases: HQWYE688812MAY05 and HQWYE743916MAY05. No additional information was available at the time of this report.
Age: 2.0
Sex: M
Vaccine: PNC, PNC, PNC, PNC
Symptoms: Catatonia, Coma, Convulsion, Crying, Cyanosis
Clinical narrative: Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a mother of a 27 month old male pt who was found limp, cyanotic, catatonic, and experienced generalized seizures. At 27 months of age, the pt received a dose on 13Jan05. History of seizure episode (reported occurring on 16Jan05) lasting 45 minutes; no trauma or injury. Indication for Prevnar was immunization. Product was administered on 13Jan05. Dose regimen was 1 dose. Pt was not taking concomitant therapy.  Early in the morning on 26Jan05, the reporter found the pt limp. He became cyanotic and catatonic. The pt  was hospitalized for evaluation. He was started on Depakote sprinkles (divalproex sodium) 150mg twice daily, which was later increased to 250mg twice daily. It was reported that the pt's EEG results showed "spikes indicative of generalized seizures/convulsion). The mother stated that the doctors seemed perplexed and that the pt was referred to as not a typical case by a neurologist. The pt remained hospitalized for 2 days; no other treatment was given. See related cases: HQWYE688812MAY05 and HQWYE743916MAY05. No additional information was available at the time of this report.
Age: 2.0
Sex: M
Vaccine: PNC, PNC, PNC, PNC
Symptoms: Drooling, Feeling abnormal, Gaze palsy, Hypotonia, Hypoventilation
Clinical narrative: Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a mother of a 27 month old male pt who was found limp, cyanotic, catatonic, and experienced generalized seizures. At 27 months of age, the pt received a dose on 13Jan05. History of seizure episode (reported occurring on 16Jan05) lasting 45 minutes; no trauma or injury. Indication for Prevnar was immunization. Product was administered on 13Jan05. Dose regimen was 1 dose. Pt was not taking concomitant therapy.  Early in the morning on 26Jan05, the reporter found the pt limp. He became cyanotic and catatonic. The pt  was hospitalized for evaluation. He was started on Depakote sprinkles (divalproex sodium) 150mg twice daily, which was later increased to 250mg twice daily. It was reported that the pt's EEG results showed "spikes indicative of generalized seizures/convulsion). The mother stated that the doctors seemed perplexed and that the pt was referred to as not a typical case by a neurologist. The pt remained hospitalized for 2 days; no other treatment was given. See related cases: HQWYE688812MAY05 and HQWYE743916MAY05. No additional information was available at the time of this report.
Age: 2.0
Sex: M
Vaccine: PNC, PNC, PNC, PNC
Symptoms: Screaming
Clinical narrative: Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a mother of a 27 month old male pt who was found limp, cyanotic, catatonic, and experienced generalized seizures. At 27 months of age, the pt received a dose on 13Jan05. History of seizure episode (reported occurring on 16Jan05) lasting 45 minutes; no trauma or injury. Indication for Prevnar was immunization. Product was administered on 13Jan05. Dose regimen was 1 dose. Pt was not taking concomitant therapy.  Early in the morning on 26Jan05, the reporter found the pt limp. He became cyanotic and catatonic. The pt  was hospitalized for evaluation. He was started on Depakote sprinkles (divalproex sodium) 150mg twice daily, which was later increased to 250mg twice daily. It was reported that the pt's EEG results showed "spikes indicative of generalized seizures/convulsion). The mother stated that the doctors seemed perplexed and that the pt was referred to as not a typical case by a neurologist. The pt remained hospitalized for 2 days; no other treatment was given. See related cases: HQWYE688812MAY05 and HQWYE743916MAY05. No additional information was available at the time of this report.
Age: 2.0
Sex: M
Vaccine: PNC, PNC, PNC, PNC
Symptoms: Apnoea, Coma, Drooling, Electrocardiogram abnormal, Electroencephalogram abnormal
Clinical narrative: This case was considered medically important (OMIC). Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a mother of a 27 month old male pt who experienced crying after vaccination. Three days later the child was found limp and lifeless, eyes wide open, barely breathing, unresponsive, catatonic, lips turned blue and experienced seizures. At 27 months of age, the pt received the third dose on 13Jan05. No family history, no trauma or injury. Indication for Prevnar was immunization. Product was administered on 13Jan05. Dose regimen was 1 dose. Pt was not taking concomitant therapy. It was reported that after receiving his third dose of Prevnar vaccine on 13Jan05, the pt cried all day and half of the following day. The injection site looked normal. At 6AM on 16Jan05, the reporter awoke to find her son limp and lifeless in her bed with his eyes wide open barely breathing, drooling, lips turned blue and completely unresponsive. The reporter called 911; when the EMT's arrived, they also could not get a response. The child was taken to the ER. The reporter stated that although her son continued breathing, he was catatonic for 45 minutes. He did not jerk or convulse. The EMT's suspected a febrile seizure. The mother stated that her child was not hot and when checked by hospital staff, his temp was normal. Reportedly, the event resolved spontaneously on the same day without treatment. The child was later evaluated by a pediatrician and no cause for the event was determined. The reporter referred to all events as seizures. See related cases: HQWYE743816MAY05 and HQWYE743916MAY05. No additional information was available at the time of this report.
Age: 2.0
Sex: M
Vaccine: PNC, PNC, PNC, PNC
Symptoms: Hypoventilation, Staring
Clinical narrative: This case was considered medically important (OMIC). Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a mother of a 27 month old male pt who experienced crying after vaccination. Three days later the child was found limp and lifeless, eyes wide open, barely breathing, unresponsive, catatonic, lips turned blue and experienced seizures. At 27 months of age, the pt received the third dose on 13Jan05. No family history, no trauma or injury. Indication for Prevnar was immunization. Product was administered on 13Jan05. Dose regimen was 1 dose. Pt was not taking concomitant therapy. It was reported that after receiving his third dose of Prevnar vaccine on 13Jan05, the pt cried all day and half of the following day. The injection site looked normal. At 6AM on 16Jan05, the reporter awoke to find her son limp and lifeless in her bed with his eyes wide open barely breathing, drooling, lips turned blue and completely unresponsive. The reporter called 911; when the EMT's arrived, they also could not get a response. The child was taken to the ER. The reporter stated that although her son continued breathing, he was catatonic for 45 minutes. He did not jerk or convulse. The EMT's suspected a febrile seizure. The mother stated that her child was not hot and when checked by hospital staff, his temp was normal. Reportedly, the event resolved spontaneously on the same day without treatment. The child was later evaluated by a pediatrician and no cause for the event was determined. The reporter referred to all events as seizures. See related cases: HQWYE743816MAY05 and HQWYE743916MAY05. No additional information was available at the time of this report.
Age: 2.0
Sex: M
Vaccine: PNC, PNC, PNC, PNC
Symptoms: Blepharospasm, Coma, Convulsion, Fatigue, Gaze palsy
Clinical narrative: This case was considered medically important (OMIC). Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a mother of a 27 month old male pt who experienced crying after vaccination. Three days later the child was found limp and lifeless, eyes wide open, barely breathing, unresponsive, catatonic, lips turned blue and experienced seizures. At 27 months of age, the pt received the third dose on 13Jan05. No family history, no trauma or injury. Indication for Prevnar was immunization. Product was administered on 13Jan05. Dose regimen was 1 dose. Pt was not taking concomitant therapy. It was reported that after receiving his third dose of Prevnar vaccine on 13Jan05, the pt cried all day and half of the following day. The injection site looked normal. At 6AM on 16Jan05, the reporter awoke to find her son limp and lifeless in her bed with his eyes wide open barely breathing, drooling, lips turned blue and completely unresponsive. The reporter called 911; when the EMT's arrived, they also could not get a response. The child was taken to the ER. The reporter stated that although her son continued breathing, he was catatonic for 45 minutes. He did not jerk or convulse. The EMT's suspected a febrile seizure. The mother stated that her child was not hot and when checked by hospital staff, his temp was normal. Reportedly, the event resolved spontaneously on the same day without treatment. The child was later evaluated by a pediatrician and no cause for the event was determined. The reporter referred to all events as seizures. See related cases: HQWYE743816MAY05 and HQWYE743916MAY05. No additional information was available at the time of this report.
Age: 2.0
Sex: M
Vaccine: PNC, PNC, PNC, PNC
Symptoms: Laboratory test abnormal
Clinical narrative: This case was considered medically important (OMIC). Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a mother of a 27 month old male pt who experienced crying after vaccination. Three days later the child was found limp and lifeless, eyes wide open, barely breathing, unresponsive, catatonic, lips turned blue and experienced seizures. At 27 months of age, the pt received the third dose on 13Jan05. No family history, no trauma or injury. Indication for Prevnar was immunization. Product was administered on 13Jan05. Dose regimen was 1 dose. Pt was not taking concomitant therapy. It was reported that after receiving his third dose of Prevnar vaccine on 13Jan05, the pt cried all day and half of the following day. The injection site looked normal. At 6AM on 16Jan05, the reporter awoke to find her son limp and lifeless in her bed with his eyes wide open barely breathing, drooling, lips turned blue and completely unresponsive. The reporter called 911; when the EMT's arrived, they also could not get a response. The child was taken to the ER. The reporter stated that although her son continued breathing, he was catatonic for 45 minutes. He did not jerk or convulse. The EMT's suspected a febrile seizure. The mother stated that her child was not hot and when checked by hospital staff, his temp was normal. Reportedly, the event resolved spontaneously on the same day without treatment. The child was later evaluated by a pediatrician and no cause for the event was determined. The reporter referred to all events as seizures. See related cases: HQWYE743816MAY05 and HQWYE743916MAY05. No additional information was available at the time of this report.
Age: 2.0
Sex: M
Vaccine: PNC, PNC, PNC, PNC
Symptoms: Catatonia, Convulsion, Cyanosis, Hypotonia
Clinical narrative: This case was considered medically important (OMIC). Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a mother of a 27 month old male pt who experienced crying after vaccination. Three days later the child was found limp and lifeless, eyes wide open, barely breathing, unresponsive, catatonic, lips turned blue and experienced seizures. At 27 months of age, the pt received the third dose on 13Jan05. No family history, no trauma or injury. Indication for Prevnar was immunization. Product was administered on 13Jan05. Dose regimen was 1 dose. Pt was not taking concomitant therapy. It was reported that after receiving his third dose of Prevnar vaccine on 13Jan05, the pt cried all day and half of the following day. The injection site looked normal. At 6AM on 16Jan05, the reporter awoke to find her son limp and lifeless in her bed with his eyes wide open barely breathing, drooling, lips turned blue and completely unresponsive. The reporter called 911; when the EMT's arrived, they also could not get a response. The child was taken to the ER. The reporter stated that although her son continued breathing, he was catatonic for 45 minutes. He did not jerk or convulse. The EMT's suspected a febrile seizure. The mother stated that her child was not hot and when checked by hospital staff, his temp was normal. Reportedly, the event resolved spontaneously on the same day without treatment. The child was later evaluated by a pediatrician and no cause for the event was determined. The reporter referred to all events as seizures. See related cases: HQWYE743816MAY05 and HQWYE743916MAY05. No additional information was available at the time of this report.
Age: 2.0
Sex: M
Vaccine: PNC, PNC, PNC, PNC
Symptoms: Catatonia, Coma, Convulsion, Crying, Cyanosis
Clinical narrative: This case was considered medically important (OMIC). Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a mother of a 27 month old male pt who experienced crying after vaccination. Three days later the child was found limp and lifeless, eyes wide open, barely breathing, unresponsive, catatonic, lips turned blue and experienced seizures. At 27 months of age, the pt received the third dose on 13Jan05. No family history, no trauma or injury. Indication for Prevnar was immunization. Product was administered on 13Jan05. Dose regimen was 1 dose. Pt was not taking concomitant therapy. It was reported that after receiving his third dose of Prevnar vaccine on 13Jan05, the pt cried all day and half of the following day. The injection site looked normal. At 6AM on 16Jan05, the reporter awoke to find her son limp and lifeless in her bed with his eyes wide open barely breathing, drooling, lips turned blue and completely unresponsive. The reporter called 911; when the EMT's arrived, they also could not get a response. The child was taken to the ER. The reporter stated that although her son continued breathing, he was catatonic for 45 minutes. He did not jerk or convulse. The EMT's suspected a febrile seizure. The mother stated that her child was not hot and when checked by hospital staff, his temp was normal. Reportedly, the event resolved spontaneously on the same day without treatment. The child was later evaluated by a pediatrician and no cause for the event was determined. The reporter referred to all events as seizures. See related cases: HQWYE743816MAY05 and HQWYE743916MAY05. No additional information was available at the time of this report.
Age: 2.0
Sex: M
Vaccine: PNC, PNC, PNC, PNC
Symptoms: Drooling, Feeling abnormal, Gaze palsy, Hypotonia, Hypoventilation
Clinical narrative: This case was considered medically important (OMIC). Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a mother of a 27 month old male pt who experienced crying after vaccination. Three days later the child was found limp and lifeless, eyes wide open, barely breathing, unresponsive, catatonic, lips turned blue and experienced seizures. At 27 months of age, the pt received the third dose on 13Jan05. No family history, no trauma or injury. Indication for Prevnar was immunization. Product was administered on 13Jan05. Dose regimen was 1 dose. Pt was not taking concomitant therapy. It was reported that after receiving his third dose of Prevnar vaccine on 13Jan05, the pt cried all day and half of the following day. The injection site looked normal. At 6AM on 16Jan05, the reporter awoke to find her son limp and lifeless in her bed with his eyes wide open barely breathing, drooling, lips turned blue and completely unresponsive. The reporter called 911; when the EMT's arrived, they also could not get a response. The child was taken to the ER. The reporter stated that although her son continued breathing, he was catatonic for 45 minutes. He did not jerk or convulse. The EMT's suspected a febrile seizure. The mother stated that her child was not hot and when checked by hospital staff, his temp was normal. Reportedly, the event resolved spontaneously on the same day without treatment. The child was later evaluated by a pediatrician and no cause for the event was determined. The reporter referred to all events as seizures. See related cases: HQWYE743816MAY05 and HQWYE743916MAY05. No additional information was available at the time of this report.
Age: 2.0
Sex: M
Vaccine: PNC, PNC, PNC, PNC
Symptoms: Screaming
Clinical narrative: This case was considered medically important (OMIC). Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a mother of a 27 month old male pt who experienced crying after vaccination. Three days later the child was found limp and lifeless, eyes wide open, barely breathing, unresponsive, catatonic, lips turned blue and experienced seizures. At 27 months of age, the pt received the third dose on 13Jan05. No family history, no trauma or injury. Indication for Prevnar was immunization. Product was administered on 13Jan05. Dose regimen was 1 dose. Pt was not taking concomitant therapy. It was reported that after receiving his third dose of Prevnar vaccine on 13Jan05, the pt cried all day and half of the following day. The injection site looked normal. At 6AM on 16Jan05, the reporter awoke to find her son limp and lifeless in her bed with his eyes wide open barely breathing, drooling, lips turned blue and completely unresponsive. The reporter called 911; when the EMT's arrived, they also could not get a response. The child was taken to the ER. The reporter stated that although her son continued breathing, he was catatonic for 45 minutes. He did not jerk or convulse. The EMT's suspected a febrile seizure. The mother stated that her child was not hot and when checked by hospital staff, his temp was normal. Reportedly, the event resolved spontaneously on the same day without treatment. The child was later evaluated by a pediatrician and no cause for the event was determined. The reporter referred to all events as seizures. See related cases: HQWYE743816MAY05 and HQWYE743916MAY05. No additional information was available at the time of this report.
Age: 1.42
Sex: M
Vaccine: FLUX
Symptoms: Autism, Gastrointestinal disorder, Immune system disorder, Influenza, Laboratory test abnormal
Clinical narrative: After his flu vaccine, he had stomach flu (low energy levels) etc for 10 days. He is now autistic.
Age: 1.42
Sex: M
Vaccine: FLUX
Symptoms: Viral infection
Clinical narrative: After his flu vaccine, he had stomach flu (low energy levels) etc for 10 days. He is now autistic.
Age: 3.0
Sex: M
Vaccine: PPV
Symptoms: Abdominal distension, Abdominal pain, Bacterial infection, Drug ineffective, Headache
Clinical narrative: Information has been received from a health professional concerning a 6 year old pt who was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine at 3 years of age. Subsequently, at 6 years old, the pt died from pneumococcal disease. The physician indicated that she believes the child did not get a second vaccination.  Additional information has been requested. Discharge Summary rec'd 06/21/2005 states additional terms as abdominal pain, tachycardia, photophobia, headache, distended abdomen, pulse absent and hypotension.
Age: 3.0
Sex: M
Vaccine: PPV
Symptoms: Hypotension, Photophobia, Pulse absent, Tachycardia
Clinical narrative: Information has been received from a health professional concerning a 6 year old pt who was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine at 3 years of age. Subsequently, at 6 years old, the pt died from pneumococcal disease. The physician indicated that she believes the child did not get a second vaccination.  Additional information has been requested. Discharge Summary rec'd 06/21/2005 states additional terms as abdominal pain, tachycardia, photophobia, headache, distended abdomen, pulse absent and hypotension.
Age: 11.0
Sex: M
Vaccine: MNQ, TD
Symptoms: Swelling face, Urticaria
Clinical narrative: From initial information received on 06May05 from a health care professional, it was reported that an 11 year old male pt received a booster dose of Decavac, lot number U1215AA, in the left deltoid and a dose of Menactra, lot number U1526AC, in the right deltoid on 04May05 at 5:00PM. Three hours later, on 04May05 at 8:00PM, the pt developed generalized hives throughout his body and lip swelling. He was seen by a physician and was treated with epinephrine and prednisone. At the time of this report the pt was improving, but had not yet recovered from these events.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Alveolitis allergic, Dyspnoea, Hypoxia, Laboratory test abnormal, Lung disorder
Clinical narrative: Information has been received from a physician concerning a 78 year old male who on 10Aug04 was vaccinated IM in the left deltoid with a 0.5ml dose of pneumococcal 23v polysaccharide vaccine (lot 645255/1212M). On 12Aug04, two days post vaccination, the pt developed a macular, papular rash on the arm that spread all over his body. The pt was treated with unspecified oral steroids and the rash did not improve. One month after vaccination, the client was seen by two dermatologists and was treated with unspecified creams, unspecified steroids and salve. In Jan 2005, the pt was seen by an allergist and there was no improvement in the rash. The pt presented to his primary care physician on 08Feb05 with shortness of breath and rash. Chest x-ray and computed axial tomography (CT scan) were ordered. Two days later on 11Feb05, the client was enroute to see his physician when he collapsed. He was taken via ambulance to the hospital and admitted with the diagnosis of allergic alveolitis. The pt had diffuse infiltrates of both lungs and kidney failure. A Ct scan was performed (results not reported). He was taken to intensive care and placed on very high doses of steroids for weeks, and a full face mask for breathing. While on the high dose steroids the rash disappeared, but when the steroids were reduced to 2.5mg the rash reappeared. The pt was hospitalized for approx two weeks and released when he was breathing better, kidneys were responding and he was able to urinate. The outcome of the reappearing rash was unk. A concern regarding the lot was reported by the physician. Macular papular rash, allergic alveolitis, kidney failure and collapse were considered to be disabling and immediately life threatening events that required intervention to prevent serious criteria.  Additional information has been requested.