chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.37
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Aspartate aminotransferase increased, Bacterial test positive, Band neutrophil count, Band neutrophil percentage increased, Base excess
Clinical narrative: This female subject was enrolled in a study. On 09 March 2011 and 04 May 2011, she received the 1st, 2nd dose of HIBERIX (IM R thigh), PEDIARIX (IM L thigh), PREVNAR 13 (IM L thigh or deltoid) and ROTARIX (po). On 08 May 2011, four days after the 2nd dose of PEDIARIX, four days after the 2nd dose of ROTARIX, four days after the 2nd dose of HIBERIX, four days after the 2nd dose of PREVNAR 13, this four-month-old subject experienced seizure. The subject was hospitalised. the subject was treated with phenobarbitone, ceftriaxone, lorazepam, vancomycin, levetiracetam, acyclovir and DW 5% NaCl 0.9% + KCl. The event was unresolved at time of reporting. The investigator considered that there was a reasonable possibility that the seizure may have been caused by PEDIARIX, ROTARIX, HIBERIX and PREVNAR 13. The subject was withdrawn from the study due to the SAE. Investigator Comments: Received immunizations on 04MAY11, fussy and difficult to console on 07May, vomited x3 on 07MAY. 08MAY AM noted to be staring straight ahead and not responding for up to 30 sec. and seemed somewhat limp and pale. Otherwise crying inconsolably and not interactive, with eyes open but not tracking. Brought to ED for C/O fussiness. Temperature in ED was 99.6 F (rectal), TYLENOL and MYLICON were given with no improvement of fussiness. ED Dr. noted what appeared to be possible a partial seizure with stiffening of left arm and wrist with tremors of same lasting around 30 sec and occurred twice. CT of head and LP were done. Ceftriaxone IV given pending Blood, urine and CSF cultures. When admitted to pediatrics ward was staring straight ahead with no response to verbal or visual stimulation, dilated and equal pupils were minimally responsive to light. Also noted slow, rhythmic flexion of right wrist and stiffening of right arm. Rhythmically sucking pacifier and rhythmic tongue thrusting/sucking even when pacifier removed. Given IV ATIVAN for presumed seizure and subsequently had resolution of seizure. 11MAY2011-Patient was doing better for majority of 09MAY and into 10MAY until 0530 on 10MAY when MD was called for respiratory distress, grunting, flaring, some stiffness, poor perfusion and ? seizure activity. Upon examination not clear that patient was having seizure, although there was some posturing with leg extension and right arm flexion at elbow, left arm extension. A code blue was called and after administration of lorazepam the rigidity resolved and perfusion and respiratory status markedly improved. Seizure activity now resolved with large doses of ATIVAN and KEPPRA bolus, remains sedated and likely has an aspiration pneumonitis. Transferring to another facility for further observation.
Age: 0.37
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Basophil percentage decreased, Bilirubin urine, Blood bicarbonate increased, Blood calcium normal, Blood chloride normal
Clinical narrative: This female subject was enrolled in a study. On 09 March 2011 and 04 May 2011, she received the 1st, 2nd dose of HIBERIX (IM R thigh), PEDIARIX (IM L thigh), PREVNAR 13 (IM L thigh or deltoid) and ROTARIX (po). On 08 May 2011, four days after the 2nd dose of PEDIARIX, four days after the 2nd dose of ROTARIX, four days after the 2nd dose of HIBERIX, four days after the 2nd dose of PREVNAR 13, this four-month-old subject experienced seizure. The subject was hospitalised. the subject was treated with phenobarbitone, ceftriaxone, lorazepam, vancomycin, levetiracetam, acyclovir and DW 5% NaCl 0.9% + KCl. The event was unresolved at time of reporting. The investigator considered that there was a reasonable possibility that the seizure may have been caused by PEDIARIX, ROTARIX, HIBERIX and PREVNAR 13. The subject was withdrawn from the study due to the SAE. Investigator Comments: Received immunizations on 04MAY11, fussy and difficult to console on 07May, vomited x3 on 07MAY. 08MAY AM noted to be staring straight ahead and not responding for up to 30 sec. and seemed somewhat limp and pale. Otherwise crying inconsolably and not interactive, with eyes open but not tracking. Brought to ED for C/O fussiness. Temperature in ED was 99.6 F (rectal), TYLENOL and MYLICON were given with no improvement of fussiness. ED Dr. noted what appeared to be possible a partial seizure with stiffening of left arm and wrist with tremors of same lasting around 30 sec and occurred twice. CT of head and LP were done. Ceftriaxone IV given pending Blood, urine and CSF cultures. When admitted to pediatrics ward was staring straight ahead with no response to verbal or visual stimulation, dilated and equal pupils were minimally responsive to light. Also noted slow, rhythmic flexion of right wrist and stiffening of right arm. Rhythmically sucking pacifier and rhythmic tongue thrusting/sucking even when pacifier removed. Given IV ATIVAN for presumed seizure and subsequently had resolution of seizure. 11MAY2011-Patient was doing better for majority of 09MAY and into 10MAY until 0530 on 10MAY when MD was called for respiratory distress, grunting, flaring, some stiffness, poor perfusion and ? seizure activity. Upon examination not clear that patient was having seizure, although there was some posturing with leg extension and right arm flexion at elbow, left arm extension. A code blue was called and after administration of lorazepam the rigidity resolved and perfusion and respiratory status markedly improved. Seizure activity now resolved with large doses of ATIVAN and KEPPRA bolus, remains sedated and likely has an aspiration pneumonitis. Transferring to another facility for further observation.
Age: 0.37
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Blood creatinine normal, Blood glucose normal, Blood ketone body, Blood lactic acid normal, Blood magnesium
Clinical narrative: This female subject was enrolled in a study. On 09 March 2011 and 04 May 2011, she received the 1st, 2nd dose of HIBERIX (IM R thigh), PEDIARIX (IM L thigh), PREVNAR 13 (IM L thigh or deltoid) and ROTARIX (po). On 08 May 2011, four days after the 2nd dose of PEDIARIX, four days after the 2nd dose of ROTARIX, four days after the 2nd dose of HIBERIX, four days after the 2nd dose of PREVNAR 13, this four-month-old subject experienced seizure. The subject was hospitalised. the subject was treated with phenobarbitone, ceftriaxone, lorazepam, vancomycin, levetiracetam, acyclovir and DW 5% NaCl 0.9% + KCl. The event was unresolved at time of reporting. The investigator considered that there was a reasonable possibility that the seizure may have been caused by PEDIARIX, ROTARIX, HIBERIX and PREVNAR 13. The subject was withdrawn from the study due to the SAE. Investigator Comments: Received immunizations on 04MAY11, fussy and difficult to console on 07May, vomited x3 on 07MAY. 08MAY AM noted to be staring straight ahead and not responding for up to 30 sec. and seemed somewhat limp and pale. Otherwise crying inconsolably and not interactive, with eyes open but not tracking. Brought to ED for C/O fussiness. Temperature in ED was 99.6 F (rectal), TYLENOL and MYLICON were given with no improvement of fussiness. ED Dr. noted what appeared to be possible a partial seizure with stiffening of left arm and wrist with tremors of same lasting around 30 sec and occurred twice. CT of head and LP were done. Ceftriaxone IV given pending Blood, urine and CSF cultures. When admitted to pediatrics ward was staring straight ahead with no response to verbal or visual stimulation, dilated and equal pupils were minimally responsive to light. Also noted slow, rhythmic flexion of right wrist and stiffening of right arm. Rhythmically sucking pacifier and rhythmic tongue thrusting/sucking even when pacifier removed. Given IV ATIVAN for presumed seizure and subsequently had resolution of seizure. 11MAY2011-Patient was doing better for majority of 09MAY and into 10MAY until 0530 on 10MAY when MD was called for respiratory distress, grunting, flaring, some stiffness, poor perfusion and ? seizure activity. Upon examination not clear that patient was having seizure, although there was some posturing with leg extension and right arm flexion at elbow, left arm extension. A code blue was called and after administration of lorazepam the rigidity resolved and perfusion and respiratory status markedly improved. Seizure activity now resolved with large doses of ATIVAN and KEPPRA bolus, remains sedated and likely has an aspiration pneumonitis. Transferring to another facility for further observation.
Age: 0.37
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Blood pH normal, Blood potassium decreased, Blood sodium normal, Blood test, Blood urea decreased
Clinical narrative: This female subject was enrolled in a study. On 09 March 2011 and 04 May 2011, she received the 1st, 2nd dose of HIBERIX (IM R thigh), PEDIARIX (IM L thigh), PREVNAR 13 (IM L thigh or deltoid) and ROTARIX (po). On 08 May 2011, four days after the 2nd dose of PEDIARIX, four days after the 2nd dose of ROTARIX, four days after the 2nd dose of HIBERIX, four days after the 2nd dose of PREVNAR 13, this four-month-old subject experienced seizure. The subject was hospitalised. the subject was treated with phenobarbitone, ceftriaxone, lorazepam, vancomycin, levetiracetam, acyclovir and DW 5% NaCl 0.9% + KCl. The event was unresolved at time of reporting. The investigator considered that there was a reasonable possibility that the seizure may have been caused by PEDIARIX, ROTARIX, HIBERIX and PREVNAR 13. The subject was withdrawn from the study due to the SAE. Investigator Comments: Received immunizations on 04MAY11, fussy and difficult to console on 07May, vomited x3 on 07MAY. 08MAY AM noted to be staring straight ahead and not responding for up to 30 sec. and seemed somewhat limp and pale. Otherwise crying inconsolably and not interactive, with eyes open but not tracking. Brought to ED for C/O fussiness. Temperature in ED was 99.6 F (rectal), TYLENOL and MYLICON were given with no improvement of fussiness. ED Dr. noted what appeared to be possible a partial seizure with stiffening of left arm and wrist with tremors of same lasting around 30 sec and occurred twice. CT of head and LP were done. Ceftriaxone IV given pending Blood, urine and CSF cultures. When admitted to pediatrics ward was staring straight ahead with no response to verbal or visual stimulation, dilated and equal pupils were minimally responsive to light. Also noted slow, rhythmic flexion of right wrist and stiffening of right arm. Rhythmically sucking pacifier and rhythmic tongue thrusting/sucking even when pacifier removed. Given IV ATIVAN for presumed seizure and subsequently had resolution of seizure. 11MAY2011-Patient was doing better for majority of 09MAY and into 10MAY until 0530 on 10MAY when MD was called for respiratory distress, grunting, flaring, some stiffness, poor perfusion and ? seizure activity. Upon examination not clear that patient was having seizure, although there was some posturing with leg extension and right arm flexion at elbow, left arm extension. A code blue was called and after administration of lorazepam the rigidity resolved and perfusion and respiratory status markedly improved. Seizure activity now resolved with large doses of ATIVAN and KEPPRA bolus, remains sedated and likely has an aspiration pneumonitis. Transferring to another facility for further observation.
Age: 0.37
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Body temperature increased, C-reactive protein increased, C-reactive protein normal, CSF culture, CSF glucose normal
Clinical narrative: This female subject was enrolled in a study. On 09 March 2011 and 04 May 2011, she received the 1st, 2nd dose of HIBERIX (IM R thigh), PEDIARIX (IM L thigh), PREVNAR 13 (IM L thigh or deltoid) and ROTARIX (po). On 08 May 2011, four days after the 2nd dose of PEDIARIX, four days after the 2nd dose of ROTARIX, four days after the 2nd dose of HIBERIX, four days after the 2nd dose of PREVNAR 13, this four-month-old subject experienced seizure. The subject was hospitalised. the subject was treated with phenobarbitone, ceftriaxone, lorazepam, vancomycin, levetiracetam, acyclovir and DW 5% NaCl 0.9% + KCl. The event was unresolved at time of reporting. The investigator considered that there was a reasonable possibility that the seizure may have been caused by PEDIARIX, ROTARIX, HIBERIX and PREVNAR 13. The subject was withdrawn from the study due to the SAE. Investigator Comments: Received immunizations on 04MAY11, fussy and difficult to console on 07May, vomited x3 on 07MAY. 08MAY AM noted to be staring straight ahead and not responding for up to 30 sec. and seemed somewhat limp and pale. Otherwise crying inconsolably and not interactive, with eyes open but not tracking. Brought to ED for C/O fussiness. Temperature in ED was 99.6 F (rectal), TYLENOL and MYLICON were given with no improvement of fussiness. ED Dr. noted what appeared to be possible a partial seizure with stiffening of left arm and wrist with tremors of same lasting around 30 sec and occurred twice. CT of head and LP were done. Ceftriaxone IV given pending Blood, urine and CSF cultures. When admitted to pediatrics ward was staring straight ahead with no response to verbal or visual stimulation, dilated and equal pupils were minimally responsive to light. Also noted slow, rhythmic flexion of right wrist and stiffening of right arm. Rhythmically sucking pacifier and rhythmic tongue thrusting/sucking even when pacifier removed. Given IV ATIVAN for presumed seizure and subsequently had resolution of seizure. 11MAY2011-Patient was doing better for majority of 09MAY and into 10MAY until 0530 on 10MAY when MD was called for respiratory distress, grunting, flaring, some stiffness, poor perfusion and ? seizure activity. Upon examination not clear that patient was having seizure, although there was some posturing with leg extension and right arm flexion at elbow, left arm extension. A code blue was called and after administration of lorazepam the rigidity resolved and perfusion and respiratory status markedly improved. Seizure activity now resolved with large doses of ATIVAN and KEPPRA bolus, remains sedated and likely has an aspiration pneumonitis. Transferring to another facility for further observation.
Age: 0.37
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: CSF protein normal, CSF test normal, CSF white blood cell count negative, Calcium ionised decreased, Calcium ionised increased
Clinical narrative: This female subject was enrolled in a study. On 09 March 2011 and 04 May 2011, she received the 1st, 2nd dose of HIBERIX (IM R thigh), PEDIARIX (IM L thigh), PREVNAR 13 (IM L thigh or deltoid) and ROTARIX (po). On 08 May 2011, four days after the 2nd dose of PEDIARIX, four days after the 2nd dose of ROTARIX, four days after the 2nd dose of HIBERIX, four days after the 2nd dose of PREVNAR 13, this four-month-old subject experienced seizure. The subject was hospitalised. the subject was treated with phenobarbitone, ceftriaxone, lorazepam, vancomycin, levetiracetam, acyclovir and DW 5% NaCl 0.9% + KCl. The event was unresolved at time of reporting. The investigator considered that there was a reasonable possibility that the seizure may have been caused by PEDIARIX, ROTARIX, HIBERIX and PREVNAR 13. The subject was withdrawn from the study due to the SAE. Investigator Comments: Received immunizations on 04MAY11, fussy and difficult to console on 07May, vomited x3 on 07MAY. 08MAY AM noted to be staring straight ahead and not responding for up to 30 sec. and seemed somewhat limp and pale. Otherwise crying inconsolably and not interactive, with eyes open but not tracking. Brought to ED for C/O fussiness. Temperature in ED was 99.6 F (rectal), TYLENOL and MYLICON were given with no improvement of fussiness. ED Dr. noted what appeared to be possible a partial seizure with stiffening of left arm and wrist with tremors of same lasting around 30 sec and occurred twice. CT of head and LP were done. Ceftriaxone IV given pending Blood, urine and CSF cultures. When admitted to pediatrics ward was staring straight ahead with no response to verbal or visual stimulation, dilated and equal pupils were minimally responsive to light. Also noted slow, rhythmic flexion of right wrist and stiffening of right arm. Rhythmically sucking pacifier and rhythmic tongue thrusting/sucking even when pacifier removed. Given IV ATIVAN for presumed seizure and subsequently had resolution of seizure. 11MAY2011-Patient was doing better for majority of 09MAY and into 10MAY until 0530 on 10MAY when MD was called for respiratory distress, grunting, flaring, some stiffness, poor perfusion and ? seizure activity. Upon examination not clear that patient was having seizure, although there was some posturing with leg extension and right arm flexion at elbow, left arm extension. A code blue was called and after administration of lorazepam the rigidity resolved and perfusion and respiratory status markedly improved. Seizure activity now resolved with large doses of ATIVAN and KEPPRA bolus, remains sedated and likely has an aspiration pneumonitis. Transferring to another facility for further observation.
Age: 0.37
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Carbon dioxide, Carbon dioxide normal, Computerised tomogram head, Convulsion, Crying
Clinical narrative: This female subject was enrolled in a study. On 09 March 2011 and 04 May 2011, she received the 1st, 2nd dose of HIBERIX (IM R thigh), PEDIARIX (IM L thigh), PREVNAR 13 (IM L thigh or deltoid) and ROTARIX (po). On 08 May 2011, four days after the 2nd dose of PEDIARIX, four days after the 2nd dose of ROTARIX, four days after the 2nd dose of HIBERIX, four days after the 2nd dose of PREVNAR 13, this four-month-old subject experienced seizure. The subject was hospitalised. the subject was treated with phenobarbitone, ceftriaxone, lorazepam, vancomycin, levetiracetam, acyclovir and DW 5% NaCl 0.9% + KCl. The event was unresolved at time of reporting. The investigator considered that there was a reasonable possibility that the seizure may have been caused by PEDIARIX, ROTARIX, HIBERIX and PREVNAR 13. The subject was withdrawn from the study due to the SAE. Investigator Comments: Received immunizations on 04MAY11, fussy and difficult to console on 07May, vomited x3 on 07MAY. 08MAY AM noted to be staring straight ahead and not responding for up to 30 sec. and seemed somewhat limp and pale. Otherwise crying inconsolably and not interactive, with eyes open but not tracking. Brought to ED for C/O fussiness. Temperature in ED was 99.6 F (rectal), TYLENOL and MYLICON were given with no improvement of fussiness. ED Dr. noted what appeared to be possible a partial seizure with stiffening of left arm and wrist with tremors of same lasting around 30 sec and occurred twice. CT of head and LP were done. Ceftriaxone IV given pending Blood, urine and CSF cultures. When admitted to pediatrics ward was staring straight ahead with no response to verbal or visual stimulation, dilated and equal pupils were minimally responsive to light. Also noted slow, rhythmic flexion of right wrist and stiffening of right arm. Rhythmically sucking pacifier and rhythmic tongue thrusting/sucking even when pacifier removed. Given IV ATIVAN for presumed seizure and subsequently had resolution of seizure. 11MAY2011-Patient was doing better for majority of 09MAY and into 10MAY until 0530 on 10MAY when MD was called for respiratory distress, grunting, flaring, some stiffness, poor perfusion and ? seizure activity. Upon examination not clear that patient was having seizure, although there was some posturing with leg extension and right arm flexion at elbow, left arm extension. A code blue was called and after administration of lorazepam the rigidity resolved and perfusion and respiratory status markedly improved. Seizure activity now resolved with large doses of ATIVAN and KEPPRA bolus, remains sedated and likely has an aspiration pneumonitis. Transferring to another facility for further observation.
Age: 0.37
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Culture urine, Emotional distress, Eosinophil percentage decreased, Glucose urine absent, Grunting
Clinical narrative: This female subject was enrolled in a study. On 09 March 2011 and 04 May 2011, she received the 1st, 2nd dose of HIBERIX (IM R thigh), PEDIARIX (IM L thigh), PREVNAR 13 (IM L thigh or deltoid) and ROTARIX (po). On 08 May 2011, four days after the 2nd dose of PEDIARIX, four days after the 2nd dose of ROTARIX, four days after the 2nd dose of HIBERIX, four days after the 2nd dose of PREVNAR 13, this four-month-old subject experienced seizure. The subject was hospitalised. the subject was treated with phenobarbitone, ceftriaxone, lorazepam, vancomycin, levetiracetam, acyclovir and DW 5% NaCl 0.9% + KCl. The event was unresolved at time of reporting. The investigator considered that there was a reasonable possibility that the seizure may have been caused by PEDIARIX, ROTARIX, HIBERIX and PREVNAR 13. The subject was withdrawn from the study due to the SAE. Investigator Comments: Received immunizations on 04MAY11, fussy and difficult to console on 07May, vomited x3 on 07MAY. 08MAY AM noted to be staring straight ahead and not responding for up to 30 sec. and seemed somewhat limp and pale. Otherwise crying inconsolably and not interactive, with eyes open but not tracking. Brought to ED for C/O fussiness. Temperature in ED was 99.6 F (rectal), TYLENOL and MYLICON were given with no improvement of fussiness. ED Dr. noted what appeared to be possible a partial seizure with stiffening of left arm and wrist with tremors of same lasting around 30 sec and occurred twice. CT of head and LP were done. Ceftriaxone IV given pending Blood, urine and CSF cultures. When admitted to pediatrics ward was staring straight ahead with no response to verbal or visual stimulation, dilated and equal pupils were minimally responsive to light. Also noted slow, rhythmic flexion of right wrist and stiffening of right arm. Rhythmically sucking pacifier and rhythmic tongue thrusting/sucking even when pacifier removed. Given IV ATIVAN for presumed seizure and subsequently had resolution of seizure. 11MAY2011-Patient was doing better for majority of 09MAY and into 10MAY until 0530 on 10MAY when MD was called for respiratory distress, grunting, flaring, some stiffness, poor perfusion and ? seizure activity. Upon examination not clear that patient was having seizure, although there was some posturing with leg extension and right arm flexion at elbow, left arm extension. A code blue was called and after administration of lorazepam the rigidity resolved and perfusion and respiratory status markedly improved. Seizure activity now resolved with large doses of ATIVAN and KEPPRA bolus, remains sedated and likely has an aspiration pneumonitis. Transferring to another facility for further observation.
Age: 0.37
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Haematocrit decreased, Haemoglobin decreased, Hypotonia, Irritability, Lumbar puncture
Clinical narrative: This female subject was enrolled in a study. On 09 March 2011 and 04 May 2011, she received the 1st, 2nd dose of HIBERIX (IM R thigh), PEDIARIX (IM L thigh), PREVNAR 13 (IM L thigh or deltoid) and ROTARIX (po). On 08 May 2011, four days after the 2nd dose of PEDIARIX, four days after the 2nd dose of ROTARIX, four days after the 2nd dose of HIBERIX, four days after the 2nd dose of PREVNAR 13, this four-month-old subject experienced seizure. The subject was hospitalised. the subject was treated with phenobarbitone, ceftriaxone, lorazepam, vancomycin, levetiracetam, acyclovir and DW 5% NaCl 0.9% + KCl. The event was unresolved at time of reporting. The investigator considered that there was a reasonable possibility that the seizure may have been caused by PEDIARIX, ROTARIX, HIBERIX and PREVNAR 13. The subject was withdrawn from the study due to the SAE. Investigator Comments: Received immunizations on 04MAY11, fussy and difficult to console on 07May, vomited x3 on 07MAY. 08MAY AM noted to be staring straight ahead and not responding for up to 30 sec. and seemed somewhat limp and pale. Otherwise crying inconsolably and not interactive, with eyes open but not tracking. Brought to ED for C/O fussiness. Temperature in ED was 99.6 F (rectal), TYLENOL and MYLICON were given with no improvement of fussiness. ED Dr. noted what appeared to be possible a partial seizure with stiffening of left arm and wrist with tremors of same lasting around 30 sec and occurred twice. CT of head and LP were done. Ceftriaxone IV given pending Blood, urine and CSF cultures. When admitted to pediatrics ward was staring straight ahead with no response to verbal or visual stimulation, dilated and equal pupils were minimally responsive to light. Also noted slow, rhythmic flexion of right wrist and stiffening of right arm. Rhythmically sucking pacifier and rhythmic tongue thrusting/sucking even when pacifier removed. Given IV ATIVAN for presumed seizure and subsequently had resolution of seizure. 11MAY2011-Patient was doing better for majority of 09MAY and into 10MAY until 0530 on 10MAY when MD was called for respiratory distress, grunting, flaring, some stiffness, poor perfusion and ? seizure activity. Upon examination not clear that patient was having seizure, although there was some posturing with leg extension and right arm flexion at elbow, left arm extension. A code blue was called and after administration of lorazepam the rigidity resolved and perfusion and respiratory status markedly improved. Seizure activity now resolved with large doses of ATIVAN and KEPPRA bolus, remains sedated and likely has an aspiration pneumonitis. Transferring to another facility for further observation.
Age: 0.37
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Lymphocyte morphology abnormal, Lymphocyte percentage, Mean cell volume normal, Monocyte percentage, Muscle rigidity
Clinical narrative: This female subject was enrolled in a study. On 09 March 2011 and 04 May 2011, she received the 1st, 2nd dose of HIBERIX (IM R thigh), PEDIARIX (IM L thigh), PREVNAR 13 (IM L thigh or deltoid) and ROTARIX (po). On 08 May 2011, four days after the 2nd dose of PEDIARIX, four days after the 2nd dose of ROTARIX, four days after the 2nd dose of HIBERIX, four days after the 2nd dose of PREVNAR 13, this four-month-old subject experienced seizure. The subject was hospitalised. the subject was treated with phenobarbitone, ceftriaxone, lorazepam, vancomycin, levetiracetam, acyclovir and DW 5% NaCl 0.9% + KCl. The event was unresolved at time of reporting. The investigator considered that there was a reasonable possibility that the seizure may have been caused by PEDIARIX, ROTARIX, HIBERIX and PREVNAR 13. The subject was withdrawn from the study due to the SAE. Investigator Comments: Received immunizations on 04MAY11, fussy and difficult to console on 07May, vomited x3 on 07MAY. 08MAY AM noted to be staring straight ahead and not responding for up to 30 sec. and seemed somewhat limp and pale. Otherwise crying inconsolably and not interactive, with eyes open but not tracking. Brought to ED for C/O fussiness. Temperature in ED was 99.6 F (rectal), TYLENOL and MYLICON were given with no improvement of fussiness. ED Dr. noted what appeared to be possible a partial seizure with stiffening of left arm and wrist with tremors of same lasting around 30 sec and occurred twice. CT of head and LP were done. Ceftriaxone IV given pending Blood, urine and CSF cultures. When admitted to pediatrics ward was staring straight ahead with no response to verbal or visual stimulation, dilated and equal pupils were minimally responsive to light. Also noted slow, rhythmic flexion of right wrist and stiffening of right arm. Rhythmically sucking pacifier and rhythmic tongue thrusting/sucking even when pacifier removed. Given IV ATIVAN for presumed seizure and subsequently had resolution of seizure. 11MAY2011-Patient was doing better for majority of 09MAY and into 10MAY until 0530 on 10MAY when MD was called for respiratory distress, grunting, flaring, some stiffness, poor perfusion and ? seizure activity. Upon examination not clear that patient was having seizure, although there was some posturing with leg extension and right arm flexion at elbow, left arm extension. A code blue was called and after administration of lorazepam the rigidity resolved and perfusion and respiratory status markedly improved. Seizure activity now resolved with large doses of ATIVAN and KEPPRA bolus, remains sedated and likely has an aspiration pneumonitis. Transferring to another facility for further observation.
Age: 0.37
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Musculoskeletal stiffness, Mydriasis, Neutrophil count, Neutrophil percentage decreased, Nitrite urine absent
Clinical narrative: This female subject was enrolled in a study. On 09 March 2011 and 04 May 2011, she received the 1st, 2nd dose of HIBERIX (IM R thigh), PEDIARIX (IM L thigh), PREVNAR 13 (IM L thigh or deltoid) and ROTARIX (po). On 08 May 2011, four days after the 2nd dose of PEDIARIX, four days after the 2nd dose of ROTARIX, four days after the 2nd dose of HIBERIX, four days after the 2nd dose of PREVNAR 13, this four-month-old subject experienced seizure. The subject was hospitalised. the subject was treated with phenobarbitone, ceftriaxone, lorazepam, vancomycin, levetiracetam, acyclovir and DW 5% NaCl 0.9% + KCl. The event was unresolved at time of reporting. The investigator considered that there was a reasonable possibility that the seizure may have been caused by PEDIARIX, ROTARIX, HIBERIX and PREVNAR 13. The subject was withdrawn from the study due to the SAE. Investigator Comments: Received immunizations on 04MAY11, fussy and difficult to console on 07May, vomited x3 on 07MAY. 08MAY AM noted to be staring straight ahead and not responding for up to 30 sec. and seemed somewhat limp and pale. Otherwise crying inconsolably and not interactive, with eyes open but not tracking. Brought to ED for C/O fussiness. Temperature in ED was 99.6 F (rectal), TYLENOL and MYLICON were given with no improvement of fussiness. ED Dr. noted what appeared to be possible a partial seizure with stiffening of left arm and wrist with tremors of same lasting around 30 sec and occurred twice. CT of head and LP were done. Ceftriaxone IV given pending Blood, urine and CSF cultures. When admitted to pediatrics ward was staring straight ahead with no response to verbal or visual stimulation, dilated and equal pupils were minimally responsive to light. Also noted slow, rhythmic flexion of right wrist and stiffening of right arm. Rhythmically sucking pacifier and rhythmic tongue thrusting/sucking even when pacifier removed. Given IV ATIVAN for presumed seizure and subsequently had resolution of seizure. 11MAY2011-Patient was doing better for majority of 09MAY and into 10MAY until 0530 on 10MAY when MD was called for respiratory distress, grunting, flaring, some stiffness, poor perfusion and ? seizure activity. Upon examination not clear that patient was having seizure, although there was some posturing with leg extension and right arm flexion at elbow, left arm extension. A code blue was called and after administration of lorazepam the rigidity resolved and perfusion and respiratory status markedly improved. Seizure activity now resolved with large doses of ATIVAN and KEPPRA bolus, remains sedated and likely has an aspiration pneumonitis. Transferring to another facility for further observation.
Age: 0.37
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Oxygen consumption, PCO2 increased, PO2 decreased, PO2 increased, Pallor
Clinical narrative: This female subject was enrolled in a study. On 09 March 2011 and 04 May 2011, she received the 1st, 2nd dose of HIBERIX (IM R thigh), PEDIARIX (IM L thigh), PREVNAR 13 (IM L thigh or deltoid) and ROTARIX (po). On 08 May 2011, four days after the 2nd dose of PEDIARIX, four days after the 2nd dose of ROTARIX, four days after the 2nd dose of HIBERIX, four days after the 2nd dose of PREVNAR 13, this four-month-old subject experienced seizure. The subject was hospitalised. the subject was treated with phenobarbitone, ceftriaxone, lorazepam, vancomycin, levetiracetam, acyclovir and DW 5% NaCl 0.9% + KCl. The event was unresolved at time of reporting. The investigator considered that there was a reasonable possibility that the seizure may have been caused by PEDIARIX, ROTARIX, HIBERIX and PREVNAR 13. The subject was withdrawn from the study due to the SAE. Investigator Comments: Received immunizations on 04MAY11, fussy and difficult to console on 07May, vomited x3 on 07MAY. 08MAY AM noted to be staring straight ahead and not responding for up to 30 sec. and seemed somewhat limp and pale. Otherwise crying inconsolably and not interactive, with eyes open but not tracking. Brought to ED for C/O fussiness. Temperature in ED was 99.6 F (rectal), TYLENOL and MYLICON were given with no improvement of fussiness. ED Dr. noted what appeared to be possible a partial seizure with stiffening of left arm and wrist with tremors of same lasting around 30 sec and occurred twice. CT of head and LP were done. Ceftriaxone IV given pending Blood, urine and CSF cultures. When admitted to pediatrics ward was staring straight ahead with no response to verbal or visual stimulation, dilated and equal pupils were minimally responsive to light. Also noted slow, rhythmic flexion of right wrist and stiffening of right arm. Rhythmically sucking pacifier and rhythmic tongue thrusting/sucking even when pacifier removed. Given IV ATIVAN for presumed seizure and subsequently had resolution of seizure. 11MAY2011-Patient was doing better for majority of 09MAY and into 10MAY until 0530 on 10MAY when MD was called for respiratory distress, grunting, flaring, some stiffness, poor perfusion and ? seizure activity. Upon examination not clear that patient was having seizure, although there was some posturing with leg extension and right arm flexion at elbow, left arm extension. A code blue was called and after administration of lorazepam the rigidity resolved and perfusion and respiratory status markedly improved. Seizure activity now resolved with large doses of ATIVAN and KEPPRA bolus, remains sedated and likely has an aspiration pneumonitis. Transferring to another facility for further observation.
Age: 0.37
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Platelet count, Pneumonia aspiration, Poor peripheral circulation, Posture abnormal, Protein urine absent
Clinical narrative: This female subject was enrolled in a study. On 09 March 2011 and 04 May 2011, she received the 1st, 2nd dose of HIBERIX (IM R thigh), PEDIARIX (IM L thigh), PREVNAR 13 (IM L thigh or deltoid) and ROTARIX (po). On 08 May 2011, four days after the 2nd dose of PEDIARIX, four days after the 2nd dose of ROTARIX, four days after the 2nd dose of HIBERIX, four days after the 2nd dose of PREVNAR 13, this four-month-old subject experienced seizure. The subject was hospitalised. the subject was treated with phenobarbitone, ceftriaxone, lorazepam, vancomycin, levetiracetam, acyclovir and DW 5% NaCl 0.9% + KCl. The event was unresolved at time of reporting. The investigator considered that there was a reasonable possibility that the seizure may have been caused by PEDIARIX, ROTARIX, HIBERIX and PREVNAR 13. The subject was withdrawn from the study due to the SAE. Investigator Comments: Received immunizations on 04MAY11, fussy and difficult to console on 07May, vomited x3 on 07MAY. 08MAY AM noted to be staring straight ahead and not responding for up to 30 sec. and seemed somewhat limp and pale. Otherwise crying inconsolably and not interactive, with eyes open but not tracking. Brought to ED for C/O fussiness. Temperature in ED was 99.6 F (rectal), TYLENOL and MYLICON were given with no improvement of fussiness. ED Dr. noted what appeared to be possible a partial seizure with stiffening of left arm and wrist with tremors of same lasting around 30 sec and occurred twice. CT of head and LP were done. Ceftriaxone IV given pending Blood, urine and CSF cultures. When admitted to pediatrics ward was staring straight ahead with no response to verbal or visual stimulation, dilated and equal pupils were minimally responsive to light. Also noted slow, rhythmic flexion of right wrist and stiffening of right arm. Rhythmically sucking pacifier and rhythmic tongue thrusting/sucking even when pacifier removed. Given IV ATIVAN for presumed seizure and subsequently had resolution of seizure. 11MAY2011-Patient was doing better for majority of 09MAY and into 10MAY until 0530 on 10MAY when MD was called for respiratory distress, grunting, flaring, some stiffness, poor perfusion and ? seizure activity. Upon examination not clear that patient was having seizure, although there was some posturing with leg extension and right arm flexion at elbow, left arm extension. A code blue was called and after administration of lorazepam the rigidity resolved and perfusion and respiratory status markedly improved. Seizure activity now resolved with large doses of ATIVAN and KEPPRA bolus, remains sedated and likely has an aspiration pneumonitis. Transferring to another facility for further observation.
Age: 0.37
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pupillary light reflex tests abnormal, Pupillary reflex impaired, Red blood cell anisocytes present, Red blood cell count, Red blood cell hypochromic morphology present
Clinical narrative: This female subject was enrolled in a study. On 09 March 2011 and 04 May 2011, she received the 1st, 2nd dose of HIBERIX (IM R thigh), PEDIARIX (IM L thigh), PREVNAR 13 (IM L thigh or deltoid) and ROTARIX (po). On 08 May 2011, four days after the 2nd dose of PEDIARIX, four days after the 2nd dose of ROTARIX, four days after the 2nd dose of HIBERIX, four days after the 2nd dose of PREVNAR 13, this four-month-old subject experienced seizure. The subject was hospitalised. the subject was treated with phenobarbitone, ceftriaxone, lorazepam, vancomycin, levetiracetam, acyclovir and DW 5% NaCl 0.9% + KCl. The event was unresolved at time of reporting. The investigator considered that there was a reasonable possibility that the seizure may have been caused by PEDIARIX, ROTARIX, HIBERIX and PREVNAR 13. The subject was withdrawn from the study due to the SAE. Investigator Comments: Received immunizations on 04MAY11, fussy and difficult to console on 07May, vomited x3 on 07MAY. 08MAY AM noted to be staring straight ahead and not responding for up to 30 sec. and seemed somewhat limp and pale. Otherwise crying inconsolably and not interactive, with eyes open but not tracking. Brought to ED for C/O fussiness. Temperature in ED was 99.6 F (rectal), TYLENOL and MYLICON were given with no improvement of fussiness. ED Dr. noted what appeared to be possible a partial seizure with stiffening of left arm and wrist with tremors of same lasting around 30 sec and occurred twice. CT of head and LP were done. Ceftriaxone IV given pending Blood, urine and CSF cultures. When admitted to pediatrics ward was staring straight ahead with no response to verbal or visual stimulation, dilated and equal pupils were minimally responsive to light. Also noted slow, rhythmic flexion of right wrist and stiffening of right arm. Rhythmically sucking pacifier and rhythmic tongue thrusting/sucking even when pacifier removed. Given IV ATIVAN for presumed seizure and subsequently had resolution of seizure. 11MAY2011-Patient was doing better for majority of 09MAY and into 10MAY until 0530 on 10MAY when MD was called for respiratory distress, grunting, flaring, some stiffness, poor perfusion and ? seizure activity. Upon examination not clear that patient was having seizure, although there was some posturing with leg extension and right arm flexion at elbow, left arm extension. A code blue was called and after administration of lorazepam the rigidity resolved and perfusion and respiratory status markedly improved. Seizure activity now resolved with large doses of ATIVAN and KEPPRA bolus, remains sedated and likely has an aspiration pneumonitis. Transferring to another facility for further observation.
Age: 0.37
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Red blood cells urine negative, Respiratory distress, Sedation, Slow response to stimuli, Specific gravity urine normal
Clinical narrative: This female subject was enrolled in a study. On 09 March 2011 and 04 May 2011, she received the 1st, 2nd dose of HIBERIX (IM R thigh), PEDIARIX (IM L thigh), PREVNAR 13 (IM L thigh or deltoid) and ROTARIX (po). On 08 May 2011, four days after the 2nd dose of PEDIARIX, four days after the 2nd dose of ROTARIX, four days after the 2nd dose of HIBERIX, four days after the 2nd dose of PREVNAR 13, this four-month-old subject experienced seizure. The subject was hospitalised. the subject was treated with phenobarbitone, ceftriaxone, lorazepam, vancomycin, levetiracetam, acyclovir and DW 5% NaCl 0.9% + KCl. The event was unresolved at time of reporting. The investigator considered that there was a reasonable possibility that the seizure may have been caused by PEDIARIX, ROTARIX, HIBERIX and PREVNAR 13. The subject was withdrawn from the study due to the SAE. Investigator Comments: Received immunizations on 04MAY11, fussy and difficult to console on 07May, vomited x3 on 07MAY. 08MAY AM noted to be staring straight ahead and not responding for up to 30 sec. and seemed somewhat limp and pale. Otherwise crying inconsolably and not interactive, with eyes open but not tracking. Brought to ED for C/O fussiness. Temperature in ED was 99.6 F (rectal), TYLENOL and MYLICON were given with no improvement of fussiness. ED Dr. noted what appeared to be possible a partial seizure with stiffening of left arm and wrist with tremors of same lasting around 30 sec and occurred twice. CT of head and LP were done. Ceftriaxone IV given pending Blood, urine and CSF cultures. When admitted to pediatrics ward was staring straight ahead with no response to verbal or visual stimulation, dilated and equal pupils were minimally responsive to light. Also noted slow, rhythmic flexion of right wrist and stiffening of right arm. Rhythmically sucking pacifier and rhythmic tongue thrusting/sucking even when pacifier removed. Given IV ATIVAN for presumed seizure and subsequently had resolution of seizure. 11MAY2011-Patient was doing better for majority of 09MAY and into 10MAY until 0530 on 10MAY when MD was called for respiratory distress, grunting, flaring, some stiffness, poor perfusion and ? seizure activity. Upon examination not clear that patient was having seizure, although there was some posturing with leg extension and right arm flexion at elbow, left arm extension. A code blue was called and after administration of lorazepam the rigidity resolved and perfusion and respiratory status markedly improved. Seizure activity now resolved with large doses of ATIVAN and KEPPRA bolus, remains sedated and likely has an aspiration pneumonitis. Transferring to another facility for further observation.
Age: 0.37
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Staring, Tongue disorder, Tremor, Unresponsive to stimuli, Urinary casts
Clinical narrative: This female subject was enrolled in a study. On 09 March 2011 and 04 May 2011, she received the 1st, 2nd dose of HIBERIX (IM R thigh), PEDIARIX (IM L thigh), PREVNAR 13 (IM L thigh or deltoid) and ROTARIX (po). On 08 May 2011, four days after the 2nd dose of PEDIARIX, four days after the 2nd dose of ROTARIX, four days after the 2nd dose of HIBERIX, four days after the 2nd dose of PREVNAR 13, this four-month-old subject experienced seizure. The subject was hospitalised. the subject was treated with phenobarbitone, ceftriaxone, lorazepam, vancomycin, levetiracetam, acyclovir and DW 5% NaCl 0.9% + KCl. The event was unresolved at time of reporting. The investigator considered that there was a reasonable possibility that the seizure may have been caused by PEDIARIX, ROTARIX, HIBERIX and PREVNAR 13. The subject was withdrawn from the study due to the SAE. Investigator Comments: Received immunizations on 04MAY11, fussy and difficult to console on 07May, vomited x3 on 07MAY. 08MAY AM noted to be staring straight ahead and not responding for up to 30 sec. and seemed somewhat limp and pale. Otherwise crying inconsolably and not interactive, with eyes open but not tracking. Brought to ED for C/O fussiness. Temperature in ED was 99.6 F (rectal), TYLENOL and MYLICON were given with no improvement of fussiness. ED Dr. noted what appeared to be possible a partial seizure with stiffening of left arm and wrist with tremors of same lasting around 30 sec and occurred twice. CT of head and LP were done. Ceftriaxone IV given pending Blood, urine and CSF cultures. When admitted to pediatrics ward was staring straight ahead with no response to verbal or visual stimulation, dilated and equal pupils were minimally responsive to light. Also noted slow, rhythmic flexion of right wrist and stiffening of right arm. Rhythmically sucking pacifier and rhythmic tongue thrusting/sucking even when pacifier removed. Given IV ATIVAN for presumed seizure and subsequently had resolution of seizure. 11MAY2011-Patient was doing better for majority of 09MAY and into 10MAY until 0530 on 10MAY when MD was called for respiratory distress, grunting, flaring, some stiffness, poor perfusion and ? seizure activity. Upon examination not clear that patient was having seizure, although there was some posturing with leg extension and right arm flexion at elbow, left arm extension. A code blue was called and after administration of lorazepam the rigidity resolved and perfusion and respiratory status markedly improved. Seizure activity now resolved with large doses of ATIVAN and KEPPRA bolus, remains sedated and likely has an aspiration pneumonitis. Transferring to another facility for further observation.