Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Opisthotonus, Pyrexia, Respiratory rate, Scan brain, Unresponsive to stimuli
Clinical narrative: Initial information received on 11 August 2014 from another manufacturer. A case of a 4 month old female infant who is enrolled in another manufacturer's study. On 09 February 2007 the patient received a second intramuscular dose of ACT-HIB batch number UE962AE, site not reported, along with a second intramuscular dose of PEDIARIX (GlaxoSmithKline) batch number AC21E065AA, site not reported and a second intramuscular dose of Pneumococcal 13-Valent Conjugate Vaccine (Pfizer batch number LPL06-007, site not reported. The patient was a normal newborn delivered by cesarean section at 40 weeks. The patient has a history of gastrooesophageal reflux disease for which PREVACID was ordered, but not received by the patient. There was no known drug allergies. The patient's concomitant medications were not reported. On 12 February 2007, the patient was hospitalized with a febrile seizure and fever "(viral vs due to vaccine)" that began the day before along with a cough and a decrease in oral intake. The patient's temperature ranged from 102 degrees Fahrenheit to 104 degrees Fahrenheit. On admission to the hospital, the family also described the child as having had an episode at home where she was "arching her back and the eyes seem to roll into the back of her head. This lasted 20 minutes following which she was somewhat limp and unresponsive for a few minutes." The emergency room physician noted possible seizure activity or febrile seizures. Treatment included TYLENOL, MOTRIN, Ampicillin/Gentamycin, intravenous fluids and the patient was to be placed on a CR (cardio-respiratory) monitor overnight. Other symptoms while hospitalized included several episodes of diarrhea for which several cultures were obtained. On 16 February 2007 the patient recovered from the fever. Laboratory tests performed were: culture stool (results: negative) was done on an unspecified date in 2007. Body temperature (results 103 degrees F) on 11 February 2007, on 12 Feb 2007 the heart rate was 170's, respiratory rate (results: 16), CSF culture (results: negative); culture urine (results: negative) blood bicarbonate (results: "slightly low at 14"), chest x-ray (results: unremarkable); scan brain (results: no CT evidence of acute intracranial abnormality); body temperature (results: "up to 104 degrees Fahrenheit), body temperature (results 39.2 degrees C), body temperature (results 102 degrees F) and blood culture (results pending). Other manufacturer relatedness assessment: "The investigator(s) and medical monitor(s) considered pyrexia and febrile convulsion possibly related to the study product. The investigator also noted the event of fever could have been related to a "medical condition". No additional information was available at the time of this report." Follow-up on (6 June 2014): Following the integration of the legacy safety adverse event reporting database, this case has been migrated from the legacy company database into the current safety database for processing follow-up information. As a consequence of this migration, the follow-up CIOMSI, VAERS or MedWatch report may indicate in the appropriate field that it is an initial report. New information reported includes: study drug data. Protocol (BLANK) was unblinded, due to end of study unblinding. End of study unblinding indicated the patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm 197 protein). The patient outcome is unknown. Documents held by sender: None.