Age: 0.75
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Pyrexia, Seizure
Clinical narrative: This is a spontaneous report from a contactable pharmacist and from a contactable physician. A 9-month-old male patient received on 06Aug2014 the third dose of PREVNAR 13 (Lot H06568, expiry date Feb2015) at 0.5 ml single on left thigh, third dose of ACT HIB (Lot UI047AA, Exp: 10May2015; Sanofi-Pasteur) at 0.5 ml single on left thigh and first dose of PEDIARIX (Lot E4T92, expiry date 09Oct2015) at 0.5ml single in right thigh. Patient was born via vaginal delivery; he was preterm 35 weeks (at birth: APGAR: 8/9; Length 19 inches and Head circumference: 33 cm). Patient had history of congenital hypotonia, development delay, motor delays (not rolling over or sitting up) but was socially interactive and had birth defects. No known allergies. The patient had a sister with CP, asthma, convulsions, high cholesterol and development delay. Mother had gestational diabetes, which resolved. Concomitant medications included lactulose and multivitamins. Previously patient received: ACT HIB on 12Feb2014 (1st dose) and on 06Jun2014 (2nd dose); 1st dose of DAPTACEL on 12Feb2014; hepatitis B vaccine on 05Nov2013 (1st dose), on 17Dec2013 (2nd dose) and on 12Feb2014 (3rd dose); 1st dose of IPV on 12Feb2014; PREVNAR-13 on 12Feb2014 (1st dose) and on 06Jun2014 (2nd dose); 1st dose of rotavirus vaccine on 12Feb2014. Lab test performed on 06Aug2014 showed: Weight Percentile: 4%; Blood Pressure: 76/58; Pulse: 125/minute; Respirations: 36/minute; Temperature: 97.9 degrees F; Head Circumference: 43.5 centimeters; Body Mass Index BMI: 15.7 kg/m2. On 08Aug0214 at around 5 am patient had fever at 106 F (rectally) and seizures (reported as 10 minutes) and so was taken to hospital; seizures was considered possibly related to very high fever. At hospital temperature was 101.6 F and patient did not have any seizures. After few hours of observation in ER patient was discharged with ibuprofen every 6-8 hours and TYLENOL every 4 hours for next 24 hours then as needed. Next day the baby was fine and the mother stated she would only allow 1 vaccine at a time, when he needs it. On 13Aug2014 patient was seen by Pediatric Neurologist and no treatment given, no further seizures reported. Patient was seen again in the office on 03Sep2014 and he was back to his baseline function/status. The outcome of both events was reported as recovered. Follow-up (03Dec2014): New information received from a contactable physician includes: event details, vaccination history/details, suspect vaccines, patient details, lab tests. Follow-up attempts completed. No further information expected. Follow-up (05Jan2015): This is a follow up report combining information from duplicate reports 2014315410 and 2014315607. The current and all subsequent follow-up information will be reported under manufacturer report number 2014315410. The new information reported from Non-clinical study program through contactable pharmacist and then from a contactable physician includes. PREVNAR-13 was administered on 06Aug2014 at 12:53, intramuscularly; Lot# for 3rd dose of ACT-HIB was 01047AA. No adverse events following prior vaccinations. Patient's medical history included constipation, flat feet, underlying muscle weakness and areflexia. Mother had nasal allergy, anemia and gestational diabetes (diet-controlled and resolved); the father was a tobacco user; the sister had high cholesterol (under treatments), epilepsy and hypotonic encephalopathy with global developmental delays: there was a positive family history for encephalopathy (involved older sister) so a genetic condition must be considered, although mother said that there were complications around the time of delivery that may have predisposed to neonatal hypoxia. Physician stated that the possibility of mitochondrial disease was to be considered. Concomitant medications included lactulose for treatment of constipation at 5ml 1x/day and POLY-VI-FLOR, drops as vitamins at 0.25mg/1ml 1x/day. On 07Aug2014 at 05:00 AM (at home) the patient had high fever (106 F) and generalized seizure for about 10 minutes, so he was taken to ER. At hospital temperature was 106.6 F, no seizures while. He was not placed on anticonvulsants and was discharged with ibuprofen and TYLENOL. The patient was not admitted to hospital. Events recovered on 07Aug2014. Follow-up attempts completed. No further information expected. Follow-up (12Feb2015): This is a follow-up report from a contactable nurse on behalf of physician. PEDIARIX lot number was E4T94. On 07Aug2014 at 05:00 AM (at home) the patient had high fever (106 F) and generalized seizure for about 10 minutes. Temperature in the ER was measured as 101.1 F. The reporter was not sure if PREVNAR 13 had a causal effect to the adverse event. Follow-up (04Mar2015): This is a follow-up spontaneous report from a contactable nurse, who is reporting on behalf of the same physician. This nurse reported that no new adverse event occurred. Additional information included also Sanofi-Aventis manufacturer control number 2015SA024941.