Age: 0.51
Sex: M
Vaccine: DTAPIPVHIB, HEP, MNQ, PNC, RV5
Symptoms: Bacterial test negative, Blood sodium decreased, CSF glucose increased, CSF mononuclear cell count decreased, CSF polymorphonuclear cell count decreased
Clinical narrative: Case previously recorded as MA2009-2190. Initial - 07 AUG 2009: In study a 7-month-old male was vaccinated i.m. with 0.5 ml Men ACWY vaccine (batch no. 017011) on 24 FEB 2009, 23 APR 2009 and 30 JUN 2009. The subject was seen at the physician's office on 07 AUG 2009 with a history of fever and diarrhea. The examination revealed an otitis medical (assessed as not serious), with onset date on 07 AUG 2009. Diarrhea was noted as an associated symptom. During the visit the child's temperature went up, and he experienced a febrile seizure for 6 minutes (assessed as serious). He was transferred to the hospital by ambulance and was admitted on the same day. The results of a spinal tap are pending. The child remained hospitalized at the time of the report. Outcome for both events: AE persisting. Assessment: Seriousness criteria: hospitalisation, intervention, medically significant. Causality (investigator's assessment): possibly related for febrile seizure, not related for otitis media. Causality (sponsor's assessment): not related for both events. Otitis media and diarrhea occurred concurrently which may have caused the fever. A rationale for the investigator's assessment of the febrile seizure was requested since there was no time relationship. Febrile seizure is expected, otitis media is unexpected according to current IB (version 12). On the case level, the case is considered expected and possibly related. Follow-up # 1 - 19 AUG 2009: The subject also received PENTACEL, PREVNAR, Hepatitis B and ROTATEQ on 30 JUN 2009. The child was seen in the office on 07 AUG 2009 with a temperature of 103 degrees F (39.4 C). The exam revealed a left tympanic membrane that was erythematous, bulging and dull. There was fluid, which was thought to be serous although there was a thin purulent rim. While in the office, the child had a staring and stiffening spell, and his temperature at the time was 104.9 degrees (40.5 C). The child was placed on oxygen and cooled with TYLENOL and rags. This episode lasted about 6 minutes, and a second 1 minute staring spell occurred while in the office. The child was then transferred from the office to the hospital by ambulance. Laboratory reports of an evaluation of cerebrospinal fluid (CSF) from a spinal tap performed on 07 AUG showed: glucose 76 mg/dL, protein 23.2 mg/dL, WBC 0 cumm, RBC 2 cumm, poly 0 %, mononuclear 0 %, and crenated RBC 100%. The CSF was clear, colorless and without xanthochromia, and was negative for S. pneumococci; H. influenzae type B; Group B streptococci; N. Meningitis A, Y; N. Meningitis B; E. coli and N. Meningitis C, W135. No further seizure activity was seen during the hospital stay. Diarrhea was added, assessed not serious. Outcome of febrile seizure and diarrhea: complete recovery on 07 AUG 2009. Outcome for otitis media: AE persisting. The subject was discharged from the hospital on 09 AUG 2009. Further information on the diagnosis of roseola (mentioned in the investigator's letter) was requested. Hospital admission and discharge summaries will be provided when they become available. Assessment: Seriousness criteria: hospitalisation, intervention, medically significant. Causality (investigator's assessment): the investigator stressed his assessment of the febrile seizure as possibly related to the study vaccine. He stated that he considers seizure activity within 4-6 weeks of study vaccine as possibly related to vaccine (38-day interval in this case) and that possible etiologies of the febrile seizure included:1) otitis media; 2) roseola (which was observed when the fever subsided), and 3) possible relation to study vaccine. Diarrhea and otitis media are assessed as not related. Causality (sponsor's assessment): not related for all events due to time relationship. Infectious cause most likely (exanthema subitum). Febrile seizure and diarrhea are expected, otitis media is unexpected according to current IB (version 12). On the case level, the case assessment remains expected and possibly related. Follow-up - 31 AUG 2009: The subject also received PEDIARIX, ROTATEQ, PREVNAR and ACTHIB on 24 FEB 2009 and ROTATEQ, PREVNAR and PENTACEL on 23 APR 2009. A discharge summary and history and physical examination notes were provided. According to the discharge summary, the child initially had sodium of 126 that later returned at 130, and then improved to 134. The investigator has been queried if the mild hyponatremia should be reported as an additional adverse event. The history and physical examination notes that an influenza test was negative. The complete blood count (CBC) on 07 AUG 2009 was as follows: WBC- 13.1x1000/l, RBC- 4.36x1000000/l, Hgb- 11.5 gm/dl; Hct- 33.4%; MCV- 76.8 fl, MCH- 26.4pg, MCHC- 34.3 gm/dl, Plts- 399x1000/l, RDW- 11.5%, MPV- 6.2 fl, Polys- 63.5%, Lymphs- 31.0%, Monos- 5.5%. The VSAE report states that the infant developed roseola while in the hospital, which started after the fever broke. When fever resolved, the rash disappeared. The physician believed this to be roseola as this is the normal course for roseola. The investigator has been queried if roseola should be reported as an AE. Outcome of the otitis media: complete recovery/return to baseline on 09 AUG 2009. According to the discharge summary, the child was treated for the otitis media with IV antibiotics in the hospital. No further antibiotics or medications were initiated at discharge. Further information has been requested. Assessment: Unchanged. Follow-up - 17 SEP 2009: A note was received from the site stating that the investigator feels that neither mild hyponatremia nor roseola should be added as a non-serious AE or as a SAE. No further information has been requested. Assessment: Unchanged. Follow-up 1 receipt date has to be modified from 19 AUG 2009 to 18 AUG 2009. Follow-up received on 19 Oct 2010: The patient's rash was diagnosed as 'viral exanthem'. There were no serology or PCR tests done to confirm HHV6 or HHV7 etiology. The rash was described as 'all over', blanching, started after the fever defervesced and did not cause the patient any discomfort or distress. The rash as assessed as non-serious. Follow up report received on 17 Jan 2014: The reported event of "febrile convulsion" was cited in an article.