Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEP, MNQ, PNC, RV5
Symptoms: Viral diarrhoea, Vomiting
Clinical narrative: Initial report received on 15 Apr 2010: This patient was enrolled in a study, a phase 3b, open-label, randomized, parallel-group, multi-center study to evaluate the safety of MENACWY when administered with routine infant vaccinations to healthy infants. The patient received the first dose of the study vaccine on 23 Sep 2009, the second dose on 23 Nov 2009 and the third dose on 26 Jan 2010. Concomitant vaccines included ENGERIX B on 25 Jul 2009 and 23 Sep 2009, PENTACEL, ROTATEQ and PREVNAR on 23 Sep 2009, 23 Nov 2009 and 26 Jan 2010, RECOMBIVAX on 26 Jan 2010 and FLUZONE on 26 Jan 2010 and 26 Feb 2010. On 13 Apr 2010, the patient experienced a seizure disorder. The patient's mother notices symptoms which included foaming from the mouth, blue lips, shaking and the patient was rigid/stiff. The patient's mother stated the event lasted 2-3 minutes. The patient was taken to the emergency room (ER) and the patient was reported to have a seizure based on the symptoms which had occurred in the morning. A physical examination was conducted and no abnormal findings were noted. On 14 Apr 2010, the patient was evaluated by the neurologist and diagnosed with epilepsy. On 13 Apr 2010, the patient completely recovered from the event. The investigator did suspect a possible relationship between the seizure disorder and the study vaccine. In the absence of the investigators assessment of causality, the Novartis medical safety physician provisionally assessed epilepsy as suspected to be related to the study vaccine. Case correction was performed on 29 Apr 2010, after internal review: The event of epilepsy was assessed as unexpected as per current version of investigator brochure (previously assessed as listed). Follow up received on 29 Apr 2010: On 12 Feb 2010, the patient experienced a vasovagal episode. On 14 Apr 2010, on evaluation by the neurologist, the patient's mother stated she had not begun administering KEPPRA which had been prescribed due to their concern of the medications side effects. On 03 May 2010, the patient was scheduled for an MRI (magnetic resonance imaging) and will return to the doctor's office on 19 May 2010 to review the results and discuss their concerns regarding the medication. The seriousness criterion for the epilepsy was medically significant. The investigator assessed the epilepsy as possibly related to the study vaccine. Follow up received on 04 May 2010: The patient did not have a family history of epilepsy. A computerised tomography (CT) scan of the head on 12 Feb 2010 was normal. The investigator stated that the course of labour was normal and there were no difficulties or abnormalities. Follow up received on 26 May 2010: On 09 Feb 2010, the patient developed vomiting and viral diarrhea. The patient's vomiting resolved on 09 Feb 2010. The vomiting and viral diarrhoa were reported to be symptoms of the vasovagal episode experienced on 12 Feb 2010. The patient was hospitalised on an unspecified date. On 13 Feb 2010, the patient made a complete recovery from the vasovagal episode. The patient's viral diarrhea was resolved on 16 Feb 2010. The investigator did not suspect a relationship between the vasovagal episode and the study vaccine. Follow-up received 01 Oct 2010: The onset date of epilepsy was confirmed as 13 Apr 2010. On 03 May 2010, the patient underwent an MRI which was normal. On 04 Aug 2010, a second compliance call was completed and the patient's parent stated that the patient had started taking KEPPRA on 10 May 2010.