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Administered by: Unknown Purchased by: Unknown
Life Threatening? No
Write-up: This case was considered invalid as it is a duplicate of 2013315917. This case has been migrated from another database into the current safety database for processing follow-up information. As a consequence of this migration, the follow-up report may indicate in the appropriate field that it is an initial report. This is a regulatory report of fatal hypoxia, cardiac arrest, apnoea, syncope and irritable in a 5 month old Female patient subsequent to NEISVAC-C (0.5 ml Suspension for injection in pre-filled syringe). This report was received by Regulatory Authorities (reference number: 22297675) via a Physician and forwarded to Baxter. Suspect Product Details: on 19Aug2013 at 1430 hours, the patient received NEISVAC-C, intramuscularly (lot number, dose and injection site were not reported). The patient also received vaccinations with PEDIACEL, intramuscularly and PREVENAR 13, intramuscularly on the same date and time. The lot numbers, doses and injection sites were not reported. The action taken was Not Applicable. Baxter and the Reporter considered PEDIACEL and PREVENAR 13 as co-suspect drugs. Event Details: On 19Aug2013, about four hours after having been vaccinated (1900 hours), the patient became irritable. At an unreported time, the patient experienced syncope (described as collapsed). The patient recovered from the syncope at an unreported time. At 2030 hours, the patient was apnoeic which led to cardiac arrest. The patient was successfully resuscitated by 2110 hours. However, the patient died on 19Aug2013 due to hypoxia (described as severe hypoxic injury). The cause of the cardiac arrest was unknown despite magnetic resonance imaging, toxicology tests, septic screen and a metabolic screen. An unspecified culture and polymerase chain reaction (PCR) were negative, no evidence of sepsis. An autopsy was not performed. Outcome: Hypoxia: Fatal, Cardiac Arrest: Recovered/resolved, Apnoea: Not reported, Syncope: Recovered/resolved, Irritable: Not reported. Medical History: Constipation, Vitiligo. Concomitant Therapy: MOVICOL. Causality Assessment: Unassessible for all suspect products. The reporter stated it was "unclear" whether the vaccinations played any part in the collapse. Follow-up Information (28Feb2014): Additional information was received from a physician. Suspect product information was added or revised. Suspect Product Details: The lot number for NEISVAC-C was VN920622. The lot number for the PEDIACEL used was J0110-1 and the lot number for the PREVENAR 13 that was used was G19208. Follow-up Information (14Apr2014): Batch review results for NEISVAC-C lost number VN920622 were received. The review did not reveal any quality issues. This batch (VN920622) of NEISVAC-C was manufactured and released in compliance with established procedures and specifications. This investigation did not identify any product quality issues with this batch that could be associated with the reported events. Follow-up Information (22May2014): Follow-up information received from the physician. Suspect product details were added (unit dose). Suspect Product Details: On 19Aug2013, at 14:30 the patient received NEISVAC-C one dose (lot number VN920622) administered intramuscularly (site of administration not reported). Follow-up (02Jul2015): This is a follow-up report to notify that the case 2013BAX043887 and 2013315917 are duplicates. All subsequent follow-up information will be reported under manufacturer report number 2013315917.
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