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Administered by: Unknown Purchased by: ?
Life Threatening? No
Write-up: Initial unsolicited report received from health care professional on 14-Jul-2017. This case is related to case SW50157l (same reporter). This case involves nine-month-old female patient who was vaccinated with primary dose of PEDIACEL (Batch number: N1D891V, expiration date, dose and route was not reported) in thigh on an unspecified date. The patient''s medical history and concomitant medications were not reported. Relevant comorbidities including immunity status was reported as unknown. On 07 Jul 2017, within 24 hours of receiving PEDIACEL the patient died (cause of death was not reported). The information about autopsy was not reported. The reporter felt the causality between the reaction and the drug. Follow-up report received from health care professional on 18-Jul-2017. It was reported that two-month-old (also reported as 9-week-old) was vaccinated with PEDIACEL as well as primary dose of ROTAVIX and MENINGITIS B and PREVENAR (batch number, expiry date, dose, route and site of administration was not reported for last three vaccines) on 06-Jul-2017. On 06-Jul-2017, on the same day after vaccination, the patient experienced low grade fever at home and was put to bed. It was also reported that patient was fit and well during the vaccination and left the clinic shortly after vaccination. List of documents held by sender: none. Sender''s Comments: Follow-up information received on 18-Jul-2017, changes the previous medical assessment. In this case a 9 weeks old female experienced low grade fever on the same day of vaccination and died within 24 hours of receiving PEDIACEL. The patient was concomitantly vaccinated with ROTAVIX, Meningitis B and PREVENAR vaccines (other manufacturer). No information is provided on conditions at the time of death, sleeping position, patient''s medical history especially any congenital anomaly or prematurity, previous vaccination history, autopsy and results of investigations, etc. This case is insufficiently documented to draw a conclusion on a relationship with vaccine administration. Moreover, as multiple vaccines were administered concomitantly, the role of each component cannot be assessed separately. GB-SA-SW50157L. Reported Cause(s) of Death: Death.
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