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Life Threatening? No
Write-up: Severe pneumonia; vomiting; Respiratory failure; This spontaneous report was received from an Agency and refers to a 7-week-old male patient. The patient''s medical history included unspecified BCG Vaccine and unspecified hepatitis B vaccine (reported as Hep B) at zero month (31-AUG-2019) according to the normal schedule. On 24-OCT-2019 the patient received one dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (lot # R028634 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 26-JUN-2020) for prophylaxis at a county health center. The patient''s concomitant vaccines included 2nd shot of unspecified hepatitis Bat 1 month (also reported as on 09-OCT-2019). Prior to the vaccination, the patient had a pre-check and had no cough and fever, but the child was in poor condition. During the period between the class-1 vaccination and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vaccination, no other vaccine was vaccinated. No other vaccine was administered in combination with rotavirus vaccine, live, oral, pentavalent (ROTATEQ). After vaccination the patient went back home. In the afternoon of 24-OCT-2019, the patient experienced vomiting and received infusion treatment in the health center. The town health centers suspected it as pneumonia and suggested further treatment to the hospital as they considered it as a severe condition. The patient was transferred to the hospital for treatment. At around 7 a.m. of the next day (25-OCT-2019), the patient died. The diagnosis of hospital was death due to respiratory failure caused by severe pneumonia. The hospital did not provide the certificate of diagnosis at the reporting time. The county center for disease control and the city center for disease control had communicated with the patient''s parents, autopsy was suggested. The relatives initially agreed but refused the autopsy at the reporting time. By the reporting time, parents of the patient were stable in emotion. The parents had bought the class-2 vaccine insurance at their own expense, the insurance company had stepped in the event. Attempts were making to obtain further information such as the patient''s medical records. Upon internal review, the events of severe pneumonia and respiratory failure were considered to be medically significant.; Reported Cause(s) of Death: Respiratory failure
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