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Life Threatening? No Write-up: pulseless electrical activity(PEA); asystole; cardio-respiratory arrest(CPA) (asystole with early waveforms); he had no appetite; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from Regulatory Authority. Regulatory number: v2210003166 (RA). An 11-year-old male patient received BNT162b2 (COMIRNATY FOR 5 TO 11 YEARS OLD), on 13Dec2022 at 15:40 as dose 3 (orange cap, booster), single (Lot number: FW5101, Expiration Date: 31Dec2022) at the age of 11 years for covid-19 immunisation. The patient''s relevant medical history included: "Rhinitis allergic" (unspecified if ongoing), notes: The patient was taking oral REMICUT. Concomitant medication(s) included: REMICUT oral taken for rhinitis allergic. Vaccination history included: Covid-19 vaccine (Dose 1, manufacturer unknown, Another hospital), for COVID-19 immunisation; Covid-19 vaccine (Dose 2, manufacturer unknown, Another hospital), for COVID-19 immunisation. The following information was reported: DECREASED APPETITE (non-serious) with onset 13Dec2022, outcome "unknown", described as "he had no appetite"; CARDIO-RESPIRATORY ARREST (death) with onset 13Dec2022 at 19:30, outcome "fatal", described as "cardio-respiratory arrest(CPA) (asystole with early waveforms)"; CARDIAC ARREST (death) with onset 13Dec2022 at 19:57, outcome "fatal", described as "asystole"; PULSELESS ELECTRICAL ACTIVITY (death) with onset 13Dec2022 at 19:57, outcome "fatal", described as "pulseless electrical activity(PEA)". The events "cardio-respiratory arrest(cpa) (asystole with early waveforms)", "pulseless electrical activity(pea)", "asystole" and "he had no appetite" required emergency room visit. The patient underwent the following laboratory tests and procedures: Body temperature: (13Dec2022) 37.1 Centigrade, notes: before vaccination. Therapeutic measures were taken as a result of cardio-respiratory arrest. The patient date of death was 13Dec2022. Reported cause of death: "cardio-respiratory arrest(CPA) (asystole with early waveforms)", "pulseless electrical activity(PEA)", "asystole". It was not reported if an autopsy was performed. Clinical courses: The patient was a 11-year and 11-month-old male. The patient had no special note of family history. On 13Dec2022 at 19:00 ( 3 hours 20 minutes after the vaccination), the patient experienced unspecified event. On 13Dec2022 (after the vaccination), the outcome of the event was fatal. The course of the event was as follows: At 19:15, the patient was found by his family member with his face immersed in the bathtub, and they called for emergency services. He was bathing around 18:40, but no information was available after the bath. They also said that, before the bath, he had no appetite. At 19:30, when paramedics arrived, he was in cardio-respiratory arrest(CPA) (asystole with early waveforms). The paramedics obtained an intravenous line, administered adrenaline every 3-4 minutes, and performed cardiopulmonary resuscitation during transport. At 19:57, the patient arrived at the hospital. He once showed pulseless electrical activity(PEA) but soon went into asystole, which repeated but did not result in a return of spontaneous circulation. At 21:07, his death was confirmed. The reporting other HCP classified the event as serious (death) and assessed that the causality between the event and BNT162b2 as unassessable. Other possible cause(s) of the event such as any other diseases was unknown.; Reported Cause(s) of Death: pulseless electrical activity(PEA); asystole; cardio-respiratory arrest(CPA) (asystole with early waveforms) | ||||||||||||||||
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