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Life Threatening? No
Write-up: drowning; cardiorespiratory arrest; This is a spontaneous report from a contactable physician downloaded from the regulatory authority-WEB manufacturer report number ES-AEMPS-745520. A 43-years-old male patient received fist dose of BNT162B2 (COMIRNATY), intramuscular on 13Jan2021 at 0.3 ml, single for COVID-19 immunisation; adalimumab, subcutaneous from 26Feb2020 to 2020 at 40 mg once a day (induction 160 mg), then via an unspecified route of administration, from 08May2020 to 2020 at 40 mg/ 10 days, then from 03Nov2020 to an unspecified date at 8 mg, then from an unspecified date to 15Jan2021 at 40 mg/14 days, for Crohn''s disease. Medical history included Traumatic brain injury (TBI) from 1998, ventriculo-peritoneal bypass valve (after TBI) in 1998, Crohn''s disease from 2011. Concomitant medications were not reported. On 19Jan2021 patient went for a digestive control visit, being asymptomatic of his digestive pathology, with normal laboratory tests and with pre-dose adalimumab levels in the therapeutic range. It is decided to keep the same treatment. On 19Jan2021: cholesterol 229, Triglycerides (TG) 139, Hb 15, international normalized ratio (INR) 0.87, K 4.36 (prior to 24Nov2020: Cholesterol 246 and pharmacokinetic study of adalimumab pre-dose adalimumab levels of 8030). On 19Jan2021 they notify the medical emergency service for finding the patient submerged in a public swimming pool. Advanced CPR measures are initiated without response, first recorded rhythm: asystole. Resuscitation maneuvers were stopped when the pool cameras verified that the patient had been submerged for 30 minutes. Death due to cardiorespiratory arrest due to drowning by immersion was reported. The family is notified, which is the one that communicates the information to the digestive service. Pending autopsy by court order. Lab data included: on 11Mar2020 an antigen test for COVID-19 by contact with a possible case, which was negative. The action taken to the events for adalimumab was permanently withdrawn on 15Jan2021. It was unknown if an autopsy was done or not. Pfizer is a marketing authorization holder of adalimumab in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of adalimumab has submitted the same report to the regulatory authorities No follow-up attempts are possible; information about lot/batch number cannot be obtained; Reported Cause(s) of Death: drowning; cardiorespiratory arrest
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