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Life Threatening? No
Write-up: cause of death was due to a heart attack/complained of chest pain and had difficulty breathing/ became unconscious.; seizure; feeling ache of hand at the vaccination site; dizziness; This is a spontaneous report from press release by regulatory authority from a non-contactable healthcare professional which identified by a sales representative. A 42-year-old male patient received first dose of bnt162b2 (COMIRNATY) on 02Mar2021 morning at single dose for COVID-19 immunisation. Medical history included heart attack from unspecified date and undergone an angioplasty procedure in 2013. Concomitant medications were not reported. The patient showed no contraindications and did not have any side effects when he was observed at the Vaccine Centre. A day after vaccination (on 03Mar2021), he had only complained of feeling ache of hand at the vaccination site and symptoms of dizziness but was able to continue working as usual. On the second day of vaccination, there were no problems and he had carried on with his daily duties as usual until 19Mar2021. Early morning on 21Mar2021, the patient''s wife who is a specialist doctor said he had complained of chest pain and had difficulty breathing, then suffered a seizure and became unconscious. The patient''s wife made an emergency call and performed cardiopulmonary resuscitation (CPR) at home. He was rushed to a hospital''s emergency and trauma department where an active resuscitation was done but failed to be rescued. Based on the symptoms, clinical signs and case presentation, the emergency specialist confirmed that the cause of death was due to a heart attack and there was no link to the Covid-19 vaccination. Outcome of other events was unknown. The patient died on 21Mar2021. It was unknown if autopsy was performed. No follow up attempts are possible, information about lot/batch number cannot be obtained.; Sender''s Comments: The events heart attack and seizure were considered as intercurrent conditions and unrelated to the use of bnt162b2. Seizure could be secondary to heart attack. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.; Reported Cause(s) of Death: cause of death was due to a heart attack/complained of chest pain and had difficulty breathing/ became unconscious.
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