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Life Threatening? Yes
Write-up: General physical health deterioration; Rectum to skin fistula; Abdomen enlarged; This is a spontaneous report from a contactable physician from the Regulatory Authority-WEB FR-AFSSAPS-NY20210243. An 89-year-old patient female patient received the first dose of bnt162b2 (COMIRNATY) via Intramuscular on 04Feb2021 Arm Left at single dose (Lot # EJ6788) for covid-19 immunisation. Medical history included bedridden, dementia, severe psoriasis, osteoporosis, dyslipidemia all unknown if ongoing. 24 hours after the injection (05Feb2021), deterioration of the general condition with abdominal distension in the context of a wound in the buttock, deterioration of the general condition a few days earlier in a communicating patient. No general infectious symptoms, nor skin. Following the discovery of stool in the wound of internal origin with the presence of a commensal germ of digestive origin on the wound, suspicion of an anorecto-cutaneous fistula. Abdominal enlarged, general physical health deterioration and suspicion of rectum to skin fistula in the patient after a vaccination on 05Feb2021. 06Feb2021, death of the patient. Unfavorable evolution with death of the patient. All events were death and Life-threatening. It is unknown if autopsy was done. Outcome of the events was fatal. No accountability in the absence of direct causation according to the declarant. No follow-up attempts possible. No further information expected.; Sender''s Comments: Based on the information currently available, there was not a reasonable possibility that the events "General physical health deterioration, Rectum to skin fistula and Abdomen enlarged" were related to bnt162b2. The patient''s advance age with multiple underlying disease provide plausible alternative explanation.; Reported Cause(s) of Death: General physical health deterioration; Rectum to skin fistula; Abdomen enlarged
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