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Administered by: Unknown Purchased by: ?
Life Threatening? No
Write-up: Guillain-Barre Syndrome; This is a spontaneous report from a non-contactable physician. A 64-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. It was reported that, male 64 admitted at (Institution name) on 30Jan2021 with Guillain-Barre Syndrome after receiving Pfizer COVID vaccine. Event took place after use of product. It was shared on 30Jan2021 with physician by a doctor in town. They were in the doctors lounge this morning discussing the case. This was all of the information physician have. The event was considered as serious (hospitalization) by the physician. The outcome of the event was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of Guillain-Barre Syndrome due to temporal relationship. This case will be reassessed once additional information is available. 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 RAs, Ethics Committees, and Investigators, as appropriate.
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