Received Jun 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | UNK | — | — |
neurological complications; This is a literature report for the following literature source(s). A patient (age and gender not provided) received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NERVOUS SYSTEM DISORDER (medically significant), outcome "unknown", described as "neurological complications". Follow-up(30MAY2025) This is a literature report for the following literature source(s).This a follow-up report based on the receipt of the publication the case has been updated to include additional information identified in the publication.; Sender's Comments: The reasonable possibility that the event is related to BNT162b2 (COVID-19 Vaccine - Manufacturer Unknown) administration cannot be excluded. This case will be reassessed should additional information become 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 Regulatory Authorities, Ethics Committees and Investigators as appropriate.