Received Jul 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | EW2017 | — |
Blood clot; Hives; This is a spontaneous report received from an Other HCP from a sales representative. An adult female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Jun2021 as dose number unknown, single (Lot number: EW2017) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: THROMBOSIS (hospitalization) with onset 01Jul2021, outcome "recovered", described as "Blood clot"; URTICARIA (hospitalization) with onset 01Jul2021, outcome "recovered", described as "Hives". The patient was hospitalized for thrombosis, urticaria (start date: 01Jul2021, hospitalization duration: 1 day(s)). Therapeutic measures were taken as a result of thrombosis, urticaria and included treatment with apixaban (ELIQUIS).; Sender's Comments: There is not a reasonable possibility that the reported events blood clot and urticaria were related to the suspect product event most likely due to patient underlying contributory factors. 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.