Received Sep 5, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | UNK | — | — |
pleuropericardial effusions following mRNA COVID-19 vaccination; pleuropericardial effusions following mRNA COVID-19 vaccination; This is a literature report for the following literature source(s). A 78-year-old male patient 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: PERICARDIAL EFFUSION (medically significant), PLEURAL EFFUSION (medically significant), outcome "recovered" and all described as "pleuropericardial effusions following mRNA COVID-19 vaccination". Therapeutic measures were taken as a result of pericardial effusion, pleural effusion. Clinical course: Several case reports have described pleuropericardial effusions following mRNA COVID-19 vaccination. Patient who developed unilateral pleural effusion without identifiable infection or malignancy. All resolved with anti-inflammatory therapy and supportive care, supporting an inflammatory rather than infectious or neoplastic etiology.; Sender's Comments: Although it is difficult to establish temporal association between the reported events pericardial effusion and pleural effusion and suspect drug BNT162B2 based on the limited information provided in the case, the causal association between the Reported events and the suspect drug cannot be excluded as there is no concrete evidence available to eliminate the causal association. The impact of this report on the benefit/risk profile of the Pfizer drug 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