Received Mar 24, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 2 | — | — |
severe PMR symptoms characterized by bilateral shoulder pain and hip muscle pain and stiffness; This is a literature report for the following literature source(s): A 65-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, 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: POLYMYALGIA RHEUMATICA (medically significant) with onset 2022, outcome "recovered", described as "severe PMR symptoms characterized by bilateral shoulder pain and hip muscle pain and stiffness". The patient underwent the following laboratory tests and procedures: C-reactive protein: elevated; extensive evaluation: was unremarkable, notes: except for elevated ESR and CRP levels; Red blood cell sedimentation rate: elevated. Therapeutic measures were taken as a result of polymyalgia rheumatica. Clinical Course: A 65-year-old previously healthy male received two doses of the Pfizer COVID-19 vaccine in 2021. In 2022, he developed severe PMR symptoms characterized by bilateral shoulder pain and hip muscle pain and stiffness. An extensive evaluation was unremarkable except for elevated ESR and CRP levels. The diagnosis of PMR was confirmed by a rheumatologist. He was treated with oral prednisone 40 mg daily, followed by a gradual taper to 5 mg daily over six months. He remains asymptomatic on a maintenance dose of prednisone 5 mg daily.; Sender's Comments: Based on limited information in the case provided and considering temporal association, there is reasonable possibility of causal association between the event POLYMYALGIA RHEUMATICA and the suspect drug BNT162B2. 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.
Test Name: CRP level; Result Unstructured Data: Test Result:elevated; Test Name: extensive evaluation; Result Unstructured Data: Test Result:was unremarkable; Comments: except for elevated ESR and CRP levels; Test Name: ESR; Result Unstructured Data: Test Result:elevated