Received Oct 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
Polymyalgia Rheumatic with extremely high inflammation markers; Patient had episode where she could not move and was vomiting; This is a spontaneous report received from a Consumer or other non HCP. An elderly female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), in Jul2025 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Allergy: steroids, notes: Stated she was allergic to one of the steroids provided so they gave her a new one. The following information was reported: VOMITING (hospitalization) with onset Jul2025, outcome "recovering", described as "Patient had episode where she could not move and was vomiting"; POLYMYALGIA RHEUMATICA (hospitalization, medically significant) with onset Jul2025, outcome "recovering", described as "Polymyalgia Rheumatic with extremely high inflammation markers". The patient was hospitalized for polymyalgia rheumatica, vomiting (start date: 2025, discharge date: 2025, hospitalization duration: 1 day(s)). The event "polymyalgia rheumatic with extremely high inflammation markers" required emergency room visit. The patient underwent the following laboratory tests and procedures: C-reactive protein: extreme inflammation; Sedimentation test: extreme inflammation. Therapeutic measures were taken as a result of polymyalgia rheumatica, vomiting. Clinical course: Patient was unable to move body and was in extreme pain . Dr prescribed two separate Medrol does packs and it came back. Went to ER and rant multiple test. C reactive and Sedimentation test showed extreme inflammation. Patient had episode where she could not move and was vomiting. Hospitalized for 24 to 36 hours thinking it was a stroke but vaccine considered the cause.. Did steroid IV followed by 40 MG steroid orally. Problem continues. Diagnosed with Polymyalgia Rheumatic with extremely high inflammation markers. Vomiting and inability to move continue when not on steroids. Advised to never have vaccine again and not to have a flu shot this year. Stated she was allergic to one of the steroids provided so they gave her a new one. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Test Name: C reactive; Result Unstructured Data: Test Result:extreme inflammation; Test Name: Sedimentation test; Result Unstructured Data: Test Result:extreme inflammation