Received Feb 4, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | — |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
Muscle contraction; This is a solicited report received from an Other HCP and a Consumer or other non HCP, Program ID. A 61-year-old female patient received BNT162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), in 2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), in 2023 as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCLE CONTRACTIONS INVOLUNTARY (hospitalization) with onset 2023, outcome "recovered", described as "Muscle contraction". The patient was hospitalized for muscle contractions involuntary (hospitalization duration: 1 day(s)). Clinical course: She also reported that 3 years ago she had a bad reaction to the COVID-19 and influenza vaccines. She experienced muscle contractions and was hospitalized for 1 day (date not provided). The contractions resolved. The treating physician was aware and advised her not to receive vaccinations in the future. The reporter's assessment of the causal relationship of "muscle contraction" with the suspect product(s) BNT162b2 omi xbb.1.5 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event muscle contraction and the suspect drug BNT162b2 omi xbb.1.5 can be excluded as there is no compelling evidence to implicate any relations, hence assessed as Unrelated. Other vaccinations and medical history should be confounding factors. The case will be reassessed once new information is available.