Received Dec 8, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | — |
chronic weakness; This is a spontaneous report received from a Physician from medical information team, Program ID:. A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; unknown manufacturer). The following information was reported: ASTHENIA (non-serious) with onset 2022, outcome "unknown", described as "chronic weakness". The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 will be requested and submitted if and when received. Additional information: The inquiry was from a family medicine doctor who had a patient believing her chronic weakness began on the same day as receiving the Pfizer COVID booster in 2022. The doctor asked if there were any studies suggesting the vaccine could cause lower extremity weakness. A search was conducted in system and PI for weakness. The PI mentioned weakness as a symptom associated with an allergic reaction to the vaccine. Additionally, an SRD on Guillain-Barre Syndrome was found, but it was unclear if that was appropriate to share.