Received Dec 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
Body completely convulsing shaking; Body completely convulsing shaking; extreme pain throughout the whole body; Sciatica pain radiating through my leg; Ear pain; Headache; Arm was numb; Swollen lymph node underneath my armpit; Injection site area extremely painful; This is a spontaneous report received from a Consumer or other non HCP. A patient (age and gender not provided) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 21Nov2025 as dose 1, 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: SEIZURE (medically significant), TREMOR (non-serious), outcome "not recovered" and all described as "Body completely convulsing shaking"; PAIN (non-serious), outcome "not recovered", described as "extreme pain throughout the whole body"; SCIATICA (non-serious), outcome "not recovered", described as "Sciatica pain radiating through my leg"; EAR PAIN (non-serious), outcome "not recovered"; HEADACHE (non-serious), outcome "not recovered"; HYPOAESTHESIA (non-serious), outcome "not recovered", described as "Arm was numb"; LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "Swollen lymph node underneath my armpit"; VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "Injection site area extremely painful". Clinical course: Consumer stated, "I received the vaccine this past Friday and I had an Adverse effect to the vaccine." Consumer stated, So, started up woke up in the middle at night with body completely convulsing shaking, extreme pain throughout the whole body. Sciatica pain radiating through my leg. Arm was numb. Ear pain, headache. Swollen lymph node underneath my armpit. The injection site area extremely painful. It's still painful to touch." The information on the batch/lot number for [BNT162B2 OMICRON (LP.8.1)] will be requested and submitted if and when received.