Received Oct 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | RA |
Local knot at site of injection 2-3 days post vaccine; Muscle pain around back that began after vaccination and continues; This is a spontaneous report received from a Pharmacist from a sales representative. A 66-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 25Sep2025 as dose number unknown, single (Batch/Lot number: unknown) at the age of 66 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: TIRZEPATIDE. Past drug history included: Morphine, reaction(s): "Morphine: Allergy". The following information was reported: VACCINATION SITE NODULE (non-serious) with onset 26Sep2025, outcome "recovered", described as "Local knot at site of injection 2-3 days post vaccine"; BACK PAIN (non-serious) with onset 26Sep2025, outcome "not recovered", described as "Muscle pain around back that began after vaccination and continues". Therapeutic measures were not taken as a result of vaccination site nodule, back pain. Additional information: Did the patient receive any other vaccines on the same date as the vaccine(s) for which you are reporting?: No. Did the patient receive any other vaccines within 4 weeks PRIOR to the vaccine(s) for which you are reporting?: No. Were you/Was the patient taking any other medications within 2 weeks of the event starting?: Yes. The reported Event: Local knot at site of injection 2-3 days post vaccine (resolved); muscle pain around back that began after vaccination and continued. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Medical History/Concurrent Conditions: Hypertension
TIRZEPATIDE