Received Oct 14, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | UNK | — | RA |
Off balance; Fever; Chills; feel like I am going to vomit; Dizziness; This is a spontaneous report received from a Consumer or other non HCP. An 80-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 06Oct2025 at 12:30 as dose number unknown,single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: Blood pressure high. Concomitant medication(s) included: LEVOTHYROXINE; LOSARTAN POTASSIUM taken for hypertension. The following information was reported: BALANCE DISORDER (non-serious), outcome "unknown", described as "Off balance"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; CHILLS (non-serious), outcome "unknown"; NAUSEA (non-serious), outcome "unknown", described as "feel like I am going to vomit"; DIZZINESS (non-serious), outcome "unknown". The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received. Additional information: Patient stated, "It said on the website to report when you had a reaction to the Pfizer COVID Shot (Clarified as Comirnaty), Patient was reporting it." She stated, "Fever, chills, feel like I am going to vomit and dizziness, off balance." Age at the time of event of the patient was "80 years, 8 months." Product details (LOT#, expiration date, NDC# and UPC#): She stated, "So, Stop and shop Pharmacy and it said Comirnaty 12 plus." Indication was stated by patient as "Because it was recommended that everyone over 80 years get it to prevent various sickness." She stated Thyroid was Indication of Levothyroxine. She stated the Date and time of vaccination was On Monday the 6Oct2025 probably about 12:30 in the afternoon. Patient stated For the Treatment Just a Ibuprofen as recommended. Additional Information for Other medicines Losartan Potassium: Indication: Patient stated, "Mild high blood pressure."
Medical History/Concurrent Conditions: Blood pressure high
LEVOTHYROXINE; LOSARTAN POTASSIUM