Received Sep 17, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | LA |
Body aches; Chills; Fever; Headache; This is a spontaneous report received from a Consumer or other non HCP. A 76-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 05Sep2025 as dose 1, single (Batch/Lot number: unknown) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "AFib" (ongoing); "Aortic valve replacement" (ongoing); "cardiac disease", start date: Jun1949 (unspecified if ongoing), notes: congenital; "thyroid was removed" (unspecified if ongoing), notes: years ago. Concomitant medication(s) included: SOTALOL taken for atrial fibrillation (ongoing); AMLODIPINE (ongoing); WARFARIN (ongoing); LEVOTHYROXINE taken for thyroidectomy (ongoing). Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE, UNKNOWN MANUFACTURER), for Covid-19 Immunization. The following information was reported: PAIN (non-serious) with onset 05Sep2025, outcome "recovered" (06Sep2025), described as "Body aches"; CHILLS (non-serious) with onset 05Sep2025, outcome "recovered" (06Sep2025); PYREXIA (non-serious) with onset 05Sep2025, outcome "recovered" (06Sep2025), described as "Fever"; HEADACHE (non-serious) with onset 05Sep2025, outcome "recovered" (06Sep2025). Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain, chills, pyrexia, headache. Additional Information: Consumer stated, Well, couple of weeks ago, she got her updated COVID vaccine, and she had never had side effects with that vaccine ever at all, but she just wanted to let you all know that with this particular one. She did had chills and fever and body aches and a headache and it was pretty miserable for 24 hours and so, she was just reported side effects the name of the COVID vaccine she got was the she guess, Comirnaty and she mean, it only last for 24 hours but she had never had side effects from any vaccine she had received and she had received her COVID vaccine ever since they were available and she had received her covered vaccine ever since they were available and she know this one was, this one is for the more for the updated version of COVID and so she was just, she was just letting you all know. It's kind of an FYI. Yes, reporter does have cardiac disease. She do not had to specify it was congenital, She had the, recently been suffering from AFib. She had an aortic valve replacement. The list kind of goes on and so. Consumer stated, she was on Sotalol. She was taking amlodipine. She was taking Warfarin. She also don't had a thyroid, so she take levothyroxine. She was taking Sotalol, amlodipine, Warfarin and because her thyroid was removed years ago, She take levothyroxine. Its Sotalol, it's for the AFib that she was battling. Patient was on Sotalol. She was taking amlodipine. She was taking Warfarin. She also don't have a thyroid, so she take levothyroxine. She was taking Sotalol, amlodipine, Warfarin and because her thyroid was removed years ago, She take levothyroxine. Its Sotalol, it was for the AFib that she was battling. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.
AFib; Aortic valve replacement
Medical History/Concurrent Conditions: Cardiac disorder (congenital); Thyroidectomy (years ago)
SOTALOL; AMLODIPINE; WARFARIN; LEVOTHYROXINE
Test Date: 202508; Test Name: blood work; Result Unstructured Data: Test Result:Unknown results; Comments: past two weeks