Received Oct 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | RA |
atrial fibrillation with rapid ventricular response; heart dysrhythmia; abdomen hurt; Fever; her guts hurt bad; The muscle aches and joints and everything hurt severely including her head; The muscle aches and joints and everything hurt severely including her head; muscle aches; ache/hurts all over/hurt severely; This is a spontaneous report received from a Consumer or other non HCP. A 75-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 24Sep2025 at 09:00 as dose 1, 0.3 ml single (Batch/Lot number: unknown) at the age of 75 years, in right upeer arm for covid-19 immunisation. The patient's relevant medical history included: "Atrial fibrillation", start date: Apr2014 (unspecified if ongoing); "had long covid twice" (unspecified if ongoing). Concomitant medication(s) included: FLECAINIDE oral taken for atrial fibrillation. Vaccination history included: Bnt162b2 (dose number unknown, Last year she had a horrible time too with side effects when she got the Pfizer covid vaccine), administration date: 2024, for Covid-19 immunization, reaction(s): "side effects". The following information was reported: ARTHRALGIA (non-serious), HEADACHE (non-serious) all with onset 24Sep2025, outcome "recovering" and all described as "The muscle aches and joints and everything hurt severely including her head"; PAIN (non-serious) with onset 24Sep2025, outcome "recovering", described as "ache/hurts all over/hurt severely"; MYALGIA (non-serious) with onset 24Sep2025, outcome "recovering", described as "muscle aches"; PYREXIA (non-serious) with onset 25Sep2025, outcome "unknown", described as "Fever"; ABDOMINAL PAIN (non-serious) with onset 25Sep2025, outcome "recovered", described as "abdomen hurt"; ATRIAL FIBRILLATION (medically significant) with onset 25Sep2025, outcome "recovered" (25Sep2025); ARRHYTHMIA (medically significant) with onset 25Sep2025, outcome "recovered" (25Sep2025), described as "heart dysrhythmia"; GASTROINTESTINAL PAIN (non-serious) with onset 25Sep2025, outcome "recovered", described as "her guts hurt bad". Therapeutic measures were taken as a result of atrial fibrillation, arrhythmia. Therapeutic measures were not taken as a result of myalgia, pain, abdominal pain, pyrexia, arthralgia, headache, gastrointestinal pain. Clinical course: She got Comirnaty 12 plus on Wednesday 24Sep2025 around 9am and she had rather serious side effects within 12 hours. She kept going about her day and started to ache and ache and ached and ached until she could barely stand, she hurts all over, she hurt badly. This started on Wednesday two days ago. She is still not all better and has improved but slowly. The muscle aches and joints and everything hurt severely including her head. She was not back to herself yet. She declined any and then stated it hurt worse and worse. About 2:30 in the morning on 25Sep2025 she started with atrial fibrillation, heart dysrhythmia. She took an antidysrhythmic called Flecainide. She had a maintenance dose of Flecainide and she had dose that she takes of Flecainide when she has atrial fibrillation. Her Flecainide maintenance dose was 100mg tablet in the morning and half of a 100mg tablet at night (to equal 50mg at night) by mouth. At 2:30 in the morning when she had the dysrhythmia and atrial fibrillation she took 200mg more of Flecainide. She took a total of 250mg of Flecainide within just a few hours of each other and she took the Flecainide along with diltiazem extended release (ER) 180mg capsule. She had a Kardia device which she stated was an electrocardiogram device that was showing atrial fibrillation at 2:30 in the morning and RVR which she states stands for rapid ventricular response. The dysrhythmia and atrial fibrillation stopped some time before 9 am on 25Sep2025. She experienced something else which is her guts hurt bad, and her abdomen hurt all day yesterday (25Sep2025). she got a fever of 100.3 that lasted for hours which was during the middle of the night around 1am, 2am, 3 am on 25Sep2025 and her fever kept going for hours. She was wondering if she should not have the covid vaccine in the future and if the benefits outnumber or outweigh the risks. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.
Medical History/Concurrent Conditions: Atrial fibrillation; Long COVID
FLECAINIDE
Test Date: 20250925; Test Name: fever; Result Unstructured Data: Test Result:100.3; Test Date: 20250925; Test Name: electrocardiogram; Result Unstructured Data: Test Result:atrial fibrillation; Comments: showing atrial fibrillation at 2:30 in the morning and RVR which she stated stands for rapid ventricular response