Received Sep 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
Really bad pain in my heart; heart issue/his heart started to hurt; still feel a tens of tightening of the chest; Palpitation; chills; This is a spontaneous report received from a Consumer or other non HCP from medical information team. A 72-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 16Sep2025 as dose 1, single (Batch/Lot number: unknown) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (ongoing). Concomitant medication(s) included: PRAVASTATIN oral taken for blood cholesterol increased (ongoing). The following information was reported: CHILLS (non-serious) with onset 17Sep2025, outcome "unknown"; PALPITATIONS (non-serious) with onset 20Sep2025, outcome "unknown", described as "Palpitation"; ANGINA PECTORIS (medically significant) with onset 20Sep2025, outcome "unknown", described as "Really bad pain in my heart"; CARDIAC DISORDER (medically significant) with onset 20Sep2025, outcome "unknown", described as "heart issue/his heart started to hurt"; CHEST DISCOMFORT (non-serious) with onset 20Sep2025, outcome "unknown", described as "still feel a tens of tightening of the chest". Therapeutic measures were taken as a result of chills. Clinical course: The consumer reported receiving the most recent dose of the Comirnaty (Pfizer COVID-19) vaccine on Tuesday, 16Sep2025. He experienced chills the following day, which subsided after taking Advil. On Saturday, 20Sep2025, he experienced significant chest pain and subsequently consulted his primary care physician on Monday and a physician assistant at a cardiology clinic on Tuesday. Both assessments reportedly found no acute cardiac issues. The consumer described ongoing heart discomfort since the event and expressed concern about the nature and duration of symptoms, noting they are impacting his daily life. He mentioned previous fatigue with earlier Pfizer vaccines but stated that this current reaction is unlike any past experience. The consumer reported taking 10 mg of Pravastatin orally once daily for high cholesterol, ongoing for approximately three years. He has been self-treating the current symptoms with over-the-counter Advil since Monday night, though exact dosage is unknown. Product details such as vaccine lot number and expiration date were not available. Vaccine was administered at a retail pharmacy. No vaccine card was available, but the consumer mentioned having a vaccine record. The call was transferred to Pfizer Medical Information for further assistance. The information on the batch/lot number for BNT162b2 omicron (lp.8.1) will be requested and submitted if and when received.
High cholesterol
PRAVASTATIN