Received Sep 22, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
Elevated heart rate; Fever high at as 101F; muscle aches; headache; joint pain; This is a spontaneous report received from a Consumer or other non HCP. A 47-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 15Sep2025 at 11:15 as dose 1, single (Batch/Lot number: unknown) at the age of 47 years for covid-19 immunisation. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "hypercholesterolemia" (unspecified if ongoing); "depression" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: May2016; ATORVASTATIN, start date: May2022; SKYRIZI [RISANKIZUMAB], start date: Dec2023; DULOXETINE, start date: Jul2025. Past drug history included: Carbamazepine, reaction(s): "Allergy". The following information was reported: HEART RATE INCREASED (non-serious) with onset 16Sep2025 at 03:00, outcome "recovered" (17Sep2025), described as "Elevated heart rate"; PYREXIA (non-serious) with onset 16Sep2025 at 03:00, outcome "recovered" (17Sep2025), described as "Fever high at as 101F"; HEADACHE (non-serious) with onset 16Sep2025 at 03:00, outcome "recovered" (17Sep2025); ARTHRALGIA (non-serious) with onset 16Sep2025 at 03:00, outcome "recovered" (17Sep2025), described as "joint pain"; MYALGIA (non-serious) with onset 16Sep2025 at 03:00, outcome "recovered" (17Sep2025), described as "muscle aches". Therapeutic measures were not taken as a result of heart rate increased, pyrexia, myalgia, headache, arthralgia. Additional information: The patient did not receive any other vaccines on the same date as the vaccines. He did not receive any other vaccines within 4 weeks PRIOR to the vaccines. He was taking medications within 2 weeks of the event starting. 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: Crohn's disease; Depression; Hypercholesterolemia; Hypertension
LISINOPRIL; ATORVASTATIN; SKYRIZI [RISANKIZUMAB]; DULOXETINE