Received Sep 29, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | LA |
Fever; weakness; fatigue; headache; soreness at injection sight; general all-over body aches; extreme thirst; This is a spontaneous report received from a Consumer or other non HCP. A 68-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 24Sep2025 at 09:00 as dose 1, single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hyperthyroidism" (unspecified if ongoing); "obesity" (unspecified if ongoing); "gastric reflux" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; OMEPRAZOLE; SEMAGLUTIDE, start date: 19Apr2025. The following information was reported: PYREXIA (non-serious) with onset 24Sep2025 at 12:00, outcome "not recovered", described as "Fever"; THIRST (non-serious) with onset 24Sep2025 at 12:00, outcome "not recovered", described as "extreme thirst"; FATIGUE (non-serious) with onset 24Sep2025 at 12:00, outcome "not recovered"; PAIN (non-serious) with onset 24Sep2025 at 12:00, outcome "not recovered", described as "general all-over body aches"; HEADACHE (non-serious) with onset 24Sep2025 at 12:00, outcome "not recovered"; VACCINATION SITE PAIN (non-serious) with onset 24Sep2025 at 12:00, outcome "not recovered", described as "soreness at injection sight"; ASTHENIA (non-serious) with onset 24Sep2025 at 12:00, outcome "not recovered", described as "weakness". Therapeutic measures were taken as a result of pyrexia, asthenia, fatigue, headache, vaccination site pain, pain, thirst. Additional information: The patient did not receive any other vaccines on the same date as the vaccine(s) for which you are reporting. The patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine(s) for which you are reporting. The patient was taking any other medications within 2 weeks of the event starting. The Pt was received treatment Advil for the adverse events. 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: Gastroesophageal reflux; Hyperthyroidism; Obesity
LEVOTHYROXINE; OMEPRAZOLE; SEMAGLUTIDE