Received Nov 12, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | LA |
Chills; Hot and cold; First few days felt my heart in my ears and maybe a few times maybe skipping a beat; Ringing in ears/ First few days felt my heart in my ears and maybe a few times maybe skipping a beat; Brief fever; feeling vertigo; headaches; Tired; Two cold sores never get two at a time; feeling off; This is a spontaneous report received from a Nurse. A 58-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 04Nov2025 as dose 1, single (Batch/Lot number: unknown) at the age of 58 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Dairy allergy" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Erythromycin, reaction(s): "erythromycin allergy". The following information was reported: PYREXIA (non-serious) with onset 04Nov2025, outcome "not recovered", described as "Brief fever"; CHILLS (non-serious) with onset 04Nov2025, outcome "not recovered"; EXTRASYSTOLES (non-serious) with onset 04Nov2025, outcome "not recovered", described as "First few days felt my heart in my ears and maybe a few times maybe skipping a beat"; FEELING OF BODY TEMPERATURE CHANGE (non-serious) with onset 04Nov2025, outcome "not recovered", described as "Hot and cold"; TINNITUS (non-serious) with onset 04Nov2025, outcome "not recovered", described as "Ringing in ears/ First few days felt my heart in my ears and maybe a few times maybe skipping a beat"; FATIGUE (non-serious) with onset 04Nov2025, outcome "not recovered", described as "Tired"; ORAL HERPES (non-serious) with onset 04Nov2025, outcome "not recovered", described as "Two cold sores never get two at a time"; FEELING ABNORMAL (non-serious) with onset 04Nov2025, outcome "not recovered", described as "feeling off"; VERTIGO (non-serious) with onset 04Nov2025, outcome "not recovered", described as "feeling vertigo"; HEADACHE (non-serious) with onset 04Nov2025, outcome "not recovered", described as "headaches". Therapeutic measures were taken as a result of chills, feeling of body temperature change, extrasystoles, tinnitus, pyrexia, vertigo, headache, fatigue, oral herpes, feeling abnormal. Additional information: The patient did not receive any other vaccines on the same date as the vaccine COMIRNATY. The patient did not receive any other vaccines within 4 weeks PRIOR to the vaccine COMIRNATY. The patient was not taking any other medications within 2 weeks of the event starting. Treatment received for the adverse event was Tylenol which was told to take by the pharmacist
Medical History/Concurrent Conditions: Milk allergy