Received May 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
Headache; severe fatigue; chills; This is a spontaneous report received from a Nurse. A 76-year-old female patient (not pregnant) received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 27May2025 as dose 1, single (Batch/Lot number: unknown) at the age of 76 years for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "Lichens planopilaris" (unspecified if ongoing); "Gerd" (unspecified if ongoing); "OAB" (unspecified if ongoing); "Adhesive tape allergy" (unspecified if ongoing). Concomitant medication(s) included: PANTOPRAZOLE, start date: 06Sep2006. Past drug history included: Anticholinergics, reaction(s): "Drug hypersensitivity"; Fosamax, reaction(s): "Drug hypersensitivity"; Lisinopril, reaction(s): "Drug hypersensitivity". The patient did not receive other vaccines on the same date as the vaccine(s) reported. The patient did not receive other vaccines within 4 weeks prior to the vaccine(s) reported. The following information was reported: HEADACHE (non-serious) with onset 28May2025, outcome "unknown"; CHILLS (non-serious) with onset 28May2025, outcome "unknown"; FATIGUE (non-serious) with onset 28May2025, outcome "unknown", described as "severe fatigue". Therapeutic measures were taken as a result of headache, fatigue, chills. Treatment received for the adverse event included Tylenol and rest. The information on the batch/lot number for BNT162b2 omicron (kp.2) will be requested and submitted if and when received.
Medical History/Concurrent Conditions: Adhesive tape allergy; GERD; Hypertension; Lichen planopilaris; Overactive bladder
PANTOPRAZOLE