Received Nov 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | LA |
Chills; Fever; Malaise; This is a spontaneous report received from a Pharmacist. A 63-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 29Oct2025 at 18:00 as dose 1 , single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypercholesterolemia" (unspecified if ongoing); "Mixed Connective Tissue Disorder" (unspecified if ongoing); "Cramping and Fasciculitis Syndorme" (unspecified if ongoing). Concomitant medication(s) included: MYCOPHENOLATE, start date: Dec2014; NIFEDIPINE, start date: Dec2014; PANTOPRAZOLE, start date: Feb2014; ATORVASTATIN, start date: Aug2011; CYCLOBENZAPRINE, start date: Jun2016. Past drug history included: Penicillins, reaction(s): "Hypersensitivity"; Sulphonamide, reaction(s): "Hypersensitivity". Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3(BOOSTER), SINGLE), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunisation; Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE), for COVID-19 immunisation; Covid-19 vaccine (DOSE 6 (BOOSTER), SINGLE), for COVID-19 immunisation; Covid-19 vaccine (DOSE 7 (BOOSTER), SINGLE), for COVID-19 immunisation. The following information was reported: CHILLS (non-serious) with onset 30Oct2025 at 14:00, outcome "recovered" (31Oct2025); PYREXIA (non-serious) with onset 30Oct2025 at 14:00, outcome "recovered" (31Oct2025), described as "Fever"; MALAISE (non-serious) with onset 30Oct2025 at 14:00, outcome "recovered" (31Oct2025). Therapeutic measures were taken as a result of chills, pyrexia, malaise. Additional information: The reported that patient experienced Chills, fever, malaise started approximately 2pm day after vaccines. The patient had been taking other medications within two weeks prior to the onset of the event. To treat the symptoms, the patient took Tylenol, which provided relief. The patient received unspecified suspect drug on 29Oct2025, Right arm. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Medical History/Concurrent Conditions: Cramp-fasciculation syndrome; Hypercholesterolemia; Mixed connective tissue disease
MYCOPHENOLATE; NIFEDIPINE; PANTOPRAZOLE; ATORVASTATIN; CYCLOBENZAPRINE