Received Nov 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 4 | — | OT |
flu; muscle aches; headache; sleepiness; This is a spontaneous report received from a Consumer or other non HCP. Other Case identifier(s): MOD-2025-790487 (Moderna). A 69-year-old patient received BNT162b2 (BNT162B2 NOS), as dose 4 (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 nos (DOSE 1, SINGLE), for Covid-19 Immunization, reaction(s): "Headache", "Flu", "Muscle ache", "Sleepiness"; Bnt162b2 nos (DOSE 2, SINGLE), for Covid-19 Immunization, reaction(s): "Headache", "Flu", "Muscle ache", "Sleepiness"; Bnt162b2 nos (DOSE 3 (BOOSTER), SINGLE), for Covid-19 Immunization, reaction(s): "Headache", "Flu", "Muscle ache", "Sleepiness". The following information was reported: INFLUENZA (non-serious), outcome "unknown", described as "flu"; MYALGIA (non-serious), outcome "unknown", described as "muscle aches"; HEADACHE (non-serious), outcome "unknown"; SOMNOLENCE (non-serious), outcome "unknown", described as "sleepiness". Additional information: The reporter stated that patient has received 6 doses of the Pfizer COVID vaccine and had a reaction every time. The reporter states that patient would be sick for a day or two and it felt like the flu with muscle aches, headache, sleepiness and everything. The reporter states that patient is not looking forward to getting the vaccine, but on the flip side has never had COVID. The reporter states that even had COVID in the same house so feels like it works. No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.