Received Sep 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
his arm was hurting him; redness at the site/injection site redness; he had a tremendous headache; his whole body ached/whole body ache; vertigo/Developed vertigo; Swelling in my arm; all my joints hurt me; This is a spontaneous report received from a Consumer or other non HCP from medical information team. An 83-year-old male patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 16Sep2025 as dose 1, single (Batch/Lot number: unknown) at the age of 83 years for covid-19 immunisation. The patient's relevant medical history included: "had knee replacements" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE (Pfizer manufacturer)), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE (Pfizer manufacturer)), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE (Pfizer manufacturer)), for COVID-19 immunization. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset Sep2025, outcome "recovered" (Sep2025), described as "Swelling in my arm"; ARTHRALGIA (non-serious) with onset Sep2025, outcome "unknown", described as "all my joints hurt me"; VERTIGO (non-serious) with onset Sep2025, outcome "not recovered", described as "vertigo/Developed vertigo"; HEADACHE (non-serious) with onset 17Sep2025, outcome "not recovered", described as "he had a tremendous headache"; PAIN IN EXTREMITY (non-serious) with onset 17Sep2025, outcome "unknown", described as "his arm was hurting him"; PAIN (non-serious) with onset 17Sep2025, outcome "recovered" (Sep2025), described as "his whole body ached/whole body ache"; VACCINATION SITE ERYTHEMA (non-serious) with onset 17Sep2025, outcome "recovered" (Sep2025), described as "redness at the site/injection site redness". Additional information: Patient was received the 2025/2026 Comirnaty vaccine a week ago from reported day. The next morning patient got up his arm was hurting him, he had redness at the site, his whole body ached, and he had a tremendous headache. patient stated a week has gone by in which the redness and body aches are gone, however he ended up with vertigo and still has a headache. patient provided that he has received 3 Pfizer Covid-19 vaccines prior to this vaccination and prefers to stick with Pfizer as "they worked." Patient provided that he called his doctor and was waiting for a call back. he was trying to rule out the possibilities of what could be causing these issues and he stated "it could be an ear infection, but he was not sure." No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.
Medical History/Concurrent Conditions: Knee replacement