Received Oct 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | NA4452 | LA |
severe chest pressure; Chills; body aches; Joint pain; Nausea; Dizziness; Fatigue; vascular issues; Migraine; had migraines before; This is a spontaneous report received from a Consumer or other non HCP. A 79-year-old female patient received BNT162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 18Oct2025 as dose 1 (0.3 units unknown), single (Lot number: NA4452, Expiration Date: 09Jul2026) at the age of 79 years, in left arm for covid-19 immunisation, Device Lot Number: NA4452. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing), notes: Arthritis, From: 20 years ago; "Severe allergies to antibiotics" (unspecified if ongoing), notes: As a child, so in distant past; "major surgeries" (unspecified if ongoing); "breast cancer", start date: 2024 (unspecified if ongoing); "mastectomy" (unspecified if ongoing); "chemo therapy" (unspecified if ongoing); "migraines" (unspecified if ongoing). Concomitant medication(s) included: FLUZONE HIGH DOSE taken for immunisation, on 03Oct2025 as dose number unknown, single. Vaccination history included: Moderna covid-19 vaccine (prior doses, got Covid in 2022.), administration date: 2020, for COVID-19 immunisation, reaction(s): "Got Covid". The following information was reported: CHILLS (non-serious) with onset 18Oct2025, outcome "recovered" (19Oct2025); DIZZINESS (non-serious) with onset 18Oct2025, outcome "recovered" (19Oct2025); FATIGUE (non-serious) with onset 18Oct2025, outcome "recovered" (19Oct2025); ARTHRALGIA (non-serious) with onset 18Oct2025, outcome "recovered" (19Oct2025), described as "Joint pain"; MIGRAINE (non-serious) with onset 18Oct2025, outcome "recovered" (19Oct2025); NAUSEA (non-serious) with onset 18Oct2025, outcome "recovered" (19Oct2025); PAIN (non-serious) with onset 18Oct2025, outcome "recovered" (19Oct2025), described as "body aches"; DISEASE RECURRENCE (non-serious) with onset 18Oct2025, outcome "recovered" (19Oct2025), described as "had migraines before"; CHEST DISCOMFORT (non-serious) with onset 18Oct2025, outcome "recovered" (19Oct2025), described as "severe chest pressure"; ANGIOPATHY (non-serious) with onset 18Oct2025, outcome "recovered" (19Oct2025), described as "vascular issues". Therapeutic measures were taken as a result of chest discomfort, chills, pain, arthralgia, nausea, dizziness, fatigue, angiopathy, migraine, disease recurrence. Additional information: No other concomitants, patient was fairly healthy. The patient had bad reaction to it within 12 hours, woke up with severe chest pressure, chills, migraine, body aches, joint pain, nausea, dizziness, and fatigue. Fatigue continued. Only thing that hung on a little, doesn't know if call handler is familiar with migraines, but migraines hang on for a little bit, not as a migraine, but as a little headache. Caller has had migraines before. All resolved by next morning, 19Oct2025. Events were not required a visit to the Emergency Room or Physician's Office. Treatment included normally took Aspirin 325mg at night for vascular issues. Did get up and take two Tylenol extra strength and was able to go back to sleep with an ice pack.
Medical History/Concurrent Conditions: Allergic reaction to antibiotics (As a child, so in distant past); Arthritis (Arthritis From: 20 years ago); Breast cancer; Chemotherapy; Mastectomy; Migraine; Surgery