Received Dec 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | — |
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 2 | EL8982 | — |
URI-possible COVID infection; URI-possible COVID infection; This is a spontaneous report received from a Consumer or other non HCP and an Other HCP. A 60-year-old female patient received BNT162b2 (BNT162B2), on 11Jan2021 as dose 1, single (Lot number: EL3248) and on 29Jan2021 as dose 2, single (Lot number: EL8982) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history included: "low risk (IPSS-R 2.5) MDS" (unspecified if ongoing), notes: with 45% ring sideroblasts; "SF3B1 and TET2 mutations" (unspecified if ongoing); "Atrial fibrillation" (unspecified if ongoing); "Breast lift", start date: 2011 (unspecified if ongoing); "Breast reduction surgery", start date: 2011 (unspecified if ongoing), notes: bilateral; "Smoking status: Never/Smokeless tobacco: Never" (unspecified if ongoing), notes: Non-tobacco user; "Alcohol use: Not Currently" (unspecified if ongoing); "Allergen: Latex" (unspecified if ongoing), notes: Natural Rubber; "anemia" (unspecified if ongoing), notes: with stable Gl work-up. The patient had Breast biopsy benign in 2010. The patient's family history included Melanoma (Brother), Breast cancer and Ovarian cancer (Mother's Sister), BRCA 1/2, Colon cancer and Endometrial cancer (Neg Hx). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Allergen: Codeine"; Moxifloxacin, reaction(s): "Rash", notes: Allergen. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "URI-possible COVID infection". Clinical course: The patient was healthy till 30-45 days prior this last "shot". Patient complaint of intermittent palpitations, accompanied by dyspnea, dizziness, lightheadedness, presyncope, and fatigue, starting in Sep2022 post an URI-possible COVID infection. Worsened beginning in Jan2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202500160526 same reporter/patient ,different dose/AE;
Medical History/Concurrent Conditions: Anemia (with stable Gl work-up); Atrial fibrillation; Breast cosmetic surgery; Breast reduction (bilateral); Ex-alcohol user; Latex allergy (Natural Rubber); MDS (with 45% ring sideroblasts); Non-tobacco user; SF3B1 gene mutation; TET2 gene mutation