Received Jan 27, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | MY9550 | OT / LA |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | U8764BB | RA |
within that short amount of time getting covid (covid-19); within that short amount of time getting covid (covid-19); This is a spontaneous report received from a Pharmacist from License Party and product quality group. Other Case identifier(s): 2025SA297196 (Sanofi), AE-022247 (BionTech SE). A 71-year-old female patient (not pregnant) received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), in 2025 as dose 1, 0.3 ml single (Lot number: MY9550) at the age of 71 years intramuscular, in left deltoid for covid-19 immunisation; influenza vaccine inact split 3v (INFLUENZA VACCINE (SPLIT VIRION), INACTIVATED), in 2025 as dose number unknown, 0.5 ml single (Lot number: U8764BB), in right deltoid for immunisation. The patient's relevant medical history included: "Hypothyroidism" (ongoing); "Hypertension" (ongoing); "Illness" (unspecified if ongoing); "fever", start date: 25Sep2025 (unspecified if ongoing), notes: treated with paracetamol (Tylenol) for pyrexia and flank pain. Outcome: Recovered.; "flank pain", start date: 25Sep2025 (unspecified if ongoing), notes: treated with paracetamol (Tylenol) for pyrexia and flank pain. Outcome: Recovered.; "nasal congestion", start date: 25Sep2025 (ongoing), notes: treated with acrivastine (Benadryl) for nasal congestion. Concomitant medication(s) included: SYNTHROID taken for hormone therapy, hypothyroidism (ongoing); HYDROCHLOROTHIAZIDE taken for hypertension, hormone therapy (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2025, outcome "unknown" and all described as "within that short amount of time getting covid (covid-19)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2025) Positive. Clinical course: On an unknown date in 2025, the patient had a vaccine about 3 weeks ago and patent ended up within that short amount of time getting covid (covid-19) (Unknown latency) after receiving Nirmatrelvir, ritonavir (paxlovid), tozinameran (Comirnaty) and influenza USP TRIVAL A-B high dose sub virion vaccine. Product Quality Group provided investigational results on 23Jan2026 for bnt162b2 omicron (lp.8.1) (device constituent): The complaint for "has had Covid" of "Comirnaty PFS" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the involved scope and Annual Product Review. A complaint sample was not returned. The complaint is not confirmed. No root cause or CAPA were identified as the complaint was not confirmed. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation, stability and patient safety. The Issue Escalation (NTM) process determined that no regulatory notification was required. The final scope was determined to be the associated lot(s) of the reported lot MY9550. The reported defect is not representative of the quality of the batch, and reported lot remains acceptable for further distribution. COMIRNATY is under agreement with BIONTECH SE. Follow-up (22Jan2026): This is a spontaneous follow-up report received from the Product Quality Complaints Group providing investigation results. COMIRNATY is under agreement with BIONTECH SE.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure (LOE) and its related events cannot be ruled out.
Hypertension; Hypothyroidism; Nasal congestion (treated with acrivastine (Benadryl) for nasal congestion)
Medical History/Concurrent Conditions: Fever (treated with paracetamol (Tylenol) for pyrexia and flank pain. Outcome: Recovered.); Flank pain (treated with paracetamol (Tylenol) for pyrexia and flank pain. Outcome: Recovered.); Illness
SYNTHROID; HYDROCHLOROTHIAZIDE
Test Date: 2025; Test Name: SARS-CoV-2 test; Test Result: Positive