Received Oct 1, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | MY9550 | OT / LA |
had a vaccine about 3 weeks ago and ended up within that short amount of time getting COVID; had a vaccine about 3 weeks ago and ended up within that short amount of time getting COVID; This is a spontaneous report received from a Pharmacist. A 71-year-old female patient received BNT162b2 omicron (lp.8.1) (COMIRNATY (2025-2026 FORMULA)), on 08Sep2025 as dose 1, 0.3 ml, single (Lot number: MY9550) at the age of 71 years intramuscular, in left deltoid for covid-19 immunisation. The time of vaccination was at the end of the day, 4 or 5 in the afternoon, pm, eastern time. The vaccination facility in a clinic and not administered in a military facility. The patient got it through their physician assistant or nurse practitioner through their emergent care program. The patient's relevant medical history included: "hypertension/high blood pressure" (ongoing), notes: date of diagnosis for hypertension was 42 that was like 30 years ago; "hypothyroid" (ongoing), notes: date of diagnosis for hypothyroid was 42 that was like 30 years ago. Concomitant medication(s) included: INFLUENZA HA VACCINE PF taken for immunisation, on 08Sep2025 as dose 1, 0.5 ml, single; SYNTHROID taken for hypothyroidism (ongoing); HYDROCHLOROTHIAZIDE oral taken for hypertension (ongoing). The patient also took other concomitant therapy. Vaccination history included: comirnaty, 2024-2025 (dose 1, 0.3 ml, batch/lot number LN0590, left arm and IM injection, it was fifth or sixth time, had it twice a year), administration date: 15Mar2025, when the patient was 70-year-old, for COVID-19 Immunization; Bnt162b2 (dose 1), administration date: 2021, when the patient was 67 years old, for COVID-19 immunization; Bnt162b2 (dose number unknown (booster)), for COVID-19 immunization; Bnt162b2 (dose 2), administration date: 2021, when the patient was 67 years old, for COVID-19 immunization. The patient did not received other vaccine within 4 weeks. The patient adverse event after previous vaccination was no. The patient was not allergic to any vaccination. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Sep2025, outcome "not recovered" and all described as "had a vaccine about 3 weeks ago and ended up within that short amount of time getting COVID". The patient underwent the following laboratory tests and procedures: Blood thyroid stimulating hormone: (08Sep2025) everything looks good, the values are good, notes: done every 3 months; Thyroxine: (08Sep2025) everything looks good, the values are good, notes: done every 3 months; Tri-iodothyronine: (08Sep2025) everything looks good, the values are good, notes: done every 3 months. Therapeutic measures were not taken as a result of vaccination failure, covid-19. Clinical course: The patient was diagnosed today (26Sep2025) and still suffering from COVID. The patient informed that it worsened a little. The patient treatment was no. The patient was trying to get Paxlovid from Pfizer but she cannot get it. The patient informed that there were no adverse event required hospitalization.; Sender's Comments: Vaccine efficacy varies from person to person and is affected by many factors. The association between the event lack of effect/ vaccination failure (COVID-19) with the suspect product BNT162B2 OMICRON (LP.8.1) cannot be fully excluded.
Blood pressure high (date of diagnosis for hypertension was 42 that was like 30 years ago); Hypothyroidism (date of diagnosis for hypothyroid was 42 that was like 30 years ago)
INFLUENZA HA VACCINE PF; SYNTHROID; HYDROCHLOROTHIAZIDE
Test Date: 20250908; Test Name: TSH; Result Unstructured Data: Test Result:everything looks good, the values are good; Comments: done every 3 months; Test Date: 20250908; Test Name: T4; Result Unstructured Data: Test Result:everything looks good, the values are good; Comments: done every 3 months; Test Date: 20250908; Test Name: T3; Result Unstructured Data: Test Result:everything looks good, the values are good; Comments: done every 3 months