Received Apr 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | 3044202 | IM / LA |
| FLUX | INFLUENZA (SEASONAL) (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
The patient had COVID; have COVID; This spontaneous case was reported by a non-health professional and describes the occurrence of COVID-19 (The patient had COVID) and DRUG INEFFECTIVE (have COVID) in an 8-decade-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. 3044202) for COVID-19 immunisation. Co-suspect product included non-company product Influenza vaccine (Flu) for Immunisation. Previously administered products included for Immunisation: FLU VACCINE VII (DOSE NUMBER UNKNOWN, SINGLE, Lot: 1204201) on 10-Sep-2012, Pneumococcal vaccine (DOSE 1, SINGLE, Lot: H010515) on 10-Sep-2012, FLU VACCINE VII (DOSE NUMBER UNKNOWN, SINGLE, Lot: 1307601) on 07-Oct-2013, Pneumococcal vaccine on 12-Jul-2022, Pneumococcal vaccine (Dose 2, single) on 07-Dec-2022, FLU VACCINE VII (DOSE NUMBER UNKNOWN, SINGLE) on 11-Sep-2023, Zoster (Dose 1, single) on 03-Oct-2023, Zoster (Dose 2 and single) on 04-Dec-2023; for COVID-19 immunisation: BNT162b2 (Dose 1, single (Lot number: EN5318)) on 28-Jan-2021, BNT162b2 (Dose 2, single (Lot number: EN6201)) on 18-Feb-2021, BNT162b2 (Dose 3 (booster), single (Lot number: FF2589)) on 27-Sep-2021, BNT162b2 (Dose 4 (booster), single (Lot number: FM0698)) on 08-Mar-2022, BNT162b2 (Dose 5 (booster) and single (Batch/Lot number: unknown)) on 08-Nov-2022. Past adverse reactions to the above products included No adverse effect with BNT162b2, BNT162b2, BNT162b2, BNT162b2, BNT162b2, FLU VACCINE VII, FLU VACCINE VII, FLU VACCINE VII, Pneumococcal vaccine, Pneumococcal vaccine, Pneumococcal vaccine, Zoster and Zoster. Concurrent medical conditions included Vision abnormal. On 11-Dec-2024, the patient received seventh dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form and dose of Influenza vaccine (Flu) (unknown route) 1 dosage form. On 01-Mar-2025, the patient experienced COVID-19 (The patient had COVID) (seriousness criterion medically significant) and DRUG INEFFECTIVE (have COVID) (seriousness criterion medically significant). The patient was treated with Nirmatrelvir, Ritonavir (Paxlovid) for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (The patient had COVID) and DRUG INEFFECTIVE (have COVID) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Smear test: Positive. Concomitant product information was not provided by the reporter. It was reported that the patient had COVID and was too sick and all by herself. When offered an online enrollment, patient stated that "when you get old, you can't see". Patient cannot even spell her name anymore when she was sick. The patient had never been this sick in her life and she had eight COVID shots. It was reported that patient's neighbor had to go to pick up her stuff. She could not go as she was too sick. On 07-Apr-2025, it was reported that the patient was not taking any other medications within 2 weeks prior to the event onset. The patient did not receive any other vaccines within 4 weeks prior to the first administration of the suspect vaccine. The patient was not allergic to any previous vaccination, medications, food or other products and there were no other diagnosed illnesses/medical history/chronic health conditions to report. This case was linked to MOD-2025-784895 (Patient Link). Reporter did not allow further contact; Reporter's Comments: The benefit-risk relationship of product is not affected by this report.
Medical History/Concurrent Conditions: Vision abnormal
Test Name: Smear test; Test Result: Positive