Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, Smear test
Clinical narrative: The patient had COVID; Have COVID; Interchange of vaccine products; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (The patient had COVID), DRUG INEFFECTIVE (Have COVID) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in an 8-decade-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030373) for COVID-19 immunisation.     Previously administered products included for Immunisation: FLU VACCINE VII (Lot: 1204201, Dose number -Uknown, single shot, Patient was 62-year-old) on 10-Sep-2012, Pneumococcal vaccine (As  dose 2) on 07-Dec-2022, FLU VACCINE VII on 11-Sep-2023, Zoster (dose 1, single) on 03-Oct-2023, Zoster (dose 2 and single) on 03-Dec-2023; for Immunization: Pneucon (Patient was 62-year-old, Dose 1, Lot: H010515, Pneucon) on 10-Sep-2012, flu vaccine (the patient was 63-year-old, Dose number-Unknown and single shot. Lot: 1307601) on 07-Oct-2013; for COVID-19 immunization: BNT162b2 (Dose 1 and Batch Number: EN5318) on 28-Jan-2021; for COVID-19 immunisation: BNT162b2 (Dose 2, Batch Number: EN6201) on 18-Feb-2021, BNT162b2 (Dose 3, Batch Number: FF2589, booster) on 27-Sep-2021, BNT162b2 (Dose 4, Batch Number: FM0698, Booster) on 08-Mar-2022, BNT162b2 omi ba.4-5 (Dose 5, Batch Number: Unknown and Booster) on 08-Nov-2022. Past adverse reactions to the above products included No adverse effect with BNT162b2, BNT162b2, BNT162b2, BNT162b2, BNT162b2 omi ba.4-5, FLU VACCINE VII, FLU VACCINE VII, Pneucon, Pneumococcal vaccine, Zoster, Zoster and flu vaccine. Concomitant products included Influenza vaccine (Flu vaccine VII) from 11-Dec-2024 to an unknown date for Immunisation.    On 03-Nov-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 03-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) (seriousness criterion medically significant). 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 treatment, at a dose of unknown. At the time of the report, COVID-19 (The patient had COVID), DRUG INEFFECTIVE (Have COVID) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Smear test: Positive.         It was reported that patient was not allergies, patient had no important medical conditions, and patient had no previous vaccine reactions. It was reported that the patient had Covid. She was too sick, and all by herself. The patient was never this sick in her life and she had total seven Covid-19 vaccine shots. The patient was not allergic to any previous vaccination, medications, food or other products and there were no other diagnosed illnesses and chronic health conditions was reported for patient. It was reported that the patient did not take any other medications within 2 weeks prior to the event onset.   This case was linked to MOD-2025-784897, MOD-2025-784897 (Patient Link).; Reporter's Comments: As primary schedule was not administrated with moderna vaccine, Drug ineffective event was assessed as not related. The benefit -risk relationship of product is not affected by this report.