Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inflammation, Peripheral swelling, Skin discolouration, Urticaria, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (COVID 19) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027721B) for COVID-19 prophylaxis. The patient's past medical history included Redness (arm getting red) and Sleeve gastrectomy on 09-Apr-2022. Previously administered products included for Product used for unknown indication: Pfizer (Dose 2) and Pfizer (Dose 1). Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer. Concurrent medical conditions included Hypertension (More than 20 year ago.), Penicillin allergy, Iodine allergy, Sulfonamide allergy, Allergy to antibiotic (Keflex), Allergy to antibiotic (Minocycline) and Thyroid disorder. Concomitant products included CANDESARTAN CILEXETIL (ATACAND), LANSOPRAZOLE (PREVACID), METOPROLOL, BARIATRIC ADVANTAGE ULTRA MULTI WITH IRON, DULOXETINE, DOCUSATE SODIUM (COLACE), MAGNESIUM, VITAMIN D [VITAMIN D NOS], VITAMIN B12 [VITAMIN B12 NOS] and PROBIOTICS NOS for an unknown indication. On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced COVID-19 (COVID 19). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). At the time of the report, COVID-19 (COVID 19) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram abdomen: No Abnormalities, did not see anything. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Further concomitant medications include blood pressure medication and thyroid medication. Patient had concerns about her arm which was unintelligible and her doctors suggested to visit Emergency room (ER) because it was not related to the surgery. Patient had reactions to other vaccine but not turning blue. No treatment medications were provided. Company comment: This spontaneous case concerns a female patient aged 63 years with no relevant medical history reported, who experienced the unexpected non serious AESI of Covid 19 on an unknown date after receiving third dose (1st booster) of mRNA-1273 vaccine in the Covid 19 vaccination series. Additionally Interchange of vaccine products was noted as patient had received initial vaccination with TOZINAMERAN prior to current vaccination. No further clinical course, lab reports or treatment details were reported. Outcome of the event Covid 19 was unknown at the time of report. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement. This case was linked to MOD-2022-598990 (Patient Link). Sender's Comments: This spontaneous case concerns a female patient aged 63 years with no relevant medical history reported, who experienced the unexpected non serious AESI of Covid 19 on an unknown date after receiving third dose (1st booster) of mRNA-1273 vaccine in the Covid 19 vaccination series. Additionally, Interchange of vaccine products was noted as patient had received initial vaccination with TOZINAMERAN prior to current vaccination. No further clinical course, lab reports or treatment details were reported. Outcome of the event Covid 19 was unknown at the time of report. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.