Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Immunisation reaction, SARS-CoV-2 test
Clinical narrative: Got a reaction after the vaccines but nothing serious, slight reaction/Big red mark, big one on arm; Caught COVID-19; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Got a reaction after the vaccines but nothing serious, slight reaction/Big red mark, big one on arm) and COVID-19 (Caught COVID-19) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 002B21A and 011M2017) for COVID-19 prophylaxis.     No Medical History information was reported.  Concomitant products included SIMVASTATIN for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Caught COVID-19). On an unknown date, the patient experienced IMMUNISATION REACTION (Got a reaction after the vaccines but nothing serious, slight reaction/Big red mark, big one on arm). At the time of the report, IMMUNISATION REACTION (Got a reaction after the vaccines but nothing serious, slight reaction/Big red mark, big one on arm) and COVID-19 (Caught COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Mar-2022, SARS-CoV-2 test: Positive.         Patient caught COVID in April.  No treatment medication was reported by reporter.  Company comment: This spontaneous case concerns a 70 year old female patient with no reported medical history, who experienced the unexpected non serious AESI of COVID 19, about 5 months after receiving the third dose (first booster) of mRNA-1273 vaccine. The patient received the primary series of 2 doses with mRNA-1273 in accordance with the recommended schedule. The patient's COVID-19 PCR test was positive. No further information on risk factors, co morbidities, clinical course and treatment details were available in the report. The COVID 19 pandemic could be a confounder for the event COVID 19. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-607761 (Patient Link).; Sender's Comments: This spontaneous case concerns a 70 year old female patient with no reported medical history, who experienced the unexpected non serious AESI of COVID 19 , about 5 months after receiving the third dose (first booster) of mRNA-1273 vaccine. The patient received the primary series of 2 doses with mRNA-1273 in accordance with the recommended schedule. The patient's COVID-19 PCR test was positive. No further information on risk factors, co morbidities, clinical course and treatment details were available in the report. The COVID 19 pandemic could be a confounder for the event COVID 19. The benefit-risk relationship of mRNA-1273 is not affected by this report.