Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Malaise, SARS-CoV-2 test
Clinical narrative: Caller was positive for COVID-19/Wife was hospitalized and nearly died from COVID-19; Feeling unwell/Felt bad, taken out for a day or two; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Caller was positive for COVID-19/Wife was hospitalized and nearly died from COVID-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Caller was positive for COVID-19/Wife was hospitalized and nearly died from COVID-19) (seriousness criterion hospitalization) and MALAISE (Feeling unwell/Felt bad, taken out for a day or two). At the time of the report, COVID-19 (Caller was positive for COVID-19/Wife was hospitalized and nearly died from COVID-19) and MALAISE (Feeling unwell/Felt bad, taken out for a day or two) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         The concomitant medication was not reported.  The treatment information was not provided.  Company comment: This is a spontaneous case concerning a female patient of unknown age with no reported medical history and with vaccine history of fully vaccinated and boosted with mRNA-1273 vaccine, who experienced the unexpected serious (hospitalization) AESI event of Covid-19 and the unexpected non-serious event of malaise. The event Covid-19 occurred after the booster dose of mRNA-1273 vaccine administration. The event malaise occurred after the unknown dose number of mRNA-1273 vaccine administration. Allegedly, the events were described as, on unknown date patient was fully vaccinated and boosted against Covid-19. On unknown date, patient was taken out for a day or two of feeling unwell after the unknown dose number of mRNA-1273 vaccine administration. On unknown date, patient experienced Covid-19 positive after receiving mRNA-1273 vaccines. On unknown date, patient was hospitalized and nearly died from Covid-19 after being fully vaccinated and boosted. No other information surrounding the events was reported. The outcome of the events was unknown. The current Covid-19 pandemic remain confounder for the event Covid-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a female patient of unknown age with no reported medical history and with vaccine history of fully vaccinated and boosted with mRNA-1273 vaccine, who experienced the unexpected serious (hospitalization) AESI event of Covid-19 and the unexpected non-serious event of malaise. The event Covid-19 occurred after the booster dose of mRNA-1273 vaccine administration. The event malaise occurred after the unknown dose number of mRNA-1273 vaccine administration. Allegedly, the events were described as, on unknown date patient was fully vaccinated and boosted against Covid-19. On unknown date, patient was taken out for a day or two of feeling unwell after the unknown dose number of mRNA-1273 vaccine administration. On unknown date, patient experienced Covid-19 positive after receiving mRNA-1273 vaccines. On unknown date, patient was hospitalized and nearly died from Covid-19 after being fully vaccinated and boosted. No other information surrounding the events was reported. The outcome of the events was unknown. The current Covid-19 pandemic remain confounder for the event Covid-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.