Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for COVID the day she is scheduled for the booster dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID the day she is scheduled for the booster dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for an unknown indication.    No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (Oral) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (tested positive for COVID the day she is scheduled for the booster dose) (seriousness criterion hospitalization). At the time of the report, COVID-19 (tested positive for COVID the day she is scheduled for the booster dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         Concomitant drugs were not reported.  The mother-in-law is in the hospital and in ventilator and they have tried normal standard treatment.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This spontaneous case concerns a female patient, of unknown age, with no medical history reported, who experienced the unexpected, serious (hospitalization) AESI of COVID-19. The event occurred unknown number of days after receiving the second dose of the mRNA-1273 vaccine. Of note, the vaccination date was reported as unspecified date in Feb2021 and the event onset date was not provided, hence, the onset latency could not be assessed. It was reported that the patient tested positive for SARS-CoV-2 on the day (unspecifed date) she was scheduled to receive the booster dose of the mRNA-1273 vaccine. No symptoms were reported. On an unspecified date, the patient was admitted and was placed under mechanical ventilation. No further clinical information (including details about hospitalization, other laboratory test/s and clinical course) was available for medical review. It was reported that 'normal standard treatment' (unspecified) was provided to the patient. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient, of unknown age, with no medical history reported, who experienced the unexpected, serious (hospitalization) AESI of COVID-19. The event occurred unknown number of days after receiving the second dose of the mRNA-1273 vaccine. Of note, the vaccination date was reported as unspecified date in Feb2021 and the event onset date was not provided, hence, the onset latency could not be assessed. It was reported that the patient tested positive for SARS-CoV-2 on the day (unspecifed date) she was scheduled to receive the booster dose of the mRNA-1273 vaccine. No symptoms were reported. On an unspecified date, the patient was admitted and was placed under mechanical ventilation. No further clinical information (including details about hospitalization, other laboratory test/s and clinical course) was available for medical review. It was reported that 'normal standard treatment' (unspecified) was provided to the patient. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.