Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid-19) in a 76-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetic and Blood pressure high. Concomitant products included LISINOPRIL and ATENOLOL for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On 09-Aug-2022, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Aug-2022, SARS-CoV-2 test: (Positive) Positive.         The patient was prescribed Paxlovid after being fully vaccinated but did not start taking the medication at the time of this report. The patient was tested positive for COVID-19 a day prior to this report even though was fully vaccinated with Moderna. The patient had Covid and mentioned diarrhea but did not clarify whether was experiencing or was known as a side effect of Paxlovid. The patient had a lot of muscle aches. The patient did not think that would recover quick. The patient did not think to take the Paxlovid further.  No treatment details were reported.  Company comment-This spontaneous case concerns an elderly male patient aged 76 years with no relevant medical history reported, who experienced the unexpected non-serious AESI of Covid 19 that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. Patient had received two doses of Moderna vaccination on unknown dates. SARS-CoV-2 test was positive as on 09-AUG-2022. Patient was advised Paxlovid. No further information on risk factors, detailed clinical course, investigations, treatment of the event and details pertaining to the doses was available in the report. 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 (non-serious) assessed as per medical judgement and available information.; Sender's Comments: This spontaneous case concerns an elderly male patient aged 76 years with no relevant medical history reported, who experienced the unexpected non-serious AESI of Covid 19 that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. Patient had received two doses of Moderna vaccination on unknown dates. SARS-CoV-2 test was positive as on 09-AUG-2022. Patient was advised Paxlovid. No further information on risk factors, detailed clinical course, investigations, treatment of the event and details pertaining to the doses was available in the report. 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 (non-serious) assessed as per medical judgement and available information.