Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19 / Tested negative on day 7 (2 days after treatment ended). Symptoms returned 3 days later and tested positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Symptoms returned 3 days later and tested positive) and COVID-19 (Treatment of COVID-19 / Tested negative on day 7 (2 days after treatment ended). Symptoms returned 3 days later and tested positive) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Previously administered products included for Drug use for unknown indication: Johnson and johnson (batch number- unknown and injection site-left arm) on 12-Apr-2021. Past adverse reactions to the above products included No adverse event with Johnson and johnson.   On 15-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 16-May-2022, the patient experienced COVID-19 (Symptoms returned 3 days later and tested positive). On an unknown date, the patient experienced COVID-19 (Treatment of COVID-19 / Tested negative on day 7 (2 days after treatment ended). Symptoms returned 3 days later and tested positive). In May 2022, COVID-19 (Treatment of COVID-19 / Tested negative on day 7 (2 days after treatment ended). Symptoms returned 3 days later and tested positive) had resolved. At the time of the report, COVID-19 (Symptoms returned 3 days later and tested positive) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: negative (Negative) Negative. On 16-May-2022, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products were not provided. No treatment information provided.  Company Comment: This is a spontaneous case concerning a 54-year-old male patient with no reported medical history, who experienced two episodes of the unexpected non-serious adverse events of special interest, COVID-19 (Treatment of COVID-19 / Tested negative on day 7 (2 days after treatment ended). Symptoms returned 3 days later and tested positive) which occurred on an unknown date after receiving a dose of mRNA-1273 vaccine, and COVID-19 (reported as reported as "Symptoms returned 3 days later and tested positive") which occurred approximately 6 months after receiving a dose of mRNA-1273 and 7 days after receiving the co-suspect, non-company product Nirmatrelvir, Ritonavir (Paxlovid) for COVID-19 treatment. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. The events were considered related to the product per the reporter's assessment.; Sender's Comments: This is a spontaneous case concerning a 54-year-old male patient with no reported medical history, who experienced two episodes of the unexpected non-serious adverse events of special interest, COVID-19 (Treatment of COVID-19 / Tested negative on day 7 (2 days after treatment ended). Symptoms returned 3 days later and tested positive) which occurred on an unknown date after receiving a dose of mRNA-1273 vaccine, and COVID-19 (reported as reported as "Symptoms returned 3 days later and tested positive") which occurred approximately 6 months after receiving a dose of mRNA-1273 and 7 days after receiving the co-suspect, non-company product Nirmatrelvir, Ritonavir (Paxlovid) for COVID-19 treatment. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. The events were considered related to the product per the reporter's assessment.