Sex: U
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  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS (Unspecified).    On 30-Oct-2021, 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 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 29-Apr-2022 to 03-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. In May 2022, COVID-19 (COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: negative (Negative) Negative, positive (Positive) Following day patient tested positive. and. On 15-May-2022, SARS-CoV-2 test negative (Negative) tested negative about a week after. On an unknown date, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient previously received a COVID-19 Vaccine. It was reported that on  9-MAY-2022, five days after completing Paxlovid and after testing negative, patient started having nasal congestion and headache. Following day, the patient tested positive, had symptoms for 3-4 days and tested negative about a week after that, tested negative on 15-MAY-2022. Device Date was reported as 04Jun2022. Company comment: This spontaneous case concerns a patient with unspecified age and gender with no medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 which occurred on unspecified day after a dose of mRNA-1273 vaccine (dose number not specified). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 29-Apr-2022 to 03-May-2022 for COVID-19 treatment. It was reported that 9-MAY-2022, five days after completing Paxlovid and after testing negative, patient started having nasal congestion and headache. Following day, the patient tested positive, had symptoms for 3-4 days and tested negative about a week after that, tested negative on 15-MAY-2022. Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a patient with unspecified age and gender with no medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 which occurred on unspecified day after a dose of mRNA-1273 vaccine (dose number not specified). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 29-Apr-2022 to 03-May-2022 for COVID-19 treatment. It was reported that 9-MAY-2022, five days after completing Paxlovid and after testing negative, patient started having nasal congestion and headache. Following day, the patient tested positive, had symptoms for 3-4 days and tested negative about a week after that, tested negative on 15-MAY-2022. Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.