Age: 69.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19/Tested Omicron2 POS May 11th and 12th) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination. Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment. No Medical History information was reported. On 31-Jan-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 11-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (COVID-19/Tested Omicron2 POS May 11th and 12th). At the time of the report, COVID-19 (COVID-19/Tested Omicron2 POS May 11th and 12th) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 12-May-2022, SARS-CoV-2 test: positive (Positive) Positive. In May 2022, SARS-CoV-2 test: positive (Positive) Positive. On 19-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 20-May-2022, SARS-CoV-2 test: negative (Negative) Negative. No concomitant medication was reported. Reportedly, patient started feeling very sick when he started the Paxlovid. Within two days, he felt greatly improved and completed the Paxlovid. Then he was not feeling great on a day before reporting and tested positive again. On a reporting day in the morning, he took an a home Antigen test and was immediately Positive. Device Date was reported as 23-May-2022. No treatment information was provided. Company comment: This spontaneous case concerns a 59-year-old, male patient with no reported medical history who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (with a positive SARS-CoV-2 test), which occurred 3 months and 11 days after receiving the fourth dose of mRNA-1273 vaccine. Patient tested positive for COVID-19(Omicron variant) and was prescribed with Nirmatrelvir, Ritonavir (Paxlovid) for 4 days. Within two days of medication patient felt improvement of symptoms. The patient tested negative 2 days after completing Paxlovid treatment. However a few days later patient complained of not feeling well, he re-tested positive for both test and via an antigen test kit which was self administered. The event has not yet resolved at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a 59-year-old, male patient with no reported medical history who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (with a positive SARS-CoV-2 test), which occurred 3 months and 11 days after receiving the fourth dose of mRNA-1273 vaccine. Patient tested positive for COVID-19(Omicron variant) and was prescribed with Nirmatrelvir, Ritonavir (Paxlovid) for 4 days. Within two days of medication patient felt improvement of symptoms. The patient tested negative 2 days after completing Paxlovid treatment. However a few days later patient complained of not feeling well, he re-tested positive for both PCR test and via an antigen test kit which was self administered. The event has not yet resolved at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.