Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive rapid test 5 days after completing Paxlovid treatment. Symptoms worse than before. Now on Day 15 and still positive rapid test) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0121721b, 038A21A and 039A21A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (Penicillin) and Herpes simplex type II. Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALTREX) for an unknown indication. On 28-Dec-2021 at 9:30 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2022 at 9:00 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2022 at 2:00 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Positive rapid test 5 days after completing Paxlovid treatment. Symptoms worse than before. Now on Day 15 and still positive rapid test). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 13-May-2022 to 18-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Positive rapid test 5 days after completing Paxlovid treatment. Symptoms worse than before. Now on Day 15 and still positive rapid test.) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive. It was reported that patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. It was reported that patient had previously received COVID-19 vaccine. The event reported as Positive rapid test 5 days after completing Paxlovid treatment. The Symptoms were worse than before. Now on Day 15 and still positive rapid test with Device date was reported as 27-May-2022. Company Comment: This spontaneous case concerns a patient of unknown age and gender with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving a dose of mRNA-1273 vaccine (dose number not specified). It was reported that patient was treated with Paxlovid for Covid-19. 5 days after the treatment with Paxlovid patient tested positive for Covid-19 with rapid antigen test. 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. Sender's Comments: This spontaneous case concerns a patient of unknown age and gender with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 unspecified days after receiving a dose of mRNA-1273 vaccine (dose number not specified). It was reported that patient was treated with Paxlovid for Covid-19. 5 days after the treatment with Paxlovid patient tested positive for Covid-19 with rapid antigen test. 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.