Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Initial COVID-19 infection prior to Paxlovid treatment; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Initial COVID-19 infection prior to Paxlovid treatment) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Drug allergy (Codeine) and Allergy to plants (celery). Concomitant products included LORATADINE from 15-May-2022 to 27-May-2022 and FAMOTIDINE from 08-May-2022 to 27-May-2022 for an unknown indication.    On 11-Nov-2021 at 11:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2022, the patient experienced COVID-19 (Initial COVID-19 infection prior to Paxlovid treatment). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 15-May-2022 to 19-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Initial COVID-19 infection prior to Paxlovid treatment) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-May-2022, SARS-CoV-2 test: negative (Negative) tested negative on both rapid & PCR tests for COVID . and negative (Negative) tested negative on both rapid & PCR tests for COVID .. On 27-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment (Paxlovid). Patient was prescribed Paxlovid for COVID-19 symptoms on 15-May-2022. He took the 5-day course of Paxlovid and tested negative on both rapid & PCR tests for COVID on 21-May-2022. He started feeling poorly again on 27-May-2022 and just tested positive for COVID. He believed this was a rebound symptoms after taking Paxlovid. No treatment information was provided. The device date was reported as 27-May-2022.  Company Comment:  This is a spontaneous case concerning a 31-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, described as initial COVID-19 infection prior to Paxlovid treatment, which occurred approximately 6 months after receiving a dose of mRNA-1273 as the third dose of COVID-19 vaccine (no information disclosed on previous COVID-19 vaccinations). Patient was treated with a five-day-course of Paxlovid for the initial COVID-19 infection and tested negative on both rapid & PCR tests for COVID-19 after 2 days. However, eight days after completion of Paxlovid treatment, patient reported rebound symptoms and tested positive for COVID-19. Outcome of the event for the initial COVID-19 infection was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 31-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, described as initial COVID-19 infection prior to Paxlovid treatment, which occurred approximately 6 months after receiving a dose of mRNA-1273 as the third dose of COVID-19 vaccine (no information disclosed on previous COVID-19 vaccinations). Patient was treated with a five-day-course of Paxlovid for the initial COVID-19 infection and tested negative on both rapid & PCR tests for COVID-19 after 2 days. However, eight days after completion of Paxlovid treatment, patient reported rebound symptoms and tested positive for COVID-19. Outcome of the event for the initial COVID-19 infection was unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report.