Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID relapse after antiviral treatment; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID relapse after antiviral treatment) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939905) for COVID-19 vaccination.     The patient's past medical history included Breast cancer in 2006 and Parathyroid tumor in 2017. Concurrent medical conditions included Hypercholesterolaemia, Asthma and Allergy. Concomitant products included EZETIMIBE (ZETIA) from 01-Nov-2018 to 12-Apr-2022 for an unknown indication.    On 27-Oct-2021 at 4:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2022, the patient experienced COVID-19 (COVID relapse after antiviral treatment). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 13-Apr-2022 to 18-Apr-2022 for COVID-19 treatment, at an unspecified dose and frequency. On 03-May-2022, COVID-19 (COVID relapse after antiviral treatment) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Apr-2022, SARS-CoV-2 test: barely a positive result (Positive) barely a positive result. On 23-Apr-2022, SARS-CoV-2 test: strongly positive (Positive) strongly positive and strongly positive (Positive) strongly positive. In May 2022, SARS-CoV-2 test: negative (Negative) negative. On an unknown date, SARS-CoV-2 test: positive rapid tests for next 11 days (Positive) positive rapid tests for next 11 days (after 23-Apr-2022).         It was reported that the patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment.  The patient reported that On Wed, 20-Apr-2022 (2 days after finishing Paxlovid 5-day treatment) the patient felt good, and rapid test was barely a positive result. On Thursday, 21-Apr-2022 in the afternoon the patient started feeling congestion, tired and lungs hurt. The symptoms got worse so on 23-Apr-2022 did a rapid test and a PCR test. Both strongly positive. Continued with congestion and positive rapid tests for next 11 days. Then finally congestion went away and negative rapid test. The patient believed this was a COVID relapse after antiviral treatment.   No treatment medication given for relapse symptoms post treatment with Paxlovid  The device date was reported as 29-May-2022. Company comment: This spontaneous case concerns a 62-year-old female patient, with no relevant medical history, who experienced the unexpected, non-serious AESI of COVID-19, approximately 3 months after the third dose of mRNA-1273 vaccine. No details of previous doses were provided. As per source document, after finishing Paxlovid treatment for COVID-19, she felt good, and rapid test was barely a positive result. On the following day she started to feel congestion, tired and lungs hurt. Symptoms got worse and after two days a rapid test and a PCR test were positive. A few days later symptoms were gone and a negative rapid test was performed. Concomitant PAXLOVID remains as a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 62-year-old female patient, with no relevant medical history, who experienced the unexpected, non-serious AESI of COVID-19, approximately 3 months after the third dose of mRNA-1273 vaccine. No details of previous doses were provided. As per source document, after finishing Paxlovid treatment for COVID-19, she felt good, and rapid test was barely a positive result. On the following day she started to feel congestion, tired and lungs hurt. Symptoms got worse and after two days a rapid test and a PCR test were positive. A few days later symptoms were gone and a negative rapid test was performed. Concomitant PAXLOVID remains as a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.