Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: I was recovering from COVID19 and had two negative tests then a few days later started having symptoms again (mostly congestion). I retested and was positive.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I was recovering from COVID19 and had two negative tests then a few days later started having symptoms again (mostly congestion). I retested and was positive.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Pfizer / BioNTech (Dose Number: 1 Batch/Lot No: EN6200 Location of injection: Arm Left) on 23-Feb-2021, Pfizer / BioNTech (Dose Number: 2 Batch/Lot No: EN6208 Location of injection: Arm Right) on 16-Mar-2021 and Pfizer / BioNTech (Dose Number: 3 Batch/Lot No: FF2593 Location of injection: Arm Left) on 25-Oct-2021. Past adverse reactions to the above products included No adverse event with Pfizer / BioNTech, Pfizer / BioNTech and Pfizer / BioNTech. Concurrent medical conditions included Hypertension. Concomitant products included LOSARTAN for an unknown indication.    On 29-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2022, the patient experienced COVID-19 (I was recovering from COVID19 and had two negative tests then a few days later started having symptoms again (mostly congestion). I retested and was positive.). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 13-May-2022 to 17-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (I was recovering from COVID19 and had two negative tests then a few days later started having symptoms again (mostly congestion). I retested and was positive.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative and negative (Negative) Negative.         Patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously received COVID-19 vaccine. The patient was recovering from COVID19 and had two negative tests then a few days later started having symptoms again mostly congestion 24-MAY-2022 21:00. The patient retested and was positive. Treatment medications were not reported. Company comment: This spontaneous case concerns a patient of an unknown age and gender, with no relevant medical history, who experienced the unexpected, non-serious AESI of COVID-19, approximately a month after the fourth dose of mRNA-1273 vaccine, considered as the fourth dose of the vaccine schedule. Previously the patient received three doses of Pfizer/BioNTech vaccine. As per source document, the patient was recovering from COVID-19 and had two negative tests but a few days later started having symptoms again and had a positive retested. 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 patient of an unknown age and gender, with no relevant medical history, who experienced the unexpected, non-serious AESI of COVID-19, approximately a month after the fourth dose of mRNA-1273 vaccine, considered as the fourth dose of the vaccine schedule. Previously the patient received three doses of Pfizer/BioNTech vaccine. As per source document, the patient was recovering from COVID-19 and had two negative tests but a few days later started having symptoms again and had a positive retested. Concomitant PAXLOVID remains as a confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.