Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test
Clinical narrative: COVID-19; Rebound/relapse after completion of 5 day Paxlovid courseTested positive on BINAX antigen home test with mild symptoms after negative tests; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Rebound/relapse after completion of 5 day Paxlovid courseTested positive on BINAX antigen home test with mild symptoms after negative tests) and COVID-19 (COVID-19) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer / BioNTech (Batch/Lot No: Unknown.) on 19-Mar-2021, Pfizer / BioNTech (Batch/Lot No: Unknown. Location of injection: Arm Right) on 09-Apr-2021 and Pfizer / BioNTech (Batch/Lot No: Unknown. Location of injection: Arm Right) on 11-Oct-2021. Past adverse reactions to the above products included No adverse reaction with Pfizer / BioNTech, Pfizer / BioNTech and Pfizer / BioNTech.    On 11-Mar-2022 at 5:30 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-May-2022 at 9:00 PM, the patient experienced COVID-19 (Rebound/relapse after completion of 5 day Paxlovid courseTested positive on BINAX antigen home test with mild symptoms after negative tests). On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 05-May-2022 to 10-May-2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (Rebound/relapse after completion of 5 day Paxlovid courseTested positive on BINAX antigen home test with mild symptoms after negative tests) was resolving and COVID-19 (COVID-19) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-May-2022, SARS-CoV-2 antibody test: positive Positive on BINAX antigen home test at 21:00pm.. On an unknown date, SARS-CoV-2 antibody test: positive Positive and negative negative.         No concomitant medication reported. Device Date was reported as 16-May-2022. company comment This spontaneous case reported by a patient, concerns a 50 year old male patient with no medical history reported, who experienced the unexpected, non-serious AESI of covid 19 Infection with a positive SARS-CoV-2 antibody test on an unknown date, about 2 months after receiving the 4 dose of Modena mRNA1273 vaccine in the covid 19 vaccination series. Patient previously received the 3 dose with Pfizer vaccine about 5 months prior to the 4 dose of Moderna vaccine and the 2 primary doses also with Pfizer about 6 months prior to 3 dose, with no adverse events reported for the Pfizer vaccines. Interchange of vaccine products was noted. He was treated with Paxlovid for 5 days. The event had resolved with negative covid 19 test. Ongoing Covid 19 pandemia could be considered as a confounder to the event. It was reported that there was a rebound/relapse  after the negative test and was tested positive on BINAX antigen home test, with mild symptoms, about 5 days after completion of Paxlovid course. This event was resolving. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2022: Follow up received contains No New Information.; Sender's Comments: This spontaneous case reported by a patient, concerns a 50 year old male patient with no medical history reported, who experienced the unexpected, non-serious AESI of covid 19 Infection with a positive SARS-CoV-2 antibody test on an unknown date, about 2 months after receiving the 4 dose of Modena mRNA1273 vaccine in the covid 19 vaccination series. Patient previously received the 3 dose with Pfizer vaccine about 5 months prior to the 4 dose of Moderna vaccine and the 2 primary doses also with Pfizer about 6 months prior to 3 dose, with no adverse events reported for the Pfizer vaccines. Interchange of vaccine products was noted. He was treated with Paxlovid for 5 days. The event had resolved with negative covid 19 test. Ongoing Covid 19 pandemia could be considered as a confounder to the event. It was reported that there was a rebound/relapse  after the negative test and was tested positive on BINAX antigen home test, with mild symptoms, about 5 days after completion of Paxlovid course. This event was resolving. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.