Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test, Vaccination failure
Clinical narrative: COVID Rebound. Paxlovid started evening of Day 2 of symptoms. Paxlovid dose completed on Day 7. Positive Test Day 7. Asymptomatic through day 12. Negative tests on days 9 and 11. Mild symptoms beginning day 13 and positive test on day 14. Negative te; COVID Rebound. Paxlovid started evening of Day 2 of symptoms. Paxlovid dose completed on Day 7. Positive Test Day 7. Asymptomatic through day 12. Negative tests on days 9 and 11. Mild symptoms beginning day 13 and positive test on day 14. Negative te; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID Rebound. Paxlovid started evening of Day 2 of symptoms. Paxlovid dose completed on Day 7. Positive Test Day 7. Asymptomatic through day 12. Negative tests on days 9 and 11. Mild symptoms beginning day 13 and positive test on day 14. Negative te) and VACCINATION FAILURE (COVID Rebound. Paxlovid started evening of Day 2 of symptoms. Paxlovid dose completed on Day 7. Positive Test Day 7. Asymptomatic through day 12. Negative tests on days 9 and 11. Mild symptoms beginning day 13 and positive test on day 14. Negative te) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19.    Previously administered products included for Product used for unknown indication: Pfizer / BioNTech (Dose Number: 1  Batch/Lot No: ER8737 Location: Left arm) on 31-Mar-2021 and Pfizer / BioNTech (Dose Number: 2  Batch/Lot No: ER8736  Location: Left arm) on 21-Apr-2021; for Drug use for unknown indication: Augmentin. Past adverse reactions to the above products included Allergy with Augmentin; and No adverse reaction with Pfizer / BioNTech and Pfizer / BioNTech. Concurrent medical conditions included Hashimoto's thyroiditis (Hashimotos thyroiditis in remission), Blood pressure high and Cholesterol. Concomitant products included FISH OIL, L-THEANINE, COLECALCIFEROL (D3), VITAMIN B COMPLEX (B COMPLEX [VITAMIN B COMPLEX]) and UBIDECARENONE (COQ10 [UBIDECARENONE]) for an unknown indication.   On 06-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 14-May-2022, the patient experienced COVID-19 (COVID Rebound. Paxlovid started evening of Day 2 of symptoms. Paxlovid dose completed on Day 7. Positive Test Day 7. Asymptomatic through day 12. Negative tests on days 9 and 11. Mild symptoms beginning day 13 and positive test on day 14. Negative te) and VACCINATION FAILURE (COVID Rebound. Paxlovid started evening of Day 2 of symptoms. Paxlovid dose completed on Day 7. Positive Test Day 7. Asymptomatic through day 12. Negative tests on days 9 and 11. Mild symptoms beginning day 13 and positive test on day 14. Negative te). At the time of the report, COVID-19 (COVID Rebound. Paxlovid started evening of Day 2 of symptoms. Paxlovid dose completed on Day 7. Positive Test Day 7. Asymptomatic through day 12. Negative tests on days 9 and 11. Mild symptoms beginning day 13 and positive test on day 14. Negative te) and VACCINATION FAILURE (COVID Rebound. Paxlovid started evening of Day 2 of symptoms. Paxlovid dose completed on Day 7. Positive Test Day 7. Asymptomatic through day 12. Negative tests on days 9 and 11. Mild symptoms beginning day 13 and positive test on day 14. Negative te) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-May-2022, SARS-CoV-2 antibody test: positive (Positive) Positive, Day 7. In May 2022, SARS-CoV-2 antibody test: negative (Negative) negative, Day 9, negative (Negative) negative, Day 11, positive (Positive) Positive, Day 14 and negative (Negative) negative, Day 17.         Device date was reported as 18-May-2022. Company comment: This is a spontaneous case concerning a patient of unspecified age and gender with no relevant medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 (COVID-19) and unexpected, non-serious event of Drug Ineffective which occurred 5 months 8 days after receiving the third dose of mRNA-1273 vaccine. The event COVID-19 (COVID Rebound. Paxlovid started evening of Day 2 of symptoms. Paxlovid dose completed on Day 7. Positive Test Day 7. Asymptomatic through day 12. Negative tests on days 9 and 11. Mild symptoms beginning day 13 and positive test on day 14. Negative test). SARS-CoV-2 test was positive as on 8-May-2022. Ongoing Covid 19 pandemia could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This is a spontaneous case concerning a patient of unspecified age and gender with no relevant medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 (COVID-19) and unexpected, non-serious event of Drug Ineffective which occurred 5 months 8 days after receiving the third dose of mRNA-1273 vaccine. The event COVID-19 (COVID Rebound. Paxlovid started evening of Day 2 of symptoms. Paxlovid dose completed on Day 7. Positive Test Day 7. Asymptomatic through day 12. Negative tests on days 9 and 11. Mild symptoms beginning day 13 and positive test on day 14. Negative test). SARS-CoV-2 test was positive as on 8-May-2022. Ongoing Covid 19 pandemia could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.