Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, UNK
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: Interchange of vaccine products; After taking Paxlovid and testing negative for consecutive days, got Covid symptoms again and tested positive.; Lack of drug effect; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (After taking Paxlovid and testing negative for consecutive days, got Covid symptoms again and tested positive.), VACCINATION FAILURE (Lack of drug effect) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 031M20A) for COVID-19 vaccination.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication and NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    The patient's past medical history included COVID-19. Concomitant products included ACETYLSALICYLIC ACID (BAYER ASPIRIN) from 29-Apr-2022 to 01-May-2022 for an unknown indication.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, the patient received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 02-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 08-May-2022, the patient experienced COVID-19 (After taking Paxlovid and testing negative for consecutive days, got Covid symptoms again and tested positive.) and VACCINATION FAILURE (Lack of drug effect). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). At the time of the report, COVID-19 (After taking Paxlovid and testing negative for consecutive days, got Covid symptoms again and tested positive.), VACCINATION FAILURE (Lack of drug effect) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-May-2022, SARS-CoV-2 test: positive (Positive) Positive. In May 2022, SARS-CoV-2 test: negative for consecutive days (Negative) negative for consecutive days.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient had allergy to unspecified drug. The patient was taking other medications within 2 weeks of starting COVID-19 treatment. The patient had previously receive a COVID-19 Vaccine. Hospitalization prolonged and treatment received reported as NO.  Device Date-08-May-2022. Treatment medication was not reported.  Company Comment: This spontaneous case concerns a 61-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious AESI of COVID-19 approximately 1 year 2 months after receiving the second dose of mRNA-1273 vaccine and approximately 6 months after the third dose of Tozinameran vaccine in COVID-19 vaccination series. Additionally, Vaccination failure is also reported.  Its reported after taking Paxlovid and testing negative for consecutive days patient got Covid symptoms again and tested positive. Patient was noted to have received a dose with Tozinameran approximately 8 months after the vaccination with mRNA-1273 vaccine (Interchange of vaccine products). COVID-19 pandemic could be confounding for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 61-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious AESI of COVID-19 approximately 1 year 2 months after receiving the second dose of mRNA-1273 vaccine and approximately 6 months after the third dose of Tozinameran vaccine in COVID-19 vaccination series. Additionally, Vaccination failure is also reported.  Its reported after taking Paxlovid and testing negative for consecutive days patient got Covid symptoms again and tested positive. Patient was noted to have received a dose with Tozinameran approximately 8 months after the vaccination with mRNA-1273 vaccine (Interchange of vaccine products). COVID-19 pandemic could be confounding for the events. The benefit-risk relationship of mRNA-1273 is not affected by this report.