Age: 72.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: After full course of Paxlovid, patient tested negative 3 days in a row for covid. On the 4th day, patient tested positive again.; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (After full course of Paxlovid, patient tested negative 3 days in a row for covid. On the 4th day, patient tested positive again.) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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.    Concurrent medical conditions included Allergy (Unknown historical drug). Concomitant products included LEVOTHYROXINE for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Mar-2022, the patient received fourth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 11-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 19-May-2022, the patient experienced COVID-19 (After full course of Paxlovid, patient tested negative 3 days in a row for covid. On the 4th day, patient tested positive again.). At the time of the report, COVID-19 (After full course of Paxlovid, patient tested negative 3 days in a row for covid. On the 4th day, patient tested positive again.) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 17-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 18-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 19-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         No treatment medication were provided.  After full course of Paxlovid, patient tested negative 3 days in a row for COVID. On the 4th day, patient was tested positive again.  Company Comment: This spontaneous case concerns a 72-year-old, female patient with no reported relevant medical history, who experienced the unexpected, non-serious adverse event of special interest COVID-19. The event occurred approximately 7 months after receiving the third dose of mRNA-1273, wherein he contracted COVID-19 infection and was treated with a full course of NIRMATRELVIR/RITONAVIR (Paxlovid). After completion of treatment, the patient reported testing positive in COVID-19 tests after 3 consecutive days of negative result. The accompanying symptoms after the positive test post-therapy and exact COVID-19 tests, whether rapid antigen or PCR, conducted were not provided in the case. The patient also received Tozinameran as fourth COVID-19 vaccine dose approximately 5 months after primary series and first booster dose of mRNA-1273; this was cited as co-suspect in the case. The elderly age of the patient and ongoing COVID-19 pandemic remain as confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 72-year-old, female patient with no reported relevant medical history, who experienced the unexpected, non-serious adverse event of special interest COVID-19. The event occurred approximately 7 months after receiving the third dose of mRNA-1273, wherein he contracted COVID-19 infection and was treated with a full course of NIRMATRELVIR/RITONAVIR (Paxlovid). After completion of treatment, the patient reported testing positive in COVID-19 tests after 3 consecutive days of negative result. The accompanying symptoms after the positive test post-therapy and exact COVID-19 tests, whether rapid antigen or PCR, conducted were not provided in the case. The patient also received Tozinameran as fourth COVID-19 vaccine dose approximately 5 months after primary series and first booster dose of mRNA-1273; this was cited as co-suspect in the case. The elderly age of the patient and ongoing COVID-19 pandemic remain as confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report.