Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: had COVID and I now have Rebound COVID; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (had COVID and I now have Rebound COVID) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062E21A, 002021A and 032L20A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19.    Previously administered products included for Drug use for unknown indication: Cyclosporines. Past adverse reactions to the above products included Allergy with Cyclosporines. Concurrent medical conditions included Hypertension, Skin cancer and Rosacea. Concomitant products included AMLODIPINE BESILATE, VALSARTAN (EXFORGE) for Hypertension.   On 05-Feb-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021 at 3:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021 at 3:30 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On an unknown date, the patient experienced COVID-19 (had COVID and I now have Rebound COVID). At the time of the report, COVID-19 (had COVID and I now have Rebound COVID) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient previously received a COVID-19 Vaccine.  The indication for Paxlovid was reported as Treatment of COVID-19.  Pfizer have permission to contact you about this report. Pfizer have permission to contact your/the patient's healthcare provider about this report.  the patient taking  other medications/products within 2 weeks of starting COVID-19 treatment.  the patient previously receive a COVID-19 Vaccine Reported Event: Patient had COVID and I now have Rebound COVID. Device Date : 27May2022  Company comment: This spontaneous case concerns a 71 year-old, female patient with underlying medical condition of hypertension and skin cancer who experienced the unexpected, non-serious adverse event of special interest of COVID-19, which occurred at an unspecified date after receiving a dose of mRNA-1273 as third dose of COVID-19 vaccine. The patient was initially diagnosed with COVID-19 at an unknown date and started Nirmatrelvir, Ritonavir (Paxlovid) on 17-MAY-2022 and completed the course for 4 days. The patient reported that she had COVID-19 and now has rebound disease. The patient's  advanced age and underlying medical condition of hypertension and skin cancer may be considered as risk factors for the event COVID-19. The benefit-risk relationship of mRNA-1273 is not affected by this report; Sender's Comments: This spontaneous case concerns a 71 year-old, female patient with underlying medical condition of hypertension and skin cancer who experienced the unexpected, non-serious adverse event of special interest of COVID-19, which occurred at an unspecified date after receiving a dose of mRNA-1273 as third dose of COVID-19 vaccine. The patient was initially diagnosed with COVID-19 at an unknown date and started Nirmatrelvir, Ritonavir (Paxlovid) on 17-MAY-2022 and completed the course for 4 days. The patient reported that she had COVID-19 and now has rebound disease. The patient's  advanced age and underlying medical condition of hypertension and skin cancer may be considered as risk factors for the event COVID-19. The benefit-risk relationship of mRNA-1273 is not affected by this report