Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Recovered after a dose of Paxlovid but the symptoms recurred after 2 days; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Recovered after a dose of Paxlovid but the symptoms recurred after 2 days) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Bronchiectasis and Drug allergy (Unspecified). Concomitant products included AMLODIPINE BESILATE, VALSARTAN (EXFORGE), OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), TOCOPHEROL (VITAMIN E [TOCOPHEROL]), VITAMIN C [ASCORBIC ACID] and ERGOCALCIFEROL (VITAMIN D [ERGOCALCIFEROL]) for an unknown indication.   On 24-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Recovered after a dose of Paxlovid but the symptoms recurred after 2 days). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 20-May-2022 to 25-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Recovered after a dose of Paxlovid but the symptoms recurred after 2 days) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: negative (Negative) Negative. On 29-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         The patient received other medications or products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. Device Date: 31May2022  Company comment: This spontaneous case concerns a 79-year-old female patient, with concurrent bronchiectasis who experienced the unexpected non-serious adverse event of special interest COVID-19, which occurred at an unspecified date after receiving a dose of mRNA1273. The patient was initially diagnosed with COVID-19 and was started with Nirmatrelvir/Ritonavir (Paxlovid) for 5 days. Patient reported to have recovered after treatment but symptoms have returned after 2 days, the patient tested positive for SARS-COV-2 4 days after completion of Paxlovid course. Further details regarding the diagnostic test done to the patient were not provided. The patient's advanced age and concurrent bronchiectasis may be considered as risk factors for the event COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 79-year-old female patient, with concurrent bronchiectasis who experienced the unexpected non-serious adverse event of special interest COVID-19, which occurred at an unspecified date after receiving a dose of mRNA1273. The patient was initially diagnosed with COVID-19 and was started with Nirmatrelvir/Ritonavir (Paxlovid) for 5 days. Patient reported to have recovered after treatment but symptoms have returned after 2 days, the patient tested positive for SARS-COV-2 4 days after completion of Paxlovid course. Further details regarding the diagnostic test done to the patient were not provided. The patient's advanced age and concurrent bronchiectasis may be considered as risk factors for the event COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.