Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Malaise, SARS-CoV-2 test
Clinical narrative: feeling sick; Rebound. Tested positive 4/23; Interchange of vaccine products; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling sick), COVID-19 (Rebound. Tested positive 4/23) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018F21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: PFIZER (Dose Number: 1 Batch/Lot No: EW0161) on 13-Apr-2021 and PFIZER (Dose Number: 2 Batch/Lot No: EW0173) on 04-May-2021. Past adverse reactions to the above products included No adverse event with PFIZER and PFIZER. Concomitant products included VITAMIN C [ASCORBIC ACID], VITAMIN D [VITAMIN D NOS], MULTIVITAMIN [VITAMINS NOS] and PROBIOTICS NOS for an unknown indication.    On 08-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Dec-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). On an unknown date, the patient experienced MALAISE (feeling sick) and COVID-19 (Rebound. Tested positive 4/23). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 24-Apr-2022 to 28-Apr-2022 for Adverse event, at an unspecified dose and frequency. At the time of the report, MALAISE (feeling sick) and COVID-19 (Rebound. Tested positive 4/23) was resolving and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         She tested positive with immediate strong test line in rapid antigen test on day 12 and day 14. It was reported that device date was 07-May-2022. Company comment: This spontaneous case concerns a 54-year-old female patient, with no relevant medical history, who experienced the non-serious unexpected AESI of COVID-19 (among other non-serious events). The event was report on an unspecified date; hence latency cannot be assessed. The reported dose of mRNA-1273 vaccine was considered as the third dose of the vaccine schedule, she received previously 2 doses of Pfizer COVID-19 vaccine (Interchange of vaccine products). A positive COVID test was performed on an unspecified date. As per narrative of the source document, she received Paxlovid (ritonavir) as treatment for COVID-19. The benefit-risk relationship of the mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 54-year-old female patient, with no relevant medical history, who experienced the non-serious unexpected AESI of COVID-19 (among other non-serious events). The event was report on an unspecified date; hence latency cannot be assessed. The reported dose of mRNA-1273 vaccine was considered as the third dose of the vaccine schedule, she received previously 2 doses of Pfizer COVID-19 vaccine (Interchange of vaccine products). A positive COVID test was performed on an unspecified date. As per narrative of the source document, she received Paxlovid (ritonavir) as treatment for COVID-19. The benefit-risk relationship of the mRNA-1273 is not affected by this report.