Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Was feeling great at completion of treatment but symptoms recurred in 3 days and have continued for 4 days so far; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Was feeling great at completion of treatment but symptoms recurred in 3 days and have continued for 4 days so far) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A, 028L20A and 039K20A) for COVID-19 vaccination.  Previously administered products included for Product used for unknown indication: Aspirin and Sulfa. Past adverse reactions to the above products included Drug allergy with Aspirin and Sulfa. Concurrent medical conditions included Hypertension. Concomitant products included LISINOPRIL, METOPROLOL and ATORVASTATIN for an unknown indication.  On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Was feeling great at completion of treatment but symptoms recurred in 3 days and have continued for 4 days so far). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 22-May-2022 to 26-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Was feeling great at completion of treatment but symptoms recurred in 3 days and have continued for 4 days so far) had not resolved.  The patient received unspecified medications/products within 2 weeks of starting COVID-19 treatment. The patient felt great at completion if treatment but symptoms recurred in 3 days and had continued for 4 days so far. The device date was reported as 01-Jun-2022.  Company comment: This spontaneous case concerns a 68-years-old female patient with no relevant medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 (Was feeling great at completion of treatment but symptoms recurred in 3 days and have continued for 4 days so far) which occurred 8 months 12 days after the third dose of mRNA-1273 vaccine. The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 22-May-2022 to 26-May-2022 for COVID-19 treatment. Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This spontaneous case concerns a 68-years-old female patient with no relevant medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 (Was feeling great at completion of treatment but symptoms recurred in 3 days and have continued for 4 days so far) which occurred 8 months 12 days after the third dose of mRNA-1273 vaccine. The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 22-May-2022 to 26-May-2022 for COVID-19 treatment. Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.