Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (COVID-19) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 030L20A and 012F21A) for COVID-19 vaccination.     The patient's past medical history included Kidney stones. Concurrent medical conditions included Obesity, Hypoglycemia and Drug allergy.   On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third 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 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 14-May-2022 to 19-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter.  The patient had allergy to an unknown product. The patient took other medications/products within 2 weeks of starting COVID-19 treatment. Could tell when time for the PM dose would have been due, except the was complete on the 5 days. The patient was beginning to feel bad once again. Had regressed every day since completing the Paxlovid and by Sunday, May 22, 2022 she was in the bed again all day.  Device Date was reported as 23May2022.  Company comment: This spontaneous case concerns a 62 year old female patient, with no relevant medical history, who experienced the unexpected non serious AESI of COVID-19, unknown days after receiving the third dose with mRNA-1273 vaccine in the COVID-19 vaccination series. The patient received the previous two doses with mRNA-1273 vaccine, the second dose being given about 9 months and 5 days prior to the third dose, with no reported adverse events. The date of first and third doses were same in the report. Patient took Paxlovid for COVID-19 for 5 days and started getting the symptoms back after completing the Paxlovid course. No further information on COVID-19 tests was available in the report. The event was not resolved. The ongoing COVID-19 pandemic could be a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 62 year old female patient, with no relevant medical history, who experienced the unexpected non serious AESI of COVID-19, unknown days after receiving the third dose with mRNA-1273 vaccine in the COVID-19 vaccination series. The patient received the previous two doses with mRNA-1273 vaccine, the second dose being given about 9 months and 5 days prior to the third dose, with no reported adverse events. The date of first and third doses were same in the report. Patient took Paxlovid for COVID-19 for 5 days and started getting the symptoms back after completing the Paxlovid course. No further information on COVID-19 tests was available in the report. The event was not resolved. The ongoing COVID-19 pandemic could be a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.