Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid again; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for Covid again) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included AFib (AFB) and Allergy (unknown drug). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN E.C) from 11-Apr-2022 to an unknown date, METOPROLOL from 11-Apr-2022 to an unknown date, ESCITALOPRAM, BUPROPION HYDROCHLORIDE (BUPROPION HCL XL), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and MELATONIN for an unknown indication.   On 01-Jan-2021 at 2:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021 at 2:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021 at 2:30 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced COVID-19 (tested positive for Covid again). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 08-May-2022 to 13-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (tested positive for Covid again) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: positive (Positive) fifteen days out from testing Covid positive the first time. On 20-May-2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. Patient tested positive for Covid again.It was reported that the patient was fifteen days out from testing Covid positive the first time. Company comment  This spontaneous case reported by a 58 year old female patient, with no relevant medical history reported, who experienced the unexpected, non-serious AESI of covid 19 Infection about 5 months after receiving the 3 dose of Modena mRNA1273 vaccine in the covid 19 vaccination series. Patient previously received 2 primary doses with mRNA vaccines with the last dose taken about 08 months prior to the 3 dose. On an unknown date in In May 2022, SARS-CoV-2 test was positive. On 08-May-2022, the patient was started on Paxlovid for Covid 19 Infection for 6 days till 13 may 2022.. On 20-May-2022, SARS-CoV-2 test was again positive. It was reported that the patient was fifteen days out from testing Covid positive the first time. The event was resolving. Ongoing Covid 19 pandemia 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 reported by a 58 year old female patient, with no relevant medical history reported, who experienced the unexpected, non-serious AESI of covid 19 Infection about 5 months after receiving the 3 dose of Modena mRNA1273 vaccine in the covid 19 vaccination series. Patient previously received 2 primary doses with mRNA vaccines with the last dose taken about 08 months prior to the 3 dose. On an unknown date in In May 2022, SARS-CoV-2 test was positive. On 08-May-2022, the patient was started on Paxlovid for Covid 19 Infection for 6 days till 13 may 2022.. On 20-May-2022, SARS-CoV-2 test was again positive. It was reported that the patient was fifteen days out from testing Covid positive the first time. The event was resolving. Ongoing Covid 19 pandemia 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.