Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included DORZOLAMIDE, BUPROPION HYDROCHLORIDE (WELLBUTRIN) from 05-May-2022 to an unknown date and NABUMETONE (RELAFEN) from 11-Apr-2022 to an unknown date for an unknown indication.   On 23-Feb-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021 at 3:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Nov-2021 at 12:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-May-2022 at 12:00 PM, received fourth 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 24-May-2022 to 29-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.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jun-2022, SARS-CoV-2 test: positive (Positive) Positive.         No medical history was reported. Concomitant medication included Advair Diskus with batch number B95J. The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. It was reported  four days after course of Paxlovid, COVID symptoms returned along with a positive test on 02 Jun 2022 at 4:00 pm and was not recovered. The patient previously received a COVID-19 Vaccine. Device Date was reported as03 Jun 2022.  Company comment: This spontaneous case concerns a 65-year-old female patient with no medical history reported, who experienced the unexpected non-serious AESI of Covid-19, on an unspecified date after receiving the 4th dose of mRNA-1273 vaccine. She had taken a course of Paxlovid (Nirmatrelvir + Ritonavir) for five days. Four days after the treatment she had recurrence of symptoms and tested positive for SARS-CoV-2 test. The outcome was reported as unknown. Details of symptoms, start date, clinical course, further investigation reports and treatment were not provided. One year prior to the 4th dose the patient has taken two primary doses of mRNA-1273 vaccine and 3rd dose of mRNA-1273 vaccine five months prior. The current pandemic situation of Covid-19 could be a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 65-year-old female patient with no medical history reported, who experienced the unexpected non-serious AESI of Covid-19, on an unspecified date after receiving the 4th dose of mRNA-1273 vaccine. She had taken a course of Paxlovid (Nirmatrelvir + Ritonavir) for five days. Four days after the treatment she had recurrence of symptoms and tested positive for SARS-CoV-2 test. The outcome was reported as unknown. Details of symptoms, start date, clinical course, further investigation reports and treatment were not provided. One year prior to the 4th dose the patient has taken two primary doses of mRNA-1273 vaccine and 3rd dose of mRNA-1273 vaccine five months prior. The current pandemic situation of Covid-19 could be a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.