Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive again on 5/21; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Tested positive again on 5/21) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005M21A, 939905, 004M20A and 030M20A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Allergy. Concomitant products included SIMVASTATIN from 11-May-2022 to an unknown date for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 21-May-2022, the patient experienced COVID-19 (Tested positive again on 5/21). At the time of the report, COVID-19 (Tested positive again on 5/21) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 21-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.   It was reported that patient had no allergy. It was reported that patient had taken other medications/products within 2 weeks of starting COVID-19 treatment. Patient finished paxlovid on 16-May-2022 nd tested negative on the rapid test on 18-May-2022 (day 9 after first symptoms). symptoms reappeared on 20-May-2022 tested positive again on 21-May-2022. symptoms are, fatigue, upper respiratory congestion and cough Device Date : 24-May-2022 No treatment medications were reported.  Company comment: This spontaneous case concerns a 73-year-old male patient with no medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 44 after receiving fourth dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid from 11-may-2022 to 15-may-2022. She was tested positive 6 days after the treatment with Paxlovid, Patient Tested negative on day  9 after first symptoms The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 73-year-old male patient with no medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 44 after receiving fourth dose of mRNA-1273 vaccine. It was reported that patient was treated with Paxlovid from 11-may-2022 to 15-may-2022. She was tested positive 6 days after the treatment with Paxlovid, Patient Tested negative on day  9 after first symptoms The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.