Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: 10 days post initiation of therapy and 5 days post cessation of therapy I tested strongly positive again for covid; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (10 days post initiation of therapy and 5 days post cessation of therapy I tested strongly positive again for covid) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C01A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Allergy. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (10 days post initiation of therapy and 5 days post cessation of therapy I tested strongly positive again for covid). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 13-May-2022 to 17-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (10 days post initiation of therapy and 5 days post cessation of therapy I tested strongly positive again for covid) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-May-2022, SARS-CoV-2 test: positive (Positive) weekly positive 3 days post cessation of  therapy. On 22-May-2022, SARS-CoV-2 test: positive (Positive) Tested strongly  positive again for COVID to day 1..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 20-May-2022 patient tested weekly positive 3 days post cessation of therapy with no symptoms.  On 22-May-2022 post initiation of therapy and 5 days post cessation of therapy patient tested strongly positive again for COVID with similar symptoms to day 1.   Paxlovid taken as treatment for covid-19 from 13-May-2022 to 17-May-2022  Company comment-This spontaneous case concerns a male patient aged 75 years, with no relevant medical history reported, who experienced the non-serious unexpected AESI of COVID-19 on an unknown date after third dose of mRNA-1273 vaccine. Patient was being treated with Paxlovid (NIRMATRELVIR, RITONAVIR) for Covid from 13th to 17th May2022, 10 days post initiation of therapy and 5 days post cessation of therapy patient was tested strongly positive again for Covid with similar symptoms to day one. He was tested very weekly positive 3 days post cessation of therapy with no symptoms. Outcome of the event was resolving at the time of report. Patient has received a dose (4th dose) of TOZINAMERAN 75 days after mRNA-1273 vaccine. (interchange of vaccine products). The current pandemic situation of COVID 19 may remain as confounder and elderly age remains a risk factor 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 male patient aged 75 years, with no relevant medical history reported, who experienced the non-serious unexpected AESI of COVID-19 on an unknown date after third dose of mRNA-1273 vaccine. Patient was being treated with Paxlovid (NIRMATRELVIR, RITONAVIR) for Covid from 13th to 17th May2022, 10 days post initiation of therapy and 5 days post cessation of therapy patient was tested strongly positive again for Covid with similar symptoms to day one. He was tested very weekly positive 3 days post cessation of therapy with no symptoms. Outcome of the event was resolving at the time of report. Patient has received a dose (4th dose) of TOZINAMERAN 75 days after mRNA-1273 vaccine. (interchange of vaccine products). The current pandemic situation of COVID 19 may remain as confounder and elderly age remains a risk factor to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.