Age: 76.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: I tested positive for Covid on May 12, received Paxlovid and completed the series on May 16; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I tested positive for Covid on May 12, received Paxlovid and completed the series on May 16) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005M21A, 012F21A, 010M20A and 014I20A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Blood pressure high, Premature ventricular contractions (PVCs) and Allergy NOS. Concomitant products included ATORVASTATIN from 28-Apr-2022 to 12-May-2022, DOXAZOSIN from 28-Apr-2022 to 23-May-2022 and METOPROLOL from 28-Apr-2022 to an unknown date for an unknown indication.   On 16-Jan-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021 at 2:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2022 at 2:00 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 12-May-2022, the patient experienced COVID-19 (I tested positive for Covid on May 12, received Paxlovid and completed the series on May 16). At the time of the report, COVID-19 (I tested positive for Covid on May 12, received Paxlovid and completed the series on May 16) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-May-2022, SARS-CoV-2 test: positive Positive. On 20-May-2022, SARS-CoV-2 test: negative Negative.         Vaccine Administration Time reported 02:00 PM for date 10-Apr-2022 and 23-Oct-2021. Vaccine Administration Time reported 03:00 PM for date 12-Feb-2021 and 16-Jan-2021.It had been reported that tested positive for Covid on May 12, received Paxlovid and completed the series on May 16.  Symptoms improved and was symptom free and tested negative on May 20. However, on May 21 cough returned and I became congested for the first time. No Treatment medication reported. Patient reported that It appears to be a Covid rebound after Paxlovid.  Company comment:  This spontaneous case concerns a 76-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 , which occurred 32 days after receiving fourth dose of mRNA-1273 vaccine. SARS Covid test is positive on 12-may-2022. It was reported that patient was treated with Paxlovid from 12-Apr-2022 to 16-Apr-202. Patient Tested negative on may-20, she started feeling ill again with cough, nasal congestion, fatigue. 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 76-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 , which occurred 32 days after receiving fourth dose of mRNA-1273 vaccine. SARS Covid test is positive on 12-may-2022. It was reported that patient was treated with Paxlovid from 12-Apr-2022 to 16-Apr-202. Patient Tested negative on may-20, she started feeling ill again with cough, nasal congestion, fatigue. 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.