Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested negative with home antigen test 3 days after completion of Paxlovid and tested positive again 8 days later; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Tested negative with home antigen test 3 days after completion of Paxlovid and tested positive again 8 days later) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033k21-2a) for COVID-19 vaccination.     The patient's past medical history included Low back pain. Concurrent medical conditions included Reflux gastritis, Prostatic hypertrophy, Asthma and Drug allergy.    On 01-Apr-2022 at 9:00 AM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2022 at 5:00 PM, the patient experienced COVID-19 (Tested negative with home antigen test 3 days after completion of Paxlovid and tested positive again 8 days later). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 04-May-2022 to 09-May-2022 for COVID-19 prophylaxis, at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested negative with home antigen test 3 days after completion of Paxlovid and tested positive again 8 days later) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 18-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.   Concomitant medications details were not reported by the reporter.  Patient tested negative with home antigen test 3 days after completion of Paxlovid five day course. Felt better afterwards and then tested positive again 8 days later, experienced symptoms of congestion, cough, headache and mild fever and so far, not as severe as symptoms before starting Paxlovid.  Device Date was reported as 18-May-2022.  Company Comment: This is a Spontaneous case concerning a 62-year-old male patient, with no relevant medical history, who experienced the unexpected, non-serious AESI of COVID-19, approximately 1 month and a half after the fourth dose of mRNA-1273 vaccine. No information about previous doses was disclosed. Patient reported he tested negative with home antigen test 3 days after completion of Nirmatrelvir, Ritonavir (Paxlovid) 5 day course. Felt better afterwards and then tested positive again 8 days later. He experienced symptoms of congestion, cough, headache and mild fever, not as severe as symptoms before starting Paxlovid. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a Spontaneous case concerning a 62-year-old male patient, with no relevant medical history, who experienced the unexpected, non-serious AESI of COVID-19, approximately 1 month and a half after the fourth dose of mRNA-1273 vaccine. No information about previous doses was disclosed. Patient reported he tested negative with home antigen test 3 days after completion of Nirmatrelvir, Ritonavir (Paxlovid) 5 day course. Felt better afterwards and then tested positive again 8 days later. He experienced symptoms of congestion, cough, headache and mild fever, not as severe as symptoms before starting Paxlovid. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.