Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Initial COVID-19 infection prior to COVID-19 treatment; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Initial COVID-19 infection prior to COVID-19 treatment) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A, 011A21A and 037F21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Name of the drug is not reported), Hypertension, Acid reflux (esophageal) and Hyperlipidemia.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2022, the patient experienced COVID-19 (Initial COVID-19 infection prior to COVID-19 treatment). 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 (Initial COVID-19 infection prior to COVID-19 treatment) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: positive (Positive) Daily antigen tests positive until May  17 and positive (Positive) scratchy throat and positive  test.. On 18-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 19-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 20-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.   No concomitant medication information was provided.  It was reported that patient was tested daily because of choir concert in 9 days. Only scratchy throat and positive test. Daily antigen tests were positive until May 17, by which time symptoms gone. On May 21st test turned positive and the next day, intense congestion, fatigue and some cough ever since. Perhaps slightly improved (May 24th). So experience was of feeling much worse during rebound period than with initial symptoms.   No treatment medication information was provided.  Company Comment:  This is a spontaneous case concerning a 67-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, which occurred approximately 8-9 months after receiving the third dose of mRNA-1273 vaccine. Patient had received 2-dose primary series of mRNA-1273 vaccine with no reported adverse event, given at an interval of 32 days which falls within the recommended vaccine dosing schedule, approximately 6 months prior to third mRNA-1273 vaccination. Initially, patient experienced itchy throat and was tested postive for COVID-19. Patient was given a five-day-course of Paxlovid treatment and tested negative for COVID-19 for three consecutive days after the treatment course. However, four days after the treatment with Paxlovid, patient noted intense congestion, fatigue and some cough then tested positive again for COVID-19. The patient reported that he felt much worse during rebound period than with initial symptoms. After few days, patient had slightly improved. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 67-year-old male patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, which occurred approximately 8-9 months after receiving the third dose of mRNA-1273 vaccine. Patient had received 2-dose primary series of mRNA-1273 vaccine with no reported adverse event, given at an interval of 32 days which falls within the recommended vaccine dosing schedule, approximately 6 months prior to third mRNA-1273 vaccination. Initially, patient experienced itchy throat and was tested postive for COVID-19. Patient was given a five-day-course of Paxlovid treatment and tested negative for COVID-19 for three consecutive days after the treatment course. However, four days after the treatment with Paxlovid, patient noted intense congestion, fatigue and some cough then tested positive again for COVID-19. The patient reported that he felt much worse during rebound period than with initial symptoms. After few days, patient had slightly improved. The benefit-risk relationship of mRNA-1273 is not affected by this report.