Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: The adverse event is a relapse of Covid infection; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (The adverse event is a relapse of Covid infection) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065k21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer / BioNTech (Dose Number: 1, Batch/Lot No: EP7534, Location of injection: Arm Left) on 16-Mar-2021, Pfizer / BioNTech (Dose Number: 2, Batch/Lot No: ER8729, Location of injection: Arm Left) on 06-Apr-2021, Pfizer / BioNTech (Dose Number: 3, Batch/Lot No: FH8027 and Location of injection: Arm Left) on 16-Nov-2021. Past adverse reactions to the above products included No adverse event with Pfizer / BioNTech, Pfizer / BioNTech and Pfizer / BioNTech. Concurrent medical conditions included Bee sting hypersensitivity (Bee stings) and Allergic to cats (cat hair). Concomitant products included LISDEXAMFETAMINE MESILATE (VYVANSE) from 01-Jan-2022 to an unknown date for an unknown indication.    On 09-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2022 at 9:00 PM, the patient experienced COVID-19 (The adverse event is a relapse of Covid infection). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 14-May-2022 to 19-May-2022 for COVID-19 vaccination, at a dose of 1 dosage form. At the time of the report, COVID-19 (The adverse event is a relapse of Covid infection) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-May-2022, SARS-CoV-2 test: positive (Positive) Positive. On 18-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 21-May-2022, SARS-CoV-2 test: negative (Negative) Negative. On 22-May-2022, SARS-CoV-2 test: positive (Positive) strong positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient's race was reported.  Patient was positive for the first time for COVID on 12-May-2022. After taking the prescribed Pfizer Antiviral, on 18-May-2022 patient became negative till 21-May-2022 and positive symptoms reappeared on 22-May-2022 in the evening and patient was strong positive till the time of this report. Patient had same symptoms level than first time, including strong head cold and sinuses congestion, slight cough to none, wake up every 1 hour 30 min in night without reason.  Company Comment: This is a spontaneous case concerning  a  57-year-old, male patient with no relevant medical history, who experienced the unexpected non-serious AESI event of Covid-19. The events occurred 33 days after the fourth dose of mRNA-1273 COVID 19 Vaccine. Patient tested positive for SARS-CoV-2 test twice ( May 12, 2022 and May 22, 2022). Patient was treated with nirmatrelvir, ritonavir tablet at 1 dosage form. The events were reported as not resolved. Patient was positive for the first time for COVID on 12-May-2022. After taking the prescribed Pfizer Antiviral, on 18-May-2022 patient became negative till 21-May-2022 and positive symptoms reappeared on 22-May-2022 in the evening and patient was strong positive till the time of this report. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.; Sender's Comments: Company Comment: This is a spontaneous case concerning  a  57-year-old, male patient with no relevant medical history, who experienced the unexpected non-serious AESI event of Covid-19. The events occurred 33 days after the fourth dose of mRNA-1273 COVID 19 Vaccine. Patient tested positive for SARS-CoV-2 test twice ( May 12, 2022 and May 22, 2022). Patient was treated with nirmatrelvir, ritonavir tablet at 1 dosage form. The events were reported as not resolved. Patient was positive for the first time for COVID on 12-May-2022. After taking the prescribed Pfizer Antiviral, on 18-May-2022 patient became negative till 21-May-2022 and positive symptoms reappeared on 22-May-2022 in the evening and patient was strong positive till the time of this report. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.