Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Relapse in symtoms and rapid test. Timeline:20May2022:Rapid Antigen Test Negative + Recovery 21May2022:Rapid Antigen Test Strongly Positive 22May2022:new symptoms, Rhinorrhea + mild cough Today (May242022):Still have nasal congestion; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Relapse in symtoms and rapid test. Timeline:20May2022:Rapid Antigen Test Negative + Recovery 21May2022:Rapid Antigen Test Strongly Positive 22May2022:new symptoms, Rhinorrhea + mild cough Today (May242022):Still have nasal congestion) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 treatment.    Concomitant products included IBUPROFEN (MOTRIN [IBUPROFEN]) from 13-May-2022 to 16-May-2022 for an unknown indication.   On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2022, the patient received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 22-May-2022, the patient experienced COVID-19 (Relapse in symtoms and rapid test. Timeline:20May2022:Rapid Antigen Test Negative + Recovery 21May2022:Rapid Antigen Test Strongly Positive 22May2022:new symptoms, Rhinorrhea + mild cough Today (May242022):Still have nasal congestion). At the time of the report, COVID-19 (Relapse in symtoms and rapid test. Timeline:20May2022:Rapid Antigen Test Negative + Recovery 21May2022:Rapid Antigen Test Strongly Positive 22May2022:new symptoms, Rhinorrhea + mild cough Today (May242022):Still have nasal congestion) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-May-2022, SARS-CoV-2 test: negative (Negative) Negative+recovery. On 21-May-2022, SARS-CoV-2 test: rapid antigen test strongly (Positive) Rapid Antigen Test Strongly Positive. On 22-May-2022, SARS-CoV-2 test: positive (Positive) new symptoms, Rhinorrhea + mild cough Today. On 24-May-2022, SARS-CoV-2 test: positive (Positive) Still have nasal congestion, Rapid Antigen Test Strongly Positive.         Patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously received a COVID-19 Vaccine. It was reported that there was relapse in symptoms and rapid test. COVID-19 symptoms include rhinorrhea on 22-May-2022, mild cough and nasal congestion on 24-May-2022.  No treatment medications were reported by the reporter.  Pfizer have permission to contact you about this report Pfizer have permission to contact the patient's healthcare provider about this report  Patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment  Patient previously receive a COVID-19 Vaccine Device Date : 24May2022 Company comment: This spontaneous case concerns a 40-year-old, male patient with no reported medical history, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred 8 days after administration of an unknown dose of Pfizer vaccine, the third dose of mRNA-1273 was given approximately 6 months prior. On May 21, 22 and 24, 2022, SARS-CoV-2 test was done which revealed a positive result. Details of concomitant medications, medical history, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 40-year-old, male patient with no reported medical history, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred 8 days after administration of an unknown dose of Pfizer vaccine, the third dose of mRNA-1273 was given approximately 6 months prior. On May 21, 22 and 24, 2022, SARS-CoV-2 test was done which revealed a positive result. Details of concomitant medications, medical history, clinical course, treatment and outcome were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.