Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for Covid-19) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M21A) for COVID-19 prophylaxis. Prior to vaccination patient was not diagnosed with COVID-19. Previously administered products included for Product used for unknown indication: Pfizer (Dose Number: 1, Batch/Lot No: EN5318, Location of injection: Right Arm, Route of Administration: Intramuscular.) on 01-Feb-2021, Pfizer (Dose Number: 2, Batch/Lot No: Unknown, Location of injection: Left Arm, Route of Administration: Intramuscular) on 20-Feb-2021, Pfizer (Dose Number: 3, Batch/Lot No: FC3183, Location of injection: Right Arm and Route of Administration: Intramuscular) on 24-Sep-2021. Past adverse reactions to the above products included No adverse reaction with Pfizer, Pfizer and Pfizer. Concurrent medical conditions included Allergy (Name of Drug as Reported as no). On 15-Jul-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2022, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (tested positive for Covid-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (tested positive for Covid-19) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jul-2022, SARS-CoV-2 test: (Positive) Positive. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. There were list of other medications the patient received within 2 weeks of vaccination (unspecified). Company Comment: This is a spontaneous case concerning a 43-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, supported by a positive SARS-CoV-2 test, which occurred 7 days after receiving a dose of mRNA-1273 as the fourth dose of COVID-19 vaccine. Patient had received 3 doses of Pfizer COVID-19 vaccine with no reported adverse event, approximately 9 months and 3 weeks prior to mRNA-1273 vaccination (Interchange of vaccine products). The patient was treated with Nirmatrelvir/ Ritonavir (Paxlovid) for COVID-19, at an unspecified dose and frequency. No further details about the clinical course was provided. It was reported that the event was resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This is a spontaneous case concerning a 43-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19, supported by a positive SARS-CoV-2 test, which occurred 7 days after receiving a dose of mRNA-1273 as the fourth dose of COVID-19 vaccine. Patient had received 3 doses of Pfizer COVID-19 vaccine with no reported adverse event, approximately 9 months and 3 weeks prior to mRNA-1273 vaccination (Interchange of vaccine products). The patient was treated with Nirmatrelvir/ Ritonavir (Paxlovid) for COVID-19, at an unspecified dose and frequency. No further details about the clinical course was provided. It was reported that the event was resolving. The benefit-risk relationship of mRNA-1273 is not affected by this report.