Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: stuffy nose started on covid day 13. tested positive antigen and PCR; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (stuffy nose started on covid day 13. tested positive antigen and PCR) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033f214) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose Number: 1 Batch/Lot No: en6206 Location of injection: Arm Left) on 11-Mar-2021 and PFIZER BIONTECH COVID-19 VACCINE (Dose Number: 2 Batch/Lot No: er8730 Location of injection: Arm Left) on 01-Apr-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. Concomitant products included GUAIFENESIN (MUCINEX) from 28-Apr-2022 to 08-May-2022 and PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]) from 28-Apr-2022 to 08-May-2022 for an unknown indication.    On 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2022, the patient experienced COVID-19 (stuffy nose started on covid day 13. tested positive antigen and PCR). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 29-Apr-2022 to 04-May-2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (stuffy nose started on covid day 13. tested positive antigen and PCR) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-May-2022, SARS-CoV-2 test: positive (Positive) Positive.         It was reported that patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.  Device date was reported as 12-May-2022.  Company Comment:  This spontaneous case concerns a 58-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19 approximately 5 months and 19 days after receiving a dose of mRNA-1273 as third in the COVID-19 vaccination series. Patient had already completed a 5-day COVID-19 treatment with Nirmatrelvir, Ritonavir (Paxlovid) when she presented with stuffy nose on the 13th day of COVID-19 infection (6 days after completion of Paxlovid treatment) for which a COVID-19 antigen test and PCR done yielded positive results.  Outcome of the event COVID-19 was unknown. Patient previously received 2 doses of non-company brand COVID-19 PFIZER BIONTECH, with the last dose given approximately 7 months prior to current mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 58-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19 approximately 5 months and 19 days after receiving a dose of mRNA-1273 as third in the COVID-19 vaccination series. Patient had already completed a 5-day COVID-19 treatment with Nirmatrelvir, Ritonavir (Paxlovid) when she presented with stuffy nose on the 13th day of COVID-19 infection (6 days after completion of Paxlovid treatment) for which a COVID-19 antigen test and PCR done yielded positive results.  Outcome of the event COVID-19 was unknown. Patient previously received 2 doses of non-company brand COVID-19 PFIZER BIONTECH, with the last dose given approximately 7 months prior to current mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report.