Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Recurrent symptoms and recurrent positive Ag test (was negative day 9, retested due to symptoms and positive day 15); This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Recurrent symptoms and recurrent positive Ag test (was negative day 9, retested due to symptoms and positive day 15)) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer / BioNTech (Dose Number: 1 Batch/Lot No: EK5730) on 20-Dec-2020, PFIZER BIONTECH COVID-19 VACCINE (Dose Number: 2 Batch/Lot No: EL1284) on 07-Jan-2021 and PFIZER BIONTECH COVID-19 VACCINE (Dose Number: 3 Batch/Lot No: EW0198 Location of injection: Arm Left) on 05-Oct-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and Pfizer / BioNTech. Concurrent medical conditions included Asthma (mild).    In November 2021, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Recurrent symptoms and recurrent positive Ag test (was negative day 9, retested due to symptoms and positive day 15)). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 10-May-2022 to 15-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Recurrent symptoms and recurrent positive Ag test (was negative day 9, retested due to symptoms and positive day 15)) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative on day 9 and positive (Positive) positive on day 15.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  Patient had Recurrent symptoms and recurrent positive Ag test.  Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  Company comment: This spontaneous case concerns a 52-year-old female patient, with concurrent asthma who experienced the unexpected non-serious adverse event of special interest COVID-19, which occurred at an unspecified date after receiving the fourth dose of mRNA1273. It should be noted that the patient received 3 doses of different COVID-19 Vaccine (Pfizer Biontech Tozinameran) prior to the latest dose of mRNA1273. The patient was initially diagnosed with COVID-19 and was started with Nirmatrelvir/Ritonavir (Paxlovid) for 5 days.  Patient tested negative for SARS-COV2 antigen on day 9. However on day 15 patient experienced recurrence of symptoms and tested positive again for SARS-COV2 antigen. The patient's concurrent asthma may be considered as a risk factor for COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 52-year-old female patient, with concurrent asthma who experienced the unexpected non-serious adverse event of special interest COVID-19, which occurred at an unspecified date after receiving the fourth dose of mRNA1273. It should be noted that the patient received 3 doses of different COVID-19 Vaccine (Pfizer Biontech Tozinameran) prior to the latest dose of mRNA1273. The patient was initially diagnosed with COVID-19 and was started with Nirmatrelvir/Ritonavir (Paxlovid) for 5 days.  Patient tested negative for SARS-COV2 antigen on day 9. However on day 15 patient experienced recurrence of symptoms and tested positive again for SARS-COV2 antigen. The patient's concurrent asthma may be considered as a risk factor for COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.