Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID 19) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904, 030N20A and 029L20A) for COVID-19 vaccination. The patient's past medical history included Rib injury (history of rib injury with surgery) since an unknown date. Concurrent medical conditions included Asthma, Eczema, Pre-eclampsia (severe) since 2011, HELLP syndrome since 2011 and Latex allergy. Concomitant products included NAPROXEN SODIUM (ALEVE) from 01-Mar-2022 to an unknown date, MULTIVITAMINS [VITAMINS NOS] from 01-Sep-2021 to an unknown date and PARACETAMOL (TYLENOL) from 01-May-2022 to an unknown date for an unknown indication. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID 19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 11-May-2022 to 16-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID 19) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-May-2022, SARS-CoV-2 test: negative (Negative) Negative (tested at home). On 22-May-2022, SARS-CoV-2 test: positive (Positive) Positive. No treatment medications were reported. Company comment: This spontaneous case concerns a 41-year-old female patient with no relevant medical history who experienced the unexpected non serious AESI of COVID-19 which occurred unknown days after the administration of third dose of mRNA-1273 vaccine in COVID-19 vaccination series. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) for 6 days as treatment for COVID-19 from 11-May to 16-May. Patient tested negative for COVID-19 on 16-May. 5 days later the symptoms returned, and patient again tested positive for COVID-19 on 22-May. Patient received 2 doses of mRNA-1273 vaccine as per recommended schedule approximately 8 and 9 months prior to the last dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This spontaneous case concerns a 41-year-old female patient with no relevant medical history who experienced the unexpected non serious AESI of COVID-19 which occurred unknown days after the administration of third dose of mRNA-1273 vaccine in COVID-19 vaccination series. Patient received NIRMATRELVIR, RITONAVIR (Paxlovid) for 6 days as treatment for COVID-19 from 11-May to 16-May. Patient tested negative for COVID-19 on 16-May. 5 days later the symptoms returned, and patient again tested positive for COVID-19 on 22-May. Patient received 2 doses of mRNA-1273 vaccine as per recommended schedule approximately 8 and 9 months prior to the last dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.