Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Symptomatic COVID after Moderna Dose 3) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A and 011L20A) for COVID-19 vaccination. Concurrent medical conditions included Ulcerative colitis, Psoriatic arthritis and Allergy to antibiotic (Duricef). Concomitant products included METHOTREXATE, ESTRADIOL (ESTROGEN), FOLIC ACID, METHOCARBAMOL, OXYCODONE, GABAPENTIN, VITAMINS NOS (MVI NEO 9), CALCIUM CITRATE (CALCITRATE), AZELASTINE HYDROCHLORIDE (ASTELIN [AZELASTINE HYDROCHLORIDE]), BUDESONIDE (NASACORT) and OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) for an unknown indication. On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-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 (Symptomatic COVID after Moderna Dose 3). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 16-May-2022 to 20-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Symptomatic COVID after Moderna Dose 3) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously received a COVID-19 Vaccine. Device date was reported as '25May2022'. Company Comment: This spontaneous case concerns a 56-year-old, female patient with history of concomitant intake of methotrexate and past drug history of administration of two doses of the mRNA-1273 vaccine, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred almost 9 months after receiving the third dose of the mRNA-1273 vaccine. The patient developed symptomatic COVID-19, however, the symptoms were not reported. She took and completed a 5-day course of Paxlovid (nirmatrelvir, ritonavir) from 16May2022 to 20May2022. It was reported that the patient developed rebound symptomatic COVID-19 (symptoms unspecified) 4 days after treatment with Paxlovid. No additional details were provided at the time of the report. The history of concomitant intake of methotrexate, an immunosuppressant, remains a confounder since people with weakened immune system are at risk of developing COVID-19. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a 56-year-old, female patient with history of concomitant intake of methotrexate and past drug history of administration of two doses of the mRNA-1273 vaccine, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred almost 9 months after receiving the third dose of the mRNA-1273 vaccine. The patient developed symptomatic COVID-19, however, the symptoms were not reported. She took and completed a 5-day course of Paxlovid (nirmatrelvir, ritonavir) from 16May2022 to 20May2022. It was reported that the patient developed rebound symptomatic COVID-19 (symptoms unspecified) 4 days after treatment with Paxlovid. No additional details were provided at the time of the report. The history of concomitant intake of methotrexate, an immunosuppressant, remains a confounder since people with weakened immune system are at risk of developing COVID-19. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.