Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 066F21A, 036B21A and 027A21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: levoquin and zithromax. Past adverse reactions to the above products included Allergy with levoquin and zithromax. Concurrent medical conditions included IgA deficiency (IGA absent/ Susceptible to lung issues). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-May-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) from 07-May-2022 to 12-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Tested positive for COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-May-2022, SARS-CoV-2 test: positive (Positive) Tested positive for COVID-19. On an unknown date, SARS-CoV-2 test: negative (Negative) Day 9 tested negative for COVID and positive (Positive) Tested positive again for COVID on day 16..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient received Paxlovid on day 2 of COVID-19 symptoms and same day of testing positive for COVID-19. Completed 5 day treatment and on day 9 tested negative for COVID-19. On day 12-13 cold symptoms and cough returned and continued to worsen. Tested positive again for COVID on day 16.  Company Comment: This spontaneous case concerns a 59-year-old female patient, with relevant medical history of IgA deficiency (lung issues), had received 2 doses of mRNA-1273 as primary series, who experienced the unexpected non-serious AESI of COVID-19 that occurred 5 months and 29 days after receiving the 3rd dose of mRNA-1273 vaccine. The event was supported with SARS-CoV-2 test positive. As reported, patient received Paxlovid on day 2 of symptoms and completed 5 day treatment regimen. SARS-CoV-2 test reported negative on day 9. On day 12-13 cough and colds worsened, and tested positive on day 16. At the time of reporting, the outcome of event was not resolved. The medical history of IgA deficiency could be considered as a risk factor and current COVID-19 pandemic remains as confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event assessed as non-serious based on medical judgement.; Sender's Comments: This spontaneous case concerns a 59-year-old female patient, with relevant medical history of IgA deficiency (lung issues), had received 2 doses of mRNA-1273 as primary series, who experienced the unexpected non-serious AESI of COVID-19 that occurred 5 months and 29 days after receiving the 3rd dose of mRNA-1273 vaccine. The event was supported with SARS-CoV-2 test positive. As reported, patient received Paxlovid on day 2 of symptoms and completed 5 day treatment regimen. SARS-CoV-2 test reported negative on day 9. On day 12-13 cough and colds worsened, and tested positive on day 16. At the time of reporting, the outcome of event was not resolved. The medical history of IgA deficiency could be considered as a risk factor and current COVID-19 pandemic remains as confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report. Event assessed as non-serious based on medical judgement.