Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Lack of drug effect; Relapse of covid symptoms and positive antigen test; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Relapse of covid symptoms and positive antigen test) and DRUG INEFFECTIVE (Lack of drug effect) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A, 012A21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Relapse of covid symptoms and positive antigen test). On an unknown date, the patient experienced DRUG INEFFECTIVE (Lack of drug effect). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 04-May-2022 to 08-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Relapse of covid symptoms and positive antigen test) was resolving and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, SARS-CoV-2 test: negative (Negative) Negative. On 16-May-2022, SARS-CoV-2 test: positive (Positive) Positive-Relpase of covid symptoms. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medication was reported  The patient had Relapse of covid symptoms and positive antigen test, following conclusion of symptoms and negative antigen tests after full course of Paxlovid.    Company Comment: This spontaneous case concerns a 38-year-old, female patient with no relevant medical history who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (with a positive SARS-CoV-2 test) which occurred 5 months after receiving the third dose of mRNA-1273 vaccine. Drug ineffective was also considered (COVID-19 occurred 14 months post-completion of primary vaccination of mRNA-1273 and with the first 2 doses taken within the recommended dosing interval). Patient was treated for COVID-19 for five days with Nirmatrelvir, Ritonavir (Paxlovid) but reported recurrence of COVID-19 symptoms and positive COVID-19 antigen test 8 days after treatment. The date of initial diagnosis of COVID-19 and date of the initial COVID-19 test were not provided in this report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 38-year-old, female patient with no relevant medical history who experienced the unexpected, non-serious adverse event of special interest of COVID-19 (with a positive SARS-CoV-2 test) which occurred 5 months after receiving the third dose of mRNA-1273 vaccine. Drug ineffective was also considered (COVID-19 occurred 14 months post-completion of primary vaccination of mRNA-1273 and with the first 2 doses taken within the recommended dosing interval). Patient was treated for COVID-19 for five days with Nirmatrelvir, Ritonavir (Paxlovid) but reported recurrence of COVID-19 symptoms and positive COVID-19 antigen test 8 days after treatment. The date of initial diagnosis of COVID-19 and date of the initial COVID-19 test were not provided in this report. The benefit-risk relationship of mRNA-1273 is not affected by this report.