Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: Vaccination failure; Suspected COVID-19 infection; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (Suspected COVID-19 infection) and VACCINATION FAILURE (Vaccination failure) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for Prophylactic vaccination.     Previously administered products included for Prophylactic vaccination: JANSSEN COVID-19 VACCINE (vaccinated to left arm, batch no 202A21A,Reaction started on 04 Jan 2022) on 09-Apr-2021, JANSSEN COVID-19 VACCINE (vaccinated to left arm, batch no 202A21A and Reaction started on 30 December 2021) on 09-Apr-2021. Past adverse reactions to the above products included Suspected COVID-19 with JANSSEN COVID-19 VACCINE; and Vaccination failure with JANSSEN COVID-19 VACCINE.    On 06-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced SUSPECTED COVID-19 (Suspected COVID-19 infection) (seriousness criterion medically significant). On 04-Jan-2022, the patient experienced VACCINATION FAILURE (Vaccination failure) (seriousness criterion medically significant). At the time of the report, SUSPECTED COVID-19 (Suspected COVID-19 infection) had not resolved and VACCINATION FAILURE (Vaccination failure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant medication were not reported.  On 06 Nov 2021, patient received booster dose of Moderna vaccine.  On 30 Dec 2021, the patient experienced symptoms of congestion, runny nose and sneezing (Suspected Covid 19 infection)  and reported her illness was a mild case.  Treatment medication were not reported.  Company comment: This case concerns a 43-year-old female patient with unknown medical history who experienced the serious unexpected events of Suspected COVID-19 and Vaccination failure after the dose of mRNA-1273. The event of Suspected COVID-19 occurred approximately one month and twenty five days and the event of vaccination failure occurred about one month and thirty days after the booster dose of mRNA-1273. At the time of the report, outcome of Suspected COVID-19  was not recovered and the outcome of vaccination failure was unknown. Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing COVID-19 infection after vaccination, therefore, the causality for Suspected COVID-19 is not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.; Sender's Comments: This case concerns a 43-year-old female patient with unknown medical history who experienced the serious unexpected events of Suspected COVID-19 and Vaccination failure after the dose of mRNA-1273. The event of Suspected COVID-19 occurred approximately one month and twenty five days and the event of vaccination failure occurred about one month and thirty days after the booster dose of mRNA-1273. At the time of the report, outcome of Suspected COVID-19  was not recovered and the outcome of vaccination failure was unknown. Based on the current available information, the mRNA-1273 vaccine does not contain a virus capable of causing COVID-19 infection after vaccination, therefore, the causality for Suspected COVID-19 is not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Event seriousness assessed as per Regulatory Authority reporting.