Symptomtext
Covid; Vaccine did not work; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid) and VACCINATION FAILURE (Vaccine did not work) in a 45-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. AU3834B) for COVID-19 prophylaxis. No Medical History information was reported. On 07-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On an unknown date, the patient experienced COVID-19 (Covid) and VACCINATION FAILURE (Vaccine did not work). At the time of the report, COVID-19 (Covid) and VACCINATION FAILURE (Vaccine did not work) outcome was unknown. The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown. For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments. No Concomitant medication was reported. It was unknown if the patient experienced any additional symptoms/events. No treatment information was reported. Company Comment: This is a spontaneous case concerning a 45-year-old, female patient with no reported medical history, who experienced the non-serious unexpected events of COVID 19 and vaccination failure. The events occurred on an unknown date, after a dose of SPIKEVAX 2023-2024 (onset date and dose number were not reported, hence, latency could not be calculated). Clinical course, supportive diagnostic procedures and treatment were not provided. The outcome of the events was not provided. The event Vaccination failure was considered unrelated to the vaccine with the information provided at this time because onset date of COVID-19 and details on vaccination schedule were not provided. The benefit-risk relationship of SPIKEVAX 2023-2024 vaccine is not affected by this report.