Sex: U
Vaccine: COVID19, COVID19-2
Symptoms: COVID-19, Chills, Fatigue, Pyrexia, Vaccination failure
Clinical narrative: The only adverse thing is that the vaccine didn't stop me from contracting COVID-19, The vaccine didn't fully protect me from getting COVID but that's understandable; vaccine didn't stop me from contracting COVID-19; Temperature; chill; throwing up; tired; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION FAILURE (The only adverse thing is that the vaccine didn't stop me from contracting COVID-19, The vaccine didn't fully protect me from getting COVID but that's understandable), COVID-19 (vaccine didn't stop me from contracting COVID-19), PYREXIA (Temperature), CHILLS (chill) and VOMITING (throwing up) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057F22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular use) dosage was changed to 1 dosage form. On 13-Nov-2021, received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular use) dosage was changed to 1 dosage form. On 30-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular use) 1 dosage form. On an unknown date, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced VACCINATION FAILURE (The only adverse thing is that the vaccine didn't stop me from contracting COVID-19, The vaccine didn't fully protect me from getting COVID but that's understandable), COVID-19 (vaccine didn't stop me from contracting COVID-19), PYREXIA (Temperature), CHILLS (chill), VOMITING (throwing up) and FATIGUE (tired). At the time of the report, VACCINATION FAILURE (The only adverse thing is that the vaccine didn't stop me from contracting COVID-19, The vaccine didn't fully protect me from getting COVID but that's understandable), COVID-19 (vaccine didn't stop me from contracting COVID-19), PYREXIA (Temperature), CHILLS (chill), VOMITING (throwing up) and FATIGUE (tired) outcome was unknown.            No concomitant medications were reported.  Reported that patient had filled out the online form in regard to Paxlovid which patient already filled out the paper forms for.  No treatment medications were reported.  Company Comment: This is a Spontaneous case reported by a patient, concerning a patient of unknown age and gender, with no medical history reported, who experienced the unexpected and non-serious event of Vaccination failure, and other non-serious events (COVID-19, Pyrexia, Chills, Vomiting, Fatigue), which occurred on an unknown date related to mRNA-1273.222 vaccine, administered as fourth dose within COVID-19 vaccination schedule. First 3 doses were administered with Tozinameran, which remains as a co-suspect product. No information disclosed about diagnostic tests performed , clinical course or treatments received. The company considers the event Vaccination failure as not related to mRNA-1273.222 vaccine, as onset date for COVID-19 was not provided, and vaccination failure criteria does not apply as per SMP. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.