Sex: U
Vaccine: COVID19, COVID19
Symptoms: Angiotensin converting enzyme, Antibody test, Vaccination failure, Vaccine breakthrough infection
Clinical narrative: BREAKTHROUGH INFECTION; CONFIRMED CLINICAL VACCINATION FAILURE; This spontaneous report was received from literature. This report concerned a patient of unspecified age and sex, race and ethnicity. The objective of this was to analysis the SARS-CoV-2 specific antibody and cellular responses in healthy vaccine recipients who experienced breakthrough infections a median of 50 days after receiving a booster mRNA vaccine. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no comorbidities. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (suspension for injection, route of admin was not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. The patient received non-company suspect vaccine Elasomeran (Moderna) (Dose number in series: 2) (form of admin, route of admin were not reported, batch number: Unknown and expiry: Unknown), dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient had mild upper respiratory tract symptoms and experienced breakthrough infection (Dose number in series: 2) which was confirmed clinical vaccination failure (Dose number in series: 1). It was reported that, the days between booster shot and symptom onset was 34, days between symptom onset and blood drawn was 10, and days between booster shot and blood drawn was 44. Laboratory data (dates unspecified) included: Angiotensin converting enzyme (ACE inhibiting antibodies) (NR: not provided) slightly higher, and Antibody test (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s, and Elasomeran (Moderna) was not applicable. The outcome of the confirmed clinical vaccination failure and breakthrough infection was not reported. The author emphasized that breakthrough infections with the Omicron variant can occur despite robust immune responses to the vaccine strain spike protein. This report was serious (Other Medically Important Condition). This case is associated with a product quality complaint, and reference number requested. This case, from the same reporter is linked to 20220430845 and 20220452187.; Sender's Comments: V0: 20220452198- covid-19 vaccine ad26.cov2.s - Breakthrough  infection. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable. 20220452198- covid-19 vaccine ad26.cov2.s- Confirmed clinical vaccination failure . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.