Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, COVID-19 immunisation, Vaccination failure
Clinical narrative: DRUG-INDUCED VACCINE FAILURE; severe covid-19; revaccination with different covid-19 vaccine; This solicited report received from a health care professional by a regulatory authority (RA), US-JNJFOC-20241156340  was received by Johnson and Johnson on 22-Nov-2024 by NON-COMPANY STUDY: No Description Available. This report was referenced in literature: The patient's height and weight were not reported. Age at time of vaccination was unknown.  The patient's concurrent conditions included: asthma, diabetes, and stiff person syndrome spectrum disorder. The patient was previously treated with tozinameran for covid-19 prophylaxis and experienced covid-19.  Non-company past vaccine included tozinameran (form of admin not reported, route of admin not reported, batch number not reported) dose, frequency and therapy dates not reported, for covid-19 prophylaxis. Additional dosage information included: dose series 1. The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number not reported) dose, frequency and therapy dates not reported, for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up. Additional dosage information included: dose series 2. Non-company products included: iviglob-ex (form of admin not reported, route of admin not reported, batch number not reported) dose, frequency and therapy dates not reported, for stiff person syndrome.  Concomitant medications included: benzodiazepine derivatives.  On an unspecified date, the patient experienced revaccination with different covid-19 vaccine (dose series 2). On an unspecified date, the patient experienced drug-induced vaccine failure (dose series 2) and was hospitalized on an unspecified date. On an unspecified date, the patient experienced severe covid-19 (dose series 2) and was hospitalized on an unspecified date.  The patient had been receiving immunosuppressant therapy with IV immune-globulin [intravenous immunoglobulin] for stiff person syndrome. The patient was also receiving unspecified benzodiazepines. On an unspecified date, the patient develop severe COVID-19 secondary immunoglobulin, suggesting vaccine failure. The oxygen therapy and symptomatic therapy with ibuprofen, unspecified Virtussin and benzonatat. Eventually, severe COVID-19 resolved.   Treatment medications included: remdesivir for covid-19; ibuprofen for covid-19; virtussin ac for covid-19; benzonatate for covid-19.  The action taken with janssen covid-19 vaccine was not applicable.  The outcome of drug-induced vaccine failure and revaccination with different covid-19 vaccine was not reported. The patient recovered from severe covid-19 on an unspecified date.  The reporter considered the causality between janssen covid-19 vaccine and drug-induced vaccine failure, severe covid-19, and revaccination with different covid-19 vaccine as not reported. Company causality between janssen covid-19 vaccine and drug-induced vaccine failure, severe covid-19, and revaccination with different covid-19 vaccine was not related.  This report was serious (caused/prolonged hospitalization).; Sender's Comments: V0-COVID-19. The event 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. Specifically: CONMEDS-OTHER SUSPECT DRUGS(Intravenous immunoglobulin), UNDERLYING DISEASE(Diabetes, asthma). Therefore, this event is considered inconsistent with vaccine administration. Vaccination failure. The event 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. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.