Age: 66.0
Sex: U
Vaccine: COVID19, COVID19, UNK
Symptoms: Diarrhoea, Immunodeficiency, SARS-CoV-2 antibody test, SARS-CoV-2 antibody test positive
Clinical narrative: IMMUNOCOMPROMISED; LIMITED ANTIBODY RESPONSE TO JANSSEN COVID-19 VACCINE AND MODERNA COVID-19 VACCINE; DIARRHEA; This solicited report received from a consumer via a company by a Business partner (AbbVie Inc, US-ABBVIE-21K-163-4211547-00) and concerned an elderly patient of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: Waldenstrom's macroglobulinemia. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date in APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  The patient was treated with ibrutinib (capsule, oral, batch number: unknown) dose, frequency, and therapy dates were not reported for Waldenstrom's macroglobulinemia.  On an unspecified date, the patient received additional non-company suspect Moderna vaccine (mrna 1273) (dose number in series 2) (form of admin not reported, intramuscular and batch number was not reported) dose was not reported for prophylactic vaccination.  Concomitant medications included zanubrutinib. On an unspecified date, the patient experienced immunocompromised, limited antibody response to Janssen covid-19 vaccine and moderna covid-19 vaccine, and diarrhea (dose number in series 1 and 2). Laboratory data (dates unspecified) included: COVID-19 antibody test (NR: not provided) positive, limited response. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with ibrutinib, and mrna 1273 was not reported. The outcome of the limited antibody response to Janssen covid-19 vaccine and moderna covid-19 vaccine, immunocompromised and diarrhea was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and immunocompromised, and limited antibody response to Janssen covid-19 vaccine and moderna covid-19 vaccine was not related, and between covid-19 vaccine ad26.cov2.s, and diarrhea was related; and between ibrutinib, and immunocompromised, and limited antibody response to Janssen covid-19 vaccine and moderna covid-19 vaccine was not related, and between ibrutinib, and diarrhea was related.  This report was serious (Other Medically Important Condition).  Version created to amend previously reported information on 16-DEC-2021. Upon review following information was amended: product re-ranking of Janssen covid-19 vaccine, age group of patient and narrative updated.; Sender's Comments: V2:Version created to amend previously reported information on 16-DEC-2021. Upon review following information was amended: product re-ranking of Janssen covid-19 vaccine, age group of patient and narrative updated.  20211254222- covid-19 vaccine ad26.cov2.s-immunocompromised,. 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: MEDICAL HISTORY, Therefore, this event(s) is considered not related.  20211254222-ibrutinib-immunocompromised. 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:  UNDERLYING DISEASE. Therefore, this event(s) is considered not related.