Sex: M
Vaccine: COVID19, COVID19, UNK
Symptoms: Blood immunoglobulin G, Blood immunoglobulin G decreased, Deep vein thrombosis, Plantar fasciitis, SARS-CoV-2 antibody test
Clinical narrative: DEEP VEIN THROMBOSIS; SUSPECTED IMMUNOLOGICAL VACCINATION FAILURE; WHITE BLOOD CELLS ABNORMAL; PLANTAR FASCIITIS; IMMUNOGLOBULIN G DECREASED; This spontaneous report received from a patient concerned a 74 year old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: chronic lymphocytic leukemia. The patient received non-company suspect drug included Imbruvica (ibrutinib) (tablet, oral, batch number: unknown, expiry: unknown) dose, frequency, and therapy dates were not reported for chronic lymphocytic leukemia.  The patient received three doses of Tozinameran (Pfizer biontech covid-19 vaccine) (Dose number in series 1) (form of admin not reported, intramuscular, batch number: unknown, expiry: unknown) dose, start therapy date were not reported for prophylactic vaccination. No adverse events were reported following administration of Pfizer vaccine (dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) dose, 1 total start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. On 2022, the patient experienced immunoglobulin g decreased. Laboratory data included: Immunoglobulin G (NR: not provided) lower (20).  On an unspecified date, the patient experienced deep vein thrombosis, suspected immunological vaccination failure, white blood cell count abnormal, and plantar fasciitis (dose number in series 2). Laboratory data (dates unspecified) included: COVID-19 antibody test (NR: not provided) negative, and White blood cell count (NR: not provided) 130000. Treatment medications (dates unspecified) included: methylprednisolone, and apixaban. The outcome of the deep vein thrombosis, immunoglobulin g decreased, plantar fasciitis, white blood cell count abnormal and suspected immunological vaccination failure was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with tozinameran, and ibrutinib was not reported. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20220336671. This report was associated with product quality complaint: 90000223848.; Sender's Comments: V0:20220346079-covid-19 vaccine ad26.cov2.s- Deep vein thrombosis, white blood cells abnormal. 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 (chronic lymphocytic leukemia). Therefore, this event(s) is considered not related. 20220346079-covid-19 vaccine ad26.cov2.s-suspected immunological 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.