Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Prostate cancer metastatic, Prostatic specific antigen, Pulmonary thrombosis, Suspected COVID-19
Clinical narrative: BLOOD CLOTS IN LUNGS; PROSTATE CANCER SPREAD TO BONES; SUSPECTED COVID-19 INFECTION; This solicited report received from a consumer via PPSONC000117: Janssen for Apalutamide concerned a 6 decade old male of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: prostate cancer and had prostatectomy (prostate removed in 2019), and concurrent conditions included: prostate cancer. The patient was treated with apalutamide (film-coated tablet, oral, batch number and expiry date was not reported) dose, frequency, and therapy dates were not reported for prostate cancer. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 1 total was administered on an unspecified date in 2020 for covid-19 prophylaxis (therapy date was captured as reported, but the reported date was prior to approval). The batch number was not reported and has been requested. Age at time of vaccination 6 decade old. Concomitant medications included leuprorelin acetate.  On an unspecified date in 2020 after receiving the covid-19 vaccine, the patient was sick, had a fever of 103 degrees, sweating and could not get out of bed, and ended up with covid-19 infection (suspected covid-19 infection). On an unspecified date, the patient experienced prostate cancer spreading to the bones. Patients PSA (prostate specific antigen) levels went to 6.5. The patient had radiation for bone cancer. Patient thought he broke a rib, however it was blood clot in lungs and was hospitalized for 6 days on 14-MAR-2022. Patient also received radiation to his spine. Patient was treated with Paxlovid for suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with apalutamide was not reported. The outcome of the suspected covid-19 infection, blood clots in lungs and prostate cancer spread to bones was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and prostate cancer spread to bones, blood clots in lungs, and suspected covid-19 infection was not related; and between apalutamide, and prostate cancer spread to bones, blood clots in lungs, and suspected covid-19 infection was not related.  This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20231150735- covid-19 vaccine ad26.cov2.s-blood clot in lungs. The event shows an incompatible temporal relationship. Therefore, this event is considered inconsistent with vaccine administration. 20231150735- covid-19 vaccine ad26.cov2.s-prostate cancer spread to bones. 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: MEDICAL HISTORY. Therefore, this event is considered inconsistent with vaccine administration. 20231150735- Apalutamide -prostate cancer spread to bones. This event(s) is labeled by standard procedures. Therefore, the event(s) is considered not related. 20231150735- Apalutamide -blood clot in lungs. 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.