Sex: M
Vaccine: COVID19
Symptoms: Hot flush, Magnetic resonance imaging, Muscle atrophy, Paraesthesia oral, SARS-CoV-2 test
Clinical narrative: PLAQUE ON CAROTID VEIN OF NECK; DEHYDRATED; LEFT EYE TOOK A LOT LONGER TO ADJUST TO THE LIGHT; LIPS AND FACE TINGLY; COVID INFECTION; FATIGUE; HOT FLASHES; LOSING MUSCLE MASS; This solicited report received from a patient via agency: Erleada SPP Fee for Service Accredo concerned a 63 year old male. The patient's height, and weight were not reported. The patient's past medical history included: prostate surgery, surgery in hands, shoulder, and knees, and multiple covid infections, and concurrent conditions included: prostate cancer, and amblyopia (lazy eye in his right eye), and had history of no known allergies. The patient was treated with apalutamide (film-coated tablet, oral, batch number: 23KG356, and 23LG421 expiry: AUG-2026) 240 mg, 1 time every 1 day, from 15-DEC-2023, and 240 mg, 1 time every 1 day, from 12-JAN-2024 for prostate cancer. The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 2021 for an COVID-19 prophylaxis. No concomitant medications were reported. It was reported that patient missed about 12 doses because of COVID. His physician took him off apalutamide. He had COVID over the Christmas holiday and his doctor had him off the 5 days. He was on nirmatrelvir;ritonavir plus an additional 7 days. By 12-JAN-2024, patient was back on apalutamide. He also experienced some fatigue, occasional hot flashes and thought he might be losing muscle mass. Upon follow up, it was reported that patient experienced a minor incident 6-7 days. Also mentioned that he had not reached out to Janssen; and he did not recall his HCPs reaching out to report anything to Janssen. According to the consumer, the medicine had been fine. He had experienced no rashes or no other potential things. He got hot flashes every now and then. He also shared that he had a dull headache in the back of the head area; and he got a positive COVID test. This happened while he was on apalutamide. He contacted his doctor, who advised him to stop apalutamide around 31-DEC-2023 or 02-JAN-2024. Then, he took nirmatrelvir;ritonavir; and he was told to wait an additional 7 days before starting apalutamide again. He took 4 tablets of apalutamide 60 mg every day. And he said that everything was just fine. But around the middle to late January on either 21-JAN-2024 or 22-JAN-2024, he was sitting up; and his lips felt tingly. The side of his face also felt tingly. He also reported that he went into his wife's room, which was dark. And when he turned on the lights, his left eye took a lot longer to adjust to the light that his right eye. He added that he had amblyopia or lazy eye in his right eye. So, he can hardly see out of his right eye; but he had eyes of a hawk in his left eye. Later they ran some tests after this. They checked the carotid on either side of his neck. They also said that he had very little plaque for his age. They also did an MRI. Ever since then, he had no problems. He was not even sure what he was experienced had anything to do with apalutamide. He said that he was still taking apalutamide; and everything was fine. He said that he probably got dehydrated. He was doing some work outside; and he probably didn't hydrate good enough. He added that the MRI will likely validate that it was nothing. He also shared that he took other medications; but none of them interacted with apalutamide. That's why apalutamide was chosen. Consumer also shared that he was 63 years old; and he said that he got his COVID shot. MISE agent didn't get a chance to ask him which COVID shot he got. But a couple of years ago before he started on apalutamide, he tested positive for COVID after already getting the COVID shot; but according to him he was asymptomatic except for a headache. MISE agent also didn't get a chance to ask him where he got the COVID shot. Treatment with apalutamide was withdrawn - covid infection; dose of apalutamide was not changed - fatigue, hot flashes, losing muscle mass, left eye took a lot longer to adjust to the light, lips and face tingly, dehydrated and plaque on carotid vein of neck; and action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from covid infection, had not recovered from fatigue, hot flashes, and losing muscle mass, and the outcome of lips and face tingly, dehydrated, left eye took a lot longer to adjust to the light and plaque on carotid vein of neck was not reported. The reporter considered the causality between apalutamide, and covid infection, fatigue, hot flashes, and losing muscle mass as not related. The reporter did not provide a causality assessment between apalutamide, and plaque on carotid vein of neck, lips and face tingly, dehydrated, and left eye took a lot longer to adjust to the light; and between covid-19 vaccine ad26.cov2.s, and plaque on carotid vein of neck, covid infection, fatigue, hot flashes, losing muscle mass, lips and face tingly, dehydrated, and left eye took a lot longer to adjust to the light. Company causality between apalutamide, and  lips and face tingly, dehydrated, and left eye took a lot longer to adjust to the light was not related, and between apalutamide, and plaque on carotid vein of neck, fatigue, and hot flashes was related; and between covid-19 vaccine ad26.cov2.s, and plaque on carotid vein of neck, covid infection, hot flashes, losing muscle mass, left eye took a lot longer to adjust to the light and dehydrated was not related, and between covid-19 vaccine ad26.cov2.s, and fatigue, lips and face tingly was related.  This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20240238264.  Case was reassessed as serious based upon additional information received from consumer on 13-FEB-2024. The following information was updated and incorporated into the case narrative: Additional reporters, patient age, past medical history (prostate surgery, surgery in hands, shoulder and knees, multiple covid infections), concurrent conditions (amblyopia), additional serious event (plaque on carotid vein of neck), non-serious events (left eye took a lot longer to adjust to the light, lips and face tingly, dehydrated), lab data, additional suspect drug (Janssen COVID-19 vaccine), suspect drug (apalutamide) - batch number, expiry date, and narrative information.; Sender's Comments: V1: F/u to non serious case. Serious event (plaque on carotid vein of neck), non-serious events (left eye took a lot longer to adjust to the light, lips and face tingly, dehydrated) added. -Apalutamide-Carotid arteriosclerosis. This event(s) is labeled per RSI and is therefore considered potentially related. -Carotid arteriosclerosis. 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, NATURE OF EVENT. Therefore, this event is considered inconsistent with vaccine administration.