Age: 66.0
Sex: M
Vaccine: COVID19, UNK, UNK
Symptoms: Dizziness, Fatigue, Gait disturbance, Malaise, Weight
Clinical narrative: Took morning dose and and felt dizzy after about 30 minutes; Stumbling around / staggering across at his lawn; He was not feeling just right but kept doing things/ Still not feeling right, still struggling some, but not as much, but still felt he should not go to work; Tiredness; This spontaneous case from the Regulatory Authority was received on 12-Jan-2023 (reference number: 2022US038956), with additional information on 15-Jan-2023 (being processed together), reported by other non-healthcare professional and concerned a 66-year-old, male patient.  The patient's concurrent conditions included bone metastases, secondary malignant neoplasm of bone, malignant neoplasm of prostate and an unspecified malignant primary neoplasm. The patient's past medical history included an unspecified liver disorder, also reported as other specified diseases of liver. The patient had no known allergies, as reported. The patient's concomitant medications included Lupron depot (leuprorelin acetate), Zometa (zoledronic acid monohydrate) and Metamucil sugar free (plantago ovata), all used for an unreported indication. This patient was enrolled in an Astellas sponsored patient support program with study ID: Regulatory Authority as reported.  On 30-Sep-2022, the patient started treatment with Xtandi (enzalutamide) at the dose of 160 mg, as tablet, orally, once daily for malignant neoplasm of prostate. Th batch number reported was FE6116 and the expiry date was 30-Sep-2024.  On 22-Oct-2022, on Saturday, the patient was vaccinated with Flucelvax (TIV) (influenza vaccine inact sag 3v; dose, route of administration, anatomical location and indication: not reported). The batch number was not reported. The reporter stated that the patient received Flucelvax TIV. However, the product (Flucelvax TIV) has been withdrawn since 2021.  On the same date, the patient was vaccinated with non-company, co-suspect COVID-19 vaccine (reported as 'Pfizer booster (4th)') (active ingredients not specified; dose, route of administration, anatomical location and indication: not reported). The batch number was not reported.  On 27-Oct-2022, at approximately 3:30 am, five days after receiving Flucelvax (TIV) and non-company, co-suspect COVID-19 vaccine, the patient took four tablets of 40mg of enzalutamide with water. After about 30 minutes, the patient felt dizzy and was stumbling around, as reported. At 4:30 am the patient noticed that he was not feeling just right but kept doing things. At about 5:30 am, the patient was staggering across at his lawn, as reported. The patient then checked his paperwork and found dizziness was a side effect. The patient did not go to work because he did not want to drive. Later, after 9 am, the patient called the pharmacy and emailed his doctor's office. The reply from his doctor's office was to reduce the dosage to three tablets of 40 mg. The patient did not do much in the rest of the day, as reported.  On 28-Oct-2022, the patient's dose of Xtandi (enzalutamide) was reduced to 120 mg, as per doctor's orders. It was reported that the patient followed his schedule by only taking three tablets. The patient was still not feeling right as still struggling some, not as much, but still felt he should not go to work, as reported.  On 30-Oct-2022, reported as Sunday, the patient recovered from the events of 'dizzy', 'gait disturbance' and 'feeling unwell', as it was reported that it got better and that the patient had felt fine. The patient had continued taking three tablets and had no problem since, he was doing good with the three.  On an unspecified date in 2022, an unknown amount of time after receiving Flucelvax (TIV) and non-company, co-suspect COVID-19 vaccine, the patient experienced tiredness, sometimes, as reported, but he was sleeping better at night by then. The patient confirmed he did not skip any days (probably with taking enzalutamide), as reported, and that he will have an appointment with his doctor on 19-Dec-2022 to discuss about the correspondence about the release of information from him.  On an unspecified date, the patient took enzalutamide at the dose of 40 mg. The batch number reported was FY6671 (also reported as 8144638) and the expiry date was 31-Jan-2025 (also reported as 28-Feb-2025).There was never a stop date, as reported.   On an unspecified date, the patient's weight was 205 lbs.  On 15-Aor-2023, the patient started Nubeqa (darolutamide) as the patient had an unspecified reaction when taking prescription, so physician took off and switched a different drug.  At the time of the initial reporting, the patient had not recovered from the event of 'tiredness'.  The reporter did not provide causality assessment. However, the reporter assessed the events of 'dizzy', ''gait disturbance' and 'tiredness' as related to enzalutamide based on temporal relationship and positive de-challenge. Underlying malignancy, multiple co-suspects and elderly age can act as risk factors, dizziness may confound stumbling, as reported.  The case was assessed as non-serious.  Company comment: A 66-year-old patient experienced dizziness, gait disturbance, and malaise five days after receiving the suspect product Flucelvax (TIV) and non-company, co-suspect COVID-19 vaccine. The patient also experienced tiredness, within 12 days after vaccination. Underlying medical history of bone metastases, secondary malignant neoplasm of bone, malignant neoplasm of prostate and an unspecified malignant primary neoplasm contributed to the development of the events. Despite confounding by co-suspect vaccine and medical history, causal role of the suspect product cannot be excluded. Therefore, causality for the reported events is assessed as possibly related due to compatible temporal relationship.; Reporter's Comments: However, the reporter assessed the events of 'dizzy', ''gait disturbance' and 'tiredness' as related to enzalutamide based on temporal relationship and positive de-challenge. Underlying malignancy, multiple co-suspects and elderly age can act as risk factors, dizziness may confound stumbling, as reported.; Sender's Comments: A 66-year-old patient experienced dizziness, gait disturbance, and malaise five days after receiving the suspect product Flucelvax (TIV) and non-company, co-suspect COVID-19 vaccine. The patient also experienced tiredness, within 12 days after vaccination. Underlying medical history of bone metastases, secondary malignant neoplasm of bone, malignant neoplasm of prostate and an unspecified malignant primary neoplasm contributed to the development of the events. Despite confounding by co-suspect vaccine and medical history, causal role of the suspect product cannot be excluded. Therefore, causality for the reported events is assessed as possibly related due to compatible temporal relationship.