Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Diarrhoea, Food craving, Musculoskeletal discomfort
Clinical narrative: Neuralgia pain that was more dull in his thigh/nerve pain; Lowenergy; Lowappetites; weight loss; Feels sluggishness when walking up; Feeling a little congested; Crave more crabs and sugar; Diarrhoea; Kles and Groin; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Kles and Groin), DIARRHOEA (Diarrhoea), NEURALGIA (Neuralgia pain that was more dull in his thigh/nerve pain), ASTHENIA (Lowenergy) and DECREASED APPETITE (Lowappetites) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ENZALUTAMIDE capsule for Malignant neoplasm of prostate.    Concurrent medical conditions included Tendon injury, Cancer (NOS) and Rib pain. Concomitant products included CORTISONE from 27-Oct-2021 to an unknown date for Rib pain, LEUPRORELIN ACETATE (ELIGARD) from 28-Oct-2021 to an unknown date, GABAPENTIN, PARACETAMOL (TYLENOL EXTRA STRENGTH), FUROSEMIDE, LISINOPRIL, MAGNESIUM, BICALUTAMIDE, AMLODIPINE BESILATE (AMLODIPIN [AMLODIPINE BESILATE]) and SULFAMETHOXAZOLE for an unknown indication.   On 22-May-2021, the patient ENZALUTAMIDE (Oral) dosage was changed to 160 milligram once a day. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and ENZALUTAMIDE (Oral) 80 milligram once a day. On 29-Oct-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Kles and Groin). On 30-Oct-2021, the patient experienced DIARRHOEA (Diarrhoea). On an unknown date, the patient experienced NEURALGIA (Neuralgia pain that was more dull in his thigh/nerve pain), ASTHENIA (Lowenergy), DECREASED APPETITE (Lowappetites), WEIGHT DECREASED (weight loss), SLUGGISHNESS (Feels sluggishness when walking up), NASAL CONGESTION (Feeling a little congested) and FOOD CRAVING (Crave more crabs and sugar). At the time of the report, MUSCULOSKELETAL DISCOMFORT (Kles and Groin), DIARRHOEA (Diarrhoea), NEURALGIA (Neuralgia pain that was more dull in his thigh/nerve pain), ASTHENIA (Lowenergy), DECREASED APPETITE (Lowappetites), WEIGHT DECREASED (weight loss), SLUGGISHNESS (Feels sluggishness when walking up), NASAL CONGESTION (Feeling a little congested) and FOOD CRAVING (Crave more crabs and sugar) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: loss (Low) loss.         The patient had malignancy as underlying disease.  The patient received eligard in morning and booster in evening.  It was reported that, the patient reported to MD and agreed to decreased his dose of treatment to 2 pills a day due to system wide nerve pain and diarrhea. The patient felt that the symptoms were both dosage and idiosyncratic related. The doctor stopped the xtandi for a few days and was now on day seven of taking 2 pills a day.  Action taken with enzalutamide in response to the events of diarrhea and neuralgia pain that was more dull in his thighs/nerve pain/ system wide nerse pain was reported as withdrawn, and for the events of Kles and groin was reported as unknown and action taken in response to the rest of the events was no change.  It was reported that, according to the patient's physician event diarrhea and Kles and Groin were related to the moderna booster.  The patients assessed the causality of diarrhea and nerve pain as possible and unknown for rest of the events as respect to enzalutamide.