Age: 66.0
Sex: M
Vaccine: COVID19, UNK, UNK
Symptoms: Biopsy, Colonoscopy, Pain, Platelet count decreased, Prostatomegaly
Clinical narrative: enlarged prostate; pain; This spontaneous case was reported by a physician and describes the occurrence of PROSTATOMEGALY (enlarged prostate) and PAIN (pain) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03L120A and 044A21A) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Crohn's disease and DICYCLOMINE HCL for Spastic colon.    Previously administered products included for Product used for unknown indication: Plavix and LIPITOR; for an unreported indication: STATIN EZ. Concurrent medical conditions included Insomnia, Spastic colon, Nausea, Neck pain, Back pain, Hypertension, GERD, Enlarged prostate, Sinusitis (Sinus allergy) and Seasonal allergy. Concomitant products included LANSOPRAZOLE (PREVACID) for Acid reflux (esophageal), MONTELUKAST for Allergy, MORNIFLUMATE (FLOMAX [MORNIFLUMATE]) for Enlarged prostate, AMLODIPINE and METOPROLOL for Hypertension, TRAZODONE for Insomnia, OXYCODONE for Neck pain and Back pain, GABAPENTIN for Pain and Nerve damage, FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Sinusitis, CENTRUM SILVER [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM;CHROMIUM;COLECALCIFEROL;COPPER;FOLIC ACID;IODINE;IRON;LYCOPENE;MAGNESIUM;MANGANESE;NICOTINAMIDE;PANTOTHENIC ACID;PHOSPHORUS;PHYTOMENADIONE;POTASSIUM;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN for Vitamin supplementation, ONDANSETRON for Vomiting and Nausea, ACETYLSALICYLIC ACID (ASPIRIN 81), VITAMIN D3, FOLIC ACID and MECOBALAMIN (VITAMIN B12 [MECOBALAMIN]) for an unknown indication.   In 2019, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started DICYCLOMINE HCL (unknown route) dosage form. On 18-Feb-2021, the patient experienced PROSTATOMEGALY (enlarged prostate). 18-Feb-2021, the patient experienced PAIN (pain). At the time of the report, PROSTATOMEGALY (enlarged prostate) and PAIN (pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Jan-2021, Colonoscopy: abnormal (abnormal) Discovered a three polyps and one internal hemorrhoids. On 18-Feb-2021, Platelet count decreased: low (Low) Low. In 2021, Biopsy: inconclusive (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details not provided.  Company Comment: Very limited information regarding these events has been provided at this time. No further information is expected at this time. Of note, the patient's age and medical history of enlarged prostate, neck pain and back pain are confounding factors that may play possible contributory roles.   This case was linked to MOD-2021-195824 (Patient Link); Sender's Comments: Very limited information regarding these events has been provided at this time. No further information is expected at this time. Of note, the patient's age and medical history of enlarged prostate, neck pain and back pain are confounding factors that may play possible contributory roles.