Age: 66.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Biopsy, Colonoscopy, Haemorrhoids, Large intestine polyp, Neck pain
Clinical narrative: Post procedural bleeding; Internal hemorrhoids; enlarged prostate; Colonic polyp; cervical pain; pain; Low platelets; This spontaneous case was reported by a physician and describes the occurrence of POST PROCEDURAL HAEMORRHAGE (Post procedural bleeding), HAEMORRHOIDS (Internal hemorrhoids), PROSTATOMEGALY (enlarged prostate), LARGE INTESTINE POLYP (Colonic polyp) and NECK PAIN (cervical pain) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 03L120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease aggravated.    Previously administered products included for Product used for unknown indication: PLAVIX, Lipitor, statin, clopidogrel and atorvastatin. Past adverse reactions to the above products included No adverse event with Lipitor, PLAVIX, atorvastatin, clopidogrel and statin. Concurrent medical conditions included Drug allergy (allergic to lipitor), Drug allergy (allergy to Plavix, reaction to Plavix are scratching and itchiness to the point of bleeding), Drug allergy (allergy to statins), Tobacco user (uses cigarette sticks a pack per day), Alcohol use (rarely drink), Pain, Nerve damage, Acid reflux (esophageal), Insomnia, Enlarged prostate, Spastic colon, Vomiting, Nausea, Back pain, Neck pain, Blood pressure high and Sinusitis. Concomitant products included LANSOPRAZOLE (PREVACID) for Acid reflux (esophageal), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Allergic sinusitis, MONTELUKAST for Allergy, OXYCODONE for Back pain, AMLODIPINE and METOPROLOL for Blood pressure high, MORNIFLUMATE (FLOMAX [MORNIFLUMATE]) for Enlarged prostate, TRAZODONE for Insomnia, ONDANSETRON for Nausea and Vomiting, GABAPENTIN for Nerve damage and Pain, DICYCLOMINE [DICYCLOVERINE] for Spastic colon, MINERALS NOS, VITAMINS NOS (CENTRUM A TO ZINC), ACETYLSALICYLIC ACID, ASCORBIC ACID (ASPIRIN COMPOUND [ACETYLSALICYLIC ACID;ASCORBIC ACID]), VITAMIN D3, FOLIC ACID and CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) for an unknown indication.   In 2019, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form(s) once a week. 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 experienced POST PROCEDURAL HAEMORRHAGE (Post procedural bleeding), HAEMORRHOIDS (Internal hemorrhoids), PROSTATOMEGALY (enlarged prostate), LARGE INTESTINE POLYP (Colonic polyp), NECK PAIN (cervical pain), PAIN (pain) and PLATELET COUNT DECREASED (Low platelets). At the time of the report, POST PROCEDURAL HAEMORRHAGE (Post procedural bleeding), NECK PAIN (cervical pain) and PAIN (pain) had resolved and HAEMORRHOIDS (Internal hemorrhoids), PROSTATOMEGALY (enlarged prostate), LARGE INTESTINE POLYP (Colonic polyp) and PLATELET COUNT DECREASED (Low platelets) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Biopsy: unknown (Inconclusive) Inconclusive. On 26-Jan-2021, Colonoscopy: abnormal (abnormal) showed a three polyps and one internal hemorrhoids. On an unknown date, Platelet count: decreased (Low) Decreased.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NECK PAIN (cervical pain) and PAIN (pain) to be probably related. No further causality assessments were provided for POST PROCEDURAL HAEMORRHAGE (Post procedural bleeding), HAEMORRHOIDS (Internal hemorrhoids), PROSTATOMEGALY (enlarged prostate), LARGE INTESTINE POLYP (Colonic polyp) and PLATELET COUNT DECREASED (Low platelets).    Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-195640, MOD-2021-195640 (Patient Link); Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.