Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Stoma site hypergranulation, Stoma site pain, Wrong technique in product usage process, X-ray
Clinical narrative: stiffness; rigidity; swallowing disorder; freezing phenomenon; worsened blood pressure fluctuation; Dementia aggravated; wrong technique in product usage process; stoma site pain; Abdominal pain; complication associated with device; stoma site granulation; pain in arm; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ABDOMINAL PAIN (Abdominal pain) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Weight loss in December 2019, Aspiration pneumonia since 06-Feb-2021, Stomach ulcer, Chronic pancreatitis, Anxiety, Arthritis, Dementia, Pulse pressure wide, Urination impaired, Parkinson's disease, Abdominal pain since 21-Jan-2021, Abdominal discomfort since 21-Jan-2021, Abdominal bloating since 21-Jan-2021, Device migration since 21-Jan-2021, Distended abdomen since 21-Jan-2021, Nausea since 21-Jan-2021, Dementia aggravated and Blood pressure fluctuation. Concomitant products included CARBIDOPA, LEVODOPA (DUOPA) for Parkinson's disease, LINACLOTIDE (LINZESS), MACROGOL 3350 (MIRALAX) and ACETAMINOPHEN for an unknown indication.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in arm). On 08-Mar-2021, the patient experienced ABDOMINAL PAIN (Abdominal pain) (seriousness criterion medically significant), COMPLICATION ASSOCIATED WITH DEVICE (complication associated with device) and STOMA SITE PAIN (stoma site pain). On 10-Mar-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (wrong technique in product usage process). In March 2021, the patient experienced STOMA SITE HYPERGRANULATION (stoma site granulation). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness), MUSCLE RIGIDITY (rigidity), DYSPHAGIA (swallowing disorder), FREEZING PHENOMENON (freezing phenomenon), BLOOD PRESSURE FLUCTUATION (worsened blood pressure fluctuation) and DEMENTIA (Dementia aggravated). On 10-Mar-2021, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (wrong technique in product usage process) and STOMA SITE PAIN (stoma site pain) had resolved. At the time of the report, ABDOMINAL PAIN (Abdominal pain), COMPLICATION ASSOCIATED WITH DEVICE (complication associated with device) and PAIN IN EXTREMITY (pain in arm) had resolved, STOMA SITE HYPERGRANULATION (stoma site granulation) and DEMENTIA (Dementia aggravated) outcome was unknown and MUSCULOSKELETAL STIFFNESS (stiffness), MUSCLE RIGIDITY (rigidity), DYSPHAGIA (swallowing disorder), FREEZING PHENOMENON (freezing phenomenon) and BLOOD PRESSURE FLUCTUATION (worsened blood pressure fluctuation) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, Computerised tomogram: abnormal Abdominal: Revealed the internal retention plate of the G tube was rubbing up against the abdominal wall causing the pain. On 08-Mar-2021, X-ray: abnormal Abdominal unclear; PEG J Placement was okay. On 10-Mar-2021, Computerised tomogram: abnormal Abdomen: Balloon was pushed up against the stoma. On 10-Mar-2021, X-ray: abnormal Abdomen: PEG J Placement was okay.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PAIN IN EXTREMITY (pain in arm) to be probably related and ABDOMINAL PAIN (Abdominal pain), STOMA SITE HYPERGRANULATION (stoma site granulation), COMPLICATION ASSOCIATED WITH DEVICE (complication associated with device), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (wrong technique in product usage process), STOMA SITE PAIN (stoma site pain), MUSCULOSKELETAL STIFFNESS (stiffness), MUSCLE RIGIDITY (rigidity), DYSPHAGIA (swallowing disorder), FREEZING PHENOMENON (freezing phenomenon), BLOOD PRESSURE FLUCTUATION (worsened blood pressure fluctuation) and DEMENTIA (Dementia aggravated) to be not related.    Treatment: The patient's PEG tube was moved back in from position 2 to position 4.  The patient received treatment with silver nitrate and trimethobenzamide (Tigan).