Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Alanine aminotransferase, Amylase increased, Aspartate aminotransferase, Bilirubin conjugated
Clinical narrative: ABDOMINAL PAIN; Protocol: 21-0012: After Receipt of EUA Vaccines  Manufacturer Receipt Date: 24-AUG-2021  A clinical investigator reported that a 61-year old male (number: 808600959, site number not reported) experienced abdominal pain.  The event occurred 16 days after COVID-19 vaccine  Ad26.COV2.S was administered intramuscularly for prevention of symptomatic SARS-CoV-2 virus infection. The action taken with COVID-19 vaccine Ad26.COV2.S was not applicable.  At reporting, the subject was recovering from abdominal pain.  The subject's weight was 103 kilograms, and height was not reported. The subject's past medical history included: cataract surgery, and cataract surgery, and concurrent conditions included: depression, obesity, vitamin d deficiency, suspected sleep apnea, sedentary lifestyle, and non-smoker, and other pre-existing medical conditions included: Patient had no history of abdominal surgery. Patient family history included hypertension and giant cell glioblastoma of the brain.  Concomitant medications included fluoxetine for depression, curcuma longa rhizome, ergocalciferol, ibuprofen, ketorolac, minoxidil, and prednisolone. The subject received 2 doses of Moderna vaccine (dates were not provided).  On 30-JUL-2021, the subject was treated with COVID-19 vaccine Ad26.COV2.S (suspension for injection, intramuscular, batch number was not reported 0.5ml, anatomical vaccine site was not reported.  On an unknown date, the subject has lower back pain.  On 15-AUG-2021, the subject developed dull ache periumbilical pain.  On 16-AUG-2021, the subject presented to emergency department (ED) with abdominal pain and back pain. His lower back pain showed improvement. The abdominal pain was associated with nausea, bloating, lightheadedness, dizziness, and headache, as well as some sweating and chills during the night. He denied vomiting and bowel movement changes. Review of systems was negative for shortness of breath and chest pain. Vitals showed blood pressure 172/102, respiratory rate 18, temperature 36.4 degrees Celsius (97.5 degrees Fahrenheit), SpO2 99% and heart rate 107. Abdominal examination showed tenderness in peri-umbilical area, however, there was no guarding or rebound. Musculoskeletal examination of the lumbar back showed no swelling, edema, deformity, signs of trauma, lacerations, spasms, tenderness, or scoliosis, as well as normal range of motion, negative right straight leg raise test and negative left straight leg raise test. Complete blood count with differential showed white blood cells 12.9 (elevated), red blood cells (RBC) 4.8, hemoglobin 14.6, hematocrit 42 and platelets 271 (Normal Range (NR) and units were not provided). Basic metabolic panel results showed glucose 130, sodium 139, potassium 4.3, chloride 101, carbon dioxide 24, anion gap 14, urea nitrogen 14, creatinine 0.99, calcium 9.9 (NR and units were not provided), glomerular filtration rate 81 ml/min/1.73, glomerular filtration rate 94 ml/min/1.73 (NR not provided). Right upper quadrant (RUQ) panel results showed amylase 404, lipase 19, total protein 7.6, albumin 4.7, total bilirubin 0.9, direct bilirubin < 0.2, alkaline phosphatase 86, aspartate transaminase 16, alanine transaminase 21 (NR and units were not provided). Urinalysis showed 2+ ketones and trace blood, 0-2 RBC and negative for leukocyte esterase, nitrites, protein and glucose. Computed tomography (CT) head without contrast showed no evidence for acute intracranial hemorrhage, midline shift or mass effect, however, the right maxillary sinus contained a large retention cyst measuring approximately 3.1 cm in its greatest dimensions. CT abdomen and pelvis with contrast showed cholelithiasis and two sclerotic osseous lesions incidentally noted, largest measuring approximately 2.1 cm in the left iliac wing which could be bone islands but are nonspecific and neoplasia cannot be fully excluded. Ultrasound abdomen showed cholelithiasis, but no signs of acute cholecystitis.  The subject was recovering from abdominal pain.  Investigator's causality assessment: The event of abdominal pain was not related to the study vaccine.  Company causality assessment: The event of abdominal pain was not related to the study vaccine.; Sender's Comments: V0-Abdominal pain. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY(obesity), UNDERLYING DISEASE(cholelithiasis)