Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal sounds abnormal, Hyperhidrosis, Lipase, Liver function test, Malaise
Clinical narrative: Gut is tender; Stomach bug; Vomiting brown; Sharp abdominal pain (gut was screaming, guts hurt); Diarrhea; Whooshing and gushing of liquid in my gut; Malaise; Diaphoretic; Freezing cold; Chills; Aching all over; Arm started hurting; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of ABDOMINAL TENDERNESS (Gut is tender), GASTROINTESTINAL SOUNDS ABNORMAL (Whooshing and gushing of liquid in my gut), GASTROENTERITIS VIRAL (Stomach bug), FEELING COLD (Freezing cold) and MYALGIA (Aching all over) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Hypertension, Atrial fibrillation, Drug allergy (to  NSAIDs), Food allergy (unspecified) and Allergy (reported as allergy to environment). Concomitant products included MONTELUKAST, FLECAINIDE, CETIRIZINE, FLUTICASONE, CALCIUM, FISH OIL and AMLODIPINE for an unknown indication, B-COMPLEX [CALCIUM PANTOTHENATE;CYANOCOBALAMIN;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE].    On 14-Jan-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021 at 7:00 PM, the patient experienced MYALGIA (Aching all over). On 15-Jan-2021, the patient experienced FEELING COLD (Freezing cold). On 15-Jan-2021 at 10:00 PM, the patient experienced GASTROINTESTINAL SOUNDS ABNORMAL (Whooshing and gushing of liquid in my gut). On 17-Jan-2021, the patient experienced GASTROENTERITIS VIRAL (Stomach bug). On 20-Jan-2021, the patient experienced ABDOMINAL TENDERNESS (Gut is tender). At the time of the report, ABDOMINAL TENDERNESS (Gut is tender) had not resolved and GASTROINTESTINAL SOUNDS ABNORMAL (Whooshing and gushing of liquid in my gut), GASTROENTERITIS VIRAL (Stomach bug), FEELING COLD (Freezing cold) and MYALGIA (Aching all over) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jan-2021, Computerised tomogram: negative (Negative) Negative for diverticulitis. On 16-Jan-2021, Full blood count: unknown (Inconclusive) Unknown. On 16-Jan-2021, Lipase: unknown (Inconclusive) Unknown. On 16-Jan-2021, Liver function test: unknown (Inconclusive) Unknown. On 16-Jan-2021, Metabolic function test: unknown (Inconclusive) Unknown. On 16-Jan-2021, SARS-CoV-2 test: negative (Negative) Negative. On 16-Jan-2021, Urine analysis: unknown (Inconclusive) Unknown. On 17-Jan-2021, Analgesic drug level: unknown (Inconclusive) Unknown. On 17-Jan-2021, Blood potassium: 3.3 (Low) Low. On 17-Jan-2021, Full blood count: unknown (Inconclusive) Unknown. On 17-Jan-2021, Lipase: unknown (Inconclusive) Unknown. On 17-Jan-2021, Metabolic function test: unknown (Inconclusive) Unknown.     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.   Concomitant medication also included Gundry bio-complete (herb for GI). Treatment for the events included Zofran, saline IV, Tylenol, Fentanyl, Bentyl, and Benadryl. The patient has an appointment with a GI specialist soon.  Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.