Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Gastrointestinal pain, Headache, Illness, Magnetic resonance imaging, Off label use
Clinical narrative: Sickness; Passed 77 days after the first dose; Irritated stomach lining; Severe and constant cramps in small intestine/pain was more intense/same amount of pain; Headache; Inflammation in the small intestine; Lost 14 pounds; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 27-May-2021. The most recent information was received on 16-Jun-2021 and was forwarded to Moderna on 16-Jun-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GASTROINTESTINAL PAIN (Severe and constant cramps in small intestine/pain was more intense/same amount of pain), GASTROINTESTINAL INFLAMMATION (Inflammation in the small intestine), GASTRITIS (Irritated stomach lining), WEIGHT DECREASED (Lost 14 pounds) and ILLNESS (Sickness) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LANSOPRAZOLE (PREVACID) from 01-Jan-2008 to an unknown date for Gastritis bile acid.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced GASTROINTESTINAL PAIN (Severe and constant cramps in small intestine/pain was more intense/same amount of pain) and HEADACHE (Headache). In March 2021, the patient experienced GASTROINTESTINAL INFLAMMATION (Inflammation in the small intestine) and WEIGHT DECREASED (Lost 14 pounds). In April 2021, the patient experienced GASTRITIS (Irritated stomach lining). On 27-May-2021, the patient experienced OFF LABEL USE (Passed 77 days after the first dose). On an unknown date, the patient experienced ILLNESS (Sickness). The patient was treated with BUDESONIDE for Intestinal cramps, at a dose of 3 mg three times a day; BUDESONIDE for Intestinal cramps, at a dose of 3 mg twice a day; BUDESONIDE for Intestinal cramps, at a dose of 3 mg once a day; HYOSCYAMINE SULFATE for Intestinal cramps, at a dose of 0.125 mg and RIFAXIMIN at a dose of 550 mg. On 27-May-2021, OFF LABEL USE (Passed 77 days after the first dose) had resolved. At the time of the report, GASTROINTESTINAL PAIN (Severe and constant cramps in small intestine/pain was more intense/same amount of pain) and HEADACHE (Headache) had not resolved and GASTROINTESTINAL INFLAMMATION (Inflammation in the small intestine), GASTRITIS (Irritated stomach lining), WEIGHT DECREASED (Lost 14 pounds) and ILLNESS (Sickness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Blood test: inconclusive (Inconclusive) Inconclusive. In March 2021, Computerised tomogram: inconclusive (Inconclusive) Inflammation in the small intestine. In March 2021, Magnetic resonance imaging: normal (normal) MRI was clear. In April 2021, Endoscopy: abnormal (abnormal) Very irritated stomach lining.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Treatment mediation included antispasmodic drugs for gastrointestinal pain and antibiotic which was stopped later.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow-up received on 16-JUN-2021 contains significant information: Added patient demographics, concomitant medications, treatment medications and new events and updated laboratory results of MRI , Endoscopy and event outcome from unknown to not recovered for gastrointestinal pain and headache.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested. 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.