Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrointestinal disorder, Pyrexia, Vaccination site pain
Clinical narrative: Intestinal issues/Real bad stomach cramping/Severe diarrhea/Vomiting; low grade fever; pain in the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of GASTROINTESTINAL DISORDER (Intestinal issues/Real bad stomach cramping/Severe diarrhea/Vomiting) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A, 038A21A, 032F21A and 0542AA2) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2020 and COVID-19 in October 2020. Concurrent medical conditions included Gluten sensitivity, Drug allergy (All pain medications), Allergy (preservatives in medications), Celiac disease, Thyroid disorder NOS, Acid reflux (esophageal) and Blood pressure high.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GASTROINTESTINAL DISORDER (Intestinal issues/Real bad stomach cramping/Severe diarrhea/Vomiting) (seriousness criterion medically significant), PYREXIA (low grade fever) and VACCINATION SITE PAIN (pain in the injection site). At the time of the report, GASTROINTESTINAL DISORDER (Intestinal issues/Real bad stomach cramping/Severe diarrhea/Vomiting), PYREXIA (low grade fever) and VACCINATION SITE PAIN (pain in the injection site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient height was reported as 5.3. No vaccines were given within 1 month prior to Moderna COVID-19 vaccine. Concomitant product included Thyroid medication, Acid reflux medication and Blood pressure medication.  Patient experienced the symptoms with every vaccine. The symptoms went for hours and hours. Patient experienced a similar event in the past when contaminated with gluten. The AE did not cause patient to seek medical care.  No treatment information was provided by the reporter.  Company Comment:  This is a spontaneous case, reported, concerning a 62-year-old female patient with relevant medical condition of Gluten sensitivity, Celiac disease and Gastroesophageal reflux disease, who experienced the unexpected serious (medically significant) event of Gastrointestinal disorder, reported as intestinal issues, in the context of the four doses of mRNA-1273 vaccine. Latency cannot be properly assessed since the event onset date was not provided. Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 34 days which falls within the recommended vaccine dosing schedule, approximately 6 months and 1 week prior to third mRNA-1273 vaccination, and approximately 13 months prior to fourth mRNA-1273 vaccination. Patient also had low grade fever, pain at the injection site, and associated stomach cramps, severe diarrhea and vomiting. It was reported that the patient experienced the symptoms with every vaccine which persisted for hours and experienced similar events in the past when eaten a food contaminated with gluten. No further details about the clinical course, diagnostic procedures and treatments were provided. It was reported that the events have resolved. The medical condition of Gluten sensitivity, Celiac disease and Gastroesophageal reflux disease remain as confounders for the event Gastrointestinal disorder. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-656991 (Patient Link).; Sender's Comments: This is a spontaneous case, reported, concerning a 62-year-old female patient with relevant medical condition of Gluten sensitivity, Celiac disease and Gastroesophageal reflux disease, who experienced the unexpected serious (medically significant) event of Gastrointestinal disorder, reported as intestinal issues, in the context of the four doses of mRNA-1273 vaccine. Latency cannot be properly assessed since the event onset date was not provided. Patient had received 2-dose primary series of mRNA-1273 vaccine given at an interval of 34 days which falls within the recommended vaccine dosing schedule, approximately 6 months and 1 week prior to third mRNA-1273 vaccination, and approximately 13 months prior to fourth mRNA-1273 vaccination. Patient also had low grade fever, pain at the injection site, and associated stomach cramps, severe diarrhea and vomiting. It was reported that the patient experienced the symptoms with every vaccine which persisted for hours and experienced similar events in the past when eaten a food contaminated with gluten. No further details about the clinical course, diagnostic procedures and treatments were provided. It was reported that the events have resolved. The medical condition of Gluten sensitivity, Celiac disease and Gastroesophageal reflux disease  remain as confounders for the event Gastrointestinal disorder. The benefit-risk relationship of mRNA-1273 is not affected by this report.