Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Eructation, Gastric emptying study, Gastric hypomotility, Illness, Impaired gastric emptying
Clinical narrative: Can still feel body tremoring/can still feel episodes trying to occur/Progressed to shaking; Gastroparesis/ Gastric emptying profoundly decreased within 4 hours; Gastric motility issues/dysmotility of the whole digestive system/motility of the stomach is greatly reduced; Constipation; Gets sicker; Lost almost 50 pounds; Can't eat or swallowdue to dysmotility of the whole digestive system; Deep belches/episodes where body starts belching; Hard to breath; Hard to speak; This spontaneous case was reported by an other health care professional and describes the occurrence of IMPAIRED GASTRIC EMPTYING (Gastroparesis/ Gastric emptying profoundly decreased within 4 hours), GASTRIC HYPOMOTILITY (Gastric motility issues/dysmotility of the whole digestive system/motility of the stomach is greatly reduced), CONSTIPATION (Constipation), ILLNESS (Gets sicker), ABNORMAL LOSS OF WEIGHT (Lost almost 50 pounds), DYSPHAGIA (Can't eat or swallowdue to dysmotility of the whole digestive system), ERUCTATION (Deep belches/episodes where body starts belching), DYSPNOEA (Hard to breath), SPEECH DISORDER (Hard to speak) and TREMOR (Can still feel body tremoring/can still feel episodes trying to occur/Progressed to shaking) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Gastroparesis (Gastroparesis "on and off") and Hypertension.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced IMPAIRED GASTRIC EMPTYING (Gastroparesis/ Gastric emptying profoundly decreased within 4 hours) (seriousness criteria hospitalization and medically significant), GASTRIC HYPOMOTILITY (Gastric motility issues/dysmotility of the whole digestive system/motility of the stomach is greatly reduced) (seriousness criterion hospitalization), CONSTIPATION (Constipation) (seriousness criterion hospitalization), ILLNESS (Gets sicker) (seriousness criterion hospitalization), ABNORMAL LOSS OF WEIGHT (Lost almost 50 pounds) (seriousness criterion hospitalization), DYSPHAGIA (Can't eat or swallowdue to dysmotility of the whole digestive system) (seriousness criterion hospitalization), ERUCTATION (Deep belches/episodes where body starts belching) (seriousness criterion hospitalization), DYSPNOEA (Hard to breath) (seriousness criterion hospitalization) and SPEECH DISORDER (Hard to speak) (seriousness criterion hospitalization). On 26-Jul-2021, the patient experienced TREMOR (Can still feel body tremoring/can still feel episodes trying to occur/Progressed to shaking) (seriousness criterion hospitalization). The patient was treated with LORAZEPAM (ATIVAN) on 04-May-2021 for Adverse event, at a dose of UNK, qid and OLANZAPINE on 04-May-2021 for Adverse event, at a dose of UNK. At the time of the report, IMPAIRED GASTRIC EMPTYING (Gastroparesis/ Gastric emptying profoundly decreased within 4 hours), CONSTIPATION (Constipation), ILLNESS (Gets sicker), ABNORMAL LOSS OF WEIGHT (Lost almost 50 pounds), DYSPHAGIA (Can't eat or swallowdue to dysmotility of the whole digestive system), ERUCTATION (Deep belches/episodes where body starts belching), DYSPNOEA (Hard to breath) and SPEECH DISORDER (Hard to speak) outcome was unknown and GASTRIC HYPOMOTILITY (Gastric motility issues/dysmotility of the whole digestive system/motility of the stomach is greatly reduced) and TREMOR (Can still feel body tremoring/can still feel episodes trying to occur/Progressed to shaking) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-May-2021, Gastric emptying study: decreased (Low) Profoundly decreased within 4 hours. On 04-May-2021, Weight: decreased (abnormal) lost almost 50 pounds. On an unknown date, Biopsy: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter stated that, she believed that there is something wrong with the patient's autonomic nervous system.  Concomitant medications included blood pressure medications. Other lab tests included MRI and EEG. But the results were not available. Other treatment provided included medications to increase motility.  Company Comment :Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.