Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: severe diarrhea; Two urinary track infections; severe vomiting; Second dose was given more than 36 days apart from first dose; Minerals were very low; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (severe diarrhea), URINARY TRACT INFECTION (Two urinary track infections), MINERAL DEFICIENCY (Minerals were very low) and VOMITING (severe vomiting) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced DIARRHOEA (severe diarrhea) (seriousness criterion hospitalization), URINARY TRACT INFECTION (Two urinary track infections) (seriousness criterion hospitalization), MINERAL DEFICIENCY (Minerals were very low) (seriousness criterion hospitalization) and VOMITING (severe vomiting) (seriousness criterion hospitalization). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose was given more than 36 days apart from first dose). The patient was hospitalized on 19-Mar-2021 due to DIARRHOEA, URINARY TRACT INFECTION and VOMITING. The patient was treated with Rehabilitation therapy for Diarrhoea; Rehabilitation therapy for Urinary tract infection; Rehabilitation therapy for Mineral deficiency and Rehabilitation therapy for Vomiting. At the time of the report, DIARRHOEA (severe diarrhea), URINARY TRACT INFECTION (Two urinary track infections), MINERAL DEFICIENCY (Minerals were very low), VOMITING (severe vomiting) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose was given more than 36 days apart from first dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Blood electrolytes: severely (Low) severely.         Patient called in to report an adverse event on behalf of her mother. Mother received the Moderna COVID 19 vaccine 2 dose series on 6 February and 18 March (left arm). On March 19 patient suffered from severe vomiting and diarrhea which led her to have 2 different urinary tract infections. Additionally, her minerals and electrolytes were very low. Patient was hospitalized as a result of this on March 19th. She was currently in rehabilitation. Patient has gone through IV antibiotics, oral antibiotics, and IV electrolyte supplements.  Treatment medications included: IV antibiotics, oral antibiotics, and IV electrolyte supplements.  Based on the current available information and temporal association between the use of the product and the start date of the event, 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 event, a causal relationship cannot be excluded.