Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Ventricular extrasystoles, Vertigo
Clinical narrative: Large colon had inflammation; PVC - Premature Ventricular Contractions; Body aches; Chills; Fever; Almost passed out; Dizzy with turning; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (Almost passed out), VERTIGO (Dizzy with turning), COLITIS (Large colon had inflammation), VENTRICULAR EXTRASYSTOLES (PVC - Premature Ventricular Contractions) and MYALGIA (Body aches) in a 40-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.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PRESYNCOPE (Almost passed out), VERTIGO (Dizzy with turning), MYALGIA (Body aches), CHILLS (Chills) and PYREXIA (Fever). In July 2021, the patient experienced VENTRICULAR EXTRASYSTOLES (PVC - Premature Ventricular Contractions). On 21-Oct-2021, the patient experienced COLITIS (Large colon had inflammation). At the time of the report, PRESYNCOPE (Almost passed out), VERTIGO (Dizzy with turning), COLITIS (Large colon had inflammation), VENTRICULAR EXTRASYSTOLES (PVC - Premature Ventricular Contractions), MYALGIA (Body aches), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Oct-2021, Colonoscopy: abnormal (abnormal) Her large colon had inflammation..         Concomitant product use was not provided by the reporter.   Treatment medications included Gatorade and water.  The patient received her first Moderna vaccine at the end of January 2021 and had a strong reaction on the same day. She felt a little lightheaded the same day of her shot. Patient also received 2nd shot the end of February 2021 and experienced chills, body aches, fever, and almost passed out.  She drank Gatorade and water to help with the symptoms. She was also dizzy with turning. The end of May 2021 her bowel patterns also changed and on 21OCT2021 she had a colonoscopy. Her large colon had inflammation. Patient also reported that she had heart palpitations in July 2021 and was diagnosed with PVC - Premature Ventricular Contractions. She further stated that the palpitations had subsided.  Company comment: This case concerns a 40-year-old female patient with no medical history provided who experienced non-serious unexpected events of Presyncope, Vertigo, Colitis, Ventricular extrasystoles and non-serious expected events of Myalgia, Chills and Pyrexia. The precise temporal relationship for the events Presyncope, Vertigo, Myalgia, Chills and Pyrexia cannot be determined, having in mind that the exact start date of the reported events was not provided. The event Ventricular extrasystole occurred approximately five months after the second dose of mRNA-1273 whereas the event Colitis occurred approximately eight months after the second dose of the vaccine. The outcome of the events was unknown at the time of the report and no information regarding the clinical course of the events was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 40-year-old female patient with no medical history provided who experienced non-serious unexpected events of Presyncope, Vertigo, Colitis, Ventricular extrasystoles and non-serious expected events of Myalgia, Chills and Pyrexia. The precise temporal relationship for the events Presyncope, Vertigo, Myalgia, Chills and Pyrexia cannot be determined, having in mind that the exact start date of the reported events was not provided. The event Ventricular extrasystole occurred approximately five months after the second dose of mRNA-1273 whereas the event Colitis occurred approximately eight months after the second dose of the vaccine. The outcome of the events was unknown at the time of the report and no information regarding the clinical course of the events was provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.