Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: Cough; extreme diarrhea; I'm experiencing Covid-19 symptoms; Chills; Nausea; Headache; This spontaneous case was reported by an other health care professional and describes the occurrence of COUGH (Cough), DIARRHOEA (extreme diarrhea), SUSPECTED COVID-19 (I'm experiencing Covid-19 symptoms), CHILLS (Chills) and NAUSEA (Nausea) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034J21A, 044B21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Wheelchair user (Immobile- uses wheelchair) and Immobile.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022, the patient experienced COUGH (Cough), DIARRHOEA (extreme diarrhea), SUSPECTED COVID-19 (I'm experiencing Covid-19 symptoms), CHILLS (Chills), NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, COUGH (Cough), NAUSEA (Nausea) and HEADACHE (Headache) had not resolved, DIARRHOEA (extreme diarrhea) had resolved and SUSPECTED COVID-19 (I'm experiencing Covid-19 symptoms) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Patient received booster dose on 02-Feb-2022. It was reported that the patient was never diagnosed or tested positive for COVID -19.  Patient took anti-diarrhea pills and that stopped the diarrhea. No, AE cause patient to seek medical care.  Company Comments: This spontaneous case concerns a patient of an unknown age and gender, wheelchair borne, with no reported medical history, who experienced the unexpected non-serious AESI of Suspected COVID-19 that occurred 3 months and 15 days after receiving the booster dose of mRNA-1273 vaccine. The event was reported along with the non- serious events of cough, diarrhoea, chills, nausea, and headache. Clinical course and treatment details were not reported. No laboratory test reported. Booster dose was administered approximately 10 months after the 2nd dose mRNA-1273 vaccine, which is not in accordance with the recommended vaccine interval (Inappropriate schedule of product administration noted). The benefit-risk relationship of mRNA-1273 is not affected by this report. Event was assessed non-serious based on medical judgement and available information.; Sender's Comments: This spontaneous case concerns a patient of an unknown age and gender, wheelchair borne, with no reported medical history, who experienced the unexpected non-serious AESI of Suspected COVID-19 that occurred 3 months and 15 days after receiving the booster dose of mRNA-1273 vaccine. The event was reported along with the non- serious events of cough, diarrhoea, chills, nausea, and headache. Clinical course and treatment details were not reported. No laboratory test reported. Booster dose was administered approximately 10 months after the 2nd dose mRNA-1273 vaccine, which is not in accordance with the recommended vaccine interval (Inappropriate schedule of product administration noted). The benefit-risk relationship of mRNA-1273 is not affected by this report. Event was assessed non-serious based on medical judgement and available information.