Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Irritable bowel syndrome, Myalgia, Nausea, Neuralgia
Clinical narrative: IBS; My hands dont feel normal yet; Stomach spasms; I eventually went to the ER where they just stated it was a pinched nerve/I was crying in pain almost daily from the nerve pain; Brain fog; Intense burning pain in my torso/I felt like my hands and arms and chest and back were on fire; Myalgia; Arthralgia; My body felt exhausted; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of IRRITABLE BOWEL SYNDROME (IBS) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Chronic sinusitis, Chronic rhinitis, Irritable bowel syndrome, Contact dermatitis and Skin sensitisation (skin sensitivities).   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IRRITABLE BOWEL SYNDROME (IBS) (seriousness criterion medically significant), FEELING ABNORMAL (My hands dont feel normal yet), ABDOMINAL DISCOMFORT (Stomach spasms), NEURALGIA (I eventually went to the ER where they just stated it was a pinched nerve/I was crying in pain almost daily from the nerve pain), FEELING ABNORMAL (Brain fog), BURNING SENSATION (Intense burning pain in my torso/I felt like my hands and arms and chest and back were on fire), MYALGIA (Myalgia), ARTHRALGIA (Arthralgia), FATIGUE (My body felt exhausted) and NAUSEA (Nausea). The patient was treated with DICYCLOVERINE HYDROCHLORIDE (BENTYL) for Stomach pain, at an unspecified dose and frequency; DIMENHYDRINATE (DRAMAMINE) for Nausea, at an unspecified dose and frequency and GABAPENTIN for Pain, at an unspecified dose and frequency. At the time of the report, IRRITABLE BOWEL SYNDROME (IBS), FEELING ABNORMAL (My hands dont feel normal yet), ABDOMINAL DISCOMFORT (Stomach spasms), NEURALGIA (I eventually went to the ER where they just stated it was a pinched nerve/I was crying in pain almost daily from the nerve pain), FEELING ABNORMAL (Brain fog), BURNING SENSATION (Intense burning pain in my torso/I felt like my hands and arms and chest and back were on fire), MYALGIA (Myalgia), ARTHRALGIA (Arthralgia), FATIGUE (My body felt exhausted) and NAUSEA (Nausea) outcome was unknown.            Concomitant medications was not reported.  Company Comment: This case concerns a 35-year-old, female patient with medical history of Irritable Bowel Syndrome, who experienced the unexpected event of Irritable Bowel Syndrome. The event occurred at an unknown date. The events were considered related to the product per the reporter's assessment. The medical history of Irritable Bowel Syndrome remains a confounder. The events are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 35-year-old, female patient with medical history of Irritable Bowel Syndrome, who experienced the unexpected event of Irritable Bowel Syndrome. The event occurred at an unknown date. The events were considered related to the product per the reporter's assessment. The medical history of Irritable Bowel Syndrome remains a confounder. The events are consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.