Age: 78.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Haematochezia, Loss of consciousness, Pain in extremity, Urinary incontinence
Clinical narrative: Bloody stool; Rib contusion/Bruised ribs; Fell; Constipated; Blood pressure abnormal/ Blood pressure issues; Passed out; Absent bowel movement/ Lost bowels; Urinary tract disorder/ Urined on self; Cerebral disorder/Not in control of mind, Disorientated; Foot hurt; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out), CONSTIPATION (Absent bowel movement/ Lost bowels), URINARY INCONTINENCE (Urinary tract disorder/ Urined on self), CEREBRAL DISORDER (Cerebral disorder/Not in control of mind, Disorientated), PAIN IN EXTREMITY (Foot hurt) and HAEMATOCHEZIA (Bloody stool) in a 78-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.   Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis.  No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, Citrate free. On 11-Jul-2022, the patient experienced BONE CONTUSION (Rib contusion/Bruised ribs) and FALL (Fell). On 14-Jul-2022, the patient experienced HAEMATOCHEZIA (Bloody stool) (seriousness criterion medically significant). In July 2022, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), CONSTIPATION (Absent bowel movement/ Lost bowels) (seriousness criterion medically significant), URINARY INCONTINENCE (Urinary tract disorder/ Urined on self) (seriousness criterion medically significant), CEREBRAL DISORDER (Cerebral disorder/Not in control of mind, Disorientated) (seriousness criterion medically significant), PAIN IN EXTREMITY (Foot hurt) (seriousness criterion medically significant), CONSTIPATION (Constipated) and BLOOD PRESSURE ABNORMAL (Blood pressure abnormal/ Blood pressure issues). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), CONSTIPATION (Absent bowel movement/ Lost bowels), URINARY INCONTINENCE (Urinary tract disorder/ Urined on self), CEREBRAL DISORDER (Cerebral disorder/Not in control of mind, Disorientated) and PAIN IN EXTREMITY (Foot hurt) had resolved, HAEMATOCHEZIA (Bloody stool), CONSTIPATION (Constipated) and BLOOD PRESSURE ABNORMAL (Blood pressure abnormal/ Blood pressure issues) had not resolved, BONE CONTUSION (Rib contusion/Bruised ribs) was resolving and FALL (Fell) outcome was unknown.    No concomitant and treatment medications were provided. On 14-Jul-2022, the patient had blood in stool. She believes it was from being constipated. She had episode with the second covid shot. She woke up in the middle of the night and was not in control of mind and was disorientated. She hurt her foot in the process. She then passed out and lost her bowels and urined on herself. She also had blood pressure issues. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter provided causality for the events of passed out, blood pressure abnormal, absent bowel movement, urinary tract disorder, cerebral disorder, bloody stool, foot pain and disorientated as not related to Humira. The reporter did not provide any causality assessment for the events of rib contusion, constipation and fall with Humira. The reporter provided causality for the events of passed out, absent bowel movement, urinary tract disorder, cerebral disorder, disorientated and foot pain as probably related to Moderna vaccine. The reporter did not provide any causality assessment for the events of rib contusion, blood pressure abnormal, constipation, fall and bloody stool with Moderna vaccine.  Company Comment: This regulatory authority case concerns a 78-years-old female patient, with medical history of Ulcerative colitis, who experienced the unexpected serious (medically significant) events of loss of consciousness, constipation, urinary in continence, cerebral disorder, pain in extremity, hematochezia. Event hematochezia occurred approximately 1 month after second dose of mRNA-1273 vaccine. Additionally non serious event constipation, blood pressure abnormal, fall is also reported. Patient experienced blood in stool, she believes it was from being constipated, after second dose of vaccination patient woke up in the middle of night and not in control of mind and was disoriented, she hurt her foot in the process, she then passed out and lost her bowels and urinated on herself, patient also had blood pressure issues. Medical history of Ulcerative colitis could be confounding for the event constipation. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This regulatory authority case concerns a 78-years-old female patient, with medical history of Ulcerative colitis, who experienced the unexpected serious (medically significant) events of loss of consciousness, constipation, urinary in continence, cerebral disorder, pain in extremity, hematochezia. Event hematochezia occurred approximately 1 month after second dose of mRNA-1273 vaccine. Additionally non serious event constipation, blood pressure abnormal, fall is also reported. Patient experienced blood in stool, she believes it was from being constipated, after second dose of vaccination patient woke up in the middle of night and not in control of mind and was disoriented, she hurt her foot in the process, she then passed out and lost her bowels and urinated on herself, patient also had blood pressure issues. Medical history of Ulcerative colitis could be confounding for the event constipation. The benefit-risk relationship of mRNA-1273 is not affected by this report.