Reporte zur Charge 015U20A

Symptomtext

Nerve problems in her feet and lower leg; Ended up with no memory of what happened; Extreme pain; Didn't feel good after the shot; Couldn't walk for 3 days; Passed out on the floor for 2 day/Woke up in the middle of her tile floor; Hiatal hernia; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out on the floor for 2 day/Woke up in the middle of her tile floor), NEUROPATHY PERIPHERAL (Nerve problems in her feet and lower leg), MEMORY IMPAIRMENT (Ended up with no memory of what happened), GAIT DISTURBANCE (Couldn't walk for 3 days), PAIN (Extreme pain) and MALAISE (Didn't feel good after the shot) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 015U20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Myocarditis (When younger she had a inflammation of the heart lining.) and Heart failure (It was in her 40s. Doctor sent her to the hospital.). Concurrent medical conditions included Blood pressure high (It was in her 40s. Doctor sent her to the hospital.). On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-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 LOSS OF CONSCIOUSNESS (Passed out on the floor for 2 day/Woke up in the middle of her tile floor) (seriousness criteria hospitalization and medically significant), NEUROPATHY PERIPHERAL (Nerve problems in her feet and lower leg) (seriousness criterion hospitalization), MEMORY IMPAIRMENT (Ended up with no memory of what happened) (seriousness criterion hospitalization), GAIT DISTURBANCE (Couldn't walk for 3 days) (seriousness criterion hospitalization), PAIN (Extreme pain) (seriousness criterion hospitalization), MALAISE (Didn't feel good after the shot) (seriousness criterion hospitalization) and HIATUS HERNIA (Hiatal hernia). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out on the floor for 2 day/Woke up in the middle of her tile floor), MEMORY IMPAIRMENT (Ended up with no memory of what happened), PAIN (Extreme pain), MALAISE (Didn't feel good after the shot) and HIATUS HERNIA (Hiatal hernia) outcome was unknown, NEUROPATHY PERIPHERAL (Nerve problems in her feet and lower leg) had not resolved and GAIT DISTURBANCE (Couldn't walk for 3 days) had resolved. No concomitant drug information provided. Patient reported that in Dec-2021 she is having a hiatal hernia surgery, from the stomach to the esophagus, a large one. Doctor was going to use a robot to go in and give her that surgery, said it could take up to 3 days in the hospital, and she has no one to help her in her house. The patient passed out for 2 days. Patient states they didn't have a diagnose, they observed her. She was run up in the hospital for about 2 weeks, 3 or 4 days after that episode where she passed out, and then at a care place for about a week. Caller stated she would have been dead if her son hadn't called the neighbor, and she called the ambulance and got her to the hospital. Doctors were kind of in denial that it could have been the shot, she states she was fine until after she had the shot. Doctors treated her giving her extra fluids. She was run up in the hospital for about 2 weeks. Company Comment - This spontaneous case concerns a 77-year-old female patient with relevant medical history of heart failure and myocarditis, and concurrent condition of hypertension, who experienced serious unexpected events of loss of consciousness, malaise, memory impairment, pain, peripheral neuropathy and gait disturbance. The events occurred unspecified time after the second dose of the Moderna COVID-19 vaccine . Patient's medical history and comorbidities are possible confounders. Rechallenge was not applicable since the event occurred after the second dose so, no rechallenge was done and recurrence was not applicable. The benefit-risk relationship of drug is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow up received includes no new information.; Sender's Comments: This spontaneous case concerns a 77-year-old female patient with relevant medical history of heart failure and myocarditis, and concurrent condition of hypertension, who experienced serious unexpected events of loss of consciousness, malaise, memory impairment, pain, peripheral neuropathy and gait disturbance. The events occurred unspecified time after the second dose of the Moderna COVID-19 vaccine . Patient's medical history and comorbidities are possible confounders. Rechallenge was not applicable since the event occurred after the second dose so, no rechallenge was done and recurrence was not applicable. The benefit-risk relationship of drug is not affected by this report.