Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Gait disturbance, Hyperhidrosis, Interchange of vaccine products, Loss of control of legs
Clinical narrative: could no control his bottoms half of his body; could not walk; could not sit up; could not do anything; he got back to bed because he had  slip to the floor; he was sweating real bad; The 1st dose of the vaccine that was administered to the patient was Pfizer; This spontaneous case was reported by a patient family member or friend and describes the occurrence of LOSS OF CONTROL OF LEGS (could no control his bottoms half of his body) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060A22A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient had no allergies (medications, food and other products). Patient never had COVID + test or diagnosis.  Previously administered products included for Drug use for unknown indication: Pfizer vaccine (The 1st dose of the vaccine that was administered to the patient was Pfizer with lot number EN6207.) on 23-Mar-2021 and Pfizer vaccine on 14-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer vaccine and Pfizer vaccine. Concurrent medical conditions included Blood pressure high, Diabetes and High cholesterol. Concomitant products included INSULIN for an unknown indication.    On 28-Jun-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jun-2022, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (The 1st dose of the vaccine that was administered to the patient was Pfizer). On 29-Jun-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LOSS OF CONTROL OF LEGS (could no control his bottoms half of his body) (seriousness criterion medically significant), GAIT DISTURBANCE (could not walk), SITTING DISABILITY (could not sit up), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not do anything), FALL (he got back to bed because he had  slip to the floor) and HYPERHIDROSIS (he was sweating real bad). On 28-Jun-2022, INTERCHANGE OF VACCINE PRODUCTS (The 1st dose of the vaccine that was administered to the patient was Pfizer) outcome was unknown. On 29-Jun-2022, LOSS OF CONTROL OF LEGS (could no control his bottoms half of his body), FALL (he got back to bed because he had  slip to the floor) and HYPERHIDROSIS (he was sweating real bad) had resolved. At the time of the report, GAIT DISTURBANCE (could not walk), SITTING DISABILITY (could not sit up) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not do anything) outcome was unknown.            Concomitant medications of the patient included, blood pressure medications, diabetes medications, Cholesterol medications and other 11 different medications. Patient had no medical history related to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. Patient did not received any other vaccines within 1 month prior to Moderna COVID-19 vaccine. The AE did not cause patient to seek medical care. Patient did not experience a similar event in the past.  It was reported that patient slept for a couple of hours and everything was working again. No treatment medications were reported. Company comment: This is a spontaneous case concerns 67-years-old male patient with Concurrent medical conditions included Blood pressure high, Diabetes and High cholesterol, who experienced the unexpected serious (medically significant) Loss of control of legs, which occurred next day after receiving the third dose of mRNA-1273 vaccine. It was reported that patient experienced unexpected non serious events of Gait disturbance, sitting disability, Loss of personal independence in daily activities and Hyperhidrosis which occurred after a fall (he got back to bed because he had slip to the floor). Patient was not hospitalized, and treatment details and concomitant medications was not provided. It was noted that patient received 2 doses with Pfizer vaccine 14 months 14 days prior to current vaccination (interchange of vaccine products). The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2022: Follow up contains significant information, new events added, historical vaccine details updated.; Sender's Comments: This is a spontaneous case concerns 67-years-old male patient with Concurrent medical conditions included Blood pressure high, Diabetes and High cholesterol, who experienced the unexpected serious (medically significant) Loss of control of legs, which occurred next day after receiving the third dose of mRNA-1273 vaccine. It was reported that patient experienced unexpected non serious events of Gait disturbance, sitting disability, Loss of personal independence in daily activities and Hyperhidrosis which occurred after a fall (he got back to bed because he had slip to the floor). Patient was not hospitalized, and treatment details and concomitant medications was not provided. It was noted that patient received 2 doses with Pfizer vaccine 14 months 14 days prior to current vaccination (interchange of vaccine products). The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.