Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Musculoskeletal stiffness, Presyncope, Seizure
Clinical narrative: thinks it was a potential seizure; vasovagal effect from the needle; Patient fell off the bench onto the floor and became rigid and stiff and exhibited some rigid movement; Patient fell off the bench onto the floor and became rigid and stiff and exhibited some rigid movement; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of SEIZURE (thinks it was a potential seizure) and PRESYNCOPE (vasovagal effect from the needle) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, the patient experienced SEIZURE (thinks it was a potential seizure) (seriousness criterion medically significant), PRESYNCOPE (vasovagal effect from the needle) (seriousness criterion medically significant), MUSCULOSKELETAL STIFFNESS (Patient fell off the bench onto the floor and became rigid and stiff and exhibited some rigid movement) and FALL (Patient fell off the bench onto the floor and became rigid and stiff and exhibited some rigid movement). At the time of the report, SEIZURE (thinks it was a potential seizure), PRESYNCOPE (vasovagal effect from the needle), MUSCULOSKELETAL STIFFNESS (Patient fell off the bench onto the floor and became rigid and stiff and exhibited some rigid movement) and FALL (Patient fell off the bench onto the floor and became rigid and stiff and exhibited some rigid movement) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications taken by the patient were not provided.  The reporter reported that patient never had any allergic reactions to vaccines or medications before and had no past medical histories for vasovagal reactions. After receiving the vaccine, the patient waited in the pharmacy for 15 minutes - 20 minutes. The patient fell off the bench onto the floor and became rigid and stiff and exhibited some rigid movement. The patient was out of it for 15-30 seconds. The reporter stated that she called 911. The patient came to, his eyes were huge, but he was aware to self and surroundings. The emergency team came, took the patient's vitals which were stable and stated the patient likely experienced a vasovagal effect from the needle. However, the reporter thinks it was a potential seizure; more than a vasovagal response. Emergency team offered no treatment. The emergency team had encouraged the patient to follow up with a doctor but the patient did not want to make a big scene.  Emergency team offered no treatment for the patient.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.