Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Gastrointestinal disorder, Paralysis
Clinical narrative: Having episodes of the full body paralysis; Several episodes of weakness for 6 months along with gastrointestinal problems; This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (Having episodes of the full body paralysis) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Paralysis periodic (It was reported that the patient had lived with PPP (primary periodic paralysis) for 15 years and had very few episodes.).   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced PARALYSIS (Having episodes of the full body paralysis) (seriousness criteria hospitalization and medically significant) and GASTROINTESTINAL DISORDER (Several episodes of weakness for 6 months along with gastrointestinal problems). The patient was treated with GLUCOSE (GLUCOSE INTRAVENOUS) (intravenous) at an unspecified dose and frequency. In October 2021, PARALYSIS (Having episodes of the full body paralysis) and GASTROINTESTINAL DISORDER (Several episodes of weakness for 6 months along with gastrointestinal problems) had resolved.            No concomitant medication were reported.   It was reported that once the COVID left his body, he didn't had any issues for 5 months. Related to 12-MAY-2022 he had a very few episodes of PPP (primary periodic paralysis). After the second dose of vaccination patient had full body paralysis. He went to the ER (emergency room) several times to get glucose by IV (intravenous). He then started about an 80-day period that he had the paralysis every day. He was hospitalized twice for the paralysis; the rest were ER visits. They put a PICC (peripherally inserted central catheter) line in so he could give the glucose by himself.  Company comment: This is a spontaneous case concerning a 56-year-old male patient with medical history of Primary periodic paralysis for 15 years, who experienced the serious unexpected event paralysis. Patient had several episodes of paralysis for 6 months after the second dose of mRNA-1273, along with gastrointestinal disorders, that lead to hospitalizations twice and visits to ER for treatment with glucose intravenous. A peripherally inserted central catheter (PICC) was inserted to receive treatment with glucose by himself.  Patient´s medical condition and concomitant gastrointestinal disorder remains as confounder and contributor factor for paralysis episodes. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: Company comment: This is a spontaneous case concerning a 56-year-old male patient with medical history of Primary periodic paralysis for 15 years, who experienced the serious unexpected event paralysis. Patient had several episodes of paralysis for 6 months after the second dose of mRNA-1273, along with gastrointestinal disorders, that lead to hospitalizations twice and visits to ER for treatment with glucose intravenous. A peripherally inserted central catheter (PICC) was inserted to receive treatment with glucose by himself.  Patient´s medical condition and concomitant gastrointestinal disorder remains as confounder and contributor factor for paralysis episodes. The benefit-risk relationship of mRNA-1273 is not affected by this report.