Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inflammatory marker test, Pain, Paralysis, Weight
Clinical narrative: Paralyzed; No appetite; Chemical taste in mouth; Pain in whole body; Loss in energy; Poison ivy; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (Paralyzed) in an adult male 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 products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination and ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    The patient's past medical history included Toe nail removal and Knee operation. Concurrent medical conditions included Rheumatoid arthritis (Moderate to Severe Rheumatoid Arthritis). Concomitant products included METHOTREXATE for an unknown indication.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PARALYSIS (Paralyzed) (seriousness criterion medically significant), DECREASED APPETITE (No appetite), DYSGEUSIA (Chemical taste in mouth), PAIN (Pain in whole body), ASTHENIA (Loss in energy), DERMATITIS CONTACT (Poison ivy) and DIARRHOEA (Diarrhea). At the time of the report, PARALYSIS (Paralyzed) and DERMATITIS CONTACT (Poison ivy) had resolved, DECREASED APPETITE (No appetite) and DYSGEUSIA (Chemical taste in mouth) had not resolved and PAIN (Pain in whole body), ASTHENIA (Loss in energy) and DIARRHOEA (Diarrhea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Inflammatory marker test: Back to normal. On an unknown date, Weight: Gain.         Patient received Pfizer vaccine as booster dose The patient had received shingles vaccine. He had pain in whole body after working construction. The reporter's causality for the event(s) of pain, asthenia ,knee operation, decreased appetite, nail operation, paralysis, dysgeusia and diarrhea with Humira was reported as not provided The reporter's causality for the event dermatitis contact with Humira was reported as no reasonable possibility The reporter's causality for the event(s) of pain, asthenia ,knee operation, decreased appetite, nail operation, paralysis, dysgeusia and diarrhea and dermatitis contact with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was reported as reasonable possibility. No treatment medication was provided.  Company comment- This spontaneous case concerns a male patient of unknown age with relevant medical history of Rheumatoid arthritis, who experienced unexpected, serious (medically significant) event of Paralysis, which occurred at an unknown time with regards to vaccination with a third dose of mRNA-1273. No further information was provided. The outcome of the events was reported as resolved. The relevant medical history of Rheumatoid arthritis can be a confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a male patient of unknown age with relevant medical history of Rheumatoid arthritis, who experienced unexpected, serious (medically significant) event of Paralysis, which occurred at an unknown time with regards to vaccination with a third dose of mRNA-1273. No further information was provided. The outcome of the events was reported as resolved. The relevant medical history of Rheumatoid arthritis can be a confounder for the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.