Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Hypoaesthesia, Movement disorder, Muscle tightness, Pain
Clinical narrative: extreme pain in legs, hamstrings, shoulders, and hands/ severe pain in both hands; Tightness in hamstrings and buttocks has gotten worse and has spread to the shoulders; couldnt move and muscles totally froze; numbness in various parts of my body/ both hands are numb/ cannot make a fist; both hands are burning; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-May-2021 and was forwarded to Moderna on 24-May-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MUSCLE TIGHTNESS (Tightness in hamstrings and buttocks has gotten worse and has spread to the shoulders), MOVEMENT DISORDER (couldnt move and muscles totally froze) and PAIN (extreme pain in legs, hamstrings, shoulders, and hands/ severe pain in both hands) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03B21A and 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Mar-2021 at 11:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021 at 11:20 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MOVEMENT DISORDER (couldnt move and muscles totally froze) (seriousness criterion hospitalization). On 04-Apr-2021, the patient experienced MUSCLE TIGHTNESS (Tightness in hamstrings and buttocks has gotten worse and has spread to the shoulders) (seriousness criterion hospitalization). On 06-May-2021, the patient experienced PAIN (extreme pain in legs, hamstrings, shoulders, and hands/ severe pain in both hands) (seriousness criterion hospitalization). On 24-May-2021, the patient experienced HYPOAESTHESIA (numbness in various parts of my body/ both hands are numb/ cannot make a fist). 24-May-2021, the patient experienced BURNING SENSATION (both hands are burning). The patient was hospitalized from 06-May-2021 to 09-May-2021 due to MOVEMENT DISORDER, MUSCLE TIGHTNESS and PAIN. The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form; IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date at a dose of 1 dosage form; PREDNISONE for Pain, at a dose of 1 dosage form; GABAPENTIN on 26-May-2021 for Hand pain, at a dose of 1 dosage form and MELOXICAM on 26-May-2021 for Hand pain, at a dose of 1 dosage form. At the time of the report, MUSCLE TIGHTNESS (Tightness in hamstrings and buttocks has gotten worse and has spread to the shoulders) and MOVEMENT DISORDER (couldnt move and muscles totally froze) outcome was unknown and PAIN (extreme pain in legs, hamstrings, shoulders, and hands/ severe pain in both hands), HYPOAESTHESIA (numbness in various parts of my body/ both hands are numb/ cannot make a fist) and BURNING SENSATION (both hands are burning) had not resolved.            No concomitant medications were reported.  On04APR2021 the patient went to the ER due to muscle tightness and received a steroid shot.   On06MAY2021 the patient went to the ER due to extreme pain and was admitted. The patient underwent an X-ray, MRI, and blood work (the results of which were not provided). The patient was "hooked up to IV steroids for three days." The patient was discharged to home with a prescription for prednisone.   On 24MAY2021 the patient went to his HCP due to severe pain in both hands. He was given a steroid shot.   On 26MAY2021 the patient went to his neurologist due to severe pain in both hands. He was prescribed gabapentin and meloxicam.  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.   This case was linked to MOD-2021-197351 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Lot number and expiration date of vaccine provided On 01-Jun-2021: Completed ADR Form includes patient demographic details, lab data, vaccine details, vaccine facility information and treatment medication.; 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.