Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Burning sensation, Diarrhoea, Fatigue, Movement disorder
Clinical narrative: Burning sensation in shins of her legs; Diarrhea; Pain in all bones/severe long bone pain in legs; Patient could not move anything; Nausea; Tired; Sore arm/aching arms; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Sore arm/aching arms), BURNING SENSATION (Burning sensation in shins of her legs), DIARRHOEA (Diarrhea), BONE PAIN (Pain in all bones/severe long bone pain in legs) and MOVEMENT DISORDER (Patient could not move anything) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Osteoarthritis, Diverticulitis and Blood pressure high. Concomitant products included AMLODIPINE BESILATE (NORVASC) for Blood pressure management, AMLODIPINE for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm/aching arms). On 25-Mar-2021, the patient experienced BURNING SENSATION (Burning sensation in shins of her legs), DIARRHOEA (Diarrhea), BONE PAIN (Pain in all bones/severe long bone pain in legs), MOVEMENT DISORDER (Patient could not move anything), NAUSEA (Nausea) and FATIGUE (Tired). On 25-Mar-2021, PAIN IN EXTREMITY (Sore arm/aching arms), BURNING SENSATION (Burning sensation in shins of her legs), DIARRHOEA (Diarrhea), BONE PAIN (Pain in all bones/severe long bone pain in legs), MOVEMENT DISORDER (Patient could not move anything), NAUSEA (Nausea) and FATIGUE (Tired) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered BURNING SENSATION (Burning sensation in shins of her legs), DIARRHOEA (Diarrhea), BONE PAIN (Pain in all bones/severe long bone pain in legs), MOVEMENT DISORDER (Patient could not move anything) and NAUSEA (Nausea) to be possibly related. No further causality assessments were provided for PAIN IN EXTREMITY (Sore arm/aching arms) and FATIGUE (Tired).    The reporter was a Nurse who said they had arthritis. The patient post receiving their second dose of vaccine had a sore arm and the patient was not able to lift their arm until the next day. On 25-Mar-2021, the patient woke at 1 am with burning in shins of their legs and experienced pain in all bones, nausea, and diarrhea. All these symptoms resolved by 11 am on the same day. The patient was just tired for the rest of the day.  On 11-May-2021, the patient described the events and informed that the pain began 12 hours post shot and experienced excruciating pain in the long bones of the legs, left leg on the shin area where the patient was injured years ago felt like a burning sensation and someone was peeling their skin off with a razor blade The patient also reported that they could barely turn over in bed because both of their arms were so sore and experienced nausea and diarrhea.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow-up was received on 11-May-2021. Updated the reporter details. Added concomitant medication. On 11-May-2021: Follow-up was received on 11-May-2021. Added and updated Patients demographics. Added patient's relevant medical history. Added  concomitant medication. Updated the case narrative/ event description. narrative information updated. Updated the reporter causality for the events Burning sensation in shins of their legs, diarrhea, Pain in all bones/severe long bone pain in legs, nausea and could not move anything.