Reporte zur Charge 004M20A/004M204

Symptomtext

the pain level it was a 6 and now it's up to 9; Everything is sore; The arm was sore but that it's hard to tell as everything is sore; A spontaneous report was received from a consumer concerning, a 66 years old, male patient, who received MODERNA'S COVID-19 vaccine (mRNA-1273) and experienced the arm was sore but that it's hard to tell as everything is sore/pain in extremity and everything is sore/myalgia, and the pain level it was a 6 and now it's up to 9/condition aggravated. The patient's medical history was provided as rare autoimmune disease and extreme pain. Concomitant medications reported were prednisone, naproxen, paracetamol, oxycodone for drug use for unknown indication. On 09 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number:004M20A/004M204) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced the arm was sore but that it's hard to tell as everything is sore, the pain level it was a 6 and now it's up to 9. The patient stopped taking the medication in order to receive the vaccine to avoid the diminishing of the efficacy and wanted to know when can start taking the prednisone again. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, the arm was sore but that it's hard to tell as everything is sore/pain in extremity and everything is sore/myalgia, and the pain level it was a 6 and now it's up to 9, were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event (Vaccination site pain and myalgia) a causal relationship cannot be excluded. Very limited information regarding the event (condition aggravated) has been provided at this time. Noting underlying autoimmune disease may remain as risk factor. Further information has been requested.