Sex: F
Vaccine: COVID19
Symptoms: Immune-mediated adverse reaction, Infection, Intentional product use issue, Myalgia, Pain
Clinical narrative: arm is still really bad, had excruciating pain in her bicep muscle in the arm; a couple days ago it started to get worse; put her on antibiotics in caseit was an infection; Doctor advised her that she did not get the second dose she has scheduled on saturday, as if it was a immune reaction; Has passed the window for the second dose; excruciating pain in her bicep muscle in the arm; (injection) it was way up from there,maybe 2 inches from my shoulder; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (arm is still really bad, had excruciating pain in her bicep muscle in the arm), PAIN (a couple days ago it started to get worse), INFECTION (put her on antibiotics in caseit was an infection), IMMUNE-MEDIATED ADVERSE REACTION (Doctor advised her that she did not get the second dose she has scheduled on saturday, as if it was a immune reaction) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE ((injection) it was way up from there,maybe 2 inches from my shoulder) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE ((injection) it was way up from there,maybe 2 inches from my shoulder) and MYALGIA (excruciating pain in her bicep muscle in the arm). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm is still really bad, had excruciating pain in her bicep muscle in the arm), PAIN (a couple days ago it started to get worse), INFECTION (put her on antibiotics in caseit was an infection), IMMUNE-MEDIATED ADVERSE REACTION (Doctor advised her that she did not get the second dose she has scheduled on saturday, as if it was a immune reaction) and INTENTIONAL PRODUCT USE ISSUE (Has passed the window for the second dose). On 20-Feb-2021, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE ((injection) it was way up from there,maybe 2 inches from my shoulder) had resolved. At the time of the report, PAIN IN EXTREMITY (arm is still really bad, had excruciating pain in her bicep muscle in the arm), PAIN (a couple days ago it started to get worse), INFECTION (put her on antibiotics in caseit was an infection), IMMUNE-MEDIATED ADVERSE REACTION (Doctor advised her that she did not get the second dose she has scheduled on saturday, as if it was a immune reaction), INTENTIONAL PRODUCT USE ISSUE (Has passed the window for the second dose) and MYALGIA (excruciating pain in her bicep muscle in the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The symptoms (infection) started to get better while on antibiotics. However, on an unspecified date, the infection started to worsen. On an unknown date, the doctor advised to put ice and told the patient not to receive the second dose, as it was an immune reaction and could be worse on the second dose. On an unknown date, the patient scheduled her second dose appointment. She wanted to make sure if it is ok to get her second dose since her appointment is nowoutside the window. Concomitant medications were not provided. Treatment medications included antibiotics and ice.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Event information updated