Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (little soreness in the arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the third dose prior to 6 months of receiving the primary dose series of vaccine) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination. The patient's past medical history included Cancer (cancer free at this time) and Heart disorder (Heart condition).Concurrent medical conditions included Depression and Anxiety.On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.On 23-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On 11-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the third dose prior to 6 months of receiving the primary dose series of vaccine). On an unknown date, the patient experienced PAIN IN EXTREMITY (little soreness in the arm). On 11-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the third dose prior to 6 months of receiving the primary dose series of vaccine) had resolved. At the time of the report, PAIN IN EXTREMITY (little soreness in the arm) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PAIN IN EXTREMITY (little soreness in the arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the third dose prior to 6 months of receiving the primary dose series of vaccine) to be possibly related. No concomitant medication reported. The patient did not receive any additional treatments.This is a case of inappropriate schedule of product administration for this 43-year-old, female patient with a medical history of unspecified cancer (currently in remission) and unspecified heart condition, who experienced the unexpected, non-serious event of pain in extremity after administration of the booster dose of the Moderna mRNA-1273. The start date of the event pain in extremity was not provided. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna mRNA-1273 is not affected by this report. Sender's Comments: This is a case of inappropriate schedule of product administration for this 43-year-old, female patient with a medical history of unspecified cancer (currently in remission) and unspecified heart condition, who experienced the unexpected, non-serious event of pain in extremity after administration of the booster dose of the Moderna mRNA-1273. The start date of the event pain in extremity was not provided. The rechallenge was not applicable as no additional dosing will be given. The benefit-risk relationship of the Moderna mRNA-1273 is not affected by this report.