Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Myalgia, Tremor, Vaccination site pain
Clinical narrative: Muscle soreness, very sore arm muscles and inability to lift arm out and away from the body; elbow is a little sore; Injection site soreness; Bursitis left elbow about half the size of a ping pong ball, looks like a blister but doesn't hurt; Pinky is a little numb; Shaking uncontrollably; First dose administered 10-Mar-2021, second dose administered 16-Apr-2021; Headache; Chills; This spontaneous case was reported by a patient and describes the occurrence of BURSITIS (Bursitis left elbow about half the size of a ping pong ball, looks like a blister but doesn't hurt), HYPOAESTHESIA (Pinky is a little numb), TREMOR (Shaking uncontrollably), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered 10-Mar-2021, second dose administered 16-Apr-2021) and MYALGIA (Muscle soreness, very sore arm muscles and inability to lift arm out and away from the body) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included GABAPENTIN for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced TREMOR (Shaking uncontrollably), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered 10-Mar-2021, second dose administered 16-Apr-2021), CHILLS (Chills) and HEADACHE (Headache). On 23-Apr-2021, the patient experienced BURSITIS (Bursitis left elbow about half the size of a ping pong ball, looks like a blister but doesn't hurt) and HYPOAESTHESIA (Pinky is a little numb). On an unknown date, the patient experienced MYALGIA (Muscle soreness, very sore arm muscles and inability to lift arm out and away from the body), ARTHRALGIA (elbow is a little sore) and VACCINATION SITE PAIN (Injection site soreness). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Headache, at an unspecified dose and frequency. On 17-Apr-2021, TREMOR (Shaking uncontrollably) and CHILLS (Chills) had resolved. On 18-Apr-2021, HEADACHE (Headache) had resolved. At the time of the report, BURSITIS (Bursitis left elbow about half the size of a ping pong ball, looks like a blister but doesn't hurt), HYPOAESTHESIA (Pinky is a little numb) and ARTHRALGIA (elbow is a little sore) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose administered 10-Mar-2021, second dose administered 16-Apr-2021), MYALGIA (Muscle soreness, very sore arm muscles and inability to lift arm out and away from the body) and VACCINATION SITE PAIN (Injection site soreness) outcome was unknown.            Treatment also included Ice applied to left elbow  Action taken with mRNA-1273 in response to the event was Not Applicable   This case was linked to MOD-2021-101917 (Patient Link).