Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Joint swelling, Muscular weakness, Myalgia
Clinical narrative: Swollen elbow; Numbness and Tingling to left side of the face; weakness in L) arm more than R) arm; Muscle pain in elbow; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 22-Feb-2021 and second dose administered on 25-Apr-2021), MUSCULAR WEAKNESS (weakness in L) arm more than R) arm), MYALGIA (Muscle pain in elbow), JOINT SWELLING (Swollen elbow) and HYPOAESTHESIA (Numbness and Tingling to left side of the face) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 001a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concurrent medical conditions included Cholesterol, Thyroid hormone replacement therapy and Hypertension. Concomitant products included ROSUVASTATIN CALCIUM for Cholesterol, HYDROCHLOROTHIAZIDE and LOSARTAN POTASSIUM for Hypertension, LEVOTHYROXINE for Thyroid hormone replacement therapy.   On 22-Feb-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021 at 3:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 22-Feb-2021 and second dose administered on 25-Apr-2021), MUSCULAR WEAKNESS (weakness in L) arm more than R) arm) and MYALGIA (Muscle pain in elbow). 25-Mar-2021, the patient experienced HYPOAESTHESIA (Numbness and Tingling to left side of the face). On an unknown date, the patient experienced JOINT SWELLING (Swollen elbow) and ARTHRALGIA (Pain in left elbow). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 25-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 22-Feb-2021 and second dose administered on 25-Apr-2021) had resolved. On 05-Apr-2021, HYPOAESTHESIA (Numbness and Tingling to left side of the face) had resolved. At the time of the report, MUSCULAR WEAKNESS (weakness in L) arm more than R) arm), MYALGIA (Muscle pain in elbow) and JOINT SWELLING (Swollen elbow) outcome was unknown and ARTHRALGIA (Pain in left elbow) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 25-Mar-2021, the patient had numbness and tingling in the left side of the face with jaw up to underside of eye. The laboratory tests were done after first COVID vaccine shot.   On an unknown date, after weeks of first vaccination, the patient had pain in left elbow.   On 22-JUn-2021, the patient had an appointment with the physician.   This case was linked to MOD-2021-025820 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Additional information was received on 13-Jul-2021: additional suspect product details with facility details, concomitant medications were added and additional event details were added.