Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Incorrect route of product administration, Nausea, Underdose, Vaccination site movement impairment
Clinical narrative: Nausea; Right arm some of the fluid came out of her arm; Right arm some of the fluid came out of her arm; the dose was given in back of her arm instead of her muscle/ The second dose of vaccine was given in the correct location the deltoid muscle but to the side; Arm was sore and hard to lift; Arm was sore and hard to lift; This spontaneous case was reported by a consumer and describes the occurrence of DEVICE CONNECTION ISSUE (Right arm some of the fluid came out of her arm), UNDERDOSE (Right arm some of the fluid came out of her arm), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (the dose was given in back of her arm instead of her muscle/ The second dose of vaccine was given in the correct location the deltoid muscle but to the side), VACCINATION SITE MOVEMENT IMPAIRMENT (Arm was sore and hard to lift) and VACCINATION SITE PAIN (Arm was sore and hard to lift) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0043L20A and 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic (Type 1 Diabetes) since 09-Jan-1985, Polycystic ovarian syndrome in 1987 and Drug allergy. Concomitant products included SEMAGLUTIDE for Diabetes, ESOMEPRAZOLE for Heartburn, ATORVASTATIN for Hypertension, SPIRONOLACTONE for Polycystic ovarian syndrome, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]), BUPROPION, STRESS B COMPLEX [AMINOBENZOIC ACID;ASCORBIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CHOLINE BITARTRATE;CYANOCOBALAMIN;FOLIC ACID;INOSITOL;NICOTINIC ACID;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;ROSA CANINA;THIAMINE MONONITRATE] and BIOTIN for an unknown indication.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In January 2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Arm was sore and hard to lift). On 22-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DEVICE CONNECTION ISSUE (Right arm some of the fluid came out of her arm), UNDERDOSE (Right arm some of the fluid came out of her arm) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (the dose was given in back of her arm instead of her muscle/ The second dose of vaccine was given in the correct location the deltoid muscle but to the side). On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm was sore and hard to lift) and NAUSEA (Nausea). On 22-Jan-2021, DEVICE CONNECTION ISSUE (Right arm some of the fluid came out of her arm), UNDERDOSE (Right arm some of the fluid came out of her arm) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (the dose was given in back of her arm instead of her muscle/ The second dose of vaccine was given in the correct location the deltoid muscle but to the side) had resolved. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Arm was sore and hard to lift) and VACCINATION SITE PAIN (Arm was sore and hard to lift) had resolved and NAUSEA (Nausea) outcome was unknown.            Concomitant medications taken by the patient included Humalog insulin pump for diabetes, tumenc.   The second dose of vaccine was given in the correct location the deltoid muscle but to the side.   On an unknown date, patient had tested for antibodies twice at a fast med ,was not sure if it was tested for correct ones and had no antibodies.  Treatment information was not provided.   This case was linked to MOD-2021-057973 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: Significant follow up  included information about historical condition, start date of dose 1,concomitant medications and events; Sender's Comments: This report refers to a case of  Device connection issue and Underdose, and  Incorrect route of product administration for mRNA-1273, lot # 0043L20A with no associated AEs.