Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Pain in extremity, Product administered at inappropriate site, Vaccination site bruising, Vaccination site movement impairment
Clinical narrative: This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Mother can not lift arm/Extreme pain in arm; unable to lift arm (1 month after vaccination still injured)), PAIN IN EXTREMITY (Pain in arm/Extreme pain in arm; unable to lift arm), VACCINATION SITE NERVE DAMAGE (Appears vaccination given too high on arm: Possible nerve damage and/or in the bone), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine given in wrong location maybe the bone) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Appears vaccination given too high on arm: Possible nerve damage and/or in the bone) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Breast cancer (Breast cancer survivor 9 lymph nodes removed) since 2000, Diabetes since 2011, Blood pressure high since 2000, High cholesterol since 2011, Penicillin allergy, Food allergy (Allergy to spicy foods) and Latex allergy. Concomitant products included AMLODIPINE;OLMESARTAN from 2011 to an unknown date for Blood pressure high, LETROZOLE (FEMARA) from 2011 to an unknown date for Breast cancer, DENOSUMAB (PROLIA) from 2011 to an unknown date for Cancer, METFORMIN from 2011 to an unknown date for Diabetes, ATORVASTATIN from 2011 to an unknown date for High cholesterol. On 04-Feb-2021 at 2:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021 at 2:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021 at 5:30 PM, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Mother can not lift arm/Extreme pain in arm; unable to lift arm (1 month after vaccination still injured)) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine given in wrong location maybe the bone). 02-Mar-2021 at 5:30 PM, the patient experienced PAIN IN EXTREMITY (Pain in arm/Extreme pain in arm; unable to lift arm). 02-Mar-2021 at 5:30 PM, the patient experienced VACCINATION SITE NERVE DAMAGE (Appears vaccination given too high on arm: Possible nerve damage and/or in the bone) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Appears vaccination given too high on arm: Possible nerve damage and/or in the bone). In March 2021, the patient experienced VACCINATION SITE BRUISING (Bruise from the injection). On 02-Mar-2021 at 5:30 PM, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine given in wrong location maybe the bone) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Appears vaccination given too high on arm: Possible nerve damage and/or in the bone) had resolved. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Mother can not lift arm/Extreme pain in arm; unable to lift arm (1 month after vaccination still injured)), PAIN IN EXTREMITY (Pain in arm/Extreme pain in arm; unable to lift arm) and VACCINATION SITE NERVE DAMAGE (Appears vaccination given too high on arm: Possible nerve damage and/or in the bone) had not resolved and VACCINATION SITE BRUISING (Bruise from the injection) outcome was unknown. Unknown. Patient went to her primary care physician 6 days after receiving the vaccination (09-Mar-2021). He assessed the vaccination site was too high and may have gone into her bone and/or damaged her nerve. The patient was referred to a specialist who gave her a block to relieve the pain on 10-Mar-2021. It took a full day before she felt some relief.  Both physicians felt the injection wasn't properly administered and caused this injury. It is expected to take weeks-to-months to heal if it is able to heal on its own. The patient had unspecified blood tests to rule out infection and an X-ray (results not provided). Most recent FOLLOW-UP information incorporated above includes: On 02-Apr-2021: Follow-up received on 02-04-2021:contains Patient demographics, vaccination details, events, concomitant medications, medical history and treatment added; Reporter's Comments: This report refers to a case of inappropriate route of vaccination for mRNA-1273, lot # unknow with associated AE: arm discomfort. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.