Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Product administered at inappropriate site, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: The site of injection was hot, it lasted 2 days; Patient experienced swelling; Patient experienced redness; Patient experienced local pain in the site of injection during 2 days, Pain in the arm but laterally it was much more intense; There was an administration error because the injection was given very low in her arm, and possibly it was given subcutaneous instead of intramuscular; There was an administration error because the injection was given very low in her arm, and possibly it was given subcutaneous instead of intramuscular; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE WARMTH (The site of injection was hot, it lasted 2 days), VACCINATION SITE SWELLING (Patient experienced swelling), VACCINATION SITE ERYTHEMA (Patient experienced redness), VACCINATION SITE PAIN (Patient experienced local pain in the site of injection during 2 days, Pain in the arm but laterally it was much more intense) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (There was an administration error because the injection was given very low in her arm, and possibly it was given subcutaneous instead of intramuscular) in a 72-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7145B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Patient had never tested COVID-19 Positive. No other vaccines were given within 1 month prior to Moderna COVID-19 Vaccine.  Previously administered products included for Product used for unknown indication: Pfizer (1st Dose) on 01-Mar-2021, Pfizer (2nd Dose, Lot no. EN6200) on 21-Mar-2021, Pfizer (1st Booster dose and Lot no. SF2588) on 25-Sep-2021. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer. Concurrent medical conditions included Sulfonamide allergy (Sulfa drugs), High cholesterol (Recent change in status such as improvement or worsening: no) since 2005, GERD (Improved since 2 years ago) and Osteoarthritis (No changes in improvement or worsening). Concomitant products included SIMVASTATIN for High cholesterol, ESTRADIOL, AMMONIUM LACTATE, CALCIUM and VITAMIN D NOS for an unknown indication.    On 22-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 22-Sep-2022, the patient experienced VACCINATION SITE WARMTH (The site of injection was hot, it lasted 2 days), VACCINATION SITE SWELLING (Patient experienced swelling), VACCINATION SITE ERYTHEMA (Patient experienced redness), VACCINATION SITE PAIN (Patient experienced local pain in the site of injection during 2 days, Pain in the arm but laterally it was much more intense), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (There was an administration error because the injection was given very low in her arm, and possibly it was given subcutaneous instead of intramuscular) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (There was an administration error because the injection was given very low in her arm, and possibly it was given subcutaneous instead of intramuscular). On 24-Sep-2022, VACCINATION SITE WARMTH (The site of injection was hot, it lasted 2 days), VACCINATION SITE SWELLING (Patient experienced swelling), VACCINATION SITE ERYTHEMA (Patient experienced redness) and VACCINATION SITE PAIN (Patient experienced local pain in the site of injection during 2 days, Pain in the arm but laterally it was much more intense) had resolved. At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (There was an administration error because the injection was given very low in her arm, and possibly it was given subcutaneous instead of intramuscular) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (There was an administration error because the injection was given very low in her arm, and possibly it was given subcutaneous instead of intramuscular) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   AE did not cause the patient to seek medical care. Patient had not experienced similar events in the past.  There was an administration error with bivalent booster because the injection was given very low in the arm, and patient thought it was given subcutaneous instead of intramuscular. After receiving bivalent vaccine, patient experienced swelling and redness, pain in the arm but laterally and it was much more intense, the site of injection was hot. It lasted 2 days. No treatment was given.  No treatment details were reported.   This case was linked to MOD-2022-662783 (Patient Link).