Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site warmth, Somnolence, Vaccination site erythema, Vaccination site pain
Clinical narrative: the injection site left arm is warm; she feels very sleepy; injection site left arm  got very swollen; The redness in the area covers the top of the forearm / entry point of the needle is so red; hard to touch like a knot; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE WARMTH (the injection site left arm is warm ), SOMNOLENCE (she feels very sleepy), INJECTION SITE SWELLING (injection site left arm  got very swollen), VACCINATION SITE ERYTHEMA (The redness in the area covers the top of the forearm / entry point of the needle is so red) and VACCINATION SITE PAIN (hard to touch like a knot) in an 83-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: flu vaccine in September 2021. Past adverse reactions to the above products included No adverse event with flu vaccine. Concurrent medical conditions included Blood pressure abnormal, Environmental allergy, Penicillin allergy, Sulfonamide allergy, Drug allergy (codeine) and UTI. Concomitant products included AMLODIPINE for Blood pressure, NITROFURANTOIN for UTI, SIMVASTATIN, SALINE [SODIUM CHLORIDE] and IPRATROPIUM for an unknown indication.    On 20-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE WARMTH (the injection site left arm is warm ), SOMNOLENCE (she feels very sleepy), INJECTION SITE SWELLING (injection site left arm  got very swollen), VACCINATION SITE ERYTHEMA (The redness in the area covers the top of the forearm / entry point of the needle is so red) and VACCINATION SITE PAIN (hard to touch like a knot). At the time of the report, INJECTION SITE WARMTH (the injection site left arm is warm ), SOMNOLENCE (she feels very sleepy), INJECTION SITE SWELLING (injection site left arm  got very swollen), VACCINATION SITE ERYTHEMA (The redness in the area covers the top of the forearm / entry point of the needle is so red) and VACCINATION SITE PAIN (hard to touch like a knot) had not resolved.            Patient Height was reported as 4.11 ft and 3/4 inch. Patient calls in to report that she had adverse reactions after getting the 4 doses of the Moderna Covid-19 vaccine (monovalent and bivalent).  On 13-JAN-2021 patient received 1st Dose of the Moderna Covid-19 vaccine, Lot Number 041L20A. On 10-FEB-2021 patient received 2nd Dose of the Moderna Covid-19 vaccine, Lot Number 024M20A. On 24-MM-2021 patient received 1st Booster Dose of the Moderna Covid-19 vaccine, Lot Number 002L21A.  After she got the 2nd booster dose (bivalent), the injection site (left arm) got very swollen, it is warm and hard to touch like a knot. The redness in the area covers the top of the forearm. The entry point of the needle is so red. She also claims that she is not her usual energetic self and she feels very sleepy.  Recent change in status such as improvement or worsening - medical conditions were present prior to getting the vaccine and have not gotten worse.  The allergy shots every month for 20 years.  No treatment information was provided.   This case was linked to MOD-2022-649434 (Patient Link).