Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Vaccination site swelling
Clinical narrative: injection site, the area is still swollen; knot 2-3 inches besidee the injection site; chills; fever; sore muscles; lack of energy; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (lack of energy), VACCINATION SITE SWELLING (injection site, the area is still swollen), VACCINATION SITE MASS (knot 2-3 inches besidee the injection site), CHILLS (chills) and PYREXIA (fever) in a 71-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Patient had no allergies to medications, food and other products. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  The patient's past medical history included COVID-19 (COVID-19 prior to getting the 1st dose and stayed at home, mild symptoms). Previously administered products included for Product used for unknown indication: Pfizer (There was a mention of Pfizer being given as a 1st booster dose and but could not tell definitely.). Past adverse reactions to the above products included No adverse event with Pfizer. Concurrent medical conditions included Coronary artery disease and Cholesterol. Concomitant products included MULTIVITAMINS [VITAMINS NOS] for Blood cholesterol abnormal, ATORVASTATIN, ACETYLSALICYLIC ACID (BABY ASPIRIN), MAGNESIUM, ZINC and VITAMIN D [VITAMIN D NOS] for Cholesterol, AMLODIPINE for Coronary artery disease.    On 19-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 19-Sep-2022, the patient experienced ASTHENIA (lack of energy), CHILLS (chills), PYREXIA (fever) and MYALGIA (sore muscles). On 22-Sep-2022, the patient experienced VACCINATION SITE SWELLING (injection site, the area is still swollen) and VACCINATION SITE MASS (knot 2-3 inches besidee the injection site). In September 2022, ASTHENIA (lack of energy), CHILLS (chills), PYREXIA (fever) and MYALGIA (sore muscles) had resolved. At the time of the report, VACCINATION SITE SWELLING (injection site, the area is still swollen) and VACCINATION SITE MASS (knot 2-3 inches besidee the injection site) had not resolved.            On 20-Feb-2021, the patient received the first dose and on 20-Mar-2021 second dose of Moderna COVID-19 vaccine. On 18-Apr-2022, the patient received second booster of Moderna COVID-19 vaccine (lot number: 005M21A).   Patient states that, after getting all the doses of the vaccine, he had all of the side effects except vomiting and diarrhea; he had chills, fever, sore muscles, and lack of energy which lasted for 2-3 days. He claims that these side effects were worse than having the COVID-19. Further patient stated, after he got the bivalent booster dose, he reports that he had a strange side effect; at the injection site, the area was still swollen and there was a knot around 2-3 inches beside it. Later, he went to his doctor and was told that the injection site was not infected.  The patient did not experience a similar event in the past.  No treatment medications were reported.   This case was linked to MOD-2022-649310 (Patient Link).