Age: 32.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Pain, Pyrexia, Vaccination site mass, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: 4 inch hot, itchy, slightly swollen and tender lump in area where vaccine was given; 4 inch hot, itchy, slightly swollen and tender lump in area where vaccine was given; 4 inch hot, itchy, slightly swollen and tender lump in area where vaccine was given; 4 inch hot, itchy, slightly swollen and tender lump in area where vaccine was given; Felt odd, like sort of drunk and out of it; loss of appetite; low-grade fever; Felt extreme fatigue; splitting headache; chills; body aches; This spontaneous case was reported by a patient and describes the occurrence of PAIN (body aches), VACCINATION SITE WARMTH (4 inch hot, itchy, slightly swollen and tender lump in area where vaccine was given), FEELING ABNORMAL (Felt odd, like sort of drunk and out of it), DECREASED APPETITE (loss of appetite) and VACCINATION SITE PRURITUS (4 inch hot, itchy, slightly swollen and tender lump in area where vaccine was given) in a 32-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product Influenza vaccine for an unknown indication.    The patient's past medical history included Psoriasis.   On 08-Jan-2025, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form and Influenza vaccine (unknown route) 1 dosage form. On 08-Jan-2025, the patient experienced PAIN (body aches), FEELING ABNORMAL (Felt odd, like sort of drunk and out of it), DECREASED APPETITE (loss of appetite), PYREXIA (low-grade fever), FATIGUE (Felt extreme fatigue), HEADACHE (splitting headache) and CHILLS (chills). On an unknown date, the patient experienced VACCINATION SITE WARMTH (4 inch hot, itchy, slightly swollen and tender lump in area where vaccine was given), VACCINATION SITE PRURITUS (4 inch hot, itchy, slightly swollen and tender lump in area where vaccine was given), VACCINATION SITE SWELLING (4 inch hot, itchy, slightly swollen and tender lump in area where vaccine was given) and VACCINATION SITE MASS (4 inch hot, itchy, slightly swollen and tender lump in area where vaccine was given). The patient was treated with Diphenhydramine hydrochloride (Benadryl) (oral use) on 10-Jan-2025 at a dose of 25 milligram every six hours. At the time of the report, PAIN (body aches), VACCINATION SITE WARMTH (4 inch hot, itchy, slightly swollen and tender lump in area where vaccine was given), FEELING ABNORMAL (Felt odd, like sort of drunk and out of it), DECREASED APPETITE (loss of appetite), VACCINATION SITE PRURITUS (4 inch hot, itchy, slightly swollen and tender lump in area where vaccine was given), PYREXIA (low-grade fever), FATIGUE (Felt extreme fatigue), HEADACHE (splitting headache), CHILLS (chills), VACCINATION SITE SWELLING (4 inch hot, itchy, slightly swollen and tender lump in area where vaccine was given) and VACCINATION SITE MASS (4 inch hot, itchy, slightly swollen and tender lump in area where vaccine was given) was resolving.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported. Within 3 hours patient felt odd, like sort of drunk and out of it 3 hours-48 hours. Patient also felt extreme fatigue, splitting headache, body aches, chills, low-grade fever, loss of appetite 48 hours after vaccine. Symptoms previously mentioned mostly gone but then patient started developing a 4-inch hot, itchy, slightly swollen and tender lump in area where vaccine was given. The patient did not experience any additional symptoms/events. Patient started taking one benadryl tablet 10Jan25 and have taken 5 tablets so far once every 6-12 hours sporadically. The patient did not have any additional medical history, concomitant disease or risk factor. There were no lab data/results available.