Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: She thought she was going to get a cold sore because she gets them once in a awhile on her lips; sort of hard and warm; heart rate has been elevated; feeling very lethargic; achy; arm is very red, really itchy, swollen and sort of hardened; ankles are swollen; She states that her arm is very red, really itchy, swollen and sort of hardened; arm is very red, really itchy, swollen and sort of hardened; arm is very red, really itchy, swollen and sort of hardened; tired in her bones; it still itches and burns; This spontaneous case was reported by a patient and describes the occurrence of ORAL HERPES (She thought she was going to get a cold sore because she gets them once in a awhile on her lips), VACCINATION SITE WARMTH (sort of hard and warm), HEART RATE INCREASED (heart rate has been elevated), LETHARGY (feeling very lethargic) and PAIN (achy) in a 71-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy. Concomitant products included Metformin hydrochloride (Metformin) for an unknown indication.    On 28-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. In 2024, the patient experienced ORAL HERPES (She thought she was going to get a cold sore because she gets them once in a awhile on her lips), VACCINATION SITE WARMTH (sort of hard and warm), HEART RATE INCREASED (heart rate has been elevated), LETHARGY (feeling very lethargic), PAIN (achy), VACCINATION SITE HYPERTROPHY (arm is very red, really itchy, swollen and sort of hardened), JOINT SWELLING (ankles are swollen), VACCINATION SITE ERYTHEMA (She states that her arm is very red, really itchy, swollen and sort of hardened), VACCINATION SITE PRURITUS (arm is very red, really itchy, swollen and sort of hardened), VACCINATION SITE SWELLING (arm is very red, really itchy, swollen and sort of hardened), FATIGUE (tired in her bones) and VACCINATION SITE PAIN (it still itches and burns). The patient was treated with Diphenhydramine hydrochloride (Benadryl) at an unspecified dose and frequency. At the time of the report, ORAL HERPES (She thought she was going to get a cold sore because she gets them once in a awhile on her lips), VACCINATION SITE WARMTH (sort of hard and warm), HEART RATE INCREASED (heart rate has been elevated), LETHARGY (feeling very lethargic), PAIN (achy), VACCINATION SITE HYPERTROPHY (arm is very red, really itchy, swollen and sort of hardened), JOINT SWELLING (ankles are swollen), VACCINATION SITE ERYTHEMA (She states that her arm is very red, really itchy, swollen and sort of hardened), VACCINATION SITE PRURITUS (arm is very red, really itchy, swollen and sort of hardened), VACCINATION SITE SWELLING (arm is very red, really itchy, swollen and sort of hardened), FATIGUE (tired in her bones) and VACCINATION SITE PAIN (it still itches and burns) had not resolved.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   Patient symptoms started 8 hours after the vaccination. All symptoms happened for patient in the left arm, where she was vaccinated. She said the person who vaccinating her did not hurt her at all, she barely felt it. She states that her arm is very red, itchy, swollen and sort of hardened. She put treatment medication on it, and it helped for a bit, but she stated that it was probably internal. She also felt very lethargic, achy, tired in her bones and out of it. Patient stated that she felt like she was almost gone to get sick with something, but it did not go into that. She thought she was had a cold sore because she got them once in an awhile on her lips. She stated that the vaccine brought her fighting thing down. She did go to the pharmacy and showed them that there was swelling, the redness and sort of hard and warm. She stated that she knows it has nothing to do with the shot, but her ankles were swollen, and she has never had swollen ankles like this. She stated that her heart rate has been elevated. Her symptoms did not stop, it has been 3 days, and patient still experienced itches and burns.   This case was linked to US-MODERNATX, INC.-MOD-2024-776430, US-MODERNATX, INC.-MOD-2024-776432, US-MODERNATX, INC.-MOD-2024-776465, US-MODERNATX, INC.-MOD-2024-776468 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2024: Live-non-significant follow-up received in which new reporter details were added, and new reference number was added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-776432:Same reporter with different report US-MODERNATX, INC.-MOD-2024-776430:Doctor case US-MODERNATX, INC.-MOD-2024-776468:Same reporter with diffrent patient (2) US-MODERNATX, INC.-MOD-2024-776465:Same reporter with diffrent patient (1)