Age: 63.0
Sex: F
Vaccine: COVID19-2
Symptoms: Lymphangitis, Vaccination site pain
Clinical narrative: I was given antibiotics for lymphangitis related to COVID vaccine,acute onset of pain, Ear swelling, pressure/hardness, redness below right ear and over my right jaw, when I put hand in that area to touch, it hurts/extending towards jawline, extendin; soreness in arm  after injection; This spontaneous case was reported by a patient and describes the occurrence of LYMPHANGITIS (I was given antibiotics for lymphangitis related to COVID vaccine,acute onset of pain, Ear swelling, pressure/hardness, redness below right ear and over my right jaw, when I put hand in that area to touch, it hurts/extending towards jawline, extendin) in a 63-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 050D22A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Codeine (vasovagal reaction)), Penicillin allergy, Allergy to antibiotic (Avelox) and Drug allergy (Sulfa). Concomitant products included EMPAGLIFLOZIN (JARDIANCE) for Hyperglycemia, LEVOTHYROXINE, TERAZOSIN, CARVEDILOL (COREG) and SPIRONOLACTONE for an unknown indication.    On 23-Oct-2022, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 23-Oct-2022, the patient experienced VACCINATION SITE PAIN (soreness in arm  after injection). On 24-Oct-2022, the patient experienced LYMPHANGITIS (I was given antibiotics for lymphangitis related to COVID vaccine,acute onset of pain, Ear swelling, pressure/hardness, redness below right ear and over my right jaw, when I put hand in that area to touch, it hurts/extending towards jawline, extendin) (seriousness criterion medically significant). The patient was treated with DOXYCYCLINE at an unspecified dose and frequency. On 23-Oct-2022, VACCINATION SITE PAIN (soreness in arm  after injection) had not resolved. On 24-Oct-2022, LYMPHANGITIS (I was given antibiotics for lymphangitis related to COVID vaccine,acute onset of pain, Ear swelling, pressure/hardness, redness below right ear and over my right jaw, when I put hand in that area to touch, it hurts/extending towards jawline, extendin) had not resolved.        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.   The patient never tested COVID positive. Events Pain, Ear swelling, Ear discomfort, Erythema, Pain in jaw, Swelling face, Mastication disorder and Immunisation reaction were subsumed under the event Lymphangitis. Moderna COVID 19 dose 1 was administered on 1-FEB-2021 Moderna COVID 19 dose 2,3,4,5 was administered on unknown date. Ice pack was used as treatment.  Company Comment: This spontaneous case concerns a 63-year-old female patient with no relevant medical history reported, who experienced unexpected serious (medically significant) event of Lymphangitis which occurred 1 day after the sixth dose of mRNA-1273 bivalent BA.4/BA.5 vaccination in covid -19 vaccination series. Patient also experienced other non-serious event of Vaccination site pain. After the vaccination patient had acute onset of pain, swelling, pressure, hardness, and redness below her right ear and over right jaw, extending towards the jawline. She also had pain while chewing on the right side. Symptoms worsen on chewing. She went to ER as symptoms were not improving, was diagnosed with lymphangitis, and was prescribed Doxycycline. She also reports having a sore arm. The outcome of the events was reported as not resolved. The benefit -risk relationship of mRNA-1273 bivalent BA.4/BA.5 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-663909 (E2B Linked Report).; Sender's Comments: This spontaneous case concerns a 63-year-old female patient with no relevant medical history reported, who experienced unexpected serious (medically significant) event of Lymphangitis which occurred 1 day after the sixth dose of mRNA-1273 bivalent BA.4/BA.5 vaccination in covid -19 vaccination series. Patient also experienced other non-serious event of Vaccination site pain. After the vaccination patient had acute onset of pain, swelling, pressure, hardness, and redness below her right ear and over right jaw, extending towards the jawline. She also had pain while chewing on the right side. Symptoms worsen on chewing. She went to ER as symptoms were not improving, was diagnosed with lymphangitis, and was prescribed Doxycycline. She also reports having a sore arm. The outcome of the events was reported as not resolved. The benefit -risk relationship of mRNA-1273 bivalent BA.4/BA.5 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2022-663909:Same reporter(Crosslink Case Number)