Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: swollen up to the point that I could not open the eyes; sore and swollen lymph nodes in the neck and base of my skull; Sore and swollen lymph nodes in the neck and base of my skull; Nerve pain; Swelling, blisters on my face around my left eye into my scalp; It was sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWELLING FACE (Swelling, blisters on my face around my left eye into my scalp), EYE SWELLING (swollen up to the point that I could not open the eyes), LYMPH NODE PAIN (sore and swollen lymph nodes in the neck and base of my skull), LYMPHADENOPATHY (Sore and swollen lymph nodes in the neck and base of my skull) and NEURALGIA (Nerve pain) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Shingles (a few bumps and slight rash before getting the vaccine) since 02-Jan-2021. Concomitant products included AZELASTINE, MONTELUKAST SODIUM (SINGULAIR) and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for an unknown indication.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE PAIN (It was sore). On 06-Jan-2021, the patient experienced SWELLING FACE (Swelling, blisters on my face around my left eye into my scalp). On an unknown date, the patient experienced EYE SWELLING (swollen up to the point that I could not open the eyes), LYMPH NODE PAIN (sore and swollen lymph nodes in the neck and base of my skull), LYMPHADENOPATHY (Sore and swollen lymph nodes in the neck and base of my skull) and NEURALGIA (Nerve pain). At the time of the report, SWELLING FACE (Swelling, blisters on my face around my left eye into my scalp), EYE SWELLING (swollen up to the point that I could not open the eyes), LYMPH NODE PAIN (sore and swollen lymph nodes in the neck and base of my skull), LYMPHADENOPATHY (Sore and swollen lymph nodes in the neck and base of my skull), NEURALGIA (Nerve pain) and VACCINATION SITE PAIN (It was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient had developed shingles on 02-JAN-2021. She had never had shingles before, so thought it was a rash. She had a few bumps and slight rash before she got the vaccine on 05-JAN-2021. The patient got the vaccine in the left muscle in the shoulder. After getting the vaccine, it was sore and then on 06-JAN-2021, the shingles exploded with swelling, blisters on her face around the left eye and into the scalp. The patient went to her primary care physician and was diagnosed with shingles. She followed up with an ophthalmologist because of the proximity to her eye. It was swollen up to the point that she could not open the eyes. She also reported very sore and swollen lymph nodes in the neck and base of her skull. The patient reported still having a few symptoms like nerve pain. The second dose of the vaccine was scheduled for 02-FEB-2021. The patient was treated with valacyclovir (VALTREX) for the shingles.  Company comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded for vaccination site pain. However, the event of Herpes Zoster began before the vaccination so is not related and not an AE.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded for vaccination site pain. However, the event of Herpes Zoster began before the vaccination so is not related and not an AE.