Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site swelling, Vulvovaginal burning sensation
Clinical narrative: Inflammation; Blister; Vulval burning sensation; Vaccination site pruritus; Vaccination site rash; Rash aggravated; Vaccination site induration; Vaccination site swelling; sore throat; Itchy; Flu like symptoms; Myalgia; Ear ache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VULVOVAGINAL BURNING SENSATION (Vulval burning sensation), EAR PAIN (Ear ache), INFLAMMATION (Inflammation), BLISTER (Blister) and OROPHARYNGEAL PAIN (sore throat) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 017O21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Fibromyalgia, Inflammation and Blistering. Concurrent medical conditions included Hypertension and Headache. Concomitant products included SUMATRIPTAN for Headache, CLONIDINE, LISINOPRIL and DILTIAZEM for Hypertension, GABAPENTIN (NEURONTIN) for an unknown indication.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Apr-2021, the patient experienced EAR PAIN (Ear ache), PRURITUS (Itchy), INFLUENZA LIKE ILLNESS (Flu like symptoms ) and MYALGIA (Myalgia). 11-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat). On 12-Apr-2021, the patient experienced VACCINATION SITE INDURATION (Vaccination site induration). 12-Apr-2021, the patient experienced VACCINATION SITE SWELLING (Vaccination site swelling). On 13-Apr-2021, the patient experienced RASH (Rash aggravated) and VACCINATION SITE RASH (Vaccination site rash ). On 15-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (Vaccination site pruritus). On an unknown date, the patient experienced VULVOVAGINAL BURNING SENSATION (Vulval burning sensation), INFLAMMATION (Inflammation) and BLISTER (Blister). The patient was treated with HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) for Pain, at a dose of 1 dosage form; CORTISONE at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. On 15-Apr-2021, EAR PAIN (Ear ache), OROPHARYNGEAL PAIN (sore throat), PRURITUS (Itchy), INFLUENZA LIKE ILLNESS (Flu like symptoms ) and MYALGIA (Myalgia) had resolved. At the time of the report, VULVOVAGINAL BURNING SENSATION (Vulval burning sensation), INFLAMMATION (Inflammation), BLISTER (Blister), VACCINATION SITE RASH (Vaccination site rash ), VACCINATION SITE INDURATION (Vaccination site induration) and VACCINATION SITE SWELLING (Vaccination site swelling) outcome was unknown and RASH (Rash aggravated) and VACCINATION SITE PRURITUS (Vaccination site pruritus) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details included diphenhydramine, cortisone cream, hydrocodone/acetaminophen for achiness  Action taken with mRNA-1273 in response to the event was not applicable..   This case was linked to MOD21-076878 (E2B Linked Report).; Sender's Comments:  MOD21-076878: