Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Skin exfoliation, Urticaria
Clinical narrative: Blisters on top of her head; rash became a big welt; eyes and throat are swollen; eyes and throat are swollen; dried flaky skin on neck and throat; voice changed a bit; itchy eyes; ears like cauliflower; feels like body was ran down over by truck; Rash/spreading from elbow up; rash all over hairline/hair line rash /  Last weekend broke out with rash/ This weekend all over rash; chills; body aches; headaches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EAR DEFORMITY ACQUIRED (ears like cauliflower), PHARYNGEAL SWELLING (eyes and throat are swollen), EYE SWELLING (eyes and throat are swollen), SKIN EXFOLIATION (dried flaky skin on neck and throat) and DYSPHONIA (voice changed a bit) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy. Concomitant products included PROCAINE HYDROCHLORIDE (NOVOCAIN) from 29-Apr-2021 to an unknown date for Dental treatment, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and VITAMIN C [ASCORBIC ACID] for an unknown indication.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced EAR DEFORMITY ACQUIRED (ears like cauliflower), FEELING ABNORMAL (feels like body was ran down over by truck), RASH (Rash/spreading from elbow up), RASH (rash all over hairline/hair line rash /  Last weekend broke out with rash/ This weekend all over rash), CHILLS (chills), MYALGIA (body aches) and HEADACHE (headaches). On 02-May-2021, the patient experienced PHARYNGEAL SWELLING (eyes and throat are swollen), EYE SWELLING (eyes and throat are swollen), SKIN EXFOLIATION (dried flaky skin on neck and throat), DYSPHONIA (voice changed a bit), EYE PRURITUS (itchy eyes) and URTICARIA (rash became a big welt). On an unknown date, the patient experienced BLISTER (Blisters on top of her head). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; LORATADINE (CLARITIN [LORATADINE]) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; CORTISONE at a dose of 2 dosage form; EPINEPHRINE (EPIPEN) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (PHENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. On 02-May-2021, FEELING ABNORMAL (feels like body was ran down over by truck), CHILLS (chills), MYALGIA (body aches) and HEADACHE (headaches) had resolved. At the time of the report, EAR DEFORMITY ACQUIRED (ears like cauliflower), PHARYNGEAL SWELLING (eyes and throat are swollen), EYE SWELLING (eyes and throat are swollen), SKIN EXFOLIATION (dried flaky skin on neck and throat), DYSPHONIA (voice changed a bit), EYE PRURITUS (itchy eyes), BLISTER (Blisters on top of her head), URTICARIA (rash became a big welt), RASH (Rash/spreading from elbow up) and RASH (rash all over hairline/hair line rash /  Last weekend broke out with rash/ This weekend all over rash) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.  Thursday before the vaccine, Patient had dental work done - deep cleansing of gums and teeth, where patient was given lots of Novocain. Treatment with Tylenol every 6 hours taken pertained to the symptoms was provided by the patient. Patient was received treatment of Anti-histamines from first emergency room visit. Patient was consulted Healthcare professional and patient was on steroids before for 15 days (around MAY).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: New events with treatment medications were added.