Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Lip blister
Clinical narrative: Ears became itchy and hot; Ears became itchy and hot; Lips more swollen, red and burnseemed to have a blister formation on inside lips; Tongue burns; Ears itchy; Still experiencing arm redness, swollen lip area; Rash; Arm became hot, very itchy and somewhat hard; Arm swollen and increased in size (4X3 in) hot, itchy; Arm slightly red/warm, but swelling is reducingstill a demarcation line; Lips still "burns" a little; Lips started to swell; Area below the injection site felt like it had been sunburned; Eyes became swollen; Eyes became hot; Area below injection site became swollen; Ears were swollen; Itching on her chest, arms, palms, ears, eyes, lips, below injection site; Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching on her chest, arms, palms, ears, eyes, lips, below injection site), EAR SWELLING (Ears were swollen), EYE SWELLING (Eyes became swollen), OCULAR DISCOMFORT (Eyes became hot) and PERIPHERAL SWELLING (Area below injection site became swollen) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy (Generalized itching and hives. Have not taken since that time.) since 1970, Allergy (Red dye #27. Generalized itching and hives. Have not taken since that time.) since 1990 and Allergy (Raspberry and acai juice. Generalized itching and hives. Have not taken since that time.) since 1990.    On 12-Feb-2021 at 2:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PRURITUS (Itching on her chest, arms, palms, ears, eyes, lips, below injection site) and INJECTION SITE PAIN (Soreness at the injection site). On 18-Feb-2021, the patient experienced EAR SWELLING (Ears were swollen). On 19-Feb-2021, the patient experienced EYE SWELLING (Eyes became swollen), OCULAR DISCOMFORT (Eyes became hot) and PERIPHERAL SWELLING (Area below injection site became swollen). On 20-Feb-2021, the patient experienced FEELING HOT (Area below the injection site felt like it had been sunburned). On 21-Feb-2021, the patient experienced LIP SWELLING (Lips started to swell). On 22-Feb-2021, the patient experienced ORAL DISCOMFORT (Lips still "burns" a little). On an unknown date, the patient experienced EAR PRURITUS (Ears became itchy and hot), EAR DISCOMFORT (Ears became itchy and hot), LIP BLISTER (Lips more swollen, red and burnseemed to have a blister formation on inside lips), TONGUE DISCOMFORT (Tongue burns; Ears itchy), PARAESTHESIA ORAL (Still experiencing arm redness, swollen lip area), RASH (Rash), INJECTION SITE INDURATION (Arm became hot, very itchy and somewhat hard), INJECTION SITE SWELLING (Arm swollen and increased in size (4X3 in) hot, itchy) and INJECTION SITE ERYTHEMA (Arm slightly red/warm, but swelling is reducingstill a demarcation line). On 14-Feb-2021, INJECTION SITE PAIN (Soreness at the injection site) had resolved. On 21-Feb-2021, PERIPHERAL SWELLING (Area below injection site became swollen) had resolved. At the time of the report, PRURITUS (Itching on her chest, arms, palms, ears, eyes, lips, below injection site), EAR SWELLING (Ears were swollen), EYE SWELLING (Eyes became swollen), OCULAR DISCOMFORT (Eyes became hot), FEELING HOT (Area below the injection site felt like it had been sunburned), ORAL DISCOMFORT (Lips still "burns" a little), EAR PRURITUS (Ears became itchy and hot), EAR DISCOMFORT (Ears became itchy and hot), LIP BLISTER (Lips more swollen, red and burnseemed to have a blister formation on inside lips), TONGUE DISCOMFORT (Tongue burns; Ears itchy), PARAESTHESIA ORAL (Still experiencing arm redness, swollen lip area), RASH (Rash), INJECTION SITE INDURATION (Arm became hot, very itchy and somewhat hard), INJECTION SITE SWELLING (Arm swollen and increased in size (4X3 in) hot, itchy) and INJECTION SITE ERYTHEMA (Arm slightly red/warm, but swelling is reducingstill a demarcation line) outcome was unknown and LIP SWELLING (Lips started to swell) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include metoprolol succinate ER of 50 mg dose used for tachycardia, levothyroxine of 50 mcg dose for thyroid condition,  lovastatin of 40 mg dose for cholesterol condition, calcium with vitamin D of 1000 mg/50 mcg for bone health, vitamin B12 of 1000mcg for vitamin support.  Treatment information was not provided.   This case was linked to MOD-2021-262895 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Follow up received on 28-Apr-2021 included no new information. On 20-Jul-2021: Events, concomitant medication, Patient demographics, allergies updated.