Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Feeling hot, Headache, Lip swelling
Clinical narrative: Lip ridge on bottom slightly swollen and itchy; Arm still red; headache; hot swollen sore arm; Swollen arm; sore arm; Chills; slight fever; opposite arm was itchy/Body itchy/Itchy body areas, lips, ears, neck, palms, etc; lips and tongue tingled for about an hour; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (hot swollen sore arm), PRURITUS (opposite arm was itchy/Body itchy/Itchy body areas, lips, ears, neck, palms, etc), PARAESTHESIA ORAL (lips and tongue tingled for about an hour), LIP SWELLING (Lip ridge on bottom slightly swollen and itchy) and ERYTHEMA (Arm still red) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy (Patient developed generalize itching and hives due to penicillin pills and have not taken since that time) since 1970, Reaction to azo-dyes (Patient developed generalize itching and hives due to Red dye and have not taken since that time) since 1990 and Fruit allergy (Patient developed generalize itching and hives due to raspberry and acai juice and have not taken since that time) since 1990. Concomitant products included CALCIUM CARBONATE, VITAMIN D NOS (CALCIUM + VIT D) for Bone loss, LOVASTATIN for Cholesterol, METOPROLOL SUCCINATE for Tachycardia, LEVOTHYROXINE for Thyroid disorder, CYANOCOBALAMIN (VIT B12) for Vitamin B12 supplementation.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced PRURITUS (opposite arm was itchy/Body itchy/Itchy body areas, lips, ears, neck, palms, etc) and PARAESTHESIA ORAL (lips and tongue tingled for about an hour). On 12-Mar-2021, the patient experienced CHILLS (Chills) and PYREXIA (slight fever). On 13-Mar-2021, the patient experienced FEELING HOT (hot swollen sore arm) and PERIPHERAL SWELLING (Swollen arm). 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 14-Mar-2021, the patient experienced ERYTHEMA (Arm still red) and HEADACHE (headache). On 17-Mar-2021, the patient experienced LIP SWELLING (Lip ridge on bottom slightly swollen and itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) (oral) from 11-Mar-2021 to 18-Mar-2021 for Itching, Redness and Swollen arm, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) on 12-Mar-2021 for Chills and Fever, at an unspecified dose and frequency. On 11-Mar-2021, PARAESTHESIA ORAL (lips and tongue tingled for about an hour) had resolved. On 12-Mar-2021, CHILLS (Chills) and PYREXIA (slight fever) had resolved. On 15-Mar-2021, FEELING HOT (hot swollen sore arm) and PERIPHERAL SWELLING (Swollen arm) had resolved. On 20-Mar-2021, LIP SWELLING (Lip ridge on bottom slightly swollen and itchy), ERYTHEMA (Arm still red), PAIN IN EXTREMITY (sore arm) and HEADACHE (headache) had resolved. At the time of the report, PRURITUS (opposite arm was itchy/Body itchy/Itchy body areas, lips, ears, neck, palms, etc) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient treatment information was reported as cool wet cloth on arm at times and took Tylenol and Benedryl as needed for itching and headache-arm pain as per PCP instructions. It was reported that  Both seemed to alleviate the patient itching symptoms and reduce time frame of symptoms compared with the first vaccine.     This case was linked to MOD-2021-020651 (Patient Link).