Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Erythema, Heart rate increased, Injection site urticaria, Pain
Clinical narrative: Erythema; heart rate > 100 beats per minute; Shortness of breath; Itchy Rash; rash came back at the injection site and ran to the back of the arm., went up to her cheek; Baseball Size Red Hive at injection site, Ran to the back of the arm, Cheek and was itchy; little pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (little pain), RASH PRURITIC (Itchy Rash), RASH (rash came back at the injection site and ran to the back of the arm., went up to her cheek), INJECTION SITE URTICARIA (Baseball Size Red Hive at injection site, Ran to the back of the arm, Cheek and was itchy) and DYSPNOEA (Shortness of breath) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer in 2014, Radiation therapy (was treated with radiation for breast cancer) in 2014 and Surgery (had surgery for her breast cancer) in 2014. Concurrent medical conditions included Asthma (she has some asthma issues.), Food allergy (Crab), Penicillin allergy, Drug allergy (Anesthesics) and Drug allergy (versed). Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) for Depression.   On 12-Jan-2021 at 2:20 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jan-2021, the patient experienced PAIN (little pain). On 24-Jan-2021, the patient experienced RASH PRURITIC (Itchy Rash) and RASH (rash came back at the injection site and ran to the back of the arm., went up to her cheek). 24-Jan-2021, the patient experienced INJECTION SITE URTICARIA (Baseball Size Red Hive at injection site, Ran to the back of the arm, Cheek and was itchy). On 26-Jan-2021, the patient experienced DYSPNOEA (Shortness of breath). On an unknown date, the patient experienced ERYTHEMA (Erythema) and HEART RATE INCREASED (heart rate > 100 beats per minute). The patient was treated with HYDROCORTISONE (HYDROCORTIZON [HYDROCORTISONE]) (topical) from 18-Jan-2021 to 23-Jan-2021 for Welts, at a dose of 2.5 percent every four hours; HYDROCORTISONE SODIUM SUCCINATE (CORTIZON) (topical) on 26-Jan-2021 at an unspecified dose and frequency; METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE] PAK) on 26-Jan-2021 at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 26-Jan-2021 at an unspecified dose and frequency. At the time of the report, PAIN (little pain), RASH PRURITIC (Itchy Rash), RASH (rash came back at the injection site and ran to the back of the arm., went up to her cheek), INJECTION SITE URTICARIA (Baseball Size Red Hive at injection site, Ran to the back of the arm, Cheek and was itchy), DYSPNOEA (Shortness of breath), ERYTHEMA (Erythema) and HEART RATE INCREASED (heart rate > 100 beats per minute) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Depression is caused by death of son at age 41. 03-FEB-2021 armpit lump lasted until end of February and rash going down inner thighs and back. Red welt gone on 23-JAN-2021 and returned larger below injection site elbow, front and back of arm on 24-JAN-2021.       Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: General tab-Reporter details added, Patient Tab- Medical history added, Product tab- Concomitant medication and treatment medication, Event Tab- Dates added