Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Skin mass, Vaccination site urticaria
Clinical narrative: My mouth was swollen; My body became sore to touch; Bumps reappeared at moderna injection site; She now wants second dose but they will be too far apart.; Anaphylactic reaction; Bumps turned into lumps; Bumps in her mouth that would burn; Anything she would put in her mouth to eat or drink would burn; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anaphylaxis since an unknown date. Concurrent medical conditions included Hypersensitivity reaction and Penicillin allergy (large bump on face, eyes, throat swelling).    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant), SKIN MASS (Bumps turned into lumps), ORAL DISORDER (Bumps in her mouth that would burn) and ORAL DISCOMFORT (Anything she would put in her mouth to eat or drink would burn). On an unknown date, the patient experienced MOUTH SWELLING (My mouth was swollen), MYALGIA (My body became sore to touch), VACCINATION SITE URTICARIA (Bumps reappeared at moderna injection site) and INTENTIONAL PRODUCT USE ISSUE (She now wants second dose but they will be too far apart.). The patient was treated with HYDROXYZINE (oral) ongoing from 24-Mar-2021 at a dose of 25 mg three times a day; METHYLPREDNISOLONE (intramuscular) ongoing since an unknown date at a dose of 40 mg once a day and FAMOTIDINE (oral) at a dose of 20 mg once a day. On 25-Mar-2021, ANAPHYLACTIC REACTION (Anaphylactic reaction), MOUTH SWELLING (My mouth was swollen), MYALGIA (My body became sore to touch) and VACCINATION SITE URTICARIA (Bumps reappeared at moderna injection site) had resolved. On 28-Mar-2021, SKIN MASS (Bumps turned into lumps), ORAL DISORDER (Bumps in her mouth that would burn) and ORAL DISCOMFORT (Anything she would put in her mouth to eat or drink would burn) had resolved. At the time of the report, INTENTIONAL PRODUCT USE ISSUE (She now wants second dose but they will be too far apart.) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Blood pressure measurement: 123/78 (normal) Normal. On 25-Mar-2021, Body temperature: 96.8 (normal) Normal. On 25-Mar-2021, Heart rate: 104 (High) High. On 25-Mar-2021, Respiratory rate: 18 (normal) Normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient did not receive her second dose because of advice from her doctor, however at the time of this report the patient wanted her second dose but the doses would be too far apart. After the shot patient noticed bumps on arms. The bumps became cluster on the scalp, neck, face, legs and feet. The facial bumps enlarged and disfigured face. The patient had unbelieve burning in mouth. After 2 weeks bumps and cluster repeated at injection site and next day bump went away. The patient body became sore to touch for couple of days and developed cough for 2 weeks that treated with cough syrup congestion. Concomitant medication was not provided  Company comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Additional adverse event: Hives from her first injection; added 'intentional deviation from product regimen. On 13-Aug-2021: Upon follow-up receipt: Patient demographics added, Medical history added, lab data added, Anatomical location of vaccine administration added, treatment medication added, Events are added.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.