Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Angioedema, Arthralgia, Blood pressure measurement, Body temperature
Clinical narrative: Anaphylactic reaction; sensitive to touch / thighs were sensitive to touch; sore joints; drowsiness; knot on forhead over my eye; hives; Swallowing difficult; sore arm/ bilateral aching of hands; swollen lips; Angioedema; This spontaneous case was reported by a consumer and describes the occurrence of ANGIOEDEMA (Angioedema) and ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anaphylaxis. Concomitant products included MINOCYCLINE from 21-May-2010 to 20-May-2021 and CLINDAMYCIN PHOSPHATE from 11-Mar-2021 to an unknown date for Acne, OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) from 22-Feb-2008 to an unknown date for Allergy, AMLODIPINE from 20-May-2010 to an unknown date and HCTZ from 21-May-2010 to an unknown date for Hypertension.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced ANGIOEDEMA (Angioedema) (seriousness criterion medically significant), LIP SWELLING (swollen lips), ARTHRALGIA (sore joints), SOMNOLENCE (drowsiness), SWELLING FACE (knot on forhead over my eye), URTICARIA (hives), DYSPHAGIA (Swallowing difficult) and MYALGIA (sore arm/ bilateral aching of hands). On 30-Mar-2021, the patient experienced SENSITIVE SKIN (sensitive to touch / thighs were sensitive to touch). On an unknown date, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant). The patient was treated with EPINEPHRINE (intramuscular) on 20-Apr-2021 for Adverse event, at a dose of .3 mg as required; METHYLPREDNISOLONE (oral) from 29-Mar-2021 to 03-Apr-2021 for Adverse event, at a dose of 04 mg METHYLPREDNISONE; OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) (oral) ongoing from 22-Feb-2008 at a dose of 10 mg twice a day and FAMOTIDINE for Adverse event, at a dose of 20 mg four times per day. On 30-Mar-2021, ANGIOEDEMA (Angioedema), LIP SWELLING (swollen lips), SENSITIVE SKIN (sensitive to touch / thighs were sensitive to touch), ARTHRALGIA (sore joints), SOMNOLENCE (drowsiness), SWELLING FACE (knot on forhead over my eye), URTICARIA (hives), DYSPHAGIA (Swallowing difficult) and MYALGIA (sore arm/ bilateral aching of hands) had resolved. At the time of the report, ANAPHYLACTIC REACTION (Anaphylactic reaction) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-May-2021, Blood pressure measurement: 108/72 mmHg (Inconclusive) 108/72. On 29-May-2021, Body temperature: 99.1 (Inconclusive) 99.1 Fahrenheit. On 29-May-2021, Heart rate: 103 (Inconclusive) 103 beat per min. On 29-May-2021, Respiratory rate: 20 (Inconclusive) 20 breaths per minute.         Patient reported that she experienced hypersensitivity in the skin of the thigh after shower and knot on forehead. Patient was diagnosed with anaphylactic reaction which was recovered on 30-Mar-2021.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Patient received the second dose,, vitals reported, Urticaria ,swelling of the upper airway, difficulty swallowing, angioedema adverse events were reported. Treatment medications were reported. Outcome of the events were recovered/resolved .; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.