Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: injection site area becomes warm to touch; I developed a rash on my left arm lateral to the injection site; injection site extreme itching; injection site feeling of burning; swelling face; tongue thickening; lip thickening; Feel as if the roof of my mouth had been burnt; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Jun-2021 and was forwarded to Moderna on 03-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (swelling face), TONGUE DISORDER (tongue thickening), LIP SWELLING (lip thickening), ORAL DISCOMFORT (Feel as if the roof of my mouth had been burnt) and VACCINATION SITE WARMTH (injection site area becomes warm to touch) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension (Medicine changed  from Lisinopril to Losartan) since 2008, Hay fever, Urticaria, Tingling lips (Patient have dermagraphy and sensitive skin. No particular food but in that time she ate something and got this reaction.), Pre-diabetic and Sensitive skin. Concomitant products included LISINOPRIL from an unknown date to 23-Mar-2021 and LOSARTAN from 24-Mar-2021 to an unknown date for Hypertension, METFORMIN for Pre-diabetic, ZINC and COLECALCIFEROL, MENAQUINONE-7 (VITAMIN D3 K2) for an unknown indication.   On 26-Feb-2021 at 9:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021 at 9:45 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced SWELLING FACE (swelling face), TONGUE DISORDER (tongue thickening), LIP SWELLING (lip thickening) and ORAL DISCOMFORT (Feel as if the roof of my mouth had been burnt). On 13-Apr-2021, the patient experienced VACCINATION SITE WARMTH (injection site area becomes warm to touch), RASH (I developed a rash on my left arm lateral to the injection site), VACCINATION SITE PRURITUS (injection site extreme itching) and VACCINATION SITE PAIN (injection site feeling of burning). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) (oral) from 25-Mar-2021 to 27-Mar-2021 for Allergy NOS, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) 26-Feb-2021 at an unspecified dose and frequency. At the time of the report, SWELLING FACE (swelling face), TONGUE DISORDER (tongue thickening), LIP SWELLING (lip thickening), ORAL DISCOMFORT (Feel as if the roof of my mouth had been burnt), VACCINATION SITE WARMTH (injection site area becomes warm to touch), RASH (I developed a rash on my left arm lateral to the injection site), VACCINATION SITE PRURITUS (injection site extreme itching) and VACCINATION SITE PAIN (injection site feeling of burning) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, SARS-CoV-2 test: 44.7 (Inconclusive) 44.7. On 26-Mar-2021, Blood pressure measurement: 130/80 mmHg (Inconclusive) 130/80. On 26-Mar-2021, Body temperature: 98.6 (Inconclusive) 98.6. On 26-Mar-2021, Heart rate: 80 (Inconclusive) 80. On 26-Mar-2021, Respiratory rate: 16 (Inconclusive) 16.         The patient went to the emergency room and was observed for 1.5 hours after the second shot.   This case was linked to MOD-2021-029984 (Patient Link).