Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Skin burning sensation, Vaccination site swelling, Vaccination site warmth
Clinical narrative: hurt with a burning/itching at same time; tenderness of the lymph node; swelling of the lymph node; hard; Burning; red; Itching; Vaccination site very hot to touch/felt very warm above site; my arm was bright red/arm was red; hurt with a burning/itching at same time; left arm started to swell under the vaccination site/arm swollen just below vaccination site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BURNING SENSATION (Burning), ERYTHEMA (red), PRURITUS (Itching), VACCINATION SITE WARMTH (Vaccination site very hot to touch/felt very warm above site) and ERYTHEMA (my arm was bright red/arm was red) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Anaphylaxis (Full blown anaphylaxis on tablet) in February 2017. Concurrent medical conditions included Allergy to antibiotic, Autoimmune thyroiditis since 15-Jun-2014, Arthritis, Increased blood pressure and Hypothyroidism. Concomitant products included HYDROXYCHLOROQUINE from 19-Jun-2019 to an unknown date and DULOXETINE HYDROCHLORIDE from 19-Jun-2019 to an unknown date for Arthritis, LIOTHYRONINE and LEVOTHYROXINE for Hypothyroidism, LISINOPRIL for Increased blood pressure, PARACETAMOL (TYLENOL) and COLECALCIFEROL (VIT D [COLECALCIFEROL]) for an unknown indication.   On 15-Mar-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Vaccination site very hot to touch/felt very warm above site) and ERYTHEMA (my arm was bright red/arm was red). 15-Mar-2021, the patient experienced PRURITUS (hurt with a burning/itching at same time). 15-Mar-2021, the patient experienced VACCINATION SITE SWELLING (left arm started to swell under the vaccination site/arm swollen just below vaccination site). On 17-Mar-2021, the patient experienced BURNING SENSATION (Burning), ERYTHEMA (red), PRURITUS (Itching), LYMPH NODE PAIN (tenderness of the lymph node), LYMPHADENOPATHY (swelling of the lymph node) and LYMPH NODE PAIN (hard). On an unknown date, the patient experienced SKIN BURNING SENSATION (hurt with a burning/itching at same time). On 21-Mar-2021, BURNING SENSATION (Burning), PRURITUS (Itching), VACCINATION SITE SWELLING (left arm started to swell under the vaccination site/arm swollen just below vaccination site), LYMPH NODE PAIN (tenderness of the lymph node), LYMPHADENOPATHY (swelling of the lymph node) and LYMPH NODE PAIN (hard) had resolved, ERYTHEMA (red) outcome was unknown. At the time of the report, VACCINATION SITE WARMTH (Vaccination site very hot to touch/felt very warm above site), PRURITUS (hurt with a burning/itching at same time) and SKIN BURNING SENSATION (hurt with a burning/itching at same time) outcome was unknown and ERYTHEMA (my arm was bright red/arm was red) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Dec-2020, SARS-CoV-2 test: positive (Positive) The patient tested positive for COVID-19 and lasted for three to four weeks.. On an unknown date, Blood group A: negative (Negative) Negative. On an unknown date, Blood pressure measurement: normal (normal) Felt fine. On an unknown date, Heart rate: normal (normal) Normal. On an unknown date, Respiratory rate: abnormal (abnormal) abnormal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications were not provided. Upon internal review on 24-May-2021, age was corrected to unknown.  The patient's blood group was group A negative.   The red arm continued for three weeks but was encouraged by the physician for second vaccination dose. The patient had no reaction after second shot on the same arm. The patient cough a lot seemed like COVID mucous in bronchial tubes. The patient was treated with ipratropium bromide as inhaler and nasal solution worked but was too tired than usual.   This case was linked to MOD-2021-255764 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Additional information was received on 14-Jul-21: Consumer address was updated, product details updated for second dose of vaccination, facility name updated, relevant medical history was updated, concomitant medications were added and events were added