Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Oral discomfort, Paraesthesia, Throat irritation, Throat tightness, Urticaria
Clinical narrative: mouth burning; face burning; hot and cold issues with nerves; she gets burning hot and heat waves come up; chills; metallic taste in mouth; difficulty in breathing\ntermittent difficulty in breathing; hives rash around throat and face; chest wall tingling/throat tingling/Tingling in her arms, legs, mouth, face; throat burning; throat closing; chest wall burning; chest wall closing; light-headed; anaphylactic reaction; This spontaneous case was reported by a health care professional 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 nos. 012L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy. Concomitant products included TAFLUPROST (ZIOPTAN) for Glaucoma, LIOTHYRONINE SODIUM and LEVOTHYROXINE for Thyroid disorder.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced ANAPHYLACTIC REACTION (anaphylactic reaction) (seriousness criterion medically significant), DYSPNOEA (difficulty in breathing\ntermittent difficulty in breathing), URTICARIA (hives rash around throat and face), PARAESTHESIA (chest wall tingling/throat tingling/Tingling in her arms, legs, mouth, face), THROAT IRRITATION (throat burning), THROAT TIGHTNESS (throat closing), CHEST PAIN (chest wall burning), CHEST DISCOMFORT (chest wall closing) and DIZZINESS (light-headed). On 05-Apr-2021, the patient experienced DYSGEUSIA (metallic taste in mouth). On an unknown date, the patient experienced ORAL DISCOMFORT (mouth burning), BURNING SENSATION (face burning), DYSAESTHESIA (hot and cold issues with nerves), FEELING HOT (she gets burning hot and heat waves come up) and CHILLS (chills). On 05-Feb-2021, ANAPHYLACTIC REACTION (anaphylactic reaction) had resolved. At the time of the report, DYSGEUSIA (metallic taste in mouth), DYSPNOEA (difficulty in breathing\ntermittent difficulty in breathing), URTICARIA (hives rash around throat and face), PARAESTHESIA (chest wall tingling/throat tingling/Tingling in her arms, legs, mouth, face), THROAT IRRITATION (throat burning), THROAT TIGHTNESS (throat closing), CHEST PAIN (chest wall burning), CHEST DISCOMFORT (chest wall closing), DIZZINESS (light-headed), ORAL DISCOMFORT (mouth burning), BURNING SENSATION (face burning), DYSAESTHESIA (hot and cold issues with nerves), FEELING HOT (she gets burning hot and heat waves come up) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jan-2021, COVID-19: positive (Positive) Positive. On 31-Jan-2021, COVID-19: negative (Negative) Negative. On 02-Feb-2021, COVID-19: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   She was not admitted to the hospital. She stated she had to go back to the emergency room a few times since then for symptoms of burning and tingling in her arms, legs, mouth, face, as well as hot and cold issues with her nerves, and tightening of her throat and chest. She immediately treated with Bedadryl (unknown dosage), Pepcid40mg, Prednisone 40mg, ongoing- Prednisone 5mg daily, Pepcid 20mg daily, Claritin 10mg daily.   Company comment: This case concerns a 61 Y/O F with a serious expected anaphylactic reaction, and dyspnea, urticaria, paraesthesia, throat irritation, throat tightness, chest pain, chest discomfort, dizziness, dysgeusia, oral discomfort, burning sensation, feeling hot, chills, and nervous system disorder. Event onset immediately after second dose. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-087026, US-MODERNATX, INC.-MOD-2021-087026 (E2B Linked Report).; Sender's Comments: This case concerns a 61 Y/O F with a serious expected anaphylactic reaction, and dyspnea, urticaria, paraesthesia, throat irritation, throat tightness, chest pain, chest discomfort, dizziness, dysgeusia, oral discomfort, burning sensation, feeling hot, chills, and nervous system disorder. Event onset immediately after second dose. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-087026:Case for dose 1 US-MODERNATX, INC.-MOD-2021-087026:case for dose 2