Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Hypersensitivity
Clinical narrative: Hypersensitivity reaction; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Hypersensitivity reaction) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included Hives, Birth control pill since 08-Jan-2018 and Tonsillectomy (At age of 4, doctors had to remove tonsils because since she was a baby always suffered from severe allergies.). Previously administered products included for Product used for unknown indication: Chickenpox (Never had anaphylaxis with other vaccines (chickenpox)) and Tetanus (Never had anaphylaxis with other vaccines (tetanus)). Past adverse reactions to the above products included No adverse event with Chickenpox and Tetanus. Concurrent medical conditions included Anaphylaxis, Hypersensitivity reaction, Asthma, Seasonal allergy (Had asthma) on 01-May-2019, Dust allergy (Had asthma) on 01-May-2019, Allergy to plants (Allergy to olive tree/other tree- had asthma) on 01-May-2019, Food allergy (Had hives) on 01-Apr-2018, Allergy to chemicals (Allergy to showel gel, creams, hair dye products- Had asthma) on 01-Mar-2014 and Allergy to plants (Allergy to olive trees, platanaceae, cypress, other trees- had asthma) on 01-May-2005. Concomitant products included ETHINYLESTRADIOL, NORGESTIMATE (SPRINTEC) from 01-Aug-2018 to an unknown date for Birth control pill.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021 at 8:00 AM, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction) (seriousness criterion medically significant). The patient was treated with ADRENALINE [EPINEPHRINE] on 20-Mar-2021 for Shortness of breath, at a dose of UNK, qd. At the time of the report, HYPERSENSITIVITY (Hypersensitivity reaction) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Mar-2021, Heart rate: >100 (abnormal) Heart rate >100 beats per min, Irregular heart rate/palpitations.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered HYPERSENSITIVITY (Hypersensitivity reaction) to be related.    Race reported as   It was reported that on 20-Mar-2022, the second night after first Moderna vaccine her husband had to put her the epipen due to shortness of breath. Her entire arm, lips and face were red and swollen. Signs and symptoms pertaining to final diagnosis of hypersensitivity reaction reported included tinnitus, tachycardia, insomnia, cramps, tingling, generalized itching/pruritus, local hives/urticaria, irregular heart rate/palpitation, heart rate >100 beats per min, nausea/vomiting, generalized redness/erythema, swelling of upper airway (lips, tongue, throat, uvula, or larynx), sensation of throat closing, red/itchy eyes, difficulty breathing, generalized rash, chest tightness, decreased level of consciousness, chills, unusual taste, prickling/tingling sensation, numbness and feeling hot.  She never had tachycardia, tinnitus, tingling, insomnia, cramps in hands, back and feet before her two Covid vaccines. It was also reported that this horrible tinnitus has changed her life in so many ways. The noises patient hear the 24hrs make her feel as a robot and not as a person.  Company Comment: This is a spontaneous case concerning a 41 year old female patient with a relevant medical history of allergy to chemicals, plant products and dust, asthma and post tonsillectomy status, who experienced the unexpected, serious (medically significant) event of Hypersensitivity, about 1 day after receiving the first dose of mRNA-1273 vaccine. The patient experienced itching, hives, tinnitus connected to tachycardia, nausea, swelling of upper airways, difficulty breathing, chest tightness, decreased level of consciousness, chills, numbness and tingling sensation for which the patient sought medical care. She was diagnosed with hypersensitivity reaction and treated with epinephrine. At the time of the report, the event was ongoing. Allergic predisposition and post tonsillectomy status of the patient could be risk factors for the event. The benefit-risk relationship of mRNA-1273 in not affected by this report.  This case was linked to MOD-2021-276660 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 41 year old female patient with a relevant medical history of allergy to chemicals, plant products and dust, asthma and post tonsillectomy status, who experienced the unexpected, serious (medically significant) event of Hypersensitivity, about 1 day after receiving the first dose of mRNA-1273 vaccine.The patient experienced itching, hives, tinnitus connected to tachycardia, nausea, swelling of upper airways, difficulty breathing, chest tightness, decreased level of consciousness, chills, numbness and tingling sensation for which the patient sought medical care. She was diagnosed with hypersensitivity reaction and treated with epinephrine. At the time of the report, the event was ongoing. Allergic predisposition and post tonsillectomy status of the patient could be risk factors for the event. The benefit-risk relationship of mRNA-1273 in not affected by this report.