Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pruritus, Pustule, Pyrexia, Stevens-Johnson syndrome
Clinical narrative: possibly a Stevens Johnson syndrome reaction; Blisters itch; blisters have white pustules/pustules have a grey white color of fluid in them/pustules sometimes burst; possibly a case of the shingles.; blisters burn; Greater then 35 days between Covid-19 vaccinations.; Developed a blister on her chest on 4JAN2022./developed what looks like blisters on her neck; chest pain; heart palpitations; shortness of breath; chest pressure; Rapid beating heart; body aches; fever of 102.9 degrees F; This spontaneous case was reported by a nurse and describes the occurrence of BURNS SECOND DEGREE (blisters burn), BLISTER (Developed a blister on her chest on 4JAN2022./developed what looks like blisters on her neck), STEVENS-JOHNSON SYNDROME (possibly a Stevens Johnson syndrome reaction), PRURITUS (Blisters itch), PUSTULE (blisters have white pustules/pustules have a grey white color of fluid in them/pustules sometimes burst), HERPES ZOSTER (possibly a case of the shingles.) and CHEST PAIN (chest pain) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Headache (Two headaches), Tachycardia (20 years) and Toxic shock syndrome (At the age of 14 years). Concomitant products included ATENOLOL, CLOPIDOGREL, SIMVASTATIN, ALPRAZOLAM, VENLAFAXINE and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 03-Jan-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2022, the patient experienced BLISTER (Developed a blister on her chest on 4JAN2022./developed what looks like blisters on her neck) (seriousness criterion medically significant), CHEST PAIN (chest pain) (seriousness criterion medically significant), PALPITATIONS (heart palpitations), DYSPNOEA (shortness of breath), CHEST DISCOMFORT (chest pressure), HEART RATE INCREASED (Rapid beating heart), MYALGIA (body aches) and PYREXIA (fever of 102.9 degrees F). On an unknown date, the patient experienced BURNS SECOND DEGREE (blisters burn) (seriousness criterion medically significant), STEVENS-JOHNSON SYNDROME (possibly a Stevens Johnson syndrome reaction) (seriousness criterion medically significant), PRURITUS (Blisters itch) (seriousness criterion medically significant), PUSTULE (blisters have white pustules/pustules have a grey white color of fluid in them/pustules sometimes burst) (seriousness criterion medically significant), HERPES ZOSTER (possibly a case of the shingles.) (seriousness criterion medically significant) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater then 35 days between Covid-19 vaccinations.). On 05-Jan-2022, CHEST PAIN (chest pain), PALPITATIONS (heart palpitations), CHEST DISCOMFORT (chest pressure) and HEART RATE INCREASED (Rapid beating heart) had resolved, DYSPNOEA (shortness of breath) outcome was unknown. At the time of the report, BURNS SECOND DEGREE (blisters burn), BLISTER (Developed a blister on her chest on 4JAN2022./developed what looks like blisters on her neck), STEVENS-JOHNSON SYNDROME (possibly a Stevens Johnson syndrome reaction), PRURITUS (Blisters itch), PUSTULE (blisters have white pustules/pustules have a grey white color of fluid in them/pustules sometimes burst), HERPES ZOSTER (possibly a case of the shingles.), MYALGIA (body aches) and PYREXIA (fever of 102.9 degrees F) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater then 35 days between Covid-19 vaccinations.) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jan-2022, Body temperature: 102.9 f (High) Increased.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No laboratory data was provided.  Patient experienced Cardiac related signs and symptoms like rapid beating heart and difficulty breathing. Patient was not diagnosed with myocarditis or pericarditis and COVID-19.  Treatment for the events were not provided.  Company comment:This is case concerning a 56-year-old female patient with past medical history of Tachycardia (20 years) and Toxic shock syndrome (At the age of 14 years), experienced the unexpected serious events of Blister, Chest pain, Burns second degree, Stevens Johnson syndrome, Pruritus, Pustule, Herpes zoster and other nonserious events (seriousness criterion medically significant). The events Blister, Chest pain Palpitations, Dyspnea, Chest discomfort, Heart rate increased occurred one day after the second dose ofmRNA-1273 vaccine and events of Burns second degree, Stevens-Johnson, Pruritus, Pustule Herpes zoster occurred on unknown date after the vaccination. Additionally, Inappropriate schedule of product administration (greater than 35 days between first and second dose of vaccinations.) was captured as an event. The outcome was reported as unknown .The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2022-449543 (E2B Linked Report). This case was linked to MOD-2022-449302 (Patient Link).; Sender's Comments: This is case concerning a 56-year-old female patient with past medical history of Tachycardia (20 years) and Toxic shock syndrome (At the age of 14 years), experienced the unexpected serious events of Blister, Chest pain, Burns second degree, Stevens Johnson syndrome, Pruritus, Pustule, Herpes zoster and other nonserious events (seriousness criterion medically significant). The events Blister, Chest pain Palpitations, Dyspnea, Chest discomfort, Heart rate increased occurred one day after the second dose ofmRNA-1273 vaccine and events of Burns second degree, Stevens-Johnson, Pruritus, Pustule Herpes zoster occurred on unknown date after the vaccination. Additionally, Inappropriate schedule of product administration (greater than 35 days between first and second dose of vaccinations.) was captured as an event. The outcome was reported as unknown .The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. MOD-2022-449543:Case is crosslinked to MOD22-002375