Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Stevens-Johnson syndrome
Clinical narrative: Stevens-Johnson syndrome (SJS) and it gave her an outbreak; Chills; This spontaneous case was reported by a patient and describes the occurrence of STEVENS-JOHNSON SYNDROME (Stevens-Johnson syndrome (SJS) and it gave her an outbreak) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stevens-Johnson syndrome.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced STEVENS-JOHNSON SYNDROME (Stevens-Johnson syndrome (SJS) and it gave her an outbreak) (seriousness criterion medically significant) and CHILLS (Chills). The patient was treated with PREDNISONE in 2021 for Rash, at an unspecified dose and frequency. At the time of the report, STEVENS-JOHNSON SYNDROME (Stevens-Johnson syndrome (SJS) and it gave her an outbreak) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient ethnicity was reported.  No concomitant medication was reported.  Reportedly, patient had a reaction to 1st shot of Moderna, she had Stevens-Johnson syndrome (SJS) and it gave her an outbreak, it was pretty bad and she had to be put in prednisone to help her with the rash. She also had fever, headache, chills, bad rash all over her. Her doctor told her not to get the Moderna shot for the 2nd dose.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This spontaneous case concerns a 71-year-old, female patient with medical history of Stevens-Johnson syndrome (SJS), who experienced the unexpected, serious (medically significant) AESI of Stevens-Johnson syndrome and an expected, non-serious event. The events occurred unknown number of days after receiving the first dose of the mRNA-1273 vaccine. Of note, the vaccination date was reported as unspecified date in Mar2021 and the event onset dates were reported as unspecified dates in 2021, hence, the onset latency could not be assessed. It was reported that the patient had Stevens-Johnson syndrome and the vaccine gave her an outbreak. The patient experienced fever, headache, chills and 'bad rash all over'. She was treated with prednisone (unspecified dose, frequency and duration) to help with the rash. Her doctor also advised her not to receive the second dose of the mRNA-1273 vaccine. The history of SJS remains a risk factor for the event Stevens-Johnson syndrome since it increases the risk of developing SJS. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 71-year-old, female patient with medical history of Stevens-Johnson syndrome (SJS), who experienced the unexpected, serious (medically significant) AESI of Stevens-Johnson syndrome and an expected, non-serious event. The events occurred unknown number of days after receiving the first dose of the mRNA-1273 vaccine. Of note, the vaccination date was reported as unspecified date in Mar2021 and the event onset dates were reported as unspecified dates in 2021, hence, the onset latency could not be assessed. It was reported that the patient had Stevens-Johnson syndrome and the vaccine gave her an outbreak. The patient experienced fever, headache, chills and 'bad rash all over'. She was treated with prednisone (unspecified dose, frequency and duration) to help with the rash. Her doctor also advised her not to receive the second dose of the mRNA-1273 vaccine. The history of SJS remains a risk factor for the event Stevens-Johnson syndrome since it increases the risk of developing SJS. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.