Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Allergy to vaccine, Biopsy skin, Fatigue, Inflammation
Clinical narrative: Pemphigus vulgaris/autoimmune disease; Really bad reaction; Hurting so much/not able to do anything/is in a lot of pain/rash was still very painful like second degree burns/it's affecting lips, throat, inside of the mouth; Abdominal pain; Rashes in the body/rashes in the belly/it was a little rash/rash got worse/It's a very different rash/rash was still very painful like second degree burns; Diagnosed with a skin disorder/ Rash vesicular; Again like sore throat; Allergic reaction; Not able to do anything; Inflammation on throat; This spontaneous case was reported by a consumer and describes the occurrence of PEMPHIGUS (Pemphigus vulgaris/autoimmune disease), VACCINATION COMPLICATION (Really bad reaction), PAIN (Hurting so much/not able to do anything/is in a lot of pain/rash was still very painful like second degree burns/it's affecting lips, throat, inside of the mouth), ABDOMINAL PAIN (Abdominal pain), RASH (Rashes in the body/rashes in the belly/it was a little rash/rash got worse/It's a very different rash/rash was still very painful like second degree burns) and RASH VESICULAR (Diagnosed with a skin disorder/ Rash vesicular) in a 67-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.     No Medical History information was reported.   In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Jun-2021, the patient experienced INFLAMMATION (Inflammation on throat). On an unknown date, the patient experienced PEMPHIGUS (Pemphigus vulgaris/autoimmune disease) (seriousness criterion medically significant), VACCINATION COMPLICATION (Really bad reaction) (seriousness criterion medically significant), PAIN (Hurting so much/not able to do anything/is in a lot of pain/rash was still very painful like second degree burns/it's affecting lips, throat, inside of the mouth) (seriousness criterion medically significant), ABDOMINAL PAIN (Abdominal pain) (seriousness criterion medically significant), RASH (Rashes in the body/rashes in the belly/it was a little rash/rash got worse/It's a very different rash/rash was still very painful like second degree burns) (seriousness criterion medically significant), RASH VESICULAR (Diagnosed with a skin disorder/ Rash vesicular) (seriousness criterion medically significant), OROPHARYNGEAL PAIN (Again like sore throat), ALLERGY TO VACCINE (Allergic reaction) and FATIGUE (Not able to do anything). At the time of the report, PEMPHIGUS (Pemphigus vulgaris/autoimmune disease), VACCINATION COMPLICATION (Really bad reaction), PAIN (Hurting so much/not able to do anything/is in a lot of pain/rash was still very painful like second degree burns/it's affecting lips, throat, inside of the mouth), ABDOMINAL PAIN (Abdominal pain), RASH (Rashes in the body/rashes in the belly/it was a little rash/rash got worse/It's a very different rash/rash was still very painful like second degree burns), RASH VESICULAR (Diagnosed with a skin disorder/ Rash vesicular), INFLAMMATION (Inflammation on throat), OROPHARYNGEAL PAIN (Again like sore throat), ALLERGY TO VACCINE (Allergic reaction) and FATIGUE (Not able to do anything) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy skin: abnormal (abnormal) Pemphigus vulgaris.         No concomitant products use was reported.  It was reported that the patient had the Moderna COVID-19 vaccine back in May (beginning of May first dose and end of May the second). She did not know she had a reaction until 02Jun2021 after the second shot, but she had it after the first shot. After the second shot she had again like sore throat, on 02Jun2021 went to emergency and the doctor only saw inflammation on her throat. It was like that for 5 days and when she came back from the hospital she was sent back to the hospital again with abdominal pain and rashes in the body and the belly, it was a little rash and She went to the family care doctor and a dermatologist that prescribed her antibiotics and nothing worked. They did a test in the skin and she was diagnosed with a skin disorder. She was given a creamand more antibiotics, nothing worked and the rash got worse. She was seen by around five different doctors. After the second biospy on her skin she was diagnosed with pemphigus vulgaris, it's actually a blister rash from head to toe (in June started a little bit but then it got worse). She does not have bacteria on the skin that's why the antibiotics were not working. She took her to a specialist back at the end of July. It's a very different rash and doctors had not seen it before either.  Treatment medication included  steroids and antibiotics, unspecified.  company comment: This case concerns a 67 year-old female patient with no reported medical history who experienced the unexpected event of pemphigus vulgaris, vaccination complication, rash, vesicular rash, pain, and abdominal pain. The events occurred approximately 3 days after the second dose of mRNA-1273. The rechallenge was not applicable as no additional dosing will be administered. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-339272 (Patient Link).; Sender's Comments: This case concerns a 67 year-old female patient with no reported medical history who experienced the unexpected event of pemphigus vulgaris, vaccination complication, rash, vesicular rash, pain, and abdominal pain. The events occurred approximately 3 days after the second dose of mRNA-1273. The rechallenge was not applicable as no additional dosing will be administered. The benefit-risk relationship of mRNA-1273 is not affected by this report.