Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatologic examination, Histology, Immunology test, Pemphigoid
Clinical narrative: Bullous pemphigoid; This literature-non-study case was reported in a literature article and describes the occurrence of PEMPHIGOID (Bullous pemphigoid) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.        Concurrent medical conditions included Raynaud's syndrome and Major depression.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PEMPHIGOID (Bullous pemphigoid) (seriousness criterion medically significant). At the time of the report, PEMPHIGOID (Bullous pemphigoid) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Dermatologic examination: cutaneous bullae distant from the injection site. On an unknown date, Histology: (Positive) hematoxylin and eosin staining positive (Consistent with BP (subepidermal split, infiltrate with eosinophils). On an unknown date, Immunology test: (Negative) at dermal epidermal junction: Negative; IIF (indirect immunofluorescence) result: Negative and (Negative) Neg/Neg (Serum IgG level according to ELISA, U/mL. Test results were considered negative if BP180 was less than 14 U/mL and BP230 was less than 9 U/mL).     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was temporarily withheld on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  The patient was treated with oral corticosteroid and topical corticosteroid. The event was ongoing at month 2.  Company Comment: This literature non-study case concerns an 83-year-old female patient, with relevant medical condition of Raynaud´s syndrome, and without history of bullous pemphigoid, who experienced the unexpected and serious (due to medically significant) event of Pemphigoid, which occurred 8 days after the first dose of mRNA-1273 vaccine. Patient developed inflammatory vesicles and bullae. She was evaluated by a dermatologist, who recorded cutaneous bullae distant from the injection site. Skin biopsy was performed and showed hematoxylin and eosin staining positive, consistent with bullous pemphigoid, with subepidermal split and infiltrate with eosinophils; direct immunofluorescence histology at dermal epidermal junction was negative, with indirect immunofluorescence negative too. IgG level according to ELISA was negative. Patient received treatment with oral and topical corticosteroids. At 2 months follow up, the event was ongoing. Underlying Raynaud´s syndrome could be a confounder for the case. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.- MOD-2021-309334, US-MODERNATX, INC.- MOD-2021-309422, US-MODERNATX, INC.- MOD-2021-309421 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Sep-2021: Upon internal review on 19-Dec-2022, correction was performed to update the event bullous pemphigoid. On 07-Sep-2021: Follow up received by safety 09-Sep-2021 included an email with full text article and does not contain any new information.; Sender's Comments: This literature non-study case concerns an 83-year-old female patient, with relevant medical condition of Raynaud´s syndrome, and without history of bullous pemphigoid, who experienced the unexpected and serious (due to medically significant) event of Pemphigoid, which occurred 8 days after the first dose of mRNA-1273 vaccine. Patient developed inflammatory vesicles and bullae. She was evaluated by a dermatologist, who recorded cutaneous bullae distant from the injection site. Skin biopsy was performed and showed hematoxylin and eosin staining positive, consistent with bullous pemphigoid, with subepidermal split and infiltrate with eosinophils; direct immunofluorescence histology at dermal epidermal junction was negative, with indirect immunofluorescence negative too. IgG level according to ELISA was negative. Patient received treatment with oral and topical corticosteroids. At 2 months follow up, the event was ongoing. Underlying Raynaud´s syndrome could be a confounder for the case. The benefit-risk relationship of mRNA-1273 is not affected by this report.