Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin, 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 a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.   LITERATURE REFERENCE:      Concurrent medical conditions included Herpes simplex.    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 resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy skin: Abnormal. Subepidermal separation and dermal infiltrates with eosinophils. On an unknown date, Histology: (Positive) hematoxylin and eosin (H&E staining) positive. On an unknown date, Immunology test: (Negative) negative, at dermal epidermal junction (DEJ).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided by the reporter.  Patient was treated with oral corticosteroids.  The patient 4 lab test included BP180-IgG ELISA (BP180/230) with no data available. It was reported that there were no flares after dose 2. Company comment: This is a literature non-study case concerning a 70-year-old female patient, with no history of bullous pemphigoid or autoimmunity, but with concurrent medical condition of herpes simplex, who experienced the unexpected and serious (medically significant) event of bullous pemphigoid 9 days after the first dose of mRNA-1273 vaccine. The dermatological evaluation recorded cutaneous bullae distant from the injection site and the skin biopsy demonstrated subepidermal separation and dermal infiltrates with eosinophils and with positive result of hematoxylin and eosin staining. The direct immunofluorescence histology at dermal epidermal junction was negative. She was treated with oral corticosteroid and resolved.  Patient´s age could be a risk factor for the event and her current condition of herpes simplex could be a confounder for the event. No further clinical information was available for medical review.  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-2021-309423 (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. On 08-Sep-2021: Follow up received by safety on 09-Sep-2021 with No new information was received from the author upon follow up.; Sender's Comments: This is a literature non-study case concerning a 70-year-old female patient, with no history of bullous pemphigoid or autoimmunity, but with concurrent medical condition of herpes simplex, who experienced the unexpected and serious (medically significant) event of bullous pemphigoid 9 days after the first dose of mRNA-1273 vaccine. The dermatological evaluation recorded cutaneous bullae distant from the injection site and the skin biopsy demonstrated subepidermal separation and dermal infiltrates with eosinophils and with positive result of hematoxylin and eosin staining. The direct immunofluorescence histology at dermal epidermal junction was negative. She was treated with oral corticosteroid and resolved.  Patient´s age could be a risk factor for the event and her current condition of herpes simplex could be a confounder for the event. No further clinical information was available for medical review.  The benefit-risk relationship of mRNA-1273 is not affected by this report.