Age: 87.0
Sex: M
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 an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.   LITERATURE REFERENCE:  Concurrent medical conditions included Stasis dermatitis and Alzheimer's disease.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PEMPHIGOID (bullous pemphigoid) (seriousness criterion medically significant). The patient was treated with DOXYCYCLINE at an unspecified dose and frequency and NICOTINAMIDE at an unspecified dose and frequency. 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, Biopsy skin: demonstrated sub epidermal separation and dermal infiltrates with eosinophils. On an unknown date, Histology: (Positive) positive result of hematoxylin and eosin staining.. On an unknown date, Immunology test: Positive and C3.     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's dermatitis was worsened after the first dose and after second dose patient developed inflammatory vesicles and bullae  The event was treated with oral corticosteroid.   The event was ongoing at day 105.  The patient showed positive result of hematoxylin and eosin staining. Company comment: This is a literature non-study case concerning an 87-year-old male patient, with no history of bullous pemphigoid or autoimmunity, but with concurrent medical condition of stasis dermatitis that got worse after the first dose of the mRNA-1273 vaccine, who experienced the unexpected and serious (medically significant) event of bullous pemphigoid 21 days after the second dose of mRNA-1273 vaccine (dates were not reported; hence, latency could not be properly assessed). 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 positive for C3. Serum samples analyzed by ELISA technique (enzyme-linked immunosorbent assay) with recombinant BP180 and BP230 were both positive. He was treated with oral corticosteroid, doxycycline and nicotinamide, but event was on going at day 105.  Patient´s age could be a risk factor 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 MOD-2021-309422, MOD-2021-309423, MOD-2021-309421, MOD-2021-309420 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Sep-2021: Upon internal review on 14-Dec-2022, significant corrections performed. Event details, lab data, product indication, dose description and I narrtaive updated. On 07-Sep-2021: Follow up received by safety 09-Sep-2021 included an Email with FTA received from team and does not contain any new information. On 08-Sep-2021: Follow up received by safety 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 an 87-year-old male patient, with no history of bullous pemphigoid or autoimmunity, but with concurrent medical condition of stasis dermatitis that got worse after the first dose of the mRNA-1273 vaccine, who experienced the unexpected and serious (medically significant) event of bullous pemphigoid 21 days after the second dose of mRNA-1273 vaccine (dates were not reported; hence, latency could not be properly assessed). 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 positive for C3. Serum samples analyzed by ELISA technique with recombinant BP180 and BP230 were both positive. He was treated with oral corticosteroid, doxycycline and nicotinamide, but event was on going at day 105.  Patient´s age could be a risk factor 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.