Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis, Extrasystoles, Rash
Clinical narrative: was in the hospital Saturday night due to the ugly rash; suddenly got premature heartbeat and came out of nowhere; Had rash after vaccine shot (Moderna), Doctor thinks its dermatitis and not eczema/had a reaction; This spontaneous case was reported by a consumer and describes the occurrence of RASH (was in the hospital Saturday night due to the ugly rash) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product DUPILUMAB solution for injection for Dermatitis atopic.    The patient's past medical history and family history were not provided.    On 05-Nov-2021, the patient DUPILUMAB (Subcutaneous) dosage was changed to 600 milligram once a day. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and DUPILUMAB (Subcutaneous) 300 milligram. On 14-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (was in the hospital Saturday night due to the ugly rash) (seriousness criterion hospitalization). In November 2021, the patient experienced EXTRASYSTOLES (suddenly got premature heartbeat and came out of nowhere) and DERMATITIS (Had rash after vaccine shot (Moderna), Doctor thinks its dermatitis and not eczema/had a reaction). The patient was treated with PREDNISONE at a dose of high dose. At the time of the report, RASH (was in the hospital Saturday night due to the ugly rash) outcome was unknown and EXTRASYSTOLES (suddenly got premature heartbeat and came out of nowhere) and DERMATITIS (Had rash after vaccine shot (Moderna), Doctor thinks its dermatitis and not eczema/had a reaction) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient never had been on any real medication. The patient had been on more medications in the past 3 months than his entire life.  concomitant medication and vaccination(s) were not provided.  The patient had rash after receiving the Moderna vaccine & the doctor thought that it's Dermatitis. It was reported that the said rash got progressively worse & worse (rash erythematous) hence it was subsumed under Dermatitis.  Company comment: This spontaneous case concerns a 60-year-old, male patient with medical history of Atopic Dermatitis treated with the co-suspect product Dupixent (dupilumab), who experienced the unexpected, serious (hospitalization) event of rash, and the unexpected, non-serious events of extrasystoles (AESI) and dermatitis. The event rash occurred 9 days after receiving Dupixent and unknown number of days after receiving an unspecified dose of the mRNA-1273 vaccine. Of note, the vaccination date was not provided, hence, the onset latency could not be assessed. The other events occurred unknown number of days after receiving Dupixent and unknown number of days after receiving an unspecified dose of the mRNA-1273 vaccine. Of note, the event onset dates were reported as unspecified dates in Nov2021, hence, the onset latency could not be assessed. It was reported that patient was in the hospital on a Saturday night (date was not provided) due to the 'ugly rash'. He suddenly experienced premature heartbeat which came out of nowhere. No further details were provided regarding the premature heartbeat. It was also reported that the Dupixent shots did not work and the patient had a reaction. The drug was discontinued and the patient started with a different therapy of high-dose prednisone. On an unspecified date after vaccination, the patient had a rash and the doctor thought that it was dermatitis and not eczema. It was also reported that the patient woke up and had two giant red marks on his stomach which got progressively worse and worse. Treatment information was not provided. Of note, the reporter assessed the event dermatitis as not related to the mRNA-1273 vaccine. The medical history of Atopic Dermatitis remains a confounder for the events rash and dermatitis (erythematous rash) which are common symptoms of this medical condition. The co-suspect product Dupixent also remains a confounder for the events rash and dermatitis. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.  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.; Sender's Comments: This spontaneous case concerns a 60-year-old, male patient with medical history of Atopic Dermatitis treated with the co-suspect product Dupixent (dupilumab), who experienced the unexpected, serious (hospitalization) event of rash, and the unexpected, non-serious events of extrasystoles (AESI) and dermatitis. The event rash occurred 9 days after receiving Dupixent and unknown number of days after receiving an unspecified dose of the mRNA-1273 vaccine. Of note, the vaccination date was not provided, hence, the onset latency could not be assessed. The other events occurred unknown number of days after receiving Dupixent and unknown number of days after receiving an unspecified dose of the mRNA-1273 vaccine. Of note, the event onset dates were reported as unspecified dates in Nov2021, hence, the onset latency could not be assessed. It was reported that patient was in the hospital on a Saturday night (date was not provided) due to the 'ugly rash'. He suddenly experienced premature heartbeat which came out of nowhere. No further details were provided regarding the premature heartbeat. It was also reported that the Dupixent shots did not work and the patient had a reaction. The drug was discontinued and the patient started with a different therapy of high-dose prednisone. On an unspecified date after vaccination, the patient had a rash and the doctor thought that it was dermatitis and not eczema. It was also reported that the patient woke up and had two giant red marks on his stomach which got progressively worse and worse. Treatment information was not provided. Of note, the reporter assessed the event dermatitis as not related to the mRNA-1273 vaccine. The medical history of Atopic Dermatitis remains a confounder for the events rash and dermatitis (erythematous rash) which are common symptoms of this medical condition. The co-suspect product Dupixent also remains a confounder for the events rash and dermatitis. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.