Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Nasopharyngitis, Rash
Clinical narrative: Severe watery blister; Few weeks after getting vaccine starting developing cold symptoms; Rash around neck area, in the last 3 weeks caller says rash started to get bigger and occupy most areas around the body in the limbs, legs and under arms; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Severe watery blister) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Ataxia (disability with the Ataxia.).    On 17-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLISTER (Severe watery blister) (seriousness criterion medically significant), NASOPHARYNGITIS (Few weeks after getting vaccine starting developing cold symptoms) and RASH (Rash around neck area, in the last 3 weeks caller says rash started to get bigger and occupy most areas around the body in the limbs, legs and under arms). At the time of the report, BLISTER (Severe watery blister) and RASH (Rash around neck area, in the last 3 weeks caller says rash started to get bigger and occupy most areas around the body in the limbs, legs and under arms) had not resolved and NASOPHARYNGITIS (Few weeks after getting vaccine starting developing cold symptoms) outcome was unknown.            Concomitant medication of the patient was not reported.  Few weeks after vaccination patient had cold symptoms and rash around neck area, in the last 3 weeks rash started to get bigger and occupy most areas around the body in the limbs, legs and under arms. watery blister reaction got more severe and patient reported to emergency room for it. Patient was treated 3 different times and HCP did not find anything relevant.   Seriousness of blister event has been retained as serious changing the hospitalization criteria for the medically significant criteria because in case narrative, there is no evidence of hospitalization (the patient goes to emergency room but it is not clear if stays). Nevertheless, following medical judgment, the patient required in addition multiple medical consultations and the blisters were not resolved and thus, considered serious.  Company comment: This case concerns a 57-year-old, male patient with no relevant medical history, who experienced the unexpected serious event of blister with other non-serious unlisted and listed adverse events. The event of blister occurred on unknown date, at least more than four weeks after the second dose of Spikevax (Moderna COVID-19 vaccine). The rechallenge was not applicable since the events occurred after the second dose. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.; Sender's Comments: This case concerns a 57-year-old, male patient with no relevant medical history, who experienced the unexpected serious event of blister with other non-serious unlisted and listed adverse events. The event of blister occurred on unknown date, at least more than four weeks after the second dose of Spikevax (Moderna COVID-19 vaccine). The rechallenge was not applicable since the events occurred after the second dose. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report.