Sex: M
Vaccine: COVID19
Symptoms: Rosacea, Skin bacterial infection, Swelling face
Clinical narrative: acute localized exanthematous pustulosis; facial swelling; nonpruritic erythema/ bilateral edematous, erythematous; leukocytosis with neutrophil predominance; Demodex folliculitis; skin and soft tissue infection; neutrophilic dermatosis; rosacea fulminans; chills; facial rash; This literature-non-study case was reported in a literature article and describes the occurrence of ACUTE GENERALISED EXANTHEMATOUS PUSTULOSIS (acute localized exanthematous pustulosis) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   LITERATURE REFERENCE:  No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ACUTE GENERALISED EXANTHEMATOUS PUSTULOSIS (acute localized exanthematous pustulosis) (seriousness criterion medically significant), LEUKOCYTOSIS (leukocytosis with neutrophil predominance), FOLLICULITIS (Demodex folliculitis), SKIN BACTERIAL INFECTION (skin and soft tissue infection), NEUTROPHILIC DERMATOSIS (neutrophilic dermatosis), ROSACEA (rosacea fulminans) and RASH (facial rash). an unknown date, the patient experienced SWELLING FACE (facial swelling), ERYTHEMA (nonpruritic erythema/ bilateral edematous, erythematous) and CHILLS (chills). The patient was treated with CEPHALEXIN [CEFALEXIN] for Adverse event, at an unspecified dose and frequency and HALOBETASOL for Adverse event, at a dose of 0.05 percent. At the time of the report, ACUTE GENERALISED EXANTHEMATOUS PUSTULOSIS (acute localized exanthematous pustulosis), SWELLING FACE (facial swelling), ERYTHEMA (nonpruritic erythema/ bilateral edematous, erythematous), LEUKOCYTOSIS (leukocytosis with neutrophil predominance), FOLLICULITIS (Demodex folliculitis), SKIN BACTERIAL INFECTION (skin and soft tissue infection), NEUTROPHILIC DERMATOSIS (neutrophilic dermatosis), ROSACEA (rosacea fulminans) and CHILLS (chills) outcome was unknown and RASH (facial rash) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Bacterial test: negative (Negative) bacterial culture from a pustule did not reveal a causative organism. In 2021, Histology: infiltrate of neutrophils interstitially (abnormal) Interstitial and intrafollicular infiltrate composed mostly of neutrophils with some admixed lymphocytes and plasma cells that are present in the superficial and deep dermis, showing negative infectious stains. There is follicular dilatation and plugging. Neutrophils with prominent involvement of hair follicles.. In 2021, Neutrophil count: high (High) leukocytosis with neutrophil predominance.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ACUTE GENERALISED EXANTHEMATOUS PUSTULOSIS (acute localized exanthematous pustulosis), SWELLING FACE (facial swelling), ERYTHEMA (nonpruritic erythema/ bilateral edematous, erythematous), LEUKOCYTOSIS (leukocytosis with neutrophil predominance), FOLLICULITIS (Demodex folliculitis), SKIN BACTERIAL INFECTION (skin and soft tissue infection), NEUTROPHILIC DERMATOSIS (neutrophilic dermatosis), ROSACEA (rosacea fulminans), RASH (facial rash) and CHILLS (chills) to be possibly related.    Concomitant product use was not provided by the reporter.  It was reported that the patient involved was presented to their department 4 days after receiving initial dose of the mRNA-1273 vaccine. On examination, a well-demarcated plaque with overlying punctate monomorphic pustules and crusting on the central face and eyelids at 4 days after administration of an mRNA-1273 vaccine in patient 1 was observed.  The abrupt onset of facial erythema, edema, and pustules may be consistent with rosacea fulminans, although the lack of nodules, papules, and cysts and occurrence in 2 older men go against that diagnosis. It was unclear if that facial eruption in the setting of the mRNA-1273 vaccine represents a distinct entity or an unmasking of a dermatologic condition in a predisposed individual.  The patient received the second vaccine dose as scheduled without recurrence.  Company Comment: Based on the current available information which includes a temporal association between the use of the product and onset of the event and excluding bother etiologies, a causal relationship cannot be excluded. Rash and chills are consistent with the product known safety profile   This case was linked to MOD-2021-273838 (Patient Link).; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the event and excluding bother etiologies, a causal relationship cannot be excluded. Rash and chills are consistent with the product known safety profile