Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin, Skin bacterial infection, Type IV hypersensitivity reaction
Clinical narrative: Delayed Hypersensitivity; superimposed bacterial skin infection; This literature-non-study case was reported in a literature article and describes the occurrence of TYPE IV HYPERSENSITIVITY REACTION (Delayed Hypersensitivity) and SKIN BACTERIAL INFECTION (superimposed bacterial skin infection) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.   LITERATURE REFERENCE:     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TYPE IV HYPERSENSITIVITY REACTION (Delayed Hypersensitivity) (seriousness criteria hospitalization and medically significant) and SKIN BACTERIAL INFECTION (superimposed bacterial skin infection) (seriousness criteria hospitalization and medically significant). At the time of the report, TYPE IV HYPERSENSITIVITY REACTION (Delayed Hypersensitivity) and SKIN BACTERIAL INFECTION (superimposed bacterial skin infection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy skin: acanthosis, spongiosis and superficial and mild dermal perivascular lymphocytic infiltration with occasional eosinophils compatible with a dermal hypersensitivity reaction.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The patient presented with widespread pruritic urticarial indurated papules on the arms, legs and palms, sparing the face; six months following the booster vaccine. The patient denied constitutional symptoms, new medications, recent illnesses or new personal care products.  The patient was admitted to the hospital due to the need for systemic steroids as well as IV antibiotics secondary to a superimposed bacterial skin infection in the setting of severe itching and skin injury. The patient was discharged on oral steroids with recommendation for follow-up to dermatology and rheumatology.  Company Comment: This literature non study case concerns an elderly female patient aged 83 years with no medical history reported, who experienced the unexpected, serious (Medically significant/Hospitalization) events of Type IV hypersensitivity reaction, Skin bacterial infection that occurred after a dose (reported as booster) of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date nor event onset date was disclosed. It was reported that patient presented with widespread pruritic urticarial indurated papules on the arms, legs and palms, sparing the face; six months following the booster vaccine. The patient denied constitutional symptoms, new medications, recent illnesses or new personal care products. The patient was admitted to the hospital due to the need for systemic steroids as well as IV antibiotics secondary to a superimposed bacterial skin infection in the setting of severe itching and skin injury. Punch biopsy skin showed acanthosis, spongiosis and superficial and mild dermal perivascular lymphocytic infiltration with occasional eosinophils compatible with a dermal hypersensitivity reaction. The patient was discharged on oral steroids with recommendation for follow-up to dermatology and rheumatology. No further clinical information was available for medical review. Outcome of the events was unknown at the time of report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This literature non study case concerns an elderly female patient aged 83 years with no medical history reported, who experienced the unexpected, serious (Medically significant/Hospitalization) events of Type IV hypersensitivity reaction, Skin bacterial infection that occurred after a dose (reported as booster) of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date nor event onset date was disclosed. It was reported that patient presented with widespread pruritic urticarial indurated papules on the arms, legs and palms, sparing the face; six months following the booster vaccine. The patient denied constitutional symptoms, new medications, recent illnesses or new personal care products. The patient was admitted to the hospital due to the need for systemic steroids as well as IV antibiotics secondary to a superimposed bacterial skin infection in the setting of severe itching and skin injury. Punch biopsy skin showed acanthosis, spongiosis and superficial and mild dermal perivascular lymphocytic infiltration with occasional eosinophils compatible with a dermal hypersensitivity reaction. The patient was discharged on oral steroids with recommendation for follow-up to dermatology and rheumatology. No further clinical information was available for medical review. Outcome of the events was unknown at the time of report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.