Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Body temperature, COVID-19, Drug ineffective, Pruritus
Clinical narrative: COVID Disease; Lack of drug effect; red spots some middle clusters, looked like a rash; Some itching/severe itching started all over the body from head to toe; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (red spots some middle clusters, looked like a rash), PRURITUS (Some itching/severe itching started all over the body from head to toe), COVID-19 (COVID Disease) and DRUG INEFFECTIVE (Lack of drug effect) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced RASH MACULAR (red spots some middle clusters, looked like a rash) and PRURITUS (Some itching/severe itching started all over the body from head to toe). In October 2021, the patient experienced COVID-19 (COVID Disease) and DRUG INEFFECTIVE (Lack of drug effect). The patient was treated with IVERMECTIN at an unspecified dose and frequency. At the time of the report, RASH MACULAR (red spots some middle clusters, looked like a rash), PRURITUS (Some itching/severe itching started all over the body from head to toe), COVID-19 (COVID Disease) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Body temperature: high (High) High fever. In October 2021, SARS-CoV-2 test: positive (Positive) Positive in late October 2021. On an unknown date, Biopsy: results not provided Dermatologist did biopsy, but the results were not provided.         Concomitant medication of the patient was not reported.  In late October 2021, the patient had COVID Disease, high fever, bad headache and received an unknown shot. MD sent the patient to a specialist.  For the event, some itching the patient did not connect it to the vaccine and did not seek medical attention. Company comment: This case concerns a 75-year-old female patient with no medical history reported, who experienced the non-serious, unexpected events of drug ineffective and COVID-19 (AESI), approximately 8 months days after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The patient experienced COVID-19 with SARS-CoV-2 test: positive, high fever, bad headache and severe itching all over the body and was treated with IVERMECTIN. A biopsy was done and the results not reported. The outcome of the events is unknown. The risk-benefit relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.   This case was linked to MOD-2022-489029 (Patient Link).; Sender's Comments: This case concerns a 75-year-old female patient with no medical history reported, who experienced the non-serious, unexpected events of drug ineffective and COVID-19 (AESI), approximately 8 months days after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The patient experienced COVID-19 with SARS-CoV-2 test: positive, high fever, bad headache and severe itching all over the body and was treated with IVERMECTIN. A biopsy was done and the results not reported. The outcome of the events is unknown. The risk-benefit relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.