Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Cutaneous lupus erythematosus, Immunisation reaction
Clinical narrative: Cutaneous Lupus/bumps in the skin 2 weeks after the covid arm; Covid arm 3 weeks after receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of CUTANEOUS LUPUS ERYTHEMATOSUS (Cutaneous Lupus/bumps in the skin 2 weeks after the covid arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Iodine allergy, Drug allergy (Darvocet) and Hypotension (Hypotension, started before receiving the vaccines.).    On 20-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In December 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced IMMUNISATION REACTION (Covid arm 3 weeks after receiving the vaccine). On an unknown date, the patient experienced CUTANEOUS LUPUS ERYTHEMATOSUS (Cutaneous Lupus/bumps in the skin 2 weeks after the covid arm) (seriousness criterion medically significant). The patient was treated with HYDROXYCHLOROQUINE on 04-Apr-2022 for Adverse event, at an unspecified dose and frequency. At the time of the report, CUTANEOUS LUPUS ERYTHEMATOSUS (Cutaneous Lupus/bumps in the skin 2 weeks after the covid arm) had not resolved and IMMUNISATION REACTION (Covid arm 3 weeks after receiving the vaccine) outcome was unknown.            On 29-JAN-2021 Patient had first dose of Moderna COVID-19 Vaccine  with Lot no 032L20A. On 26-FEB-2021 patient had Second dose of Moderna covid-19 Vaccine with LOT NO 031M20A. Patient had  "Covid arm" about 3 weeks after the shot and then 2 weeks later she developed bumps in the skin, a biopsy diagnosed her with cutaneous lupus, patient states that no one in her family has history of Lupus. Concomitant medications were not reported. Height: 5'2  Company comment: This is a spontaneous case concerning a 65-year-old, female patient with relevant medical history of allergy to Iodine and Propoxyphene napsylate + Acetaminophen (Darvocet) and vaccine history of receiving first and second dose of mRNA-1273, who experienced the unexpected serious (medically significant) event of cutaneous lupus erythematosus and unexpected non-serious event of Covid arm. The event Covid arm occurred 3 weeks after the first booster dose of mRNA-1273 vaccine administration while the event cutaneous lupus erythematosus exact occurrence unknown but stated that the event occurred after the first booster dose of mRNA-1273 vaccine administration. The events were described as, patient experienced Covid arm about 3 weeks after the first booster dose and then 2 weeks later patient developed bumps in the skin, a biopsy diagnosed the patient with cutaneous lupus. It was reported that the patient has no family history of Lupus. Patient received treatment with Hydroxychloroquine. No other information surrounding the events was reported. The medical history of allergy remain confounder for the event Covid arm. Patient's gender remain confounder for the event cutaneous lupus erythematosus. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 65-year-old, female patient with relevant medical history of allergy to Iodine and Propoxyphene napsylate + Acetaminophen (Darvocet) and vaccine history of receiving first and second dose of mRNA-1273, who experienced the unexpected serious (medically significant) event of cutaneous lupus erythematosus and unexpected non-serious event of Covid arm. The event Covid arm occurred 3 weeks after the first booster dose of mRNA-1273 vaccine administration while the event cutaneous lupus erythematosus exact occurrence unknown but stated that the event occurred after the first booster dose of mRNA-1273 vaccine administration. The events were described as, patient experienced Covid arm about 3 weeks after the first booster dose and then 2 weeks later patient developed bumps in the skin, a biopsy diagnosed the patient with cutaneous lupus. It was reported that the patient has no family history of Lupus. Patient received treatment with Hydroxychloroquine. No other information surrounding the events was reported. The medical history of allergy remain confounder for the event Covid arm. Patient's gender remain confounder for the event cutaneous lupus erythematosus. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.