Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis, Erythema, Feeling hot, Insomnia, Loss of personal independence in daily activities
Clinical narrative: At night it gets worse, i can not sleep; My face and neck is completely wrinkled; Feeling hot; I need a fan on my neck during the day and at night; Dermatitis/ rash on her face, neck, chest; Red skin on face and neck/ redness/ erythema local; during the day I cannot do my work; I will kill myself because I can not tolerate this situation anymore; Itchiness started on the neck, and face/ itching local; This spontaneous case was reported by a nurse and describes the occurrence of PRURITUS (Itchiness started on the neck, and face/ itching local), INSOMNIA (At night it gets worse, i can not sleep), SKIN WRINKLING (My face and neck is completely wrinkled), FEELING HOT (Feeling hot; I need a fan on my neck during the day and at night) and DERMATITIS (Dermatitis/ rash on her face, neck, chest) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sleep apnea (Obstructive sleep apnea on cpap), Chronic interstitial cystitis, Irritable bowel syndrome, Prediabetes and Rhinitis. Concomitant products included PENTOSAN POLYSULFATE SODIUM (ELMIRON) for Chronic interstitial cystitis, BACLOFEN, CITALOPRAM, METFORMIN, MELOXICAM (MOBIC), ESTRADIOL (ESTRACE) and CAFFEINE, CODEINE PHOSPHATE, PARACETAMOL (TYLENOL WITH CODEIN #3) for an unknown indication.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced PRURITUS (Itchiness started on the neck, and face/ itching local). On an unknown date, the patient experienced INSOMNIA (At night it gets worse, i can not sleep), SKIN WRINKLING (My face and neck is completely wrinkled), FEELING HOT (Feeling hot; I need a fan on my neck during the day and at night), DERMATITIS (Dermatitis/ rash on her face, neck, chest), ERYTHEMA (Red skin on face and neck/ redness/ erythema local), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (during the day I cannot do my work) and SUICIDAL IDEATION (I will kill myself because I can not tolerate this situation anymore). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) ongoing since an unknown date for Dermatitis, at a dose of 1 dosage form twice a day; PREDNISONE (oral) on 03-Mar-2021 at a dose of 20 milligram; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) ongoing since an unknown date for Dermatitis, at a dose of UNK dosage form, bid, prn; TRIAMCINOLONE ACETONIDE (KENALOG [TRIAMCINOLONE ACETONIDE]) (intramuscular) for Dermatitis, at a dose of 60 milligram, 2 shots; TRIAMCINOLONE ACETONIDE (KENALOG [TRIAMCINOLONE ACETONIDE]) (intramuscular) for Dermatitis, at a dose of 40 milligram; DOXYCYCLINE for Dermatitis, at a dose of 100 milligram twice a day; MUPIROCIN for Dermatitis, at a dose of UNK dosage form, bid; CLOBETASOL for Dermatitis, at a dose of UNK dosage form, bid; TACROLIMUS MONOHYDRATE (PROTOPIC) (topical) for Dermatitis, at a dose of .1 percent twice a day; HYDROXYZINE (ATARAX [HYDROXYZINE]) (oral) for Itching, at a dose of 50 milligram at bedtime; MOMETASONE FUROATE (MOMETASONE [MOMETASONE FUROATE]) (topical) for Dermatitis, at a dose of 1 dosage form twice a day; SULFACETAMIDE SODIUM, SULFUR (SULFACETAMIDE SODIUM AND SULFUR [SULFACETAMIDE SODIUM;SULFUR]) (topical) for Dermatitis, at a dose of 10-5% and LIDOCAINE (XYLOCAINE [LIDOCAINE]) at a dose of 50 milligram. At the time of the report, PRURITUS (Itchiness started on the neck, and face/ itching local), INSOMNIA (At night it gets worse, i can not sleep), SKIN WRINKLING (My face and neck is completely wrinkled), FEELING HOT (Feeling hot; I need a fan on my neck during the day and at night), DERMATITIS (Dermatitis/ rash on her face, neck, chest), ERYTHEMA (Red skin on face and neck/ redness/ erythema local) and SUICIDAL IDEATION (I will kill myself because I can not tolerate this situation anymore) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On an unspecified date, she visited the emergency room for severe itching and was treated with an injectable cortisol.  Additional treatment included topical steroid creams and foams obtained.  Punch biopsy of skin lesions was done on 17-Jun-2021, the results of which were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-132664 (E2B Linked Report). This case was linked to MOD-2021-245696 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow up ADR form with doctor visit notes appended on 30-Jun-2021. Added patient demographics, race, ethnicity, medical history, diagnostic tests, treatment medications and events with outcome. On 30-Jun-2021: Non-significant Follow-up. Dose 1 and Dose 2 Crosslinking done.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-132664:Crosslinked case