Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Lip swelling, Pruritus, Pyrexia, Rash
Clinical narrative: Red; Red circular patches on both her inner arm / big red patches on her thighs about 6x12 inches wide/ big red patches on both arms / red patches on shoulders; fever; swollen lips; Generalized urticaria; itchy foot that developed with blisters / intermittent itching; hard for her to sit at work as the patches became swollen on her buttocks; Smaller red itchy patches on chest, nape's hairline, neck; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (swollen lips), URTICARIA (Generalized urticaria), PRURITUS (itchy foot that developed with blisters / intermittent itching), SWELLING (hard for her to sit at work as the patches became swollen on her buttocks) and RASH PRURITIC (Smaller red itchy patches on chest, nape's hairline, neck) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A121A and 0012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) for Urticaria, METFORMIN, INSULIN DEGLUDEC (TRESIBA), METOPROLOL, LISINOPRIL, SPIRONOLACTONE, FUROSEMIDE, VENLAFAXINE, ELDERBERRY [SAMBUCUS NIGRA] from an unknown date to 04-Apr-2021, ZINC SULFATE (ZINC SANDOZ) from an unknown date to 04-Apr-2021 and VITAMIN C [ASCORBIC ACID] from an unknown date to 04-Apr-2021 for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Apr-2021, the patient experienced LIP SWELLING (swollen lips), URTICARIA (Generalized urticaria), PRURITUS (itchy foot that developed with blisters / intermittent itching), SWELLING (hard for her to sit at work as the patches became swollen on her buttocks), RASH PRURITIC (Smaller red itchy patches on chest, nape's hairline, neck), RASH (Red circular patches on both her inner arm / big red patches on her thighs about 6x12 inches wide/ big red patches on both arms / red patches on shoulders) and PYREXIA (fever). On an unknown date, the patient experienced ERYTHEMA (Red). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) ongoing since an unknown date for Urticaria, at a dose of 1 dosage form once a day; LORATADINE (CLARITIN [LORATADINE]) ongoing since an unknown date for Urticaria, at a dose of 1 dosage form once a day; PREDNISONE at a dose of 1 dosage form once a day; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form and MENTHOL, ZINC OXIDE (GOLD BOND) for Adverse event, at an unspecified dose and frequency. At the time of the report, LIP SWELLING (swollen lips), URTICARIA (Generalized urticaria), PRURITUS (itchy foot that developed with blisters / intermittent itching), SWELLING (hard for her to sit at work as the patches became swollen on her buttocks), RASH PRURITIC (Smaller red itchy patches on chest, nape's hairline, neck), ERYTHEMA (Red), RASH (Red circular patches on both her inner arm / big red patches on her thighs about 6x12 inches wide/ big red patches on both arms / red patches on shoulders) and PYREXIA (fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On an unknown date, the patient had consulted a doctor via a tele consult twice who prescribed unknown anti-allergy medications, but the symptoms persisted.  On an unknown date, the patient reported then visited a primary care doctor. The doctor gave the patient a steroid shot and the symptoms were gone for a week. Then the symptoms came back and the doctor prescribed the oral form of steroid that the patient took for 2 weeks.  On 01 Jun 2021, the patient consulted a dermatologist and was given a steroid cream to be used for 2 weeks. Outcome unknown.  Patient states it is hard to sit at work due to patches on the buttocks becoming swollen.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Significant follow up appended - New reporters added (Physicians) On 02-Jun-2021: Non-significant Follow up appended On 02-Jun-2021: Non-Significant follow-up appended On 01-Aug-2021: Follow up  document received contains No New Information