Age: 78.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Injection site pruritus, Injection site rash, Injection site warmth, Laboratory test, Malaise
Clinical narrative: URINARY TRACT INFECTION; VERTIGO PROBLEM WHICH WAS WORSE THAN RASH; STUCK MONITORS TO HER SKIN SHE HAD AN ALLERGIC REACTION; HANDS START TO FLARE UP AND GET IRRITATED; NOT FEELING WELL; 1 TO 1.5 INCH SPOT AT THE INJECTION SITE WAS WARM TO THE TOUCH/ RASH WAS WARMTH; RASH THAT WAS IRRITATED; RASH THAT WAS SORE; 1 TO 1.5 INCH SPOT AT THE INJECTION SITE THAT WAS LIGHT PINK/ RASH WAS RED; RASH AT THE INJECTION SITE/ PINK RASH; 1 TO 1.5 INCH SPOT AT THE INJECTION SITE WAS ITCHY; This spontaneous report received from a patient via a company representative concerned a 78 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: atopic dermatitis/eczema, allergy to propylene glycol, 17 allergies, and rash. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: dupilumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) 300 mg, frequency was not reported, from 27-APR-2021, 600 mg, frequency was not reported from 13-MAY-2021 to 13-MAY-2021, 300 mg, frequency, and therapy dates were not reported, dose and frequency were not reported from 10-JUN-2021, dose and frequency were not reported from 24-JUN-2021, and dose and frequency were not reported from 08-JUL-2021 for atopic dermatitis/eczema. No concomitant medications were reported. On JUN-2021, the patient experienced 1 to 1.5 inch spot at the injection site was itchy. On 10-JUN-2021, the patient experienced rash that was irritated, rash at the injection site/ pink rash, rash that was sore, and 1 to 1.5 inch spot at the injection site that was light pink/ rash was red. On 24-JUN-2021, the patient experienced 1 to 1.5 inch spot at the injection site was warm to the touch/ rash was warmth. On an unspecified date, the patient experienced urinary tract infection, vertigo problem which was worse than rash, stuck monitors to her skin she had an allergic reaction, hands start to flare up and get irritated, and not feeling well. Laboratory data (dates unspecified) included: Laboratory test (NR: not provided) Not reported. Treatment medications (dates unspecified) included: loratadine, and paraffin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of dupilumab was not changed. The patient recovered from rash that was irritated, and rash that was sore on 14-JUN-2021, was recovering from not feeling well, urinary tract infection, vertigo problem which was worse than rash, and stuck monitors to her skin she had an allergic reaction, and had not recovered from 1 to 1.5 inch spot at the injection site that was light pink/ rash was red, 1 to 1.5 inch spot at the injection site was itchy, 1 to 1.5 inch spot at the injection site was warm to the touch/ rash was warmth, rash at the injection site/ pink rash, and hands start to flare up and get irritated. This report was non-serious. Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.