Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Pruritus genital, Skin lesion, Urticaria
Clinical narrative: Headache; Scrotal pruritis; Lesions on whole body and moreso where clothing touches or pressure especially feet and back/He then developed skin lesions on scrotal area and anywhere; Itching; Lesions on whole body and moreso where clothing touches or pressure especially feet, that he was wearing clothes and it was almost like contact dermatitis; Urticaria that has developed; received third dose of the vaccine last week; received third dose of the vaccine last week; This is a spontaneous report received from a contactable consumer (patient's daughter). A 68-year-old male patient received third dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported, via an unspecified route of administration, on an unspecified date in Sep2021 (age at vaccination: 69-years-old), single dose for COVID-19 immunization. The patient's medical history reported as none and concomitant medications were not reported. The patient did not receive any vaccine in four week prior to covid vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported, via an unspecified route of administration on an unspecified date, as DOSE 1, SINGLE for COVID-19 immunization and second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported, via an unspecified route of administration on an unspecified date, as DOSE 2, SINGLE for COVID-19 immunization. The consumer reported that, on an unspecified date in Sep2021, day 1 post administration of third dose, he had a slight headache, and thought that, he was advised by a friend who was an RN, not to take ibuprofen and he did not premedicate. When he got the headache, he took Aspirin, but he would typically take Tylenol, and did not. On day 2, the headache became more severe and he took additional Aspirin. By Friday, on Day 3, he still had a headache and took Aspirin. She did not have the manufacturer, dose, lot or expiration for the Aspirin he took. He developed scrotal pruritis and then lesions on whole body, on scrotal area and anywhere that he was wearing clothes and it was almost like contact dermatitis, wherever skin was touching anything. He was in his truck on a long drive and on his back, where it was pressure or touching seat, he had Urticaria that had developed. She said that was a specific type of skin lesion that he used to describe it. It had improved slightly because he was also trying to had looser boxers and was modifying his clothing. The itching began in scrotal area and proceeded to feet and back. The Pruritis preceded the Urticaria. He was over 65 years old and was with the public in an area highly resistant to masks and vaccines. He never had any adverse events taking Aspirin before either. After his second dose, he did have antibody levels tested and his immune response to the two doses was undetectable. He had no titers present. She was surprised with so many anti-maskers that he was exposed to. He may have had a COVID test prior to being vaccinated, but she does not know for certain. He did not develop any titers through natural exposure., and shortly after second dose, there were none. The patient received treatment aspirin for the event headache. On an unspecified date, the patient underwent lab test and procedure which include antibody test which showed no antibodies present. Outcome of the events headache, scrotal pruritis, skin lesion and urticaria was recovering and outcome for the rest of the events itching, contact dermatitis, off label use and booster was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.