Age: 62.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Extra dose administered, Immunisation, Off label use, Rash pruritic
Clinical narrative: Itchy rash (Rash pruritic); Pfizer Biontech Covid-19 Vaccine: 14Jul2022 - 14Jul2022; Pfizer Biontech Covid-19 Vaccine: 14Jul2022 - 14Jul2022; Pfizer Biontech Covid-19 Vaccine: 14Jul2022 - 14Jul2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient received BNT162b2 (BNT162B2), on 14Jul2022 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 62 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at 1 in 2 wk, subcutaneous. The patient's relevant medical history included: "Crohn's disease" (unspecified if ongoing). Concomitant medication(s) included: CITRACAL [CALCIUM CARBONATE;COLECALCIFEROL;VITAMIN K NOS], start date: May2020, stop date: 14Jul2022; OMEPRAZOLE, start date: Jan2021, stop date: 14Jul2022; ACETAMINOPHEN, start date: 13Jul2022, stop date: 13Jul2022; EVUSHELD. Past drug history included: Ampicillin, reaction(s): "Ampicillin allergy", notes: Ampicillin allergy; Vicodin, reaction(s): "Allergy to vicodin", notes: Allergy to vicodin. Vaccination history included: moderna (1st dose - Moderna 1st dose 30Mar2021), administration date: 30Mar2021, when the patient was 61-year-old, for COVID-19 immunization; BNT162b2 (2nd dose - Pfizer 1st dose 15Aug2021), administration date: 15Aug2021, when the patient was 61-year-old, for COVID-19 immunization; BNT162b2 (3rd dose (1st booster) - Pfizer 2nd dose 02Mar2022), administration date: 02Mar2022, when the patient was 62-year-old, for COVID-19 immunization; moderna (4th dose (2nd booster) - Moderna 2nd dose 27Apr2022), administration date: 27Apr2022, when the patient was 62-year-old, for Covid-19 Immunization; BNT162b2 (5th dose (3rd booster) - Pfizer 3rd dose 03Jul2022), administration date: 03Jul2022, when the patient was 62-year-old, for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious), EXTRA DOSE ADMINISTERED (non-serious) all with onset 14Jul2022 and all described as "Pfizer Biontech Covid-19 Vaccine: 14Jul2022 - 14Jul2022"; RASH PRURITIC (non-serious) with onset 16Jul2022, described as "Itchy rash (Rash pruritic)". The action taken for adalimumab was unknown.  Additional information: On 16Jul2022, the patient experienced Itchy rash between thighs for which Humira (Adalimumab) and Tozinameran was considered as suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Concomitant drugs included multivitamins plus iron(ascorbic acid; cyanocobalamin; ferrous sulfate; folic acid; nicotinamide; pyridoxine hydrochloride; riboflavin; thia-mine hydrochloride)(ascorbic acid, pyridoxine hydrochloride, folic acid, thiamine  hydrochloride, cya-nocobalamin, riboflavin, nicotinamide, ferrous sulfate) from May2020 to14Jul2022 and nature's bounty adult multivitamin(ascorbic acid; biotin; calcium pantothenate; choline bitartrate; colecalciferol; cyanocobalamin; dl-alpha tocopheryl acetate; fibre soluble;folic acid; inositol; magnesium  citrate; nico-tinic acid; pyridoxine hydrochloride; retinol palmitate; zinc citrate)(ascorbic acid, pyridoxine hydrochloride, biotin, folic acid, nicotinic acid, colecalciferol, cyanocobalamin, retinol palmitate, choline bitartrate, inositol, calcium pantothenate, zinc citrate, magnesium citrate, dl-alpha tocopheryl acetate, fibre soluble) from May2022 to 14May2022 Causality for Humira (Adalimumab): The reporter's causality for the event of Itchy rash between thighs was not provided. Causality as per reporter (Drug/Vaccine) was Not Reported. Causality for Itchy rash (Rash pruritic) with Tozinameran: Causality as per reporter (Drug/Vaccine) was possible  Follow-up attempts are completed. No further information is expected.