Age: 78.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Biopsy, Hypersensitivity, Pruritus, Rash morbilliform
Clinical narrative: developed rash to the chest, head and all over the body/Rash looked like measles; Scalp was extremely itchy; dermal hypersensitivity reaction; This is spontaneous stimulated report received from a contactable health care professional. A 78-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose intramuscular, administered in right arm on 04Mar2021 (Lot Number: EN2605) as single dose for covid-19 immunisation; hydrocodone bitartrate, paracetamol (NORCO), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included gastrooesophageal reflux disease (GERD), hyperlipidaemia, chronic lymphocytic leukaemia (CLL), Degenerative joint disease (DJD). No allergies to medications, food, or other products. Concomitnat medications the patient received within 2 weeks of vaccination including amlodipine, celebrex, lipitor, omeprazole. The patient previously took first dose BNT162B2 on 11Feb2021 for covid-19 immunisation via intramuscular at left arm, developed rash on chest bilaterally on 20Feb2021. Went to dermatology, doctor gave triamcinolone for treatment. The most recent COVID-19 vaccine was administered at hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Few days after second dose patient developed rash to the chest, head and all over the body. He went back to dermatology and had biopsy near his hair line. Scalp was extremely itchy, so given clobetasol. Rash looked like measles. Not on face or hands. Saw derm again on 18Mar2021, received cortisone injection with second one on 25Mar2021- first shot-4 hours of relief from itching, rash lessened temporarily and then new areas started developing. BX results (as reported): some of the features raise possibility of angiolyphoid hyperplasia with eosinophilia but favors dermal hypersensitivity reaction. No swollen lymph nodes that patient notes. Patient is extremely itchy. Taking benadryl and taking allegra during the day. Only change recently has been switching norco from 7.5/325 three times a day to 5/325 four times a day.  Wonders if the increased APAP dose caused the rash. Events resulted in doctor or other healthcare professional office/clinic visit. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Treatment received for adverse events included pepcid, benadryl, clobesatol, allegra, Zyrtec. The event outcome for events was recovering.; Sender's Comments: Based on the temporal relationship, the association between the events measles-like rash, itchiness, and dermal hypersensitivity with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.