Sex: F
Vaccine: COVID19
Symptoms: Allergy test, Blood immunoglobulin E, Rash, SARS-CoV-2 test
Clinical narrative: neck rash 21Apr2021; This is a spontaneous report received from a contactable reporter(s) (Physician).  A female patient received BNT162b2 (BNT162B2), on 31Mar2021 at 14:30 as dose 2, single (Lot number: ER8734) intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Mild eczema" (ongoing), notes: Intermittent. The patient's family history included: "Hay Fever" (ongoing), notes: Childhood. Family medical history relevant to ae(s): Father and Grandmother: Hay fever. No prior vaccinations (within 4 weeks). There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Time: 14:30, Site and route of injection: Left deltoid, Route of administration: Intramuscular, Batch/Lot number: EP6955), administration date: 10Mar2021, for Covid-19 immunization.  The following information was reported: RASH (medically significant) with onset 21Apr2021, outcome "not recovered", described as "neck rash 21Apr2021". Patient Age at Time of Vaccination: 32 (as reported). Clinical course included: (name withheld) has developed an eruption on her face, neck, chest and hands about 3 weeks after her recovery from Covid-19 in Jan2022. She was treated as eczema by her primary care M.D with Desonide, Fluocinenide and protopic without improvement. The distribution of her eruption seemed to localize on the sun-exposed area of her skin (face, neck, "v" of chest doral hands and upper arms with few spots) and she was taking Zyrtec for her pruritus. The pattern suggested a possibility of Rx induced photodermatitis or polymorphous light eruption. She was advised to d/c Zyrtec and avoid sun exposure. Her eruption was clear but only for only then it received + became persistent. She was seen by a dermatologist and subsequently she was treated with a 2 week tapering course of prednisone 60 mg. she was clear while on prednisone, but 2 days after her prednisone course, the eruption recurred on her face, neck, chest and upper extremities and also spreaded to her trunk and lower extremities. Her eruption has persisted without change over the last few weeks. The patient underwent the following laboratory tests and procedures: Allergy test: (15Feb2022) Unknown results; (unspecified date) 0.13 kU/L, notes: Very low level; (unspecified date) 20.6 kU/L, notes: very high level; (unspecified date) 11.3 kU/L, notes: High Level; (unspecified date) 26.0 kU/L, notes: Very high level; Blood immunoglobulin E: (unspecified date) 576 kU/L, notes: Standard range: 114 or less kU/L; SARS-CoV-2 test: (16Jan2022) Positive. Therapeutic measures were not taken as a result of rash.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event rash and BNT162B2. 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.