Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash macular, SARS-CoV-2 antibody test, Skin disorder, Viral rash
Clinical narrative: eczema; her eruption seemed to localize on the sun-exposed area of her skin; pruritus; Photodermatitis; polymorphous light eruption; photodermatitis; Dog dander 11.3 KU/L high level/ Cladosporium herbarum(m2) IgE very low level/ Dermatophagoides 20.6 KU/L very high level/ Farinae (d2), pteronyssinus 26.0 KU/L very high level; immunoglobulin E 576 KU/L; upper arms with few spots; more severe viral exanthem rash; neck rash 26Nov2021; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 32-year-old female patient received BNT162b2 (BNT162B2), on 05Nov2021 as dose 3 (booster), single (Lot number: 320308D) intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Mild eczema" (ongoing), notes: Intermittent; "Hay fever" (ongoing), notes: Childhood. The patient's family history included: "Hay Fever" (ongoing), notes: Father and grandmother - Hay fever. The patient's concomitant medications were not reported. 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; BNT162b2 (DOSE 2, SINGLE, Time: 14:30, Site and route of injection: Left Deltoid, Route of administration: Intramuscular, Batch/Lot number: ER8734), administration date: 31Mar2021, for COVID-19 immunization. The following information was reported: RASH (medically significant) with onset 26Nov2021, outcome "not recovered", described as "neck rash 26Nov2021"; VIRAL RASH (medically significant) with onset 10Feb2022, outcome "not recovered", described as "more severe viral exanthem rash"; ECZEMA (non-serious), outcome "unknown"; SKIN DISORDER (non-serious), outcome "not recovered", described as "her eruption seemed to localize on the sun-exposed area of her skin"; PRURITUS (non-serious), outcome "unknown"; PHOTOSENSITIVITY REACTION (non-serious), outcome "not recovered", described as "Photodermatitis"; POLYMORPHIC LIGHT ERUPTION (non-serious), outcome "not recovered", described as "polymorphous light eruption"; DERMATITIS (non-serious), outcome "not recovered", described as "photodermatitis"; LABORATORY TEST ABNORMAL (non-serious), outcome "unknown", described as "Dog dander 11.3 KU/L high level/ Cladosporium herbarum(m2) IgE very low level/ Dermatophagoides 20.6 KU/L very high level/ Farinae (d2), pteronyssinus 26.0 KU/L very high level"; BLOOD IMMUNOGLOBULIN E INCREASED (non-serious), outcome "unknown", described as "immunoglobulin E 576 KU/L"; RASH MACULAR (non-serious), outcome "unknown", described as "upper arms with few spots". The events "eczema", "her eruption seemed to localize on the sun-exposed area of her skin", "pruritus", "photodermatitis", "polymorphous light eruption" and "photodermatitis" required physician office visit. The event "more severe viral exanthem rash" required emergency room visit. 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) 26.0 kU/L, notes: Very high level; Allergy to animal: (unspecified date) 11.3 kU/L, notes: High level; Blood immunoglobulin E: (unspecified date) 576 kU/L, notes: Standard range: 114 or less kU/L; SARS-CoV-2 antibody test: (16Jan2022) Positive. Therapeutic measures were taken as a result of viral rash, eczema, skin disorder, pruritus, photosensitivity reaction, polymorphic light eruption, dermatitis, rash macular. Therapeutic measures were not taken as a result of rash.  Clinical information: Patient has developed an eruption on her face, neck, chest and hands about 3 weeks after her recovery from Covid-19 in Jan2022. Patient 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. Patient was advised to d/c Zyrtec and avoid sun exposure. Patient eruption was clear but only for only then it received + became persistent. Patient was seen by a dermatologist and subsequently she was treated with a 2 week tapering course of prednisone 60 mg. Patient 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. Patient eruption has persisted without change over the last few weeks.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be 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.