Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Borrelia test negative, C-reactive protein increased, Complement factor C4 decreased, Cryoglobulins absent, Cutaneous vasculitis
Clinical narrative: Leukocytoclastic vasculitis; A left sided mass below the parotid gland with associated lymphadenopathy.; A left sided mass below the parotid gland with associated lymphadenopathy.; Left sided neck swelling; Cervical lymph node biopsy was done but was nondiagnostic, suggestive of nongranulomatous lymphadenitis.; Neck mass; Purpuric rash; This is a spontaneous report from a contactable physician. A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 01Apr2021 (Lot number was not reported) as UNKNOWN, SINGLE for covid-19 immunisation. Medical history included prior breast DCIS, bipolar disorder, GERD (gastrooesophageal reflux disease), allergies to penicillins, cephalosporins, sulfamethoxizole. Concomitant medication included valproate semisodium (DIVALPROEX), sertraline (SERTRALINE), lorazepam (LORAZEPAM), all taken for an unspecified indication, start and stop date were not reported. The patient experienced leukocytoclastic vasculitis, a left sided mass below the parotid gland with associated lymphadenopathy, left sided neck swelling, cervical lymph node biopsy was done but was non-diagnostic, suggestive of non-granulomatous lymphadenitis, neck mass, all on 02Apr2021 with outcome of recovering, purpuric rash on Apr2021 with outcome of recovering. The patient was hospitalized for all events for 7 days. Events were caused doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No treatment received for all events. The patient underwent lab tests and procedures which included biopsy lymph gland: non-diagnostic, suggestive of non-granulomatous lymphadenitis on an unknown date, computerised tomogram - a left sided mass below the parotid gland with associated lymphadenopathy on an unknown date, biopsy skin - leukocytoclastic vasculitis on an unknown date. It is reported that, patient developed left sided neck swelling one day after vaccination. CT showed a left sided mass below the parotid gland with associated lymphadenopathy. Cervical lymph node biopsy was done but was non-diagnostic, suggestive of non-granulomatous lymphadenitis. Neck mass started to decrease in size about three weeks after vaccination. An additional symptom of purpuric rash developed about two weeks after vaccination. Skin biopsy showed leukocytoclastic vasculitis. Rash persisted x 5-7 days before dissipating without any specific treatment. The patient is not pregnant.  Information on the lot/batch number has been requested.; 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.