Sex: F
Vaccine: COVID19
Symptoms: Polymerase chain reaction, Red blood cell sedimentation rate, Rheumatoid factor, Ultrasound scan
Clinical narrative: vaccination supported the association of KFD like lymphadenopathy related to COVID-19 vaccine; She only experienced mild and transitory general malaise without axillary symptoms; This is a literature report.  A female patient in her 40's received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE UNKNOWN MANUFACTURER), for COVID-19 Immunisation. The following information was reported: HISTIOCYTIC NECROTISING LYMPHADENITIS (medically significant), outcome "recovered", described as "vaccination supported the association of KFD like lymphadenopathy related to COVID-19 vaccine"; MALAISE (medically significant), outcome "unknown", described as "She only experienced mild and transitory general malaise without axillary symptoms". The patient underwent the following laboratory tests and procedures: Antinuclear antibody: Negative; Negative, notes: For SLE; Biopsy: showed multifocal necrotising lymphadenopathy, notes: characterised by foci of necrosis surrounded by reactive appearing small lymphoid cells, histiocytes and plasma cells. The interface of the viable reactive lymphoid cells (left of arrow) and the necrotic foci (right of arrow) is shown (A, H&E stain, x40 magnification). Foci of necrosis showed apoptotic cellular debris and haemorrhage (B, H&E stain, x40 magnification). The lymphoid cells at the interface and surrounding foci of necrosis are small and mature without overt cytological atypia (C, arrow; H&E stain, x40 magnification). Immunohistochemistry testing confirmed the presence of small B cells expressing CD20 and small T cells expressing CD3, the former present in perinecrotic foci in the latter also present within necrotic foci. CD68 highlights reactive histiocytes present within necrotic foci (CD20, CD3 and CD68 immunohistochemistry-stained slides, x20 magnification). Not shown are negative for organisms stains including GMS fungal stain, acid-fast bacillus stain, Warthin-Starry silver stain, cytomegalovirus and herpes simplex virus immunohistochemistry stains; using a 14-gauge and automated gun; Blood immunoglobulin M: Negative; Cell marker: confirmed the presence of aggregates, notes: of plasmacytoid dendritic cells surrounding necrotic foci; highlights frequent histiocytes, notes: which were present in aggregates surrounding necrotic foci and also in a diffuse paracortical distribution; C-reactive protein: Normal; Culture: Negative, notes: for fungal organisms; Negative, notes: for Bartonella species; cytomegalovirus test: Negative; Flow cytometry: Negative, notes: for detection of abnormal B-cell or T-cell populations; Haematocrit: 41.6 %; Haemoglobin: 13.7 g/dl; Herpes simplex test: Negative; Histology: evidence of malignancy was not identified; showed necrotising lymphadenitis, notes: with associated aggregates of histiocytes and plasmacytoid dendritic cells, suggesting an infectious or inflammatory/autoimmune aetiology; Immunohistochemistry: CD20-positive B cells were present, notes: in aggregates and in a scattered paracortical distribution. cells were small in size without cytological atypia. CD3-positive T cells were relatively more abundant and present within the nodal paracortex surrounding B-cell aggregates; Clinical examination: in addition to the palpable right axillary, notes: lymph node, a slightly prominent left inguinal lymph node was palpated; Mammogram: Were stable and negative, notes: without any signs to suggest a breast primary malignancy; demonstrated a new large, notes: and dense right axillary mass with irregular margins on the mediolateral oblique view without other mammographic abnormalities. Cropped right mediolateral oblique synthetic two-dimensional view showing an enlarged, dense right axillary mass with irregular margins (arrow) corresponding to the palpable abnormality as denoted by a triangular marker; Mycobacterium test: Negative, notes: for acid-fast bacilli; General examination: Normal; Platelet count: Normal; Polymerase chain reaction: Negative; Red blood cell sedimentation rate: Normal; Rheumatoid factor: Negative; Ultrasound scan: Were stable and negative, notes: without any signs to suggest a breast primary malignancy; the lymph node measured 2.5 cm, with, notes: a markedly hypoechoic cortex which measured 0.6 cm and mild hilar displacement. Right axillary ultrasound showed an enlarged axillary lymph node with a 0.6 cm hypoechoic cortex with mild hilar displacement (arrow) corresponding to the palpable and mammographic mass.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events HISTIOCYTIC NECROTISING LYMPHADENITIS , MALAISE 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.