Sex: F
Vaccine: COVID19
Symptoms: Platelet count
Clinical narrative: 20 days after the second dose, seen to have a painful, distorted Baker IV capsular contracture; Six days after the second dose, she noted an enlarged lymph node in her left axilla; small delayed hematoma was the cause of the contracture; Thirteen days after the second dose, she reported that her left breast was firm, swollen, and "tight".; This is a literature report.  A 34 year-old female patient received bnt162b2 (BNT162B2) 21 days after first dose, administered in deltoid left/ left shoulder (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "augmentation/periareolar mastopexy" (unspecified if ongoing), notes: she underwent augmentation/ peri areolar mastopexy with a sub pectoral 440 cc smooth-walled implant; "gravida 3, para 3" (unspecified if ongoing), notes: healthy gravida 3, para 3 woman. The patient's concomitant medications were not reported. Past drug history included: Cefazolin, notes: Preoperative intravenous cefazolin (1 g) was given. The implant pocket was irrigated with triple antibiotic solution (1 g cefazolin, 50,000 U of bacitracin, 80 mg gentamicin); Bacitracin, notes: The implant pocket was irrigated with triple antibiotic solution (1 g cefazolin, 50,000 U of bacitracin, 80 mg gentamicin); Gentamicin, notes: The implant pocket was irrigated with triple antibiotic solution (1 g cefazolin, 50,000 U of bacitracin, 80 mg gentamicin); Povidone-iodine solution. Poly-4-hydroxybutyrate mesh reinforcement was used inside the implant pocket; this product is routinely used by the author for augmentation/mastopexies to support both the parenchyma and the implant position. Tegaderm nipple shields, routinely used by the author for augmentations, were not used in this case due to the need to transpose the nipple-areolar complex. The implant was placed with an insertion funnel through a separate inframammary incision. Postoperatively she did well, and at 6 weeks, postoperative photographs demonstrate good implant position, and at 10 weeks, postop was noted to have good implant position with soft and movable implants (Baker I) bilaterally. Vaccination history included: Bnt162b2 (Dose 1 (five months postoperatively received first dose of the Pfizer vaccine), Anatomical location: Left shoulder). The following information was reported: CAPSULAR CONTRACTURE ASSOCIATED WITH BREAST IMPLANT (hospitalization, medically significant), outcome "unknown", described as "20 days after the second dose, seen to have a painful, distorted Baker IV capsular contracture"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Six days after the second dose, she noted an enlarged lymph node in her left axilla"; HAEMATOMA (non-serious), outcome "unknown", described as "small delayed hematoma was the cause of the contracture"; BREAST SWELLING (non-serious), outcome "unknown", described as "Thirteen days after the second dose, she reported that her left breast was firm, swollen, and "tight".". Because of the severity of her symptoms, she underwent early revisional surgery with capsulectomy and implant exchange. Intraoperatively she was found to have an intact implant and a dense fibrotic capsule containing 37 cc of a thin reddish-brown fluid but no hematoma or organized blood clot. Although capsular contracture is typically thought of as a process that takes place over weeks to months, there is experimental evidence that provides a mechanism for capsular contracture evolving over only a few days, as seems to have occurred in this case. For example, tissue cultures obtained from the contracted capsules of women with silicone implants demonstrated the ability to induce a rapid upregulation of the genes for TGFB1, interleukin 8 as well as other inflammatory and profibrotic cytokines in vitro, which in turn, were thought to be responsible for the stimulation of contracture of fibroblast-populated collagen lattices over a 48- to 120-hour period. Another study also using tissue media derived from the capsules of women with implants showed enhanced T-cell proliferation and increased cytokine levels as compared to peripheral blood. These studies further support the concept of an immunologically mediated and rapid process for capsular contracture; the cellular composition of the capsule and the surrounding tissue seems poised to respond to an immunological stimulus. It is possible that the timing of the capsular contracture vis-a-vis the vaccine was a mere coincidence. The contracture occurred during the typical time frame for contracture (most are within the first year14), and it occurred following an operation (augmentation/mastopexy) that has a high contracture rate. In fact, the presence of a clearly hemorrhagic collection within the capsule raises an alternative hypothesis, that a small, delayed hematoma was the cause of the contracture. There are just over 30 case reports in the literature of hematomas occurring at least 6 months following cosmetic breast augmentation. Many of these had instigating events, such as trauma or physical strain or a recent iatrogenic coagulopathy, and many occurred in cases with aggressively textured implants, where the separation of the implant from the adherent capsule was thought to be the reason for the bleeding. This patient had none of these possible factors in her history. She denied trauma, was not engaged in implant displacement exercises or any kind of weightlifting, and her coagulation tests and platelet counts were normal. In delayed hematomas without a discernible etiology, the so-called called spontaneous cases, several authors suggest a variety of nonspecific inflammatory conditions as possible causes. Along these lines, the inflammatory response seen in a delayed hypersensitivity reaction (as in the aforementioned post-vaccine reactions to hyaluronic acid fillers) can induce angiogenesis and increased vascular permeability within days in animal models. Furthermore, the complex inflammatory and angiogenesis cascades share some of the same mediators, for example, TGFB1 and interleukin 820-22 and can be activated in concert. Therefore, the finding of a small amount of a bloody fluid in the capsule does not preclude an inflammatory, vaccine-induced mechanism for capsular contracture. Additionally, with the tight temporal sequence of events-the second dose of the vaccine, then lymph node enlargement, then a discernible tightening that rapidly progressed to a Baker IV contracture it seems hard to completely exculpate the vaccination as a possible cause, by one mechanism or another. It is also possible that the placement of the poly-4- hydroxybutyrate mesh in direct opposition to the implant contributed to the contracture, although the limited evidence that is available seems to suggest, if anything, that poly-4-hydroxybutyrate is more preventative than causative when it comes to capsular contracture. The ipsilaterally of the contracture to the vaccine site is also interesting; one might suspect that a systemic response to a vaccine would demonstrate no such side preference, although in this case there was an ipsilateral regional reaction with the enlarged lymph node. It would be premature to propose any protocol based upon a single case report. The pre-emptive use of zafirlukast has been suggested, for augmented patients getting the vaccine who experience any tightening, on at least 1 plastic surgical practice website and this makes sense from a mechanistic point of view. However, as a blanket recommendation for all augmented patients getting the vaccine, this would seem to treat many patients unnecessarily with a drug that is not entirely benign. Furthermore, even though zafirlukast acts upon a somewhat distal part of the immunological/inflammatory cascade (suppression of myofibroblasts), any interference with the body's immune response immediately after the vaccine might seem to be unwise and counterproductive to the entire point of the vaccine. The patient underwent the following laboratory tests and procedures: coagulation test: normal; platelet count: normal. Therapeutic measures were taken as a result of capsular contracture associated with breast implant with early revisional surgery with capsulectomy and implant exchange and for breast swelling with montelukast.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case, a contributory effect of the vaccine BNT162B2 to the reported events cannot be ruled out. 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.