Age: 11.0
Sex: M
Vaccine: COVID19, HPV4, HPV9, MEN
Symptoms: Product origin unknown, Vaccination site discolouration, Vaccination site erythema, Vaccination site fibrosis, Vaccination site necrosis
Clinical narrative: Fat necrosis, tissue necrosis, skin necrosis; the vaccination site eventually ulcerated; Large erythematous wheal near the vaccination site; Associated with pruritus, burning and pain; Associated with pruritus, burning and pain; The rash progressed to include vesicles and bullae over several hours; The rash progressed to include vesicles and bullae over several hours; Dermal fibrosis; Large scar with areas of hypopigmentation and hyperpigmentation; Vaccination site hypopigmentation/hyperpigmentation; Product origin unknown.  This literature marketed report was received from the authors in a published literature article titled as stated above, concerning a 11-year-old male patient. Concurrent conditions, historical conditions and concomitant medications were not reported and no prior vaccine reactions, known allergies, or SARS-CoV-2 infection.   On an unknown date, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(unknown manufacturer) or Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (unknown manufacturer)(also reported as human papilloma Virus vaccine)( Product origin unknown) administered in his left arm (strength, dose, dosage regimen, route of administration, lot number and expiration date were not reported) for prophylaxis. Additionally, the patient received tozinameran (PFIZER BIONTECH COVID-19 VACCINE) at 12-year-old dose of 30 µg/0.3 mL administered in his left arm; and the patient also received meningococcal vaccine and diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid vaccine in his right arm.  On an unknown date (also reported as within minutes-to-hours), the patient developed a large erythematous wheal (vaccination site erythema) on his left arm near the coronavirus disease 19 (COVID-19) and human papilloma Virus vaccines injection sites associated with pruritus, burning and pain (vaccination site pain and vaccination site pruritus). Then, the rash (vaccination site rash) progressed to include vesicles (vaccination site vesicles) and bullae over several hours and eventually ulcerated (vaccination site ulcer).  On an unknown date (reported as 8 days after vaccination), erythema had notably subsided, but ulceration was prominent. Laboratory workup was done and showed mildly elevated sedimentation rate at 26 mm/h, but normal values for C-reactive protein, Blood immunoglobulin E (IgE), tryptase and complete blood counts. Biopsy peripheral to the ulcer was taken and showed non-specific reactive epidermal changes, dermal fibrosis (vaccination site fibrosis) and fat necrosis (vaccination site necrosis). Over several weeks, his ulceration healed with central scarring and surrounding post-inflammatory pigment changes. After 10 months of vaccination, it was noted a large scar (vaccination site scar) with areas of hypopigmentation and hyperpigmentation (vaccination site hypopigmentation/hyperpigmentation). The outcome of the events of vaccination site necrosis and vaccination site ulcer was considered as recovered due to it was reported that his ulceration healed. The outcome of the events of vaccination site erythema, vaccination site pain, vaccination site pruritus, vaccination site rash, vaccination site vesicles, vaccination site fibrosis, vaccination site scar, and vaccination site discolouration was not reported.  The causality assessment between suspect vaccines and the events were considered as related as the authors concluded that it was important to consider that one or a combination of vaccines administered with the COVID-19 vaccine led to our patient's severe reaction. Furthermore, it was reported immunologic dysregulation triggered by the tozinameran (PFIZER BIONTECH COVID-19 VACCINE) vaccine, possibly with contributions from one or more of the other vaccines administered, may have led to robust immune cell trafficking and activation in our patient, resulting in significant tissue necrosis and ulceration.  A copy of the published article is attached as further documentation of the patient's experience.  Upon internal review, the event of vaccination site necrosis was determined to be medically significant.