Sex: M
Vaccine: COVID19, HPVX, TDAP
Symptoms: Red blood cell sedimentation rate, Scab, Skin fibrosis, Skin hyperpigmentation, Skin hypopigmentation
Clinical narrative: Ulcerating reaction/Large ulceration; Patient developed a large erythematous wheal on his left arm near the COVID-19 and HPV vaccine injection sites; pruritus; Injection site pain/Injection site burning; rash progressed; vesicle; dermal fibrosis; fat necrosis; central scarring; large erythematous wheal on his left arm near the COVID-19 and HPV vaccine injection sites/Oedematous urticarial plaque; crusting; hypopigmentation; hyperpigmentation; bullae; Skin plaque; Skin necrosis; This serious case was reported in a literature article and described the occurrence of injection site ulcer in a 11-year-old male patient who received HPV 16-18 (HPV vaccine) for prophylaxis. Literature Reference.  Co-suspect products included DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis and TOZINAMERAN (PFIZER BIONTECH VACCINE FOR COVID-19 (BNT162B2)) for prophylaxis.   Additional patient notes included Patient had no prior vaccine reactions, known allergies, or SARSCoV-2 infection..   On an unknown date, the patient received HPV vaccine (left arm), Tdap Vaccine (right arm) and PFIZER BIONTECH VACCINE FOR COVID-19 (BNT162B2) (left arm). On an unknown date, an unknown time after receiving HPV vaccine and Tdap Vaccine, the patient experienced injection site ulcer (Verbatim: Ulcerating reaction/Large ulceration), injection site erythema (Verbatim: Patient developed a large erythematous wheal on his left arm near the COVID-19 and HPV vaccine injection sites), injection site itching (Verbatim: pruritus), injection site pain (Verbatim: Injection site pain/Injection site burning), rash aggravated (Verbatim: rash progressed), injection site vesicles (Verbatim: vesicle), skin fibrosis (Verbatim: dermal fibrosis), fat necrosis (Verbatim: fat necrosis), injection site scar (Verbatim: central scarring), injection site urticaria (Verbatim: large erythematous wheal on his left arm near the COVID-19 and HPV vaccine injection sites/Oedematous urticarial plaque), crust (Verbatim: crusting), skin hypopigmentation (Verbatim: hypopigmentation), skin hyperpigmentation (Verbatim: hyperpigmentation), bullae (Verbatim: bullae), injection site plaque (Verbatim: Skin plaque) and injection site necrosis (Verbatim: Skin necrosis) (serious criteria GSK medically significant). The outcome of the injection site ulcer and injection site erythema were resolved and the outcome of the injection site itching, injection site pain, rash aggravated, injection site vesicles, skin fibrosis, fat necrosis, injection site scar, injection site urticaria, crust, skin hypopigmentation, skin hyperpigmentation, bullae, injection site plaque and injection site necrosis were not reported.   The reporter considered the injection site ulcer, injection site erythema, injection site itching, injection site pain, rash aggravated, injection site vesicles, skin fibrosis, fat necrosis, injection site scar, injection site urticaria, crust, skin hypopigmentation, skin hyperpigmentation, bullae, injection site plaque and injection site necrosis to be related to HPV vaccine and Tdap Vaccine.   The company considered the injection site ulcer, injection site erythema, injection site itching, injection site pain, rash aggravated, injection site vesicles, skin fibrosis, fat necrosis, injection site scar, injection site urticaria, crust, skin hypopigmentation, skin hyperpigmentation, bullae, injection site plaque and injection site necrosis to be related to HPV vaccine and Tdap Vaccine.   Additional Information: GSK receipt date: 28-AUG-2023  Suspect included Meningococcal vaccine. During a paediatric wellness visit, an 11-year-old boy received Pfizer-BioNTech's COVID-19 vaccine (12-year-old dose of 30µg/0.3mL) and human papilloma virus (HPV) vaccine in left arm and meningococcal and tetanus, diphtheria and pertussis (Tdap) vaccines in right arm. Within minutes-to-hours after receiving the vaccines, patient developed a large erythematous wheal on left arm near the COVID-19 and HPV vaccine injection sites associated with pruritus, burning and pain. The rash progressed to include vesicles and bullae over several hours and eventually ulcerated. Eight days after vaccination, erythema had notably subsided, but ulceration was prominent. Laboratory workup at this time revealed a mildly elevated sedimentation rate at 26mm/h (0-15mm/h), C-reactive protein, IgE, tryptase and complete blood counts were normal. A punch biopsy peripheral to the ulcer revealed non-specific reactive epidermal changes, dermal fibrosis and fat necrosis. Over several weeks, patients' ulceration healed with central scarring and surrounding postinflammatory pigment changes.  Upon internal review the case was updated on 25-Sep-2023:  Non-GSK suspect drug (PFIZER BIONTECH VACCINE FOR COVID-19 (BNT162B2)) was recoded. PT changed for the event Erythema to Injection site Erythema. Description as reported "large erythematous wheal on his left arm near the COVID-19 and HPV vaccine injection sites" was added in the event Urticaria and PT changed from Urticaria to Injection site urticaria Event Injection site necrosis was added. Injection site reaction event removed.  Summary of Changes: Product tab and Event tab.