Age: 51.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site necrosis, Injection site pain
Clinical narrative: Injection site necrosis/eroded blister progressed into a grossly necrotic ulcer; Injection site ulceration/eroded blister progressed into a grossly necrotic ulcer; injection site induration; injection site tenderness; injection site redness; Injection site bruising; Injection site blisters; The blister ruptured draining serosanguinous fluid; Injection site plaque/erythematous plaque; Incorrect route of vaccination (patient received  Tdap Vaccine subcutaneously instead of intramuscularly); Off label use (patient received  Tdap Vaccine subcutaneously instead of intramuscularly); This case was reported in a literature article and described the occurrence of injection site necrosis in a 51-year-old female patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.  Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMOVAX) for prophylaxis.   On an unknown date, the patient received Tdap Vaccine (subcutaneous) and PNEUMOVAX (subcutaneous). On an unknown date, 10 days after receiving Tdap Vaccine, the patient experienced injection site necrosis (serious criteria GSK medically significant), injection site ulcer, injection site induration, injection site tenderness, injection site erythema, injection site bruising, injection site blisters, incision site serosanguineous discharge, injection site plaque, incorrect route of product administration and off label use. The patient was treated with neomycin, doxycycline and steroids nos, steroids nos, steroids nos, steroids nos (Steroid (Not Specified)). On an unknown date, the outcome of the injection site necrosis, injection site ulcer, injection site induration, injection site tenderness, injection site erythema, injection site bruising, injection site blisters, incision site serosanguineous discharge, injection site plaque, incorrect route of product administration and off label use were unknown.   The reporter considered the injection site necrosis, injection site ulcer, injection site induration, injection site tenderness, injection site erythema, injection site bruising, injection site blisters, incision site serosanguineous discharge and injection site plaque to be related to Tdap Vaccine.  Additional information was provided.  This case was reported in a literature article and described the occurrence of injection site necrosis, injection site ulceration in a 51-year- old adult female who was vaccinated with unspecified tetanus-diphtheria-acellular pertussis (Tdap) and Pneumovax (Merck & Co) for prophylaxis for both.   The patient was female. The patient had no previous history of local or systemic vaccine reaction. No information on patient's family history or concurrent condition or concomitant medication was provided. On an unspecified date at the age of 51 years, the patient received unspecified tetanus-diphtheria-acellular pertussis (Tdap) and Pneumovax (dosages unknown; batch number not provided for both) subcutaneously in the right deltoid arm.   On an unspecified date, on the evening of vaccination, the patient experienced tenderness, redness, and induration at the vaccination site. The next day bruising developed followed by blistering. A short course of oral doxycycline and a gluteal intramuscular steroid injection provided only mild transient relief. The blister ruptured on day 4, draining serosanguinous fluid. There was no purulent drainage, but redness persisted at the site. Over the following few days, the patient's site of vaccination in right deltoid exhibited the eroded blister progressed into a grossly necrotic ulcer with black anesthetic eschar with a surrounding large tender ill-defined indurated erythematous plaque. The patient applied neomycin to the ulcerated area and covered with a bandage prior to presentation, but this did not provide any relief. 10 days after vaccination the patient presented with a necrotic ulcer at the site of recent Tdap and Pneumovax vaccination. At presentation, the patient was afebrile and had no leukocytosis. Wound and blood cultures returned negative at 48 hours. Punch biopsy for tissue culture and histological evaluation was performed. Tissue cultures were negative. Dermatopathology results showed nonspecific diffuse and extensive dermal and epidermal necrosis. There was mixed inflammatory cell infiltrate within the dermis with preservation of dermal collagen. Eccrine coils and hair follicles were necrotic. No definitive granulomas were identified. Periodic acid-Schiff, Fite, Gram, silver, and acid-fast stains did not reveal microorganisms. The patient was counseled to apply Vaseline and Silvadene cream for wound care and ibuprofen as needed for pain.   The outcome of the event was not provided.  The authors commented that "To our knowledge, this is the first adult case of vaccine site necrosis to be reported. The presumed etiology has been aluminum salt adjuvants and improper vaccination technique. This necrotic ulceration was likely due to robust inflammatory response to aluminum salt subcutaneous injection. Correct vaccine placement, needle size, and needle length may reduce adverse local skin reactions.  The authors stated, "The Tdap vaccine contains aluminum salt adjuvants, which have been implicated in the pathogenesis of local skin vaccine reactions. "Clinically necrotic and rapidly progressive severe local reactions to vaccines containing aluminum salts are very rare; a single case of a severe necrotic ulcerative reaction to 13-valent pneumococcal conjugate vaccine (PCV13) has been reported in an infant.       Lab Comments: Lab tests were performed on unspecified dates Wound and blood cultures returned negative at 48 hours. Punch biopsy for tissue culture and histological evaluation was performed. Tissue cultures were negative. Dermatopathology results showed nonspecific diffuse and extensive dermal and epidermal necrosis. There was mixed inflammatory cell infiltrate within the dermis with preservation of dermal collagen. Eccrine coils and hair follicles were necrotic. No definitive granulomas were identified. Periodic acid-Schiff, Fite, Gram, silver, and acid-fast stains did not reveal microorganisms.