Sex: F
Vaccine: DTAP, PPV
Symptoms: Epidermal necrosis, Injection site bruising, Injection site plaque, Injection site reaction, Injection site vesicles
Clinical narrative: Initial unsolicited report received from the literature on 17-Sep-2018. The following is the abstract from the article: Local adverse reactions to vaccination are typically mild and often quickly resolve. Vaccine adjuvants such as aluminum salts in combination with improper vaccination technique may result in severe local adverse reactions. As far as we know, there is only one prior case of frankly necrotic rapidly progressing vaccine site necrosis, which occurred in a pediatric patient.1 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. Here we present an adult case of a severe local reaction to a vaccine resulting in necrosis of the epidermis and dermis with central ulceration. Skin appendages were also involved, with necrosis of eccrine coils and hair follicles. 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. This case involves a 51 years old female patient who experienced blister ruptured draining serosanguinous fluid, eroded blister progressed in a necrotic ulcer with large tender ill-defined indurated erythematous plaque, tenderness, redness, and induration at the vaccination site, bruising developed and blistering, while she received vaccines DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (produced by unknown manufacturer) and PNEUMOVAX (not produced by Sanofi Pasteur) (batch number, expiry date and route was not reported in the right deltoid) on an unspecified date. The patients past medical history, concomitant medication and family history were not provided. The patient had no previous history of local or systemic vaccine reaction. It was an actual medication error due to Wrong injection technique as patient received both Tdap and PNEUMOVAX vaccines in her right deltoid. The patient presented with a necrotic ulcer at the site of recent Tdap and PNEUMOVAX vaccination. The patient received both vaccines in her right deltoid 10 days prior to presentation. She had no previous history of local or systemic vaccine reaction. On the evening of vaccination, the patient experienced tenderness, redness, and induration at the vaccination site. The next day bruising developed followed by blistering. 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 eroded blister progressed into a necrotic ulcer with black anesthetic eschar with a surrounding large tender ill-defined indurated erythematous plaque. Laboratory investigation includes-At presentation, she 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. Corrective treatment included- A short course of oral doxycycline and a gluteal intramuscular steroid injection provided only mild transient relief. The patient applied neomycin to the ulcerated area and covered with a bandage prior to presentation, but this did not provide any relief. The patient was counseled to apply Vaseline and Silvadene cream for wound care and ibuprofen as needed for pain. Outcome of events were unknown. Upon internal review the case was considered as serious because of important medical event: Vaccination site necrosis. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.; Sender's Comments: This case concerns a 51 years old female patient who developed blister with serosanguinous fluid, which eroded and progressed into a necrotic ulcer with large tender ill-defined indurated erythematous plaque, tenderness, redness, and induration at the vaccination site, bruising developed and blistering after vaccination with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (produced by unknown manufacturer) and PNEUMOVAX. The time to onset is not clearly defined. However, there is no information regarding the patient's condition at the time of vaccination and the etiology for Ulceration. There is a possibility that the infection is due to a faulty vaccination procedure that introduced skin organisms into the patient or due to a pre-existing skin infection. Based upon the reported information, the role of the vaccine cannot be assessed.