Sex: U
Vaccine: UNK
Symptoms: Discomfort, Inflammation, Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: Large localized reaction to the vaccine; Hard lump at the injection site that was hot to the touch with redness; Hard lump at the injection site that was hot to the touch with redness; Hard lump at the injection site that was hot to the touch with redness; Itching at the injection site; Spontaneous report was received on 28MAR2022 along with additional information received on 31MAR2022 from a patient.  The female patient (unknown age) developed "hard lump at the injection site that was hot to the touch with redness" (PT: Injection site mass, Injection site warmth, and Injection site erythema), "itching at the injection site" (PT: Injection site pruritus) and was determined that it was a "large, localized reaction to the vaccine" (PT: Injection site reaction), following immunisation with BioThrax (anthrax vaccine adsorbed). On 25MAR2022, the patient received first dose of BioThrax (lot number: unknown) via intramuscular route in the left arm. On 27MAR2022, it was noticed that there was a hard lump at the injection site that was hot to touch with redness and was increasing in diameter. The patient also experienced itching at the injection site. Thus, on 28MAR2022, the patient went to occupational health to get the injection site examined and it was determined that it was a large, localized reaction to the vaccine. The patient was prescribed some medications included Atarax (25 mg) and Ibuprofen (800 mg) along with icing the area 3 times a day for 20 minutes to ease the discomfort and treat the inflammation. The patient still had a large lump at the injection site.   Action taken with BioThrax with respect to the reported events was not applicable.  The patient had not recovered from the events "large localized reaction to the vaccine" and "hard lump at the injection site that was hot to the touch with redness" (PT: Injection site mass)" while the outcome of the other reported events "hard lump at the injection site that was hot to the touch with redness" (PT: Injection site warmth and Injection site erythema), "itching at the injection site" was unknown at the time of this report.  Medical history included flu like symptoms, body aches and low-grade fatigue with Covid-19 booster dose. It was reported that the patient had no allergies.  Concomitant medication included Lexapro (escitalopram oxalate), iron supplements (ferrous sulfate), vitamin D supplements (colecalciferol), and Humira (adalimumab).  No additional information was reported.  Company comment: A consumer received BioThrax via intramuscular route in the left arm and developed hard lump at the injection site that was hot to the touch with redness (injection site mass, injection site warmth, and injection site erythema), itching at the injection site (injection site pruritus) and was determined that it was a large, localized reaction to the vaccine (injection site reaction). Considering the case information, the causality of injection site reaction, injection site mass, injection site warmth, injection site erythema, and injection site pruritus is assessed as possible with BioThrax.; Sender's Comments: A consumer received BioThrax via intramuscular route in the left arm and developed hard lump at the injection site that was hot to the touch with redness (injection site mass, injection site warmth, and injection site erythema), itching at the injection site (injection site pruritus) and was determined that it was a large, localized reaction to the vaccine (injection site reaction). Considering the case information, the causality of injection site reaction, injection site mass, injection site warmth, injection site erythema, and injection site pruritus is assessed as possible with BioThrax.