Sex: F
Vaccine: UNK
Symptoms: Myalgia, Vaccination site mass, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Still a lump kind of a thing where the vaccine was administered; Sore muscle; Very warm to touch; My upper arm where I received the vaccine was swollen; A spontaneous report was received from a patient on 18AUG2022. Additional information was received on 23AUG2022. It described a 29-years-old female patient (height: 5'2"/157 cm and weight: 195 lbs/88.435 kg) who stated that "my upper arm where I received the vaccine was swollen" (PT: Peripheral swelling), "very warm to touch" (PT: skin warm), "still a lump kind of a thing where the vaccine was administered" (PT: injection site mass), and "sore muscle" (PT: Myalgia) following immunisation with BioThrax (anthrax vaccine adsorbed). It was reported that the patient received the first dose of BioThrax on 23JUL2021, the second dose on 24AUG2021, and the third dose on 03FEB2022. She had sore muscle after the first dose, but she didn't remember it after the other dose. She stated that she didn't take any treatment for the sore muscle, and she recovered from it. She received the fourth dose of BioThrax on 16AUG2022 around 13:30 in the right arm via intramuscular. On 17AUG2022 (around 19:00), she noticed that the upper arm where she received the vaccine was swollen. In 18AUG2022, in the morning the arm was still swollen, and she noticed that very warm to touch. She confirmed that the swelling and warmness were not there but there was still a lump kind of a thing where the vaccine was administered. The patient reported that she had not received any treatment for the adverse events. The patient had recovered from the reported events "my upper arm where I received the vaccine was swollen", "very warm to touch", and "sore muscle" while the patient was not recovered from the event "still a lump kind of a thing where the vaccine was administered".  Past medication included Covid vaccine in Nov-2021.   Concomitant medication was spironolactone (25 mg) for acne.  Additionally, it was reported that she didn't observe any adverse events before with the other three doses.   Action taken with BioThrax with respect to the reported events was not applicable.  No additional information was reported.  Company comment: A consumer received BioThrax vaccine and her upper arm was swollen (peripheral swelling), very warm to touch (skin warm), still a lump kind of a thing where the vaccine was administered (injection site mass), and sore muscle (myalgia). Further information regarding the events is limited. Considering the case information, the causality of all events peripheral swelling, skin warm, injection site mass, and myalgia is assessed as possible with BioThrax. The case is considered non-serious as per medical assessment.; Sender's Comments: A consumer received BioThrax vaccine and her upper arm was swollen (peripheral swelling), very warm to touch (skin warm), still a lump kind of a thing where the vaccine was administered (injection site mass), and sore muscle (myalgia). Further information regarding the events is limited. Considering the case information, the causality of all events peripheral swelling, skin warm, injection site mass, and myalgia is assessed as possible with BioThrax. The case is considered non-serious as per medical assessment.