Sex: M
Vaccine: UNK
Symptoms: Palpitations, Somnolence
Clinical narrative: Full body ache/ Soreness; Headache; Started to feel worst; Chest pain; Heart racing; Massive drowsiness; Chills; A spontaneous report was received from a male patient (age unknown) on 24JAN2023 who experienced "headache" (Headache), "full body ache/ soreness" (Pain), "chills" (Chills), "chest pain" (Chest pain), "heart racing" (Palpitations), "massive drowsiness" (Somnolence) and "started to feel worst" (Feeling abnormal) following the administration of BioThrax (anthrax vaccine adsorbed; lot number: unknown) for immunisation.  The patient's medical history, concomitant medications, or known allergies were not reported.   On 23JAN2023 around 15:00, the patient received the sixth dose of BioThrax. On 24JAN2023 in the morning at 05:30, the patient had a headache and full body ache for which he took ibuprofen. The symptoms slightly subsided and the patient proceeded to go to work. Reportedly, on the same day, around 09:30, the patient started to feel worse, and the headache came back along with chills, chest pain, heart racing, full body aches, soreness, and massive drowsiness.  The patient had not recovered from the reported events, at the time this report.  The action was taken with BioThrax with respect to the reported events was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer received BioThrax and experienced headache, full body ache/ soreness (pain), chills, chest pain, heart racing (palpitations), massive drowsiness (somnolence) and started to feel worst (feeling abnormal). Considering the case information, the role of BioThrax cannot be ruled out and the causality of headache, pain, chills, chest pain, palpitations, somnolence and feeling abnormal is assessed as possible with BioThrax. The case is considered non-serious as per medical assessment.  Significant follow-up information was received from the patient on 06FEB2023. Patient demographics (date of birth) was added.  It was reported that a 31-year-old patient had no adverse reaction to any of the previous 5 BioThrax vaccinations.  Reportedly, the patient received no treatment for the symptoms of "chills, chest pain, heart racing, massive drowsiness and feeling worst".  It was updated that the patient had recovered from the reported events on 25JAN2023 at 01:00 PM.  Company comment: It was reported that a consumer received BioThrax and experienced headache, full body ache/ soreness (pain), chills, chest pain, heart racing (palpitations), massive drowsiness (somnolence) and started to feel worst (feeling abnormal). This patient had recovered from these events. Considering the case information, the role of BioThrax cannot be ruled out and the causality of headache, pain, chills, chest pain, palpitations, somnolence and feeling abnormal is assessed as possible with BioThrax. The case is considered non-serious as per medical assessment.; Sender's Comments: It was reported that a consumer received BioThrax and experienced headache, full body ache/ soreness (pain), chills, chest pain, heart racing (palpitations), massive drowsiness (somnolence) and started to feel worst (feeling abnormal). Considering the case information, the role of BioThrax cannot be ruled out and the causality of headache, pain, chills, chest pain, palpitations, somnolence and feeling abnormal is assessed as possible with BioThrax. The case is considered non-serious as per medical assessment.