Received Sep 30, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| ANTH | ANTHRAX (BIOTHRAX) | EMERGENT BIOSOLUTIONS | 3 | — | — |
Type 1 diabetes; His health had went downhill; He felt like fire had went through his entire body; Blacked out/Collapsed; Hit his head and got a concussion; Hit his head and got a concussion; Hit his head and got a concussion; This spontaneous case report was received on 22-Sep-2025 from a 30-year-old male patient (Height: 5'9"/175.26 cm and weight: 160 lbs/72.57 kg) "who felt like fire had went through his entire body" (PT: Burning sensation), "blacked out/collapsed" (PT: Loss of consciousness), "hit his head and got a concussion" (PT: Concussion, PT: Fall, PT: Head injury), "type 1 diabetes" (PT: Type 1 diabetes mellitus ), "health had went downhill" (PT: General physical health deterioration) following BioThrax (anthrax vaccine adsorbed) administration. The patient's concomitant medications, concurrent conditions were not reported and patient had allergy to pollen. On an unknown date in 2019, the patient was administered BioThrax (lot number: unknown) for an unknown indication. The patient received BioThrax in 2019 while serving. Following the initial dose, he experienced a severe reaction, collapsed and hooked onto a heart monitor. He described the sensation as "fire running through his entire body," and he subsequently blacked out, hit his head (corrected*) that resulted in a concussion. The consumer received two additional doses of BioThrax, after which he reported a decline in his overall health. In 2021 or early 2022, he was diagnosed with type 1 diabetes. He had reported no other significant medical conditions. The patient took insulin therapy. He administered long-acting insulin once daily (20 units, exact brand unknown) and short-acting insulin (Novolog) based on carbohydrate intake at a ratio of 1 unit per 15-20 grams of carbohydrates. No labs or imaging were reported. The outcome of the reported events was unknown. Company comment: This case is regarding a 30-year-old male patient who blacked out/collapsed (loss of consciousness), felt like fire had went through his entire body (burning sensation), hit his head and got a concussion (concussion, fall, head injury), reported that his health had went downhill (general physical health deterioration) following BioThrax (anthrax vaccine adsorbed) administration. On an unknown date in 2021 or 2022, he was diagnosed with type 1 diabetes. The events of loss of consciousness, concussion, fall, head injury, and Type 1 diabetes mellitus have been assessed as serious (medically significant), while burning sensation and general physical health deterioration is considered non-serious. The events of loss of consciousness and burning sensation have been assessed as possibly related to BioThrax (anthrax vaccine adsorbed) in view of a strong temporal association and the known potential of BioThrax to cause syncope and burning sensation. The events of fall, consequent head injury and concussion were the consequences of the recent loss of consciousness experienced by this patient following BioThrax administration, hence, assessed as possibly related to BioThrax. Moreover, the event of general physical health deterioration has been assessed as related to BioThrax in view of a temporal association and a clear reporter's implication that this event occurred following administration of two additional doses of BioThrax. Considering lack of information regarding the latency, exact onset date, complete medical history, clinical course of the event, treatment provided, concomitant medications, and outcome, the causality of Type 1 diabetes mellitus has been assessed as not related to BioThrax.; Sender's Comments: This case is regarding a 30-year-old male patient who blacked out/collapsed (loss of consciousness), felt like fire had went through his entire body (burning sensation), hit his head and got a concussion (concussion, fall, head injury), reported that his health had went downhill (general physical health deterioration) following BioThrax (anthrax vaccine adsorbed) administration. On an unknown date in 2021 or 2022, he was diagnosed with type 1 diabetes. The events of loss of consciousness, concussion, fall, head injury, and Type 1 diabetes mellitus have been assessed as serious (medically significant), while burning sensation and general physical health deterioration is considered non-serious. The events of loss of consciousness and burning sensation have been assessed as possibly related to BioThrax (anthrax vaccine adsorbed) in view of a strong temporal association and the known potential of BioThrax to cause syncope and burning sensation. The events of fall, consequent head injury and concussion were the consequences of the recent loss of consciousness experienced by this patient following BioThrax administration, hence, assessed as possibly related to BioThrax. Moreover, the event of general physical health deterioration has been assessed as related to BioThrax in view of a temporal association and a clear reporter's implication that this event occurred following administration of two additional doses of BioThrax. Considering lack of information regarding the latency, exact onset date, complete medical history, clinical course of the event, treatment provided, concomitant medications, and outcome, the causality of Type 1 diabetes mellitus has been assessed as not related to BioThrax.
Medical History/Concurrent Conditions: Pollen allergy