Received Nov 21, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
Hearing loss; Migraine headache; Anxiety; Unbearable restless leg; Central nervous system related problems; Insomnia; This spontaneous case report was received on 13-Nov-2025 and additional information was received on 14-Nov-2025, male patient (weight: 168 lbs/ 76.20 kg and height: 5'3"/ 160.02 cm) who experienced "migraine headache"(PT: Migraine), "loss of hearing"(PT: Deafness), "anxiety"(PT: Anxiety), "unbearable restless leg"(PT: Restless legs syndrome), "central nervous system related problems"(PT: Nervous system disorder) and "insomnia"(PT: Insomnia), following BioThrax administration for immunisation. The patient's medical history included Lyme disease during childhood with no known allergies, and he was not taking any medications. On an unknown date, the patient administered BioThrax (Lot number: unknown, six doses of BioThrax between 2006 and 2007) for immunisation. It was reported that the patient received a total of six doses of BioThrax between 2006 and 2007. The patient had ongoing symptoms that attributes to prior BioThrax vaccination. No additional product details were available as National Drug Code (NDC), lot numbers, route of administration, dosage frequency, exact administration dates, or expiry dates. The patient experienced insomnia, which began after receiving the first BioThrax dose in 2006. He reported that since that time, he had "never slept more than four hours" per night. In 2007, he began noticing additional symptoms, including migraines associated with loss of hearing. He described these headaches as "hypertension migraines behind the ear," and further clarified that the sensation felt like pressure similar to an ear infection rather than a normal headache. The consumer stated that he began noticing his symptoms in 2009. The consumer reported additional ongoing symptoms, including anxiety, unbearable restless legs, and patient believed that central nervous system related problems related to BioThrax exposure. The patient had no other medical conditions aside from a history of Lyme disease during childhood. He reported having no known allergies and confirmed that he was not taking any medications. He further stated that he had not received any treatment for the symptoms described. No labs or imaging was reported. The patient was not recovered from reported events. Company comment: This case concerns a male patient of unknown age who experienced migraine headache (migraine), loss of hearing (deafness), anxiety, unbearable restless leg (restless legs syndrome), central nervous system related problems (nervous system disorder) and insomnia, following BioThrax administration for immunization. The event deafness has been assessed as serious (important medical event), and events migraine, anxiety, restless legs syndrome, nervous system disorder and insomnia have been assessed as non-serious. The report lacks information regarding latency, complete medical history, concomitant medication, treatment provided, complete clinical course of the events. The information in the case does not provide evidence to support a causal association between the drug and the events. Hence, the causality for these events is assessed as not related to BioThrax.; Sender's Comments: This case concerns a male patient of unknown age who experienced migraine headache (migraine), loss of hearing (deafness), anxiety, unbearable restless leg (restless legs syndrome), central nervous system related problems (nervous system disorder) and insomnia, following BioThrax administration for immunization. The event deafness has been assessed as serious (important medical event), and events migraine, anxiety, restless legs syndrome, nervous system disorder and insomnia have been assessed as non-serious. The report lacks information regarding latency, complete medical history, concomitant medication, treatment provided, complete clinical course of the events. The information in the case does not provide evidence to support a causal association between the drug and the events. Hence, the causality for these events is assessed as not related to BioThrax.
Medical History/Concurrent Conditions: Lyme disease (Lyme disease during childhood)