Received Aug 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | UNK | FDP00683 | — |
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 1 | FDP00683 | — |
Patient was hospitalized with diagnosis of stroke due to blood clot; Patient received RabAvert vaccine in intragluteal site; Pleocytosis; Case reference number US-BN-2025-001405 is a spontaneous case initially received from a pharmacist via MedComm (reference number: USBAV25-2040) on 15-Aug-2025 and concerns an 82-year-old female patient. The patient's medical history included history of chronic lymphomatic leukemia (CLL) and atrial fibrillation with coagulation. The patient's concomitant medication details included Eliquis for anticoagulation. On 25-Jul-2025, the patient was bitten by a dog. On the same day, the patient received the first dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: FDP00683; expiration date: 20-Nov-2027), at 1 mL, via unknown route reported as gluteal, for indication post exposure to dog bite. The patient also received wound care and antibiotics, but no immunoglobulin G (IGG). The dog had been vaccinated. (explicitly coded as 'vaccine administered at inappropriate site') On 31-Jul-2025, six days after the first dose of RabAvert, the patient came back to the hospital as her family had concerns of weakness. The family was very concerned that the neurological decline occurred shortly after the patient receiving the vaccine and then the patient continued to decline to the point that they brought the patient in. Patient was transferred to the rehab unit (to be confirmed). CT imaging was performed, and no clot was seen. Subsequent imaging detected a clot. On the same day, the patient experienced a stroke due to blood clot and patient was hospitalized. Providers seem to attribute the stroke to the clot. On 06-Aug-2025, a lumbar puncture was obtained. The report states: Pleocytosis, including many lymphocytes and monocytes and occasional neutrophils with rare glial cells, the patient has a history of CLL (Chronic lymphocytic leukaemia) but it is negative for malignancy. At the time of the initial report, the events of 'stroke', and 'pleocytosis' were still ongoing and the patient remains admitted to the hospital rehab unit. The reporter assessed the events of 'stroke', and 'pleocytosis' as serious due to seriousness criteria of hospitalization. However, event of 'stroke' was assessed as serious due to seriousness criteria of medical significance. The reporter provided causality assessment as unknown. The reporter did hypothesize an alternate explanation for the stroke, as follows: Did the patient stop taking it (Eliquis) when she had been bitten by a dog and her wound was maybe oozing and there was some kind of, you know, not compliance with her anticoagulation. And could that have contributed as well? No further information was provided.; Reporter's Comments: An 82-year-old female patient received the first dose of RabAvert, reported as gluteal, for indication post exposure to dog bite, which is considered as vaccine administered at inappropriate site. Reportedly, six days after the first dose of RabAvert, the patient went to the hospital as her family had concerns of weakness, and the patient experienced a serious event of stroke (hospitalization and medical significance) due to blood clot. Also, the patient experienced a serious event of pleocytosis (hospitalization). Cerebrovascular accident and pleocytosis are unlisted and unexpected for RabAvert per CCDS v6 and USPI, whilst product administered at inappropriate site is considered as listed per company convention. The patient's medical history included chronic lymphocytic leukaemia (CLL) and atrial fibrillation with coagulation, and concomitant medication details included Eliquis for anticoagulation. The outcome was unknown. Considering information provided and the possibility of discontinued anticoagulant therapy, the evaluation did not find evidence to suggest a reasonable possibility of a causal relationship between the reported event of stroke and RabAvert, therefore the causality is assessed as not related. The causality for the event of pleocytosis is considered as unlikely related to RabAvert. Also, the advanced age of this patient is a contributing factor. Product administered at inappropriate site is not related to the suspect vaccine, but to a human factor. This case is considered as serious due to hospitalization and medical significance.; Sender's Comments: An 82-year-old female patient received the first dose of RabAvert, reported as gluteal, for indication post exposure to dog bite, which is considered as vaccine administered at inappropriate site. Reportedly, six days after the first dose of RabAvert, the patient went to the hospital as her family had concerns of weakness, and the patient experienced a serious event of stroke (hospitalization and medical significance) due to blood clot. Also, the patient experienced a serious event of pleocytosis (hospitalization). Cerebrovascular accident and pleocytosis are unlisted and unexpected for RabAvert per CCDS v6 and USPI, whilst product administered at inappropriate site is considered as listed per company convention. The patient's medical history included chronic lymphocytic leukaemia (CLL) and atrial fibrillation with coagulation, and concomitant medication details included Eliquis for anticoagulation. The outcome was unknown. Considering information provided and the possibility of discontinued anticoagulant therapy, the evaluation did not find evidence to suggest a reasonable possibility of a causal relationship between the reported event of stroke and RabAvert, therefore the causality is assessed as not related. The causality for the event of pleocytosis is considered as unlikely related to RabAvert. Also, the advanced age of this patient is a contributing factor. Product administered at inappropriate site is not related to the suspect vaccine, but to a human factor. This case is considered as serious due to hospitalization and medical significance.
Medical History/Concurrent Conditions: Atrial fibrillation; CLL; Coagulation disorder
ELIQUIS
Test Date: 20250731; Test Name: CT imaging; Result Unstructured Data: No clot detected; Test Date: 20250731; Test Name: CT imaging; Result Unstructured Data: clot detected; Test Date: 20250806; Test Name: LP; Result Unstructured Data: Pleocytosis, including many lymphocytes and monocytes and occasional neutrophils with rare glial cells and malignant for or negative for malignant cells because she does have a history of CL but it is negative for malignancy.