Received Jun 26, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 4 | Unknown | — |
Sharp shooting pains down my legs (especially the quadriceps); muscle twitching primarily in my feet/calves/Twitching in feet became constant (at night/rest and during activity normal day), muscle twitching had never dissipated since the 3rd shot and it had spread over more of body and was present daily; Neurologic symptoms; Sharp shooting pains down my legs (especially the quadriceps); symptoms ramped up following the 4th shot of RabAvert, more tingling/pins/needles; flushing/hot flashes; became so weak (especially "quads" and shoulders/trunk); heaviness in jaw with mild swallowing problems; loss of a significant amount of muscle mass in all 4 limbs and possibly trunk, progressively getting weaker and thinner; numbness/tingling in limbs; 'heaviness' in legs; flushing/hot flashes; numbness/tingling in limbs; abdominal pain; headache; ankle pain; throbbing muscle pain in various muscles; The patient received the fourth dose 27 days after first dose; |Case reference number US-BN-2026-001006 is a spontaneous case initially received from a consumer via Bavarian Nordic (reference number: CASE-2026-001627) on 19-Jun-2026 and concerns a female patient of an unknown age. The patient's past medical history included was not provided. The patient's concomitant medications details included antibiotics and tetanus immunization. On an unspecified date the patient dog bite, as reported. It was not a severe bite and was through long pants (patient was on a run when bitten from behind on the back of patient's leg). Patient did not realize that the dog had broken the skin (pants were not torn) until after dog and the owner were gone. Patient washed the wound thoroughly asap and went to an urgent care for assessment-they provided antibiotics and tetanus immunization. On 20-Jan-2026, the patient received first dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown), at an unknown dose, site or route of administration for indication dog bite and prophylaxis and immunoglobulin (brand name: unknown; batch number: unknown), at dose of three shots, in buttocks and thigh at unknown route for unknown indication. On 23-Jan-2026, three days after receiving the first RabAvert vaccine, the patient received second dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown), at an unknown dose, site or route of administration. On 27-Jan-2026 seven days after receiving the first dose RabAvert vaccine, the patient received third dose of RabAvert along with its constituent parts, prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown), at an unknown dose, site or route of administration. On an unspecified date, reported as 12 hours after receiving the third shot, the patient experienced numbness/tingling in limbs, muscle twitching primarily in feet/calves, severe headache, abdominal pain, sharp shooting pains down legs (especially the quadriceps), throbbing muscle pain in various muscles, flushing/hot flashes. The patient was advised to take allergy meds/anti-inflammatory meds prior to the fourth shot to assist with minimizing symptoms. The emergency room (ER) delayed the RabAvert shot until 16-Feb-2026 to allow time for their symptoms to alleviate (which they did not). The patient also took allergy/anti-inflammatory meds prior to and after the vaccine. On 16-Feb-2026 (to be confirmed), 27 days after receiving the first dose of RabAvert vaccine, the patient received fourth dose of RabAvert along with its constituent parts prefilled syringe, needle for injection and needle for reconstitution (batch number: unknown), at an unknown dose, site or route of administration (explicitly coded as 'inappropriate schedule of vaccine administered'). On an unspecified date, the symptoms ramped up following the fourth shot. Twitching in feet became constant (at night/rest and during activity normal day), more tingling/pins/needles, heaviness' in legs, ankle pain, and various other symptoms persisted. The patient went to primary care physician (PCP) and got prescribed with methylprednisone. Within three days into this medication regimen, the patient became so weak (especially quads' and shoulders/trunk) and was having heaviness' in jaw with mild swallowing problems. On an unspecified date, the patient went to the Emergency Room and was admitted for three days. Multiple tests were run. On an unspecified date the patient was discharged with continued care/testing under the care of a neurologist in the hospital system. On an unspecified date, the patient was prescribed Vit B complex, Vit B12, Magnesium and go to physical therapy. The patient reported that none of that had been successful and continued to deteriorate, with loss of a significant amount of muscle mass in all four limbs and possibly trunk. The patient progressively got weaker and thinner. The muscle twitching had never dissipated since the third shot and it had spread over more of the body and was present daily. Some days were worse than others-exercise, even light, appears to exacerbate it. At the time of initial report, the patient did not recover from the events of 'pain', 'muscle twitching', 'neurological symptom', 'pain in leg', 'condition worsened', 'flushing', 'weakness muscle', 'dysphagia', 'muscle atrophy', 'numbness of limbs', 'heaviness in leg', 'hot flushes', 'tingling of extremity', 'abdominal pain', 'headache', 'pain in ankle' and 'myalgia'. The reporter assessed the events of ''pain', 'muscle twitching', 'neurological symptom','pain in leg', 'condition worsened', 'flushing', 'weakness muscle', 'dysphagia', 'muscle atrophy', 'numbness of limbs', 'heaviness in leg', 'hot flushes', 'tingling of extremity', 'abdominal pain', 'headache', 'pain in ankle' and 'myalgia' as serious due to seriousness criteria of hospitalization and did not provide a causality assessment. Additional information received from consumer on 22-Jun-2026: New reference number BN-2026-00094, event details, product dosing details, treatment details, seriousness criteria, severity, outcome details and country of occurrence and reporter's country confirmed.; Reporter's Comments: This spontaneous case concerns a female patient of an unknown age, who developed a serious events pain, muscle twitching, neurological symptom, pain in extremity, condition aggravated, flushing, muscular weakness, dysphagia, muscle atrophy, hypoaesthesia, limb discomfort, hot flush, paraesthesia, abdominal pain, headache, arthralgia, myalgia (hospitalization), on unspecified date after receiving the third dose of RabAvert vaccine for an unknown indication. As reported, patient received fourth dose, 27 days after the first dose, which is considered as inappropriate schedule of product administered. Paraesthesia, abdominal pain, headache, arthralgia, myalgia are considered as listed and expected per CCDS v6.0 and USPI, whilst pain, muscle twitching, neurological symptom, pain in extremity, condition aggravated, flushing, muscular weakness, dysphagia, muscle atrophy, hypoaesthesia, limb discomfort is unlisted and unexpected. Event hot flush is considered as unlisted and expected. Inappropriate schedule of product administered is considered as listed as per company convention. The outcome of events was not recovered. The patient's medical history details were not provided and concomitant medication details included antibiotics and tetanus immunization. Considering implied temporal relationship, biological plausibility and insufficient information regarding presence of confounding factors or alternative explanations, the causality is assessed as possibly related to the suspect vaccine for regulatory reporting purposes. Inappropriate schedule of product administered is not related to the suspect vaccine, but to a human factor. This case is considered as serious due to hospitalization.; Sender's Comments: This spontaneous case concerns a female patient of an unknown age, who developed a serious events pain, muscle twitching, neurological symptom, pain in extremity, condition aggravated, flushing, muscular weakness, dysphagia, muscle atrophy, hypoaesthesia, limb discomfort, hot flush, paraesthesia, abdominal pain, headache, arthralgia, myalgia (hospitalization), on unspecified date after receiving the third dose of RabAvert vaccine for an unknown indication. As reported, patient received fourth dose, 27 days after the first dose, which is considered as inappropriate schedule of product administered. Paraesthesia, abdominal pain, headache, arthralgia, myalgia are considered as listed and expected per CCDS v6.0 and USPI, whilst pain, muscle twitching, neurological symptom, pain in extremity, condition aggravated, flushing, muscular weakness, dysphagia, muscle atrophy, hypoaesthesia, limb discomfort is unlisted and unexpected. Event hot flush is considered as unlisted and expected. Inappropriate schedule of product administered is considered as listed as per company convention. The outcome of events was not recovered. The patient's medical history details were not provided and concomitant medication details included antibiotics and tetanus immunization. Considering implied temporal relationship, biological plausibility and insufficient information regarding presence of confounding factors or alternative explanations, the causality is assessed as possibly related to the suspect vaccine for regulatory reporting purposes. Inappropriate schedule of product administered is not related to the suspect vaccine, but to a human factor. This case is considered as serious due to hospitalization.
Comments: None
ANTIBIOTICS; TETANUS VACCINE; IMMUNOGLOBULIN