Received Jun 29, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| RAB | RABIES (RABAVERT) | NOVARTIS VACCINES AND DIAGNOSTICS | 3 | RF3050125A | IM |
The patient received only three doses of RabAvert and did not receive further doses; The patient experienced shortness of air after the administration of Rabavert; Case reference number US-BN-2025-001608 is a spontaneous case initially received from a pharmacist via communication (reference number: USBAV25-2402) on 26-Sep-2025 and concerns *43-years-old* adult female patient. The patient's past medical history *included deep vein thrombosis/ pulmonary embolism (DVT/PE), obstructive sleep apnea (OSA), asthma, depression, migraine, and obesity*. The patient's current condition included Alpha-gal *allergy* and *lactose intolerance, schizoaffective disorder, hypothyroidism, dilated cardiomyopathy, Generalised anxiety disorder (GAD). * The patient's concomitant therapy *Augmentin (amoxicillin sodium, clavulanate potassium) 875 mg twice daily for 7 days was prescribed at the initiation of RabAvert therapy on 15-Sep-2025. * On *15-Sep-2025*, the patient received *first* dose of RabAvert vaccine along with its constituent parts: prefilled syringe, needle for injection and needle for reconstitution *(batch number: RF3050125A, expiration date: 15-Jul-2027*) at a dose of 1 ml, intramuscularly in the deltoid region, for indication cat bite (vaccine history of animal was unknown). * On *18-Sep-2025, three days after the first dose*, the patient received *second* dose of RabAvert vaccine along with its constituent parts: prefilled syringe, needle for injection and needle for reconstitution (*batch number: FDP00720, expiration date: 31-Dec-2027*) at a dose of 1 ml, intramuscularly in the deltoid region. * On *22-Sep-2025, seven days after the first dose*, the patient received *third* dose of RabAvert vaccine along with its constituent parts: prefilled syringe, needle for injection and needle for reconstitution (*batch number: FDP00720, expiration date: 31-Dec-2027*) at a dose of 1 ml, intramuscularly in the deltoid region. * *As reported, the patient received only three doses of RabAvert and did not receive further doses (explicitly coded as 'incomplete course of vaccination'). * On *23-Sep-2025, upon awakening, one day after the third dose*, the patient experienced shortness of air *lasted for approximately 12 hours*. *It was reported that no laboratories investigations have been performed*. At the time of the *follow-up*, the patient was *recovered* from the event of 'shortness of breath'. The reporter *assessed the event of 'shortness of breath' as non-serious, mild, and causality as probably related to RabAvert. * All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*). Follow up information received from pharmacist on 23-Oct-2025: New information included updated patient details, suspect product details, and adverse event details and confirmation that no laboratories investigations have been performed.; Reporter's Comments: This case concerns a 43-years-old adult female patient, who experienced non-serious event of dyspnoea, one day after the patient receiving the third dose of RabAvert vaccine for an indication of cat bite. As reported patient received only three doses, which is considered as incomplete course of vaccination. Dyspnoea is unlisted as per CCDS v6 and unexpected per USPI. Incomplete course of vaccination is considered as listed per company convention. Patient's medical history details include deep vein thrombosis/ pulmonary embolism (DVT/PE), obstructive sleep apnea (OSA), asthma, depression, migraine, and obesity. and concomitant medication details include Augmentin. Outcome is recovered. Considering compatible temporal relationship and biological plausibility, for regulatory reporting purposes the causality for the reported event, is assessed as possibly related to suspect. Incomplete course of vaccination is not related to then suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: This case concerns a 43-years-old adult female patient, who experienced non-serious event of dyspnoea, one day after the patient receiving the third dose of RabAvert vaccine for an indication of cat bite. As reported patient received only three doses, which is considered as incomplete course of vaccination. Dyspnoea is unlisted as per CCDS v6 and unexpected per USPI. Incomplete course of vaccination is considered as listed per company convention. Patient's medical history details include deep vein thrombosis/ pulmonary embolism (DVT/PE), obstructive sleep apnea (OSA), asthma, depression, migraine, and obesity. and concomitant medication details include Augmentin. Outcome is recovered. Considering compatible temporal relationship and biological plausibility, for regulatory reporting purposes the causality for the reported event, is assessed as possibly related to suspect. Incomplete course of vaccination is not related to then suspect vaccine, but to a human factor. This case is considered as non-serious.
Alpha-gal allergy; Dilated cardiomyopathy; Generalised anxiety disorder; Hypothyroidism; Lactose intolerance; Obesity; Schizoaffective disorder
Medical History/Concurrent Conditions: Asthma; Deep vein thrombosis; Depression; Migraine; Obstructive sleep apnea; Pulmonary embolism
AUGMENTIN [AMOXICILLIN SODIUM;CLAVULANATE POTASSIUM]