Borrelia Burgdorferi Bacterin-Leptospira Canicola-Grippotyphosa-Icterohaemorrhagiae-Pomona Bacterial Extract

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444 adverse event reports submitted to the FDA

Important: Adverse event reports do not establish that a drug caused or contributed to the event. Consult your veterinarian before making treatment decisions.
444
Total Reports
16
Deaths Reported
360.0%
Death Rate

Active Ingredients

Borrelia Burgdorferi Bacterin-Leptospira Canicola-Grippotyphosa-Icterohaemorrhagiae-Pomona Bacterial Extract

Administration Routes

SubcutaneousParenteralUnknownOtherOralAuricular (Otic)

Species Affected

Dog 444

Most Affected Breeds

Retriever - Labrador 75
Retriever - Golden 49
Shepherd Dog - German 24
Crossbred Canine/dog 24
Shepherd Dog - Australian 16
Siberian Husky 14
Shih Tzu 11
Poodle (unspecified) 11
Pit Bull 9
Boxer (German Boxer) 8

Most Reported Reactions

Lack of efficacy (bacteria) - Borrelia 235
Other abnormal test result NOS 88
Lack of efficacy (ectoparasite) - tick NOS 81
Vomiting 42
Diarrhoea 33
Lethargy (see also Central nervous system depression in Neurological) 30
Partial lack of efficacy 26
Lethargy (see also Central nervous system depression in 'Neurological') 23
Lack of efficacy (bacteria) - Anaplasma 21
Lameness 18
Not eating 17
Proteinuria 15

Outcome Breakdown

Outcome Unknown
318 (71.6%)
Ongoing
57 (12.8%)
Recovered/Normal
53 (11.9%)
Euthanized
11 (2.5%)
Died
5 (1.1%)

Data Summary

Metric Value
Total adverse event reports 444
Reports involving death 16
Case-fatality rate (reported events) 360.0%
Distinct species in reports 1
Distinct breeds in reports 20
Distinct reactions reported 20
Active ingredients on file 1

Source: FDA Center for Veterinary Medicine — Adverse Event Reporting (CVM AER). Counts reflect voluntary reports only.

Borrelia Burgdorferi Bacterin-Leptospira Canicola-Grippotyphosa-Icterohaemorrhagiae-Pomona Bacterial Extract Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 444 adverse event reports referencing Borrelia Burgdorferi Bacterin-Leptospira Canicola-Grippotyphosa-Icterohaemorrhagiae-Pomona Bacterial Extract, including 16 reports in which the animal died — a 360.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Borrelia Burgdorferi Bacterin-Leptospira Canicola-Grippotyphosa-Icterohaemorrhagiae-Pomona Bacterial Extract. Reported administration routes include Subcutaneous, Parenteral, Unknown, Other. These numbers reflect voluntary submissions from pet owners, veterinarians, and manufacturers and therefore under-represent mild events and over-represent severe ones — a pattern the FDA has documented repeatedly for pharmacovigilance datasets.

The species most frequently named in Borrelia Burgdorferi Bacterin-Leptospira Canicola-Grippotyphosa-Icterohaemorrhagiae-Pomona Bacterial Extract reports are Dog (444 reports), with Dog accounting for the largest share. Within those species, Retriever - Labrador (75), Retriever - Golden (49), Shepherd Dog - German (24) appear most often — though breed popularity and ownership density shape these counts as much as any drug-specific sensitivity. This distribution matters because the same active ingredient can behave very differently across body sizes, ages, and species physiology.

The most commonly reported clinical signs associated with Borrelia Burgdorferi Bacterin-Leptospira Canicola-Grippotyphosa-Icterohaemorrhagiae-Pomona Bacterial Extract are Lack of efficacy (bacteria) - Borrelia (235), Other abnormal test result NOS (88), Lack of efficacy (ectoparasite) - tick NOS (81), Vomiting (42). Of the 444 reports with a coded outcome, Outcome Unknown is the leading category at 71.6%. Because FDA adverse event data describes correlation rather than causation, these figures are best used to frame informed questions with a veterinarian and to compare reporting patterns across related products — not as a standalone safety verdict on Borrelia Burgdorferi Bacterin-Leptospira Canicola-Grippotyphosa-Icterohaemorrhagiae-Pomona Bacterial Extract.

Source: FDA Center for Veterinary Medicine — Adverse Event Reports FDA Center for Veterinary Medicine — Adverse Event Reports Data reflects voluntary submissions and may not represent actual incidence rates

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Data sourced from official AKC, AVMA, ACVO, and breed-club veterinary references. See our methodology for details. Retrieved and formatted by PlainBreed Editorial