Unknown Lyme Vaccine

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72 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.
72
Total Reports
2
Deaths Reported
280.0%
Death Rate

Active Ingredients

Unknown Lyme Vaccine

Administration Routes

UnknownSubcutaneous

Species Affected

Dog 72

Most Affected Breeds

Retriever - Labrador 11
Pit Bull 6
Crossbred Canine/dog 5
Retriever - Golden 4
Dog (unknown) 3
Mountain Dog - Bernese 3
Shih Tzu 2
Siberian Husky 2
Spaniel (unspecified) 2
Cattle Dog - Australian (blue heeler, red heeler, Queensland cattledog) 2

Most Reported Reactions

Lack of efficacy (bacteria) - Borrelia 53
Lack of efficacy (ectoparasite) - tick NOS 24
Emesis (multiple) 3
Itching 3
Diarrhoea 3
Lack of efficacy (bacteria) - Anaplasma 3
Ataxia 2
Lack of efficacy (bacteria) - NOS 2
Lack of efficacy (bacteria) - Ehrlichia 2
Anorexia 2
Blood in faeces 1
Lethargy (see also Central nervous system depression in 'Neurological') 1

Outcome Breakdown

Outcome Unknown
39 (54.2%)
Ongoing
28 (38.9%)
Recovered/Normal
3 (4.2%)
Died
1 (1.4%)
Euthanized
1 (1.4%)

Data Summary

Metric Value
Total adverse event reports 72
Reports involving death 2
Case-fatality rate (reported events) 280.0%
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.

Unknown Lyme Vaccine Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 72 adverse event reports referencing Unknown Lyme Vaccine, including 2 reports in which the animal died — a 280.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Unknown Lyme Vaccine. Reported administration routes include Unknown, Subcutaneous. 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 Unknown Lyme Vaccine reports are Dog (72 reports), with Dog accounting for the largest share. Within those species, Retriever - Labrador (11), Pit Bull (6), Crossbred Canine/dog (5) 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 Unknown Lyme Vaccine are Lack of efficacy (bacteria) - Borrelia (53), Lack of efficacy (ectoparasite) - tick NOS (24), Emesis (multiple) (3), Itching (3). Of the 72 reports with a coded outcome, Outcome Unknown is the leading category at 54.2%. 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 Unknown Lyme Vaccine.

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

Related

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