Distemper/Leptospirosis Vaccine

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13 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.
13
Total Reports
1
Deaths Reported
770.0%
Death Rate

Active Ingredients

Distemper/Leptospirosis Vaccine

Administration Routes

UnknownSubcutaneous

Species Affected

Dog 13

Most Affected Breeds

Chihuahua 2
Bichon Frise 2
Cattle Dog - Australian (blue heeler, red heeler, Queensland cattledog) 2
Terrier - Bull - American Pit 1
Bulldog 1
Retriever - Golden 1
Poodle - Standard 1
Terrier - Yorkshire 1
Siberian Husky 1
Schnauzer - Miniature 1

Most Reported Reactions

Vomiting 5
Lethargy (see also Central nervous system depression in Neurological) 3
Seizure NOS 2
Falling 2
Not sleeping 2
Whining 2
Cough 2
Lymphocytosis 2
Monocytosis 2
Platelet disorder NOS 2
Dehydration 2
Facial swelling (see also Skin) 2

Outcome Breakdown

Recovered/Normal
6 (46.2%)
Ongoing
5 (38.5%)
Died
1 (7.7%)
Outcome Unknown
1 (7.7%)

Data Summary

Metric Value
Total adverse event reports 13
Reports involving death 1
Case-fatality rate (reported events) 770.0%
Distinct species in reports 1
Distinct breeds in reports 10
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.

Distemper/Leptospirosis Vaccine Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 13 adverse event reports referencing Distemper/Leptospirosis Vaccine, including 1 reports in which the animal died — a 770.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Distemper/Leptospirosis 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 Distemper/Leptospirosis Vaccine reports are Dog (13 reports), with Dog accounting for the largest share. Within those species, Chihuahua (2), Bichon Frise (2), Cattle Dog - Australian (blue heeler, red heeler, Queensland cattledog) (2) 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 Distemper/Leptospirosis Vaccine are Vomiting (5), Lethargy (see also Central nervous system depression in Neurological) (3), Seizure NOS (2), Falling (2). Of the 13 reports with a coded outcome, Recovered/Normal is the leading category at 46.2%. 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 Distemper/Leptospirosis 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