Vaccine (Unknown)

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157 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.
157
Total Reports
26
Deaths Reported
1660.0%
Death Rate

Active Ingredients

Vaccine (Unknown)

Administration Routes

UnknownParenteralNasalOtherSubcutaneousOral

Species Affected

Dog 112
Cat 29
Cattle 14
Pig 2

Most Affected Breeds

Domestic Shorthair 18
Retriever - Labrador 13
Mixed (Cattle) 7
Retriever - Golden 7
Pit Bull 6
Terrier - Boston 6
Dog (unknown) 5
Shepherd Dog - Australian 5
Poodle (unspecified) 5
Maltese 4

Most Reported Reactions

Vomiting 43
Diarrhoea 17
Death 16
Lack of efficacy (endoparasite) - heartworm 13
Lethargy (see also Central nervous system depression in Neurological) 13
Lethargy (see also Central nervous system depression in 'Neurological') 12
Not eating 12
Anorexia 12
Death by euthanasia 11
Emesis (multiple) 11
Behavioural disorder NOS 9
Decreased appetite 9

Outcome Breakdown

Outcome Unknown
63 (37.5%)
Recovered/Normal
46 (27.4%)
Ongoing
32 (19.0%)
Died
16 (9.5%)
Euthanized
11 (6.5%)

Data Summary

Metric Value
Total adverse event reports 157
Reports involving death 26
Case-fatality rate (reported events) 1660.0%
Distinct species in reports 4
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.

Vaccine (Unknown) Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 157 adverse event reports referencing Vaccine (Unknown), including 26 reports in which the animal died — a 1660.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredient on file: Vaccine (Unknown). Reported administration routes include Unknown, Parenteral, Nasal, 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 Vaccine (Unknown) reports are Dog (112 reports), Cat (29 reports), Cattle (14 reports), with Dog accounting for the largest share. Within those species, Domestic Shorthair (18), Retriever - Labrador (13), Mixed (Cattle) (7) 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 Vaccine (Unknown) are Vomiting (43), Diarrhoea (17), Death (16), Lack of efficacy (endoparasite) - heartworm (13). Of the 168 reports with a coded outcome, Outcome Unknown is the leading category at 37.5%. 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 Vaccine (Unknown).

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