Bovine Parainfluenza 3 Virus, Killed Virus + Bovine Respiratory Syncytial Virus, Killed Virus + Bovine Rhinotracheitis Virus, Killed Virus + Bovine Virus Diarrhea Type 1, Killed Virus + Bovine Virus Diarrhea Type 2, Killed Virus + Leptospira Canicola Bacterin + Leptospira Grippotyphosa Bacterin + Leptospira Hardjo Bacterin + Leptospira Icterohaemorrhagiae Bacterin + Leptospira Pomona Bacterin

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24 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.
24
Total Reports
10
Deaths Reported
4170.0%
Death Rate

Active Ingredients

Bovine Parainfluenza 3 Virus, Killed VirusBovine Respiratory Syncytial Virus, Killed VirusBovine Rhinotracheitis Virus, Killed VirusBovine Virus Diarrhea Type 1, Killed VirusBovine Virus Diarrhea Type 2, Killed VirusLeptospira Canicola BacterinLeptospira Grippotyphosa BacterinLeptospira Hardjo BacterinLeptospira Icterohaemorrhagiae BacterinLeptospira Pomona Bacterin

Administration Routes

UnknownSubcutaneous

Species Affected

Cattle 24

Most Affected Breeds

Cattle (other) 13
Aberdeen Angus 5
Holstein-Friesian also known as Holstein 2
Cattle (unknown) 2
Crossbred Bovine/Cattle 1
Brangus 1

Most Reported Reactions

Lack of efficacy - NOS 9
Death 9
Lack of efficacy (bacteria) - NOS 3
Abortion 2
Injection site lump 2
Lack of efficacy (virus) - NOS 2
Injection site infection 1
Recumbency 1
Injection site inflammation 1
Injection site stiffness 1
Unrelated death 1
Blindness 1

Outcome Breakdown

Outcome Unknown
10 (33.3%)
Died
10 (33.3%)
Recovered/Normal
8 (26.7%)
Ongoing
2 (6.7%)

Data Summary

Metric Value
Total adverse event reports 24
Reports involving death 10
Case-fatality rate (reported events) 4170.0%
Distinct species in reports 1
Distinct breeds in reports 6
Distinct reactions reported 20
Active ingredients on file 10

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

Bovine Parainfluenza 3 Virus, Killed Virus + Bovine Respiratory Syncytial Virus, Killed Virus + Bovine Rhinotracheitis Virus, Killed Virus + Bovine Virus Diarrhea Type 1, Killed Virus + Bovine Virus Diarrhea Type 2, Killed Virus + Leptospira Canicola Bacterin + Leptospira Grippotyphosa Bacterin + Leptospira Hardjo Bacterin + Leptospira Icterohaemorrhagiae Bacterin + Leptospira Pomona Bacterin Adverse Event Insights

The FDA Center for Veterinary Medicine database currently holds 24 adverse event reports referencing Bovine Parainfluenza 3 Virus, Killed Virus + Bovine Respiratory Syncytial Virus, Killed Virus + Bovine Rhinotracheitis Virus, Killed Virus + Bovine Virus Diarrhea Type 1, Killed Virus + Bovine Virus Diarrhea Type 2, Killed Virus + Leptospira Canicola Bacterin + Leptospira Grippotyphosa Bacterin + Leptospira Hardjo Bacterin + Leptospira Icterohaemorrhagiae Bacterin + Leptospira Pomona Bacterin, including 10 reports in which the animal died — a 4170.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredients on file: Bovine Parainfluenza 3 Virus, Killed Virus, Bovine Respiratory Syncytial Virus, Killed Virus, Bovine Rhinotracheitis Virus, Killed Virus, Bovine Virus Diarrhea Type 1, Killed Virus, Bovine Virus Diarrhea Type 2, Killed Virus. 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 Bovine Parainfluenza 3 Virus, Killed Virus + Bovine Respiratory Syncytial Virus, Killed Virus + Bovine Rhinotracheitis Virus, Killed Virus + Bovine Virus Diarrhea Type 1, Killed Virus + Bovine Virus Diarrhea Type 2, Killed Virus + Leptospira Canicola Bacterin + Leptospira Grippotyphosa Bacterin + Leptospira Hardjo Bacterin + Leptospira Icterohaemorrhagiae Bacterin + Leptospira Pomona Bacterin reports are Cattle (24 reports), with Cattle accounting for the largest share. Within those species, Cattle (other) (13), Aberdeen Angus (5), Holstein-Friesian also known as Holstein (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 Bovine Parainfluenza 3 Virus, Killed Virus + Bovine Respiratory Syncytial Virus, Killed Virus + Bovine Rhinotracheitis Virus, Killed Virus + Bovine Virus Diarrhea Type 1, Killed Virus + Bovine Virus Diarrhea Type 2, Killed Virus + Leptospira Canicola Bacterin + Leptospira Grippotyphosa Bacterin + Leptospira Hardjo Bacterin + Leptospira Icterohaemorrhagiae Bacterin + Leptospira Pomona Bacterin are Lack of efficacy - NOS (9), Death (9), Lack of efficacy (bacteria) - NOS (3), Abortion (2). Of the 30 reports with a coded outcome, Outcome Unknown is the leading category at 33.3%. 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 Bovine Parainfluenza 3 Virus, Killed Virus + Bovine Respiratory Syncytial Virus, Killed Virus + Bovine Rhinotracheitis Virus, Killed Virus + Bovine Virus Diarrhea Type 1, Killed Virus + Bovine Virus Diarrhea Type 2, Killed Virus + Leptospira Canicola Bacterin + Leptospira Grippotyphosa Bacterin + Leptospira Hardjo Bacterin + Leptospira Icterohaemorrhagiae Bacterin + Leptospira Pomona Bacterin.

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