Bovine Parainfluenza 3 Virus, Modified Live Virus + Bovine Respiratory Syncytial Virus, Modified Live Virus + Bovine Rhinotracheitis Virus, Modified Live Virus + Bovine Virus Diarrhea, Modified Live Virus + Leptospira Canicola Bacterin + Leptospira Grippotyphosa Bacterin + Leptospira Hardjo Bacterin + Leptospira Icterohaemorrhagiae Bacterin + Leptospira Pomona Bacterin

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16 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.
16
Total Reports
13
Deaths Reported
8120.0%
Death Rate

Active Ingredients

Bovine Parainfluenza 3 Virus, Modified Live VirusBovine Respiratory Syncytial Virus, Modified Live VirusBovine Rhinotracheitis Virus, Modified Live VirusBovine Virus Diarrhea, Modified Live VirusLeptospira Canicola BacterinLeptospira Grippotyphosa BacterinLeptospira Hardjo BacterinLeptospira Icterohaemorrhagiae BacterinLeptospira Pomona Bacterin

Administration Routes

UnknownSubcutaneousIntrauterine

Species Affected

Cattle 16

Most Affected Breeds

Cattle (other) 7
Cattle (unknown) 3
Charolais 3
Holstein-Friesian also known as Holstein 2
Red Angus 1

Most Reported Reactions

Death 11
Lack of efficacy - NOS 8
Necropsy performed 4
Lack of efficacy (virus) - bovine viral diarrhoea virus 2
Respiratory signs 1
INEFFECTIVE, ANTIBIOTIC 1
Tachypnoea 1
Fever 1
Anorexia 1
Lung sound 1
Laboured breathing 1
Abnormal necropsy finding 1

Outcome Breakdown

Died
12 (48.0%)
Outcome Unknown
5 (20.0%)
Recovered/Normal
5 (20.0%)
Ongoing
2 (8.0%)
Euthanized
1 (4.0%)

Data Summary

Metric Value
Total adverse event reports 16
Reports involving death 13
Case-fatality rate (reported events) 8120.0%
Distinct species in reports 1
Distinct breeds in reports 5
Distinct reactions reported 20
Active ingredients on file 9

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

Bovine Parainfluenza 3 Virus, Modified Live Virus + Bovine Respiratory Syncytial Virus, Modified Live Virus + Bovine Rhinotracheitis Virus, Modified Live Virus + Bovine Virus Diarrhea, Modified Live 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 16 adverse event reports referencing Bovine Parainfluenza 3 Virus, Modified Live Virus + Bovine Respiratory Syncytial Virus, Modified Live Virus + Bovine Rhinotracheitis Virus, Modified Live Virus + Bovine Virus Diarrhea, Modified Live Virus + Leptospira Canicola Bacterin + Leptospira Grippotyphosa Bacterin + Leptospira Hardjo Bacterin + Leptospira Icterohaemorrhagiae Bacterin + Leptospira Pomona Bacterin, including 13 reports in which the animal died — a 8120.0% case-fatality figure among reported events only, not a population-level mortality rate. Active ingredients on file: Bovine Parainfluenza 3 Virus, Modified Live Virus, Bovine Respiratory Syncytial Virus, Modified Live Virus, Bovine Rhinotracheitis Virus, Modified Live Virus, Bovine Virus Diarrhea, Modified Live Virus, Leptospira Canicola Bacterin. Reported administration routes include Unknown, Subcutaneous, Intrauterine. 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, Modified Live Virus + Bovine Respiratory Syncytial Virus, Modified Live Virus + Bovine Rhinotracheitis Virus, Modified Live Virus + Bovine Virus Diarrhea, Modified Live Virus + Leptospira Canicola Bacterin + Leptospira Grippotyphosa Bacterin + Leptospira Hardjo Bacterin + Leptospira Icterohaemorrhagiae Bacterin + Leptospira Pomona Bacterin reports are Cattle (16 reports), with Cattle accounting for the largest share. Within those species, Cattle (other) (7), Cattle (unknown) (3), Charolais (3) 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, Modified Live Virus + Bovine Respiratory Syncytial Virus, Modified Live Virus + Bovine Rhinotracheitis Virus, Modified Live Virus + Bovine Virus Diarrhea, Modified Live Virus + Leptospira Canicola Bacterin + Leptospira Grippotyphosa Bacterin + Leptospira Hardjo Bacterin + Leptospira Icterohaemorrhagiae Bacterin + Leptospira Pomona Bacterin are Death (11), Lack of efficacy - NOS (8), Necropsy performed (4), Lack of efficacy (virus) - bovine viral diarrhoea virus (2). Of the 25 reports with a coded outcome, Died is the leading category at 48.0%. 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, Modified Live Virus + Bovine Respiratory Syncytial Virus, Modified Live Virus + Bovine Rhinotracheitis Virus, Modified Live Virus + Bovine Virus Diarrhea, Modified Live 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