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M I N I   -  I N D E X
Alphabetical-List  |   FluVaccines  |   TB-VAX/Tubersol  |   5-in-one/6-in-one(hexa)  |   Animal Vaccines
COVID  |   GlaxoSmithKline/GSK  |   Merck  |   Misc   |   Military  |   Monkeypox  |   RotaVirus/ProQuad-MMRV/VAQTA-HepA  |   RSV  |   SwineFluVaccines  |   Vaccine_Information_Sheets_(VIS)  |   VitaminK

If you do not see the vaccine of interest in our "Mini Index", then use your browser Edit/Find to locate on this page the inserts of interest.

Monkeypox/smallpopx Vaccine Package Inserts/Prescribing Information
FDA Highlights: JYNNEOS (monkeypox and smallpox)

ACAM2000, (Smallpox (Vaccinia) Vaccine, Live)

Respiratory syncytial virus (RSV)
Information   |   Prescribing Information for ABRYSVO from Pfizer  |   Package Insert for ABRYSVO from FDA

GlaxoSmithKline: AREXVY
Package Insert for AREXVY from FDA

Swedish Orphan Biovitrum AB (publ): SYNAGIS
SYNAGIS Packae Insert

Sanofi: BEYFORTUS Package Insert
BEYFORTUS Package Insert on FDA site

COVID Vaccine Package Inserts/Prescribing Information
Global Information (Pfizer‑BioNTech):

FDA approved package insert for Pfizer-Biontech COVID-19 vaccine

Web Page: PFIZER-BIONTECH COVID-19 VACCINE- bnt162b2 injection, suspension

Material Safety Data Sheet - Pfizer

Lethal injection of potassium chloride: first description of the pathological appearance of organs

Moderna ...

Johnson & Johnson (Janssen)

AstraZeneca (Europe) Vaccine [PDF]

FDA Product Approval: index for approved vaccines
Immunization Action Coalition
has posted the FDA list of links to Product Approval documents as well as Package Inserts.

Note: This FDA site has links to all vaccines licensed in the USA
Vaccines Licensed for Immunization and Distribution in the US with Supporting Documents including package inserts

Law regarding Prescribing Information (PI or Package Inserts)
Contraindications | Warnings and precautions | Adverse reactions

Links to CDC lists of Vaccine Ingredients
Includes some archived material for research

Vaccine Ingredients and Manufacturer Information (

For more Material Safety Data Sheets See: Animal Vaccines

Alphabetical list of Vaccines
Their page may also be sorted by Antigen or by Manufacturer
A One Stop page for links to current vaccine package inserts

Manufacturers: sanofi pasteur, CLS Limited, Novartis, Bayer, Emergent BioSolutions, GlaxoSmithKline, Merck, Aventis Pasteur, MedImmune, Intercell Biomedical, NABI, Chiron, Mass Biol Labs, Berna/

Package Inserts
Vaccines, Blood & Biologics

Military Vaccine Agency
Includes childhood vaccines

Listed here are all the products currently distributed by sanofi pasteur, sorted by disease category. Click on the PDF graphic to download the package insert.

GlaxoXmithKline Vaccines
See links under Alphabetical list of Vaccines above

FluMist package inserts:
PDR Drug information for Flumist Vaccine

Other Flu Vaccine Package Inserts:
Name - Manufacturer
Fluarix - GlaxoSmithKline |

Fluzone - sanofi pasteur |

FluMist - MedImmune |

The site includes package inserts for common vaccines including those for children, as well as links to smallpox vaccine and travel or military service related vaccines.

See the next section (below) for links to RotaVirus, MMRV and HepA vaccine Package Insert pages as well as information pages.
Vaccine Info: Vaccines
AFLURIA® (Influenza Virus Vaccine)
COMVAX® [Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine]
GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant]
M-M-R®II (Measles, Mumps, and Rubella Virus Vaccine Live)
PedvaxHIB® [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)]
PNEUMOVAX®23 (Pneumococcal Vaccine Polyvalent)
ProQuad® (Measles, Mumps, Rubella, and Varicella Virus Vaccine Live)
RECOMBIVAX HB® [Hepatitis B Vaccine (Recombinant)]
RotaTeq® (Rotavirus Vaccine, Live, Oral, Pentavalent)
Tetanus and Diphtheria Toxoids Adsorbed
VAQTA® (Hepatitis A Vaccine, Inactivated)
VARIVAX® (Varicella Virus Vaccine Live)
ZOSTAVAX® (Zoster Vaccine Live)
On Merck's web page, Click on disease of interest.
On each vaccine, click on prescribing information for the pdf package insert for that vaccine.
Package Inserts
Merck: Pneumococcal/Rotavirus/MMRV/HepA/Varicella
Pneumovax 23® Package Insert

[Rotavirus Vaccine, Live, Oral, Pentavalent]

ProQuad® (MMRV)


ZOSTAVAX® (live Varicella/Chicken Pox)

Swine Flu Vaccines

2009-2010 [For Reference]
CSL Biotherapies INC.
CSL Package insert for Influenza A (H1N1) 2009 Monovalent Vaccine
Note: the 2009 Monovalent Vaccine is an inactivated influenza virus vaccine manufactured by the same process as AFLURIA. There have been no controlled clinical studies demonstrating a decrease in influenza disease after vaccination with AFLURIA.

MedImmune LLC
Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal manufactured by MedImmune LLC
package insert and related documents:  ||   Package Insert for Medimmune:

Novartis’ Influenza A (H1N1) 2009 Monovalent Vaccine and seasonal trivalent Influenza Virus Vaccine (FLUVIRIN) are manufactured by the same process.
package insert and related documents:
Influenza A (H1N1) 2009 Monovalent Vaccine (Novartis Vaccines and Diagnostics Limited) Package Insert:

Sanofi Pasteur
Influenza A (H1N1) 2009 Monovalent Vaccine is an inactivated influenza virus vaccine
package insert and related documents:
Influenza A (H1N1) 2009 Monovalent Vaccine (Sanofi Pasteur, Inc.) package insert:

Vitamin K
Merck & Co., Inc
AquaMEPHYTON® (Phytonadione)
Aqueous Colloidal Solution of Vitamin K

Not a vaccine, but Vitamin K is often given at birth.

There are warnings about Intravenous and Intramuscular administration including severe reactions including death in situations where subcutanneous injection is not feasible.

The Merck PDF document is available on the Web Archives site. ... AquaMEPHYTON_PI.pdf

Prescribing information for Vitamin K (Phytonadione)
Drugs & Medications - Aqua-Mephyton InjDrugs
The injectable form of vitamin K can rarely cause severe (sometimes fatal) allergic reactions when given by injection into a muscle or vein. Therefore, vitamin K should be injected into a muscle or vein only when it cannot be given by injection under the skin or taken by mouth, or when your doctor has judged that the benefit is greater than the risk. Seek immediate medical attention if you experience symptoms of an allergic reaction such as rash, itching, swelling, dizziness, or trouble breathing.
Common names:
AquaMEPHYTON, Mephyton, phylloquinone , phytomenadione , vitamin K 1 , and vitamin K 4 .

Phytonadione is available in both Tablets and by injection.

See above link for a list of risks versus benefits.
Phytonadione is the generic name for Vitamin K.
Pharmasave library on Vitamin K (general info)

The link to Tubersol's package insert is available online here:
another version is here:
Commonly used brand name(s): Aplisol; Aplitest; Tuberculin PPD TINE TEST; Tubersol.


Infanrix, DTaP, PediaRix, Infanrix hexa, many MISC Vaccines
Infanrix, DTaP vaccine package insert - 2002 -

5 in 1 vaccine PediaRix Vaccine Package Insert

Infanrix hexa (6 in 1 vaccine), package leaflet
European Public Assessment Report (EPAR)
Package Leaflet for Infanrix hexa in 11 European languages, includes Danish, German, Greek, English, Spanish, Finnish, French, Italian, Dutch, Portuguese and Swedish.
The DTaP-HepB-IPV component is a white, slightly milky liquid presented in a prefilled syringe (0.5 ml).
The Hib component is a white powder presented in a glass vial. Both components must be mixed together...

M I S C site has a page of links to Package Inserts

Prevnar 13 (New) Package Insert:

Prevnar 7 (Old) Package Insert:

Smallpox - Archived
[This vaccine has been replaced by a newer smallpox vaccine, see Military package inserts.
Smallpox Vaccine - Dryvax - (Wyeth) Revised 04-05
DRYVAX, Wyeth smallpox package insert formerly on US GOV site .PDF Rev. Oct. 2004
Now archived on

Smallpox Vaccine - Dryvax - (Wyeth) Revised 11/02.
If you dont want the .PDF file you can download the [archived] HTML file at: Rev. Nov 6, 2002

Animal Vaccines - Here:
Human Vaccines (Click)

Products, including vaccines, for animals:

Merial Canada - Animal Vaccines

Pfizer - has become Zoetis- Animal Vaccines
2 March 2015 - No ready resource for package inserts found.

CFR - Code of Federal Regulations Title 21 (Drugs/Biologics/Vaccine Adverse Reactions)
Excerpts from:

Subpart B--Labeling Requirements for Prescription Drugs and/or Insulin
(9) Contraindications. A concise statement of each of the product's contraindications, as required under paragraph (c)(5) of this section, with any appropriate subheadings.

(10) Warnings and precautions. A concise summary of the most clinically significant information required under paragraph (c)(6) of this section, with any appropriate subheadings, including information that would affect decisions about whether to prescribe a drug, recommendations for patient monitoring that are critical to safe use of the drug, and measures that can be taken to prevent or mitigate harm.

(11) Adverse reactions. (i) A list of the most frequently occurring adverse reactions, as described in paragraph (c)(7) of this section, along with the criteria used to determine inclusion (e.g., incidence rate). Adverse reactions important for other reasons (e.g., because they are serious or frequently lead to discontinuation or dosage adjustment) must not be repeated under this heading in Highlights if they are included elsewhere in Highlights (e.g., Warnings and Precautions, Contraindications).

(ii) For drug products other than vaccines, the verbatim statement "To report SUSPECTED ADVERSE REACTIONS, contact (insert name of manufacturer ) at (insert manufacturer's phone number ) or FDA at (insert current FDA phone number and Web address for voluntary reporting of adverse reactions )."

(iii) For vaccines, the verbatim statement "To report SUSPECTED ADVERSE REACTIONS, contact (insert name of manufacturer ) at (insert manufacturer's phone number ) or VAERS at (insert the current VAERS phone number and Web address for voluntary reporting of adverse reactions )."

current as of April 1 2019.