Vaccine Package Inserts
[Links to Sources]
Alphabetical list of Vaccines
Their page may also be sorted by Antigen or by Manufacturer
A good One Stop page for links to current vaccine package inserts is this
John Hopkins Bloomberg School of Public Health web site:
Manufacturers: sanofi pasteur, CLS Limited, Novartis, Bayer, Emergent BioSolutions, GlaxoSmithKline, Merck, Aventis Pasteur, MedImmune, Intercell Biomedical, NABI, Chiron, Mass Biol Labs, Berna/
Vaccines, Blood & Biologics
Military Vaccine Agency
Includes childhood vaccines
Package Inserts maintained by Immunization Action Coalition [several manufacturers]
See the next section (below) for links to RotaVirus, MMRV and
HepA vaccine Package Insert pages as well as information pages.
On Merck's web page, Click on disease of interest.
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 each vaccine, click on prescribing
information for the pdf package insert for that vaccine.
Pneumovax 23® Package Insert
[Rotavirus Vaccine, Live, Oral, Pentavalent]
RotaTeq PACKAGE INSERT:http://www.merck.com/product/usa/pi_circulars/r/rotateq/rotateq_pi.pdf
ProQuad (MMRV) PACKAGE INSERT: http://www.merck.com/product/usa/pi_circulars/p/proquad/proquad_pi.pdf
ZOSTAVAX® (live Varicella/Chicken Pox)
Merck & Co., Inc
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.
Archive.org ... AquaMEPHYTON_PI.pdf
Prescribing information for Vitamin K (Phytonadione)
Drugs & Medications - Aqua-Mephyton InjDrugs
VITAMIN K - INJECTION
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.
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)
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
Whale.to site has a page of links to Package Inserts
Prevnar 13 (New) Package Insert: http://www.wyeth.com/content/showlabeling.asp?id=501
Prevnar 7 (Old) Package Insert: http://www.wyeth.com/content/showlabeling.asp?id=134
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 wayback.archive.org
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
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)
ITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER C--DRUGS: GENERAL
PART 201 -- LABELING
Subpart B--Labeling Requirements for Prescription Drugs and/or Insulin
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.