FYI #2: Vaccine Package Inserts

 

Note: FYI #1 through FYI#5 is basic vaccine information. It should be agreed that it is important to be knowledgeable about the vaccine system that is currently in place. Otherwise, the rest of the information on this site wouldn’t do the reader much good.

These vaccine package inserts (PDFs) are listed in the order the vaccines are given, beginning at birth. (All of the vaccine package inserts may not be listed.) For a good source to get a package insert for just about any vaccine, go here: https://www.immunize.org/fda/#top To get “caught-up-to-speed”, all in one place, about the information within the vaccine package inserts, go here: https://childrenshealthdefense.org/news/read-the-fine-print-vaccine-package-inserts-reveal-hundreds-of-medical-conditions-linked-to-vaccines/ (At this link there is also available a PDF with the same content.)

Vaccines given at birth:

Vitamin K

AquaMEPHYTON® (PHYTONADIONE) Aqueous Colloidal Solution of Vitamin K

WARNING – INTRAVENOUS AND INTRAMUSCULAR USE Severe reactions, including fatalities, have occurred during and immediately after INTRAVENOUS injection of AquaMEPHYTON* (Phytonadione), even when precautions have been taken to dilute the AquaMEPHYTON and to avoid rapid infusion. Severe reactions, including fatalities, have also been reported following INTRAMUSCULAR administration. Typically these severe reactions have resembled hypersensitivity or anaphylaxis, including shock and cardiac and/or respiratory arrest. Some patients have exhibited these severe reactions on receiving AquaMEPHYTON for the first time. Therefore the INTRAVENOUS and INTRAMUSCULAR routes should be restricted to those situations where the subcutaneous route is not feasible and the serious risk involved is considered justified.

FAQ: Vitamin K and the Vitamin K Shot Given at Birth

Side Effects:

https://www.drugs.com/sfx/vitamin-k-side-effects.html

The Potential Dark Side of the Routine Newborn Vitamin K Shot

Avoid That Newborn Vitamin K Shot

Hepatitus B (See Vaccine Schedule for more information and ask your doctor which of these HepB vaccines will your baby receive so that you will know which package insert to read.)

ENGERIX-B [Hepatitis B Vaccine (Recombinant)]injectable suspension, for intramuscular useInitial U.S. Approval: 1989

HEPLISAV-B[HepatitisBVaccine (Recombinant),Adjuvanted] Solutionfor Intramuscular InjectionInitialUSApproval:2017

RECOMBIVAX HB® Hepatitis B Vaccine (Recombinant)Suspension for intramuscular injectionInitial U.S. Approval:1986

TWINRIX[Hepatitis A & Hepatitis B (Recombinant)Vaccine]injectable suspension, for intramuscular useInitial U.S. Approval: 2001

Vaccines (6) given at 2 months:

Vaccine #1:

Hepatitus B (See Vaccine Schedule for more information and ask your doctor which of these HepB vaccines your baby will receive so that you will know which package insert to read.)

ENGERIX-B [Hepatitis B Vaccine (Recombinant)]injectable suspension, for intramuscular useInitial U.S. Approval: 1989

HEPLISAV-B[HepatitisBVaccine (Recombinant),Adjuvanted] Solutionfor Intramuscular InjectionInitialUSApproval:2017

RECOMBIVAX HB® Hepatitis B Vaccine (Recombinant)Suspension for intramuscular injectionInitial U.S. Approval:1986

TWINRIX[Hepatitis A & Hepatitis B (Recombinant)Vaccine]injectable suspension, for intramuscular useInitial U.S. Approval: 2001

Vaccine #2:

Rotavirus (See Vaccine Schedule for more information and ask your doctor which of these Rotavirus vaccines your baby will receive so that you will know which package insert to read.)

RotaTeq(Rotavirus Vaccine, Live, Oral, Pentavalent ) Oral SolutionInitial U.S. Approval: 2006

INDICATIONS AND USAGE – RotaTeq is a vaccine indicated for the prevention of rotavirus gastroenteritis caused by types G1, G2, G3, G4, and G9. RotaTeq is approved for use in infants 6 weeks to 32 weeks of age.

ROTARIX(Rotavirus Vaccine, Live, Oral)Oral SuspensionInitial U.S. Approval: 2008

INDICATIONS AND USAGE- ROTARIX is a vaccine indicated for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9). ROTARIX is approved for use in infants 6 weeks and up to 24 weeks of age.

Vaccine #3:

DTaP – Diphtheria, Tetanus and Whooping Cough (See Vaccine Schedule for more information and ask your doctor which of these DTaP vaccines your baby will receive so that you will know which package insert to read.)

Quadracel®(Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbedand Inactivated Poliovirus Vaccine)

KINRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine)

DAPTACEL (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed)

INFANRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed)

PEDIARIX [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine]

Pentacel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine

Vaccine #4:

Haemophilus influenzae type b (See Vaccine Schedule for more information and ask your doctor which of these HIB vaccines your baby will receive so that you will know which package insert to read.)

ActHIB® [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)]Solution for Intramuscular Injection Initial U.S. Approval: 1993

INDICATIONS AND USAGE – ActHIB is a vaccine indicated for the prevention of invasive disease caused by Haemophilus influenzae type b. ActHIB vaccine is approved for use as a four dose series in infants and children 2 months through 5 years of age.

HIBERIX [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)]for injection, for intramuscular use Initial U.S. Approval: 2009

INDICATIONS AND USAGE – HIBERIX isa vaccine indicated for active immunization for the prevention of invasive disease caused by Haemophilus influenzae type b. HIBERIX is approved for use in children aged 6 weeks through 4 years (prior to fifth birthday).

LiquidPedvaxHIB®[Haemophilusb Conjugate Vaccine(Meningococcal Protein Conjugate)]

Pentacel® (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine Suspension for Intramuscular Injection Initial U.S. Approval: 2008

INDICATIONS AND USAGE – Pentacel is a vaccine indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to Haemophilus influenzae type b. Pentacel is approved for use as a four dose series in children 6 weeks through 4 years of age (prior to 5thbirthday)

VAXELISTM (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine) Suspension for Intramuscular Injection Initial U.S. Approval: 2018

INDICATIONS AND USAGE – VAXELIS is a vaccine indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzaetype b. VAXELIS is approved for use as a 3-dose series in children from 6 weeks through 4 years of age (prior to the 5thbirthday).

Vaccine #5:

Pneumococcal conjugate (PCV13) (See Vaccine Schedule for more information and ask your doctor is this the PCV13 vaccine your baby will receive.)

PREVNAR 13 (Pneumococcal 13-valent Conjugate Vaccine
[Diphtheria CRM197 Protein]) Suspension for intramuscular injection. Initial U.S. Approval: 2010

 

Vaccine #6:

Inactivated poliovirus (IPV) (See Vaccine Schedule for more information and ask your doctor which of these polio vaccines your baby will receive so that you will know which package insert to read.)

Poliovirus Vaccine InactivatedIPOL®

IPOL vaccine is indicated for active immunization of infants (as young as 6 weeks of age), children, and adults for the prevention of poliomyelitis caused by poliovirus Types 1, 2, and 3.

KINRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine) Suspension for Intramuscular InjectionInitial U.S. Approval: 2008

INDICATIONS AND USAGE – A single dose of KINRIX is indicated for active immunization against diphtheria, tetanus, pertussis, and poliomyelitis as the fifth dose in the diphtheria, tetanus, and acellular pertussis (DTaP) vaccine series and the fourth dose in the inactivated poliovirus vaccine (IPV) series in children aged 4 through 6 years (prior to the 7th birthday) whose previous DTaP vaccine doses have been with INFANRIX and/or PEDIARIX for the first 3 doses and INFANRIX for the fourth dose.

PEDIARIX [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine], Suspension for Intramuscular InjectionInitial U.S. Approval: 2002

PEDIARIX is a vaccine indicated for active immunization against diphtheria, tetanus, pertussis, infection caused by all known subtypes of hepatitis B virus, and poliomyelitis. PEDIARIX is approved for use as a 3-dose series in infants born of hepatitis B surface antigen (HBsAg)-negative mothers. PEDIARIX may be given as early as 6 weeks of age through 6 years of age (prior to the 7th birthday).

Pentacel®(Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, InactivatedPoliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine Suspension for Intramuscular InjectionInitial U.S. Approval: 2008

INDICATIONS AND USAGE – Pentacel is a vaccine indicated for active immunization against diphtheria, tetanus, pertussis,poliomyelitis and invasive disease due to Haemophilus influenzae type b. Pentacel is approved for use as a four dose series in children 6 weeks through 4 years of age (prior to 5thbirthday).

Quadracel®(Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbedand Inactivated Poliovirus Vaccine)Suspension for Intramuscular InjectionInitial U.S. Approval: 2015

INDICATIONS AND USAGE – Quadracel is a vaccine indicated for active immunization against diphtheria, tetanus,pertussis and poliomyelitis. A single dose of Quadracel is approved for use in children 4 through 6 years of age as a fifth dose in the diphtheria, tetanus, pertussis vaccination (DTaP) series, and as a fourth or fifth dose in the inactivated poliovirus vaccination (IPV) series, in children who have received 4 doses of Pentacel and/or DAPTACEL vaccine.

VAXELISTM (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine) Suspension for Intramuscular InjectionInitial U.S. Approval: 2018

INDICATIONS AND USAGE – VAXELIS is a vaccine indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzaetype b. VAXELIS is approved for use as a 3-dose series in children from 6 weeks through 4 years of age (prior to the 5thbirthday).

 

Flu/Influenza

AFLURIA, Influenza VaccineSuspension for Intramuscular Injection2018-2019SeasonInitial U.S. Approval: 2007

AFLURIA QUADRIVALENT, Influenza VaccineSuspension for Intramuscular Injection2019-2020 FormulaInitial U.S. Approval (AFLURIA QUADRIVALENT): 2016

FLUAD® (Influenza Vaccine, Adjuvanted) Suspension for Intramuscular Injection 2019-2020 FormulaInitial U.S. Approval: 2015

Flublok®Quadrivalent (Influenza Vaccine) Sterile Solution for Intramuscular Injection 2018-2019 FormulaInitial U.S. Approval: 2013

FLUCELVAXQUADRIVALENT(InfluenzaVaccine) Suspension for Intramuscular Injection2018-2019FormulaInitial U.S. Approval: 23 May 2016

FLULAVALQUADRIVALENT(Influenza Vaccine)injectable suspension,for intramuscular use2019-2020FormulaInitial U.S. Approval: 2013

FluMist® Quadrivalent (Influenza Vaccine Live, Intranasal)Intranasal Spray2019-2020 FormulaInitial U.S. Approval: 2003

Fluzone High-Dose (Influenza Vaccine) Suspension for Intramuscular Injection2018-2019 FormulaInitial US Approval: 2009

Fluzone Intradermal Quadrivalent (Influenza Vaccine)Suspension for Intradermal Injection2017-2018 FormulaInitial US Approval (Fluzone Intradermal Quadrivalent): 2014

Fluzone Quadrivalent (Influenza Vaccine)Suspension for Intramuscular Injection2018-2019 FormulaInitial US Approval (Fluzone Quadrivalent): 2013

 

If I get the time I’ll add more but for now you can get more information here: http://www.vaccinesafety.edu/package_inserts.htm (It’s not an active/clickable link–you’ll have to copy it and paste it into your browser.)

https://www.immunize.org/fda/

Vaccine “Side Effects” are Real and Plenty