Can Pneumococcal vaccine cause injury and death?
According to the CDC, problems that may result following vaccination with PCV13, PPSV23, and any other vaccine include:1 2
- Severe allergic reactions occurring within a few minutes or a few hours of vaccination
- Severe shoulder pain limiting the movement in the arm where administration occurred.
- Fainting or collapse following vaccination. It may be advised to sit or lie down for approximately 15 minutes following vaccination to prevent fainting and injuries that could result from a fall. It is important to notify your health care provider if you have ringing in the ears, visual changes, or dizziness following vaccination.
PCV13 vaccine side-effects (Pneumococcal Conjugate Vaccine)
Adverse reactions following administration of PCV13 differed by dose in the series and age of the recipient. In children, the most commonly reported reactions included irritability, drowsiness, loss of appetite, redness, pain, or swelling to the vaccine site, and mild or moderate fever.
Children who received PCV13 at the same time as the inactivated influenza vaccine were noted to be at a higher risk for febrile seizures.
In adults, injection site redness, swelling, and pain, fatigue, fever, chills, headache, and muscle pain were most commonly reported.3
Prevnar 13 (PCV13) adverse reactions reported in infants and young children during pre-licensing clinical trials: injection site pain, swelling, redness, fever, decreased appetite, increased and decreased sleep, irritability, diarrhea, vomiting, rash, hives, hypersensitivity reaction including bronchospasm, facial swelling, and shortness of breath, seizures, pneumonia, gastroenteritis, bronchiolitis, and death (reported as SIDS).4
Prevnar 13 (PCV13) adverse reactions reported in adults during pre-licensing clinical trials: Injection site pain, swelling, and redness, limited arm movement, fever, vomiting, chills, muscle pain, fatigue, headache, decreased appetite, rash, joint pain, and death (deaths reported in the pre-licensing clinical trials included deaths from cancer, cardiac disorders, peritonitis, Mycobacterium avium complex pulmonary infection, and septic shock.)5
Prevnar 13 (PCV13) adverse reactions reported post-marketing: Cyanosis, lymphadenopathy at the injection site, anaphylaxis, shock, hypotonia, pallor, apnea, angioneurotic edema, erythema multiforme, injection site itching, hives, and rash.6
Pre-licensing clinical trials of the first pneumococcal conjugate vaccine, Prevnar (PCV7), compared the safety of Prevnar (PCV7) against an experimental meningitis C vaccine, seriously compromising the scientific validity of the trial.
In pre-licensing clinical trials of Prevnar (PCV7), children in groups who received the pneumococcal vaccine suffered more seizures, irritability, high fevers and other reactions. There were 12 deaths in the Prevnar (PCV7) group, including 5 Sudden Infant Death Syndrome (SIDS) deaths. No long term studies were completed to evaluate whether Prevnar (PCV7) vaccine given alone or in combination with other vaccines had any association with chronic illness or disabilities, such as the development of diabetes, asthma, seizure disorders, learning disabilities, ADHD, or autism.7
Pre-licensing clinical safety trials of Prevnar 13 (PCV13) compared this next generation vaccine against the original Prevnar (PCV7) vaccine, a vaccine inadequately studied for safety and by 2012, concerns regarding a link between febrile seizure and Prevnar 13(PCV13) had been reported.8 9
PCV13 was found to be associated with an elevated risk of febrile seizures when administered independently10 as well as when given in combination with the inactivated injected influenza vaccine (IIV). 11 The CDC continues to encourage simultaneous vaccine of both PCV13 and IIV vaccines despite knowledge of an increased risk of seizures in children.12
Studies have also linked PCV vaccine to Guillain-Barre Syndrome,13 polyserositis,14 septic shoulder15 and erythema multiforme.16
PPSV23 vaccine side-effects (Pneumococcal Polysaccharide)
According to the CDC, approximately 50 percent of individuals who receive the pneumococcal polysaccharide vaccine (PPSV23) experience pain and redness at the injection site. Muscles aches, fever, and more severe localized reactions can also occur following administration of PPSV23.17
PNEUMOVAX23 (PPSV23) adverse reactions reported in adults during pre-licensing clinical trials: injection site pain, redness, itching, bruising and swelling, headache, chills, fever, diarrhea, dyspepsia, nausea, upper respiratory infection, back pain, neck pain, pharyngitis, muscle pain, fatigue, depression, ulcerative colitis, chest pain, angina pectoris, heart failure, tremor, stiffness, sweating, stroke, lumbar radiculopathy, pancreatitis, myocardial infarction, and death.18
Nearly 80 percent of individuals participating in pre-licensing clinical trials experienced an injection-site adverse reaction following revaccination at three to five years following the initial vaccine. The rate of systemic adverse reactions (headache, fatigue, myalgia) following revaccination with PPSV23 was also higher with 33 percent of adults aged 65 and older and 37.5 percent of adults between 50 and 64 reporting an adverse reaction.19
PNEUMOVAX23 (PPSV23) adverse reactions reported post-marketing: Anaphylactoid reactions, serum sickness, angioneurotic edema, arthritis, arthralgia, vomiting, nausea, decreased limb mobility, peripheral edema in the limb where injection occurred, fever, malaise, cellulitis, injection site warmth, lymphadenopathy, lymphadenitis, leukocytosis, thrombocytopenia in patients with stabilized idiopathic thrombocytopenic purpura, hemolytic anemia in patients who have had other hematologic disorders, paresthesia, Guillain-Barré syndrome, radiculoneuropathy, febrile convulsion, rash, erythema multiforme, urticaria, and cellulitis-like reactions.20
While PNEUMOVAX23 (PPSV23) is approved for use in children aged two and older with conditions such as chronic heart and lung disease, diabetes, cochlear implants, cerebrospinal fluid leaks, sickle cell anemia, functional or anatomic asplenia, and immunosuppression, no information on vaccine safety or effectiveness in children is available from the vaccine’s product insert.21
Studies have linked PPSV23 to systemic inflammatory reactions,22 cellulitis and fever.23 24 25 26 27
As of May 31, 2019, there have been 21,536 serious adverse events reported to the Vaccine Adverse Events Reporting System (VAERS) in connection with pneumococcal vaccinations (PCV7, PCV13, PPSV23). Over 60 percent of these reported serious pneumococcal vaccine-related adverse events occurred in children 6 and under. Of these pneumococcal-vaccine related adverse event reports to VAERS, 2,306 were deaths, with nearly 70 percent occurring in children under 6 years of age. However, the numbers of vaccine-related injuries and deaths reported to VAERS may not reflect the true number of serious health problems that occur after pneumococcal vaccination.
Even though the National Childhood Vaccine Injury Act of 1986 legally required pediatricians and other vaccine providers to report serious health problems following vaccination to federal health agencies (VAERS), many doctors and other medical workers giving vaccines to children and adults fail to report vaccine-related health problem to VAERS. There is evidence that only between 1 and 10 percent of serious health problems that occur after use of prescription drugs or vaccines in the U.S. are ever reported to federal health officials who are responsible for regulating the safety of drugs and vaccines and issue national vaccine policy recommendations.28 29 30 31 32
As of July 1, 2019, there have been 217 claims filed in the federal Vaccine Injury Compensation Program (VICP) for injuries and deaths following vaccination with pneumococcal conjugate vaccine (PCV), including 16 deaths and 201 serious injuries. Of that number, the U.S. Court of Claims administering the VICP has compensated 56 children and adults, who have filed claims for pneumococcal conjugate vaccine injury.33 Pneumococcal polysaccharide vaccine (PPSV23) is not covered under the federal Vaccine Injury Compensation Program (VICP) and compensation for injuries and deaths related to vaccination with PPSV23 are pursued in civil court.34
IMPORTANT NOTE: NVIC encourages you to become fully informed about Pneumococcal and the Pneumococcal vaccine by reading all sections in the Table of Contents , which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.
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1 CDC Pneumococcal Conjugate (PCV13) VIS. Nov. 5, 2015
2 CDC Pneumococcal Polysaccharide VIS. Apr. 24, 2015
3 CDC Pneumococcal Conjugate (PCV13) VIS. Nov. 5, 2015
4 FDA Prevnar 13 Package Insert Aug. 22, 2017
7 FDA Pneumococcal 7-Valent Conjugate Vaccine (PREVNAR) - Product Manufacturer Insert. Oct 1, 2002
8 Hitt, E Prevnar 13 Should Be Watched for Febrile Seizure Risk, FDA Panel Says. Medscape. Jan 31, 2012
9 Tse A, Tseng HF, Greene SK, et al. Signal identification and evaluation for risk of febrile seizures in children following trivalent inactivated influenza vaccine in the Vaccine Safety Datalink Project, 2010-2011. Vaccine. 2012 Mar 2;30(11):2024-31
10 Baker M, Jankosky C, Yih K et al. The Risk of Febrile Seizures Following Influenza and 13-Valent Pneumococcal Conjugate Vaccines. Open Forum Infect Dis. 2017 Fall; 4(Suppl 1): S464–S465.
11 CDC Childhood Vaccines and Febrile Seizures Jun. 20, 2016
13 Ravishankar,N Guillain-Barre Syndrome Following PCV Vaccine. J Neurol Neurosurg 4(1): 134
14 Tawfik P, Elie Gertner E, McEvoy CE Severe polyserositis induced by the 13-valent pneumococcal conjugate vaccine: a case report J Med Case Rep. 2017; 11: 142.
15 DeRogatis MJ, Parameswaran L, Lee P et al. Septic Shoulder Joint After Pneumococcal Vaccination Requiring Surgical Debridement. HSS J. 2018 Oct;14(3):299-301
16 Monastirli A, Pasmatzi E, Badavanis G et al. Erythema multiforme following pneumococcal vaccination. Acta Dermatovenerol Alp Pannonica Adriat. 2017 Mar;26(1):25-26.
17 CDC Pneumococcal Polysaccharide VIS. Apr. 24, 2015
18 FDA Pneumovax 23 - Pneumococcal Vaccine, Polyvalent. Package Insert Dec 30, 2014
22 von Elten, KA, Duran LL, Banks TA, et al. Systemic inflammatory reaction after pneumococcal vaccine A case series Hum Vaccin Immunother. 2014 Jun 1; 10(6): 1767–1770.
23 Huang DT, Chiu NC, Chi H, et al. Protracted fever with cellulitis-like reaction in pneumococcal polysaccharide-vaccinated children. Pediatr Infect Dis J. 2008 Oct;27(10):937-9.
24 Yousef E, Mannan S. Systemic reaction to pneumococcal vaccine: how common in pediatrics? Allergy Asthma Proc. 2008 Jul-Aug;29(4):397-9
25 Gabor EP, Seeman M. Acute febrile systemic reaction to polyvalent pneumococcal vaccine. JAMA. 1979 Nov 16;242(20):2208-9.
26 Hasan S, Yousef M, Shridharani S Severe febrile systemic reaction to pneumococcal vaccine. J Natl Med Assoc. 2005 Feb; 97(2): 284–285.
27 Lee A, Goyal R, Shan HY. Severe protracted fever following pneumococcal vaccine. Am J Med Sci. 2006 Dec;332(6):351-3.
28 Kessler DA, the Working Group, Natanblut S, et al. A New Approach to Reporting Medication and Device Adverse Effects and Product Problems. JAMA. 1993;269(21):2765-2768.
29 FDA.gov. Kessler DA. Introducing MEDWatch: A New Approach to Reporting Medication and Device Adverse Effects and Product Problems. Reprint from JAMA. June 9, 1993.
30 Braun M. Vaccine adverse event reporting system (VAERS): usefulness and limitations. Johns Hopkins Bloomberg School of Public Health
31 Rosenthanl S, Chen R. The reporting sensitivities of two passive surveillance systems for vaccine adverse events. Am J Public Health 1995; 85: pp. 1706-9.
32 AHRQ Electronic Support for Public Health–Vaccine Adverse Event Reporting System (ESP:VAERS) Dec 1, 2007-Sep. 30, 2010
33 U.S. Department of Health and Human Services. National Vaccine Injury Compensation Program Data—July 1, 2019. National Vaccine Injury Compensation Program. Jul. 1, 2019
34 Health Resources & Services Administration (HRSA) Covered Vaccines. June 2019