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Can Pneumococcal vaccine cause injury & death?

Updated May 04, 2024


vaccine injury death

According to the CDC, problems that may result following vaccination with PCV13, PCV15, PCV20, and PPSV23 include:   

  • Severe allergic reactions occurring within a few minutes or a few hours of vaccination
  • 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.
 

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.

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. 

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). 

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.) 

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. 

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 five 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. 

Pre-licensing clinical safety trials of Prevnar 13 (PCV13) compared this next generation vaccine against the original Prevnar (PCV7) vaccine, a vaccine with outstanding safety questions and by 2012, concerns regarding a link between febrile seizure and Prevnar 13(PCV13) had been reported.   

PCV13 was associated with an elevated risk of febrile seizures when administered independently  as well as when given in combination with the inactivated injected influenza vaccine (IIV).   The CDC continues to encourage simultaneous administration of both PCV13 and IIV vaccines despite knowledge of an increased risk of seizures in children. 

Studies have also linked PCV vaccine to Guillain-Barre Syndrome,  polyserositis,  septic shoulder  and erythema multiforme. 

According to the CDC, approximately 50 percent of individuals who receive the pneumococcal polysaccharide vaccine (PPSV23) experience pain and redness at the injection site. Muscle aches, fever, and more severe localized reactions can also occur following administration of PPSV23. 

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. 

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. 

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. 

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. 

Studies have linked PPSV23 to systemic inflammatory reactions,  cellulitis and fever.         

All pre-licensing clinical safety trials of PCV15 in adults compared the vaccine to PCV13. In clinical trials, common side effects reported following vaccination included injection site pain, redness, and swelling, headache, fatigue, muscle pain, and joint stiffness. Higher reaction rates were reported in those individuals receiving PCV15. 

There were nine serious adverse events (SAE) in the PCV15 group and 13 SAEs in the PCV13 group. Two cardiac SAEs (arrythmia and myocardial infarction) were reported among PCV15 recipients. No other details on SAEs in either group were disclosed but trial investigators reported that all SAEs were unrelated to vaccination. 

During the clinical trial phase, one death occurred in both the PCV15 and PCV13 groups. A 74-year-old male with a history of atrial fibrillation died of unknown causes 55 days post vaccination with PCV15 and an 82-year-old male with a history of heart disease died of an arrythmia and an acute myocardial infarction 87 days post vaccination. In the safety follow-up period (40 or more days post vaccination), there were eight deaths among those who received PCV15, compared to three deaths among PCV13 vaccine recipients. Trial investigators determined all deaths to be unrelated to vaccination. 

Pre-licensing clinical safety of PCV15 in infants and children compared this vaccine to the PCV13 vaccine. Infants and children in the study also received Pentacel, a combination Diphtheria and Tetanus Toxoids and acellular pertussis, inactivated poliovirus (IPV) and Haemophilus b Conjugate (HIB) Vaccine (DTaP-IPV-Hib vaccine) or a similar non-US-licensed DTaP-IPV-Hib product in studies conducted outside the U.S. at two, four, and six months of age. Additional vaccines administered at two, four, and six months included rotavirus vaccine (RotaTeq) and Hepatitis B (RECOMBIVAX HB). At 12 through 15 months, when the fourth dose was administered, clinical trial participants also received the MMR, Varicella, Hepatitis A, and HIB vaccines concomitantly. 

According to the package insert, in infants and children who received four doses of PCV15 at two, four, six, and 12-15 month, the most common adverse events were irritability, drowsiness, injection site pain, fever greater than 38.0°, decreased appetite, and injection site redness, induration, and swelling. Nearly 10 percent of infants and children in the PCV15 group and 9 percent in the PCV13 group experienced a serious adverse event up to six months after dose one and all additional vaccines. 

In children and adolescents age two through 17, the most common adverse reactions reported after vaccination with a single dose of PCV15 were injection site pain, muscle pain, injection site redness and swelling, fatigue, headache, and injection site induration. 

According to the PCV20 package insert, in pre-licensing clinical trials, the most commonly reported side effects following vaccination in children 15 months of age and younger who received four doses of the vaccine included irritability, injection site pain, redness and swelling, drowsiness, decreased appetite, and fever. Within six months of the fourth dose of PCV20, 4.5 percent of children reported at least one or more serious adverse events, compared with 3.7 percent of children who received four doses of PCV13. Two children who received PCV20 experienced febrile seizures, with one considered serious. Both were considered to be possibly related to vaccination. One child experienced injection site hypersensitivity within 30 minutes of vaccination with receipt of each of the first three PCV20 vaccine doses that resolved on the same day. No reaction was reported post dose four of PCV20 in this child. 

In children aged 15 months through 17 years who received a single vaccine dose, the most commonly reported side effects included irritability, injection site pain, swelling, and redness, decreased appetite, headache, fatigue and muscle pain, drowsiness, and fever.  

The most common adverse reactions reported among adults 18 years and older included injection site pain and swelling, muscle and joint pain, headache, and fatigue. Within six months of PCV20 administration, 1.5 percent of adults reported experiencing a serious adverse event, compared to 1.8 percent of adults who received PCV13 vaccine or other control vaccine. According to the package insert, rates between the groups were comparable, and no serious adverse events were considered to have a causal relationship to PCV20. 

All pre-licensing clinical safety trials of PCV20 compared the vaccine to PCV13 and/or PPSV23.  Adults 65 years of age and older who received PCV20 at the same time as the quadrivalent flu vaccine experienced higher rates of systemic reactions (fever, muscle or joint pain, headache and fatigue) within seven days of administration when compared to individuals who received PCV20 and quadrivalent flu vaccine on separate occasions.  

The PCV20 package insert does not contain information on post-marketing safety of the vaccine but rather it lists adverse events reported following PCV13 vaccine administration. These adverse events include cyanosis (bluish or grayish coloring of the skin, lips or nails), apnea, hypotonia, and pallor in children, swelling of lymph nodes, vaccine injection site swelling, itching, and redness, anaphylaxis including shock, angioneurotic edema, and erythema multiforme.  

As of April 26, 2024, there have been 27,506 serious adverse events reported to the Vaccine Adverse Events Reporting System (VAERS) in connection with pneumococcal vaccinations (PCV7, PCV13, PCV15, PCV20, PPSV23). Over 57 percent of these reported serious pneumococcal vaccine-related adverse events occurred in children under six years of age. Of these pneumococcal-vaccine related adverse event reports to VAERS, 2,747 were deaths, with nearly 66 percent occurring in children under six 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.       

As of May 1, 2024, there have been 390 claims filed in the federal Vaccine Injury Compensation Program (VICP) for injuries and deaths following vaccination with pneumococcal conjugate vaccine (PCV), including 26 deaths and 364 serious injuries. Of that number, the U.S. Court of Claims administering the VICP has compensated 158 children and adults, who have filed claims for pneumococcal conjugate vaccine injury. 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. 


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