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.
