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Life Threatening? No
Write-up: This case was reported by a physician and described the occurrence of swelling injection site in a 14-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). In July 2011, the subject received 1st dose of CERVARIX (intramuscular, unknown injection site and batch number). One week after the first vaccination, the subject experienced injection site swelling, pyrexia, headache, and urticaria. The symptoms subsided in approximately 1 week, but headache and urticaria lasted 2 weeks. In October 2011, the subject received 2nd dose of CERVARIX (intramuscular, unknown injection site and batch number). Within one month after 2nd dose of vaccine, the subject experienced the same symptoms as those after the first vaccination except urticaria. She also experienced malaise. One month after the second vaccination, the subject also experienced stomatitis, pyrexia, diarrhoea, abdominal pain, and dermatitis developed, and 2 months after vaccination, severe urticaria developed. In March 2012, the subject received 2nd dose of CERVARIX (intramuscular, unknown injection site and batch number). One week after the third vaccination, the subject experienced arthralgia along with the same symptoms as those experienced after the second vaccination. Fourteen days after the vaccination, exertional dyspnoea and severe malaise were also developed. One month and a half after the vaccination, urticaria, pain in the lower and upper extremities, dermatitis, and stomatitis developed. Stomatitis, dermatitis, malaise, low back pain, slight fever, arthralgia, abdominal pain, and headache were developed and lasted for 2 or 3 months after vaccination. Hyperpnoea and a feeling of dyspnoea were also experienced even at rest as well as pedal oedema. Three to five months after the third vaccination, the subject experienced generalised joint pains, abdominal pain, headache, multiple stomatitis, inappetence, vomiting, slight fever, and parotitis. Six to nine months after the third vaccination, she experienced abnormal malaise, clouding of consciousness, anterior chest pain similar to angina pectoris and palpitations also developed. In addition, giddiness and excessive sleep were developed. The physician considered the events were clinically significant (or requiring intervention). Approximately 10 months after the third vaccination, the chest pain was resolved but replaced by hyperpnoea. Although the pain in the body improved, the subject still experienced fatigue, hypobulia, and reduced thinking. It was considered that the subject had depressive symptoms. The outcome of the rest of the events was unspecified.
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