Age: 35.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Computerised tomogram abnormal, Injection site cellulitis, Injection site pain, Injection site swelling, Oedema
Clinical narrative: This report was received from GlaxoSmithKline and was assigned manufacturer report A0626767A. This was originally reported by a pharmacist concerning a 35 year old hospitalized female with sickle cell beta thalassemia and in sickle cell pain crisis at the time of the vaccination. It was reported that the patient had a history of cellulitis following prior receipt of concomitant administration of influenza virus split virion 3v vaccine inactivated and pneumococcal 23v polysaccharide vaccine (date unknown). It was reported that the patient had received multiple unspecified concurrent medications. On 30-OCT-2006, the patient was vaccinated with pneumococcal 23c polysaccharide vaccine (lot # not reported) IM in the right thigh at 9:00 AM. On 30-OCT-2006, at 9:00 AM, the patient concomitantly received a dose of influenza virus split virion 3v vaccine inactivated (Fluarix) IM in the right thigh. At the time of the concomitant administration of pneumococcal 23v polysaccharide vaccine and influenza virus split virion 3v vaccine inactivated (Fluarix), 30-OCT-2006, the patient was hospitalized for sickle cell anemia. On 31-OCT-2006, 1 day after vaccination with pneumococcal 23v polysaccharide vaccine and influenza virus split virion 3v vaccine (Fluarix), the patient developed injection site cellulitis. The reporter did not specify at which site of injection the cellulitis occurred. The patient's hospitalization was extended as a result of the injection site cellulitis. The patient was treated with intravenous and oral clindamycin. At the time of this report, the patient had not recovered from the event. The pharmacist reported that she "does not know if the injection site cellulitis was due to the pneumococcal 23v polysaccharide vaccine or the influenza virus split virion 3v vaccine inactivated (Fluarix)". Additional information was received from the pharmacist who reported that on 31-OCT-2006, the patient developed pain and swelling at the injection site, presenting as cellulitis. A computed tomography (CT) scan was positive for diffuse subcutaneous edema in the right thigh. The patient was treated with clindamycin IV and orally. On 10-NOV-2006, the patient recovered. The pharmacist considered the injection site cellulitis to be disabling. The pharmacist considered the injection site cellulitis to be an Other Important Medical Event. Follow-up information was received from the PharmD. The patient had no history of smoking and rarely drank alcohol. In October 2004, the patient received both the flu vaccine and "pneumonia" vaccine. The patient had no documented reaction. According to the reporter, it was unknown if the patient had experienced any adverse events following previous vaccination with the flu vaccine or Pneumococcal 23v polysaccharide vaccine. On 30-OCT-2006, the patient received the received the first dose of pneumococcal 23v polysaccharide vaccine intramuscularly in the right thigh. The patient experienced injection site swelling and injection site pain on 31-OCT-2006. The patient was diagnosed with injection site cellulitis. A biopsy was not performed. The event resolved on 10-NOV-2006. The pharmacist considered the events were possibly related to vaccination with pneumococcal 23v polysaccharide vaccine and influenza virion 3v vaccine inactivated. No additional information is expected.