Age: 33.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site oedema, Injection site warmth, Leukocytosis
Clinical narrative: This case was reported in a literature article and described the occurrence of inflammatory reaction in a 33-year-old female patient who received Influenza vaccine. Co-suspect products included pneumococcal vaccine for immunosuppression. Concurrent medical conditions included rheumatoid arthritis. Concomitant products included immunosuppressive agents. On an unknown date, the patient received Influenza vaccine and Pneumococcal vaccine. On an unknown date, less than a day after receiving Influenza vaccine, the patient experienced inflammatory reaction (serious criteria hospitalization), injection site erythema, injection site edema, injection site warmth, body temperature increased, rigors and extensive swelling of vaccinated limb (serious criteria hospitalization). The patient was treated with Antibiotics Therapy (Unknown). On an unknown date, the outcome of the inflammatory reaction, body temperature increased and rigors were recovered/resolved and the outcome of the injection site erythema, injection site edema, injection site warmth and extensive swelling of vaccinated limb were recovering/resolving. It was unknown if the reporter considered the inflammatory reaction, injection site erythema, injection site edema, injection site warmth, body temperature increased, rigors and extensive swelling of vaccinated limb to be related to Influenza vaccine. Additional information received: This case was reported in a literature article and it described the occurrence of a systemic inflammatory reaction in a 33-year-old female patient who had received an unspecified influenza vaccine and an unspecified pneumococcal vaccine (manufacturers unknown). Concurrent medical conditions included rheumatoid arthritis for which the patient was receiving an unspecified immunosuppressive therapy concomitantly. This therapy was the reason the patient received the pneumococcal vaccine. The patient had not received this vaccine previously. No further information on the patient's concurrent medical conditions, medical and family history or concomitant medication was provided by the authors. On an unspecified date, the patient received an unspecified influenza vaccine and an unspecified pneumococcal vaccine (dosages unknown; both vaccines were administered in the same arm; batch numbers not provided). On an unspecified date, within 1 day of the administration of the vaccines, the patient developed severe local erythema, oedema and warm at the pneumococcal and influenza vaccines administration sites to the extent that treatment was commenced for presumed cellulitis. In addition to this the patient also suffered an increase in the temperature up to 101.8 deg. F (within 1 day of the vaccination) and rigors. The local reaction expanded well beyond the injection site by day 3-4 post-vaccination. The patient sought medical attention and was admitted to hospital for observation and antibiotic treatment. Once there she was found to have a leukocytosis with a predominance of neutrophils, as well as elevated erythrocyte sedimentation rate and her C-reactive protein. Her skin erythema worsened despite aggressive intravenous antibiotic treatment, so she received different antibiotics. The patient experienced an improvement in the skin problems and a resolution of the systemic symptoms within 5-7 days, and was eventually discharged home on antibiotics. This was a serious case as the patient required admission to hospital. The patient white blood cell count at the time of the event was 19.2 x 10E3/uL, her erythrocyte sedimentation rate was 71 mm/h and her C-reactive protein was 14 mg/dL. Initial treatment consisted of full courses of unspecified antibiotics to cover for common skin flora as well as methicillin-resistant Staphylococcus aureus, but she later received several different antibiotics as her skin erythema worsened and she was believed to be suffering from cellulitis. The outcome of the skin conditions was improvement within 5-7 days. Outcome of the systemic events was resolution within 5-7 days. The authors believed that the reactions were due to the pneumococcal vaccine based on its known side effects, the lack of similar findings in patients who receive the influenza vaccine in isolation and patient's lack of influenza vaccine-associated local symptoms. The authors concluded that "this case series highlights potential side effects of the pneumococcal vaccine that are not well described in the adult literature. Antibiotics were not helpful in treating these patients' local and systemic symptoms. Patients with histories consistent with that highlighted in this case series may avoid antibiotics and hospitalization if their providers recognize these symptoms as a non-infectious reaction to the pneumococcal vaccine". This case is 1 of the 5 valid cases reported in the same literature article (see case US2015GSK149063).