Age: 73.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Muscle spasms, Myalgia, Nausea, Osteomyelitis
Clinical narrative: This case was reported in a literature article and described the occurrence of spinal osteomyelitis in a 73-year-old female subject who received Flu seasonal TIV Dresden. Concurrent medical conditions included hypothyroidism, allergic rhinitis, chronic sinusitis, asthma and osteoarthritis. Concomitant products included PREMARIN, SYNTHROID, Albuterol, ADVAIR, NASONEX and ZYRTEC. On 6th October 2002, 7 hrs after receiving Flu seasonal TIV Dresden, the subject developed spinal osteomyelitis. Serious criteria included hospitalization and GSK medically significant. Additional events(s) included muscle pain on 6th October 2002 with serious criteria hospitalization, spasms on 6th October 2002 with serious criteria of hospitalization, chills on 6th October 2002 with serious criteria of hospitalization, nausea on 6th October 2002 with serious criteria of hospitalization, vaccination site cellulitis on 6th October 2002 with serious criteria of hospitalization and streptococcal septicemia on 8th October 2002 with serious criteria of hospitalization and GSK medically significant. The outcome of spinal osteomyelitis was recovered/resolved. The outcome(s) of the additional event(s) included muscle pain (recovered/resolved), spasms (recovered/resolved), chills (recovered/resolved), nausea (recovered/resolved), vaccination site cellulitis (recovered/resolved) and streptococcal septicemia (recovered/resolved). The investigator considered that there was a reasonable possibility that the spinal osteomyelitis, muscle pain, spasms, chills, nausea, vaccination site cellulitis and streptococcal septicemia may have been caused by Flu seasonal TIV Dresden. Diagnostic results (unless otherwise stated, normal values were not provided): On 8th October 2002, Blood culture result was group B beta streptococcus unknown and White blood cell count result was 34,000 with L shift unknown. Additional information was provided. This case was reported in a literature article and described the occurrence of Osteomyelitis in a 73-year-old female patient who was vaccinated with unspecified seasonal influenza vaccine (manufacturer unknown). This case corresponds to VAERS ID: 192508. The patient's other medications included PREMARIN, SYNTHROID, Albuterol, ADVAIR, NASONEX, ZYRTEC. The patient's preexisting conditions included hypothyroid, allergic rhinitis, chronic sinusitis, asthma, osteoarthritis. No information on patient's medical or family history was provided. On 6 October 2002, the patient received unspecified seasonal influenza vaccine (administration route and site unspecified; dosages unknown; batch number not provided). On 6 October 2002, 7 hours after vaccination, the patient was presented to the emergency department (ED) with muscle aches, spasms, chills, nausea. The patient developed right shoulder/upper arm cellulitis (at the location of vaccine). On 8 October 2002, diagnostic laboratory data showed white blood cells: 34,000 with L shift and blood culture group B beta streptococcus x 2 cultures. Subsequently, the patient was diagnosed with L3-4 vertebral osteomyelitis due to group B streptococcus septicemia. The source and mode of spread was reported to be haematogenous. The patient was hospitalised for 13 days. This case has been considered serious due to hospitalisation. Treatment was unknown. The patient had recovered. The authors did not comment on the relationship of osteomyelitis with unspecified seasonal influenza vaccine. The authors concluded that "Evidence based medicine has been championed as a paradigm which results in improved medical practice. However, it is evident from the body of data collated in this review that very large randomized trials would be needed to adequately address the issue of skin disinfection prior to vaccine administration and the prevention of sepsis. Consequently, a new paradigm118 might be evoked to cover this clinical issue, namely the use of a very low cost intervention (disposable skin swab) to prevent a very low prevalence event (sepsis related to parenteral vaccination) of high cost (medical attention including hospitalisation with morbidity/mortality)". This is 1 of the 7 valid cases reported in the same literature article.