Age: 4.0
Sex: F
Vaccine: DTAP, FLUX, IPV, PPV
Symptoms: Injection site pain, Injection site reaction, Myositis, Nuclear magnetic resonance imaging abnormal, Osteomyelitis
Clinical narrative: Initial unsolicited report received from a healthcare professional on 30-Aug-2017. This case involves a female patient (age at time of the reaction was not reported) who was vaccinated with doses of IPV (VERO) (IPOL), PNEUMOVAX (manufacturer: Other), DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS (DTAP) and with INFLUENZA VACCINE (manufacturer: GSK for DTAP and INFLUENZA VACCINE) (Batch number, expiration date, dose, dose in series and route of administration were not reported for all the vaccines) on both proximal thighs on 22-Aug-2017 while in the post-anesthesia care unit (PACU). The patient had complex coronary heart disease for five years, polysplenia but supposedly had functioning spleen OFF of pcn ppx who had HTX (Heterotaxy, visceral, X-linked) in 2014, now with transplant related vascular disease that would require another HTX. The patient was admitted to hospital on 22-Aug-2017 for catheter guided stent placement. Concomitant medications were not reported. On 22-Aug-2017, immediately post operation, the patient looked awesome but, on the same day, few hours following the vaccination (also reported as then 12 hours after the operation), the patient refused to move her left leg (holds it straight). On 23-Aug-2017 (reported as next day), one day following the vaccination, she spiked to 39.5 degree Celsius but still refusing to move her leg due to pain. On 24-Aug-2017 (also reported as the day after or hospitalization day three), two days after the vaccination, she was still febrile but now holding her left hip in a frog leg position only and refusing to move it. She would not bear weight, her erythrocyte sedimentation rate (ESR) was normal and C-reactive protein (CRP) was 12 (unit not reported). On 25-Aug-2017 (also reported as Friday), three days after the vaccination, the patient was still not moving her leg. On an unknown date, following the vaccination, the patient developed bilateral myositis along her proximal thighs where vaccines were given, BUT also bone marrow edema in the left ischium and into pubic ramus concerning for osteomyelitis (revealed by Magnetic resonance imaging or MRI) and also had a lot of ecchymosis at the left injection site which indicated that that her left leg pain was really from the injection site.  Laboratory investigations includes on 26-Aug-2017 ESR was 37 and CRP 10 (units were not reported for both the tests). Corrective treatment was not reported. On 25-Aug-2017, the patient was recovered from fever (reported that her fever was gone) and outcome of all other events was recovering (reported that on 26-Aug-2017, she now was starting to ambulate and now would bear full weight on her left leg, on 27-Aug-2017, the next day, she still limps but was much better). Upon internal review, the company decided to consider the case as serious due to important medical events: movement disorder and osteomyelitis. List of documents held by sender: none.; Sender's Comments: Patient was vaccinated with IPV, pneumovax, DTap and influenza and presented with unable to move leg due to pain, Time to onset is compatible with role of vaccine. Additional information regarding, patient medical history, infection history, past vaccination history and its tolerance are needed to further assess the case. Multiple vaccines were administered concomitantly, the role of each component cannot be assessed separately.