Age: 56.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Red blood cell sedimentation rate increased, Skin ulcer, Tenderness
Clinical narrative: Initial report received on 03/29/2006, from a health care professional. A 55 year old female patient with a history of diabetes and asthma, who was taking albuterol, insulin, metformin, glyburide and aspirin at the time of the vaccination, had received her first administration (route not reported) of Adacel (lot number C2454AA), in the left deltoid, on 03/14/2006. That evening, she experienced a fever of 102 degrees Fahrenheit, headache, increased blood sugar (300), and generalized flat, red, tender, circular lesions that were forming over her old scars and over the "plates" in the left arm and right leg. She was referred to an orthopedic and infectious disease specialists.  The patient was seen by her primary care physician for the adverse events on three different dates, 03/19/2006, 03/20/2006, and 03/21/2006. She had a  CBC completed (no results provided), her CRP was 5.4 and the sedimentation rate was 39. Per the reporter, the headache and fever subsided after 10 days, and the other symptoms were still present but getting better at the time of the initial report. Follow up information received from a physician on 5/15/2006: Rash eruptions occurred over a wound site on the left forearm corresponding to the placement of palate and screws to secure a prior wrist fracture (2003). The patient also had rash in other scars, unassociated areas on the left arm and legs. The patient has a history of mild, intermittent asthma and is under good control with Albuterol MDI. She also has a history of pertussis as a child and has an allergy to penicillin. She has not undergone any sensitization tests. She is not on hormone replacement and is on no other medications. The duration of the patient's diabetes is approximately seven years, and her "usual am. sugars are less than 100". Treatment for the event included Tylenol for fever and "watchful monitoring". There were no injection site abnormalities other than tenderness, and the patient's fever was felt to be due to immunization. Laboratory results conducted on 03/22/2006, included WBC8.3, Hematocrit 37.7, Platelets 288,000, CRP 5.4, glucose 317 and ESR 39. Laboratory results, conducted on 04/26/2006, included glucose 158, CRP1.0 and ESR 7. Per the reporter, " the interval between Adacel and the last Td was thought to be greater than five years, but I am not sure if might have had in 2003 emergency visit due to closed wrist fracture and forehead laceration repair". "Administration of Td is not mentioned in the emergency record." The patient was examined in follow up on 04/26/2006 and was feeling well with no rash or fever. Medical assessment: Fever and headache have been observed following Adacel administration. Considering the reported elevation of inflammatory parameters (CRP and ESR), it is likely that the elevated blood glucose levels were result of the destabilized glycemic control normally observed during infectious and inflammatory episodes. The time to onset did not exclude temporal association between the vaccination and the reported eruption although it is to be noted, that the patient had old scars (of unknown origin), both of her pre-existing conditions (asthma and diabetes) could be factors predisposing to skin eruptions, and hypersensitivity has been reported with some of her concomitant medications (metformin, glyburide, aspirin). (OMIC)