Age: 68.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood alkaline phosphatase normal, Blood bilirubin normal, Blood calcium increased, Blood chloride normal, Blood creatinine normal
Clinical narrative: Based on additional information received on 29 April 2015, this case initially considered as non-serious was upgraded to serious due to important medical event (differential diagnoses at this time as vasculitis, autoimmune disorders, reaction to her influenza vaccination, tick bite). Initial unsolicited report received from non-health care professional (patient's husband) on 27 May 2014. A 69-year-old female patient whose medical history and concomitant medications not reported had received a dose of FLUZONE HIGH-DOSE (lot number, dose, route and site of administration not reported) on 21 October 2013. The patient's husband reported two days after vaccination his wife could not turn her neck and it followed down to her extremities. She developed a rash on both lower extremities (between toes). Even the patient is well now she could not turn her neck all the way. Lab investigations and corrective treatments were not reported. The patient had not recovered from events at the time of this report. Documents held by sender: none. Follow-up information received from health care professional on 29 April 2015. Medical history included hypertension, hypercholesterolemia and hysterectomy performed on an unspecified date. On an unspecified date after vaccination, the patient experienced vasculitis, autoimmune disorders, reaction to her influenza vaccination, tick bit, limited range of motion, neck pain, tenderness / pain on palpation, ringworm on arm, joint swelling, generalized joint ache / polyarthralgia / bone pain, myalgias and fatigue. Laboratory investigations details are as follows: On 29-Oct-2013: Blood Pressure (BP): 128/76. Pulse: 72, body temperature- 98.5. Bilateral Ears: Both TMs are normal. Anterior and posterior pharynx is clear. Lungs: clear. Cardiovascular: Regular. Abdomen: soft and non-tender. Does have neck stiffness and meningeal symptoms. Pain on palpation of both trapezius muscles. Limited range of motion, but can put chin to chest. Does have a mild red raised maculopapular rash on legs. On 30-Oct 2013 at 12:31 following tests were performed and results are as follows: Sodium-142 mmol/L, Potassium-3.8 mmol/L, Chloride-105 mmol/L, Carbon dioxide-29 mmol/L, Glucose-106 mg/dL, BUN-16 mg/dL, Creatinine-0.73 mg/dL, Calcium-9.4 mg/dL, Total protein 7.7 g/dL, Albumin-3.5 g/dL, Total bilirubin-0.6 mg/dL, Alkaline phosphatase-75 U/L, AST-8 U/L, ALT-19 U/L, Anion gap-8 mmol/L, Osmolality Calc-285 mosm/kg, Globulin-4.2 g/dl, A/G Ratio-0.8, INR-1.0, WBC-6.6 th/mm3, RBC count-4.58 mill/mm3, Haemoglobin-13.9 g/dL, Haematocrit-40.3%, MCV-88 fl, MCH-30.3 pg, MCHC -34.5 g/dL, platelet count-242 th/mm3, red cell distribution width- 40.6 fl, neutrophils-59.4%, Absolute neutrophil count-3.94 th/mm3, lymphocytes-30.2%, monocytes-8.3%, eosinophils-1.4%, pH-7.5, urobilinogen-0.2 EU/DL, WBC-2 mm3, RBC count-2 mm3, glucose-58 mg/dL, protein total 45 mg/dL. Other lab tests included BUN/ Creatinine Ratio-21.9, EGFR- Greater than 60. EGFR-Greater than 60. Protime-10.8, PTT-26.2, Sedimentation Rate-39, NRBC Absolute 0.00, Eosinophils Absolute 0.09, Basophils Relative-0.2, Lymphocyte Absolute 2.00, Monos Absolute 0.55, Basophils Absolute-0.01, Immature Neutro% 0.5, Immature Neutro 0.03. On 31-Oct-2013: Spinal tap was done and meningitis was ruled out. BP: 122/68. Pulse: 72. Body temperature - 95.5 Degree Fahrenheit. Lungs: clear. Cardiovascular: Regular. Almost complete range of motion of neck now, very little stiffness. Rash on legs is gone. On 25-Apr-2014: BP: 120/78. Pulse: 60. Body temperature- 97. Bilateral Ears: TMs are normal. Anterior and posterior pharynx is clear. Lungs: clear. Cardiovascular: Regular. No murmurs, S3, or S4 are heard. Abdomen: soft and nontender. No headaches. No changes in vision. No cough, congestion, shortness of breath or chest pain. Ringworm on arm is getting better. BP: 155/72. Pulse: 61. Respiratory: 18. Body temperature- 36.6 Degree Celsius, body mass index- 27.44 kg/m2, oxygen saturation- 98% at 12:31 on an unspecified date. Respiratory: Negative for shortness of breath. Cardiovascular: Negative for chest pain. Gastrointestinal: Negative for abdominal distention. Neurological: Negative for lightheadedness. Psychiatric/ Behavioral: Negative for confusion. Patient was prescribed with FLEXERIL just a half tablet and doxycycline 100 mg twice a day for 21 days. At the time of this report, the outcome of event differential diagnoses as vasculitis, autoimmune disorders, reaction to her influenza vaccination, tick bite was unknown and for events could not turn her neck and it followed down to her extremities / stiff neck / meningeal symptoms, limited range of motion, neck pain, tenderness / pain on palpation, ringworm on arm, joint swelling, generalized joint ache / polyarthralgia / bone pain, myalgias, fatigue and mild red raised bilateral maculopapular rash on her legs / rash on both of her lower legs / petechial rash outcome was reported as recovering. Upon internal review, the company decided to consider the case serious because of important medical event differential diagnoses as vasculitis, autoimmune disorders, reaction to her influenza vaccination, tick bite. Documents held by the sender: None.