Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site pain, Injection site warmth, Lethargy, Lip dry
Clinical narrative: Information has been received from a healthcare worker concerning a 65 year old female patient with hypertension, no drug reactions and no drug allergies who on 13-DEC-2011, was vaccinated with PNEUMOVAX 23, (lot number 671553/1138AA, 0.5ml, IM.; exp. date 27-APR-2013). The healthcare worker reported that on 14-DEC-2011, the patient developed symptoms after receiving a dose of PNEUMOVAX 23. The patient developed high fever, sore arm, headaches and elevated liver function tests. AST (aspartate aminotransferase) was at 61 and ALT (alanine aminotransferase) at 110 and her bilirubin was 53. The patient also complained of hot flush and developed thrush. The healthcare worker reported that on 03-JAN-2012, the patient was seen by the physician and complained headaches, chest pain, dry lips, swollen eyes, lethargy and yeast infection. The treatment therapy for the adverse events included: amoxicillin, VICODIN, LEVAQUIN and DIFLUCAN. The patient's outcome was unknown at the time of report. Performed lab diagnostics studies included urine test, ultrasound, liver function test (LFT) and complete blood cell count (CBC). Follow-up information has been received from a physician and a health care professional who provided medical records regarding a 65 year old female (weight: 171 pounds, height: 64 inches) non-smoker with occasional alcohol use, migraines, hypercholesterolemia, hematuria, benign essential hypertension, overweight, generalized osteoarthritis, insomnia, tachycardia, anxiety, allergic rhinitis, hypothyroidism, esophageal reflux, vitamin D deficiency, bone/cartilage disorder, a family history of cancer, breast cancer, alcoholism, peptic ulcer disease, pulmonary embolism with phlebitis, hypercholesterolemia, hypertension, migraines headaches, myocardial infarctions and a history of chicken pox, interstitial cystitis, tonsillectomy, adenoidectomy, sinusitis, cervical and lumbar laminectomy, C4 bone spur, diverticulitis of colon and a sigmoid colon resection who on 13-DEC-2011, at 14:15 was vaccinated intramuscularly in her left (previously reported as right) deltoid with PNEUMOVAX 23, (lot number 671553/1138AA). Concomitant medications included montelukast sodium (MSD), LIPITOR, SYNTHROID, XANAX, CELEBREX, amitriptyline hydrochloride (MSD), CENTRUM SILVER, cyclobenzaprine hydrochloride, gabapentin, metoprolol succinate, vitamin D, zolpidem tartrate. The patient had a pulse rate of 116. A urinalysis done on13-DEC-2011 showed trace blood and leukocyte esterase. On 14-DEC-2011, the physician reported the patient presented with fever and headache which the patient reported had started that morning. The patient's temperature was 102.2 degrees Fahrenheit. The physician reported she had a pneumonia shot yesterday and the area was red and hot. There was a 9 x 6.5 cm area of erythema and induration to the right upper deltoid (conflicting information, injection site was also reported as left deltoid). This entire area was painful to the touch and warm. The physician reported the patient had full range of motion in her right arm with report of pain but was able to move the arm. Her complete blood count showed red blood cells of 3.72 x 10E6/uL, hemoglobin of 11.7 g/dL, hematocrit of 33.9%, white blood cell of 14.2 x 10E3/uL, neutrophils of 75%, neutrophils (Absolute) of 10.6 x 10E3/uL (the adverse event of bilirubin increased was removed), monocytes (Absolute) of 1.1 x 10E3/uL and a total bilirubin of 0.6 mg/dL (previously reported as 53. The adverse event of elevated liver function test/bilirubin was 53 was removed). The physician's impressions were fever and cellulitis/abscess. Possibly a reaction the pneumonia shot. She was treated with amoxicillin 875 mg one tablet two times daily for 10 days and VICODIN 5-500 mg, one tablet four times a day as needed. The physician noted that her liver function tests were slightly elevated compared to prior readings. On 15-DEC-2011, the patient called her physician and reported she continued to have a fever of 102 and could not sit up. Due to increased liver function tests, the patient underwent an upper abdomen ultrasound. The impressions: 10 mm simple cyst in the liver stable compared to previous computed tomography scan of 21-MAY-2009; minimal increased echogenicity of the liver which can be seen with hepatic steatosis or mild fatty infiltration of the liver. Her complete blood count showed red blood cell of 3.63 x 10E6/uL, hemoglobin of 11.1 g/dL, hematocrit of 32.7%, white blood cell of 9.0 x 10E3/uL, neutrophils of 72%, neutrophils (Absolute) of 6.4 x 10E3/uL, monocytes (Absolute) of 0.6 x 10E3/uL, total bilirubin of 0.8 mg/dL, direct bilirubin of 0.53 mg/dL, aspartate aminotransferase of 72 IU/L and alanine aminotransferase of 99 IU/L. On 16-DEC-2011, the patient saw her physician at which time she reported her "left" arm swelling was larger and more red. She had nausea, felt drained, had trouble swallowing, had no appetite and felt weak. She was so weak she could not drive herself to the office. She reported her face became flushed and hot "right after the shot" and she did not increase her metoprolol after that. Her temperature was 99.9 degrees Fahrenheit. The physician's assessments were elevation transaminase/lactate dehydrogenase levels, thrush (diffuse pharyngeal erythema on tongue and inner outer cheeks) for which she was started on nystatin suspension and was given one dose of BENADRYL 25 mg orally in the office and "reaction to shot". On 17-DEC-2011, the patient's complete blood count showed red blood cell of 3.6 M/mm3, hemoglobin of 10.7 g/dL, hematocrit of 32.5%, white blood cell of 5.7 K/mm3, neutrophils of 43.3%, neutrophils (Absolute) of 2.9 K/mm3, monocytes of 10.4%, monocytes (Absolute) of 0.7 x K/mm3 and a glucose of 140 mg/dL and glomerular filtration rate of 68.5 mL/min. On 03-JAN-2012, the patient presented to her physician with a runny nose, hoarseness, dry cough, general malaise, headache but no fever (98.5 degrees Fahrenheit). These symptoms started five days ago. The physician noted a history of allergy to PNEUMOVAX 23: "nausea, fever, chills, cellulitis, extreme redness and swelling of the left arm." The patient said she "has felt really bad since the shot." The physician reported the following laboratory results (no date provided): white blood cell of 7.0 x 10E3/uL, red blood cell of 3.63 x 10E6/uL, hemoglobin of 11.3 g/dL, hematocrit of 33.7%, lymphocytes of 60%, neutrophils of 29%, neutrophils (Absolute) of 2.1 x 10E3/uL and monocytes (Absolute) of 0.6 x 10E3/uL. The patient's liver tests are still high as the aspartate aminotransferase was 63 IU/L and alanine aminotransferase was 102 IU/L. The physician's assessments were elevation, transaminase/lactate dehydrogenase levels (stay off atorvastatin calcium), anemia, and acute sinusitis. She was started on DIFLUCAN and LEVAQUIN. The health care professional reported the onset of the event was around 11:00. She also reported there were no pre-existing allergies and no illness at the time of the vaccination. At the time of this report, no outcome had been reported. Follow up information has been received from the patient. The patient reported "I was hospitalized overnight." She did not provide any other details. Follow-up information has been received from a patient who reported that on 13-DEC-2011 she had gone to her doctor's office and she was advised to get PNEUMOVAX 23. The patient received a dose of PNEUMOVAX 23 and almost immediately her blood pressure spiked very high as well has her heart rate. The patient reported that she did not feel very good and felt that something was terribly wrong. On 14-DEC-2011 the patient returned to her physician's office with a temperature of 103.9 and a very red and swollen upper arm down to her elbow. The physician told the patient she was having a reaction to the vaccine. The patient was prescribed amoxicillin (manufacturer unknown) and pain medication. The patient stated that her "condition went down hill quickly with chills, sweating, fever, headache and nausea". On 16-DEC-2011 the pt was driven by her son to her doctor's office as she was too sick to drive. The patient was prescribed BENADRYL and the patient stated that her doctor "seem perplexed on how to treat the reaction". On 17-DEC-2011 the patient was taken to the emergency room by her son. The patient was asked if she has received PNEUMOVAX 23. The patient's son was advised that the patient had a "severe reaction and needed medical treatment as soon as possible". The patient's condition was stabilized and she was transported to a hospital and admitted for close observation and treatment. The patient reported that the doctor at the hospital confirmed her reaction to the vaccine. The patient reported that she "almost died from this reaction". At the time of reporting, no outcome had been reported. Patient having severe reaction to vaccine was considered live threatening. All available medical records will be provided upon request. Additional information has been requested.