Age: 93.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Local reaction, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable medical assistant who reported on behalf of a physician through a Pfizer sales representative and then from a contactable physician. A 93-year-old female patient received a single dose of PREVNAR 13 (lot number J23867) subcutaneously in left arm on 16Oct2014. Concomitant vaccine included on 13Oct2014 FLUZONE for immunization. Medical history included, anal and rectal polup, rotator cuff syndrome, cataract, hydronephrosis, hyperlipidemia, varicose veins, leg, disorders of plasma protein metabolism, hypercalcemia, acospondylolisthesis, Pulmonary Embolism in Jun2013, pulmonary. Surgical history included appendectomy, hip replacement on 02Feb2009 (repair of fracture with hemiarthroplasty), thyroidectomy on 26May1948 (partial thyroidectomy because of a nodule), excision of rectal polyp in 2008, varicose vein stripping on unspecified data many years before this report. Concurrent conditions included age-related hearing loss, osteoporosis, irritable bowel syndrome, nontox uninodular goiter, cervical spondylosis with radiculopathy, chronic kidney disease, Stage II (mild), chronic pulmonary embolism, chronic simple anemia, generalized osteoarthritis, idiopathic insomnia, joint effusion left shoulder, lower back pain, lung nodule, mixed hyperlipidemia, polyarticular osteoarthritis, prediabetes, renal mass, right knee DJD, sebaceous cyst, senile atrophic vaginitis and varicose veins of lower extremities, asymptomatic. Family history included fatal myocardial infarct (father and brother), stroke (mother) asthma and renal failure (brother). Past vaccine history included: PREVNAR 7 IM on 07Mar2008, FLUZONE on 01Dec2010, on 15Nov2012 and on 11Nov2013, unspecified Influenza Virus Vaccine on 07Mar2008 and ZOSTAVAX on 20Dec2007. Allergies included: CRESTOR, SKELAXIN, sulfa (rash), penicillins (rash), NSAID (rash), clindamycin hydrochloride (itching) and cipro (rash). Concomitant medications included atropine sulfate, hyoscine hydrobromiide, hyoscyamine sulfate, DONNATAL EXTENTABS 1 tablet by mouth q12h, SYNTHROID 0.075mg Tablet 1 DF mouth daily, ACTOS 15mg tablet 1 tablet by mouth daily, ESTRACE 0.1 mg/1 gm Vaginal Cream apply as directed once daily, Calcium/Vitamin D 600mg/200IU Tablet refills. The medical assistant reported that on 17Oct2014, the patient had a local reaction. Her arm where she received the vaccine was seriously inflamed and a rash developed at the injection site. The systemic reaction was vomiting the same night. According to patient, vomiting was recovered (Oct2014). Rash was recovered on 24Oct2014, while inflammation was recovering. The physician reported that on 17Oct2014 the patient experienced swollen red rash that recovered on 24Oct2014. Treatment included triamcinolone acetonide 0.1% Cream Apply thin film to affected area tid and complete use of MEDROL dose pack. Physical examination (2014) was as follows: well developed and nourished, appropriately groomed, in no apparent distress. Reddened sore area over lateral left arm below site of recent injection of PREVNAR 13. Limb pain that appeared to be reaction to PREVNAR 13, outcome unknown. The reporter considered there is a reasonable possibility that the events swollen red rash and limb pain are related to suspect product. Follow-up (21Nov2014): New information received from a contactable physician includes: patient details, route of administration, vaccination date, treatment, medical history, family history, past vaccine history, concomitant medications, reactions details, new events (swollen red rash and limb pain). Follow-up attempts completed. No further information expected.