Age: 46.0
Sex: F
Vaccine: PPV, TD, PPV, TTOX
Symptoms: Dyspnoea, Fatigue, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a registered nurse concerning a 46 year old female with an allergy to prochlorperazine who on 5/28/03 was vaccinated IM in the arm with a first 0.5ml dose of pneumococcal vaccine 23 polyvalent (lot # 645225/1212M). On 5/28/03 the patient was also vaccinated in her opposite arm with a dose of tetanus toxoid. On 5/30/03 the patient came back to the physician's office with pain and swelling in the her arm where the pneumococcal vaccine 23 polyvalent was given. It was reported that the pain and swelling in her arm began on 5/28/03. The physician gave her topical triamcinolone acetonide cream to put on it. On approximately 5/30/03, it got worse over the weekend, and the patient felt profound fatigue and shortness of breath. She went to the emergency room where she was given IV cefazolin sodium and IV dexamethasone. No diagnostic studies were performed. Subsequently, she was discharged. On 6/4/03 it was reported that, at this point, the patient is still recovering. No product quality complaint was involved. Upon internal review, shortness of breath was determined to be an other important medical event (OMIC). Additional information has been requested.  Follow up on 06/26/2003: "Information has been received from a registered nurse concerning a "basically healthy" 46 year old female with asthma and an allergy to prochlorperazine who on 05/28/2003 was vaccinated IM in the arm with a first 0.5 ml dose of pneumococcal vaccine 23 polyvalent (lot # 645255/1212M).  On 05/28/2003 the patient was also vaccinated in her opposite arm with a dose of tetanus toxoid.  Concomitant therapy included fluticasone propionate (+) salmeterol xinafoate and montelukast sodium for asthma.  On 05/30/2003 the patient came back to the physician's office with pain and swelling in her arm where the pneumococcal vaccine 23 polyvalent was given.  It was reported that the pain and swelling in her arm begain on 05/28/2003.  The physician treated her with topical triamcinolone acetonide cream.  The patient reported that her symptoms worsened and that she felt profound fatigue and shortness of breath.  On approximately 05/31/2003 she went to the emergency room where she was given intravenous cefazolin sodium and intravenous dexamethasone.  No diagnostic studies were performed. Subsequently, she was discharged.  On 06/04/2003 the patient returned to the office and reported that she was very fatigued and that "to get up and walk any distance was very exhausting."  The physician sent the patient to a neurologist because she thought that the patient may have Guillian-Barre.  On 06/06/2003 the patient was seen by a neurologist who did not think that she had Guillian-Barre.  On 06/10/2003 the patient had not been diagnosed with anything 'as of yet'.  The nurse reported that the patient's arm pain and swelling had improved but that the patient still felt fatigued and terrible.  She reported that the patient was still being followed.  No product quality complaitn was involved.  Upon internal review, shortness of breath was determined to be an other important medical event. (OMIC)  Additional information has been requested.   A 15-day follow up report received 7/3/2003 adds: On 06/16/2003 the pt recovered. It was also reported that the pt was vaccinated with a dose of influenza virus vaccine at the age of "46" and developed a small area of redness. No product quality complaint was involved. No further info is expected.