Age: 40.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Fatigue, Injection site erythema, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Information has been received from a physician concerning a 40 year old white female with an allergy to acetaminophen (+) codeine phosphate, depression, irritable bowel syndrome, possible bronchitis, and gastroesophageal reflux disease who on 11/17/03 was vaccinated IM in the arm with a dose of pneumococcal 23v polysaccharide (lot # 645249/1196M). Concomitant vaccination on the same day included an IM dose in the arm of influenza virus vaccine (lot # 765703). Illness at the time of vaccination included peptic ulcer disease. The physician reported that after vaccination the patient developed redness, warmth, and pain at the injection site. The pain has continued to the present. The patient was treated and released from her local emergency room where she was placed on prednisone. A product quality complaint was not involved. Follow up information was received from the physician which indicated that on 11/17/03 the patient had a decreased appetite, little chest pain, abdominal pain above the belly button, and a minimal rash on right. The patient was in the emergency room and got morphine and acetaminophen (+) hydrocodone bitartrate for a pain in muscle. A sedimentation rate was elevated and a white blood cell count was normal. On 11/24/03 an abdominal ultrasound result indicated that the liver, pancreas, kidneys, gallbladder, and spleen appeared normal. The impression was a normal abdominal ultrasound and the patient was noted to have a small left sided pleural effusion. It was noted that the patient was hospitalized and at the time of the report, had not recovered. See lab section for all other lab results. Information was received on 12/23/03 which pertained to an event which occurred approximately seven days after vaccination with pneumococcal 23v polysaccharide vaccine. This information contained the following adverse experience: small left sided pleural effusion (approximately (11/24/03). Additional information has been requested. Follow up information received on 01DEC2003 from the patient indicated that she went back into the hospital on 25NOV2003. She reported that she was admitted for excruciating pain at the site of injection and that the swelling is still 3 inches in diameter at the vaccination site. Additional follow up information received from a registered nurse on 11FEB2004 indicated that on 06FEB2004, the pt reported t her that her arm was stillsore and theat she was having tingling in her fingers. The nurse also reported that the pt has not been seen in the office for awhile and reports that "she cannot come into the office because she can not afford to be seen". Medical records will follow. Additional follow up information was received from medical records. It was noted that the patient "said that the doctors said she might have a staph infection". On 18NOV2003, the pt presented "because she had a pneuonia shot and had a bad raction". At this time, she had a somewhat productive cough, sinus congestion and drainage, fatigue, little appetite, "little" chest pain, abdominal pain above the belly button, and shortness of breath. The plan was ibuprofen 800 mg, ice and follow up in one week. On 19NOV2003, it was noted that the pt was in the emergency room. No fever was noted and the pt received morphine and antibiotics. On 23NOV2003, a chest x-ray showed no infiltrate. On 24NOV2003, abnormal laboratory data included: other laboratory data is listed below On 26NOV2003, the pt presented with "arm pain from flu shot". Treatment included meperidine hydrochloride and an ice wrap. On 01DEC2003, the pt canceled her appointment because she was "too weak to come in; been at ER and hospital for five days". On 03DEC2003, she presented to the physician's office with pain under her rib cage, swelling, arm pain and swollen lymph nodes in her neck. She had no appetite, moderate chest pain and was very short of breath. The plan was to check a SED rate. On 12DEC2003, she complained of an increase in swelling and noted that "she is broke; no one is helping her; no one knows what's wrong. On 06JAN2004, she was prescribed valdecoxib 10mg po daily. On 15JAN2004, she noted that she "can't drive with that arm, hurting for 3 months. She also indicated that she could not lif her purse with that arm. On 21JAN2004, it was noted that the physician wanted to start physical therapy on her arm. The reporter considered the swelling at the site of injection, the excruciating pain in the arm, the inability to raise her arm, the swelling of the lymph nodes and the swelling over the entire body to be immediately life-threatening. Information was received on 23DEC2003 which pertained to an event whcih occurred approximately seven days after vaccination with pneumococcal 23v polysaccharide vaccine. This information contained the following adverse experience: smallleft sided pleural effusion (approximately 24NOV2003) . Additional information has been requested. Follow up information received on 01-Dec-2003 from the patient indicated that she went back into the hospital on 25-Nov-2003. She reported that she was admitted for excruciating pain at the site of injection, and that the swelling is still 3 inches in diameter at the vaccination site. Additional follow up information received from a registered nurse on 11-Feb-2004 indicated taht on 05-Feb-2004, the patient reported to her that her arm was still sore that she was having tingling in her fingers. The nurse also reported that the patient has not been seen in the office for awhile and reports that "she cannot come into the office because she can not afford to be seen". Medical records will follow. The reporter considered the swelling at the site of injection, the excruciating pain in the arm, the inability to raise her arm, the swelling of the lymph nodes, and the swelling over the entire body to be immediately life-threatening. Information was received on 23-Dec-2003 which pertained to an event which occurred approximately seven days after vaccination with pneumococcal 23 v polysaccharide vaccine. This information contained the following adverse experienced; small left sided pleural effusion (approximately 24-Nov-2003). Additional information has been requested.