Age: 40.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Injection site warmth, Lymphadenopathy, Myalgia, Pleural effusion
Clinical narrative: A report was received from another manufacturer on 1/27/04, who received a report from a health care professional, concerning a 40 year old female vaccinee who experienced chest pain, abdominal pain, decreased appetite, lymphadenopathy, myalgia, pleural effusion, swelling over the entire body, and a rash which led to hospitalization and was considered to be life-threatening after receiving Fluvirin and Pneumovax 23 on 11/17/03. The vaccinee experienced chest pain, abdominal pain, decreased appetite and rash on the same day as, lymphadenopathy, myalgia, and swelling over the entire body three days after the pleural effusion approximately 7 days after receiving Fluvirin and Pneumovax 23. The vaccinee had a history of allergy to acetaminophen with codeine phosphate, depression, irritable bowel syndrome, possible bronchitis, gastroesophageal reflux disease and peptic ulcer disease. On 11/17/03, the vaccinee developed redness, warmth and pain. The vaccinee also experienced decreased appetite, a little chest pain, abdominal pain above the belly button and a minimal rash on the thigh. The vaccinee went to the local emergency room, was treated with prednisone and released. On the11/19/03, the vaccinee presented to the emergency room again with excruciating pain in her arm and swelling at the injection site. The vaccinee stated that within 3 days the site of injection had swelled to 5 inches in diameter. The vaccinee also experienced swelling at the lymph nodes, and over her entire body. She also stated that she could not raise her arm. The vaccinee was admitted to hospital on 11/19/03. While she was in the emergency room she was treated with morobine suphate and acetaminophen with hydrocodone bitartrate for a pain in muscle which did not relieve her pain. The site of vaccination was x-rayed and unspecified blood work was carried out, the results were not reported. A sedimentation rate was elevated and a white blood cell count was normal. On 11/24/03, an abdominal ultrasound showed that the liver, pancreas, kidneys, gall bladder, and spleen appeared normal. The impression was a normal abdominal ultrasound but the vaccinee was noted to have a small left sided pleural effusion. The vaccinee was discharged from hospital on 11/20/03. On 11/23/03, the vaccinee returned to the emergency room and was given prednisone which she stated did not help. Her white blood cell count was 7.6 K/uL (normal range 4.0 K/uL - 11.0 k/uL). On 11/25/03, the vaccinee was re-admitted to hospital, the swelling at the site of injection was 3 inches in diameter and the vaccinee was still having excruciating pain at the injection site. The vaccinee had not recovered at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.  Follow up on 03/22/04 states: "Update 1, 03/01/04: A follow up report was received from another manufacturer, who received a report from a health care professional indicating that on 02/06/04, the vaccinee reported that her arm was still sore and that she was experiencing tingling in her fingers. The reporting health care professional also indicated that the vaccinee had not been seen for a while b/c "she cannot come into the office b/c she cannot afford to be seen". Follow up pending."