Age: 60.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Cellulitis, Diarrhoea, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Information has been received from a pharmacist concerning a 60 year old female patient with a medical history of an allergy to penicillin and neomycin and a small benign brain tumor who was part of a group of 24 reported reactions out of 200 vaccinated employees and was vaccinated in the left arm during the first week of October, 2003 (also reported as October 2003) with a first dose of pneumococcal 23v polysaccharide vaccine (lot number 643784/0676M). Concomitant therapy during the first week of October 2003 (also reported as October 2003) included influenza virus vaccine (unspecified). The patient was not taking any prescription drugs at the time she received the vaccinations. It was noted that both vaccines were administered only minutes apart and that the patient received both vaccines in the same arm at her request. During the first week of October 2003 (also reported as October 2003) almost immediately, the patient developed an adverse reaction described as a fever and her left arm turned red, began to swell, and became extremely warm and painful (also reported as redness up and down the arm, swelling, warmth, pain, knot at site and still had warmth in knot and a knot in elbow which was very painful by the end of the day and had difficulty using it). Other complaints were sore throat, nausea, vomiting, diarrhea and aches all over. A couple of days later, she went to an emergency department of a hospital and was diagnosed with cellulitis. The patient was given a prescription for cephaloridine (Cefalexin). It was also noted that the patient went to her doctor and was diagnosed with cellulitis. The patient noted that even though it had been more than one month since she received these vaccines, some symptoms still persist. She mentioned that the discomfort had progressed down her arm to the area of her elbow and that she still had discomfort and redness in her left elbow. It was noted that many spent the entire weekend in bed after being vaccinated on a Friday. The patient reported that she had missed 3 and a half days from work due to this. The pharmacist suggested Ibuprofen or acetaminophen for the symptoms and to follow up with their physicians. The reporter expressed concern about the particular lot of vaccine and mentioned that the patient's were vaccinated all from lot # 0676M. The patient indicated that she was seeking reimbursement for some of her expenses, such as lost time from work, which resulted from the adverse experience. The patient reported that the site had improved, however she did still have a small amount of swelling in her left elbow. There was no product quality complaint involved. Follow up information indicated that the reporter did not have more information to add to the reports as she did not speak directly to any of the 24 patients in this case. Upon internal review, cellulitis was considered an other important medical event (OMIC). The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. The reporter also mentioned two other patients and 21 patients who were part of the 24 reported reactions and were vaccinated with pneumococcal 23v polysaccharide vaccine (lot # 643784/0676M). Additional information has been requested.