Age: 10.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Livedo reticularis, Wheezing
Clinical narrative: Information has been received from a healthcare worker concerning a patient who on 15-NOV-2010 was vaccinated with a dose of PNEUMOVAX 23 (Lot# 667271/0880Z) (Exp date 11-DEC-2011), SQ. The healthcare worker reported that the patient experienced infection at the injection site "including cellulitis", which was treated with antibiotics. At the time of the report the patient had recovered, the patient may have been treated in the Emergency Room. Due to the high number of adverse events, the reporter requested a lot check for lot# 667271/0880Z. Additional information was received from a physician regarding the patient, a 10 year old male (110 pounds) with allergy to aspirin and ibuprofen (EENT-angioedema) and a history of hospitalisation at age 2 for asthma and previous immunization with influenza vaccine (live) (02OCT09) who received a SQ dose of PNEUMOVAX 23 (Lot# 0880Z) on 17NOV10 at 13:30 in the left arm. The patient also received a FLUZONE injection in the right arm. Concomitant therapy included CLARITIN, RITALIN LA, PULMICORT, FLOVENT and PROAIR. The patient was concomitantly vaccinated with a dose of influenza vaccine, inactivated (Sanofi-Pasteur) in the right deltoid. (Also reported as "both injections were given in the left arm.") The patient received his vaccinations on 17NOV10 at a well visit. At the time, there were concerns about the patient's wheezing. Patient had had a previous dose of influenza vaccine, inactivated, but the patient had not received a previous dose of PNEUMOVAX 23. On 18NOV10 at 20:02, the patient's mother contacted physician and then took the patient to the physician. The patient presented with a 3 cm perfectly round, warm, non-painful with redness at site of injection. No fever. No chills. No systemic signs. Physician stated (to) use ice, mark margins around injection site. If worse in the morning contact physician. On 19NOV10 pt seen in follow-up. Since the administration, those areas looked red and raised, especially the night of 18NOV10. No associated shortness of breath, dizziness, lightheadedness, drooling, voice changes, etc. No fever. The patient had been taking CLARITIN anyway for his seasonal allergies. Since demarcating those areas yesterday night, the patient's mother noticed significant improvement. She stated she thought it looked 80% better, especially the area where he had the pneumonia shot. There was an approximately 8x4 cm ellipsoid warm, non-tender induration on right deltoid area. Likewise, there was some mottling of the skin in the ipsilateral shoulder joint area. There was another similar looking lesion, this time irregular in shape, approximately 10 widest diameter, in the left ventral aspect of upper arm. No palpable axillary LN bilaterally. Assessment was adverse reaction to vaccine. No evidence of cellulitis. The pt recovered from the event. Additional information was received from a healthcare professional regarding a 10 year old male patient (59.5 inches). It was reported that PNEUMOVAX 23 was given in the left arm. The patient's mother contacted the physician at 8:01 am and the patient presented with redness at site of injection. No fever, chills; no systemic signs were noted. Physician instructed the patient to use ice and make margins around injection site. If (the reaction) worsened in the morning, contact the physician. Onset time of event reported as 8:02 a.m. (previously reported as 8:02 p.m.). Patient was reported as recovered from event. This is one of several reports received from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested. All available medical records will be provided upon request.