Age: 65.0
Sex: F
Vaccine: PNC13, FLU3, PNC13
Symptoms: Injection site pain, Rash
Clinical narrative: Initial unsolicited report received from a consumer (patient himself) via other company (Pfizer) (Manufacturer Report Number: 2016485579) on 05 Dec 2016. This case involves a 65 year old female patient who was vaccinated with a 0.5 ml injection of FLUZONE HIGH DOSE (Batch number: UI659AA, Expiry date: 29 Mar 2017, route of administration was not reported) in arm right and 0.5 ml one time injection of PREVENAR 13 (manufacturer: Pfizer, batch number: N16515, Expiry date: Oct 2017, dose and route was not reported) in arm right on an unspecified date in 27 Sep 2016. The patient had a medical history of rapid heartbeat diagnosed around twenty years ago, blood pressure diagnosed after she was diagnosed with rapid heartbeat, acid reflux diagnosed eleven or twelve years ago, low vitamin D numbers. Patient was previously vaccinated with a dose of ZOSTAVAX (manufacturer: Merck, batch number: M005727, expiry date, dose and route was not reported) in arm left on an unspecified date in Jun 2016. It was reported as on an unspecified date in Jun 2016 after receiving ZOSTAVAX the patient broke out with cellulitis at the injection site and though it was just a normal reaction but the redness and heat got bigger and bigger. It grew and was spreading more and more. Patient received cellulitis and cleared up the cellulitis. The patient concomitant drugs include atenolol 25mg twice a day reported as started taking product probably twenty years ago for rapid heart rate and high blood pressure, ranitidine 300 mg twice a day from 2015 for acid reflux, multivitamin started taking years ago as preventive medicine, vitamin D 5000 units for low vitamin D numbers, it was reported as the patient receives flu shot annually not sure which brand she was taking. On 27 Sep 2016, within 24 hours post vaccination, the patient's arm was really painful, as she received both vaccines on same arm, so she did not pay attention and patient broke out again with a worse case of cellulitis. On an unspecified date in Sep 2016, post Fluzone vaccine (reported as 2 days after PREVENAR 13), the patient realized that her arm was huge, the area covered too much and the area was really getting big. The cellulitis started fairly soon after she got PREVNAR vaccine. On 29 September 2016, the patient went to doctor who recognized it as cellulitis. On 30 Sep 2016, patient's friends drew a circle around the area and on 01 Oct 2016, in morning more area was out of the circle, the patient went to ER, where she was told to give it time and sent her home. On 01 Oct 2016, post vaccination, the are doubled in size and it was darker red. The patient lab tests were reported as blood test on 01Oct 2016: blood work came back fine. Culture on 01 Oct 2016, never got the results back does not know what kind of culture was drawn. The patient received IV antibiotics as a corrective treatment. On an unspecified date in Oct 2016, the patient was recovered from event painful arm and on an unspecified date, patient recovered from other events. Upon internal review the case was considered as serious because of important medical event. List of documents held by sender: none. Sender's Comments: This case concerns 65 year old female patient who received PNEUMOCOCCAL POLYSACCHARIDE VACCINE simultaneously with LIVE INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE and developed cellulitis. Time to onset is not provided. Further information regarding etiological work up, allergological and immunological work up, reaction to previous vaccination and investigation results to rule out the alternative cause are needed for complete assessment of the case.