Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Dizziness, Injection site cellulitis, Injection site pain, Nausea, Pyrexia
Clinical narrative: The initial case was missing the following minimum criteria: ICH-Unspecified number of patients. Upon receipt of follow-up information on 21Nov2018, this case now contains all required information to be considered valid. New information received: This is a follow-up spontaneous report from a contactable Nurse. This Nurse reported similar events for 2 patients. This is 1st of 2 reports. A 66-year-old female patient received PREVNAR 13, (lot # S13847, Exp date 01Jul2020, NDC # 0005197101) via an unspecified route of administration at 0.5 ml, single at left upper arm on 13Nov2018 for immunisation, administered at physician office. Medical history included stomach ache and diarrhea (the patient was being seen on 13Nov2018 for a stomach ache and diarrhea started after eating eggs, resolved prior to coming to the office and receiving the vaccine), urinary issues (the patient was being seen on 13Nov2018 for the urinary issues, resolved prior to coming to the office and receiving the vaccine. There were no concomitant medications. No history of previous immunization. No additional vaccines administered on same date of the PREVENAR 13. No prior Vaccinations within 4 weeks prior to the first administration date of PREVENAR 13. No adverse events occurred following prior vaccinations. The patient had cellulitis at injection site, fever, nausea, dizziness, pain injection site. It was further reported that the patient experienced the symptoms of cellulitis/vaccination site reaction, fever, nausea, dizziness, pain injection site starting from the evening on 13Nov2018. The patient returned to the doctor's office on 14Nov2018 and stated that she had cellulitis at injection site reaction, fever, nausea, dizziness, and pain at the injection site. She went into the hospital, but was discharged. She was not sure of the date of the Emergency Room visit and she clarified that the patient was not admitted to the hospital at that time. The patient went back to the hospital and was admitted on 19Nov2018 with the admission diagnosis as cellulitis at injection site due to PREVNAR 13. The patient was still hospitalized at the time of reporting. No relevant tests in the office, but there may have been tests or labs done at the hospital. The outcome of all events was not recovered. Seriousness assessment for cellulitis at injection site was hospitalization, for nausea, dizziness was not reported and all the other events were considered non serious. The reporter causality was provided as: Cellulitis at injection site unknown, fever related, pain injection site related. The causality for both nausea and dizziness was not reported. Sender's Comments: Based on the information currently available, a contributory role of PREVNAR 13 towards the occurrence of cellulitis at injection site cannot be fully excluded considering the plausible time association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Linked Report(s) : US-PFIZER INC-2018484948 same reporter same drug similar events different patients.