Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Caesarean section, Exposure during pregnancy, Injection site pain, Neck pain
Clinical narrative: Report received from a registered nurse on 07-OCT-2009. A female patient received AFLURIA injection (lot # 01549211A) in the upper portion of the deltoid in September 2009. It was unknown if the vaccine was at room temperature. Another registered nurse administered the vaccination to the patient. She was not pregnant at the time of vaccination. At the time of reporting, the registered nurse noted being advised, within the past 24 hours, that the patient was still experiencing upper arm pain at the injection site 2.5 weeks after vaccination. The pain gradually radiated to her neck. The patient had not recovered. She was not seen or examined by a physician for the pain. Additional information has been requested. The pharmacist reported experiences for 2 other female patients (2009020865 and 2009020866). Follow-up information was received on 13-OCT-2009 from the initial reporter. The 27 year old female was vaccinated with AFLURIA IM in the left deltoid on 16-SEP-2009 at 13:15 PM. The  patient was not ill at the time of vaccination, had no pre-existing physician-diagnosed allergies, birth defects, or medical conditions. She was pregnant at the time of vaccination. There was no concomitant therapy. On 16-SEP-2009 at 15:15 PM, within 2 hours, the patient experienced neck pain which was gone by the next day. However, she developed sharp grabbing pain at the left arm injection site. She had pain from her shoulder to elbow and reported as a level 7 (on the scale of 1-10) that continued. The patient's pain was much worse at night ar rest (level 6-7). At the time of reporting, her pain had gradually lessened with movement (pain level was 4), however increases at night to 6 or 7. Treatment with ALEVE an ibuprofen had helped. No weakness, numbness or tingling reported. Additional information has been requested. Assessment: The company considers events as probable to AFLURIA administration given the time to onset of the reaction. Furthermore, the patient had no pre-existing illnesses or was not on any concomitant medications. Information derived from this AE repot does not change the current safety profile of the product. Batch review result received on 02-NOV-2009. Batch number: 01549211A Result: In conclusion, there has been no assignable cause drawn from this investigation that would indicate any association with the adverse event reported. Follow-up information was received on 19-NOV-2009 from the initial reporter. The patient's estimated due date is 27-MAY-2010. No further information was provided. Information was received from the nurse on 21-JUN-2010. The nurse claimed that the female ha her baby. Everything was "fine" as far as she knew. Patient outcome is considered recovered. Additional information is expected. Follow up information received from the nurse on 16-SEP-2010. The patient's last menstrual period was 20-JUL-2009 and has previously had one pregnancy (without any stillbirth or miscarriage). Current pregnancy outcome: Female baby born (39 weeks) by caesarean. Baby weight 7lb, length 21in. There were no birth defects or congenital anomalies. There were no adverse pregnancy outcomes. Information derived from this AE report does not change the current safety profile of the product. 19-Aug-2013: Case reopened for medically significant edit- care unlisted for the event of 'drug exposure during pregnancy' updated to listed in the relatedness field; outcome for all the adverse events changed to recovered (per the narrative); duration for the event of 'pain radiates to neck' estimated as one day (per the narrative). 30-Aug-2013: Case reopened for non-medically significant edit - the outcome for the AEs, 1, 2 and 2 changed back to not recovered in the adverse event page and as this does not lead to any medically significant change, therefore the last received date also changed back to 16-Sep-2010 ((per the narrative) in the overview page, age group changed back to blank int the patient field, outcome for 'drug exposure  during pregnancy' changed back to recovered in the adverse event field, the estimated duration for the event of 'pain radiates to neck' changed back to blank, core unlistedness added as listed in relatedness page for 'drug exposure during pregnancy '. 18-Jun-2015 - This case was reopened and the listedness of the individual events were reviewed. This activity was carried out as part of the company's commitment to the MHRA to improve quality and consistency of the company safety database.