Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Needle issue, Pain in extremity, Syringe issue
Clinical narrative: Case number PHEL2016US030847, is a spontaneous report initially received from a pharmacist on 18 Nov 2016. This report refers to a 46 year old female patient (non pregnant). Medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 168701 and expiry date: 31 May 2017) in her left arm on 05 Nov 2016 at a dose of 0.5 ml, intramuscularly. On 05 Nov 2016, shortly after the patient received the vaccine, the patient began to experience a sharp pain in her left arm (sore arm) that ran down to her hand and could barely move her arm. It was reported that, the package condition was good, the doses usually stored in the original box until use and stored collected all together. When the product was removed from the refrigerator to prepare to administer, they noticed that the plunger was stiff. It was reported that, upon injection of the vaccine into the patient, she noticed that the vaccine needle had some issues entering the skin to inject into the muscle and that there was some resistance when she depressed the plunger to administered the dose, no vaccine came out of the syringe. The reporter confirmed that, the patient received the full dose of FLUVIRIN. The reporter stated that, they did not from the patient since that time and had no further updates to provide. Upon follow up with the pharmacist, pharmacist confirmed that the date of events is 5 Nov 2016 and this is the same patient (product complaint and adverse event for same patient). It was clarified that the pharmacist attempted to give first prefilled syringe that would not inject, she removed that one and injection with a different prefilled syringe. The patient called back about 2 weeks later and reported symptom of pain in her left arm that ran down to her hand. The patient states that she can barely move her arm. The outcome of the event sharp pain in her left arm (sore arm) was condition unchanged (ongoing or not recovered) and the outcome of the other events was not reported. The event sharp pain in her left arm (sore arm) was reported as non serious by the pharmacist and the seriousness of other events was not reported. The causality of the events was not reported. Follow up information received from a pharmacist on 18 Nov 2016 and 06 Feb 2017 (combined report): Added expiry date of FLUVIRIN, new event and updated reporters comment. Follow up information received from a pharmacist on 18 Nov 2016 and from Quality Assurance department (QA reference number: 1019406) on 09 Feb 2017 (combined report): Added reporter comment. (Upon follow up with the pharmacist, pharmacist confirmed that the date of events is 5 Nov 2016 and this is the same patient (product complaint and adverse event for same patient). It was clarified that the pharmacist attempted to give first prefilled syringe that would not inject, she removed that one and injected with a different prefilled syringe. The patient called back about 2 weeks later and reported symptom of pain in her left arm that ran down to her hand. The patient states that she can barely move her arm). Added QA reference number. Follow up received on 01-May-2017: Batch review report (reference number: 1019406) received from quality assurance department on 01-May-2017: Based on the document review, it was stated that the concerned FLUVIRIN (NVD) batch number (168701) was manufactured in accordance with approved internal procedures and on compliance with the current good manufacturing practices (cGMP) requirements. Non-significant case correction received on 12-Oct-2017: changed to 01-Apr-2017 and was changed to 01-May-2017.