Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Middle insomnia, Musculoskeletal pain, Musculoskeletal stiffness, Pain
Clinical narrative: Case number PHHY2014US001115 is an initial spontaneous report received from a consumer via the Vaccine Adverse Event Reporting System (VAERS reference number: 509422) website on 06 Jan 2014 with a follow up information received from the quality assurance department (QA reference number: 274849) on 11 Feb 2014. This report refers to a 32-year-old male patient. His medical history included seasonal allergies and a shoulder injury in 2006. His concomitant medications included a daily multi-vitamin (OTC) and 24 hour allergy (OTC) (chlorphenamine). He had a past vaccination history of flu shots (manufacturer and batch number: not reported) which were well tolerated. He did not have any illness or health issues prior to vaccination. On 09 Oct 2013, he was vaccinated with FLUVIRIN (batch number: 1308901) intramuscularly in the left arm but much higher (in the shoulder) than it should have been given. On the same day after vaccination, he began to feel soreness in his left shoulder at around 2:00 pm and gradually the soreness was increasing. He reported that he had a high tolerance of pain and dealt with it well. At around 8:00 pm in that night, he began to realize that there was really something wrong because the pain was intense and he could not lift his left arm above his head. He reported that he had never experienced such pain in his past after receiving flu shots and at that point he compared his pain to the shoulder injury pain, he had experienced in 2006 while playing rugby. He reported that, on the night of vaccination, he woke many times with pain shooting into his shoulder when he attempted to move. He was also unable to turn off his alarm clock with his left arm like he usually did before. He further reported that, when he got in his truck to leave for work, he attempted to close the door with his left arm and immediately recoiled in pain. He had to use his right arm and was also uncomfortable while driving, no matter what position he put his arm he felt aches or pain. Following these events he visited the company nurse, who also noticed that injection site was visibly higher than the deltoid muscle. He was still experiencing the pain on 16 Oct 2013, which further increased on 20 Oct 2013. He reported that at that point his shoulder stiffness along with the pain in the morning when he woke up was almost unbearable. He complained that the shoulder would loosen up a little during the day, but during the night and in the morning it was awful. He finally visited a physician who suspected that the needle might have got into his supraspinatus tendon and caused this issue and advised him to get his shoulder moving because he was at a risk of getting frozen shoulder. He reported that currently he was trying his best to keep his shoulder moving but the pain had not subsided. The event outcome was reported as condition unchanged as of 24 Oct 2013. The seriousness and causality of the events were not assessed. Upon follow up receipt from the quality assurance department (reference number: 274849), it was reported that based on the batch review, the FLUVIRIN batch number 1308901 was manufactured in accordance with the approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Follow up information received from the quality assurance department on 11 Feb 2014: Batch summary updated.