Age: 73.0
Sex: M
Vaccine: FLU3, PNC13, FLUX, PNC13, FLU4
Symptoms: Injection site pain, Muscular weakness, Poor quality sleep
Clinical narrative: This is a spontaneous report from a contactable pharmacist reporting for himself. A 73-year-old male patient received as routine vaccination first dose of PREVNAR 13 on 20Oct2017 at 13:12 in right deltoid at single dose and influenza vaccine, intramuscular in left deltoid on 20Oct2017 at 21:30. Since 2012, the patient knew he needed a total knee replacement (unspecified knee disorder); medical history also included deep vein thrombosis (3 events).Concomitant medication included COUMADIN from 1990 and ongoing for three deep vein thrombosis events in the past; ongoing balsalazide started 10 or 12 years before for ulcerative colitis; ongoing timolol 0.5% started 20 years before (1997) for glaucoma; ongoing SUPER B COMPLEX taking this for 10 years (2007) for wellness, VITAMIN B12 from 2015 and ongoing for vegan diet, VITAMIN D3 from 2015 and ongoing for vegan diet, folic acid from 2015 and ongoing for vegan diet, COLACE from 2015 and ongoing for stool softener. The patient received probably 15 or 20 influenza vaccines in the past, he thought his first flu shot would've been given to him in the 1980s. On 20Oct2017 (evening) the patient experienced severe shoulder pain with both shoulders. On 21Oct2017 lack of movement in his shoulders (so severe he couldn't move the covers off him and he still can't raise his arms), fatigue, muscle weakness, headache. The patient stated that his right shoulder pain was more severe than the left. He did not sleep good in the last 3 weeks. In the mornings it flared up and then his right knee flares up. He knew since 2012 that he needed a total knee replacement on that knee, but it had been asymptomatic up until this event. He thought this may be a systemic inflammatory reaction. Events shoulder pain and lack of movement required a visit to physician office: patient visited doctor who told him to drink a lot of water but he didn't understand the correlation. On 29Oct2017 patient went to the walk-in clinic: doctor was worried about him having Guillain-Barre Syndrome, no further details provided on this. Doctor did not know of any bad injections and suggested MEDROL dose pack and it helped but it wore off. Patient stated he took one of his wife's NAPROSYN; manufacturer TEVA and within 2 hours he felt almost normal. Outcome of sleep disorder and joint disorder was unknown, final outcome of the other events was not recovered. Severe shoulder pain with both shoulders and lack of movement in his shoulders were serious per disability. Sender's Comments: There is not a reasonable possibility that the reported events shoulder pain and lack of movement is related to the suspect product. 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.