Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Cartilage injury, Incorrect route of product administration, Inflammation, Joint range of motion decreased, Magnetic resonance imaging
Clinical narrative: injection into the tendon; Inflammation; decreased range of motion; MRI that showed the brachial tendon torn and labrum torn; MRI that showed the brachial tendon torn and labrum torn; This is a spontaneous report from a contactable nurse (patient) via Pfizer sponsored program.  A 46-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 06Jan2021 (Lot Number: EJ1685; Expiration Date: Mar2021) as single dose (at the age of 46) in the morning for covid-19 immunisation. First dose was administered on 18Dec2020 in the morning in the left arm; lot EH9899; expiration date Mar2021 (at the age of 46).  There was no medical history. The patient's concomitant medications were not reported. Caller reports she got her second dose of the Pfizer COVID 19 vaccine on 06Jan2021 and did not get it in the right place, the shot went into her tendon. States it has triggered an inflammatory reaction to the point of being in physical therapy. Caller states this happened on her second dose; as soon as the shot was put in, she could feel it was too high up. Adds you know how there should be no tension but she could feel the tension and the person had to really push. Patient had decreased range of motion on 2021, MRI that showed the brachial tendon torn and labrum torn on 2021. Reports she noticed inflammation right away. Adds as a result of the inflammation process, she has experienced progressive decreased range of motion. She went to the doctor and had an MRI that showed the brachial tendon torn and labrum torn; she is unsure if one was torn in two places or if it was just the two locations. States she is doing physical therapy but it is still inflamed and tight. Adds she knows inflammation makes adhesions. She can't even reach to unbuckle her bra and has had to alter how she gets dressed. She gets pulled to work the floor but that has been a real challenge as it is in her dominant arm. Adds the physical therapy is helping a little but unless she figures out how to stop the inflammation process, she feels they are just chasing her tails getting nowhere. The patient underwent lab tests and procedures which included magnetic resonance imaging: brachial tendon torn and labrum torn on 2021. The outcome of injection into the tendon was unknown, of the other events was recovering.  Reporter states all of her events are medically significant, related to the vaccine.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the events Incorrect route of product administration, Inflammation, Joint range of motion decrease, Tendon injury, Cartilage injury and the suspect BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer drug 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.