Age: 53.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Spondylitis, Vaccination complication, Vaccination site pain, X-ray, X-ray limb
Clinical narrative: Vaccine first dose: Date: 11Feb2021; she had wrist drop which comes with radial nerve issues; that she had complications from the Pfizer Covid-19 vaccine after receiving the second dose; adhesive capsulitis; was concerned for cervical spondylitis; The next day after getting the vaccine, she woke up with a sore are in the morning; Left arm and shoulder pain/any movement of the shoulder joint that involves force causes pain; Left arm and shoulder pain; limited range of motion; neck pain; neurological issues; She could feel tingling in her hands; This is a spontaneous report received from contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A 53 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 24Jun2021 (Lot number: EW0170, Expiration Date: 31Aug2021) at the age of 53 years as dose 2, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Uvulitis", start date: 2020 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Vaccine first dose: Covid Vaccine , Date: 11Feb2021, Lot: EL3247, NDC: Unknown, Expiry: 31May2021 , Administered in the Right Deltoid.), administration date: 11Feb2021, when the patient was 52 years old, for Covid-19 immunization; Flu vaccine (No but she does take the flu vaccine. She did not get the flu vaccine 2019, but recalls getting it in 2017), administration date: 2017, for Immunization. The following information was reported: VACCINATION COMPLICATION (non-serious) with onset 25Jun2021, outcome "unknown", described as "that she had complications from the Pfizer Covid-19 vaccine after receiving the second dose"; ARTHRALGIA (disability, medically significant) with onset 25Jun2021, outcome "recovering", described as "Left arm and shoulder pain/any movement of the shoulder joint that involves force causes pain"; PAIN IN EXTREMITY (disability, medically significant) with onset 25Jun2021, outcome "recovering", described as "Left arm and shoulder pain"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (disability, medically significant) with onset 25Jun2021, outcome "not recovered", described as "limited range of motion"; NECK PAIN (disability, medically significant) with onset 25Jun2021, outcome "not recovered", described as "neck pain"; NERVOUS SYSTEM DISORDER (disability, medically significant) with onset 25Jun2021, outcome "recovering", described as "neurological issues"; PARAESTHESIA (disability, medically significant) with onset 25Jun2021, outcome "recovering", described as "She could feel tingling in her hands"; RADIAL NERVE PALSY (disability, medically significant) with onset Aug2021, outcome "recovering", described as "she had wrist drop which comes with radial nerve issues"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Vaccine first dose: Date: 11Feb2021"; PERIARTHRITIS (non-serious) with onset 25Jun2021, outcome "not recovered", described as "adhesive capsulitis"; SPINAL OSTEOARTHRITIS (non-serious) with onset 25Jun2021, outcome "unknown", described as "was concerned for cervical spondylitis"; INJECTION SITE PAIN (non-serious) with onset 25Jun2021, outcome "recovering", described as "The next day after getting the vaccine, she woke up with a sore are in the morning". The patient underwent the following laboratory tests and procedures: magnetic resonance imaging: (Aug2021) there was no foraminal narrowing, notes: More information available (Y/N): No; x-ray: (Aug2021) no joint issues but she had anterior osteophytes n, notes: More information available (Y/N): No; x-ray limb: (Aug2021) no joint issues or dislocation, notes: More information available (Y/N): No. Therapeutic measures were taken as a result of vaccination complication, arthralgia, pain in extremity, loss of personal independence in daily activities, neck pain, nervous system disorder, paraesthesia, radial nerve palsy, periarthritis, spinal osteoarthritis, vaccination site pain.   clinical course:Prior Vaccinations (within 4 weeks) was No.Patient's Medical History and Family History was no.Emergency Room was No. and Physician Office visit was yes.Additional Vaccines Administered on Same Date was no.All the symptoms started the next day. Vaccination Facility Type was Workplace, employee health. Investigation Assessment was Yes. Present was No. Seriousness was No.Provider the patient provided was her family doctor, she explains that this provider did not know anything about this situation. The first physician she approached was an orthopedic doctor with 3-4 months afterwards. If Pfizer contacted her family doctor that doctor will not know anything. patient adds that she approached a doctor to see if she can get an MRI or something. She followed the ortho doctor for the shoulder pain. patient saw her family doctor one time for the pain to see if she could get anything for the pain. patient explains that she told her employer that she was going to report this event. The patent states that 24Jun2021 is when she got the vaccine and 25Jun2021 is when the pain started. The patient adds that she wanted to report this so she went to employee health at her employer, employee health told her to go to a doctor to be evaluated. That was when she went to see the orthopedic doctor, he didn't do anything at that time. She had to be persistent. The patient adds that since 24Jun2021 after the vaccine she did not sleep on the same side she got the vaccine in, it hurts so bad, extremely bad. She thought she dislocated her shoulder. She thought the joint was moving. States it was not dislocated but it felt like it was. The joint was slightly moving, but not dislocated. States she got an X-Ray and confirmed it was not dislocated but extremely painful. States she went to work and then she abducted her shoulder and it felt like electricity was passing through her hand, it was classic on the ulnar side, like neurological issues. It was severe and no one will acknowledge it. There was a period when it was very painful. Neurological Issues: The patient initially states that the neurological symptoms started the next day when she woke up. She could feel tingling in her hands and confirms only on her left hand. States when she saw the Ortho specialist they said it was severe adhesive capsulitis and sent her home, doctor told her it would get better. The patient states it got worse, even after seeing the ortho doctor, the next morning and she was given anti-inflammatories to take around the clock and recommended physical therapy. The doctor told her if it worsens to call the ortho doctor on call. The neurological symptoms got worse and so it made her go to the Ortho doctor on call. She states she was giving something like Advil it was an anti-inflammatory she does not have the details. The patient clarified that neurological symptoms did not start the next day 25Jun2021, it was actually after some time. The patient adds that the physical therapy doctor was not a good fit, she just evaluated her, she kept moving her arm and would stop when the pain got to a 5 or 6. The PT doctor instructed her to not hold her arm close to her body, she didn't want adhesions to form. The ortho doctor she does not know if this was the same day, the neck pain started the neurological symptoms started after the physical therapy appointment. The patient wanted to have an MRI of her shoulder done, but the doctor told her No, it was classic adhesive capsulitis and after physical therapy it will go away, if she wants she can have a steroid injection. The doctor said that she may be having neurological symptoms and was concerned for cervical spondylitis since she had neck pain so then a MRI of the cervical spine was ordered and she was placed on oral steroids. It was something like a Medrol dose pack, a taper dose for 7 days. Product details unknown, The patient does not have. He also ordered her not to work for 5 days. Neurological symptoms: Went up and down they come and go but the pain is still there, the Medrol dose pack did help but she states she still has the limited abduction. Towards the end of the Medrol dose pack her neurological symptoms definitely came down. The Medrol dose pack helped her move a little bit more. After physical therapy her pain exponentially went up, but after the Medrol dose pack it exponentially went down. The ortho doctor she does not know if this was the same day, the neck pain started the neurological symptoms started after the physical therapy appointment. The patient wanted to have an MRI of her shoulder done, but the doctor told her No, it was classic adhesive capsulitis and after physical therapy it will go away, if she wants she can have a steroid injection. The doctor said that she may be having neurological symptoms and was concerned for cervical spondylitis since she had neck pain so then a MRI of the cervical spine was ordered and she was placed on oral steroids. It was something like a Medrol dose pack, a taper dose for 7 days. Product details unknown, The patient did not have. He also ordered her not to work for 5 days. iceeds to state at this point she changed her doctor, after the cervical spine MRI showed changed but nothing neurological to call a neurologist. When the doctor examined her initially, she had no neurological symptoms but when he examined her he saw she had wrist drop which comes with radial nerve issues and that is why the MRI of the neck was ordered. The patient states that she perceives the neurological symptoms are on the medial ulnar side of the left arm, the 5th and 4th finger, it was like a zing electricity current passing through the finger and after the steroids it all stopped. Product: Causality: in the patient medical opinion, she questions if the shot was not given right. She talked to her colleagues and the managers and they get very defensive. Something cannot be given right and she first thought it could have been given into the joint. She did not have this pain with the first dose. She cannot give proof of that. Maybe it got worse because of the physical therapy and inflamed. Medical history: states in 2020 she had uvulitis, but did not have immunological disorders and not immunocompromised, not sure if that was related. The patient adds she was on limited duty, she was a physician and she feels bad this was not being followed up if there was something wrong. She  was concerned people  trying to blame other and she wants to find the real cause of this.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.  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.