Age: 58.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Nasopharyngitis, Nausea, Nodule, Pain, Pancreatic disorder
Clinical narrative: Pneumonia; Crohn's disease flare up; Pancreas not functioning properly it caused pain and nausea; left shoulder inflamed; Torn Rotator cuff/ tendon in right shoulder/ torn bicep; Two Bone spurs on collar bone/shoulder; Benign nodules on bottom of foot; Non serious Anxiety and depression during pandemic because of not being to go to work and no duties; Non serious Anxiety and depression during pandemic because of not being to go to work and no duties; Pancreas not functioning properly it caused pain and nausea; Pancreas not functioning properly it caused pain and nausea; Not sleeping well; asthma; Benign cyst on the bottom of foot; Stress; sick with cold and allergy symptoms; Light headeness/ dizziness; sick with cold and allergy symptoms; sick with cold and allergy symptoms; This is a solicited report from a Non-Interventional Study (FACILITATED COLLECT) based on infor-mation received by Pfizer, manufacturer control number: 21K-163-4006943-00. A female consumer (patient) reporter for herself that:  A 58 years old female patient received (Pfizer-BioNTech Covid-19 Vaccine, solution for injection) via Intramuscular route of administration on 03Aug2021 as dose 1, single for Covid-19 vaccination. The medical history included in Jun2021, patient underwent surgery on her right shoulder to repair a tears in her rotator cuff, In Jul2021, patient underwent surgery on foot because nodules came up, The patient's pancreas was not functioning properly so, in Apr2021, patient was hospitalized and the issue caused her to experience pain and nausea. Patient took Humira (Solution for injection in pre-filled pen) (Adalimumab), Unknown CF Subcutaneous for Indication of Moderate to severe Adult Crohn's Disease. On 2021 patient experienced rotator cuff tear, pancreatic disorder, pain, nausea and on Aug2021 patient experienced sick with cold and allergy symptoms, left shoulder became inflamed, bone spur, nodule, situational depression, dizziness, situational anxiety, joint inflammation, cold, allergy on Aug2021.  Upon follow up, it was reported that on an unspecified date patient had Nausea, Pneumonia, Sleep unwell, Asthma, Cyst, Stress, Crohn's disease aggravated. Allergy was worsened. Case level outcome was worsened. The outcome of stress, benign cyst on the bottom of foot, asthma, not sleeping well, crohn's disease flare up, pneumonia was unknown, sick with cold and allergy symptoms, torn rotator cuff/ tendon in right shoulder/ torn bicep, two bone spurs on collar bone/shoulder was not recovered and all events were recovered on an unspecified date in 2021.   Solicited report by a consumer of an adult female with events of torn rotator cuff/tendon in right shoulder, pancreas not functioning properly it caused pain and nausea, two bone spurs on collar bone and benign nodules on bottom of foot and non-serious anxiety and depression during pandemic because of not being to go to work and do duties, light headedness/dizziness, left shoulder inflammed, cold, allergy symptoms and pancreas not functioning properly it caused pain and nausea with humira (Adalimumab). there was no reported medical history.  On unknown dates, the patient experienced torn rotator cuff/tendon in right shoulder, pancreas not functioning properly it caused pain and nausea, two bone spurs on collar bone, benign nodules on bottom of foot, anxiety and depression during pandemic because of not being to go to work and do duties and left shoulder inflammed.  In Aug2021, the patient experienced light headedness/dizziness, cold and allergy symptoms. in 2021, the pancreas not functioning properly it caused pain and nausea, light headedness/dizziness and cold resolved. on unknown dates, torn rotator cuff/tendon in right shoulder, two bone spurs on collar bone, benign nodules on bottom of foot, anxiety and depression during pandemic because of not being to go to work and do duties and left shoulder inflammed resolved. pfizer biontech covid-19 vaccine (TOZINAMERAN) was also considered suspect.  The patient's pancreas was not functioning properly so, in Apr2021, she was hospitalized and the issue caused her to experience pain and nausea. She experienced depression and anxiety during the pandemic because of not being able to go to work and do her duties. She was told not to get the covid vaccine by her physician. She had torn rotator cuff, tendon in right shoulder and so in Jun2021, she underwent surgery on her right shoulder to repair a tears in her rotator cuff, tendon and she also had another tear which she did not recall. She takes care of two bone spurs on her collar bone and another location. Her left shoulder became inflamed and was not sure of the cause however believed it could be more tears. She had nodules on bottom of foot which was determined as benign. In Jul2021, she underwent surgery on foot because nodules came up. In Aug2021, she was sick with cold and allergy symptoms. In 2021, When she took her second Pfizer vaccination, she had light headedness, dizziness and believed it made her allergy symptoms worse. She was not certain about the allergy symptoms as she got the vaccination during allergy season.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 03Aug2021, she received 1st dose COVID-19 Vaccine manufactured by Pfizer/BioNTech. On 27Aug2021, she received 2nd dose COVID-19 Vaccine manufactured by Pfizer/BioNTech.   Causality for HUMIRA(ADALIMUMAB) The reporter's causality for the events of torn rotator cuff/tendon in right shoulder, pancreas not functioning properly it caused pain and nausea unknown onset, two bone spurs on collar bone, benign nodules on bottom of foot, anxiety and depression during pandemic because of not being to go to work and do duties unknown on-set, anxiety and depression during pandemic because of not being to go to work and do duties unknown onset, left shoulder inflammed, cold, pancreas not functioning properly it caused pain and nausea unknown onset and pancreas not functioning properly it caused pain and nausea unknown onset was not provided. the reporter's causality for the event(s) of light headedness/dizziness and allergy symptoms with humira(ADALIMUMAB) was no reasonable possibility.   AbbVie's opinion is that there is no reasonable possibility that the events of torn rotator cuff/tendon in  right shoulder/torn bicep, two bone spurs on collar bone/shoulder, anxiety and depression during pandemic  because of not being to go to work and do duties unknown onset, light headedness/dizziness, anxiety and  depression during pandemic because of not being to go to work and do duties unknown onset, left shoulder  inflammed, not sleeping well, asthma, stress and crohns disease flare up are related to humira(adalimumab). abbvie's opinion is that the events of pancreas not functioning properly it caused pain and nausea unknown onset, benign nodules on bottom of foot, cold, allergy symptoms, pancreas not functioning properly it caused  pain and nausea unknown onset, pancreas not functioning properly it caused pain and nausea unknown onset,  pneumonia and benign cyst on the bottom of foot are not assessable.    Change history  On 11 Nov 2021, received updates to patient demographics, event information, reporter opinion of causality,  company opinion of causality, company alternative etiology, suspect drug information and narrative description. The events of "pneumonia", "not sleeping well", "asthma", "benign cyst on the bottom of foot", "stress" and crohn disease flare up were added. the event of torn rotator cuff/tendon in right shoulder" was amended  to "torn rotator cuff/tendon in right shoulder/torn bicep". the event of "two bone spurs on collar bone" was amended to "two bone spurs on collar bone/shoulder".  Drug: Pfizer-BioNTech Covid-19 Vaccine (Tozinameran) (Injection) (Tozinameran):  Not Related for Rotator cuff tear, Bone spur, pain, nausea, pneumonia, sleep unwell, asthma, cyst, Crohn's disease aggravated, stress not reported for Joint inflammation, Pancreatic disorder, Nodule, Situational depression, Situational anxiety, cold, possible for dizziness, allergy.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Updated coding of suspect product BNT162B2 using EUA license.   Follow-up (19Nov2021): New information reported from a non-interventional (FACILITATED COLLECT) based on the information received by Pfizer from manufacture number (21K-163-4006943-00). New events added, updated outcome.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the description given in the narrative, there is reasonable possibility of causal association between the serious events and the suspect BNT162B2 cannot be excluded. 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.