Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Dizziness, Drug ineffective, Eye irritation
Clinical narrative: eye irritation; aches and pain; coughing; fever; Sneezing; Pulled muscle; tested positive for COVID; tested positive for COVID; Pleurisy; Pneumonia; Dizziness/ Light headedness; allergy symptoms worse; Cold; This is a solicited report received from contactable consumer or other non-health care professional (Patient) from a Non-Interventional Study based on information received by Pfizer, manufacturer control number: 21K-163-4006943-00.  A 58-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number and expiration date were not reported), via intramuscular on 27Aug2021 (Age at vaccination was 58 years) as dose 2, single for COVID-19 immunisation and also patient received adalimumab (HUMIRA, Solution for injection in pre-filled pen), via subcutaneous from an unspecified date (Lot number was not reported) to an unspecified date, at an unknown dose and frequency (CF) for Moderate to severe Adult Crohn's Disease. Medical history included Moderate to severe Adult Crohn's Disease, 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 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. The patient's concomitant medications were not reported. The patient previously received historical vaccine first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number and expiration date were not reported), via an unspecified route of administration, on 03Aug2021 (Age at vaccination was 58 years) as dose 1, single for COVID-19 immunization and experienced sick with cold and allergy symptoms. It was unknown if she was enrolled in a COVID-19 Vaccine Trial. On 07Jan2022, she was tested positive for COVID and other drug ineffective, In Oct2021 had pneumonia; In Aug2021, had Dizziness/ Light headedness and allergy symptoms worse, Cold; On an unspecified date, had eye irritation and coughing, aches/pain, fever ; In Nov2021, had Pleurisy; On 12Jan2022, had Sneezing, Pulled muscle. Patient believed it made her allergy symptoms worse. She was not certain about the allergy symptoms as she got the vaccination during allergy season. Action taken with adalimumab was unknown. The outcome of fever, coughing, tested positive for COVID and other drug ineffective was unknown and not recovered for allergy symptoms worse, aches and pain, Pulled muscle, Sneezing, eye irritation. The outcome of Cold was recovered on unspecified date. The outcome of Pleurisy, Dizziness/ Light headedness, Pneumonia recovered in 2021.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of light headedness/dizziness and allergy symptoms with Humira (Adalimumab) was no reasonable possibility. Eye irritation, Pleurisy, Sneezing, Pulled muscle, Cold, COVID-19 virus test positive and other drug ineffective, Pneumonia, aches/ pain with Humira (Adalimumab) was Not Reported. opinion is that there is no reasonable possibility that the events Eye irritation, Pleurisy, Sneezing, Pulled muscle, COVID-19 virus test positive and other drug ineffective, aches/ pain and not assessable for events Cold, allergy symptoms, Pneumonia.  Causality for PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN): The reporter's causality for the event(s) of light headedness/dizziness and allergy symptoms was possible. Eye irritation, Pleurisy, Sneezing, Pulled muscle, Cold, COVID-19 virus test positive and other drug ineffective, aches/ pain was Not Reported and not related for Pneumonia.   Follow-up(19Nov2021): This is a follow-up Solicited report from a non-interventional study based on the information received by Pfizer from manufacture number (21K-163-4006943-00). A contactable female consumer(patient) reported for herself that new information included as Relevant medical history and causality updated.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (21Jan2022): This is a follow-up Solicited report from a non-interventional study based on the information received by Pfizer from manufacture number (21K-163-4006943-00). A contactable 58-year-old female consumer (patient) reported for herself that: Updated information included as causality and events details updated  Primary reporter did not have the lot number information, because the information was not accessible to the physician at his/her clinical setting.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between the events with the suspect drug BNT162B2 cannot be excluded. 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