Sex: F
Vaccine: COVID19
Symptoms: Inflammatory marker test, Pulmonary fibrosis, SARS-CoV-2 test
Clinical narrative: COVID pneumonia; COVID pneumonia; Lung scarring; Bladder inflamed; Inflammatory markers were high; Joint pain; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4045763-00.  A 42 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1140349) as unk (citrate free) and subcutaneous (Lot number: 1154832) as unk (citrate free) for hidradenitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 PNEUMONIA (hospitalization, medically significant), outcome "unknown" and all described as "COVID pneumonia"; PULMONARY FIBROSIS (medically significant), outcome "unknown", described as "Lung scarring"; CYSTITIS NONINFECTIVE (non-serious), outcome "unknown", described as "Bladder inflamed"; INFLAMMATORY MARKER INCREASED (non-serious), outcome "unknown", described as "Inflammatory markers were high"; ARTHRALGIA (non-serious), outcome "not recovered", described as "Joint pain". The patient was hospitalized for drug ineffective, covid-19 pneumonia (start date: Aug2021, hospitalization duration: 4 day(s)). The patient underwent the following laboratory tests and procedures: inflammatory marker test: (unspecified date) high; sars-cov-2 test: (2021) positive. The action taken for adalimumab was unknown. Clinical course: The reporter's causality for the event(s) of LUNG SCARRING, COVID PNEUMONIA, BLADDER INFLAMED, INFLAMMATORY MARKERS WERE HIGH and JOINT PAIN was not provided. (withheld) opinion is that there is no reasonable possibility that the events of LUNG SCARRING, COVID PNEUMONIA, INFLAMMATORY MARKERS WERE HIGH and JOINT PAIN are related to HUMIRA(ADALIMUMAB). (withheld) opinion is that the event of BLADDER INFLAMED is not assessable.  The reporter's causality for the event(s) of LUNG SCARRING, COVID PNEUMONIA, JOINT PAIN, was possible and for the event BLADDER INFLAMED, INFLAMMATORY MARKERS WERE HIGH and was not provided for the drug bnt162b2. On 21Sep2021, received updates to patient demographics, event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information, concomitant drug information, laboratory/diagnostic procedures and narrative description. The events of "PNEUMONIA" and "BLADDER INFLAMED" were added. The event of "COVID POSITIVE" was amended to "COVID". The event of "COVID" is now considered serious. On 22Oct2021, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative etiology, laboratory/diagnostic procedures and narrative description. The event of "INFLAMMATORY MARKERS WERE HIGH" was added. On 19Jan2022, received updates to event information, reporter opinion of causality, company opinion of causality, company alternative etiology, suspect drug information, concomitant drug information and narrative description. The events of "LUNG SCARRING", "COVID PNEUMONIA" and "JOINT PAIN" were added. The events of "PNEUMONIA" and "COVID" were removed.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events and suspect product 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