Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram pelvis, Computerised tomogram thorax, Malaise, Myalgia, Pneumonia
Clinical narrative: Incidentally this picked up inflammatory changes within her lung parenchyma consistent with organizing pneumonia.; elevated ESR; CRP to moderate to high level; muscle aches; fever; malaise; GI upset; chills; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Jan2021 as dose 2, single (Lot number: EL3249) at the age of 57 years for covid-19 immunisation. The patient's relevant medical history included: "Anxiety" (unspecified if ongoing); "chronic back pain" (unspecified if ongoing); "asthma" (unspecified if ongoing). Concomitant medication(s) included: CYMBALTA; MORPHINE SULPHATE. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Lot: EK9231), administration date: 30Dec2020, when the patient was 56-year-old, for COVID-19 immunization. The following information was reported: C-REACTIVE PROTEIN INCREASED (non-serious) with onset 29Mar2021, outcome "not recovered", described as "CRP to moderate to high level"; ABDOMINAL DISCOMFORT (non-serious) with onset 29Mar2021, outcome "not recovered", described as "GI upset"; PNEUMONIA (medically significant) with onset 29Mar2021, outcome "not recovered", described as "Incidentally this picked up inflammatory changes within her lung parenchyma consistent with organizing pneumonia."; CHILLS (non-serious) with onset 29Mar2021, outcome "not recovered"; RED BLOOD CELL SEDIMENTATION RATE INCREASED (non-serious) with onset 29Mar2021, outcome "not recovered", described as "elevated ESR"; PYREXIA (non-serious) with onset 29Mar2021, outcome "not recovered", described as "fever"; MALAISE (non-serious) with onset 29Mar2021, outcome "not recovered"; MYALGIA (non-serious) with onset 29Mar2021, outcome "not recovered", described as "muscle aches". The events "incidentally this picked up inflammatory changes within her lung parenchyma consistent with organizing pneumonia.", "elevated esr", "crp to moderate to high level", "muscle aches", "fever", "malaise", "gi upset" and "chills" required physician office visit. The patient underwent the following laboratory tests and procedures: Computerised tomogram abdomen: (unspecified date) inflammatory changes within her lung parenchyma, notes: consistent with organizing pneumonia; Computerised tomogram pelvis: (unspecified date) inflammatory changes within her lung parenchyma, notes: consistent with organizing pneumonia; C-reactive protein: (29Mar2021) elevated, notes: moderate to high level; Red blood cell sedimentation rate: (29Mar2021) elevated, notes: moderate to high level; SARS-CoV-2 test: (19Oct2021) Negative, notes: Nasal Swab; Computerised tomogram thorax: (unspecified date) inflammatory changes within her lung parenchyma, notes: consistent with organizing pneumonia. Therapeutic measures were taken as a result of pneumonia, red blood cell sedimentation rate increased, c-reactive protein increased, myalgia, pyrexia, malaise, abdominal discomfort, chills. Patient describes receiving the COVID-19 vaccine and developing approximately 1 weeks of fever, muscle aches and malaise. With the second dose she really developed the similar symptoms and some associated GI upset. Subsequently, she developed periodic fever, muscle aches, chills and malaise. Her inflammatory markers were checked and she has an elevated ESR and CRP to moderate to high level. Due to her cyclical symptoms of fever a CT chest abdomen and pelvis was ordered to rule out underlying malignancy such as lymphoma. Incidentally, this picked up inflammatory changes within her lung parenchyma consistent with organizing pneumonia. Initiation of steroid therapy improved her symptoms but with weaning of the dose her symptoms have recurred now out to approximately 16 months.  Additional information: Facility type vaccine: Hospital. If other vaccine in four weeks: no. Other medication in two weeks: Cymbalta, Morphine sulphate. If covid prior vaccination: No. If covid tested post vaccination: Yes. Known allergies: No; Sender's Comments: Based on the information in the case, an association between the reported events and the suspect product BNT162B2 cannot be ruled out.  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.,Linked Report(s) : US-PFIZER INC-202200742984 Same reporter, patient, drug, different event