Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Hepatic cancer, Magnetic resonance imaging, Night sweats, Pallor
Clinical narrative: white count being very elevated; PET scan showed mass in liver; was diagnosed with anemia; Chills; Fever; was very weak; was very active and now she can barely get out of bed; night sweats; very pale; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team for a Pfizer sponsored program.  A 68-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Cerebrovascular accident" (unspecified if ongoing), notes: Verbatim: Stroke; "Hypertension" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ASPIRIN 81; LOSARTAN taken for hypertension; ROSUVASTATIN taken for blood cholesterol increased. Vaccination history included: Covid-19 vaccine (Dose 1, Primary immunization series completed but unknown manufacturer), administration date: Dec2020, for Covid-19 Immunization; Covid-19 vaccine (Dose 2, Primary immunization series completed but unknown manufacturer), administration date: Jan2021, for covid-19 immunization. The following information was reported: WHITE BLOOD CELL COUNT INCREASED (hospitalization), outcome "unknown", described as "white count being very elevated"; HEPATIC CANCER (medically significant), outcome "unknown", described as "PET scan showed mass in liver"; ANAEMIA (non-serious), outcome "unknown", described as "was diagnosed with anemia"; PALLOR (non-serious) with onset Nov2021, outcome "unknown", described as "very pale"; CHILLS (non-serious), outcome "unknown", described as "Chills"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; ASTHENIA (non-serious), outcome "unknown", described as "was very weak"; BEDRIDDEN (non-serious), outcome "unknown", described as "was very active and now she can barely get out of bed"; NIGHT SWEATS (non-serious), outcome "unknown", described as "night sweats". The patient was hospitalized for white blood cell count increased (start date: 27Feb2022). The patient underwent the following laboratory tests and procedures: blood test: can't find anything wrong in the blood; computerised tomogram: unknown result; magnetic resonance imaging: unknown result; positron emission tomogram: liver had enlarged and showed a mass in her liver., notes: The PET scan showed how the patient's liver had enlarged and showed a mass in her liver; white blood cell count: elevated. Therapeutic measures were taken as a result of white blood cell count increased, anaemia. Clinical course: Reaction assessed: was diagnosed with anemia . Source of assessment: Primary Source Reporter. Drug result: Related. Relatedness of drug to reaction(s)/event(s): Reaction assessed: very pale. Source of assessment: Primary Source Reporter. Drug result: Related. Relatedness of drug to reaction(s)/event(s): Reaction assessed: Chills. Source of assessment: Primary Source Reporter. Drug result: Related. Relatedness of drug to reaction(s)/event(s): Reaction assessed: Fever. Source of assessment: Primary Source Reporter. Drug result: Related. Relatedness of drug to reaction(s)/event(s): Reaction assessed: was very weak. Source of assessment: Primary Source Reporter. Drug result: Related. Relatedness of drug to reaction(s)/event(s): Reaction assessed: PET scan showed mass in liver. Source of assessment: Primary Source Reporter. Drug result: Related. Relatedness of drug to reaction(s)/event(s): Reaction assessed: white count being very elevated. Source of assessment: Primary Source Reporter. Drug result: Related Relatedness of drug to reaction(s)/event(s): Reaction assessed: was very active and now she can barely get out of bed. Source of assessment: Primary Source Reporter. Drug result: Related. Reporter stated that the patient has lost about 16 pounds. The reason she was calling because she understands there are studies being done for patients who have had severe reactions from the vaccine. She wants to know if that can be done in (city name). She was just trying to find some answers and they were trying to do every single test to find out what went wrong with the patient. In Nov2021, she noticed her mom was very pale and the doctor had diagnosed her with anemia. From there, she was very weak and was experiencing chills and fever. Test were done and they did a CT scan, MRI, PET scans and biopsy. The PET scan showed how the patient's liver had enlarged and showed a mass in her liver. The mass was very liquified, which the caller states was very unusual for liver cancer. The mass in the liver was unspecified. Caller stated that liver cancer did not have a liquefied shape. She stated that it was also necrotic. Caller stated when that happens, cancer from other organs that metastasized to the liver. She stated that her mom did not have any other cancers anywhere in her body. They did a full body scan and can't find where it originated. Caller stated they want to treat her mom with broad spectrum antibiotics and chemotherapy but she, the caller, did not agree. Caller stated she was consulting with an infectious disease doctor in (city name), who was very well known. The biopsy showed an unspecified carcinoma and she stated that unspecified liver cancer usually was caused by another organ. Her mom does not have any other cancers in her body. They had been turning her mom inside and out and couldn't find anything. She was recently hospitalized with her white count being very elevated. They started her on antibiotics, which are helping her and she has been receiving IV fluids. Right now, they want to treat her for cancer but they don't know what kinds of cancer it was or what kind of infection she had. Caller states that nothing shows infection. Caller stated there have studies in (withheld) with patients with similar recent scenarios that show direct correlation with the Pfizer vaccine. She was calling Pfizer to find out if it was worth investigating. She was convinced that this is all directly related to the Pfizer vaccine. Seriousness Criteria: Very serious. She states that the doctors checked to see if the Covid vaccine was causing her numbers to decrease. She states that 125 was the max and her mom's numbers were 8 or 9,000. She states that is showing the vaccine was all in her system. The doctor's are not doing anything. They are focusing on the cancer and they don't know what kind of cancer it was. Caller stated she was going to do some investigation with the infectious disease doctor. They have turned her inside out and everything imagined was done.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on limited information in the case  a possible causal association between the reported  event and 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.,Linked Report(s) : PFIZER INC-202200364021 Same product and event, different patient