Age: 74.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Laboratory test, Nausea, Pain in extremity, SARS-CoV-2 antibody test, Weight
Clinical narrative: severe leg pain in the morning; She was unable to walk; white blood cell count was also very high; c reactive protein was 283; She was nauseous and unable to eat; She was nauseous and unable to eat; She has lost 17lbs; This is a spontaneous report from a contactable consumer reported that a 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), via an unspecified route of administration, administered in arm left on 07Apr2021 15:45 (at the age of 74-years-old) as 2nd dose, single for covid-19 immunization; and atorvastatin calcium, ezetimibe (STATIN EZ), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The vaccine was administered at the hospital. The patient medical history was reported as none. The patient was not pregnant at the time of vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not provided), administered on left arm on 17Mar2021 03:30PM as 1st dose, single for covid-19 immunization. There were no concomitant medications. It was roughly 3 days after the second shot (10Apr2021) that the patient experienced severe leg pain in the morning. She was unable to walk for about an hour after waking up. Her physician did blood test and her c-reactive protein was 283. Her white blood cell count was also very high. She was nauseous and unable to eat. The extreme leg pain has since subsided but she still cannot eat. She has lost 17lbs. It has been a month of this and she's had every test known to man. The patient was hospitalized for 1 day due to severe leg pain, unable to walk and white blood cell count high on an unspecified date. The events resulted in doctor or other healthcare professional office/clinic visit and in emergency room/department or urgent care. The patient underwent lab tests and procedures which included sars-cov-2 antibody test (Nasal swab): negative on 21Apr2021. The outcome of severe leg pain, unable to walk and white blood cell count high was not recovered; and unknown for the other events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported events  and the use of  BNT162B2 seems unlikely. The limited information available precludes a more meaningful assessment. The case will be assessed further upon receipt of additional information.   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 appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.