Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Renal failure, SARS-CoV-2 test
Clinical narrative: KIDNEY FAILURE; Neurological disorder; Headache; anosmia; COVID-19; 2nd dose on 01Jan2021; 2nd dose on 01Jan2021; This is a spontaneous report from a contactable physician. A 31-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Formulation: Solution for injection, Batch/Lot Number: EL8982), dose 2 intramuscular, administered in Deltoid Left on 01Jan2021 as an unspecified dose for covid-19 immunisation. Patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Formulation: Solution for injection, Batch/Lot number: EL0142) on 29Dec2020 via R deltoid intramuscular as unspecified route for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient had a history of diabetes: Borderline and the patient was a non-smoker/former. It was stated patient have a positive test for SARS-Cov2 and New infection Dxdt RT-PCR was done on 06Jan2021 and patient have SARS-CoV2 antibodies at diagnosis was unknown. Patient willing to be contacted again by Pfizer on the reported adverse event. It was reported that patient experienced Covid a week after the 1st dose of the vaccine. When to get the 2nd dose/tested positive for COVID 04Jan2021. There was a Renal failure on unspecified date. And no other details were provided and Neurological is Yes, and no details were provided. Other provided as Yes as headache, anosmia. The patient was not hospitalized and the patient was not admitted to an Intensive Care Unit. The patient display no clinical signs at rest indicative of severe systemic illness. The patient does not require supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation. Patient does not have Mutliorgan failure, Respiratory, Dyspnea, Tachypnea, Hypoxemia and COVID-Pneumonia was Unknown, No Respiratory failure and no Acute respiratory distress syndrome (ARDS). Patient had no Cardiovascular, Heart failure, Cardiogenic shock, Acute myocardial failure, Arrhythmia, Myocarditis, Gastrointestinal/Hepatic, Vomiting, Diarrhea, Abdominal pain, Jaundice, Acute liver failure, Other, Vascular, Deep vein thrombosis, Pulmonary embolism, Limb ischemia, Vasculitis, Renal and Unknown Acute kidney injury. The was no altered consciousness, Convulsions/Seizures, Encephalopathy, Meningitis, Cerebrovascular accident. There was no Hematological, Thrombocytopenia, Disseminated intravascular coagulation, Other, Dermatological, Chillblains, Erythema multiforme. patient had not received any additional therapies for COVID-19. the event does not require the initiation of new medication or other treatment or procedure. Patient did not retest from the SARS-CoV2 diagnosis before the SARS-CoV2 antigen test became negative. It was reported that Laboratory Test or Diagnostic Studies: Test for SARS-CoV-2 by PCR, or other Performed on 06Jan2021 Results with units as Positive. The patient has not been taking any medications routinely prior to the event being reported. Patient do not have any pre-existing diseases worsened during the SARS-CoV2 infection. The patient had not been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. The outcome with COVID-19 was recovered and the remaining events were unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of  Renal failure,covid 19 anosmia,headache. The case will be reassessed once new information is available. 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  Committees, and Investigators, as appropriate