chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Central venous catheterisation, Chest X-ray abnormal, Chills, Cough
Clinical narrative: Narrative:  COVID infection following COVID vaccine series 01/20, Pfizer, dose #1 02/19, Pfizer, dose #2 07/13 COVID swab, result: not detected 08/31, Pfizer, dose #3 09/18 SARS-COV-2 Variant Sequencing result: pending 09/18 COVID swab, result: detected 09/21 pt cc: chills, cough, diarrhea, fever, loss of taste or smell, myalgias, headache, fatigue, exposure: unknown 09/27 pt admit to medicine cc: covid, hypoxia dx: covid 19 pneumonia LOS: 4 days 09/27 CXR impression: Several EKG wires overlie the chest. There is a right internal jugular port catheter with tip in the region of the right atrium. An aortic valve stent graft is again seen. The heart is magnified by technique. Patchy bilateral alveolar opacities are seen distributed throughout the lungs, worrisome for Covid pneumonia. The visualized pleural spaces are well preserved. 09/27 CTA PE impression: 1. Negative for pulmonary embolus. 2. Known Covid pneumonia with diffuse groundglass infiltrates similar to chest radiograph performed earlier today. 09/27 US EXTREMITY VENOUS LTD impression: No evidence of acute or progressive deep venous thrombosis bilateral lower extremities. Chronic appearing nonocclusive/recanalized thrombus left popliteal vein initially imaged 10/2/2017 09/27 TROPONIN I <0.016 09/27 procalcitonin <0.05 09/27 ESR 31 09/27 DDIMER 7.00 09/27 bnp 51.7 09/27 ABG: i-pH 7.50, i-PC02 31.4, i-P02 73; i-HCO3 24.3 09/28 lactic acid 1.07 09/28 procalcitonin <0.05 09/28 FIBRINOGEN 469 09/28 DDIMER: 4.02 09/28 ESR 22 09/29 FIBRINOGEN: 342 09/29 DDIMER: 4.24 09/29 ESR 13 09/30 FIBRINOGEN: 250 09/30 DDIMER: 3,32 09/30 ESR 6 10/01 FIBRINOGEN: 226 10/01 DDIMER: 4.75 10/01 ESR 1
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Diarrhoea, Electrocardiogram, Fatigue, Fibrin D dimer
Clinical narrative: Narrative:  COVID infection following COVID vaccine series 01/20, Pfizer, dose #1 02/19, Pfizer, dose #2 07/13 COVID swab, result: not detected 08/31, Pfizer, dose #3 09/18 SARS-COV-2 Variant Sequencing result: pending 09/18 COVID swab, result: detected 09/21 pt cc: chills, cough, diarrhea, fever, loss of taste or smell, myalgias, headache, fatigue, exposure: unknown 09/27 pt admit to medicine cc: covid, hypoxia dx: covid 19 pneumonia LOS: 4 days 09/27 CXR impression: Several EKG wires overlie the chest. There is a right internal jugular port catheter with tip in the region of the right atrium. An aortic valve stent graft is again seen. The heart is magnified by technique. Patchy bilateral alveolar opacities are seen distributed throughout the lungs, worrisome for Covid pneumonia. The visualized pleural spaces are well preserved. 09/27 CTA PE impression: 1. Negative for pulmonary embolus. 2. Known Covid pneumonia with diffuse groundglass infiltrates similar to chest radiograph performed earlier today. 09/27 US EXTREMITY VENOUS LTD impression: No evidence of acute or progressive deep venous thrombosis bilateral lower extremities. Chronic appearing nonocclusive/recanalized thrombus left popliteal vein initially imaged 10/2/2017 09/27 TROPONIN I <0.016 09/27 procalcitonin <0.05 09/27 ESR 31 09/27 DDIMER 7.00 09/27 bnp 51.7 09/27 ABG: i-pH 7.50, i-PC02 31.4, i-P02 73; i-HCO3 24.3 09/28 lactic acid 1.07 09/28 procalcitonin <0.05 09/28 FIBRINOGEN 469 09/28 DDIMER: 4.02 09/28 ESR 22 09/29 FIBRINOGEN: 342 09/29 DDIMER: 4.24 09/29 ESR 13 09/30 FIBRINOGEN: 250 09/30 DDIMER: 3,32 09/30 ESR 6 10/01 FIBRINOGEN: 226 10/01 DDIMER: 4.75 10/01 ESR 1
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypoxia, Laboratory test, Lung infiltration, Lung opacity
Clinical narrative: Narrative:  COVID infection following COVID vaccine series 01/20, Pfizer, dose #1 02/19, Pfizer, dose #2 07/13 COVID swab, result: not detected 08/31, Pfizer, dose #3 09/18 SARS-COV-2 Variant Sequencing result: pending 09/18 COVID swab, result: detected 09/21 pt cc: chills, cough, diarrhea, fever, loss of taste or smell, myalgias, headache, fatigue, exposure: unknown 09/27 pt admit to medicine cc: covid, hypoxia dx: covid 19 pneumonia LOS: 4 days 09/27 CXR impression: Several EKG wires overlie the chest. There is a right internal jugular port catheter with tip in the region of the right atrium. An aortic valve stent graft is again seen. The heart is magnified by technique. Patchy bilateral alveolar opacities are seen distributed throughout the lungs, worrisome for Covid pneumonia. The visualized pleural spaces are well preserved. 09/27 CTA PE impression: 1. Negative for pulmonary embolus. 2. Known Covid pneumonia with diffuse groundglass infiltrates similar to chest radiograph performed earlier today. 09/27 US EXTREMITY VENOUS LTD impression: No evidence of acute or progressive deep venous thrombosis bilateral lower extremities. Chronic appearing nonocclusive/recanalized thrombus left popliteal vein initially imaged 10/2/2017 09/27 TROPONIN I <0.016 09/27 procalcitonin <0.05 09/27 ESR 31 09/27 DDIMER 7.00 09/27 bnp 51.7 09/27 ABG: i-pH 7.50, i-PC02 31.4, i-P02 73; i-HCO3 24.3 09/28 lactic acid 1.07 09/28 procalcitonin <0.05 09/28 FIBRINOGEN 469 09/28 DDIMER: 4.02 09/28 ESR 22 09/29 FIBRINOGEN: 342 09/29 DDIMER: 4.24 09/29 ESR 13 09/30 FIBRINOGEN: 250 09/30 DDIMER: 3,32 09/30 ESR 6 10/01 FIBRINOGEN: 226 10/01 DDIMER: 4.75 10/01 ESR 1
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, PCO2 decreased, PO2 decreased, Procalcitonin, Pyrexia
Clinical narrative: Narrative:  COVID infection following COVID vaccine series 01/20, Pfizer, dose #1 02/19, Pfizer, dose #2 07/13 COVID swab, result: not detected 08/31, Pfizer, dose #3 09/18 SARS-COV-2 Variant Sequencing result: pending 09/18 COVID swab, result: detected 09/21 pt cc: chills, cough, diarrhea, fever, loss of taste or smell, myalgias, headache, fatigue, exposure: unknown 09/27 pt admit to medicine cc: covid, hypoxia dx: covid 19 pneumonia LOS: 4 days 09/27 CXR impression: Several EKG wires overlie the chest. There is a right internal jugular port catheter with tip in the region of the right atrium. An aortic valve stent graft is again seen. The heart is magnified by technique. Patchy bilateral alveolar opacities are seen distributed throughout the lungs, worrisome for Covid pneumonia. The visualized pleural spaces are well preserved. 09/27 CTA PE impression: 1. Negative for pulmonary embolus. 2. Known Covid pneumonia with diffuse groundglass infiltrates similar to chest radiograph performed earlier today. 09/27 US EXTREMITY VENOUS LTD impression: No evidence of acute or progressive deep venous thrombosis bilateral lower extremities. Chronic appearing nonocclusive/recanalized thrombus left popliteal vein initially imaged 10/2/2017 09/27 TROPONIN I <0.016 09/27 procalcitonin <0.05 09/27 ESR 31 09/27 DDIMER 7.00 09/27 bnp 51.7 09/27 ABG: i-pH 7.50, i-PC02 31.4, i-P02 73; i-HCO3 24.3 09/28 lactic acid 1.07 09/28 procalcitonin <0.05 09/28 FIBRINOGEN 469 09/28 DDIMER: 4.02 09/28 ESR 22 09/29 FIBRINOGEN: 342 09/29 DDIMER: 4.24 09/29 ESR 13 09/30 FIBRINOGEN: 250 09/30 DDIMER: 3,32 09/30 ESR 6 10/01 FIBRINOGEN: 226 10/01 DDIMER: 4.75 10/01 ESR 1
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate increased, SARS-CoV-2 test positive, Troponin I normal, Ultrasound Doppler abnormal, Venous recanalisation
Clinical narrative: Narrative:  COVID infection following COVID vaccine series 01/20, Pfizer, dose #1 02/19, Pfizer, dose #2 07/13 COVID swab, result: not detected 08/31, Pfizer, dose #3 09/18 SARS-COV-2 Variant Sequencing result: pending 09/18 COVID swab, result: detected 09/21 pt cc: chills, cough, diarrhea, fever, loss of taste or smell, myalgias, headache, fatigue, exposure: unknown 09/27 pt admit to medicine cc: covid, hypoxia dx: covid 19 pneumonia LOS: 4 days 09/27 CXR impression: Several EKG wires overlie the chest. There is a right internal jugular port catheter with tip in the region of the right atrium. An aortic valve stent graft is again seen. The heart is magnified by technique. Patchy bilateral alveolar opacities are seen distributed throughout the lungs, worrisome for Covid pneumonia. The visualized pleural spaces are well preserved. 09/27 CTA PE impression: 1. Negative for pulmonary embolus. 2. Known Covid pneumonia with diffuse groundglass infiltrates similar to chest radiograph performed earlier today. 09/27 US EXTREMITY VENOUS LTD impression: No evidence of acute or progressive deep venous thrombosis bilateral lower extremities. Chronic appearing nonocclusive/recanalized thrombus left popliteal vein initially imaged 10/2/2017 09/27 TROPONIN I <0.016 09/27 procalcitonin <0.05 09/27 ESR 31 09/27 DDIMER 7.00 09/27 bnp 51.7 09/27 ABG: i-pH 7.50, i-PC02 31.4, i-P02 73; i-HCO3 24.3 09/28 lactic acid 1.07 09/28 procalcitonin <0.05 09/28 FIBRINOGEN 469 09/28 DDIMER: 4.02 09/28 ESR 22 09/29 FIBRINOGEN: 342 09/29 DDIMER: 4.24 09/29 ESR 13 09/30 FIBRINOGEN: 250 09/30 DDIMER: 3,32 09/30 ESR 6 10/01 FIBRINOGEN: 226 10/01 DDIMER: 4.75 10/01 ESR 1
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Narrative: COVID infection following COVID vaccine series 01/05, Pfizer, dose #1 01/27 , Pfizer, dose #2 09/20 COVID swab, result: detected 09/20 pt cc: exposure: unknown
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Blood bicarbonate normal, Blood gases, Blood lactic acid decreased, Blood pH increased
Clinical narrative: Narrative:  COVID infection following COVID vaccine series after previous COVID infection 03/29, Pfizer, dose #1 04/27, Pfizer, dose #2 02/27 pt cc:myalgias, fatigue, fever, exposure: unknown 03/01 COVID swab, result: detected 03/09 ABG result: i-pH 7.47, i-PC02 34.0, i-P02 70, i-HCO3 24.9 03/09 FERRITIN: 548.3 03/09 LACTIC ACID: 1.53 03/09 PROCALCITONIN <0.05 03/09 DDIMER: 0.24 03/13 pt admit to Medicine cc: SOB dx: Acute Hypoxic Respiratory Failure due to COVID-19 Pneumonia LOS: 6 DAYS 05/11 COVID swab, result: not detected 05/11 FIBRINOGEN: 508 05/11 DDIMER: 1.33 05/11 ESR: 33 09/20 COVID swab, result: detected 09/21 BinaxNOW COVID-19 Ag result: not detected 09/21 clinically resolved
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Dyspnoea, Fatigue, Fibrin D dimer
Clinical narrative: Narrative:  COVID infection following COVID vaccine series after previous COVID infection 03/29, Pfizer, dose #1 04/27, Pfizer, dose #2 02/27 pt cc:myalgias, fatigue, fever, exposure: unknown 03/01 COVID swab, result: detected 03/09 ABG result: i-pH 7.47, i-PC02 34.0, i-P02 70, i-HCO3 24.9 03/09 FERRITIN: 548.3 03/09 LACTIC ACID: 1.53 03/09 PROCALCITONIN <0.05 03/09 DDIMER: 0.24 03/13 pt admit to Medicine cc: SOB dx: Acute Hypoxic Respiratory Failure due to COVID-19 Pneumonia LOS: 6 DAYS 05/11 COVID swab, result: not detected 05/11 FIBRINOGEN: 508 05/11 DDIMER: 1.33 05/11 ESR: 33 09/20 COVID swab, result: detected 09/21 BinaxNOW COVID-19 Ag result: not detected 09/21 clinically resolved
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, PCO2 decreased, PO2 decreased, Procalcitonin, Pyrexia
Clinical narrative: Narrative:  COVID infection following COVID vaccine series after previous COVID infection 03/29, Pfizer, dose #1 04/27, Pfizer, dose #2 02/27 pt cc:myalgias, fatigue, fever, exposure: unknown 03/01 COVID swab, result: detected 03/09 ABG result: i-pH 7.47, i-PC02 34.0, i-P02 70, i-HCO3 24.9 03/09 FERRITIN: 548.3 03/09 LACTIC ACID: 1.53 03/09 PROCALCITONIN <0.05 03/09 DDIMER: 0.24 03/13 pt admit to Medicine cc: SOB dx: Acute Hypoxic Respiratory Failure due to COVID-19 Pneumonia LOS: 6 DAYS 05/11 COVID swab, result: not detected 05/11 FIBRINOGEN: 508 05/11 DDIMER: 1.33 05/11 ESR: 33 09/20 COVID swab, result: detected 09/21 BinaxNOW COVID-19 Ag result: not detected 09/21 clinically resolved
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate increased, SARS-CoV-2 test negative, SARS-CoV-2 test positive, Serum ferritin increased
Clinical narrative: Narrative:  COVID infection following COVID vaccine series after previous COVID infection 03/29, Pfizer, dose #1 04/27, Pfizer, dose #2 02/27 pt cc:myalgias, fatigue, fever, exposure: unknown 03/01 COVID swab, result: detected 03/09 ABG result: i-pH 7.47, i-PC02 34.0, i-P02 70, i-HCO3 24.9 03/09 FERRITIN: 548.3 03/09 LACTIC ACID: 1.53 03/09 PROCALCITONIN <0.05 03/09 DDIMER: 0.24 03/13 pt admit to Medicine cc: SOB dx: Acute Hypoxic Respiratory Failure due to COVID-19 Pneumonia LOS: 6 DAYS 05/11 COVID swab, result: not detected 05/11 FIBRINOGEN: 508 05/11 DDIMER: 1.33 05/11 ESR: 33 09/20 COVID swab, result: detected 09/21 BinaxNOW COVID-19 Ag result: not detected 09/21 clinically resolved
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Pyrexia, Respiratory failure, SARS-CoV-2 test positive
Clinical narrative: Narrative:  Patient received the first dose of COVID19 vaccine in August 2021. On 1 September, the patient tested positive for COVID 19 and was hospitalized with respiratory failure, fever, and COVID pneumonia. The patient received treatment and was discharged to Rehab on 30 Sep 21. The EUA requires that any patients that tested positive for COVID 19 and required hospitalization after receiving the vaccine must be reported.
Age: 81.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Respiratory failure, SARS-CoV-2 test positive
Clinical narrative: Narrative:  Patient received two doses of Pfizer COVID 19 vaccine in Jan/Feb 21. The patient tested positive for COVID 19 on 7 September 2021 and was hospitalized with respiratory failure and COVID pneumonia. The patient was treated and was discharged still requiring oxygen on 20 Sep 21. The EUA requires that any patients that tested positive for COVID 19 and required hospitalization after receiving the vaccine must be reported.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Hypokalaemia, Hyponatraemia, Post-acute COVID-19 syndrome
Clinical narrative: Narrative:  Patient received three doses of COVID 19 vaccine (Feb/Mar 21 and Sep 21). The patient tested positive for COVID 19 on 14 October 2021 and was admitted with COVID pneumonia, sepsis, hyponatremia, hypokalemia, and respiratory failure. The patient was discharged on 23 Oct with some improvement, but was readmitted on 31 Oct 21 for long COVID pneumonia. Reported per EUA.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Respiratory failure, SARS-CoV-2 test positive, Sepsis
Clinical narrative: Narrative:  Patient received three doses of COVID 19 vaccine (Feb/Mar 21 and Sep 21). The patient tested positive for COVID 19 on 14 October 2021 and was admitted with COVID pneumonia, sepsis, hyponatremia, hypokalemia, and respiratory failure. The patient was discharged on 23 Oct with some improvement, but was readmitted on 31 Oct 21 for long COVID pneumonia. Reported per EUA.
Age: 82.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Chest pain, Cough, SARS-CoV-2 test positive
Clinical narrative: Narrative:  Patient received two doses of COVID 19 vaccine in Jan 2021. The patient tested positive for COVID 19 on 5 Oct 21 and was hospitalized with chest pain and cough. The patient was monitored and discharged on 6 October 2021. Reported per EUA.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, COVID-19 pneumonia, Diarrhoea, Dyspnoea, Myalgia
Clinical narrative: Narrative:  Patient received two doses of Pfizer vaccine in Feb/Mar 21. The patient tested positive for COVID 19 on 19 Oct 21 and hospitalized with multiple symptoms to include diarrhea, shortness of breath, myalgia, COVID pneumonia and tachycardia. The patient was treated and discharged on 23 October 2021. Reported per EUA.
Age: 47.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Tachycardia
Clinical narrative: Narrative:  Patient received two doses of Pfizer vaccine in Feb/Mar 21. The patient tested positive for COVID 19 on 19 Oct 21 and hospitalized with multiple symptoms to include diarrhea, shortness of breath, myalgia, COVID pneumonia and tachycardia. The patient was treated and discharged on 23 October 2021. Reported per EUA.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, COVID-19, COVID-19 pneumonia, Headache, Hypoxia
Clinical narrative: Narrative:  Patient received two Pfizer vaccine doses in Feb/Mar 21 and a 3rd dose on 22 Oct 21. The patient tested positive for COVID 19 on 24 Oct 21 (two days later) and was hospitalized with Sepsis, hypoxia, weakness, headache, and COVID pneumonia. Reported per EUA.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Sepsis
Clinical narrative: Narrative:  Patient received two Pfizer vaccine doses in Feb/Mar 21 and a 3rd dose on 22 Oct 21. The patient tested positive for COVID 19 on 24 Oct 21 (two days later) and was hospitalized with Sepsis, hypoxia, weakness, headache, and COVID pneumonia. Reported per EUA.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Pancreatic carcinoma
Clinical narrative: Narrative:  patient with of pancreatic cancer and was on hospice
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Anticoagulant therapy, COVID-19 pneumonia, Cardiac arrest, Pulseless electrical activity
Clinical narrative: Narrative:  Patient had covid pneumonia with bilateral PEs off isolation on anticoagulation. Was discharged 1 day after receiving covid vaccine on oxygen therapy and he PEA arrested in Ambulance going home from the hospital.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Narrative:  Patient received COVID vaccine at outside facility. At PCP follow up on 8/18, he reported he had an anaphylactic reaction to his first dose. He was treated with epinephrine and methylprednisolone. Subsequent COVID titer was negative and patient did not receive the second dose. Exact date of vaccine and reaction are unknown.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Platelet count decreased
Clinical narrative: Narrative:  Patient discharged home after 2 days in hospital. PLT improved with steroids
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Oral disorder, Oropharyngeal pain
Clinical narrative: Narrative:  MOderna vaccine in March 2021,pt reported angioedema of lips and ears, sore throat started 24 hours later and pt still have ear, mouth, sore throat reaction." unclear if patient sought or received treatment for adverse reaction. No additional information available regarding ADR
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Myalgia, Fever, Chills Narrative:
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: Headache, Myalgia, FATIGUE, CHILLS Narrative:
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Narrative:  Patient was a resident of community living center, tested positive for COVID-19 8/23/21 and was admitted to hospital for isolation in airborne precaution room and for administration of Remdesivir.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Narrative:  68yo male with hx of CVA & DM resided in nursing facility died on 8/9/2021. No information regarding pt's death provided. Pt had received only one moderna covid vaccine.on 4/17/21. Likely death not related to vaccine due to length of time btwn death & vaccine administration date.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, COVID-19, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: Narrative:  Patient presented for covid test with runny nose and loss of smell. COVID test positive despite 2 doses of moderna vaccine. Given monoclonal antibody treatment.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Incorrect dose administered
Clinical narrative: pt given the adult covid Pfizer vaccine by mistake, instead of receiving pediatric vaccine. MD notified. Pharmacist followed up 11/30 6:45 pm & parent reported pt doing okay, "feeling warm"
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Paraesthesia
Clinical narrative: Pt received vaccine and had increased joint pain, chest pain, and hand/feet tingling--she went to Urgent care who recommended some rest time. Symptoms lasted about a month and she feels like she continues to have "flares" from this vaccine.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Arteriogram coronary abnormal, Pericarditis
Clinical narrative: [Prod] use for COVID-19 under Emergency Use Authorization (EUA):Pericarditis 12 days after third Pfizer COVID 19 booster.
Sex: M
Vaccine: COVID19
Symptoms: Audiogram abnormal, Deafness, Deafness neurosensory, Deafness unilateral, Sudden hearing loss
Clinical narrative: I received the astrazeneca vaccine 11/5/2020 and 12/3/2020 as part of a trial to test safety and efficacy. I had no side effects. After a year had passed, with no boosters offered in the trial, I left the trial to receive the moderna booster dose vaccine lot 048F21A for covid on 10/25/21. On 11/5/21 I developed sudden onset right sided sensorineural hearing loss, primary in the high frequencies at 4000hz up to 60 db. I have not had recovery despite a course of oral prednisone and intra trampanic membrane steroid injection by an ENT provider. I thought this should be tracked incase it is related. I am a health care provider and take care of covid patients and am pro vaccine but this has been difficult.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, SARS-CoV-2 test positive
Clinical narrative: Tested Positive for COVID-19 after full vaccination and booster dose. Completed 2 doses on April 8 2021 and Booster on 21 Nov 2021. Tested positive for COVID on 28 Nov 2021. Symptom-Lost sense of smell and taste
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Vaccine breakthrough infection
Clinical narrative: Fully vaccinated with COVID infection breakthrough and inpatient hospital stay.
Age: 93.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Peripheral swelling, Ultrasound scan abnormal, Ultrasound scan normal
Clinical narrative: runny nose and cough starting 11/28/2021
Age: 93.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Cough, Rhinorrhoea
Clinical narrative: runny nose and cough starting 11/28/2021
Age: 93.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Angiogram pulmonary, Blood test, Computerised tomogram, Jugular vein thrombosis, Subclavian vein thrombosis
Clinical narrative: runny nose and cough starting 11/28/2021
Age: 93.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Ultrasound scan
Clinical narrative: runny nose and cough starting 11/28/2021
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Body temperature increased, Decreased appetite, Head discomfort, Malaise, Tinnitus
Clinical narrative: Body heat; Severe ears ringing/Tinnitus; pressure on the left side of the head behind left ear/elevated pressure in my head; feeling very sick; Anxiety/anxious; very frequent urination; Lack of appetite; Fatigue; Slight numbness in the fingers; Pain in the neck and ear; Pain in the neck and ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 22Jul2021 18:00 (Lot number: EW0181) at the age of 61 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: NAC [ACETYLCYSTEINE]; OMEGA3 JACK; VITAMIN D 3; VITAMIN C [ASCORBIC ACID;SODIUM ASCORBATE]; COLLAGEN; PQQ. The following information was reported: FEELING HOT (non-serious) with onset 27Jul2021 20:00, outcome "not recovered", described as "Body heat"; TINNITUS (non-serious) with onset 27Jul2021 20:00, outcome "not recovered", described as "Severe ears ringing/Tinnitus"; HEAD DISCOMFORT (non-serious) with onset 27Jul2021 20:00, outcome "not recovered", described as "pressure on the left side of the head behind left ear/elevated pressure in my head"; MALAISE (non-serious) with onset 27Jul2021 20:00, outcome "not recovered", described as "feeling very sick"; ANXIETY (non-serious) with onset 27Jul2021 20:00, outcome "not recovered", described as "Anxiety/anxious"; POLLAKIURIA (non-serious) with onset 27Jul2021 20:00, outcome "not recovered", described as "very frequent urination"; DECREASED APPETITE (non-serious) with onset 27Jul2021, outcome "not recovered", described as "Lack of appetite"; FATIGUE (non-serious) with onset 27Jul2021, outcome "not recovered", described as "Fatigue"; HYPOAESTHESIA (non-serious) with onset 27Jul2021, outcome "not recovered", described as "Slight numbness in the fingers"; NECK PAIN (non-serious), EAR PAIN (non-serious) all with onset 27Jul2021, outcome "not recovered" and all described as "Pain in the neck and ear". The events "body heat", "severe ears ringing/tinnitus", "pressure on the left side of the head behind left ear/elevated pressure in my head", "feeling very sick", "anxiety/anxious", "very frequent urination", "lack of appetite", "fatigue", "slight numbness in the fingers", "pain in the neck and ear" and "pain in the neck and ear" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of feeling hot, tinnitus, head discomfort, malaise, anxiety, pollakiuria, decreased appetite, fatigue, hypoaesthesia, neck pain, ear pain. Follow-up attempts completed. No further information expected.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Blood test, Decreased appetite, Ear pain, Fatigue
Clinical narrative: Body heat; Severe ears ringing/Tinnitus; pressure on the left side of the head behind left ear/elevated pressure in my head; feeling very sick; Anxiety/anxious; very frequent urination; Lack of appetite; Fatigue; Slight numbness in the fingers; Pain in the neck and ear; Pain in the neck and ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 22Jul2021 18:00 (Lot number: EW0181) at the age of 61 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: NAC [ACETYLCYSTEINE]; OMEGA3 JACK; VITAMIN D 3; VITAMIN C [ASCORBIC ACID;SODIUM ASCORBATE]; COLLAGEN; PQQ. The following information was reported: FEELING HOT (non-serious) with onset 27Jul2021 20:00, outcome "not recovered", described as "Body heat"; TINNITUS (non-serious) with onset 27Jul2021 20:00, outcome "not recovered", described as "Severe ears ringing/Tinnitus"; HEAD DISCOMFORT (non-serious) with onset 27Jul2021 20:00, outcome "not recovered", described as "pressure on the left side of the head behind left ear/elevated pressure in my head"; MALAISE (non-serious) with onset 27Jul2021 20:00, outcome "not recovered", described as "feeling very sick"; ANXIETY (non-serious) with onset 27Jul2021 20:00, outcome "not recovered", described as "Anxiety/anxious"; POLLAKIURIA (non-serious) with onset 27Jul2021 20:00, outcome "not recovered", described as "very frequent urination"; DECREASED APPETITE (non-serious) with onset 27Jul2021, outcome "not recovered", described as "Lack of appetite"; FATIGUE (non-serious) with onset 27Jul2021, outcome "not recovered", described as "Fatigue"; HYPOAESTHESIA (non-serious) with onset 27Jul2021, outcome "not recovered", described as "Slight numbness in the fingers"; NECK PAIN (non-serious), EAR PAIN (non-serious) all with onset 27Jul2021, outcome "not recovered" and all described as "Pain in the neck and ear". The events "body heat", "severe ears ringing/tinnitus", "pressure on the left side of the head behind left ear/elevated pressure in my head", "feeling very sick", "anxiety/anxious", "very frequent urination", "lack of appetite", "fatigue", "slight numbness in the fingers", "pain in the neck and ear" and "pain in the neck and ear" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of feeling hot, tinnitus, head discomfort, malaise, anxiety, pollakiuria, decreased appetite, fatigue, hypoaesthesia, neck pain, ear pain. Follow-up attempts completed. No further information expected.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Head discomfort, Hypoaesthesia, Malaise, Neck pain
Clinical narrative: Body heat; Severe ears ringing/Tinnitus; pressure on the left side of the head behind left ear/elevated pressure in my head; feeling very sick; Anxiety/anxious; very frequent urination; Lack of appetite; Fatigue; Slight numbness in the fingers; Pain in the neck and ear; Pain in the neck and ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 22Jul2021 18:00 (Lot number: EW0181) at the age of 61 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: NAC [ACETYLCYSTEINE]; OMEGA3 JACK; VITAMIN D 3; VITAMIN C [ASCORBIC ACID;SODIUM ASCORBATE]; COLLAGEN; PQQ. The following information was reported: FEELING HOT (non-serious) with onset 27Jul2021 20:00, outcome "not recovered", described as "Body heat"; TINNITUS (non-serious) with onset 27Jul2021 20:00, outcome "not recovered", described as "Severe ears ringing/Tinnitus"; HEAD DISCOMFORT (non-serious) with onset 27Jul2021 20:00, outcome "not recovered", described as "pressure on the left side of the head behind left ear/elevated pressure in my head"; MALAISE (non-serious) with onset 27Jul2021 20:00, outcome "not recovered", described as "feeling very sick"; ANXIETY (non-serious) with onset 27Jul2021 20:00, outcome "not recovered", described as "Anxiety/anxious"; POLLAKIURIA (non-serious) with onset 27Jul2021 20:00, outcome "not recovered", described as "very frequent urination"; DECREASED APPETITE (non-serious) with onset 27Jul2021, outcome "not recovered", described as "Lack of appetite"; FATIGUE (non-serious) with onset 27Jul2021, outcome "not recovered", described as "Fatigue"; HYPOAESTHESIA (non-serious) with onset 27Jul2021, outcome "not recovered", described as "Slight numbness in the fingers"; NECK PAIN (non-serious), EAR PAIN (non-serious) all with onset 27Jul2021, outcome "not recovered" and all described as "Pain in the neck and ear". The events "body heat", "severe ears ringing/tinnitus", "pressure on the left side of the head behind left ear/elevated pressure in my head", "feeling very sick", "anxiety/anxious", "very frequent urination", "lack of appetite", "fatigue", "slight numbness in the fingers", "pain in the neck and ear" and "pain in the neck and ear" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of feeling hot, tinnitus, head discomfort, malaise, anxiety, pollakiuria, decreased appetite, fatigue, hypoaesthesia, neck pain, ear pain. Follow-up attempts completed. No further information expected.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pollakiuria, SARS-CoV-2 test, Tinnitus
Clinical narrative: Body heat; Severe ears ringing/Tinnitus; pressure on the left side of the head behind left ear/elevated pressure in my head; feeling very sick; Anxiety/anxious; very frequent urination; Lack of appetite; Fatigue; Slight numbness in the fingers; Pain in the neck and ear; Pain in the neck and ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 22Jul2021 18:00 (Lot number: EW0181) at the age of 61 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: NAC [ACETYLCYSTEINE]; OMEGA3 JACK; VITAMIN D 3; VITAMIN C [ASCORBIC ACID;SODIUM ASCORBATE]; COLLAGEN; PQQ. The following information was reported: FEELING HOT (non-serious) with onset 27Jul2021 20:00, outcome "not recovered", described as "Body heat"; TINNITUS (non-serious) with onset 27Jul2021 20:00, outcome "not recovered", described as "Severe ears ringing/Tinnitus"; HEAD DISCOMFORT (non-serious) with onset 27Jul2021 20:00, outcome "not recovered", described as "pressure on the left side of the head behind left ear/elevated pressure in my head"; MALAISE (non-serious) with onset 27Jul2021 20:00, outcome "not recovered", described as "feeling very sick"; ANXIETY (non-serious) with onset 27Jul2021 20:00, outcome "not recovered", described as "Anxiety/anxious"; POLLAKIURIA (non-serious) with onset 27Jul2021 20:00, outcome "not recovered", described as "very frequent urination"; DECREASED APPETITE (non-serious) with onset 27Jul2021, outcome "not recovered", described as "Lack of appetite"; FATIGUE (non-serious) with onset 27Jul2021, outcome "not recovered", described as "Fatigue"; HYPOAESTHESIA (non-serious) with onset 27Jul2021, outcome "not recovered", described as "Slight numbness in the fingers"; NECK PAIN (non-serious), EAR PAIN (non-serious) all with onset 27Jul2021, outcome "not recovered" and all described as "Pain in the neck and ear". The events "body heat", "severe ears ringing/tinnitus", "pressure on the left side of the head behind left ear/elevated pressure in my head", "feeling very sick", "anxiety/anxious", "very frequent urination", "lack of appetite", "fatigue", "slight numbness in the fingers", "pain in the neck and ear" and "pain in the neck and ear" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of feeling hot, tinnitus, head discomfort, malaise, anxiety, pollakiuria, decreased appetite, fatigue, hypoaesthesia, neck pain, ear pain. Follow-up attempts completed. No further information expected.
Age: 51.0
Sex: F
Vaccine: FLU4, FLUC3
Symptoms: Injection site nerve damage, Injection site pain, Injection site swelling, Urticaria
Clinical narrative: Nerve damage; Pain and swelling at injection site; Pain and swelling at injection site; Three circular welt; This spontaneous case was retrieved on 17-Nov-2021 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 1836533-1), reported by other healthcare professional and concerned a 51-year-old, female patient.  The patient's concurrent conditions included Hashimoto, pernicious anaemia, allergy to soy, latex, aluminium, nickel, molds, erythromycin, sulfa, singular and anything with Prozac derrivates. The patient's concomitant medications included hydrochlorothiazide, spironolactone, Klor-on (Potassium chloride), magnesium citrate, Vitamin D3 (colecalciferol) and Can balm injection, all used for unreported indication.  On 19-Nov-2020, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose reported as one, route of administration reported as injection, anatomical location: left arm (LA) and indication: not reported). The batch number reported was 279833.  On 21-Nov-2020, one day after receiving Flucelvax Quadrivalent, the patient experienced severe nerve damage, pain and swelling at injection site, and developed 3 circular welt lasting more than 10 days.  On an unspecified date, the patient had medical appointment and was advised on medical clinic physical therapy until August 2021, until there was no more improvement, as reported.  At the time of this reporting, the patient had not recovered from the events.  The reporter did not provide a causality assessment.  All events were assessed as serious due to seriousness criteria of disability.  Company Comment: A 51-year-old, female patient experienced nerve damage, vaccination site pain, vaccination site swelling and urticaria one day after vaccination with Flucelvax Quadrivalent. More information regarding relevant diagnostic findings is needed. Causal role of the suspect vaccine is unassessable for the event nerve damage based on the currently available information. Causal role of the suspect vaccine is assessed as possibly related for all other events, due to biological and chronological plausibility.; Sender's Comments: A 51-year-old, female patient experienced nerve damage, vaccination site pain, vaccination site swelling and urticaria one day after vaccination with Flucelvax Quadrivalent. More information regarding relevant diagnostic findings is needed. Causal role of the suspect vaccine is unassessable for the event nerve damage based on the currently available information. Causal role of the suspect vaccine is assessed as possibly related for all other events, due to biological and chronological plausibility.
Age: 51.0
Sex: F
Vaccine: FLU4, FLUC3
Symptoms: Injection site pain, Injection site swelling, Nerve injury, Urticaria
Clinical narrative: Nerve damage; Pain and swelling at injection site; Pain and swelling at injection site; Three circular welt; This spontaneous case was retrieved on 17-Nov-2021 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 1836533-1), reported by other healthcare professional and concerned a 51-year-old, female patient.  The patient's concurrent conditions included Hashimoto, pernicious anaemia, allergy to soy, latex, aluminium, nickel, molds, erythromycin, sulfa, singular and anything with Prozac derrivates. The patient's concomitant medications included hydrochlorothiazide, spironolactone, Klor-on (Potassium chloride), magnesium citrate, Vitamin D3 (colecalciferol) and Can balm injection, all used for unreported indication.  On 19-Nov-2020, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose reported as one, route of administration reported as injection, anatomical location: left arm (LA) and indication: not reported). The batch number reported was 279833.  On 21-Nov-2020, one day after receiving Flucelvax Quadrivalent, the patient experienced severe nerve damage, pain and swelling at injection site, and developed 3 circular welt lasting more than 10 days.  On an unspecified date, the patient had medical appointment and was advised on medical clinic physical therapy until August 2021, until there was no more improvement, as reported.  At the time of this reporting, the patient had not recovered from the events.  The reporter did not provide a causality assessment.  All events were assessed as serious due to seriousness criteria of disability.  Company Comment: A 51-year-old, female patient experienced nerve damage, vaccination site pain, vaccination site swelling and urticaria one day after vaccination with Flucelvax Quadrivalent. More information regarding relevant diagnostic findings is needed. Causal role of the suspect vaccine is unassessable for the event nerve damage based on the currently available information. Causal role of the suspect vaccine is assessed as possibly related for all other events, due to biological and chronological plausibility.; Sender's Comments: A 51-year-old, female patient experienced nerve damage, vaccination site pain, vaccination site swelling and urticaria one day after vaccination with Flucelvax Quadrivalent. More information regarding relevant diagnostic findings is needed. Causal role of the suspect vaccine is unassessable for the event nerve damage based on the currently available information. Causal role of the suspect vaccine is assessed as possibly related for all other events, due to biological and chronological plausibility.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood lactic acid, CSF glucose, CSF protein, CSF red blood cell count, CSF white blood cell count
Clinical narrative: The weakness began 10 days after receiving the first dose of mRNA-1273 (Moderna Vaccine). Weakness involving lower extremities over a period of 8 weeks. Numbness in lower extremities and voice changes were also reported. Spinal tap revealed albumino-cytological dissociation. Nerve conduction velocity studies (NCVS) revealed absent sural response and decreased peroneal motor response and the median and ulnar motor responses were of low amplitude. Plasma exchange was continued for a total of five sessions.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electromyogram, Forced vital capacity, Guillain-Barre syndrome, Hypotension, Lumbar puncture
Clinical narrative: The weakness began 10 days after receiving the first dose of mRNA-1273 (Moderna Vaccine). Weakness involving lower extremities over a period of 8 weeks. Numbness in lower extremities and voice changes were also reported. Spinal tap revealed albumino-cytological dissociation. Nerve conduction velocity studies (NCVS) revealed absent sural response and decreased peroneal motor response and the median and ulnar motor responses were of low amplitude. Plasma exchange was continued for a total of five sessions.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Magnetic resonance imaging head, Magnetic resonance imaging neck, Nerve conduction studies, Physical examination
Clinical narrative: The weakness began 10 days after receiving the first dose of mRNA-1273 (Moderna Vaccine). Weakness involving lower extremities over a period of 8 weeks. Numbness in lower extremities and voice changes were also reported. Spinal tap revealed albumino-cytological dissociation. Nerve conduction velocity studies (NCVS) revealed absent sural response and decreased peroneal motor response and the median and ulnar motor responses were of low amplitude. Plasma exchange was continued for a total of five sessions.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test, Serology test, Xanthochromia
Clinical narrative: The weakness began 10 days after receiving the first dose of mRNA-1273 (Moderna Vaccine). Weakness involving lower extremities over a period of 8 weeks. Numbness in lower extremities and voice changes were also reported. Spinal tap revealed albumino-cytological dissociation. Nerve conduction velocity studies (NCVS) revealed absent sural response and decreased peroneal motor response and the median and ulnar motor responses were of low amplitude. Plasma exchange was continued for a total of five sessions.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Dysphonia, Hypoaesthesia, Lumbar puncture abnormal, Muscular weakness
Clinical narrative: The weakness began 10 days after receiving the first dose of mRNA-1273 (Moderna Vaccine). Weakness involving lower extremities over a period of 8 weeks. Numbness in lower extremities and voice changes were also reported. Spinal tap revealed albumino-cytological dissociation. Nerve conduction velocity studies (NCVS) revealed absent sural response and decreased peroneal motor response and the median and ulnar motor responses were of low amplitude. Plasma exchange was continued for a total of five sessions.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nerve conduction studies abnormal, Plasmapheresis, Protein total increased
Clinical narrative: The weakness began 10 days after receiving the first dose of mRNA-1273 (Moderna Vaccine). Weakness involving lower extremities over a period of 8 weeks. Numbness in lower extremities and voice changes were also reported. Spinal tap revealed albumino-cytological dissociation. Nerve conduction velocity studies (NCVS) revealed absent sural response and decreased peroneal motor response and the median and ulnar motor responses were of low amplitude. Plasma exchange was continued for a total of five sessions.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 46 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known allergies. The patient was previously treated with covid-19 vaccine ad26. cov2. s for prophylactic vaccination (unspecified manufacturer), dose series 1. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, expiry: 11-APR-2022) dose was not reported, administered at right arm on 10-NOV-2021 19:02 for prophylactic vaccination, dose series 2. No concomitant medications were reported.  On 10-NOV-2021, the vaccine vial was punctured at 10:50 and was stored in a cooler and administered as a booster dose to the patient at 19:02. The reporter did not administer the vaccine, but reports that the reason for the error was that the administering nurse did not pay attention to the expiration time of punctured vaccine. The patient was not yet aware of error. The reporting nurse noted the patient did not have any adverse reaction after administration and the patient was sent home after observation with no incident. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Angiogram cerebral abnormal, Atrial fibrillation, Atrial flutter, Blood cholesterol increased, Blood glucose normal
Clinical narrative: severe Bell's palsy; dose number=3; This is a spontaneous report from a contactable nurse. A 71 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 09Nov2021 10:00 (Batch/Lot number: unknown) at the age of 71 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "HTN" (unspecified if ongoing); "gout" (unspecified if ongoing). The patient was not diagnosed with COVID-19 prior to the vaccine. The patient had no known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for Covid-19 immunization. The following information was reported: IMMUNISATION (hospitalization) with onset 09Nov2021 10:00, outcome "unknown", described as "dose number=3"; BELL'S PALSY (hospitalization) with onset 10Nov2021 10:00, outcome "recovering", described as "severe Bell's palsy". The patient was hospitalized for immunisation, bell's palsy (hospitalization duration: 2 days). The events "dose number=3" and "severe bell's palsy" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: computerised tomogram: (unspecified date) unknown results; magnetic resonance imaging: (unspecified date) unknown results; sars-cov-2 test: (11Nov2021) negative. Therapeutic measures were taken as a result of bell's palsy. The patient received treatment with valacyclovir (VALTREX) and prednisone.   The lot number for bnt162b2 was not provided and will be requested during follow-up.; Sender's Comments: Based on the available reported information, the causal association between the events immunization and bell's palsy and the suspect drug BNT162B2 cannot be excluded. 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.