chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Exposure to SARS-CoV-2, Fatigue, Glycosylated haemoglobin increased, HIV test negative, Haematocrit decreased
Clinical narrative: Patient presented to the ED on 5/25/21 w/worsening cough, fatigue and fever. He had been sick for approx 4 days and hadreportedly tested positive for SARS-CoV-2 on 5/19. He had a known exposure to a grandson w/COVID.. His was sent home from the ED initially and returned several hours later stating that his home pulse ox was 75%. In the ED he had a temp of 103.3 and a RA pulse ox of 88% CTA of the chest showed subacute pulmonary emboli and ground glass infiltrates consistent w/ atypical pneumonia. The pt was admitted. Acute hypoxic respiratory failure Combination of COVID-19 pneumonia with pulmonary embolism Required transfer to stepdown requiring OptiFlow FiO2 50%, flow rate 50 L Suspect secondary to fluid congestion. Significant improvement overnight diuresis Was able to wean down to 2 L of NC Pulmonology followed in the hospital.  Appreciate help Checked O2 requirement prior to discharge and qualified for 2L via NC C/w pul toilette OP f/u with pulmonary Doctor and PCP as instructed    2. COVID 19 pneumonia Date of onset of symptoms: 5/19/21 Date of covid positive test: 5/21/2021 (outside facility), here positive from 5/26/21 Symptoms: shortness of breath, fever, fatigue Special isolation precautions implemented: yes Imaging: Chest x-ray-bibasilar and alveolar infiltrates Left >Right with probable small left pleural effusion Oxygen requirements as outlined above Medical therapy: Continue Decadron, completed remdesivir Continue pulmonary toilet, bronchodilators Inflammatory markers improving DC on Decadron 6 mg daily for 2 more days to complete 10 days course Pulmonary followed and felt stable for discharge OP f/u with Doctor/pul for PFT in 3 months    3. Pulmonary emboli,bilateral CTA chest with b/l submassive pulmonary emboli Most likely secondary to COVID-19 pneumonia Continue Eliquis, will need 3 months therapy Patient and spouse educated to check D-dimer level towards end of 3 month before stopping Eliquis, and they acknowledged.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Haemoglobin decreased, Hepatitis B test negative, Hepatitis C antibody negative, Inflammatory marker test, Legionella test
Clinical narrative: Patient presented to the ED on 5/25/21 w/worsening cough, fatigue and fever. He had been sick for approx 4 days and hadreportedly tested positive for SARS-CoV-2 on 5/19. He had a known exposure to a grandson w/COVID.. His was sent home from the ED initially and returned several hours later stating that his home pulse ox was 75%. In the ED he had a temp of 103.3 and a RA pulse ox of 88% CTA of the chest showed subacute pulmonary emboli and ground glass infiltrates consistent w/ atypical pneumonia. The pt was admitted. Acute hypoxic respiratory failure Combination of COVID-19 pneumonia with pulmonary embolism Required transfer to stepdown requiring OptiFlow FiO2 50%, flow rate 50 L Suspect secondary to fluid congestion. Significant improvement overnight diuresis Was able to wean down to 2 L of NC Pulmonology followed in the hospital.  Appreciate help Checked O2 requirement prior to discharge and qualified for 2L via NC C/w pul toilette OP f/u with pulmonary Doctor and PCP as instructed    2. COVID 19 pneumonia Date of onset of symptoms: 5/19/21 Date of covid positive test: 5/21/2021 (outside facility), here positive from 5/26/21 Symptoms: shortness of breath, fever, fatigue Special isolation precautions implemented: yes Imaging: Chest x-ray-bibasilar and alveolar infiltrates Left >Right with probable small left pleural effusion Oxygen requirements as outlined above Medical therapy: Continue Decadron, completed remdesivir Continue pulmonary toilet, bronchodilators Inflammatory markers improving DC on Decadron 6 mg daily for 2 more days to complete 10 days course Pulmonary followed and felt stable for discharge OP f/u with Doctor/pul for PFT in 3 months    3. Pulmonary emboli,bilateral CTA chest with b/l submassive pulmonary emboli Most likely secondary to COVID-19 pneumonia Continue Eliquis, will need 3 months therapy Patient and spouse educated to check D-dimer level towards end of 3 month before stopping Eliquis, and they acknowledged.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lung infiltration, Lung opacity, Malaise, Mycobacterium tuberculosis complex test negative, Patient isolation
Clinical narrative: Patient presented to the ED on 5/25/21 w/worsening cough, fatigue and fever. He had been sick for approx 4 days and hadreportedly tested positive for SARS-CoV-2 on 5/19. He had a known exposure to a grandson w/COVID.. His was sent home from the ED initially and returned several hours later stating that his home pulse ox was 75%. In the ED he had a temp of 103.3 and a RA pulse ox of 88% CTA of the chest showed subacute pulmonary emboli and ground glass infiltrates consistent w/ atypical pneumonia. The pt was admitted. Acute hypoxic respiratory failure Combination of COVID-19 pneumonia with pulmonary embolism Required transfer to stepdown requiring OptiFlow FiO2 50%, flow rate 50 L Suspect secondary to fluid congestion. Significant improvement overnight diuresis Was able to wean down to 2 L of NC Pulmonology followed in the hospital.  Appreciate help Checked O2 requirement prior to discharge and qualified for 2L via NC C/w pul toilette OP f/u with pulmonary Doctor and PCP as instructed    2. COVID 19 pneumonia Date of onset of symptoms: 5/19/21 Date of covid positive test: 5/21/2021 (outside facility), here positive from 5/26/21 Symptoms: shortness of breath, fever, fatigue Special isolation precautions implemented: yes Imaging: Chest x-ray-bibasilar and alveolar infiltrates Left >Right with probable small left pleural effusion Oxygen requirements as outlined above Medical therapy: Continue Decadron, completed remdesivir Continue pulmonary toilet, bronchodilators Inflammatory markers improving DC on Decadron 6 mg daily for 2 more days to complete 10 days course Pulmonary followed and felt stable for discharge OP f/u with Doctor/pul for PFT in 3 months    3. Pulmonary emboli,bilateral CTA chest with b/l submassive pulmonary emboli Most likely secondary to COVID-19 pneumonia Continue Eliquis, will need 3 months therapy Patient and spouse educated to check D-dimer level towards end of 3 month before stopping Eliquis, and they acknowledged.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Physiotherapy chest, Platelet count decreased, Pleural effusion, Polyuria, Pulmonary congestion
Clinical narrative: Patient presented to the ED on 5/25/21 w/worsening cough, fatigue and fever. He had been sick for approx 4 days and hadreportedly tested positive for SARS-CoV-2 on 5/19. He had a known exposure to a grandson w/COVID.. His was sent home from the ED initially and returned several hours later stating that his home pulse ox was 75%. In the ED he had a temp of 103.3 and a RA pulse ox of 88% CTA of the chest showed subacute pulmonary emboli and ground glass infiltrates consistent w/ atypical pneumonia. The pt was admitted. Acute hypoxic respiratory failure Combination of COVID-19 pneumonia with pulmonary embolism Required transfer to stepdown requiring OptiFlow FiO2 50%, flow rate 50 L Suspect secondary to fluid congestion. Significant improvement overnight diuresis Was able to wean down to 2 L of NC Pulmonology followed in the hospital.  Appreciate help Checked O2 requirement prior to discharge and qualified for 2L via NC C/w pul toilette OP f/u with pulmonary Doctor and PCP as instructed    2. COVID 19 pneumonia Date of onset of symptoms: 5/19/21 Date of covid positive test: 5/21/2021 (outside facility), here positive from 5/26/21 Symptoms: shortness of breath, fever, fatigue Special isolation precautions implemented: yes Imaging: Chest x-ray-bibasilar and alveolar infiltrates Left >Right with probable small left pleural effusion Oxygen requirements as outlined above Medical therapy: Continue Decadron, completed remdesivir Continue pulmonary toilet, bronchodilators Inflammatory markers improving DC on Decadron 6 mg daily for 2 more days to complete 10 days course Pulmonary followed and felt stable for discharge OP f/u with Doctor/pul for PFT in 3 months    3. Pulmonary emboli,bilateral CTA chest with b/l submassive pulmonary emboli Most likely secondary to COVID-19 pneumonia Continue Eliquis, will need 3 months therapy Patient and spouse educated to check D-dimer level towards end of 3 month before stopping Eliquis, and they acknowledged.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pulmonary embolism, Pyrexia, SARS-CoV-2 test positive, Urine analysis normal, White blood cell count decreased
Clinical narrative: Patient presented to the ED on 5/25/21 w/worsening cough, fatigue and fever. He had been sick for approx 4 days and hadreportedly tested positive for SARS-CoV-2 on 5/19. He had a known exposure to a grandson w/COVID.. His was sent home from the ED initially and returned several hours later stating that his home pulse ox was 75%. In the ED he had a temp of 103.3 and a RA pulse ox of 88% CTA of the chest showed subacute pulmonary emboli and ground glass infiltrates consistent w/ atypical pneumonia. The pt was admitted. Acute hypoxic respiratory failure Combination of COVID-19 pneumonia with pulmonary embolism Required transfer to stepdown requiring OptiFlow FiO2 50%, flow rate 50 L Suspect secondary to fluid congestion. Significant improvement overnight diuresis Was able to wean down to 2 L of NC Pulmonology followed in the hospital.  Appreciate help Checked O2 requirement prior to discharge and qualified for 2L via NC C/w pul toilette OP f/u with pulmonary Doctor and PCP as instructed    2. COVID 19 pneumonia Date of onset of symptoms: 5/19/21 Date of covid positive test: 5/21/2021 (outside facility), here positive from 5/26/21 Symptoms: shortness of breath, fever, fatigue Special isolation precautions implemented: yes Imaging: Chest x-ray-bibasilar and alveolar infiltrates Left >Right with probable small left pleural effusion Oxygen requirements as outlined above Medical therapy: Continue Decadron, completed remdesivir Continue pulmonary toilet, bronchodilators Inflammatory markers improving DC on Decadron 6 mg daily for 2 more days to complete 10 days course Pulmonary followed and felt stable for discharge OP f/u with Doctor/pul for PFT in 3 months    3. Pulmonary emboli,bilateral CTA chest with b/l submassive pulmonary emboli Most likely secondary to COVID-19 pneumonia Continue Eliquis, will need 3 months therapy Patient and spouse educated to check D-dimer level towards end of 3 month before stopping Eliquis, and they acknowledged.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Blood test, Cardiac monitoring, Echocardiogram, Electrocardiogram
Clinical narrative: 4/5 I woke up at 03:00am and  my heart was racing 130 bpm went to an urgent care and they gave me fluids took lab work and had an EKG done they said I was fine but later that day I went to the ER and they gave me a heart monitor my heart and I was kept for observation for 1 day.  other symptoms was loss of appetite and lost 5-6 pounds.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Malaise
Clinical narrative: 4/5 I woke up at 03:00am and  my heart was racing 130 bpm went to an urgent care and they gave me fluids took lab work and had an EKG done they said I was fine but later that day I went to the ER and they gave me a heart monitor my heart and I was kept for observation for 1 day.  other symptoms was loss of appetite and lost 5-6 pounds.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac monitoring, Decreased appetite, Electrocardiogram, Laboratory test, Palpitations
Clinical narrative: 4/5 I woke up at 03:00am and  my heart was racing 130 bpm went to an urgent care and they gave me fluids took lab work and had an EKG done they said I was fine but later that day I went to the ER and they gave me a heart monitor my heart and I was kept for observation for 1 day.  other symptoms was loss of appetite and lost 5-6 pounds.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Weight decreased
Clinical narrative: 4/5 I woke up at 03:00am and  my heart was racing 130 bpm went to an urgent care and they gave me fluids took lab work and had an EKG done they said I was fine but later that day I went to the ER and they gave me a heart monitor my heart and I was kept for observation for 1 day.  other symptoms was loss of appetite and lost 5-6 pounds.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: Blood clot in lower left leg.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thrombosis
Clinical narrative: Blood clot in lower left leg.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angina pectoris
Clinical narrative: Having stabbing pain in his heart; This is a spontaneous report from a contactable consumer.   A 55-years-old male patient received bnt162b2 (PFIZER BIONTECH COVID 19 VACCINE ), dose 1 via an unspecified route of administration, administered in Arm Left on 18May2021 (Batch/Lot Number: EW0170) as 1ST DOSE, SINGLE for covid-19 immunisation.  Medical history included Sleep apnea which he had surgery for sleep apnea a long time ago, arthritis in his hand.The patient's concomitant medications were not reported.  The patient previously took lisinopril for blood pressure, and has been on it for 2 years or so and has never had that experience with it.  He received flu vaccine vii.  A week after, he started having stabbing pain in his heart. He said it was not real bad, but enough to know it was there. He added that it was periodically on and off, and in the last 2 days, he did not feel it anymore. Outcome of event was unknown.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acoustic stimulation tests, Blood test, Computerised tomogram, Deafness unilateral, Hypoaesthesia
Clinical narrative: Experienced hearing loss after second vaccine; severe tinnitus; Experiencing nerve pains and tingling sensations through out limbs and back; Experiencing nerve pains and tingling sensations through out limbs and back; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 34-year-old (non-pregnant) female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EW0168) dose 2 via an unspecified route of administration, administered in Arm Right on 06May2021 02:15pm (at the age of 34-year-old) as 2nd dose, single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included drug hypersensitivity (Known allergies: Penicillin) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EW0153) via unspecified route of administration, administered in arm right on 15Apr2021 at 03:00 PM (at the age of 34-year-old) for COVID-19 immunization. On 17May2021 08:00AM, the patient experienced hearing loss after second vaccine and severe tinnitus. Hearing loss treated by ENT with steroids and had 85% recovered. The patient was also experiencing nerve pains and tingling sensations throughout limbs and back. All of this was onset after vaccine with no prior symptoms in place. These events caused disability. The patient required visit to Emergency room/department or urgent care and Doctor or other healthcare professional office/clinic visit. The patient was recovering from hearing loss after second vaccine. The outcome of the severe tinnitus, nerve pain and tingling sensations was unknown.  Device Date : 07Jun2021  No follow up required. No further information expected. Information on lot/batch number was available.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ocular discomfort, Paraesthesia, Tinnitus
Clinical narrative: Experienced hearing loss after second vaccine; severe tinnitus; Experiencing nerve pains and tingling sensations through out limbs and back; Experiencing nerve pains and tingling sensations through out limbs and back; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 34-year-old (non-pregnant) female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EW0168) dose 2 via an unspecified route of administration, administered in Arm Right on 06May2021 02:15pm (at the age of 34-year-old) as 2nd dose, single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included drug hypersensitivity (Known allergies: Penicillin) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EW0153) via unspecified route of administration, administered in arm right on 15Apr2021 at 03:00 PM (at the age of 34-year-old) for COVID-19 immunization. On 17May2021 08:00AM, the patient experienced hearing loss after second vaccine and severe tinnitus. Hearing loss treated by ENT with steroids and had 85% recovered. The patient was also experiencing nerve pains and tingling sensations throughout limbs and back. All of this was onset after vaccine with no prior symptoms in place. These events caused disability. The patient required visit to Emergency room/department or urgent care and Doctor or other healthcare professional office/clinic visit. The patient was recovering from hearing loss after second vaccine. The outcome of the severe tinnitus, nerve pain and tingling sensations was unknown.  Device Date : 07Jun2021  No follow up required. No further information expected. Information on lot/batch number was available.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deafness, Neuralgia, Paraesthesia, Tinnitus
Clinical narrative: Experienced hearing loss after second vaccine; severe tinnitus; Experiencing nerve pains and tingling sensations through out limbs and back; Experiencing nerve pains and tingling sensations through out limbs and back; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 34-year-old (non-pregnant) female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EW0168) dose 2 via an unspecified route of administration, administered in Arm Right on 06May2021 02:15pm (at the age of 34-year-old) as 2nd dose, single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included drug hypersensitivity (Known allergies: Penicillin) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EW0153) via unspecified route of administration, administered in arm right on 15Apr2021 at 03:00 PM (at the age of 34-year-old) for COVID-19 immunization. On 17May2021 08:00AM, the patient experienced hearing loss after second vaccine and severe tinnitus. Hearing loss treated by ENT with steroids and had 85% recovered. The patient was also experiencing nerve pains and tingling sensations throughout limbs and back. All of this was onset after vaccine with no prior symptoms in place. These events caused disability. The patient required visit to Emergency room/department or urgent care and Doctor or other healthcare professional office/clinic visit. The patient was recovering from hearing loss after second vaccine. The outcome of the severe tinnitus, nerve pain and tingling sensations was unknown.  Device Date : 07Jun2021  No follow up required. No further information expected. Information on lot/batch number was available.
Age: 14.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fall, Seizure, Seizure like phenomena, Syncope
Clinical narrative: Approximately 10 minutes after receiving the vaccine she fainted and at the same time he had convulsed about 20 seconds.; Approximately 10 minutes after receiving the vaccine she fainted and at the same time he had convulsed about 20 seconds.; due to fainting he fell to the ground; cut herself below from lip inside out 3/4 in; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 14-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EW0177) via an unspecified route of administration (age at vaccination 14-year-old) in Left Arm on 07Jun2021 as first dose,single dose for COVID-19 immunization. Medical history included known allergies: yes, Cephalosporins, Keflex, Morphine indicated to clinic staff before vaccination. The patient did not receive any other vaccines within 4 weeks.The patient did not receive any other medication within 2 week of vaccination.The patient's concomitant medications were not reported. Since the vaccination the patient has not been tested for COVID-19 and prior to vaccination the patient was not diagnosed with COVID-19. On 07Jun2021 15:15, the patient experienced, approximately 10 minutes after receiving the vaccine she fainted and at the same time she had convulsed about 20 seconds. she regained consciousness and approximately 5minutes later she had another convulsion. Due to fainting she fell to the ground and cut herself below from lip inside out 3/4 in. They took her by ambulance to hospital.The event resulted in emergency room/ department or emergencies.The clinical outcome of the events was recovering.  Follow-up attempts are needed, Additional information is requested.
Age: 14.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fall, Lip injury, Seizure, Syncope
Clinical narrative: Approximately 10 minutes after receiving the vaccine she fainted and at the same time he had convulsed about 20 seconds.; Approximately 10 minutes after receiving the vaccine she fainted and at the same time he had convulsed about 20 seconds.; due to fainting he fell to the ground; cut herself below from lip inside out 3/4 in; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 14-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EW0177) via an unspecified route of administration (age at vaccination 14-year-old) in Left Arm on 07Jun2021 as first dose,single dose for COVID-19 immunization. Medical history included known allergies: yes, Cephalosporins, Keflex, Morphine indicated to clinic staff before vaccination. The patient did not receive any other vaccines within 4 weeks.The patient did not receive any other medication within 2 week of vaccination.The patient's concomitant medications were not reported. Since the vaccination the patient has not been tested for COVID-19 and prior to vaccination the patient was not diagnosed with COVID-19. On 07Jun2021 15:15, the patient experienced, approximately 10 minutes after receiving the vaccine she fainted and at the same time she had convulsed about 20 seconds. she regained consciousness and approximately 5minutes later she had another convulsion. Due to fainting she fell to the ground and cut herself below from lip inside out 3/4 in. They took her by ambulance to hospital.The event resulted in emergency room/ department or emergencies.The clinical outcome of the events was recovering.  Follow-up attempts are needed, Additional information is requested.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Chest pain, Discomfort, Dyspnoea, Electrocardiogram
Clinical narrative: painful chest tightness; painful chest tightness; breathing difficulties; faint feeling; throbbing heart beat; pre-ventricular contractions; This is a spontaneous report from a contactable consumer (the patient). A 26-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0169) via an unspecified route of administration in right arm on 01Jun2021 10:30 at age of 26-year-old at single dose for COVID-19 immunisation. Medical history included asthma. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient experienced painful chest tightness, breathing difficulties and heart problems (throbbing heart beat, pre-ventricular contractions) and faint feeling on 02Jun2021 02:00 AM. The patient had been to the ER twice since Tuesday. The events resulted in emergency room/department or urgent care. Treatment received for the events included albuterol inhaler and injectable anti-inflammatory. The outcome of the events was not recovered. The reporter considered the events non-serious.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Laboratory test, SARS-CoV-2 test, Urine analysis, X-ray
Clinical narrative: painful chest tightness; painful chest tightness; breathing difficulties; faint feeling; throbbing heart beat; pre-ventricular contractions; This is a spontaneous report from a contactable consumer (the patient). A 26-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0169) via an unspecified route of administration in right arm on 01Jun2021 10:30 at age of 26-year-old at single dose for COVID-19 immunisation. Medical history included asthma. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient experienced painful chest tightness, breathing difficulties and heart problems (throbbing heart beat, pre-ventricular contractions) and faint feeling on 02Jun2021 02:00 AM. The patient had been to the ER twice since Tuesday. The events resulted in emergency room/department or urgent care. Treatment received for the events included albuterol inhaler and injectable anti-inflammatory. The outcome of the events was not recovered. The reporter considered the events non-serious.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Chest pain, Dizziness, Dyspnoea, Palpitations
Clinical narrative: painful chest tightness; painful chest tightness; breathing difficulties; faint feeling; throbbing heart beat; pre-ventricular contractions; This is a spontaneous report from a contactable consumer (the patient). A 26-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0169) via an unspecified route of administration in right arm on 01Jun2021 10:30 at age of 26-year-old at single dose for COVID-19 immunisation. Medical history included asthma. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient experienced painful chest tightness, breathing difficulties and heart problems (throbbing heart beat, pre-ventricular contractions) and faint feeling on 02Jun2021 02:00 AM. The patient had been to the ER twice since Tuesday. The events resulted in emergency room/department or urgent care. Treatment received for the events included albuterol inhaler and injectable anti-inflammatory. The outcome of the events was not recovered. The reporter considered the events non-serious.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ventricular extrasystoles
Clinical narrative: painful chest tightness; painful chest tightness; breathing difficulties; faint feeling; throbbing heart beat; pre-ventricular contractions; This is a spontaneous report from a contactable consumer (the patient). A 26-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0169) via an unspecified route of administration in right arm on 01Jun2021 10:30 at age of 26-year-old at single dose for COVID-19 immunisation. Medical history included asthma. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient experienced painful chest tightness, breathing difficulties and heart problems (throbbing heart beat, pre-ventricular contractions) and faint feeling on 02Jun2021 02:00 AM. The patient had been to the ER twice since Tuesday. The events resulted in emergency room/department or urgent care. Treatment received for the events included albuterol inhaler and injectable anti-inflammatory. The outcome of the events was not recovered. The reporter considered the events non-serious.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Disease recurrence, Pain, SARS-CoV-2 test, Seizure
Clinical narrative: Seizures, shortness of breath, chills, body aches, chest pains due to the shot it strained the heart muscle. Chest pain, briings out severe jaw pains, and very strong pain that radiated up and down left arm. All these symptoms have been going on since the beginning of Mary 2021 to the present time  now.  I can no longer, cook for myself, or do grocery shopping. My left arm is immoblle after shot was given causing me more heart issues. I have ask my doctor to put me on  Disablity because I live alone and if I died no one would find my body until a month from now.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Cardiac disorder, Chest pain, Chills, Computerised tomogram
Clinical narrative: Seizures, shortness of breath, chills, body aches, chest pains due to the shot it strained the heart muscle. Chest pain, briings out severe jaw pains, and very strong pain that radiated up and down left arm. All these symptoms have been going on since the beginning of Mary 2021 to the present time  now.  I can no longer, cook for myself, or do grocery shopping. My left arm is immoblle after shot was given causing me more heart issues. I have ask my doctor to put me on  Disablity because I live alone and if I died no one would find my body until a month from now.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Disability, Dyspnoea, Injected limb mobility decreased, Loss of personal independence in daily activities
Clinical narrative: Seizures, shortness of breath, chills, body aches, chest pains due to the shot it strained the heart muscle. Chest pain, briings out severe jaw pains, and very strong pain that radiated up and down left arm. All these symptoms have been going on since the beginning of Mary 2021 to the present time  now.  I can no longer, cook for myself, or do grocery shopping. My left arm is immoblle after shot was given causing me more heart issues. I have ask my doctor to put me on  Disablity because I live alone and if I died no one would find my body until a month from now.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myocardial strain, Pain, Pain in extremity, Pain in jaw, SARS-CoV-2 test
Clinical narrative: Seizures, shortness of breath, chills, body aches, chest pains due to the shot it strained the heart muscle. Chest pain, briings out severe jaw pains, and very strong pain that radiated up and down left arm. All these symptoms have been going on since the beginning of Mary 2021 to the present time  now.  I can no longer, cook for myself, or do grocery shopping. My left arm is immoblle after shot was given causing me more heart issues. I have ask my doctor to put me on  Disablity because I live alone and if I died no one would find my body until a month from now.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Scan with contrast, Seizure, X-ray
Clinical narrative: Seizures, shortness of breath, chills, body aches, chest pains due to the shot it strained the heart muscle. Chest pain, briings out severe jaw pains, and very strong pain that radiated up and down left arm. All these symptoms have been going on since the beginning of Mary 2021 to the present time  now.  I can no longer, cook for myself, or do grocery shopping. My left arm is immoblle after shot was given causing me more heart issues. I have ask my doctor to put me on  Disablity because I live alone and if I died no one would find my body until a month from now.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bell's palsy, Eye pain, Facial asymmetry, Nightmare, Taste disorder
Clinical narrative: Symptoms began on 02Jun2021. Diagnosed with Bells Palsy on 05Jun2021 on the left side of my face.; This is a spontaneous report received from a contactable consumer or other non hcp. A 34-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 25May2021 11:30 (Batch/Lot Number: ER8736) as 2nd dose, single dose for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications were not reported. Historical vaccine information included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) 1st dose on 04May2021, administration site (Arm left), administered at 11:30 PM, lot number EW0171. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not have known allergies. Patient was not pregnant at the time of vaccination. The patient experienced symptoms began on 02jun2021 and diagnosed with bell's palsy on 05jun2021 on the left side of my face. The seriousness criteria for event were medically significant. Therapeutic measures were taken as a result event which include PREDNISONE. The outcome for event was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bell's palsy
Clinical narrative: Symptoms began on 02Jun2021. Diagnosed with Bells Palsy on 05Jun2021 on the left side of my face.; This is a spontaneous report received from a contactable consumer or other non hcp. A 34-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 25May2021 11:30 (Batch/Lot Number: ER8736) as 2nd dose, single dose for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications were not reported. Historical vaccine information included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) 1st dose on 04May2021, administration site (Arm left), administered at 11:30 PM, lot number EW0171. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not have known allergies. Patient was not pregnant at the time of vaccination. The patient experienced symptoms began on 02jun2021 and diagnosed with bell's palsy on 05jun2021 on the left side of my face. The seriousness criteria for event were medically significant. Therapeutic measures were taken as a result event which include PREDNISONE. The outcome for event was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: C-reactive protein increased, Cardiac telemetry abnormal, Chest pain, Echocardiogram normal, Electrocardiogram ST segment elevation
Clinical narrative: Patient Developed Myo-pericarditis with chest pain and troponins peaking at 3000.  Normal Echocardiogram  treated with colchicine
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram T wave inversion, Myocarditis, Red blood cell sedimentation rate increased, Troponin increased, Ventricular extrasystoles
Clinical narrative: Patient Developed Myo-pericarditis with chest pain and troponins peaking at 3000.  Normal Echocardiogram  treated with colchicine
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ventricular tachycardia
Clinical narrative: Patient Developed Myo-pericarditis with chest pain and troponins peaking at 3000.  Normal Echocardiogram  treated with colchicine
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Echocardiogram normal, Myocarditis, Troponin
Clinical narrative: Patient Developed Myo-pericarditis with chest pain and troponins peaking at 3000.  Normal Echocardiogram  treated with colchicine
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac arrest, Death, Intensive care, Respiratory arrest
Clinical narrative: passed away on 26Apr2021 in ICU (intensive care unit); stopped breathing at 6:15 on 22Apr2021; This is a spontaneous report from a contactable consumer (patient's brother)   A 63-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0161), via an unknown route of administration, on 19Apr2021 (at the age of 63-year-old) at single dose for COVID-19 immunisation. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ER8732) on 29Mar2021 for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. On 22Apr2021 at 18:15 the patient stopped breathing at 18:15. He was admitted to the intensive care unit (ICU) where he died on 26Apr2021. The cause of death was not provided. It was unknown if an autopsy was performed.; Reported Cause(s) of Death: passed away on 26Apr2021 in ICU (intensive care unit)
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death, Respiratory arrest
Clinical narrative: passed away on 26Apr2021 in ICU (intensive care unit); stopped breathing at 6:15 on 22Apr2021; This is a spontaneous report from a contactable consumer (patient's brother)   A 63-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0161), via an unknown route of administration, on 19Apr2021 (at the age of 63-year-old) at single dose for COVID-19 immunisation. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ER8732) on 29Mar2021 for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. On 22Apr2021 at 18:15 the patient stopped breathing at 18:15. He was admitted to the intensive care unit (ICU) where he died on 26Apr2021. The cause of death was not provided. It was unknown if an autopsy was performed.; Reported Cause(s) of Death: passed away on 26Apr2021 in ICU (intensive care unit)
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram abnormal, Eye inflammation, Eye pain, Headache, Idiopathic orbital inflammation
Clinical narrative: Patient received his second dose of Pfizer on 05/13/2021, and he had a "normal" three day flu symptoms.  Around 12 days later he rushed to ER with an extremely intense pain behind his right ey; intense pain behind his right eye; headaches that lasted couple days; extraocular muscle movement; Patient received his second dose of Pfizer on 05/13/2021, and he had a "normal" three day flu symptoms.  Around 12 days later he rushed to ER with an extremely intense pain behind his right ey; Patient was diagnosed with Idiopathic orbital inflammatory syndrome (IOIS); This is a spontaneous report from a contactable consumer. A 63-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0177) via an unspecified route of administration, administered in left arm on 13May2021 15:45 (at the age of 28-years-old) as second dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0170), via an unspecified route of administration administered in left arm on 21Apr2021 16:00 as first dose, single dose for COVID-19 immunization. It was unknown, whether the patient receive any other vaccines within 4 weeks prior to the COVID vaccine; other medications received within 2 weeks of vaccination; prior to the vaccination, whether the patient was diagnosed with COVID-19 or since the vaccination, whether the patient was tested for COVID-19. It was also unknown whether the patient had covid prior vaccination or covid tested post vaccination. On 27May2021 17:30, the patient had a normal three day flu symptoms. Around 12 days later he rushed to ER with an extremely intense pain behind his right eye and headaches that lasted couple days. His pain was exacerbated by extraocularmuscle movement, particularly when looking to his left. Patient spent one night at the hospital and they did a CT scan and blood work. His CT showed subtle retroocular inflammation, which correlates with his symptoms. Patient was diagnosed with Idiopathic orbital inflammatory syndrome (IOIS). After being seen at the ER and following up with his Ophthalmologist, patient was advised to report his case since it is very unique and unusual. He is very concerned since there is not much information about the syndrome, and since he never experienced eye problems for the past 63 years. The adverse event resulted patient to visit emergency room/department or urgent care, hospitalization and was hospitalized for one day. It was unknown, whether patient receive any treatment for events. The seriousness criteria was considered as caused/prolonged hospitalization by reporter. The outcome of the events was recovering.  Device Date : 09Jun2021.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness, Pain
Clinical narrative: Patient received his second dose of Pfizer on 05/13/2021, and he had a "normal" three day flu symptoms.  Around 12 days later he rushed to ER with an extremely intense pain behind his right ey; intense pain behind his right eye; headaches that lasted couple days; extraocular muscle movement; Patient received his second dose of Pfizer on 05/13/2021, and he had a "normal" three day flu symptoms.  Around 12 days later he rushed to ER with an extremely intense pain behind his right ey; Patient was diagnosed with Idiopathic orbital inflammatory syndrome (IOIS); This is a spontaneous report from a contactable consumer. A 63-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0177) via an unspecified route of administration, administered in left arm on 13May2021 15:45 (at the age of 28-years-old) as second dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0170), via an unspecified route of administration administered in left arm on 21Apr2021 16:00 as first dose, single dose for COVID-19 immunization. It was unknown, whether the patient receive any other vaccines within 4 weeks prior to the COVID vaccine; other medications received within 2 weeks of vaccination; prior to the vaccination, whether the patient was diagnosed with COVID-19 or since the vaccination, whether the patient was tested for COVID-19. It was also unknown whether the patient had covid prior vaccination or covid tested post vaccination. On 27May2021 17:30, the patient had a normal three day flu symptoms. Around 12 days later he rushed to ER with an extremely intense pain behind his right eye and headaches that lasted couple days. His pain was exacerbated by extraocularmuscle movement, particularly when looking to his left. Patient spent one night at the hospital and they did a CT scan and blood work. His CT showed subtle retroocular inflammation, which correlates with his symptoms. Patient was diagnosed with Idiopathic orbital inflammatory syndrome (IOIS). After being seen at the ER and following up with his Ophthalmologist, patient was advised to report his case since it is very unique and unusual. He is very concerned since there is not much information about the syndrome, and since he never experienced eye problems for the past 63 years. The adverse event resulted patient to visit emergency room/department or urgent care, hospitalization and was hospitalized for one day. It was unknown, whether patient receive any treatment for events. The seriousness criteria was considered as caused/prolonged hospitalization by reporter. The outcome of the events was recovering.  Device Date : 09Jun2021.