chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Flushing, Heart rate increased, Paraesthesia oral, Rash
Clinical narrative: Tachycardia; Rash; This is a spontaneous report from a contactable healthcare professional. This is the second of two reports for the same patient with reoccurring events separated in time.  A 45-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), second dose (Batch/Lot Number: UNKNOWN) via an unspecified route of administration on 26Jan2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. The vaccination was received at the hospital. Medical history included asthma, clotting disorder and allergies. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included unspecified medications. It was reported that the patient had received other medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 on 05Jan2021 for COVID-19 immunisation and experienced tachycardia, rash and presyncope. The patient developed tachycardia and rash which started approximately 2 weeks after the first vaccine and worsened after the second vaccine on 26Jan2021. The tachycardia and rash required a visit to the Emergency Room and Physician Office. Treatment included steroid injections, oral steroids and Diphenhydramine (BENADRYL). The patient was not admitted to the hospital. The outcome of event tachycardia was recovered on an unknown date. The outcome of event rash was recovering. The healthcare professional reported casual effect of the events  tachycardia and rash to the vaccine.  The lot number for the vaccine was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of  tachycardia and rash  due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including EKG, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional 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.,Linked Report(s) : US-PFIZER INC-2021092876 same patient/reporter, different vaccine dose and event.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Brain natriuretic peptide normal, Computerised tomogram normal, Dyspnoea, Heart rate increased, Pleuritic pain
Clinical narrative: 1/19/21 - received vaccine around 6:45 pm 1/20/21 - woke up noticing shortness of breath with minimal activity.  Monitored, but symptom progressed throughout the day 1/21/21 - woke up with extreme fatigue and more shortness of breath.  Unable to walk at all without gasping.  Self-monitored with home pulse ox.  O2 down in mid 80s and pulse up to 150 with minimal activity 1/22/21 - woke up with worse shortness of breath symptoms.  Had husband drive me to the ER and was admitted for 4 days with bilateral moderate to extensive pulmonary emboli
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pulmonary embolism, Troponin normal, Ultrasound Doppler normal
Clinical narrative: 1/19/21 - received vaccine around 6:45 pm 1/20/21 - woke up noticing shortness of breath with minimal activity.  Monitored, but symptom progressed throughout the day 1/21/21 - woke up with extreme fatigue and more shortness of breath.  Unable to walk at all without gasping.  Self-monitored with home pulse ox.  O2 down in mid 80s and pulse up to 150 with minimal activity 1/22/21 - woke up with worse shortness of breath symptoms.  Had husband drive me to the ER and was admitted for 4 days with bilateral moderate to extensive pulmonary emboli
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Computerised tomogram thorax, Decreased activity, Dyspnoea, Electrocardiogram
Clinical narrative: 1/19/21 - received vaccine around 6:45 pm 1/20/21 - woke up noticing shortness of breath with minimal activity.  Monitored, but symptom progressed throughout the day 1/21/21 - woke up with extreme fatigue and more shortness of breath.  Unable to walk at all without gasping.  Self-monitored with home pulse ox.  O2 down in mid 80s and pulse up to 150 with minimal activity 1/22/21 - woke up with worse shortness of breath symptoms.  Had husband drive me to the ER and was admitted for 4 days with bilateral moderate to extensive pulmonary emboli
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Gait inability, Pulmonary embolism, SARS-CoV-2 test negative, Ultrasound scan
Clinical narrative: 1/19/21 - received vaccine around 6:45 pm 1/20/21 - woke up noticing shortness of breath with minimal activity.  Monitored, but symptom progressed throughout the day 1/21/21 - woke up with extreme fatigue and more shortness of breath.  Unable to walk at all without gasping.  Self-monitored with home pulse ox.  O2 down in mid 80s and pulse up to 150 with minimal activity 1/22/21 - woke up with worse shortness of breath symptoms.  Had husband drive me to the ER and was admitted for 4 days with bilateral moderate to extensive pulmonary emboli
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Chest discomfort, Dyspnoea, Pruritus, Rash
Clinical narrative: Shortness of breath; allergic reaction; Rash on arms, neck, chest, hands.; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose of bnt162b2 (Lot number: EL3249; solution for injection), via an unspecified route of administration in left arm on 21Jan2021 at 11:30 AM at a single dose and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9269), via an unspecified route of administration in left arm on 09Feb2021 at 01:45 PM at a single dose, for COVID-19 immunisation. The patient's medical history included asthma and hypertension. Concomitant medication included montelukast sodium (SINGULAIR), ammonium chloride, diphenhydramine hydrochloride, menthol, sodium citrate, sulfogaiacol (BENACOL EXPECTORANT), fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA). The patient was not diagnosed with COVID-19 prior to vaccination. On 12Feb2021 at 06:30 PM (52 hours after second dose of bnt162b2), the patient experienced allergic reaction, rash on arms, neck, chest, hands and shortness of breath. The patient received diphenhydramine (BENADRYL) and albuterol as treatment for the events. The outcome of the events was recovered on an unspecified date. It was also reported that post vaccination, the patient had not been tested for COVID-19.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Hypersensitivity, Rash
Clinical narrative: Shortness of breath; allergic reaction; Rash on arms, neck, chest, hands.; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose of bnt162b2 (Lot number: EL3249; solution for injection), via an unspecified route of administration in left arm on 21Jan2021 at 11:30 AM at a single dose and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9269), via an unspecified route of administration in left arm on 09Feb2021 at 01:45 PM at a single dose, for COVID-19 immunisation. The patient's medical history included asthma and hypertension. Concomitant medication included montelukast sodium (SINGULAIR), ammonium chloride, diphenhydramine hydrochloride, menthol, sodium citrate, sulfogaiacol (BENACOL EXPECTORANT), fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA). The patient was not diagnosed with COVID-19 prior to vaccination. On 12Feb2021 at 06:30 PM (52 hours after second dose of bnt162b2), the patient experienced allergic reaction, rash on arms, neck, chest, hands and shortness of breath. The patient received diphenhydramine (BENADRYL) and albuterol as treatment for the events. The outcome of the events was recovered on an unspecified date. It was also reported that post vaccination, the patient had not been tested for COVID-19.
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Heart rate increased, Hypertension, Tachycardia, Vision blurred
Clinical narrative: Hospitalization within 6 weeks after receiving vaccine
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Hospitalization within 6 weeks after receiving vaccine
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure increased, Computerised tomogram, Electrocardiogram, Headache, Heart rate increased
Clinical narrative: Hospitalization within 6 weeks after receiving vaccine
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Metabolic function test, Tachycardia, Troponin, Troponin I increased, Vision blurred
Clinical narrative: Hospitalization within 6 weeks after receiving vaccine
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Acoustic stimulation tests normal, Blood pressure increased, Colonoscopy normal, Computerised tomogram abdomen abnormal
Clinical narrative: has a constant severe headache; tinnitus in right ear/Tinnitus continues to persist/Right Ear ringing; stomach pain; high BP; sore arm; tinging in in throat and right side of face,; irritated right eye; Right Ear ringing worsened culminated in 8 days of insomnia from severe ringing; mesenteric inflammation; This is a spontaneous report from a contactable nurse (patient) and a consumer. A 51-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm left on 29Jan2021 (Batch/Lot Number: EL3247) at single dose for COVID-19 immunization. Medical history included sciatica (resolved), and the patient took the first dose of BNT162B2 (lot/batch number: EL0142) at 15:00 on 29Dec2020 administered in arm right for COVID-19 immunization and developed paresthesias in right arm, into axilla, nex and right side of face and burning irritation of right eye, both on 24Jan2021. The patient's concomitant medications were not reported. Clinical course: 3 days after vaccination, patient developed sore arm, tinging in in throat and right side of face, irritated right eye. 6 days after vaccination, patient woke up with tinnitus in right ear, stomach pain and high BP. On 30Jan2021 (as reported), patient went to Emergency Room. CT scan showed mesenteric inflammation. Right Ear ringing worsened which culminated in 8 days of insomnia from severe ringing. Tinnitus continues to persist. He also had a constant severe headache. All events were reported as serious and seriousness criteria were disability. No allergies to medications, food, or other products. The adverse event result in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was not recovered.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ear discomfort, Endoscopy normal, Eye irritation, Magnetic resonance imaging brain normal, Mesenteritis
Clinical narrative: has a constant severe headache; tinnitus in right ear/Tinnitus continues to persist/Right Ear ringing; stomach pain; high BP; sore arm; tinging in in throat and right side of face,; irritated right eye; Right Ear ringing worsened culminated in 8 days of insomnia from severe ringing; mesenteric inflammation; This is a spontaneous report from a contactable nurse (patient) and a consumer. A 51-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm left on 29Jan2021 (Batch/Lot Number: EL3247) at single dose for COVID-19 immunization. Medical history included sciatica (resolved), and the patient took the first dose of BNT162B2 (lot/batch number: EL0142) at 15:00 on 29Dec2020 administered in arm right for COVID-19 immunization and developed paresthesias in right arm, into axilla, nex and right side of face and burning irritation of right eye, both on 24Jan2021. The patient's concomitant medications were not reported. Clinical course: 3 days after vaccination, patient developed sore arm, tinging in in throat and right side of face, irritated right eye. 6 days after vaccination, patient woke up with tinnitus in right ear, stomach pain and high BP. On 30Jan2021 (as reported), patient went to Emergency Room. CT scan showed mesenteric inflammation. Right Ear ringing worsened which culminated in 8 days of insomnia from severe ringing. Tinnitus continues to persist. He also had a constant severe headache. All events were reported as serious and seriousness criteria were disability. No allergies to medications, food, or other products. The adverse event result in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was not recovered.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Scan with contrast abnormal, Throat irritation, Tinnitus
Clinical narrative: has a constant severe headache; tinnitus in right ear/Tinnitus continues to persist/Right Ear ringing; stomach pain; high BP; sore arm; tinging in in throat and right side of face,; irritated right eye; Right Ear ringing worsened culminated in 8 days of insomnia from severe ringing; mesenteric inflammation; This is a spontaneous report from a contactable nurse (patient) and a consumer. A 51-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm left on 29Jan2021 (Batch/Lot Number: EL3247) at single dose for COVID-19 immunization. Medical history included sciatica (resolved), and the patient took the first dose of BNT162B2 (lot/batch number: EL0142) at 15:00 on 29Dec2020 administered in arm right for COVID-19 immunization and developed paresthesias in right arm, into axilla, nex and right side of face and burning irritation of right eye, both on 24Jan2021. The patient's concomitant medications were not reported. Clinical course: 3 days after vaccination, patient developed sore arm, tinging in in throat and right side of face, irritated right eye. 6 days after vaccination, patient woke up with tinnitus in right ear, stomach pain and high BP. On 30Jan2021 (as reported), patient went to Emergency Room. CT scan showed mesenteric inflammation. Right Ear ringing worsened which culminated in 8 days of insomnia from severe ringing. Tinnitus continues to persist. He also had a constant severe headache. All events were reported as serious and seriousness criteria were disability. No allergies to medications, food, or other products. The adverse event result in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was not recovered.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Computerised tomogram, Eye irritation, Headache, Hypertension
Clinical narrative: has a constant severe headache; tinnitus in right ear/Tinnitus continues to persist/Right Ear ringing; stomach pain; high BP; sore arm; tinging in in throat and right side of face,; irritated right eye; Right Ear ringing worsened culminated in 8 days of insomnia from severe ringing; mesenteric inflammation; This is a spontaneous report from a contactable nurse (patient) and a consumer. A 51-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm left on 29Jan2021 (Batch/Lot Number: EL3247) at single dose for COVID-19 immunization. Medical history included sciatica (resolved), and the patient took the first dose of BNT162B2 (lot/batch number: EL0142) at 15:00 on 29Dec2020 administered in arm right for COVID-19 immunization and developed paresthesias in right arm, into axilla, nex and right side of face and burning irritation of right eye, both on 24Jan2021. The patient's concomitant medications were not reported. Clinical course: 3 days after vaccination, patient developed sore arm, tinging in in throat and right side of face, irritated right eye. 6 days after vaccination, patient woke up with tinnitus in right ear, stomach pain and high BP. On 30Jan2021 (as reported), patient went to Emergency Room. CT scan showed mesenteric inflammation. Right Ear ringing worsened which culminated in 8 days of insomnia from severe ringing. Tinnitus continues to persist. He also had a constant severe headache. All events were reported as serious and seriousness criteria were disability. No allergies to medications, food, or other products. The adverse event result in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was not recovered.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inflammation, Insomnia, Pain in extremity, Pharyngeal paraesthesia, Tinnitus
Clinical narrative: has a constant severe headache; tinnitus in right ear/Tinnitus continues to persist/Right Ear ringing; stomach pain; high BP; sore arm; tinging in in throat and right side of face,; irritated right eye; Right Ear ringing worsened culminated in 8 days of insomnia from severe ringing; mesenteric inflammation; This is a spontaneous report from a contactable nurse (patient) and a consumer. A 51-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm left on 29Jan2021 (Batch/Lot Number: EL3247) at single dose for COVID-19 immunization. Medical history included sciatica (resolved), and the patient took the first dose of BNT162B2 (lot/batch number: EL0142) at 15:00 on 29Dec2020 administered in arm right for COVID-19 immunization and developed paresthesias in right arm, into axilla, nex and right side of face and burning irritation of right eye, both on 24Jan2021. The patient's concomitant medications were not reported. Clinical course: 3 days after vaccination, patient developed sore arm, tinging in in throat and right side of face, irritated right eye. 6 days after vaccination, patient woke up with tinnitus in right ear, stomach pain and high BP. On 30Jan2021 (as reported), patient went to Emergency Room. CT scan showed mesenteric inflammation. Right Ear ringing worsened which culminated in 8 days of insomnia from severe ringing. Tinnitus continues to persist. He also had a constant severe headache. All events were reported as serious and seriousness criteria were disability. No allergies to medications, food, or other products. The adverse event result in Doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was not recovered.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Facial paralysis, Feeling abnormal, Hypoaesthesia, Laboratory test
Clinical narrative: I ultimately suffered from Acute Disseminated Encephalomyelitis and was hospitalized for 5 days due to brain and spine inflammation.  I had numbness in my feet 2 days after my vaccine, then suffered from dizziness and nausea 3 days after my vaccine, and had face paralysis 4 days after my vaccine. I went to the ER 4 days after the vaccine and was told I have Bell's Palsy and Vertigo. I was prescribed oral steroids and anti-nausea medicine. In the following weeks, I had more tingleness/numbness of the legs, brain fog and confusion, blurred vision, unsteady gait, loss of balance, blurred vision and leg muscle weakness, increased anxiety, hearing sensitivity, lethargy, sleeplessness, 6th cranial nerve palsy, tingles in the face, and headaches. I finally got an MRI and when doctor?s saw the MRI results 3 days later, I was told to go to the ER immediately because I had brain and spine inflammation that needed treatment, and was diagnosed with ADEM. I then spent 5 days in the hospital to receive intravenous steroids and monitoring. During this stay, I had more MRIs and a lumbar puncture. I was released on oral steroids for 25 days, as well as follow up appointments and monitoring progress in recovery. Inflammation has decreased. I continue to have tingleness in lower extremities, headaches, pain in legs, and sensitive hearing.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Vision blurred
Clinical narrative: I ultimately suffered from Acute Disseminated Encephalomyelitis and was hospitalized for 5 days due to brain and spine inflammation.  I had numbness in my feet 2 days after my vaccine, then suffered from dizziness and nausea 3 days after my vaccine, and had face paralysis 4 days after my vaccine. I went to the ER 4 days after the vaccine and was told I have Bell's Palsy and Vertigo. I was prescribed oral steroids and anti-nausea medicine. In the following weeks, I had more tingleness/numbness of the legs, brain fog and confusion, blurred vision, unsteady gait, loss of balance, blurred vision and leg muscle weakness, increased anxiety, hearing sensitivity, lethargy, sleeplessness, 6th cranial nerve palsy, tingles in the face, and headaches. I finally got an MRI and when doctor?s saw the MRI results 3 days later, I was told to go to the ER immediately because I had brain and spine inflammation that needed treatment, and was diagnosed with ADEM. I then spent 5 days in the hospital to receive intravenous steroids and monitoring. During this stay, I had more MRIs and a lumbar puncture. I was released on oral steroids for 25 days, as well as follow up appointments and monitoring progress in recovery. Inflammation has decreased. I continue to have tingleness in lower extremities, headaches, pain in legs, and sensitive hearing.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acute disseminated encephalomyelitis, Anxiety, Balance disorder, Bell's palsy, Blood test normal
Clinical narrative: I ultimately suffered from Acute Disseminated Encephalomyelitis and was hospitalized for 5 days due to brain and spine inflammation.  I had numbness in my feet 2 days after my vaccine, then suffered from dizziness and nausea 3 days after my vaccine, and had face paralysis 4 days after my vaccine. I went to the ER 4 days after the vaccine and was told I have Bell's Palsy and Vertigo. I was prescribed oral steroids and anti-nausea medicine. In the following weeks, I had more tingleness/numbness of the legs, brain fog and confusion, blurred vision, unsteady gait, loss of balance, blurred vision and leg muscle weakness, increased anxiety, hearing sensitivity, lethargy, sleeplessness, 6th cranial nerve palsy, tingles in the face, and headaches. I finally got an MRI and when doctor?s saw the MRI results 3 days later, I was told to go to the ER immediately because I had brain and spine inflammation that needed treatment, and was diagnosed with ADEM. I then spent 5 days in the hospital to receive intravenous steroids and monitoring. During this stay, I had more MRIs and a lumbar puncture. I was released on oral steroids for 25 days, as well as follow up appointments and monitoring progress in recovery. Inflammation has decreased. I continue to have tingleness in lower extremities, headaches, pain in legs, and sensitive hearing.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray normal, Computerised tomogram normal, Confusional state, Dizziness, Electrocardiogram normal
Clinical narrative: I ultimately suffered from Acute Disseminated Encephalomyelitis and was hospitalized for 5 days due to brain and spine inflammation.  I had numbness in my feet 2 days after my vaccine, then suffered from dizziness and nausea 3 days after my vaccine, and had face paralysis 4 days after my vaccine. I went to the ER 4 days after the vaccine and was told I have Bell's Palsy and Vertigo. I was prescribed oral steroids and anti-nausea medicine. In the following weeks, I had more tingleness/numbness of the legs, brain fog and confusion, blurred vision, unsteady gait, loss of balance, blurred vision and leg muscle weakness, increased anxiety, hearing sensitivity, lethargy, sleeplessness, 6th cranial nerve palsy, tingles in the face, and headaches. I finally got an MRI and when doctor?s saw the MRI results 3 days later, I was told to go to the ER immediately because I had brain and spine inflammation that needed treatment, and was diagnosed with ADEM. I then spent 5 days in the hospital to receive intravenous steroids and monitoring. During this stay, I had more MRIs and a lumbar puncture. I was released on oral steroids for 25 days, as well as follow up appointments and monitoring progress in recovery. Inflammation has decreased. I continue to have tingleness in lower extremities, headaches, pain in legs, and sensitive hearing.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial paralysis, Feeling abnormal, Gait disturbance, Headache, Hyperacusis
Clinical narrative: I ultimately suffered from Acute Disseminated Encephalomyelitis and was hospitalized for 5 days due to brain and spine inflammation.  I had numbness in my feet 2 days after my vaccine, then suffered from dizziness and nausea 3 days after my vaccine, and had face paralysis 4 days after my vaccine. I went to the ER 4 days after the vaccine and was told I have Bell's Palsy and Vertigo. I was prescribed oral steroids and anti-nausea medicine. In the following weeks, I had more tingleness/numbness of the legs, brain fog and confusion, blurred vision, unsteady gait, loss of balance, blurred vision and leg muscle weakness, increased anxiety, hearing sensitivity, lethargy, sleeplessness, 6th cranial nerve palsy, tingles in the face, and headaches. I finally got an MRI and when doctor?s saw the MRI results 3 days later, I was told to go to the ER immediately because I had brain and spine inflammation that needed treatment, and was diagnosed with ADEM. I then spent 5 days in the hospital to receive intravenous steroids and monitoring. During this stay, I had more MRIs and a lumbar puncture. I was released on oral steroids for 25 days, as well as follow up appointments and monitoring progress in recovery. Inflammation has decreased. I continue to have tingleness in lower extremities, headaches, pain in legs, and sensitive hearing.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Inflammation, Insomnia, Lethargy, Lumbar puncture
Clinical narrative: I ultimately suffered from Acute Disseminated Encephalomyelitis and was hospitalized for 5 days due to brain and spine inflammation.  I had numbness in my feet 2 days after my vaccine, then suffered from dizziness and nausea 3 days after my vaccine, and had face paralysis 4 days after my vaccine. I went to the ER 4 days after the vaccine and was told I have Bell's Palsy and Vertigo. I was prescribed oral steroids and anti-nausea medicine. In the following weeks, I had more tingleness/numbness of the legs, brain fog and confusion, blurred vision, unsteady gait, loss of balance, blurred vision and leg muscle weakness, increased anxiety, hearing sensitivity, lethargy, sleeplessness, 6th cranial nerve palsy, tingles in the face, and headaches. I finally got an MRI and when doctor?s saw the MRI results 3 days later, I was told to go to the ER immediately because I had brain and spine inflammation that needed treatment, and was diagnosed with ADEM. I then spent 5 days in the hospital to receive intravenous steroids and monitoring. During this stay, I had more MRIs and a lumbar puncture. I was released on oral steroids for 25 days, as well as follow up appointments and monitoring progress in recovery. Inflammation has decreased. I continue to have tingleness in lower extremities, headaches, pain in legs, and sensitive hearing.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head abnormal, Magnetic resonance imaging neck, Magnetic resonance imaging spinal abnormal, Muscular weakness, Nausea
Clinical narrative: I ultimately suffered from Acute Disseminated Encephalomyelitis and was hospitalized for 5 days due to brain and spine inflammation.  I had numbness in my feet 2 days after my vaccine, then suffered from dizziness and nausea 3 days after my vaccine, and had face paralysis 4 days after my vaccine. I went to the ER 4 days after the vaccine and was told I have Bell's Palsy and Vertigo. I was prescribed oral steroids and anti-nausea medicine. In the following weeks, I had more tingleness/numbness of the legs, brain fog and confusion, blurred vision, unsteady gait, loss of balance, blurred vision and leg muscle weakness, increased anxiety, hearing sensitivity, lethargy, sleeplessness, 6th cranial nerve palsy, tingles in the face, and headaches. I finally got an MRI and when doctor?s saw the MRI results 3 days later, I was told to go to the ER immediately because I had brain and spine inflammation that needed treatment, and was diagnosed with ADEM. I then spent 5 days in the hospital to receive intravenous steroids and monitoring. During this stay, I had more MRIs and a lumbar puncture. I was released on oral steroids for 25 days, as well as follow up appointments and monitoring progress in recovery. Inflammation has decreased. I continue to have tingleness in lower extremities, headaches, pain in legs, and sensitive hearing.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Noninfective encephalitis, Ophthalmological examination normal, Pain in extremity, Paraesthesia, Spinal X-ray
Clinical narrative: I ultimately suffered from Acute Disseminated Encephalomyelitis and was hospitalized for 5 days due to brain and spine inflammation.  I had numbness in my feet 2 days after my vaccine, then suffered from dizziness and nausea 3 days after my vaccine, and had face paralysis 4 days after my vaccine. I went to the ER 4 days after the vaccine and was told I have Bell's Palsy and Vertigo. I was prescribed oral steroids and anti-nausea medicine. In the following weeks, I had more tingleness/numbness of the legs, brain fog and confusion, blurred vision, unsteady gait, loss of balance, blurred vision and leg muscle weakness, increased anxiety, hearing sensitivity, lethargy, sleeplessness, 6th cranial nerve palsy, tingles in the face, and headaches. I finally got an MRI and when doctor?s saw the MRI results 3 days later, I was told to go to the ER immediately because I had brain and spine inflammation that needed treatment, and was diagnosed with ADEM. I then spent 5 days in the hospital to receive intravenous steroids and monitoring. During this stay, I had more MRIs and a lumbar puncture. I was released on oral steroids for 25 days, as well as follow up appointments and monitoring progress in recovery. Inflammation has decreased. I continue to have tingleness in lower extremities, headaches, pain in legs, and sensitive hearing.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: VIth nerve paralysis, Vertigo, Vision blurred
Clinical narrative: I ultimately suffered from Acute Disseminated Encephalomyelitis and was hospitalized for 5 days due to brain and spine inflammation.  I had numbness in my feet 2 days after my vaccine, then suffered from dizziness and nausea 3 days after my vaccine, and had face paralysis 4 days after my vaccine. I went to the ER 4 days after the vaccine and was told I have Bell's Palsy and Vertigo. I was prescribed oral steroids and anti-nausea medicine. In the following weeks, I had more tingleness/numbness of the legs, brain fog and confusion, blurred vision, unsteady gait, loss of balance, blurred vision and leg muscle weakness, increased anxiety, hearing sensitivity, lethargy, sleeplessness, 6th cranial nerve palsy, tingles in the face, and headaches. I finally got an MRI and when doctor?s saw the MRI results 3 days later, I was told to go to the ER immediately because I had brain and spine inflammation that needed treatment, and was diagnosed with ADEM. I then spent 5 days in the hospital to receive intravenous steroids and monitoring. During this stay, I had more MRIs and a lumbar puncture. I was released on oral steroids for 25 days, as well as follow up appointments and monitoring progress in recovery. Inflammation has decreased. I continue to have tingleness in lower extremities, headaches, pain in legs, and sensitive hearing.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood glucose increased, Cardioversion, Death, Dyspnoea, Respiratory arrest
Clinical narrative: patient died; BP 83/55; no respiration noted; patient unresponsive; blood glucose level of 193; This is a spontaneous report received from a contactable nurse.  A 68-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN9581, expiry date: unknown), via an unspecified route of administration in the right arm, on 01Mar2021 13:50, as single dose, for covid-19 immunization, at a public health department. Medical history included diabetes, obesity, hypertension (HTN), myocardial infarction (MI) in 2011, gastroparesis, home oxygen use, motorize scooter use, pulmonary embolism (PE) in Oct2020, and iodine allergy. Concomitant medications included insulin for diabetes and fentanyl patch. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date: unknown) received at age 68 years, on 08Feb2021, for COVID-19 immunization and experienced breathing difficulty. The patient's doctor stopped "Zarello" (as reported) subsequent to the first dose of BNT162B2 vaccine due to breathing difficulty. It was reported that the patient did not have an adverse event following any previous vaccine. On 01Mar2021 at 13:50, the patient received the second dose of the Pfizer COVID-19 vaccine. At 14:18, a nurse was called to the parking lot and observed the patient having difficulties (unspecified). The nurse called for emergency medical services (EMS) and for a crash cart. The patient's vitals were taken and the patient had pressure (BP) 83/55, no respiration noted and the patient was unresponsive. The EMS arrived as 14:22 and look over care. The patient was transported to the hospital at 14:40. Per the EMS, the patient had a blood glucose level of 193. It was reported that the patient died on 01Mar2021. It was not reported if an autopsy was performed. The outcome of the event "patient died" was fatal; and the outcome of the events "BP 83/55", "no respiration noted", "patient unresponsive" and "blood glucose level of 193" was unknown.; Sender's Comments: Based on temporal association and limited information, the causal relationship between BNT162B2 and the events death, hypotension, apnea, unresponsive to stimuli and blood glucose increased cannot be excluded. The contributory role of other pre-existing diseases cannot be excluded as well. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes 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.; Reported Cause(s) of Death: patient died
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Resuscitation, Unresponsive to stimuli
Clinical narrative: patient died; BP 83/55; no respiration noted; patient unresponsive; blood glucose level of 193; This is a spontaneous report received from a contactable nurse.  A 68-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN9581, expiry date: unknown), via an unspecified route of administration in the right arm, on 01Mar2021 13:50, as single dose, for covid-19 immunization, at a public health department. Medical history included diabetes, obesity, hypertension (HTN), myocardial infarction (MI) in 2011, gastroparesis, home oxygen use, motorize scooter use, pulmonary embolism (PE) in Oct2020, and iodine allergy. Concomitant medications included insulin for diabetes and fentanyl patch. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date: unknown) received at age 68 years, on 08Feb2021, for COVID-19 immunization and experienced breathing difficulty. The patient's doctor stopped "Zarello" (as reported) subsequent to the first dose of BNT162B2 vaccine due to breathing difficulty. It was reported that the patient did not have an adverse event following any previous vaccine. On 01Mar2021 at 13:50, the patient received the second dose of the Pfizer COVID-19 vaccine. At 14:18, a nurse was called to the parking lot and observed the patient having difficulties (unspecified). The nurse called for emergency medical services (EMS) and for a crash cart. The patient's vitals were taken and the patient had pressure (BP) 83/55, no respiration noted and the patient was unresponsive. The EMS arrived as 14:22 and look over care. The patient was transported to the hospital at 14:40. Per the EMS, the patient had a blood glucose level of 193. It was reported that the patient died on 01Mar2021. It was not reported if an autopsy was performed. The outcome of the event "patient died" was fatal; and the outcome of the events "BP 83/55", "no respiration noted", "patient unresponsive" and "blood glucose level of 193" was unknown.; Sender's Comments: Based on temporal association and limited information, the causal relationship between BNT162B2 and the events death, hypotension, apnea, unresponsive to stimuli and blood glucose increased cannot be excluded. The contributory role of other pre-existing diseases cannot be excluded as well. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes 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.; Reported Cause(s) of Death: patient died
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Apnoea, Blood glucose, Blood glucose increased, Blood pressure measurement, Death
Clinical narrative: patient died; BP 83/55; no respiration noted; patient unresponsive; blood glucose level of 193; This is a spontaneous report received from a contactable nurse.  A 68-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN9581, expiry date: unknown), via an unspecified route of administration in the right arm, on 01Mar2021 13:50, as single dose, for covid-19 immunization, at a public health department. Medical history included diabetes, obesity, hypertension (HTN), myocardial infarction (MI) in 2011, gastroparesis, home oxygen use, motorize scooter use, pulmonary embolism (PE) in Oct2020, and iodine allergy. Concomitant medications included insulin for diabetes and fentanyl patch. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date: unknown) received at age 68 years, on 08Feb2021, for COVID-19 immunization and experienced breathing difficulty. The patient's doctor stopped "Zarello" (as reported) subsequent to the first dose of BNT162B2 vaccine due to breathing difficulty. It was reported that the patient did not have an adverse event following any previous vaccine. On 01Mar2021 at 13:50, the patient received the second dose of the Pfizer COVID-19 vaccine. At 14:18, a nurse was called to the parking lot and observed the patient having difficulties (unspecified). The nurse called for emergency medical services (EMS) and for a crash cart. The patient's vitals were taken and the patient had pressure (BP) 83/55, no respiration noted and the patient was unresponsive. The EMS arrived as 14:22 and look over care. The patient was transported to the hospital at 14:40. Per the EMS, the patient had a blood glucose level of 193. It was reported that the patient died on 01Mar2021. It was not reported if an autopsy was performed. The outcome of the event "patient died" was fatal; and the outcome of the events "BP 83/55", "no respiration noted", "patient unresponsive" and "blood glucose level of 193" was unknown.; Sender's Comments: Based on temporal association and limited information, the causal relationship between BNT162B2 and the events death, hypotension, apnea, unresponsive to stimuli and blood glucose increased cannot be excluded. The contributory role of other pre-existing diseases cannot be excluded as well. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes 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.; Reported Cause(s) of Death: patient died