chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Hypoaesthesia, Immediate post-injection reaction, Injection site pain, Muscle spasms
Clinical narrative: Tingling hands; Heart palpitations; Elevated heart rate and blood pressure; Elevated heart rate and blood pressure; Nausea; Vomiting; Shaking; Chills; Blurred vision; Injection site pain; Muscle pain; Headache; Fatigue; Malaise; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 37-years-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN 6204 and expiry date: unknown), via an unspecified route of administration, in left arm on 10Mar2021 at 16:30 (at the age of vaccination was 37-years-old) as single dose for COVID-19 immunization. The patient's medical history included mild aortic regurgitation, abdominal adhesions, inappropriate sinus tachycardia, had emergency laparotomy and hysterectomy on 4Apr2020 for severe infection post C-section. The patient had no concomitant medications. The patient had known allergies: sulfa drugs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 10Mar2021 at 16:45, the patient experienced tingling hands, heart palpitations, elevated heart rate and blood pressure, nausea, vomiting, shaking, chills, blurred vision, injection site pain, muscle pain, headache, fatigue and malaise. The patient did not receive any treatment medication for the events. The patient received large doses of zosyn, augmentin, as well as lovenox from 23Mar2020 through about 15Apr2020. On 10Mar2021, the patient underwent lab tests which included blood pressure measurement was elevated, heart rate was elevated. The outcome of all the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Nausea, Neck pain, Palpitations, Paraesthesia
Clinical narrative: Tingling hands; Heart palpitations; Elevated heart rate and blood pressure; Elevated heart rate and blood pressure; Nausea; Vomiting; Shaking; Chills; Blurred vision; Injection site pain; Muscle pain; Headache; Fatigue; Malaise; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 37-years-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN 6204 and expiry date: unknown), via an unspecified route of administration, in left arm on 10Mar2021 at 16:30 (at the age of vaccination was 37-years-old) as single dose for COVID-19 immunization. The patient's medical history included mild aortic regurgitation, abdominal adhesions, inappropriate sinus tachycardia, had emergency laparotomy and hysterectomy on 4Apr2020 for severe infection post C-section. The patient had no concomitant medications. The patient had known allergies: sulfa drugs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 10Mar2021 at 16:45, the patient experienced tingling hands, heart palpitations, elevated heart rate and blood pressure, nausea, vomiting, shaking, chills, blurred vision, injection site pain, muscle pain, headache, fatigue and malaise. The patient did not receive any treatment medication for the events. The patient received large doses of zosyn, augmentin, as well as lovenox from 23Mar2020 through about 15Apr2020. On 10Mar2021, the patient underwent lab tests which included blood pressure measurement was elevated, heart rate was elevated. The outcome of all the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral coldness, Tachycardia, Tremor, Vomiting
Clinical narrative: Tingling hands; Heart palpitations; Elevated heart rate and blood pressure; Elevated heart rate and blood pressure; Nausea; Vomiting; Shaking; Chills; Blurred vision; Injection site pain; Muscle pain; Headache; Fatigue; Malaise; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 37-years-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN 6204 and expiry date: unknown), via an unspecified route of administration, in left arm on 10Mar2021 at 16:30 (at the age of vaccination was 37-years-old) as single dose for COVID-19 immunization. The patient's medical history included mild aortic regurgitation, abdominal adhesions, inappropriate sinus tachycardia, had emergency laparotomy and hysterectomy on 4Apr2020 for severe infection post C-section. The patient had no concomitant medications. The patient had known allergies: sulfa drugs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 10Mar2021 at 16:45, the patient experienced tingling hands, heart palpitations, elevated heart rate and blood pressure, nausea, vomiting, shaking, chills, blurred vision, injection site pain, muscle pain, headache, fatigue and malaise. The patient did not receive any treatment medication for the events. The patient received large doses of zosyn, augmentin, as well as lovenox from 23Mar2020 through about 15Apr2020. On 10Mar2021, the patient underwent lab tests which included blood pressure measurement was elevated, heart rate was elevated. The outcome of all the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Chills, Fatigue, Headache
Clinical narrative: Tingling hands; Heart palpitations; Elevated heart rate and blood pressure; Elevated heart rate and blood pressure; Nausea; Vomiting; Shaking; Chills; Blurred vision; Injection site pain; Muscle pain; Headache; Fatigue; Malaise; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 37-years-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN 6204 and expiry date: unknown), via an unspecified route of administration, in left arm on 10Mar2021 at 16:30 (at the age of vaccination was 37-years-old) as single dose for COVID-19 immunization. The patient's medical history included mild aortic regurgitation, abdominal adhesions, inappropriate sinus tachycardia, had emergency laparotomy and hysterectomy on 4Apr2020 for severe infection post C-section. The patient had no concomitant medications. The patient had known allergies: sulfa drugs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 10Mar2021 at 16:45, the patient experienced tingling hands, heart palpitations, elevated heart rate and blood pressure, nausea, vomiting, shaking, chills, blurred vision, injection site pain, muscle pain, headache, fatigue and malaise. The patient did not receive any treatment medication for the events. The patient received large doses of zosyn, augmentin, as well as lovenox from 23Mar2020 through about 15Apr2020. On 10Mar2021, the patient underwent lab tests which included blood pressure measurement was elevated, heart rate was elevated. The outcome of all the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate, Heart rate increased, Malaise, Myalgia, Nausea
Clinical narrative: Tingling hands; Heart palpitations; Elevated heart rate and blood pressure; Elevated heart rate and blood pressure; Nausea; Vomiting; Shaking; Chills; Blurred vision; Injection site pain; Muscle pain; Headache; Fatigue; Malaise; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 37-years-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN 6204 and expiry date: unknown), via an unspecified route of administration, in left arm on 10Mar2021 at 16:30 (at the age of vaccination was 37-years-old) as single dose for COVID-19 immunization. The patient's medical history included mild aortic regurgitation, abdominal adhesions, inappropriate sinus tachycardia, had emergency laparotomy and hysterectomy on 4Apr2020 for severe infection post C-section. The patient had no concomitant medications. The patient had known allergies: sulfa drugs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 10Mar2021 at 16:45, the patient experienced tingling hands, heart palpitations, elevated heart rate and blood pressure, nausea, vomiting, shaking, chills, blurred vision, injection site pain, muscle pain, headache, fatigue and malaise. The patient did not receive any treatment medication for the events. The patient received large doses of zosyn, augmentin, as well as lovenox from 23Mar2020 through about 15Apr2020. On 10Mar2021, the patient underwent lab tests which included blood pressure measurement was elevated, heart rate was elevated. The outcome of all the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Paraesthesia, Tremor, Vaccination site pain, Vision blurred
Clinical narrative: Tingling hands; Heart palpitations; Elevated heart rate and blood pressure; Elevated heart rate and blood pressure; Nausea; Vomiting; Shaking; Chills; Blurred vision; Injection site pain; Muscle pain; Headache; Fatigue; Malaise; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 37-years-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN 6204 and expiry date: unknown), via an unspecified route of administration, in left arm on 10Mar2021 at 16:30 (at the age of vaccination was 37-years-old) as single dose for COVID-19 immunization. The patient's medical history included mild aortic regurgitation, abdominal adhesions, inappropriate sinus tachycardia, had emergency laparotomy and hysterectomy on 4Apr2020 for severe infection post C-section. The patient had no concomitant medications. The patient had known allergies: sulfa drugs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 10Mar2021 at 16:45, the patient experienced tingling hands, heart palpitations, elevated heart rate and blood pressure, nausea, vomiting, shaking, chills, blurred vision, injection site pain, muscle pain, headache, fatigue and malaise. The patient did not receive any treatment medication for the events. The patient received large doses of zosyn, augmentin, as well as lovenox from 23Mar2020 through about 15Apr2020. On 10Mar2021, the patient underwent lab tests which included blood pressure measurement was elevated, heart rate was elevated. The outcome of all the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Tingling hands; Heart palpitations; Elevated heart rate and blood pressure; Elevated heart rate and blood pressure; Nausea; Vomiting; Shaking; Chills; Blurred vision; Injection site pain; Muscle pain; Headache; Fatigue; Malaise; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 37-years-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN 6204 and expiry date: unknown), via an unspecified route of administration, in left arm on 10Mar2021 at 16:30 (at the age of vaccination was 37-years-old) as single dose for COVID-19 immunization. The patient's medical history included mild aortic regurgitation, abdominal adhesions, inappropriate sinus tachycardia, had emergency laparotomy and hysterectomy on 4Apr2020 for severe infection post C-section. The patient had no concomitant medications. The patient had known allergies: sulfa drugs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 10Mar2021 at 16:45, the patient experienced tingling hands, heart palpitations, elevated heart rate and blood pressure, nausea, vomiting, shaking, chills, blurred vision, injection site pain, muscle pain, headache, fatigue and malaise. The patient did not receive any treatment medication for the events. The patient received large doses of zosyn, augmentin, as well as lovenox from 23Mar2020 through about 15Apr2020. On 10Mar2021, the patient underwent lab tests which included blood pressure measurement was elevated, heart rate was elevated. The outcome of all the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphonia, Flushing, Hyperhidrosis, Paraesthesia oral, Throat tightness
Clinical narrative: Immediately following, patient reports that tingling sensation to her tongue, dyspnea and ?my throat feels tight.? Patient reports a similar prodrome to when she had an anaphylactic reaction to eggs.  Ed medications-sodium chloride 0.9 % bolus 1,000 mL (0 mL Intravenous Stopped 5/7/21 1332) famotidine (PEPCID) injection 20 mg (20 mg Intravenous Given 5/7/21 1054) diphenhydrAMINE (BENADRYL) injection 50 mg (50 mg Intravenous Given 5/7/21 1055) EPINEPHrine PF (ADRENALIN) 1 mg/mL injection 0.3 mg (0.3 mg Subcutaneous Given 5/7/21 1044) methylPREDNISolone sodium succinate (Solu-MEDROL) injection 125 mg (125 mg Intravenous Given 5/7/21 1100) ibuprofen (MOTRIN) tablet 600 mg (600 mg Oral Given 5/7/21 1443)
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Immediate post-injection reaction, Paraesthesia oral, Throat tightness
Clinical narrative: Immediately following, patient reports that tingling sensation to her tongue, dyspnea and ?my throat feels tight.? Patient reports a similar prodrome to when she had an anaphylactic reaction to eggs.  Ed medications-sodium chloride 0.9 % bolus 1,000 mL (0 mL Intravenous Stopped 5/7/21 1332) famotidine (PEPCID) injection 20 mg (20 mg Intravenous Given 5/7/21 1054) diphenhydrAMINE (BENADRYL) injection 50 mg (50 mg Intravenous Given 5/7/21 1055) EPINEPHrine PF (ADRENALIN) 1 mg/mL injection 0.3 mg (0.3 mg Subcutaneous Given 5/7/21 1044) methylPREDNISolone sodium succinate (Solu-MEDROL) injection 125 mg (125 mg Intravenous Given 5/7/21 1100) ibuprofen (MOTRIN) tablet 600 mg (600 mg Oral Given 5/7/21 1443)
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Hyperhidrosis, Hypotension, Lethargy, Presyncope
Clinical narrative: Patient became lethargic and diaphoretic. VS BP 80/42, HR 112 99% on room air.  Patient answered all questions appropriately.  Cool cloth applied.  History of vagal reactions.   VS rechecked about 30 minutes later BP 116/50, HR 60 96% on room air.  Patient felt back to normal.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Lethargy
Clinical narrative: Patient became lethargic and diaphoretic. VS BP 80/42, HR 112 99% on room air.  Patient answered all questions appropriately.  Cool cloth applied.  History of vagal reactions.   VS rechecked about 30 minutes later BP 116/50, HR 60 96% on room air.  Patient felt back to normal.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anticoagulant therapy, Blood lactic acid, Cardiac operation, Cerebral haemorrhage, Computerised tomogram abnormal
Clinical narrative: pt developed STEMI approx 32 hours after Moderna dose #2.  admitted to hospital, subsequently underwent cath, and management for cardiopulmonary collapse, diagnosed with DIC, PE, developed multisystem organ failure and family made decision to remove life support, pt died on 5/8/2021.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Coronary artery embolism, Hepatic vascular thrombosis, Intracardiac thrombus, Myocardial infarction, Pulmonary thrombosis
Clinical narrative: pt developed STEMI approx 32 hours after Moderna dose #2.  admitted to hospital, subsequently underwent cath, and management for cardiopulmonary collapse, diagnosed with DIC, PE, developed multisystem organ failure and family made decision to remove life support, pt died on 5/8/2021.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Renal vascular thrombosis, SARS-CoV-2 test negative, Thrombosis
Clinical narrative: pt developed STEMI approx 32 hours after Moderna dose #2.  admitted to hospital, subsequently underwent cath, and management for cardiopulmonary collapse, diagnosed with DIC, PE, developed multisystem organ failure and family made decision to remove life support, pt died on 5/8/2021.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute myocardial infarction, Catheterisation cardiac, Chest pain, Computerised tomogram abdomen abnormal, Computerised tomogram head abnormal
Clinical narrative: pt developed STEMI approx 32 hours after Moderna dose #2.  admitted to hospital, subsequently underwent cath, and management for cardiopulmonary collapse, diagnosed with DIC, PE, developed multisystem organ failure and family made decision to remove life support, pt died on 5/8/2021.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram pelvis abnormal, Computerised tomogram thorax abnormal, Coronary artery occlusion, Cyanosis, Death
Clinical narrative: pt developed STEMI approx 32 hours after Moderna dose #2.  admitted to hospital, subsequently underwent cath, and management for cardiopulmonary collapse, diagnosed with DIC, PE, developed multisystem organ failure and family made decision to remove life support, pt died on 5/8/2021.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Deep vein thrombosis, Dyspnoea, Echocardiogram abnormal, Electrocardiogram abnormal, Hypoaesthesia
Clinical narrative: pt developed STEMI approx 32 hours after Moderna dose #2.  admitted to hospital, subsequently underwent cath, and management for cardiopulmonary collapse, diagnosed with DIC, PE, developed multisystem organ failure and family made decision to remove life support, pt died on 5/8/2021.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Intra-aortic balloon placement, Myocardial infarction, Pulmonary embolism, Pulse absent, Renal infarct
Clinical narrative: pt developed STEMI approx 32 hours after Moderna dose #2.  admitted to hospital, subsequently underwent cath, and management for cardiopulmonary collapse, diagnosed with DIC, PE, developed multisystem organ failure and family made decision to remove life support, pt died on 5/8/2021.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Subarachnoid haemorrhage, Thrombectomy, Thrombosis, Ultrasound Doppler abnormal
Clinical narrative: pt developed STEMI approx 32 hours after Moderna dose #2.  admitted to hospital, subsequently underwent cath, and management for cardiopulmonary collapse, diagnosed with DIC, PE, developed multisystem organ failure and family made decision to remove life support, pt died on 5/8/2021.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute myocardial infarction, Angiogram, Cardiopulmonary failure, Catheterisation cardiac, Death
Clinical narrative: pt developed STEMI approx 32 hours after Moderna dose #2.  admitted to hospital, subsequently underwent cath, and management for cardiopulmonary collapse, diagnosed with DIC, PE, developed multisystem organ failure and family made decision to remove life support, pt died on 5/8/2021.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Disseminated intravascular coagulation, Laboratory test, Life support, Multiple organ dysfunction syndrome, Myocardial haemorrhage
Clinical narrative: pt developed STEMI approx 32 hours after Moderna dose #2.  admitted to hospital, subsequently underwent cath, and management for cardiopulmonary collapse, diagnosed with DIC, PE, developed multisystem organ failure and family made decision to remove life support, pt died on 5/8/2021.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pulmonary embolism
Clinical narrative: pt developed STEMI approx 32 hours after Moderna dose #2.  admitted to hospital, subsequently underwent cath, and management for cardiopulmonary collapse, diagnosed with DIC, PE, developed multisystem organ failure and family made decision to remove life support, pt died on 5/8/2021.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Nausea, Nystagmus, Vertigo, Vertigo positional
Clinical narrative: dizziness; nausea; vomiting; Vertigo increased with eye opening or changes in position; Horizontal nystagmus; This is a spontaneous report from a contactable other health care professional. A 75-year-old non pregnant female patient received bnt162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number and Expiration date was not reported), via an intramuscular route of administration on 11May2021(at the age of 75 years-old) as DOSE NUMBER UNKNOWN, SINGLE for Covid-19 immunisation. The patient medical history included vertigo. She received the covid vaccine 2 days prior. The patient's concomitant medications were not reported. It was reported that the patient presented to emergency department on an unspecified date with symptoms of dizziness, nausea, and vomiting. Patient has had similar episodes of vertigo in the past. Patient notes vertigo is much more severe than past experiences. During hospitalization patient continued to endorse severe dizziness and nausea. Vertigo increased with eye opening or changes in position. Horizontal nystagmus present. Patient received the treatment which included ondansetron, metoclopramide, methylprednisolone and lorazepam for symptom control and physical therapy also worked with patient. Patient discharged on an unspecified with new prescriptions for meclizine and ondansetron as needed. Result or outcome of adverse event(s): Hospitalization. The outcome of all the event was unknown.   Follow-up (14May2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation below mentioned query. The response included.  Follow-up (14May2021): This is a follow-up spontaneous report from a contactable other hcp. This other hcp reported for a patient.  Information about lot/batch no has been requested.  Follow-up (06Jul2021): Follow-up attempts completed. No further information expected.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events dizziness, nausea, vomiting, vertigo Positional and nystagmus cannot be fully assessed/exclude. The case will be reassessed if 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.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: dizziness; nausea; vomiting; Vertigo increased with eye opening or changes in position; Horizontal nystagmus; This is a spontaneous report from a contactable other health care professional. A 75-year-old non pregnant female patient received bnt162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number and Expiration date was not reported), via an intramuscular route of administration on 11May2021(at the age of 75 years-old) as DOSE NUMBER UNKNOWN, SINGLE for Covid-19 immunisation. The patient medical history included vertigo. She received the covid vaccine 2 days prior. The patient's concomitant medications were not reported. It was reported that the patient presented to emergency department on an unspecified date with symptoms of dizziness, nausea, and vomiting. Patient has had similar episodes of vertigo in the past. Patient notes vertigo is much more severe than past experiences. During hospitalization patient continued to endorse severe dizziness and nausea. Vertigo increased with eye opening or changes in position. Horizontal nystagmus present. Patient received the treatment which included ondansetron, metoclopramide, methylprednisolone and lorazepam for symptom control and physical therapy also worked with patient. Patient discharged on an unspecified with new prescriptions for meclizine and ondansetron as needed. Result or outcome of adverse event(s): Hospitalization. The outcome of all the event was unknown.   Follow-up (14May2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation below mentioned query. The response included.  Follow-up (14May2021): This is a follow-up spontaneous report from a contactable other hcp. This other hcp reported for a patient.  Information about lot/batch no has been requested.  Follow-up (06Jul2021): Follow-up attempts completed. No further information expected.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events dizziness, nausea, vomiting, vertigo Positional and nystagmus cannot be fully assessed/exclude. The case will be reassessed if 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.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Nausea, Nystagmus, Vertigo positional, Vomiting
Clinical narrative: dizziness; nausea; vomiting; Vertigo increased with eye opening or changes in position; Horizontal nystagmus; This is a spontaneous report from a contactable other health care professional. A 75-year-old non pregnant female patient received bnt162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number and Expiration date was not reported), via an intramuscular route of administration on 11May2021(at the age of 75 years-old) as DOSE NUMBER UNKNOWN, SINGLE for Covid-19 immunisation. The patient medical history included vertigo. She received the covid vaccine 2 days prior. The patient's concomitant medications were not reported. It was reported that the patient presented to emergency department on an unspecified date with symptoms of dizziness, nausea, and vomiting. Patient has had similar episodes of vertigo in the past. Patient notes vertigo is much more severe than past experiences. During hospitalization patient continued to endorse severe dizziness and nausea. Vertigo increased with eye opening or changes in position. Horizontal nystagmus present. Patient received the treatment which included ondansetron, metoclopramide, methylprednisolone and lorazepam for symptom control and physical therapy also worked with patient. Patient discharged on an unspecified with new prescriptions for meclizine and ondansetron as needed. Result or outcome of adverse event(s): Hospitalization. The outcome of all the event was unknown.   Follow-up (14May2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation below mentioned query. The response included.  Follow-up (14May2021): This is a follow-up spontaneous report from a contactable other hcp. This other hcp reported for a patient.  Information about lot/batch no has been requested.  Follow-up (06Jul2021): Follow-up attempts completed. No further information expected.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported events dizziness, nausea, vomiting, vertigo Positional and nystagmus cannot be fully assessed/exclude. The case will be reassessed if 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.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ear discomfort, Feeling hot, Head discomfort, Tinnitus
Clinical narrative: Tingling and pins-and-needles to the arm of the injection; Tingling and pins-and-needles to the arm of the injection; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204), via an unspecified route of administration in the left arm on 22Mar2021 at 10:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included very light heart murmur (1/6). The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 26Mar2021, the patient experienced tingling and pins-and-needles to the arm of the injection. This was started at elbow down to the ring finger and pinky finger. This persisted since fourth day after injection. The adverse events resulted in emergency room or department or urgent care. The patient did not receive any treatment for the events tingling and pins and needles. The clinical outcomes of the events tingling and pins and needles were not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling and pins-and-needles to the arm of the injection; Tingling and pins-and-needles to the arm of the injection; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204), via an unspecified route of administration in the left arm on 22Mar2021 at 10:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included very light heart murmur (1/6). The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 26Mar2021, the patient experienced tingling and pins-and-needles to the arm of the injection. This was started at elbow down to the ring finger and pinky finger. This persisted since fourth day after injection. The adverse events resulted in emergency room or department or urgent care. The patient did not receive any treatment for the events tingling and pins and needles. The clinical outcomes of the events tingling and pins and needles were not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Musculoskeletal stiffness, Panic attack, Tinnitus
Clinical narrative: Tingling and pins-and-needles to the arm of the injection; Tingling and pins-and-needles to the arm of the injection; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204), via an unspecified route of administration in the left arm on 22Mar2021 at 10:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included very light heart murmur (1/6). The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 26Mar2021, the patient experienced tingling and pins-and-needles to the arm of the injection. This was started at elbow down to the ring finger and pinky finger. This persisted since fourth day after injection. The adverse events resulted in emergency room or department or urgent care. The patient did not receive any treatment for the events tingling and pins and needles. The clinical outcomes of the events tingling and pins and needles were not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antinuclear antibody, Antinuclear antibody positive, Computerised tomogram, Laboratory test, Noninfective sialoadenitis
Clinical narrative: On 4/20 I had a very sore arm and left lower buttock pain. I had a sore throat and inside my throat hurt. My left side jaw also hurt. I also had shooting pains up both my arms from carpal tunnel. I had pins and needles in my hands which is something I never experienced on 4/22; I had diarrhea begin. On 4/23, the ear pain came back in both ears. On 4/24, I had sudden nerve pain on the right lower back, and I had to go to an afterhours clinic. I was given a cortisone shot that provided immediate relief. On 4/25, I got a CT scan that was ordered. On 4/27, I saw an ENT. He said my carotid glands were inflamed. He said my blood tests showed I was ANA positive. He said it could indicate an autoimmune disease. Due to the cortisone shot, further workups had to be delayed. He told me to see a rheumatologist. On 4/28, my arms swelled up, more on the left side, and I had left ear pain and the left side of my neck was very inflamed. My IBS was also really bad. On 6/3, I saw the rheumatologist, who said I needed to wait on my blood work. I had continued ear, back and arm pain. On 5/4, I had what I thought was a clogged pore. I wear glasses and it was very tender It got to a point that I had to get contacts because I could not wear glasses. On 5/4, my nose started bleeding in the outside and the inside of my nose hurt. On 5/5, I saw the dermatologist. I had more blood and pus come out that day as well. The dermatologist said it was a boil. He told me to put mupirocin. This was not helpful. I had intermittent hand pain, dry mouth and continued ear pain. On 5/9, I was able to get lab work. On 5/12, after the doctors thought I had Sjogren's, everything came back normal, and I did not have any disorder. On 5/14, I woke up with both sciatic nerves completely on fire. I went to the chiropractor, sports medicine doctor I was referred to. They did a deep muscle massage and 30 mins of active therapy. I was taught some stretching exercises which were helpful and provided relief. On 4/24, the sciatica pain subsided for the weekend but came back. I looked up some exercises which provided relief. The next day, I might have done something wrong because the pain got worse. The boil on my nose finally went away after I used cystic acne medication on it. The arm pain calmed a bit as I was not having constant pain. On the week on 6/21, I started having chest pains. I was not sure what was going on. On 6/25, I realized things were not getting better. I decided to take things easy. Things got worse. It felt like an elephant sitting on my chest. On 7/2, I was remarkably worse. I went to the ER where my vitals were okay. I was in so much pain. The pain reminds me of shingles pain although not as bad. I was told to visit and internal doctor. I was given lidocaine patches and prednisone. The blister on my chest has gotten worse and I have developed a few more. The pain on my chest now wraps around my back. I am seeing a doctor today.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Parotid gland enlargement, Sciatica
Clinical narrative: On 4/20 I had a very sore arm and left lower buttock pain. I had a sore throat and inside my throat hurt. My left side jaw also hurt. I also had shooting pains up both my arms from carpal tunnel. I had pins and needles in my hands which is something I never experienced on 4/22; I had diarrhea begin. On 4/23, the ear pain came back in both ears. On 4/24, I had sudden nerve pain on the right lower back, and I had to go to an afterhours clinic. I was given a cortisone shot that provided immediate relief. On 4/25, I got a CT scan that was ordered. On 4/27, I saw an ENT. He said my carotid glands were inflamed. He said my blood tests showed I was ANA positive. He said it could indicate an autoimmune disease. Due to the cortisone shot, further workups had to be delayed. He told me to see a rheumatologist. On 4/28, my arms swelled up, more on the left side, and I had left ear pain and the left side of my neck was very inflamed. My IBS was also really bad. On 6/3, I saw the rheumatologist, who said I needed to wait on my blood work. I had continued ear, back and arm pain. On 5/4, I had what I thought was a clogged pore. I wear glasses and it was very tender It got to a point that I had to get contacts because I could not wear glasses. On 5/4, my nose started bleeding in the outside and the inside of my nose hurt. On 5/5, I saw the dermatologist. I had more blood and pus come out that day as well. The dermatologist said it was a boil. He told me to put mupirocin. This was not helpful. I had intermittent hand pain, dry mouth and continued ear pain. On 5/9, I was able to get lab work. On 5/12, after the doctors thought I had Sjogren's, everything came back normal, and I did not have any disorder. On 5/14, I woke up with both sciatic nerves completely on fire. I went to the chiropractor, sports medicine doctor I was referred to. They did a deep muscle massage and 30 mins of active therapy. I was taught some stretching exercises which were helpful and provided relief. On 4/24, the sciatica pain subsided for the weekend but came back. I looked up some exercises which provided relief. The next day, I might have done something wrong because the pain got worse. The boil on my nose finally went away after I used cystic acne medication on it. The arm pain calmed a bit as I was not having constant pain. On the week on 6/21, I started having chest pains. I was not sure what was going on. On 6/25, I realized things were not getting better. I decided to take things easy. Things got worse. It felt like an elephant sitting on my chest. On 7/2, I was remarkably worse. I went to the ER where my vitals were okay. I was in so much pain. The pain reminds me of shingles pain although not as bad. I was told to visit and internal doctor. I was given lidocaine patches and prednisone. The blister on my chest has gotten worse and I have developed a few more. The pain on my chest now wraps around my back. I am seeing a doctor today.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antinuclear antibody positive, Blister, Chest pain, Computerised tomogram, Condition aggravated
Clinical narrative: On 4/20 I had a very sore arm and left lower buttock pain. I had a sore throat and inside my throat hurt. My left side jaw also hurt. I also had shooting pains up both my arms from carpal tunnel. I had pins and needles in my hands which is something I never experienced on 4/22; I had diarrhea begin. On 4/23, the ear pain came back in both ears. On 4/24, I had sudden nerve pain on the right lower back, and I had to go to an afterhours clinic. I was given a cortisone shot that provided immediate relief. On 4/25, I got a CT scan that was ordered. On 4/27, I saw an ENT. He said my carotid glands were inflamed. He said my blood tests showed I was ANA positive. He said it could indicate an autoimmune disease. Due to the cortisone shot, further workups had to be delayed. He told me to see a rheumatologist. On 4/28, my arms swelled up, more on the left side, and I had left ear pain and the left side of my neck was very inflamed. My IBS was also really bad. On 6/3, I saw the rheumatologist, who said I needed to wait on my blood work. I had continued ear, back and arm pain. On 5/4, I had what I thought was a clogged pore. I wear glasses and it was very tender It got to a point that I had to get contacts because I could not wear glasses. On 5/4, my nose started bleeding in the outside and the inside of my nose hurt. On 5/5, I saw the dermatologist. I had more blood and pus come out that day as well. The dermatologist said it was a boil. He told me to put mupirocin. This was not helpful. I had intermittent hand pain, dry mouth and continued ear pain. On 5/9, I was able to get lab work. On 5/12, after the doctors thought I had Sjogren's, everything came back normal, and I did not have any disorder. On 5/14, I woke up with both sciatic nerves completely on fire. I went to the chiropractor, sports medicine doctor I was referred to. They did a deep muscle massage and 30 mins of active therapy. I was taught some stretching exercises which were helpful and provided relief. On 4/24, the sciatica pain subsided for the weekend but came back. I looked up some exercises which provided relief. The next day, I might have done something wrong because the pain got worse. The boil on my nose finally went away after I used cystic acne medication on it. The arm pain calmed a bit as I was not having constant pain. On the week on 6/21, I started having chest pains. I was not sure what was going on. On 6/25, I realized things were not getting better. I decided to take things easy. Things got worse. It felt like an elephant sitting on my chest. On 7/2, I was remarkably worse. I went to the ER where my vitals were okay. I was in so much pain. The pain reminds me of shingles pain although not as bad. I was told to visit and internal doctor. I was given lidocaine patches and prednisone. The blister on my chest has gotten worse and I have developed a few more. The pain on my chest now wraps around my back. I am seeing a doctor today.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Dry mouth, Ear pain, Furuncle, Inflammation
Clinical narrative: On 4/20 I had a very sore arm and left lower buttock pain. I had a sore throat and inside my throat hurt. My left side jaw also hurt. I also had shooting pains up both my arms from carpal tunnel. I had pins and needles in my hands which is something I never experienced on 4/22; I had diarrhea begin. On 4/23, the ear pain came back in both ears. On 4/24, I had sudden nerve pain on the right lower back, and I had to go to an afterhours clinic. I was given a cortisone shot that provided immediate relief. On 4/25, I got a CT scan that was ordered. On 4/27, I saw an ENT. He said my carotid glands were inflamed. He said my blood tests showed I was ANA positive. He said it could indicate an autoimmune disease. Due to the cortisone shot, further workups had to be delayed. He told me to see a rheumatologist. On 4/28, my arms swelled up, more on the left side, and I had left ear pain and the left side of my neck was very inflamed. My IBS was also really bad. On 6/3, I saw the rheumatologist, who said I needed to wait on my blood work. I had continued ear, back and arm pain. On 5/4, I had what I thought was a clogged pore. I wear glasses and it was very tender It got to a point that I had to get contacts because I could not wear glasses. On 5/4, my nose started bleeding in the outside and the inside of my nose hurt. On 5/5, I saw the dermatologist. I had more blood and pus come out that day as well. The dermatologist said it was a boil. He told me to put mupirocin. This was not helpful. I had intermittent hand pain, dry mouth and continued ear pain. On 5/9, I was able to get lab work. On 5/12, after the doctors thought I had Sjogren's, everything came back normal, and I did not have any disorder. On 5/14, I woke up with both sciatic nerves completely on fire. I went to the chiropractor, sports medicine doctor I was referred to. They did a deep muscle massage and 30 mins of active therapy. I was taught some stretching exercises which were helpful and provided relief. On 4/24, the sciatica pain subsided for the weekend but came back. I looked up some exercises which provided relief. The next day, I might have done something wrong because the pain got worse. The boil on my nose finally went away after I used cystic acne medication on it. The arm pain calmed a bit as I was not having constant pain. On the week on 6/21, I started having chest pains. I was not sure what was going on. On 6/25, I realized things were not getting better. I decided to take things easy. Things got worse. It felt like an elephant sitting on my chest. On 7/2, I was remarkably worse. I went to the ER where my vitals were okay. I was in so much pain. The pain reminds me of shingles pain although not as bad. I was told to visit and internal doctor. I was given lidocaine patches and prednisone. The blister on my chest has gotten worse and I have developed a few more. The pain on my chest now wraps around my back. I am seeing a doctor today.