chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Gastric emptying study, Magnetic resonance imaging spinal, Nausea, Oesophagogastroduodenoscopy
Clinical narrative: intermittent vomiting; lack of energy; inertia; bedridden; constipation; This is a spontaneous report from a contactable physician.   A 18-year-old (non-pregnant) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration, administered on 15Apr2021 as SINGLE dose and patient administered second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration, administered on unspecified date in May2021 as SINGLE dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown patient did not receive other medications within 2 weeks of vaccination. The patient stated 4 days later she began to have intermittent vomiting, lack of energy, inertia on 19Apr2021. Over the next 8 weeks she went from being a healthy 18 year old who ran 6 miles a day to being bedridden on 19Apr2021. She has constipation on 19Apr2021 and requires bladder catheterization. She has been evaluated by multiple doctors including the (Withheld) and was to be evaluated yesterday at the (Withheld). She is too weak to travel by plane. The patient was hospitalized for intermittent vomiting, lack of energy, inertia and constipation for 8 days.  Prior to vaccination, the patient did not diagnosed with COVID-19. Since the vaccination, it was unknown if the patient tested for COVID-19. Therapeutic measures were taken as a result of intermittent vomiting, lack of energy, inertia, bedridden and constipation The patient underwent lab tests and procedures which included Cardiac ( investigation): unknown on unspecified date, Multiple MRIs (magnetic resonance imaging): unknown on unspecified date, Neurologic (neurological examination): unknown  on unspecified date, psychiatric evaluation (psychiatric evaluation): unknown on unspecified date, GI ( x-ray gastrointestinal tract): unknown on unspecified date. The outcome of all event was not recovered.  Information on lot/batch number has been requested.; Sender's Comments: Based on plausible temporal relationship, a possible causal association between the reported events and the suspect drug BNT162B2 cannot be excluded. 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: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound abdomen, Ultrasound bladder, Urinary retention, Urine analysis, Vomiting
Clinical narrative: intermittent vomiting; lack of energy; inertia; bedridden; constipation; This is a spontaneous report from a contactable physician.   A 18-year-old (non-pregnant) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration, administered on 15Apr2021 as SINGLE dose and patient administered second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration, administered on unspecified date in May2021 as SINGLE dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown patient did not receive other medications within 2 weeks of vaccination. The patient stated 4 days later she began to have intermittent vomiting, lack of energy, inertia on 19Apr2021. Over the next 8 weeks she went from being a healthy 18 year old who ran 6 miles a day to being bedridden on 19Apr2021. She has constipation on 19Apr2021 and requires bladder catheterization. She has been evaluated by multiple doctors including the (Withheld) and was to be evaluated yesterday at the (Withheld). She is too weak to travel by plane. The patient was hospitalized for intermittent vomiting, lack of energy, inertia and constipation for 8 days.  Prior to vaccination, the patient did not diagnosed with COVID-19. Since the vaccination, it was unknown if the patient tested for COVID-19. Therapeutic measures were taken as a result of intermittent vomiting, lack of energy, inertia, bedridden and constipation The patient underwent lab tests and procedures which included Cardiac ( investigation): unknown on unspecified date, Multiple MRIs (magnetic resonance imaging): unknown on unspecified date, Neurologic (neurological examination): unknown  on unspecified date, psychiatric evaluation (psychiatric evaluation): unknown on unspecified date, GI ( x-ray gastrointestinal tract): unknown on unspecified date. The outcome of all event was not recovered.  Information on lot/batch number has been requested.; Sender's Comments: Based on plausible temporal relationship, a possible causal association between the reported events and the suspect drug BNT162B2 cannot be excluded. 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: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Weight decreased
Clinical narrative: intermittent vomiting; lack of energy; inertia; bedridden; constipation; This is a spontaneous report from a contactable physician.   A 18-year-old (non-pregnant) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration, administered on 15Apr2021 as SINGLE dose and patient administered second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration, administered on unspecified date in May2021 as SINGLE dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown patient did not receive other medications within 2 weeks of vaccination. The patient stated 4 days later she began to have intermittent vomiting, lack of energy, inertia on 19Apr2021. Over the next 8 weeks she went from being a healthy 18 year old who ran 6 miles a day to being bedridden on 19Apr2021. She has constipation on 19Apr2021 and requires bladder catheterization. She has been evaluated by multiple doctors including the (Withheld) and was to be evaluated yesterday at the (Withheld). She is too weak to travel by plane. The patient was hospitalized for intermittent vomiting, lack of energy, inertia and constipation for 8 days.  Prior to vaccination, the patient did not diagnosed with COVID-19. Since the vaccination, it was unknown if the patient tested for COVID-19. Therapeutic measures were taken as a result of intermittent vomiting, lack of energy, inertia, bedridden and constipation The patient underwent lab tests and procedures which included Cardiac ( investigation): unknown on unspecified date, Multiple MRIs (magnetic resonance imaging): unknown on unspecified date, Neurologic (neurological examination): unknown  on unspecified date, psychiatric evaluation (psychiatric evaluation): unknown on unspecified date, GI ( x-ray gastrointestinal tract): unknown on unspecified date. The outcome of all event was not recovered.  Information on lot/batch number has been requested.; Sender's Comments: Based on plausible temporal relationship, a possible causal association between the reported events and the suspect drug BNT162B2 cannot be excluded. 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: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Accommodation disorder, Asthenia, Bedridden, Constipation, Investigation
Clinical narrative: intermittent vomiting; lack of energy; inertia; bedridden; constipation; This is a spontaneous report from a contactable physician.   A 18-year-old (non-pregnant) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration, administered on 15Apr2021 as SINGLE dose and patient administered second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration, administered on unspecified date in May2021 as SINGLE dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown patient did not receive other medications within 2 weeks of vaccination. The patient stated 4 days later she began to have intermittent vomiting, lack of energy, inertia on 19Apr2021. Over the next 8 weeks she went from being a healthy 18 year old who ran 6 miles a day to being bedridden on 19Apr2021. She has constipation on 19Apr2021 and requires bladder catheterization. She has been evaluated by multiple doctors including the (Withheld) and was to be evaluated yesterday at the (Withheld). She is too weak to travel by plane. The patient was hospitalized for intermittent vomiting, lack of energy, inertia and constipation for 8 days.  Prior to vaccination, the patient did not diagnosed with COVID-19. Since the vaccination, it was unknown if the patient tested for COVID-19. Therapeutic measures were taken as a result of intermittent vomiting, lack of energy, inertia, bedridden and constipation The patient underwent lab tests and procedures which included Cardiac ( investigation): unknown on unspecified date, Multiple MRIs (magnetic resonance imaging): unknown on unspecified date, Neurologic (neurological examination): unknown  on unspecified date, psychiatric evaluation (psychiatric evaluation): unknown on unspecified date, GI ( x-ray gastrointestinal tract): unknown on unspecified date. The outcome of all event was not recovered.  Information on lot/batch number has been requested.; Sender's Comments: Based on plausible temporal relationship, a possible causal association between the reported events and the suspect drug BNT162B2 cannot be excluded. 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: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging, Neurological examination, Psychiatric evaluation, Vomiting, X-ray gastrointestinal tract
Clinical narrative: intermittent vomiting; lack of energy; inertia; bedridden; constipation; This is a spontaneous report from a contactable physician.   A 18-year-old (non-pregnant) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration, administered on 15Apr2021 as SINGLE dose and patient administered second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration, administered on unspecified date in May2021 as SINGLE dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown patient did not receive other medications within 2 weeks of vaccination. The patient stated 4 days later she began to have intermittent vomiting, lack of energy, inertia on 19Apr2021. Over the next 8 weeks she went from being a healthy 18 year old who ran 6 miles a day to being bedridden on 19Apr2021. She has constipation on 19Apr2021 and requires bladder catheterization. She has been evaluated by multiple doctors including the (Withheld) and was to be evaluated yesterday at the (Withheld). She is too weak to travel by plane. The patient was hospitalized for intermittent vomiting, lack of energy, inertia and constipation for 8 days.  Prior to vaccination, the patient did not diagnosed with COVID-19. Since the vaccination, it was unknown if the patient tested for COVID-19. Therapeutic measures were taken as a result of intermittent vomiting, lack of energy, inertia, bedridden and constipation The patient underwent lab tests and procedures which included Cardiac ( investigation): unknown on unspecified date, Multiple MRIs (magnetic resonance imaging): unknown on unspecified date, Neurologic (neurological examination): unknown  on unspecified date, psychiatric evaluation (psychiatric evaluation): unknown on unspecified date, GI ( x-ray gastrointestinal tract): unknown on unspecified date. The outcome of all event was not recovered.  Information on lot/batch number has been requested.; Sender's Comments: Based on plausible temporal relationship, a possible causal association between the reported events and the suspect drug BNT162B2 cannot be excluded. 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: 81.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Choking, Death, Drug reaction with eosinophilia and systemic symptoms, Dysphagia, Fatigue
Clinical narrative: Post-vaccine auto-immune reaction, organ failure (DRESS syndrome); This is a spontaneous report from a contactable consumer. An 81-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date not provide) on 23Mar2021 12:00 at age of 81 years old as single dose on left arm via an unspecified route of administration for COVID-19 immunization. Relevant medical history included hypertension, temporomandibular joint syndrome, tinnitus and joint discomfort. On 02Mar2021 at 12:00 PM at 81 years old, on Left arm the patient received first dose of BNT162B2 for COVID-19 immunization. Concomitant medications included hydrochlorothiazide, valsartan (CO-DIOVAN), vitamin D3, ginkgo biloba, collagen and melatonin. It was informed that on 29Apr2021 the patient died after developing a severe allergic auto-immune reaction, diagnosed as DRESS Syndrome, started on 24Mar2021 09:00. The adverse event result in emergency room visit and physician office visit. It was mentioned that patient was hospitalized 13 days due to the event and was treated with high-dose of cortico-steorids, antibiotics. It was also informed that It took a lot of effort by several doctors, and ultimately the intervention of a premiere infectious disease expert in another location, on 18Apr2021, to make a definitive diagnosis and to confirm it was a reaction to the Pfizer COVID vaccine. (as reported). The doctors tried but failed to save him, and he died on 29Apr2021 (as reported). The patient underwent a SARS-CoV-2 test (Blood test) on 28Apr2021 which resulted negative. An autopsy was not performed. Serious criteria was fatal, life-threatening and hospitalization.  The event [Post-vaccine auto-immune reaction, organ failure (DRESS syndrome)] occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency.  Information on the lot/batch number has been requested.  Follow-up (20May2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: updated the reporter's country.; Reported Cause(s) of Death: Post-vaccine auto-immune reaction, organ failure (DRESS syndrome)
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: General physical health deterioration, Hepatic failure, Hiccups, Multiple organ dysfunction syndrome, Pulmonary haemorrhage
Clinical narrative: Post-vaccine auto-immune reaction, organ failure (DRESS syndrome); This is a spontaneous report from a contactable consumer. An 81-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date not provide) on 23Mar2021 12:00 at age of 81 years old as single dose on left arm via an unspecified route of administration for COVID-19 immunization. Relevant medical history included hypertension, temporomandibular joint syndrome, tinnitus and joint discomfort. On 02Mar2021 at 12:00 PM at 81 years old, on Left arm the patient received first dose of BNT162B2 for COVID-19 immunization. Concomitant medications included hydrochlorothiazide, valsartan (CO-DIOVAN), vitamin D3, ginkgo biloba, collagen and melatonin. It was informed that on 29Apr2021 the patient died after developing a severe allergic auto-immune reaction, diagnosed as DRESS Syndrome, started on 24Mar2021 09:00. The adverse event result in emergency room visit and physician office visit. It was mentioned that patient was hospitalized 13 days due to the event and was treated with high-dose of cortico-steorids, antibiotics. It was also informed that It took a lot of effort by several doctors, and ultimately the intervention of a premiere infectious disease expert in another location, on 18Apr2021, to make a definitive diagnosis and to confirm it was a reaction to the Pfizer COVID vaccine. (as reported). The doctors tried but failed to save him, and he died on 29Apr2021 (as reported). The patient underwent a SARS-CoV-2 test (Blood test) on 28Apr2021 which resulted negative. An autopsy was not performed. Serious criteria was fatal, life-threatening and hospitalization.  The event [Post-vaccine auto-immune reaction, organ failure (DRESS syndrome)] occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency.  Information on the lot/batch number has been requested.  Follow-up (20May2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: updated the reporter's country.; Reported Cause(s) of Death: Post-vaccine auto-immune reaction, organ failure (DRESS syndrome)
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash, Renal failure, Vaccination complication
Clinical narrative: Post-vaccine auto-immune reaction, organ failure (DRESS syndrome); This is a spontaneous report from a contactable consumer. An 81-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date not provide) on 23Mar2021 12:00 at age of 81 years old as single dose on left arm via an unspecified route of administration for COVID-19 immunization. Relevant medical history included hypertension, temporomandibular joint syndrome, tinnitus and joint discomfort. On 02Mar2021 at 12:00 PM at 81 years old, on Left arm the patient received first dose of BNT162B2 for COVID-19 immunization. Concomitant medications included hydrochlorothiazide, valsartan (CO-DIOVAN), vitamin D3, ginkgo biloba, collagen and melatonin. It was informed that on 29Apr2021 the patient died after developing a severe allergic auto-immune reaction, diagnosed as DRESS Syndrome, started on 24Mar2021 09:00. The adverse event result in emergency room visit and physician office visit. It was mentioned that patient was hospitalized 13 days due to the event and was treated with high-dose of cortico-steorids, antibiotics. It was also informed that It took a lot of effort by several doctors, and ultimately the intervention of a premiere infectious disease expert in another location, on 18Apr2021, to make a definitive diagnosis and to confirm it was a reaction to the Pfizer COVID vaccine. (as reported). The doctors tried but failed to save him, and he died on 29Apr2021 (as reported). The patient underwent a SARS-CoV-2 test (Blood test) on 28Apr2021 which resulted negative. An autopsy was not performed. Serious criteria was fatal, life-threatening and hospitalization.  The event [Post-vaccine auto-immune reaction, organ failure (DRESS syndrome)] occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency.  Information on the lot/batch number has been requested.  Follow-up (20May2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: updated the reporter's country.; Reported Cause(s) of Death: Post-vaccine auto-immune reaction, organ failure (DRESS syndrome)
Age: 81.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Drug reaction with eosinophilia and systemic symptoms, SARS-CoV-2 test
Clinical narrative: Post-vaccine auto-immune reaction, organ failure (DRESS syndrome); This is a spontaneous report from a contactable consumer. An 81-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date not provide) on 23Mar2021 12:00 at age of 81 years old as single dose on left arm via an unspecified route of administration for COVID-19 immunization. Relevant medical history included hypertension, temporomandibular joint syndrome, tinnitus and joint discomfort. On 02Mar2021 at 12:00 PM at 81 years old, on Left arm the patient received first dose of BNT162B2 for COVID-19 immunization. Concomitant medications included hydrochlorothiazide, valsartan (CO-DIOVAN), vitamin D3, ginkgo biloba, collagen and melatonin. It was informed that on 29Apr2021 the patient died after developing a severe allergic auto-immune reaction, diagnosed as DRESS Syndrome, started on 24Mar2021 09:00. The adverse event result in emergency room visit and physician office visit. It was mentioned that patient was hospitalized 13 days due to the event and was treated with high-dose of cortico-steorids, antibiotics. It was also informed that It took a lot of effort by several doctors, and ultimately the intervention of a premiere infectious disease expert in another location, on 18Apr2021, to make a definitive diagnosis and to confirm it was a reaction to the Pfizer COVID vaccine. (as reported). The doctors tried but failed to save him, and he died on 29Apr2021 (as reported). The patient underwent a SARS-CoV-2 test (Blood test) on 28Apr2021 which resulted negative. An autopsy was not performed. Serious criteria was fatal, life-threatening and hospitalization.  The event [Post-vaccine auto-immune reaction, organ failure (DRESS syndrome)] occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency.  Information on the lot/batch number has been requested.  Follow-up (20May2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: updated the reporter's country.; Reported Cause(s) of Death: Post-vaccine auto-immune reaction, organ failure (DRESS syndrome)
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Pain in extremity, Skin burning sensation
Clinical narrative: Dizziness, light headedness, left sided abdominal pain, felt like she was "floating", sweating.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Dizziness, Feeling abnormal, Hyperhidrosis
Clinical narrative: Dizziness, light headedness, left sided abdominal pain, felt like she was "floating", sweating.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Eye inflammation, Laboratory test normal, Macular fibrosis, SARS-CoV-2 antibody test positive
Clinical narrative: Covid test result=Positive; Covid test result=Positive; Vision in R eye became blurry and wavy 10 days after receiving 1st shot. Macular change was detected. Vision was 20/60 in R eye; Vision in R eye became blurry and wavy 10 days after receiving 1st shot. Macular change was detected. Vision was 20/60 in R eye; This is a spontaneous report from a contactable consumer (patient). A 16-years-old male patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, Lot number: EW0153), via an unspecified route of administration, administered in left arm on 07Apr2021 at 12:00 (at the age of 16-years-old) as single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included methylphenidate hydrochloride (CONCERTA) received in two weeks. The patient had no known allergies. The patient did not receive other vaccine in four weeks. Prior to vaccination, the patient did not had COVID. On 18Apr2021 at 12:00, the patient experienced "vision in R eye became blurry and wavy 10 days after receiving 1st shot, macular change was detected, vision was 20/60 in R eye". The events vision blurred and eye disorder resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage. On 23Apr2021, the patient experienced COVID test result=positive. The patient received treatment for the events vision blurred and eye disorder, and surgery would be scheduled in next couple weeks. The outcome of the event COVID-19 was unknown and for the rest of the events was not resolved.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Surgery, Vision blurred, Vomiting
Clinical narrative: Covid test result=Positive; Covid test result=Positive; Vision in R eye became blurry and wavy 10 days after receiving 1st shot. Macular change was detected. Vision was 20/60 in R eye; Vision in R eye became blurry and wavy 10 days after receiving 1st shot. Macular change was detected. Vision was 20/60 in R eye; This is a spontaneous report from a contactable consumer (patient). A 16-years-old male patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, Lot number: EW0153), via an unspecified route of administration, administered in left arm on 07Apr2021 at 12:00 (at the age of 16-years-old) as single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included methylphenidate hydrochloride (CONCERTA) received in two weeks. The patient had no known allergies. The patient did not receive other vaccine in four weeks. Prior to vaccination, the patient did not had COVID. On 18Apr2021 at 12:00, the patient experienced "vision in R eye became blurry and wavy 10 days after receiving 1st shot, macular change was detected, vision was 20/60 in R eye". The events vision blurred and eye disorder resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage. On 23Apr2021, the patient experienced COVID test result=positive. The patient received treatment for the events vision blurred and eye disorder, and surgery would be scheduled in next couple weeks. The outcome of the event COVID-19 was unknown and for the rest of the events was not resolved.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Eye disorder, SARS-CoV-2 test positive, Vision blurred
Clinical narrative: Covid test result=Positive; Covid test result=Positive; Vision in R eye became blurry and wavy 10 days after receiving 1st shot. Macular change was detected. Vision was 20/60 in R eye; Vision in R eye became blurry and wavy 10 days after receiving 1st shot. Macular change was detected. Vision was 20/60 in R eye; This is a spontaneous report from a contactable consumer (patient). A 16-years-old male patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, Lot number: EW0153), via an unspecified route of administration, administered in left arm on 07Apr2021 at 12:00 (at the age of 16-years-old) as single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included methylphenidate hydrochloride (CONCERTA) received in two weeks. The patient had no known allergies. The patient did not receive other vaccine in four weeks. Prior to vaccination, the patient did not had COVID. On 18Apr2021 at 12:00, the patient experienced "vision in R eye became blurry and wavy 10 days after receiving 1st shot, macular change was detected, vision was 20/60 in R eye". The events vision blurred and eye disorder resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage. On 23Apr2021, the patient experienced COVID test result=positive. The patient received treatment for the events vision blurred and eye disorder, and surgery would be scheduled in next couple weeks. The outcome of the event COVID-19 was unknown and for the rest of the events was not resolved.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Vaccination Error. Patient needed Moderna Vaccine but received the Pfizer vaccine.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anticoagulant therapy, Heart rate abnormal, Intracardiac thrombus, Joint swelling, Peripheral swelling
Clinical narrative: On July 15 I had surgery to remove significant blood clots from my heart and lungs as a result from a saddle pulmonary embolism. I have done testing to eliminate Cancer, Hereditary and red blood cells; On July 15 I had surgery to remove significant blood clots from my heart and lungs as a result from a saddle pulmonary embolism. I have done testing to eliminate Cancer, Hereditary and red blood cells; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0153; Expiry date: unknown) via an unspecified route of administration, administered in arm right on 15Apr2021 13:00 (at age of 59-year-old) as dose 2, single for COVID-19 immunization. Medical history included chronic low back pain from multiple back surgeries and allergy to sulfa from an unknown date and unknown if ongoing. Concomitant medications included magnesium sulfate, Vitamin D Nos taken for an unspecified indication. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6207; Expiry date: unknown) on 25Mar2021 at 13:00 (at age of 59-year-old) as dose 1 single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that, on July 15 patient had surgery to remove significant blood clots from his heart and lungs as a result from a saddle pulmonary embolism which was reported on 14Jul2021 (at 04:00). patient had done testing to eliminate cancer, hereditary and red blood cells for as a cause 8 days. The adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient was hospitalized due to adverse event. Therapeutic measures were taken as a result of adverse event as patient underwent surgery (to remove significant blood clots from heart and lungs as a result from a saddle pulmonary embolism) on 15Jul2021 and unspecified medication. The outcome of events was resolving.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pulmonary embolism, Pulmonary thrombosis, Red blood cell count, Surgery, Thrombectomy
Clinical narrative: On July 15 I had surgery to remove significant blood clots from my heart and lungs as a result from a saddle pulmonary embolism. I have done testing to eliminate Cancer, Hereditary and red blood cells; On July 15 I had surgery to remove significant blood clots from my heart and lungs as a result from a saddle pulmonary embolism. I have done testing to eliminate Cancer, Hereditary and red blood cells; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0153; Expiry date: unknown) via an unspecified route of administration, administered in arm right on 15Apr2021 13:00 (at age of 59-year-old) as dose 2, single for COVID-19 immunization. Medical history included chronic low back pain from multiple back surgeries and allergy to sulfa from an unknown date and unknown if ongoing. Concomitant medications included magnesium sulfate, Vitamin D Nos taken for an unspecified indication. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6207; Expiry date: unknown) on 25Mar2021 at 13:00 (at age of 59-year-old) as dose 1 single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that, on July 15 patient had surgery to remove significant blood clots from his heart and lungs as a result from a saddle pulmonary embolism which was reported on 14Jul2021 (at 04:00). patient had done testing to eliminate cancer, hereditary and red blood cells for as a cause 8 days. The adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient was hospitalized due to adverse event. Therapeutic measures were taken as a result of adverse event as patient underwent surgery (to remove significant blood clots from heart and lungs as a result from a saddle pulmonary embolism) on 15Jul2021 and unspecified medication. The outcome of events was resolving.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Thrombosis
Clinical narrative: On July 15 I had surgery to remove significant blood clots from my heart and lungs as a result from a saddle pulmonary embolism. I have done testing to eliminate Cancer, Hereditary and red blood cells; On July 15 I had surgery to remove significant blood clots from my heart and lungs as a result from a saddle pulmonary embolism. I have done testing to eliminate Cancer, Hereditary and red blood cells; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0153; Expiry date: unknown) via an unspecified route of administration, administered in arm right on 15Apr2021 13:00 (at age of 59-year-old) as dose 2, single for COVID-19 immunization. Medical history included chronic low back pain from multiple back surgeries and allergy to sulfa from an unknown date and unknown if ongoing. Concomitant medications included magnesium sulfate, Vitamin D Nos taken for an unspecified indication. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6207; Expiry date: unknown) on 25Mar2021 at 13:00 (at age of 59-year-old) as dose 1 single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that, on July 15 patient had surgery to remove significant blood clots from his heart and lungs as a result from a saddle pulmonary embolism which was reported on 14Jul2021 (at 04:00). patient had done testing to eliminate cancer, hereditary and red blood cells for as a cause 8 days. The adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient was hospitalized due to adverse event. Therapeutic measures were taken as a result of adverse event as patient underwent surgery (to remove significant blood clots from heart and lungs as a result from a saddle pulmonary embolism) on 15Jul2021 and unspecified medication. The outcome of events was resolving.
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pulmonary embolism, Thrombosis
Clinical narrative: On July 15 I had surgery to remove significant blood clots from my heart and lungs as a result from a saddle pulmonary embolism. I have done testing to eliminate Cancer, Hereditary and red blood cells; On July 15 I had surgery to remove significant blood clots from my heart and lungs as a result from a saddle pulmonary embolism. I have done testing to eliminate Cancer, Hereditary and red blood cells; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0153; Expiry date: unknown) via an unspecified route of administration, administered in arm right on 15Apr2021 13:00 (at age of 59-year-old) as dose 2, single for COVID-19 immunization. Medical history included chronic low back pain from multiple back surgeries and allergy to sulfa from an unknown date and unknown if ongoing. Concomitant medications included magnesium sulfate, Vitamin D Nos taken for an unspecified indication. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6207; Expiry date: unknown) on 25Mar2021 at 13:00 (at age of 59-year-old) as dose 1 single for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that, on July 15 patient had surgery to remove significant blood clots from his heart and lungs as a result from a saddle pulmonary embolism which was reported on 14Jul2021 (at 04:00). patient had done testing to eliminate cancer, hereditary and red blood cells for as a cause 8 days. The adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient was hospitalized due to adverse event. Therapeutic measures were taken as a result of adverse event as patient underwent surgery (to remove significant blood clots from heart and lungs as a result from a saddle pulmonary embolism) on 15Jul2021 and unspecified medication. The outcome of events was resolving.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute respiratory failure, Asthenia, Cardiac arrest, Dyspnoea, Electromyogram abnormal
Clinical narrative: 7/19 numbness leading to paraplegia on 8/1
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Endotracheal intubation, Eye movement disorder, Facial paralysis, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: 7/19 numbness leading to paraplegia on 8/1
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Immunoglobulin therapy, Lumbar puncture abnormal, Magnetic resonance imaging head normal, Magnetic resonance imaging spinal normal, Motor dysfunction
Clinical narrative: 7/19 numbness leading to paraplegia on 8/1
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nerve conduction studies abnormal, Paraesthesia, Unresponsive to stimuli
Clinical narrative: 7/19 numbness leading to paraplegia on 8/1
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood glucose normal, CSF protein increased, CSF test abnormal, Cytomegalovirus test, Demyelinating polyneuropathy
Clinical narrative: 7/19 numbness leading to paraplegia on 8/1
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electromyogram abnormal, Epstein-Barr virus test negative, Gram stain negative, Guillain-Barre syndrome, Herpes simplex test negative
Clinical narrative: 7/19 numbness leading to paraplegia on 8/1
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Inflammation, Paraplegia, Red blood cell count decreased, Viral test
Clinical narrative: 7/19 numbness leading to paraplegia on 8/1
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: White blood cell count decreased
Clinical narrative: 7/19 numbness leading to paraplegia on 8/1
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bladder catheterisation, Cardiac arrest, Catheter placement, Chest X-ray, Computerised tomogram
Clinical narrative: 7/19 numbness leading to paraplegia on 8/1
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeding disorder, Gait inability, Gastrointestinal tube insertion, Grip strength decreased, Guillain-Barre syndrome
Clinical narrative: 7/19 numbness leading to paraplegia on 8/1
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia, Immunoglobulin therapy, Intensive care, Lumbar puncture, Magnetic resonance imaging
Clinical narrative: 7/19 numbness leading to paraplegia on 8/1
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Mechanical ventilation, Paralysis, Platelet rich plasma therapy, Refusal of treatment by patient, Respiration abnormal
Clinical narrative: 7/19 numbness leading to paraplegia on 8/1
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Respiratory arrest, Speech disorder, Tracheostomy
Clinical narrative: 7/19 numbness leading to paraplegia on 8/1
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Dysphagia, Dyspnoea, Speech disorder, Throat tightness
Clinical narrative: Approximately 8 minutes after receiving vaccine, patient complained of throat tightness and shortness of breath. Patient was given diphenhydramine 50mg and epinephrine 0.3 mg. 911 was called and patient was transferred by EMT to nearby hospital emergency room.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Throat tightness
Clinical narrative: Approximately 8 minutes after receiving vaccine, patient complained of throat tightness and shortness of breath. Patient was given diphenhydramine 50mg and epinephrine 0.3 mg. 911 was called and patient was transferred by EMT to nearby hospital emergency room.
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2, Headache, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: Asymptomatic
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test positive
Clinical narrative: Asymptomatic
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Extra dose administered
Clinical narrative: I received my COVID (moderna) vaccines on 2/13/21 and 3/13/21. My doctor gave me orders to get my shingles vaccination. My first shot was given at the pharmacy on 6/3/21. When I went to get my second shingles vaccination at the pharmacy on 8/3/21, I was mistakenly given an additional COVID (pfizer) vaccination. On 8/4/21 I started having headaches unresolved by medication, heart palpitations, fatigue, joint pain, and low grade fever. I reported it to physician on 8/4/21 and the regulatory authority on 8/5/21. I was told to monitor my symptoms and stay hydrated. If the palpitations do not subside to contact my physician or call emergency services if my condition gets any worse.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Arthralgia, Extra dose administered, Fatigue, Headache, Interchange of vaccine products
Clinical narrative: I received my COVID (moderna) vaccines on 2/13/21 and 3/13/21. My doctor gave me orders to get my shingles vaccination. My first shot was given at the pharmacy on 6/3/21. When I went to get my second shingles vaccination at the pharmacy on 8/3/21, I was mistakenly given an additional COVID (pfizer) vaccination. On 8/4/21 I started having headaches unresolved by medication, heart palpitations, fatigue, joint pain, and low grade fever. I reported it to physician on 8/4/21 and the regulatory authority on 8/5/21. I was told to monitor my symptoms and stay hydrated. If the palpitations do not subside to contact my physician or call emergency services if my condition gets any worse.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Palpitations, Pyrexia, Wrong product administered
Clinical narrative: I received my COVID (moderna) vaccines on 2/13/21 and 3/13/21. My doctor gave me orders to get my shingles vaccination. My first shot was given at the pharmacy on 6/3/21. When I went to get my second shingles vaccination at the pharmacy on 8/3/21, I was mistakenly given an additional COVID (pfizer) vaccination. On 8/4/21 I started having headaches unresolved by medication, heart palpitations, fatigue, joint pain, and low grade fever. I reported it to physician on 8/4/21 and the regulatory authority on 8/5/21. I was told to monitor my symptoms and stay hydrated. If the palpitations do not subside to contact my physician or call emergency services if my condition gets any worse.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Facial paralysis, Fatigue, Headache
Clinical narrative: contracting and then drooping muscles on the left side of my upper body and face, blurry vision to the point of causing dizziness and vertigo.  Extreme fatigue, uncontrolable chills. Severe headache. Severe muscle cramping.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Hemiparesis, Muscle contractions involuntary, Muscle spasms, Vertigo, Vision blurred
Clinical narrative: contracting and then drooping muscles on the left side of my upper body and face, blurry vision to the point of causing dizziness and vertigo.  Extreme fatigue, uncontrolable chills. Severe headache. Severe muscle cramping.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Paraesthesia, Pyrexia
Clinical narrative: Fever and tingling/burning sensation in hands and feet. Fever is lasted roughly 48hrs but the tingling/burning sensation is still present as of 08/05.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site pain
Clinical narrative: Sore arm at injection site
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Arm is swollen,  red and itchy