chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Herpes simplex test, Immunoglobulin therapy, Lethargy, Magnetic resonance imaging head abnormal
Clinical narrative: Small stroke; Meningitis; Acute encephalitis; I lost my balance and endurance; could not walk on my own; This is a spontaneous report received from a contactable consumer reporting for himself. A 62-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 62 years old on 20Apr2021 (Lot number EW0161) on Right arm at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. Medical history included high cholesterol, depression, anxiety. Concomitant medications included colecalciferol (VITAMIN D), venlafaxine, acetylsalicylic acid (ASPRIN), atorvastatin. Historical Vaccine included first dose of BNT162B2 (Lot number ER8734) at the age of 62 years old on 30Mar2021 on Right arm for COVID-19 immunization. The patient stated "I could not walk on my own. I lost my balance and endurance. I spent two weeks in the hospital with a diagnosis of meningitis and acute encephalitis. I also had a small stroke. I am learning how to do everything again. I have outpatient physical therapy and occupational therapy along with several follow up appointments." The events start date were on 24Apr2021. All events resulted in Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. Number days hospitalization was 15 days. Lab data also included Nasal Swab on 29Apr2021 with Negative result. Treatment received for the events included IVIg therapy, antibiotics, PT, OT, SLP. The outcome of the events were not resolved.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Tremor, Varicella virus test
Clinical narrative: Small stroke; Meningitis; Acute encephalitis; I lost my balance and endurance; could not walk on my own; This is a spontaneous report received from a contactable consumer reporting for himself. A 62-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 62 years old on 20Apr2021 (Lot number EW0161) on Right arm at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. Medical history included high cholesterol, depression, anxiety. Concomitant medications included colecalciferol (VITAMIN D), venlafaxine, acetylsalicylic acid (ASPRIN), atorvastatin. Historical Vaccine included first dose of BNT162B2 (Lot number ER8734) at the age of 62 years old on 30Mar2021 on Right arm for COVID-19 immunization. The patient stated "I could not walk on my own. I lost my balance and endurance. I spent two weeks in the hospital with a diagnosis of meningitis and acute encephalitis. I also had a small stroke. I am learning how to do everything again. I have outpatient physical therapy and occupational therapy along with several follow up appointments." The events start date were on 24Apr2021. All events resulted in Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. Number days hospitalization was 15 days. Lab data also included Nasal Swab on 29Apr2021 with Negative result. Treatment received for the events included IVIg therapy, antibiotics, PT, OT, SLP. The outcome of the events were not resolved.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Blood cholesterol, Cerebrovascular accident, Encephalitis, Gait inability
Clinical narrative: Small stroke; Meningitis; Acute encephalitis; I lost my balance and endurance; could not walk on my own; This is a spontaneous report received from a contactable consumer reporting for himself. A 62-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 62 years old on 20Apr2021 (Lot number EW0161) on Right arm at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. Medical history included high cholesterol, depression, anxiety. Concomitant medications included colecalciferol (VITAMIN D), venlafaxine, acetylsalicylic acid (ASPRIN), atorvastatin. Historical Vaccine included first dose of BNT162B2 (Lot number ER8734) at the age of 62 years old on 30Mar2021 on Right arm for COVID-19 immunization. The patient stated "I could not walk on my own. I lost my balance and endurance. I spent two weeks in the hospital with a diagnosis of meningitis and acute encephalitis. I also had a small stroke. I am learning how to do everything again. I have outpatient physical therapy and occupational therapy along with several follow up appointments." The events start date were on 24Apr2021. All events resulted in Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. Number days hospitalization was 15 days. Lab data also included Nasal Swab on 29Apr2021 with Negative result. Treatment received for the events included IVIg therapy, antibiotics, PT, OT, SLP. The outcome of the events were not resolved.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Meningitis, SARS-CoV-2 test
Clinical narrative: Small stroke; Meningitis; Acute encephalitis; I lost my balance and endurance; could not walk on my own; This is a spontaneous report received from a contactable consumer reporting for himself. A 62-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the age of 62 years old on 20Apr2021 (Lot number EW0161) on Right arm at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. Medical history included high cholesterol, depression, anxiety. Concomitant medications included colecalciferol (VITAMIN D), venlafaxine, acetylsalicylic acid (ASPRIN), atorvastatin. Historical Vaccine included first dose of BNT162B2 (Lot number ER8734) at the age of 62 years old on 30Mar2021 on Right arm for COVID-19 immunization. The patient stated "I could not walk on my own. I lost my balance and endurance. I spent two weeks in the hospital with a diagnosis of meningitis and acute encephalitis. I also had a small stroke. I am learning how to do everything again. I have outpatient physical therapy and occupational therapy along with several follow up appointments." The events start date were on 24Apr2021. All events resulted in Emergency room/department or urgent care, Hospitalization, Disability or permanent damage. Number days hospitalization was 15 days. Lab data also included Nasal Swab on 29Apr2021 with Negative result. Treatment received for the events included IVIg therapy, antibiotics, PT, OT, SLP. The outcome of the events were not resolved.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthma, Dyspnoea
Clinical narrative: she cannot breathe; hasn't been able to work or walk; hasn't been able to work or walk; This is a spontaneous report from a contactable consumer (patient's mother) who reported for the patient.   A 42 year old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ek5730; Expiration date: UNKNOWN), via an unspecified route of administration on 08Jan2021 as single dose for COVID-19 immunisation. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: ek5730), on 18Dec2020. Patient's medical history and concomitant medications were not reported.   The reporter stated that, the patient (daughter) had trouble breathing after 6 hours after receiving the second shot and was not been able to work or walk since then. The patient had been admitted to the ICU (intensive care unit) in PRIVACY 4-5 times. The patient had sleep studies performed and she was most recently seen in the ER (emergency room) yesterday. The patient had been on Steroids since January. The reporter stated that "Something is wrong with her lungs where she can not breath". The patient was treated with steroids for the event difficulty breathing. The outcome of the events were unknown.; Sender's Comments: Linked Report(s) : 00240201  INT linked
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Gait inability, Impaired work ability, Intensive care, Lung disorder
Clinical narrative: she cannot breathe; hasn't been able to work or walk; hasn't been able to work or walk; This is a spontaneous report from a contactable consumer (patient's mother) who reported for the patient.   A 42 year old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ek5730; Expiration date: UNKNOWN), via an unspecified route of administration on 08Jan2021 as single dose for COVID-19 immunisation. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: ek5730), on 18Dec2020. Patient's medical history and concomitant medications were not reported.   The reporter stated that, the patient (daughter) had trouble breathing after 6 hours after receiving the second shot and was not been able to work or walk since then. The patient had been admitted to the ICU (intensive care unit) in PRIVACY 4-5 times. The patient had sleep studies performed and she was most recently seen in the ER (emergency room) yesterday. The patient had been on Steroids since January. The reporter stated that "Something is wrong with her lungs where she can not breath". The patient was treated with steroids for the event difficulty breathing. The outcome of the events were unknown.; Sender's Comments: Linked Report(s) : 00240201  INT linked
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sleep study
Clinical narrative: she cannot breathe; hasn't been able to work or walk; hasn't been able to work or walk; This is a spontaneous report from a contactable consumer (patient's mother) who reported for the patient.   A 42 year old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ek5730; Expiration date: UNKNOWN), via an unspecified route of administration on 08Jan2021 as single dose for COVID-19 immunisation. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: ek5730), on 18Dec2020. Patient's medical history and concomitant medications were not reported.   The reporter stated that, the patient (daughter) had trouble breathing after 6 hours after receiving the second shot and was not been able to work or walk since then. The patient had been admitted to the ICU (intensive care unit) in PRIVACY 4-5 times. The patient had sleep studies performed and she was most recently seen in the ER (emergency room) yesterday. The patient had been on Steroids since January. The reporter stated that "Something is wrong with her lungs where she can not breath". The patient was treated with steroids for the event difficulty breathing. The outcome of the events were unknown.; Sender's Comments: Linked Report(s) : 00240201  INT linked
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: Pain in legs leading  to Guillain-Barré syndrome.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome, Magnetic resonance imaging abnormal, Nerve injury, Pain in extremity
Clinical narrative: Pain in legs leading  to Guillain-Barré syndrome.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer concerned a 51 year old female. The patient's weight was 130 pounds, and height was 60 inches. The patient's concurrent conditions included COPD (Chronic obstructive pulmonary disease) and ex-alcohol user. The patient had no known allergies. The patient had drug abuse or illicit drug usage in past The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: 23-JUN-2021) dose was not reported, administered, 1 total on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-MAY-2021, 5 days after vaccination the patient died. Consumer was waiting toxicology reports of patient at the time of reporting. On 03-MAY-2021, the subject died from unknown cause of death. An autopsy was not performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20210546992 -covid-19 vaccine ad26.cov2.s-Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Discomfort, Incorrect route of product administration, Mobility decreased, Pain
Clinical narrative: severe shoulder pain which is not getting much better almost a month after the injection.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia
Clinical narrative: severe shoulder pain which is not getting much better almost a month after the injection.
Age: 87.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death
Clinical narrative: Patient hospitalized on 4/4/2021 after testing positive for COVID-19. Patient was fully vaccinated. Patient died 4/13/2021.
Age: 87.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: Patient hospitalized on 4/4/2021 after testing positive for COVID-19. Patient was fully vaccinated. Patient died 4/13/2021.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Biopsy heart, Cardiomyopathy, Eosinophilia, Eosinophilic myocarditis, Intensive care
Clinical narrative: Eosinophilic myocarditis presenting as pleuritic chest pain, elevated troponin and cardiogenic pulmonary edema related to heart failure, ejection fraction and improved and patient successfully discharge from the hospital. Of note, patient also tested positive for rhino/entero on RVP and FIP1L1-PDGFRA rearrangement.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interferon gamma normal, Magnetic resonance imaging abnormal, Smear site unspecified normal
Clinical narrative: Eosinophilic myocarditis presenting as pleuritic chest pain, elevated troponin and cardiogenic pulmonary edema related to heart failure, ejection fraction and improved and patient successfully discharge from the hospital. Of note, patient also tested positive for rhino/entero on RVP and FIP1L1-PDGFRA rearrangement.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac failure, Chest pain, Ejection fraction, Enterovirus test positive, Eosinophilic myocarditis
Clinical narrative: Eosinophilic myocarditis presenting as pleuritic chest pain, elevated troponin and cardiogenic pulmonary edema related to heart failure, ejection fraction and improved and patient successfully discharge from the hospital. Of note, patient also tested positive for rhino/entero on RVP and FIP1L1-PDGFRA rearrangement.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Human rhinovirus test positive, Pleuritic pain, Pulmonary oedema, Respiratory viral panel, Troponin increased
Clinical narrative: Eosinophilic myocarditis presenting as pleuritic chest pain, elevated troponin and cardiogenic pulmonary edema related to heart failure, ejection fraction and improved and patient successfully discharge from the hospital. Of note, patient also tested positive for rhino/entero on RVP and FIP1L1-PDGFRA rearrangement.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Biopsy artery, Blindness, Blood test, Laboratory test
Clinical narrative: Neuromyelitis optica (G36.0)   sudden change in vision OS and now OU 4-1-21
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia
Clinical narrative: Neuromyelitis optica (G36.0)   sudden change in vision OS and now OU 4-1-21
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy artery, Magnetic resonance imaging, Neuromyelitis optica spectrum disorder, Visual impairment
Clinical narrative: Neuromyelitis optica (G36.0)   sudden change in vision OS and now OU 4-1-21
Sex: U
Vaccine: COVID19, UNK, COVID19
Symptoms: Atrial fibrillation, Extra dose administered, Fatigue, Inappropriate schedule of product administration, Pyrexia
Clinical narrative: 104 temperature; afib; he had to get a third dose on 21Apr2021; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2, dose 3 via an unspecified route of administration on 21Apr2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 10Mar2021, he got the first vaccine, then on 31Mar2021 he got the second vaccine and found out the hospital had 92 good vaccines and 6 that were just saline so he had to get a third dose on 21Apr2021 and ended up with a 104 temperature and afib, he was in the hospital for 4 days and then home for 8 days. He had blood work done for his chemo keydruda and his calcium was 14.5 and his creatine was high, he went to (hospital name) and was given Lasix and peed a lot, the calcium level took 5 days to get down from 14 to 10. The patient was hospitalized due to events for 4 days and assessed as medically significant. Outcome of the events was unknown. Therapeutic measures were taken as a result of 104 temperature (pyrexia) and afib (atrial fibrillation).  Information on lot/batch has been requested.
Sex: U
Vaccine: COVID19, UNK, COVID19
Symptoms: Atrial fibrillation, Blood calcium, Blood creatine, Blood test, Body temperature
Clinical narrative: 104 temperature; afib; he had to get a third dose on 21Apr2021; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2, dose 3 via an unspecified route of administration on 21Apr2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 10Mar2021, he got the first vaccine, then on 31Mar2021 he got the second vaccine and found out the hospital had 92 good vaccines and 6 that were just saline so he had to get a third dose on 21Apr2021 and ended up with a 104 temperature and afib, he was in the hospital for 4 days and then home for 8 days. He had blood work done for his chemo keydruda and his calcium was 14.5 and his creatine was high, he went to (hospital name) and was given Lasix and peed a lot, the calcium level took 5 days to get down from 14 to 10. The patient was hospitalized due to events for 4 days and assessed as medically significant. Outcome of the events was unknown. Therapeutic measures were taken as a result of 104 temperature (pyrexia) and afib (atrial fibrillation).  Information on lot/batch has been requested.
Sex: U
Vaccine: COVID19, UNK, COVID19
Symptoms: Incorrect dose administered, Pyrexia
Clinical narrative: 104 temperature; afib; he had to get a third dose on 21Apr2021; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2, dose 3 via an unspecified route of administration on 21Apr2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 10Mar2021, he got the first vaccine, then on 31Mar2021 he got the second vaccine and found out the hospital had 92 good vaccines and 6 that were just saline so he had to get a third dose on 21Apr2021 and ended up with a 104 temperature and afib, he was in the hospital for 4 days and then home for 8 days. He had blood work done for his chemo keydruda and his calcium was 14.5 and his creatine was high, he went to (hospital name) and was given Lasix and peed a lot, the calcium level took 5 days to get down from 14 to 10. The patient was hospitalized due to events for 4 days and assessed as medically significant. Outcome of the events was unknown. Therapeutic measures were taken as a result of 104 temperature (pyrexia) and afib (atrial fibrillation).  Information on lot/batch has been requested.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Campylobacter infection, Computerised tomogram, Guillain-Barre syndrome, Laboratory test
Clinical narrative: Acute somnolence; Flaccid Areflexia in legs; Suspected Guillain-Barre Syndrome; Possible linkage to simultaneous campylobacter infection; This is a spontaneous report from a contactable consumer (patent). A 16-years-old male patient received bnt162b2 (FIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration,  in Arm Left (at the age of 16 years old) on 01May2021 at 10:00 (Batch/Lot Number: ER8736) as 1ST DOSE, SINGLE for covid-19 immunization. Medical history included campylobacter infection from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medication included lisdexamfetamine mesilate (VYVANSE) taken for an unspecified indication, start and stop date were not reported. The facility in which the most recent COVID-19 vaccine was administered was a Public Health Clinic/Administration facility. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced Acute somnolence, Flaccid areflexia in legs, Suspected Guillain-Barre Syndrome, Possible linkage to simultaneous campylobacter infection on 03May2021 at 0000. The events required an emergency room visit. The patient was hospitalized for acute somnolence, flaccid areflexia in legs, suspected guillain-barre syndrome, possible linkage to simultaneous campylobacter infection from 2021 to an unknown date for 5 days. The patient underwent lab tests and procedures which included polymerase chain reaction (post vaccination) results: negative on 09May2021 (Nasal Swab). Therapeutic measures were taken as a result of acute somnolence, flaccid areflexia in legs, suspected guillain-barre syndrome, possible linkage to simultaneous campylobacter infection. Treatment included IV immunoglobulin. The clinical outcome of the events was not recovered. Additional information was requested.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lumbar puncture, Magnetic resonance imaging head, Magnetic resonance imaging spinal, Narcolepsy, Polymerase chain reaction
Clinical narrative: Acute somnolence; Flaccid Areflexia in legs; Suspected Guillain-Barre Syndrome; Possible linkage to simultaneous campylobacter infection; This is a spontaneous report from a contactable consumer (patent). A 16-years-old male patient received bnt162b2 (FIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration,  in Arm Left (at the age of 16 years old) on 01May2021 at 10:00 (Batch/Lot Number: ER8736) as 1ST DOSE, SINGLE for covid-19 immunization. Medical history included campylobacter infection from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medication included lisdexamfetamine mesilate (VYVANSE) taken for an unspecified indication, start and stop date were not reported. The facility in which the most recent COVID-19 vaccine was administered was a Public Health Clinic/Administration facility. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced Acute somnolence, Flaccid areflexia in legs, Suspected Guillain-Barre Syndrome, Possible linkage to simultaneous campylobacter infection on 03May2021 at 0000. The events required an emergency room visit. The patient was hospitalized for acute somnolence, flaccid areflexia in legs, suspected guillain-barre syndrome, possible linkage to simultaneous campylobacter infection from 2021 to an unknown date for 5 days. The patient underwent lab tests and procedures which included polymerase chain reaction (post vaccination) results: negative on 09May2021 (Nasal Swab). Therapeutic measures were taken as a result of acute somnolence, flaccid areflexia in legs, suspected guillain-barre syndrome, possible linkage to simultaneous campylobacter infection. Treatment included IV immunoglobulin. The clinical outcome of the events was not recovered. Additional information was requested.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Areflexia, Campylobacter infection, Guillain-Barre syndrome, Polymerase chain reaction, Somnolence
Clinical narrative: Acute somnolence; Flaccid Areflexia in legs; Suspected Guillain-Barre Syndrome; Possible linkage to simultaneous campylobacter infection; This is a spontaneous report from a contactable consumer (patent). A 16-years-old male patient received bnt162b2 (FIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration,  in Arm Left (at the age of 16 years old) on 01May2021 at 10:00 (Batch/Lot Number: ER8736) as 1ST DOSE, SINGLE for covid-19 immunization. Medical history included campylobacter infection from an unknown date and unknown if ongoing. The patient had no known allergies. Concomitant medication included lisdexamfetamine mesilate (VYVANSE) taken for an unspecified indication, start and stop date were not reported. The facility in which the most recent COVID-19 vaccine was administered was a Public Health Clinic/Administration facility. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced Acute somnolence, Flaccid areflexia in legs, Suspected Guillain-Barre Syndrome, Possible linkage to simultaneous campylobacter infection on 03May2021 at 0000. The events required an emergency room visit. The patient was hospitalized for acute somnolence, flaccid areflexia in legs, suspected guillain-barre syndrome, possible linkage to simultaneous campylobacter infection from 2021 to an unknown date for 5 days. The patient underwent lab tests and procedures which included polymerase chain reaction (post vaccination) results: negative on 09May2021 (Nasal Swab). Therapeutic measures were taken as a result of acute somnolence, flaccid areflexia in legs, suspected guillain-barre syndrome, possible linkage to simultaneous campylobacter infection. Treatment included IV immunoglobulin. The clinical outcome of the events was not recovered. Additional information was requested.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Aphasia, Computerised tomogram head abnormal, Facial paralysis, Hemiparesis
Clinical narrative: Stroke in left frontal lobe in brain; I was in the hospital for 4 days undergoing multiple tests to determine the stroke cause.  2 and a half weeks later the cause is not known. I am a young, healthy individual with very good blood pressure, cholesterol, and I don't smoke. I maintain a healthy diet. Some of the doctors I have seen since the stroke think the strongest possibility for a cause is the Johnson & Johnson vaccine I received a month before the stroke since J & J has documented issues with clotting.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Cerebrovascular accident, Computerised tomogram coronary artery, Computerised tomogram head abnormal, Echocardiogram
Clinical narrative: Stroke in left frontal lobe in brain; I was in the hospital for 4 days undergoing multiple tests to determine the stroke cause.  2 and a half weeks later the cause is not known. I am a young, healthy individual with very good blood pressure, cholesterol, and I don't smoke. I maintain a healthy diet. Some of the doctors I have seen since the stroke think the strongest possibility for a cause is the Johnson & Johnson vaccine I received a month before the stroke since J & J has documented issues with clotting.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Implantable cardiac monitor insertion, Magnetic resonance imaging abnormal, Ultrasound Doppler
Clinical narrative: Stroke in left frontal lobe in brain; I was in the hospital for 4 days undergoing multiple tests to determine the stroke cause.  2 and a half weeks later the cause is not known. I am a young, healthy individual with very good blood pressure, cholesterol, and I don't smoke. I maintain a healthy diet. Some of the doctors I have seen since the stroke think the strongest possibility for a cause is the Johnson & Johnson vaccine I received a month before the stroke since J & J has documented issues with clotting.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Drooling, Eating disorder, Electroencephalogram, Electromyogram
Clinical narrative: I can't eat; can talk now unlike before; Vomiting; Nauseated; I had a Bell's palsy after the vaccine; temperature happened; body ache; My lymph nodes are swollen; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received bnt162b2 (Pfizer COVID-19 vaccine), dose 2 via an unspecified route of administration, administered in left arm on 08Jan2021 (Lot Number: EL1283) as single dose for COVID-19 immunization. Medical history included hypertension, asthma and gallstones from an unknown date and unknown if ongoing. Concomitant medication included lisinopril taken for an unspecified indication, start and stop date were not reported. The patient previously received 1st dose of bnt162b2 (Pfizer COVID-19 vaccine), via an unspecified route of administration, administered in left arm on 21Dec2020 (Lot Number: EH9899) as single dose for COVID-19 immunization. Second dose was on 08Jan2021 and then after that, the patient had those like lower mouth pain, experienced a headache and the temperature and the body ache and everything all happened. Lymph nodes are swollen already and so patient went to doctor and they gave Augmentin (treatment) on 17Jan2021. The patient saw how her face was looking, she had a Bell's palsy after the vaccine. She didn't worked since January until the time of report because of so many tests that she did and have spent a lot of money already. She was depressed for how many months and can't eat and face has droop and eyes was hurting a lot, it is kind of emotional thing and spending a lot of money already on tests and everything. Still experiencing Bell's palsy, still have some droop in face but can talk now unlike before but every time she talks there is saliva coming out in left face. For the treatment of events: they gave Augmentin, that is the antibiotic, the tablet, 3 times a day. The other one is Valtrex, 1 gram, three times a day also. There is another one, it is Medrol, one tablet three times a day. Also, as patient was having the headache that time, taking (not clear) two tablets every six hours. Anti-nausea over the counter medicine as needed because of vomiting and nauseated always that time. The Medrol they gave twice on that time after she finish the first Medrol, they gave her Prednisone three times a day also. Outcome of event Bell's palsy was not recovered, for event can talk now unlike before was recovering, for the other events was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eyelid function disorder, Lymphadenopathy, Magnetic resonance imaging head, Nerve conduction studies, Pain
Clinical narrative: I can't eat; can talk now unlike before; Vomiting; Nauseated; I had a Bell's palsy after the vaccine; temperature happened; body ache; My lymph nodes are swollen; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received bnt162b2 (Pfizer COVID-19 vaccine), dose 2 via an unspecified route of administration, administered in left arm on 08Jan2021 (Lot Number: EL1283) as single dose for COVID-19 immunization. Medical history included hypertension, asthma and gallstones from an unknown date and unknown if ongoing. Concomitant medication included lisinopril taken for an unspecified indication, start and stop date were not reported. The patient previously received 1st dose of bnt162b2 (Pfizer COVID-19 vaccine), via an unspecified route of administration, administered in left arm on 21Dec2020 (Lot Number: EH9899) as single dose for COVID-19 immunization. Second dose was on 08Jan2021 and then after that, the patient had those like lower mouth pain, experienced a headache and the temperature and the body ache and everything all happened. Lymph nodes are swollen already and so patient went to doctor and they gave Augmentin (treatment) on 17Jan2021. The patient saw how her face was looking, she had a Bell's palsy after the vaccine. She didn't worked since January until the time of report because of so many tests that she did and have spent a lot of money already. She was depressed for how many months and can't eat and face has droop and eyes was hurting a lot, it is kind of emotional thing and spending a lot of money already on tests and everything. Still experiencing Bell's palsy, still have some droop in face but can talk now unlike before but every time she talks there is saliva coming out in left face. For the treatment of events: they gave Augmentin, that is the antibiotic, the tablet, 3 times a day. The other one is Valtrex, 1 gram, three times a day also. There is another one, it is Medrol, one tablet three times a day. Also, as patient was having the headache that time, taking (not clear) two tablets every six hours. Anti-nausea over the counter medicine as needed because of vomiting and nauseated always that time. The Medrol they gave twice on that time after she finish the first Medrol, they gave her Prednisone three times a day also. Outcome of event Bell's palsy was not recovered, for event can talk now unlike before was recovering, for the other events was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: I can't eat; can talk now unlike before; Vomiting; Nauseated; I had a Bell's palsy after the vaccine; temperature happened; body ache; My lymph nodes are swollen; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received bnt162b2 (Pfizer COVID-19 vaccine), dose 2 via an unspecified route of administration, administered in left arm on 08Jan2021 (Lot Number: EL1283) as single dose for COVID-19 immunization. Medical history included hypertension, asthma and gallstones from an unknown date and unknown if ongoing. Concomitant medication included lisinopril taken for an unspecified indication, start and stop date were not reported. The patient previously received 1st dose of bnt162b2 (Pfizer COVID-19 vaccine), via an unspecified route of administration, administered in left arm on 21Dec2020 (Lot Number: EH9899) as single dose for COVID-19 immunization. Second dose was on 08Jan2021 and then after that, the patient had those like lower mouth pain, experienced a headache and the temperature and the body ache and everything all happened. Lymph nodes are swollen already and so patient went to doctor and they gave Augmentin (treatment) on 17Jan2021. The patient saw how her face was looking, she had a Bell's palsy after the vaccine. She didn't worked since January until the time of report because of so many tests that she did and have spent a lot of money already. She was depressed for how many months and can't eat and face has droop and eyes was hurting a lot, it is kind of emotional thing and spending a lot of money already on tests and everything. Still experiencing Bell's palsy, still have some droop in face but can talk now unlike before but every time she talks there is saliva coming out in left face. For the treatment of events: they gave Augmentin, that is the antibiotic, the tablet, 3 times a day. The other one is Valtrex, 1 gram, three times a day also. There is another one, it is Medrol, one tablet three times a day. Also, as patient was having the headache that time, taking (not clear) two tablets every six hours. Anti-nausea over the counter medicine as needed because of vomiting and nauseated always that time. The Medrol they gave twice on that time after she finish the first Medrol, they gave her Prednisone three times a day also. Outcome of event Bell's palsy was not recovered, for event can talk now unlike before was recovering, for the other events was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Body temperature, Body temperature abnormal, Eating disorder, Investigation
Clinical narrative: I can't eat; can talk now unlike before; Vomiting; Nauseated; I had a Bell's palsy after the vaccine; temperature happened; body ache; My lymph nodes are swollen; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received bnt162b2 (Pfizer COVID-19 vaccine), dose 2 via an unspecified route of administration, administered in left arm on 08Jan2021 (Lot Number: EL1283) as single dose for COVID-19 immunization. Medical history included hypertension, asthma and gallstones from an unknown date and unknown if ongoing. Concomitant medication included lisinopril taken for an unspecified indication, start and stop date were not reported. The patient previously received 1st dose of bnt162b2 (Pfizer COVID-19 vaccine), via an unspecified route of administration, administered in left arm on 21Dec2020 (Lot Number: EH9899) as single dose for COVID-19 immunization. Second dose was on 08Jan2021 and then after that, the patient had those like lower mouth pain, experienced a headache and the temperature and the body ache and everything all happened. Lymph nodes are swollen already and so patient went to doctor and they gave Augmentin (treatment) on 17Jan2021. The patient saw how her face was looking, she had a Bell's palsy after the vaccine. She didn't worked since January until the time of report because of so many tests that she did and have spent a lot of money already. She was depressed for how many months and can't eat and face has droop and eyes was hurting a lot, it is kind of emotional thing and spending a lot of money already on tests and everything. Still experiencing Bell's palsy, still have some droop in face but can talk now unlike before but every time she talks there is saliva coming out in left face. For the treatment of events: they gave Augmentin, that is the antibiotic, the tablet, 3 times a day. The other one is Valtrex, 1 gram, three times a day also. There is another one, it is Medrol, one tablet three times a day. Also, as patient was having the headache that time, taking (not clear) two tablets every six hours. Anti-nausea over the counter medicine as needed because of vomiting and nauseated always that time. The Medrol they gave twice on that time after she finish the first Medrol, they gave her Prednisone three times a day also. Outcome of event Bell's palsy was not recovered, for event can talk now unlike before was recovering, for the other events was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Nausea, Pain, Speech disorder, Vomiting
Clinical narrative: I can't eat; can talk now unlike before; Vomiting; Nauseated; I had a Bell's palsy after the vaccine; temperature happened; body ache; My lymph nodes are swollen; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received bnt162b2 (Pfizer COVID-19 vaccine), dose 2 via an unspecified route of administration, administered in left arm on 08Jan2021 (Lot Number: EL1283) as single dose for COVID-19 immunization. Medical history included hypertension, asthma and gallstones from an unknown date and unknown if ongoing. Concomitant medication included lisinopril taken for an unspecified indication, start and stop date were not reported. The patient previously received 1st dose of bnt162b2 (Pfizer COVID-19 vaccine), via an unspecified route of administration, administered in left arm on 21Dec2020 (Lot Number: EH9899) as single dose for COVID-19 immunization. Second dose was on 08Jan2021 and then after that, the patient had those like lower mouth pain, experienced a headache and the temperature and the body ache and everything all happened. Lymph nodes are swollen already and so patient went to doctor and they gave Augmentin (treatment) on 17Jan2021. The patient saw how her face was looking, she had a Bell's palsy after the vaccine. She didn't worked since January until the time of report because of so many tests that she did and have spent a lot of money already. She was depressed for how many months and can't eat and face has droop and eyes was hurting a lot, it is kind of emotional thing and spending a lot of money already on tests and everything. Still experiencing Bell's palsy, still have some droop in face but can talk now unlike before but every time she talks there is saliva coming out in left face. For the treatment of events: they gave Augmentin, that is the antibiotic, the tablet, 3 times a day. The other one is Valtrex, 1 gram, three times a day also. There is another one, it is Medrol, one tablet three times a day. Also, as patient was having the headache that time, taking (not clear) two tablets every six hours. Anti-nausea over the counter medicine as needed because of vomiting and nauseated always that time. The Medrol they gave twice on that time after she finish the first Medrol, they gave her Prednisone three times a day also. Outcome of event Bell's palsy was not recovered, for event can talk now unlike before was recovering, for the other events was unknown.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Arthralgia, Back pain, Computerised tomogram, Dizziness
Clinical narrative: Flu like symptoms x 5-10 days, back/pleuritic pain the following 5 days, SOB x 3 days later, finally went to ER dx with DVT, and PE
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness, Peripheral swelling, Pulmonary thrombosis, Thrombosis, Ultrasound scan
Clinical narrative: Flu like symptoms x 5-10 days, back/pleuritic pain the following 5 days, SOB x 3 days later, finally went to ER dx with DVT, and PE
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Back pain, Computerised tomogram thorax abnormal, Deep vein thrombosis, Dyspnoea, Influenza like illness
Clinical narrative: Flu like symptoms x 5-10 days, back/pleuritic pain the following 5 days, SOB x 3 days later, finally went to ER dx with DVT, and PE
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pleuritic pain, Ultrasound Doppler abnormal
Clinical narrative: Flu like symptoms x 5-10 days, back/pleuritic pain the following 5 days, SOB x 3 days later, finally went to ER dx with DVT, and PE
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Erythema, Eye pain, Eye pruritus, Eye swelling, Pain in extremity
Clinical narrative: onset itching, redness, warmth, bulleyes rash at injection site which woke Pt from sleep. Onset hives and periorbital swelling later that day. It prescribed benadryl, prednisone, and Keflex at urgent care. Pt presents to ED the following day for fatigue and heart palpitations. Pt advised to not seek dose #2
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: onset itching, redness, warmth, bulleyes rash at injection site which woke Pt from sleep. Onset hives and periorbital swelling later that day. It prescribed benadryl, prednisone, and Keflex at urgent care. Pt presents to ED the following day for fatigue and heart palpitations. Pt advised to not seek dose #2
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Erythema, Eye pain, Eye pruritus, Eye swelling, Feeling hot
Clinical narrative: onset itching, redness, warmth, bulleyes rash at injection site which woke Pt from sleep. Onset hives and periorbital swelling later that day. It prescribed benadryl, prednisone, and Keflex at urgent care. Pt presents to ED the following day for fatigue and heart palpitations. Pt advised to not seek dose #2
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: onset itching, redness, warmth, bulleyes rash at injection site which woke Pt from sleep. Onset hives and periorbital swelling later that day. It prescribed benadryl, prednisone, and Keflex at urgent care. Pt presents to ED the following day for fatigue and heart palpitations. Pt advised to not seek dose #2
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram, Fatigue, Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: onset itching, redness, warmth, bulleyes rash at injection site which woke Pt from sleep. Onset hives and periorbital swelling later that day. It prescribed benadryl, prednisone, and Keflex at urgent care. Pt presents to ED the following day for fatigue and heart palpitations. Pt advised to not seek dose #2
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site warmth, Palpitations, Periorbital swelling, Sleep disorder, Urticaria
Clinical narrative: onset itching, redness, warmth, bulleyes rash at injection site which woke Pt from sleep. Onset hives and periorbital swelling later that day. It prescribed benadryl, prednisone, and Keflex at urgent care. Pt presents to ED the following day for fatigue and heart palpitations. Pt advised to not seek dose #2
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain upper, Appendicectomy, Appendicitis, Computerised tomogram abdomen abnormal, Laparoscopic surgery
Clinical narrative: severe abdominal pain/appendicitis; This is a spontaneous report from a contactable consumer (patient). A 47-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 24Apr2021 12:30 (Batch/Lot Number: ER8736) as 1st dose, single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient did not have any other medications within 2 weeks of vaccination. On 30Apr2021 (six days later), the patient had severe abdominal pain and ended up in emergency room on 03May2021 where a CAT scan revealed the patient had appendicitis. The patient had surgery for laparoscopic appendectomy/appendectomy surgery on 04May2021. The patient has been tested with nasal swab on 03May2021: negative. The event resulted in a doctor or healthcare professional clinic visit and emergency room visit. The outcome of the event was unknown.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Appendicitis, Computerised tomogram, SARS-CoV-2 test
Clinical narrative: severe abdominal pain/appendicitis; This is a spontaneous report from a contactable consumer (patient). A 47-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 24Apr2021 12:30 (Batch/Lot Number: ER8736) as 1st dose, single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient did not have any other medications within 2 weeks of vaccination. On 30Apr2021 (six days later), the patient had severe abdominal pain and ended up in emergency room on 03May2021 where a CAT scan revealed the patient had appendicitis. The patient had surgery for laparoscopic appendectomy/appendectomy surgery on 04May2021. The patient has been tested with nasal swab on 03May2021: negative. The event resulted in a doctor or healthcare professional clinic visit and emergency room visit. The outcome of the event was unknown.