chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: I felt a little light headed and I have not had any alcohol, I haven't take any pills; I have been left with some fatigue here and there; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0187) via an unspecified route of administration on 01Jun2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0168) via an unspecified route of administration on 11May2021 as single dose for covid-19 immunisation and had no reaction. After second dose of vaccine, the patient had been left with some fatigue here and there and this afternoon again the patient just had it. It seems very at times. The patient reported that nothing changed and had another fatigue and went to sleep but when came out of sleep it just seems very heavy like and had taken a sleeping pill and also stated that yesterday that it seems a little better than two weeks ago. Today (20Jul2021) afternoon, the patient felt a little lightheaded which was unusual that I have not had that yet. The patient did not have any alcohol. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: I felt a little light headed and I have not had any alcohol, I haven't take any pills; I have been left with some fatigue here and there; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0187) via an unspecified route of administration on 01Jun2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: EW0168) via an unspecified route of administration on 11May2021 as single dose for covid-19 immunisation and had no reaction. After second dose of vaccine, the patient had been left with some fatigue here and there and this afternoon again the patient just had it. It seems very at times. The patient reported that nothing changed and had another fatigue and went to sleep but when came out of sleep it just seems very heavy like and had taken a sleeping pill and also stated that yesterday that it seems a little better than two weeks ago. Today (20Jul2021) afternoon, the patient felt a little lightheaded which was unusual that I have not had that yet. The patient did not have any alcohol. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cardiac disorder, Electrocardiogram, Electrocardiogram ambulatory, Heart rate increased, Supraventricular tachycardia
Clinical narrative: Heart Rate for no reason would jump up to 180-200 beats per minute, confusion, high blood pressure. Called 911 because I thought I was having a heart attack. I did not go to the hospital during that event. I told them I had a cup of coffee with breakfast and that I had my vaccine two days prior and they said it was probably from that. I had 20 other events the following months sometimes at night, same symptoms. The worst was on 6/13/21 I was helping my friend move and my heart rate jumped up and blood pressure went up as well. I called my wife to pick me up and I could not communicate my location, I was standing under a street sign in a neighborhood I am familiar with. I though I was going to lose consciousness. I called 911 and decided to go to the hospital and see what was happening to me. I have had several EKG and came back clean. The doctor said for some reason I am having episodes of SVT and that I need to wear a holter monitor to figure out what is happening to me. After that day I removed any and all alcohol and caffeine from my diet. Beers on the weekend and I would have one to two cups of coffee a day from our coffee machine at home. 6 weeks later the monitor has been approved and I am wearing it now. I set up a doctor because I did not one and had an EKG and explained my sysptoms and he said he has seen this happen to a lot of men specifically and it usually takes several months and it "should" go away. I meet with a Cardiologist on July 29th. Since removing alcohol and caffeine the episodes decreased and went away within a week and I have not had any episodes for the past 4 weeks.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Confusional state, Electrocardiogram ambulatory, Electrocardiogram normal, Language disorder
Clinical narrative: Heart Rate for no reason would jump up to 180-200 beats per minute, confusion, high blood pressure. Called 911 because I thought I was having a heart attack. I did not go to the hospital during that event. I told them I had a cup of coffee with breakfast and that I had my vaccine two days prior and they said it was probably from that. I had 20 other events the following months sometimes at night, same symptoms. The worst was on 6/13/21 I was helping my friend move and my heart rate jumped up and blood pressure went up as well. I called my wife to pick me up and I could not communicate my location, I was standing under a street sign in a neighborhood I am familiar with. I though I was going to lose consciousness. I called 911 and decided to go to the hospital and see what was happening to me. I have had several EKG and came back clean. The doctor said for some reason I am having episodes of SVT and that I need to wear a holter monitor to figure out what is happening to me. After that day I removed any and all alcohol and caffeine from my diet. Beers on the weekend and I would have one to two cups of coffee a day from our coffee machine at home. 6 weeks later the monitor has been approved and I am wearing it now. I set up a doctor because I did not one and had an EKG and explained my sysptoms and he said he has seen this happen to a lot of men specifically and it usually takes several months and it "should" go away. I meet with a Cardiologist on July 29th. Since removing alcohol and caffeine the episodes decreased and went away within a week and I have not had any episodes for the past 4 weeks.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Supraventricular tachycardia
Clinical narrative: Heart Rate for no reason would jump up to 180-200 beats per minute, confusion, high blood pressure. Called 911 because I thought I was having a heart attack. I did not go to the hospital during that event. I told them I had a cup of coffee with breakfast and that I had my vaccine two days prior and they said it was probably from that. I had 20 other events the following months sometimes at night, same symptoms. The worst was on 6/13/21 I was helping my friend move and my heart rate jumped up and blood pressure went up as well. I called my wife to pick me up and I could not communicate my location, I was standing under a street sign in a neighborhood I am familiar with. I though I was going to lose consciousness. I called 911 and decided to go to the hospital and see what was happening to me. I have had several EKG and came back clean. The doctor said for some reason I am having episodes of SVT and that I need to wear a holter monitor to figure out what is happening to me. After that day I removed any and all alcohol and caffeine from my diet. Beers on the weekend and I would have one to two cups of coffee a day from our coffee machine at home. 6 weeks later the monitor has been approved and I am wearing it now. I set up a doctor because I did not one and had an EKG and explained my sysptoms and he said he has seen this happen to a lot of men specifically and it usually takes several months and it "should" go away. I meet with a Cardiologist on July 29th. Since removing alcohol and caffeine the episodes decreased and went away within a week and I have not had any episodes for the past 4 weeks.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arrhythmia, Chest discomfort
Clinical narrative: arrhythmia with many pvcs; Tightness in chest; This case was initially received via another Manufacturer (Reference number: PVIUS2021001107) on 27-Jun-2021. The most recent information was received on 20-Jul-2021 and was forwarded to Moderna on 20-Jul-2021. The license partner had received the report from FDA VAERS (Reference number: 1453466).    This regulatory authority case was reported by an other health care professional and describes the occurrence of ARRHYTHMIA (arrhythmia with many pvcs) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Pre-diabetic.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced ARRHYTHMIA (arrhythmia with many pvcs) (seriousness criterion medically significant) and CHEST DISCOMFORT (Tightness in chest). On 27-Jun-2021, ARRHYTHMIA (arrhythmia with many pvcs) and CHEST DISCOMFORT (Tightness in chest) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On an unknown date, the patient had a nuclear stress test and echocardiogram done but the results were not reported. On an unknown date, the patient was scheduled for a patch monitor.  No concomitant medications or treatment details were reported.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Report type was changed to Regulatory Authority as follow up was received from RA source. Action taken was updated to not applicable from unknown.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bradycardia
Clinical narrative: Bradycardia; This is a spontaneous report from a contactable consumer. A 17-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14May2021 16:00 (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation in public health clinic/facility.  Medical history included cerebral palsy. The patient's concomitant medications were none. The patient experienced bradycardia (hospitalization, disability, life threatening) on 15May2021 08:00 with outcome of recovering.  The patient was hospitalized for bradycardia (bradycardia) for 3 days. The patient underwent lab tests and procedures which included sars-cov-2 test negative: negative.  Therapeutic measures were taken as a result of bradycardia as Fluid and enema. Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care visit required.  Information on the lot/batch number has been requested.
Age: 17.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bradycardia, SARS-CoV-2 test negative
Clinical narrative: Bradycardia; This is a spontaneous report from a contactable consumer. A 17-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14May2021 16:00 (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation in public health clinic/facility.  Medical history included cerebral palsy. The patient's concomitant medications were none. The patient experienced bradycardia (hospitalization, disability, life threatening) on 15May2021 08:00 with outcome of recovering.  The patient was hospitalized for bradycardia (bradycardia) for 3 days. The patient underwent lab tests and procedures which included sars-cov-2 test negative: negative.  Therapeutic measures were taken as a result of bradycardia as Fluid and enema. Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care visit required.  Information on the lot/batch number has been requested.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Catheterisation cardiac, Chest pain, Guillain-Barre syndrome, Hypertension, Hypoaesthesia
Clinical narrative: Guillian-Barre Syndrome; my ongoing struggles with strength and mobility; cannot walk independently; This is a spontaneous report from a contactable consumer (patient). A 60-years-old male patient received second dose bnt162b2 (Pfizer COVID19 Vaccine, Solution for injection, Batch/Lot Number: EW0176) via an unspecified route of administration, administered in Arm Right on 01Apr2021 14:30 as DOSE 2, SINGLE for covid-19 immunisation. Patient didn't received other vaccines within 4 weeks prior to vaccination patient had received other medications within two weeks Finasteride, Omeprazole, Advil, BUT/ASA/CAFF patient previously received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0150) via an unspecified route of administration, administered in Arm Right on APR2021 14:30 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included BPH without urinary obstruction, achillies tendinitis, elevated PSA, ejaculatory dysfunction, chronic dental health issues August 2020-February 2021, drug hypersensitivity amoxicillin from an unknown date and unknown if ongoing. Concomitant medications included finasteride (FINASTERIDE) taken for an unspecified indication, start and stop date were not reported; omeprazole (OMEPRAZOLE) taken for an unspecified indication, start and stop date were not reported; ibuprofen (ADVIL 12 HOUR) taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (A S A) taken for an unspecified indication, start and stop date were not reported; CAFF;CHLO MAL;ETHEN;HERB;METHO HYDROB;METHY HCL;PARA;THIA SULF;VB2 taken for an unspecified indication, start and stop date were not reported; BUT-2-ENEDIOIC ACID MONO-(2-DIETHYLAMINOETHYL)-ESTER; COMPOUND WITH VINYLBENZENE taken for an unspecified indication, start and stop date were not reported patient didn't had COVID prior to vaccination patient was tested for COVID to post vaccination. On 08Apr2021 21:30 the patient experienced guillian-barre syndrome, my ongoing struggles with strength and mobility, cannot walk independently. The patient was hospitalized at Hospital for guillian-barre syndrome and for my ongoing struggles with strength and mobility and for cannot walk independently for 12 days patient had Emergency room and physicians office visit for the events patient had disability due to the events. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 10May2021. Therapeutic measures were taken as a result of guillian-barre syndrome, my ongoing struggles with strength and mobility, cannot walk independently IVIG treatment for Guillian Barre Syndrome. The outcome of the events guillian-barre syndrome, mobility decreased, gait inability was not recovered.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Immunoglobulin therapy, Laboratory test, Lumbar puncture, Nausea, Paraesthesia
Clinical narrative: Guillian-Barre Syndrome; my ongoing struggles with strength and mobility; cannot walk independently; This is a spontaneous report from a contactable consumer (patient). A 60-years-old male patient received second dose bnt162b2 (Pfizer COVID19 Vaccine, Solution for injection, Batch/Lot Number: EW0176) via an unspecified route of administration, administered in Arm Right on 01Apr2021 14:30 as DOSE 2, SINGLE for covid-19 immunisation. Patient didn't received other vaccines within 4 weeks prior to vaccination patient had received other medications within two weeks Finasteride, Omeprazole, Advil, BUT/ASA/CAFF patient previously received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0150) via an unspecified route of administration, administered in Arm Right on APR2021 14:30 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included BPH without urinary obstruction, achillies tendinitis, elevated PSA, ejaculatory dysfunction, chronic dental health issues August 2020-February 2021, drug hypersensitivity amoxicillin from an unknown date and unknown if ongoing. Concomitant medications included finasteride (FINASTERIDE) taken for an unspecified indication, start and stop date were not reported; omeprazole (OMEPRAZOLE) taken for an unspecified indication, start and stop date were not reported; ibuprofen (ADVIL 12 HOUR) taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (A S A) taken for an unspecified indication, start and stop date were not reported; CAFF;CHLO MAL;ETHEN;HERB;METHO HYDROB;METHY HCL;PARA;THIA SULF;VB2 taken for an unspecified indication, start and stop date were not reported; BUT-2-ENEDIOIC ACID MONO-(2-DIETHYLAMINOETHYL)-ESTER; COMPOUND WITH VINYLBENZENE taken for an unspecified indication, start and stop date were not reported patient didn't had COVID prior to vaccination patient was tested for COVID to post vaccination. On 08Apr2021 21:30 the patient experienced guillian-barre syndrome, my ongoing struggles with strength and mobility, cannot walk independently. The patient was hospitalized at Hospital for guillian-barre syndrome and for my ongoing struggles with strength and mobility and for cannot walk independently for 12 days patient had Emergency room and physicians office visit for the events patient had disability due to the events. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 10May2021. Therapeutic measures were taken as a result of guillian-barre syndrome, my ongoing struggles with strength and mobility, cannot walk independently IVIG treatment for Guillian Barre Syndrome. The outcome of the events guillian-barre syndrome, mobility decreased, gait inability was not recovered.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Troponin increased, Vitamin B12 decreased, Vomiting
Clinical narrative: Guillian-Barre Syndrome; my ongoing struggles with strength and mobility; cannot walk independently; This is a spontaneous report from a contactable consumer (patient). A 60-years-old male patient received second dose bnt162b2 (Pfizer COVID19 Vaccine, Solution for injection, Batch/Lot Number: EW0176) via an unspecified route of administration, administered in Arm Right on 01Apr2021 14:30 as DOSE 2, SINGLE for covid-19 immunisation. Patient didn't received other vaccines within 4 weeks prior to vaccination patient had received other medications within two weeks Finasteride, Omeprazole, Advil, BUT/ASA/CAFF patient previously received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0150) via an unspecified route of administration, administered in Arm Right on APR2021 14:30 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included BPH without urinary obstruction, achillies tendinitis, elevated PSA, ejaculatory dysfunction, chronic dental health issues August 2020-February 2021, drug hypersensitivity amoxicillin from an unknown date and unknown if ongoing. Concomitant medications included finasteride (FINASTERIDE) taken for an unspecified indication, start and stop date were not reported; omeprazole (OMEPRAZOLE) taken for an unspecified indication, start and stop date were not reported; ibuprofen (ADVIL 12 HOUR) taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (A S A) taken for an unspecified indication, start and stop date were not reported; CAFF;CHLO MAL;ETHEN;HERB;METHO HYDROB;METHY HCL;PARA;THIA SULF;VB2 taken for an unspecified indication, start and stop date were not reported; BUT-2-ENEDIOIC ACID MONO-(2-DIETHYLAMINOETHYL)-ESTER; COMPOUND WITH VINYLBENZENE taken for an unspecified indication, start and stop date were not reported patient didn't had COVID prior to vaccination patient was tested for COVID to post vaccination. On 08Apr2021 21:30 the patient experienced guillian-barre syndrome, my ongoing struggles with strength and mobility, cannot walk independently. The patient was hospitalized at Hospital for guillian-barre syndrome and for my ongoing struggles with strength and mobility and for cannot walk independently for 12 days patient had Emergency room and physicians office visit for the events patient had disability due to the events. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 10May2021. Therapeutic measures were taken as a result of guillian-barre syndrome, my ongoing struggles with strength and mobility, cannot walk independently IVIG treatment for Guillian Barre Syndrome. The outcome of the events guillian-barre syndrome, mobility decreased, gait inability was not recovered.
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gait inability, Guillain-Barre syndrome, Mobility decreased, SARS-CoV-2 antibody test
Clinical narrative: Guillian-Barre Syndrome; my ongoing struggles with strength and mobility; cannot walk independently; This is a spontaneous report from a contactable consumer (patient). A 60-years-old male patient received second dose bnt162b2 (Pfizer COVID19 Vaccine, Solution for injection, Batch/Lot Number: EW0176) via an unspecified route of administration, administered in Arm Right on 01Apr2021 14:30 as DOSE 2, SINGLE for covid-19 immunisation. Patient didn't received other vaccines within 4 weeks prior to vaccination patient had received other medications within two weeks Finasteride, Omeprazole, Advil, BUT/ASA/CAFF patient previously received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0150) via an unspecified route of administration, administered in Arm Right on APR2021 14:30 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included BPH without urinary obstruction, achillies tendinitis, elevated PSA, ejaculatory dysfunction, chronic dental health issues August 2020-February 2021, drug hypersensitivity amoxicillin from an unknown date and unknown if ongoing. Concomitant medications included finasteride (FINASTERIDE) taken for an unspecified indication, start and stop date were not reported; omeprazole (OMEPRAZOLE) taken for an unspecified indication, start and stop date were not reported; ibuprofen (ADVIL 12 HOUR) taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (A S A) taken for an unspecified indication, start and stop date were not reported; CAFF;CHLO MAL;ETHEN;HERB;METHO HYDROB;METHY HCL;PARA;THIA SULF;VB2 taken for an unspecified indication, start and stop date were not reported; BUT-2-ENEDIOIC ACID MONO-(2-DIETHYLAMINOETHYL)-ESTER; COMPOUND WITH VINYLBENZENE taken for an unspecified indication, start and stop date were not reported patient didn't had COVID prior to vaccination patient was tested for COVID to post vaccination. On 08Apr2021 21:30 the patient experienced guillian-barre syndrome, my ongoing struggles with strength and mobility, cannot walk independently. The patient was hospitalized at Hospital for guillian-barre syndrome and for my ongoing struggles with strength and mobility and for cannot walk independently for 12 days patient had Emergency room and physicians office visit for the events patient had disability due to the events. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 10May2021. Therapeutic measures were taken as a result of guillian-barre syndrome, my ongoing struggles with strength and mobility, cannot walk independently IVIG treatment for Guillian Barre Syndrome. The outcome of the events guillian-barre syndrome, mobility decreased, gait inability was not recovered.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: his arm pain for14 days now; he cannot move his arm / He can only move it at 40 degrees; unable to sleep properly; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient).  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration on 24Jun2021 as dose 2, single for Covid-19 immunization.Medical history and concomitant medications were not reported.The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) on 03Jun2021 via an unspecified route of administration on 03Jun2021 at dose 1, single for Covid-19 immunization and did not experience any reaction to vaccine.On an unspecified date in Jun2021, patient experienced arm pain for 14 days now. He said that after the 2nd dose he received, he cannot move his arm and was unable to sleep properly. He could only move it at 40 degrees.The outcome of unable to sleep properly was unknown and patient had not yet recovered from rest of the events.  Information about lot/batch number is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Insomnia, Pain in extremity, Vaccination site movement impairment
Clinical narrative: his arm pain for14 days now; he cannot move his arm / He can only move it at 40 degrees; unable to sleep properly; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient).  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration on 24Jun2021 as dose 2, single for Covid-19 immunization.Medical history and concomitant medications were not reported.The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) on 03Jun2021 via an unspecified route of administration on 03Jun2021 at dose 1, single for Covid-19 immunization and did not experience any reaction to vaccine.On an unspecified date in Jun2021, patient experienced arm pain for 14 days now. He said that after the 2nd dose he received, he cannot move his arm and was unable to sleep properly. He could only move it at 40 degrees.The outcome of unable to sleep properly was unknown and patient had not yet recovered from rest of the events.  Information about lot/batch number is expected.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Computerised tomogram, Facial paralysis, Laboratory test
Clinical narrative: I got a bell's palsy; I started left cheek completely you know got little paralyzed so on Wednesday I got a little severe; This is a spontaneous report from a contactable consumer. This 39-year-old male consumer (patient) reported himself that he received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EW0198) via an unspecified route of administration on 02Jul2021 on left arm (at 39-years-old), as dose 1, single for COVID-19 immunization. The patients medical history was not reported. It was mentioned that patient had no other medical condition, did not use concomitant medication. On 05Jul2021, after vaccination he got a bell's palsy after that from Monday onwards, his left cheek completely got little paralyzed so on Wednesday he got a little severe and went to the emergency, he went to normal physician first and then they send him to the emergency and then he got the CT scan and then they basically found him diagnosed with bell's palsy, one of the side effect and currently they have put him on the medication which was a steroid. He wanted to report it and at the same time he would like to see, what was the assistance that Pfizer was providing. When paraphrased the concern, Consumer stated, that he was taking it right now, every day they prescribed me to take this steroid Prednisolone, 60 mg, you know for next one week. The outcome of the events was not recovered.  Follow-up attempts were completed. No further information was expected.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy, Computerised tomogram, Facial paralysis
Clinical narrative: I got a bell's palsy; I started left cheek completely you know got little paralyzed so on Wednesday I got a little severe; This is a spontaneous report from a contactable consumer. This 39-year-old male consumer (patient) reported himself that he received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EW0198) via an unspecified route of administration on 02Jul2021 on left arm (at 39-years-old), as dose 1, single for COVID-19 immunization. The patients medical history was not reported. It was mentioned that patient had no other medical condition, did not use concomitant medication. On 05Jul2021, after vaccination he got a bell's palsy after that from Monday onwards, his left cheek completely got little paralyzed so on Wednesday he got a little severe and went to the emergency, he went to normal physician first and then they send him to the emergency and then he got the CT scan and then they basically found him diagnosed with bell's palsy, one of the side effect and currently they have put him on the medication which was a steroid. He wanted to report it and at the same time he would like to see, what was the assistance that Pfizer was providing. When paraphrased the concern, Consumer stated, that he was taking it right now, every day they prescribed me to take this steroid Prednisolone, 60 mg, you know for next one week. The outcome of the events was not recovered.  Follow-up attempts were completed. No further information was expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy artery, Blood glucose abnormal, C-reactive protein, Computerised tomogram abdomen, Computerised tomogram pelvis
Clinical narrative: admission to hospital 1 month later with headache, ear pressure, visual change diagnosis with giant cell arteritis and intra cranial hypertension
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram thorax, Ear discomfort, Giant cell arteritis, Headache, Idiopathic intracranial hypertension
Clinical narrative: admission to hospital 1 month later with headache, ear pressure, visual change diagnosis with giant cell arteritis and intra cranial hypertension
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Imaging procedure, Lumbar puncture, Magnetic resonance imaging, Ocular discomfort, Red blood cell sedimentation rate
Clinical narrative: admission to hospital 1 month later with headache, ear pressure, visual change diagnosis with giant cell arteritis and intra cranial hypertension
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Steroid diabetes, Vision blurred
Clinical narrative: admission to hospital 1 month later with headache, ear pressure, visual change diagnosis with giant cell arteritis and intra cranial hypertension
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy artery, Ear discomfort, Giant cell arteritis, Headache, Intracranial pressure increased
Clinical narrative: admission to hospital 1 month later with headache, ear pressure, visual change diagnosis with giant cell arteritis and intra cranial hypertension
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lumbar puncture, Visual impairment
Clinical narrative: admission to hospital 1 month later with headache, ear pressure, visual change diagnosis with giant cell arteritis and intra cranial hypertension
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood cholesterol, Blood magnesium, Blood magnesium decreased, Diarrhoea, Dyspepsia
Clinical narrative: Three to four days after, he started having diarrhea/he had diarrhea nonstop for two weeks; This is a spontaneous report from a contactable consumer or other non hcp. A 66-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 10Apr2021 (age at vaccination was 66 years) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date on Apr2021 the patient experienced three to four days after, he started having diarrhea. The patient had diarrhea nonstop for two weeks and was taking probiotics. The patient was okay for four weeks. Now the patient was back to having diarrhea once a day daily. The patient had a stool test done, and it came back normal. The patient had a colonoscopy done to be on the safe side. The patient did not know if the diarrhea was a coincidence or related to the COVID vaccine. Right after the covid vaccine, the patient started having diarrhea. The patient received treatment for the event. The patient had a colonoscopy done to be on the safe side, stool analysis shown normal on an unspecified date in 2021. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Extrasystoles, Full blood count, Glycosylated haemoglobin, Stool analysis, Weight
Clinical narrative: Three to four days after, he started having diarrhea/he had diarrhea nonstop for two weeks; This is a spontaneous report from a contactable consumer or other non hcp. A 66-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 10Apr2021 (age at vaccination was 66 years) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date on Apr2021 the patient experienced three to four days after, he started having diarrhea. The patient had diarrhea nonstop for two weeks and was taking probiotics. The patient was okay for four weeks. Now the patient was back to having diarrhea once a day daily. The patient had a stool test done, and it came back normal. The patient had a colonoscopy done to be on the safe side. The patient did not know if the diarrhea was a coincidence or related to the COVID vaccine. Right after the covid vaccine, the patient started having diarrhea. The patient received treatment for the event. The patient had a colonoscopy done to be on the safe side, stool analysis shown normal on an unspecified date in 2021. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Weight decreased
Clinical narrative: Three to four days after, he started having diarrhea/he had diarrhea nonstop for two weeks; This is a spontaneous report from a contactable consumer or other non hcp. A 66-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 10Apr2021 (age at vaccination was 66 years) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date on Apr2021 the patient experienced three to four days after, he started having diarrhea. The patient had diarrhea nonstop for two weeks and was taking probiotics. The patient was okay for four weeks. Now the patient was back to having diarrhea once a day daily. The patient had a stool test done, and it came back normal. The patient had a colonoscopy done to be on the safe side. The patient did not know if the diarrhea was a coincidence or related to the COVID vaccine. Right after the covid vaccine, the patient started having diarrhea. The patient received treatment for the event. The patient had a colonoscopy done to be on the safe side, stool analysis shown normal on an unspecified date in 2021. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Colonoscopy, Diarrhoea, Stool analysis
Clinical narrative: Three to four days after, he started having diarrhea/he had diarrhea nonstop for two weeks; This is a spontaneous report from a contactable consumer or other non hcp. A 66-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 10Apr2021 (age at vaccination was 66 years) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date on Apr2021 the patient experienced three to four days after, he started having diarrhea. The patient had diarrhea nonstop for two weeks and was taking probiotics. The patient was okay for four weeks. Now the patient was back to having diarrhea once a day daily. The patient had a stool test done, and it came back normal. The patient had a colonoscopy done to be on the safe side. The patient did not know if the diarrhea was a coincidence or related to the COVID vaccine. Right after the covid vaccine, the patient started having diarrhea. The patient received treatment for the event. The patient had a colonoscopy done to be on the safe side, stool analysis shown normal on an unspecified date in 2021. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram abdomen, Electromyogram, Hypoaesthesia, Magnetic resonance imaging, Muscular weakness
Clinical narrative: GUILLAIN BARRE SYNDROME; UNABLE TO SLEEP; BELL'S PALSY; ALTERED TASTE; ALTERED SMELL; This spontaneous report was received from a patient and concerned a 59 year old male. The patient's weight was 152 pounds, and height was 76 inches. The patient's concurrent conditions included high blood pressure controlled with unspecified medication, smoker 6-8 cigarettes per day, and no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 23-MAY-2021 to his left arm for prophylactic vaccination. Batch number was not reported. Company will perform follow up to obtain batch number. Concomitant medications included unspecified medication for blood pressure.  On 30-MAY-2021, the patient experienced Guillain Barre syndrome requiring hospitalization. He also experienced altered taste and altered smell. His symptoms started off as minor leg pain as cramps, then spread to abdomen, lower back, upper back, chest, arms and feet. He also had tingling in fingers and toes and numbness in hands and feet. The patient was seen by a doctor 2 weeks after receiving vaccine because was was experiencing  Bell's Palsy. The doctor prescribed ibuprofen to help alleviate the pain, but it did not help much. The doctor continued to give him pain killers. He was unable to sleep and went days without sleep. He recently was prescribed Percocet which also did not help much either. The patient was hospitalized on an unspecified date in JUN-2021 and discharged on an unspecified date in JUL-2021.   The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the Guillain Barre syndrome, altered taste, altered smell, unable to sleep and Bell's Palsy was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0:  This spontaneous report received from a consumer concerns a 59-year-old white male patient who was hospitalized with Guillain Barre syndrome (GBS) 7 days after receiving the Janssen Covid-19 vaccine.  The patient have concurrent high blood pressure and is a smoker (6-8 sticks/day).  Symptoms reported were altered taste and smell, leg pain and cramps that spreads to abdomen/lower back/upper back/chest/arms/feet, tingling in fingers and toes, and numbness in hands and feet.  No treatment was reported.  Approximately 2 weeks after vaccination, the patient was found to have Bell's palsy, and was prescribed with ibuprofen and Percocet.  The outcome of the events was not reported.  No other pertinent details reported.  The information available precludes a complete and meaningful assessment.  Based on the information available, the occurrence of the events could represent background incidence of such events in the general population. However, a relationship with Janssen Covid-19 vaccine cannot be ruled out and thus the relationship is considered indeterminate.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myalgia, Pain in extremity, Paraesthesia
Clinical narrative: GUILLAIN BARRE SYNDROME; UNABLE TO SLEEP; BELL'S PALSY; ALTERED TASTE; ALTERED SMELL; This spontaneous report was received from a patient and concerned a 59 year old male. The patient's weight was 152 pounds, and height was 76 inches. The patient's concurrent conditions included high blood pressure controlled with unspecified medication, smoker 6-8 cigarettes per day, and no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 23-MAY-2021 to his left arm for prophylactic vaccination. Batch number was not reported. Company will perform follow up to obtain batch number. Concomitant medications included unspecified medication for blood pressure.  On 30-MAY-2021, the patient experienced Guillain Barre syndrome requiring hospitalization. He also experienced altered taste and altered smell. His symptoms started off as minor leg pain as cramps, then spread to abdomen, lower back, upper back, chest, arms and feet. He also had tingling in fingers and toes and numbness in hands and feet. The patient was seen by a doctor 2 weeks after receiving vaccine because was was experiencing  Bell's Palsy. The doctor prescribed ibuprofen to help alleviate the pain, but it did not help much. The doctor continued to give him pain killers. He was unable to sleep and went days without sleep. He recently was prescribed Percocet which also did not help much either. The patient was hospitalized on an unspecified date in JUN-2021 and discharged on an unspecified date in JUL-2021.   The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the Guillain Barre syndrome, altered taste, altered smell, unable to sleep and Bell's Palsy was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0:  This spontaneous report received from a consumer concerns a 59-year-old white male patient who was hospitalized with Guillain Barre syndrome (GBS) 7 days after receiving the Janssen Covid-19 vaccine.  The patient have concurrent high blood pressure and is a smoker (6-8 sticks/day).  Symptoms reported were altered taste and smell, leg pain and cramps that spreads to abdomen/lower back/upper back/chest/arms/feet, tingling in fingers and toes, and numbness in hands and feet.  No treatment was reported.  Approximately 2 weeks after vaccination, the patient was found to have Bell's palsy, and was prescribed with ibuprofen and Percocet.  The outcome of the events was not reported.  No other pertinent details reported.  The information available precludes a complete and meaningful assessment.  Based on the information available, the occurrence of the events could represent background incidence of such events in the general population. However, a relationship with Janssen Covid-19 vaccine cannot be ruled out and thus the relationship is considered indeterminate.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Adverse reaction, Bell's palsy, Condition aggravated, Electromyogram abnormal, Guillain-Barre syndrome
Clinical narrative: GUILLAIN BARRE SYNDROME; UNABLE TO SLEEP; BELL'S PALSY; ALTERED TASTE; ALTERED SMELL; This spontaneous report was received from a patient and concerned a 59 year old male. The patient's weight was 152 pounds, and height was 76 inches. The patient's concurrent conditions included high blood pressure controlled with unspecified medication, smoker 6-8 cigarettes per day, and no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 23-MAY-2021 to his left arm for prophylactic vaccination. Batch number was not reported. Company will perform follow up to obtain batch number. Concomitant medications included unspecified medication for blood pressure.  On 30-MAY-2021, the patient experienced Guillain Barre syndrome requiring hospitalization. He also experienced altered taste and altered smell. His symptoms started off as minor leg pain as cramps, then spread to abdomen, lower back, upper back, chest, arms and feet. He also had tingling in fingers and toes and numbness in hands and feet. The patient was seen by a doctor 2 weeks after receiving vaccine because was was experiencing  Bell's Palsy. The doctor prescribed ibuprofen to help alleviate the pain, but it did not help much. The doctor continued to give him pain killers. He was unable to sleep and went days without sleep. He recently was prescribed Percocet which also did not help much either. The patient was hospitalized on an unspecified date in JUN-2021 and discharged on an unspecified date in JUL-2021.   The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the Guillain Barre syndrome, altered taste, altered smell, unable to sleep and Bell's Palsy was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0:  This spontaneous report received from a consumer concerns a 59-year-old white male patient who was hospitalized with Guillain Barre syndrome (GBS) 7 days after receiving the Janssen Covid-19 vaccine.  The patient have concurrent high blood pressure and is a smoker (6-8 sticks/day).  Symptoms reported were altered taste and smell, leg pain and cramps that spreads to abdomen/lower back/upper back/chest/arms/feet, tingling in fingers and toes, and numbness in hands and feet.  No treatment was reported.  Approximately 2 weeks after vaccination, the patient was found to have Bell's palsy, and was prescribed with ibuprofen and Percocet.  The outcome of the events was not reported.  No other pertinent details reported.  The information available precludes a complete and meaningful assessment.  Based on the information available, the occurrence of the events could represent background incidence of such events in the general population. However, a relationship with Janssen Covid-19 vaccine cannot be ruled out and thus the relationship is considered indeterminate.