chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Limb discomfort, Pain, Vaccination site mass
Clinical narrative: still has throbbing in her arm; feels like there's a ball in her arm; pain is so bad that it wakes her up at night per the caller; This is a spontaneous report from a contactable consumer or other non hcp. A 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm on 21May2021 (at the age of 74 years old), as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Previously the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation and experienced feeling sick, loss of appetite, low energy levels, high blood pressure, and fever. The patient experienced still has throbbing in her arm, feels like there's a ball in her arm and pain is so bad that it wakes her up at night per the caller on an unspecified date. The patient reports that she does not have her energy back yet; appetite is coming back. After she had her 2nd dose of the vaccine on 21May2021 and starting last week Monday or Tuesday that patient started to have the complaints of throbbing during the day and night and felt like there's a ball in her left upper arm where shot was administered. Has been putting ice on her shoulder and the pain is so bad that it wakes her up at night. The patient would like to know if her complaints with her left upper extremity is normal and if it is going away. The outcome of the events was unknown.  Information about batch/lot number has been requested.
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eating disorder, Fear, Malaise
Clinical narrative: Has been sick ever since receiving the product; Having a headache in the back of her head; All her other conditions are aggravated; Can hardly walk; This is a spontaneous report from a contactable consumer (patient). A 86-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: Not provided, Expiration date: Not provided), via an unspecified route of administration on 20Jan2021 (86-year-old at vaccination) as a 1st dose, single dose for COVID-19 immunisation. The patient's medical history included heart disorder and cancer. The patient's concomitant medications were not reported. The patient took the first dose of the COVID vaccine about a week ago, or two weeks ago, on 20Jan2021. The patient stated that she had been sick ever since. The patient stated that she was having some reaction. The patient had lots of other conditions. The patient stated that she was having a headache in the back of her head, and all her other conditions are aggravated. The patient stated that she can hardly walk. The patient stated that she was a heart patient, and a cancer survivor. The patient stated that it took her a while to decide to get the vaccine in the first place, and she came home sick and had been sick ever since. The patient stated that when she woke up, she can't hardly hold her head up, until she gets a wet towel, or something hot to drink on an unspecified date 2021. The patient was wondering if this was a normal reaction. The patient declined to provide her email address. The outcome of the events was unknown.  Information on the lot/batch number has been requested.  The follow-up was being submitted to notify that the lot/batch number was not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information was expected.
Age: 86.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Gait disturbance, Headache, Illness
Clinical narrative: Has been sick ever since receiving the product; Having a headache in the back of her head; All her other conditions are aggravated; Can hardly walk; This is a spontaneous report from a contactable consumer (patient). A 86-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: Not provided, Expiration date: Not provided), via an unspecified route of administration on 20Jan2021 (86-year-old at vaccination) as a 1st dose, single dose for COVID-19 immunisation. The patient's medical history included heart disorder and cancer. The patient's concomitant medications were not reported. The patient took the first dose of the COVID vaccine about a week ago, or two weeks ago, on 20Jan2021. The patient stated that she had been sick ever since. The patient stated that she was having some reaction. The patient had lots of other conditions. The patient stated that she was having a headache in the back of her head, and all her other conditions are aggravated. The patient stated that she can hardly walk. The patient stated that she was a heart patient, and a cancer survivor. The patient stated that it took her a while to decide to get the vaccine in the first place, and she came home sick and had been sick ever since. The patient stated that when she woke up, she can't hardly hold her head up, until she gets a wet towel, or something hot to drink on an unspecified date 2021. The patient was wondering if this was a normal reaction. The patient declined to provide her email address. The outcome of the events was unknown.  Information on the lot/batch number has been requested.  The follow-up was being submitted to notify that the lot/batch number was not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information was expected.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Deafness unilateral, Tinnitus
Clinical narrative: complete hearing loss in right ear; 10 fold increase in tinnitus; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route of administration, administered in left arm on 31Mar2021 13:30 (batch/lot number ER8733 and expiry date unknown) at 66 years of age as dose 1, single for covid-19 immunization received in a hospital. Medical history included ocular MG (migraine), benign prostate enlargement, hiatal hernia, high cholesterol, ongoing tinnitus. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had no covid prior vaccination. Concomitant medications included omeprazole, simvastatin, finasteride; all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient informed that he experienced 10 fold increase in tinnitus, complete hearing loss in right ear (medically significant). The patient informed that the adverse events start date was 27Apr2021 and start time 09:45 am. The events resulted in doctor or other healthcare professional office/clinic visit. The patient has not been tested for COVID-19 since the vaccination. The patient was not covid tested post vaccination. The patient received steroids due to the events. The outcome of the events was not recovered.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Deafness unilateral, Tinnitus
Clinical narrative: complete hearing loss in right ear; 10 fold increase in tinnitus; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route of administration, administered in left arm on 31Mar2021 13:30 (batch/lot number ER8733 and expiry date unknown) at 66 years of age as dose 1, single for covid-19 immunization received in a hospital. Medical history included ocular MG (migraine), benign prostate enlargement, hiatal hernia, high cholesterol, ongoing tinnitus. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had no covid prior vaccination. Concomitant medications included omeprazole, simvastatin, finasteride; all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient informed that he experienced 10 fold increase in tinnitus, complete hearing loss in right ear (medically significant). The patient informed that the adverse events start date was 27Apr2021 and start time 09:45 am. The events resulted in doctor or other healthcare professional office/clinic visit. The patient has not been tested for COVID-19 since the vaccination. The patient was not covid tested post vaccination. The patient received steroids due to the events. The outcome of the events was not recovered.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal discomfort, Condition aggravated, Death, Headache
Clinical narrative: Systemic: informed pt passed. observed no side effects when administered-Mild, Additional Details: Dr. contacted pharmacy on 6-23-21 to notify us of patients passing. At the time of this report, I can not confirm, nor has it been confirmed to my knowledge, that the vaccine was the cause of death.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Autopsy, Death, Malaise, Pathology test, Toxicologic test
Clinical narrative: Systemic: informed pt passed. observed no side effects when administered-Mild, Additional Details: Dr. contacted pharmacy on 6-23-21 to notify us of patients passing. At the time of this report, I can not confirm, nor has it been confirmed to my knowledge, that the vaccine was the cause of death.
Age: 16.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Death
Clinical narrative: Systemic: informed pt passed. observed no side effects when administered-Mild, Additional Details: Dr. contacted pharmacy on 6-23-21 to notify us of patients passing. At the time of this report, I can not confirm, nor has it been confirmed to my knowledge, that the vaccine was the cause of death.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Brudzinski's sign, CSF protein increased, Chills, Headache, Kernig's sign
Clinical narrative: High fever, pain in bones and muscles, lower back, virus associated with meningitis, nerve pains, can't walk without assistance
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Leukocytosis, Lumbar puncture abnormal, Nausea, Neuralgia, Nuchal rigidity
Clinical narrative: High fever, pain in bones and muscles, lower back, virus associated with meningitis, nerve pains, can't walk without assistance
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain, Photophobia, Physical examination abnormal, Polymerase chain reaction positive, Pyrexia
Clinical narrative: High fever, pain in bones and muscles, lower back, virus associated with meningitis, nerve pains, can't walk without assistance
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Rash, Varicella virus test positive, Varicella zoster virus infection
Clinical narrative: High fever, pain in bones and muscles, lower back, virus associated with meningitis, nerve pains, can't walk without assistance
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Back pain, Blood test, Bone pain, Gait disturbance, Lumbar puncture
Clinical narrative: High fever, pain in bones and muscles, lower back, virus associated with meningitis, nerve pains, can't walk without assistance
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Meningitis, Myalgia, Neuralgia, Pyrexia, Viral infection
Clinical narrative: High fever, pain in bones and muscles, lower back, virus associated with meningitis, nerve pains, can't walk without assistance
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebral venous sinus thrombosis, Headache, Magnetic resonance imaging head abnormal
Clinical narrative: Patient developed headache, nausea, vomiting 05/31. Developed diplopia 06/04
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebral venous sinus thrombosis, Diplopia, Headache, Magnetic resonance imaging abnormal, Nausea
Clinical narrative: Patient developed headache, nausea, vomiting 05/31. Developed diplopia 06/04
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Venogram, Vomiting
Clinical narrative: Patient developed headache, nausea, vomiting 05/31. Developed diplopia 06/04
Age: 92.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, General physical health deterioration, Hypersomnia, Hypophagia, Weight decreased
Clinical narrative: PASSED AWAY; This spontaneous report received from a health care professional concerned a 92-year-old . The patient's height, and weight were not reported. The patient was a home bound patient and had health issues but no more information was reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, frequency 1 total, administered on 30-MAR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On 10-MAY-2021, the patient passed away due to unknown cause. It was unknown if autopsy was performed. No more details were reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20210642437.; Sender's Comments: V0: 20210642925-Covid-19 vaccine ad26.cov2.s -passed away. 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: 92.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: PASSED AWAY; This spontaneous report received from a health care professional concerned a 92-year-old . The patient's height, and weight were not reported. The patient was a home bound patient and had health issues but no more information was reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, frequency 1 total, administered on 30-MAR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On 10-MAY-2021, the patient passed away due to unknown cause. It was unknown if autopsy was performed. No more details were reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20210642437.; Sender's Comments: V0: 20210642925-Covid-19 vaccine ad26.cov2.s -passed away. 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: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death, SARS-CoV-2 test negative
Clinical narrative: PASSED AWAY; This spontaneous report received from a health care professional (nurse) concerned an 83-year-old female. The patient's height, and weight were not reported. The patient was a home bound patient and had health issues.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, frequency 1 total, administered on 30-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the patient passed away and cause of death was unknown. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20210642925.; Sender's Comments: V0-20210642437-Covid-19 vaccine ad26.cov2.s - PASSED AWAY . 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: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: PASSED AWAY; This spontaneous report received from a health care professional (nurse) concerned an 83-year-old female. The patient's height, and weight were not reported. The patient was a home bound patient and had health issues.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, frequency 1 total, administered on 30-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On 15-MAY-2021, the patient passed away and cause of death was unknown. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20210642925.; Sender's Comments: V0-20210642437-Covid-19 vaccine ad26.cov2.s - PASSED AWAY . 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: 22.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Blood test, Chest X-ray, Chest discomfort, Chest pain
Clinical narrative: myocarditis
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Computerised tomogram, Electrocardiogram abnormal, Feeling of body temperature change, Influenza like illness
Clinical narrative: myocarditis
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Migraine, Myocarditis, Pain, Troponin increased, Vomiting
Clinical narrative: myocarditis
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myocarditis
Clinical narrative: myocarditis
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Angiogram cerebral abnormal, Arteriovenous malformation, Cerebral mass effect, Computerised tomogram head, Haemorrhage intracranial
Clinical narrative: Father called and reported child had a brain aneurysm and stroke.  He is currently at hospital undergoing multiple brain surgeries and will be at inpatient rehab for 4 to 6 weeks. He is non verbal.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Hyporesponsive to stimuli, Pyrexia, Vascular rupture, Vomiting
Clinical narrative: Father called and reported child had a brain aneurysm and stroke.  He is currently at hospital undergoing multiple brain surgeries and will be at inpatient rehab for 4 to 6 weeks. He is non verbal.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Arteriovenous malformation, Cerebral haemorrhage, Computerised tomogram, Hemiplegia, Intensive care
Clinical narrative: Father called and reported child had a brain aneurysm and stroke.  He is currently at hospital undergoing multiple brain surgeries and will be at inpatient rehab for 4 to 6 weeks. He is non verbal.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Laboratory test, Mental status changes, Pyrexia, Therapeutic embolisation, Vascular rupture
Clinical narrative: Father called and reported child had a brain aneurysm and stroke.  He is currently at hospital undergoing multiple brain surgeries and will be at inpatient rehab for 4 to 6 weeks. He is non verbal.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Father called and reported child had a brain aneurysm and stroke.  He is currently at hospital undergoing multiple brain surgeries and will be at inpatient rehab for 4 to 6 weeks. He is non verbal.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Brain operation, Cerebrovascular accident, Intracranial aneurysm, Speech disorder
Clinical narrative: Father called and reported child had a brain aneurysm and stroke.  He is currently at hospital undergoing multiple brain surgeries and will be at inpatient rehab for 4 to 6 weeks. He is non verbal.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Cerebral haemorrhage, Cerebrovascular accident, Computerised tomogram abnormal, Hypertension, Intensive care
Clinical narrative: Father called and reported child had a brain aneurysm and stroke.  He is currently at hospital undergoing multiple brain surgeries and will be at inpatient rehab for 4 to 6 weeks. He is non verbal.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Paralysis, Pyrexia, Therapeutic embolisation, Vomiting
Clinical narrative: Father called and reported child had a brain aneurysm and stroke.  He is currently at hospital undergoing multiple brain surgeries and will be at inpatient rehab for 4 to 6 weeks. He is non verbal.
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Angiogram cerebral abnormal, Arteriovenous malformation, Cerebral mass effect, Computerised tomogram head, Haemorrhage intracranial
Clinical narrative: My son had a fever the even of receiving his 2nd COVID vaccination that resulted in high blood pressure, vomiting  and the a massive brain hemorrhage. Patient (12 year old) suffered a stroke and become paralyzed.  We took him to Hospital, they ordered a CT scan an identified the massive brain bleed. We were transferred by emergency ambulation to Stroke Center.. They conducted a embolization to stop the brain bleed. He has been in the Pediatric Intensive care unit since 6/16 under going close monitoring,
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Hyporesponsive to stimuli, Pyrexia, Vascular rupture, Vomiting
Clinical narrative: My son had a fever the even of receiving his 2nd COVID vaccination that resulted in high blood pressure, vomiting  and the a massive brain hemorrhage. Patient (12 year old) suffered a stroke and become paralyzed.  We took him to Hospital, they ordered a CT scan an identified the massive brain bleed. We were transferred by emergency ambulation to Stroke Center.. They conducted a embolization to stop the brain bleed. He has been in the Pediatric Intensive care unit since 6/16 under going close monitoring,
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Arteriovenous malformation, Cerebral haemorrhage, Computerised tomogram, Hemiplegia, Intensive care
Clinical narrative: My son had a fever the even of receiving his 2nd COVID vaccination that resulted in high blood pressure, vomiting  and the a massive brain hemorrhage. Patient (12 year old) suffered a stroke and become paralyzed.  We took him to Hospital, they ordered a CT scan an identified the massive brain bleed. We were transferred by emergency ambulation to Stroke Center.. They conducted a embolization to stop the brain bleed. He has been in the Pediatric Intensive care unit since 6/16 under going close monitoring,
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Laboratory test, Mental status changes, Pyrexia, Therapeutic embolisation, Vascular rupture
Clinical narrative: My son had a fever the even of receiving his 2nd COVID vaccination that resulted in high blood pressure, vomiting  and the a massive brain hemorrhage. Patient (12 year old) suffered a stroke and become paralyzed.  We took him to Hospital, they ordered a CT scan an identified the massive brain bleed. We were transferred by emergency ambulation to Stroke Center.. They conducted a embolization to stop the brain bleed. He has been in the Pediatric Intensive care unit since 6/16 under going close monitoring,
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: My son had a fever the even of receiving his 2nd COVID vaccination that resulted in high blood pressure, vomiting  and the a massive brain hemorrhage. Patient (12 year old) suffered a stroke and become paralyzed.  We took him to Hospital, they ordered a CT scan an identified the massive brain bleed. We were transferred by emergency ambulation to Stroke Center.. They conducted a embolization to stop the brain bleed. He has been in the Pediatric Intensive care unit since 6/16 under going close monitoring,
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Brain operation, Cerebrovascular accident, Intracranial aneurysm, Speech disorder
Clinical narrative: My son had a fever the even of receiving his 2nd COVID vaccination that resulted in high blood pressure, vomiting  and the a massive brain hemorrhage. Patient (12 year old) suffered a stroke and become paralyzed.  We took him to Hospital, they ordered a CT scan an identified the massive brain bleed. We were transferred by emergency ambulation to Stroke Center.. They conducted a embolization to stop the brain bleed. He has been in the Pediatric Intensive care unit since 6/16 under going close monitoring,
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Cerebral haemorrhage, Cerebrovascular accident, Computerised tomogram abnormal, Hypertension, Intensive care
Clinical narrative: My son had a fever the even of receiving his 2nd COVID vaccination that resulted in high blood pressure, vomiting  and the a massive brain hemorrhage. Patient (12 year old) suffered a stroke and become paralyzed.  We took him to Hospital, they ordered a CT scan an identified the massive brain bleed. We were transferred by emergency ambulation to Stroke Center.. They conducted a embolization to stop the brain bleed. He has been in the Pediatric Intensive care unit since 6/16 under going close monitoring,
Age: 12.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Paralysis, Pyrexia, Therapeutic embolisation, Vomiting
Clinical narrative: My son had a fever the even of receiving his 2nd COVID vaccination that resulted in high blood pressure, vomiting  and the a massive brain hemorrhage. Patient (12 year old) suffered a stroke and become paralyzed.  We took him to Hospital, they ordered a CT scan an identified the massive brain bleed. We were transferred by emergency ambulation to Stroke Center.. They conducted a embolization to stop the brain bleed. He has been in the Pediatric Intensive care unit since 6/16 under going close monitoring,
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Received first dose on 14Mar. Tested positive. Finished isolation period.; Tested positive; This is Spontaneous report from a contactable consumer reported for himself via Pfizer sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported),via an unspecified route of administration on 14Mar2021 as 1st Dose, Single Dose for COVID-19 immunization. The patients medical history and concomitant medications were not reported. The patient received first dose on 14Mar2021,tested positive and finished isolation period. The patient underwent lab tests and procedures which included sars-cov-1 test resulted as positive. The outcome for the events was Unknown. No follow-up attempts are possible. Information about lot/batch cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-1 test
Clinical narrative: Received first dose on 14Mar. Tested positive. Finished isolation period.; Tested positive; This is Spontaneous report from a contactable consumer reported for himself via Pfizer sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported),via an unspecified route of administration on 14Mar2021 as 1st Dose, Single Dose for COVID-19 immunization. The patients medical history and concomitant medications were not reported. The patient received first dose on 14Mar2021,tested positive and finished isolation period. The patient underwent lab tests and procedures which included sars-cov-1 test resulted as positive. The outcome for the events was Unknown. No follow-up attempts are possible. Information about lot/batch cannot be obtained.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Fatigue, Heart rate increased, Insomnia, Neck pain
Clinical narrative: LOSS OF APETITE; ACHES AROUND SHOULDERS; CHILLS; LEGS DO NOT WANT TO MOVE/SOME WEAKNESS IN THE LEG; TIREDNESS; PALPITATION; This spontaneous report received from a patient concerned a 77 year old male. The patient's weight was 135 pounds, and height was not reported. The patient's past medical history included blood thinner, and hospitalisation, and concurrent conditions included weak heart, alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergy and had no drug abuse or illicit drug use. The patient was previously treated with furosemide for weak heart, atorvastatin calcium for weak heart, and acetylsalicylic acid for weak heart.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On JUN-2021, Laboratory data included: Oxygen saturation (NR: not provided) 140 (unit was not provided), 68 (unit was not provided). On 15-JUN-2021, the subject experienced palpitation. On 15-JUN-2021, the subject experienced aches around shoulders. On 15-JUN-2021, the subject experienced chills. On 15-JUN-2021, the subject experienced legs do not want to move/some weakness in the leg. On 15-JUN-2021, the subject experienced tiredness. On 16-JUN-2021, the subject experienced loss of apetite. Laboratory data (dates unspecified) included: Palpitation (NR: not provided) 74. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches around shoulders on 17-JUN-2021, and chills on 16-JUN-2021, and was recovering from palpitation, tiredness, loss of apetite, and legs do not want to move/some weakness in the leg. This report was non-serious.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Decreased appetite, Fatigue, Muscular weakness
Clinical narrative: LOSS OF APETITE; ACHES AROUND SHOULDERS; CHILLS; LEGS DO NOT WANT TO MOVE/SOME WEAKNESS IN THE LEG; TIREDNESS; PALPITATION; This spontaneous report received from a patient concerned a 77 year old male. The patient's weight was 135 pounds, and height was not reported. The patient's past medical history included blood thinner, and hospitalisation, and concurrent conditions included weak heart, alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergy and had no drug abuse or illicit drug use. The patient was previously treated with furosemide for weak heart, atorvastatin calcium for weak heart, and acetylsalicylic acid for weak heart.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On JUN-2021, Laboratory data included: Oxygen saturation (NR: not provided) 140 (unit was not provided), 68 (unit was not provided). On 15-JUN-2021, the subject experienced palpitation. On 15-JUN-2021, the subject experienced aches around shoulders. On 15-JUN-2021, the subject experienced chills. On 15-JUN-2021, the subject experienced legs do not want to move/some weakness in the leg. On 15-JUN-2021, the subject experienced tiredness. On 16-JUN-2021, the subject experienced loss of apetite. Laboratory data (dates unspecified) included: Palpitation (NR: not provided) 74. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches around shoulders on 17-JUN-2021, and chills on 16-JUN-2021, and was recovering from palpitation, tiredness, loss of apetite, and legs do not want to move/some weakness in the leg. This report was non-serious.
Age: 77.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Oxygen saturation, Palpitations
Clinical narrative: LOSS OF APETITE; ACHES AROUND SHOULDERS; CHILLS; LEGS DO NOT WANT TO MOVE/SOME WEAKNESS IN THE LEG; TIREDNESS; PALPITATION; This spontaneous report received from a patient concerned a 77 year old male. The patient's weight was 135 pounds, and height was not reported. The patient's past medical history included blood thinner, and hospitalisation, and concurrent conditions included weak heart, alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergy and had no drug abuse or illicit drug use. The patient was previously treated with furosemide for weak heart, atorvastatin calcium for weak heart, and acetylsalicylic acid for weak heart.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 15-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On JUN-2021, Laboratory data included: Oxygen saturation (NR: not provided) 140 (unit was not provided), 68 (unit was not provided). On 15-JUN-2021, the subject experienced palpitation. On 15-JUN-2021, the subject experienced aches around shoulders. On 15-JUN-2021, the subject experienced chills. On 15-JUN-2021, the subject experienced legs do not want to move/some weakness in the leg. On 15-JUN-2021, the subject experienced tiredness. On 16-JUN-2021, the subject experienced loss of apetite. Laboratory data (dates unspecified) included: Palpitation (NR: not provided) 74. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches around shoulders on 17-JUN-2021, and chills on 16-JUN-2021, and was recovering from palpitation, tiredness, loss of apetite, and legs do not want to move/some weakness in the leg. This report was non-serious.
Age: 38.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Acute kidney injury, Acute myocardial infarction, Blood ethanol, Cardiac arrest, Cardiomyopathy
Clinical narrative: Patient got Moderna vaccine and 1 week later was pronounced brain dead
Age: 38.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Ejection fraction decreased, Electrocardiogram abnormal, Fatigue, Hyperkalaemia, Lactic acidosis
Clinical narrative: Patient got Moderna vaccine and 1 week later was pronounced brain dead
Age: 38.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Left ventricular dysfunction, Leukocytosis, Liver function test increased, Mitral valve incompetence, Myocarditis
Clinical narrative: Patient got Moderna vaccine and 1 week later was pronounced brain dead
Age: 38.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pallor, Respiratory arrest, Resuscitation, Troponin increased, Vaccination complication
Clinical narrative: Patient got Moderna vaccine and 1 week later was pronounced brain dead
Age: 38.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Brain death
Clinical narrative: Patient got Moderna vaccine and 1 week later was pronounced brain dead
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia
Clinical narrative: she "has numbness" and "tingling"in her left and right hands; It feels like pins and needles/tingling in her left and right hands; This is a spontaneous report received from a contactable consumer (patient herself) via Medical Information Team. A 49-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 14Jun2021 as 2nd dose, single (at the age of 49-years-old) for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as 1st dose, single for COVID-19 immunization and had no reaction. Patient received her 2nd Pfizer vaccine a day before (14Jun2021) and stated today (15Jun2021) she had numbness and tingling in her left and right hands, but mostly in her right hand. It felt like pins and needles, like when you leave your arm or leg in a position too long. The outcome of the events was unknown.   Follow up attempts are needed; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: she "has numbness" and "tingling"in her left and right hands; It feels like pins and needles/tingling in her left and right hands; This is a spontaneous report received from a contactable consumer (patient herself) via Medical Information Team. A 49-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 14Jun2021 as 2nd dose, single (at the age of 49-years-old) for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as 1st dose, single for COVID-19 immunization and had no reaction. Patient received her 2nd Pfizer vaccine a day before (14Jun2021) and stated today (15Jun2021) she had numbness and tingling in her left and right hands, but mostly in her right hand. It felt like pins and needles, like when you leave your arm or leg in a position too long. The outcome of the events was unknown.   Follow up attempts are needed; information about lot/batch number cannot be obtained.
Age: 14.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 14 YEAR FEMALE RECEIVED VACCINE IN ERROR; This spontaneous report received from a parent via a company representative concerned a 14 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included no alcohol use, and non-smoker, and other pre-existing medical conditions included patient had no known allergies. patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 18-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 18-JUN-2021, the subject experienced 14 year female received vaccine in error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of 14 year female received vaccine in error was not reported. This report was non-serious. This case, from the same reporter is linked to 20210637860.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Brain natriuretic peptide, C-reactive protein, Chills, Condition aggravated, Electrocardiogram
Clinical narrative: 41.7kg 12 yo F with seizure history was given Covid19 vaccine #2 on 6/14.  20 lifetime seizures typically lasting 2-3 minutes.  Unclear if she missed her 6/14 PM antiseizure meds.  On 6/15, patient fatigued with low grade fever and  somewhat decreased  PO intake.  Spent the day in PJs and on couch.   Seizure ~1610 started suddenly with eye rolling followed by jerking movements, desaturations per her normal pattern.  Then she had a 2nd seizure and EMS was called. Received 2.5mg IV versed in route by EMS. Admitted for status epileticus.  In the ED she had 3 more seizures; during the 3rd seizure in the ED she desatted to 28% and received 3mg ativan in 1mg increments.  Loaded with fosphenytoin 20mg/kg. Then no
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electroencephalogram, Fatigue, Full blood count, Headache, Metabolic function test
Clinical narrative: 41.7kg 12 yo F with seizure history was given Covid19 vaccine #2 on 6/14.  20 lifetime seizures typically lasting 2-3 minutes.  Unclear if she missed her 6/14 PM antiseizure meds.  On 6/15, patient fatigued with low grade fever and  somewhat decreased  PO intake.  Spent the day in PJs and on couch.   Seizure ~1610 started suddenly with eye rolling followed by jerking movements, desaturations per her normal pattern.  Then she had a 2nd seizure and EMS was called. Received 2.5mg IV versed in route by EMS. Admitted for status epileticus.  In the ED she had 3 more seizures; during the 3rd seizure in the ED she desatted to 28% and received 3mg ativan in 1mg increments.  Loaded with fosphenytoin 20mg/kg. Then no
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Myalgia, Pyrexia, SARS-CoV-2 test negative, Status epilepticus, Troponin
Clinical narrative: 41.7kg 12 yo F with seizure history was given Covid19 vaccine #2 on 6/14.  20 lifetime seizures typically lasting 2-3 minutes.  Unclear if she missed her 6/14 PM antiseizure meds.  On 6/15, patient fatigued with low grade fever and  somewhat decreased  PO intake.  Spent the day in PJs and on couch.   Seizure ~1610 started suddenly with eye rolling followed by jerking movements, desaturations per her normal pattern.  Then she had a 2nd seizure and EMS was called. Received 2.5mg IV versed in route by EMS. Admitted for status epileticus.  In the ED she had 3 more seizures; during the 3rd seizure in the ED she desatted to 28% and received 3mg ativan in 1mg increments.  Loaded with fosphenytoin 20mg/kg. Then no
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anion gap increased, Blood bicarbonate decreased, Blood pH, C-reactive protein increased, Condition aggravated
Clinical narrative: 41.7kg 12 yo F with seizure history was given Covid19 vaccine #2 on 6/14.  20 lifetime seizures typically lasting 2-3 minutes.  Unclear if she missed her 6/14 PM antiseizure meds.  On 6/15, patient fatigued with low grade fever and  somewhat decreased  PO intake.  Spent the day in PJs and on couch.   Seizure ~1610 started suddenly with eye rolling followed by jerking movements, desaturations per her normal pattern.  Then she had a 2nd seizure and EMS was called. Received 2.5mg IV versed in route by EMS. Admitted for status epileticus.  In the ED she had 3 more seizures; during the 3rd seizure in the ED she desatted to 28% and received 3mg ativan in 1mg increments.  Loaded with fosphenytoin 20mg/kg. Then no
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyskinesia, Electrocardiogram normal, Electroencephalogram normal, Eye movement disorder, Fatigue
Clinical narrative: 41.7kg 12 yo F with seizure history was given Covid19 vaccine #2 on 6/14.  20 lifetime seizures typically lasting 2-3 minutes.  Unclear if she missed her 6/14 PM antiseizure meds.  On 6/15, patient fatigued with low grade fever and  somewhat decreased  PO intake.  Spent the day in PJs and on couch.   Seizure ~1610 started suddenly with eye rolling followed by jerking movements, desaturations per her normal pattern.  Then she had a 2nd seizure and EMS was called. Received 2.5mg IV versed in route by EMS. Admitted for status epileticus.  In the ED she had 3 more seizures; during the 3rd seizure in the ED she desatted to 28% and received 3mg ativan in 1mg increments.  Loaded with fosphenytoin 20mg/kg. Then no
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Laboratory test, Laboratory test normal, Pyrexia, Seizure, Status epilepticus
Clinical narrative: 41.7kg 12 yo F with seizure history was given Covid19 vaccine #2 on 6/14.  20 lifetime seizures typically lasting 2-3 minutes.  Unclear if she missed her 6/14 PM antiseizure meds.  On 6/15, patient fatigued with low grade fever and  somewhat decreased  PO intake.  Spent the day in PJs and on couch.   Seizure ~1610 started suddenly with eye rolling followed by jerking movements, desaturations per her normal pattern.  Then she had a 2nd seizure and EMS was called. Received 2.5mg IV versed in route by EMS. Admitted for status epileticus.  In the ED she had 3 more seizures; during the 3rd seizure in the ED she desatted to 28% and received 3mg ativan in 1mg increments.  Loaded with fosphenytoin 20mg/kg. Then no
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tachycardia, White blood cell count normal
Clinical narrative: 41.7kg 12 yo F with seizure history was given Covid19 vaccine #2 on 6/14.  20 lifetime seizures typically lasting 2-3 minutes.  Unclear if she missed her 6/14 PM antiseizure meds.  On 6/15, patient fatigued with low grade fever and  somewhat decreased  PO intake.  Spent the day in PJs and on couch.   Seizure ~1610 started suddenly with eye rolling followed by jerking movements, desaturations per her normal pattern.  Then she had a 2nd seizure and EMS was called. Received 2.5mg IV versed in route by EMS. Admitted for status epileticus.  In the ED she had 3 more seizures; during the 3rd seizure in the ED she desatted to 28% and received 3mg ativan in 1mg increments.  Loaded with fosphenytoin 20mg/kg. Then no
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Body temperature, Chills, Disease recurrence, Epilepsy, Fatigue
Clinical narrative: 41.7kg 12 yo F with seizure history was given Covid19 vaccine #2 on 6/14.  20 lifetime seizures typically lasting 2-3 minutes.  Unclear if she missed her 6/14 PM antiseizure meds.  On 6/15, patient fatigued with low grade fever and  somewhat decreased  PO intake.  Spent the day in PJs and on couch.   Seizure ~1610 started suddenly with eye rolling followed by jerking movements, desaturations per her normal pattern.  Then she had a 2nd seizure and EMS was called. Received 2.5mg IV versed in route by EMS. Admitted for status epileticus.  In the ED she had 3 more seizures; during the 3rd seizure in the ED she desatted to 28% and received 3mg ativan in 1mg increments.  Loaded with fosphenytoin 20mg/kg. Then no
Age: 12.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Myalgia, Pyrexia, SARS-CoV-2 test, Status epilepticus
Clinical narrative: 41.7kg 12 yo F with seizure history was given Covid19 vaccine #2 on 6/14.  20 lifetime seizures typically lasting 2-3 minutes.  Unclear if she missed her 6/14 PM antiseizure meds.  On 6/15, patient fatigued with low grade fever and  somewhat decreased  PO intake.  Spent the day in PJs and on couch.   Seizure ~1610 started suddenly with eye rolling followed by jerking movements, desaturations per her normal pattern.  Then she had a 2nd seizure and EMS was called. Received 2.5mg IV versed in route by EMS. Admitted for status epileticus.  In the ED she had 3 more seizures; during the 3rd seizure in the ED she desatted to 28% and received 3mg ativan in 1mg increments.  Loaded with fosphenytoin 20mg/kg. Then no