chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Swelling, Troponin, X-ray
Clinical narrative: AFTER RECEIVING THE PFIZER VACCINE ON MY WAY HOME AFTER 15 MINUTES I FELT A COUGH COMING ON THEN AFTER I GO HOME I FELT WEIRD SO I SAT DOWN AND WAS JUST SITTING DOWN, AFTER ABOUT 3 HOURS HAD PASSED I COULDN'T EVEN WALK TO THE RESTROOM ON MY OWN, SO MY SON HAD TO TAKE ME, AFTER COMING OUT OF THE BATHROOM I WENT TO LAY DOWN ON THE BED AROUND 8PM, BY THEN I WAS SWELLING UP ALL OVER AND ITICHING AND FEELING HORRIBLE LIKE IF SOMETHNG WAS KEEPING DOWN, I WAS IN SO SO MY PAIN AND FELT MY LUNG SO TIGHT THE I WAS HAVING DIFFICULT BREATHING, THIS IS WHO I WAS ALL NIGHT, HAVING CHILLS AND ACHING EVERY INCH OF MY BODY, NEXT DAY I HAD TO GO INTO THE ER AND I WAS TOLD I HAD A ALLERGY REACTION TO THE PFIZER VACCINE AND RECOMMENDED I DON'T TAKE THE SECOND DOSE ON AUGUST 2, 2021, THEN AFTER THIS ER VISIT I HAD TO GO AGAIN ON THE 15 OF JULY AS I GOT WORSE AND WAS TOLD THE SAME ALLERGIC TO COVID 19 VACCINE
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Colitis, Diarrhoea, Haematochezia, Laboratory test abnormal, Vomiting
Clinical narrative: Eventually my diarrhea turned to blood; colitis; throw up; Severe diarrhea; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, dose 1 via an unspecified route of administration, administered in Arm Left on 13May2021 09:30 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included thyroid disease, celiac, rocky mountain spotted fever, lymes, and known allergies: penicillin and gluten. Patient is not pregnant at time of vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID); and thyroid (ARMOUR THYROID). The patient previously took amoxicillin and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 8 days later, patient started to throw up a then have severe diarrhea eventually her diarrhea turned to blood. She was diagnosis with colitis, but she believed her attack was brought on by her vaccine. Adverse events started on 21May2021 01:00 PM. Adverse event result in Emergency room/department or urgent care. Patient was given an IV, antibiotics, steroids. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included Nasal Swab: negative on 23May2021. The outcomes of events were recovering.   The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.  The events occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Colitis, Diarrhoea, Diarrhoea haemorrhagic, SARS-CoV-2 test, Vomiting
Clinical narrative: Eventually my diarrhea turned to blood; colitis; throw up; Severe diarrhea; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, dose 1 via an unspecified route of administration, administered in Arm Left on 13May2021 09:30 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included thyroid disease, celiac, rocky mountain spotted fever, lymes, and known allergies: penicillin and gluten. Patient is not pregnant at time of vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID); and thyroid (ARMOUR THYROID). The patient previously took amoxicillin and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 8 days later, patient started to throw up a then have severe diarrhea eventually her diarrhea turned to blood. She was diagnosis with colitis, but she believed her attack was brought on by her vaccine. Adverse events started on 21May2021 01:00 PM. Adverse event result in Emergency room/department or urgent care. Patient was given an IV, antibiotics, steroids. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included Nasal Swab: negative on 23May2021. The outcomes of events were recovering.   The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.  The events occurred in a country different from that of the reporter. This may be a duplicate report if another reporter from the country where the event occurred has submitted the same information to his/her local agency.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia
Clinical narrative: After getting the second shot, roughly two weeks after my joints ( elbows, knees, fingers etc.) feel like are have sever arthritis. The pain never goes away.; After getting the second shot, roughly two weeks after my joints ( elbows, knees, fingers etc.) feel like are have sever arthritis. The pain never goes away.; This is a spontaneous report from a contactable other HCP (health care professional reporting for himself). A 51-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number: ER8732) via an unspecified route of administration, administered in arm left, on 14Apr2021 at 15:30 as dose 2, single dose for covid-19 immunization (at the age of 51-years-old). Medical history included hashimoto's disease and hypoglycemia from an unknown date and unknown if ongoing. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported. Patient had no COVID prior vaccination and not tested for COVID post vaccination. Patient did not receive any other vaccine in four weeks. It was reported that after getting the second shot, roughly two weeks after on 28Apr2021 patient's joints (elbows, knees, fingers etc.) felt like are have severe arthritis and stated that the pain never goes away. Patient did not receive any treatment for the events. The outcome of the events was not recovered.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Arthritis
Clinical narrative: After getting the second shot, roughly two weeks after my joints ( elbows, knees, fingers etc.) feel like are have sever arthritis. The pain never goes away.; After getting the second shot, roughly two weeks after my joints ( elbows, knees, fingers etc.) feel like are have sever arthritis. The pain never goes away.; This is a spontaneous report from a contactable other HCP (health care professional reporting for himself). A 51-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number: ER8732) via an unspecified route of administration, administered in arm left, on 14Apr2021 at 15:30 as dose 2, single dose for covid-19 immunization (at the age of 51-years-old). Medical history included hashimoto's disease and hypoglycemia from an unknown date and unknown if ongoing. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported. Patient had no COVID prior vaccination and not tested for COVID post vaccination. Patient did not receive any other vaccine in four weeks. It was reported that after getting the second shot, roughly two weeks after on 28Apr2021 patient's joints (elbows, knees, fingers etc.) felt like are have severe arthritis and stated that the pain never goes away. Patient did not receive any treatment for the events. The outcome of the events was not recovered.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antinuclear antibody positive, Asthenia, Blood test, Haemangioma of skin, Red blood cell nucleated morphology present
Clinical narrative: Patient described sudden onset of petichial rash on arms and torso 28 days later that continued to spread and increase over the lower extremities as well and increase in number with some associated fatigue.  Patient was seen by Hematology and dermatology and diagnosed with Eruptive Angiomas of which there is no known treatment.  Then in June, the patient started with hives
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound abdomen normal
Clinical narrative: Patient described sudden onset of petichial rash on arms and torso 28 days later that continued to spread and increase over the lower extremities as well and increase in number with some associated fatigue.  Patient was seen by Hematology and dermatology and diagnosed with Eruptive Angiomas of which there is no known treatment.  Then in June, the patient started with hives
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Activated partial thromboplastin time, Antinuclear antibody, Antiphospholipid antibodies, Blood testosterone, C-reactive protein
Clinical narrative: Patient described sudden onset of petichial rash on arms and torso 28 days later that continued to spread and increase over the lower extremities as well and increase in number with some associated fatigue.  Patient was seen by Hematology and dermatology and diagnosed with Eruptive Angiomas of which there is no known treatment.  Then in June, the patient started with hives
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiolipin antibody, Eruptive pseudoangiomatosis, Fatigue, Full blood count, Metabolic function test
Clinical narrative: Patient described sudden onset of petichial rash on arms and torso 28 days later that continued to spread and increase over the lower extremities as well and increase in number with some associated fatigue.  Patient was seen by Hematology and dermatology and diagnosed with Eruptive Angiomas of which there is no known treatment.  Then in June, the patient started with hives
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Petechiae, Platelet aggregation test, Prothrombin time, Rash, Red blood cell sedimentation rate
Clinical narrative: Patient described sudden onset of petichial rash on arms and torso 28 days later that continued to spread and increase over the lower extremities as well and increase in number with some associated fatigue.  Patient was seen by Hematology and dermatology and diagnosed with Eruptive Angiomas of which there is no known treatment.  Then in June, the patient started with hives
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria, Vitamin B12, Vitamin B6, Vitamin C, Vitamin K
Clinical narrative: Patient described sudden onset of petichial rash on arms and torso 28 days later that continued to spread and increase over the lower extremities as well and increase in number with some associated fatigue.  Patient was seen by Hematology and dermatology and diagnosed with Eruptive Angiomas of which there is no known treatment.  Then in June, the patient started with hives
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Von Willebrand's factor activity test
Clinical narrative: Patient described sudden onset of petichial rash on arms and torso 28 days later that continued to spread and increase over the lower extremities as well and increase in number with some associated fatigue.  Patient was seen by Hematology and dermatology and diagnosed with Eruptive Angiomas of which there is no known treatment.  Then in June, the patient started with hives
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bell's palsy
Clinical narrative: I got Bell's Palsy.; dose 1 on  27Apr2021, dose 2 on 27Apr2021; This is a spontaneous report from a contactable consumer or other non healthcare professional.   A 27 year old male patient (age at vaccination 27 years old) received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 27Apr2021 (Batch/Lot Number: EW0171) as dose 1, single dose 2 via an unspecified route of administration, administered in Arm Left on 27Apr2021 (Batch/Lot Number: EW0185) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. No known allergies. The patient was no prior to vaccination, was the patient diagnosed with COVID-19 and the patient not had the patient been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine The patient experienced Bell's palsy, on 02Jun2021. The outcome of the event was not recovered.    Upon follow-up on 22Jul2021 the follow-up attempts are completed. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Bell's palsy, Inappropriate schedule of product administration
Clinical narrative: I got Bell's Palsy.; dose 1 on  27Apr2021, dose 2 on 27Apr2021; This is a spontaneous report from a contactable consumer or other non healthcare professional.   A 27 year old male patient (age at vaccination 27 years old) received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 27Apr2021 (Batch/Lot Number: EW0171) as dose 1, single dose 2 via an unspecified route of administration, administered in Arm Left on 27Apr2021 (Batch/Lot Number: EW0185) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. No known allergies. The patient was no prior to vaccination, was the patient diagnosed with COVID-19 and the patient not had the patient been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine The patient experienced Bell's palsy, on 02Jun2021. The outcome of the event was not recovered.    Upon follow-up on 22Jul2021 the follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Eructation, Gastrooesophageal reflux disease, Headache, Pain
Clinical narrative: he experiences unnecessary belching.; acid reflux from the neck (throat area), going down to the stomach between the chest line.; This is a spontaneous report from a contactable consumer. A 37-year-old male consumer (patient) reported for himself that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date in May2021 dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in 2021, ever since vaccination patient experienced acid reflux from the neck (throat area), going down to the stomach between the chest line. He also stated that he commonly experiences this whenever he lays down during sleep but in the day when he goes to the gym, he does not experience the acid reflux. He also stated that he experiences unnecessary belching. He stated that he already contacted his HCP and he undergone x-ray but showed no correlation with what he was experiencing. The event outcome was unknown. Caller wanted to know if unnecessary belching and acid reflux was included among the commonly reported adverse events of the Pfizer BioNTech Covid-19 Vaccine and potentially how long it lasted if confirmed as an event. There was no information specific to acid reflux and unnecessary belching and patient was referred to HCP.  Information about batch/Lot number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pyrexia, Ultrasound thyroid
Clinical narrative: he experiences unnecessary belching.; acid reflux from the neck (throat area), going down to the stomach between the chest line.; This is a spontaneous report from a contactable consumer. A 37-year-old male consumer (patient) reported for himself that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date in May2021 dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in 2021, ever since vaccination patient experienced acid reflux from the neck (throat area), going down to the stomach between the chest line. He also stated that he commonly experiences this whenever he lays down during sleep but in the day when he goes to the gym, he does not experience the acid reflux. He also stated that he experiences unnecessary belching. He stated that he already contacted his HCP and he undergone x-ray but showed no correlation with what he was experiencing. The event outcome was unknown. Caller wanted to know if unnecessary belching and acid reflux was included among the commonly reported adverse events of the Pfizer BioNTech Covid-19 Vaccine and potentially how long it lasted if confirmed as an event. There was no information specific to acid reflux and unnecessary belching and patient was referred to HCP.  Information about batch/Lot number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Eructation, Gastrooesophageal reflux disease
Clinical narrative: he experiences unnecessary belching.; acid reflux from the neck (throat area), going down to the stomach between the chest line.; This is a spontaneous report from a contactable consumer. A 37-year-old male consumer (patient) reported for himself that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date in May2021 dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in 2021, ever since vaccination patient experienced acid reflux from the neck (throat area), going down to the stomach between the chest line. He also stated that he commonly experiences this whenever he lays down during sleep but in the day when he goes to the gym, he does not experience the acid reflux. He also stated that he experiences unnecessary belching. He stated that he already contacted his HCP and he undergone x-ray but showed no correlation with what he was experiencing. The event outcome was unknown. Caller wanted to know if unnecessary belching and acid reflux was included among the commonly reported adverse events of the Pfizer BioNTech Covid-19 Vaccine and potentially how long it lasted if confirmed as an event. There was no information specific to acid reflux and unnecessary belching and patient was referred to HCP.  Information about batch/Lot number has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Vaccination site vesicles
Clinical narrative: water filled blisters (vesicles) on her arm/ looked like pimples; a little rash; This case was reported by a consumer via call center representative and described the occurrence of vesicles in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number TP943, expiry date 28th January 2023) for prophylaxis.   Previously administered products included Bupropion SR with an associated reaction of cough (also experienced Feeling abnormal refer case US2021AMR157982) and bupropion XL with an associated reaction of syncope (also experienced heat stroke, anhidrosis refer case US2021AMR158140).   On 16th July 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 17th July 2021, 1 days after receiving Shingrix, the patient experienced vesicles and rash. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the vesicles was recovered/resolved and the outcome of the rash was unknown.   It was unknown if the reporter considered the vesicles and rash to be related to Shingrix.  Additional details were provided as follows: The patient received first dose of Shingrix and on 17th July 2021, she noticed 4 water filled blisters (vesicles) on her arm and on 18th July 2021 they were dry and looked like pimples and she took Benadryl by mouth. On 20th July 2021, similar vesicles appeared on her other arm. Patient went to an urgent care (medical clinic) and the physician described it as, a little rash. The vesicles are now resolved. The physician went urgent care on 20th July 2021 and patient dose not remember the name of the physician that saw her. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR157982:Same reporter US-GLAXOSMITHKLINE-US2021AMR158140:Same reporter
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Acne, Anhidrosis, Blister, Dermatitis acneiform, Feeling abnormal
Clinical narrative: water filled blisters (vesicles) on her arm/ looked like pimples; a little rash; This case was reported by a consumer via call center representative and described the occurrence of vesicles in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number TP943, expiry date 28th January 2023) for prophylaxis.   Previously administered products included Bupropion SR with an associated reaction of cough (also experienced Feeling abnormal refer case US2021AMR157982) and bupropion XL with an associated reaction of syncope (also experienced heat stroke, anhidrosis refer case US2021AMR158140).   On 16th July 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 17th July 2021, 1 days after receiving Shingrix, the patient experienced vesicles and rash. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the vesicles was recovered/resolved and the outcome of the rash was unknown.   It was unknown if the reporter considered the vesicles and rash to be related to Shingrix.  Additional details were provided as follows: The patient received first dose of Shingrix and on 17th July 2021, she noticed 4 water filled blisters (vesicles) on her arm and on 18th July 2021 they were dry and looked like pimples and she took Benadryl by mouth. On 20th July 2021, similar vesicles appeared on her other arm. Patient went to an urgent care (medical clinic) and the physician described it as, a little rash. The vesicles are now resolved. The physician went urgent care on 20th July 2021 and patient dose not remember the name of the physician that saw her. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR157982:Same reporter US-GLAXOSMITHKLINE-US2021AMR158140:Same reporter
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Syncope, Temperature intolerance
Clinical narrative: water filled blisters (vesicles) on her arm/ looked like pimples; a little rash; This case was reported by a consumer via call center representative and described the occurrence of vesicles in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number TP943, expiry date 28th January 2023) for prophylaxis.   Previously administered products included Bupropion SR with an associated reaction of cough (also experienced Feeling abnormal refer case US2021AMR157982) and bupropion XL with an associated reaction of syncope (also experienced heat stroke, anhidrosis refer case US2021AMR158140).   On 16th July 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 17th July 2021, 1 days after receiving Shingrix, the patient experienced vesicles and rash. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the vesicles was recovered/resolved and the outcome of the rash was unknown.   It was unknown if the reporter considered the vesicles and rash to be related to Shingrix.  Additional details were provided as follows: The patient received first dose of Shingrix and on 17th July 2021, she noticed 4 water filled blisters (vesicles) on her arm and on 18th July 2021 they were dry and looked like pimples and she took Benadryl by mouth. On 20th July 2021, similar vesicles appeared on her other arm. Patient went to an urgent care (medical clinic) and the physician described it as, a little rash. The vesicles are now resolved. The physician went urgent care on 20th July 2021 and patient dose not remember the name of the physician that saw her. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR157982:Same reporter US-GLAXOSMITHKLINE-US2021AMR158140:Same reporter
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Anticoagulant therapy, Cerebral haemorrhage, Cerebral venous sinus thrombosis, Computerised tomogram head abnormal, Headache
Clinical narrative: We were notified by family member , patient is currently in ICU/ surgery being treated for blood clots in the brain
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Mechanical ventilation, Mental impairment, Seizure
Clinical narrative: We were notified by family member , patient is currently in ICU/ surgery being treated for blood clots in the brain
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Anticoagulant therapy, Cerebral haemorrhage, Cerebral venous sinus thrombosis, Craniectomy, Platelet count decreased
Clinical narrative: We were notified by family member , patient is currently in ICU/ surgery being treated for blood clots in the brain
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Platelet transfusion, Thrombectomy, Thrombocytopenia
Clinical narrative: We were notified by family member , patient is currently in ICU/ surgery being treated for blood clots in the brain
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Cerebral thrombosis, Intensive care, Surgery
Clinical narrative: We were notified by family member , patient is currently in ICU/ surgery being treated for blood clots in the brain
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Brain oedema, Brain operation, Cerebral thrombosis, Cerebrovascular accident, Headache
Clinical narrative: We were notified by family member , patient is currently in ICU/ surgery being treated for blood clots in the brain
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Hemiplegia, Intensive care, Seizure
Clinical narrative: We were notified by family member , patient is currently in ICU/ surgery being treated for blood clots in the brain
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Activated partial thromboplastin time prolonged, Blood fibrinogen normal, Brain oedema, Cerebral infarction, Cerebral ischaemia
Clinical narrative: We were notified by family member , patient is currently in ICU/ surgery being treated for blood clots in the brain
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Cerebral mass effect, Cerebral venous sinus thrombosis, Computerised tomogram head abnormal, Cytotoxic oedema, Decompressive craniectomy
Clinical narrative: We were notified by family member , patient is currently in ICU/ surgery being treated for blood clots in the brain
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Fall, Fibrin D dimer, Gastrostomy, Haemorrhagic infarction, Head injury
Clinical narrative: We were notified by family member , patient is currently in ICU/ surgery being treated for blood clots in the brain
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Headache, Heparin-induced thrombocytopenia test, Loss of consciousness, Magnetic resonance imaging head abnormal, Platelet count decreased
Clinical narrative: We were notified by family member , patient is currently in ICU/ surgery being treated for blood clots in the brain
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Prothrombin time prolonged, SARS-CoV-2 test, Superior sagittal sinus thrombosis, Thrombectomy, Tracheostomy
Clinical narrative: We were notified by family member , patient is currently in ICU/ surgery being treated for blood clots in the brain
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Transverse sinus thrombosis, Vasogenic cerebral oedema, Venogram abnormal
Clinical narrative: We were notified by family member , patient is currently in ICU/ surgery being treated for blood clots in the brain
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Headache, Hypoaesthesia, Nausea
Clinical narrative: pt waited full observation period then left with parent.  after about 15 minutes mom brought pt back, complained of headache, nausea, and dizziness.  escorted patient to er for treatment.
Age: 15.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: pt waited full observation period then left with parent.  after about 15 minutes mom brought pt back, complained of headache, nausea, and dizziness.  escorted patient to er for treatment.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of personal independence in daily activities, Myalgia, Pain
Clinical narrative: CANNOT WALK DUE TO PAIN; MUSCLE PAIN ALL OVER BODY/CANNOT GET IN CAR DUE TO PAIN; MUSCLE PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. the patient had no known allergies, no history of drug abuse or illicit drug use and no history of medical issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced muscle pain at injection site. On 13-APR-2021, the subject experienced cannot walk due to pain. On 13-APR-2021, the subject experienced muscle pain all over body/cannot get in car due to pain. Laboratory data (dates unspecified) included: Laboratory test (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cannot walk due to pain, and muscle pain all over body/cannot get in car due to pain, and the outcome of muscle pain at injection site was not reported. This report was non-serious.; Sender's Comments: V0-Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Injection site pain, Laboratory test, Myalgia
Clinical narrative: CANNOT WALK DUE TO PAIN; MUSCLE PAIN ALL OVER BODY/CANNOT GET IN CAR DUE TO PAIN; MUSCLE PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, and non-smoker, and other pre-existing medical conditions included the patient was not pregnant at the time of reporting. the patient had no known allergies, no history of drug abuse or illicit drug use and no history of medical issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced muscle pain at injection site. On 13-APR-2021, the subject experienced cannot walk due to pain. On 13-APR-2021, the subject experienced muscle pain all over body/cannot get in car due to pain. Laboratory data (dates unspecified) included: Laboratory test (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cannot walk due to pain, and muscle pain all over body/cannot get in car due to pain, and the outcome of muscle pain at injection site was not reported. This report was non-serious.; Sender's Comments: V0-Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Seizure
Clinical narrative: PATIENT HAD 2 SEIZURES IMMEDIATELY AFTER ADMINISTRATION WITHIN 5 MINUTES. PATIENT WAS OFFERED 911/EMERGENCY MEDICAL SERVICES, BUT REFUSED. PHARMACIST STAYED WITH PATIENT FOR APPROXIMATELY 15 MINUTES AND THEY LEFT WITH A FRIEND. ENCOURAGED EMERGENCY MEDICAL SERVICES, UNKNOWN IF PATIENT WENT.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram pulmonary abnormal, Pulmonary embolism, Pulmonary infarction
Clinical narrative: Patient presenting with a segmental pulmonary embolism 2 weeks after first dose of the Moderna COVID-19 vaccination. Has history of provoked DVT from knee replacement surgery.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Dose was given 13 days after first dose. No adverse events noted.
Age: 12.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product administration error
Clinical narrative: PATIENT WAS ADMINISTERED A SHOT WITH AN EMPTY SYRINGE (NO VACCINE OR DILUENT WAS PRESENT) IN THE LEFT ARM. THE PATIENT WAS INFORMED OF THE MISTAKE AND WAS GIVEN THE CORRECT VACCINE IN THE OPPOSITE ARM. NO ADVERSE EFFECTS WERE NOTICED OR REPORTED BY THE PATIENT BEFORE LEAVING THE PHARMACY.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose given 13 days after first dose
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Fear of injection, Syncope
Clinical narrative: Patient came to get a COVID vaccination on 7/25/2021. Patient fainted after receiving his COVID-19 1st dose Pfizer vaccine. He recovered within a few minutes. Per patient, he has history of fainting from vaccination and bloodwork because of fear or anxiety from needles. He was sitting in a chair. Patient's father held him when he fainted. Patient's father and patient refused to call 911. I recommended him to go to hospital so that further treatment/evaluation can be determined. I called patient on 7/26/2021 at 4:45 pm to follow-up. He said he went to hospital/ER for post-vaccination evaluation and everything was ok.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Dehydration, Electrocardiogram normal, Loss of consciousness, Nausea
Clinical narrative: Patient received the vaccination and was sitting in counseling room when he passed out. Called for Assistance 88 and 911 EMT. BP 100/60, EKG WNL; Patient states he had worked out, had protein drinks, was dehydrated and anxious about getting the vaccination. Recommended patient go to urgent care to get rehydrated and take care of nausea.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Condition aggravated, Eczema, Rash erythematous, Rash pustular
Clinical narrative: Eczema, worst breakout ever. Big red patches of blisters and pus. Took several days to clear with topical medications.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Oral herpes, Paraesthesia, Rash, Tinnitus
Clinical narrative: Cold sores on nose and mouth Tingling nerve sensation on face, scalp, and neck Minor first outbreak of shingles (painful bumps under right armpit) Tinnitus (from a 1 out of 10, to a 2 out of 10)
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Feeling abnormal, Pain in extremity, Palpitations
Clinical narrative: initial reactions for 5 days:  sore arm, tiredness, fuzzy brain, fever, gastric distress.  All of these would fluctuate in intensity and sometimes weren't noticeable at all, except the sore arm which started strong and gradually lessened and disappeared after 3 days.  The real adverse reaction I've experienced and has actually been getting worse is a racing heart.   It may have actually started in May but I simply thought I had gotten out shape.  I really noticed it going uphill.  But starting in July, especially the last two weeks, the racing from just a brisk walk on flat land.  I have to stop and rest when I haven't really exerted myself.  There's no rational explanation where this has suddenly come from, until I just googled and found that it's been a reaction for some to the vaccine.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: initial reactions for 5 days:  sore arm, tiredness, fuzzy brain, fever, gastric distress.  All of these would fluctuate in intensity and sometimes weren't noticeable at all, except the sore arm which started strong and gradually lessened and disappeared after 3 days.  The real adverse reaction I've experienced and has actually been getting worse is a racing heart.   It may have actually started in May but I simply thought I had gotten out shape.  I really noticed it going uphill.  But starting in July, especially the last two weeks, the racing from just a brisk walk on flat land.  I have to stop and rest when I haven't really exerted myself.  There's no rational explanation where this has suddenly come from, until I just googled and found that it's been a reaction for some to the vaccine.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Bradycardia
Clinical narrative: Developed bradycardia. Resting heart rate was 62-65bpm prior to vaccine and is now 52-57bpm.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes in left armpit. Noticed 5/7. Had second dose of Pfizer 4/26 lot number EW 0171.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Headache, Injection site pruritus, Injection site warmth
Clinical narrative: All day and night body aches, head ache, nausea, and chills. "Covid arm," with redness/rash, hardness, heat and itching at the injection site.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Rash
Clinical narrative: All day and night body aches, head ache, nausea, and chills. "Covid arm," with redness/rash, hardness, heat and itching at the injection site.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Dizziness, Dysarthria, Facial paralysis, Hypoaesthesia
Clinical narrative: Within 15 minutes my face started to go numb.  I was on a Zoom call for work within one hour of 2nd vaccine.  the person i was meeting with sated and i saw the right side of my face droop.  Speech was slurred and I was struggle to complete a sentence.   I had a fever of 101, and was extremely dizzy for 4-5 days after 2nd vaccine.     i had speech deficits for at least two months after 2nd shot.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Within 15 minutes my face started to go numb.  I was on a Zoom call for work within one hour of 2nd vaccine.  the person i was meeting with sated and i saw the right side of my face droop.  Speech was slurred and I was struggle to complete a sentence.   I had a fever of 101, and was extremely dizzy for 4-5 days after 2nd vaccine.     i had speech deficits for at least two months after 2nd shot.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Discomfort
Clinical narrative: Experiencing discomfort to left underarm/breast area since 7/24/21
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, C-reactive protein increased, Chest X-ray abnormal, Chest discomfort, Dermatitis contact
Clinical narrative: Experiencing discomfort to left underarm/breast area since 7/24/21
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Lymph node pain, Lymphadenopathy, Palpitations, Red blood cell sedimentation rate increased
Clinical narrative: Experiencing discomfort to left underarm/breast area since 7/24/21
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Dizziness, Dry mouth, Incontinence
Clinical narrative: Patient temporarily lost consciousness twice becoming incontinent after the second episode. Patient complained of lightheadedness, dry mouth and was pale throughout. EMT arrived and administered an IV ultimately transporting the patient to the hospital as they remained weak and unable to maintain balance.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Pallor
Clinical narrative: Patient temporarily lost consciousness twice becoming incontinent after the second episode. Patient complained of lightheadedness, dry mouth and was pale throughout. EMT arrived and administered an IV ultimately transporting the patient to the hospital as they remained weak and unable to maintain balance.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Malaise, SARS-CoV-2 test positive
Clinical narrative: fully vaccinated (moderna: 3/20/21, 4/18/21); onset of symptoms 7/23/21
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Coagulation test abnormal, Coagulation time, Coagulopathy
Clinical narrative: Unexplained hypercoagulable disorder that is negative for conventional tests with threat for limb loss and need for thrombolytic treatment.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Nausea, Pain, Pyrexia
Clinical narrative: aches, fever 99-100, nausea, tiredness
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Dry throat, Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: Pt vaccinated on 3/28/21 and 4/25/21. Covid positive on 7/27/21. Runny nose, congestion, dry throat
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Cholecystitis, Illness, Laboratory test, Magnetic resonance imaging, Nausea
Clinical narrative: 12 Days later, Nausea, Vomiting, Cholecystitis. Hospitalized July 24, 2021.  Currently still hospitalized.   This may not be due to the COVID-19 vaccine BUT my Mother was fine prior to the shot and the proximity of her severe illness is very suspicious. Currently, she better but she is still hospitalized (6 days). She has never been in the hospital this longer than 2 days for tests and observation.  Because of her age Surgery is a risky option.    I am requesting research be done to discover others with Gastric issues after Pfizer's COVID-19 Vaccine.   I, personally,  another Pfizer COVID Vaccine recipient  with severe stomach pain since her Pfizer shot a few mos ago.   There's another friend (healthcare worker) who has been experiencing  a sense of malaise since her Moderna shot 3 mos ago.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound scan, Vomiting
Clinical narrative: 12 Days later, Nausea, Vomiting, Cholecystitis. Hospitalized July 24, 2021.  Currently still hospitalized.   This may not be due to the COVID-19 vaccine BUT my Mother was fine prior to the shot and the proximity of her severe illness is very suspicious. Currently, she better but she is still hospitalized (6 days). She has never been in the hospital this longer than 2 days for tests and observation.  Because of her age Surgery is a risky option.    I am requesting research be done to discover others with Gastric issues after Pfizer's COVID-19 Vaccine.   I, personally,  another Pfizer COVID Vaccine recipient  with severe stomach pain since her Pfizer shot a few mos ago.   There's another friend (healthcare worker) who has been experiencing  a sense of malaise since her Moderna shot 3 mos ago.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Pyrexia, Tinnitus
Clinical narrative: Tinnitus has worsened to unbearable levels following the fever caused by second shot of vaccination
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardioversion, Electrocardiogram abnormal, Inappropriate schedule of product administration
Clinical narrative: First issue is that the pharmacy gave his doses two weeks apart, not three. As a physician and his daughter I called them to see how this could have happened. They seemed unconcerned. About three weeks later he went into atrial fibrillation rhythm requiring cardioversion. No prior history of arrhythmias.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Hedheac (headache); This is a spontaneous report from a contactable consumer, the patient. A 43 year old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 01Apr2021 at 12:00(at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021 at 13:15 the patient experienced headache. The adverse event did not result in a visit to the doctors or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event headache was not recovered.  Amendment: This follow-up report is being submitted to amend previously reported information: 1. Slider#2 reporter was removed since same as 1st reporter 2. in slide#1 reporter, State format updated 3. patient address added in patient tab 4. Vaccine Facility Information added  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pruritus, Vaccination site mass
Clinical narrative: allergic reaction; Whole body was itching; Spot where the vaccine was administered turned into a lump; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 24Mar2021 at 15:45 (at the age of 39-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included levothyroxine sodium (SYNTHROID), amlodipine besilate (NORVASC), simvastatin (MANUFACTURER UNKNOWN) and ramipril (ALTACE); all for unknown indication from an unknown date . Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Mar2021, after the vaccine was administered, the patient felt whole body was itching, as if patient had allergic reaction. That lasted till the day after the vaccine. Then on an unknown date in 2021, the spot where the vaccine was administered turned into a lump, which was present even after 2 weeks. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of the events  itching and  allergic reaction was recovered on 25Mar2021; while that of the event vaccination site mass was not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no additional AEs; administration of an expired vaccine; Information has been received from a registered nurse referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On 29-JUN-2021, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis, (1 time dose, lot# S005856, expiry date 03-DEC-2020; strength and route of administration were not reported) (Expired product administered). No other adverse event involved. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S005856; expirationdate: 03-DEC-2020; deviceage and unit: 0; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability