chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nerve conduction studies abnormal, Scan with contrast abnormal
Clinical narrative: Guillain Barre Syndrome Bilateral Bell's Palsy  He was a hiker prior to injection. Now he is unable to walk. He needs assist x3 to be able to stand and take only a few steps. Face paralyzed (upper motor neuron weakness). He had 5 days of IVig and then transferred to a higher level care as he developed the UMN weakness after the IVIg was completed. He is now in outpatient rehabilitation.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain Barre Syndrome Bilateral Bell's Palsy  He was a hiker prior to injection. Now he is unable to walk. He needs assist x3 to be able to stand and take only a few steps. Face paralyzed (upper motor neuron weakness). He had 5 days of IVig and then transferred to a higher level care as he developed the UMN weakness after the IVIg was completed. He is now in outpatient rehabilitation.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Pneumonia, Thrombosis, Ultrasound scan, X-ray
Clinical narrative: The first Pfizer shot landed me in the hospital with blood clots and pneumonia; The first Pfizer shot landed me in the hospital with blood clots and pneumonia; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The first Pfizer shot landed patient in the hospital with blood clots and pneumonia. The outcome of events was unknown.   Information about lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pneumonia, Thrombosis
Clinical narrative: The first Pfizer shot landed me in the hospital with blood clots and pneumonia; The first Pfizer shot landed me in the hospital with blood clots and pneumonia; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The first Pfizer shot landed patient in the hospital with blood clots and pneumonia. The outcome of events was unknown.   Information about lot/batch number has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood glucose abnormal, Blood glucose increased, Gastrointestinal haemorrhage
Clinical narrative: We were at my Hair Stylist and  the Pharamist came over and asked if anyone if they needed a Covid 19 shot and I said to the patient ) there's your shot, we walked next door and she got it in her left arm . I drove her home right after this she seemed fine then. We went back to pick her up to take her to a Primary Dr. for a follow up so she establbblishd a Primary in the area, She did not answer the door, we banged on the door and no one answered 3-4 days she was dead.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: We were at my Hair Stylist and  the Pharamist came over and asked if anyone if they needed a Covid 19 shot and I said to the patient ) there's your shot, we walked next door and she got it in her left arm . I drove her home right after this she seemed fine then. We went back to pick her up to take her to a Primary Dr. for a follow up so she establbblishd a Primary in the area, She did not answer the door, we banged on the door and no one answered 3-4 days she was dead.
Age: 57.0
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylactic shock; Gassing which can't stop; Allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 57-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in right arm on 25Apr2021 (Batch/Lot Number: EW0169) at the age of 57 years old, as 2ND DOSE, SINGLE for COVID-19 immunisation. Medical history included hypothyroidism, Sjogren's syndrome, rheumatoid arthritis, depression, asthma and ICP (unspecified). Concomitant medications included levothyroxine taken for hypothyroidism; paroxetine taken for depression; omeprazole taken for acid reflux; all from unknown start and stop date. The patient was taking unspecified "locale" medication for Sjogren's syndrome. Historical vaccination included first dose of BNT162B2 on 04Apr2021 at the age of 57 years old, (lot number: ER8732) for COVID-19 immunization and patient did not get any reaction to it. On 25Apr2021, the patient experienced anaphylactic shock, gassing which can't stop and allergic reaction. Clinical course of events was reported as follows: The patient had the COVID Shot on 25Apr2021 and went to anaphylactic shock and the patient was sent to the emergency room. The patient has some issues like gassing which cannot stop. The patient was out of work for 2 weeks. The patient thought, an allergic reaction because of the COVID shot. The patient was also brought to the ICU. The patient just wanted to know more information about that because the doctor could not tell the patient. Treatment for the adverse events: Albuterol inhaler as the patient was asthmatic. Zyrtec 10 mg twice a day. Docusate 100 mg for two days, Prednisone 40mg to lower a down for 4 days. Senna 1 tab bed time. Acetaminophen, Hydrochloroquine, Lower peroxin, Melatonin, Methazole, and Paroxetine all these medications were given to the patient when the patient was discharged from hospital on 30Apr2021. The patient was hospitalized for all the events from 25Apr2021 to 30Apr2021. The patient recovered with sequelae from all the events on 30Apr2021.
Age: 57.0
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic shock, Flatulence, Hypersensitivity
Clinical narrative: Anaphylactic shock; Gassing which can't stop; Allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 57-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in right arm on 25Apr2021 (Batch/Lot Number: EW0169) at the age of 57 years old, as 2ND DOSE, SINGLE for COVID-19 immunisation. Medical history included hypothyroidism, Sjogren's syndrome, rheumatoid arthritis, depression, asthma and ICP (unspecified). Concomitant medications included levothyroxine taken for hypothyroidism; paroxetine taken for depression; omeprazole taken for acid reflux; all from unknown start and stop date. The patient was taking unspecified "locale" medication for Sjogren's syndrome. Historical vaccination included first dose of BNT162B2 on 04Apr2021 at the age of 57 years old, (lot number: ER8732) for COVID-19 immunization and patient did not get any reaction to it. On 25Apr2021, the patient experienced anaphylactic shock, gassing which can't stop and allergic reaction. Clinical course of events was reported as follows: The patient had the COVID Shot on 25Apr2021 and went to anaphylactic shock and the patient was sent to the emergency room. The patient has some issues like gassing which cannot stop. The patient was out of work for 2 weeks. The patient thought, an allergic reaction because of the COVID shot. The patient was also brought to the ICU. The patient just wanted to know more information about that because the doctor could not tell the patient. Treatment for the adverse events: Albuterol inhaler as the patient was asthmatic. Zyrtec 10 mg twice a day. Docusate 100 mg for two days, Prednisone 40mg to lower a down for 4 days. Senna 1 tab bed time. Acetaminophen, Hydrochloroquine, Lower peroxin, Melatonin, Methazole, and Paroxetine all these medications were given to the patient when the patient was discharged from hospital on 30Apr2021. The patient was hospitalized for all the events from 25Apr2021 to 30Apr2021. The patient recovered with sequelae from all the events on 30Apr2021.
Age: 57.0
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Cough, Pharyngeal swelling, Wheezing
Clinical narrative: Anaphylactic shock; Gassing which can't stop; Allergic reaction; This is a spontaneous report from a contactable consumer (patient). A 57-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in right arm on 25Apr2021 (Batch/Lot Number: EW0169) at the age of 57 years old, as 2ND DOSE, SINGLE for COVID-19 immunisation. Medical history included hypothyroidism, Sjogren's syndrome, rheumatoid arthritis, depression, asthma and ICP (unspecified). Concomitant medications included levothyroxine taken for hypothyroidism; paroxetine taken for depression; omeprazole taken for acid reflux; all from unknown start and stop date. The patient was taking unspecified "locale" medication for Sjogren's syndrome. Historical vaccination included first dose of BNT162B2 on 04Apr2021 at the age of 57 years old, (lot number: ER8732) for COVID-19 immunization and patient did not get any reaction to it. On 25Apr2021, the patient experienced anaphylactic shock, gassing which can't stop and allergic reaction. Clinical course of events was reported as follows: The patient had the COVID Shot on 25Apr2021 and went to anaphylactic shock and the patient was sent to the emergency room. The patient has some issues like gassing which cannot stop. The patient was out of work for 2 weeks. The patient thought, an allergic reaction because of the COVID shot. The patient was also brought to the ICU. The patient just wanted to know more information about that because the doctor could not tell the patient. Treatment for the adverse events: Albuterol inhaler as the patient was asthmatic. Zyrtec 10 mg twice a day. Docusate 100 mg for two days, Prednisone 40mg to lower a down for 4 days. Senna 1 tab bed time. Acetaminophen, Hydrochloroquine, Lower peroxin, Melatonin, Methazole, and Paroxetine all these medications were given to the patient when the patient was discharged from hospital on 30Apr2021. The patient was hospitalized for all the events from 25Apr2021 to 30Apr2021. The patient recovered with sequelae from all the events on 30Apr2021.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Nausea, Paraesthesia, Pruritus, Swelling
Clinical narrative: Red skin (hives), skin swelling, itching, head tingling, vomiting and diarrhea. I took multiple doses of liquid Benadryl to reduce some symptoms.  I did this each time I?ve had a flare.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Red skin (hives), skin swelling, itching, head tingling, vomiting and diarrhea. I took multiple doses of liquid Benadryl to reduce some symptoms.  I did this each time I?ve had a flare.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Erythema, Food allergy, Nausea, Paraesthesia
Clinical narrative: Red skin (hives), skin swelling, itching, head tingling, vomiting and diarrhea. I took multiple doses of liquid Benadryl to reduce some symptoms.  I did this each time I?ve had a flare.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin swelling, Urticaria, Vomiting
Clinical narrative: Red skin (hives), skin swelling, itching, head tingling, vomiting and diarrhea. I took multiple doses of liquid Benadryl to reduce some symptoms.  I did this each time I?ve had a flare.
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram, Computerised tomogram head abnormal, Hemiparesis, Magnetic resonance imaging
Clinical narrative: CVA with left hemiplegia
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head abnormal
Clinical narrative: CVA with left hemiplegia
Age: 75.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident, Hemiplegia, Magnetic resonance imaging head abnormal
Clinical narrative: CVA with left hemiplegia
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear infection viral, Vertigo
Clinical narrative: could not hear from 1 ear; ear/hearing totally stuffed; vertigo; ringing in the ear; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient mentioned "Pfizer leaving people in the middle of nowhere, make decisions based on what. You should support and provide more medical information about permanent hearing loss or how long this should last. You can't put the responsibility on doctor, they don't know. Patient reported AE symptoms such as ear/hearing totally stuffed, could not hear from 1 ear, had vertigo and ringing in the ear after receiving the first dose of the Pfizer BioNtech COVID-19 vaccine. Patient had a follow up with her HCP on 10May2021 as hearing has improved, but she was still experiencing vertigo and ringing in the ear. Patient wants to know if she should receive the second dose of the Pfizer BioNtech COVID-19 vaccine, as HCP could not recommend her. She also read or heard that hundreds of people already reported this effect. Serious: No. Outcome of events could not hear from 1 ear and ear/hearing totally stuffed was recovering, for vertigo and ringing in the ear was not recovered.    Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deafness transitory, Hypoacusis, Tinnitus, Vertigo
Clinical narrative: could not hear from 1 ear; ear/hearing totally stuffed; vertigo; ringing in the ear; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient mentioned "Pfizer leaving people in the middle of nowhere, make decisions based on what. You should support and provide more medical information about permanent hearing loss or how long this should last. You can't put the responsibility on doctor, they don't know. Patient reported AE symptoms such as ear/hearing totally stuffed, could not hear from 1 ear, had vertigo and ringing in the ear after receiving the first dose of the Pfizer BioNtech COVID-19 vaccine. Patient had a follow up with her HCP on 10May2021 as hearing has improved, but she was still experiencing vertigo and ringing in the ear. Patient wants to know if she should receive the second dose of the Pfizer BioNtech COVID-19 vaccine, as HCP could not recommend her. She also read or heard that hundreds of people already reported this effect. Serious: No. Outcome of events could not hear from 1 ear and ear/hearing totally stuffed was recovering, for vertigo and ringing in the ear was not recovered.    Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Allergy to vaccine, Arthralgia, Eye disorder, Fall, Fatigue
Clinical narrative: just went out cold; fell flat on tile in bedroom; still have pain being treated by plastic surgeon that operated in hospital; The initial case was missing the following minimum criteria: reporter with firsthand knowledge. Upon receipt of follow-up information on 18May2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the right arm on 18Feb2021 (Batch/Lot Number: EL9267) as 1st dose, single and via an unspecified route of administration, administered in the right arm on 11Mar2021 14:00 (Batch/Lot Number: EN6205) as 2nd dose, single for COVID-19 immunization. The patient had no prior vaccinations within 4 weeks. The patient's medical history included heart attack from 25Aug2017 to an unknown date (stent right coronary artery (RCA)). Concomitant medications included escitalopram; vitamin D NOS; cyanocobalamin (B-12); ubidecarenone (COQ 10); calcium; omeprazole; fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA); ketotifen fumarate (ZADITOR); ticagrelor (BRILINTA); alprazolam; telmisartan; atorvastatin; montelukast; fluticasone; salbutamol sulfate (VENTOLIN HFA); and unspecified probiotic; all taken for an unspecified indication from an unspecified start date and ongoing. The patient reported that she has never passed out or fainted. On an unspecified date at 07:30 pm, she had no warning and just went out cold. Emergency room visit was required. The patient further reported that she fell flat on tile in the bedroom. There was no warning. The patient reported the events as serious with seriousness criteria hospitalization (in the hospital for 5 days) and important medical event. The patient stated "Both knees, left eye, left arm (shoulder, left) 3 layers of stitches in the upper lip. Still have pain, being treated by plastic surgeon that operated in hospital". The patient was hospitalized for 5 days and she was treated by plastic surgeon - underwent plastic surgery and reconstruction of lips. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Loss of consciousness, Mouth injury, Pain in extremity
Clinical narrative: just went out cold; fell flat on tile in bedroom; still have pain being treated by plastic surgeon that operated in hospital; The initial case was missing the following minimum criteria: reporter with firsthand knowledge. Upon receipt of follow-up information on 18May2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the right arm on 18Feb2021 (Batch/Lot Number: EL9267) as 1st dose, single and via an unspecified route of administration, administered in the right arm on 11Mar2021 14:00 (Batch/Lot Number: EN6205) as 2nd dose, single for COVID-19 immunization. The patient had no prior vaccinations within 4 weeks. The patient's medical history included heart attack from 25Aug2017 to an unknown date (stent right coronary artery (RCA)). Concomitant medications included escitalopram; vitamin D NOS; cyanocobalamin (B-12); ubidecarenone (COQ 10); calcium; omeprazole; fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA); ketotifen fumarate (ZADITOR); ticagrelor (BRILINTA); alprazolam; telmisartan; atorvastatin; montelukast; fluticasone; salbutamol sulfate (VENTOLIN HFA); and unspecified probiotic; all taken for an unspecified indication from an unspecified start date and ongoing. The patient reported that she has never passed out or fainted. On an unspecified date at 07:30 pm, she had no warning and just went out cold. Emergency room visit was required. The patient further reported that she fell flat on tile in the bedroom. There was no warning. The patient reported the events as serious with seriousness criteria hospitalization (in the hospital for 5 days) and important medical event. The patient stated "Both knees, left eye, left arm (shoulder, left) 3 layers of stitches in the upper lip. Still have pain, being treated by plastic surgeon that operated in hospital". The patient was hospitalized for 5 days and she was treated by plastic surgeon - underwent plastic surgery and reconstruction of lips. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fall, Loss of consciousness, Pain
Clinical narrative: just went out cold; fell flat on tile in bedroom; still have pain being treated by plastic surgeon that operated in hospital; The initial case was missing the following minimum criteria: reporter with firsthand knowledge. Upon receipt of follow-up information on 18May2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the right arm on 18Feb2021 (Batch/Lot Number: EL9267) as 1st dose, single and via an unspecified route of administration, administered in the right arm on 11Mar2021 14:00 (Batch/Lot Number: EN6205) as 2nd dose, single for COVID-19 immunization. The patient had no prior vaccinations within 4 weeks. The patient's medical history included heart attack from 25Aug2017 to an unknown date (stent right coronary artery (RCA)). Concomitant medications included escitalopram; vitamin D NOS; cyanocobalamin (B-12); ubidecarenone (COQ 10); calcium; omeprazole; fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA); ketotifen fumarate (ZADITOR); ticagrelor (BRILINTA); alprazolam; telmisartan; atorvastatin; montelukast; fluticasone; salbutamol sulfate (VENTOLIN HFA); and unspecified probiotic; all taken for an unspecified indication from an unspecified start date and ongoing. The patient reported that she has never passed out or fainted. On an unspecified date at 07:30 pm, she had no warning and just went out cold. Emergency room visit was required. The patient further reported that she fell flat on tile in the bedroom. There was no warning. The patient reported the events as serious with seriousness criteria hospitalization (in the hospital for 5 days) and important medical event. The patient stated "Both knees, left eye, left arm (shoulder, left) 3 layers of stitches in the upper lip. Still have pain, being treated by plastic surgeon that operated in hospital". The patient was hospitalized for 5 days and she was treated by plastic surgeon - underwent plastic surgery and reconstruction of lips. The outcome of the events was unknown.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation, Cardiomegaly, Chest pain, Dyspnoea, Pericarditis
Clinical narrative: Severe Chest Pain, difficulty breathing.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pulmonary pain
Clinical narrative: Severe Chest Pain, difficulty breathing.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dyspnoea, Laboratory test, Pericardial effusion, Pleural effusion
Clinical narrative: Severe Chest Pain, difficulty breathing.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Crohn's disease, Deep vein thrombosis, Dyspnoea, Endoscopy, Fatigue
Clinical narrative: After vaccination I still had output out of my Ilestomy bag (diarrhea). By Friday evening I began omitting with extreme nausea, incredible chills mixed with incredible sweats (where I saturated the bed and wanted to die). I was too weak to get out of bed and go to the ER in the City.  So I emailed my GI clinic to tell her what happened on Mon March 5th and was told to go to the ER for evaluation. I went to the ER on the 6th. I asked her if she could schedule a CTE to see if the Chron's was flaring / if I had a blockage. I continued to drink clear broths. Then I had sips of a smoothie and it triggered the nausea vomiting's, extreme pain of #25 but without chill/night sweats. I went to the ER on the 6th, they did a CT which showed I had an acute Chron's flair going up a foot of my Ilestomy bag and inflamed causing the bowel obstruction and was discharged to follow-up with my GI.  my leg continued to hurt and when they did the contrast test in the ER my leg turned dark and all veins were really dark.  On the 9th  I saw Dr and told him about the leg pain and what was going on and he told me to follow up with my GI. I tried to get a port in my chest because of the continued diarrhea. On the 13th in the morning I was called to go to the Hospital and went the same day, the nurse was preparing me for all the tests to be done the 14th. I asked the Nurse to look at my leg and she did and then left and got other clinicians and they confirmed I had multiple blood clots. They treated me with high dose Heparin for the blood clots. I couldn?t because I was in so much pain. I was in the hospital for 8 days and left the 20th of April.  I had falls in the hospital. I continue to have difficulty eating and losing a lot of weight. And now getting the Entivio infusions every 4 weeks.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pain in extremity, Sigmoidoscopy, Thrombosis, Ultrasound scan
Clinical narrative: After vaccination I still had output out of my Ilestomy bag (diarrhea). By Friday evening I began omitting with extreme nausea, incredible chills mixed with incredible sweats (where I saturated the bed and wanted to die). I was too weak to get out of bed and go to the ER in the City.  So I emailed my GI clinic to tell her what happened on Mon March 5th and was told to go to the ER for evaluation. I went to the ER on the 6th. I asked her if she could schedule a CTE to see if the Chron's was flaring / if I had a blockage. I continued to drink clear broths. Then I had sips of a smoothie and it triggered the nausea vomiting's, extreme pain of #25 but without chill/night sweats. I went to the ER on the 6th, they did a CT which showed I had an acute Chron's flair going up a foot of my Ilestomy bag and inflamed causing the bowel obstruction and was discharged to follow-up with my GI.  my leg continued to hurt and when they did the contrast test in the ER my leg turned dark and all veins were really dark.  On the 9th  I saw Dr and told him about the leg pain and what was going on and he told me to follow up with my GI. I tried to get a port in my chest because of the continued diarrhea. On the 13th in the morning I was called to go to the Hospital and went the same day, the nurse was preparing me for all the tests to be done the 14th. I asked the Nurse to look at my leg and she did and then left and got other clinicians and they confirmed I had multiple blood clots. They treated me with high dose Heparin for the blood clots. I couldn?t because I was in so much pain. I was in the hospital for 8 days and left the 20th of April.  I had falls in the hospital. I continue to have difficulty eating and losing a lot of weight. And now getting the Entivio infusions every 4 weeks.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Activated partial thromboplastin time prolonged, Angiogram, Anticoagulant therapy, Asthenia, Chills
Clinical narrative: After vaccination I still had output out of my Ilestomy bag (diarrhea). By Friday evening I began omitting with extreme nausea, incredible chills mixed with incredible sweats (where I saturated the bed and wanted to die). I was too weak to get out of bed and go to the ER in the City.  So I emailed my GI clinic to tell her what happened on Mon March 5th and was told to go to the ER for evaluation. I went to the ER on the 6th. I asked her if she could schedule a CTE to see if the Chron's was flaring / if I had a blockage. I continued to drink clear broths. Then I had sips of a smoothie and it triggered the nausea vomiting's, extreme pain of #25 but without chill/night sweats. I went to the ER on the 6th, they did a CT which showed I had an acute Chron's flair going up a foot of my Ilestomy bag and inflamed causing the bowel obstruction and was discharged to follow-up with my GI.  my leg continued to hurt and when they did the contrast test in the ER my leg turned dark and all veins were really dark.  On the 9th  I saw Dr and told him about the leg pain and what was going on and he told me to follow up with my GI. I tried to get a port in my chest because of the continued diarrhea. On the 13th in the morning I was called to go to the Hospital and went the same day, the nurse was preparing me for all the tests to be done the 14th. I asked the Nurse to look at my leg and she did and then left and got other clinicians and they confirmed I had multiple blood clots. They treated me with high dose Heparin for the blood clots. I couldn?t because I was in so much pain. I was in the hospital for 8 days and left the 20th of April.  I had falls in the hospital. I continue to have difficulty eating and losing a lot of weight. And now getting the Entivio infusions every 4 weeks.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram abdomen abnormal, Computerised tomogram intestine, Condition aggravated, Crohn's disease, Decreased appetite
Clinical narrative: After vaccination I still had output out of my Ilestomy bag (diarrhea). By Friday evening I began omitting with extreme nausea, incredible chills mixed with incredible sweats (where I saturated the bed and wanted to die). I was too weak to get out of bed and go to the ER in the City.  So I emailed my GI clinic to tell her what happened on Mon March 5th and was told to go to the ER for evaluation. I went to the ER on the 6th. I asked her if she could schedule a CTE to see if the Chron's was flaring / if I had a blockage. I continued to drink clear broths. Then I had sips of a smoothie and it triggered the nausea vomiting's, extreme pain of #25 but without chill/night sweats. I went to the ER on the 6th, they did a CT which showed I had an acute Chron's flair going up a foot of my Ilestomy bag and inflamed causing the bowel obstruction and was discharged to follow-up with my GI.  my leg continued to hurt and when they did the contrast test in the ER my leg turned dark and all veins were really dark.  On the 9th  I saw Dr and told him about the leg pain and what was going on and he told me to follow up with my GI. I tried to get a port in my chest because of the continued diarrhea. On the 13th in the morning I was called to go to the Hospital and went the same day, the nurse was preparing me for all the tests to be done the 14th. I asked the Nurse to look at my leg and she did and then left and got other clinicians and they confirmed I had multiple blood clots. They treated me with high dose Heparin for the blood clots. I couldn?t because I was in so much pain. I was in the hospital for 8 days and left the 20th of April.  I had falls in the hospital. I continue to have difficulty eating and losing a lot of weight. And now getting the Entivio infusions every 4 weeks.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Deep vein thrombosis, Diarrhoea, Endoscopy gastrointestinal abnormal, Fall, Gastrointestinal inflammation
Clinical narrative: After vaccination I still had output out of my Ilestomy bag (diarrhea). By Friday evening I began omitting with extreme nausea, incredible chills mixed with incredible sweats (where I saturated the bed and wanted to die). I was too weak to get out of bed and go to the ER in the City.  So I emailed my GI clinic to tell her what happened on Mon March 5th and was told to go to the ER for evaluation. I went to the ER on the 6th. I asked her if she could schedule a CTE to see if the Chron's was flaring / if I had a blockage. I continued to drink clear broths. Then I had sips of a smoothie and it triggered the nausea vomiting's, extreme pain of #25 but without chill/night sweats. I went to the ER on the 6th, they did a CT which showed I had an acute Chron's flair going up a foot of my Ilestomy bag and inflamed causing the bowel obstruction and was discharged to follow-up with my GI.  my leg continued to hurt and when they did the contrast test in the ER my leg turned dark and all veins were really dark.  On the 9th  I saw Dr and told him about the leg pain and what was going on and he told me to follow up with my GI. I tried to get a port in my chest because of the continued diarrhea. On the 13th in the morning I was called to go to the Hospital and went the same day, the nurse was preparing me for all the tests to be done the 14th. I asked the Nurse to look at my leg and she did and then left and got other clinicians and they confirmed I had multiple blood clots. They treated me with high dose Heparin for the blood clots. I couldn?t because I was in so much pain. I was in the hospital for 8 days and left the 20th of April.  I had falls in the hospital. I continue to have difficulty eating and losing a lot of weight. And now getting the Entivio infusions every 4 weeks.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Ileostomy, Infusion, Intestinal obstruction, Mobility decreased
Clinical narrative: After vaccination I still had output out of my Ilestomy bag (diarrhea). By Friday evening I began omitting with extreme nausea, incredible chills mixed with incredible sweats (where I saturated the bed and wanted to die). I was too weak to get out of bed and go to the ER in the City.  So I emailed my GI clinic to tell her what happened on Mon March 5th and was told to go to the ER for evaluation. I went to the ER on the 6th. I asked her if she could schedule a CTE to see if the Chron's was flaring / if I had a blockage. I continued to drink clear broths. Then I had sips of a smoothie and it triggered the nausea vomiting's, extreme pain of #25 but without chill/night sweats. I went to the ER on the 6th, they did a CT which showed I had an acute Chron's flair going up a foot of my Ilestomy bag and inflamed causing the bowel obstruction and was discharged to follow-up with my GI.  my leg continued to hurt and when they did the contrast test in the ER my leg turned dark and all veins were really dark.  On the 9th  I saw Dr and told him about the leg pain and what was going on and he told me to follow up with my GI. I tried to get a port in my chest because of the continued diarrhea. On the 13th in the morning I was called to go to the Hospital and went the same day, the nurse was preparing me for all the tests to be done the 14th. I asked the Nurse to look at my leg and she did and then left and got other clinicians and they confirmed I had multiple blood clots. They treated me with high dose Heparin for the blood clots. I couldn?t because I was in so much pain. I was in the hospital for 8 days and left the 20th of April.  I had falls in the hospital. I continue to have difficulty eating and losing a lot of weight. And now getting the Entivio infusions every 4 weeks.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain, Pain in extremity, Thrombosis, Vomiting
Clinical narrative: After vaccination I still had output out of my Ilestomy bag (diarrhea). By Friday evening I began omitting with extreme nausea, incredible chills mixed with incredible sweats (where I saturated the bed and wanted to die). I was too weak to get out of bed and go to the ER in the City.  So I emailed my GI clinic to tell her what happened on Mon March 5th and was told to go to the ER for evaluation. I went to the ER on the 6th. I asked her if she could schedule a CTE to see if the Chron's was flaring / if I had a blockage. I continued to drink clear broths. Then I had sips of a smoothie and it triggered the nausea vomiting's, extreme pain of #25 but without chill/night sweats. I went to the ER on the 6th, they did a CT which showed I had an acute Chron's flair going up a foot of my Ilestomy bag and inflamed causing the bowel obstruction and was discharged to follow-up with my GI.  my leg continued to hurt and when they did the contrast test in the ER my leg turned dark and all veins were really dark.  On the 9th  I saw Dr and told him about the leg pain and what was going on and he told me to follow up with my GI. I tried to get a port in my chest because of the continued diarrhea. On the 13th in the morning I was called to go to the Hospital and went the same day, the nurse was preparing me for all the tests to be done the 14th. I asked the Nurse to look at my leg and she did and then left and got other clinicians and they confirmed I had multiple blood clots. They treated me with high dose Heparin for the blood clots. I couldn?t because I was in so much pain. I was in the hospital for 8 days and left the 20th of April.  I had falls in the hospital. I continue to have difficulty eating and losing a lot of weight. And now getting the Entivio infusions every 4 weeks.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Weight decreased
Clinical narrative: After vaccination I still had output out of my Ilestomy bag (diarrhea). By Friday evening I began omitting with extreme nausea, incredible chills mixed with incredible sweats (where I saturated the bed and wanted to die). I was too weak to get out of bed and go to the ER in the City.  So I emailed my GI clinic to tell her what happened on Mon March 5th and was told to go to the ER for evaluation. I went to the ER on the 6th. I asked her if she could schedule a CTE to see if the Chron's was flaring / if I had a blockage. I continued to drink clear broths. Then I had sips of a smoothie and it triggered the nausea vomiting's, extreme pain of #25 but without chill/night sweats. I went to the ER on the 6th, they did a CT which showed I had an acute Chron's flair going up a foot of my Ilestomy bag and inflamed causing the bowel obstruction and was discharged to follow-up with my GI.  my leg continued to hurt and when they did the contrast test in the ER my leg turned dark and all veins were really dark.  On the 9th  I saw Dr and told him about the leg pain and what was going on and he told me to follow up with my GI. I tried to get a port in my chest because of the continued diarrhea. On the 13th in the morning I was called to go to the Hospital and went the same day, the nurse was preparing me for all the tests to be done the 14th. I asked the Nurse to look at my leg and she did and then left and got other clinicians and they confirmed I had multiple blood clots. They treated me with high dose Heparin for the blood clots. I couldn?t because I was in so much pain. I was in the hospital for 8 days and left the 20th of April.  I had falls in the hospital. I continue to have difficulty eating and losing a lot of weight. And now getting the Entivio infusions every 4 weeks.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Petechiae, SARS-CoV-2 test, Thrombocytopenia
Clinical narrative: On Wednesday April 28th I began to develop thrombocytopenia. I had excessive bruising (purpura) Superficial bleeding into the skin that appears as a rash of pinpoint-sized reddish-purple spots (petechiae), from my head to my toes   Bleeding from my gums Fatigue The petechiae all over my body that resulted with a hospital stay with a platelet count of 1(one). Hospitalized for a 2 platelet infusion, IVIG (Immunoglobulin) and IV steroids
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Contusion, Fatigue, Gingival bleeding, Immunoglobulin therapy, Petechiae
Clinical narrative: On Wednesday April 28th I began to develop thrombocytopenia. I had excessive bruising (purpura) Superficial bleeding into the skin that appears as a rash of pinpoint-sized reddish-purple spots (petechiae), from my head to my toes   Bleeding from my gums Fatigue The petechiae all over my body that resulted with a hospital stay with a platelet count of 1(one). Hospitalized for a 2 platelet infusion, IVIG (Immunoglobulin) and IV steroids
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Platelet count decreased, Platelet transfusion, Purpura, Rash, Thrombocytopenia
Clinical narrative: On Wednesday April 28th I began to develop thrombocytopenia. I had excessive bruising (purpura) Superficial bleeding into the skin that appears as a rash of pinpoint-sized reddish-purple spots (petechiae), from my head to my toes   Bleeding from my gums Fatigue The petechiae all over my body that resulted with a hospital stay with a platelet count of 1(one). Hospitalized for a 2 platelet infusion, IVIG (Immunoglobulin) and IV steroids
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Oxygen saturation decreased, Pyrexia
Clinical narrative: Patient developed sudden onset of fevers and malaise on 5/7/21 (26 days after his 2nd Pfizer COVID vaccine).  His symptoms progressed to involve shortness of breath which prompted his admission to our Hospital on 5/12/21.  He rapidly deteriorated requiring intubation and ultimately placement on ECMO and temporary internal heart pump (Impella device) placement.  He was thought to have myocarditis due to elevated troponins at the time of admission and cardiac MRI showing wide spread myocardial inflammation suggestive of myocarditis.   He was treated with high dose steroids and supportive care due to the concern for cytokine storm and eventually started to show signs of improvement.   He was eventually taken off ECMO, internal heart pump and ventilatory support and went home after 20 days in the hospital.  However, follow up cardiac MRI revealed ongoing myocarditis, but his ejection fraction had improved.
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood lactate dehydrogenase increased, C-reactive protein increased, Cardiac imaging procedure abnormal
Clinical narrative: Patient developed sudden onset of fevers and malaise on 5/7/21 (26 days after his 2nd Pfizer COVID vaccine).  His symptoms progressed to involve shortness of breath which prompted his admission to our Hospital on 5/12/21.  He rapidly deteriorated requiring intubation and ultimately placement on ECMO and temporary internal heart pump (Impella device) placement.  He was thought to have myocarditis due to elevated troponins at the time of admission and cardiac MRI showing wide spread myocardial inflammation suggestive of myocarditis.   He was treated with high dose steroids and supportive care due to the concern for cytokine storm and eventually started to show signs of improvement.   He was eventually taken off ECMO, internal heart pump and ventilatory support and went home after 20 days in the hospital.  However, follow up cardiac MRI revealed ongoing myocarditis, but his ejection fraction had improved.
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Ejection fraction abnormal, Endotracheal intubation, General physical health deterioration, Lung assist device therapy
Clinical narrative: Patient developed sudden onset of fevers and malaise on 5/7/21 (26 days after his 2nd Pfizer COVID vaccine).  His symptoms progressed to involve shortness of breath which prompted his admission to our Hospital on 5/12/21.  He rapidly deteriorated requiring intubation and ultimately placement on ECMO and temporary internal heart pump (Impella device) placement.  He was thought to have myocarditis due to elevated troponins at the time of admission and cardiac MRI showing wide spread myocardial inflammation suggestive of myocarditis.   He was treated with high dose steroids and supportive care due to the concern for cytokine storm and eventually started to show signs of improvement.   He was eventually taken off ECMO, internal heart pump and ventilatory support and went home after 20 days in the hospital.  However, follow up cardiac MRI revealed ongoing myocarditis, but his ejection fraction had improved.
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Malaise, Myocarditis, Pyrexia, Troponin increased, Ventricular assist device insertion
Clinical narrative: Patient developed sudden onset of fevers and malaise on 5/7/21 (26 days after his 2nd Pfizer COVID vaccine).  His symptoms progressed to involve shortness of breath which prompted his admission to our Hospital on 5/12/21.  He rapidly deteriorated requiring intubation and ultimately placement on ECMO and temporary internal heart pump (Impella device) placement.  He was thought to have myocarditis due to elevated troponins at the time of admission and cardiac MRI showing wide spread myocardial inflammation suggestive of myocarditis.   He was treated with high dose steroids and supportive care due to the concern for cytokine storm and eventually started to show signs of improvement.   He was eventually taken off ECMO, internal heart pump and ventilatory support and went home after 20 days in the hospital.  However, follow up cardiac MRI revealed ongoing myocarditis, but his ejection fraction had improved.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Dizziness, Fatigue, Magnetic resonance imaging, Nausea
Clinical narrative: Two days after second does developed blurred vision ,nystagmus,  extreme dizziness and nausea and vomiting.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nystagmus, Vertigo, Vestibular neuronitis, Vomiting
Clinical narrative: Two days after second does developed blurred vision ,nystagmus,  extreme dizziness and nausea and vomiting.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Audiogram, Computerised tomogram head, Dizziness, Magnetic resonance imaging head, Nausea
Clinical narrative: Two days after second does developed blurred vision ,nystagmus,  extreme dizziness and nausea and vomiting.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nystagmus, Vision blurred, Vomiting
Clinical narrative: Two days after second does developed blurred vision ,nystagmus,  extreme dizziness and nausea and vomiting.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Eye pain, Eye swelling
Clinical narrative: swollen eye; pain; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration administered in left arm on 01May2021 12:15 (as reported) (Batch/Lot Number: ER8737) as single dose, and dose 2 via an unspecified route of administration administered in left arm on 01May2021 (as reported) (Batch/Lot Number: Ew8170) as single dose for COVID-19 immunisation. There was no other medical history, no known allergies. The patient had not had COVID prior to the vaccination. COVID was not tested post the vaccination. There was no concomitant drugs, no other vaccine in four weeks. The patient experienced swollen eye and pain on 02May2021 02:00, serious due to hospitalization. The events were treated with antibiotics and eye medication. The events were not resolved.
Age: 46.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Eye swelling, Pain
Clinical narrative: swollen eye; pain; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration administered in left arm on 01May2021 12:15 (as reported) (Batch/Lot Number: ER8737) as single dose, and dose 2 via an unspecified route of administration administered in left arm on 01May2021 (as reported) (Batch/Lot Number: Ew8170) as single dose for COVID-19 immunisation. There was no other medical history, no known allergies. The patient had not had COVID prior to the vaccination. COVID was not tested post the vaccination. There was no concomitant drugs, no other vaccine in four weeks. The patient experienced swollen eye and pain on 02May2021 02:00, serious due to hospitalization. The events were treated with antibiotics and eye medication. The events were not resolved.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Facial pain, Hypoaesthesia
Clinical narrative: Bell's Palsy; This is a spontaneous report from a contactable consumer reported for herself. A 41-year-old female patient (not pregnant) received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on 30Apr2021 10:00 for Covid-19 immunization. Medical history and concomitant drug were not provided. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Apr2021 for Covid-19 immunization. The patient reported events diagnosed as Bell's Palsy, left sided facial droop, inability to move the left forehead, left facial numbness, inability to close the left eye. The adverse event started since 14May2021. Treatment included prescription of a seven-day course of Prednisone, etc. The adverse event result in Emergency room/department or urgent care. Outcome of the event was not resolved. Since the vaccination, the patient has not been tested for COVID-19. The report was not assessed as serious.  Information on the lot/batch number has been requested.