chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Catheterisation cardiac, Chest pain, Dyspnoea, Electrocardiogram, Troponin
Clinical narrative: substernal chest pain; shortness of breath; Troponin peaked at 9.100; This is a spontaneous report from contactable physician. A 30-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown), intramuscular in left arm on 04Mar2021 at 15:45 at single dose for COVID-19 immunization. Medical history and concomitant medication were reported as none. The patient has no known allergies and has other medications in two weeks. It was unknown if the patient has other vaccine in four weeks. He has no COVID prior to vaccination. The patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on 10Feb2021 at single dose for COVID-19 immunization. The facility the vaccine was administered was reported to be other. On 07Mar2021, the patient who has no prior medical history was admitted for substernal chest pain and shortness of breath; troponin peaked at 9.100 with no EKG changes. Heart catherization was normal. The patient was not tested for COVID post vaccination. The events resulted in emergency room/department or urgent care and required hospitalization for one day. The outcome of the events was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug in the reported events cannot be completely ruled out given the known suspect drug profile and/or implied temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regul atory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Troponin increased
Clinical narrative: substernal chest pain; shortness of breath; Troponin peaked at 9.100; This is a spontaneous report from contactable physician. A 30-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown), intramuscular in left arm on 04Mar2021 at 15:45 at single dose for COVID-19 immunization. Medical history and concomitant medication were reported as none. The patient has no known allergies and has other medications in two weeks. It was unknown if the patient has other vaccine in four weeks. He has no COVID prior to vaccination. The patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on 10Feb2021 at single dose for COVID-19 immunization. The facility the vaccine was administered was reported to be other. On 07Mar2021, the patient who has no prior medical history was admitted for substernal chest pain and shortness of breath; troponin peaked at 9.100 with no EKG changes. Heart catherization was normal. The patient was not tested for COVID post vaccination. The events resulted in emergency room/department or urgent care and required hospitalization for one day. The outcome of the events was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug in the reported events cannot be completely ruled out given the known suspect drug profile and/or implied temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regul atory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Dehydration, Diarrhoea, Renal disorder, SARS-CoV-2 test, Vomiting
Clinical narrative: Significant diarrehri; vomiting; severe dehydration; kidney damage; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm at 14:15 on 27Feb2021 (Batch/Lot number was not reported) at single dose for COVID-19 immunization. Medical history included Crohn's disease. On 28Feb2021, the patient experienced significant diarrehri (diarrhoea) and vomiting resulting in hospitalization for 3 days for severe dehydration and kidney damage. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received over the counter medications within 2 weeks of vaccination. The adverse event resulted Emergency room/department or urgent care and admitted for 3 days. Treatment (IV of fluids and pain medications and anti-nausea) received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19. The outcome of events was recovering.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: received his first dose of Pfizer COVID19 vaccine and five days later tested positive for COVID; This is a spontaneous report from a contactable pharmacist. An 80-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient received his first dose of Pfizer COVID19 vaccine and five days later tested positive for COVID. His doctor ordered monoclonal antibody infusion. He is doing much better after receiving the monoclonal antibodies. The reporter wanted to know if he has to wait 90 days to get the second dose of vaccine. The outcome of the event was unknown.  Information on lot/batch number has been requested.; Sender's Comments: The association between the event positive for COVID with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Heart rate, Heart rate increased, Tachycardia
Clinical narrative: Vaccine had triggered my heart arrhythmia; My heart rate start to race; Tachycardia; This is a spontaneous report from a contactable consumer. A 55-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL 9261), via an unspecified route of administration, administered in the left arm  on 19Jan2021 16:15 as a single dose for covid-19 immunisation. The patient's medical history included supraventricular tachycardia (SVT), atrial fibrillation (Afib), atrial flutter, colon cancer, endometrial cancer, Lynch Syndrome, asthma, osteoarthritis, lung nodules being watched, kidney cysts, obesity and enlarged liver all from unknown date. Concomitant medications included metoprolol tartrate; alprazolam; acetylsalicylic acid (ASPIRIN LOW); ascorbic acid (VIT C); and colecalciferol (VIT D3). The patient previously took epinephrine and experienced sensitivity (reported as (sensitive to epinephrine due to heart arrytmia). The patient received the first dose of bnt162b2 (lot:ELI284) on 29Dec2020 in the left arm for covid-19 immunization. On 19Jan2010 at 16:15, the patient experienced within the first minute or two, she felt her heart rate start to race.  She used Kardia device to check it and she was in Tachycardia at 16:15. The patient mentioned that she carry device with her since she have a history of SVT, Atrial Flutter, and AFib, with prior ablations. Patient was pretty familiar with what Tachycardia feels like so she was pretty sure she was not having an allergic reaction to the vaccine, but rather the vaccine had triggered her heart arrhythmia.  After continuing to monitor her HR, for approx. 20 minutes, and it continued to stay at 135 -145, the doctor who had administered the vaccine took her to the local hospital to have her evaluated. The patient received this vaccine at the facility where she was employed. The outcome of the events was recovered on an unspecified date in 2021.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Dizziness, Dysarthria, Haematochezia
Clinical narrative: Blood in stool; Diarrhea; Severe weakness; Dizziness; Slurred speech; This is a spontaneous report from a contactable consumer (patient's daughter). An 83-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 25Feb2021 at a single dose for covid-19 immunization. Medical history included ongoing high blood pressure and enlarged prostate. Concomitant medications included lisinopril taken for high blood pressure from an unspecified date and ongoing; tamsulosin taken for enlarged prostate; and amlodipine taken for high blood pressure. The patient had side effects: blood in stool, coupled with diarrhea on 02Mar2021, severe weakness and dizziness on 01Mar2021, and slurred speech in2021. The patient felt fine during the day and was able to exercise and it was in the evening of 01Mar2021, that he started to feel the weakness and dizziness. It was followed by diarrhea and he started to get some blood in his stool. The patient's daughter took him to the hospital on 07Mar2021. They were still diagnosing him now. The patient's daughter said that he was still having the weakness, but he has not really eaten anything. Outcome of events blood in stool, severe weakness and diarrhea was not recovered, reported as ongoing; event dizziness was recovered on 04Mar2021; outcome of other event was unknown. The patient was hospitalized from 07Mar2021 and ongoing for the event blood in stool.  Information on lot/batch number has been requested.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Blood creatine phosphokinase increased, Myalgia
Clinical narrative: Severe polymyalgias; CPKs very high at 80,000; This is a spontaneous report from a contactable physician. A 30-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Not Provided, second dose) solution for injection intramuscular on an unknown date (at the age of 30-years-old) as a single dose for COVID-19 vaccination. Medical history included Cystic Fibrosis and Autoimmune Necrotizing Myositis. Concomitant medications were unknown. Historical vaccine included BNT162B2 (first dose) for COVID-19 vaccination on an unknown date with no adverse effect reported (tolerated first COVID-19 vaccine). The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Less than 24 hours after second COVID-19 vaccine injection, the patient had severe polymyalgia. CPKs checked very high at 80,000. The patient was currently admitted to the hospital. Unspecified treatment was provided for the events severe polymyalgias and CPKs very high. The outcome of the events severe polymyalgias and CPKs very high was unknown. Since the vaccination, the patient has not been tested for COVID-19. The patient was supposed to get RITUXAN as a regimen for his muscle disorder and was interested in Pfizer checking his neutralizing antibody level both pre and post Rituxan. The patient will receive RITUXAN shortly in the next week.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on chronological connection to the vaccine causality between events severe polymyalgia and CPKs checked very high and  BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE0 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Flushing, Hyperhidrosis, Loss of consciousness, Movement disorder
Clinical narrative: sweaty; flushing; Hardly move; Passing out; Chills; shakes; My arm started hurting; This is a spontaneous case received from a contactable consumer (patient reported for herself). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot EN6198, expiry date not reported), via an unspecified route of administration on 01Mar2021 at a single dose for Covid-19 Immunization. Medical history included Covid and been in the hospital because of that, from Nov2020 to an unknown date. The patient's concomitant medications were not reported. Patient just had a question here about the shot, first shot on 01Mar2021 and arm started hurting, no big deal, 7 o' clock at night, patient got shot in the morning, and took Tylenol then about 9:30 at night, patient got chills and the shakes and at 3:30, the next morning (02Mar2021), patient got all sweaty and flushing everything. On 02Mar32021, patient was passing out, and son was trying to give patient the stuff.  Patient did have Covid back in Nov2020 and had "rubbed out swab and the passing out stuff". Patient actually had been in the hospital because of that. It was exactly the same symptoms that patient had when patient got the shot. Patient did not know if patient should get the second shot and asked if those were going to happen again. Patient said that it was so scary when passing out like that. Patient just did not know what to do and then called the next day cannot, "hardly move" (02Mar2021). Patient asked if it was alright if patient just talk to the physician and will just call doctor. Patient asked if patient should get the second shot or if it was going to happen again. Therapeutic measure were taken as a result of the events arm started hurting and passing out. The outcome of the events reported was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Tremor
Clinical narrative: sweaty; flushing; Hardly move; Passing out; Chills; shakes; My arm started hurting; This is a spontaneous case received from a contactable consumer (patient reported for herself). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot EN6198, expiry date not reported), via an unspecified route of administration on 01Mar2021 at a single dose for Covid-19 Immunization. Medical history included Covid and been in the hospital because of that, from Nov2020 to an unknown date. The patient's concomitant medications were not reported. Patient just had a question here about the shot, first shot on 01Mar2021 and arm started hurting, no big deal, 7 o' clock at night, patient got shot in the morning, and took Tylenol then about 9:30 at night, patient got chills and the shakes and at 3:30, the next morning (02Mar2021), patient got all sweaty and flushing everything. On 02Mar32021, patient was passing out, and son was trying to give patient the stuff.  Patient did have Covid back in Nov2020 and had "rubbed out swab and the passing out stuff". Patient actually had been in the hospital because of that. It was exactly the same symptoms that patient had when patient got the shot. Patient did not know if patient should get the second shot and asked if those were going to happen again. Patient said that it was so scary when passing out like that. Patient just did not know what to do and then called the next day cannot, "hardly move" (02Mar2021). Patient asked if it was alright if patient just talk to the physician and will just call doctor. Patient asked if patient should get the second shot or if it was going to happen again. Therapeutic measure were taken as a result of the events arm started hurting and passing out. The outcome of the events reported was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Chills, Dyspnoea, Erosive oesophagitis, Gastrooesophageal reflux disease
Clinical narrative: throat feels like its tightening up breathing feels forced/ Anaphylactic shot the next day/ Throat closing up and went to the ER; throat feels like its tightening/ Throat closing up; breathing feels forced; acid refluxes or an erosion and threw up; acid refluxes or an erosion and threw up; acid refluxes or an erosion and threw up; Could not sleep; fever; chills; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on 04Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose Feb 4th, the patient got fever and chills. Lasted four hours and took acetaminophen (TYLENOL). The next day acid refluxes or an erosion and threw up. Could not sleep for a few days, throat feels like its tightening up breathing feels forced. Anaphylactic shot the next day. Throat closing up and went to the ER wanted to know if she should receive the second dose. Outcome of the events fever and chills was recovered on an unspecified date while outcome of the other events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pyrexia, Throat tightness, Vomiting
Clinical narrative: throat feels like its tightening up breathing feels forced/ Anaphylactic shot the next day/ Throat closing up and went to the ER; throat feels like its tightening/ Throat closing up; breathing feels forced; acid refluxes or an erosion and threw up; acid refluxes or an erosion and threw up; acid refluxes or an erosion and threw up; Could not sleep; fever; chills; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on 04Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose Feb 4th, the patient got fever and chills. Lasted four hours and took acetaminophen (TYLENOL). The next day acid refluxes or an erosion and threw up. Could not sleep for a few days, throat feels like its tightening up breathing feels forced. Anaphylactic shot the next day. Throat closing up and went to the ER wanted to know if she should receive the second dose. Outcome of the events fever and chills was recovered on an unspecified date while outcome of the other events was unknown.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Epistaxis, Immune thrombocytopenia
Clinical narrative: possible ITP; nose bleeds; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received COVID-19 vaccine (UNSPECIFIED TRADE NAME), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient experienced possible ITP (Idiopathic thrombocytopenic purpura) on an unspecified date, nose bleeds on an unspecified date, right after vaccine administration. The outcome of the events was unknown.  No follow-up attempts are possible. Information about Lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Brain oedema, Head discomfort, Herpes zoster, Neuralgia, Vaccination site pruritus
Clinical narrative: feels like the back of brain is swollen, its like the back of her head is heavy and pulsing; Shingles; sharp shooting nerve pain down the right arm, on the right side of head and between breast; had a rash at the injection site which was bubbly, itchy; had a rash at the injection site which was bubbly, itchy; feels like the back of brain is swollen, its like the back of her head is heavy and pulsing; This is a spontaneous report from a contactable consumer. An elderly female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 28Jan2021 at 11:00 as a single dose for COVID-19 immunisation. Medical history included shingles in eyebrows from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient stated that her first shot activated a virus. In trying to recall the name of the virus, she stated that she is almost 80 and forgot the word, it's the virus with awful rashes in the body, she has been waiting for a month to report it. It's shingles. She had no symptom in first 4-5 days but then she had sharp shooting nerve pain down the right arm, on the right side of head and between breast. It was sharp pain, like someone poking with a knife every 20 seconds to a minute. It went on for a few days till she took gabapentin which is strong stuff. Then 2.5 weeks later she had a rash at the injection site, which was bubbly, itchy, and then she started getting shingles. She has shingles on 2 sites in the body. She's had no attack in the body, and she is not stressed. She has the shingles in the back and the 2 days ago she experienced shingles in the right eyebrow. She knows the shingles lives in her trigeminal nerve, because this is not the first time, she has had it in her eyebrow. She is pretty sure the shot aggravated the virus. Since then, she wakes up in the night to what feels like the back of brain is swollen, it's like the back of her head is heavy and pulsing. She can't get the second dose, no one is scheduling her. She thinks she is past the time they recommend, but then again, she got the shingles. She is not happy right now. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: feels like the back of brain is swollen, its like the back of her head is heavy and pulsing; Shingles; sharp shooting nerve pain down the right arm, on the right side of head and between breast; had a rash at the injection site which was bubbly, itchy; had a rash at the injection site which was bubbly, itchy; feels like the back of brain is swollen, its like the back of her head is heavy and pulsing; This is a spontaneous report from a contactable consumer. An elderly female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 28Jan2021 at 11:00 as a single dose for COVID-19 immunisation. Medical history included shingles in eyebrows from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient stated that her first shot activated a virus. In trying to recall the name of the virus, she stated that she is almost 80 and forgot the word, it's the virus with awful rashes in the body, she has been waiting for a month to report it. It's shingles. She had no symptom in first 4-5 days but then she had sharp shooting nerve pain down the right arm, on the right side of head and between breast. It was sharp pain, like someone poking with a knife every 20 seconds to a minute. It went on for a few days till she took gabapentin which is strong stuff. Then 2.5 weeks later she had a rash at the injection site, which was bubbly, itchy, and then she started getting shingles. She has shingles on 2 sites in the body. She's had no attack in the body, and she is not stressed. She has the shingles in the back and the 2 days ago she experienced shingles in the right eyebrow. She knows the shingles lives in her trigeminal nerve, because this is not the first time, she has had it in her eyebrow. She is pretty sure the shot aggravated the virus. Since then, she wakes up in the night to what feels like the back of brain is swollen, it's like the back of her head is heavy and pulsing. She can't get the second dose, no one is scheduling her. She thinks she is past the time they recommend, but then again, she got the shingles. She is not happy right now. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Appendicitis
Clinical narrative: Appendicitis; This is a spontaneous report from a contactable consumer reporting for her female colleague.  A female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 23Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced appendicitis on an unspecified date and had to have an emergency appendectomy 01Mar2021. She was home and healing. The outcome of the event was unknown.  No follow-up attempts are possible, information on batch number cannot be obtained.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac stress test, Computerised tomogram head, Echocardiogram, Fall, Haemorrhage
Clinical narrative: your head is bleeding; My wife heard my fall; This is a spontaneous report from a contactable consumer (patient). An 86-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on 08Feb2021 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Jan2021 for COVID-19 immunization and experienced fall, felt dizzy and cut on his head. On Tuesday, 16Feb2021, the patient went to bathroom and the patient next remembered he was on his bed (3 yards away). Patient's wife heard his fall and came into the bedroom and she said that patient's head is bleeding. He had no recollection of episode. EMT arrived and patient was hospitalized on 16Feb2021. 5 staples were put in his head in hospital. On Tuesday and Wednesday (16Feb2021 and 17Feb2021), scan of his head was done, loop recorder inserted in his chest, ultrasound of carotids, echo cardiogram and pharmacologic stress test were also performed. On Wednesday 17Feb2021 17:30, the patient discharged from hospital. On 24Feb2021, chest incision was checked by technician and on 02Mar2021, staples were removed in hospital. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Ultrasound skull
Clinical narrative: your head is bleeding; My wife heard my fall; This is a spontaneous report from a contactable consumer (patient). An 86-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on 08Feb2021 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Jan2021 for COVID-19 immunization and experienced fall, felt dizzy and cut on his head. On Tuesday, 16Feb2021, the patient went to bathroom and the patient next remembered he was on his bed (3 yards away). Patient's wife heard his fall and came into the bedroom and she said that patient's head is bleeding. He had no recollection of episode. EMT arrived and patient was hospitalized on 16Feb2021. 5 staples were put in his head in hospital. On Tuesday and Wednesday (16Feb2021 and 17Feb2021), scan of his head was done, loop recorder inserted in his chest, ultrasound of carotids, echo cardiogram and pharmacologic stress test were also performed. On Wednesday 17Feb2021 17:30, the patient discharged from hospital. On 24Feb2021, chest incision was checked by technician and on 02Mar2021, staples were removed in hospital. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Condition aggravated, Heart rate increased
Clinical narrative: I do have Atrial fibrillation but I have never had it go on continuously for 5 days; fast heartbeat; fast heartbeat; This is a spontaneous report from a contactable consumer (patient). An 85-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on 17Feb2021 (Lot Number: Unknown) as SINGLE DOSE for COVID-19 immunisation. Medical history included atrial fibrillation and rapid heart rate from an unknown date and unknown if ongoing. Concomitant medication included apixaban (ELIQUIS) and sotalol; both taken for atrial fibrillation, start and stop date were not reported. For 5 days, the patient had a fast heartbeat from 01Mar2021 but now she is okay. On 01Mar2021, the patient stated "I do have the atrial fibrillation but I have never had it go on continuously for 5 days before The patient was feeling better now. The outcome of the events was  recovered on unspecified date.  Information on the lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac monitoring normal, Dizziness, Hypertension, Tachycardia, Tachypnoea
Clinical narrative: Patient complained of feeling dizzy 5 minutes after vaccination. Patient was tachypneic, slightly tachytardic, and was hypertensive. Patient remained warm, pink, and dry. Patient was concious, breathing, and alert through time of transfer of care upon EMS arrival. Paramedic evaluated, no signs of an allergic reaction, vitals taken, assisted EMS with cardiac monitoring which showed patient in a sinus rhythm without ectopy. Patient remained stable through trasnfer to EMS. EMS transported.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Fatigue, Heart rate irregular, Knee arthroplasty
Clinical narrative: I was submitting my events daily on website and two days it tells me my session has expired and won't let me report anything.  On Sunday night, March 21st, I started with very painful joint and muscle aches with fatigue.  The next morning I felt terrible and could barely function, I had a bought with diarrhea that lasted almost the entire day and had no energy.  I developed a large lump on my left clavicle area that seemed to be filled with fluid.  My knees I had replaced are still very painful today ( 7 days post vaccine).  I phoned my Dr. yesterday and they told me to take 1000mg of Tylenol 3 times a day.  I am doing this now for the second day with some relief.  I feel this is very unusual to feel this way 7 days after the vaccine.  On day 1-2 the only symptoms were a sore arm from the vaccine.  Saturday was actually a good day with no symptoms, the other symptoms started on Sunday.  I feel like my heartbeat is irregular also but my BP is good.  I would like to be able to to report daily on v-safe like I was the first few days.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Swelling
Clinical narrative: I was submitting my events daily on website and two days it tells me my session has expired and won't let me report anything.  On Sunday night, March 21st, I started with very painful joint and muscle aches with fatigue.  The next morning I felt terrible and could barely function, I had a bought with diarrhea that lasted almost the entire day and had no energy.  I developed a large lump on my left clavicle area that seemed to be filled with fluid.  My knees I had replaced are still very painful today ( 7 days post vaccine).  I phoned my Dr. yesterday and they told me to take 1000mg of Tylenol 3 times a day.  I am doing this now for the second day with some relief.  I feel this is very unusual to feel this way 7 days after the vaccine.  On day 1-2 the only symptoms were a sore arm from the vaccine.  Saturday was actually a good day with no symptoms, the other symptoms started on Sunday.  I feel like my heartbeat is irregular also but my BP is good.  I would like to be able to to report daily on v-safe like I was the first few days.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Fatigue, Headache, Nausea, Pain
Clinical narrative: Nauseous ( vomiting) - Started 12 hours after 2nd injection & continued for 36 hours.  Had Temp 100.3.  Headache, body aches, and no energy. Started feeling better on 4th day after Covid injection.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Nauseous ( vomiting) - Started 12 hours after 2nd injection & continued for 36 hours.  Had Temp 100.3.  Headache, body aches, and no energy. Started feeling better on 4th day after Covid injection.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Platelet count decreased, Unevaluable event
Clinical narrative: Low platelets in two lab results
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Haemorrhage, Head injury, Hyperhidrosis, Loss of consciousness, Pallor
Clinical narrative: Patient was placed in observation area post Pfizer COVID vac administration. After Approximately 10 minutes, patient Passed out and was found on the floor with wound on (L) side of forehead with bleeding noted. Large knot noted above (L) eyebrow. BP 116/60  Awake, responsive, diaphoretic, bounding pulse, pale. Patient was assisted to stretcher with O2 at 2L NC and ED team transported to  ER. Given fluids in ER.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pulse abnormal, Swelling face
Clinical narrative: Patient was placed in observation area post Pfizer COVID vac administration. After Approximately 10 minutes, patient Passed out and was found on the floor with wound on (L) side of forehead with bleeding noted. Large knot noted above (L) eyebrow. BP 116/60  Awake, responsive, diaphoretic, bounding pulse, pale. Patient was assisted to stretcher with O2 at 2L NC and ED team transported to  ER. Given fluids in ER.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Rash macular, Skin reaction
Clinical narrative: ?covid arm? - large red and itchy splotch right by injection site appeared 8 days later.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Eye movement disorder, Memory impairment, Paraesthesia
Clinical narrative: Around 7-7:30 PM, I started to feel weird tingly feelings run up and down all of my limbs at the same time but it was over in about 2 minutes. Then I couldn?t stop my eyes from continuously rolling back into my head. That happened for about 4 minutes or so sometimes it would happen like 3 or 4 times in a row and sometimes it would be every 20 seconds or so. I was extremely confused and forgetful for the next 40 minutes and then I slowly began to be able to recall stuff.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: On 3/3/21 noticed a full body rash.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Periarthritis, Physiotherapy
Clinical narrative: left shoulder  adhesive capilitis - physical therapy
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Computerised tomogram, Headache, Lymphadenopathy, Mumps antibody test negative
Clinical narrative: Swollen lymph nodes left side of neck. 12:00 pm  03/12/2021 Headache pain in left temple  12:00pm , 03/18/2021 Treated at clinic 03/21/2021  Swollen glands (Parotitis). 4:15PM  03/22/2021. Treated at clinic on 03/ 23/2021.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Parotitis
Clinical narrative: Swollen lymph nodes left side of neck. 12:00 pm  03/12/2021 Headache pain in left temple  12:00pm , 03/18/2021 Treated at clinic 03/21/2021  Swollen glands (Parotitis). 4:15PM  03/22/2021. Treated at clinic on 03/ 23/2021.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: death
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: Rash Itching
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose normal, Blood pressure increased, Chest discomfort, Dizziness, Electrocardiogram normal
Clinical narrative: Within a minute or so of the injection, I started to feel wooozy and like my chest was getting tight. My heart rate felt like it had jumped and my heart was pounding. I started to feel like it was very hot and I was getting somewhat nauseated and feeling like I might pass out. I checked my smart watch and my heart rate had jumped to over 120. The lady who administered the shot got the EMT on site and they took me for observation. They took my blood pressure and it was 157/114 (which is far beyond the norm for me). They took an EKG on site which they said was not alarming in any way. They checked my blood sugar and it was normal. My oxygen level stayed within a normal range. I had some mild feeling of itching/tingling  in my mouth and felt like I had a lump in my throat like a marble. My BP and HR came down some after about 15 minutes but was still high. They called an ambulance and had me go to an ER for further observation since the feeling in my mouth and throat was not resolving and my BP was not coming down to a better range after about 30 minutes. By the time I got to the ER and they monitored me, my BP was still 154/70 and my HR was still in the 80s while at rest. They kept me in observation for long enough for the doctor to feel that I was not in any immediate danger so they discharged me with instructions to return to the ER if things got worse.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Heart rate increased, Nausea, Oral pruritus, Palpitations
Clinical narrative: Within a minute or so of the injection, I started to feel wooozy and like my chest was getting tight. My heart rate felt like it had jumped and my heart was pounding. I started to feel like it was very hot and I was getting somewhat nauseated and feeling like I might pass out. I checked my smart watch and my heart rate had jumped to over 120. The lady who administered the shot got the EMT on site and they took me for observation. They took my blood pressure and it was 157/114 (which is far beyond the norm for me). They took an EKG on site which they said was not alarming in any way. They checked my blood sugar and it was normal. My oxygen level stayed within a normal range. I had some mild feeling of itching/tingling  in my mouth and felt like I had a lump in my throat like a marble. My BP and HR came down some after about 15 minutes but was still high. They called an ambulance and had me go to an ER for further observation since the feeling in my mouth and throat was not resolving and my BP was not coming down to a better range after about 30 minutes. By the time I got to the ER and they monitored me, my BP was still 154/70 and my HR was still in the 80s while at rest. They kept me in observation for long enough for the doctor to feel that I was not in any immediate danger so they discharged me with instructions to return to the ER if things got worse.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Sensation of foreign body
Clinical narrative: Within a minute or so of the injection, I started to feel wooozy and like my chest was getting tight. My heart rate felt like it had jumped and my heart was pounding. I started to feel like it was very hot and I was getting somewhat nauseated and feeling like I might pass out. I checked my smart watch and my heart rate had jumped to over 120. The lady who administered the shot got the EMT on site and they took me for observation. They took my blood pressure and it was 157/114 (which is far beyond the norm for me). They took an EKG on site which they said was not alarming in any way. They checked my blood sugar and it was normal. My oxygen level stayed within a normal range. I had some mild feeling of itching/tingling  in my mouth and felt like I had a lump in my throat like a marble. My BP and HR came down some after about 15 minutes but was still high. They called an ambulance and had me go to an ER for further observation since the feeling in my mouth and throat was not resolving and my BP was not coming down to a better range after about 30 minutes. By the time I got to the ER and they monitored me, my BP was still 154/70 and my HR was still in the 80s while at rest. They kept me in observation for long enough for the doctor to feel that I was not in any immediate danger so they discharged me with instructions to return to the ER if things got worse.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate increased
Clinical narrative: Within about 3 to 4 minutes of vaccine I experience extreme rapid heart beat that made me light headed.  I do have anxiety but I have never experienced this with my anxiety nor was I feeling anxious at the time.  It last about a minute and left, I did not experience any other reactions at the time of vaccination.   Wondering if this is normal or should I get my next vaccine in a more medical type setting?
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: I had a low grade fever (99.8) for about 12 hours.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: FLU SHOT GIVEN 4TH TIME AS CHILD HAS DUPLICATE GRITS ACCOUNT - ONLY 1 ACCOUNT WAS BEING UPDATED. FLU #1 - 10/01/2020 FLU#2 - 11/02/2020 FLU#3 - 12/02/2020 FLU#4 - 03/01/2021
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: The day after the vaccine I had injection site pain, some redness in the area of the injection and it was hot to the touch. This lasted one day, then the arm was sore for 1 more day following the injection. Then on Tuesday, March 23 (a week after the vaccination) my right arm (injection site) started to itch terribly. The redness returned, along with heat, swelling, and pain at the injection site. The symptoms have carried on to Wednesday, March 24 and now include nausea, exhaustion, diarrhea.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site warmth, Nausea, Pain in extremity
Clinical narrative: The day after the vaccine I had injection site pain, some redness in the area of the injection and it was hot to the touch. This lasted one day, then the arm was sore for 1 more day following the injection. Then on Tuesday, March 23 (a week after the vaccination) my right arm (injection site) started to itch terribly. The redness returned, along with heat, swelling, and pain at the injection site. The symptoms have carried on to Wednesday, March 24 and now include nausea, exhaustion, diarrhea.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Hyperhidrosis, Myalgia
Clinical narrative: Felt fine the first 6 hours, then around the 6.5 hour mark started feeling mild chills and muscle aches. Progressively got worse through the night into really bad chills, aches, feverish, sweaty, and woke up at 7am the following day with pounding headache, mild chills, and moderate achy muscles.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Felt fine the first 6 hours, then around the 6.5 hour mark started feeling mild chills and muscle aches. Progressively got worse through the night into really bad chills, aches, feverish, sweaty, and woke up at 7am the following day with pounding headache, mild chills, and moderate achy muscles.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Patient has had flu like symptoms after shot that he says has continued over the last 3 weeks
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: right sided bell's palsy
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Syringe issue, Underdose
Clinical narrative: When administering the vaccine, after needle was inserted into the arm, syringe separated from needle. Part of the dose was lost and dripped down patient's arm. Patient was afraid that entire dose was not administered and asked for half of a dose to ensure he received entire second dose of vaccine.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram abnormal, Lymphadenopathy, Neck mass, Pain in extremity
Clinical narrative: Went to the ED on 1/23 with complaints of left sided arm pain and left sided neck mass. Assessment strongly suspected that she was experiencing cervical chain lymphadenopathy from the vaccine due to the vaccine being administered on the left side. Diagnosis Lymphadenopathy of head and neck .
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash, Lymphadenopathy
Clinical narrative: rash, red hot under shot arm. Swollen glands under shot arm
Sex: U
Vaccine: COVID19
Symptoms: Lip disorder, Paraesthesia, Pruritus
Clinical narrative: 12:30pm, red Swollen bump on upper lip. Felt like a bruise, it was gone the next Day. Around 5pm, my skin (all over) started to Tingle and itch.  Call Doctor and I?m taking Zyrtec and Tagamet for the itching. Still itching today, but not as bad.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Ear, nose and throat examination, Tinnitus
Clinical narrative: Persistent tinnitus
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Moderna COVID?19 Vaccine EUA  I had a rash that began at the site of the injection a week after my first Moderna vaccine.  The rash started about the size of a dime and grew over several days to about 4 inches by 4 inches.  It was warm to the touch, my skin felt firm, and it was extremely itchy.  It is March 24, about 10 days after the reaction started, and the rash is gone by the area is still itchy.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: Pt had no adverse event after the vaccine was given.  He sat at the clinic for 20  minutes after vaccination with no adverse events observed.  He walked away from clinic showing no signs of any adverse reaction.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Frequent bowel movements, Gastrointestinal sounds abnormal, Gastrooesophageal reflux disease
Clinical narrative: Pfizer-BioNTech VOCID-19 Vaccine EUA 3 days after the injective, I had a bout of diarrhea. Since them I had had increasing bowel movements each day.  Yesterday I had 6 bowel movements, stomach gurgling, acid reflux.  I am getting worse each day.  I need to know what to  do and if I should avoid the second shot.