chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Psychotic disorder
Clinical narrative: I had a psychotic episode. I literally thought I was going to drive my self and my nephew to Heaven. I was going to Heaven and I was going to take him with me. I left the house without a phone and drove all the way to where my vehicle ran out of gas. I was apprehended by the highway patrol and taken to the local hospital. They ran all types of test and found nothing. The entire night I was out of my mind. My family came and I treated them badly. I refused to eat, drink, sleep, because I was fearful they would poison me or hurt me. It was awful. After they finally got me to take some sleeping pills, I woke up in my right mind. Why didn't you all have psychosis as a possible side effect? I would have never taken this vaccine had you all put this on the sheet of paper. Only thing you all had was "feeling unwell." What the heck is that? I was out of my mind and I was this hospital's third patient.  You all are dead wrong and psychosis should be added to the list ASAP. Who is going to pay this hospital bill plus two ambulance rides?
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Swollen tongue
Clinical narrative: Patient has a history of anaphylaxsis. Vaccine was administered at 9:46am to right deltoid.  At 10:15, patient described feeling a little bit funny.  The patient complained of tongue swelling at 10:20am.  Vitals signs Heart Rate 61 BP 152/62 spo2 was 97%.  At 10:25, the patient was assessed by an on site APN and was administered Benedryl 50mg IM.  She was placed in a supine position. At 10;52am, the patient reported feeling better and was discharge to home setting.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Pain, Pyrexia, Vomiting
Clinical narrative: I had headache, body ache and low grade fever forv2 days.  I had vomiting within 24 hours.  I still have diarrhea when eating 6 days later.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Pruritus, Rash, Urticaria
Clinical narrative: I woke up the next morning around 4am itching all over and started breaking out in red spots all over my body .  This has not lessened, but has become worse over time.  My eyes are swollen, I'm still itching all over and breaking out in hives.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Motor dysfunction, Oropharyngeal discomfort, Paraesthesia, Pyrexia
Clinical narrative: After receiving my Johnson and Johnson COVID vaccine I experienced a lack of motor function in my throat. Approximately 40 minutes after having received the shot, I lost the ability swallow. A tingling sensation took the back of my throat and eventually felt as though it moved into my head. The whole experience lasted a couple of minutes. Since that time all other symptoms have been normal, sore, slight fever, etc.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Hypoacusis
Clinical narrative: Woke at 3:50am. Right ear felt as though it very much needed to pop; internal pressure beyond external areas where finger can access. Hearing very much muffled. Not tinnitus (no ringing, screeching, etc.), which I have had before (in this ear), or if it were tinnitus then a very different tinnitus. Ear not significantly different by current time, 11:10am.   Though no scientific background to connect ear issue to vaccine received around 40 hours prior, no other changes in habit or precursors.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Chills, muscle aches, diarrhea, fatigue,headache, joint pain, congestion, sneezing. Flu like symptoms.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Myalgia, Nasal congestion, Sneezing
Clinical narrative: Chills, muscle aches, diarrhea, fatigue,headache, joint pain, congestion, sneezing. Flu like symptoms.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Skin mass
Clinical narrative: Veteran developed small bump behind left ear on 3/23/21, then on right ear morning of 3/24, two hours later to right upper leg, then spread to groin, then entire abdomen /chest area.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Dizziness postural, Dyspnoea, Palpitations
Clinical narrative: Shortness of breath, dizzy/lightheadedness, chest heaviness.    Occurred nearing the end of 15 minutes waiting period following vaccine administration.  Pt began feeling short of breath, dizzy upon standing, chest heaviness and heart racing.  Breathing slowed and eased, chest heaviness resolved and Pt reported feeling back to normal within 40 minutes following initial event.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Fatigue, Lethargy, Myocardial infarction
Clinical narrative: symptoms of heart attack; chest pain; hands and fingers tingly; dizzy; blurred vision; Vision decreased; extreme tiredness; lethargic; hurting all over; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EN6198) intramuscularly in left arm on 01Mar2021 05:45PM (at the age of 70-year-old) at single dose for COVID-19 immunisation. Relevant medical history included 5 back surgeries, Barrett's esophagus and H. pylori. Known allergies included Eliquis. Concomitant medications included dexlansoprazole (DEXILANT), hydrocodone, atorvastatin (LIPITOR), famotidine and chondroitin sulfate sodium, glucosamine hydrochloride (TAZAN). For 4-5 days after vaccine the patient had extreme tiredness, was lethargic and hurting all over. On day 5 chest pain started, hands and fingers tingly, dizzy, blurred vision both eyes off and in, vision decreased by 50% right eye. He experienced all symptoms of heart attack. Onset date for extreme tiredness, lethargic and hurting all over was 02Mar2021, while all the other events occurred on 06Mar2021. The patient was hospitalized for 1 day. No treatment was received. The patient underwent COVID test post vaccination, nasal swab on 07Mar2021 and it was negative. The events resolved in Mar2021.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, SARS-CoV-2 test, Vision blurred, Visual impairment
Clinical narrative: symptoms of heart attack; chest pain; hands and fingers tingly; dizzy; blurred vision; Vision decreased; extreme tiredness; lethargic; hurting all over; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot # EN6198) intramuscularly in left arm on 01Mar2021 05:45PM (at the age of 70-year-old) at single dose for COVID-19 immunisation. Relevant medical history included 5 back surgeries, Barrett's esophagus and H. pylori. Known allergies included Eliquis. Concomitant medications included dexlansoprazole (DEXILANT), hydrocodone, atorvastatin (LIPITOR), famotidine and chondroitin sulfate sodium, glucosamine hydrochloride (TAZAN). For 4-5 days after vaccine the patient had extreme tiredness, was lethargic and hurting all over. On day 5 chest pain started, hands and fingers tingly, dizzy, blurred vision both eyes off and in, vision decreased by 50% right eye. He experienced all symptoms of heart attack. Onset date for extreme tiredness, lethargic and hurting all over was 02Mar2021, while all the other events occurred on 06Mar2021. The patient was hospitalized for 1 day. No treatment was received. The patient underwent COVID test post vaccination, nasal swab on 07Mar2021 and it was negative. The events resolved in Mar2021.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dehydration, Hypotension, Loss of consciousness, Pneumonia
Clinical narrative: went to the hospital because he passed out from low blood pressure; went to the hospital because he passed out from low blood pressure; pneumonia; was dehydrated; This is a spontaneous report from Pfizer-sponsored program. A contactable 73-year-old male consumer received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Feb2021 via an unspecified route of administration, at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient went to the hospital because he passed out from low blood pressure. He was scheduled for his second dose on 17Feb2021, but he never made it to his second appointment because he was in the hospital. He was in rehab now. It was almost 6 weeks. The patient felt ok after getting the shot, but that night his son found him on the floor and took him to the hospital. It turned out he had pneumonia, low blood pressure and was dehydrated. The outcome of the events was unknown at the time of report.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: have a "a big black bruise" on her arm; This is a spontaneous report from a contactable consumer (patient).  An 82-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), via an unspecified route of administration on 06Mar2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had a big black bruise on her arm on an unspecified date in Mar2021. She was asking if this is a normal side effect of the vaccine. The outcome of the event was unknown. The reporter assessed the event as serious (medically significant).   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Meningitis, Vertigo
Clinical narrative: she became very ill with Viral Meningitis and Vertigo and has been in the hospital for a month now; she became very ill with Viral Meningitis and Vertigo and has been in the hospital for a month now; This is a spontaneous report from a contactable consumer.  A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. It was reported that the patient became very ill with viral meningitis and vertigo and had been in the hospital for a month now. The events was reported as non-serious. The consumer wanted to know if there had been any reports of serious side effects or serious illnesses after receiving a dose of the Pfizer Covid Vaccine other than the ones that is listed which is anaphylaxis. Stated that she is asking about this since her sister had a Pfizer Vaccine and 2 1/2 weeks later she became very ill with Viral Meningitis and Vertigo and has been in the hospital for a month now. The clinical outcome of the event became very ill with viral meningitis and vertigo unknown.  Information on the lot number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Blood cholesterol, Blood triglycerides
Clinical narrative: This is a spontaneous report from a contactable consumer. A 66-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6206) at the age of 66-years-old, via an unspecified route of administration in left arm on 07Mar2021 at 11:00 at single dose for COVID-19 immunization. Medical history included high blood cholesterol and triglycerides. The patient was allergic to medications, food, or other products (unspecified). She was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. She received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was at a hospital. On 09Mar2021 at 15:00, the patient presented with Bell's palsy which required a doctor or other healthcare professional office/clinic visit and was treated with BETAMETASONA 5.0 mg. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was not recovered.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy; This is a spontaneous report from a contactable Nurse (patient).  A 64-year-old Female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Feb2021 at single dose in left deltoid for COVID-19 immunisation at the age of 64-year-old. Lot number was EN6200. Relevant medical history and concurrent conditions included Herpes zoster/ shingles, Bells palsy, overweight. Concomitant medications included ergocalciferol (Vitamin D) for her bones and that kind of stuff. First dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) was received on 21Jan2021 for COVID-19 immunisation at the age of 64-year-old. Historical vaccine included typhoid, malaria and yellow jacket. Patient initially confirmed she has had no reactions after prior vaccinations. On 06Mar2021 at 02:30, the patient experienced Bells palsy; the event was considered Medically significant; the patient visited emergency room; the patient was given Zanamivir, antiviral in the Emergency Room. The patient had been told by other people that she should get started on a steroid, so she started prednisone, prescribed by the NP at her primary care. Patient had right facial paralysis right at the time of report, it was slightly worse than when she first noticed it. The patient did not think she has reached the maximum of the Bells Palsy and she had to drink coffee out to of a straw and issues with her words. The patient did not recover from the event. The reporter mentioned that she has had several family members who have had Bells Palsy. The odds that she received something that could trigger some kind of immune response, the time frame, the fact she got the vaccine, also fact she has a history of shingles she would have to associate with the vaccination. The reporter had done mission work and has never had a reaction to any of the vaccines that she received for that.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event facial paralysis cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. 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: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling abnormal, Heart rate, Heart rate irregular, Loss of consciousness
Clinical narrative: struggling to catch my breath; swinging from 120+ BPM to 50 BPM in an instant; pass out; racing heart; big rush of the room spinning; I could feel the medicine in my body, almost to my toes; This is a spontaneous report from a contactable consumer.  A 37-year-old male patient received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine; lot number: EL9267) on 26Feb2021 and the second dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine; lot number: EN6202) on 12Mar2021, via an unspecified route of administration on Left Arm at single  dose for COVID-19 immunisation. The administration of first dose of BNT162B2 resulted in Palpitations, dizziness, hyperhidrosis and Syncope the same day of administration. Relevant medical history included allergy to penicillin.  Relevant concomitant medications included testosterone cipionate (TESTOSTERONE CYPIONATE). During second dose of vaccine the patient stated that he feels the medicine in his body, almost to his toes. The patient was fine for a minute or two but then he reported a big rush of the room spinning, struggling to catch my breath, racing heart. EMS personnel was called over and they monitored my heart rate. It was swinging from 120+ BPM to 50 BPM in an instant and during the low BPM was when he passed out.   The patient was treated with Epinephrine due a potential reaction and transported to hospital.  The reported events were feeling abnormal, vertigo, dyspnoea, palpitations, heart rate irregular and loss of consciousness. All events were serious as hospitalization and Life-threatening illness (immediate risk of death from the event).
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations, Vertigo
Clinical narrative: struggling to catch my breath; swinging from 120+ BPM to 50 BPM in an instant; pass out; racing heart; big rush of the room spinning; I could feel the medicine in my body, almost to my toes; This is a spontaneous report from a contactable consumer.  A 37-year-old male patient received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine; lot number: EL9267) on 26Feb2021 and the second dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine; lot number: EN6202) on 12Mar2021, via an unspecified route of administration on Left Arm at single  dose for COVID-19 immunisation. The administration of first dose of BNT162B2 resulted in Palpitations, dizziness, hyperhidrosis and Syncope the same day of administration. Relevant medical history included allergy to penicillin.  Relevant concomitant medications included testosterone cipionate (TESTOSTERONE CYPIONATE). During second dose of vaccine the patient stated that he feels the medicine in his body, almost to his toes. The patient was fine for a minute or two but then he reported a big rush of the room spinning, struggling to catch my breath, racing heart. EMS personnel was called over and they monitored my heart rate. It was swinging from 120+ BPM to 50 BPM in an instant and during the low BPM was when he passed out.   The patient was treated with Epinephrine due a potential reaction and transported to hospital.  The reported events were feeling abnormal, vertigo, dyspnoea, palpitations, heart rate irregular and loss of consciousness. All events were serious as hospitalization and Life-threatening illness (immediate risk of death from the event).
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pericardial effusion, Pulmonary embolism
Clinical narrative: Patient developed a pericardial effusion and PE within 2-3 days of vaccine. Unclear if related.; Patient developed a pericardial effusion and PE within 2-3 days of vaccine. Unclear if related.; This is a spontaneous report from a non-contactable physician. A 72-year-old male patient received bnt162b2 (COVID-19, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concurrent medications were not reported. The patient was unclear if related. The patient experienced pericardial effusion and PE (Pulmonary embolism) within 2-3 days of vaccine on an unspecified date. The outcome of event was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events pericardial effusion and pulmonary embolism and the suspect drug. 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: M
Vaccine: COVID19
Symptoms: Post procedural complication, Seizure
Clinical narrative: He was in a hospital now having an emergency due to complications that had something to do with a prostate procedure; he experienced having seizures; This is a spontaneous report received from the Pfizer sponsored program . A contactable consumer (patient himself) reported that a male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration date was unknown), via an unspecified route of administration on 10Feb2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, initially, caller wants to cancel his second vaccine dose which according to him was today, 11Mar2021. He said that he was in a hospital now (on an unspecified date in 2021) having an emergency due to complications on an unspecified date in 2021 that had something to do with a prostate procedure he had 2 days ago. He had his first vaccine shot on 10Feb2021. That's more than 21 days if his next schedule was today, 11Mar2021. Consequently, during the call, he experienced having seizures on an unspecified date in 2021. The event "he was in a hospital now having an emergency due to complications that had something to do with a prostate procedure" was considered as serious (hospitalization) by the consumer. The outcome of the event he experienced having seizures was not recovered and unknown for the other event.  Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal relationship the causal relationship between BNT162B2 and event, post prostate procedural complications, seizures cannot be completely ruled out.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cardiac arrest, Haemoglobin, Haemoglobin decreased, Lower gastrointestinal haemorrhage, Rash
Clinical narrative: Lose of blood found to be from small intestine; Cardiac arrest; Going into shock; Rash all over face; Hemoglobin low; This is a spontaneous report from a contactable consumer. A 70-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) dose 1 via an unspecified route of administration on 05Feb2021 as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications in two weeks included atorvastatin 40 mg, gabapentin 300 mg, amlodipine 5 mg, losartan 100 mg, aspirin [acetylsalicylic acid] 81 mg and potassium. The patient previously took tylenol and codeine and both experienced allergies. No other vaccine in four weeks. The patient experienced rash all over face, lose of blood found to be from small intestine, hemoglobin low, cardiac arrest, going into shock on 05Feb2021. Events resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient was hospitalized for 6 days due to above events. Covid test post vaccination included Nasal swab with Negative result on 11Mar2021. Treatment included blood transfusion. The outcome of events was not recovered.  Information on the lot/batch number has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: SARS-CoV-2 test, Shock
Clinical narrative: Lose of blood found to be from small intestine; Cardiac arrest; Going into shock; Rash all over face; Hemoglobin low; This is a spontaneous report from a contactable consumer. A 70-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) dose 1 via an unspecified route of administration on 05Feb2021 as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications in two weeks included atorvastatin 40 mg, gabapentin 300 mg, amlodipine 5 mg, losartan 100 mg, aspirin [acetylsalicylic acid] 81 mg and potassium. The patient previously took tylenol and codeine and both experienced allergies. No other vaccine in four weeks. The patient experienced rash all over face, lose of blood found to be from small intestine, hemoglobin low, cardiac arrest, going into shock on 05Feb2021. Events resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient was hospitalized for 6 days due to above events. Covid test post vaccination included Nasal swab with Negative result on 11Mar2021. Treatment included blood transfusion. The outcome of events was not recovered.  Information on the lot/batch number has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood culture, Cardiac disorder, Computerised tomogram, Death, Electrocardiogram
Clinical narrative: Lose of blood found to be from small intestine; Cardiac arrest; Going into shock; Rash all over face; Hemoglobin low; This is a spontaneous report from a contactable consumer. A 70-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) dose 1 via an unspecified route of administration on 05Feb2021 as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications in two weeks included atorvastatin 40 mg, gabapentin 300 mg, amlodipine 5 mg, losartan 100 mg, aspirin [acetylsalicylic acid] 81 mg and potassium. The patient previously took tylenol and codeine and both experienced allergies. No other vaccine in four weeks. The patient experienced rash all over face, lose of blood found to be from small intestine, hemoglobin low, cardiac arrest, going into shock on 05Feb2021. Events resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient was hospitalized for 6 days due to above events. Covid test post vaccination included Nasal swab with Negative result on 11Mar2021. Treatment included blood transfusion. The outcome of events was not recovered.  Information on the lot/batch number has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Endoscopy, Faeces discoloured, Full blood count, Gastrointestinal haemorrhage, Haemoglobin decreased
Clinical narrative: Lose of blood found to be from small intestine; Cardiac arrest; Going into shock; Rash all over face; Hemoglobin low; This is a spontaneous report from a contactable consumer. A 70-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) dose 1 via an unspecified route of administration on 05Feb2021 as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications in two weeks included atorvastatin 40 mg, gabapentin 300 mg, amlodipine 5 mg, losartan 100 mg, aspirin [acetylsalicylic acid] 81 mg and potassium. The patient previously took tylenol and codeine and both experienced allergies. No other vaccine in four weeks. The patient experienced rash all over face, lose of blood found to be from small intestine, hemoglobin low, cardiac arrest, going into shock on 05Feb2021. Events resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient was hospitalized for 6 days due to above events. Covid test post vaccination included Nasal swab with Negative result on 11Mar2021. Treatment included blood transfusion. The outcome of events was not recovered.  Information on the lot/batch number has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Laboratory test, Melaena, Metabolic function test, Presyncope, Rash
Clinical narrative: Lose of blood found to be from small intestine; Cardiac arrest; Going into shock; Rash all over face; Hemoglobin low; This is a spontaneous report from a contactable consumer. A 70-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) dose 1 via an unspecified route of administration on 05Feb2021 as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications in two weeks included atorvastatin 40 mg, gabapentin 300 mg, amlodipine 5 mg, losartan 100 mg, aspirin [acetylsalicylic acid] 81 mg and potassium. The patient previously took tylenol and codeine and both experienced allergies. No other vaccine in four weeks. The patient experienced rash all over face, lose of blood found to be from small intestine, hemoglobin low, cardiac arrest, going into shock on 05Feb2021. Events resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient was hospitalized for 6 days due to above events. Covid test post vaccination included Nasal swab with Negative result on 11Mar2021. Treatment included blood transfusion. The outcome of events was not recovered.  Information on the lot/batch number has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash erythematous, Urine analysis
Clinical narrative: Lose of blood found to be from small intestine; Cardiac arrest; Going into shock; Rash all over face; Hemoglobin low; This is a spontaneous report from a contactable consumer. A 70-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) dose 1 via an unspecified route of administration on 05Feb2021 as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications in two weeks included atorvastatin 40 mg, gabapentin 300 mg, amlodipine 5 mg, losartan 100 mg, aspirin [acetylsalicylic acid] 81 mg and potassium. The patient previously took tylenol and codeine and both experienced allergies. No other vaccine in four weeks. The patient experienced rash all over face, lose of blood found to be from small intestine, hemoglobin low, cardiac arrest, going into shock on 05Feb2021. Events resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event). The patient was hospitalized for 6 days due to above events. Covid test post vaccination included Nasal swab with Negative result on 11Mar2021. Treatment included blood transfusion. The outcome of events was not recovered.  Information on the lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: At 10am crashed.  Fatigue,  body aches, chills, fever (101.6), headache, and ringing in ears.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: At 10am crashed.  Fatigue,  body aches, chills, fever (101.6), headache, and ringing in ears.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pruritus
Clinical narrative: Patient experienced shortness of breath and itching after receiving first dose of Pfizer vaccine. Was administered Benadryl 25 mg, P.O.  Onsite provider recommended EMS transport for eval, but patient refused.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Chills, achy, sweats, headache, diahrea, general fatigue
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Chills, achy, sweats, headache, diahrea, general fatigue
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Asthenia, Chills, Feeling abnormal
Clinical narrative: The day after my second dose of the Pfizer vaccine,  I experienced chills, severe body aches, stomach upset, vomiting. I had loss of sensitivity in my right thigh area that comes and goes. I also have brain fog, joint aches that overwhelming. Subsequently, I had Covid tests through my PCP which were negative but I had symptoms that mimicked Covid symptoms. My PCP recommended I go to the ER and I was admitted for two and a half days.  They monitored my heart, did lab work, liver test. I continue with headaches that are more profound. I still have loss of strength in my right thigh, which is intermittent, comes and goes. I still have itchiness on my right thigh and leg with loss of sensation lasting from three to five hours. I will be seeing a neurologist next month.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Liver function test, Pain, Pruritus, SARS-CoV-2 test negative
Clinical narrative: The day after my second dose of the Pfizer vaccine,  I experienced chills, severe body aches, stomach upset, vomiting. I had loss of sensitivity in my right thigh area that comes and goes. I also have brain fog, joint aches that overwhelming. Subsequently, I had Covid tests through my PCP which were negative but I had symptoms that mimicked Covid symptoms. My PCP recommended I go to the ER and I was admitted for two and a half days.  They monitored my heart, did lab work, liver test. I continue with headaches that are more profound. I still have loss of strength in my right thigh, which is intermittent, comes and goes. I still have itchiness on my right thigh and leg with loss of sensation lasting from three to five hours. I will be seeing a neurologist next month.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Sensory loss, Vomiting
Clinical narrative: The day after my second dose of the Pfizer vaccine,  I experienced chills, severe body aches, stomach upset, vomiting. I had loss of sensitivity in my right thigh area that comes and goes. I also have brain fog, joint aches that overwhelming. Subsequently, I had Covid tests through my PCP which were negative but I had symptoms that mimicked Covid symptoms. My PCP recommended I go to the ER and I was admitted for two and a half days.  They monitored my heart, did lab work, liver test. I continue with headaches that are more profound. I still have loss of strength in my right thigh, which is intermittent, comes and goes. I still have itchiness on my right thigh and leg with loss of sensation lasting from three to five hours. I will be seeing a neurologist next month.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Firm red circle (about 1.5 inch in diameter) appeared around injection site, on upper left arm, about one week after the injection.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient received her first vaccine Thursday, March 11 and noticed on Monday (4 days later) the injection site and down her upper arm became warm, itchy, red, and swollen.  She used hydrocortisone cream starting Tuesday to relieve symptoms  and it was resolved 2 days later on Thursday.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Oral pain, Paraesthesia oral, Stomatitis
Clinical narrative: On evening of 3/24/21 patient has weird sensation in mouth, altered sensations like tingling. Patient woke up 3/25/21 with more pain and lesions in mouth. Patient called PCP and is being prescription magic mouthwash for symptoms.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Injection site pain, Injection site warmth, Pain in extremity
Clinical narrative: I have a lump at the injection site that hurts, and feels warm to touch. also I have what feels like nerve pain in my arm when I move it a certain way
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Hospitalisation, Hypotension, Syncope
Clinical narrative: Patient experienced very low blood pressure and fainted. He came to quickly, but was transported to hospital by ambulance as a precaution
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Dizziness, Dyspepsia, Rash macular, Skin burning sensation
Clinical narrative: Skin and stomach felt on fire Felt light headed Broke out in blotchy rash, but went away and did not itch a week out. Light headed
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Gait disturbance, Movement disorder
Clinical narrative: Got the vaccine, and yesterday 3/24/21 somewhere around 3:30 he started feeling weak, tried to walk and  had weakness.  By 6:30 he could not get up.  He was on the floor as he slid off the bed and could not push himself up on his arms, and got worse and worse.  He went up to bed, and his son had to come over and help him into bed as he was not even able to lift his legs to get into bed.   Then at 3:00 AM this morning he could start walking again.  Now this morning he is a little wobbly and otherwise getting better.  He did take 2 Tylenol.  No soreness around the injection site, just the extreme weakness.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Breast discomfort, Breast tenderness, Feeling hot, Mammogram, Pruritus
Clinical narrative: Right breast: nipple initially intensely itchy for about 12-24 hours; then tender; then breast feeling a little full; didn't feel tender exactly, just different. Bra felt slightly tighter fitting. Seemed to get better, then right breast tenderness again after second COVID shot, also in right arm on 27 Feb 2021, lot # EN 6202.  Very mild discomfort diffuse through breast; 25 days after second shot (and after mammogram) nipple tender again, breast mild discomfort, including vague sensation of warmth in breast.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound breast
Clinical narrative: Right breast: nipple initially intensely itchy for about 12-24 hours; then tender; then breast feeling a little full; didn't feel tender exactly, just different. Bra felt slightly tighter fitting. Seemed to get better, then right breast tenderness again after second COVID shot, also in right arm on 27 Feb 2021, lot # EN 6202.  Very mild discomfort diffuse through breast; 25 days after second shot (and after mammogram) nipple tender again, breast mild discomfort, including vague sensation of warmth in breast.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Pyrexia
Clinical narrative: Running a fever of 101.25 soreness at the injection site  Fatigue
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: VACCINATION WAS GIVEN 5 DAYS EARLY. DUE DATE FOR SECOND VACCINATION IS 3/30
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Blood thyroid stimulating hormone, C-reactive protein, Discomfort, Full blood count
Clinical narrative: 4 days after second dose patient has noted a feeling of heaviness and unsteadiness when walking.  He also feels sweaty in the morning
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Gait disturbance, Hyperhidrosis, Metabolic function test, Neutrophil percentage, Vitamin B12
Clinical narrative: 4 days after second dose patient has noted a feeling of heaviness and unsteadiness when walking.  He also feels sweaty in the morning
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue disorder, Urticaria
Clinical narrative: HIVES ON BOTH ARMS/LEGS/TRUNK, THICK TOUNGE
Age: 4.0
Sex: F
Vaccine: MMR, UNK
Symptoms: Peripheral swelling, Rash
Clinical narrative: Per mom Pts thigh swelled up and a red rash appeared after the vaccines were given.
Age: 27.0
Sex: F
Vaccine: UNK
Symptoms: Dysgeusia
Clinical narrative: Metallic taste in mouth for 2 days after getting vaccine
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Pain in extremity
Clinical narrative: Upon receiving the first dose, I had the usual reaction of a sore arm which faded after two-three days. Five-six days later, exactly eight days after I received my injection, I developed Covid arm. Pain at the injection site, a rash on the arm, skin was warm to the touch, and the area was swollen. The pain, rash, warmth and swelling are going down.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: Upon receiving the first dose, I had the usual reaction of a sore arm which faded after two-three days. Five-six days later, exactly eight days after I received my injection, I developed Covid arm. Pain at the injection site, a rash on the arm, skin was warm to the touch, and the area was swollen. The pain, rash, warmth and swelling are going down.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Nervousness, Pruritus, Throat tightness
Clinical narrative: Described throat tightness, itching of face/skin. BP 160/110 with medium BP cuff. HR 85 SPO2 97%. Describes feeling shaky. Reports history of anaphylactic reaction to allergy shot for bee stings. Reports history of feeling "panicky". After 30 minutes at rest, reports throat tightness improved. Reports never had difficulty breathing, just a tightness in the throat. Reports increase in skin itching, but has a history of similar reaction when exposed to mold in buildings.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness, Feeling hot, Presyncope, Tunnel vision
Clinical narrative: Classic vasovagal reaction without syncope Warmth, clamminess, dizziness, partial tunnel vision Self resolving symptoms with BP, pulse, O2 sat all within acceptable ranges with 60 minute observation No orthostasis and comfortable ambulation at discharge from observation unit
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Injected limb mobility decreased
Clinical narrative: Inability to move arm to full capacity.  Left arm with limited range of motion after first injection and worsened after second injection
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Diarrhoea, Dizziness, Fatigue
Clinical narrative: Left arm soreness, shoulder joint pain, neck pain, migraine, nausea, diarrhea, upset stomach, dizziness, sleeplessness, tiredness
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Migraine, Nausea, Neck pain, Pain in extremity
Clinical narrative: Left arm soreness, shoulder joint pain, neck pain, migraine, nausea, diarrhea, upset stomach, dizziness, sleeplessness, tiredness
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Insomnia, Nausea, Pain
Clinical narrative: fever >102, chills, aches, headache, nausea, insomnia.  Started 6 hours after vaccine administration and last about 18 hours
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever >102, chills, aches, headache, nausea, insomnia.  Started 6 hours after vaccine administration and last about 18 hours
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Foetal exposure during pregnancy, Pyrexia, Restless legs syndrome
Clinical narrative: I was 35 weeks pregnant at the time. I am due April 25. I?m not sure this was an adverse effect, but I had a high fever of 103.5 and some kind of restless leg syndrome. Both were short term - less than five hours.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Fatigue, Feeling cold, Injection site abscess
Clinical narrative: Besides arm pain that went to my pinky, I was fine. Later that night, I started to get chills and was really cold. The next day, I developed a fever of 100.2 and was really cold. For about a week, I would be fine during the day and would get really tired by the evening and extremely cold. I also started feeling tightness in my chest about 2 days after I got the vaccine. I contacted my doctor and she told me to take Tylenol and Albuterol.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Besides arm pain that went to my pinky, I was fine. Later that night, I started to get chills and was really cold. The next day, I developed a fever of 100.2 and was really cold. For about a week, I would be fine during the day and would get really tired by the evening and extremely cold. I also started feeling tightness in my chest about 2 days after I got the vaccine. I contacted my doctor and she told me to take Tylenol and Albuterol.
Age: 69.0
Sex: F
Vaccine: UNK
Symptoms: Injection site reaction
Clinical narrative: received her Moderna #1 on 3/10. She developed a Large Local Reaction at the vaccine injection site(left Deltoid) on 3/16. She was seen in Facility on the 19th and 22nd. It was resolving nicely on 3/22.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Depressed level of consciousness, Dizziness, Hypotension
Clinical narrative: March 10 - onset with dizziness March 11 - 12:45 PM while sitting symptoms progressed to vertigo, tingling throughout body, ear pitching sounds, tunneling vision, total blackout and falling from chair.  Upon coming to, symptoms of weakness, in and out of alertness, confusion and diminished responsiveness. Remained on floor for an hour and my symptoms contined for 5 hours until about 6pm.  Had severe hypotension:  no readings upon reaction, but three hours later they were: 4pm - 84/48, 6pm - 94/54, 7pm - 97/58, 9pm - 100/60. Regular readings are 110/90.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Paraesthesia, Tinnitus, Tunnel vision, Vertigo
Clinical narrative: March 10 - onset with dizziness March 11 - 12:45 PM while sitting symptoms progressed to vertigo, tingling throughout body, ear pitching sounds, tunneling vision, total blackout and falling from chair.  Upon coming to, symptoms of weakness, in and out of alertness, confusion and diminished responsiveness. Remained on floor for an hour and my symptoms contined for 5 hours until about 6pm.  Had severe hypotension:  no readings upon reaction, but three hours later they were: 4pm - 84/48, 6pm - 94/54, 7pm - 97/58, 9pm - 100/60. Regular readings are 110/90.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Vertigo
Clinical narrative: Body aches, vertigo, headache, tiredness
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swelling of Lymph nodes under left arm
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Hospitalization within 6 weeks after receiving vaccine
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Oropharyngeal pain
Clinical narrative: Sore arm, low-grade fever, sore throat, muscle & joint aches, headache and fatigue
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Sore arm, low-grade fever, sore throat, muscle & joint aches, headache and fatigue
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac failure, Death, Hypotension
Clinical narrative: She was transferred to the hospital on 3/4/2021 due to low blood pressure, she understands that due to heart failure.  The death certification information is unknown.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Injection site pruritus
Clinical narrative: 3/14 - Cold feet, headache at 3pm; by 6pm severe chills, nausea, throbbing headache, extreme fatigue 3/15 - 2am woke up drenched in sweat; tired all day; headache; pain and itching at injection site 3/16 - fatigue; pain and itching at injection site itching at injection site still has continued through today 3/25; also today a square rash has developed on my forearm of the arm I received the injection
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Night sweats, Peripheral coldness, Rash
Clinical narrative: 3/14 - Cold feet, headache at 3pm; by 6pm severe chills, nausea, throbbing headache, extreme fatigue 3/15 - 2am woke up drenched in sweat; tired all day; headache; pain and itching at injection site 3/16 - fatigue; pain and itching at injection site itching at injection site still has continued through today 3/25; also today a square rash has developed on my forearm of the arm I received the injection
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fall, Head injury, Hospitalisation
Clinical narrative: Patient became dizzy and fainted approximately 15 minutes following vaccination.  Fell and hit forehead on tile floor in hallway outside clinic room. Brief loss of consciousness.  Patient continued to have periods of dizziness, spotted vision and weakness as well as developed nausea.  Ambulance was called and patient was transported to the hospital for further evaluation. Patient was given water and a snack, but continued to have symptoms.  Later determined patient had not eaten breakfast prior to vaccination.