chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Pulmonary embolism, Pulmonary thrombosis
Clinical narrative: Pulmonary embolism/ two large blood clots, one in each lung; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in arm right on an unspecified date (Lot Number: EP6955) as single dose for COVID-19 immunisation.  Medical history included high blood pressure and cholesterol abnormal, both from an unknown date and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination the patient has not been tested for COVID-19.  The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in arm right on 28Feb2021 at 08:00 (Lot Number: EN6202) as single dose for COVID-19 immunization. On 29Apr2021 at 07:00, roughly one month after second dose of vaccine, the patient couldn't breathe, sweating profusely, accelerated heart rate and chest tightness. He was diagnosed with a pulmonary embolism. He had two large blood clots, one in each lung. The events were serious, it required emergency surgery to save his life. The patient spent 2 days in ICU (Intensive Care Unit) and 3 additional days in the hospital. The doctors told to the patient that they had never seen blood clots like those and that large. The patient reported that he is now on blood thinners. The patient outcome of the event was recovering.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Two extremely itchy, circular welts begin growing on the side on my face; Two extremely itchy, circular welts begin growing on the side on my face; This is a spontaneous report from a contactable other nurse (patient herself).  A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL3246, Expiration date: unknown), intramuscularly, administered in left arm on 13Jan2021 10:30 AM as 2nd Dose, single dose for covid-19 immunisation. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL5730), intramuscularly, administered in left arm on Dec2020 11:00 AM as 1st Dose, single dose for covid-19 immunisation. The patient's medical history included known allergies to Mastisol. The patient's concomitant medications included Levothyroxine within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Facility where the most recent COVID-19 vaccine was administered was reported as Hospital. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 14Jan2021 08:00 AM, the patient experienced two extremely itchy, circular welts begin growing on the side on my face. They continued to grow. Since the vaccination, the patient had not been tested for COVID-19. These adverse events led patient to visit doctor or other healthcare professional office/clinic visit. The patient had received antibiotics, steroids, multiple creams and now she was on Dupixent injections every two weeks as a treatment medication for resulted events. The seriousness of the event was assessed as non-serious by nurse. The outcome of the events was not recovered.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 in triggering the onset of Urticaria and Pruritis  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 agency as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Neurological symptom
Clinical narrative: neurological problems; This is a spontaneous report received from two contactable consumers. This consumer reported in response to letter via follow-up letter. A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiration Date not reported), via unspecified route on an unspecified date as for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced serious neurological problems. The outcome of the event was reported as unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: I was for positive for Covid exactly on May 15/had to cancel my appointment for my second shot because I had Covid; I was for positive for Covid exactly on May 15/had to cancel my appointment for my second shot because I had Covid; This is a spontaneous report from a contactable consumer (patient)via team. A 51-year-old female patient received first dose of PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0158), via an unspecified route of administration on 24Apr2021 as single dose for covid-19 immunisation.  The patient medical history was none. The patient's concomitant medications were not reported. The patient stated I was for positive for covid exactly on 15May/had to cancel my appointment for my second shot because I had covid on 15May2021. The patient stated, she received the first dose of the Pfizer COVID-19 vaccine on 24Apr2021 and tested positive for COVID on 15May2021 the same day she was due to get the second dose of the Pfizer COVID-19 vaccine. She cancelled her appointment. She states she is getting conflicting information as to when to get the second dose of the vaccine. She would like to know when she can receive the second dose and if the series needs to be repeated. The events were treated with Tylenol and Robitussin. The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021598751 similar report from same reporter
Sex: M
Vaccine: COVID19
Symptoms: Cardiac arrest
Clinical narrative: Cardiac arrest; This is a spontaneous report received by a contactable consumer.  A male patient of unknown age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number not provided), via an unknown route, on unknown date at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. Recently the patient received the first shot of COVID-19 vaccine and subsequently went into cardiac arrest. He unfortunately passed away one week later. It was unknown if an autopsy was performed.  Information about lot/batch number has been requested.; Reported Cause(s) of Death: cardiac arrest
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Flat affect, Head injury, Loss of consciousness, Malaise
Clinical narrative: Syncopal Episode; hit her head; Malaise; Felt weird; Feeling a little flat; She "passed out"; Syncope; This is a spontaneous report from a contactable consumer (patient).  An unspecified year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: not reported, Expiration date: Unknown), via an unspecified route of administration in the left arm on 01Apr2021, as a 1ST DOSE, SINGLE for COVID-19 immunization. The patients medical history and concomitant medications were not reported. The patent stated that on an unspecified date (9 days later) in Apr2021, she had a syncopal episode while she got up to go to the bathroom and passed out in the morning after waking. She hit her head and ended up in the hospital. She had undergone blood work and said because this event was 9 days after the vaccine, it was probably not related to the vaccine. The patient has been feeling a little flat since the first shot. She experienced syncope, malaise, felt weird, Syncopal Episode, Feeling a little flat. Patient was just feeling the general malaise since the first shot. Patient had a syncope, day nine after the first shot The outcome of all the events were Unknown.  No follow up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Syncopal Episode; hit her head; Malaise; Felt weird; Feeling a little flat; She "passed out"; Syncope; This is a spontaneous report from a contactable consumer (patient).  An unspecified year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: not reported, Expiration date: Unknown), via an unspecified route of administration in the left arm on 01Apr2021, as a 1ST DOSE, SINGLE for COVID-19 immunization. The patients medical history and concomitant medications were not reported. The patent stated that on an unspecified date (9 days later) in Apr2021, she had a syncopal episode while she got up to go to the bathroom and passed out in the morning after waking. She hit her head and ended up in the hospital. She had undergone blood work and said because this event was 9 days after the vaccine, it was probably not related to the vaccine. The patient has been feeling a little flat since the first shot. She experienced syncope, malaise, felt weird, Syncopal Episode, Feeling a little flat. Patient was just feeling the general malaise since the first shot. Patient had a syncope, day nine after the first shot The outcome of all the events were Unknown.  No follow up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, SARS-CoV-2 test
Clinical narrative: severe headache; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in left arm, on 15May2021 12:00 PM (at the age of 41-years-old) at 2nd dose, single for COVID-19 immunization. Medical history was reported as none. The patient had not known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and/or any other medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 on 24Apr2021 (at the age of 41-years-old) administered in left arm for COVID-19 immunisation. After four days from taking a second shot, on 20May2021 at 16:00 (as reported), the patient started feeling severe headache, it was getting worse until the reporting day (25May2021). The event was reported as serious due to life-threatening event and 2 days of hospitalization from May2021 to May2021. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient underwent lab tests and procedures, which included COVID test, nasal swab on 22May2021: negative. Therapeutic measures were taken as a result of the event and included treatment with blood thinner medicine injected. The patient had not recovered from the event.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Had COVID-19 Virus; Had COVID-19 Virus; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 15Apr2021 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient reported that she have the first dose of Pfizer Vaccine around March and she doesn't remember the exact date and was supposed to get 2nd dose on 15May2021, however the patient had COVID-19 Virus on an unspecified date 2021 and she missed her 2nd dose and she want to know is she eligible or supposed to get the 2nd dose now. She was also stated that, I got my vaccine card, my first shot was 15Apr2021 and then I was due to get my other shot 15May2021. I had COVID-19 on, that was a week before Mother's Day, so I didn't get my shot of course. So, my question is can I get the 2nd shot. The outcome is reported as unknown.   Information related to batch/Lot no. was requested.
Sex: U
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: 3 days after the second shot, 2 seizures within 1 hour, hospital for help for 3 days; This is a spontaneous report from a contactable consumer(patient).   A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number and Expiration date was unknown), via an unspecified route of administration, on an unknown date, as SINGLE DOSE for COVID-19 immunisation. Patient medical history and concomitant medications were not provided. The patient previously received first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Batch/Lot number and Expiration date was unknown), via an unspecified route of administration, on an unknown date as SINGLE DOSE for COVID-19 immunisation. After 1 week of first dose of vaccination patient had experienced two strokes on both sides of the brain. On an unknown date, after 3days of second dose of vaccination, patient had two seizures within 1hour and was hospitalized for help for 3 days. The patient truly believed it was not a good thing, and patient suffered a lot. The outcome of the event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy; This is a spontaneous report from a contactable pharmacist. A elderly female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: unknown, Expiry date: unknown) via an unspecified route of administration on an unspecified date as a 1st dose single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. As per the description, the caller was a pharmacist who called on behalf of a patient who received the first dose of the Pfizer covid vaccine and developed bell's palsy. The caller stated that the patient is an elderly with a high risk for covid 19 infection and the caller was looking for guidance on second dose of the Pfizer Covid 19 vaccine for patients who develop bell's palsy after the first dose. The outcome of the event was unknown.   Information on the lot/batch number has been requested. ; Sender's Comments: As there is limited information in the case provided, the causal association between the event Bell's palsy and the suspected vaccine BNT162B2  cannot be excluded. The case will be reassessed once new information is 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.
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: absent seizure; This is a spontaneous report from a non-contactable consumer reported for her husband. A male patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BONTECH, COVID-19 Vaccine, Solution for injection, Lot number and expiration date: Not reported), via an unspecified route of administration on 26May2021, as (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced absent seizure on 26May2021. It was reported that, the caller states her husband received his second dose of the Pfizer COIVD-19 vaccine today, 26May2021. and during the 15 mins wait time from after receiving the vaccine he had what she states the nurses there are calling and absent seizure. The caller states his eyes were awake but he was not responding, as she was getting ready to bring him to the ER, he became responsive so they did not go to the ER. She is wondering if there has been reports of this and what she should do next. A review of the Pfizer COVID-19 vaccine did not find information regarding seizures. The seriousness criteria of the event was reported as serious (medically significant) by the reporter. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia
Clinical narrative: arrhythmia two weeks after first shot.; This is a spontaneous report received from a contactable consumer (patient).   An 18-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: EW0161, expiry date was not provided) via an unspecified route of administration, administered in left arm on 04May2021 at 17:00 (age at vaccination 18-year-old) as 1st dose, single for COVID-19 immunisation in Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have any medical history or any known allergies. The patient concomitant medications were not reported. The patient was not the diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 17May2021 (two weeks after first shot), patient experienced arrhythmia. The patient visited emergency room/department or urgent care for adverse event. The outcome of the events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable nurse (patient) from a Pfizer sponsored program. A 30-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0170; Expiration Date: 31Aug2021), via an unspecified route of administration on Apr2021 (at the age of 30-year-old) as single dose, administered in Deltoid Left for covid-19 immunization. Medical history included allergy. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), cetirizine hydrochloride (ZYRTEC ALLERGY) both taken for allergy (Further not clarified). On 17May2021, after the first dose (on last Apr2021), the patient was tested positive for covid-19. The patient was scheduled for her second dose on 18May2021 but missed the dose as she was tested positive. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 17May2021. The outcome of the events was unknown.   Follow up needed, further information has been requested.; Sender's Comments: Based on known drug safety profile and temporal relationship there is reasonable possibility of causal association between the reported events and the suspect drug.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Still's disease
Clinical narrative: exacerbation adult-onset still's disease; exacerbation adult-onset still's disease; HERO-TOGETHER: A POST-EMERGENCY USE AUTHORIZATION OBSERVATIONAL COHORT STUDY TO EVALUATE THE SAFETY OF THE PFIZER-BIONTECH COVID-19 VACCINE IN HEALTHCARE WORKERS  This is a report from a non-interventional study source and post authorization safety study.   A 28-year-old female subject received first dose of BNT162B2 (reported as COVID-19 vaccine) on 19Dec2020 and the second dose on 16Jan2021, both via an unspecified route of administration as single dose for covid-19 immunization. Medical history included adult onset still's disease (her last flare about 2 years ago). The subject's concomitant medications were not reported. In Dec2020, the subject experienced exacerbation adult-onset still's disease, which was considered as medically significant event (reported as non-serious by the investigator). On 01Feb2021, the subject presented to rheumatology office for follow-up of adult onset stills disease. She was doing very well with her last flare about 2 years ago, until 2 months ago when she had a flare lasting about a week. This flare was followed by a second flare after she received her second dose of her COVID vaccine, again lasting about a week. She was treated both with 20 mg of prednisone. On 26May2021 (Today), she stated that she was doing well, denied any fever, chills, or significant joint pain or stiffness. The only joint where she was experiencing pain is her left knee, which had been a chronic problem for last 2 years. She denied trauma to the knee. Received methylprednisolone 40mg left knee injection for symptom relief. Rheumatologist assessment: "This 28-year-old female with previously stable and very quiet adult onset stills disease. It is likely that her current flares were related to the receipt of Covid vaccine. If she continued to have more frequent flares, she would let me know, and we would discuss treatment with a disease-modifying antirheumatic drug (DMARD)". The action taken in response to the event for BNT162B2 was not applicable.  The outcome of the event was recovering.  There was a reasonable possibility that the event exacerbation adult-onset still's disease was related to COVID-19 vaccine.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, A possible causal relationship between reported events and suspect drug BNT162B2 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.
Age: 3.0
Sex: M
Vaccine: DTAP, DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: A patient received Quadracel instead of Daptacel, no AE; A 3 year old patient received Quadracel, no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00607334) and transmitted to Sanofi on 19-May-2021.  This case involves a three-year-old male patient who received 0.5 mL dose DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot C5763AA and expiry date: 26-Aug-2022) via an intramuscular route in the left thigh for prophylactic vaccination on 03-May-2021 (wrong product administered and product administered to patient of inappropriate age) instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (batch number and expiry date not reported).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for prophylactic vaccination.  The healthcare professional (HCP) asked about potential side effects, and about comparison of the two vaccines. HCP also asked about the recommended dosing of the IPV (Ipol) component, about the dose being too soon if given at age 3 rather than age 4. The reporter stated that she had spoken to the patient's mother to notify her, and the patient's mother had told her that the patient was running around and seemed fine and was experiencing no side effects from it. Reporter did not know which dose in the series the intended DTaP was.    This was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration (latency same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 75.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: A 75 year old patient was administered Adacel, no AE.; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via Medical Information (Reference number- 00612908) and transmitted to Sanofi on 24-May-2021.  This case involves a 75 years old male patient who was administered DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] VACCINE (lot number not reported) via unknown route in unknown administration site for prophylactic vaccination on 21-MAY-2021 (Product administered to patient of inappropriate age)  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   It was a case of an actual medication error due to Inappropriate age at vaccine administration (latency same day).  The caller wanted to know if it was okay for his in-laws to be administered Adacel based on their age (70's). The family members were 73 and 75 years of age and were administered Adacel last week. He asks if it was ok.   At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: family members who are 73 and 75 years of age were administered Adacel last week with no reported adverse event; Initial information received on 24-May-2021 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional (Inquiry number: 00612961).  It was reported that DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (Suspension For Injection) was administered to patients who were 73 and 75 years of age on an unknown date for prophylactic vaccination (product administered to patient of inappropriate age).  It was a case of actual medication error due to inappropriate age at vaccine administration.  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for this case.; Sender's Comments:  00612908:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Paraesthesia
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: fingers tingling-Medium, Additional Details: pt complained of chest pain after injection & tingling in fingers-bp was taken-143/82 -called  911 & they checked her out in ambulance-paramedics released her a few minutes later to go home
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fall, Nausea
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Additional Details: Patient fell down but did not hit his head. He was advised to lay down at which point he was able to cool down and relax. Drank some water too.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Fall, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient was seated waiting after her vaccination. She collapses to the floor. I went out after being alerted what happened and flipped her from her face, she was awake and confused as to what had happened. I sat with her while our front store manager grabbed her water. I asked if she felt she needed an ambulance and seeing as she was breathing fine and starting to come to she said she did not want an ambulance. She later informed our front store manager that she had fainted 3 times that morning.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site vesicles
Clinical narrative: Site: Swelling at Injection Site-Mild, Systemic: blister-like protrusion on injection site - looks to be filled with fluid-Mild
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Within 9 hours of the shot, I developed a low grade fever, body aches, headache and extreme fatigue.  These symptoms lasted for about 2 days, although they lessened after the first 24 hours or so.
Age: 59.0
Sex: M
Vaccine: UNK
Symptoms: Condition aggravated, Pancreatitis acute
Clinical narrative: Acute pancreatitis lasting 3 days after injection. Normal normally last less than 20 minutes when they occur.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test abnormal, Breast pain, C-reactive protein increased, Chest discomfort
Clinical narrative: Fever, body aches, joint pain, exhaustion, breast pain, shortness of breath, migraines, cough, chest tightness, diarrhea  Ventolin Amoxicillin-clav 875-125mg Azithromycin 250mg dose pack Benzonatate 200mg Cefdinir 300mg Levofloxacin 750mg Methylprednisolone 4 mg Prednisone 20mg
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Diarrhoea, Dyspnoea, Eosinophil count increased, Fatigue
Clinical narrative: Fever, body aches, joint pain, exhaustion, breast pain, shortness of breath, migraines, cough, chest tightness, diarrhea  Ventolin Amoxicillin-clav 875-125mg Azithromycin 250mg dose pack Benzonatate 200mg Cefdinir 300mg Levofloxacin 750mg Methylprednisolone 4 mg Prednisone 20mg
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Pain, Pyrexia
Clinical narrative: Fever, body aches, joint pain, exhaustion, breast pain, shortness of breath, migraines, cough, chest tightness, diarrhea  Ventolin Amoxicillin-clav 875-125mg Azithromycin 250mg dose pack Benzonatate 200mg Cefdinir 300mg Levofloxacin 750mg Methylprednisolone 4 mg Prednisone 20mg
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Hypoaesthesia, Injected limb mobility decreased, Muscle spasms, Pain
Clinical narrative: After the first shot I could barely move my left arm and with in a few days I had pain on my left side of my stomach. This pain got worse and spread to mostly my left side back, leg, arm. And is now all over. It?s a horrible burning stabbing pain. Within a week after my second shot my left arm went numb while driving and currently experiencing random numbness and tingling in my left foot and arm. Also on May 9th my left calf got a charley horse feeling for 3 days nonstop. This will come and go but that was the longest it lasted.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: After the first shot I could barely move my left arm and with in a few days I had pain on my left side of my stomach. This pain got worse and spread to mostly my left side back, leg, arm. And is now all over. It?s a horrible burning stabbing pain. Within a week after my second shot my left arm went numb while driving and currently experiencing random numbness and tingling in my left foot and arm. Also on May 9th my left calf got a charley horse feeling for 3 days nonstop. This will come and go but that was the longest it lasted.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, X-ray
Clinical narrative: I started having severe shoulder pain 2 days after injection. I believe it?s SIRVA (shoulder I hurt related to vaccine administration ? the pain persisted for over 6 weeks and now I?m still having pain. I have seen my PCP, had x Ray, doing physical therapy and acupuncture, all provided little to no relief.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Impaired work ability, Pyrexia
Clinical narrative: I had a temperature of 99.1, massive headache which I still have and it's June 1, 2021, extremely exhausted like I've not slept at all. I've had to miss work due to this as well.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Menstruation irregular, Oligomenorrhoea
Clinical narrative: skipped period between 2 shots.  had light period on 3/29.  again 4/8 was heavy lasted 8 days.  again 5/1 was light lasted 2 days.  again 5/7 started light, became heavy have been bleeding since non-stop.  Dr prescribed progestin for 10 days on 5/18 because of upcoming vacation to make lighter/stop.   was lighter but Never stopped, bleeding slowly became heavier on day 7 of meds and hasn't stopped as of today (6/1)
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Persistent hissing and ringing in my left ear from 21st April 2021. It has been more than two months but the sound has not gone away.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: I had a fever up to 100 degrees for a whole day, and I recovered without treatment after 1 day.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Cough, Dizziness, Headache, Hypertension
Clinical narrative: First day - dizziness, headache, temperature: 37.5 (paracetamol) Second day - flu syndromes, temperature: 40.0, sinus headaches, runny nose (paracetamol, ibuprofen) 3rd-6th day - temperature: 37-38, flu, runny nose, strong sinus headaches, cough (ibuprofen, aspirin - but not together) 7th - 10th day - runny nose, cough, sinus headaches, temperature back to normal (aspirin) 11th day - high blood pressure (160/100), strong sinus headaches 12-14th day - blood pressure 130/90, sinus headaches
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Rhinorrhoea, Sinus headache
Clinical narrative: First day - dizziness, headache, temperature: 37.5 (paracetamol) Second day - flu syndromes, temperature: 40.0, sinus headaches, runny nose (paracetamol, ibuprofen) 3rd-6th day - temperature: 37-38, flu, runny nose, strong sinus headaches, cough (ibuprofen, aspirin - but not together) 7th - 10th day - runny nose, cough, sinus headaches, temperature back to normal (aspirin) 11th day - high blood pressure (160/100), strong sinus headaches 12-14th day - blood pressure 130/90, sinus headaches
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Pain
Clinical narrative: I have a painful almost baseball size know that feels like there is a rash at injection site.  Didn?t really notice it until this morning it is sore to the touch and movement is uncomfortable. Sister in law told me to report it.
Age: 67.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Chills, Headache, Nausea
Clinical narrative: Nauseau, extreme headache for 2 days. Weak, no strength. Chills.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Axillary pain, Chills, Fatigue, Headache
Clinical narrative: Swelling, redness & pain at injection site & armpit Low grade fever, chills,headache,muscle pain, tiredness, lost of taste buds
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Lymphadenopathy, Myalgia
Clinical narrative: Swelling, redness & pain at injection site & armpit Low grade fever, chills,headache,muscle pain, tiredness, lost of taste buds
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Swelling, redness & pain at injection site & armpit Low grade fever, chills,headache,muscle pain, tiredness, lost of taste buds
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eye disorder, Headache, Pain, Scan
Clinical narrative: I had, chills, fainting, left eye dropping, headache and body ached.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, X-ray
Clinical narrative: I had, chills, fainting, left eye dropping, headache and body ached.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives and itching around the neckline for >15 minutes after giving but only lasted about 2-3 hours. No trouble breathing and medical assistance was not deemed necessary.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Pt experienced syncopal episode at vaccine table. According to vaccinator, episode lasted only "a few seconds". Pt was assisted to wheelchair and was taken to medical evaluation room for observation. Vitals were regularly obtained and Pt was observed for 15 minutes; during this time, Pt was administered water. After observation, Pt was assisted to observation area, where family was met, and Pt left without further incident.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: I got covid arm about 8 days after first shot.  That went away.  Then I had a swollen lymph on feb 17.  The swollen lymph went down some but it?s still swollen on my left back hand to date. 4 months later still swollen.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal faeces, Faeces discoloured, Fatigue, Haematochezia, Injected limb mobility decreased
Clinical narrative: Same restricted mobility as first dose on left arm near vaccination location lasted 24-48h after second dose. Persistent fatigue (not after first dose), specially arms and legs.  No other side effects until 06/1@8:00am blood in stool, foul-smelling. Usual shape/color.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Dry eye, Vitreous floaters
Clinical narrative: EXTREME  DEBILITY FOR 2 WEEKS (AT THE DATE OF THE REPORT  IS IMPROVING) VERY SIMILAR TO THE SYMPTOMS OF ZIKA VIRUS, I AM AN ACTIVE OUTDOORS PERSON, HAVE EXPERIENCE LOSS OF STAMINA AT THE DATE OF THE REPORT STILL AT 80%,  TAKE LONGER  TO  RECUPERATE AFTER EXERCISE OR OUTDOOR WORKING ACTIVITY  NEED TO  REST  MUCH MORE. , MORE FLOATERS AND DRYNESS IN THE EYES STILL USING OTC EYE DROPS FROM TIME TO TIME, JOINT PAIN (THIS HAS IMPROVED WITH JOINT VITAMINS)
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Laboratory test, Tinnitus
Clinical narrative: Tinnitus.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Anion gap decreased, Blood calcium normal, Blood chloride normal, Blood creatinine normal, Blood glucose normal
Clinical narrative: severe, continuous status migraine daily March 31-May 17th. Not responsive to any medications or "migraine cocktail" in ER. Interrupted by nerve block injection but returned May 25th through present. Lymph nodes in neck are also still swollen and painful since March 24th.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Blood potassium normal, Blood sodium normal, Blood urea normal, Carbon dioxide normal, Computerised tomogram normal
Clinical narrative: severe, continuous status migraine daily March 31-May 17th. Not responsive to any medications or "migraine cocktail" in ER. Interrupted by nerve block injection but returned May 25th through present. Lymph nodes in neck are also still swollen and painful since March 24th.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Haematocrit normal, Haemoglobin normal, Lymph node pain, Lymphadenopathy, Magnetic resonance imaging normal
Clinical narrative: severe, continuous status migraine daily March 31-May 17th. Not responsive to any medications or "migraine cocktail" in ER. Interrupted by nerve block injection but returned May 25th through present. Lymph nodes in neck are also still swollen and painful since March 24th.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Mean cell haemoglobin normal, Mean cell volume normal, Nucleated red cells, Platelet count normal, Red blood cell count normal
Clinical narrative: severe, continuous status migraine daily March 31-May 17th. Not responsive to any medications or "migraine cocktail" in ER. Interrupted by nerve block injection but returned May 25th through present. Lymph nodes in neck are also still swollen and painful since March 24th.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Red blood cell sedimentation rate increased, Red cell distribution width normal, Sleep study normal, Status migrainosus, White blood cell count normal
Clinical narrative: severe, continuous status migraine daily March 31-May 17th. Not responsive to any medications or "migraine cocktail" in ER. Interrupted by nerve block injection but returned May 25th through present. Lymph nodes in neck are also still swollen and painful since March 24th.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: fever, body aches, chills
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Limb mass, Paraesthesia, Pruritus, Sensitive skin
Clinical narrative: Right arm experiencing pins and needles all the way up to the chest.  Itching on the same arm but no sign of rash. Sensitivity to heat, cold, water and clothing.  Mild visible lump on wrist. Mild numbness of arm/hand while walking.  24 hours of symptoms even while sleeping.  symptoms moving toward middle of chest.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Temperature intolerance
Clinical narrative: Right arm experiencing pins and needles all the way up to the chest.  Itching on the same arm but no sign of rash. Sensitivity to heat, cold, water and clothing.  Mild visible lump on wrist. Mild numbness of arm/hand while walking.  24 hours of symptoms even while sleeping.  symptoms moving toward middle of chest.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: "Heavy" fatigue, body aches, chills, and intermittent low-grade fever.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Tinnitus
Clinical narrative: As soon as I arrived home I noticed the sound was louder.  I was very distressed already having experience with Tinnitus.  The next night on the news i heard that  an increase of cases of Tinnitus after the shot and also as I had and increase in loudness.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Headache, Magnetic resonance imaging head abnormal, Photophobia
Clinical narrative: Constant daily headaches located at front of head, on/above eyebrows. Light sensitivity and pain when pressing around eyes. Headaches started on 4/12 and have continued daily since.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Patient started to get a runny nose around 2100 tonight. Denies any pain, no fever, nothing else, just  a running nose.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Myocarditis, Troponin increased
Clinical narrative: started developing chest pressure - admitted in the hospital for myopericarditis
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pain, Pain in extremity
Clinical narrative: having trouble breathing, arm hurts, entire body aches
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles presentation that started on 5/27/2021, placed on antivirals on 6/1/2021
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Developed small patch of shingles on mid back right side. I have had one shingles vaccine in February 2021. I take acyclovir 400mg everyday for prevention of herpes simplex 1
Age: 23.0
Sex: U
Vaccine: UNK
Symptoms: Suicidal ideation
Clinical narrative: Don?t get a vaccine I nearly killed myself over it
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Laboratory test, Lymphadenopathy
Clinical narrative: Swollen or neurotic lymph node on left front throat.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: My daughter had started her menstrual cycle a day or two prior to receiving the vaccine.  She has had her cycle since August 2020.  Her bleeding became VERY heavy after receiving the shot, where she was bleeding through super plus and ultra tampons in just a couple of hours.  She is still bleeding like this 6 days later.  It has not stopped.  Her regular periods are quite lite and nothing like this.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rhinorrhoea
Clinical narrative: runny nose, rash
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Cough, Pruritus, Throat irritation
Clinical narrative: About 15 minutes after the shot started having sever itching on face & neck.  Had taken a benadryl before going due to getting hives on first shot.  No hives this time.  They had me take a 2nd benadryl when this started.  About 10 or 15 minutes later had asthma cough start with severe itchy throat.  After 2nd benadryl started working it went away.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray normal, Dyspnoea, Full blood count normal, Red blood cell sedimentation rate normal
Clinical narrative: Shortness of breath with and without exertion. Feeling like she cannot take a deep enough breath.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Rash erythematous
Clinical narrative: 6 days after vaccine, I noticed a red small circle at the injection site. I pressed on it slightly and noticed it hurt to the touch. The next day I woke up with a red rash at the injection site. It hurts to the touch still.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram pulmonary abnormal, Pulmonary embolism
Clinical narrative: Bilateral spontaneous PE
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Intermenstrual bleeding
Clinical narrative: Breakthrough period bleeding.  Longer period than ever
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis, Tinnitus
Clinical narrative: pulsatile tinnitus - constant - whooshing sound in ear correlating to the beat of my heart - hard time hearing
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Depression, Disturbance in attention, Emotional distress, Impaired work ability, Judgement impaired
Clinical narrative: I COULDN'T THINK CLEARLY, EXTREMELY EMOTIONAL, HIGH MANIC FOR THREE TO FOUR HOURS, THEN CRASHED INTO DEPRESSION (THIS TYPE OF EPISODE NEVER HAPPENED BEFORE), LOSS OF HOPE, DEPRESSION HIGHER THAN N0RMAL, BAD JUDGEMENT AT WORK CAUSED LOSS OF CLIENT'S BUSINESS.  I KNEW MY PSYCHOTROPIC MEDICINES WERE NOT WORKING AND THOUGHT I WAS GOING INSANE.  OR MAYBE EARLY ONSET DEMENTIA.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Mania
Clinical narrative: I COULDN'T THINK CLEARLY, EXTREMELY EMOTIONAL, HIGH MANIC FOR THREE TO FOUR HOURS, THEN CRASHED INTO DEPRESSION (THIS TYPE OF EPISODE NEVER HAPPENED BEFORE), LOSS OF HOPE, DEPRESSION HIGHER THAN N0RMAL, BAD JUDGEMENT AT WORK CAUSED LOSS OF CLIENT'S BUSINESS.  I KNEW MY PSYCHOTROPIC MEDICINES WERE NOT WORKING AND THOUGHT I WAS GOING INSANE.  OR MAYBE EARLY ONSET DEMENTIA.