chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Medication error, No adverse event, Wrong product administered
Clinical narrative: given QUADRACEL instead of PENTACEL on his 15th month with no reported adverse event; Initial information received on 18-Mar-2022 regarding an unsolicited valid non-serious case received from call center.  This case involves a 30 months old male patient who was given quadracel instead of pentacel on his 15th month with no reported adverse event while receiving vaccine Diphtheria-15/tetanus/5 hybrid AC Pertussis/IPV (MRC5) Vaccine [Quadracel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received unknown dose of suspect Diphtheria-15/tetanus/5 hybrid AC Pertussis/IPV (MRC5) Vaccine (dose, formulation, lot number and expiry date: unknown) via unknown route in unknown administration site for Immunization.  On an unknown date the patient was given quadracel instead of pentacel on his 15th month with no reported adverse event (wrong product administered) (unknown latency) following the administration of Diphtheria-15/tetanus/5 hybrid AC Pertussis/IPV (MRC5) Vaccine.  Action taken: was not applicable.  At time of reporting, the outcome was Unknown for the event.    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: 4.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired dose of menactra administered with no reported adverse event; Initial information received on 21-Mar-2022 regarding an unsolicited valid  non-serious case received from a non-healthcare professional.  This case involves a 4 years old female patient who was administered an expired dose of Meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria vaccine toxoid, Pertussis vaccine acellular, Tetanus vaccine toxoid (TDAP); polio vaccine inact (IPV); and varicella zoster vaccine (Varicella vaccine), all for Prophylactic vaccination.  On 21-Mar-2022, the patient received a dose of suspect Meningococcal A-C-Y-W135 (D CONJ) vaccine (with an unknown formulation and strength) (lot number: U6787AA and expiry date: 08-Nov-2021) at a dose of 0.5 mL via intramuscular route in the right thigh for prophylactic immunization.   The patient was administered an expired dose of Meningococcal A-C-Y-W135 (D CONJ) vaccine with no reported adverse event (expired product administered).  Action taken was not applicable.  Outcome: Unknown   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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Computerised tomogram head, Dizziness, Hypoaesthesia, Inflammation
Clinical narrative: hip/leg arm numbness, dizzy, heart, inflammation, pass out
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Magnetic resonance imaging heart
Clinical narrative: hip/leg arm numbness, dizzy, heart, inflammation, pass out
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, SARS-CoV-2 test positive
Clinical narrative: Pt admit 3/22/22 w/ acute hypoxemic respiratory failure d/t COVID19 (positive test result 3/18/22). Pt had previously received 3 doses of Pfizer on 12/28/20, 1/18/21, & 10/29/21. Pt had also received 6 of 10 doses of Paxlovid prior to being admitted.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired dose was administered/ It was the patient's third dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HBV (Engerix B) (batch number 2224M, expiry date 1st March 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th March 2022, the patient received the 3rd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 18th March 2022, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. Medical assistant reported that, an expired dose of Engerix-B was administered by another staff member to the patient, which led to expired vaccine used. The reporter declined to provide additional information. The reporter did not consent to follow-up.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose Sept 23  2019 and 2nd dose Dec 13 2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 84-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 23rd September 2019).   On 13th December 2021, the patient received the 2nd dose of Shingrix. On 13th December 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The reporter reported that patient received a second dose of Shingrix outside recommended schedule, which led to lengthening of vaccination schedule. No know side effect was reported. No lot number and expiration date provided. The reporter consented to follow up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: only received adjuvant; only received adjuvant; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number 49N3S, expiry date 24th August 2023) for prophylaxis.   On 22nd March 2022, the patient received the 1st dose of Shingrix. On 22nd March 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The reporter stated that a patient only received a single-dose vial of adjuvant suspension component and they did not reconstitute the vial of lyophilized gE antigen component of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Myalgia
Clinical narrative: Headache for a few days; Body aches for a few days; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache for a few days) and MYALGIA (Body aches for a few days) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced HEADACHE (Headache for a few days) and MYALGIA (Body aches for a few days). At the time of the report, HEADACHE (Headache for a few days) and MYALGIA (Body aches for a few days) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was provided. No treatment information was provided.   This case was linked to MOD-2022-518808, MOD-2022-518813 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Mar-2022: Follow-up received contains no new information.
Age: 38.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Myalgia
Clinical narrative: Headache for a few days; Generalized body ache for a few days; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache for a few days) and MYALGIA (Generalized body ache for a few days) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced HEADACHE (Headache for a few days) and MYALGIA (Generalized body ache for a few days). At the time of the report, HEADACHE (Headache for a few days) and MYALGIA (Generalized body ache for a few days) had resolved.            No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.   This case was linked to MOD-2022-518224, MOD-2022-518813 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Mar-2022: Follow-up received contains no new information.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: headache for a few days; body ache for a few days; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache for a few days) and MYALGIA (body ache for a few days) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 016M20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, the patient experienced HEADACHE (headache for a few days) and MYALGIA (body ache for a few days). At the time of the report, HEADACHE (headache for a few days) and MYALGIA (body ache for a few days) had resolved.            No concomitant medications were provided by reporter.  No treatment medications were provided by reporter.   This case was linked to MOD-2022-518808 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Mar-2022: Follow-up received contains no new information.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: For over a year his wife had this AE.; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (For over a year his wife had this AE.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (For over a year his wife had this AE.). At the time of the report, VACCINATION COMPLICATION (For over a year his wife had this AE.) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered VACCINATION COMPLICATION (For over a year his wife had this AE.) to be related.    No concomitant medication was reported.  It was reported that the patient had the AE for over a year and went to the doctor all that time. Also, the patient can't associate this AE with anything else other than the vaccine.  No treatment medications was reported.   Reporter did not allow further contact
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest discomfort, Chest pain, Electrocardiogram, Myocarditis
Clinical narrative: Woke up with chest pain.  Presented to ER and was cleared after examination. I felt it was myocardia due to booster shot.  ER Physician agreed and told me to take OTC medication for swelling.  I am still feeling mild chest discomfort occasionally as of today, 3/24/22.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Ultrasound scan
Clinical narrative: Woke up with chest pain.  Presented to ER and was cleared after examination. I felt it was myocardia due to booster shot.  ER Physician agreed and told me to take OTC medication for swelling.  I am still feeling mild chest discomfort occasionally as of today, 3/24/22.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: HOSPITALIZATION
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Syncope, Unresponsive to stimuli, Visual impairment
Clinical narrative: Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Visual Changes/Disturbances-Mild
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Chills, Cough, Dyspnoea, Feeling hot
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Systemic: Chills-Medium, Additional Details: Pt states she has asthma and is experiencing SOB, cough, "can't catch her breath", congestion, hot/chills at the same time, and is constantly clearing her throat. She has a bruise at injectino site about 6"X3".
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site pain, Oropharyngeal discomfort, Respiratory tract congestion
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Systemic: Chills-Medium, Additional Details: Pt states she has asthma and is experiencing SOB, cough, "can't catch her breath", congestion, hot/chills at the same time, and is constantly clearing her throat. She has a bruise at injectino site about 6"X3".
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: TEMPERATURE EXCURSION. vaccine (covid) was stored in the freezer longer than manufacture recommendations. Patient did not have any adverse reactions.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: P.T. Presented Feeling lightheaded about 5 min. after vaccine. P.T. was moved to private observation area. P.T. was A/ox4 with normal vital signs. PT. started to Feel better after about 10 min of observation. Pt was Discharged home after 30 min oF observation. PT. stated that she has had vasovagal Reactions to injections
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Blood glucose, Diabetic ketoacidosis, Glycosylated haemoglobin, Insulin C-peptide
Clinical narrative: Diabetickeyoacidosis
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: TEMPERATURE EXCURSION. vaccine (covid) was stored in the freezer longer than manufacture recommendations. Patient did not have any adverse reactions.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Acute febrile neutrophilic dermatosis, Blister, Blood test abnormal, Injected limb mobility decreased, Joint range of motion decreased
Clinical narrative: Patient received vaccination and experienced adverse effect within 24 hours. Patient developed a large painful blister in periumbilical area. Patient visited emergency room for treatment. Bloodwork was drawn and patient was given diagnosis of "Sweet's Syndrome". Patient was treated with steroids. Patient followed up with primary care provider. Patient also experiencing left arm pain and limited range of motion since vaccination which persists a year later. Patient has been seeing orthopedist for treatment. Blister has resolved but  patient still experiences pain in left arm and limited range of motion.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Patient received vaccination and experienced adverse effect within 24 hours. Patient developed a large painful blister in periumbilical area. Patient visited emergency room for treatment. Bloodwork was drawn and patient was given diagnosis of "Sweet's Syndrome". Patient was treated with steroids. Patient followed up with primary care provider. Patient also experiencing left arm pain and limited range of motion since vaccination which persists a year later. Patient has been seeing orthopedist for treatment. Blister has resolved but  patient still experiences pain in left arm and limited range of motion.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: covid positive pt fully vaccinated.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Chills, Feeling of body temperature change, Headache, Pain
Clinical narrative: Person received Covid 19 Booster vaccine of Pfizer at vaccine event on 03/23/2022. Started to have side effects on 03/24/2022, which states  Headache, Fever (temp unknown) just keep getting cold and hot episodes, chills, and Body aches, Took Advil to help alleviate some pain and help with fever. Will Continue  to monitor her side effects for the next 48 hours
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Person received Covid 19 Booster vaccine of Pfizer at vaccine event on 03/23/2022. Started to have side effects on 03/24/2022, which states  Headache, Fever (temp unknown) just keep getting cold and hot episodes, chills, and Body aches, Took Advil to help alleviate some pain and help with fever. Will Continue  to monitor her side effects for the next 48 hours
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Emotional disorder, Glycosylated haemoglobin increased, Stress
Clinical narrative: Approximately a month after the vaccine which was gradually oncoming, I started noticing anxiety which was getting worse, getting more stressed easily, and getting more emotional. Also, my blood sugar was higher than normal than it was before even when I wake up in the morning. This was different than before the vaccine. I use to get low numbers and now the numbers are high on my blood sugar tests. I went to my doctor and was prescribed Xanax to be taken as needed for the anxiety. My doctor also discussed the high blood sugar and I do have an future appt with the endocrinologist. I am not for sure if it is connected with the vaccine but I wanted to report because my health did change after the 3rd dose.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, COVID-19 pneumonia, Computerised tomogram abdomen abnormal, Death, Echocardiogram
Clinical narrative: 79 year old vaccinated female was admitted for Covid-19 pneumonia. She had underlying COPD which did not help in her recovery. She was seen by cardiology for a fib with RVR. TTE showed normal LVEF. She had recurrent coffee ground emesis but GI did not see the need to perform endoscopy. She was then seen by GS. CT abdomen showed ileus with retroperitoneal mass. She had NGT placed to wall suction. She was treated with Daptomycin for possible VRE UTI. She became unresponsive and unconscious while on NGT. Even after it was removed 2 days ago, she did not regain consciousness. Family requested DNR with comfort care measures yesterday. She passed away today at 1022 hours.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Ejection fraction normal, Gastrointestinal tube insertion, Haematemesis, Ileus, Loss of consciousness
Clinical narrative: 79 year old vaccinated female was admitted for Covid-19 pneumonia. She had underlying COPD which did not help in her recovery. She was seen by cardiology for a fib with RVR. TTE showed normal LVEF. She had recurrent coffee ground emesis but GI did not see the need to perform endoscopy. She was then seen by GS. CT abdomen showed ileus with retroperitoneal mass. She had NGT placed to wall suction. She was treated with Daptomycin for possible VRE UTI. She became unresponsive and unconscious while on NGT. Even after it was removed 2 days ago, she did not regain consciousness. Family requested DNR with comfort care measures yesterday. She passed away today at 1022 hours.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Retroperitoneal mass, Unresponsive to stimuli
Clinical narrative: 79 year old vaccinated female was admitted for Covid-19 pneumonia. She had underlying COPD which did not help in her recovery. She was seen by cardiology for a fib with RVR. TTE showed normal LVEF. She had recurrent coffee ground emesis but GI did not see the need to perform endoscopy. She was then seen by GS. CT abdomen showed ileus with retroperitoneal mass. She had NGT placed to wall suction. She was treated with Daptomycin for possible VRE UTI. She became unresponsive and unconscious while on NGT. Even after it was removed 2 days ago, she did not regain consciousness. Family requested DNR with comfort care measures yesterday. She passed away today at 1022 hours.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cerebellar stroke, Echocardiogram normal, Headache, Hypoaesthesia
Clinical narrative: Left cerebellar stroke - right sided numbness, weakness and headache.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test normal
Clinical narrative: Left cerebellar stroke - right sided numbness, weakness and headache.
Age: 40.0
Sex: F
Vaccine: VARCEL
Symptoms: Blood test abnormal, Decreased immune responsiveness
Clinical narrative: PT IS GOING TO BE DOING IVF,  HER OB/GYN DID BLOOD WORK TO CHECK HER IMMUNITY TO SOME DISEASES AND IT WAS FOUND SHE DID NOT HAVE IMMUNITY TO VARICELLA.  THEY HAD PT CONTACT US TO GET A VARICELLA VAXINE.  IT WAS APPROVED BY THE PROVIDER THAT SHE COULD COME IN FOR A NURSE VISIT.  PT CAME IN FOR SAID VISIT AND DID NOT INFORM STAFF SHE WAS ON A MEDICATION THAT AFFECTS HER IMMUNE SYSTEM (STELARA).  THE VACCINE WAS GIVEN BY THE MA.  WHEN ENTERING THE VACCINE INTO THE PATIENTS CHART, A CONTRAINDICATION WARNING CAME UP REGARDING GIVING A LIVE VACCINE WHILE ON STELARA.  THE CURRENT EMR SYSTEM DOES NOT WARN OF THIS WHEN THE ORDER IS ENTERED, ONLY AFTER WHEN VACCINE IS BEING GIVEN.  THIS IS GOING TO BE ADDRESSED WITH IT.  ONCE DISCOVERED WE CONTACTED THE PATIENT TO LET HER KNOW THAT SHE MAY DEVELOP CHICKEN POX AND TO MONITOR SYMPTOMS.  AN INCIDENT REPORT IS BEING FILED.  THE PRACTICE MANAGER AND THE MEDICAL DIRECTOR HAVE BEEN NOTIFIED.  AS OF TODAY, PT HAS NOT DEVELOPED SYMPTOMS.  PT IS FOLLOWING UP WITH OB/GYN TODAY.  PT WAS TOLD TO NOTIFY DERMATOLOGY WHICH IS PRESCRIBING THE STELARA.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test negative, Chronic spontaneous urticaria, Fatigue, Headache, Hypersensitivity
Clinical narrative: Arm soreness, fatigue, headache, fever, significant delayed chronic spontaneous urticaria (hives), increased allergic reactions
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Arm soreness, fatigue, headache, fever, significant delayed chronic spontaneous urticaria (hives), increased allergic reactions
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Mobility decreased, Pyrexia
Clinical narrative: It started that same day after getting my vaccine. I begun to have chills, fever, no energy and I couldn't get out of bed for the rest of the night. I was able to go to work, because I work from home. By the time that evening came, I was feeling better.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pains  Sharp Coming and going
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: TEMPERATURE EXCURSION. vaccine (covid) was stored in the freezer longer than manufacture recommendations. Patient did not have any adverse reactions.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: TEMPERATURE EXCURSION. vaccine (covid) was stored in the freezer longer than manufacture recommendations. Patient did not have any adverse reactions.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Nasopharyngitis, Upper-airway cough syndrome
Clinical narrative: I was feeling under the weather on 11/27/2021 so I went to a clinics and saw nurse practitioner because I was experiencing cold like symptoms with draining in my throat. I received a B12 shot and something to stop drainage around Holiday then at the end of December I saw another MD in the same clinic around the Holiday got eye drops and an antibiotic which subsided for a week or so. Then in January I start having the same symptoms and saw NP again, she said that this may be an allergy and I needed to see a specialist but she did prescribed some antibiotics and then when I saw the specialist he prescribed a stronger antibiotic and said if it does not go away in a week I will give you another prescribed antibiotic so at the end on March.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: TEMPERATURE EXCURSION. vaccine (covid) was stored in the freezer longer than manufacture recommendations. Patient did not have any adverse reactions.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Cognitive disorder, Fatigue, Headache
Clinical narrative: reversing numbers when typing, delayed cognitive thinking, tiredness, headaches
Age: 26.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Condition aggravated, Dysmenorrhoea, Heavy menstrual bleeding, Smear cervix normal
Clinical narrative: Since I got my first shot my periods had been getting worse, heavier than before. When i got my booster it all just came back again, I was in a lot of pain with heavier bleeding. The next month at my GYN I told them of my symptoms and they are working to get it under control because my birth control stopped providing the help that it was.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Participant got COVID.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Myalgia
Clinical narrative: Fatigue, muscle aches, brain fog
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Death, Vaccine breakthrough infection
Clinical narrative: covid related death- breakthrough case
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Patient had an ED visit and/or hospitalization within 6 weeks of receiving COVID vaccine.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Insomnia, Nausea, Oxygen therapy
Clinical narrative: Pt stated having common side effects of chills, nausea, diarrhea on the same day for approx 7 hours but on 3/23/22, started having a racing heart rate, not being able to sleep, and had to use her home oxygen
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Pt stated having common side effects of chills, nausea, diarrhea on the same day for approx 7 hours but on 3/23/22, started having a racing heart rate, not being able to sleep, and had to use her home oxygen
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Covid vaccine monitoring documentation. PT admission  1/23/22 ? 1/27/22. COVID-19 vaccine, 0.5 mL (JANSSEN) 03/11/2021 1802068.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chest pain, Dyspnoea, Electrocardiogram, Imaging procedure
Clinical narrative: Patient is fully vaccinated.  COVID positive on 3/12/2022.  ED visit on 3/14.62-year-old male presents the ER complaining of worsening shortness of breath. Positive for chest pain. Imaging: no evidence of acute cardiopulmonary disease.  Medications: fluid, nitrogycerin, asprin. EKG IBM:  NSR at 70; NL intervals;  LAD; No ST elevations. Discharged home.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Injection, Joint swelling, Loss of personal independence in daily activities, Mobility decreased
Clinical narrative: Starting in December, I started experiencing swollen in my left hand. It would come and go but I did not seek medical care right away. I started receiving shots and has started having unexpected knee swollen. I received a ultra-sound to see if there were any blockage and there was no blockage. My left hand got progressively worse over time and I was not able to make a fist or flex my hand. It was also causing nerve pain. I received a diagnosis of rheumatoid arthritis. I was giving a steroid to reduce the swelling. The swelling and nerve pain has not went away. I am unable to perform normal duties because of my hand.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Neuralgia, Peripheral swelling, Rheumatoid arthritis, X-ray
Clinical narrative: Starting in December, I started experiencing swollen in my left hand. It would come and go but I did not seek medical care right away. I started receiving shots and has started having unexpected knee swollen. I received a ultra-sound to see if there were any blockage and there was no blockage. My left hand got progressively worse over time and I was not able to make a fist or flex my hand. It was also causing nerve pain. I received a diagnosis of rheumatoid arthritis. I was giving a steroid to reduce the swelling. The swelling and nerve pain has not went away. I am unable to perform normal duties because of my hand.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: TEMPERATURE EXCURSION. vaccine (covid) was stored in the freezer longer than manufacture recommendations. Patient did not have any adverse reactions.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blood creatinine increased, COVID-19 pneumonia, Lower urinary tract symptoms
Clinical narrative: This 58 year old woman was admitted with covid pneumonia.  She was treated with remdesivir and steroids and is improved.  She is not hypoxic today and her lungs are clear.  She will complete steroids orally.   She did have symptoms of uti.  She will complete antibiotics orally.   She does have ckd.  Creatinine has been about 2.0.  We will arrange follow up with nephrology  outpatient
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rashes head to toe
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Hyperhidrosis, Influenza, Injection site erythema
Clinical narrative: Flu symptoms Fever low grade Sweats  Extreme exhaustion   Swelling of armpit near site and pain -swollen tender lymph that occurred with the first two but worsened with this  3rd shot- quite concerning and painful -primary care doc informed and awaiting reply - no prior abnormal breast exams   Red swollen knot at site of injection with 2 in diameter
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site nodule, Injection site pain, Injection site swelling, Lymph node pain, Lymphadenopathy
Clinical narrative: Flu symptoms Fever low grade Sweats  Extreme exhaustion   Swelling of armpit near site and pain -swollen tender lymph that occurred with the first two but worsened with this  3rd shot- quite concerning and painful -primary care doc informed and awaiting reply - no prior abnormal breast exams   Red swollen knot at site of injection with 2 in diameter
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Oedema peripheral, Pyrexia
Clinical narrative: Flu symptoms Fever low grade Sweats  Extreme exhaustion   Swelling of armpit near site and pain -swollen tender lymph that occurred with the first two but worsened with this  3rd shot- quite concerning and painful -primary care doc informed and awaiting reply - no prior abnormal breast exams   Red swollen knot at site of injection with 2 in diameter
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Back pain, Decreased appetite, Insomnia, Pyrexia
Clinical narrative: Fever ( tactile). back pain , anorexia, insomnia
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: not known, family did not return interview call
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Back pain, Blood pressure systolic increased, Chills
Clinical narrative: First, at about 3:30 p.m. on 3/23 I had my blood pressure taken and it was 130/77. This is the highest blood pressure reading that I have ever had in my entire life. I have never had a systolic number this high and rarely a diastolic that high. By about 5:00 p.m. I could bare lift my left arm. By 9:00 p.m. I began to feel sick to my stomach and had he chills - simultaneously feeling freezing cold and burning hot. I had to be covered in blankets even though the room was 71 Fahrenheit and I was too sick to move or get up from the couch. This continued until about 3:00 a.m. when I moved from the couch to the bed, feeling very weak and like I would throw up. I had severe gas during the night. By about 7:00 a.m. I could move again, and I had diarrhea. Today I feel dehydrated and have muscle soreness, lower back pain, a woozy stomach, and a headache.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Dehydration, Diarrhoea, Feeling of body temperature change, Flatulence, Headache
Clinical narrative: First, at about 3:30 p.m. on 3/23 I had my blood pressure taken and it was 130/77. This is the highest blood pressure reading that I have ever had in my entire life. I have never had a systolic number this high and rarely a diastolic that high. By about 5:00 p.m. I could bare lift my left arm. By 9:00 p.m. I began to feel sick to my stomach and had he chills - simultaneously feeling freezing cold and burning hot. I had to be covered in blankets even though the room was 71 Fahrenheit and I was too sick to move or get up from the couch. This continued until about 3:00 a.m. when I moved from the couch to the bed, feeling very weak and like I would throw up. I had severe gas during the night. By about 7:00 a.m. I could move again, and I had diarrhea. Today I feel dehydrated and have muscle soreness, lower back pain, a woozy stomach, and a headache.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Mobility decreased, Myalgia, Nausea
Clinical narrative: First, at about 3:30 p.m. on 3/23 I had my blood pressure taken and it was 130/77. This is the highest blood pressure reading that I have ever had in my entire life. I have never had a systolic number this high and rarely a diastolic that high. By about 5:00 p.m. I could bare lift my left arm. By 9:00 p.m. I began to feel sick to my stomach and had he chills - simultaneously feeling freezing cold and burning hot. I had to be covered in blankets even though the room was 71 Fahrenheit and I was too sick to move or get up from the couch. This continued until about 3:00 a.m. when I moved from the couch to the bed, feeling very weak and like I would throw up. I had severe gas during the night. By about 7:00 a.m. I could move again, and I had diarrhea. Today I feel dehydrated and have muscle soreness, lower back pain, a woozy stomach, and a headache.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness transient, Blindness unilateral
Clinical narrative: Less than a week after I had a partial vision loss in my left eye that lasted 2-3 hours then it cleared up.
Age: 79.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: Covid vaccine monitoring documentation. PT admission    1/18/22 ? 1/23/22.  COVID-19, mRNA, LNP-S, PF, 30 mcg/0.3 mL dose (PFIZER) 01/29/2021. No lot available.  COVID-19, mRNA, LNP-S, PF, 30 mcg/0.3 mL dose (PFIZER) 02/19/2021. No lot available.  COVID-19, mRNA, LNP-S, PF, 30 mcg/0.3 mL dose (PFIZER) 10/28/2021. Lot FF2593
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abnormal behaviour, Acute left ventricular failure, Blood potassium decreased, Cardiac failure congestive, Computerised tomogram head
Clinical narrative: pt started acting very strange ever since her 1st Covid dose when she developed Edema and insomnia. Her PCP told her to take 80 mg of her Lasix.  After the 2nd Covid dose she started hallucinating, seeing things that were not there and was also hearing things.  She stopped paying her bills and maxed out her credit cards.  She had insomnia and acted like she was in a  psychosis state.  She had to have extra sugar in her diet and couldn't get enough to drink since she was extremely thirsty.   She would paint every thing she could with paint and paint brush acting very oddly.  She had flashing in her eyes and felt like her body was going to explode and would vomit.  She had severe itching and became incontinent.  Her body muscles were twitching and she had swollen lymph nodes.  Her skin hurt to touch.   She went to her PCP and  was given clonidine hcl 0.1 mg told to take Benadryl.  this was not working.  PCP gave her a letter to take to the hospital regarding her odd behavior and symptoms post vaccine.  She was taken to Hospital.  She was given fluid and labs.  Her blood pressure was high.  She was diagnosed with unknown diarrhea,  Insomnia, Edema, Acute Systolic CHF.  She was held in the ER for 5 days until the Psychiatric Hospital could come pick her up. She is still there at this time.  All of these symptoms started post Covid vaccines.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Food craving, Hallucination, auditory, Hallucination, visual, Hypertension
Clinical narrative: pt started acting very strange ever since her 1st Covid dose when she developed Edema and insomnia. Her PCP told her to take 80 mg of her Lasix.  After the 2nd Covid dose she started hallucinating, seeing things that were not there and was also hearing things.  She stopped paying her bills and maxed out her credit cards.  She had insomnia and acted like she was in a  psychosis state.  She had to have extra sugar in her diet and couldn't get enough to drink since she was extremely thirsty.   She would paint every thing she could with paint and paint brush acting very oddly.  She had flashing in her eyes and felt like her body was going to explode and would vomit.  She had severe itching and became incontinent.  Her body muscles were twitching and she had swollen lymph nodes.  Her skin hurt to touch.   She went to her PCP and  was given clonidine hcl 0.1 mg told to take Benadryl.  this was not working.  PCP gave her a letter to take to the hospital regarding her odd behavior and symptoms post vaccine.  She was taken to Hospital.  She was given fluid and labs.  Her blood pressure was high.  She was diagnosed with unknown diarrhea,  Insomnia, Edema, Acute Systolic CHF.  She was held in the ER for 5 days until the Psychiatric Hospital could come pick her up. She is still there at this time.  All of these symptoms started post Covid vaccines.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Incontinence, Insomnia, Lymphadenopathy, Muscle twitching
Clinical narrative: pt started acting very strange ever since her 1st Covid dose when she developed Edema and insomnia. Her PCP told her to take 80 mg of her Lasix.  After the 2nd Covid dose she started hallucinating, seeing things that were not there and was also hearing things.  She stopped paying her bills and maxed out her credit cards.  She had insomnia and acted like she was in a  psychosis state.  She had to have extra sugar in her diet and couldn't get enough to drink since she was extremely thirsty.   She would paint every thing she could with paint and paint brush acting very oddly.  She had flashing in her eyes and felt like her body was going to explode and would vomit.  She had severe itching and became incontinent.  Her body muscles were twitching and she had swollen lymph nodes.  Her skin hurt to touch.   She went to her PCP and  was given clonidine hcl 0.1 mg told to take Benadryl.  this was not working.  PCP gave her a letter to take to the hospital regarding her odd behavior and symptoms post vaccine.  She was taken to Hospital.  She was given fluid and labs.  Her blood pressure was high.  She was diagnosed with unknown diarrhea,  Insomnia, Edema, Acute Systolic CHF.  She was held in the ER for 5 days until the Psychiatric Hospital could come pick her up. She is still there at this time.  All of these symptoms started post Covid vaccines.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Oedema, Pain of skin, Photopsia, Pruritus
Clinical narrative: pt started acting very strange ever since her 1st Covid dose when she developed Edema and insomnia. Her PCP told her to take 80 mg of her Lasix.  After the 2nd Covid dose she started hallucinating, seeing things that were not there and was also hearing things.  She stopped paying her bills and maxed out her credit cards.  She had insomnia and acted like she was in a  psychosis state.  She had to have extra sugar in her diet and couldn't get enough to drink since she was extremely thirsty.   She would paint every thing she could with paint and paint brush acting very oddly.  She had flashing in her eyes and felt like her body was going to explode and would vomit.  She had severe itching and became incontinent.  Her body muscles were twitching and she had swollen lymph nodes.  Her skin hurt to touch.   She went to her PCP and  was given clonidine hcl 0.1 mg told to take Benadryl.  this was not working.  PCP gave her a letter to take to the hospital regarding her odd behavior and symptoms post vaccine.  She was taken to Hospital.  She was given fluid and labs.  Her blood pressure was high.  She was diagnosed with unknown diarrhea,  Insomnia, Edema, Acute Systolic CHF.  She was held in the ER for 5 days until the Psychiatric Hospital could come pick her up. She is still there at this time.  All of these symptoms started post Covid vaccines.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Psychotic disorder, SARS-CoV-2 test negative, Sensory disturbance, Thirst
Clinical narrative: pt started acting very strange ever since her 1st Covid dose when she developed Edema and insomnia. Her PCP told her to take 80 mg of her Lasix.  After the 2nd Covid dose she started hallucinating, seeing things that were not there and was also hearing things.  She stopped paying her bills and maxed out her credit cards.  She had insomnia and acted like she was in a  psychosis state.  She had to have extra sugar in her diet and couldn't get enough to drink since she was extremely thirsty.   She would paint every thing she could with paint and paint brush acting very oddly.  She had flashing in her eyes and felt like her body was going to explode and would vomit.  She had severe itching and became incontinent.  Her body muscles were twitching and she had swollen lymph nodes.  Her skin hurt to touch.   She went to her PCP and  was given clonidine hcl 0.1 mg told to take Benadryl.  this was not working.  PCP gave her a letter to take to the hospital regarding her odd behavior and symptoms post vaccine.  She was taken to Hospital.  She was given fluid and labs.  Her blood pressure was high.  She was diagnosed with unknown diarrhea,  Insomnia, Edema, Acute Systolic CHF.  She was held in the ER for 5 days until the Psychiatric Hospital could come pick her up. She is still there at this time.  All of these symptoms started post Covid vaccines.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abnormal behaviour, Cognitive disorder, Confusional state, Neurological symptom
Clinical narrative: pt started acting very strange ever since her 1st Covid dose when she developed Edema and insomnia. Her PCP told her to take 80 mg of her Lasix.  After the 2nd Covid dose she started hallucinating, seeing things that were not there and was also hearing things.  She stopped paying her bills and maxed out her credit cards.  She had insomnia and acted like she was in a  psychosis state.  She had to have extra sugar in her diet and couldn't get enough to drink since she was extremely thirsty.   She would paint every thing she could with paint and paint brush acting very oddly.  She had flashing in her eyes and felt like her body was going to explode and would vomit.  She had severe itching and became incontinent.  Her body muscles were twitching and she had swollen lymph nodes.  Her skin hurt to touch.   She went to her PCP and  was given clonidine hcl 0.1 mg told to take Benadryl.  this was not working.  PCP gave her a letter to take to the hospital regarding her odd behavior and symptoms post vaccine.  She was taken to Hospital.  She was given fluid and labs.  Her blood pressure was high.  She was diagnosed with unknown diarrhea,  Insomnia, Edema, Acute Systolic CHF.  She was held in the ER for 5 days until the Psychiatric Hospital could come pick her up. She is still there at this time.  All of these symptoms started post Covid vaccines.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Asymptomatic COVID-19, Cardiac arrest, Chronic kidney disease, Death
Clinical narrative: hx of metastatic ovarian CA, DMT2; admitted with poor oral intake, N/V, acute renal failure on chronic kidney disease, esophageal dysphagia; positive test for COVID, asymptomatic; poor prognosis; DNR; experienced hypoxia and hypotension; sudden asystole and pt passed away in the hospital
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Hypophagia, Hypotension, Hypoxia, Nausea
Clinical narrative: hx of metastatic ovarian CA, DMT2; admitted with poor oral intake, N/V, acute renal failure on chronic kidney disease, esophageal dysphagia; positive test for COVID, asymptomatic; poor prognosis; DNR; experienced hypoxia and hypotension; sudden asystole and pt passed away in the hospital
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Vomiting
Clinical narrative: hx of metastatic ovarian CA, DMT2; admitted with poor oral intake, N/V, acute renal failure on chronic kidney disease, esophageal dysphagia; positive test for COVID, asymptomatic; poor prognosis; DNR; experienced hypoxia and hypotension; sudden asystole and pt passed away in the hospital
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Injection site discomfort, Injection site muscle weakness
Clinical narrative: About 4 hours after getting the vaccine that day I felt severe pain in my arm, chills, headache and fever. The next day I had more pain in my arm and at night I had an episode of diarrhea, nasal congestion for a week, and over the months the pain has intensified and is more frequent. I got COVID on January 20, 2022 and the headaches were bad. Now in my left arm I feel like ants and it feels weak.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pain in extremity, Pyrexia
Clinical narrative: About 4 hours after getting the vaccine that day I felt severe pain in my arm, chills, headache and fever. The next day I had more pain in my arm and at night I had an episode of diarrhea, nasal congestion for a week, and over the months the pain has intensified and is more frequent. I got COVID on January 20, 2022 and the headaches were bad. Now in my left arm I feel like ants and it feels weak.