chrisvoncsefalvay/vaers-outcomes huggingface dataset:
33yr old woman with a history of endometriosis, and history of "throat closing" with ingestion of ginger, treated with Benadryl.   History of adverse reaction to narcotics, but unable to specify which medications or how reactions were treated or how long ago.  Patient does not carry an epi pen for her history of reactions. Stated had tolerated flu vaccine in 2019, but had an adverse reaction 10 years prior to that. Approximately 15 minutes after receiving the vaccine, patient developed nausea, followed by tightness in chest and then vomiting.  Patient reported she was feeling very anxious.  911 was called.  Exam:  Vital signs : BP-138/76, P-95, O2 96% on RA, RR 24-26 Patient was alert and oriented, able to provide fiance's contact information.  No hives, no angioedema.  No stridor or wheezing, but continued to report chest tightness. Patient vomited during evaluation.   Intervention: Epinephrine 0.3mg IM was administered and patient was taken to ER for further evaluation and care.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age. The patient's pertinent medical history, drug reactions and allergies were not reported. Concomitant therapies included ENBREL which the patient started in approximately 27-SEP-2017 (also reported as "two weeks before"). On 11-OCT-2017, the patient was vaccinated with ZOSTAVAX lot # N009777 with an expiration date 04-MAR-2018 for prophylaxis. (Dose, route of administration an anatomical location were not reported) which was reconstituted with sterile diluent lot# L037794 with an expiration date 03-MAY-2018. There was no side effects reported.
Fever, intense seizure for 10 min causing blackout, lost feeling in face and three toes, still can't feel 3 toes, lost consciousness.
Right eyebrow twitch, twitch in bridge of my nose, brow and right ear.; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 03Apr2021(at the age of 52-year-old) as a single dose for COVID-19 immunization. Medical history included psoriasis and high cholesterol. Concomitant medications included adalimumab (HUMIRA) for unknown indication from an unknown date. The patient's past drug history was reported as no. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 04Apr2021, the patient experienced right eyebrow twitch since the day after receiving vaccine. The patient sometimes felt the twitching in the bridge of the nose, brow and right ear. Twitching lasts just for few seconds and sometimes every five minutes or longer in between, but throughout the day for over 4 weeks. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event facial twitching was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Employee feels like injection was not given in the right location. Employee stated she had dysfunction and shoulder pain.  Employee received another vaccine within 30 days of this incident occurring in the same arm. Employee reported incident 3 months later after making appointment with her PCP. She was given steroid injection on 12/20/21.
she had pain in arm, SOB, throat closing, and lightheaded.; she had pain in arm, SOB, throat closing, and lightheaded.; she had pain in arm, SOB, throat closing, and lightheaded.; she had pain in arm, SOB, throat closing, and lightheaded.; This is a spontaneous report from a contactable consumer.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route, as dose 1 at a single dose for COVID-19 immunisation. The patient's medical and Concomitant medications was not reported. on an unspecified date the patient experienced pain in arm, SOB, throat closing, and lightheaded after the first dose of vaccine. pain in arm, SOB, throat closing, and lightheaded. The outcome of events was reported as recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I was giving the baby her immunizations.  I accidentally gave the Rotovirus vaccine as injectable instead of oral.  I spoke to the provider and my supervisor right away.  The provider went and spoke to the parents and I was not aware of any reaction at the time.  Patient will be coming back to get the oral rotavirus.
Extreme muscle weakness beginning 48 hours after second Pfizer shot.  Confusion and slurring of some words.  Difficulty walking.  Still experiencing mild symptoms almost one week after the second shot.
This is a spontaneous report from a contactable physician through a Pfizer sales representative with follow-up from the contactable physician. A four-year-old female patient was administered a dose of PREVNAR intramuscularly in the right leg on 19Apr2011. A dose of DTAP was also administered intramuscularly in the same right leg on 19Apr2011. Relevant medical history was not reported. Concomitant medications were not used. Other illnesses were not reported. On 20Apr2011, the patient experienced local swelling on the vaccinated leg of 13 to 14 cm area, described as local reaction to vaccines. The patient returned to the doctor's office on 21Apr2011, and a physical examination confirmed the swelling. The outcome was unknown. The physician reported that she had noticed an increase in the number of large local reactions with PREVNAR 13 in children greater than 3.5 years-old, and questioned what would be the reason for a more elevated local reaction. Follow-up (14Jun2011): This spontaneous follow-up report from a contactable physician included: patient demographics, suspect product and administration date, description of event, event onset date, resolution unknown, concomitant medications not used, no medical history, physician comments.
Janssen COVID-19 Vaccine EUA 4/8/21 @ 3pm - extreme fatigue  4/8/21 @ 9pm - extreme fatigue and full body muscle soreness and pain 4/9/21 @ 3am - extreme fatigue, extreme full body muscle pain, and fever with chills 4/9/21 @ 7:30am - extreme fatigue, extreme left arm pain, full body fatigue, extreme migraine, fever with chills and nausea  4/9/21 @ 10:30am - fatigue, extreme left arm pain, migraine, chills, diarrhea, nausea and body aches
she experienced cardiac arrest; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 47 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Sep2021 17:00 (Lot number: FC3181) at the age of 47 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:1, Lot Number: FC3182, Anatomical Location: Left arm), administration date: 04Sep2021, when the patient was 47 years old, for COVID-19 Immunization. Prior Vaccinations (within 4 weeks): None. AE(s) following prior vaccinations: None. The following information was reported: CARDIAC ARREST (hospitalization, medically significant) with onset 11Oct2021, outcome "recovering", described as "she experienced cardiac arrest". The patient was hospitalized for cardiac arrest (start date: 11Oct2021, discharge date: 19Oct2021, hospitalization duration: 8 day(s)). The event "she experienced cardiac arrest" was evaluated at the emergency room visit and Physician Office: Unknown. She was admitted on 11Oct2021 and was in the ICU for 4 days and they had some therapies. They put her into sedation and put her in hypothermia for 24 hours and then spent the next 24 hours bringing her out of that. They did not know if she was going to have any side effects from that or if she would even make it. But she came through and then they inserted a defibrillator because they do not know why her heart stopped. They said she has strong heart and healthy, there was no blockage or nothing. On 18Oct2021 she had the AICD implanted and then on 19Oct2021 she was discharged. They do not suspect her to be fully recovered until probably 6 months or so because it was a major event. Investigation Assessment: No. Patient was advised to inform Pfizer, as there was no reason for her going into cardiac arrest and it was roughly 2 weeks after she had that 2nd dose so the doctor's advised them to inform Pfizer. The patient underwent the following laboratory tests and procedures: investigation: (Oct2021) it was clear, notes: They tested to see if it was a widow maker heart attacked and it was clear. there was no blockage to suggest heart attack; resuscitation: (Oct2021) performed cpr for an hour. Therapeutic measures were taken as a result of cardiac arrest.
About 5 minutes after vaccine was administered patient felt dizzy and nauseated and proceeded to vomit.  Once an ice pack was applied to back of neck symptoms subsided over the next 5 to 10 minutes and patient returned home.
21JUN95 cried hard about 2 1/2 hr; 23JUN95 knot in lt thigh over site of inj; no redness, no fever; resolving;
On the morning February 22nd I was outside with my family in our backyard. I was checking our plant when I started to feel that I needed to sit down. By the time I sat down, I realized I had no feeling or use from the left side of my body including my face. I also had trouble communicating. Could not form complete sentences. The entire left side of my face was drooping. At that moment my husband immediately called 911.  I was taken to the hospital by ambulance where i was immediately treated and diagnosed with a stroke. They administered TPA. I spent 3 days in the ICU. I have since been treated with blood pressure medication, blood thinners and statins.
I got the vaccine at the Pharmacy at 11:30-11:40, I went home following the vaccine to make lunch for my kids. I started to feel a tingling sensation in my left cheek. Swelling was present minor . The main symptom was that I lost feeling in my left cheek, top portion of my lip , by my ear and above my left eye. I went to urgent care who were worried about a stroke, I passed a neuro exam and was advised to go to the ER to get testing. I arrived at Medical center who did another neuro exam and said it was possible it is an allergic reaction but they can not say for sure due to the fact that there was no other markings.
Approximately 10 minutes after PROQUAD was given and before pt left the office, pt became agitated, developed facial swelling, hives and vomiting. Within 3-5 minutes pt began wheezing.  EPIPEN Jr. 0.15 mg in 0.3 ml was administered IM in Left thigh. Oxygen was administered. Some relief noted but within 5 minutes pt became more agitated and hives continued to develop on his face. The 2nd EPIPEN Jr. 0.15 mg in 0.3 ml was administered IM in right thigh. EMS had been called and was present for 2nd EPIPEN injection. Pt was then transported via ambulance to Hospital and later transferred to another Hospital for overnight observation. In the ER pt received one adult IM EPIPEN 0.3 mg in 0.3 ml dose, IV SOLU-MEDROL, PEPCID and normal saline bolus x2.
This spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown ages and genders. There was no information about patient's concomitant medications, drug reactions/allergies and pertinent medical history reported. On unknown dates, the patient were vaccinated with an improperly stored dose of GARDASIL 9; lot numbers reported as M041990 and M040412, with expiration dates of 28-JUN-2019 and 30-JUN-2019 respectively; (dose, route and anatomical location were not reported) for prophylaxis. The vaccines were exposed to temperature excursion of 47 Fahrenheit (F) to 77 Fahrenheit (F) during 10 hours and 12 minutes. There were no previous temperature excursions. The call was because of a "data logger". No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1703USA011175: US-009507513-1703USA011176: US-009507513-1703USA011177: US-009507513-1703USA011178:
pt had fever of 101.0 8MAY95 @ 630 c/o pain in both arms 9MAY95 in AM; 9MAY95 rash noted in both arms & t101.0; raised rash remains on both arms & red spot;60 cc long noted on lt arm;
Child vaccinated with H1N1 flu vaccine at her elementary school. Began to itch on back both arms, and head. Rash appeared on body. EMS indicated - 12:50 pm paramedics arrive: 4 ml BENADRYL (50 mg, 2 ml Epinephrine 1:000 cc).
Patient became limp upon the administration of the fourth vaccine, nonresponsive, slumped in chair,pale color. ammonia ampule immediately used, patient immediately responded,alert,color improved(pink), able to sit, drink juice, talk. Episode lasted about 10 seconds. Left DOH talking,alert, walked to car.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  HYPOTENSION RESPIRATORY FAILURE, UNSPECIFIED ACUITY
Narrative:  92yo male patient died on 10/25/2021. Last facility note signed on 4/15/21 regarding PCC unable to reach pt to schedule appointments. No info available regarding pt's death. Pt did receive one covid vaccine on 1/14/2021. Likely vaccines not related to pt's death given pt's age and length of time between date of vaccines given & date of pt's death.
Fever 99.7, chills, weakness, trouble focusing, HR 116, BP 165/72
second immunization for COVID on Wednesday and has developed symptoms of fever, sore joints and muscles, fever, itching at the injection sight, and she said swelling. In addition to the symptoms she complained of a sore throat.
Vertigo; nauseous; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), VERTIGO (Vertigo) and NAUSEA (nauseous) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 003B21A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (sulfa), Drug allergy (Codeine), Drug allergy (Percocet), Drug allergy (Demerol), Blood pressure high, Hypercholesteraemia and Anxiety. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Anxiety, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE & HCTZ) from an unknown date to 27-Apr-2021 for Blood pressure high, ROSUVASTATIN CALCIUM for Cholesterol blood excessive, VITAMIN C [ASCORBIC ACID] from 18-Mar-2020 to 28-Feb-2021 and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.   On 03-Mar-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced DIZZINESS (dizziness) and NAUSEA (nauseous). On an unknown date, the patient experienced VERTIGO (Vertigo). The patient was treated with POTASSIUM for Potassium supplementation, at an unspecified dose and frequency. On 06-May-2021, DIZZINESS (dizziness) and NAUSEA (nauseous) had resolved. At the time of the report, VERTIGO (Vertigo) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Apr-2021, Blood potassium: low (Low) low. On 18-Apr-2021, Computerised tomogram head: normal (normal) normal. On 18-Apr-2021, Computerised tomogram neck: normal (normal) normal. On 18-Apr-2021, Electrocardiogram: normal (normal) normal.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Patient's demographics, medical history were updated, lab test was added,  Second dose information was added and Concomitant products added, event outcome for nausea and vertigo were updated from unknown to recovered and vertigo was added and treatment medication specified.
2nd dose Hep A gave before 6 months from 1st  HepA.  Invalid dose due to given too early. Client will need third dose 6 months from today. Parent notified child will need an additional Hep A in 6 months.
Paxlovid indication=Treatment of COVID-19; Paxlovid indication=Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 20Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Paxlovid indication=Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be excluded
Pt was given vaccine on 1-10-13 and the next day developed redness, swelling, and extreme tenderness to the left arm from deltoid to elbow. Symptoms subsided after several days.
Slight Headache; Extreme Chills; Fever was 101; Weakness in my body was to the point where I  could not get up; This is a spontaneous report from a contactable consumer (patient himself). A 61-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0171; Expiration Date: unknown) via an unspecified route of administration on 22Apr2021 (at the age of 61-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included diabetes mellitus and hypertension from an unknown date and unknown if ongoing. Concomitant medications included lisinopril (LISINOPRIL) taken for hypertension and insulin (INSULIN) taken for diabetes mellitus. It was reported that patient had taken the first shot of Pfizer vaccine and he just wanted to report that 24 hours after the shot he had the adverse reactions. On 23Apr2021 he had extreme chills, fever was 101, the weakness in his body was to the point where he could not get up, slight headache. The patient underwent lab tests and procedures which included glycosylated haemoglobin (A1C): 11 on 22Apr2021 and pyrexia: normal on 23Apr2021. The outcome of all events was unknown. No follow-up attempts are needed. No further information is expected.
Tachycardia. Patient had SVT prior to. She underwent ablation had had resolution of symptoms. 5 days after her procedure she got her second dose and has had tachycardia and racing of the heart since with HR ranging from 50s-13-s. Her hands have been turning red and has to sit down due to feeling dizzy. She also now has swelling in her hands and feet.
pt was in the hospital for COVID pneumonia from 1/29 - 2/19/22; 2/20/22 pt had a positive COVID test; pt dc'd to rehab; while in rehab, pt had nausea, vomiting, diarrhea, and hypotension; 2/21/22 taken back to hospital; admitted with sepsis, AHRF; placed on mechanical ventilation; A Fib with rapid ventricular response; vasopressors for shock; respiratory culture grew mold, treated with medication; tube feedings; family decided to withdraw support and pursue comfort measures; pt passed away in the hospital
Post flu shot reported feeling anxious, pressure in the back of her head, lightheaded and chest pressure. Blood pressure = 160/110. 911 called and transported to hospital.
Patient is fully vaccinated.  COVID + on 12/26/2021 at ED visit. 28 year old female who presents to the EC for evaluation of shortness of breath. Patient states she went to bed last evening "not feeling right'". States woke up with 101 degree oral temperaturs, chills, and difficulty in breathing. States having a difficult time catching her breath. States then had bilateral hand cramping. States felt extremley anxioius. Went to the UC where she was instructed to present to the EC for further evaluation. CXR: no acute process. Treatment:  xanax and fluid. Discussed monoclonal ab therapy. Patient told to return to ED for any worsening symptoms. Discharged home.
pt recvd vax; cardiac arrest w/ VF several hrs later; in hosp pt unconscious;
Patient states her left arm is swollen and red where the vaccines were administered. The Pharmacist recommended a cold compress along with taking Tylenol and Aleve or Motrin. Patient is to monitor symptoms. It doesn't improved in 24 to 48 hours, she needs to follow up with PCP.
expired Tenivac was accidentally administered to a patient, with no reported adverse event; Initial information received on 10-Jun-2021 regarding an unsolicited valid non-serious case from a nurse practitioner (under reference id 00636554).  This case involves a 14 years old female patient who was accidentally administered with 0.5 ml expired dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (booster, lot number U6187AA and expiration date: 06-Feb-2021) via an unknown route in the right deltoid for prophylactic vaccination on 10-Jun-2021 at 13:15 (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No other vaccines were given to the patient.  It was a case of an actual medication error due to expired vaccine used (same day latency).   Reported that caller would like to find out about next steps.    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.