chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe weakness and inability to walk and prompted an emergency room visit after an ambulance ride.  Fever and a mild rash also noted.   Weakness has lasted approx. 9 so far, fever has diminished.
LPN accidentally gave an adult Hepatitis B to a 19 yr old woman, and she was supposed to receive and adult Hepatitis A vaccine to complete her series. Patient was notified and correct vaccine (adult Hep A) was given after the event.
Information has been received from a licensed practical nurse concerning a 5 year old female who on 18-OCT-2001 was vaccinated with a dose of Varivax (lot # 637667/1606K). On 27-MAR-2006 the patient was diagnosed with chickenpox. Unspecified medical attention was sought. There was no product quality complaint involved. Follow-up information from the nurse indicated that all the information on the varicella vaccine and the chickenpox was submitted. No further information is available.
Patient reported tightness in her jaw muscles & tingling along her jawline within 10 minutes of receiving the COVID vaccine. Fifty mg of liquid diphenhydramine was administered & the patient was monitored for another 45 minutes. She reported her symptoms slowly improved over time. No throat or tongue swelling was reported at any time.
At time of delivery, patient pointed out to a 'bump'. She was observed for further complications before discharge. She called back (as instructed) Friday, and said her "redness" was not abating. Saturday, I called her to pharmacy to physically inspect. The redness and swelling was localized. She had no fever, spreading, no breathing issues, no itching, uticaria, but area was warm to touch. I guided her through BENADRYL (25mg) and Aspirin (325mg) therapy and cold compress. This morning she came in and the redness was spreading tad bit more, and area was hot. No other discomfort nor systemic issues. Asked her to watch for breathing and other responses. Gave her my cell phone number, to call me at all times should anything come up. Also gave her some topical BENADRYL and hydrocortisone to aid in the local response, plus her aspirin and antihistamine oral therapy. Thanks!
Moderna vaccine was administered - reported by patient  HYPOTENSION 12/9/2021 ATHEROSCLEROSIS OF AORTA ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/9/2021 ATHEROSCLEROSIS OF AORTA CHRONIC HYPOXEMIC RESPIRATORY FAILURE 11/5/2021 ATHEROSCLEROSIS OF AORTACARDIOGENIC SHOCK 12/9/2021 ATHEROSCLEROSIS OF AORTA HYPOTENSION 12/9/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED ACUTE RESPIRATORY FAILURE 12/17/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/9/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED CHRONIC HYPOXEMIC RESPIRATORY FAILURE 11/5/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED CARDIOGENIC SHOCK 12/9/2021 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED HYPOTENSION 12/9/2021 DIVERTICULOSIS OF SIGMOID ACUTE RESPIRATORY FAILURE 12/17/2021 DIVERTICULOSIS OF SIGMOID ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/9/2021 DIVERTICULOSIS OF SIGMOIDCHRONIC HYPOXEMIC RESPIRATORY FAILURE 11/5/2021 DIVERTICULOSIS OF SIGMOID CARDIOGENIC SHOCK 12/9/2021 DIVERTICULOSIS OF SIGMOID HYPOTENSION 12/9/2021 DYSPHONIA ACUTE RESPIRATORY FAILURE 12/17/2021 DYSPHONIA ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/9/2021 DYSPHONIA  CHRONIC HYPOXEMIC RESPIRATORY FAILURE 11/5/2021 DYSPHONIA CARDIOGENIC SHOCK 12/9/2021 DYSPHONIA HYPOTENSION 12/9/2021 PALLIATIVE CARE ACUTE RESPIRATORY FAILURE 12/17/2021 PALLIATIVE CARE ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/9/2021 PALLIATIVE CARE CHRONIC HYPOXEMIC RESPIRATORY FAILURE 11/5/2021 PALLIATIVE CARE CARDIOGENIC SHOCK 12/9/2021 PALLIATIVE CARE
Chills, fever, muscle aches, joint pain, headache, nausea injection site swelling, itching and pain, tiredness, hyperglycemia, nausea
Severe muscle pain and tightness throughout body, kept me up all night   High fever and chills alternating  Sensation of tightening burning  skin Pounding headache  Did not have access to Tylenol that time of night and could not drive in my condition so I used Ibuprofen to relieve the pain. It helped for a few hours
patient past 42 days for second shot; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient past 42 days for second shot) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient past 42 days for second shot). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient past 42 days for second shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.
covid-19; Myalgia; Fever; cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough), COVID-19 (covid-19), MYALGIA (Myalgia) and PYREXIA (Fever) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Unipolar depression. Concomitant products included LITHIUM CARBONATE for Unipolar depression, CLONAZEPAM for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced COUGH (cough), MYALGIA (Myalgia) and PYREXIA (Fever). On 17-Jan-2021, the patient experienced COVID-19 (covid-19). On 20-Jan-2021, PYREXIA (Fever) had resolved. At the time of the report, COUGH (cough), COVID-19 (covid-19) and MYALGIA (Myalgia) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, Body temperature: 100.7 up to 100.7 degree Farenheit. On 17-Jan-2021, COVID-19: (Positive) going to be administered with monoclonal antibody infusion to treat his covid.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient also uses medications to treat his blood pressure. he mentioned he was going to be administered with monoclonal antibody infusion to treat his covid. on 22Jan2021 He took ibuprofen to treat his symptoms from 15Jan2021 to 21Jan2021.
No additional AE reported.; 17 year old consumer received PROQUADand VARlVAX concomitantly.; 17 year old consumer received PROQUAD and VARlVAX concomitantly.; This spontaneous report, received from a 17 year old patient, referring to himself. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies was provided.  On 19-FEB-2021, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) for prophylaxis and concomitantly received a dose of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (dose, route of administration, frequency, lot/batch # and expiration date were not reported) (inappropriate schedule of product administration and overdose). No additional AE reported.
RASH ON FRONT OF BOTH ARMS, LEGS,CHEST AND STOMACH; SORE ARM; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, and other pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 01-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 01-SEP-2021, the patient experienced sore arm. On 05-SEP-2021, the patient experienced rash on front of both arms, legs, chest and stomach. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm and rash on front of both arms, legs, chest and stomach was not reported. This report was non-serious.
Information has been received from a health NP concerning a 57 year old female, who on 4/18/01, accidentally received pneumococcal vaccine 23 polyvalent IV with renal failure and receiving dialysis 3 times a week for several years. The reporting NP stated that the pt was receiving dialysis and was scheduled to received several medications including epotin alfa (Epogen) and peucalcitol (Zemplar) during her dialysis. The pt was also scheduled to be vaccinated with pneumococcal vaccine 23 polyvalent since her last vaccination was in 9/94. It was reported that the nurse picked up the pneumococcal vaccine 23 polyvalent and administered the medication IV. The NP stated that the epotin alfa syringe and the pneumococcal vaccine were in the same size syringe. Subsequently, on the same day, 4/18/01, the pt experienced chest pain and was admitted to the hospital. A stress test was positive and results from an angiogram is still pending. Subsequently, the pt recovered from chest pain and on 4/24/01 was discharged from the hospital. On 4/25/01, the pt was in for a dialysis treatment. Additional information has been requested.
Pt given Varivax in 1997. Pt developed mild case of varicella Sept 1999.
Redness at injection site, arm aches all over. Patient reports nausea and vomiting beginning 12 to 18 hours post vaccination.
Pt experienced swelling and redness measuring 5 x 3 cm in the right arm for 72 hours.
Mother refers that the infant presented diarrhea (stools with blood) for 3 instances.
Fever 102 F, severe body aches, extreme joint pain, sharp muscle/tissue pain,  heavy fatigue, severe headache  Outcome: constant joint pain throughout body and extreme fatigue and insomnia
Vomiting about 17 hours after shot; pressure in ears; aches; chills; This is a spontaneous report from a contactable other hcp reporting for herself. A 51-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration on the left arm on 23Jan2021 15:00 at a SINGLE DOSE for covid-19 immunisation.  Medical history included vertigo from an unknown date and unknown if ongoing, food intolerance to raw eggs, red dye and bag lettuce from an unknown date and unknown if ongoing.  Concomitant medication included ibuprofen (ADVIL [IBUPROFEN]) and paracetamol (TYLENOL). The patient previously had the first dose of the vaccine on 06Jan2021 (lot number: EK5730). On 24Jan2021 09:30 AM, the patient experienced vomiting about 17 hours after shot. Also, pressure in ears and like many others aches and chills. No treatment was received for the events. The outcome of the event was recovering.
Headache, Arthralgia, NauseaVomiting, chills, sweating Narrative:  Other Relevant History:
The patient received Td vaccination on 2/5/07 in his left deltoid due to an eye injury at work. The patient developed pain in his neck behind his left ear which radiated down his left arm, into his chest and down his left leg. The patient saw his family doctor on 2/12 and was referred to a neurologist on 2/12. The neurologist prescribed Flexeril. Follow-up from 05/08/08. Adverse event onset date was 02/05/07; patient no longer attends the doctor's office, patient's recovery status remains unknown.
Congestion, fever, chills, muscle/body aches, headaches, severe nausea, cough, runny nose, sore throat
Patient was 2 at time of immunization - quadracel is 4-6 years. No other adverse effects presented.
No additional AEs were reported; patient received improperly stored vaccine; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. Information about concomitant medications, concurrent conditions, allergies and medical history was not provided.  On 08-MAR-2022, the patient was vaccinated with 1 dose of improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live rHA (PROQUAD), lot# U022729, expiration date: 16-JAN-2023 (route of administration not provided) for prophylaxis (improper storage of product in use). The vaccine was improperly stored at 13 degrees Fahrenheit (F) for 4 hours. No previous temperature excursions. Data logger was not used to capture the temperature excursion.
Large (about 3 in diameter) red, hot, raised and itchy mark on arm around injection site
Patient came into the clinic today for a COVID Vaccine.  He filled out his form. He stated on the form and verbally that he had not had a COVID Vaccine.  He requested Pfizer. After vaccine was administered, it was noted that he already had a Moderna vaccine on 06/08/2021.  As of the time of filling out this form, he had no reaction or adverse event related to receiving the Pfizer.
About 2 hours after first pfizer shot, had a solid rash on chest, and red dots on stomach.  Took 50mg of benadryl and went to bed.  By 9pm, rash was gone, but later had itching in middle of night.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Patient was feeling paralized. However, we can cleary see the patient moving all his extremities-Mild, Systemic: Headache-Mild, Systemic: Weakness-Mild
Pfizer COVID vaccine incorrectly diluted with 0.9% normal saline in multi-dose vial with preservative. Correct diluent should be 0.9% normal saline in single-dose vial without preservative. When Pfizer was called at store level, they were not able to give any information on anything other than the single-use vials that were studied. Called the morning of 8/3/21 and on the medical team at Pfizer who gave the same information. She was able to say that the reason Pfizer wants medical providers to use the single-use vials is so that there is no cross contamination from puncturing the vial multiple times to dilute multiple vaccine vials. The multi-dose vials that were used were only punctured once so no risk of contamination. Considering this a valid dose still since the vaccine was still diluted and administered with normal saline.
cardiac arrhythmia; mental disorientation; dizziness; loss of balance; This is a spontaneous report from a contactable physician (patient). This 33-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 07Jan2021 14:30 for COVID-19 immunisation. The first dose was on 10Dec2020, 02:30 PM in left arm. Medical history was not reported. There was no known allergies. There was no covid prior vaccination, no covid tested post vaccination. There was no concomitant medication taken. There was no other vaccine in four weeks, no other medications in two weeks. Patient was healthy with no medical issues. Within 2 weeks of second shot, patient developed a cardiac arrhythmia on 21Jan2021 10:30 when she was at work. Patient had continued symptoms of irregular heart beat since then. Patient had had to go to the ED 2 times. Patient was now following with EP cardiology, treated with beta blockers. About 3 weeks after vaccine (in 2021), patient also developed mental disorientation, dizziness and loss of balance. Patient had had MRI brain, Holter monitoring, event monitoring, stress test and cardiac MRI, all with unknown results. Finally patient was on medications and 3 months later beginning to feel a bit better. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care; assessed as life threatening illness (immediate risk of death from the event), disability or permanent damage. The outcome of events was resolved with sequel.  Information about lot/batch number has been requested.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between reported events and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely 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.
New onset joint pain, achy and fatigued. Monitored symptoms has not resolved seen at PCP now have Positive AHA, CRP and sent to Rheumatology
Extreme pain at the injection site and unable to lift my arm. Believe shot was not administered properly - into bursa sac and not the  muscle
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "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.
Immediately after injection clioent felt dizzy and left arm went numb. She does suffer from anxiety and Wellbutrin was due at 3pm. BP 118/78 hr 102, pulse ox 98%. Observed for 30 minutes, numbness had subsided and dizziness
Swollen arm (2 days)  Fever (1.5 days)   chills (1.5 days)   extreme tiredness (2 days)  muscle pain (2 days)  and headache (1.5 days)
Temp to 100.3 days after administration. Pain/redness/swelling involving all of upper arm where vaccine injected into deltoid. Limited history and very poor English.
numbness in lips and mouth, nausea, swelling of arm, large rash following swelling, itching following swelling, severe headache,
Child developed facial hives approximately 3 hours after vaccine administration. Advised to administer Benadryl Q6 hours and call office tomorrow if not resolved. Seek emergency care if oral/throat swelling or difficulty breathing occurs.
I had tenderness of my underarm and under my breast area, a few days later I also noticed an abscess an inflammation with redness. I called telehealth and was prescribed antibiotics Cephalexin for seven days which I received improvement from but it did not fully resolve the issue.
On Jan. 13th, I had stomach pain and it was hard to concentrate at work. I started getting a bad headache on the 14th when I was at work as well. I spoke to a nurse and they told me to monitor my symptoms. I felt fine on the 16th though. On the 25th, I experienced stomach pain again. I was also coughing and had a dry cough, throat clearing, and diarrhea. Later after work, I spoke to my Primary Care doctor and then I talked to my employee health provider. I was told to not return to work and then I took a Covid-19 test on the 26th. The test came back negative. I was cleared to return back to work. On Feb. 3rd, I did take additional tests at Medical Center. My dietician did state some of my symptoms could be related to high Fodmap.
within 5 minutes, became light headed and very sweaty. blood pressure 78/50 taken twice on our automatic cuff. got pale, felt weak. got some color back by the time the medics arrived.
Got Covid at 12 weeks pregnant. Got the vaccine on a Saturday at 27 weeks of pregnancy. 1am Sunday  I got chills, nausea, body aches and joint aches and high heart rate even when resting according to my Apple Watch and Head ache. Symptoms lasted all day Sunday. Monday symptoms subsided and were gone.
This spontaneous report was received from a health care worker refers to a male patient of unknown age. On approximately 05-DEC-2014 (reported as last week) the patient was vaccinated with PNEUMOVAX 23 lot # K004483, expiration date: 16-AUG-2015 (strength, route of administration and dose were not reported) simultaneously with a dose of FLUZONE and ADACEL. On approximately 05-DEC-2014 (reported as last week) the patient experienced convulsion, uncontrollable movements and muscle rigidity for about an hour and a half, following the administration of the vaccines. The reporter requested lot check. The outcome of the events was reported as recovered/resolved on unknown date in December 2014. Upon internal review, convulsion was determined to be medically significant. Additional information has been requested.
Information has been received from a male consumer referring to himself of unknown age. The patient's medical history, concomitant therapy and concurrent condition were not provided. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 and PREVNAR 13 concomitantly. No adverse experience was reported. Additional information is not expected as the reporter did not wish to be contacted.
Patient did not inform clinic that he had received his first dose at Health Department on 8/13/2022.  He therefore received his second dose 14 days too earlier.
Several hours after Tdap vaccine developed redness, swelling at site along with fever, vomiting, headaches, myalgias.
Information has been received from a registered nurse referring to five patients of unknown age and gender. The patients' pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with an improperly stored GARDASIL, lot # L010596 with expiration date 06-APR-2017 (dose and route of administration were not reported). No adverse effects were reported. On 19-OCT-2015 a phone call was placed to the registered nurse who was unable to provide information. Follow up information has been received on 20-OCT-2015. Patient identifiers was given. This case refers to a 13 year old patient. On 01-SEP-2015, the patient was vaccinated with the improperly stored GARDASIL. This is one of several cases from the same reporter. Additional information has been requested.
This spontaneous report was received from a physician, via a company representative, and refers to a female patient of unknown age. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 for prophylaxis (strength, dose, route, frequency, lot/batch # and expiration date were not provided). On an unknown date, the patient developed cervical cancer. The outcome of cervix carcinoma was unknown. The causality between cervical cancer and GARDASIL 9 was not reported. Upon internal review, cervical cancer was determined to be a medically significant event.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 7/5/2022 ATRIAL FIBRILLATION, UNSPECIFIED J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 7/5/2022 ATRIAL FIBRILLATION, UNSPECIFIED
Covid Arm - large red rash at injection site.  Painful to the touch.  Leathery, hardened skin feeling.
asthma flare-up, large secondary rash close to injection site with raised skin that is warm to the touch, itching and pain reported by patient