chrisvoncsefalvay/vaers-outcomes huggingface dataset:
has symptoms of an autoimmune liver injury; elevated liver function tests; elevated liver function tests and bilirubin; jaundice; This is a spontaneous report from a non-contactable pharmacist. A 79-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 18Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient has symptoms of an autoimmune liver injury with elevated liver function tests and bilirubin and the patient had jaundice. Caller stated that this is not viral and nothing else has changed with the patient. Caller would like to know if the patient's symptoms are capable of being linked to the Pfizer COVID vaccine. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: A contributory role of the vaccine BNT162B2 to reported events cannot be fully excluded based on temporal relationship and due to the lack of alternate explanation at this time. The information provided is limited and does not allow for a complete medical assessment. Case will be  reassessed if additional information is received 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.
Developed rash about 2 1/2 inches diameter on his rear lateral right torso. Severe itching on the same area on 4/16. Took BENADRYL tab - seem to improved it a bit.
HC received call from someone with desire for anthrax vaccine exemption because of previous "polyarthralgias" after his receipt of AVA # 3.  Symptoms: Rash, focal, Joint Pain, multiple joints, Flu-like symptoms < 96 hours.
Pt had 2 hours of atrial fibrillation for first time starting 7 hours after the shot and lasting 2 hours-had never at it before
This case was reported by a lawyer and described the occurrence of arthralgias in a female subject of unspecified age who was vaccinated with Lyme disease vaccine recombinant (Lymerix) for prophylaxis. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of Lymerix. On an unspecified date after vaccination with Lymerix, the subject experienced arthralgias, myalgias, difficulty concentrating, headaches, Bells palsy, jaw locking, fatigue, joint stiffness, decreased stamina, gastrointestinal problems, tinnitus, weakness, numbness and tingling in face, hands and feet, sleep difficulty, eye problems, weakness, muscle spasms, and rheumatologic, neurologic, and or cognitive impairment of an autoimmune, immune mediated or other mechanism, all reported to be caused by vaccination with Lymerix. The subject also has decreased activities of daily life and decreased ability to participate in recreational activities. At the time of reporting the outcome of the events was unspecified. This information was received via a statement of injuries.
-Severe headache that felt like my brain was exploding out the top of my skull.  Over the counter pain medication did not help with the pain.  Headache was ongoing for over a week after injection.  -Severe widespread joint pain.  This lasted for weeks after the injection.  I continue to have some joint pain lingering in my hands.
recd. vaccinations over a year ago, had at least 8 outbreaks/suspected vaccination failure; 8 Shingles outbreaks; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with tofacitinib citrate (Xeljanz). On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 17-MAY-2022 Reporter's comment: The case was reported by the patient. The patient received Shingrix vaccinations over a year prior to the reporting. The patient had at least 8 outbreaks. Since then the patient was taking Xeljanz. The patient asked if there was anything patient could do to stop outbreaks. Also the patient wanted to add that the patient had two surgeries cancelled due to physicians not wanting to operate and the patient was in a bind. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting.
I had my 1st vaccine on may 21st about 2:30. I woke up 5:45am May 22nd I was hoarse and wheezing, my tongue lips and face felt tingly numb and puffy. my ears were hot and itchy also my body  felt like my skin was crawling. taking a lot of allergy meds, My mouth is still numb 3 weeks later.
Patient 8 years old was given 0.25 ml of the monovalent covid 19 moderna pediatric (age 6-11) vaccine NDC 80777-0275-05 as a booster dose instead of the bivalent covid 19 updated booster age 6-11 NDC 80777-0285-05. No adverse events reported by the patient's family as of the time of this reporting.
child received a Dtap instead of a Tdap/no AE; Initial information received on 22-Jun-2020 regarding an unsolicited valid non-serious case received from a non health care professional(office staff).  This case involves a 11 years old female patient who was vaccinated with DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL](batch number and expiry date not reported) instead DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID[TDAP] via unknown route in unknown administration site on an unknown date for prophylactic vaccination(wrong product administered). It was reported that now patient age is 18 years old and she received vaccine when she was 11 years old and realized this because of her immunization record.  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to expired vaccine used.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on batch number for this case.
Right breast pain, first noticed on April 4th. 5pm. Took 1 advil, pain went away.  Next day, 7pm, same pain, same spot.  This is after-weeks after- the 1st shot.    2nd shot date is April 14, at 11:15am
This spontaneous report as received from an office manager (healthcare worker) refers to a patient of unknown age. Office manager reported that a patient received Dose 2 of VAQTA (lot #, expiration date, dose, frequency, and route not reported) late (on 05-FEB-2014). Dose 1 was administered on 01-MAR-2006 and Dose 2 was administered on 05-FEB-2014. No symptoms reported. Additional information has been requested.
Within 5-10 minute of vaccine administration patient  was noted to be unsteady on feet. Patient laid down on exam table. No loss of consciousness. Ice pack applied to forehead, coat removed. Patient rested for approximately 5-10 minutes. Vital signs checked- WNL. Patient sat at edge of exam table and stated felt 100% better .Able to leave with mother ambulating normally.
Pt reports shortness of breath at rest and exertion; headache and nausea; reports that she is using her inhaler much more than usual and "I don't feel like myself"; she denied any change in vision or speech; she reports that she has been having issues with her left hand shaking as well as "racing heart" that self terminates
redness to injection site for 3 days with significant pain and swelling to rt arm for 7 - 10 days
Developed appendicitis two weeks and 2 days after first dose.  Unsure if it?s related but I wanted to report it. CDC pfizer trial data shows higher numbers of appendicitis in vaccine trial group vs placebo.
Symptoms began with a tingling sensation in the back corner of the mouth, which spread to the rest of the cheek. Pain similar to the tension of muscles was felt upon touching the left jaw and neck area. Soon it was noticed that left cheek/jaw area was swollen.
Abrupt stop of menstrual and immediate onset of menopause symptoms. Extreme repeated hot flashes, menstrual cycle stopped for four months.
Initial information received on 08-Nov-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 18 years old patient (gender not reported) who suppose to received TYPHIM VI (lot N1K801M, expiry date 15 Oct 2019) on an unknown. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication involved Patient also received FLULAVAL 0.5 ml, MENACTRA 0.5 ml and GARDASIL 0.5 ml. It was a case of potential medication error due to Missed dose and Syringe leak as Pharmacist states when she showed him the syringe after the incident the needle was attached to the luer lock but the syringe was not attached and nothing looked broken. Pharmacist states patient, missed their dose because they only had the one dose. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
When patient initially received the vaccination, she complained of mild dizziness. She went home after monitoring and returned to work the PM shift rested. Approximately 45 minutes into the shift, she c/o dizziness. She had elevated BP 209/102 and HR 108 and at one point had a syncopal episode. Emergency services was called and she was transferred to the hospital for further evaluation.
Dull headache; still have intermittent headaches; do not need to take anything for it- just reporting for data
This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# not reported), via an unspecified route of administration, on Feb 28, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced pain in her arms, pain in shoulders and nausea on an unspecified date; with outcome of unknown. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.
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 67-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 19Sep2023 as dose 1, single (Lot number: HG4629), in right arm for covid-19 immunisation; for covid-19 immunisation. The patient's relevant medical history included: "thyroid cancer - removed in surgery 2013", start date: 2013 (unspecified if ongoing); "penicillin" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID, start date: 2013; CHLORTHALIDONE, start date: Apr2023. Vaccination history included: pfizer / biontech (Dose Number: 6, Batch/Lot No: GK1337, Location of injection: Arm Right), administration date: 24Apr2023, when the patient was 67-year-old, for COVID-19 immunization, reaction(s): "COVID-19"; pfizer / biontech (Dose Number: 5, Batch/Lot No: GH9693, Location of injection: Arm Right), administration date: 27Sep2022, when the patient was 66-year-old, for covid-19 immunization, reaction(s): "COVID-19"; pfizer / biontech (Dose Number: 4, Batch/Lot No: FK9894, Location of injection: Arm Left), administration date: 16Apr2022, when the patient was 66-year-old, for COVID-19 Immunization, reaction(s): "COVID-19"; pfizer / biontech (Dose Number: 3, Batch/Lot No: Ff8841, Location of injection: Arm Left), administration date: 30Sep2021, when the patient was 65-year-old, for COVID-19 Immunization, reaction(s): "COVID-19"; pfizer / biontech (Dose Number: 2, Batch/Lot No: EN6208, Location of injection: Arm Right), administration date: 18Mar2021, when the patient was 65-year-old, for COVID-19 Immunization, reaction(s): "COVID-19"; pfizer / biontech (Dose Number: 1, Batch/Lot No: EN6205, Location of injection: Arm Left), administration date: 25Feb2021, when the patient was 65-year-old, for COVID-19 immunization, reaction(s): "COVID-19".  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 05Nov2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received 2 flu vaccinations within a month of each other. Patient attended an off-site clinic and received her flu shot there, then came into the store approxmately a month later, requested and received a second flu vaccination.
Developed persistent chest pain that radiated on the left side 3 days after administration of injection, which lasted for 12 days. Chest pain would occur multiple times a day and would range from a stabbing pain to chest tightness. Sometimes would feel a random burst of adrenaline (experienced twice) that would cause extreme chest pain radiating on the left side. The pain that I would experience would last anywhere from 5 minutes up to an hour each time.
RIGHT SIDED CHEST PAIN, DYSPNEA, TACHYCARDIA.  NOTES FROM PATIENT: o         9/14/21- Sore arm; exhausted that day. Went to sleep before 9:00PM.  o         9/15/21-Restless at night; difficulty sleeping; right-side chest pain started  o         9/16/21-Chest remained uncomfortable-right side  o         9/17/21- Upper chest discomfort; Trip to the ER after his resting heart rate rose to 120. (previous to the vax, his resting rate stayed in the 50s)  o    At the ER, the staff ran and EKG, took a chest X-ray, and ran a cardio panel along with a d-dimer. All results were normal.   o        Pale in the face, at times even gray. Where he used to be someone who worked without rest (prior to the vaccine) doing yard work, house projects, working on the cars, or anything else that needed doing, now he doesn?t have the energy for near what he used to. He was an avid runner and worked out five days a week before, but no longer has the energy to maintain his previous routine.  o         A change in his sleeping heart rate (measure by his Apple Watch). His sleep rate typically was in the high forties to high fifties. Currently, the rates are in the seventies.  o         10/9/21 (late evening into the morning of 10/10) while laying in bed, his heart rate rose to 145 and he felt what he described as a jolt. Second trip to the ER. Staff ran the same tests and sent him home. They recommended he see a cardiologist.  o         10/12/21  saw  Cardiologist. He diagnosed sick sinus syndrome. He?s currently wearing a monitor for twenty-four hours, and will have an ultrasound of his heart once our insurance approves the procedure.   10/19/2021 TELEMEDICINE WITH DR. WITH PRESUMPTIVE DIAGNOSIS OF VACCINE INDUCED PULMONARY EMBOLISM  VS MYOCARDITIS.  SINCE THE FIRST CARDIOLOGIST DID AN EVALUATION MYOCARDITIS WAS PRESUMPTIVELY EXCLUDED AND A CHEST CT WAS ORDERED TO EVALUATE FOR PULMONARY EMBOLISM.
This spontaneous report as received from a medical assistant refers to 11 months infant patient of unknown gender. The medical assistant stated there was a power outage on 12-APR-2014 and the VARIVAX doses from the freezer needed to be transported to unspecified hospital for proper storage. She stated VARIVAX was exposed to 46F for 1 hour, at worst. The patient received VARIVAX dose 0.5 ml, intramuscularly, lot J006358 expiry 23-MAY-2015, between 12-APR-2014 and 24-APR-2014. There was a site visit from local health department on an unspecified date. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
Patient came in for a COVID-19 Booster.  She received J& J as her first dose, and wanted the Moderna as her booster.  Patient was administered 0.5ml dose instead of 0.25ml dose.  Patient is immunocompromised with Lupus.  No adverse reaction have been reported to us by the patient.
Patient recieved both vaccines in left deltoid. Patient stated arm started to hurt and swell. Patient went to urgentcare 9/10, said arm felt better and swelling had went down. Patients arm had yellow bruising on lower part of left arm toward elbow, not by injection site. Patient had slight elbow swelling without coloration. Doctor gave patient prescription for Keflex 500mg 1 bid x10 days and Prednisone 20mg 1 twice daily for 5 days.
Fainted and lost consciousness in bathroom overnight. Had felt slight dizziness from 6:30 pm onward on date of injection. Subsequent to incident, continued to feel severe nausea / dizziness and could not make it back to bed from floor initially. Unsure of duration of state of unconsciousness. However, made it back to bed at 4:47 am.
This case was reported by a pharmacist to a sales representative and described the occurrence of injection site irritation in an elderly subject of unspecified gender who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. On an unspecified date in 2005 on or before 10 November 2005, the subject received a dose of Fluarix (lot number not provided). Information regarding previous immunization with influenza virus vaccine was not provided. At an unspecified time following the administration of Fluarix, on or before 10 November 2005, the subject experienced injection site irritation "that required a trip to the emergency room." The outcome of the injection site irritation was not reported.
PATIENT REQUIRED A 2ND MMR BUT WAS GIVEN A VARICELLA.  THE MMR WAS PROVIDED AFTER THE MISTAKE WAS DISCOVERED..  PT ALREADY HAD 2 VALID DOSES OF VARICELLA.  PATIENT DID NOT HAVE ANY ADVERSE REACTION TO THE VARICELLA.  PATIENT AND FATHER WERE INFORMED OF THE MISTAKE AT THE TIME OF VISIT.
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 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 at 16:00 as dose 4 (booster), single at the age of 46 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Dec2022) Negative; (16Dec2022) Negative; (17Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Received paxlovid treatment from 09Dec2022 to 14Dec2022 for COVID-19. It was unknown if the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine. Rebound COVID. Tested negative 14Dec2022 and 16Dec2022. Tested positive again 17Dec2022 (mild symptoms).  No follow-up attempts are possible. No further information is expected.
This spontaneous prospective pregnancy report as received from a registered nurse refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 (lot # and expiration date was not reported) despite being pregnant. The nurse noted that prior to receipt of the dose of GARDASIL 9 a pregnancy test showed negative, therefore patient was administered the vaccine. On an unknown date, another pregnancy test was conducted after receipt of the vaccine which showed positive. The patient's Last Menstruation Period (LMP) and Estimated Delivery Date (EDD) were not reported. Additional information has been requested.
Eye soreness/pain.  Halos around light.  Light sensitivity.  Headache.  Nausea.  Dx:  Iritis both eyes.  Dx on Friday January 8, 2021.    Steroid eye drops prescribed.  Infection and steroid drops are ongoing as it has not resolved yet. Needed to stay home from work due to headache/nausea.  Headache and nausea is on the Covid symptom list and the hospital I work at would not allow me to work until I'd had a negative Covid test.
Pt. had urticaria, induration & erythema. Tx'd with Benadryl 25mg po q 4, 11/6/99-11/9/99, resolved.
Fever & chills for 2 days Nauseous & lack of appetite for 9-10 days Vomiting & dehydrated  Treatment: Anti nausea medication
Patient presented as a transfer from Hospital after initially presenting to the ED with persistent abdominal pain associated with nausea. She received her 2nd COVID-19 vaccine on 9/13. She felt okay for a couple of days afterwards but on 9/16 she started experiencing flulike symptoms and a sensation as if she was "hit by a bullet train" along with abdominal pain associated with nausea. Since then she has had practically no oral intake and has not been able to keep any food down with limited intake of water. Anything she takes in is associated with severe nausea. She has also been having abdominal pain over the mid abdomen without radiation. In the ED she was noted to have atrial fibrillation with RVR and reported heart rates over 170 (new onset Afib). Treated with diltiazem IV.
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Weakness-Mild
Vaccine stored under refrigeration beyond 30 days. Moderna: lot number 056M21A maintained the activity necessary to protect against the SARSCoV-2 (COVID-19) virus at time of administration. Did not contact patient per no action required.