chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant, for GARDASIL, a Pregnancy Registry product, concerning a 22 year old female with penicillin allergy who on 05-DEC-2008 was vaccinated with the first dose of GARDASIL (lot number unspecified). On 03-FEB-2009 the patient received the second dose of GARDASIL (lot number unspecified). On 10-JUL-2009 the patient received the third dose of GARDASIL (lot number: 661846/1312X, 0.5ml, IM. There was no concomitant medication. The patient's last documented period was 3 months ago, in approximately April 2009; however, the patient had sporadic periods. On 23-JUL-2009, the patient was seen in the office for symptoms of body aches, fatigue, nausea, vomiting and myalgia. On 23-JUL-2009 a urine pregnancy test was conducted and the result was positive for pregnancy. HCG quantitative test was ongoing (result unknown). The patient's estimated delivery date would be on 28-JAN-2010. At the report time the patient was pregnant. Follow up information has been received from a medical assistant concerning the 22 year old female who was vaccinated with 3 doses of GARDASIL on 05-DEC-2008, 03-FEB-2009 and 10-JUL-2009 respectively. The reporter noted that the patient terminated pregnancy on an unspecified date. The patient last menstrual period was on 27-APR-2009. The estimated delivery date (EDD) would be on 01-FEB-2010. At the time of the report, the outcome was unknown. No further information is available.
mom noticed redness, swelling in lt leg w/4 knots in leg;11MAR99 APAP given;had grand mal sz 430PM 11MAR99 lasted approx 10 seconds, alert, active but cranky p/sz;poss hypersensitivity to vax contents;
symptoms include: body aches, chills, headache, & significant pain at injection site (i.e. could not lift arm straight over head without extreme pain). No treatment for symptoms, all symptoms resolved or subsided (arm pain) within 24 hours of onset.
VITT "blood turned like honey" massive clots, surgical removal of >55 nickel size clots from vena cava, permanent vascular damage to vena cava to left iliac with large venous wall stent placed by surgeon, spinal damage with brief paralysis, brain damage with ongoing cognitive problems, permanent heart damage, bilateral pulmonary emboli, permanent lung damage, general edema, left arm numbness and severe pain/burning ongoing permanent
Information has been received from a consumer concerning her 4 year old niece who at 15 months old (approximately 2006) was vaccinated with a dose of MMR II. Subsequently, on an unspecified date the patient developed Gastrointestinal complications after vaccination. The reporter noted that her niece stopped talking a few months later and was diagnosed of "some sort of autism". The patient visited a pediatrician for medical attention. A blood test was performed, no results reported. At the time of the report, the patient had not recovered. Upon internal review, "some sort of autism" was considered to be an other important medical event. The patient had a twin brother who experienced an AE post vaccination with MMR II (WAES# 0911USA01875). Additional information has been requested.
nausea,  whole body muscle aches and weakness, mild fever (100.3), diarrhea, lightheadedness lasting all day (approx. 12 hours). treated with liquids and Tylenol/Motrin. symptoms were gone by next morning save a little lightheadedness/weakness likely due to not eating or drinking much the day prior.
After receiving vaccine, patient experienced light-headedness and dizziness.  She experienced difficulty thinking.  She ate a snack and powerade, but symptoms resolved.  She was seen in emergency department without the need for any intervention.
Month after COVID vaccine #3 (1rst booster), menstrual periods now 21 days instead of every 28 days. Also periods were lasting 5 days and are now 7 days.  Also intermittent vaginal spotting for days at a time  .
Initial report was received from a consumer on 01 December 2011. A 67-year-old female patient had received an intramuscular injection in the right deltoid of FLUZONE, sanofi pasteur Inc. lot number UT492AA on 19 October 2011 at 4:35 PM. The day after the vaccination, a rash started on the patient's whole body, she was hospitalized and her legs were swollen. The patient was treated with prednisone for 18 days and the symptoms went away. When the patient stopped taking the prednisone, the symptoms came back. The patient had no illness at time of vaccination, no adverse events following prior vaccinations and no known allergies. The patient had previous doses of INFLUENZA vaccine. The patient's concomitant medication was reported as vitamins. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Pt presents in ED 10/23/23 for weakness and SOB. Pt is vaccinated against COVID with 5 previous shots. He tested positive for COVID on 10/23 and was admitted to the hospital.
Opened vial for ipol is to be stored 2 Celsius to 8 Celsius.  Temperature excursion for this opened vial at 46.9F converted to Celsius is 8.28 Celsius for 30 minutes while the door was opened to store vaccine shipment in fridge unit.  After the temperature excursion the ipol was administered to the patient.  I was advised it was ok to use the vial from the region coordinator, then 1 week later I was advised from the DOH not to use it and we had already used it. I was advised 8.28 Celsius was not an out of range temp.
Hep A dose administered on 12/27 was administered less than 6 months after the first dose of Hep A, which was administered on 8/22/22. The minimum interval is 6 months, therefor the second dose is considered invalid. This dose will need to be repeated 6 months following the invalid dose, or 6/27/23. There have been no known adverse reactions following immunization on the 27th.
Local rxn swelling pain approximately 6cm, nausea, H/A, fever.
After being administered the vaccine, I started feeling very flush in my face and warmth in my ears to my throat, dryness in my throat and mild swelling in my throat.
This spontaneous report was received from a Licensed practical nurse (L.P.N) regarding an unknown number of patients of unknown age and unknown gender. No medical history and concurrent conditions were reported. On 19-NOV-2015, 22-NOV-2015, 25-NOV-2015 and 01-DEC-2015, these patients were vaccinated with improperly stored PNEUMOVAX 23 (dose number, dosing regimen, strength, anatomical location and route unknown) with a lot number # L018503, expiry date 16-MAR-2017 (incorrect product storage). No other adverse events were reported. No product quality complaint was reported. This is one of the several reports from the same reporter. Additional information has been requested.
The injection site became swollen, tender and developed a knot that was feverish.  An icepack was applied to the area.  By 4PM, the site was softer with decreased swelling and pain.  She went home.  One day later, the site continues to be swollen.
This spontaneous report as received from a nurse refers to an unspecified patients of unknown age and gender. On an unknown date, patients were vaccinated with improperly stored PNEUMOVAX 23 (dose, frequency, route of administration and indication were not provided). No concomitants were reported. No adverse events were reported. The outcome of events was unknown. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
CLIENT REPORTS THAT 4-5 DAYS AGO SHE STARTED HAVING EXTREME FATIGUE, AND RIGHT NECK, SHOULDER, PAIN THAT IS POUNDING AND REQUIRES TYLENOL PO Q 3 HOURS. ICE HELPS A LITTLE BUT ONCE MEDICATION WEARS OFF SHE HAD SEVERE PAIN IN THESE AREAS. IT STOPS AT THE LOCATION OF THE SHOT ON HER RIGHT SIDE/ARM.
(Rt) deltoid  (+) erythema and edema - warm to touch measuring 3 X 2 inch oval area.
Itchy rash; Tiredness; Headache; Chills; Joint pain; Diarrhea; This is a spontaneous report from a contactable consumer or other non hcp. A 66-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6205; Expiration Date: 30Jun2021), dose 2 via an unspecified route of administration on 05Mar2021 as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine was that patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL9267; Expiration Date: 31MAY2021), dose 1 via an unspecified route of administration on 12FEB2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included, from an unknown date and unknown if ongoing. Concomitant medications included methotrexate METHOTREXATE taken for rheumatoid arthritis, start and stop date were not reported; adalimumab (HUMIRA) taken for rheumatoid arthritis, start and stop date were not reported. Caller stated after her first vaccine, her arm hurt the next day really bad and she was tired and wanted to sleep and lounge around all day so she slept and then the next day her arm was a little sore on Sunday and then it was gone the next day. Caller stated after her second vaccine she has an itchy rash, tiredness, headaches, chills, joint pain, and diarrhea that came and went.Clarified the itchy rash started on her spine and went up her spine to her shoulder blades to her chest and to her face. Stated they are telling her it was not from the vaccine and stated she still had the itching, and it was terrible. Treatment: Caller states none because they are telling her she is not have any side effects. States he just sent her to an allergist, and he said it is not from the vaccine. On 08Mar2021 the patient experienced itchy rash, tiredness, headache, chills, joint pain, diarrhea. The outcome of the events was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
presented to ED following first COVID vaccine dose. CC generalized itching and scratching feeling in throat. Discharged home. was given steroids, benadryl, famotidine, and ketorolac while in ER.
24 hours after shot had high fever 101, chills, weakness, became listless, family called 911,  client became unresponsive and died  in the Emergency room.
A non-serious spontaneous report of inadvertently administered a dose of H1N1 to 13 weeks pregnant woman was received from a registered nurse concerning a 26-year-old female. The patient did not have ANY past medical history as well as no concomitant medications. The obstetrical history of the patient included two gravida and one para. On 09-Nov-2009, the patient was inadvertently administered H1N1, Intranasal. The last menstrual period was approximately 13-Aug-2009 while 20-May-2010 was the date reported for expected end of pregnancy. The patient was ten weeks pregnant at the time of vaccination. There was no adverse event associated with this pregnancy. Treatment and reporter's causality assessments are not applicable. The outcome of vaccine exposure during pregnancy was considered to be resolved. Additional information was received on 13-Nov-2009 and incorporated into the narrative: LMP date, expected delivery date, gravida, para, gestation period, medical history and concomitant medications. Additional information was received on 03-Jun-2010: Patient name and address, county where the patient was vaccinated, vaccine administered by and vaccinated at.
weakness (unable to stand w/o support), body aches;lasted approx 2-3 days;off work 14OCT & 15OCT95;
Pt w/hx significant for B-cell lymphoma & interstitial lung dx (on 4L O2 at baseline) p/w 5 day hx of SOB, cough, congestion, and diarrhea. COVID test was positive (6/15) despite receiving Pfizer vaccines (1/15 & 2/6). Was admitted for acute on chronic hypoxic respiratory failure secondary to COVID-19 pneumonia.  Received dexamethasone, plasma, and tocilizumab during admission with improvement, however, pt is still hospitalized and feels SOB w/any exertion and desaturates w/cough.
There is local itching and irritation where the shot was given as well as redness the size of a silver dollar.
12-36h  post-shot:  -Fever, chills. Unable to regulate body temperature. Brain fog, muscle aches. Subsided around 48h, fatigue remains  4 days post-shot:  Woke up with hives covering my entire body. Hives subsided around mid-day. The following 2 nights, experienced full-body hives - always starting in the evening.
COVID 19 Treatment; COVID 19 Treatment; Interchange of vaccine products; Off label use; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Lot number: EN6201), in left arm and on 23May2022 as dose 4 (booster), single (Lot number: FM0173) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 was not reported. Concomitant medication included: PANTOPRAZOLE.. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, the patient received the paxlovid on 31Aug2022.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201205965 Same reporter/patient, different drug, different event.;
She developed weakness in the right face and was brought to the emergency room and diagnosed with Bell's palsy.
Systemic: Confusion-Medium, Systemic: Diarrhea-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Additional Details: Patient fainted within 2 minutes after getting her vaccine. Then she recovered then got light headed and vomited after another 20 minutes. Mother states that they contacted patient's pediatrician and was told to monitor her. Patient had diarrhea about 1 hour after shot and is fine 24 hours later.
Day after Pertussis vaccine my sons arm swelled up very much and turned red at injection site.
Both hands started swelling and hurt. Finger tips started loosing sensation making normal tasks like holding a glass, un-buttoning blouse, tying shoes, sorting vitamans and minerals, etc. This started the week of the vaccinations (one in each arm). This progressed and got worse over the month of November and on December 14th her Physician, a Holistic MD, made a house call.  1/29/07 T/C to reporter who is patients son.  States patient did not start on holistic meds until 1/07 due to not being available.  States patient has neither improved or worsened but remains about the same.  All s/s are in her hands/arms w/o difficulty ambulating.  States patient has not sought neuro consult & is waiting to see PCP when he returns from sabbatical on 2/6/07.  8/10/07 Received pcp medical records which reveal patient seen 11/16/06 after having received flu & pneumo vax 10/17 at outlying flu vax clinic.  Now w/left side paresis & discomfort at injection sites & numbness of both hand/fingers. 2-3 days s/p vax. Seen 12/14/06 w/continued peripheral neuropathy, decreased sensation to pin prick all extremities & leg spasms.  Advised to have Doppler study done but deferred.  Patient is homebound per son & physician made housecalls.  No neuro consult, no EMG/NCS studies were done.  FINAL DX: peripheral neuropathy & probable Guillian Barre syndrome.
p/vax pt exp inj site pain & tenderness;the next day pt exp muscle pain, body aches, worst sore throat ever had, swollen neck glands, fever & general flu-like sx;sx resolved;
severe muscle pain in my back; i cannot function; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional. A 61-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in left arm on 21Feb2021 13:30 (at the age of 61-year-old) as dose 1, single for covid-19 immunization. Medical history included fibromyalgia from an unknown date and unknown if ongoing. Concomitant medications within 2 weeks included duloxetine hydrochloride (CYMBALTA) taken for an unspecified indication, pramipexole dihydrochloride (MIRAPEX) taken for an unspecified indication, levothyroxine sodium (SYNTHROID) taken for an unspecified indication, risedronate sodium (ACTONEL) taken for an unspecified indication, start and stop date were not reported. Patient did not received any other vaccine in four weeks. The patient was not diagnosed with covid prior to the vaccination and had been not tested for covid post the vaccination. On 22Feb2021 the patient experienced severe muscle pain in back, patient cannot function. No treatment received for the events. Outcome of the events were not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
nurse administered a 0.7 ml  Fluzone High Dose to 15 year old patient, by mistake/ no AE; nurse administered a 0.7 ml  Fluzone High Dose to 15 year old patient, by mistake/no AE; Initial information was received on 03-Sep-2020 regarding an unsolicited valid non-serious case from the nurse via phone.  This case is linked to case This case is linked to cases 2020SA242315, 2020SA243060, 2020SA242184, 2020SA242185, 2020SA242186 and 2020SA242187 (same reporter).  This case involves a 15-years-old male patient who was vaccinated with a 0.7 mL dose of vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (prefilled syringe, lot UJ450AB and expiration date 30-Jun-2021) via an intramuscular route in the left deltoid on 27-Aug-2020 by a nurse by mistake for prophylactic vaccination.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  The patient did not receive any other vaccine concomitantly.    It was an actual medication error case due to inappropriate age at vaccine administration and overdose (latency was same day).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.
After receiving shots on 03/02/17, in the evening, patients cried for more than three hours -inconsolable, started having diarrhea - bloody stool and mucus with abdominal pain. Decreased appetite. Not moving left leg, fever greater than 102 degrees F. Seen on 03/07/17.
Arrhythmia Yes, developed very frequent; Myocarditis Yes, developed very frequent; symptomatic PAC's + PVC's after 2nd vaccine dose; symptomatic PAC's + PVC's after 2nd vaccine dose; Cardiovascular Yes; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 56-year-old female patient received BNT162b2 (BNT162B2), on 08Jan2021 as dose 2, single (Lot number: EL1284) at the age of 55 years for covid-19 immunisation. The patient's relevant medical history included: "Mild asthma" (unspecified if ongoing). Concomitant medication(s) included: CALCIUM; VITAMIN D [COLECALCIFEROL]; CLARITIN [LORATADINE]. Vaccination history included: BNT162b2 (DOSE 1(single), Route of Administration: Intramuscular, Covid-19 Vaccine Name: Pfizer, Batch/Lot: EH9899.), administration date: 18Dec2020, when the patient was 55-year-old, for COVID-19 immunization, reaction(s): "Treatment of COVID-19". The following information was reported: ARRHYTHMIA (medically significant), outcome "unknown", described as "Arrhythmia Yes, developed very frequent"; MYOCARDITIS (medically significant), outcome "unknown", described as "Myocarditis Yes, developed very frequent"; SUPRAVENTRICULAR EXTRASYSTOLES (non-serious), VENTRICULAR EXTRASYSTOLES (non-serious), outcome "unknown" and all described as "symptomatic PAC's + PVC's after 2nd vaccine dose"; CARDIOVASCULAR SYMPTOM (non-serious), outcome "unknown", described as "Cardiovascular Yes". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12May2022) Positive; (10May2022) Negative.  Clinical information: The patient was non smoker. The patient did not display clinical signs at rest indicative of severe systemic illness. The patient did not require supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation.
Patient brought to the ED with first time witnessed seizure, resolved at time of presentation.  He is unsure of which COVID vaccine he received 3 days ago but it was either Moderna or Pfizer.  He is afebrile.
My arm aches at the vaccination site..deep inside my arm by the bone...it's an ache..it's not too bad. But, there are days it aches badly. It's been months since my 2nd vaccination..and it still aches..
extremely high fever of 103 degrees,; night sweating; Sweating, sweating a lot; chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Sep2021 14:00 (Lot number: 30145BA) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 2, single, Lot number: EP7534, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 24Mar2021, when the patient was 65 years old, for Covid-19 Immunization; Bnt162b2 (Dose 1, single, Lot number: EN6200, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 03Mar2021, when the patient was 65 years old, for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 29Sep2021 04:00, outcome "recovered" (02Oct2021), described as "extremely high fever of 103 degrees,"; NIGHT SWEATS (non-serious) with onset 29Sep2021 04:00, outcome "recovered" (02Oct2021), described as "night sweating"; HYPERHIDROSIS (non-serious) with onset 29Sep2021 04:00, outcome "recovered" (01Oct2021), described as "Sweating, sweating a lot"; CHILLS (non-serious) with onset 29Sep2021 04:00, outcome "recovered" (01Oct2021), described as "chills". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The most recent facility for COVID-19 vaccine administration was Pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Patient had a reaction after the booster shot, 14 hours after he got the booster shot, he had a very extremely high fever of 103 degrees, chills and sweating, sweating a lot and that lasted for 2 days and then it went down to 102.7 on the third day. So he had a very high adverse reaction with fever, chills and sweating, he sweat so much he couldn't believe it, but feel better later. He did not smoke or do anything, and he had a very hard reaction with booster shot. She had no lab test done, she haven't been to the doctor. Patient was not experiencing any problems afterwards. No Investigation Assessment. The adverse reactions started at 4 am 04:00 on the 29Sep2021.  No follow-up attempts are possible. No further information is expected.
Red swollen pain at injection site. Chills, nausea, muscle soreness, weakness, fatigue, loss of appetite, constipation