chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient requested both vaccines in one arm (left).  Administered the vaccinations, within seconds the patient leaned into her boyfriend sitting adjacent.  Given the patients young age and jovial manner, I thought she was being affectionate but, the patient soon slipped from the chair and hit her head on the floor.  Patient quickly regained consciousness, was helped to the chair, was pale and began to vomit soon thereafter.  Called emergency services which arrived within minutes.  Patient was hesitant to go with the EMT but after I suggested she go, she did.  Before the EMTs arrived the patient expressed some embarrassment as she had never fainted after a vaccination prior to this event.
AFTER RECEIVING BOTH FLU AND BIVALENT COVID BOOSTER, PATEINT REPORTED BEING DIZZY, SWEATY, AND HOT. NO ANAPHYLAXIS PRESENT.  WE GOT PATIENT A BOTTLE OF WATER TO DRINK AND PATIENT ALSO ASKED FOR SOME CRACKERS TO EAT.  AFTER ABOUT 5 MINUTES PATIENT ADDITIONALLY REPORTED HAVING BLURRY VISION AND MUFFLED HEARING. 911  WAS CALLED AND PARAMEDICS TRANSPORTED PATIENT HOSPITAL.
no adverse effects; patient administered the 1st dose of recombivax HB on 5/4/2019 and a 2nd dose on 7/8/2019; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 04-MAY-2019, the patient was vaccinated with 1st dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (dosing details not reported) for prophylaxis. On 08-JUL-2019, the patient was vaccinated with second dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) ( lot/batch# R031052, expiry date # 03-JUN-2021, strength, dose and route, therapy type not reported) for prophylaxis (inappropriate schedule of product administration). There were no adverse effects. There was no product quality complaint (PQC).
Patient started shaking approx 1 hour after administration and site was very painful, denied fever,.  Took Tylenol and went to bed. Developed nausea as well.  Was better in the mornnig.  No medical attention sought
Since receiving my vaccine, I experienced nausea, sore arm.  I also have muscular skeletal issues for 20 years, caused flare-ups, muscle spasms, nausea all these happened within two weeks after my vaccine. I still continue with flare-ups and I am currently receiving physical therapy. I also having muscle movements that are new, have also brain fogginess.   I am currently out of work on medical leave due to my symptoms.   I can not remember know which arm I received my vaccine.
ON A PACEMAKER; This spontaneous report received from a consumer via other manufacturer (Pfizer) concerned a male of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the reporter's brother-in-law got on a pacemaker. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of on a pacemaker was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220701757-covid-19 vaccine ad26.cov2.s-on a pacemaker. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Pt had PNEUMOVAX on 7/18/11, by 7/20/11 had 2x5 cm area of patchy erythema anterior (L) proximal bicep area. Treated with Doxycycline 100 mg BID for cellulitis.
Lost consciousness for about 5 minutes; Couldn't move her leg; Started feeling lightheaded, dizzy; Body started feeling weak; Right arm started shaking; Left leg felt very heavy; Couldn't wiggle her toes; A spontaneous report  was received from a consumer concerning a 66-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273), and who experienced feeling lightheaded, dizzy, body started feeling weak. Right arm started shaking, lost consciousness for about 5 minutes. Her left leg felt very heavy and couldn't move her leg or wiggle her toes.  Concomitant product use was not provided by the reporter.  On 07 Jan 2021, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 026L20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.   After patient got the vaccine, she drank some water because she was lightheaded and dizzy. She was offered crackers by the nurse. After her body started shaking, a nurse wheeled her to the emergency room. Her computerized tomogram scan on her head and magnetic resonance imaging of back came back normal. Blood tests were normal.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.   The event, lost consciousness was considered recovered/resolved on 07 Jan 2021. The events left leg felt very heavy and couldn't move it and couldn't wiggle her toes were considered recovered/resolved on 11 Jan 2021. The outcome of the events, lightheaded, body started feeling weak and right arm started shaking was not reported.; Reporter's Comments: This case concerns a 66-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot 026L20A), and who experienced the serious unlisted events of Loss of consciousness and Monoplegia and non-serious unlisted events of Dizziness, Asthenia, Tremor, Limb discomfort, and Musculoskeletal disorder.  Based on the current available information and temporal association between the use of the product and the onset of events on the day of vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Vaccine was mixed on 9/7/21 at 1650. This patient received this dose on 9/8 at 1015, The vial was "expired" past its 6-hour mix window. Patient was monitored for 15 minutes per protocol, but error was not realized until after patient was home.   We attempted to contact patient to notify of event but have not been able to reach them. we will try again.
heart palpitations, pressure in chest and left side of neck, lasting ~5 minutes 5-6 times a day from March through May. Then same symptoms but lasting ~10 minutes and occurring 1-2 times a week through June. No symptoms over last month until today when I experienced heart palpitations, pressure in chest and left side of neck, headache and nausea for over an hour then again for another hour
Pt recvd pneumococcal vax & following vax pt devel a local reaction measuring 7-9" & 3"; reaction was characterized as being indurated, hot, erythematous & lasted for about 4 to 5 days; tx was nonspecific; no further details were provided;
Patient said was experiencing a cough, scratchy throat (felt like a lump in her throat), and her throat felt tight (felt like she was needing to drink a lot of water). She said it did not appear to be anaphylasis. Said not difficulty breathing, and ok to swallow liquids.
Information has been received from a 55 year old male patient with a history of herpes virus infection 5 years ago. The patient had been having outbreaks since the fall of 2001. Some doctors had said he had shingles and a dermatologist said it was herpes (not genital). The patient, in 2007 was vaccinated with a dose of ZOSTAVAX (Merck) (rout and administrating site not reported). Subsequently the patient experienced herpes again. Additional information has been requested.
Tremors cont's Tongue darting Drug Induced subacute dyskinesia. Propranolol 7/11/17-9/9/17 with increased doses 80mg-320mg. INGREZZA 40mg 9/18/17 increased to 80mg QD x 17wk's no effect either medication.
Became very unsteady on my feet within 2 weeks of getting the fist shot. Went for second shot despite being unsteady, it has not gone away now going on 10 weeks. Hearing is down and fullness in my left year.  Saw an ENT and my family practitioner. Nothing they can do, so I  take meclizine on the really bad days, which helps a little. Very hard to function since the shot.
Information has been received from a 69 year old female patient concerning herself with breast cancer. The patient had a triple bypass heart surgery five years ago in approximately MAR-2010. The patient had no drug reaction/allergies. On 26-FEB-2015 the patient was vaccinated with ZOSTAVAX, subcutaneously in her right arm (dose, frequency and lot# were not reported). Concomitant therapies included metoprolol. On 27-FEB-2015 (reported as 24 hours later), the patient developed redness, swelling and pain at the injection site. Progressively in the next week, in approximately March 2015, the patient developed fatigue, weakness, muscle and joint pain in her extremities, feet, calves and knees, accompanied with "Charley Horse" cramps in her legs. There was no product quality complaint involved. The patient visited office to seek medical attention. ALEVE was given twice daily for the events, but there was no length of time provided. Quarterly routine blood work was performed on unknown date (no result was reported). The outcome of the events was reported as recovering. Additional information has been requested.
very fatigued; It has mostly remained above 100 all day today. As I sit and type, it is currently 135, significantly higher than normal for sitting and typing.; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982, expiry date not reported), via an unspecified route of administration on the right arm on 03Feb2021 08:30 at single dose for covid-19 immunisation. Medical history included ankylosing spondylitis, osteoarthritis, hypothyroidism, osteoporosis, known allergies: NSAIDs from an unknown date and unknown if ongoing. Concomitant medication included alendronate sodium (ALENDRONATE), arnica montana and thyroid (ARMOUR THYROID). The patient previously took neosporin, dolobid, diflunisal and experienced allergies. The patient was 69 years old when she received the first dose of bnt162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EH9899, expiry date not reported) on the right arm on 14Jan2021 08:30 for covid-19 immunisation. The patient reported that they went to bed at 10:30pm last night; very fatigued. At 4:08am on 04Feb2021, tapped them and reported that her heart rate had been above 120 for 10+ minutes while she was lying down. She checked the Heart app and it showed that her heart rate had been in excess of 120 for 2.5 hours while she slept. Her resting heart rate is normally 70 or below. She got up; the heart rate remained elevated for another hour or more, finally dropping below 120 at 5:30am. She was very fatigued (from the high heart rate?; as reported) for several more hours. It has mostly remained above 100 all day today. As she sit and type, it is currently 135, significantly higher than normal for sitting and typing. It was reported that the events occurred on 04Feb2021 at 01:30 am. No treatment was received for the events. The patient did not recover from the events.
patient received an expired dose of acthib with no reported adverse event; Initial information received on 14-Aug-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 1 years old male patient who received an expired dose of HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP); and pneumococcal vaccine (Pneumococcal 15) for Prophylactic vaccination.  On 14-Aug-2023, the patient received 0.5 mL dose 4 of expired suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection (batch number: UJ803AA; expiry date: 13-Aug-2023) via intramuscular route in the left thigh for Immunization with no reported adverse event (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event patient received an expired dose of acthib with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Extreme chills, Aches, and total lack of hunger. I have not experienced this type of reaching since I was last ill with influenza.
Swelling, redness started 5/12/06on left deltoid region. No fever.
This spontaneous report as received from a registered nurse refers to a 2 month old patient of unknown gender. No information regarding the patient's medical history and concurrent conditions was provided. On 13-SEP-2016, the patient was inadvertently vaccinated with a dose of PNEUMOVAX 23, lot # M013156, expiration date: 15-OCT-2017, (dose, route of administration and injection site were not provided). There were no concomitant medications reported. No adverse effect was reported. No product quality complaint (PQC) was involved. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of bruising of arm in a 69-year-old female patient who received SHINGRIX (batch number MY2B2, expiry date February 2019) for prophylaxis. On 4th September 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 5th September 2018, 1 days after receiving SHINGRIX, the patient experienced fatigue, fever and pain. In September 2018, the patient experienced bruising of arm, injection site erythema and injection site swelling. On an unknown date, the outcome of the bruising of arm, fatigue, fever, pain, injection site erythema and injection site swelling were unknown. It was unknown if the reporter considered the bruising of arm, fatigue, fever, pain, injection site erythema and injection site swelling to be related to SHINGRIX. Additional information was received as follows: This case was previously reported to the doctor. The patient received SHINGRIX on the right arm. The reporter stated that 16 to 18 hours after receiving SHINGRIX the patient had swelling, redness at the injection site and couple of inches below the injection site, the patient had some bruising on the right arm. The reporter stated that the patient called her physician and set an appointment however, the appointment was set for a few weeks away and till the time of reporting, the patient had not been seen by the physician. This case was 1 of 3 cases, reported by the same reporter.
Systemic: Dizziness / Lightheadness-Mild, Additional Details: pt felt dizzy so we called the paramedics immediately.  Even though her symptoms were resolve after 5 minutes, we still waited for the paramedic to make sure  she was clear to leave.  EMT cleared her after their assessment
Fever, joint pain and chest pain from 2pm on Wednesday, until now Thursday 8:45, the fever does not go down and the chest pain is sharp
Did not notice until  January 13th, but there is about a one to one and  half inch length strip by 1/2 inch wide  of discoloration running anterior to the injection side of my arm, where it is slightly discolored. I would almost call it slightly jaundiced in color to a slight bruising in color.  The area is not sore to the touch, nor warm nor itchy. I noticed it perhaps last week around January 13th, so it could have been there longer.  No need for medical care nor intervention. Thought it might be worth reporting.  I have had bruising before from a vaccine or blood draw, and this length of discoloration is too long to be bruising.  I do not bruise easily nor have any type of coagulation disorder.
This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a adult patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, less than a year after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not applicable. This case was previously reported to the physician. The age group was not provided, but was selected as adult as per the vaccine indication. The reporter stated that, she heard about 3 people while in line at her local pharmacy mention that they all had terrible reaction to the Shingrix vaccine. The patient had denied permission to contact their physician. This case was linked with case US2018192637, reported by the same reporter.
Patient had no reactions.Patient came for a pfizer 6m to 4y.Patient received a moderna 6m to 5ys.I confirmed dosage and vaccine with father before giving vaccine.Father gave consent and vaccince was given.Mom then said vaccine was supposed to be pfizer.Dad was witness and gave consent for moderna.Patient then waited 15 minutes after vaccine was given.Patient was doing great before she left.Mom and dad were aware of the situation.
C/o severe redness and swelling (L) upper arm 2 hours after receiving Flu vaccine. She visited doctor in occupational health office and was followed there.
No adverse event.  Received 2nd Prevnar 13 . 1st Prevnar 13 was given on 9/23/2018
Patient developed mouth pain with petechiae of hard palate and decreased platelet count (61) 2 days after vaccine admin.
I noticed a 3'X3" red, warm, slightly raised patch about 4 inches below vaccination site on my arm a couple of days after vaccination...itchy at times....slowly subsifing now.
Heart attack; he is in the hospital, fully on life support; he has his kidneys and liver are failing; he has his kidneys and liver are failing; This is a spontaneous report from a contactable consumer or other non hcp.  A 34-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 15Jun2021 as dose number unknown, single for covid-19 immunization. Medical history included Anxiety, depression. Concomitant medication included gabapentin (GABAPENTIN) taken for an unspecified indication, start and stop date were not reported. patient did not receive any other vaccine within 4 weeks Prior to Vaccine. Reporter stated, is it possible for heart attack to happen 8 days after the vaccine. reporter want to report a reaction, because reporter think it was vaccine reporter wanted to make sure, repoters brother is 34 and he had a heart attack yesterday and he received his vaccine (Confirmed as Pfizer Covid 19 vaccine) 8 days ago, he received his vaccine before his heart attack. Reporter stated, patient has his kidneys and liver are failing, he said they did the lab work really done, he is still waiting to get echo that for his heart. Patient is completely on life support, he still in the hospital. The patient underwent lab tests and procedures which included echoencephalogram: unknown results, Therapeutic measures were taken as a result of heart attack. The outcome for the events he has his kidneys and liver are failing was reported as unknown and for remaining events outcome was reported as not resolved.  Information on the lot/batch number has been requested.
Arm swelled up like a baseball. Injection site hot and red could not be grazed over by anything it hurt so bad. hot flashes  very bad sweating soaking clothes and hair.  Shaking uncontrollably,  as a MA this can effect my career. Sharp pains going down my right side feels like arthritis. Stiff neck hurts to move.
Swelling from the right arm to the (R) side of the neck. Severe headache initially - HA persistent 10/25/16 through form completion date.
Had Extreme Dizziness for one night and it got better over 3 days.   The morning of the Dizziness I had ringing in my Ear.  Ringing has been there for almost 4 weeks and it not getting better.  The Ringing is accompanied by headaches every once in awhile.  Seen 2 doctors was prescribed Prednisone with no help.   Had hearing test, hearing is good until I reach a certain frequency in the ringing ear then it drops out.
Developed fever to 103 and had reported increased respiratory rate, grunting and nasal flaring. No hypoxia.
Swelling; Arm painful; Nausea; Vomiting; Redness at injection site; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling), PAIN IN EXTREMITY (Arm painful), NAUSEA (Nausea), VOMITING (Vomiting) and VACCINATION SITE PAIN (Redness at injection site) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 virus test positive (I was Covid positive about 90 days ago even was positive in December.). Concomitant products included VITAMINS NOS for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced SWELLING (Swelling), PAIN IN EXTREMITY (Arm painful), NAUSEA (Nausea), VOMITING (Vomiting), VACCINATION SITE PAIN (Redness at injection site) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, SWELLING (Swelling), PAIN IN EXTREMITY (Arm painful), NAUSEA (Nausea), VOMITING (Vomiting), VACCINATION SITE PAIN (Redness at injection site) and FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were Cholesterol Medication, High Blood Pressure Medication for drug use for unknown indication.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow-up received on 13-JUL-2021 and included events outcome  information.
This spontaneous report was received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with doses of RECOMBIVAX HB (route, lot numbers and expiration dates were not provided). On unknown dates, there was incorrect product storage as an unspecified number of patients received doses of RECOMBIVAX HB improperly stored. No adverse effect was reported. It was unknown if the patient sought medical attention. At the time of the report, the patients status was unknown. This is one of several reports received from the same source. Additional information has been requested.
Patient contracted COVID-19 after receiving two COVID-19 vaccine doses (Moderna series completed on 2/27/21). Patient was admitted to the hospital on 5/16/21 for worsening confusion and was stable to discharge to Agency on 5/21/21. Patient had tested positive for SARS-CoV-2 on 5/21 while in agency
83 YO FEMALE C/O NAUSEA,REDNESS, SWELLING, IRRITATION AND WARMTH LEFT DELTOID