chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At the time of the first vaccine dose, my heart rate was elevated to over 100 bpm while just sitting in my car. I was monitored there and cleared to go about my normal life after. In the coming months, I continued to see an elevated heart rate, both while resting and also while exercising especially. In May, I had to go to the the ER after waking up in the middle of the night with a heart rate at 150 bpm, which did not come down for at least an hour. I have also had chest pains routinely now. I am concerned I am dealing with myocardia now.
Muscles aches, fever to 102F, chills, sweats, severe headache.  6 days to resolve.
Information ahs been received from physician concerning a 50 year old male who was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine. The reporter indicated that the pt recently developed a site reaction after vaccination. The reaction was marked by redness, swelling and pain at the injection site. The pt did not have an extended recovery period. Unspecified medical attention was sought. A product quality complaint was not involved. Additional info has been requested. The physician also reported similar reactions in two other adult patient after therapy with penuemococcal 23v polysaccharide vaccine.
soreness at the injection site; fatigue, tiredness; 1st dose Mar2022, no 2nd dose yet; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult male patient who received SHINGRIX for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In March 2022, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced injection site pain, fatigue and incomplete course of vaccination. On an unknown date, the outcome of the injection site pain and fatigue were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the injection site pain and fatigue to be related to Shingrix.     Additional Information: GSK Receipt Date: 14-OCT-2022. Reporter's Comments: The patient self-reported this case. The reporter stated that the patient received his first dose of Shingrix in March of 2022 and that he not had his second dose.  The patient intends to receive his second dose as soon as possible. The patient received his first dose and experienced soreness at the injection site, tiredness, and fatigue.  The reporter gave consent to follow up. Additional Supportive Information: The patient did not receive 2nd dose which led to incomplete course of vaccination.
This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown date, an unspecified number of patients were vaccinated with a dose of ROTATEQ, (strength, dose, frequency, route, anatomical location, lot number and expiration date were not reported), which were improperly stored. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Vaccine went into 2-8 Celcius thaw state on or about 24-Dec-2021 and administered on 12-Feb-2022; Vaccine went into 2-8 Celcius thaw state on or about 24-Dec-2021 and administered on 12-Feb-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celcius thaw state on or about 24-Dec-2021 and administered on 12-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celcius thaw state on or about 24-Dec-2021 and administered on 12-Feb-2022) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     Acute illness at the time of vaccination and up to one month before of vaccination was unknown. The chronic or long-standing health conditions was unknown.     On 12-Feb-2022 at 4:52 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 12-Feb-2022 at 4:52 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celcius thaw state on or about 24-Dec-2021 and administered on 12-Feb-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celcius thaw state on or about 24-Dec-2021 and administered on 12-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celcius thaw state on or about 24-Dec-2021 and administered on 12-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celcius thaw state on or about 24-Dec-2021 and administered on 12-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported  No Treatment medication was reported
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 27-NOV-2015, the patient was treated by the hospital, for a blistering vesicular outbreak, that was diagnosed as severe herpes zoster. The patient was prescribed hydrocodone and acyclovir for management of his painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX, and or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
This spontaneous report as received from a pharmacist and the consumer's mother refers to a male patient of unknown age. The patients current conditions or medical history were not reported. On 21-MAY-2013 and 25-JUN-2013, the patient was vaccinated with a dose of RECOMBIVAX HB 5 mcg/0.5 ml (route, lot number and expiration date were not reported) that were stated by the physician's office to be invalid because they had a temperature stability issue. Those vaccines were apparently two degrees off 32 F for 30 minutes. On 02-AUG-2013, the patient was given a third dose of RECOMBIVAX HB 5 mcg/0.5 ml (route, lot number and expiration date were not reported) that was stated to be valid. No adverse experiences were reported. The reporter stated that the vaccines were given to the patient in a manner inconsistent with the prescribing information. It was also reported that the physician's office wanted to revaccinate the patient. Additional information has been requested.
Beginning a few days after vaccination, patient experienced swelling of lymph node behind/under ear, specifically on the side of the body (left) that he received his vaccine. It became about "the size of an almond" and has been this way for approximately 7 days. Patient reported no pain, fever, or any other lymph node swelling or symptoms
Wrong dose given for childs age. Received 0.25mL should have been given 0.50mL. Per health department dose must be repeated with correct vaccine dose. No adverse reaction
Day 2 after the shot I began to feel chills and fatigue. My temperature was 102.2 when I checked it. Later that same day it had gone up to 102.4. I had no appetite and extreme fatigue. Took Tylenol which lowered the fever. Day 3 my temperature stayed at 102.4 and I had painful, swollen glands along my left clavicle, as well as fatigue. Also, the injection site became hot and swollen. Day 4, my temperature has gone down but I have a terrible headache, swollen clavicle glands and a chain of swollen nodes (?) from the base of my skull down the back of my neck on the right side. My left arm is still hot and swollen at the injection site. I've had to miss two days of work.
Swelling of right tonsil after about 13 minutes. Increased in intensity for both tonsils until about 25 minutes after shot.; Tongue swelling; currently breastfeeding; currently breastfeeding; This is a spontaneous report from a contactable consumer (patient). A 32-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8737 (721)), via an unspecified route of administration, administered in right arm on 01Apr2021 at 14:45 (at the age 32-year-old) as a single dose for COVID-19 immunization. Medical history included gastrointestinal disorder and Bee sting hypersensitivity. Concomitant medications included multivitamins and vitamin D. The patient previously received MMR vaccine and hospitalization after MMR vaccine in 1989, unknown cause. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was breastfeeding at the time of this report. On 01Apr2021 at 15:00, the patient experienced swelling of right tonsil after about 13 minutes. Increased in intensity for both tonsils until about 25 minutes after shot. Possible tongue swelling (unsure). Never lost ability to swallow, breathe, or speak. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of swelling of right tonsil, tongue swelling was recovered on an unspecified date in Apr2021 and for other events outcome was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101084322 maternal/child case
I was feeing bad with   left leg pain, and arm soar. Later around  11:00 PM I started having shaking chills, more soar arm, and  fever, with low blood pressure . My PCP recommended me to take acetaminophen  and keep hydrated. Symptoms keep until next day 8:00PM.
Within approximately 25 minutes, began feeling very flushed in my face (face felt very, very hot). Rash on my cheeks and some on neck. For about five minutes, I felt an "awareness" of my throat (around the area in the front where the Adam's apple would be located. This went away.  I had the flushed rash for approximately 3 hours and then it  resolved and had no further issues. I did not seek medical treatment. I had mild symptoms from the actual vaccine. Soreness in right arm for approximately 1 day.
5/7/05 Received Td vaccine. Experienced tenderness and burning at injection site. 5/8/05 Redness and swelling of upper right arm. 5/9/05 Same symptoms but worse. Right arm induration 10cm.
A report has been received from a Health Professional concerning a female patient, who received FLUMIST quadrivalent, (intranasal), 0.2 Millilitres, Once/Single administration. FLUMIST quadrivalent, (intranasal) started on an unknown date. Patient reported that patient number three received the FLUMIST vaccine, 0.2 ml dose, one time intranasally, date of vaccination not provided. It was unknown if the dose of 0.1 ml was given in each nostril. Caller reported that the patient was a female. The caller was not comfortable given patient name, address, contact number, height, weight, relevant medical history or concomitant medications due for fear of HIPAA violations. Caller stated that patient safety may contact the HCP office for additional information if needed. The office refrigerator had a temperature excursion of 1.5 degrees C for a total of 17.5 hours. The temperature would be at recommended temperature range and then dip to 1.5 degrees C, then go back to original range. FLUMIST quadrivalent, (intranasal) was continued. The outcome of the event of patient number four given FLUMIST vaccine that underwent a temperature excursion and it is unknown if the dose of 0.1ml was given in each nostril was unknown. The report was considered to be non-serious.
Swelling near the area of ??the arm where it is injected. The Dr describes it as CELLULITIS. Administered antibiotic for inflammation, infection
was administered a dose of the havrix after a temperature excursion.; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 62-year-old female patient who received HAV (Havrix) (batch number 3A22R, expiry date 24th May 2022) for prophylaxis.   On 11th April 2022, the patient received Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 10-JUN-2022  Reporter's comment: Office manager reported that a patient was administered a dose of the Havrix vaccine after a temperature excursion. The reporter consented to follow up. Additional supportive information: The patient received Havrix vaccine after a temperature excursion, which led to incorrect storage of drug.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13May2021 as dose 2, single (Lot number: EW0177) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Ulcerative Colitis" (unspecified if ongoing). 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 "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of Covid-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included treatment with Paxlovid from 22Jul2023 to 26Jul2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300266008 Same patient, different drug/AE.;
Client had finished with the immunizations being given.  He walked out of the exam room with his mother and stopped at the station to receive updated records when he told his mother that he was dizzy.  He was hanging onto his mother when he passed out.  He was assisted to the floor by both his mother and phn.  Jacket was place under his head and feet were elevated in a chair.  Ice pack was then applied to the back of his neck.  After a few minutes, the dizziness cleared enough for client to sit up and place his back against the wall.  He was given orange juice to sip on.  He was then assisted up to sit in a chair. Once dizziness completly passed, client did stand at the chair.  No dizziness reoccured and client with his mother did go out into the waiting room and again sat for another 10 minutes, then left the facility.  Client was fully recovered.
Dizziness mild shortness of breath, asthma exacerbation Narrative:  used albuterol inhaler at home which did help.
Received Jansen COVID injection at approximately 11am 4/3/2021. Developed sore left arm, shoulder, and neck approximately 10 pm evening of 4/3/2021. Woke up 3:30am 4/4/2021 and informed parents he did not feel well-awake most of that night. Felt slightly better morning of 4/4/2021, but continued feeling feverish, pain in arms, shoulders, neck. Approximately 8pm Sunday night 4/4/21 he stated he felt it was hard to breath, chest pain, and his arms felt like they were on fire. Was taken to ER at Clinic. Blood pressure 149/98, temp 100.6 complain of feeling feverish and short of breath. EKG was taken which was abnormal and enzymes noted to be elevated. Transferred to main branch of  Clinic approximately 4:30am 4/5/2021. Father states patient has inflammation around the heart.  Had a cardiac catheterization today 4/6/2021-father  states that was normal and patient was started on medication to reduce inflammation around his heart.  Patients father states that patient was very drowsy from his catheterization and was fine with his father telling me the events as they occured.  As I was speaking with patient father, patient was going down for a MRI of the heart. This information was conveyed to me by father and mother. Patient is a college student and was home for Easter break.  Patient currently remains hospitalized in Clinic and father thought he would remain hospitalized until Thursday 4/8/2021 depending on test results and his response to treatment. Both parents state they are willing to be contacted for further information.
Received Hep#2 only 4 months after Hep A#1.
had the vaccine, had shingles later/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. 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 Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient had the vaccine and had shingles years later. The case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation was not given.
The patient developed worsening pain in the left upper extremity in the bicep region which became most prominent 2 months after her 2nd pfizer vaccine dose. Symptoms improved after 3.5 month
Received call from mom @ 1:29 stating "my son got shots at Southside yesterday now he has a rash all over his body and a fever."  Mom asked what the rash looked like just states "red".  "He keeps scratching", mom asked if she has given any Benadryl and if child is having any trouble breathing.  Mom states " yes I gave Benadryl, no trouble breathing." Asked mom if child still eating and drinking, mom states "not eating but drinking." Mom encouraged to keep child drinking, seek care of primary physician if uncomfortable. Mom was also encouraged to read VIS form as these two symptoms can be mild problems of the MMR vaccine.
no adverse event; Improper storage of product in use; This spontaneous report was received from an administrator referring to a 13-month-old male patient. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  It was reported that aricella virus vaccine live (oka/merck) (VARIVAX) was under temperature excursion (TE) on 05-NOV-2022. On 11-NOV-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5ml/once, lot #W011623, expiration date: 06-APR-2024, for prophylaxis (strength, and route of administration were not provided) (product storage error). There was no additional adverse event (no adverse event).
Localized swelling and redness confounding factor-patient also had generalized hives and was on amoxicillin. Improved with Benadryl.
Gave 5th Dtap to child after his 4th birthday. So Vaccine was invalid and given to young.
Reported on 6/20/12 that pt. had taken off work 6/15, 6/18 and 6/19 due to sore arms.  Pt. saw private MD on 6/19 with c/o that she had a reaction to immunizations given on 6/14/12.  MD documented that both arms had slight redness and induration at injection site, and gave her work release until 6/25/12.
Had first of the two shingles shot at 2:00 PM on 02/11/19. I had a scratchy throat that day and told the person administering the shot that, and she said that was okay as long as no fever. I did not have a fever so got the shot. By 7:00 PM my chest was tight, I was wheezing a bit, and coughing. Had a rough night and at 5:00 AM the next morning was experiencing strong nausea. Was able to get into the doctor at 8:30 AM on 02/12/19 who administered ZOFRAN for the nausea at 9:00 AM. Took a second dose of ZOFRAN at 10:00 AM at home, and the nausea subsided completely. At the doctor's office they gave me a nebulizer treatment for the wheezing and Albuterol inhaler. Was still coughing on 02/15/19 so went back to doctor and was given the Z-PAC and a cough medicine. Still coughing up phlegm 02/19/19.
5" circ, wheal hot & swollen w/nausea, emesis p/nausea & emesis cleared diarrhea & 2-3 days; 25AUG92 pt better x/sl diarrhea;
Fatigue, urinary incontinence, trouble walking hip pain, double vision. Patient express vaccine cause MS flare up. had these symptoms years ago from MS but had subsided until vaccine
A spontaneous report has been received from a Health Professional concerning a patient of unknown age and gender, who had been received FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on an unknown date. In November 2014, the patient was inadvertently administered FLUMIST quadrivalent to 7 children under 2 years of age is unknown. The report was considered to be non-serious by the reporter.
Pt rec'd tetanus shot. Had severe-pain lasted over 2 wks. Pain-left under arm (felt like shoulder out of joint) immediately after. July-woke up, felt like a shot had been given in sleep. Pain-swelling in arm. Unbearable at times, radiating to shoulder. Muscle spasms. Feels like arm is broken. 10/5/01 (nerve block) no results.
Axilla on right side is swollen with enlarged lymph nodes, redness, warm to touch, and painful.
Vaccine error: Vaccine was administered after the use by date ( though not after the expiration date) Since it was being stored in the refrigerator.
Meant to give Pfizer adult bivalent and accidentally drew up undiluted peds Pfizer, patient reports no adverse side effects