chrisvoncsefalvay/vaers-outcomes huggingface dataset:
heart failure; stated that his resting heart rate is 160; ejection fraction is still only at 20%; grossly enlarged heart; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization. The following information was reported: CARDIAC FAILURE (medically significant), outcome "unknown", described as "heart failure"; HEART RATE INCREASED (medically significant), outcome "unknown", described as "stated that his resting heart rate is 160"; EJECTION FRACTION ABNORMAL (medically significant), outcome "unknown", described as "ejection fraction is still only at 20%"; CARDIOMEGALY (non-serious), outcome "unknown", described as "grossly enlarged heart". The patient underwent the following laboratory tests and procedures: ejection fraction: 20 %; heart rate: 160, notes: his resting heart rate is 160; echocardiogram: unknown results. Therapeutic measures were taken as a result of cardiac failure, heart rate increased, ejection fraction abnormal, cardiomegaly.  The wife reported that her husband experiencing heart issues shortly after his second dose of Pfizer vaccine. Her husband had it and her daughter when it was appropriate for their age group and her husband had been battling this since then. His resting heart rate was 160 which caused his heart to be grossly enlarged. He had heart failure for a few months from continued rapid heart rate. He had to have a defibrillator to control it and that he had been placed on Entresto. He had another echocardiogram last week and he went to see the cardiology surgeon to get the results. His ejection fraction was still only at 20% and they were saying that there was no other viable treatment other than putting him on the transplant list. She heard that it was mostly in younger men and she had her entire family vaccinated.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Diffuse erythematous papules on scalp, face, arms, trunk, legs, feet. Erythematous papules merging together on cheeks, hands and feet.
severe hot and cold chills a few hours after the vaccine then flu like symptoms, high temperature sometimes reaching 104, sore body, hot and cold, burning skin, hardly able to move swollen lymph nodes under armpit on same side as vaccine (left) metallic taste in mouth day 2,3,4
This spontaneous report was received from a pharmacist and refers to a 68 year old female patient. No pertinent medical history or concurrent condition were reported. On 13-OCT-2015, the patient was vaccinated with ZOSTAVAX (lot # L0011529, expiry date 03-JUL-2016) through an unknown route. On 13-NOV-2015, the patient was once more vaccinated with ZOSTAVAX (lot # L026414, expiry date 15-OCT-2016) along with concomitant administration of an unspecified trivalent high dose flu medication. On 14-NOV-2015, the patient contacted the pharmacist with complaints of fever, body aches and eyes feeling weak (like general malaise as per pharmacist). The patient sought medical attention and did not receive any treatment for the events. On 15-NOV-2015, the patient's symptoms were less. The reporter referred the patient to her primary care physician. The outcome of the events were reported as recovering. The reporter did not assess the causality of the events with ZOSTAVAX. Additional information has been requested.
vaccine was administered to patient after a temperature excursion of minus 1.25 degree Celsius, no AE; Initial information was received on 03-Aug-2020 regarding an unsolicited valid non-serious case from the other health care professional.  This case is linked to cases 2020SA203233, 2020SA202232, 2020SA202350, 2020SA202831, 2020SA202832, 2020SA203422, 2020SA203423 and 2020SA207050 (same reporter).  This case involves an 11 year old male patient who was vaccinated with a 0.5 ml dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (batch number and other dosing details were not reported) in the right arm on 28-Jul-2020 for prophylactic vaccination after a temperature excursion.  The patient's medical history, past treatment, vaccination and family history were not provided.  The patient did not receive any other vaccine at the same visit.  This was a case of an actual medication error case due to product storage error temperature too low.  It was reported that, the refrigerator got too cold many times due to possible batteries issues, got to frozen temperatures several times, with a minimum of minus 1.25 degrees Celsius.  No adverse event was reported at the time of reporting.  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 the batch number for this case.
POTS LIKE SYMPTOMS MAJOR DROP IN BP 10-60 POINT WHEN GETTING UP FROM LYING DOWN OR SITTING TACCHARDIA IF JUST MAKE BED OR VACCCUUM BLOOD PRESSURE AND PULSE UP.......ON BETA BLOCKERS NEVER THE CASE BEFORE  WORSE HEADACHES MUSCLE PAINS SOB EXTREMELY BAD NOW PRESSURE FIRST TIME LOW AT TIMES AS LOW AS 88/38  AS HIGH AS 197/100 UPON WAKING AND OCCAS DURING DAY. NEVER HAPPENED BEFORE UNLESS HAVING PANIC ATTACK. EXTREME WORSENING OF DEPRESSION.EMOTIONAL AND CRY OFTEN. VERTIGO DIZZY IF GET UP AND DO NOT WAIT A MINUTE.  OFF BALANCE. MY SLIGHT TREMOR MORE PRONOUNDED AT TIMES,HOME OFTEN NO STAMINA NO LIFE  SO SCARRY.........I NEVER WANTED TO TAKE BUT HAD TO FLY
Pt presenting to ER with reaction to COVID vaccine. She states she got the vaccine on Friday and noted a sore R arm with a burning sensation on Saturday. She then awoke at 0300 Sat morning with R sided facial swelling. Here R eye was swollen completely shut, she had upper and lower lip swelling, tongue swelling and a fire-like burning sensation to the R side of her body. She states she started taking benadryl. She states she was drooling which did improve with the benadryl. She has continued the benadryl and the swelling to the eye and lip improved. She is noted to have marked swelling to the R side of the face. She is able to speak and swallow without issues at this time. She is noted to have tachycardia and a temp of 100.
Patient states has had an abnormal trigger in fibromyalgia symptoms starting two weeks post dose #1 of vaccine. Patient believes fibromyalgia was doing fine prior to shot, now has tingling feeling down back and arms.
within 5 min, pt reported feeling dizzy and lightheaded. No loss of consciousness. Pt also reports  having eaten  M and Ms as only food today. Pt happened to have a pulse ox on self (is an RT). SaO2 96% on room air, pulse 94. Pt given some trail mix and water and began to feel better. Upon standing pt reported not feeling well again and returned to seated. Pt then began with jerky muscular movements of upper extremities and stuttered speech. Pt states that this is how her PNES presents.  No loss of mentation or consciousness. EMT team called for transfer to ER. Pt alert and oriented on transfer
Delayed reaction; arm was red and itchy near the site of the injection site; Described the itchiness as "not persistent, just a little subtle."; Headache and fatigue; Fatigue; A spontaneous report was received from a consumer concerning a 67-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headache and fatigue,delayed reaction, arm was red and itchy near the site of the injection site, described the itchiness as not persistent, just a little subtle.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 3 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 031L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 3 Feb 2021, the patient experienced the events headache and fatigue. On 4 Feb 2021, the patient continued to experience fatigue. On 10 Feb 2021, the patient experienced a delayed reaction, arm was red and itchy near the site of the injection site, described the itchiness as not persistent, just a little subtle.  Treatment details included acetaminophen.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events headache and fatigue,delayed reaction, arm was red and itchy near the site of the injection site, described the itchiness as not persistent, just a little subtle were unknown.
Has raised rash on chest and arms that causes intense itching off and on. This also occurred last year after flu shot. Seen doctor on  11/16/2005 started on Zyrtec and will stop levothy roxine 50 mcgs x 7 days and will try different generic thyroid. Prior to next years flu shot to start Zyrtec x7 days.
Short of breath; because of migraine my eyes I have hard time to read; lips were swelling; my tongue was swollen and tingling; my tongue was swollen and tingling; tight chest; I am still using my accessory muscles, high in the chest to breathe; This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: FH8020), intramuscular, administered in Arm Left on 12Oct2021 at the age of 63-year-old as dose 1, single for covid-19 immunisation. Medical history included allergic to phosphate, sulphate, total right shoulder replacement surgery in June end, gained weight since going off with Topiramate (The reason of going off patient was 180 in January) and patient had stage three kidney disease which was apparently from Tramadol and 'Omni Prozac' generic 45% (not clarified,  Patient nephrologist told me, in January with Psychiatrist, put down dose from 200 milligram and patient finished the last dose a month ago and she went from 3 tramadol a day to 2 and next time it will be moved down to one). The patient was on a lot of medication. On 12Oct2021 patient received vaccination, she stayed there for 30 minutes and was already having the migraine as she was leaving and 30 minutes after, she was having shorter breath and the tight chest and took the quick acting inhaler and it helped to open up the tightness but remains short of breath for 6 hours. The patient's lips were swollen and tongue was swollen and tingling. She have been taking a 100 mg of Benadryl since before the shot. They were out of Moderna and Pfizer has Phosphate in it. So, her doctor told to bring Benadryl and quick acting inhaler. she had short of breath and needed the quick inhaler three times since 12Oct2021. Patient took 100 milligrams of Benadryl about every 6 to 8 hours and quick acting inhaler (Levalbuterol Tartrate HFA) that does not have Sulphate in it. Patient still using accessory muscles, high in the chest to breathe. Patient was concerned about the 2nd dose in a month, and it will be right after her physical therapy appointment. The outcome of the events was unknown.
This spontaneous report as received from a medical assistant refers to a male patient of unknown age. The patient's not reported. The patient was vaccinated with GARDASIL 9 first dose on 12-JUL-2016 and second dose on 21-SEP-2016 (dose, route and site of administration was not reported for both doses). The third dose of GARDASIL 9 (lot # M023169, expiration date 13-JUN-2018; dose, route and site of administration was not reported) was administered earlier than recommended - on 18-OCT-2016 (also reported as 18-OCT-2018). No adverse event was reported. Additional information is not expected as no consent was given for further contact.
Pt recvd 3 doses of Engerix-B vax & 3OCT91 found to be a non-seroconverter;
73 year old male, vaccinated with the Janssen Covid-19 vaccine at the time of hospital admission (5/31/21) for a  type 3 odontoid fracture; C2 vertebral body fracture extending into bilateral transverse foramina and nasal bone fracture from a fall from standing. Admitted to the trauma service for pain control. Noted to be somnolent throughout admission. On 6/2, developed AKI, likely related to dehydration vs. contrast nephropathy. On the early morning of 6/3, found unresponsive. Given naloxone 0.02 mg x 3 with no documented response. Transferred to the ICU, intubated and had PEA arrest on induction for intubation. CPR was initiated and he received epi x 1 with ROSC within 3 minutes. Remained intubated and sedated in the ICU with labile pressures on 2 pressors throughout the day on 6/3. The patient expired following compassionate extubation 6/3 2211.
flu vaccine was given on 10/18/01 at 9:30 AM in the school based Health Center. It was then discovered that the vaccine had expired on 06/01. The client was notified and he denied any symptoms or effects. The Health Dept was notified as well as the manufacturer. The client's family Dr is aware and agreed that the client should be revaccinated, client to return next week.
sore throat; This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the  left arm on 01Apr2021 at 10:30 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included the patient was tested positive prior to vaccination. Concomitant medications were not reported. The patient had no known allergies to medications, foods or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021, a week after vaccination, the patient experienced a terrible sore throat that was not going away. The adverse event did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. The patient did not receive any treatment for the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore throat was not recovered at the time of report.   No follow attempts are possible; information about lot/batch number cannot be obtained. No further information expected.
Pt has received both doses of the Moderna COVID 19 vaccine and reached 2 weeks post vaccination.  On 5/15/2021, pt tested positive for COVID-19 during routine admission screening.  Pt was admitted for a non-COVID 19 reason and was asymptomatic.
patient reports swollen, red, and warmth about 4-6 inches of injection site.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Feb2021 at 12:00 as dose 1, single (Lot number: EN6201), in right arm, on 13Mar2021 at 12:00 as dose 2, single (Lot number: EN6204), in right arm, on 09Sep2021 at 13:00 as dose 3 (booster), single (Lot number: fc3182), in right arm and on 25Mar2022 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Presumed allergy to Penicillin" (unspecified if ongoing), notes: Known allergies: Presumed allergy to Penicillin. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (04Jul2022) Negative, notes: I tested negative on the 4th, the 5th and the 6th; (05Jul2022) Negative, notes: I tested negative on the 4th, the 5th and the 6th; (06Jul2022) Negative, notes: I tested negative on the 4th, the 5th and the 6th; (10Jul2022) Positive, notes: 10th, we both tested and were both positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient did not receive any other medication in 2 weeks.  Anti-viral details: Product: COVID 19 Treatment, start date: 02Jul2022, Stop date: 06Jul2022, Lot: FX3874 for treatment of COVID-19). Patient waited until three days after she finished the Paxlovid 5-day course. (4Jul), and She was tested negative on the 4th, the 5th and the 6th. Then on the 9th, my husband started to cough and had a fever and in general looked like heck. SO, on the a.m. of the 10th, we both were tested and were both positive again.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
After receiving immunizations child became very upset and was crying. Told mom he had difficulty swallowing and c/o of sore throat. Developed hives on face and subsequently spread to other areas of his body. Lungs were clear and no wheezing noted. Given 25mg Benadryl IM.
Nausea and fever of 103.1. Fever broke at ~9:00 PM on 11/02, nausea/vomiting ceased at 10:00 AM on 11/03 but fever of 100.4 remains as of 9:00 PM on 11/04.
Pt presented to clinic for catchup shots. DOB so it was thought that pt was one year and this was not verified by the clerk nor the nurse. Pt was given 1 year vaccinations at 10 months by mistake. Pt moth was contacted the next morning and informed. Mother stated that pt was "grumpier than usual" but was otherwise doing well. I informed her that MMR, Varicella, and Hep A would need to be repeated. Pt mother verbalized understanding.
I was given my 2nd dose of Covid-19 vaccine on 10 Feb 2021 at about 0800 am, I stayed at the facility for 15 minutes and did not have any issues at that time. My arm was a bit sore and I felt tired for a couple days following the 2nd vaccine.  On 12 Feb early afternoon (around 1100am), I noticed I was dizzy and feeling a bit nauseated like I had motion sickness.  I already had the following week off work, so I napped when I could. I have been tired as well.  I have been experiencing waves of dizziness daily now since 12 Feb (today marks the 12th day). I spoke with my PCM's team at the Spokane VAMC and they recommended I try to take Meclizine at night to see if I improve. I was advised to have someone drive me to urgent care if my condition worsens where I lose consciousness, faint, or cannot stand up straight.
Headache and fever (lasting about 24 hours) and extreme muscle fatigue, tiredness/weakness, sweating, difficulty breathing, upset stomach still present as of 10/9/17.
Food tastes bitter; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Food tastes bitter) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSGEUSIA (Food tastes bitter). At the time of the report, DYSGEUSIA (Food tastes bitter) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.
Information has been received from a nurse, referring to four unspecified patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant therapy were not reported. On 30-AUG-2017, the patients vaccinated with the improperly stored VARIVAX (lot # N000682, expiration date of 06-JAN-2019; route, dose and frequency were unknown) reconstituted with properly stored sterile diluent (manufacturer unknown), for prophylaxis (incorrect product storage). No adverse effects were reported. The administered doses of vaccine was underwent the temperature excursion from 47 to 77 degrees Fahrenheit for 2 hours. No previous temperature excursions was reported. Data logger was involved. No product quality complaint (PQC) was involved in this case. This is one of four reports received from the same reporter. Sender's Comments: US-009507513-1709USA009699: US-009507513-1709USA000552: US-009507513-1709USA009698.
Chills, fever 100.1, nausea, headache, body aches Recovered within 24 hours
Went to ER for headache. Got CAT scan.   Scan showed nothing  but ER doctor said to watch it because it might come back.  Headache lasted gir two weeks thereafter and balance was affected.
Woke up in middle of night with fever, chills, teeth rattling, nausea, dizziness, weakness. Took acetaminophen  and some anti -nausea drugs I had on hand.  Fever left, but returned next night.  Weakness, no appetite stayed for two days.  Thought it was the flu, but no upper respiratory symptoms.  Thought it might be Covid-19 but tested negative.  Finally decided it was a reaction to the vaccine.
On March 12th, a rash developed on my left shoulder.  Over the next 2 days, the rash grew, was painful, hot and itchy.  On Monday, March 15th, I went to the doctor and was prescribed Clindamycin and a topical cream - Clovetasol Propionate.  The rash has improved as of today, March 17th, but is not gone and has traveled further down my arm.
Information has been received from a certified medical assistant concerning a 7-month-old male with no medical history or allergies who on 10-AUG-2006, 12-OCT-2006 and 14-DEC-2006 was vaccinated PO with the first, second and third doses, respectively of Rotateq vaccine (human-bovine) (lot#s 65424B/0577F and 655484/1032F - administration dates not specified). There was no concomitant therapy. The CMA reported that on 26-JAN-2007, the patient presented with a rash and vomiting. The patient was diagnosed with an ileocolic intussusception that could not be reduced by Barium enema. The patient was subsequently hospitalized and surgical correction was pending. No laboratory/diagnostic tests were performed. At the time of this report, the outcome was unknown. The CMA also considered the patient's rash and ileocolic intussusception to be life-threatening and other important medical events. Additional information has been requested.  2/22/07 Received medical records from hospital which reveal patient experienced acute onset abdominal pain & vomiting.  Hospitalized from 1/26-1/30/07 after being transferred from outlying hospital.  BE done x3 at outlying hospital revealed intussusception but was unreducible & so subsequently transferred to higher level of care for management.  Air enema done at second hospital also unsuccessful at reducing.  Taken emergently to OR for exp lap & reduction w/appendectomy.  Uneventful recovery & was d/c to home to be f/u w/peds surgeon & PCP. FINAL DX: Ileocolic Intussusception, surgically reduced.
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Additional Details: patient experienced rash, followed with burning pain sensation. went to ED for follow up and they diagnosed as infection. rash is located on right upper arm posterior away from the injection site which is upper arm right deltoid. rash has continued to enlarge over past 2 days to 3 inch by 4 inch circular welt/rash on back of upper arm.