chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I received my first dose of Pfizer-BioNTech on 1/21/21, after which I felt little effect besides mild dizziness and facial flush right after administration (which I've experienced after other vaccines, esp. HPV). However, after my 2nd dose on 2/11/21, I began to feel persistent fatigue, mild for the first week, then severe since. On 2/21/21, I developed a deep achiness in my arms and legs, which eventually became a more superficial tingling in my limbs and mouth that still persists to this day. I also became suddenly exercise intolerant, fatiguing quickly and experiencing severe PEM (post-exertional-malaise). I have always been a high-level athlete, and I was suddenly unable to even go for an easy jog on 2/22/21.
little bit of itching on skin; This is a spontaneous report from a contactable consumer (patient).   A 51-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date, at the age of 51-years-old, (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient experienced have a little bit of itching on skin. The outcome of the event was unknown.  No treatment was received for the events.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Initially, patient stated a sore arm after vaccination. after 24-27 hours elapsed, pt states having some radiating pain from the shoulder to the neck of the left side, and radiating pain from the right knee to the right food. Each bout of pain would last to a maximum of 30 seconds, with varying lengths of time per bout. The pain radiating to the foot was pulsating per patient. Patient stated very sensitive chest feeling when the urge to urinate came. Through the emptying of the bladder, the sensitivity continues, and is gone after urination is finished. There can be some radiating pain from kidneys to the bladder at this point too.
1. Severe arm pain starting at 7:00pm the day of the shot - unable to lay on side, unable to reach for anything, every movement or even my shirt brushing against it is painful, this is still persisting 2. Large red patch at injection site starting a few hours after the shot; this has gotten larger over time 3. Chills/aches/shivers starting at about 8:00pm the day after the injection; feels very flu-like although no fever 4. Nausea starting at about 8:00pm the day after the injection
Initial information received on 26-Mar-2019 regarding an unsolicited valid serious case from Pfizer (Non Licensed Partner) (MFR Control No: 2019019036) via other health professional. This case involves a 16 years old male patient who fell off the exam table and split his head open on the floor, fainted and lost consciousness, while he received vaccines TRUMENBA, INFLUENZA VACCINE and MENACTRA. The patient's past vaccination(s) and family history were not provided. Notes: Patient had no history of previous adverse reactions to vaccines, fainting or seizures. Patient was well, and not sick that day. On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect TRUMENBA not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient fainted and lost consciousness (syncope and loss of consciousness) about 3 minutes after administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE, INFLUENZA VACCINE and TRUMENBA. These events were assessed as medically significant. It was reported that the patient fell off the exam table (fall) and split his head open on the floor (head injury). It was also a actual medication error due to extra dose administered (of MENINGOCOCCAL vaccine). It was reported that the patient received 3 vaccines at the same time (flu, MENACTRA and TRUMENBA) The patient was taken to the hospital. The EKG and scan were normal. The patient received sutures, and will follow up to the clinic. The outcome for any of the event was not reported. List of document held: none; Sender's Comments: This case concerns 16 years old male patient who experienced syncope after vaccination with MENACTRA, TRUMENBA and a  INFLUENZA VACCINE. The time to onset is not clearly defined. Patient had no provided history of previous adverse reactions to vaccines, fainting or seizures. Patient was well, and not sick that day. The EKG and scan were normal. Additional information regarding concomitant medications, lab tests excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Pt fainted after telling wife he feels unwell, then passed out in wheelchair & didn't recall event.  BP 99/60. Pt reported feeling nauseous & eye twitching.  Given 8oz apple juice & graham crackers & 8oz water.  After 25 min pt reported feeling better but tired. 1.5hrs after vaccine given pt was escorted to car with family and informed to follow up with PCP. Per pt's wife, pt had flushing with first dose
Sudden onset extreme fatique, muscle and joint aches, chills, fever (max of 101..6 on day 2), sinus congestion, rattle in chest on fully exhaling, hyper-sensitive skin.  Sinus congestion improved upon taking generic Zertek; could be due to seasonal high pollen and unrelated to Covid or vaccine.
Rash, enlarged lymph nodes, not feeling well, dizziness, itching lt neck enlargement; h/a;
MMR given 10/13/99 with c/o red, blotchy rash for 1 week. Seen by Dr. on 10/27/99 and dx'd w/MMR reaction.
Day 4 nodule in left collarbone Congestion Extreme fatigue Covid Arm - injection site swollen, itchy and red Dizziness Headache Ringing in the ears  Days 4 - present Nodule in collarbone Lymph nodes swollen in neck, collarbone, breasts, bellow breast, chest, armpits (both sides) Runny eyes Congestion in chest, face and head Popping ears (full) Dizziness  Extreme fatigue
This spontaneous report as received from a nurse refers to a  patient of unknown age and gender. A nurse reported that an unspecified number of unknown patients have been administered doses of PNEUMOVAX23 lot # K008409, expiration date 04-MAR-2016, intramuscular tha have underwent a temperature excursion. It was reported that PNEUMOVAX23 was stored at both 47.1 Fahrenheit degrees for 96 hours and -5 Celsius degrees for 48 hours. PNEUMOVAX23 lot # K008409 was given on 10-NOV-2014, 14-NOV-2014, 18-NOV-2014, 19-NOV-2014, 24-NOV-2014, 01-DEC-2014, 09-DEC-2014, 12-DEC-2014 and on 17-DEC-2014. No adverse effects reported. Additional information has been requested. This is one of several reports received from the same reporter.
chest pain- similar to heart attack. blood work, ekg, - elevated triponin enzyme, and inflamation.  hospital stay- two days until levels went down.  -  myocarditis
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. During 2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 04-APR-2016, the patient was treated at a hospital, for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as severe herpes zoster, or shingles. 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. Additional information has been requested.
pneumonia; chest hurt; asthma; and fever since the end of May.; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (pneumonia) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 03-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion medically significant), CHEST PAIN (chest hurt), ASTHMA (asthma) and PYREXIA (and fever since the end of May.). At the time of the report, PNEUMONIA (pneumonia), CHEST PAIN (chest hurt), ASTHMA (asthma) and PYREXIA (and fever since the end of May.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Aug-2021, Heart rate: high (High) increased.         No concomitant medication information was provided No treatment product information was provided  Company comment: Very limited information regarding these events have been provided. Further information has been requested.; Sender's Comments: Very limited information regarding these events have been provided. Further information has been requested.
Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medication were not reported. On an unknown date in Jul 2016 the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # L002310, expiration date 08-JUL-2016, dose and route unknown). No adverse event was reported. Additional information has been requested.
Nausea; Shoulder and arm pain -left and right side; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), MYALGIA (Shoulder and arm pain -left and right side) and VOMITING (Vomiting) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027BZ1A and 042B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (amoxicillin). Concomitant products included HYDROCHLOROTHIAZIDE, AMLODIPINE BESILATE (NORVASC), MULTIVITAMINS [VITAMINS NOS] and BIOTIN for an unknown indication.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced VOMITING (Vomiting). On 14-May-2021, the patient experienced MYALGIA (Shoulder and arm pain -left and right side). On 15-May-2021, the patient experienced NAUSEA (Nausea). At the time of the report, NAUSEA (Nausea), MYALGIA (Shoulder and arm pain -left and right side) and VOMITING (Vomiting) outcome was unknown.            Concomitant medication includes Potassium Chloride pill. No treatment medication was provided.
He developed a full body rash, red like bumps and blotchy. Very itchy. Bumps were in his mouth and everywhere. He was put on Steroids and Benadryl Rash is still resolving. He hasn't needed Benadryl in 2 days and is almost done with the steroids No respiratory issues
This spontaneous report as received from a medical assistant and refers to unspecified patients of unknown ages and genders. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patients were vaccinated with a dose of improperly stored PROQUAD, (which had a lot # of M033210 and an expiration date of 09-JAN-2018; however, dosage number and route of administration were not reported), for prophylaxis. Nevertheless, no adverse effects were reported. It was unknown the temperature excursions for vaccines, however it was identified due to a data logger. Furthermore, no product quality complaint was involved. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1612USA013794.
on 28JUL began having spells that would last approx 3 seconds; would get very stiff, arms & legs rigid & have a blank stare; color would turn red; afterward would cry; had a # of these episodes over 5 day period; no fever;
pt recv vax 25SEP95 & by 26SEP95 pt had devel cellulitis below the inj site;tx w/ATB;pt recovered;this is one of tow patients from this site who devel cellulitis p/vax;
MA,  gave a pfizer COVID booster to patient on 6/24/2022 at 11:18am that had expired on 6/24/2022 at 4:00am.
Sedation, NauseaVomiting, arm pain Narrative: First dose 12/24/20-noted mild arm pain and fatigue. Second dose 1/20/21- severe nausea, pronounced fatigue and arm pain. Missed work x 1 day. Symptoms improved to full resolution by 1/23/21. Prior COVID infection mid-late November 2020.  Other Relevant History:
approx 1hr p/vax pt reported itching & onset was 15min p/inj was flushed, fine red rash about chest, neck, arms;DPH given;BP 142/110, P104, R20;
Heavy menstrual cycle, pelvic ultrasound, heavy clotting with periods, BD affirm, CBC, CMP, PT, T4, LH, Urine culture. Referrals gynecology, endocrine, hematology.
fever of 38.6; chills; puking; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 38.6), CHILLS (chills) and VOMITING (puking) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever of 38.6), CHILLS (chills) and VOMITING (puking). At the time of the report, PYREXIA (fever of 38.6), CHILLS (chills) and VOMITING (puking) outcome was unknown.            No treatment medication information was provided. No Concomitant medication information was provided.
shortness of breath; dizziness; fast heart rate; This is a spontaneous report from a contactable consumer, a patient. A 28-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: ER8727) via an unspecified route of administration in right arm on 24Mar2021 at 15:15(at the age of 28-years-old), as a single dose for COVID-19 immunisation. The patients medical history included asthma and he had no known allergies. The concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR) for unknown indication from unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route of administration in left arm on 03Mar2021 on 15:45(at the age of 28-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Mar2021, the patient underwent the nasal swab and PCR test for the COVID-19 virus test and was tested negative. On 24Mar2021 at 17:00, the patient experienced shortness of breath, fast heartbeat and dizziness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the events. The clinical outcome of the events shortness of breath, dizziness and heart racing was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
gave dose that was expired; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 20-year-old male patient who received HAV (Havrix) (batch number X989B, expiry date 14th June 2020) for prophylaxis.   On 30th June 2022, the patient received Havrix. On 30th June 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 7-Jul-2022 Reporter's comment: Nurse reported that a staff member gave a dose of Havrix to a patient which was already expired. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up via email.  Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used.
75 Y/O female, PMHx of DM, Lupus, and atherosclerosis of abdominal aorta, admitted for SOB, N/V, and intermittent chest pain. Pt tested positive for Covid19 on 11/1/21. Covid treated with Regeneron, Decadron and supportive measures, possible MI treated with heparin drip. Discharged on 11/6/21.
Information has been received from a physician concerning two female children 4 to 6 years of age who were vaccinated with the second dose of varicella virus vaccine live (Oka/Merck). Subsequently, the patient experienced redness, pain and swelling at the injection site. Additional information has been requested. This is one of several reports from the same source.
crying started about 1 hrs p/#2 DTP/HIB/OPV given & lasted until next AM; pt cont to be fussy next day; t102 for 2 days; sore leg;
My husband developed flu-like symptoms (102.2 fever, chills, aches) within one hour of PPV shot.  He received PPV shot last year as well... we didn't realize it wasn't an annual shot.  The administrator never mentioned this before he received the shot, only after.
Rash, ErythemaMultiform, p vaccine day 1-3 soreness. 1/11 rash, redness and lump to injection site. warm to touch and bothersome. Narrative:  p vaccine day 1-3 soreness. 1/11 rash, redness and lump to injection site, warm to touch and bothersome. Taking benedryl and aleve PRN. Enouraged to contact PCP if symptoms worsen or is not relieved past day 10 p vaccine.
Severe headache/migraine top of head and frontal forehead, drop in blood pressure when changing position, fainting, extreme fatigue, mood changes. MRI, CT of head and lungs, lots of blood work, EKGs, EEG, Holter Monitor for 24h and 30 days, nerve test and tilt test. I?m now on Ajovy shot and Zomig for migraines. Multiple vitamins for deficiencies. Increase in salt, water, electrolytes and support socks. Been on several meds to increase blood pressure and/or decrease sinus tachycardia but nothing has worked. Going to start Midodrine. I no longer can drive or walk more than 5 minutes, clean, shower etc without fainting
Patient went from sitting to standing and became dizzy & felt faint. He instructed patient to have a seat & gave water.
Diffuse, edema and erythema with minimal soreness to injection site on (R) deltoid measuring 2x2 inches.
Patient received dose of a vaccine from an expired vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose of a vaccine from an expired vial) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose of a vaccine from an expired vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received dose of a vaccine from an expired vial) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported No treatment medication were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-122422, US-MODERNATX, INC.-MOD-2021-122517, US-MODERNATX, INC.-MOD-2021-122557 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-122422: US-MODERNATX, INC.-MOD-2021-122557:
08dec88 pt vax hep B. & pt exp numbness in lt arm. 05jan89 2nd vax. in JUN89 pt exp numbness in shoulder. 08jun89 pt 3rd vax. in july numbness increased to legs.md states that condition related to vax.
Child inadvertently given vaccine dose for age 6 -11.  Child is  large for age.  Child tolerated the vaccine well.
7x5 cm erythematous patch on Lt upper arm at injection site. No raised papilla, red streaks or swelling.
upper left  chest tightness and intermittent pain and radiate to shoulder;   did not visit doctor and hope it will go away, but it seems lingering almost a week now..
Agitation suicide attempts lost all time for four days. Had to be restrained. Doesn?t even remember shot. Walked out of house and doesn?t remember
Breakthrough case admission after 2 vaccines Pfizer 5/22/21 lot# EW0183;  Pfizer 6/12/21 lot# ER8733
This spontaneous report as received from a certified medical assistant (also provided as nurse) refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates between 06-AUG-2016 and 09-AUG-2016, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection, lot # M000442, expiration date: 31-MAR-2018 and lot # L027733, expiration date: 13-SEP-2017, (dose, dose number, route of administration and injection site were not provided). There were no concomitant medications reported. It was stated that the vaccine underwent temperature excursion of 48 degrees Fahrenheit for 1 hour 6 minutes. The temperature excursion was captured using digital data logger. No previous temperature excursion was reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient was admitted on the date of 9/13/21 and underwent a TAH with BSO for severe pelvic pain not relieved with conservative management, a large hemorrhagic ovarian cyst and h/o recurrent ovarian cysts, and large fibroid uterus. Hospital stay for 2 days then discharged. Hospital admission within 6 weeks of receiving the COVID vaccine.
Irregular periods. I had a normal period Feb 10 (after 1st dose) which was 30 days after previous period which was normal cycle for me since recovering from covid but did not have normal cycle again until April 25, and cycles now seem to be 35 days long. Blood work and monitoring done by OBGYN, has not yet resolved.  Also experience hair loss similar to experience after having covid but less intense. Still experiencing.
Extreme unrelenting headache and neck pain. Inability to eat and drink. Extreme fatigue.
We administered the Pfizer Adult Vaccine to the 9yrs old patient, but only 0.1ML. At the time the patient came in, parents were requesting the vaccine and it was just approved and we thought we could use the Pfizer Adult vaccine but just administer half the dose. After we realize that Pfizer had a different vaccine for adults and pediatrics.   We called patient to check for any reaction to vaccine, but patient was feeling good and had no reaction or other symptoms.
Chills & fatigue, 24 hours after vaccination. Lasted about 16 hours