chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Breakthrough covid + on 10/1/2021. First vaccine dose 4/9/2021, possible error with Lot # listed, correct number could be ER8737?  A 67 YO F presented to the  ED on 09/30 with complaints of multiple ground level falls in the past 2 days. Pt says that episodes feel like weakness where she sinks into the ground and her legs give out from underneath her. Pt endorses +urinary incontinence, neck pain, and ankle pain.
Pt. states that after receiving the 1st dose of Moderna 10/01/2021, started experiencing symptoms 10/06/2021 of continuous menstrual (changes light/heavy). Gynecologist visit 10/26/2021 recommendations of Observation. Still continuing to experience symptoms.
Patient reports tingling within a minute of administration and spreading sensation and numbness  down her arm to her fingers.  Patient stayed in store for 15 minutes, then an additional 15 minutes due to the development of the adverse event.   When patient left in her car, she started feeling a little warm.  After 5 or 10 minutes she felt a discomfort and eventual "lump in her throat".  Throat tightness ensued similar to an asthma attack, producing a deep ruby red in back of throat with tonsils swollen.  Patient pulled over, experiencing lightheadedness.  Patient describes this as an anaphylactic response.  Her reaction did not worsen but did not immediately improve.  Patient was on phone with husband until arriving home.  She then took a diphenhydramine (about an hour and 15 minutes after the administration of the vaccine).  Her throat discomfort started getting better but arm pain worsened, numbness turning to pain.  Patient went to doctor on 4/15 at about 11:30am.  Patient main issue was arm pain with restricted range of motion at time of dr's visit.  Throat was improved but less severe.  Dr instructed her to not take second dose.
4 inch circular swollen, red, itchy, painful injection site. Much better day 6 but still there. Flu-like symptoms day after injection, fatigue, headache, eyes hurt, chills no fever
Pfizer-BioNTECH Covid-19 Vaccine EUA Upper arm ?shoulder pain. Shaking chills, Body aches. Started at 1 a.m. on 3/23/2021. Tylenol 1000mg taken at 5a.m . Chills and muscle aches lasted until 12 noon. Deeling tired and very mild muscle aches continue. Tylenol 1000 mg taken at 4pm.
This was not a major adverse event, but I thought CDC should have for its records.  The shot was Wednesday, September 15 at 4:30 pm.  The next morning I had a very sore arm.  In the course of the day I developed  a minor fever and a headache.  I treated these with IBuprofin as recommended, and the drug seemed to work.  I went to bed very chilled on the night of September 17, but awoke on September 18 with no fever or chills.  I should note that I also had a flu shot for seniors on September 16.  All in all, it was a little more painful with more fever, if mild, than the second shot.  I just wanted you to have complete records.
Booster shot 1:10 pm, middle of the night(am of 12/11/2021)-sweating, chills, weakness, feeling cold, muscle weakness, nausea, severe head ache, pain in left arm at injection site & swelling. Day of 12/11/2021- measured fever of 103, fever, sweating, chills, severe headache, nausea, weakness. 12/11 later that day(7 pm)took a Tylenol,  fever started going down 102,100,99,98.6. side effects started going down. Left arm at injection spot still sore.
Patient received varicella on 2-3-06 & on 6-30-08, diagnosed w/ varicella disease.
Information has been received from a nurse referring to unspecified patients of unknown age and gender. The patient's concomitant medication, medical history and drug reactions/allergies were not reported. On unknown dates, the patients were administered an unspecified umber of improperly-stored doses of RECOMBIVAX HB 10/1.0 microgram/ml (lot # M032649 with expiration date 11-NOV-2018, lot # L048848 with expiration date 09-AUG-2018; dose unknown) intramuscularly. No adverse effects were reported. Additional information has been requested.
After the shot my baby's leg got red and swollen. After crying hard she turned so red and developed petechiae looking rashes on her legs.
Patient developed the classic COVID symptoms at 1.5 days after receiving the vaccine.  He had a fever ranging from 100.3 to 100.8 for almost 24 hours, cough, headache, lethargy, running eyes, clear runny nose and late in the evening what appeared to be the beginning of conjunctivitis.   Typical to most vaccine responses, he woke up on 11/13/21 without any symptoms.  I am reporting this because I have read that children did not report many symptoms with vaccine 1 and his symptoms included eye redness, inflammation and matter along with a runny nose which are not considered side effects of the vaccine at this time.  His response was much more pronounced compared to all other family members but cleared up just as quickly.
Initial information received on 02-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 5 years old male patient who received expired dose of vaccine received vaccine DAPTACEL lot C5041BA, expiry date: 02-Sep-2018, unknown route in the right deltoid On 01-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included INFLUENZA VACCINE (INFLUENZA) for Immunization; (ENDERS-EDMONSTON), (JERYL LYNN), (OKA/MERCK) PROQUAD for Immunization; and HEPATITIS A for Immunization. It was a case of actual medication error due to expired vaccine used. No known symptoms were reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the 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. List of documents held by sender: none.
Extensive local reaction with purple, hot, indurated area surrounding injection site, over 10cm.
No adverse effects reported; an improperly stored dose of PROQUAD was administered to a patient; This spontaneous report was received from a registered nurse referring to a patient of unknown age and unknown gender. Information about pertinent medical history and drug reactions/allergies was not reported. Concomitant therapy included sterile diluent.  On 17-OCT-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot# S007069 with expiration date 06-SEP-2020, dose detail was not reported) via subcutaneous route for prophylaxis. The vaccine experienced improperly stored and was stored at minus 11.5 degree Celsius (C) for 76 hours. There was no previous temperature excursion. The call was because of a data logger involved. It could not be verified if the sterile diluent was properly stored. No adverse effects were reported.
Immediately after the everything is good, 30 minutes after the vaccine I felt congested, I had water eyes and runny nose that lasted less than an hour.  As day progress I only felt sore arms, so I continue my normal activities and went to work at 7pm. By 11pm I started feeling cold and having chills, I thought it was because of the weather cause it was snowing and raining that night.  As night progressed I feel like chills is getting worst and also started to have body aches. I checked my temperature it was 97.4F. I went home  and take rest. I continue to feel chills coz I wake up several times that I feel really cold in spite of the  sweater and blanket. Chills continued until 2pm of 12/30/2020,  I feel hot checked my temperature it was 101.5F oral.  Feeling flu symptoms.
Muscle pain progressively increased during the two days after vaccination.  I used ibuprofen, normal dosage, for the following 4 months.  Then I got to see the rheumatologist who diagnosed Polymyalgia Rheumatica and diagnosed 15mg prednisone daily.  Pain declined to zero within 2 days after stopping ibuprofen and starting prednisone.  After 4 months now tapering off prednisone.  That will take 8 more months.
Swelling, severe pain, unable to raise left arm. Nausea, feels flu-like symptoms-no fever-chills, feels like she is going to pass out. Symptoms began 2.14.13.
Patient stated that about 3-4 days after vaccination he experienced a rash over a large portion of his left arm encompassing the forearm.  Patient is also experiencing pain and tenderness radiating from the injection site in the left deltoid to the wrist.  For many days he stated that it was very painful to the touch.
pt recv varicella vax instead of varicella zoster  immune globulin 2 16wk of pregnancy;pt devel swelling, redness & soreness @ the inj site;@ the time of the report, the pt had no other adverse exp;An amniocentesis was performed; This is in follow-up to report(s) submitted on 04/16/1997; 10/16/1997; 01/16/1998. Information has been received from a man concerning his 36-year-old Caucasian wife who on 13FEB97, at 15 weeks of pregnancy, was vaccinated with VARIVAX instead of VZIG. It was noted that the patient and her son were exposed to another child who developed chickenpox, and she took her son to the pediatrician's office for administration of VARIVAX. The pediatrician consulted with the woman's obstetrician, who recommended that she receive VZIG, since she was seronegative. At the pediatrician's office, the woman was inadvertently administered VARIVAX. In February 1997, she developed swelling, redness and soreness at the injection site. At the time of the report, the patient had no other adverse experience. An amniocentesis was performed at 18 weeks of pregnancy for routine evaluation of risk for chromosome aberrations based on maternal age, and not based on perceived risk from the vaccination, according to a physician. At 28 weeks, an ultrasound was normal. During the pregnancy, the patient was placed on therapy with ZOVIRAX. The estimated date of delivery was 04AUG97. On 04AUG97, the woman delivered by scheduled Cesarean ection a healthy son with an Apgar score of 9.9. No further details were provided. This is a correct report. A negative serum varicella zoster virus antibody test was added to Box 12.
hives on wrists and hands/hive is on her foot; hands are swollen, the bottom of her feet are swollen in different places; itchy rash with hives; This is a spontaneous report from a contactable consumer. A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 17Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 18Mar2021, the patient experienced rash, hives on wrists and hands/hive is on her foot, hands are swollen, the bottom of her feet are swollen in different places, hands were swollen and itching, itchy rash with hives. Reporter stated that it went away and came back and left inside of her forearm was hivey, bumpy, and itchy and had a rash. She stated that Benadryl helped to calm it down. Caller wanted to know is this a reaction that people have reported. Caller wanted to know if she should keep taking Benadryl. Reporter is wondering if this could be from the vaccine. The rash keeps coming and going and she has not eaten anything different or done anything so she does not know what this could be from besides the vaccine. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Initial report received on 23 April 2008 from a health care professional in the USA. A 20 year old female patient with no medical history received on 17 April 2008 a first subcutaneous left arm injection of Yellow Fever vaccine (Sanofi Pasteur, lot UF300AA). On 22 April 2008, 5 days post vaccination, the patient developed a fever and injection site redness, warmth, and itchiness measuring approximately 6 cm by 6 cm. The patient had also received the following vaccinations within the 4 weeks prior; on 26 March 2008, a first left deltoid intramuscular injection of Td (Sanofi Pasteur, lot # U2293CA), a first left deltoid intramuscular injection of Menactra (lot # U2606AA), and a first right deltoid intramuscular injection of Pneumonia vaccine (Merck, lot # 0380U) and on 02 April 2008 a first left deltoid intramuscular injection of Influenza vaccine (Sanofi Pasteur, lot # U2531AA). The patient had no medications and no illness at time of vaccination. Corrective treatment was not reported. At the time of the report, 23 April 2008, the patient had recovered.
Patients husband called Monday morning. The couple got the vaccine together on Thursday and were experiencing sore arms and legs. His wife woke up late Sunday night in pain. The husband called 911 and he stated that she passed away within a matter of 5 minutes.
teeth was sensitive; the floaters in eye were noticeable and intense /  looked like little worm, much more intensified; This spontaneous case was reported by a consumer and describes the occurrence of HYPERAESTHESIA TEETH (teeth was sensitive) and VITREOUS FLOATERS (the floaters in eye were noticeable and intense /  looked like little worm, much more intensified) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concomitant products included CARVEDILOL and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERAESTHESIA TEETH (teeth was sensitive) and VITREOUS FLOATERS (the floaters in eye were noticeable and intense /  looked like little worm, much more intensified). At the time of the report, HYPERAESTHESIA TEETH (teeth was sensitive) and VITREOUS FLOATERS (the floaters in eye were noticeable and intense /  looked like little worm, much more intensified) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-229885 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow up received contain significant information patient date of birth and AE contact information updated
Patient's arm is red and swollen and warm to the touch. The patient has contacted the physician and will be seen on Monday, if the reaction does not get any better, physician also suggested to ice and massage the area where the vaccines are given. Patient was also directed to monitor the injection area for any changes.
Vaccine breakthrough, symptomatic.   Inpatient admit 9/14-9/16.
ANXIETY THROUGH THE WHOLE MESS; PROBLEMS WITH THE VEINS IN LEGS; FELT LIKE JUST A MESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included big varicose veins, and problems with veins in legs.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unkown) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced anxiety through the whole mess, problems with the veins in legs, and felt like just a mess. Laboratory data (dates unspecified) included: X-ray (NR: not provided) No blood clots or anything were observed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the anxiety through the whole mess, problems with the veins in legs and felt like just a mess was not reported. This report was non-serious.
Dizziness, NauseaVomiting, HYPERtension, could "Hear her heartbeat"  Narrative: Presented to ED but left without being seen due to the wait time.
No adverse event occurred. Recipient had received an initial series of Pfizer, a Moderna booster 12/10/21, and then a second booster of Janssen--which is not approved by the CDC. The individual was not eligible for a second booster and Janssen was incorrect.
Hospitalization 1/2/22 2nd Pfizer COVID vaccination 3/16/21, LOT EL9269
About 1 minute after vaccine administration the patient fainted. She lost consciousness for 15 to 30 minutes. After coming to, she was pale, felt sick to her stomach, and just "not right." She sat in the store for about 10 minutes when her husband decided it was an ok to try and move her to take her to the ER.
First dose of Pfizer COVID-19 vaccine on 3/22/2021, followed by the 2nd dose on 4/12/2021. 7/14/21: Patient arrived to ER with COVID symptoms after testing positive on 7/7/2021. Per ER records, the patient received the positive result on 7/10/21 and went to see his PCP who prescribed the patient a Zpack and cough medicine. The patient finished the Zpack but was still having body aches, shortness of breath, fever, loss of appetite, and fatigue.  7.15.21: in the ED patient found to have hyperglycemia, anion gap metabolic acidosis, worsening kidney function, and multifocal pneumonia. Diagnosed with acute hypoxic respiratory failure due to COVID-19 pneumonia, sepsis secondary to COVID pneumonia. started on remdesivir
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. ON unknown dates, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (dose, route and lot # not reported). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
nausea, vomiting, diarrhea continuously for 8 hours; followed by gastritis
12 hours after vaccination: chills, shaking; 20 hours after vaccination: fever (below 100), headache, fatigue, body aches; 36 hours after vaccination: symptoms resolved except for extremely sore left arm.
Fever, body aches, fatigue the day following return from out-of-state conference.  Covid home test positive.  Contacted PCP who advised clinic visit for testing, which was also positive.
This was NOT an adverse event. It was a vaccine administration error. We thought we were administering the Pfizer bivalent vaccine and discovered in the mid afternoon on 9/8/22 that we were actually administering the Pfizer Grey Cap (monovalent/original) formulation of the vaccine. Upon discovery corrective action was taken. Patient was notified of vaccine administration error as was the local health department.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Site of injection is itching) and VACCINATION SITE ERYTHEMA (Site of injection has red patch) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Site of injection is itching) and VACCINATION SITE ERYTHEMA (Site of injection has red patch). At the time of the report, VACCINATION SITE PRURITUS (Site of injection is itching) and VACCINATION SITE ERYTHEMA (Site of injection has red patch) outcome was unknown. Not Provided  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant information  provided. Treatment included Neosporin ointment
Pt recvd 1 dose of Engerix-B p/24 hrs exp nausea, vomiting, diarrhea & stomach cramps for 3 days; rash, which started on lt arm & traveled from torso down w/itching;
Mom states pt felt warm to touch (did not take temp) left thigh was red, swollen & felt hot; pt seen by MD 13MAY92 t98.5 w/localized rxn lt thigh w/rash;
Headache, pain in lower back, fever low grade (99-100), feels flushed. This happened for all 3 doses, feel poorly x1 week by Hx with headaches, body aches.
the patient the third dose in RECOMBIVAX HB series less than six months after receiving the first dose.; No adverse effects reported.; Interchange of vaccine products; Reporter stated that patient "was administered a booster of ENGERIX-B; This spontaneous report was received from a nurse concerning to a patient of unknown age and gender. The patient's historical conditions, concurrent condition, and concomitant medications were not provided.  On 01-MAR-2004, the nurse reported that the patient was vaccinated with the first dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (strength, route of administration, anatomical location, lot number, and expiration date were not provided); on 03-MAY-2004, was vaccinated with the second dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (strength, route of administration, anatomical location, lot number, and expiration date were not provided),  and on 17-JUN-2019, the patient received the third dose of with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) 5/0.5 mcrg/ml ( route of administration, anatomical location, lot number, and expiration date were not provided) as prophylaxis,  series less than six months after receiving the first dose (inappropriate schedule of product administration). No adverse effects reported. On 22-APR-2019, the nurse reported that the patient was administered with hepatitis b virus vaccine rhbsag (yeast)(ENGERIX-B) (strength, route of administration, anatomical location, lot number, and expiration date were not provided) (interchange of vaccine products) (extra dose administered) as prophylaxis.  The nurse also reported that multiple unspecified dates, multiples unspecified patients also received the third shot of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) series earlier than 6 months. No adverse effects reported.
89 yo M presents with complaints of weakness and diarrhea for the last 3 days. He received his COVID-19 Vaccine about 10 days before presenting to hospital. Also complains of decreased appetite and oral intake, but denies any nausea or vomiting. Denies fever, chills, cough, and SOB. Patient tested positive for COVID-19 and was admitted on 01/27/2021 for dehydration, AKI, and pneumonia likely secondary to COVID-19 virus, although he did not exhibit any symptoms of SOB or cough. Patient was treated with IV fluids, Pulmicort, Decadron, Protonix, aspirin, and SQ heparin secondary to renal function. Dehydration and AKI were corrected and the patient was discharged on 01/30/2021 with no complaints of COVID symptoms and an
Given preschool immuns; about 2 min p/had ? convulsion; sent to MD @ 230PM; PT well & healthy; dx: probably fear caused problem;
Headache, Pain at site dose #1, Pain red swelling day 1-7 dose 2 with headache, fever and fatigue Narrative:
On 3/29/21 at 11:00pm my dad began having chills and uncontrollable shaking. My mother contacted Pfizer who instructed us to alternate Tylenol and Motrin. Tylenol given and Motrin given 4 hours later as instructed by Pfizer. On 3/30/21 around 11:10am my dad was found unresponsive, not breathing and did not have a pulse. My mother immediately called 911 and my aunt began CPR. When EMS arrived he was found to be in cardiac arrest and after 25 min of efforts by EMS my father passed away less than 24 hours after receiving his 2nd covid vaccine.
Patient expecting to receive a flu vaccine and was administers a covid vaccine. No symptoms reported at this time