chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headaches; pretty serious muscle aches; projectile vomiting; fever; chills; massive diarrhea; tiredness; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL8982; Expiration Date: May2021) on 27Jan2021 15:20-15:30 (at the age of 79-year-old) intramuscularly administered in Arm Left as single dose for prevention. The patient medical history were not reported and no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. AE following prior vaccinations was reported as none. Vaccination facility type was reported as hospital and not a military facility. The patient called for information about if her symptoms could be related to the administration of the Pfizer's COVID-19 vaccine. The patient reported that she has massive diarrhea (08:30), projectile vomiting (10:00), fever (10:00), pretty serious muscle aches (11:00), tiredness (07:30), headache (13:00) and chills (08:30) on 10Feb2021. Events fever, Pretty serious muscle aches and tiredness were reported as worsened. The patient reported that she was administered with the first dose of the vaccine 2 weeks ago and she was feeling fine starting with the symptoms today (10Feb2021). The patient reported that she thought it was possible that she has been infected of COVID-19 virus. The patient reported that she considered herself a healthy 79-year-old woman. Received call from the patient regarding the Pfizer COVID 19 vaccine. She had the first vaccine two weeks ago today (10Feb2021). She was having massive Diarrhea, Chills, projectile vomiting, fatigue, muscle aches and fever.  She started out with her normal body temp of 97.3 and this morning it was 98.2.  She took it an hour later, and it was 98.4 and then it was 100 and now it was 100.2.  That was why she was calling.  She would like to know if these were side effects. She said she cannot think. She filled out two forms on the second day after the shot. It came up on her email and it listed the symptoms and said have you had any today.  She was kind of fatigued today (10Feb2021). A week later she had pretty serious muscle aches and one more thing. The diarrhea was one massive one this morning and it got rid of everything. It was liquid. She has not had one since. Projectile vomiting was twice within 10 minutes of each other. It happened pretty fast at 09:30-10:00 this morning. She has not eaten anything at all. Muscle aches started at 10:00. The tiredness started before diarrhea and was progressively getting worse. Headache started an hour to hour and a half ago. Chills started at 08:00 and were worse for 2 hours and then got better. She could take off gloves and scarf around her neck but does not have chills now. Outcome of the events massive diarrhea, projectile vomiting and chills was reported as recovering. Outcome of the events fever, pretty serious muscle aches, tiredness and headache was reported as not recovered.
Patient administered Pfizer-BioNtech vaccine, dose #1 in series at 810AM, without notable concerns for 10 minutes. At 10 minutes post vaccination, patient developed itching and some blotching, throat becoming scratchy. No known allergies to components listed in vaccine, though does have a listed allergy to contrast dye, does not carry an epi-pen.   Patient was walked to urgent/emergency care in the clinic, where she was seen immediately. Patient was given diphenhydramine 25 mg IV, pantoprazole 40 mg IV, with mild uticaria continuing. Patient notes she feels her 'back is on fire'. Patient was then given methylprednisolone 125 mg  IV.  At this time, no SOB is noted, uticaria is still present. 0930 patient reports swelling in throat and respiratory difficulties at this time with visible edema in the neck. 0.3 mg Epinephrine given at 0935, epinephrine drip and racemic epinephrine neb given. 1006 Patient on epinephrine drip 2.5 mics/hour.  Patient transferred to Medical Center ICU, where she remains at the time of this report.
12/9/2010 5 minutes after vaccine administration: Patient complained of itching on upper arm vaccine was administered in and under her nose. Upon inspection patient pointed at site above injection site that was red due to scratching. She also had obvious dry, flaking skin. Patient was given 2 chewable Benadryl tablets and itching resolved. Instructed patient to take APAP and apply cold compress to help with redness and swelling. Also to note, patient was extremely tensed when vaccine was administered. 12/13/2010: Patient called complaining rash has gotten bigger. States yesterday it was raised, but that has subsided and she just has a red patch the size of a softball. Also reports itching that has also subsided with taking Benadryl. Did not use a cold compress or Tylenol as instructed by me on Friday. Since rash seems to be resolving again suggested cold compress and Tylenol. Instructed her to come in if she wanted us to take a look at it or if it gets worse as it may take up to a week to resolve.
she again tested positive on an antigen test on Day 9 (28Aug2022); Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 22-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Feb2021 as dose 1, single (Lot number: EN6198), in right arm, on 21Mar2021 as dose 2, single (Lot number: EP7534), in left arm and on 11Dec2021 as dose 3 (booster), single (Lot number: 331308A) at the age of 21 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies Lentils and Peas" (unspecified if ongoing), notes: Known allergies Lentils and Peas. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19"; DISEASE RECURRENCE (medically significant) with onset 28Aug2022, outcome "unknown", described as "she again tested positive on an antigen test on Day 9 (28Aug2022)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Aug2022) Negative, notes: tested negative on an antigen test on Day 7; (Aug2022) positive; (28Aug2022) Positive, notes: tested positive on an antigen test on Day 9. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received Paxlovid from 20Aug2022 to 24Aug2022 for treatment of COVID-19. She stated that she was symptomatic and tested positive for COVID. She started Paxlovid on Day 1 (20Aug2022) and completed the dosage on Day 5 (24Aug2022). She recovered from all symptoms by the Day 5. She tested negative on an antigen test on Day 7 (26Aug2022). Then she again tested positive on an antigen test on Day 9 (28Aug2022). There was no reappearance of symptoms. She believes that she was experiencing the symptoms and also the rebound effect. Other medical history.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a health care worker refers to an unspecified number of patients of unknown age and gender. Between July and August 2014 the patients were vaccinated with an improperly stored dose of ROTATEQ orally, Lot # reported as K005273, expiration date: 23-FEB-2016 (dose was not reported). No adverse effects were reported. It was reported that sterile water diluent (Lot # J015953, expiration date: 30-SEP-2016, Lot # K01010820, expiration date: 13-MAY-2017 and lot # K006954, expiration date: 28-FEB-2017) were exposed to 83F for 12 hours and to 28F for 36 hours. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a physician concerning a 10 year old male who was vaccinated with a first and second dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). It was reported that the patient was experiencing a possible case of mumps. It was noted that the patient was currently undergoing testing to determine if the experience was mumps. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Per husband patient got first dose of SHINGRIX on 09/13/2018, after vaccine patient had chills and weakness. After 2nd dose on 11/20/18, around 10 PM husband found patient on the floor unresponsive. When EMT arrived blood pressure was at 50/35. Patient was admitted to hospital where she spent a week, followed by rehab. During hospital stay patient was told that she has an infection going on, but no tests or cultures were able to determine the source or type of infection. Patient spent 4 days in intensive care, and 5 more days on the hospital floor followed by rehab 6 days
17 year old received Vaccine; Interval between 2 doses is more than 42 days; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received Vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Interval between 2 doses is more than 42 days) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received Vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Interval between 2 doses is more than 42 days). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old received Vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Interval between 2 doses is more than 42 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No conmeds and treatment history was reported .   Reporter did not allow further contact
10 days after receiving booster fever and full body hives. Swollen eyes. Extremely itchy.  Since then patches of red skin combined with feeling heat from inside body about 30 times a day maybe more. Also a esophagus irritation that has persisted since then as well extreme indigestion problems.
This individual is a COVID-19 vaccine breakthrough case. Individual was symptomatic. Not hospitalized.
Information has been received from a registered nurse concerning a female who was vaccinated with her first dose of Gardasil. Subsequently the patient became dizzy one week later. The patient received her second dose and became dizzy one week later again.
Assisted living patient at Health center who tested positive for Covid-19 on 12/20/2021.  At the time patient was asymptomatic.  Patient expired at same facility on 01/22/2022.
Case number PHEH2014US024347, is an initial spontaneous report received from a nurse on 02 Dec 2014 and with a follow-up from a nurse received on 21 Jan 2015. This report refers to a 78 year old female patient. Past medical history and concomitant medication were not reported. The patient had tolerated vaccines (no further details provided) well in the past. The patient was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) into left deltoid intramuscularly at a dose of 0.5 ml on 01 Dec 2014. The nurse reported that before vaccination the prefilled syringe (PFS) of FLUVIRIN was stored at 49 degree F for 1 hour and 15 minutes. No adverse event was reported following this maladministration. No further information was provided. Follow-up from a nurse received on 21 Jan 2015: Site of vaccination (left deltoid) and other clinically relevant information on previous vaccinations in the narrative was updated.
STATES ALL SYMPTOMS BEGAN SEVERAL HOURS FOLLOWING VACCINE ADMINISTRATION:  SWEATING, "EYES VERY DRY", DIZZY, "UNBALANCE" , DIFFICULTY CHOOSING WORDS, "EARS RINGING", HARD TO CONCENTRATE.  6/15/21- TO PCP-  HEALTHCARE.- "MOTION-SICKNESS PILLS".  - NO IMPROVEMENT.7/16/2021- TO NEUROLOGIST FOR ROUTINE CHECK FOR MIGRAINS- AGAIN GIVEN "MOTION SICKNESS" PILLS.  7/26/2021 REFERRED TO EYE CLINIC- GIVEN "MOISTURE DROPS FOR EYES- NO OTHER DX OR TX GIVEN HERE.  7/29/2021 TO ER- HOSPITAL FOR SAME SYMPTOMS- DID CT OF HEAD AND BLOODWORK- FOUND NOTHING.  8/10/2021 TO PCP AGAIN- POSSIBLE SINUS INFECTION- TX WITH ANTIBIOTIC- SYMPTOMS STILL UNCHANGED.
pt recv vax 5JUN97 & woke up 7JUN97 AM c/o leg pain & weakness;tired, temp 96.4 R, refused to walk;By 430PM 7JUN97 able to walk to bathroom;
she said she had pain; developed rashes in the crease of her left arm which started out yesterday, and has increased today/Has a few dots on the same arm; muscle in the left arm, where received the second dose Pfizer Covid 19 Vaccine is in pain, just like a throb; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 60-years-old female patient received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch number: not reported/Lot Number: EW0179), via an unspecified route of administration, administered in Arm Left on 11May2021, at 15:23 (Age at the vaccination 60 years), as DOSE 2, SINGLE for covid-19 immunization. Medical history included blood pressure and acid reflux from an unknown date and unknown if ongoing. Blood pressure medication and acid reflux medication was not specified. Patient did not receive prior vaccinations within 4 weeks. Concomitant medications were not reported. Patient previously received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch number: not reported/Lot Number: EW0161, Expiration: unknown), via an unspecified route of administration, administered in Left shoulder on 20Apr2021 (Age at the vaccination 60 years), as DOSE 1, SINGLE for covid-19 immunization. The patient said she had pain at the muscle from where she received the vaccine. She also said she developed rashes in the crease of her left arm which started out yesterday, had a few dots on the same arm and muscle in the left arm, where received the second dose pfizer covid 19 vaccine was in pain, just like a throb on 16May2021. Timeframe between vaccination and starting of symptoms was 4 days 8 hrs 37 min. The patient underwent lab tests and procedures which included weight was 220lbs or 219lbs lbs on an unspecified date. The clinical outcome of the events she had pain and she developed rashes in the crease of her left arm which started out yesterday was unknow. Outcome of the events had a few dots on the same arm, muscle in the left arm, where received the second dose Pfizer Covid 19 Vaccine was in pain, just like a throb was not recovered at the time of reporting.
Pt c/o numbness & tingling in R arm shortly after relieving H1N1 vaccine (onset date not given by pt) radiating from shoulders to fingertips. Pt states she has to shake arm/hand to regain feeling. She has not tried anything else & was advised to see physicians.
At 1410 gave Tdap, MENVEO in RA, HPV9 LA arm, FLUMIST. 1415 noted hives (R) arm down to wrist. No breathing issues. Dr notified assessed BENADRYL given 5 ml 125mg po - hives better discharge 230.
C/O BP elevated, dizziness x 3-4 days wich came and went, body aches.
Hives; itching; redness, lump, itching on injection site; redness, lump, itching on injection site; redness, lump, itching on injection site; This is a spontaneous report from a contactable consumer or other non hcp. A 64-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection with Batch/Lot Number: 8727) via an unspecified route of administration, administered in Arm Left on 23Mar2021 at 14:00 (Age at vaccination: 64 years) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included hypertension, osteoporosis, arthritis and intervertebral disc protrusion. The patient's concomitant medications were not reported. Patient did not have covid prior vaccination. Patient did not tested covid post vaccination.  Patient did not received other vaccines in 4 weeks. The patient previously took fluconazole and experienced drug hypersensitivity. The patient experienced hives and itching two and a half days after first dose on 26Mar2021 at 02:00. Hives continue until present time, 11May2021. (Over 7 weeks). The patient experienced redness, lump, itching on injection site a few days after vaccination on an unspecified date in 2021. No treatment was received for the events. Patient received second dose on 13April2021 at 12:30 PM in left arm with lot number  EW0153. The events outcome was reported as not recovered.   No follow-up attempts are required. No further information is expected.
slight soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (slight soreness) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (slight soreness). At the time of the report, PAIN (slight soreness) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medication were reported.   No treatment drug were reported.
ITCHY THROAT; CHOCKING SENSATION; RED TO PINK COLOR OF THROAT; DIFFICULTY IN SWALLOWING; INJECTION SITE PAIN; DIZZINESS; 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 past medical history included nose surgery- reconstruction., and concurrent conditions included non alcoholic, and non smoker, and other pre-existing medical conditions included no known allergies. no drug use or illicit drug use. no smoking. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-MAR-2021, the subject experienced dizziness. On 08-MAR-2021, the subject experienced injection site pain. On 10-MAR-2021, the subject experienced itchy throat. On 10-MAR-2021, the subject experienced chocking sensation. On 10-MAR-2021, the subject experienced red to pink color of throat. On 10-MAR-2021, the subject experienced difficulty in swallowing. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, and injection site pain on MAR-2021, and was recovering from itchy throat, chocking sensation, red to pink color of throat, and difficulty in swallowing. This report was non-serious.
ON 03/11/2021, PRIOR TO RECEIVING HIS 2ND MODERNA VACCINE, CLIENT REPORTED  TO NURSE HE EXPERIENCED SWELLING AND SCRATCHINESS TO LEFT SIDE OF THROAT AS WELL AS A FLUSHED FEELING IN FACE APPROXIMATELY 20-30 MINUTES AFTER RECEIVING 1ST INJECTION OF MODERNA VACCINE, 02/11/2021.   ACCORDING TO CLIENT,  SYMPTOMS SUBSIDED AND HE DID NOT SEEK MEDICAL ATTENTION.
began with burning in chest which progressed to chest pain and left arm pain.  Presented to ED (11:44 pm 1/29/22).  EKG was abnormal, labs were drawn and troponin levels were elevated.  Diagnosed with myopericarditis.  Remained in ED >12 hrs.  Discharged home after troponin levels decreased with prescription medication and advised to follow up with cardiologist for an echocardiogram within the next few days.  Patient very fatigued even at rest.    Advised to remain out of work and no activities until he sees a cardiologist for clearance.
Vertigo, headache, neck pain, nausea, sleepiness started at 12 hours and then got worse over the days afterwards. Had vomiting and diarrhea once in the first 24 hrs. Unable to work, drive or ambulate safely in my home. Can?t turn or move neck without causing vertigo. The only stable position is lying down. Appetite is way down, not able to eat/drink much. Feet and fingers feel cold.
Heart Palpitations; This is a spontaneous report from a non-contactable consumer, the patient. An adult non-pregnant female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on 12Jan2021 as a single dose for COVID-19 immunisation. The patients' medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 12Jan2021, the patient experienced heart palpitations. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event heart palpitations was resolved on an unknown date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recv vax & exp hives on abd w/no itching;the same day pt exp stomach cramps & diarrhea;diarrhea lasted for one day;5FEB96 pt exp a rash on back, arms, inner thighs, & chest;itching occurred only on the front of trunk;ER or MD visit
Mother of child states around 11:00 PM 8/11/03, child ran a temp of 104.8. Was seen by doctor 8/12/03. Doctor told mother of child it was reaction to immunizations but didn't know which one. MOC reports temp at doctor's office 99 8/12/03 AM.
dehydration; Sick for 5 days after - including chest pain; Sick for 5 days after - including chest pain; shortness if breath; nausea; vomiting; injection sight swelling; body aches; costochondritis after 2 weeks; This is a spontaneous report from a non-contactable consumer (patient). A 22-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0168) via an unspecified route of administration, administered in right arm on 18Jun2021 09:15 (at the age of 22-years-old) at dose 2, single for COVID-19 immunization. Medical history included polycystic ovarian syndrome, known allergies reported as intolerance to gluten, dairy and eggs, all from an unknown date and unknown if ongoing. Concomitant medication was not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EW0182) via an unspecified route of administration in right arm on 28May2021 10:30 at single dose for COVID-19 immunization. Prior to vaccination, the patient did not have COVID and had no other vaccines within four weeks. The patient has not been tested for COVID post-vaccination. The patient was sick for 5 days after vaccination on 18Jun2021 18:00 including chest pain, shortness of breath, nausea, vomiting, injection sight swelling, and body aches. The patient also experienced continued dehydration for two weeks. Costochondritis developed after two weeks and stated that continued shortness of breath presented similarly to asthma but she had no previous history of asthma or costochondritis. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient received treatment with NSAIDs and Zofran for the adverse events. The outcome of the events sick, chest pain, nausea, vomiting, injection site swelling, and body aches was recovered on 24Jun2021; shortness of breath was not recovered; dehydration was recovered on an unspecified date in 2021, and costochondritis as recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.