chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received the vaccine at 9:30.am on Wednesday.  By noon on Thursday,felt soreness in arm. By 6pm, I felt a heaviness in every muscle- had to go to bed. Took Advil and had a good nights rest. Woke up the next morning, feeling better but I started feeling fatigued and achy by noon. I had to leave my job and went home and slept for 3 hours. Had dinner but had to go back to bed due to fatigue. Took Advil and Tylenol and feeling better  on Friday morning.
Shaking, chills with fever of 103.6 degrees F as well as pain/redness at surrounding site of PNEUMOVAX injection.
Patient states after getting the vaccine, she felt unwell. After a week she went to the hospital. Patient also states provider informed her it was a coincidence she was feeling unwell after the vaccine.  The patient was not able to give an exact account of how long she was hospitalized.
After I got vaccinate on the second dose in the morning, I feel cold in the evening and heavy headache. This happens only for a day. But from that day until now I still get a weird feeling in my left chest. I feel like my heart is twitching sometimes. Sometimes I felt that my heart was pounding. Sometimes it feels like it's going to hurt my heart. It happened continuously about 5-6 times a day. Sometimes I was paranoid about it.
"Pt complained of blurry vision.  VS obtained.  BP 167/112; HR 76; O2 Sats 98% on RA; Temp 98.0; pt noted hx of hypertension, has not taken medication since 2019.  Visual field test.   On site MD notified, pt transferred to ER for further evaluation. ED summary: symtoms resolved and pt discharged home. Pt was primary nervous!  Upon arrival at ED, BP 141/103; HR 71; blurred vision persists "
Extreme pain and soreness in left arm following Tdap vaccination for at least a week, pain causing sleep disturbances and inability to use arm. After about a week the extreme pain subsided to a moderate pain that only became severe when using the arm, lifting the arm, etc. Still experiencing pain, discomfort, and reduced range of motion over a month after recieving the vaccination. I can't lift left arm more than 45 degrees to the side or across the body without significant pain. Treatments so far: I took  OTC antiinflammatories for several days (that didn't really help). After three weeks of pain  I eventually visited an orthoped who prescribed a topical antiinflammatory and physical therapy, to be followed up by an MRI if the physical therapy does not resolve the issues.  I have had one session of PT so far.
SORE ARM; This spontaneous report has been received from a lawyer and the patient, via a Plaintiff from a case in litigation for ZOSTAVAX (MARRS # 2105USA000853), concerning a currently 67-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  In October 2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) for prophylaxis and with influenza vaccine (FLU) (doses, routes, anatomical location, lot # and expiration dates were not reported).  On an unknown date, the patient experienced sore arm. At the reporting time, the outcome of sore arm was unknown.     The reporter considered sore arm to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) and influenza vaccine (FLU).; Sender's Comments:  US-009507513-2105USA000853:
This spontaneous report as received from a consumer refers to a 23 years old female patient. The patient was vaccinated with first dose of GARDASIL in January 2010 and with second dose on 10-JUN-2010. On 10-JUN-2010 the patient experienced lightheadedness and was feeling fuzzy and weird. The consumer received the second dose six months after the first dose, which is other than indicated in the Prescribing Information and she discontinued the series after the second dose. The patient did not receive treatment. The outcome of events was reported as recovered on 12-JUN-2010. Additional information has been requested.
This is a spontaneous report from a contactable consumer (patient). A 35-year-old (non-pregnant) female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# EW0584), at the age of 35, via an unspecified route of administration, left arm, on Jul 25, 2021, at 13:00, single dose, for COVID-19 immunisation. The patient also received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# FA7485), at the age of 35, via an unspecified route of administration, left arm, on Aug 15, 2021, at 11:00, single dose, for COVID-19 immunisation. Medical history included BRCA2 positive. The patient has no known allergies. Prior to the vaccination, patient was not diagnosed with COVID-19. Concomitant medications not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Jul 26, 2021, at 00:00, patient experienced continuous menstrual bleeding from Jul 26, 2021 to current from spotting to heavy bleeding coupled with severe cramps and exhaustion. On an unspecified date in 2021, patient underwent nasal swab test and the test result was negative. Since the vaccination, patient has been tested for COVID-19. It was unknown whether therapeutic measures were taken as a result of reported events. The outcome of continuous menstrual bleeding, spotting to heavy bleeding: not recovered; whereas severe cramps and exhaustion unknown, at the time of this report.
patient tested positive after routine testing following and Emergency Center visit for a motorcycle crash, patient is asymptomatic
2 days after recieiving MMR and Hep A Vaccine, my daughter had a fever ranging from 101.5 thru 102. It would not lower with Motrin or Tylenol. Upon placing my daughter to sleep, her arms and legs began to twitch off and on for one hour. Appeared to be a febrile seizure.
Extreme fatigue, dizziness, sore throat, light sensitivity, worsened vision deficiency. Fatigue lasted for 6 weeks. Donated blood after 6 weeks due to assumption that it was over already. Symptoms worsened significantly in the following 48 hours, then cleared up entirely.  Doctor disagreed that the vaccine was the cause, but timeline makes no sense otherwise.  Has also felt disoriented quite often since symptoms started, and this has continued despite other symptoms stopping.
8 days post COVID vaccine - right arm developed 3inch by 2 inch redness, pain and swelling.
Fever, cough, chest congestion that lasted for over a week. Treated with doxycycline.
feelings of fainting; high blood pressure in the 160s, normally <120s systolic); severe headaches; dizziness; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received first dose of BNT162B2 (Lot number and expiry date not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history concomitant medications were not reported. On an unspecified date, the patient developed severe headaches, dizziness, high blood pressure (in the 160s, normally <120s systolic), and feelings of fainting 5-10 minutes after receiving the first dose of the vaccine. This adverse event was reported already, but the pharmacist was wondering if it is still recommended to get the second dose after a reaction like this. Stated "This reaction doesn't meet your definition of anaphylaxis or allergic reaction which is why I am reaching out to see if you have any recommendations on this". The patient underwent lab tests and procedures which included blood pressure: high blood pressure (in the 160s, normally <120s systolic). The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Patient received Tdap instead of Dtap for age 4yr. old on 09/12/2009
developed a condition where his heart lost its rhythm; This is a spontaneous report from a contactable consumer or other non hcp via Pfizer- sponsored program (patient). A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as single dose and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient developed a condition where his heart lost its rhythm after both doses. The outcome of the event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Information has been received from a physician and a practice manager via company representative referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 28-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 2.5 ml/five dose vial, lot # K007773 and expiration date 01-MAY-2015 (administration route was not provided). No adverse effects were reported. The vaccine had one temperature excursion of 48 hours with a lowest recorded temperature of 1 Fahrenheit (F) (1 Celsius (C)). The storage criteria and the type of excursion for this vaccine was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Patient received PFIZER COVID19 booster.  Patient complained of feeling dizzy and lightheaded.  BP 152/92 HR 97. Provided crackers, water and juice, as patient denied having eaten at all today. Continued to monitor and encouraged to deep breath. Patient complained of feeling nauseous and had visible tremors and difficulty speaking.  BP 155/89 HR 79.  Mother notified of patient condition and status, advised EMS contacted to transport patient to hospital for further evaluation and monitoring.  Discharged from ED  with albuterol inhaler PRN.
PATIENT CAME TO THE PHARMACY ON 09/07/20 WITH A RX FROM THE EMERGENCY ROOM AND STATED SHE HAD SWOLLEN AND REDNESS AT THE SITE OF INJECTION. RX (BACTRIM DS). PHARMACIST ON DUTY AND NOTICE REDNESS AT THE SITE AND RECOMMENDED WARM COMPRESS AT THE SITE OF INJECTION AND INSTRUCTED PATIENT TO TAKE TYLENOL IF NEEDED FOR THE PAIN.
Day 1: approximately 1 hours after vaccine - dizziness, extremely tired, dosing off, , injection site tender, approximately the size of a dime knot at injection site. Day 2:  body aches all over, moderate headache, extremely tired, no energy, about 1700 hours:  profuse sweating, full body chills accompanied with entire body shakes, extreme headache, nauseated, unable to eat, lose of taste and smell, extreme body aches, sense of falling.  Lasted for 36 hours, lost 7 lbs.   Swelling at injection site, followed by a knot in arm approximately size of a quarter, raised approximately 1 ",  red rash and extreme itching. Day 3/4:  symptoms subsiding, rash and pain in arm increasing.  Rash spread from elbow and shoulder, raised approximately 2" and almost encompassed entire upper arm, approximately 1" gap on the inside of arm not affected. Day 5:  Started feeling human again.      Temperature was never higher than 99.5 degrees.  Took Aleve and Tylenol
Chills; fever; This is a spontaneous report from a non-contactable consumer (patient) by a a Pfizer sponsored program COVAX US Support.  A 79-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 16Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced chills and fever following first dose in Feb2021. The patient underwent lab tests and procedures which included sars-cov-2 test positive in Dec2020. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
The vial was initially stored in the refrigerator on 08-Jul-2022 and was administered on 09-Aug-2022; No Adverse Event; Administered Moderna COVID-19 Vaccine after 30-day use by date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVID-19 Vaccine after 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administered on 09-Aug-2022) and NO ADVERSE EVENT (No Adverse Event) in a 21-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis. No Medical History information was reported. On 09-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 09-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVID-19 Vaccine after 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administered on 09-Aug-2022) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVID-19 Vaccine after 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administered on 09-Aug-2022) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered Moderna COVID-19 Vaccine after 30-day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administered on 09-Aug-2022). No concomitant medications were reported. Treatment information was not provided.  The vial did not undergo any temperature excursions. No treatment details were reported.
Itchiness; Extreme rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchiness) and RASH (Extreme rash) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 011620A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE and MIRTAZAPINE for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced PRURITUS (Itchiness) and RASH (Extreme rash). The patient was treated with PREDNISONE at a dose of 1 dosage form; CHLORPHENAMINE MALEATE (ALLERFIN) at a dose of 1 dosage form and CORTISONE at a dose of 1 dosage form. At the time of the report, PRURITUS (Itchiness) and RASH (Extreme rash) had not resolved.            Treatment: prednisone, allerfin, eucerin cream, cortisone 10 cream   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Non significant follow up- No new information was provided.
she tested positive with Covid after the first dose; She tested positive with Covid after the first dose; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A non-contactable consumer (patient) reported that that a female patient of unspecified age received the first dose of BNT162B2 (BNT162B2, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient reported she tested positive with COVID after the first dose on an unspecified date. Outcome of the events was unknown.  No follow up attempts are possible; information regarding Lot/Batch cannot be obtained.
Day 1: Red and swollen (knot) around injection site Day 2: Redder and more swollen; called pharmacist and advised to take Benadryl (pt refused) and Tylenol (pt took APAP 500mg x1) Day 3: Expanded area--center raised and hard, edges moving down arm Day 4: Area red to elbow, painful, APAP helps; Pt asked to present to pharmacy (refused), later in afternoon pt stated arm less red Day 5: Arm pink rather than red, area involved extended past elbow; Pt again asked to present to pharmacy
Six hours after the shot at 6 PM in the evening, I went from a resting heart rate of 65 when it jumped to 100, then 105 and 108.  I have not suffered a tachycardia event for over two years. I worked hard through diet and exercise to change my heart palpitations. But this event lasted for about 30 minutes give or take and we treated at home via breathing meditation exercises. During and afterwards, I experienced Sharp pain and burning underneath the breast bone by the heart. Gerd-type symptoms in the lower esophagus also plagued me. At 1 AM I was awoken to an extreme nausea sensation. As of the next day, my heart feels better but my stomach feels off. I am able to hold foods down.
From Tuesday until now he is been puking and he hasn't left the bed at all; Diarrhea; Just don't wanna eat, no appetite , drinking lots of water.; he can't get out of bed; he is not eating anything; they told me that he get up and fall; his stomach is hurting real bad; Tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 13May2021 (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 (Verbatim: 1st dose of covid-19.), for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 13May2021, outcome "unknown", described as "Tiredness"; VOMITING (non-serious) with onset 18May2021, outcome "unknown", described as "From Tuesday until now he is been puking and he hasn't left the bed at all"; DIARRHOEA (non-serious) with onset 18May2021, outcome "unknown", described as "Diarrhea"; DECREASED APPETITE (non-serious) with onset 18May2021, outcome "unknown", described as "Just don't wanna eat, no appetite , drinking lots of water."; HYPOKINESIA (non-serious) with onset 18May2021, outcome "unknown", described as "he can't get out of bed; he is not eating anything"; FALL (non-serious) with onset 18May2021, outcome "unknown", described as "they told me that he get up and fall"; ABDOMINAL PAIN UPPER (non-serious) with onset 18May2021, outcome "unknown", described as "his stomach is hurting real bad".  Additional information: Patient got this the Pfizer shot a week ago, today will be a week, the second shot a week ago, on Thursday (confirmed as 13May2021) and he can't get out of bed until Saturday (confirmed as 15May2021) and then from Tuesday until now he is still in bed we concerned of, have this part he is not eating anything and drink up water though. When paraphrased, reporter stated, "This week from Tuesday until now he is been puking and he hasn't left the bed at all and he is not eating right and they told me that he get up and fall and he is not eating and he is drinking up water though and his stomach is hurting real bad. Is the side effects supposed to last that long? How long the side effect can last on the second shot of Pfizer (confirmed as Pfizer COVID vaccine). Reporter stated, "He don't want call any doctor, my problem, my dad wouldn't let me call the doctor". Reporter stated, "one side effect is tiredness, he still has that too, vomiting, diarrhea and just don't want to eat, no appetite, drinking lots of water."  Follow-up attempts completed. No further information expected.
Breakthrough COVID Case. CG completed Pfizer series 1/11/21. Had cohabitant home exposure to children. Tested positive 5/2/21
My adverse event started on 12/2022, on December I've noticed that my blood pressure was extremely high. I took my normal medication . On 01/28/2023 I went to the ER because my blood pressure was extremely high. I was having difficulty breathing. I couldn't walk and I was  feeling weak. They told me that my lungs were filled with fluids. They immediately took all the fluids out of my lungs.   They also  prescribe me  Furosemide  and Lasix.  I was in the hospital for 8 days and was  released on 02/04/2023.
patient c/o difficulty to swallow 27 min after vaccine administration. Vital signs stable. no rash no SOB noted. throat assessed, Left side appears swollen. given Benadryl 25min PO x1. consulted Urgent care doctor, advised to send over patient to be seen for further eval.
pt recv vax & 3-4 days p/vax exp cough, hoarse voice or loss of voice had to go to MD for ATB each time;cont now w/hoarse, gravely voice;no fever or localized effects to inj site;
SINCE GETTING THE SHOT, NO PAIN IN SHOULDER (HAD PAINFUL ARTHRITIS IN LEFT ARM); This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included arthritis in upper left arm.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. Batch number was not reported has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced since getting the shot, no pain in shoulder (had painful arthritis in left arm). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of since getting the shot, no pain in shoulder (had painful arthritis in left arm) was not reported. This report was non-serious.
Administer expired vaccine to patients, after the manufacture date of expiration.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration.) in a 64-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients, after the manufacture date of expiration.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 173 doses.  The vial did not undergo any temperature excursions.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up information received included reported details added.