chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She had arm pain that was sore to touch but it went away.; This is a spontaneous report from a contactable consumer (patient, self-reported).  A 75-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 08May2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that after the first dose of the vaccine they put a band aid on her arm due to her being on a blood thinner and she waited the fifteen minutes and she had arm pain that was sore to touch but it went away on an unknown date in May2021. She got the pain in her arm. This lasted about 2-3 days and when she touched her arm, it was still sore. The pain is gone but it was sore when she touched her arm, it went away after the first dose. Outcome of the event was unknown.  Information about batch/lot number has been requested.
Began the next day after my vaccine my teeth began to hurt after I threw up. I had severe nausea I sought medical through a telehealth visit and prescribed REGLAN. My mouth continues to hurt, prescribed gabapentin and lidocaine mouth rinse.
Administration error - pt received PCV23 1-26-07 at age 59. Then 10/24/2012 at age 65, then again 10-16-13 at age 66. MD ordered on 10/16/13 because she didn't see documentation from 01-26-07.
Left arm erythema x 4" induration x 3" warm to touch not fluctuant. Sx abscess d/w. Keflex 250 TID x 10 days.
Information has been received from a health care professional concerning her female co-worker, who on 27-APR-2007 was vaccinated with a dose, 0.5ml, IM of Gardasil. On 29-APR-2007, two days after the vaccination, the patient experienced an asthma attack, and visited the emergency room. The patient was not admitted to the hospital, and treatment was not specified. At the time of this report, it was unknown if the patient had recovered from the asthma attack. Additional information has been requested.
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 30-year-old male patient received BNT162b2 (BNT162B2), on 28Jan2021 at 12:00 as dose 1, single (Lot number: EL3249), in right arm, on 18Feb2021 at 12:00 as dose 2, single (Lot number: EN9581), in left arm and on 28Dec2021 at 12:00 as dose 3 (booster), single (Lot number: FJ8762) at the age of 30 years, in right arm for Covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset 08Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 08Apr2022, outcome "not recovered" and all described as "I tested positive again for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Apr2022) positive; (12Apr2022) Negative; (16May2022) positive. Therapeutic measures were taken as a result of Covid-19. Clinical Course: Other medication in 2 weeks was reported as no. Adverse event: patient received a positive COVID diagnosis on 08Apr2022 and began treatment of Paxlovid on the same day. Patient tested negative on 12Apr2022. On 16May2022 patient tested positive again for COVID. Anti viral details product COVID-19 Treatment, brand Paxlovid, treatment start date 08Apr2022, treatment stop date 12Apr2022, indication Treatment of COVID-19. No follow-up attempts are possible. No further information is expected.
Ringing in the ear (tinnitus); This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  An adult male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "Ringing in the ear (tinnitus)". It was unknown if therapeutic measures were taken as a result of tinnitus.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Severe pain; Fever; Redness; "Not feeling well"; This case was reported by a consumer and described the occurrence of pain in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included chronic urticaria. Concomitant products included omalizumab (Xolair).   On 20th November 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain, fever, erythema and malaise. On an unknown date, the outcome of the pain, fever, erythema and malaise were unknown.   It was unknown if the reporter considered the pain, fever, erythema and malaise to be related to Shingrix.  Additional details were provided as follows: The patient received the vaccine eight weeks ago from date of reporting and experienced severe pain, fever, redness and was not well. The reporter did not consent to follow-up.
Hearing loss in right ear - from 2:30 am to midnight 4/3/21 Racing heart and serious PVCs - from 2:30 am to 9:00 pm 4/3/21  Dizziness, fever, horrible body aches, headache, mild nausea all day 4/3/21 Complete exhaustion from 4/3/21 to 4/4/21 all day
13 hours after first Moderna Vaccination I got a fever of 100.8, headache, fatigue, chills, body aches, pain in left arm from shoulder to elbow, pain at injection site in left arm, pain in right shoulder, pain in both knees which lasted 3 days.
Slightly raised rash approximately 3"x5", center slightly hard. Appeared next day. Dr suggested BENADRYL & I also suggested ice (intermittently). Injection site became hard & slightly swollen evening of injection.
I developed shingles within 4-5 days later. I started on my backside then it started to spread. It caused pain and itchiness.
I got the J&J vaccine; I got the J&J vaccine; Vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 23Dec2021 15:30 (Batch/Lot number: unknown) as dose 2 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: J&j vaccine (Dose 1), for COVID-19 immunization. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown" and all described as "I got the J&J vaccine"; VOMITING (non-serious) with onset 24Dec2021 04:00, outcome "recovered" (Dec2021), described as "Vomiting".  Additional information: The patient did vaccine as a booster at 3:30 pm on 23Dec2021. At 4am, on the 24th the patient began vomiting until noon.  The lot number for bnt162b2 was not provided and will be requested during follow up.
right arm with 5 in induration within 12 hours of vaccine (menveo) left arm with 1.5 in induration within 12 hours of vaccine (influenza) patient also noted to have intermittent hives since immunization
20min p/vax started breaking out w/hives around all inj sites, bright red, back of neck & back, bright red;pt crying/fussiness;
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Vomiting-Medium, Additional Details: Patient received first dose of moderna vaccine and within about 13 minutes he started vomiting and sweating. I had him wait for an additional 15 minutes seated until he felt well enough to leave. He refused me calling the ambulance. Someone came to pick him up. Called patient 30 mins later to check up and he said he was okay.
Reported redness around injection site with warmth and hardness next day.  Encouraged to apply heat and take Tylenol and if it got worse to contact her provider.  Did not show up for 2nd dose of vaccine on 2/2.  Upon contacting pt. supervisor, supervisor reports pt. had arm swelling, redness and N/V for 2 weeks after first shot and was instructed by her provider  not to get vaccine dose #2.  Supervisor states pt. had to get "steroid" shots to help with side effects.  No communication received from patient or provider related to this visit to provider, no further info available.
pt developed localized swelling and induration with erythema. 4cm diameter wheal to injection site.  No streaking.   Grandmother was advised to use ice and motrin and monitor for any further reaction.
Fever 101.7, body aches and horrible body pain, intense headache, shivers, earaches
Hospice nurse reported patient started experiencing fatigue, nausea, dizziness, decreased appetite and shortness of breath immediately following vaccination.  Hospice medications were ordered and patient began receiving morphine and nebulizer treatments. She then started having dysphasia. She then died on 3/5/21 from presumed respiratory failure.
04/03/08 child received three vaccines.  Ran high fever 103 degree temp.  C/O dizziness and stayed in bed all day post vaccinations.
After administration, the nurse noticed that the vaccine was from 2018-2019/no AE; Initial information received on 21-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.   This case involves a patient of unknown demographics for whom it was reported that after administration, the nurse noticed that the vaccine was from 2018-2019 (PT: Expired product administered) for vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Lot QFAA1820, expiry date 30-Jun-2019).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to expired product administered.  At the time of this report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
aches/pains; low grade fever around 100; This is a spontaneous report from a contactable consumer. A 71-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for Covid-19 immunisation. The patient medical history and concomitant medications was not reported. Reporter's wife got her first shot 4 weeks ago and the last two weeks she has had aches, pains, low grade fever around 100. She has had 4 Covid tests, chest x ray for pneumonia, a blood panel. X ray and blood panel were negative. Advil and Tylenol is what suppresses the temperature. She was scheduled for the second shot last Thursday. She keeps moving it back and it's supposed to be this going this Thursday. The doctor advised not to take the second shot because her symptoms may have come from the first shot. Event outcome of low grade fever around 100 was recovered, of the remaining was unknown.
Extreme pain in both wrists and pain in elbows bilaterally; Pain in 4th and 5th fingers; bilateral knee swelling as well as left ankle swelling; Knee stiffness and Left ankle stffness; This is a spontaneous report from a contactable nurse (patient). A 39-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EL1283 and expiry date not reported) via an unspecified route of administration, administered in left arm on 12Jan2021 (at the age of 39-year-old) as dose 2, single, for COVID-19 immunisation. Medical history included hypothyroidism. The patient had no known allergies. Concomitant medications included vortioxetine hydrobromide (TRINTELLIX), lamotrigine (manufacturer unknown) and levothyroxine sodium (SYNTHROID) all for unknown indication from an unknown date. Historical vaccine included BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number EJ1685 and expiry date not reported) via an unspecified route of administration, administered in left arm, on 22Dec2020 (at the age of 39-year-old) as dose 1, single, for COVID-19 immunisation and experienced tingling down the arm in the 4th and 5th fingers, aching in the left wrists more than the right. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 13Jan2021, the morning after receiving second dose, patient woke up in the early morning hours with extreme pain in both wrists. This progressed to include 4th and 5th fingers and elbows bilaterally. The patient was seen by the doctor a week later and scheduled for EMG due to concern over ulnar neuropathy. EMG/NCS were completely normal. In between that time on an unknown date in Jan2021, the patient developed bilateral knee swelling and stiffness, as well as left ankle swelling and stiffness. The patient finally saw a rheumatologist who is working up the patient for inflammatory arthritis. The adverse events were reported retrospectively as, the patient didn't make the connection of the timing of symptoms corresponding with dates of vaccination until consulted the rheumatologist. The patient received prednisone (manufacturer unknown) as a therapeutic measure for the joint inflammation. The patient underwent lab tests and procedures, which included EMG/NCS: completely normal; COVID-19 virus test (nasal swab) on 02Feb2021 and the result was negative. The outcome of the events was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Began with sore throat, which progressed to become sore and swollen. Low grade fever began soon after. General body and muscle aches.
Case previously recorded as MA2009-3671. Case received from a health care professional via agency, the following information on 03 NOV 2009: 19-year-old female patient was vaccinated for the first time with H1N1 SOIV FLUVIRIN i.m. into right deltoid on 02 NOV 2009. Approximately two hours later she developed hives and itchy rash which ran from the injection site to her right hand. The patient had not recovered at reporting date on 03 NOV 2009. Agency ref no. NA09-007461.
test covid +; coughing; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing) and SARS-COV-2 TEST POSITIVE (test covid +) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced COUGH (coughing). On 09-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (test covid +). At the time of the report, COUGH (coughing) and SARS-COV-2 TEST POSITIVE (test covid +) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
as of this date patient experiencing pain at site of injection, radiating/vibrating all the way down to finger tips/hand
Nose bleed for several minutes after receiving nasal mist for H1N1. Stopped and pt went back to class.
positive covid test 3-3-2021 Narrative: tested positive in routine test for surgery, no covid symptoms.
This case was reported by a pharmacist via sales rep and described the occurrence of hives in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2017-2018 season) (batch number 4XH59, expiry date 2nd June 2018) for prophylaxis. Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. On an unknown date, the patient received Fluarix Quadrivalent 2017-2018 season and Fluarix Tetra Pre-Filled Syringe Device. On 28th November 2021, more than 2 years after receiving Fluarix Quadrivalent 2017-2018 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced hives. On an unknown date, the outcome of the hives was unknown. It was unknown if the reporter considered the hives to be related to Fluarix Quadrivalent 2017-2018 season and Fluarix Tetra Pre-Filled Syringe Device. Additional details were provided as follows. The age at vaccination was not reported. The reporter stated that, the patient received Fluarix Quadrivalent 2017-2018 season and developed hives. The reporter did not consent to follow up.
High fever - 106 max, onset 10 days after MMR. Fever lasted 4-5 days, requiring multiple doses TYLENOL & ibuprofen & cooling baths. No rash. Mom felt child had no other illness at that time.
Patient was en route to the ER but visited the pharmacy before getting admitted for symptomatic heart failure. Patient was then transferred to the ICU for exacerbated heart failure and passed two weeks later in his sleep.
Some soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Some soreness in arm) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Some soreness in arm). At the time of the report, VACCINATION SITE PAIN (Some soreness in arm) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant product use was not provided. Treatment information was not provided.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    This case was linked to MOD-2021-085479 (Patient Link).
Full body rash with dark purple, itchy bumps; Whole body rash; Fever; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 21Apr2021 at 17:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included somewhat high blood pressure, high cholesterol, gout, penicillin allergy, cat allergy and seasonal allergies. 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 vaccine. Concomitant medications included allopurinol (MANUFACTURER UNKNOWN) and atorvastatin (MANUFACTURER UNKNOWN) from unknown dates for unknown indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration on 31Mar2021 at 17:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. On 21Apr2021, the night of the second shot, the patient broke out in a whole body rash, and got better after about 3 days. The patient then got a fever that lasted for about 4-5 days and on an unknown date the patient experienced full body rash with dark purple, itchy bumps. The patient no longer had fever. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  Since the vaccination, the patient had been tested for COVID-19. On 30Apr2021, the patient underwent COVID-19 test via nasal swab and the result was negative. Therapeutic measures were taken as a result of events whole body rash and full body rash with dark purple, itchy bumps and included treatment with prednisone (MANUFACTURER UNKNOWN) and hydroxyzine (MANUFACTURER UNKNOWN). The clinical outcome of the event fever was recovered on an unknown date in Apr2021 while that of whole body rash and full rash with dark purple, itchy bumps were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Palpitations; Blood pressure high; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitations) and HYPERTENSION (Blood pressure high) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L02A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced PALPITATIONS (Palpitations) and HYPERTENSION (Blood pressure high). At the time of the report, PALPITATIONS (Palpitations) and HYPERTENSION (Blood pressure high) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Feb-2021, Blood pressure measurement: 150/70 mmHg (High) 3 weeks after second dose vaccination it's constant.. On an unknown date, Blood pressure measurement: 110/70 mmHg (normal) Baseline before receiving vaccine..         No concomitant medication was reported  No treatment medication was reported
pt woke up 1JUL w/lt arm soreness & a red spot the size of a baseball on the arm;when got home from work @ 4PM was tired & thirsty;2JUL woke up w/swollen hands & wrists & stiff joints;pt is still thirsty & has a new red spot on lt arm;
Information has been received from a physician concerning "at least two health care workers" who were vaccinated with varicella virus vaccine live. Subsequently the patients did not show seroconversion upon titer testing. The physician had no further details. Additional information has been requested.
This 77 year old female received the Moderna Covid shot on 2/18 /21    and went to the ED on  3/16/21     and was admitted  on 3/16/21 with the following diagnoses listed below. Thrombocytopenia, unspecified
Mild anaphylaxis about 20 minutes after dose. Abrupt painful tightening of the throat, no real difficulty breathing. My face felt "buzzy" but didn't swell and I did not have significant itching. I have had similar reactions in the past to cleaning products and pesticides and usually take a benadryl, though I do carry an epipen and had one with me at the time. Instead of going back in the convention center for medical attention I took a benadryl and waited in the parking garage for about an hour and felt the throat restriction ease a bit. About 10 hours later around 8pm the tightness came back suddenly over about 10 minutes and I took another benadryl. The next morning around 7am I had one more round of tightening and took one more benadryl, and it stopped after that. I told my doctor about it a few days later.