chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of fever in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and feels awful. On an unknown date, the outcome of the fever and feels awful were unknown. It was unknown if the reporter considered the fever and feels awful to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. The reporter called in for a friend who got the SHINGRIX vaccine and then experienced a fever and felt awful. The patient's healthcare provider's details were not available.
Pt received the vaccine where patient started to have Chest Pain, sob, and dizziness. Ems was called to pt's bedside. Pts symptoms continue and patient wished to be seen in ER. EMS took patient as requested.
Pernio what is known familiarly as Covid toe; gout; Pain and redness in one of the toes on my feet; Pain and redness in one of the toes on my feet; This is a spontaneous report from a contactable physician (patient).  This patient of unknown age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, two weeks before the report (Dec2020) at single dose for COVID-19 immunisation and ''on that would been 21st'' (as reported). Medical history and concomitant medications were unknown. On Thursday 31Dec2020 began to experience a pain and redness in one of the toes on the feet. The patient originally thought it was gout and treated it with non-steroidal anti-inflammatory medications but it is gone, it has got better with the anti inflammatory (treatment). It is now come back as the patient gave it another look today (03Jan2021) and the patient is wondering if developed pernio, what is known familiarly as Covid toe. Outcome was not recovered. Information on the lot/batch number has been requested.
felt like crap today; slept for 13 hours; This case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 4th July 2021, the patient received the 2nd dose of Shingles vaccine. On 5th July 2021, 1 days after receiving Shingles vaccine, the patient experienced feeling abnormal and sleepiness. On an unknown date, the outcome of the feeling abnormal and sleepiness were recovering/resolving.   It was unknown if the reporter considered the feeling abnormal and sleepiness to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the reporter himself/ herself. The patient received second dose of Shingles vaccine, a day before reporting date. On the day of reporting, the patient felt like crap and slept for 13 hours. The patient was feeling better in the evening and hoped to recovered fully by the next day.
Vomiting , diareeah,  nauaea. lots of sinus drainage.  overall tiredness. lasted a day . feeling better but not 100%.
1 week post 2nd MMR vaccine started having bilat (more on left) leg pain then moving into left arm. Then turned into Charlie-horse type cramps and stiffness in legs. States unable to bend knees and ankles all of time and severe Charlie horses 1-3 times/night. Had MRI brain, spinal tap, EMG, multiple labs. No alternative causes at this point. Patient is on steroids and states symptoms are better while on, but once stops, symptoms worsen again.
COLD; CHILLS; FELT RUNDOWN; HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced cold, chills, felt rundown, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, headache, felt rundown, and cold. This report was non-serious.
After Vaccination, dressed and walked to front desk to check out, where he became weak and passed out.  He foamed at mouth and lost bladder control.  BP dropped and he stopped breathing. Dr. brought him to consciousness in less than 60 seconds.  Estimated time from vaccination to mild seizure was 3 minutes.  Ambulance was called, but cancelled due to prompt revival.
Information has been received from a physician concerning a 13 year old female patient who on 03-MAR-2010 was vaccinated with a 0.5 ml first dose of GARDASIL (Lot number was not provided). Subsequently the patient "started getting itchy red rash on her arms that spread to her legs and her feet. The patient was also dizzy and vomiting". On an unspecified date, the patient recovered. The patient sought unspecified medical attention. Additional information has been requested.
Fever, chills, shaking, joint pain, malaise, tiredness, diarrhea
EUA was revoked the same day as the vaccine was given (Vaccine was given prior to the EUA revocation).
Provider ordered DTAP, for a 15 month patient. Patient was suppose to get DTAP,HIB, and Varicella. I confused the DTAP with TDAP. I administered TDAP to the patient on the right thigh and HIB on the left thigh. Varicella was not available at the time. An additional MA Verified me and did not catch the mistake either. These vaccines where administered on 09/01/2023 and the vaccine error was noticed on 09/08/2023. Mother has not reported any adverse events.
On April 3, 2023, I was extremely exhausted.  I then had a bad sore throat and low-grade fever on day 4.  I tested positive for COVID-19 on April 6th.  I had body aches all over and my skin hurt.  I had terrible headaches.  I contacted the doctor on the 6th and I took Paxlovid for five days beginning the following day.  Two days after I finished, I got another fever, of 100.8 and my nose was running, and I was coughing.  I began to feel better just a few days ago.
Problems with breathing, moving around on 12/03/12 Monday. On 12/06/12, pt visited ER. BP = 230/196 too high, also breathing problems. Baseline BP: 160/ at ER, seen crystallization in lung.
This spontaneous report as received from a pharmacist refers to a female patient who was current condition and medical history was not provided. She did not have any drug allergies. On an unknown date, reported as 7 years ago, the patient was vaccinated with ZOSTAVAX. The patient was on multiple unspecified concomitant medications. On an unknown date, 2 years after the vaccination, the patient experienced chicken pox. No laboratory tests were reported. No product quality complaint (PQC) was involved. The outcome of the event was unknown. The causality assessment was not provided. Additional information has been requested.
within an hour heartrate was fluctuating alot for a few hours, three hours and 40 minutes after there was hives on face, torso, arms, legs, and ankles, she reached out to doctor and the doctor recommended Benadryl and be ready to call albulance, they hives lasted the weekend, the hives on face are gone but there are still some on leg, once the hives were gone they began to scab on top similar to chicken pocks,  the moment the hives started the bottom of throat was stratchy and tight but didn't make it harder to breath.
Case number PHEH2015US019425, is an initial spontaneous report from a pharmacist received on 29 Sep 2015. This report refers to a 61 years old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUCELVAX (batch number: 174271) intramuscularly on 24 Sep 2015. Further the patient was administered a second dose of FLUCELVAX (batch number: 174271) on 28 Sep 2015. No adverse event was reported.
14MAR96 DPT site red & a little swollen;15MAR96 itchy bumps around DTP site;18MAR96 red & itchy on body & face;tx DPH & lotion;not c/o as much discomfort later on 18MAR96;
Vaccine not viable,  Stored out of temperature range. No adverse reaction,  Will revaccinate.
Per mom child had episodes of shaking before IPV on 6-26-07.  She felt shaking increased in month after IPV.  She was seen in office on 7-24-07.  Per Dr. exam was WNL.  She was referred to neurologist at mom's request.  Neurologist felt exam was normal & not related to IPV.
Pallor, dec muscle tone for 3-4 hrs p/DTp #1;
Patient experienced upper lip swelling 7 hours after receiving the flu shot. No other swelling or difficulty breathing documented. & ORAL SWELLING
This spontaneous case reported by a patient, describes the occurrence of vaccination site pain (her arm hurt for a little, then it went away but if she carries something heavy it hurts) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 054B21A and 011B21A) for COVID-19 vaccination. Patient was not allergic to medications, food and other products. Patient did not have COVID-19 positive test or diagnosis. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. On Jun 6, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jul 6, 2021, received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form.  On an unknown date, patient experienced vaccination site pain (her arm hurt for a little, then it went away but if she carries something heavy it hurts). At the time of the report, vaccination site pain (her arm hurt for a little, then it went away but if she carries something heavy it hurts): resolved.  No concomitant medications reported. The AE did not cause patient to seek medical care (i.e. office visit, urgent care, ER, hospitalization). The patient has not experienced a similar event in the past. No treatment reported. This case linked to MOD-2022-601085 (patient link).
20 minutes after injection , middle finger right hand started jumping  for approximately 10 minutes, getting less vigorous with time. 1-10-21 stared having tremors every 2-3 minutes in both hands, left leg and occasionally in right leg. Left leg  and bottom of left foot numb feeling off and on.
arm pain / is still slightly present  / a shooting pain and spasm down her arm; ithing all over; achiness/shooting pain; chills; she still could not lift her arm; spasm down her arm; low grade fever; This case was reported by a consumer via call center representative and described the occurrence of low grade fever in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 2XG53, expiry date 12th February 2022) for prophylaxis.   Concurrent medical conditions included rotator cuff tear (torn rotator cuff in right arm).   On 1st December 2020, the patient received the 1st dose of Shingrix. On 1st December 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. In December 2020, the patient experienced low grade fever, generalized pruritus, shooting pain, chills, mobility decreased and spasms. The patient was treated with steroids nos (Oral Steroid (Brand Unknown)), muscle relaxants (Muscle Relaxant) and naproxen (Aleve). On an unknown date, the outcome of the low grade fever, generalized pruritus and chills were recovered/resolved and the outcome of the pain in arm, shooting pain, mobility decreased and spasms were not recovered/not resolved.   It was unknown if the reporter considered the low grade fever, pain in arm, generalized pruritus, shooting pain, chills, mobility decreased and spasms to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself. The patient received first dose in her left arm. The patient experienced arm pain on the vaccination day and that night she experienced chills, low grade fever, itching all over and achiness. Those symptoms lasted a day or two. The arm pain persisted and was still slightly present.  The patient reported that a week following the vaccination, she still could not lift her arm and when she stretched it, it caused a shooting pain and spasm down her arm. On 7th January 2021, the patient's doctor prescribed an oral steroid, a muscle relaxer and was told to take Alleve. The reporter consented to follow-up. For tolerance of 2nd dose, refer case US2021AMR061146.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR061146:different dose.
Pt was contacted on 8/17/21 regarding setting up a second dose appointment.  Pt indicated that after the first dose vaccination at clinic, she had an allergic reaction. Pt's reaction was documented as an anaphylactic rxn.  Any needed intervention or time course of the reaction are unknown to this writer.
allergic symptoms - itchy throat, itchy eyes, hives less than an hour after the injection  Symptoms lasted the remainder of the day and all through the night.  Minimal relief with allergy medication -Claritin
Sitting post vaccine, started to feel light headed. EE was given an ice pack, had sit down in floor. Prolonged monitoring, no additional side effect. EE returned to work.
Booster; Interchange of vaccine products; extremely sore and painful; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program.  A 57 year-old female patient received bnt162b2 (BNT162B2), administration date 19Nov2021 (Batch/Lot number: unknown) at the age of 57 years as dose 2 (booster), single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (ongoing), notes: current medical condition. Concomitant medication(s) included: ENBREL taken for rheumatoid arthritis. Past drug history included: Johnson & johnson covid-19 vaccine for COVID-19 immunization, reaction(s): "did not get any antibodies", notes: dose 1. The following information was reported: IMMUNISATION (non-serious) with onset 19Nov2021, outcome "unknown", described as "Booster"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 19Nov2021, outcome "unknown", described as "Interchange of vaccine products"; PAIN (non-serious) with onset 19Nov2021, outcome "not recovered", described as "extremely sore and painful".  Additional information: Action taken with Enbrel with Single Dose Prefilled Autoinjector was reported as unknown for the event pain. The causal relationship between the event pain and Enbrel and Single Dose Prefilled Autoinjector was not provided by the consumer. No treatment information was received.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headache was not reported. This report was non-serious.
Period came every 2-3 weeks until September 3, 2021.  No periods (menstruation) since September 2021 Threw my body into peri-menopause.
pt diagnosed positive for COVID 4 dys prior to hosp admission; admitted due to worsening SOB, cough, hypoxic, A Fib with RVR; COVID pneumonia; intubated; O2 requirements increased; family decided to extubate; comfort measures were instituted; pt's condition worsened and he expired in the hosp
Saddle Pulmonary embolus occurred  on March  6th the day following his first COVID-19 vaccine.  He was found to have an extensive right leg DVT but no symptoms.  He has no prior history of DVT/PE, no family history of DVT/PE, No known risk factors  for DVT/PE.
was tested positive for Covid; flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (was tested positive for Covid) and INFLUENZA LIKE ILLNESS (flu like symptoms) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS and Blood pressure.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). On 24-Jan-2021, the patient experienced COVID-19 (was tested positive for Covid). At the time of the report, COVID-19 (was tested positive for Covid) and INFLUENZA LIKE ILLNESS (flu like symptoms) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were blood pressure medication, thyroid medication. Treatment details included Infusion  for Covid on 26Jan2021. it lasted 2 hours.
I immediately got a bruise from the vaccine the size of a quarter; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the arm on 18Mar2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on 25Feb2021 for COVID-19 immunisation and experienced no reaction or anything. On an unspecified date, the patient experienced immediately got a bruise from the vaccine the size of a quarter. The event was treated with baby aspirin. It was reported that the patient had no other side effects and it's yellowing now, looking more like a disappearing bruise. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A report received from a health professional on 06Feb03, concerning a sexagenarian female vaccinee who developed  flu with fever, body aches and pains an unspecified length of time after receiving Fluvirin on an unspecified date between Nov and Dec 2002. On an unspecified date the vaccinee developed the flu with fever, body aches and pain. A nasal swab on an unspecified date in Feb03 was positive for Type A and Type B antigens. There was insufficient information to determine the reporters causality assessment. Cross ref with: PJP200300059; PJP200300061, PJP200300062.
ARRHYTHMIA; This spontaneous report received from a consumer via a social media through company representative concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously vaccinated with Covid-19 vaccine ad26. cov2.s. (manufacturer not specified) (suspension for injection, route of admin, batch number and expiry date not reported), (dose number in series 1) 01 in total administered, dose was not reported for prophylactic vaccination on an unspecified date. No adverse events were reported following administration of covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose was not reported, (dose number in series 2) 01 in total administered on DEC-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 29-DEC-2021, the reported stated that her husband was admitted into the emergency room (ER) for arrhythmia (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of arrhythmia was not reported (dose number in series 2). This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211266428-COVID-19 VACCINE AD26.COV2.S-Arrhythmia. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Pt received Senior Flu Vaccination on 11-21-17. Pt returned to pharmacy on 11-22-17 complaining of red welt at injection site. Pt was still concerned so went to ER to have it checked out. Was prescribed 7 day course of doxycycline.
vaccines exposed to the highest temp 50 for 24 hours, no AE; Initial information received on 22-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  In this case a cold chain deviation occurred with vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ300AB, Exp. Date 26-Jun-2020) on an unknown date while it was taken to a patient home.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a potential medication error case due to incorrect product storage.  It was reported that the vaccines were in the cooler and sent out of in the morning. Caller said that the highest temp 50 for 24 hours.  It was unknown whether the vaccine was administered.  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 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
Slight sore arm at injection site for 1-2 days. Moderate to extreme tiredness 1 day after injection lasting 24 hours.  Headache. No fever.
This spontaneous report was received from a healthcare worker and refers to unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II (lot # K021950 with expiration date: 10-NOV-2016 and albumin status of recombinant human albumin (rHA); exact dose and route of administered were not reported)., The administered doses experienced temperature excursion of 10 degrees Celsius for 1 hour and 16 minutes. The temperature excursion was detected by a data logger. There was no previous excursions. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.