chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reported not feeling well and became very pale in her face and lips. Shortly after she became diaphoretic. VS taken: 121/64, P-57-61, 98% RA. Patient denied feeling short of breath. At approximately 10:35am, patient then had a large emesis x2.  Moments after, patient fell over in her chair, but staff caught her preventing her from hitting the floor, she was passing out. Staff lowered her to the floor and called 911 for EMS.  Patient's appearance was still very pale and diaphoretic. Patient did have an episode of urine and possibly bowel incontinence when she fell over in the chair. Patient remained sitting upright on the floor, awake but groggy, sipping small amounts of water until EMS arrived.  She continued to deny any shortness of breath, trouble swallowing, etc. Moments later, patient did appear to become more clear and alert. VS: 147/80, P-80, 98% RA. EMS arrived and evaluated patient. EMS and patient felt that she would be okay to go home and monitor once she was cleared by EMS. Patient's husband was there and planned to driver her home.  Writer attempted to reach patient the next day 9/16/21, left msg to call back.  9/20/21, writer spoke with husband on patient behalf and he reports she is doing great. No further symptoms or issues and they denied the need for further medical treatment. Advised that the patient needs to update her primary provider about episode and to discuss 2nd dose.
Patient have fever of 100.0 - 104.0 / due to not getting the fever controlled; not doing very good; very weak; A spontaneous report was received from 63-year-old female patient, who received Moderna's COVID-19 vaccine and experienced fever of 100.0 - 104.0/ pyrexia, not doing very good/feeling abnormal, and very weak/asthenia.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 15 Jan 2021, prior to the onset of events, the patient received an unspecified dose of two planned doses of mRNA-1273 (lot number unknown) via intramuscular route for COVID-19 infection prophylaxis.   On 16 Feb 2021, after an unspecified dose of vaccine, the patient experienced fever of 100.0 - 104.0, was not doing very good, very weak. On 14 MAR 2021, patient was admitted to the hospital due to uncontrolled fever. No treatment medication was reported.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events, fever of 100.0 - 104.0, not doing very good, very weak was ongoing at the time of this report.; Reporter's Comments: Based on the current available information which shows a temporal association between the use of the mRNA-1273  and the start date of the reported events and excluding any other etiology, a causal relationship with the events cannot be excluded.
My left arm is weaker and sore from the underside of my bicep down my arm into my ring and little finger.  This is constant.  The pain is minor but I have more significant pain when putting on a jacket or lifting something with my left hand.  The discomfort began within a week from injection into my left arm and has been daily.  It is not debilitating but is annoyingly weaker.
Patient random jerks in full body, arm, face, and legs. Patient says it is similar to a seizure.
Severe gout in left foot on the sixth day after vaccine. History of previous gout flare up especially after anesthesia but it was never this severe; Unable to walk for 4 days; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Apr2021 at 12:00 (at the age of 74-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high, heart disease, unspecified on an unknown date and gout since an unknown date. 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 vaccination. Concomitant medications included blood thinner (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing and also received unspecified concomitant medications for blood pressure on an unknown date. The patient previously received first dose of BNT162b2 (COMIRNATY; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 16Mar2021 at 12:00 (at the age of 74-year-old) as a single dose for COVID-19 immunisation. On 19Apr2021 at 08:00, the patient experienced severe gout in left foot on the sixth day after vaccine. History of previous gout flare up especially after anesthesia but it was never this severe and unable to walk for 4 days. It was reported that patient read an article written by a doctor who observed gout in several patients after they received second COVID vaccine. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of gout aggravated and unable to walk and included treatment with colchicine (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event unable to walk was recovered on 23Apr2021, after the duration of 4 days and gout was recovering at the time of reporting.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Day following vaccines at 1 pm patient was lethargic, nausea with a slight headache. Arm that received vaccination was painful and hot. She later vomited and had a temperature of 101.1 degree F. She had husband take her to ER.
19 year old, female patient received the J&J vaccine on 4/12/21. Today, 4/16/21 she reported chills (the night of), headache and abdominal pain since then, and also that she cannot feel the right side of her face. Went over the EUA information for J&J such as side effects, etc and recommended for patient to contact her health care provider/seek medical attention as a precautionary measure.
Vaccine administered 3/24/22 ~435pm. No issues until 3/28/22 ~3-4 pm. Pt alleges redness and swollen arm. Was not feeling well. Pt sates took 2 tylenol and after 5 hours took Ibuprofen, pt c/o fever and body aches (flu like symptoms) and stated she laid down whole day. 3/29/22 ~1103 AM pt states feels a lot better but arm still feels swollen, red and tender but not any worse (was in 2 spots now 1 spot) redness is little better but still swollen
Within 1 hour of first vaccine I started with a migraine that lasted 30 days total. The migraine continued through the second vaccination.  Since I have had increased migraines. I use to have a migraine 3-4 times a year, now they are almost daily. I had to be put on medication. About one month after second vaccination I started having a lot of dizziness, drainage, vertigo, nausea. I thought it was due to weather change.  Last month I started seeing a Neurologist because I could not take the migraines and vertigo anymore. They did a MRI, my optic nerves are swollen, I have intracranial pressure. I was diagnosed with transverse sinus stenosis.  I know have to get a lumbar puncture and see a neurosurgeon.
Began wheezing and "hard time breathing" on way home from office after vaccine (seen for healthy checkup with no cough or SOB).  Still was wheezing when seen in office the next day; Dr. Rx albuterol via nebulizer (had nebulizer at home from one previous wheezing episode when had bronchitis.  No fever, no cough at second office visit.
Subject, a 29 year old female, with a history of gastroesophageal reflux disease, migraine headache, irritable bowel syndrome, experienced redness at injection site, fever to 101.4, erythema 7.5-8 cm surrounding the injection site and myalgias on 12Apr00 following a vaccination with Anthrax Vaccine lot number FAV048B on 12Apr00. Other vaccinations received were Typhoid vaccine and Meningococcal vaccine on 03Apr00. Concomitant medications were Prilosec, Midrin, and Donnatal. There were no treatment drugs to report. The committee case assessment form was not provided. Additional information will be provided, as it becomes available.  Reported on: 08Feb01.
Post vax, the pt developed a temperature of 100.6 and emesis times 2. On 8/4/00, the pt developed a temperature of 103. On 8/7/00, erythema macular papular rash and pruritus on face, arms, thorax.
I had a sore throat, cough, shortness of breath. I lost taste and smell. I had some chest pain during COVID. Now, since then. I was better for 3-4 days, and now for the last 2 days, I've been short of breath again on the left side and have a cough again. I just contacted my PCP because I sneezed and looked like I had blood clots coming from my nose. I'm waiting for them to call me back. And also feeling tired all the time. I was also achy during this time and took some TYLENOL during the infection. The last two days of symptoms, unsure if in relation to COVID or not.
Pt returned to clinic, after receiving TD. Over the course of 8 days, had developed erythema and edema, gradually increasing in size to more than 20cm in diameter. Treated as cellulitis with Duricef. Pt, however, did not take Duricef and recovered.
rash about 4 inches long by 2 inches, begins at the injection site and travels from  there; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) and VACCINATION SITE RASH (rash about 4 inches long by 2 inches, begins at the injection site and travels from  there) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 24-Jan-2021, the patient experienced VACCINATION SITE RASH (rash about 4 inches long by 2 inches, begins at the injection site and travels from  there). At the time of the report, VACCINATION SITE PAIN (sore arm) and VACCINATION SITE RASH (rash about 4 inches long by 2 inches, begins at the injection site and travels from  there) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: No new information was provided.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 75-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2018). Concomitant products included pneumococcal vaccine. On 14th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 14th March 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved. The reporter considered the injection site erythema to be possibly related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX and Pneumonia vaccination on the left arm on the same day, at the physician's office. The reporter reported that, the patient experienced a 7 cm approximately in diameter red spot on her left arm where she received the SHINGRIX. No details related to pneumonia vaccination injection were known. The call was transferred to the Medical Information to discuss questions related to medical treatment for the arm.
Excruciating pain in shoulder .  First night was unbearable. Still hurts after three days. Also had flue like condition for about thirty hours. I noticed that the injection was inserted in the top of my shoulder and not on the side. The injection hurt more than any shot I have ever had, and I have had many. I don't know if my shoulder pain was caused by the way the needle was inserted of because of some reaction. I am in excellent health and have the long term covid antibodies.
Nausea, vomiting, subjective fever for 1 day the day after administration.
Child broke out in a rash from his knees down. No fever or other signs and symptoms. Took child to PMD, who gave Rx for prednisone. Pt broke out on entire body with rash within 24 hours. On 10/2/00, child was ok.
Patient received vaccine and 5 minutes later had severe chest pain on his left side that was rated a 10.  Was diaphoretic and dizzy.  Also short of breath.  Pain was a 3 after 5 minutes and then resolved.  Patient went to ER for evaluaiton
Developed LLE DVT and R sided PE. Unclear time correlation with vaccination. Symptoms worsened about 3 weeks ago.
Red rash around injection site about 3 inches. Warm to the touch and slightly firm.  After about 48 hours the inside has become more skin tone, but the outside ring is still pink/red.   No pain or itching.
patient received QUADRIVALENT INFLUENZA VACCINE instead of FLUZONE HIGH-DOSE QUADRIVALENT with no reported adverse event; Initial information was received on 14-Sep-2021 regarding an unsolicited valid non-serious case from pharmacist and non-healthcare professional via call center via Medical Information (Reference number- 00768700).  This case involves a 66 years old patient of unknown gender who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] instead of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (wrong product administered).  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported) instead of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] via an unknown route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to wrong vaccine administered (latency: same day).  At the time of reporting, no adverse event reported.  It was reported "The caller would like to know what the next steps are for the patient and if it is recommended that the patient get a second shot of the regular dose or a second shot of the high dose Fluzone."  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 the 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.  There will be no information available on the batch number for this case.
This is a spontaneous report from a contactable nurse calling from physician's office who reported similar events for 15 patients. This is the 5th of 15 reports. A patient of an unspecified gender, age and race/ethnicity received PREVNAR 13 (Lot. N4385, expiry date 31Oct2017) on an unknown date, single dose, for immunization. Relevant medical history and concomitant medications were unknown. The vaccine was administered to this patient after a temperature excursion. On an unspecified date, the patient experienced severe reactions on arm. Clinical outcome was unknown at time of this report.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017060849 Same reporter/drug/AE, different patient.
On 2-24-21 I received my first dose lot #030M20A and had flu like illness the following day that lasted all day. The 2nd dose I started to feel bad that afternoon , I didn't sleep at all that night running a fever, cold chills, my body was sore and ached,restless, headache , and very weak.  If I knew this is how I would had felt I would have never got the shot! And I will never again it was that bad.
One week after vaccine, patient returns with diffuse erythematous macular papular rash.  Involving all body, but especially face. Palms and soles involved. No treatment given.  Patient was started on Amoxicillin at time the vaccines were given.  At time of rash, patient had been on Amox for 7 days.  No fever. Otherwise doing well.
This spontaneous report as received from a Licensed Vocational Nurse regarding 4 patients of unknown demographics. There was no information about pertinent medical history, drug reactions or drug allergies. On 09-SEP-2015, the patients were vaccinated with improperly stored dose of VARIVAX (Merck) lot# L012035 and expiry date: 07-APR-2017. No adverse effect was reported. The outcome of the event was unknown. This is one of the several reports from the same reporter. Additional information has been requested.
Arm redness and heat (redness began this morning, heat this afternoon), nausea since 3 pm.
This case was reported by a consumer via call center representative and described the occurrence of headache in a 74-year-old male patient who received SHINGRIX. Concomitant products included TENORETIC and ZOCOR. On 19th April 11:30, the patient received the 1st dose of SHINGRIX. On 19th April 2018, several hours after receiving SHINGRIX, the patient experienced headache, muscle cramp, generalized muscle aches, weakness, tiredness, occipital neuralgia, lightheadedness, fever, chills, insomnia and nausea. On 24th April 2018, the outcome of the insomnia was recovered/resolved. On 25th April 2018, the outcome of the weakness, tiredness, occipital neuralgia, lightheadedness, fever, chills and nausea were recovered/resolved. On 26th April 2018, the outcome of the headache, muscle cramp and generalized muscle aches were recovered/resolved. The reporter considered the headache, muscle cramp, generalized muscle aches, weakness, tiredness, occipital neuralgia, lightheadedness, fever, chills, insomnia and nausea to be almost certainly related to SHINGRIX. Additional details were provided as follows: This case was previously not reported to anyone. The patient reported that after receiving SHINGRIX, the patient could not sleep, and the reason he could not sleep was because of the symptoms he was experiencing such as the leg cramps. The patient experienced muscle aches or muscle cramps, whole body especially in legs and lower back stated that legs were killing him and neuralgia of eyes- little bit. The patient stated that the doctor was aware that he got the SHINGRIX shot but was not aware that he experienced side effects. The pharmacy was aware that this patient experienced side effects.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age. The nurse reported that improperly stored ROTATEQ might have been administered during the month of April 2013 (exact date unspecified) to an unspecified number of patients (dose, route and lot # unknown). No adverse event reported. Additional information has been requested.
Received 5th COVID vaccine 1/16/23, when returning home became weak and nauseaous, unable to get out of bed 1/17/23, see ER, diagnosised with UTI and post vaccination reaction, initial encounter, generalized weakness, liver cirrhosis secondary to NASH, admitted to Hospital over night, discharged next day 1/18/23 home.
Rash w/in 24 hrs of 2nd dose; scaly "eczema" type rash; Will d/c last dose & do titer check;
Chills, fever, fatigue and possible early cellulitis.  Treated with ice to deltoid 20 minutes 4 times a day. Given Benadryl 25 mg every 6 hours prn; Keflex 500mg 4 times a day for 7 days.
This case was reported by a consumer and described the occurrence of joint pain in a 17 year old female pt who received hep A vaccine inactivated (Havrix). A physician or other health care professional has not verified this report. The pt's past medical history included gluten intolerance. On 6/26/01, the pt received the first dose of Havrix. On 5/28/02, the pt received the second dose of Havrix. On an unspecified date in 2003, approximately ten months after administration of the second dose of Havrix, the pt developed joint pain in her neck, knees, shoulders and hips. Between ten and sixteen months after receiving her second dose of Havrix, the pt also developed headache, blurred vision, fatigue, dizziness, "brain fog," memory loss, malaise, depression, and felt dazed. The reporter noted that the area near the pt's spine was very sensitive to pain. The reporter felt that "heavy metals are accumulating and that the pt is experiencing adrenal fatigue/ burnout/ insufficiency." The reporter also stated that the pt "cannot complete school work because of fatigue." As of 3/24/04, the events were unresolved. The reporter is the pt's mother.
Patient came in 05/22/21 for a second dose of Moderna. Patient had already received second dose on 05/14/21 which was 28 day after first dose. Patient did not have any adverse reactions. She was advised to watch for symptoms.
FEVER; TIREDNESS; This spontaneous report received from a patient concerned a 42 year old female. 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 was not reported, administered on 12-APR-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 13-APR-2021, the subject experienced fever. On 13-APR-2021, the subject experienced tiredness. Laboratory data included: Body temperature (NR: not provided) 100.1 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and tiredness. This report was non-serious.
I seem to be getting a feeling of being tired; This is a spontaneous report from a contactable consumer or other Non-health care professional.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on 06Feb2021 as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patients concomitant medications were not reported. On an unspecified date it was reported that patient seems to be getting a feeling of being tired last week and this week. Outcome of event was reported as unknown.  Information for lot/batch number has been requested.   Follow-up attempts are completed. No further information is expected.
After approximately 5 minutes after receiving Dose 1 of Moderna Vaccine patient complained of metallic taste in mouth, dizziness, and increased heart rate. Patient sat down in chair. Pharmacist called 9-1-1. Patient complained of swelling of throat. Paramedics evaluated patient for hives, took vitals, and evaluated patient. Patient was ok, but still complained of swelling in her throat. Paramedics told patient to take Benadryl to decrease swelling. Patient refused to go to hospital.
ringing in the ears; had like throbbing inside the ear; This is a spontaneous report from a contactable consumer (patient's grandfather). A 16-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number not provided), via an unspecified route of administration on an unspecified date May2021 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medication were not provided. It was reported that patient received Pfizer Vaccine like two and a half weeks ago and what happened is that he developed ringing in the ears and he had like throbbing inside the ear. Now, I am concerned because he is due to get his second vaccine, this Friday (10Jun2021). Should he get the second vaccine? The outcome of the events was reported as unknown.  Information on the lot/batch number has been requested.