chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer concerning her 80 year old husband with blood pressure high, cholesterol high and PENICILLIN allergy and a history of benign prostatic hyperplasia and kidney stone. On 31-JUL-2008, the patient was vaccinated with ZOSTAVAX vaccine (Oka/Merck). Concomitant therapy included ATENOLOL, FINASTERIDE, VYTORIN, ALLOPURINOL and  FEXOFENADINE HYDROCHLORIDE. On 31-JUL-2008 the patient started to have pain on his left arm at the injection site. On 01-AUG-2008, the injection site was very swollen and painful that lasted a couple of days. It was reported that the patient went to see his physician who took his blood pressure and told him to take IBUPROPHEN for pain and swelling. The patient reported as of 13-AUG-2008, it had been 13 days and the swelling was still there but was going down and also there was a felling of soreness at the injection site. Additional information has been requested. 12/23/08 This is in follow-up to report(s) previously submitted on 9/24/2008. Information has been received from a consumer concerning her 80 year old husband with blood pressure high, cholesterol high, hypertension, gout, osteoarthritis and penicillin allergy and a history of benign prostatic hyperplasia and kidney stone. On 31-JUL-2008, the patient was vaccinated with a first dose ZOSTAVAX (Oka/Merck) (lot no. 658859/0411X) IM. Concomitant therapy included atenolol, finasteride (MSD), ezetimibe (+) simvastatin (MSD), allopurinol and fexofenadine hydrochloride. On 31-JUL-2008 the patient started to have pain on his left arm at the injection site. On 01-AUG-2008, the injection site was very swollen and painful that lasted a couple of days. It was reported that the patient went to see his physician who took his blood pressure and told him to take ibuprofen for pain and swelling. The patient reported as of 13-AUG-2008, it had been 13 days and the swelling was still there but was going down and also there was a feeling of soreness at the injection site. No further information is available.
Information has been received from a pharmacist concerning her 12 month old daughter with no pertinent medical history, drug reactions or allergies who on 22-FEB-2008 was vaccinated with varicella virus vaccine live (Oka/Merck). Concomitant therapy included "other vaccinations appropriate for one year of age". The pharmacist reported that sometime after vaccination with varicella virus vaccine live (Oka/Merck), "within the last week" (approximately 06-Mar-2008) her daughter developed "a little rash on the side of her thigh". Three to four days later the pharmacist noticed the rash became little cysts on the outer left thigh. "Last evening", 12 MAR 2008, the pharmacist reported noticing the start of a rash on her daughter's chest. It was noted that the child was also a little congested and may have been teething. The pharmacist reported the treatment had been Tylenol. The patient recovered on 13 MAR 2008. It was report that the physician had been contacted, but is unknown if medical attention was sought. There was no product quality complaint.
Smallpox vaccine administered to roommate. Pt did not received vaccine but may have become secondarily infected on left forehead by room mate.
Initial report was received on 05 October 2010 from a health care professional which involved a cluster of four patients who experienced adverse events after receiving FLUZONE, lot number UT3570DA. This report represents one patient, and the other three patients have been captured in case numbers 2010-05757, -05758, and 05760. A nine-month-old female patient had received a first dose intramuscular injection (site not reported) of FLUZONE, lot number UT3570DA on 04 October 2010 and at 7 PM on the evening of vaccination, the patient had fever, chills, decreased appetite and glassy eyes. Outcome was reported as unknown. No additional information was provided at the time of the report. The reporter for this case is the same as for case number 2010-05761.
Pt vaccinated with Fluzone developed itching eyes; welts on body; size of quarter for a few hrs. pt took chlor-trimton
Patient developed pain radiating up into the right side of his scalp starting about two weeks after the injection which was in the right deltoid. . The pain then progressed to the right neck and supraclavicular area. He felt throbbing , sore, numbness as well and "shocks". Over the next view days the pain was shooting down his triceps and numbness and tingling and then numbness in the fourth and fifth fingers. No muscle weakness and no fever or chills. No systemic symptoms. He complained of the tingling numbness and a sense of swelling--all down the right arm in the c6-7 distribution. On April first his wife noted a vesicular rash on the right side of his neck with a few lesions on the right upper back. He was not responding to NSAIDs, ice or heat, immobilization, so at this point the clinical diagnosis of shingles/varicella zoster was made and Valtrex 1000 mg tid was started.
pt recvd vax 11AM 10FEB93 & ate undercooked hamburger @ 1300; c/o nausea, w/vomiting; stomach cramps, dizziness started around 1700-1800 while @ work; sx were not completely resolved until a wk;
Patient was experiencing sudden onset chest pain and shortness of breath on 10/11/22 and came to the emergency department. He tested positive for COVID on 10/11/22. He was discharged from the hospital on 10/23/22.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Oct2022 at 08:15 as dose 4 (booster), single (Lot number: GJ6665) at the age of 41 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 07Feb2021 at 10:00 as dose 1, single (Lot number: 029L20A), in left arm, on 07Mar2021 at 11:30 as dose 2, single (Lot number: 027A21A), in left arm and on 09Nov2021 as dose 3 (booster), single (Lot number: 017B21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Cystic fibrosis" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Known allergies: PCN" (unspecified if ongoing), notes: Known allergies: PCN. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Dec2022) Negative; (03Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. Patient treated with Paxlovid from 24Nov2022 to 28Nov2022.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.
Information has been received from a physician concerning an "about 20-year-old" female medical student who was vaccinated "last week" with a dose of Varivax (lot# not provided). "One day post vaccination" she did not feel well and developed a fever (felt "flu-like"). The patient was hospitalized in the ICU. It was discovered that the patient ad taken an over the counter diuretic and her potassium 'bottomed out" to very dangerous levels. Prior to knowing this, the physician was concerned that the events may have been due to her vaccination. Unspecified tests were performed while she was hospitalized. No outcome is reported. No product quality complaint was involved. Additional information has been requested.
9am Friday, I got the shot. 3am Saturday I had some chills, but they went away. 6am Saturday I was about to leave for work, felt bad, took my temperature, it was 101.9. Entire day, I could barely get up and walk, got 500 steps, not my usual 15,000. Later temp was 102.9. Next day, Sunday, I felt partly better.  Today I feel great. I had to miss a whole day of work over this, so I figure it ought to count as a reaction. I  hope my boss will be benevolent. The answer to #21 below, is I called the covid nurses at work. They said stay home, rest, etc.
I never had chest pain or this feeling in my heart like I am going die; feeling like I was having a stroke or something; heart pain; headache; chest pain; where your lungs are, it's pain; heartburn; My arm was still sore a week after, I could not lay on it or touch it; I can't sleep; I am nervous; I feel it in my body and something is just taking over me.  Something is happening and I could feel; This is a spontaneous report from a contactable consumer. A 58-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on 09Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 on 18Mar2021 for covid-19 immunisation it went pretty well, no problems and tylenol and experienced drug ineffective. On an unspecified date, it was reported "I can tell the drug was inside me and can feel it taking over, and going through my body. I had headache, chest pain, heart pain, and feeling like I was having a stroke or something. On my right side there is pain, where your lungs are, it's pain. I've been having symptoms every single day. I took some Tylenol one day, but that did not help.  I took some Tums, thinking maybe it is heartburn, but it has not gone away. I feel it in my body and something is just taking over me. Something is happening and I could feel.  I never had chest pain or this feeling in my heart like I am going die. My arm was still sore a week after, I could not lay on it or touch it and then other symptoms came on more and more. I have pain in my chest and head constantly, all day all night. I can't sleep because I am nervous and I don't know what is going on." Therapeutic measures were taken as a result of headache, chest pain, where your lungs are, it's pain, my arm was still sore a week after, i could not lay on it or touch it (pain in extremity). The events I never had chest pain or this feeling in my heart like I am going die, feeling like I was having a stroke or something, and heart pain were considered as serious (medically significant). The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Bleeding and cramping; I was pregnant and the ultrasound showed it was a miscarriage and so they had to do a DNC - OUT PATIENT PROCEDURE. . May 25th
After this patient received Hep A immunization approximately 1 hour later returned complaining of slight difficulty in breathing and throat tightening. Patient given Benadryl with good results.
Rapid Test Nasal Swab Positive; Rapid Test Nasal Swab Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 09Sep2021 as dose 1, single (Lot number: FF2153) at the age of 37 years, in left arm and on 30Oct2021 as dose 2, single (Lot number: FJ1618) at the age of 37 years, in left arm for covid-19 immunisation. Facility type vaccine other: Vaccination Center. The patient's relevant medical history included: "Known allergies: Cherries" (unspecified if ongoing); "Known allergies: Pollen" (unspecified if ongoing); "Known allergies: Dust mites" (unspecified if ongoing). There were no concomitant medications (patient had no other medication in two weeks). The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Rapid Test Nasal Swab Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Positive, notes: Nasal Swab.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300047485 same patient, different dose/drug/event;US-PFIZER INC-202300047486 same patient, different dose/drug/event;
Swelling; Knot; Blistering welts; Hives; This spontaneous case was received on 12-Nov-2020 from other health professional (nurse) via agency (reference number: SEQW20-05062) and concerned a 32-year-old, female patient.  The patient had no relevant medical history and was not taking any concomitant medications. The patient's historical vaccine included Flucevax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent), without adverse reactions.   On 02-Nov-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration: intramuscular and anatomical location: not reported) for flu prevention. The batch number reported was 276539 and expiry date was 14-Jun-2021.  On the same day, after receiving Flucelvax QIV, the patient experienced swelling, knot, hives and blistering welts. The patient was advised to apply ice.   At the time of initial reporting on 12-Nov-2020, the patient was recovering from the events, and she was feeling better.   The reporter did not provide a causality assessment.  The reporter assessed the events as non-serious.  This case is linked to cases 202006294 (the same reporter).  Company comment: A 32-year-old, female patient was administered Flucelvax QIV vaccine. On the same day, after receiving Flucelvax QIV, the patient experienced swelling, mass (knot), urticaria and blister. With information available, causal role of suspect vaccine is assessed as possibly related.; Sender's Comments: A 32-year-old, female patient was administered Flucelvax QIV vaccine. On the same day, after receiving Flucelvax QIV, the patient experienced swelling, mass (knot), urticaria and blister. With information available, causal role of suspect vaccine is assessed as possibly related.
Skin rash, Rash, UrticariaPruritis, itching Narrative: employee felt flushed and itchy progressively worsened over a matter of 10 minutes
Fainted. Sudden drop of blood pressure. Was given juice and monitored until blood pressure was stable again.
This spontaneous report as received from a medical assistant refers to a 23 month old female patient. There was no information about patient's concomitant medications and pertinent medical history reported. On 11-SEP-2015, the patient was vaccinated with a 0.5 ml dose of (Oka/Merck) VARIVAX lot # K002916, expiry date 26-FEB-2016, subcutaneously (site was not reported). On 04-SEP-2015, the patient was seen by physician and diagnosed with chickenpox. Labs were drawn during the office visit that confirmed the diagnosis of chickenpox. IT was reported that the patient had been exposed to family member who  had chickenpox on an unspecified date prior to developing chickenpox herself.  The patient seek medical attention. No treatment was given for the event. The outcome of the event was reported as recovering. The relatedness between (Oka/Merck) VARIVQAX and the event was not reported. Additional information has been requested.
Pt vaccinated with Influenza and was asymptomatic at time of shot; 10 days later, developed pleuritis , then progressed to diffuse arthralgia with arthritis in rt wrist.
Barrett's esophagus; Muscle shoulder and left arm are aching; Left arm are aching/arm was a little sore; Throat is tightening up; Nauseous; Gastric problems; Headache; Hands and feet are cold/extremely cold in her hands and feet and cannot get warm; Hot flashes; Achalasia; Breaking out in sweat; Cannot eat; Really sick; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 24Mar2021 as a single dose, with route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient had Barrett's esophagus; muscle shoulder and left arm were aching; arm was a little sore; throat was tightening up; nauseous; gastric problems; headache; hands and feet were cold/extremely cold in her hands and feet, and could not get warm; had hot flashes; achalasia; was breaking out in sweat; could not eat; and was really sick. The outcome of the events was unknown. The patient was supposed to get the second dose of vaccination on 14Apr2021.  Information on lot number/batch number has been requested.
This spontaneous report was received from a registered nurse and refers to a 12 months old patient of unknown gender. No medical history, concurrent conditions and concomitant therapies were reported. On 01-MAY-2015, the patient was vaccinated with an improperly stored dose of (Merck) VARIVAX lot # K021933, expiration date 10-NOV-2016, dose 0.5 ml, subcutaneously (anatomical location was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, as all required information has been received.
I have tinnitus off and on. It lasts for a few minutes at most and isn?t as bad as it was a few months ago. No treatment so far. I will report to my doctor Friday.
No adverse event; Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in an 83-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     It was unknown if patient had any relevant medical history, allergy, concomitant diseases and risk factor and information regarding previous vaccination was unknown. It was also unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 18-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 18-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    No concomitant medication was reported.  Suspect product dosage text was reported as unknown. It was unknown when the vial was initially stored in the refrigerator for this patient. The individual vial did not underwent any temperature excursions. No treatment medication was reported. This case contains information about patient 1st out of 3 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-736479, US-MODERNATX, INC.-MOD-2023-736474 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-736474:Same reporter, Patient 2 US-MODERNATX, INC.-MOD-2023-736479:Same reporter, Patient 3
Narrative:  Patient passed away in his home of Sat. 2/6/2021, family was present and 911 was called due to sudden and severe weakness/shakiness/decreased HR. Patient was ambulating with assistance and slumped over where he was pronounced deceased.
Something like a mini stroke occur; some kind of injury to his neck; This is a spontaneous report from a contactable consumer from a Pfizer Sponsored program Covax US Support. A 68-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL9263), via an unknown route of administration on 27Jan2021 (at the age of 68-years-old) as a single dose for Covid-19 immunization. Medical history included a heart patient prior to the vaccine for which he takes heart medications from an unknown date. The patient's concomitant medications were reported as a lot of medications and heart medications for which he has been taking for years (unspecified). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Feb2021 at 16:00, the patient experienced something like a mini stroke; and he had some kind of injury to his neck from an unknown date. The patient was hospitalized due to heart problems describes as mini stroke on 15Feb2021. The patient underwent lots of test (unspecified) on an unknown date with unknown results. The clinical outcome of the event mini stroke and neck injury was unknown. The patient was still hospitalized.
Fever; Urinary incontinence; "Stuck in bed for 7 days"; Pain behind ears; Pain in head; Vision problems; This case was reported by a consumer via call center representative and described the occurrence of fever in a 59-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) for prophylaxis.   Concurrent medical conditions included immunocompromised.   On 23rd October 2019, the patient received the 1st dose of Fluarix Quadrivalent 2019-2020 season (intramuscular) .5 ml. On 28th October 2019, 5 days after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced fever, urinary incontinence, bedridden, ear pain, headache and abnormal vision. On 4th November 2019, the outcome of the urinary incontinence, ear pain and abnormal vision were recovered/resolved. On an unknown date, the outcome of the fever, bedridden and headache were unknown.   It was unknown if the reporter considered the fever, urinary incontinence, bedridden, ear pain, headache and abnormal vision to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient after vaccination experienced multiple symptoms including fever, urinary incontinence, being stuck in bed for 7 days, pain behind ears, pain in head and visual problems.  The patient was advised to report this to her physician. The patient consented to follow up.
Abscess on right buttock, at injection site. Abscess drained and cultured on 1/13/01. Treated with Keflex; changed to Augmentin on 1/16/01. Abscess on left thigh drained and cultured and treated with Keflex, stated by doctor on 2/5/01.
14 and 6 weeks pregnant with identical twins. Complications of sub chorionic hemorrhages. Due date May 15, 2021. Following the flu vaccine, I developed a low grade fever at home. Stomach pain was increased. I carried the low grade fever the next three days and miscarried the twins.
Patient bleed after the shot, she was given ban-aid and she stood up to stand with her mother. Patient appeared to be feeling normal and no adverse signs, then suddenly patient collapsed onto the floor and was convulsing. Appeared pale and blank faced. pt came out about after 30 to 40 seconds. Had patient lied down seemed alert. Paramedic came checked blood pressure and pulse. Everything normal and patient went home.
5-11 Covid vaccine not diluted. 0.2mL of undiluted vaccine administered to left arm. After drawing 5 doses LVN noticed there was not sufficient amount left for 10 doses. LVN realized the vial was not diluted. MD notified.
On the evening of November 3rd I developed a very sore throat. That continued throughout the night and evening. I had a fever of 99.5 and a slight productive cough. I was seen by the clinic on Friday afternoon. A COVID-19 test was administered. The doctor advised me to push liquids and take care of myself. I remained feeling bad through part of Saturday. By November 7th I had no fever and a slight sore throat. I no longer have a sore throat or fever today.