chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received on 24-MAY-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 16-SEP-2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route administered by a physician as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster also known as shingles and other complications. On or about 09-MAY-2015, the patient was treated at a hospital for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster. The patient has been prescribed ketorolac tromethamine (TORADOL), prednisone, acetaminophen, hydrocodone bitartrate (NORCO) and acyclovir for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
About 5 min. after receiving HPV9 vaccine, patient reported dizziness. Nurse applied cold compress to patient's forehead and had pt sit with head between knees. After 5 min, patient sat up and drank 6oz. orange juice and 4 oz. water. Patient then reported headache and continued dizziness. Nurse placed mat on floor and patient lay down. Patient fully recovered in 10 min.
Initial report received from a health care professional on 03 November 2010. A patient (age not provided) received an injection (route, site and date not provided) of DTaP, manufacturer and lot number not provided. The patient had an adverse event. No other information provided. The outcome was not reported. Follow-up information was received from a physician on 07 February 2011. The patient received first doses of the following vaccines on 11 June 2010: DAPTACEL (lot number C3381AA), IPOL (lot number E0123) and ACTHIB (sanofi pasteur SA lot number E0270, sanofi pasteur inc lot number UH083A). The patient was not ill at the time of vaccination. According to mother report, the patient experienced 4 hours of uncontrollable/inconsolable crying after vaccination. Per the reporter, the patient was not brought into the office for examination. The event subsequently resolved at an unspecified time. Documents held by sender: None.
This spontaneous report was received from an administrator and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies were not reported. On 16-NOV-2018, the patient was vaccinated with PROQUAD subcutaneous injection (lot # R014353, expiration date: 18-NOV-2019, recombinant Human albumin (rHA)) (dose, anatomical location were not provided)reconstituted with properly stored sterile diluent. The vaccine was stored at a temperature of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 1 hour and 15 degrees Fahrenheit to 46 degrees Fahrenheit for 4 hour. There was no previous temperature excursions. Data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1812USA009243: US-009507513-1812USA009242: US-009507513-1811USA009124: US-009507513-1812USA009241.
Information has been reported in a study. The report includes VAERS reports following PNEUMOVAX 23 or Pneumococcal polysaccharide vaccine (PPSV23) brand unknown after 2002. The report includes reports information from 01-JAN-1990 to 13-JAN-2014. This spontaneous report as received from a other health professional refers to 11 patients. The median age of the patients was 69 years old; range being 23 to 98 years. Between 01-JAN-1990 and 31-DEC-2013 patients were vaccinated with PNEUMOVAX 23. On an unknown date the patients experienced death. The outcome of death was reported as fatal. The cause of death was reported as 'Respiratory'. The death of the patients was confirmed with medical records, autopsy reports and/or death certificates. The report has been split into cases according to cause of death. This case is linked to same reporter linked cases 1406USA003351 (Cardiovascular), 1406USA003858 (Other infectious disorder), 1406USA003859 (other non infectious disorder), 1406USA003860 (gastrointestinal), 1406USA003861 (Neurological), 1406USA003862 (Undetermined) and 1406USA003351 (Cardiovascular). Additional information has been requested.
From initial information received on 29Nov04 from the pt regarding an adverse event occurring, it was reported that this 49 year old female pt received a Fluzone SV 2004-2005 USP vaccination in Nov 2004, the lot number and route of administration were not reported. The pt stated she received the vaccination a couple of weeks ago (exact date unk). Within 24 hrs, the pt developed chills, lightheadedness, flu symptoms, tightness in chest and swollen feet. She has not been evaluated by a physician, but had an appt scheduled for 30Nov04. The pt's recovery status is currently reported as not recovered. From additional information received on 23Mar05 from the responsible physician, this case is being upgraded to serious based upon new medical information. From additional information received on 23Mar05 from the responsible physician, it was reported that the pt received a dose of Fluzone SV 2004-2005 USP vaccine, lot number U1498AA, administered in the left deltoid on 03Nov04. On 29Nov04, the pt complained of shortness of breath, dizziness and fatigue. She was seen by the physician on 01Dec04 and hospitalized on 04Dec04 with advanced sarcoidosis. Per the reporter, the pt had not recovered from these events.
This spontaneous report as received from a health care student refers to patient 2 of 2 patients (no demographics provided). On 18-NOV-2013 the patient might have received improperly stored PNEUMOVAX23. Dosing information and route and administration were not provided. Lot number J005068, expire date 17-JAN-2015. No adverse event reported. This case is linked to patient 2 of 2 patients (1312USA000989-Pneumovax23) and linked to case from same reporter (1311USA008438-Afluria). Additional information is not expected.
I received my first Shingrix 50MCG/0.5ML SUSR vaccine on 11/10/2019. On 11/16/2019 I developed a sharp pain in the left side of my back which kept getting worse. The pain extended all the way around the ribs over the next few day. On 11/16/2019 I developed a rash and saw my doctor who confirmed I had the Shingles. Several years ago I also had the Shingles and had the old Shingle vaccine in 2018.
We administered 2nd dose of Moderna early in the day at 10 am. Patient called at 5:15 pm to report leg and feet swelling and pain in her legs, otherwise she felt fine. We told her to keep her feet elevated and to call her doctor if she felt worse. Since it's a holiday weekend, told her to be aware of signs of myocarditis and blood clots and if she felt worse, to seek emergency care. Also told her to report to vsafe.
No adverse reaction, 11 year old received a COVID bivalent booster which is only approved for 12 and up
I received the Moderna vaccine. My first dose 2/1/2021, second dose 3/11/2021 and my booster 10/29/2021. After my booster dose, I started experiencing episodes where my heart felt as though it was racing for no reason. When my heart started racing I couldn't catch my breath. I would have to sit down. When I would sit down I felt like I could pass out. Sometimes my memory would get foggy.  I would go to the ER during some of these episodes. I was told by a physician that I was having a prolonged inflammatory response to the vaccine. These episodes lasted approximately one month after receiving my booster shot.  It affected my life in the fact I felt as though my life was ruined. I worried if I could safely drive a car because I never knew when these episodes would occur. I started to get scared and thought I had ruined my life forever because it was hard to lead a normal life
Pt felt dizzy and passed out. Lowered to chair, mom on site, given water and cool cloth. B/P Taken 92/68 Within normal limits.
A few days after my first shot I noticed that the armpit on the side where I got the shot was sore.  The soreness persisted for over a week and only subsided yesterday or the day before.  A week after the shot, I noticed a blotchy, raised rash at the injection site.  By the next day the rash had grown to be almost the size of my palm and was uniformly red and raised.  The rash was not itchy.  I would say it was SLIGHTLY tender.  At first I thought it was herpes but by the second day I could see that it was not and also I had never had an outbreak in that location.  As of today the rash is almost entirely gone.  It is still observable but you probably wouldn't see it if you weren't looking for it.  It is still a tiny bit tender.  I had no other concomitant symptoms. When I first noticed the rash I called an Urgent Care and spoke with the doctor who said that I should monitor it and come in if I had trouble breathing.
Pt received a dT immunization in her right deltoid on 5/31/03. She returned on 6/4/03 complaining to right arm pain after immunization. Symptoms include a very painful, slightly swollen right arm. She states the pain radiates down into her lower arm. Treatment -pt was prescribed a sling for her arm and anti-inflammatory. She has an appointment with her referral physician on 6/5/03. Pt returned to the ED on 6/13/03 complaining of hives that started on the face. She does have a history of intermittent urticaria and is seen by an allergist. Pt also complains of continued pain in the right upper extremity. She was treated for the allergic reaction with epinephrine, Benadryl, Tagamet and Prednisone. Pain from right arm appears to be coming from the right trapezius. Pt is to follow-up with primary care physician within 2 weeks, see her allergist on 6/16/03 as scheduled and follow-up with the orthopedist within 4 weeks. Warm soaks are prescribed for the shoulder pain. A prescription for Flexeril was given. She may use over the counter Tagamet and Benadryl as needed.
Patient reported feeling dizzy, short of breath, and throat tightening within 30 minutes of vaccination.   Patient improved without treatment and was released to home.
Hives, itchiness on entire body that night. Mother gave BENADRYL.
p/vax pt devel a breakthrough of chickenpox;pt was seen by MD on 7/16/98 w/approx 20 to 30 lesions on trunk;the lesions were at different stages w/no infected lesions;no fever & no other exp were noted;
flu-like symptoms:  muscle soreness, mild headache, joint pain lasting 2.3  days.
Chills and full-body shaking starting about 2:30pm, going away for a few hours, and returning about 6:00pm?resolved by 7pm (this may have been anxiety, since I was working myself up, and this symptom was markedly similar to how I sometimes get during panic attacks).  Fever (max temp 101.7F) starting around 8:30pm?broke by 2:30am 4/3/21 after taking ibuprofen 9pm on 4/2/21 (last checked temp 98.4F). Mild headache from 2:30pm to 8pm.
No additional adverse event reported; Dose of V AQT A that was inadvertently administered after its labeled expiry date; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, drug reactions or allergies pertinent medical history and concomitant therapies were not reported.   On 18-JAN-2021, the patient was inadvertently vaccinated with a expired dose of hepatitis a vaccine, inactivated (VAQTA) 25U/0.5 ml, lot # S032359, expiration date 11-JAN-2021, 1 dosage form (route was not reported) for prophylaxis. There were no known temperature excursions on vaccine. Nurse inquired about need for revaccination. No additional adverse event reported, and no further information provided. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S032359; expirationdate: 11-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
This spontaneous report was received from a registered nurse, regarding a patient of unknown age and gender. The patient's concomitant medications included sterile diluent (lot # and expiration date were not provided). The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On an unspecified date, the patient was vaccinated with (wistar ra 27-3) M-M-R II, lot #N031294 with expiration date 21-AUG-2019 and LIQUID PEDVAXHIB, lot #N024570, with expiration date 01-MAY-2020, both for prophylaxis (dose number, frequency, route and anatomical location were not provided).The administered dose of the vaccines experienced a temperature excursion in the range between 47°F to 77°F (52.7°F) during 2 hours and 15 minutes. The vaccines had not had any previous temperature excursions.There were no adverse effects reported. This is one of eleven reports received from the same reporter. Sender's Comments: US-009507513-1808USA011006: US-009507513-1808USA011007:US-009507513-1808USA011008: US-009507513-1808USA011009: US-009507513-1808USA011010: US-009507513-1808USA011011: US-009507513-1808USA011012: US-009507513-1808USA011013: US-009507513-1808USA011014: US-009507513-1808USA006003.
Pain, swelling, and soreness around the injection site. A few days later a lump formed around injection site and it was very red and sore.
APPROXIMATELY 20 MINUTES AFTER RECEIVING VACCINE PT'S TONGUE BEGAN TO SWELL AND DIFFICULTY BREATHING.  EPINEPHRING INJECTION VIA AUTO-INJECTOR @0.3 MG AND DIPHYDRAMINE @ 50 MG/ML ADMINISTERED AND EMS WASS CALLED. PT EVALUATED BY EMS BUT REFUSED TO GO TO THE EMERGENCY ROOM. PT STARTED FEELING BETTER AND LEFT WITH WIFE
Child seen at ER with drooling, slurred speech, lethargy diagnosed with probable partial complex seizure. No fever. On review child may have had two milder episodes over last 6 months also consistent with seizure - so unclear if vaccines have any association.
Patient experienced a prickly tongue for 3 days after the shot.  She treated with benadryl and it finally resolved.  She also experienced a fever, chills, nausea, headache, lightheadedness, and a sore arm for one day.
Notice pain in arm progressed to tingling going down arm to hand. Unable to make a fist. Has episodes at nite with intense pain. Hurt is relieved when she gets up and moves about happened 3x last nite. 10/28/08 went to doctor, he doesn't know what it is. Take ALEVE and call him on Monday
A non-serious spontaneous report of influenza B positive had been received from a consumer concerning a 24-month-old male, subsequent to FLUMIST. This case is submitted in accordance with post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. No medical history or concomitant medication information was provided. the patient received FLUMIST on 05-Oct-2009. On 08-Oct-2009, three days after receiving FLUMIST the patient was experiencing the following flu like symptoms: fever of 102, cough and runny nose. the patient was seen by his physician and a rapid viral flu test for A and B came back positive for influenza B.
phrenic nerve damage resulting in unilateral diaphragm paralysis; phrenic nerve damage resulting in unilateral diaphragm paralysis; This is a spontaneous report from a contactable consumer (patient). A 22-year-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unspecified route of administration at the left arm on 03Feb2021 11:45 (lot number EN9581 and expiry date unknown) at single dose for Covid-19 immunization in the physician office (doctor's office/urgent care). Medical history included anxiety, scoliosis, milk thistle allergies, laundry detergent fragrance allergies. The patient has no covid prior vaccination. Concomitant medication included clonazepam (KLONOPIN), ascorbic acid, colecalciferol, copper gluconate, cyanocobalamin, durapatite, folic acid, glucosamine hydrochloride, magnesium oxide, manganese sulfate, phytomenadione, sodium borate decahydrate, zinc amino acid chelate (BONE UP) and "multi-vita"; all from unspecified date for unspecified indication. The patient previously took diflucan and experienced allergies. The patient had no other vaccine in four weeks. On 05Feb2021 (two days after receiving vaccination), the patient experienced phrenic nerve damage resulting in unilateral diaphragm paralysis. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment due to the events. The patient was not covid tested post vaccination. The outcome of the events was recovering.  Follow-up activities are possible, information on the batch number has been requested.
Disseminated hives/urticaria x 36 hours - starting in the right lateral arm. Given 50 m in BENADRYL & 40 m in methylprednisolone.
Brown discharge from left nipple noticed approximately 5 days after vaccine. This occured on the same side the vaccine was administered. A mammogram and ultrasound could not identify the cause of the discharge. I am currently awaiting the results of a breast MRI.
Itchy site of injection from day2 but on day 7 it was a round hard red itchy spot about 3 inches in diameter.    Better in about 3 days but still a little red and itchy now
Patient developed abdominal pain and emesis 4/13/14 - these symptoms resolved and then he developed purpuric rash on lower legs 4/16/14. He was seen today (4/17/14) and diagnosed with Henoch Schonlein Purpura.
A few hours after pt recieved PNA vacc she began experiencing pain in the arm she recieved the vaccination in with associated erythema and some malaise, pt states had a fever of 99 at home.
pt recvd vax & 5 hrs later exp a low grade fever & began to cry inconsolably w/a high pitched scream; pt was placed in a bathtub; crying & screaming stopped the same day; fever cont for a few more days;
Tested positive for COVID on 12/6/21. Expired on 12/13/21. Patient was on palliative care services with significant decline in functioning prior to becoming covid positive.
Severe redness, swelling  and pain at area of injection. Given Prednisone to decrease inflammation.
elevated ongoing heart rate; fatigue; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: HEART RATE INCREASED (non-serious) with onset Oct2022, outcome "unknown", described as "elevated ongoing heart rate"; FATIGUE (non-serious) with onset Oct2022, outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Report of elevated ongoing heart rate and fatigue. Took vaccine two days ago. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200091591 same drug/ae/reporter, different patient;
Received FLUZONE immunization for the 2013-2014 influenza season. After about 10 minutes patient returned to clinic to report itching and mid-sternal chest pressure. Got one dose of EPIPEN.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 at 12:00 as dose 4 (booster), single (Lot number: G13275) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Doxycycline, reaction(s): "Known allergies", notes: Known allergies: doxycycline. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (12Jan2023) Positive, notes: Returned to testing positive for COVID four days after completing Paxlovid treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: No other medication in 2 weeks. Received anti-viral treatment for COVID 19 from 03Jan2023 to 08Jan2023. Returned to testing positive for COVID four days after completing Paxlovid treatment.
SWELLING; REDNESS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included unknown. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 2021, the subject experienced swelling. On 2021, the subject experienced redness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the swelling and redness was not reported. This report was non-serious.  Additional information received from company representative on 08-MAR-2021. The following information was updated and incorporated into the case narrative: reporter and AER at units.
Induration, reaction site measured 4.5 x 3 cm, redness, warmth, itchy, tenderness. Adverse Event lasted approx. one week. Advised to take Benadryl for itching & Tylenol for tenderness.
there was red mark at the injection site that was 2 inches by 2 inches and by 2Apr2021 the redness around the injection site was 2 inches by 4 inches/Redness at the injection site; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, on 18Mar2021, as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported, by 30Mar2021 there was red mark at the injection site that was 2 inches by 2 inches and by 2Apr2021 the redness around the injection site was 2 inches by 4 inches. Currently its still visible but not as bad as it was. The clinical outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.