chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a healthcare worker and refers to unspecified number of patients of unknown age and gender. No information about patients' pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies were provided. On unspecified dates, the patients were administered does of GARDASIL lot # K007828, expiration date 02-MAR-2017 and lot # K023432, expiration date 18-JUN-2016 (dose and route of administration were not reported) which were exposed to temperatures outside of the recommended range. No adverse experience was reported. This is one of several reports from the same reporter. Additional information has been requested.
pt arm was swollen, red, hot & hurt very bad;put ice on it every day for a week;
Shortness of breath and chest pain began in May 32 lb weight loss (18.2% of body weight) from 04/21/2021 until now Headaches, nausea, and lightheadedness begun in early June Extreme fatigue began in early July  Significant rise in blood pressure and at-rest heart rate from 76 BPM and 120/80 on 04/27/2021 to 128 BPM and 151/100 on 09/09/2021 Generalized Lymphadenopathy including the lymph nodes of the jaw, neck, head, armpits, chest, abdomen, groin, inner thighs, and upper arms began on 09/07/2021 and has continued to worsen up to the present  Papular rash developed on upper arms and thighs in late April Extreme itchy-ness began on lower legs and upper arms and has moved to chest, neck, and abdomen as well Hospitalized for SVT event, chest pain, upper center and right side abdominal pain, and shortness of breath on 09/14/2021
This spontaneous report was received from a Registered Medical Assistant (R.M.A) concerning a multiple unspecified patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (Lot # L048465: expiration date 02-DEC-2017; Lot # L037565: expiration date 29-SEP-2017) (routes and doses were not provided). No adverse effects reported. Additional information has been requested.
Had vaccines given at approx 10am of mmr, dtp and polio; by 2pm extreme fussiness with extended crying period from about 6pm to 10pm; restless sleep with occasional crying periods. Noticed swelling of left thigh with raised redness traveling down to knee up to hip at about 4pm after shot was given also very warm on entire thigh area; Next day-to present time now of almost midnight, still swollen and red with no reduction of swelling, redness still same general area without spreading, warmness gone. She says that her leg is only sore at the injection site. She had one shot in this leg and 2 in the other. I do not know which vaccine went into this leg.
Blister rashes at right back, right groin area and right thigh since yesterday, (+) burning sensation, body ache, headache.
Pt recvd Engerix-B for Hep B vax & exp a rash;
Awakened by rapid pulse (+100), dry mouth, swelling in back of throat, sore, swollen injection site (3"). Rapid pulse continuing 16 hours after injection.
Left arm - swelling, redness and pain at injection site. Symptoms started 9-2-15. 9-3-15 increase in redness noted, no change in swelling.
right after receiving covid vaccine-19 second dose , pt started having audible wheezes, can only speak 1-2 sentences, grasping for air,  cold clammy perspiration, pale. Pt states she has asthma and wheezing before she came in but worse after the  covid vaccine dose.  pt vital signs taken . Pt restless and asking for an injection to help her breath, Sats 96% RA. Pt had 2 puffs of albuterol  and with slight relief. Pt was taken to Urgent care in stable condition ( same building) for an evaluation.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 70-year-old female patient received BNT162b2 (BNT162B2), on 18Aug2021 as dose 3 (booster), single (Lot number: FA7484) at the age of 69 years for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: TYLENOL. Past drug history included: Statins, notes: She was on statins. Vaccination history included: BNT162b2 (Dose 1, single, Lot: EN5318), administration date: 21Feb2021, when the patient was 69-year-old, for COVID-19 immunization, reaction(s): "Sore arm", "Headachy"; BNT162b2 (Dose 2, single, Lot: EN6205), administration date: 16Mar2021, when the patient was 69-year-old, for COVID-19 immunization, reaction(s): "Sore arm", "Headachy". The following information was reported: PAIN IN EXTREMITY (non-serious), HEADACHE (non-serious), outcome "recovered" and all described as "Nothing outside the normal of a sore arm or headachy from time to time, but nothing longer than 24hrs".
chest inflammation (heart); fatigue; chills; fever; sweats; large got hot spot on arm (for one week); chest tension; This is a spontaneous report from a contactable consumer (patient). A 32 years old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: Ew0191), via an unspecified route, administered in Left Arm on 25May2021 (at the age of 32-year-old at vaccination) as Dose 2, single for COVID-19 immunization. The patient was non-pregnant at time of vaccination. The patient's medical history included high blood pressure, known penicillin allergy. The patient's concomitant medications included norethindrone acetate and hydrochlorothiazide, triamterene within two weeks of Covid-19 vaccination. Facility where the most recent COVID-19 vaccine was administered was reported as other. The patient had not received any other vaccine within four weeks of Covid-19 vaccination. The patient was not diagnosed with Covid infection prior to vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: Ew0179), via an unspecified route, administered in Left Arm on 04May2021 (at the age of 32-year-old at vaccination) as Dose 1, single for COVID-19 immunization. After first shot, experienced two weeks of extreme brain fog and fatigue. On 25May2021 (after the second shot), the patient had experienced fatigue, chills, fever, sweats, large got hot spot on arm (for one week) and chest tension. Diagnosed with chest inflammation (heart) and prescribed Prednisone after one month of symptoms. These adverse events resulted the patient to Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient was not been tested for COVID-19. The patient received Prednisone as treatment medication for the resulted events. The outcome of the events was recovering.  Follow-up attempts are possible. Further information is expected.
SNEEZING, STUFFY NOSE, LIP SWELLING, TINGLING MOUTH, THROAT CLOSING, UVULA SWOLLEN 1. Allergic reaction (Allergy, unspecified, initial encounter) . Pt. received Moderna COVID vaccine the morning of 12/22/20 and developed angioedema reaction the afternoon of 12/23 Vaccine is only new medication reported by pt. - denies any new products, foods, etc History of hives with spironolactone 2.5 months ago; taking HCTZ now - unknown if reaction is related to this med rather than vaccine? Due to severity of her reaction and uncertainty if all attributable to vaccine versus some other culprit I would recommend Epi pen at time of discharge Has received IM epinephrine, racemic epi neb, Solu-Medrol, Benadryl, Pepcid in the ED Continue with Benadryl 25mg IV q6h, Pepcid 20mg IV q12h, and Solu-Medrol 40mg IV q6h   2. Angioedema (Angioneurotic edema, initial encounter) . Arrived to the ED with R. side lip, tongue, and uvula and oral cavity edema Airway patent, room air O2 sats WNL - monitor throughout the night for any worsening of angioedema or airway involvement Treatment as above
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 34 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), all with onset 2022, , outcome "unknown" and all described as "Covid 19 rebound infection after taking Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: the patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. the patient was previously received a COVID-19 Vaccine. The patient was taking Paxlovid as Treatment from 04Jul2022 to 08Jul2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
started having events of asthmas and coughing type stuff; started having events of asthmas and coughing type stuff; This is a spontaneous report from a contactable consumer (Patient). A 76-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was not reported), via an unspecified route of administration on 28Jan2021 as 1st dose, single for covid-19 immunisation (76 years old when vaccinated). The patient medical history included asthma and chest congestion. Concomitant medications were not reported. On 01Feb2021(patient reported as last night) he started having events of asthmas and coughing type stuff. The patient reported that he would normally get Prednisone for this but asks if it is contraindicated between the vaccine doses. The outcome of the events was unknown. Information about batch/lot number has been requested.  Follow-up attempts are completed. No further information is expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Autoimmune arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course : The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient received COVID-19 treatment with oral paxlovid from 05Dec2022 till 10Dec2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected drug cannot be completely excluded.
Localized reaction redness & edema to upper arm. Treated with BENADRYL.
No additional adverse events reported; dose of Improperly Stored VARIVAX has been administered to a patient; This spontaneous report as received from a registered nurse refers to a 12-month-old patient. No information regarding the patient's concurrent conditions, medical history, drug allergies and concomitant medications were provided.  On 25-JAN-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) lot # U020238, expiration date 25-JUN-2023, dose: 0,5 milliliter (formulation, injection site and route of administration were not provided) for prophylaxis.  The the vaccine was stored in inappropriate range of temperature. Temperature and time frame: 6 F (Fahrenheit) degrees up to 14 F degrees (13.8F) for 1 hour 45 minutes and 0 seconds; 14 F degrees up to 46 F degrees (14.4 F) for 0 hours 25 minutes and 0 seconds (product storage error temperature too high). There was no previous temperature excursion. No additional adverse event was reported.
This spontaneous report was received from a healthcare worker (also reported as office manager) refers to multiple unspecified patients of unknown demographics. No relevant medical history of the patients were reported. On unspecified dates the multiple unspecified patients were vaccinated with (Oka/Merck) VARIVAX (strength, dose, route, site of administration and lot number were not reported). There were no concomitant medications reported. It was reported that the multiple unspecified patients were administered with (Oka/Merck) VARIVAX that was stored improperly on unknown dates. There were no adverse effects reported. It was unspecified whether the patients had sought any medical attention. There was no product quality complaint involved. The outcome of administered (Oka/Merck) VARIVAX that was stored improperly was unknown. Additional information has been requested.
3 days post vacc.- began mild Bilateral upper extremitie shaking/tremors  5 days post vacc.- seizure like activity lasting approximately 30minutes before medications were given in the Emergency Department  10 days post vacc- continuing upper extremity shakiness and began mild full body tremors with weakness to bilateral lower extremities
Arm turned black immediately, remained that way for 2 weeks. Started wheezing in throat, made complaint to nurses but no one listened with stethoscope. A couple weeks later she had blood clots in feces. Told doctor, he said not unusual. Started getting short of breath, taken to emergency room. Admitted. Swelling in legs and arms. X rays showed blood clots in lungs. Medical records available. After 2 weeks came home. Then readmitted for shortness of breath, needed catheter, started passing blood in urine. Sent to another hospital. Lungs filled with blood clots, also in limbs and breast. Too weak to get a scope in lungs.
Confusional state; Diabetes mellitus; Facial paralysis; Hypertension; Ischaemic stroke; This case was received via  VAERS (Reference number: 1358541) on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of CONFUSIONAL STATE (Confusional state), DIABETES MELLITUS (Diabetes mellitus), FACIAL PARALYSIS (Facial paralysis), HYPERTENSION (Hypertension) and ISCHAEMIC STROKE (Ischaemic stroke) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced CONFUSIONAL STATE (Confusional state) (seriousness criteria hospitalization and disability), DIABETES MELLITUS (Diabetes mellitus) (seriousness criteria hospitalization, disability and medically significant), FACIAL PARALYSIS (Facial paralysis) (seriousness criteria hospitalization, disability and medically significant), HYPERTENSION (Hypertension) (seriousness criteria hospitalization and disability) and ISCHAEMIC STROKE (Ischaemic stroke) (seriousness criteria hospitalization, disability and medically significant). The patient was hospitalized on 05-May-2021 due to CONFUSIONAL STATE, DIABETES MELLITUS, FACIAL PARALYSIS, HYPERTENSION and ISCHAEMIC STROKE. At the time of the report, CONFUSIONAL STATE (Confusional state), DIABETES MELLITUS (Diabetes mellitus), FACIAL PARALYSIS (Facial paralysis), HYPERTENSION (Hypertension) and ISCHAEMIC STROKE (Ischaemic stroke) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were given by the reporter. No Treatment information were provided by the reporter.  Patient received first dose of vaccine on 5/3/21. On 5/5, presented to urgent care clinic and was transferred to hospital with confusion, and facial droop. Patient was Diagnosed with acute ischemic stroke, new diagnosis hypertension and diabetes mellitus.    Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.
Fever to 102 after vaccines given on 5/19/2011. TYLENOL given.
Information has been received from a health professional concerning a 16 year old female patient with no illness at time of vaccination who on 17-SEP-2010 was vaccinated at right upper arm with the third dose of VARIVAX (Merck) (LOT# 666865/0468Z). On 18-SEP-2010 the patient's mother called doctor to report red, swollen and painful reaction on right arm, think it's from VARIVAX (Merck). On 19-SEP-2010 patient came to be seen, diagnosed with cellulitis. The patient was given AUGMENTIN and BENADRYL. At the time of this report, the patient's outcome was unknown. This is an amended report. The LOT# had been changed from 638902/0468L to 666865/0468Z. Additional information has been requested.
Hives/pruritis and diarrhea occurred 20 minutes after administration. No airway issues. Patient given prednisone, Benadryl, and Zantac with resolution of all symptoms within 30 minutes.
continued throwing up; diarrhea; Nausea; Slight fever; Difficult breathing/ shortness of breath; slight pain at injection site; tired; This is a spontaneous report from a contactable consumer (patient). A 64-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration at the age of 64-years-old, administered in Arm Left on 26Feb2021 09:30 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included allergies: sulfites. The patient was not pregnant. There were no concomitant medications. The patient experienced slight pain at injection site and tired on 27Feb2021 12:00, nausea, slight fever, and difficult breathing on 28Feb2021, continued throwing up, diarrhea, shortness of breath on 01Mar2021. The patient experienced slight pain at injection site, tired on Saturday, then on Sunday nausea, slight fever, difficult breathing, and on Monday continued throwing up, diarrhea, and shortness of breath. The patient was hospitalized for 1 day for the events. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 08Mar2021.Therapeutic measures were taken as a result of the events which included steroid and meds for stomach. The adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization. The outcome of the events was recovered on an unspecified date.  Facility type vaccine was Hospital. No other vaccine in four weeks. No other medications in two weeks. Patient was not diagnosed with COVID prior vaccination. The patient was tested for COVID post vaccination.  Information on the lot/batch number has been requested.
Patient had a localized adverse tissue reaction to immunizations. He had redness and swelling of (R) thigh that involved 6 inches just around the injection site. Area was warm to the touch with no edema. Dr recommended Motrin and compress. Rx given for Claritin daily.
Pt reported feeling flushed, some chest tightness, shaky, dizziness, and a sense of anxiety after injectable flu vaccination.  Pt taken to Urgent Care Clinic of the hospital.  Pt received vaccine during hospital SHOTEX.  Pt was monitored in the Urgent Care Clinic for several hours and was sent home the same day.
23 minutes following administration of vaccine began feeling nauseous, clammy, warm. Evaluated patient BP 98/62 RA, wnl per pt. P 77, RR 16, O2sat 95-97%. During evaluation pt stated felt slightly itchy throat and itching in her ears. Pt given Claritin 10 mg po at 12:19 pm and remained under observation by RN. Pt began feeling better, sipping water. P 88-91, RR 16, O2sat 98%. Reviewed pt status with MD. Pt allowed to leave at 12:35 pm.
No additional AE's reported; Improperly Stored; Administered; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 16-JUN-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot number: T028308, expiration date: 20-AUG-2022; dose and route of administration were not provided). The vaccine was stored in temperature:  11.3 degrees Celsius for 15 minutes. There was no previous temperature excursion. Digital data lodger was involved.  No adverse event was reported. The patient was asymptomatic.  This is one of the four reports from the same reporter.; Sender's Comments:  US-009507513-2106USA005134: US-009507513-2106USA005206: US-009507513-2106USA005204:
I had chilliness and body ache same day of the vaccine, second day I had sourness in my arm then after 4 days I had fever with pressure on my chest, the fever last for one day and pressure last for more than one week.
We received covid vaccine at PRIVACY from PRIVACY pharmacy in PRIVACY to give bivalent doses to our residents.  We administered 13 doses of the vaccine today and found out after administering that it was the monovalent vaccine.
101.4 temperature, hyper-sensitive to touch 8-inch diameter around injection site, aching joints, headache, fatigue. Symptoms persisted throughout day. OTC medication administered 7:30 PM. No noticeable side effects the following day.
Redness, swollen, tender. Treatment: KEFLEX 1 1/2 tsp BID x 10 days.
The patient received his COVID vaccine and about 5 minutes later reported feeling funny. The patient was nervous before getting the vaccine. After the immunization, the patient felt he needed to lay down on the floor. We had the patient lay on the floor and elevated his legs. I also took the patient's blood pressure which was 90/60, the patient stated his blood pressure always ran a bit low. We also gave the patient an ice pack. 10 minutes later the patient said he was feeling better and got back into his chair. We observed the patient an additional 15 minutes and then he left feeling fine.
body aches, fever, chills, headache started several hours after and lasted about 8 hours then mild fatigue only thereafter for 1 day
The first dose I had no problems at all. The second dose was given on 10/1/21, my legs started swelling on 10/3 around 10pm, woke up on 10/4 at 7am with a weird feeling in my chest and a mild pain underneath my right arm. During my drive to work my chest started feeling like a balloon was under my chest cavity. By the time i arrived at work i started having mild chest pains and pressure in my chest. Had to leave work early, while im driving from work, i started hearing my heartbeat in my ears followed by a headache. Later that day my skin started to itch on my chest and back and legs. Called my doctor she brought me in Tuesday at 11am. After taking my Lisinopril and Metoprolol at 7am, my blood pressure at the doctor office was and my pulse. I informed my doctor about the pain underneath my right arm and she could feel the lymph node under my arm was swollen. She made the decision to put me off work until further notice.