chrisvoncsefalvay/vaers-outcomes huggingface dataset:
24 hours post-vaccination, patient developed SEVERE arm pain, such that he has been unable to sleep thru the night and is in near constant pain.  Now 6d post vaccination and still very severe pain.  Otherwise healthy and fit 55yo.  Only able to hold his arm in a couple of positions to get relief from the pain.  Feeling numb in entire lower left arm.
Received Fluzone 11/4/03. On 11/6/03 developed Bell's Palsy with right facial droop. The medical records received on 1/12/04 states talking funny, droop of mouth, and rt sided facial paralysis.
Patient developed abcess on left upper arm following Adacel vaccination. Was evaluated at practice office and prescribed antibiotics without relief, 8 cm warmm red tender abcess. 3 days later seen at local Emergency room. admitted to local hospital  for irrigation and drainage of abcess 8/8/07-records received-DX: abscess left arm. Temp 98.6. Received tetanus shot 8 days ago and on PE noted to have an area that is firm. Treated with IV antibiotics.
Mom states that pt was seen yesterday and received vaccines. Pt had very unusual behavior last night. He cried for hours for no reason. He was also very fatigued. Seems to be better today but still tired.
Full body rash; trouble clearing throat; felt like there was something stuck in throat; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL3249), intramuscular (right arm), on 13Jan2021 09:45, at single dose, for covid-19 immunization. Medical history included allergies: sea salt, hypothyroidism, anemia, asthma, and seizures (when younger). Concomitant medications were not reported. The patient previously took tramadol and hydrocodone and experienced allergies to both drugs. The patient experienced full body rash on 13Jan2021 10:15 (also reported as about 30 mins after vaccination). On 13Jan2021 10:15 (also reported as about an hour after receiving vaccination), the patient had trouble clearing throat and felt like there was something stuck in throat. The patient has been taking Benadryl and Motrin for these adverse events. The patient had no other vaccine in four weeks, had no other medications in two weeks, had no Covid prior vaccination and, had not been Covid-tested post vaccination. The outcome of the events was recovering.
Vertigo.  I went to sleep on 11/23/22 and work up on 11/24/22 where the room was spinning. This lasted for several hours. As this didn't resolve itself I ended up going to the ER  on 11/24/22 where two CT Scans and blood work were performed. The CT scans ruled out a stroke and brain aneurism. I was discharged and it was recommended to have a nasal CT Scan. A nasal CT Scan was performed on 11/30/22 where the results of that CT scan were normal. I then went to see an ENT on 12/2, where I was diagnosed with Vestibular Neuritis. The doctor advised this needs to work its way out. I still am a bit off balance wise, especially in moving my head and I am unable to drive.
11 year old male received first dose of Pfizer covid 19 vaccine and was inadvertently administered 12+ dose instead of 5-11 year old dose.
Chills and nausea started at roughly 4:30pm. Added layers and was fully shivering and teeth shattering by 5:45pm. Laid with. Heating pad and blankets until vomiting and diarrhea started around 6pm. This continued many times throughout the night until about 8am the next morning  when I finally self medicated with Zofran to try to stop the dry heaving. I took 3 doses of zofran throughout the day to keep from vomiting more. Diarrhea slowly subsided throughout the day. I slept for 2 days straight afterwards.
First experienced lightheadedness and numbness in my arm and leg. This progressed to ringing in ears and severe imbalance.  I have had continuing problems with lightheadedness, movement sensation and dizziness. I have also been very fatigued.
anaphylactic reaction; anaphylactic shock; vomiting; broke out head to toe in hives; trouble breathing; face swelling; This is a spontaneous report received from a Pfizer-sponsored program, Support received from a contactable consumer (patient's parent). A 16-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in left arm on 08Apr2021 (Batch/Lot number was not reported) as 1st dose, SINGLE dose (at the age of 16 years old) for covid-19 immunisation.  Medical history included asthma from 2018 and ongoing (Has been asthmatic about 3 years and has it under control and hasn't had issues in years).  The patient's concomitant medications were not reported.  Last time at the doctors office was for her well check in Oct or Nov. The patient did not receive any other vaccine within 4 weeks prior to the vaccine.  On 21Apr2021, the patient experienced anaphylactic reaction, anaphylactic shock, vomiting, broke out head to toe in hives, trouble breathing and face swelling. They are not sure if it (anaphylactic reaction) is related to the vaccine. She does not have any allergic issues of any kind and is not sure if it is from the vaccine. The patient has an appointment with an allergist on 05May2021. The pediatrician recommended she wait to get the second dose until after the mother talked to the allergist. She is scheduled for the second dose 30Apr2021. The consumer stated the daughter will miss her second dose tomorrow. The pediatrician told her to wait until speaking to the allergist. If the allergist clears her, it wont be until 05May2021. How long would it be until she can get the second dose. She is not sure if it is related or not. It was 2 weeks after. She ate some kind of granola bar that may have been the cause. Before she called 911 and they gave her epinephrine, it lasted anywhere between maybe up to 15 or 20 minutes. She went to the emergency room (ER) and had to be observed 4 to 5 hours and then went home. Treatment for the events included Epinephrine, steroids and she believes a dose of Pepcid. She was on steroids for like 4 days. The steroid was prednisone. Outcome of anaphylactic shock, vomiting, broke out head to toe in hives, trouble breathing, face swelling were recovered on 21Apr2021. Outcome of anaphylactic reaction was unknown.
pt recv vax 3FEB97 & devel fever & measles-type rash 10 days later;
No adverse event; Patient received the bivalent booster as a first dose; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received the bivalent booster as a first dose) and NO ADVERSE EVENT (No adverse event) in a 50-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received the bivalent booster as a first dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received the bivalent booster as a first dose) 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 WRONG PRODUCT ADMINISTERED (Patient received the bivalent booster as a first dose).    No concomitant medications were reported.  No treatment medications were reported.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021 at 12:05 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Feb-2021 at 12:05 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 24.22 years.  Concomitant and Treatment medications were not reported.  On 24-Feb-2021, the vaccine with batch number 014M20A was moved to fridge. On 27-Feb-2021, 20 vials were moved to the clinic. On 27-Feb-2021 at 9 AM and 5 PM vials underwent temperature excursion with temperature of 33 to 35 degrees Fahrenheit The condition of vaccine prior to vaccination was not frozen. The vaccine beyond use date was reported as 26-Mar-2021.  It was reported that, the storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour. It was reported that, the patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021. The health care professional explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree Fahrenheit.
No additional AE details; TE evaluation states vaccines have been administered; This spontaneous report was received from a certified medical assistant and referring to a 22 months old male patient (also reported as 1-year-old). The patient's medical history, concomitant therapies and concurrent conditions were not provided. On 23-MAR-2022, the suspect vaccine underwent temperature excursion of -14 degrees Celsius (C) up to - 10C for 3 hours and -10C up to 8C for 1 hour and 30 minutes.   On 18-APR-2022, the patient was vaccinated with the first dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneously (lot # U025790 with expiration date: 19-AUG-2023; dose and strength were unknown) for prophylaxis (product storage error). No additional adverse event was reported (no adverse event).  There were no previous temperature excursions. It was an initial use of vaccine/vaccine-device. The operator of the vaccine/vaccine-device was healthcare professional. The vaccine/vaccine-device was not available for return/evaluation as it was given to the patient.   This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2205USA003614: US-009507513-2205USA007821: US-009507513-2205USA007847: US-009507513-2205USA007852: US-009507513-2204USA009330: US-009507513-2205USA008004: US-009507513-2205USA008051: US-009507513-2205USA008008: US-009507513-2205USA008028: US-009507513-2205USA007982: US-009507513-2205USA008105: US-009507513-2205USA008106:
Information has been received from a pharmacist concerning an unspecified patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy information was not provided. On 20-DEC-2016, the patient was inadvertently vaccinated with an expired dose of ROTATEQ (lot # L008053, expiration date 30-NOV-2016) (dose not reported) orally for prophylaxis. No adverse effects were reported. Additional information has been requested.
About 5 pm on 4/13 my right upper calf started having a pain.  Its still hurting today.  sent me for imaging.
Chills. Red and sore arm at vaccine site. Arm somewhat swollen. Patient reports taking ibuprofen. He has not applied ice to area but says he will.
Information has been received from a medical technician referring to multiple unspecified patients of unknown gender and age. The information of concurrent conditions, medical history and concomitant medications was not provided. On unknown dates the patients were vaccinated with VARIVAX (lot # L031065 and expired date 18-AUG-2017, dose, frequency and route were not provided) that were improperly stored. The vaccines were stored at temperature of -7.8 degree C with time frame of 30 hours. There was no previous temperature excursion. No adverse effects reported. This is one of two reports received from the same source (linked report # 1603USA001449). Additional information has been requested.
leukemia; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team, Program ID: (004756).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Lot number: GJ3268) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for COVID-19 immunization; Bnt162b2 (Dose 2, Single), for COVID-19 immunization. The following information was reported: LEUKAEMIA (medically significant), outcome "unknown", described as "leukemia".  Clinical course: She mentioned that patient had received a primary series and the booster bivalent; then was diagnosed with Leukemia following all these vaccines. The reporter queried about the next step or if the patient needed to start all over after the patient got the primary series and booster bivalent then he got diagnosed with leukemia. The doctor has recommended the patient to start the primary series and bivalent was all over again because leukemia may have washed away the effect.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the event leukemia and the use of suspect product BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5) cannot be fully excluded. The case will be reassessed once further information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
I got a sustained migraine-type headache, whole body aches, and vomiting/retching that lasted for about 24 hours from onset.
Redness area 3 in x 5 in, swollen, warm to touch.
Local hives at the site of subcutaneous injection of VZV developed within minutes of immunization
Initial unsolicited report received from physician on 20-Dec-2017. This case was linked to 2017SA264637 (same reporter). This case involves an adult patient (age and gender not reported) who was vaccinated with 0.5 ml dose (once) of FLUZONE QUADRIVALENT (Batch number, expiration date, dose and site of administration was not reported) via intramuscular route on 01 Dec 2017. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced anaphylactic reactions described as "very unusual". Patient had not seen reactions of this type. Lab data and corrective treatment were not reported. The patient's event outcome was not reported. Upon internal review, the company decided to consider the case serious due to important medical event anaphylactic reaction. List of documents held by sender: none.; Sender's Comments: Patient experienced anaphylactic reactions after vaccination. Exact time to onset is not mentioned. Anaphylaxis is listed with the vaccine. Additional information including but not limited to the patient's immunization history (i.e., previous immunizations and any adverse events following immunization), allergic history, previous similar episodes as well as allergy testing to identify the culprit allergen are needed to further assess this case. Based on the information available, a role of the vaccine cannot be assessed.
Expired Havrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   On 17th October 2022, the patient received Havrix. On 17th October 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 18-OCT-2022 Reporter's comment: Medical assistance reported that a patient was administered expired dose of Havrix on different dates. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow up. Additional Supportive Information: The patient received a dose of Havrix which was already expired, which led to expired vaccine used. This case was one of the 4 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022149858:Same reporter US-GSK-US2022149859:Same reporter US-GSK-US2022149857:Same reporter
Patient received 2nd COVID vaccine on 5/5/21 so fully vaccinated - on 8/19/21 patient presented to primary care MD office with symptoms of COVID and tested positive for COVID-19
STARTING ON 12/24/2020  I developed burning and itching in both feet and along both deltoids.  This resulted in raised red pruritic wheals.  I dosed Benadrly and used hydrocortisone cream to the area.  Throughout the night, the rash appeared on both thighs, knees, back of the arms and along the back of the lower legs.  Again raised pruritic wheals.  It would improve with anti-histamine use.   this continued until 12/29/2020.  No persistent symptoms.  There are no other changes in medicine, OTC medication use, no changes in foods/soaps etc.
Pt. received vaccinations 3/14/12. Mom reported reaction 3/16/12. Pt. evaluated by MD. (1) Right deltoid 3x2 cm erythematous rash, tender/warm indurated. (2) Left deltoid 5x5 cm erythematous rash, tender warm indurated - treated with BACTRIM antibiotic x 10 D.
underage son received Covid vaccine; A spontaneous report was received from the mother of a 17 year old male patient.  The patient's medical history was not provided.  No relevant concomitant medication was reported.  On 02 Jan 2021, the patient received the first of their first planned doses of mRNA-1273 (lot number unknown) intramuscularly for prophylaxis of COVID-19 infection.  The patient was 17 tears old (underage). No treatment information was provided.   Action taken with the mRNA-1273 was not reported.  The outcome of the event, product administered to patient of inappropriate age, was considered resolved on 02 Jan 2021.; Reporter's Comments: This case concerns a 17 year old male who received their first of two planned doses of mRNA-1273 (Lot number: unknown intramuscularly for prophylaxis of COVID-19 infection. There were no reported adverse events associated with this event of product administered to patient of inappropriate age.
PAIN IN THE  RIGHT ARM (FEELING OF LIKE BEING PUNCHED IN THE ARM); FEVER OF 101.2 DEGREE F; TIREDNESS (OVERWHELMINGLY TIRED); DULL HEADACHE; BODY WEAKNESS; This spontaneous report received from a patient concerned a 39 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included dermoid cyst, penicillin allergy, latex allergy, shellfish allergy, non alcohol user, cigarette smoker, and green peppers allergy, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage.  The patient experienced drug allergy when treated with morphine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 03-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 03-JUN-2021, the subject experienced body weakness. On 03-JUN-2021, the subject experienced dull headache. On 03-JUN-2021, the subject experienced tiredness (overwhelmingly tired). On 04-JUN-2021, the subject experienced pain in the right arm (feeling of like being punched in the arm). On 04-JUN-2021, the subject experienced fever of 101.2 degree f. Laboratory data included: Body temperature (NR: not provided) 101.2 F. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from body weakness, dull headache, pain in the right arm (feeling of like being punched in the arm), fever of 101.2 degree f, and tiredness (overwhelmingly tired). This report was non-serious.
Mother called 7/12/01 and stated that child developed a rash about an hour, post vax. She checked his temperature at 12:30 on 7/13/01 and it was 102.4F. The next AM at 08:00, the temperature was gone. Instructed her to take him to the doctor and have the rash checked. She saw a PA at the ER. Child was given 1 dose of Benadryl. The PA stated the rash was flat, erythemic papular over trunk and extremities with a positive wheeze and fever reaction. Skin with petechial-type lesions; not raised. The PA stated she thinks the child is allergic to a component in 1 of the vaccines; probably the tetanus in the DTAP. The rash was gone, 2 days later, without further medication or doctor visits.
syncope 30 minutes after Fluzone HD. guided to the ground. 911 called
This case was reported by a healthcare professional and described the occurrence of decreased therapeutic response in a 37-year-old male subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On 22 May 2009 and on unspecified dates the subject received 3rd dose, 2nd dose and 1st dose of ENGERIX B (unknown) respectively. On 24 August 2010, approximately, 15 months after vaccination series completion with ENGERIX B, the subject experienced decreased therapeutic response. The subject had complete the three dose of ENGERIX B series (last dose was 22 May 2009) and his titers performed on 24 August 2010 were " found to be less than 5".
I recieved the covid vaccine booster on 9/30/21. I immediately felt fatigued, headache, chills, night sweats, md general wellness. Over the next several days my symptoms got worse, my legs started to cramp and spasm and my heart was racing. I was having problems breathing and my oxygen was in the 80s. I went to the er and was diagnosed with a blood clot, admitted to the hospital for 5 days. Started have seizures, had a 2 day eeg. Was released, than started developing lesions on my legs, butt, and back. These lesions are extremely painful and are all a reaction to the vaccine I was told. My heart rate is still elevated and I still have pain and shortness of breath. This vaccination has made me so sick and could have cost me my life. I have had 3 biopsies of lesions. Countless Doctor appointments and tons of medical bills.