chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a licensed practical nurse concerning a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history, drug reactions/allergies and concurrent conditions were not informed. On an unknown dates, the patients were administered improperly stored doses of GARDASIL 9 lots # reported as K011562 and M023169 with expiration dates 08-APR-2017 and 13-JUN-2018 respectively, (dosages and therapy routes were not provided). Concomitant therapies were not informed. No adverse effects were reported. The doses of GARDASIL 9 were exposed to a temperature of 24.3C and were out of range for 5 minutes. A data logger was used to track the temperature and there were no prior excursions. No product quality complaint (PQC) was involved. Lot # K011562 is not valid for hpv rl1 5 11 16 18 31 33 45 52 58 vlp vaccine (yeast). Additional information has been requested. This is one of several reports from the same source.
About four hours after the innoculation, I began to get nauseous.  Three hours after that, I had vomiting and diarreah that lasted most of the night. I had chills, aches and headache which tylenol helped relieve.  I began to feel better 24 hours later but still experienced extreme fatigue.  It is now Tuesday (vaccine on Sunday) and I am still fatigued and have trouble concentrating.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Batch/Lot number: unknown), on 02Apr2021 as dose 2, single (Batch/Lot number: unknown), on 30Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 01Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "hashimotos" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "Known allergies: bell peppers" (unspecified if ongoing); "Known allergies: hayfever" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN; SYNTHROID; HYZAAR; SINGULAIR, all received in 2 weeks around vaccination. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (unspecified date) Negative, notes: 4 days after negative test after Paxlovid; (24Jul2022) Positive, notes: Paxlovid rebound. 4 days after negative test after Paxlovid. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: The patient received Paxlovid as treatment from 15Jul2022 to 20Jul2022. The patient had paxlovid rebound 4 days after negative test after paxlovid, the symptoms worsened and with positive testing.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
On 4/5/04 the above named patient was given DTaP, HIB, Hep B, and Prevnar.  Her mother informed several months later, on a subsequent well child visit that the patient started crying inconsolably on the day of the immunizations.  The crying was described as a high pitched cry and lasted for 2 days.
extreme dizziness, became ashen, pale w/cyanotic nail beds, altered consciousness w/speech impairment approx 1/2 p/vax;persisted for approx 1 1/2hr & resolved;
This case was reported by a consumer via call center representative and described the occurrence of rash in a 62-year-old female patient who received SHINGRIX. On 15th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 15th May 2018, immediately after receiving SHINGRIX, the patient experienced injection site muscle pain. On 18th May 2018, the patient experienced rash, localized itching, skin warm, localized erythema and local swelling. On an unknown date, the outcome of the rash, localized itching, skin warm, localized erythema, injection site muscle pain and local swelling were recovered/resolved. The reporter considered the rash, localized itching, skin warm, localized erythema, injection site muscle pain and local swelling to be related to SHINGRIX. Additional details were provided as follows: This case was previously reported to the doctor. The patient received SHINGRIX in the right deltoid. The patient experienced muscle soreness at the injection, right after receiving the vaccination with SHINGRIX. Three days after receiving the vaccination the patient noticed that the area approximately one inch below the injection site had a rash, was hot, itchy, red and swollen. There was no redness at the injection site. These symptoms were resolved after three days. The patient gave permission for her physician to be contacted and provided the details for the same.
Vaccine recipient experienced a bit of headache, nausea and vomiting after vaccination on 1/19/2021. On 1/22/2021, he started having palpitations and also mentioned that his blood pressure was really high.
BUD expiration 04/13/23 Manf expiration 06/13/23
shingles; nerve damage; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications. In or around 2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (Strength, dose, frequency, route of administration, lot number and expiration date were not reported). On unknown dates, shortly after receiving receiving zoster vaccine live (ZOSTAVAX), the patient suffered shingles and nerve damage. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's condition; sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX) wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury; and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. The lawyer considered the events to be related to zoster vaccine live (ZOSTAVAX).
pt developed large rash on arms and torso and elevated blood pressure and pulse 138-110 pulse 100 - pt given 50 mg of diphenhydramine at 10:35 am by 11:05 rash was fading and 90% clear.
Hard of hearing; her toe was itching; My toe started swelling and red; My toe started swelling and red; I hadn't been able to sleep; I put a little bit non-itch (Unspecified Medication) and all of the sudden rash went right down my arm; This is a spontaneous report from a contactable consumer (Patient). A 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EWS138), via an unspecified route of administration on 03Feb2021 (at the age of 83-year-old), as dose 2, single for COVID-19 immunization. The patient's medical history included high cholesterol, restless legs syndrome, depression, and memory disturbance. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL1283), via an unspecified route of administration on 13Jan2021 (at the age of 83-year-old), as single dose for COVID -19 immunization. Concomitant medications included levothyroxine sodium (SYNTHROID); atorvastatin (LIPITOR); apoaequorin (PREVAGEN) taken for her memory, start and stop dates were not reported. Patient was taking pills for depression and cholesterol, which was not clarified. On 18Feb2021, 15 days after second dose of vaccine, the patient's toe was itching, her toe started swelling and red and put a little bit non-itch (unspecified Medication) and all of the sudden rash went right down her arm and also felt hard to hear. Patient thought she had an attack of gout. So, took a blood test and it wasn't that. Patient was not been able to sleep and had been living on Benadryl. Patient had been itching all over. Patient thought of going to dermatologist. Patient would like to rule out the fact that it might be the injection that caused all these. The patient underwent lab test and procedure which included blood test: it was not gout, on an unspecified date. The clinical outcome of all events was unknown.  Follow-up attempts completed. No further information expected.
ITCHING, REDNESS AND SWELLING AT INJECTION SITE AT LEAST 3 INCHES IN DIAMETER
no adverse reaction; Expired dose administered; This spontaneous report was received from a female consumer of unknown age reporting on herself. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 03-MAY-2019, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (M-M-R II) 0.5 milliliter, subcutaneously, lot # N009168, expiry date 20-MAR-2019 (site of administration was not reported) for prophylaxis. There was no temperature excursion. No adverse effects were reported.
This spontaneous report was received from a health professional refers to a patient of unknown age and gender. Patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. On 22-JUN-2015 the patient received an expired dose of M-M-R II (lot # J006185, expiry date: 24-MAY-2015 .5 ml, subcutaneous. Concomitant medications were not reported. No symptoms were reported. Additional information has been requested.
Presented with SOB, AMS; + covid; dx covid PNA; CXR: clear on admission; Labs: D-dimer 0.92; CRP: 8.34; Ferritin 148;   pt was started on IV Decadron,2/3 pt with increasing oxygen needs:  Oxygen and nebs. Pulmonary and ID consults were obtained. Pt was started on  Remdesvir which was completed. Also received 1 dose Actemra; and  started on IV Meropenem. Tx with Vit D3, Vit C, lovenox, zinc.  With the above - pt did not improve and her Oxygen requirements increased and she required maximum Oxygen via Airvo . Pt did not improve and was not doing well. Palliative care eval was obtained and after discussion with pt's daughter - they did not want to continue aggressive treatment. Pt was started on comfort measures. Pt expired the same day 2/19.
Numbing sensation spreading from injection site to all of upper arm until feeling was lost. Advised to take Steroids to reverse the effects to arm. After steroids feeling gradually returned but not fully If given percentage of returning feeling i would feel "80%" returned.
Information has been received from a physician concerning a patient who was vaccinated with a dose of varicella virus vaccine live.  Within 24 hours of vaccination, the parents called to report the patient had developed an injection site rash.  Unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information has been requested.
tingling in the same arm; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in the same arm) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 045A21A) for COVID-19 vaccination.     Concurrent medical conditions included HIV disease. Concomitant products included BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (BIKTARVY) and ATORVASTATIN for an unknown indication.   On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, the patient experienced PARAESTHESIA (tingling in the same arm). At the time of the report, PARAESTHESIA (tingling in the same arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2021-335482 (Patient Link).
First I want to say that I cannot remember the exact date, but I do recall it being around Christmas time. I started to get body aches later the same night I received the vaccine. I then woke up in the morning with a 102 degree fever, body aches, and chest pain. My mother, who has been an RN for almost 20 years, was concerned and took me took the doctor. I was given an ECG where my heart waves were slightly abnormal. I have never had any cardiac condition and neither has anyone in my family. The doctor said to take ibuprofen for fever and rest. He attributed my condition to the vaccination, specifically the preservatives, as this was the first year apparently that the flu shot was offered in a triple combo (influenza A, influenza B, and H1N1). He said the more viruses in the vaccine the more preservatives. I have had a flu shot every year since 1998 and never had an issue until 2010.
Fever, slight runny nose, cough while in foreign country. Diagnosed with pneumonia and treated w/antibiotics in foreign country.
being given a Moderna vaccine instead of the Covid-19 vaccine since no available supplies of Pfizer Covid-19 vaccine; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (being given a Moderna vaccine instead of the Covid-19 vaccine since no available supplies of Pfizer Covid-19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (being given a Moderna vaccine instead of the Covid-19 vaccine since no available supplies of Pfizer Covid-19 vaccine). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (being given a Moderna vaccine instead of the Covid-19 vaccine since no available supplies of Pfizer Covid-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-073591 (E2B Linked Report).; Sender's Comments:  MOD-2021-073591:DUPLICATION
High fever, swelling, red, hot at shot area.  Lethargic . Vomiting.
shingles; Information has been received regarding a case in litigation from a lawyer and consumers, referring to a patient of unknown age and gender. Information about concurrent condition, historical condition and concomitant medication was unknown.   In 2011, the patient was prescribed and administered with zoster vaccine live (ZOSTAVAX) (dose, frequency and route unknown) for the long-term prevention of shingles and zoster-related conditions, by the pharmacist at a pharmacy.   On an unknown date, subsequently, the patient was treated by a health care provider in the medical office for shingles.   As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of event was considered as not recovered/not resolved. The event was considered to be related to zoster vaccine live (ZOSTAVAX).
This is a spontaneous report from a contactable consumer (patient's parent). A 12-year-old male patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# EW0181), at the vaccination age of 12, via an unspecified route of administration, in left arm, on Jun 6, 2021, at 12:00, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient previously received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# EW0187), at the vaccination age of 12, via an unspecified route of administration, in left arm, on May 16, 2021, at 12:00, single dose, for COVID-19 immunisation. The patient did not take any other vaccine in four weeks. The patient did not have COVID-19 prior to the vaccination. The patient has not tested for COVID-19 post vaccination. On Jun 7, 2021, at 07:00, patient experienced fever for 24 hours (varying between 99ºF and 101.6ºF), nausea and general malaise. The patient did not take any therapeutic treatment for the adverse events. The outcome of the events resolved on an unspecified date in 2021. Follow-up (Jul 15, 2021): Follow-up attempts completed. No further information expected. Follow-up (Aug 2, 2021): Follow-up attempts completed. No further information expected.
Janssen COVID-19 Vaccine EUA. About 1am I woke up short of breath. I sat up in bed to catch my breath and immediately felt nauseous. I went to the bathroom because I thought I was going to throw up but only ended up dry heaving. After sitting for a minute to catch my breath again I started shaking really bad and couldn't stand up without having blacked out vision. Luckily I grabbed my phone when I went to the bathroom so my mom could come home to help me. Until about 5 am I was shaking going between being extremely hot and extremely cold. After that my body SEVERE:Y ached all day with off and on sweats and headaches. I took Tylenol all day. I started feeling better with just some fatigue around 6pm.
17 mo child developed fever to 103 & four convulsive episodes following DTP/OPV/MMR immunization. Hospitalized, EEG within normal limits according to pt mom. Pt on no  anti-sz meds, duration of illness 4 days.
autoimmune disorder; hypersensitivity; headaches; Information has been received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. Information about concurrent condition, medical history and concomitant medication was not reported. On or around 12-DEC-2011 (at approximately 67 years old), the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequently, the pt was treated by a health care provider (reported as provider) for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: autoimmune disorder, hypersensitivity and headaches. The outcome of the events was unknown.  Upon internal review, autoimmune disorder was determined to be medically significant.
2 Very enlarged supraclavicular lymph nodes.  Remain large    today and got  2nd dose 01/29/2021
This spontaneous report as received from a medical assistant refers to a 65 year old female patient with hypertension, osteoarthrosis and lupus. The patient's drug reactions/allergies included codeine, quinine, acetaminophen, VICODIN. On 04-JUN-2014 the patient was vaccinated with a dose of PNEUMOVAX 23, (strength unknown) (lot # J008799, Exp: 15-APR-2016) 0.5 ml, intramuscular in the right arm. The reporter also noted that patient received BOOSTIX in the opposite arm at the same office visit. Concomitant therapies included hydrochlorothiazide, triamterene (manufacture unknown) and baclofen (manufacture unknown). On 05-JUN-2014, the patient experienced numbness and tingling down the right arm where the PNEUMOVAX 23 injection was administered. The patient received icy hot to administer and massage as treatment and contacted medical office for medical attention. No lab diagnostics studies was performed. The outcome of the event was reported as recovering. The causality of the event and PNEUMOVAX 23 was not provided. This is one of several reports received from the same source. Additional information has been requested.
patient was given a SQ injection of IPol instead of a PPD test/no AE; Initial information received on 12-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 48 years old female patient who was given an injection of IPV (VERO) [IPOL] instead of a TUBERCULIN TEST [TUBERCULIN PPD]/no AE (wrong product administered).  Medical history, past vaccination, family history were not reported.  This was a case of actual medication error due to wrong vaccine administered.  On 12-Feb-2020, the patient was supposed to receive TUBERCULIN PPD (TUBERCULIN TEST) (with an unknown batch number) for Tuberculin test but received a dose of suspect IPV (VERO) lot P1A242M expiry date 26-Apr-2020 via subcutaneous route in forearm..  The patient was delayed for observation for 15 minutes. No adverse reactions were observed.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
PT STATED THAT ARM WAS SEVERLY SWOLLEN AND INTENSE PAIN. pT TOOK TYLENOL AND THIS ABATED PAIN A SMALL AMOUNT. PATIENT CALLED PHARMACY 9/12 AND i TOLD PT TO ICE ON AND OFF FOR 15 MIN AND TO CALL ME LATER IN THE DAY. PT CALLED AGAIN LATER THAT DAY AND STATED THAT IT WAS STILL A BIT SWOLLEN BUT IT FELT BETTER. PT CALLED AGAIN ON 9/13 AND STATED THAT HE WAS GOING TO THE ER
Within 10 min my left arm started swelling,  very swollen, arm swelling stayed for 10 days 30 min after vaccine my face was red and hot, nausea and migraine (migraine lasted 4 days) that lasted for a few hours.  I called my GP Doctor and he said to increase my Zyrtec to twice a day, it did not help obviously. The surgery site on my hip (surgery was on 3/29/21) started to swell and was very hot.  Swelling was very large and lasted for 14 days. The skin is side mouth is shedding, started two weeks after vaccine and is still shedding. I have had three migraines since vaccine, I get migraines but would say possibly I have had two more than normal.  They last 3 to 4 days.