chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Adverse Event: As the provider started to inject the vaccine into the patient, leakage occurred and dripped around barrel of syinge. Treatment: Vaccine was estimated to be 50 % injected and 50 % lost  Outcome:  We did a safety huddle and retrained vaccinators.   The same thing happened again. Each remaining syringe  was checked by the Pharmacist who found that the connection between the syringe barrel and the needle was loose and unable to be tightened,  This was determined to be a defect with the needle device.  We changed out all the remaining vaccines with our own supply of needles and had no further problems.
This spontaneous report was received from a 60 year old male patient with sulfa allergy. The patient's medical history included prostate surgery in August 2011. On 06-MAY-2013, the patient was vaccinated with a dose 1 of ZOSTAVAX (lot # H021292, expiry: 28-APR-2014) in his left arm. Concomitant therapies included atenol, lisinopril, atorvastatin, LEVSIN, amlodipine besylate, benazepril hydrochloride and hydrochlorothiazide. On 09-MAY-2013, the patient's blood pressure skyrocketed after receiving ZOSTAVAX in his left arm. Laboratory tests included unspecified bloodwork(result not reported). Patient received treatment with an increased dose of unspecified hypertension medication. Patient sought medical attention (doctor's visit on 10-MAY-2013). The outcome of events was reported as not recovered. Additional information has been requested.
Felt scratchiness in back of throat. Denied difficulty breathing. Chest clear, no wheeze. BP 118/76, PO2 97%, Pulse 71.   Patient given Benadryl 25 mg PO x 1. Within 15 minutes felt normal again.
Comes to ED with complaint of a shortness of breath that started 2 weeks ago.  She has been having a nonproductive cough for the last 1 week.  The patient denies any fever, chills, nausea, vomiting, chest pain or diaphoresis.  The shortness of breath is aggravated by any physical activity.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The pharmacist reported that, on 28-JAN-2015, an unspecified physician's office administered an expired dose of ZOSTAVAX (lot # J006828; expiration date 14-SEP-2014) to the patient, (dose and route not provided). No symptoms were reported. Additional information is not expected because the reporter did not provide consent to follow up.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted 8 hours after shingles vaccine
Swollen lymph nodes under left arm pit. Soft & squishy to touch.  Painful upon touch and with movement of left arm.
Red and swollen area, the size of 7.5cm X 6.5cm, hard in the middle, warm to touch. Fever of 99.7F. Gave Rocephin shots.
Storage unit did not record temperature of vaccine. Could not verify for a period of time, vaccine may have been ineffetcitve; No treatment or adverse reaction.
I experienced after vaccine, sore arm and I just felt yucky for one day or so.  I also had some chills, no temperature.  I have recovered from my symptoms.
65-year-old female presenting with reaction to the Johnson & Johnson Covid vaccine.  Received vaccination in her home, about 5 to 10 minutes later, developed redness and swelling of the face.  Thought she had some stiffness of the tongue and tightness of the throat.  No chest pain, shortness of breath.
DTaP (Infarix) given after maximum age of 7. Given at 7.5 years old.
Mother called clinic at 3p stating that child developed rash all over. Also states the child c/o pain left arm and "hard to move". Denies other s/s. Denies difficulty breathing or shortness of breath. Referred to child pediatrician.
Dizziness; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and PYREXIA (Fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Vertigo.    On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PYREXIA (Fever). On 05-Feb-2021, the patient experienced DIZZINESS (Dizziness). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] on 04-Feb-2021 for Fever, at an unspecified dose and frequency. On 05-Feb-2021, PYREXIA (Fever) had resolved. At the time of the report, DIZZINESS (Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.
Information has been received from a registered nurse concerning a 10 year old white female student with no pre-existing allergies or medical conditions who on 11/03/1995 was vaccinated subcutaneously in the right thigh with the first dose of varicella virus vaccine live.  At the time of vaccination the patient had constipation.  On approximately 10/15/2004, the patient was exposed to a neighbor boy with chickenpox.  It was reported that the patient's mother noticed the appearance of bit bites about two weeks later, on Sunday, 10/31/2004 and the patient's mother reported that she developed a chickenpox rash on 11/01/2004.  Unspecified medical attention was sought.  No laboratory or diagnostic studies were performed.  The patient recovered.  No product quality complaint was involved.  Additional information has been requested.
I had my vaccination in 01/2022. In 05/2023 I was diagnosed with Breast Cancer in my left breast. I am having a mastectomy on 06/13/2023.
experiencing tinnitus / residual ringing; This case was reported by a pharmacist via call center representative and described the occurrence of tinnitus in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number C5JL7 ?, expiry date 30th November 2021) for prophylaxis.   On 24th February 2020, the patient received the 1st dose of Shingrix. On 26th February 2020, 2 days after receiving Shingrix, the patient experienced tinnitus. On an unknown date, the outcome of the tinnitus was not recovered/not resolved.   It was unknown if the reporter considered the tinnitus to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and after 2 days experienced tinnitus, till the time of reporting experiencing residual ringing.  Reporter consented to follow. This case has been linked with case US2020098378, reported by same reporter. Note:lot corresponds to Boostrix lot however it was reconfirmed that the reporter mentioned it as Shingrix.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020098378:same reporter
she pulled TENIVAC out of the refrigerator and accidentally gave a patient, TENIVAC today, 20-Oct-2022 that expired on 07-Oct-2022 with no reported adverse event; Initial information received on 20-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 32 years old female patient who experienced she pulled tenivac out of the refrigerator and accidentally gave a patient, tenivac today, 20-oct-2022 that expired on 07-oct-2022 with no reported adverse event while receiving vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation; VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation; and INFLUENZA VACCINE (INFLUENZA VACCINE) for Immunisation.  On 20-Oct-2022, the patient received 0.5 ml of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot U6852AA expiry date-07-Oct-2022) (expired product administered, latency same day) (formulation and strength: unknown) via intramuscular route in the right deltoid for prophylaxis vaccination.   Action taken with DIPHTHERIA AND TETANUS TOXOIDS (TENIVAC) was not applicable.  Outcome-Unknown   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 the guidelines. 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.
Patient was accidently given 0.2 mL of adult Pfizer 30 MCG/0.3 mL instead of peds Pfizer 10 MCG/0.2 mL. There have been no known adverse events reported, or treatments needed that facility is aware of.
I wake up and I was freezing.  I never had this happened for.  I could not get warm.  Went back to sleep, I wake up and I could not catch my breath.  I was running a fever of 101.  I had some memory loss. I had headache.  I could not get enough to drink.  I have serve fatigue.  The next morning, I still was freezing and a fever.  That later day, I started to sweat a lot through my clothes where I had to change them.  I sleep a lot.  This when on until Thursday evening.  I developed a really bad cough.  On Friday, I did feel that I have more life in me.  That night I was very tired.  That Saturday, I was more active. On Sunday, I felt better.  On Monday, I went to go back to work.  I was feeling very fatigue.  My blood pressure was high. I was light-headed, dizzy, and had blurred vision.   When I taking my medication it brings my blood pressure up.  I contact quick care.
arrhythmia; fatigue; headache; fever with temperature of 100.8; site of injection was red; arm pain; This case was reported by a other health professional via call center representative and described the occurrence of arrhythmia in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th August 2020, the patient received the 1st dose of Shingrix (intramuscular). On 11th August 2020, 1 days after receiving Shingrix, the patient experienced arrhythmia (serious criteria GSK medically significant), fatigue, headache, fever, injection site erythema and pain in arm. On 12th August 2020, the outcome of the arrhythmia, fatigue, headache and fever were recovered/resolved. On an unknown date, the outcome of the injection site erythema and pain in arm were recovered/resolved.   It was unknown if the reporter considered the arrhythmia, fatigue, headache, fever, injection site erythema and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received the first dose of the Shingrix vaccine in her left arm and the next day, she had left arm pain and site of injection was red and the arm pain and the redness lasted for 6 days.  The patient also had fever with temperature of 100.8 degree F, headache, fatigue, and arrhythmia which lasted the whole of 11th August 2020 and by 12th August 2020 it resolved. The reporter consented to follow up.
Hypothermic episode, temp 94.2 (R) without environmental exposures on 2/25/11 - Did not warm up to normothermia for several hours. Had one loose stool. No known exposures. Resolved within 24 hrs - admitted/discharged.
Patient did not have any adverse reaction to the COVID vaccine, but we were asked by our health dept to submit a VAERS report since the patient died between his first and second dose.  Received Pfizer Dose #1 12/17/2020. No side effects or adverse events noted; lived in 24/7 care facility and monitored twice daily for reaction.  Date of death 12/23/2020 from aspiration pneumonia complicated by end-stage heart failure and ischemic cardiomyopathy. Death was anticipated and not sudden.
It has been more than 36 days and the patient did not get the second dose yet; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (It has been more than 36 days and the patient did not get the second dose yet) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043120A/043L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (It has been more than 36 days and the patient did not get the second dose yet). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (It has been more than 36 days and the patient did not get the second dose yet) outcome was unknown. Not Provided      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 reported.  No treatment information provided.  This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot #unknown, with no associated AEs.; Sender's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot #unknown, with no associated AEs.
Within 30 minutes of receiving vaccines, pt broke out in hives on her face. Advised her to take antihistamine. Pt took Claritin and within 1 hour hives were much better.
Pneumoccocal conjugate PCV 13 on 24-MAR-2015 and pneumoccocal polysaccgaride PPV23 and pneumococcal, unspecified formula on 16-MAY-2016; This spontaneous report was received from a physician, referring a 68-year-old female patient. The patient's medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 24-MAY-2015, the patient was vaccinated with pneumococcal conj vaccine (unspecified) (reported as pneumococcal conj PCV 13) and on 16-MAY-2016 the patient was vaccinated with two pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (reported as pneumococcal  polysaccharide PPV 23 and pneumococcal unspecified formula) for prophylaxis (strengths, doses, routes of administration, anatomical locations, lots numbers  and expirations date were not provided) (inappropriate schedule of product administration).  This is one of three reports received from the same patient.; Sender's Comments:  US-009507513-2003USA003815:
pt recv vax 24APR97 & noted heartburn on 25APR97; Took 1st oral Typhoid 4/24/97, Noted heartburn on 4/25. Took 2nd oral Typhoid 4/26/97, with heartburn and later that day got diarrhea, worse on 4/27 & 4/28. Took ZANTAC x 2 (75 mg)  No relief. Took MAALOX liquid with some relief. 5/1/97: still taking ZANTAC PRN, queasy +/-. No heartburn or diarrhea but lingering GI Symptoms.
debilitating panic/anxiety attacks and intrusive negative thoughts for 10 straight days, especially in the morning which starts as soon as i wake up.
Rash on both thighs starting 1 day after immunization and still present on day 4.
doctor suspect that it is temporal arteritis/giant cell arteritis; he is having jaw, throat, tongue discomfort when eating; difficulty opening mouth; fatigue; on and off headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (on and off headache), FATIGUE (fatigue), GIANT CELL ARTERITIS (doctor suspect that it is temporal arteritis/giant cell arteritis) and ORAL DISCOMFORT (he is having jaw, throat, tongue discomfort when eating; difficulty opening mouth) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced HEADACHE (on and off headache). On 27-Jan-2021, the patient experienced FATIGUE (fatigue) and ORAL DISCOMFORT (he is having jaw, throat, tongue discomfort when eating; difficulty opening mouth). On 02-Feb-2021, the patient experienced GIANT CELL ARTERITIS (doctor suspect that it is temporal arteritis/giant cell arteritis). The patient was treated with PREDNISONE on 28-Jan-2021 at a dose of UNK dosage form. At the time of the report, HEADACHE (on and off headache), FATIGUE (fatigue), GIANT CELL ARTERITIS (doctor suspect that it is temporal arteritis/giant cell arteritis) and ORAL DISCOMFORT (he is having jaw, throat, tongue discomfort when eating; difficulty opening mouth) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, Biopsy: negative (Negative) biopsy was negative but doctor's believe that it is still temporal arteritis/giant cell arteritis. On an unknown date, C-reactive protein: 38 (High) elevated.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.
mom reported sl rash under lt arm on 8MAY95; now 10MAY spread to chest-legs, buttocks red, raised appearing-looks like chickenpox w/o spots; no rash seen until 11 days p/inj; no temp-other c/o-soreness @ the site; t97.6 ax;
At the pre-counsel stage, the patient said that he was a little nervous about getting this immunization, but wanted to go ahead and do it.  I counseled him on the immunization and sent him into the booth to get the shot.  Technician administered the vaccine and then told Technician that he felt a little nauseous.  Technician told him to stay seated.  A few seconds later the patient passed out and started slipping down the chair.  Technician grabbed him from behind and called me over to assist.  I yelled for Staff to call 9-1-1 and a code white.  I held him from the front and Technician held him from the back and we slowly lowered the patient to the floor.  Technician sat behind the patient to hold him up while I assessed the patient and tried see if he was responsive.  The patient was breathing and had a pulse, so I patted him on the face and chest to see if he would become responsive.  After about 15 seconds, the patient became responsive and confused.  He asked what happened and if he got the shot yet or not.  After talking to the patient for a moment he said he was fine, but needed to vomit.  I gave him a trash can and he vomited.  We gave the patient some water and sat with him on the ground for a few minutes until the paramedics arrived.  The paramedics took the patient's vitals and the patient said he felt fine and declined going to the hospital.  We had the patient sit in the observation area for another 30 minutes.  He said he felt totally fine and was ready to go home.
Onset of Shingles starting on 6/18, diagnosed by a dermatologist on 6/21. Have never had prior skin rashes or other skin issues other than Vitiligo which I have had since teen years but has not spread since 17-18 years of age. Started as an itch on right chest/armpit area and quickly reddened/blistered. Now taking anti-virals to prevent spread and steroid cream for itching/pain. Has not spread since starting the anti-viral and it is contained to the chest, armpit, and slightly on back.
Patient with dementia, erythema noted by a family member 1 week after vaccination. Cephalexin 500 mg qid.
patient near fainted post vaccine , she was evaluated and was breathing , no signs of cyanosis or labored breathing , abc evaluated and was stable and rr and heart rate 90 , rr 20 , speaking in full sentences  was constantly observed stayed at office for 2 hrs after vaccine , she had vomiting few times and at time of leaving office she was doing well no signs of distress no labored breathing vitals were stable , walked alone from office  we did offer to go to emergency room if needed  and mom said she will observe and go to er if needed
Information has been received from a licensed practical nurse concerning a 12 year old female with no known allergies or pertinent medical history who on 14-SEP-2007 was vaccinated in right arm with first dose of GARDASIL. (Lot# 658558/1061U). On 10-DEC-2007 was vaccinated in left arm with second dose of GARDASIL (Lot # 659055/1522U). There was no illness at the time of vaccination. The nurse reported the following the second vaccine of GARDASIL on 18-JAN-2008 the patient experienced seizure and on 05-FEB-2008 the patient experienced seizure. The patient did not receive other injections on or near those dates. Electroencephalogram (EEG) was performed (Unequivocal result). The patient is now on unspecified medication. On unspecified date the patient recovered. The patient sought medical attention "required emergency room/doctor visit". Upon internal seizures were determined to be an other important medical event. Additional information is not expected. 8/8/08-records received-presented to ED 1/18/08-passed out/seizure, head injury. Seizure occurred while walking to school. Bump on forehead.  PE normal. Impression: Seizure activity. Contusion of forehead. 8/27/08-records received for DOS 2/15/08-has had only 1 menarche times 1 lasted for 1 day but none since last Gardasil vaccination. PE:normal. Assessment:one-time seizure versus syncope. multiple neurocutaneous lesions. Second seizure 3/4/08. 4/21/08-felt aura, dizzy and body tingled all over. Whole body aching afterwards. 9/2/08-records received for DOS 2/15/08-pediatric neurology clinic as a follow up to 1 time seizure-like episode. DX: One-time seizure. Versus syncope. Multiple neurocutaneous lesions.
36 hours later swelling began under one eye. At 48 hours both eyes swollen almost shut and half of lip swollen. Symptoms have not resolved on 4th day. Given steroids by general doctor after seeing him during 3rd day after vaccine.
Pt. developed redness and mild swelling patch on left thigh - it was non-indurated and blanches on pressure. There is no evidence of infection. It is a little warm to touch. TX: warm compresses, BENADRYL PRN, skin care v close observation, signs of cellulitis to start antibiotics if needed.
Within 15 minutes of vaccination, patient reported feeling sweaty, hands were clammy, and chest tightness and discomfort. She stated that her "heart felt inflamed." Patient was watched for 15 more minutes, at which point she was sweating more and having some labored breathing, but no difficulty speaking. EMS was called and she was found to be highly tachycardic and hypertensive.
On Monday and Tuesday had a headache. Wednesday had coughing, sneezing and then hives all over body that lasted approx. 1-2 hours. Then after taking Benadryl, the rash appeared mild until the next day.
neighbors got sick; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (neighbors got sick) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (neighbors got sick). At the time of the report, VACCINATION COMPLICATION (neighbors got sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.  No treatment medications were provided.
Patient was given two of the flu vaccine, when she was supposed to receive a pneumonia 13 and a flu vaccine.  No side effects noted, employee contacted patient and advised per provider, that she should be fine and to call if she had any sort of reaction or issues. No call back from patient.