chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician assistant refers to an unspecified patients of unknown age and gender. Since 21-OCT-2015, the patients were vaccinated with doses of ROTATEQ (lot # K011952 and expiration date 17-JUN-2016) (dose and route were not reported) which were exposed to temperatures outside of the recommended range. No adverse experience were reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
ITCHING, SORENESS, ERYTHEMIA, SWELLING 2 DAY CORSE ORAL STEROID GIVEN LEFT THIGH.
Left arm pain since flu shot reported on 12/5/08.  As of 12/16/08 saw MD, diagnosed with bursitis, RELAFEN prescribed.  May need cortisone injection if not better.  Pain decreased with RELAFEN.
Severe chills and shaking for 15-20 minutes, followed by feeling overheated and sweats. Took 1 aleve and let it pass. No additional side effects felt.
Fainted, fell and lost consciousness for about 5-10 seconds, became pale and a cold sweat for about 30 minutes. Laid down and mother monitored symptoms and showed improvement after rest.
Information has been received from a nurse concerning a 26 year old female who on an unspecified date was vaccinated with first dose of GARDASIL vaccine (yeast) and had no reaction. On an unspecified date the patient was vaccinated with a second dose of GARDASIL vaccine (yeast). On approximately 07-MAY- 2008, "about 3 weeks ago" the patient experienced a swollen, painful and hard injection site. The patient sought medical attention at the physician's office. At the time of report, the patient was not recovered. Additional information has been requested.
Healthy 3 sport athlete with no GI symptoms prior came down with Ulcerative Colitis flare approximately 45 days after second dose of Pfizer covid vaccine .. After  medical care and meds a second flare approximately 30 days after booster on 1/8/2022.
Pt received the 3 vaccines listed below. She immediately became dizzy. She laid in supine position for 30 minutes and drank fluids. She felt better so left office in stable condition. As she was leaving the building she became syncopal and was seen in ER.
FATIGUE; HEADACHE; SORE ARM; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced fatigue. On MAR-2021, the subject experienced headache. On MAR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, headache and sore arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20210326390.
11 Weeks Pregnant; Inappropriate Schedule of Vaccine Administered; Initial Report Received on 14-Mar-2022  A pregnant patient (gestation period 11 weeks) reported to the pregnancy registry that she (age 25, race and ethnicity unknown) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history at the time of vaccination was reported.   Medications at the time of vaccination were reported as prenatal vitamins and ondansetron.  On 22-Sep-2021, the patient received the first dose of HEPLISAV-B (Lot #, expiration date, NDC #, and injection site unknown) prior to pregnancy.  On 14-Mar-2022, the patient informed the pharmacist that she was pregnant (11 weeks) and asked if it was safe to get the HEPLISAV-B vaccine during pregnancy. The pharmacist said yes and administered the second dose of HEPLISAV-B (Lot # 935848, expiration date 02-Dec-2022, and NDC # 43528-003-01) intramuscularly in an unknown site to the patient on the same date.  No adverse effects were reported at that time. After researching the HEPLISAV-B vaccine and pregnancy on her own, the patient became concerned but declined enrollment into the pregnancy registry.   No additional information was provided.  Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Information has been received from a registered nurse for VARIVAX (Merck), a Pregnancy Registered product, concerning a 25 year old female refugee patient with pain in calf and no drug allergies, who on 18-OCT-2010 was vaccinated with a dose of VARIVAX (Merck) (Lot# 668406/0999Z), Exp 10-28-2012). The patient also started Isoniazid ("INH"). The nurse stated that the patient had reported 10 to 12 days, on approximately 28-OCT-2010; after starting isoniazid and receiving the dose of VARIVAX (Merck) that she began not feeling well and vomiting. Patient discontinued Isoniazid (date not reported) and on 14-NOV-2010 patient had been to the emergency room because she was "sick" and she had discovered she was 7 weeks pregnant (LMP 17-SEP-2010; EDD on 24-Jun-2011). At the time of the report the patient had not recovered from all these symptoms. Additional information has been requested.
Info has been received through the mfr pregnancy registry from a health professional concerning a 16 year old Hispanic female with a history of chickenpox, no known allergies, and no previous pregnancies who on 7/30/04 was vaccinated with a dose of varicella virus vaccine live. At the time of vaccination, the pt was 8 1/2 weeks pregnant, with a LMP of 5/31/04. On 9/17/04, the pt started taking prenatal vitamins. On 10/1/04, a maternal serum alpha-fetoprotein test was performed and the results were within normal limits. On 10/22/04, an ultrasound was performed that showed a low-lying placenta but was within normal limits. It was unknown if the pt had al local reaction at the vaccination site or varicella and herpes zoster symptoms post/vax. There was no product quality complaint involved. Follow-up info from the health professional indicated that on 2/10/05, the pt had a live born, normal, female infant, described as slightly preterm at 36 4/7 weeks gestation. The baby weighed 6 lbs 3 oz. No other info was available at that time as the pt had not yet been seen for post partum visit. Additional info is not expected.
12 hours after the 2nd vaccine, Doctor experienced 15 hours of "severe" adverse side effects: severe fatigue, headache, nausea, vomiting, diarrhea, arm pain.
Shingles rash and pain over right breast and circling right side to middle of spine.
No additional AE; HCP calling to report an AE regarding the VAQTA and RECOMBIVAX HB vaccines. HCP reported that the patient was administered improperly stored vaccines of VAQTA and RECOMBIVAX HB. The operator of the devices are unknown. Permission was provided to cont; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.     On 13-JUL-2023 the patient was vaccinated with improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) lot # X004814 and expiration date 10-OCT-2024 for prophylaxis (exact dose, dose number, route and site of administration were not provided). On that same day the patient was vaccinated with improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) lot# W008704 and expiration date 18-NOV-2023 for prophylaxis (exact dose, dose number, route and site of administration were not provided) (product storage error and no adverse event).
Pt was leaving clinic after vaccine, stopped briefly to speak with provider, c/o feeling lightheaded, mother and provider began to support patient on either side, walking back toward exam room, pt lost consciousness and was lowered to the floor. eyes rolled back and brief posturing of the right arm and neck noted, pt regained consciousness after 10-15 seconds. She remained in the clinic additional 10-15 minutes, drank water and left in her previous state of health and cognition.
Pfizer vaccine: BUD Date 04/07/2022 administered on 04/11/2022. Pfizer could not provide stability data beyond 04/09/2022 and recommended re-vaccination
This spontaneous report as received from a physician via field representative refers to unspecified number of patients. On an unknown date the patients was vaccinated with GARDASIL (strength, formulation, lot #, dose/frequency, route and duration were unspecified0 for prophylaxis. Physician might have had an unspecified number of patients that experienced syncope following vaccination with GARDASIL. The physician did not have specific information about the patient's syncope and informed the representative that the cases of syncope were previously reported. The representative reported that the physician might also have had patients that experienced syncope following vaccination with TDAP (manufacturer unspecified) and meningococcal vaccine (manufacturer unspecified). The outcome of syncope were unknown. Additional information is not expected.
Pt called 6 days s/p injection ADACEL-Tdap c/o red raised area at injection site starting 3d after injection going from quarter to "fist" size in diameter. No relief with topical benedryl/cool compress. Brought into office that day. 8x15cm warm erythemetous plaque, slightly raised with irregular shape noted on left upper arm. Physician called into room. Vital signs stable. Pt advised to take oral Benedryl,topical hydrocortisone, monitor temp, flup in 2 days for re-evaluation.
Fevers 104.0-102.6, day 22 and still fevers over 101.0. Severe diarrhea, vomiting, and crushing headache since the second vaccine. Vaccine card shows two different Covid vaccines. Nurse wrote in my medical record that I received two of the same, we had witnesses that the second wasn?t a moderna
Reports 2 hr shot became nauseated, left arm swollen and painful.  Then vomited with arm continuing to swell with redness. "It looked like I was lifting weights with my left arm." Went to ER given "a pill for nausea", Darvocet for pain and arm put in a sling. States 2 days later swelling gone and nausea was gone that evening with medication.
24 year old was administered Fluzone HD with no adverse event; Initial information received on 03-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 24 years old and unknown gender patient who experienced 24 year old was administered fluzone hd with no adverse event while receiving vaccine Influenza quadrival a-b high dose hv vaccine [fluzone high-dose quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza quadrival a-b high dose hv vaccine unknown dose, strength, frequency, formulation, lot UT7715AA via unknown route in unknown administration site for immunization.  On an unknown date the patient developed a non-serious 24 year old was administered fluzone hd with no adverse event (product administered to patient of inappropriate age) (unknown latency) following the administration of influenza quadrival a-b high dose hv vaccine.  Action taken with quadrivalent influenza vaccine (fluzone high-dose quadrivalent) was not applicable.  At time of reporting, the outcome was Unknown for the event 24 year old was administered fluzone hd with no adverse event.  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 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.
Information has been received from a medical assistant (M.A) concerning a 16 year old female patient who on 02-JUL-2007 was vaccinated with a first dose of Gardasil. Patient came back to the office on 03-JUL-2007 and said that she had experienced seizure like activity. The physician had done an electroencephalography (EEG) on 23-JUL-2007 and did a second electroencephalography (EEG) on 21-SEP-2007 and both came back negative. No further information was available. The patient recovered on an unknown date. Upon internal review, seizure was considered to be an other important medical event. Additional information has been requested.
Secondary parkinsonism due to other external agents and Dementia with behavioral disturbance, unspecified dementia type. ED visit, then behavioral health admission. This visit was within 6 weeks of receiving the COVID vaccine.
Afib; An aneurysm in mu heart; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Afib) and CARDIAC ANEURYSM (An aneurysm in mu heart) in an 86-year-old female patient 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 ATRIAL FIBRILLATION (Afib) (seriousness criterion medically significant) and CARDIAC ANEURYSM (An aneurysm in mu heart) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (Afib) and CARDIAC ANEURYSM (An aneurysm in mu heart) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication information provided. No relevant treatment medication information provided.  Company Comment: Very limited information regarding this events has been provided at this time.  Further information can't be requested.; Sender's Comments: Very limited information regarding this events has been provided at this time.  Further information can't be requested.
Got the vaccine while pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Got the vaccine while pregnant) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Gestational diabetes. Concomitant products included INSULIN, LEVOTHYROXINE, VITAMIN D, PRENATAL VITAMINS for an unknown indication.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 15-Aug-2020 and the estimated date of delivery was 22-May-2021. On 15-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Got the vaccine while pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-sixth week of the pregnancy.  On 15-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Got the vaccine while pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-Jun-2021: Reporter details and patient demographic details were updated.
no other adverse events; temperature excursion/ administered; This spontaneous report was received from a pharmacist and refers to a 12-month-old patient of an unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported.   On 09-JUN-2021, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) dose reported as 1 time dosage, lot # T022312, expiration date 30-JUN-2022) (route of administration was not reported) for prophylaxis. No signs or symptoms was reported.  On an unknown date, the temperature excursion was 15 degrees Celsius, for a time frame of 5 hours. There was no previous temperature excursion. The digital data logger was involved.
pain to my shoulder blade on the side of the injection; This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received Shingrix. In November 2019, less than 2 weeks after receiving Shingrix, the patient experienced shoulder pain. On an unknown date, the outcome of the shoulder pain was not recovered/not resolved.   It was unknown if the reporter considered the shoulder pain to be related to Shingrix.  Additional information was received as follows: Age at vaccination was not reported but was captured as an adult as per vaccine indication. The patient had Shingrix vaccine 2 weeks ago and was still having pain to the shoulder blade on the side of the injection.
Given second lose dose flu vaccine less the 4 weeks apart. First dose given 11/15/16. Second dose given 11/29/16. No adverse reaction noted at time of event.
Administered flu vaccine indicated for 65+ years instead of <65 years. Pt reports only sore arm for 1-2 days.
mom stated pt fussy/irritable all day since vax, 8 hrs p/vax describes an episode of becoming very stiff, drooling, eyes staring & unable to breathe, turned blue/purple lasted 4 mins; then was limp & still not interacting dazed look on face
passed out in her car and got into a car accident; passed out in her car and got into a car accident; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced as, passed out in her car and got into a car accident on an unspecified date. Reported as, after receiving the Pfizer COVID-19 vaccine, she passed out in her car and got into a car accident. Her doctor confirmed that it was a result of the vaccine. She stated that it happened right after she left the doctor's office where she received the Pfizer COVID-19 vaccine. She waited 20 minutes and immediately passed out. She got into an accident and was rushed to the emergency room. Outcome of the events were unknown.  Information on the lot/ batch number has been requested.
About 24-36 hours after receiving the vaccine I experienced pain/burning on my labia (the outside, not inside). After inspecting it myself I realized I had multiple lesions 2 days post vax. I saw a nurse practitioner and I went on anti virals prescribed by a local woman?s clinic for suspected herpes which cleared things up within the 10 day regimen. They immediately did a swab of the area for suspected herpes simplex which was negative. I have since done 4+ herpes simplex 1 and 2 tests (blood and swab) and all have been negative. I have also done HIV, RPR, chlamydia, gonorrhea, and auto immune blood tests (and more) and all results have been negative. The issue is now cleared but my PCP wanted to find the root cause of the issue and potential underlying condition.   I have a history of shingles on my back/shoulder and the pain/lesions appeared similar in nature but presented on both sides of my labia in this situation (though much more on one side than the other). My last major outbreak on my back/shoulder was in 2010-2011. This was the only outbreak in which lesions appeared though I sometimes feel the area tingle/tense up when under stress or sick.   In addition to the lesions, I had typical flu like symptoms after the vaccine that began about 8 hours after and lasted for 2-3 days.
Initial unsolicited report received from a pharmacist on 15 September 2016. This case involves a patient (age and gender not reported) who was vaccinated with a 0.5 ml intramuscular dose of Fluzone QIV (batch number UT5629LA and expiration date 30 June 2017), in the arm on 13 September 2016. Illness at the time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions included no known allergies. On 13 September 2016, same day following the vaccination, the patient developed redness, rash from elbow to shoulder and itching on injection arm. Patient was seen in Emergency Room of a hospital. The patient's Lab data and corrective treatment not reported. The outcome of the event was reported as unknown. List of documents held by sender: None.
Approximately 48 after vaccine administered, patient felt numb and tingling and swelling right side of mouth. Vaccine pneumococcal, Merck and Co. S/S reviewed spontaneously 2 hour later. Lot 0486U. Benadryl 25mg with effect.
no adverse event; have received this product following the temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) underwent a temperature excursion of 8.6 Celsius degrees for 18 minutes. It was reported that the doses underwent previous temperature excursion of 11.5 Celsius degrees for 1 hour and 6 minutes, 8.8 Celsius degrees for 21 minutes, and 9.6 Celsius degrees for 6 hours and 41 minutes.  On 28-SEP-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot #W004501, expiration date: 20-APR-2023 (strength and dosage regimen were not provided) as prophylaxis. No adverse event was reported.  This is one of 9 cases reported by the same reporter.
This is a spontaneous report from a contactable consumer reporting for herself. This female patient of an unspecified age, race and ethnicity received PREVNAR 13, (lot 574424, expiry date 30Dec2019, NDC 00005-1971-02) via an unspecified route of administration in the arm on 15Jan2018 at 0.5 ml, single for immunization. The patient medical history and concomitant medications were not reported. In 2008 she had a severe allergic reaction to the over the counter product ALEVE. The patient experienced pain of the injection site, injection site was really deep red and warm and arm started to peel on an unspecified day in Jan2018. Events were described as follows: besides the pain, by 17Jan2018 or 18Jan2018, she noticed that her arm was really deep red and warm. She mentioned that she did not usually receive inoculations. Eventually her arm started to peel. The pharmacist had warned her that the injection site might be painful. The reporter classified these events as reactions to pneumococcal 13-val conj vac (dipht crm197 protein. Outcome of events was unknown.
Myalgias, weakness, chest pain, dyspnea, malaise, anorexia, nausea and dizziness; began a few hours after shots given. Patient evaluated and admitted to hospital next day when patients family called to report symptoms. Dr believes related to Gardasil/HPV vaccine.
This patient states she woke up  on 4/5/22 to a fever around 2-3am of 100-101 and states she also experienced painful urination around the same time. This patient states she checked her fever again at 8:30 am on the same day and it went down to 99. This patient states she increased her fluid intake which lessened the painful urination but states the painful urination is still present.
Pt recvd 2nd hep B vax 19OCT90.  20DEC90 titer results indicated that pt was not immune to hepatitis B.