chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a 22 year old female patient who on 20-FEB-2009 was vaccinated with the first 0.5 mL dose of GARDASIL. There was no concomitant medication. On 20-FEB-2009 (also reported as "two days after vaccination"), the patient experienced soreness at the injection site, headache and lump in her throat. Later the patient experienced acid reflux. The patient stated that she will not receive any further doses of GARDASIL. The patient sought unspecified medical attention. Two months later, on approximately 20-APR-2009, the patient recovered from soreness at the injection site, headache, lump in her throat and acid reflux. Additional information has been requested.
This spontaneous report as received from a register nurse refers to a 6 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 04-MAR-2014, the patient was vaccinated with dose 3 of ROTATEQ oral, lot #J007283; expiration date: 27-SEP-2014 (dose and strength were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm- 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
p/vax pt devel 40-50 vesicular small pox on the chest, rt arm, neck & scalp area;pt exp low grade fever;
On 19SEP91 the pt had a Jacksonian sz which progressed to grand mal & lasted about 45 seconds;
Information has been received from a company representative, reporting on a literature article (article name and author not specified) concerning female patients who were vaccinated with a dose of doses of Gardasil. According to the article, there have been "injuries" when the vaccine is given concomitantly with "vaccines other than Recombivax HB. The article indicated that "1/3 of the "adverse events" occurred in girls who were 16 years old or younger who were given Gardasil concomitantly" with other vaccines. According to the representative, the article also stated that Gardasil can "enhance cancer when given to a woman who is already infected with one of the strains of the virus included in the vaccine," although in this instance, the representative did not indicate a specific patient was involved. Follow up information confirmed that only one patient was identified or involved with the events (WAES #0610USA04009).  Therefore (WAES #0610USA04009) is being deleted from our file.  No further information is expected.
Information has been received on 9/12/01 from a pharmacist concerning a 28 year old pregnant female who "many years ago" was vaccinated with a dose of MMRII. On 9/12/01, it was reported that the pt "now" has protective titers of mumps and rubella antibodies, but is sero-negative for measles antibodies. The pt was in the 3rd trimester of pregnancy. It was noted that the pt did not receive MMRII during her pregnancy. The pt sought unspecified medical attention. Additional information has been requested.
Had major vertigo on my first shot. Saturday i felt the feeling like i was off the floor again . not so much vertigo but like i was floating. yesterday i ate lunch and very quickly after i got diarrhea very suddenly and i felt i emptied my entre body This morning i have had pain in my stomach but seems to be subsiding  as the day goes on.
pt fainted in lobby while waiting the 15 minutes after receiving vaccine. paramedics were called to assist & assess pt.
Narrative: COVID infections following completion of COVID vaccine series 05/17/21 COVID vaccine dose #1 06/07/21 COVID vaccine dose #2 06/15/21 Pt presents to ED due slip without fall inside facility, lower back strain; treated with acetaminophen 07/02/21 COVID preop test NEGATIVE 07/30/21 Pt presents to screening reporting diarrhea, fatigue, headache x3 days (07/27), and exposure to COVDID positive family member; COVID POSITIVE 07/31/21 Pt reports chills, cough, diarrhea, fatigue, headache, muscle pain; rx given for guaifenesin 08/02/21 Pt calls reporting O2 sat of 87-89%, SBP 110, HR 30-140; directed to ER 08/03/21 Pt reports he did not go to ER but is feeling better; O2 sat 98% 08/05/21 Pt presents to screening stating he was told to come in for second test but no documentation found; COVID POSITIVE 08/12/21 Pt denies COVID/flu symptoms but has active cough and congestion
Fever (99.7 degrees F), chills, muscle aches, joint aches, severe dizziness, significant fatigue, severe migraine. All symptoms started at 4:00 am 2/13 and were present throughout the entire day 2/13. Migraine and dizziness persisted until 2/15 but lessened in intensity each day. managed symptoms with Aleve
SEVERE JOINT PAIN THE DAY AFTER INJECTION, MIGRAINE BEGINNING THE DAY AFTER INJECTION LASTING  4  DAYS, JOINT PAIN CONTINUED FOR 7 DAYS FOLLOWING INJECTIONCONTINUES TO HAVE INTERMITTENT HEADACHE
patient received one odse of improperly stored ROTATEQ; No adverse effects reported; This spontaneous report was received from a office manager and a healthcare business professional referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.     On 27-JUN-2019, the patient received one dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # R025713 (verified to be a valid lot number), expiration date reported and established as 20-JUN-2020, for prophylaxis.   the vaccine was improperly stored at a temperature of 33.9°F during a time frame of 40 minutes. The previous temperature excursions were the following: 30.3°F for 93 hours and 50 minutes. Later, the stability information was updated: total time and lowest temperature below 36°F (30.3°F) for 90 hours and 7 minutes, total time and lowest temperature below 36°F (30.5°F) for 1 hour 45 minutes and total time and lowest temperature below 36°F (35.2°F) for 2 hours 5 minutes. The most recent temperature as total time and lowest temperature below 36°F (33.9°F). The call was because of a data logger and no adverse effects were reported.
Swelling at site, redness, area hot, pain at site, applied ice at heat, took ibuprofen and Tylenol, lasted 1 week, pain and redness gone, 2 weeks later continue to have painless small bump at site.
Sore arm; Fatigue; Chills; Headache; Achy; Dose received: 3; This is a spontaneous report from a non-contactable reporter (consumer or other hcp). The reporter is the patient.  A 63-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Dec2021 at 11:45 (Lot number: unknown) at the age of 63 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown; Anatomical site: unspecified; Route of administration: unspecified), for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: unknown; Anatomical site: unspecified; Route of administration: unspecified), for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 08Dec2021 at 11:45, outcome "unknown", described as "Dose received: 3"; PAIN IN EXTREMITY (non-serious) with onset 08Dec2021 at 21:00, outcome "recovering", described as "Sore arm"; FATIGUE (non-serious) with onset 08Dec2021 at 21:00, outcome "recovering", described as "Fatigue"; CHILLS (non-serious) with onset 08Dec2021 at 21:00, outcome "recovering", described as "Chills"; HEADACHE (non-serious) with onset 08Dec2021 at 21:00, outcome "recovering", described as "Headache"; PAIN (non-serious) with onset 08Dec2021 at 21:00, outcome "recovering", described as "Achy". Therapeutic measures were not taken as a result of pain in extremity, fatigue, chills, headache and pain.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Thyroiditis subacute; C-reactive protein increased; Pyrexia; Blood thyroid stimulating hormone C-reactive protein increased; This is a spontaneous report from a non-contactable consumer. A 38-years-old female patient received bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced thyroiditis subacute, blood thyroid stimulating hormone, C-reactive protein increased and pyrexia. The lab data included on an unspecified date SARS-CoV-2 test was negative, Tri-iodothyronine was normal, ultrasound scan was abnormal, blood thyroid stimulating hormone was increased C-reactive protein increased and white blood cell count was normal. The outcome of the events was recovered on an unknown date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100974883
Information has been received from a registered nurse referring to a patient of unknown age and gender. On 08-JAN-2016 the patient was vaccinated with a dose of an improperly stored oral, ROTATEQ (lot # L013203, expiration date 28-JAN-2017, dose and route unknown). No adverse effects was reported. Additional information has been requested.
0.5 ml flu vaccine Aventis Pasteur U1093AA IM left deltoid given approx 12 noon 10/22/03. Rash/itching began 6 PM 10/22/03. Rx'd with antihistamine topical/oral.
Slight arm soreness initially. 12 hours later developed nausea, chills, body aches, temp of 100.5.
I?m nauseous, I have a headache and my body ache and I have the chills!
Swelling area (L) upper arm with erythema 3 1/2" X 3".
Two days post vax (10/31/98), this child presented to a physician with total body alopecia. On 11/19, tests and cultures were conducted with negative results. Within a couple of months of onset the pt had lost all body hair, including eyelashes and eyebrows. At the time of the report, the pt still had complete body alopecia. No further information is available.
This spontaneous report as received from a physician via a company representative refers to a female patient of "high school age". On 03-DEC-2014 the patient was vaccinated with the second dose of GARDASIL (route, dose, frequency and lot # not reported). It was reported that on 03-DEC-2014 (also reported as today) the patient did not eat breakfast or lunch and fainted after being administered her second dose of GARDASIL. It was reported that the therapy with GARDASIL was continued. The patient recovered fully on 03-DEC-2014 while at the office and was released. The patient sought medical attention and was in the office at that time. The relatedness between the event and GARDASIL was not reported. Additional information is not expected as there is no consent to contact physician.
fever to 103. 6 & induration, swelling @ inj site on lt deltoid area;
This spontaneous report as received from a pharmacist, via company representative, refers to two patients of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies were unspecified. On an unknown date the two patients were vaccinated with a dose of ZOSTAVAX, subcutaneous, once (dose, dose number, anatomical location, lot number and expiration date were not reported). Concomitant therapies were unspecified. On an unknown date the two patient experienced injection site swelling and injection site erythema and sought medical attention by visiting the reporter's office. Treatment given for the adverse events and laboratory diagnostic studies performed were unspecified. The outcome of injection site swelling and injection site erythema was unknown. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
The AFIB occurred around May 5th and it was continuous almost the whole month of May. Shortness of breath, tiredness and interference with my daily interactions. I would get tired about 30 minutes of anything. Whatever the medical term is for when you get tired easily, shortness of breath etc. Just basic AFIB symptoms. The Dr gave me Solital 2x per day and as soon as he did that, within two days the AFIB went away. He took away my blood pressure medication and gave me the Solital. But I still get tired easier than I did before.
Pt recd vax on 3MAY91; mom reports pt slept day & night for 1 wk following vax;
Menveo was administered after the expiration date; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: Menveo was administered after the expiration date). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 07-NOV-2023 The pharmacy student that unknown presentation of Menveo was administered after the expiration date which led to expired vaccine used. Additional information was not known. The Healthcare professional did not want profile created due to her being a student. The reporter did not consent to follow up.
The day after vaccine pt reported cough, fever on and off, nasal congestion, mild headache, moderate fatigue, which has lasted 8 days.
This spontaneous prospective pregnancy report as received from a registered nurse (R.N.) refers to a 21 year old female patient with hypertension and seizure disorder. The patient's medical history included migraines. The patient had no drug allergies. On 31-JUL-2013 the pregnant patient received her first dose of GARDASIL (lot # not reported) (intramuscular, 0.5 ml, strength not reported). Concomitant therapies included PAMELOR and TOPAMAX. The patient had a positive urine pregnancy test in the physician's office on 31-JUL-2013. No adverse effect was reported. The patient's last menstrual period (LMP) and estimated date of delivery (EDD) were unknown. It was unspecified whether the patient sought medical attention. The outcome was unknown. Additional information has been requested.
PATIENT RECEIVED A DOSE OF EXPIRED PFIZER VACCINE.  THEY EXPERIENCED A SORE ARM AND FATIGUE.  RECOMMENDED TO REPEAT DOSE
Patient developed an extensive acute, occlusive thrombus in the external iliac, common femoral, popliteal, and gastrocnemius veins
Significantly longer menstrual cycle. Standard length for last 15 years: 3 days. Most recent cycle 7 days. Irregular cycle length (36 days, previously 28-30 days for the last 15 years).
Felt unwell, feverish the next day and had a bad headache, fatigue that lasted 4 days. I also had pain under right rib cage. Headache was bad and later had also dizziness and vertigo. I took Tylenol a few times and one dose of Benadryl.  Things subsided but vertigo I had it for a few more days, requiring /motivating a medical telehealth appointment. Things improved and subsided. But I had vertigo/dizziness again recently ( past 4 days), better today.
Only received half the dose; Patient pulled away and only half the dose was administered; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Only received half the dose) and DEVICE CONNECTION ISSUE (Patient pulled away and only half the dose was administered) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, the patient experienced UNDERDOSE (Only received half the dose) and DEVICE CONNECTION ISSUE (Patient pulled away and only half the dose was administered). At the time of the report, UNDERDOSE (Only received half the dose) and DEVICE CONNECTION ISSUE (Patient pulled away and only half the dose was administered) outcome was unknown.        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 product use was provided by the reporter.  No treatment medication was provided.
sore throat; diarrhea; shooting pains in her body; eyes hurt; felt nauseous; CHILLS; FEVER; aches in her joints; aches in her muscles; headache; fatigue; became very ill; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (became very ill), DIZZINESS (Dizziness), OROPHARYNGEAL PAIN (sore throat), DIARRHOEA (diarrhea) and PAIN (shooting pains in her body) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced ILLNESS (became very ill), DIZZINESS (Dizziness), PAIN (shooting pains in her body), EYE PRURITUS (eyes hurt), NAUSEA (felt nauseous), CHILLS (CHILLS), PYREXIA (FEVER), ARTHRALGIA (aches in her joints), MYALGIA (aches in her muscles), HEADACHE (headache) and FATIGUE (fatigue). On 30-Jan-2021, the patient experienced DIARRHOEA (diarrhea). On 31-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat). On 30-Jan-2021, ILLNESS (became very ill), PAIN (shooting pains in her body), EYE PRURITUS (eyes hurt), NAUSEA (felt nauseous), PYREXIA (FEVER), ARTHRALGIA (aches in her joints), MYALGIA (aches in her muscles) and HEADACHE (headache) had resolved. At the time of the report, DIZZINESS (Dizziness), OROPHARYNGEAL PAIN (sore throat) and DIARRHOEA (diarrhea) outcome was unknown and CHILLS (CHILLS) and FATIGUE (fatigue) had resolved. Not Provided          No concomitant medications were provided Treatment included Tylenol, Ibuprofen.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age with celiac disease. On an unknown date the patient was vaccinated with a dose of GARDASIL (dose, route and lot were not provided). On an unknown date, the patient had a decrease in control of her celiac disease following vaccination with a dose of GARDASIL. At the time of the report the patient had not recovered from the event. The patient contacted the pharmacist for medical attention. The pharmacist provided that some marker for celiac disease went from 6 to 62 following vaccination. Additional information is not expected.
Information had been received on 19-OCT-2016 from a field representative regarding an 11 year old male who received GARDASIL 9 (frequency 0, 2, 6 months) intramuscular injection. Physician reported that the patient received his first dose of GARDASIL 9 on 18-OCT-2016 and waited 15 minutes. Towards the end of this time frame, the patient stood up and looked "gray" or "green" and stated that he felt as if he was "going to vomit". The patient then vomited and laid back down and "felt better" after approximately 20 minutes. Patient sought medical attention. No treatment was given for the patient's adverse event. Patient's present status was unknown by reporter. No other information was provided. Additional information has been requested.
Information has been received from a physician concerning a 15 year old female who on 11-FEB-2008 was vaccinated with her first dose of Gardasil (lot# not reported). Subsequently the patient experienced fatigue, malaise and chest tightness at an unspecified time which lasted for several days. The patient went to a cardiologist where she had a full work up. The following tests were normal: Epstein-Barr, CRP, chem panel, MRI and CAT scan. The patient did test positive for Juvenile Rheumatoid Arthritis. The patient's outcome was not reported. Additional information has been requested.
I had an appointment at the local health dept 9/9/21 to receive the Janssen Vaccine. I went in with a friend, completed the required paperwork, and received the injection, 11:16.  We sat in the back of the clinic together. At 11:24 I felt odd and sleepy and immediately fell over, unconscious, into my friend's side. My BP at this time sitting was 182/104 and heart rate 137.- taken by a nurse at the health dept. (My normal is 108/70 and my weight is 105lbs- no history of hypertension, cardiac issues.) My friend said that my speech slurred and then I fell over onto him with him stabilizing me so that I didn't fall into the floor.  After they took my BP he moved me to lie on the floor during which time I was conscious but not able to assist much in the movement. He said that I kept saying , " I am sleepy." My heart rate and BP continued to be elevated and my breathing was shallow and rapid. I recall having diffculty staying awake with my friend telling me to keep my eyes open. I would fade off he said and then he would tap me and call my name and I would open my eyes. My body began to shake and I felt like I was very cold. All of this occurred within approximately 15 mins after the injection and continued on for some time, over an hour lying on the health dept floor with them monitoring me. I was unable to stand and every time they sat me up I would increase BP.  They called 911 and I went to the ER.
Patient had a cellulitis-like reaction on the vaccinated arm - swelling, red, heat from shoulder to elbow. Patient also had flu-like symptoms - fever, chills, body aches.
Almost immediately after receiving the vaccine, I started having really bad blepharospasms which I had not had for about a month and started having general shaking throughout, but especially in my legs. Much of these side-effects began to subside upon the self-administration of clonezepam, but not completely  There is a still a lot of pain at the injection site as well as fatigue