chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician for the Pregnant Registry for GARDASIL, concerning a 15 year old female patient who on 03-APR_2009 was vaccinated with one dose of GARDASIL and was currently pregnant. The physician reported that the patient had a positive home pregnancy test on 30-AUG-2009, her last "normal day 7" period was June 2009. The physician stated that the patient had an irregular period in July 2009 and that the dates of conception and due date have not been determined. The patient sought medical attention by calling the physician's office. The physician declined to provide a fax as it is a central fax for several offices, she preferred to be contacted by mail or phone as mail was also confusing in this practice. Follow up information was received from the physician concerning the 15 year old female with no previous pregnancies and no medical history or concurrent conditions who on 03-APR-2009 was vaccinated with first dose of GARDASIL (lot number 659184/0843X). The patient's last menstrual period was approximately on 29-AUG-2009. Follow up information was received from a physician via pregnancy questionnaire concerning a 15 year old female patient with anemia, Chlamydia (in October 2009), no previous pregnancies and no medical history who on 03-APR-2009 was vaccinated with first dose of GARDASIL (lot number 659184/0843X). Concomitant medications included prenatal vitamins, ZITHROMAX, and iron (unspecified). Laboratory diagnostic tests were performed: on 16-OCT-2009, 30-OCT-2009, 07-DEC-2009, 04-JAN-2010, and on 12-FEB-2010 an ultrasound was performed and the results were normal; on 12-NOV-2009, a serum alpha-fetoprotein test was carried out and was within normal limits. It was reported that on 09-APR-2010, at 36.6 weeks of gestation, the patient delivered a healthy female baby (weight: 6 pounds and 10 ounces; Apgar score: 8/9). There were no congenital anomalies but the mother experienced severe preeclampsia and postpartum hemorrhage (500 cc). At the time of the report the outcome of the patient was not reported. The baby's experience has been captured in WAES # 0909USA01172B1. No further information is available.
Experienced tingling and numbness in hands and feet. Got picked up from college and rode home (an hour and 30-minute ride). By the time I got home, the tingling and numbness had moved up to my hands and moving up my legs. I could not walk or stand to get in the vehicle from school. I would shake all over and had no strength left in my body and the tingling and numbness kept rising. I got treated for Guillian Barre Syndrome and had 5 days of IVIG plasma through my IV. I am still trying to make a recovery from this. I am in a wheelchair and can't walk, drive, go to the bathroom by myself, or stand by myself.
It was body aches, headache, fever for the first couple of days. I had a sore throat, cough, and congestion. I tested on 12/16/2022 and started PAXLOVID that evening and took that for 5 full days. My sore throat, body aches, fever, and headaches went away while on the antiviral. I did have a bitter taste in my mouth but I believe that was in relation to the medication. I had a couple of days after I finished the anti viral where I felt fine. Then I started with a cough and a headache again along with a lot more congestion. I did not have a fever, but just a few body aches. Nothing near like the first body aches I experienced. The headache went away a couple of days ago so on 12/28/2022. I'm still experiencing the cough and congestion, but no more body aches. Once I was finished with the medication, the bitterness went away but I did lose my taste and smell again. I'm just now regaining both of these senses.
Diagnosed with pericarditis; This case was reported by a consumer via call center representative and described the occurrence of pericarditis in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix (intramuscular). In January 2020, between 2 and 3 months after receiving Shingrix, the patient experienced pericarditis (serious criteria GSK medically significant). On an unknown date, the outcome of the pericarditis was unknown.   It was unknown if the reporter considered the pericarditis to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and last week from reporting date patient was diagnosed with pericarditis. Reporter declined consent to follow-up with physician but it was okay with herself.
pt to MD for swelling & redness since 7/15/99, had 3cm ecchymotic area w/edema on lower rt leg;dx vaccine rxn w/localized allerg rxn or cellulitis given atarax & duracef;
Swelling, redness of the upper arm area, pain, fever 104,- Developed Cellulitis, prescribed antibiotics for 7 days.
Migraine, Reynauds, cold body starting  10 days after vaccine and continuing thru today
pain in left arm right away: 6:20 pm  1/21 starting tylenol next day 1/22 start with fever, achy, headache,fatigue, fever, lightheaded all day and night.. my arm was still sore. ...through the day 99.7 about 9pm 1/22 fever was 102.7 starting ibuprofen fatigue, fever, achy,  headache, light headed. 1/23 fever 99.6  took tylenol  symptoms same as above.  1/24 no fever, just achy, fatigue and headache.
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 10-JUL-2015, the patient was vaccinated with a dose of improperly stored VARIVAX lot # L000454 expiry date 06-JAN-2017 (route and dose were not reported). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
This is a spontaneous report a contactable Practice manager who reported on behalf of physician. A 78-year-old male patient received PREVNAR 13 (NDC number: 0005-1971-01, Lot number: L84631, Expiry date: 1 Feb 2017), intramuscular in the right deltoid on 11Sep2015 at 0.5 ml single dose and FLUZONE (NDC number: 49281-397-88, Lot number: UI4278A, Expiry date: 28 Mar 2016, Manufacturer: Sanofi Pasteur) intramuscular in the left deltoid on the same date at high dose of 0.5. Medical history included diabetes mellitus, hypertension, leukaemia, anxiety, blood pressure abnormal, blood cholesterol increased and chronic kidney disease. Concomitant medication included JANUVIA, lisinopril, XANAX, NORVASC, COREG, fenofibrate, PRAVACHOL. The next day patient had swelling over his entire body then the patient was hospitalized due to fluid overload and he cannot fit into his clothes. The patient also experienced full blood count abnormal and metabolic function test abnormal on 06Oct2015. The patient underwent lab tests and procedures on 06Oct2015 which included blood test: unspecified, full blood count: abnormal, metabolic function test: abnormal. The patient did not recover from the event fluid overload while the outcome of the other adverse events was unknown. Therapeutic measures were taken as a result of the events swelling and fluid overload and included LASIX.
Swelling of left arm, left lymph node, left breast, swelling of back, diarrhea, headache
Fever started about 6 to 8 hours after HIB and Prevnar vaccine. Temperature 103 degrees. Continued fever 101 to 103 for 3 additional days. Evaluation for sepsis revealed high WBC count and also anemia and also thrombocytosis and Rocephin was given. She defervesced within 12 hours and remained afebrile and well the next 2 1/2 weeks, however, she has had continued lab abnormalities last week and as recently as yesterday - 20 days post vaccine. Discussed case with infectious disease doctors. This is thought to represent a systemic inflammatory reaction possibly to the conjugate of tetanus toxoid in the HIB vaccine (v. the conjugate in the Prevnar vaccine).
no adverse event; HCP reporting an MMRII vaccine was accidentally administered to a 4 month old. No additional clarifying statements or details were provided. No additional AE. No PQC.; This spontaneous report was received from a Medical Assistant and refers to a 4  month old patient (gender not reported). The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 10-NOV-2022, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, 0.5 milliliter, once., administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Inappropriate age at vaccine administration).   At the reporting time, no adverse events were not reported.
fatigue & soreness at injection site, treated with ibuprofen 1/16/2021.  Headache, "hard to concentrate", productive cough with mild, intermittent SOB began on Thurs 2/4/2021, called PCP and treated with antibiotics. Respiratory symptoms have resolved with use of antibiotics & inhaler, however headche & difficulty with concentration remain. PCP has told her that this is a result of the first vaccine.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Patient's medical history and concurrent conditions were not reported. On 31-AUG-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (lot # L010596, expiration date 16-APR-2017). No adverse effect reported. This is one of 4 reports from the same reporter source (MARRS #s 1509USA001921, 1509USA001922 and 1509USA001921). Additional information is not expected.
administered a dose of the Moderna vaccine to a patient from a vial that had been punctured for 19 hours; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered a dose of the Moderna vaccine to a patient from a vial that had been punctured for 19 hours) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 038C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jul-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered a dose of the Moderna vaccine to a patient from a vial that had been punctured for 19 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered a dose of the Moderna vaccine to a patient from a vial that had been punctured for 19 hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Pt received Pneumovax on 8/13/01 in right deltoid. Patient described extreme redness and splotchy red raised bumps with tenderness. On return to clinic on 8/16/01, still slight red splotchy areas observed. Pt reported no systemic symptoms.
pt exp only one sz on 30JAN86;had a fever of 103 & was on tx w/Phenytoin;AUG87 an EEG was nl;pt had learning difficulties;pt had developmental & learning disabilities
TIA; A spontaneous report was received from a nurse concerning a 76-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced TIA.  The patient's medical history was not provided. Concomitant medications were Lipitor 10 and metformin.  On 19 Feb 2021, the patient received their first dose of mRNA-1273 (Batch number: 00620) approximately one day prior to the onset of the symptoms for prophylaxis of COVID-19 infection.  On 20 Feb 2021 patient was admitted to the hospital with TIA. On 21 Feb 2021 patient went undergone for Magnetic resonance imaging (MRI) and Echo cardio. The test results were not provided by the reporter.   Treatment medication upon hospitalization included blood thinners and Lipitor 80.  Action taken with the drug in response to the event was not reported.  On 22 Feb 2021 patient was released from the hospital.  The outcome of events was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event of TIA, a causal relationship cannot be excluded. Elderly age may have been contributory.
Woke up to find itching on upper left arm., and saw rash.  Did not scratch area.  When undressing, felt soreness in upper arm.  Upon touching the area, felt swelling and feeling of fluid (soft and squishy).  Unable to get seen by provider's office.  Visited Urgent Care late in the afternoon.  Physician prescribed amoxicillin, 10 day course, twice a day.  Symptoms improved by next day.
Patient received vaccine. Pt felt dizzy and almost lost consciousness within 15-20 minutes. Heart rate was low. Patient appeared clammy and was conscious and alert. We believe blood sugar may have been low. EMS transported patient to ER to be checked out. Call to the patient on Sunday, was not answered.
Pt had a vasovagal episode approximately 20 or 30 minutes post vax, pt was dizzy and fatigued for 4 days following vax.
Patient woke up with a shingles-like rxn. It was just on her face. Reaction was red, painful, and itchy. Only half of her face was affected (symmetrical).
This spontaneous report as received from an other health professional refers to a 4 year old (at time of this report) patient. On 30-APR-2010 the patient was vaccinated with VAQTA (lot number not reported) dose 1, 0.5 ml, intravenous and was vaccinated for the second time (dose 2) on 24-SEP-2010. No adverse effect had been observed or reported. Additional information has been requested.
Pt. described itching during the night and small red dots over her body. She took Benadryl during the am and now (6-5-09,1:00pm) reports no S/S.
Pain and decreased range of motion of left arm since flu shot, reported continued issues 11/16/17.
Overnight stay in hospital. Potassium was low. Magnesium was low. Blood pressure was high.
10 days following my booster I began to get a rash after any time something came in contact with my skin.  It would burn, become very painful and would spread upon scratching and become hive-like.  After being unable to sleep, perform daily tasks and wear proper work attire, I sought medical attention from a dermatologist 3 days following the onset of the rash.  I was diagnosed with Urticaria and put on a regime of one 10mg Zyrtec in the morning and one 10mg Zyrtec in the afternoon and one Benadryl before bed.  These have made the itching more mild but I still get the rash and red spots when things come in contact with my skin.
Heavy menstrual bleeding and extended menstrual cycle duration. Completely missed menstrual period (August) after first Pfizer vaccine. Then for 7 days this month (September) menstrual bleeding has been the most heavy in my entire life. Extreme weakness and fatigue with this menstrual cycle. I will be seeking medical help tomorrow if the bleeding doesn?t stop.  Again, I?ve never experienced this much bleeding before and am frightened to receive second Pfizer vaccine due to this concerning inconsistency.
03/16/2021: At around 8:00 am my head and stomach began to hurt. A wave of drowsiness overcame me and I slept from 8:30 am- 1:30 pm. I then experienced body aches and extreme body weakness, thoughts were difficult to articulate and process, and I began to feel nauseated. This continued until 03/17/2021 in which I felt only nauseated, bloated. My headache was kept at bay with acetaminophen.
Several days following 2nd dose, middle/upper back rash size of a softball, with several pimples (?) and muscle pain in that area developed suddenly. Smaller size of quarter rash with no pimples on lower edge of front right rib cage with similar pain and sensitivity. OTC tylenol and 1% hydrocortisone used. Day 5 presently since rash appeared, seems getting better although still tender but redness has subsided. Temperature normal.
rash on her bilateral upper extremities and the trunk of her body; Booster; This is a spontaneous report from a contactable nurse. A 41-year-old female patient received third dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in left deltoid on 20Oct2021 15:00 (Batch/Lot Number: FD0809; Expiration Date: Oct2021) (Vaccination age was 41-year-old) as DOSE 3 (BOOSTER), 0.3 ML SINGLE for covid-19 immunisation. Patient received first dose BNT162B2 on 29Dec2020, second dose BNT162B2 on 19Jan2021. None Medical history reported. The patient's concomitant medications were not reported. The patient experienced rash on her bilateral upper extremities and the trunk of her body on 21Oct2021. The event does not require emergency room visit, but caused physician office visit. A doctor prescribed some sort of a steroid. The outcome of event was not recovered. The nurse assessed relatedness of drug to event "rash on her bilateral upper extremities and the trunk of her body" was "Related". Case reported as serious due to Other medically important condition.
50 days after I will take second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (50 days after I will take second dose) 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 PRODUCT DOSE OMISSION ISSUE (50 days after I will take second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (50 days after I will take second dose) had resolved.            The patient was asking what happens if I take second dose of moderna vaccine 50 days after the first one and 50 days between doses was safe.  No concomitant medication listed.   No treatment information provided.
Patient tongue went numb approximately 15 to 20 minutes after the shot, cheeks went slightly numb about an hour after shot. All symptoms resolved within 1.5 hours. Patient described as feeling like 2hrs post-novocaine shot at the dentist.
The next day I had flu-like symptoms: body aches, chills, severe headache and nausea. It was the same day two and the injection sight became irritated. It is day four and the spot of injection is hot, red and itchy. I however no longer have flu-like symptoms.
Congenital anomaly or birth defect; Congenital anomaly or birth defect; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A fetus patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The following information was reported: MATERNAL EXPOSURE TIMING UNSPECIFIED (death, congenital anomaly, medically significant), CONGENITAL ANOMALY (death, congenital anomaly, medically significant), outcome "fatal" and all described as "Congenital anomaly or birth defect". The event "congenital anomaly or birth defect" required physician office visit and emergency room visit. The pregnancy resulted in spontaneous abortion. The patient date of death was unknown. Reported cause of death: "Congenital anomaly or birth defect". It was not reported if an autopsy was performed. The mother, a 47-year-old female patient, miscarried after her Pfizer vaccine (1st shot). Patient thinks that is the reason why. Prior to vaccination, the mother was not diagnosed with COVID-19. Since the vaccination, it was unknown if the mother had been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201118114 same reporter/drug/event, different patient (baby case);; Reported Cause(s) of Death: Congenital anomaly or birth defect; Congenital anomaly or birth defect
Child had seizure approx 8 hours after immunizations. Child was also having fever at the time. Seizure occurred at home. Patient was taken to local ER, temp taken in child's ear at ER was 101.3. Mom stated that infant had rhythmic jerking of upper & lower extremities x2 minutes. No color change, CBC, RSV, flu & strep done in ER; all negative. Thought to be febrile seizure. Child was fussy & crying more than usual before & after seizure. Temp was brought down in ER with MOTRIN. No previous history of seizure but had EEG in NICU following birth. Child seen in office on the following day, exam back to baseline. EEG scheduled & referral made to pediatric neurology.
On 9/5/2022 - I thought I had allergies. I was sneezing. I had a scratchy throat. I took a home COVID-19 test and it was negative. My symptoms got a little worse on 9/6/2022 and I tested, and it was negative. On 9/7/2022, in the morning, I felt worse. I had a fever. I did a COVID-19 home test and it was positive. On 9/7/2022, I contacted my doctor. The doctor recommended Paxlovid because I was over 50. I started Paxlovid on that day. On Wednesday, 9/7/2022, I had fever, chills and a little bit of a headache. I was feeling better each day until Saturday, 9/10/2022, I started vomiting a lot. I stopped the Paxlovid on the advice of my doctor, and I was feeling better. Then on 9/13/2022 the symptoms came back. They were almost gone and then they came back.  I tested positive until 9/23/2022. I tested positive for almost 19 days, by then the symptoms went away, but I was still testing positive.
HEADACHE; INJECTION SITE SORENESS; RASH ALL OVER THE BODY AND STILL SPREADING, VERY ITCHY; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included cranberry allergy, multiple sclerosis, drinks alcohol occasionally, and non smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced fever. Treatment medications included: calamine/glycerol/zinc oxide, and paraffin. On 19-MAR-2021, the subject experienced rash all over the body and still spreading very itchy. On 19-MAR-2021, the subject experienced injection site soreness. On 21-MAR-2021, the subject experienced headache. Additional treatment medications (dates unspecified) included: cortisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and injection site soreness on 2021, had not recovered from rash all over the body and still spreading very itchy, and the outcome of headache was not reported. This report was non-serious.
patient had an anaphylactic reaction after receiving KINRIX and PROQUAD; This spontaneous report was received from  a physician (epidemiologist) via GlaxiSmithKline and refers to a 4 year old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) along with diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (KINRIX) (strength, lot #, expiration dates, doses, routes, and frequencies were not reported) for prophylaxis.  On an unknown date the patient experienced anaphylactic reaction. The patient went to the emergency room and sought medical attention; and received an unsp3ecified treatment. At the reporting time, the outcome of anaphylactic reaction was reported as recovered. The reporter did not provide a causal relationship between the event and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) or diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (KINRIX).