chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 15 year old female who on an unspecified date was vaccinated with a first dose of GARDASIL (lot number, injection site and route not reported).  There was no concomitant medication.  Within 10 minutes after the vaccination, the patient developed a seizure.  The patient stayed in the office and recovered prior to leaving the office.  The duration of the seizure was unspecified.  The physician reported that no hospitalization or laboratory work up was required for the patient.  Upon internal review, seizure was determined to be an other important medical event.  Additional information has been requested.
About two inches below the injection site started itching a week after administration of the first dose. Throughout the day a red, slightly raised area appeared around the site that has been growing in size and is warm to the touch.
I gave patient the IM injection to her right deltoid. She was fine after the injection. She is a radiation therapist and her coworker called me about five minutes after she left the nurses station and said she needed some medical attention. When we got back to her she was very pale, lethargic and felt like she was going to pass out. We helped her into a wheelchair and she became so lethargic we had to physically hold her up while we were wheeling her into an exam room, then we had to lift her onto the exam table. She was clammy, pale and said she was having trouble breathing. Our physician came in and examined her. She was placed on 2L O2.  Her BP was checked 112/54, HR 58, blood sugar was 84, oxygen saturation maintained at 99% or higher. After lying on the exam table for about 15 minutes she felt better and was urged to go home for the rest of the day but she insisted on staying on to work. She had no problems throughout the day today since this episode and continues to state that she feels fine now.
On the 3rd day following vaccination, the above patient developed an extensive maculopapular rash--erythemetous, non-confluent, distributed around his face, neck, chest, back, groin, extremites, palm and soles--spared mucous membranes. Associated symptoms included "low grade fever" (100.1) and fussiness--though no lethargy. Patient had no symptoms and was taking no medications prior to onset of symptoms. He is receiving no treatment and will resume normal activites (daycare).
Breakthrough case. Got dose 4 of Pfizer on 04/22/2022 and after having a sore throat, cold symptoms, runny nose and fever, diarrhea took home test as well at the pharmacy. Symptoms, tested positive for COVID-19 on 06/27/2022. I called Dr. and he prescribed PAXLOVID. I took it for a few days and felt better. Finished prescription then 2 days later I developed sinus problems. I went to my Dr. and he prescribed prednisone and taking OTC sinus medicine. Still taking.
Incomplete/Atypical Kawasaki's Disease development- presented (11/30) with 6 days of fever developed 3 of 5 typical symptoms of KD - nonpurulent, limbic sparing conjunctivitis, red/cracked lips and rash. Began with conjunctivitis and lips and on day 2 of hospitalization (12/1) developed  a rash.
Subsequent to receiving one dose of varicella virus vaccine live the pt experienced clinical varicella with 50+ lesions. The diagnosis of varicella was confirmed by a physician.
dizziness; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) and HEADACHE (headache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported.). Concomitant products included Allergy medicine for Allergy, Birth control pills for Birth control, MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]), GABAPENTIN (NEURONTIN), OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) and FISH OIL for an unknown indication.   On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 27-Jan-2021, the patient experienced DIZZINESS (dizziness) and HEADACHE (headache). At the time of the report, DIZZINESS (dizziness) and HEADACHE (headache) had not resolved.            Treatment information was not provided.  Reportedly, caller stated that she had headache and dizziness but is concerned because she had the vaccine 5 days ago and still feels this way. Wanted to know if this was normal. The patient denied allergies and PMH.
Injection arm was a little swollen and had red rash, arm was not painful according to her.
Very high fever 105.7, head to toe hives, cough sneezing and seazures.
5APR93 pt recvd vax & 7APR93 mom reports pt as lethargic not wanting to move around; 8APR93 mom noticed small, raised, fluid filled blisters @ inject site; also had some diarrhea; reports pt hasn't been to physician as of yet; no fever, etc
Pain in your knuckles on the right side; Swollen knuckles on the right side
Information has been received from a physician concerning a male infant who was vaccinated with a first and second oral dose of Rotateq (Lot# 655483/1116F and 656191/1365F) on 13-FEB-2007 and 13-APR-2007, respectively. Concomitant vaccine included a dose of Comvax and a dose of Dtap. On 01-JUN-2007 the patient developed intussusception. The patient was hospitalized where an air contrast enema was performed which resolved the problem. The number of days of hospitalization was not provided. No product quality complaint was involved. No other information was provided. Additional information has been requested. 7/11/07-ER note received for DOS-06/01/2007-DC DX: Intussception. C/O abdominal pain with history of not acting like himself. NG tube placed KUB suspicion of intussception vx. volvulus. Abrupt onset. 2-3 weeks prior fussy after his nightime feeds only. One BM today, blood found in rectum. Air contrast enema was completed and intussception was diagnosed.  8/15/07-DC Summary received-DC DX: Intussusception, status post reduction barium enema.
severe adverse reactions/only conclusion is it is a side effect of the vaccine.; When she stands up she gets very dizzy; has numbness on the side of body from the fingers, hands, and to the feet; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (severe adverse reactions/only conclusion is it is a side effect of the vaccine.), DIZZINESS (When she stands up she gets very dizzy) and HYPOAESTHESIA (has numbness on the side of body from the fingers, hands, and to the feet) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 429L21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised. Concomitant products included ROSUVASTATIN, DULOXETINE HYDROCHLORIDE (CYMBALTA), LOSARTAN, METOPROLOL, HYDROCHLOROTHIAZIDE, LEVOTHYROXINE SODIUM (SYNTHROID), BUPROPION HYDROCHLORIDE (WELLBUTRIN), PRAMIPEXOLE and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 30-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Aug-2021, the patient experienced VACCINATION COMPLICATION (severe adverse reactions/only conclusion is it is a side effect of the vaccine.), DIZZINESS (When she stands up she gets very dizzy) and HYPOAESTHESIA (has numbness on the side of body from the fingers, hands, and to the feet). At the time of the report, VACCINATION COMPLICATION (severe adverse reactions/only conclusion is it is a side effect of the vaccine.), DIZZINESS (When she stands up she gets very dizzy) and HYPOAESTHESIA (has numbness on the side of body from the fingers, hands, and to the feet) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: abnormal (abnormal) side effect of the vaccine.. On an unknown date, Magnetic resonance imaging: abnormal (abnormal) side effect of the vaccine..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medication were reported. Patient got the first shot on 28Jan2021 and second shot on 25Feb2021 (lot: 011A21A).
Diarrhea, facial swelling, hematuria, proteinuria, hypoalbuminemia, URI symptoms (runny nose, congestion), hypertension
Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 72 year old male pt. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 06-JUL-2016, the pt was vaccinated by a physician with zoster vaccine live (ZOSTAVAX) (strength, route, dosage schedule, lot number and expiration date were not reported) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the pt experienced shingles and he was treated by a different physician. The outcome of shingles was not specified and the reporter considered this event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medication was provided. On 23-FEB-2016, the patient was inadvertently administered an expired dose of M-M-R II (lot # K002527, expiration date: 18-FEB-2016, dose, route of administration and injection site were not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Fever up to 100.9, chills, fatigue and nausea for 24 hours 6:30 pm to 6:30 pm next day.
Pt awakened from nap with arching and stiffness of body, inconsolable crying for 10-15 minutes. On the evening of 10/26/01, the pt started with a very deep cough and production of clear mucous causing gagging and choking with fussiness which persisted through the week with onset of low-grade temperature on 10/31/01 and green and matting eyes.
UTI infection after first dose; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (UTI infection after first dose) in a male patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced URINARY TRACT INFECTION (UTI infection after first dose). The patient was treated with LEVOFLOXACIN ongoing since an unknown date for UTI, at a dose of 1 dosage form. At the time of the report, URINARY TRACT INFECTION (UTI infection after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  It was reported that, the patient was due for 2nd dose of Moderna vaccine on 11-Feb-2021 and his wife wanted to know if antibiotic interfere with vaccine.
Six months pregnant received the Afluria Quadrivalent vaccine; Sick before receiving the vaccine/accentuated after receiving the vaccine; This spontaneous case, initially received from the other health professional (nurse) on 08-Oct-2018, concerns a 37-year-old, adult pregnant patient.  The patient's historical condition included diabetes. The maternal medical history relevant to pregnancy included diabetes and the paternal medical history relevant to pregnancy included cancer and diabetes. The patient had miscarriage in her first pregnancy and premature delivery in the second pregnancy. The historical drug prior pregnancy included ortho tri-cyclen for birth control. The medication taken by the patient's husband prior conception was omeprazole. On an unspecified date, the patient underwent prenatal test and there was no evidence of defect or adverse finding.  The patient's current condition included sickness (reported as sick). The patient's concomitant medications included Effexor (venlafaxine hydrochloride) and Prenatal vitamins (minerals nos, vitamins nos) both for unknown indications.   The patient's last menstrual period date was 30-Mar-2018.  On 08-Oct-2018, the pregnant patient (27-week gestation period) was administered Afluria Quadrivalent [influenza vaccine; dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 02444611A and expiry date: not reported] (explicitly coded as vaccine exposure during pregnancy) for active immunization against influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.  On an unspecified date in Oct-2018, the patient's sickness accentuated (coded as condition aggravated). The patient administered Tylenol (paracetamol) for the treatment of sickness. On 09-Oct-2018, the patient was home sick.  At the time of this report, the outcome of the event condition aggravated was not reported.  The expected delivery date of the patient was 02-Feb-2019.  The reporter assessed the case as non-serious.  Non-significant case amendment (08-Oct-2018): The indication for the historical drug (ortho Tri-Cyclen) was corrected from indication not reported' to birth control'. The narrative was amended accordingly.  Non-significant follow up received from other health professional on 04-Feb-2019: Three unsuccessful attempts were made to reach the patient. Hence the case was considered lost to follow up. Med info number was added in the additional information tab. No changes were made in the narrative.; Reporter's Comments: A 37-year-old, pregnant patient's sickness accentuated (coded as condition aggravated) after the administration of Afluria Quadrivalent (explicitly coded as vaccine exposure during pregnancy). The company assessed the causality of the event condition aggravated as related to the suspect vaccine due to plausible temporal relationship between the events and suspect vaccine. The causality of the event vaccine exposure during pregnancy was assessed as not related considering it as a special situation.
Patient reports severe muscle soreness, weakness, and fatigue in lower extremities resulting in two falls.
Adult patient was administered booster shot with the pediatric formulation instead of the bivalent booster dose; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Adult patient was administered booster shot with the pediatric formulation instead of the bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Adult patient was administered booster shot with the pediatric formulation instead of the bivalent booster dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Adult patient was administered booster shot with the pediatric formulation instead of the bivalent booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Adult patient was administered booster shot with the pediatric formulation instead of the bivalent booster dose).    No concomitant medications were provided.  Patient was expecting to get the bivalent booster dose (dose 5).  It was reported that the patient received the pediatric formulation dose of 0.5 mL as the third booster dose instead of the bivalent booster dose of Moderna COVID-19 vaccine.  Patient had not reported any adverse reactions at this time. The reporter was looking for recommendations/guidance for the next steps to be taken in regards to the patient's dose.  No treatment details was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-644021, US-MODERNATX, INC.-MOD-2022-644022, US-MODERNATX, INC.-MOD-2022-644018 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-644021:same reporter US-MODERNATX, INC.-MOD-2022-644022:same reporter US-MODERNATX, INC.-MOD-2022-644018:same reporter
Sore arm same day, tired afternoon following  day, headache  Arm still sore 48 hours later
Information has been received from a licensed practical nurse concerning a 4 year old white male with no known allergies who on 15-JUN-2002 was vaccinated SC in the left thigh with a second dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot # 642498/0345M). Subject vaccination on the same day included a SC second dose in the right thigh of varicella virus vaccine live (MSD) (lot # 642635)/0270M). There was no illness at the time of vaccination. On 31-MAY-2006, the patient developed a rash and subsequently recovered on an unspecified date. No medical attention was sought and no diagnostic laboratory tests were performed. Additional information is not expected.
if she just walks her dog her heart rate goes up to 203BPM; She has chest pains / She also woke up in the night with severe chest pains; She has been feeling very tired since; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (if she just walks her dog her heart rate goes up to 203BPM), CHEST PAIN (She has chest pains / She also woke up in the night with severe chest pains) and FATIGUE (She has been feeling very tired since) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, the patient experienced HEART RATE INCREASED (if she just walks her dog her heart rate goes up to 203BPM), CHEST PAIN (She has chest pains / She also woke up in the night with severe chest pains) and FATIGUE (She has been feeling very tired since). At the time of the report, HEART RATE INCREASED (if she just walks her dog her heart rate goes up to 203BPM), CHEST PAIN (She has chest pains / She also woke up in the night with severe chest pains) and FATIGUE (She has been feeling very tired since) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  No treatment details were provided.
Developed chest pain. Found to have myocarditis. Receiving NSAID for treatment.
Patient developed chills, fatigue, nausea, and a generalized rash (inflammed and red).
Immediately after Hepatitis B vaccination only on 6-30-09 dose 1 and 8-30-09 dose 2 pt was pale, dizzy and lightheaded.  Observed patient both times, gave juice and talked with patient.  Prior to vaccinating with dose 2 patient ate breakfast.  Pts mom got patient lunch while patient was being observed after dose 2.  After dose one patient felt better within one hour.  After dose two patient patient felt better after 3 hours/observed for 3 hours.  Patient said she is worried when she comes in for shots and doesn't like the thought of stuff being put in her body.  No local redness or swelling noted on either visit.  Both doses were 0.5ml and dose one was gsk AHBVB659AA IM left arm. Dose 2 was merck lot # 0726x IM keft arm.  Spoke with mom the next day and patient was better when she got home the same day.
Chills, fever, body aches, headache, sore arm at injection site.  Lasted two days.
Reoccurrence of auto-immune disease ankylosing spondylitis.  Previously in remission, the 2nd shot of the COVID vaccine caused a flare up that was debilitating.
Within two weeks of my second Moderna booster I suffered sciatic pain in my left hip and increased pain in both knees, including the fully replaced right knee.  The pain shifted to my lower spine and then settled in my right sciatic nerve and increased in my right replaced knee.  I saw PTl and was referred back to my orthopedic physician who conducted a series of X-rays and scans.  I also had bloodwork done for rheumatism, inflammation and lupus,  I proved negative on everything but the inflation which scored 14 over an average of 3.  The right hip and knee remained crippling until sometime in late August or early September when everything seemed to be going back to normal again. Approximately late September or early October the pain and crippling came back with as vengeance first driving me to a cane and now a walk with a complete crippling effect in my right leg.  My inflammation score has shot up to 35 and I am currently in treatment for pain management at the local center.  This report was originally filed as a combined report featuring the results of both booster shots under number 896880.  I was advised by phone contact to file separately which I have done this date.
Patient was fine after the vaccine on Wednesday.  On Saturday evening we noticed he had a fever so we gave him Ibuprofen.  The next morning, his fever was 103 so we gave him more Ibuprofen and after 1 hour his fever was still 102.8 so we took him to the ER Hospital.    They gave him some Tylenol and some power aid.  after a few hours his fever broke and they cleared him to go home.   He is at home now and is still taking the tylenol/ibuprofen every 3 hours to control his fever, but he is feeling better and is up and around today.
she was a hospice patient due to alzheimers.   I do not have the info about when she tested +.  She deceased  3/2/22.
had a feeling like taste liberty; Diarrhea; hemorrhoids; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: unknown) via an unspecified route of administration on 22Jan2021 at a single dose for COVID-19 immunization. Medical history included diabetic. Concomitant medications were not reported. The patient stated he took the vaccine shot, Covid 19 and he suddenly got diarrhea, hemorrhoids that was on 22Jan2021 on the Friday. Then he experienced some problem with it, the next day the 23Jan2021 it was Saturday. Again he woke up this morning (on 25Jan2021) which was Monday and had a feeling like taste liberty. Asked if that was probably the side effect or a reaction to be treated. Patient stated blood work but he did not have the records right now. Patient stated he took bismuth subsalicylate (PEPTO BISMOL) and a zinc sulfate (PEPTIN, reported as Kill Peptin). He took bismuth subsalicylate Pepto Bismol. It was for the fluid of the stomach and diarrhea. It was called Pepto Bismol. He did not how to spell it. The events were considered as non-serious. The outcome of events was unknown.  Information on the lot/batch number has been requested.