chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was injected with the needle, when the immunizer depressed the plunger, the seal between the needle and the syringe became loose and an unknown amount of the vaccine leaked out. Patient made aware of the error, discussed that per CDC guidelines that if less than half of the dose is received due to error, that an additional dose is recommended in the opposite arm. Patient refused any additional doses, reported that they were hesitant to receive the vaccine in the first place and were more comfortable proceeding without receiving any additional vaccine.
I have had irregular cycles since the first one- sometimes weeks late, to drastic ?flow? changes.  My cycle ended 12/16/21, and today after having booster administered, I am bleeding vaginally. No cramping or pain present.
The pt was given Td injection in the right arm. The pt came to see the doctor on 8/20/2004 with a raised red area at the injection site, complaining of pain at the injection site. Doctor thought it may be an infection and prescribed Keflex 500 mg.
arm sore, shoulder pain down to elbow,  lymph nodes under arm sore, fever 100.3 lasting one day
Pt was given 1/4 dose on 12/4/2000. Began with chest heaviness 2 hours post vax referred to ER not related to vax, given 2nd 1/4 dose today called in 1 hour later again felt heaviness and sis take Benadryl q 4-6 hours x 24 hours Felt better in 1 hour.
Beginning about two days after the injection, a welt as big around as a softball formed, bright red, hot, and raised around the injection site. The entire area felt bruised, but the pain and redness was still mildly present after six days.
This is a spontaneous report from a non-contactable consumer reporting for her daughter. A female patient of unspecified age and ethnicity received first dose of TRUMENBA, via an unspecified route of administration, on an unspecified date, at 0.5 ml single. The patient's medical history and concomitant medications were not reported. Right after vaccination the patient experienced seizure and passed out. They did not really document it as if they called it like neurocardiogenic syncope as she passed out after vaccination. She lost her urine and had a seizure like episode so they took her to the hospital. No follow-up attempts possible. No further information expected.
Pt was seen by me for full arm thrombosis and CNS thrombosis which occurred approximately 1 week following second vaccine
Information has been received from a nurse for the Pregnancy Registry for GARDASIL concerning a 15 year old female who on 17-MAR-2009 was vaccinated with the first dose of GARDASIL 0.5ml IM (therapy site unknown) (Lot # 661760/0652X). The nurse reported that the patient received her first does of GARDASIL and then discovered she was pregnant. She sought medical attention. Urine test performed at the office on 04-MAY-2009 (results positive). No adverse effects reported. Follow-up information has been received from a physician concerning a 15 year old female who on 17-MAR-2009 was vaccinated with the first dose of GARDASIL 0.5ml IM (therapy site unknown) (Lot # 661766/06652X) and VARIVAX (MSD) (therapy dose, route and site unknown) (Lot#661558/1005X). The patient's last menstrual period (LMP) was on 01-MAR-2009 and the estimated delivery date is 06-DEC-2009. The patient had no previous pregnancies, spontaneous abortions, or fetal deaths (stillbirths). Follow-up information has been received from a physician. The patient's last menstrual period (LMP) was changed from 01-MAR-2009 to 20-FEB-2009 and the estimated delivery date was changed from 01-DEC-2009 to 27-NOV-2009. Follow-up information has been received from a physician concerning a 15 year old female with no significant concurrent conditions or medical history who on 17-MAR-2009 was vaccinated with the first dose of GARDASIL 0.5ml IM (therapy site unknown) (Lot # 661766/0652X) and VARIVAX (MSD) (therapy dose, route and site unknown) (Lot # 661558/1005X). On 09-JUN-2009 prenatal testing ultrasound was performed (results unknown). The patient's last menstrual period (LMP) was changed from 20-FEB-2009 to 01-FEB-2009 and the estimated delivery date was changed from 27-NOV-2009 to 06-DEC-2009. The physician noted the patient had no previous pregnancies. Follow-up information has been received from a physician concerning a 16 year old female student who on 17-MAR-2009 was vaccinated with the first dose of GARDASIL IM (therapy site unknown (Lot # 661766/0652X). On 16-NOV-2009 the patient delivered a normal, healthy male baby weighing 3630 grams with Apgar score 9/9. It was 41 weeks 3 days from her Last Menstrual Period (LMP). The patient underwent c section due to arrest of active pulse. Upon internal review, arrest of active pulse which induced c section was considered to be an other important medical event. No further information is available.
pt recv vax 5JUN97 & pt contacted the MD office & stated that felt ill for 2wk since the vax;pt exp rash all over face, lump in the center of head & swollen lymph nodes;
Information has been received from a physician concerning an 8 year old (also reported as 5 year old) female patient who 08-AUG-2002 was vaccinated with first dose of MMR II (dose, route and lot number not reported). On 07-JUN-2005, the patient received the second dose of MMR II (dose, route and lot number not reported). The physician reported that the patient developed mumps on 15-JAN-2010. The patient was diagnosed with mumps on 17-JAN-2010. Laboratory test performed on 17-JAN-2010 included IgM (<1:10), IgG (9.31) and amylase (169). The patient had left parotitis and experienced cough and was febrile for 3 days. The final outcome for mumps was not reported. This is one of several reports from the same source. No further information is available.
injection site soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 12Apr2022 at 10:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 68 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Skin cancer (basal squamous)", start date: 2017 (ongoing); "Prostate cancer", start date: Nov2019, stop date: Jan2020, notes: Surgical removal Jan2020; "Surgery", start date: Jan2020 (unspecified if ongoing), notes: Surgical removal Jan2020; "Cholesterol" (ongoing); "Acid Reflux" (ongoing). Concomitant medication(s) included: ATORVASTATIN oral taken for blood cholesterol abnormal (ongoing); OMEPRAZOLE oral taken for gastrooesophageal reflux disease (ongoing). Vaccination history included: BNT162b2 (DOSE: 01, Time: 10: 00AM, Lot number: EN6198, Anatomical site of injection: Left arm, Route of administration: Intramuscular), administration date: 24Feb2021, when the patient was 66-year-old, for COVID-19 immunization, reaction(s): "injection site soreness"; BNT162b2 (DOSE: 02, Time: 10: 00AM, Lot number: EN6208, Anatomical site of injection: Left arm, Route of administration: Intramuscular), administration date: 17Mar2021, when the patient was 66-year-old, for COVID-19 immunization, reaction(s): "injection site soreness"; BNT162b2 (DOSE: 03, Time: 10: 00AM, Lot number: FF2589, Anatomical site of injection: Left arm, Route of administration: Intramuscular), administration date: 28Sep2021, when the patient was 67-year-old, for COVID-19 immunization, reaction(s): "injection site soreness". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "injection site soreness".  Additional information: Patient didn't experience any adverse effects following his previous (4) shots other than a little injection site soreness. vaccination facility type was pharmacy or drug store. Prior vaccination was none. vaccine administered at specific facility was reported as no.2 or 3 previous outpatient surgeries 1 recent radiation treatment (finally 20th treatment on 25Aug2022).
Pt recvd 2 doses of Engerix-B 10JUN92 tested neg; nonresponder;
This spontaneous report was received from a certified medical assistant and refers to an unspecified number of patients of an unknown age and gender. The patients' pertinent medical history, drug reaction/allergies and concomitant medications was not reported. On an unspecified dates, the patients might had been vaccinated with improperly stored PEDVAXHIB (lot # K001124, expiration date: 22-OCT-2016; lot # L012838, expiration date: 10-MAR-2018; dose and route of administration were not provided). The vaccines were exposed to temperature of 30 degrees Fahrenheit for 3 months. No previous temperature excursion was reported. No adverse symptoms were reported. Administration of vaccine was possible. There was no product quality complaint. This is one of two reports received from the same reporter. Additional information has been requested.
approx. 10 mins after vaccination of the Bicillin Injection c/o itching in lower torso
Acute deep vein thrombosis (DVT) of proximal vein of left lower extremity, He was admitted, placed on a heparin drip.  IR consulted and performed thrombectomy of left iliocaval thrombus, along with venoplasty and stent placement in bilateral common iliac and external iliac veins. He was discharged home in stable condition. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
Tingling in 2 fingers, entire arm pain, pain in armpit,  muscle pain in chest(similar pain to pain in arm). Arm pain began 1-2 hours after injection and progressively worsened throughout day/night. Chest muscle pain began 11-12 hours after injection. Pain lessened 19 hours after injection overnight. 24 hours after injection the only symptom left was minor arm pain localized around injection site.
Sudden onset of chest pain, EKG proven acute myocardial infarction with fresh thrombus in right coronary  requiring cardiac cath and stenting
Fever, Chills, runny nose, lost taste & smell, headache, cough , wheezing, rigors  and diarrhea.
several hr p/vax both arms began to hurt;the lt arm was most sore w/pain into the shoulder & back;rt arm had some swelling in the axilla;Ibuprofen & APAP were given w/o relief;pt taken to MD;pain in both arms began to subside 31AUG96;
Thrombocytopenia and Purpura consistent with Immune Thrombocytopenic Purpura. Awaits specialist evaluation and treatment plan.
Was not feeling well within 12 hours.  Started feeling run down, just physically sick.  Within the next few hours was having shortness of breath.  Within less than 48 hours of the 2nd vaccine, went to Urgent Care.  They did some basic tests and then said that I should go and be checked out at the ER due to the shortness of breath concerns.  I went to the ER and they did a series of labs and tests.  I told them that I had the 2nd vaccine on the 12th and that's when I started having additional symptoms.  They did a CT scan and some lab work.  They sent me home 5 hours later saying that the tests and labs showed a UTI and shortness of breath but only gave an antibiotic.  The only reason I ended up in urgent care and the ER was due to my reaction to the vaccine.
pt recvd vax;became unresponsive p/ crying for a few min; mom stimulate the baby, he woke up & fell back asleep; to er for eval;
MCV vaccine was administered FIRST.  Syncope immediately after injection of Tdap (second vaccine).  Patient became pale and lost tone, was laid down on exam table and reportedly regained consciousness in under a minute. Mother of child, sisters of child and medical assistant administering vaccine were all present in the room for the event. When he "came to" he state he had to "go pee" and was noted to be diaphoretic. VS stable. Was accompanied to the restroom where he voided and was able to walk back to exam room independently. He left the clinic about 15min after the event occurred.
redness; huge welts on the leg; Initial information received on 11-Nov-2019 regarding an unsolicited valid non-serious case received from a physician.  This case is linked to case 2019SA316202 (same reporter).  This case involves a 1 years old patient who experienced redness (erythema) and huge welts on the leg (urticaria), while he/she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE 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 VACCINE lot UJ212AA and lot UT6657JA, via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious redness (erythema) and huge welts on the leg (urticaria) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Lab data was not reported.  Final diagnosis was erythema and urticaria.   It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown for erythema and urticaria.
pt recv vax 30SEP97 & same day exp fever, swollen glands, n/v;
flu like symptom's; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptom's) in a 56-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptom's). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptom's) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
itchy throat won't let me sleep  I am constantly coughing sore arm  high fever  headache
Day 2 of the vaccine the person had a headache; Trouble moving; Lethargic; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 12Mar2021 at 00:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) and COVID-19. It was unknown whether the patient had any allergies to medications, food, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications were not reported. On 14Mar2021 at 09:00, day 2 of the vaccine, the patient experienced headache, trouble moving, was very lethargic and had trouble with simple tasks. The patient had COPD and had severe Covid prior. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the events headache, trouble moving, very lethargic was recovering at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Severe coughing, hoarseness, larynx swelling, feeling of fullness in throat. Within 30 minutes: Rhinitis. One Benadryl orally (25 mg Diphenhydramine HCl) at signs of serious airway symptoms.
Both legs stiffened up and has a hard time walking; Both legs stiffened up and has a hard time walking; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 73 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 07Apr2021 14:00 (Lot number: EW0151) at the age of 73 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Lymphoma Cancer", start date: Mar2020 (unspecified if ongoing), notes: Verbatim: Lymphoma Cancer; "6 Vertebrae rubbing together" (unspecified if ongoing), notes: Verbatim: 6 Vertebrae rubbing together, Diagnosed maybe 3 years ago; "diagnosed allergies" (unspecified if ongoing); "compromised immune status" (unspecified if ongoing); "respiratory illness" (unspecified if ongoing); "genetic / chromosomal abnormalities" (unspecified if ongoing); "endocrine abnormalities" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Immune system low because of Lymphoma Cancer" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN taken for back pain; HYDROCHLOROTHIAZIDE; ALLOPURINOL; ACYCLOVIR [ACICLOVIR]; AMLODIPINE BESILATE; LISINOPRIL. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious), GAIT DISTURBANCE (non-serious) all with onset 07Apr2021 15:00, outcome "not recovered" and all described as "Both legs stiffened up and has a hard time walking". Therapeutic measures were taken as a result of musculoskeletal stiffness, gait disturbance.  Additional information: History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was reported as no previous. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Prior Vaccinations (within 4 weeks): none. AE following prior vaccinations: None. Family Medical history: none. Relevant test: No test. Investigation Assessment: No. She was calling on behalf of her husband. He has lymphoma cancer, which she confirmed was diagnosed prior to receiving the vaccine.After he got the vaccine, he stiffened up. She clarified that it was both of his legs that stiffened up and he had a hard time walking. When he walks around it improves, but he still has to walk slow because he was still stiff. Adverse event did not result in Emergency or physician office visit. He takes pain medicines. She does not know all of the name. She did not know what his medications were for, but knew that two of them were blood pressure medications, but she does not know which they were.   No follow-up attempts are possible. No further information is expected.
cough; sore throat; Postnasal drip; nausea,; Chills; did not feel good for 24 hours; arm hurt (8/10 pain scale); This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (arm hurt (8/10 pain scale)), COUGH (cough), OROPHARYNGEAL PAIN (sore throat), FEELING ABNORMAL (did not feel good for 24 hours) and UPPER-AIRWAY COUGH SYNDROME (Postnasal drip) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm hurt (8/10 pain scale)), FEELING ABNORMAL (did not feel good for 24 hours), NAUSEA (nausea,) and CHILLS (Chills). On 17-Apr-2021, the patient experienced COUGH (cough), OROPHARYNGEAL PAIN (sore throat) and UPPER-AIRWAY COUGH SYNDROME (Postnasal drip). At the time of the report, PAIN IN EXTREMITY (arm hurt (8/10 pain scale)), COUGH (cough), OROPHARYNGEAL PAIN (sore throat), FEELING ABNORMAL (did not feel good for 24 hours), UPPER-AIRWAY COUGH SYNDROME (Postnasal drip), NAUSEA (nausea,) and CHILLS (Chills) 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.
COVID 19; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID 19) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID 19). At the time of the report, COVID-19 (COVID 19) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment.  The patient took unknown  medicine for COVID-19 treatment from 31-May-2022 to 01-Jun-2022.  The patient reported Lower abdominal pain from 31-May-2022 to 01-Jun-2022 which was resolved .  Company Comment:  This spontaneous case concerns a patient of an unknown age and gender with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19 on an unknown date after receiving mRNA-1273 given as fourth dose in the COVID-19 vaccination series. Patient presented with lower abdominal pain and started an unspecified COVID-19 treatment for 2 days. No SARS-CoV-2 test result was provided. No information was provided on the previous 3 doses of COVID-19 vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of an unknown age and gender with no relevant medical history reported, who experienced the unexpected non-serious adverse event of special interest COVID-19 on an unknown date after receiving mRNA-1273 given as fourth dose in the COVID-19 vaccination series. Patient presented with lower abdominal pain and started an unspecified COVID-19 treatment for 2 days. No SARS-CoV-2 test result was provided. No information was provided on the previous 3 doses of COVID-19 vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.
crying constantly since shots recvd; high pitched (screaming), redness, swelling @ inject site- lt thigh; won't eat or take bottle; t100.1;
Puffiness, erythema, mild ache in deltoid muscle on left side lasting for about 24 hours; since resolved.
Really, really, really bad lower abdominal cramps right over where the uterus is; Very sore left arm, the full arm/very sore underneath left arm/caused a flare up in the right arm; Really, really tired; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN LOWER (Really, really, really bad lower abdominal cramps right over where the uterus is), PAIN IN EXTREMITY (Very sore left arm, the full arm/very sore underneath left arm/caused a flare up in the right arm) and FATIGUE (Really, really tired) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     no medical history was reported.  Concurrent medical conditions included Complex regional pain syndrome. Concomitant products included IBUPROFEN for Complex regional pain syndrome, ASCORBIC ACID (VIT C) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, the patient experienced ABDOMINAL PAIN LOWER (Really, really, really bad lower abdominal cramps right over where the uterus is), PAIN IN EXTREMITY (Very sore left arm, the full arm/very sore underneath left arm/caused a flare up in the right arm) and FATIGUE (Really, really tired). The patient was treated with IBUPROFEN at a dose of 800 mg every four hours. At the time of the report, ABDOMINAL PAIN LOWER (Really, really, really bad lower abdominal cramps right over where the uterus is) was resolving and PAIN IN EXTREMITY (Very sore left arm, the full arm/very sore underneath left arm/caused a flare up in the right arm) and FATIGUE (Really, really tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.