chrisvoncsefalvay/vaers-outcomes huggingface dataset:
syncope with bilateral tonic/clonic movements.   per parents, patient has history of vasovagal syncope following exposure to needles or lancets (vaccines, finger prick).  approx 2 minutes following injection, patient lost consciousness, followed by several clonic movements bilaterally of upper and lower extremities.   patient was transfered from chair to floor, legs were elevated.  She regained consciousness quickly, was given water.  When she felt better, she once again sat in a chair.   After another 5 minutes (approx), she had another episode of loss of consciousness with increased tone of UE and LE bilaterally and also several clonic movements.  She was again transferred to the floor, regained consciousness.  She was more shaky and diaphoretic following the second episode but was otherwise aware and oriented.  She was observed for another 30 minutes at the pharmacy and then left.
Pt vaccinated with DTP developed fever 105, adenopathy at injection site, & screaming episode for approx 3 hrs following third immunization, recovered in 2 days.
Fever to 100 degrees. Erythema of arm around site 150 mm x 200 mm not extending below the elbow.
Vaccine was given outside 6 hour window and it was given 40 minutes afterwards. I tried to call patient several times but he never returned my call. I called Janssen on 05/17/2021
Whole arm pain from shoulder to elbow. Difficulty moving arm and chills. No treatment given.
This spontaneous report as received from a physician refers to a multiple patients of unknown ages and genders. Pertinent medical history, concurrent conditions and drug reactions or allergies were not reported. On an unknown dates the patients were vaccinated with improperly stored ROTATEQ lot # L013206, expiration date 29-JAN-2017, (Dose, route and anatomical location were not provided). Other suspect product involved was sterile diluent lot # L041683 Expiration date 19-MAY-2018 and Lot # M002421 Expiration date 22-JUL-2018. Temperature: Lowest 25 Fahrenheit degrees (4 cycles) below. Time frame: 1 week. Previous: No. Digital data logger was involved. No product quality complain was involved. No other concomitant medication was reported. This is one of five reports received from the same reporter. Additional information has been requested.
Intussusception.  6/12/07 Received vax record which confirms RO lot & dose # as correct.  7/31/07 Received hospital medical records which reveal patient experienced emesis & bloody stools.  Admitted 6/3-6/7/07.  Surgical consult & taken to OR for reduction of IS & right hemicolectomy w/ileocolostomy.  Cardio consult done for heart murmur.  Recovery uneventful.  Surg & cardio f/u on d/c. FINAL DX: Intussusception, s/p right hemicolectomy & ileocolostomy; VSD.
I got blood clots. I do not know if they were related to the vaccine or not. I was on Eliquis and took it as prescribed. I was put on another blood thinner.
Evening of 4/8 body aches and chills. Fever throughout night. Severe body aches and chills continued for the next two days 4/9-4/10. Arm and shoulder pain in left arm 4/9 and still ongoing 4/14, but pain has decreased. Swollen and painful lymph nodes by left collarbone starting 4/9 and ongoing on 4/14, although the pain has decreased but swelling is unchanged.
deathly sick; Initial information received on 07-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves patient of unknown age and gender who experienced deathly sick while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   In 2014, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported in unknown administration site for immunization .  On an unknown date the patient developed a non-serious event of "deathly sick " (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported " Got my last flu shot 8 years ago and got deathly sick. Never got the flu and I will never get another vaccine again for anything."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (deathly sick).  At time of reporting, the outcome was Unknown for the event deathly sick.
3 hours after inj the site developed warm, red, raised area approx 5cmx5cm. On 5/8/07 pt reported area nearly resolved to only 2cmx2cm light pink non-raised, non-tender.
Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had administered dose of GARDASIL on 29-AUG-2013 (lot #H011350 and expiration date 21-FEB-2015). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
mom checked on pt taking pt out of crib to check for fever & pt outstretched extremities & shook then extremities went limp, & pt stopped breathing, lips blue-purple called 911;coughing;t101.9;r/o sepsis r/o secondary apnic episode & T;
Very Sore Arm began after shot and continued through morning of 2/26. Day after shot (2/24), fever of 100.3, chills, extreme fatigue, bone pain, headache, neckache. Everything other than sore arm resolved by morning of 2/25.
Only soreness initially, after 4 days developed swelling and redness at injection site. She took cetirizine and OTC hydrocortisone cream but it grew in size despite this self treatment. Size at time of exam 4X7 cm localized swelling with redness, nontender, slightly edematous.  Itching, no pain.  Treated with prednisone taper and continue antihistamines.
Pt recvd a dose of Engerix-B & exp allergic reaction; yeast allergy is poss per reporter;
Entire core hurt. Loss of appetite. Fatigue. Joint ache. Mild headache.  Second day less severe.  Third day weakness and fatigue.
Pt has discoloration of area, where vaccine was administered in her thighs which progressed distally, 48 hrs after vaccines were given. Pt then developed petechiae on lower extremities only.
Legs Felt Tingly, numb sleepy, & Heavy.   For about a week had random twitching in my legs
1 box of bivalent booster was thawed on 15-feb-202 and patient was administered 0.5ml on 24-Mar-2023 over 30 days passed.; no adverse event; Patient was administered 0.5ml on 3/24, over 30 days passed; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered 0.5ml on 3/24, over 30 days passed), PRODUCT STORAGE ERROR (1 box of bivalent booster was thawed on 15-feb-202 and patient was administered 0.5ml on 24-Mar-2023 over 30 days passed.) and NO ADVERSE EVENT (no adverse event) in a 59-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 047c22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Mar-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 24-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered 0.5ml on 3/24, over 30 days passed). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (1 box of bivalent booster was thawed on 15-feb-202 and patient was administered 0.5ml on 24-Mar-2023 over 30 days passed.) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered 0.5ml on 3/24, over 30 days passed), PRODUCT STORAGE ERROR (1 box of bivalent booster was thawed on 15-feb-202 and patient was administered 0.5ml on 24-Mar-2023 over 30 days passed.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered 0.5ml on 3/24, over 30 days passed) and PRODUCT STORAGE ERROR (1 box of bivalent booster was thawed on 15-feb-202 and patient was administered 0.5ml on 24-Mar-2023 over 30 days passed).    No concomitant medications were reported. 1 box of bivalent booster was thawed on 15-feb-202 and patient was administered 0.5ml on 24-Mar-2023 over 30 days passed. No symptoms were reported. No treatment information was reported.
intususception; This case was reported by a other health professional via sales rep and described the occurrence of intussusception in a infant male patient who received Rota (Rotarix oral suspension) (batch number F5L35, expiry date unknown) for prophylaxis.   On an unknown date, the patient received the 1st dose of Rotarix oral suspension (oral). On an unknown date, 3 days after receiving Rotarix oral suspension, the patient experienced intussusception (serious criteria GSK medically significant). On an unknown date, the outcome of the intussusception was unknown.   It was unknown if the reporter considered the intussusception to be related to Rotarix oral suspension.  Additional information was provided as follows: The age at vaccination was not reported, but could be less than 5 months. The patient developed intussuscpetion, it was diagnosed after 3 days. The reporter consented to follow up.
8 days after my first dose of the MODERNA COVID-19 vaccine I began having an itchy rash 1-2" below my injection site.  It was warm to the tough and moderately itchy.  Today is 11 days after my injection and I noticed that while the rash is less itchy, it has largeness to a red  raised circle that is 4" tall, 3" wide and warm to the tough.
On day7 of administration, Patient reported itchy arm at injection site. On exam dime sized area of induration with warmth and redness surrounding it.  No other symptoms.
Moderna vaccine was administered outside of HCF - reported by patient   ACUTE RESPIRATORY FAILURE 1/12/2022 ACUTE RENAL FAILURE, UNSPECIFIED
painful left palm hand; swollen at the injection site; redness at the injection site; nausea; chills; slight, mild ring in her ears; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (slight, mild ring in her ears), PAIN IN EXTREMITY (painful left palm hand), VACCINATION SITE SWELLING (swollen at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site) and NAUSEA (nausea) in a 51-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.  Concomitant products included Blood pressure medication for an unknown indication.   On 05-Jan-2021, the patient received first 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) 1 dosage form. On 19-Jan-2021, the patient experienced TINNITUS (slight, mild ring in her ears). On an unknown date, the patient experienced PAIN IN EXTREMITY (painful left palm hand), VACCINATION SITE SWELLING (swollen at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site), NAUSEA (nausea) and CHILLS (chills). On 21-Jan-2021, TINNITUS (slight, mild ring in her ears) was resolving. At the time of the report, PAIN IN EXTREMITY (painful left palm hand), VACCINATION SITE SWELLING (swollen at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site), NAUSEA (nausea) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Ice on the painful palm of her left hand.   Reporter did not allow further contact
Hospitalized 11/6/2021; COVID-19 positive 11/7/2021; fully vaccinated  BRIEF OVERVIEW:   Admit Date: 11/6/2021 11:56 PM Discharge Date: 11/12/2021  3:49 PM   Hospital Course: 82-year-old male past medical history factor 5 Leiden deficiency on Eliquis, CKD stage 3, type 2 diabetes mellitus, coronary artery disease, atrial flutter, chronic obstructive pulmonary disease presents with cough and shortness of breath.  In the emergency department, electrocardiogram with atrial flutter rate controlled no acute ischemic changes.  Patient met sepsis criteria and was administered IV fluid resuscitation.  Blood cultures obtained.  Patient was started on IV antibiotics.  Chest x-ray with notable left apical pneumonia.  Labs significant for leukocytosis, lactic acidosis, mild hyperkalemia, elevated BNP, elevated procalcitonin, and COVID-19 PCR positive.  CT thorax with consolidative pneumonia as well as COVID-19.  Lactic acidosis resolved after IV fluid intervention and IV fluids were truncated.  Hospitalist service consulted for admission further evaluation.  As MRSA screen was positive, antibiotics were transitioned to oral Doxycycline and continued for 4 more days at discharge. Peripheral blood culture 1 of 2 bottles positive for staphylococci is capitis suspected to be contamination.  Sputum culture was positive for MRSA.   Patient underwent PT/OT advised home with assist home health PT/OT.  Case manager consulted for arrange for outpatient services.  SLP evaluated and patient was cleared for oral diet.   Patient had notable AKI which was minimally improved with holding of diuresis.  He was in noted to be severely hyperkalemic and was administered hyperkalemia protocol. Patient was continued on beta blocker but lisinopril was held due to hyperkalemia. Due to elevated blood pressures, patient was started on oral hydralazine to be continued at discharge with close follow up with PCP and patient needs further adjustment of medications at follow up.  Patient had fluctuating blood sugars and was resumed on home regimen of insulin at discharge. For factor V deficiency, patient was continued on Eliquis.  Patient was discharged to Home without services in stable condition.
Patient received the Janssen vaccine 3/11/21 and developed a rash with hives on torso on 3/17/21. Told patient to take Benadryl and monitor and let me know if does not improve.
Information has been received from a physician concerning a 22 year old female with a history of positive for antibodies for herpes virus of unknown type, who on 12-JUN-2007 was vaccinated with the first dose of Gardasil and the PAP test done on that day was normal.  On 16-Aug-2007 the patient received the second dose and on 04-Dec-2007 received the third dose and a PAP test taken that day was positive for high risk HPV.  Medical attention was sought.  At the time of report the patient had not recovered.  No product quality compliant was involved.  Additional information has been requested. 02/10/2010 On 12-Jun-2007 the patient received the second dose IM in the right deltoid and tjet pap test done that day was normal with candids inflammed, and on 04-Dec-2007 received the third dose IM in the left deltoid and an PAP test tanke that day was positive for high risk HPV. Concomitant medication included Othro trycyclan to SC pills (manufacturer unknown). Medical attention was sought. At the time of report the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
Pt recvd MMR vax 04OCT90; pt was inadvertently vaxed w/diluent from HIB; pt exp no adverse effect;
No additional AEs reported; underwent a temperature excursion and then were administered to patients; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 22-JUL-2021, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live ) (albumin status rHA) (M-M-R II) 0.5 milliliter (lot # T012808 was confirmed to be valid, expiration date: 14-APR-2022; route of administration, anatomical location were not reported) for prophylaxis. The administered dose underwent a temperature excursion of 50.31 degrees Fahrenheit (F) for 1 hour. There were no previous excursions reported. No additional adverse effect was reported.   This is one of several cases received from the same reporter; Sender's Comments:  US-009507513-2108USA003333: US-009507513-2108USA003334: US-009507513-2108USA003335: US-009507513-2108USA003332: US-009507513-2108USA003331:
About 30 seconds after my shot, my throat felt like it was closing and my face started to swell up as well as my hands. Then My right ankle swelled up.  My face and hands had hives on them.  My throat felt better, I thought but about 1/2 hr. Later I started wheezing and my right ankle and leg were swollen  so, I went to the urgacare.  They saw me but told me that I should've gone to the ER. I have a history of anaphylaxis. They gave me steriods and Benadryl via shots and sent me home with the same.  I woke the next morning with a sore arm, a horrible headache and my face broke out into hives and was swollen again. Today is the 4th day after and my face still feels a little swollen, I have a headache and now an earache in my left ear.  Today I also felt nauseous and couldn't eat.
PT COMPLAINED THAT IT HURT WHEN I GAVE SHOT. HE THEN COMPLAINED TO MOM THAT NOC HIS ARM WAS SORE. RED AREA AT SITE OF INJECTION STARTED YESTERDAY. WHICH GREW. HOT TO THE TOUCH AND VERY TENDER. PT RECEIVED ADACEL.
Severe muscle pain, skin sensitivity, nausea, severe headache, neck and lower back pain, chest pain, fever
body aches; Swelling; neck pain; hives; increase in eye and face swelling; increase in eye and face swelling; It was hard to swallow; face was swollen; eye swelling; ear infection; malaise; Joint pain; chills and fever; muscle pain; bad headaches; Initial information received on 28-Jul-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 17 years old female patient who noticed that it was hard to swallow, face was swollen, eye swelling, ear infection, body aches, swelling, neck pain, malaise, hives, joint pain, chills and fever, muscle pain and bad headaches while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past vaccination(s) included MENACTRA in 2016 with no issues. The patient's past medical history, medical treatment(s) and family history were not provided.   On 12-Jul-2022, the patient received a dose of 0.5 ml of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE, injection (strength: unknown) lot U7273BA via intramuscular route in the left shoulder as Immunization.  On 13-JUL-2022, within 12 hours, the patient had malaise, joint pain (arthralgia), chills and fever (pyrexia), muscle pain (myalgia) bad headaches (headache)1 day following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  On 15-JUL-2022 the face was swollen (swelling face) eye swelling, ear infection 3 days following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. The patient went to doctor with the swelling and they stated that it looks like an ear infection and was prescribed amoxicillin.  Doctor visit on 15JUL2022 and given Amoxicillin, Benadryl, Advil, Zyrtec.  On 16-JUL-2022 , it was hard to swallow (dysphagia) 4 days following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. The patient went to Went to Emergency room due to this and they gave 80 mg injection prednisone. and discharged home with prednisone. Still having symptoms 2nd doctors visit on 19JUL2022 and was given famotidine and kidney function test performed(came back normal). Doctor recommended consult to infectious disease and ER if symptoms worsened  On 19-JUL-2022 the patient had increase in eye and face swelling (condition aggravated) 7 days following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  On 22-JUL-2022 the patient had body aches (pain) swelling, neck pain and hives (urticaria) 10 days following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Relevant laboratory test results included: Renal function test - On 19-Jul-2022: [normal]  Action taken was not applicable.  The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), IBUPROFEN (ADVIL [IBUPROFEN]), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), AMOXICILLIN (AMOXICILLIN) for Eye swelling, Swelling face and Ear infection, PREDNISONE (PREDNISONE) for Dysphagia and FAMOTIDINE (FAMOTIDINE).  At time of reporting, the outcome was Not Recovered / Not Resolved for all.
Test positive by home kit and had a virtual apt and was then referred for a Covid infusion at Facility for treatment. Recv'd an antibiotic infusion.
LOWER BACK PAIN (STILL PRESENT BUT NOT AS BAD AS IT WAS); SEVERE MUSCLE WEAKNESS  AND GOT WORSE WITH TIME; CHILLS; SEVERE BODY FATIGUE AND GOT WORSE WITH TIME; This spontaneous report received from a patient concerned a 49 year old male. The patient's weight was 205 pounds, and height was 74 inches. The patient's concurrent conditions included: stress, blood pressure, social alcohol drinker, and non-smoker, and other pre-existing medical conditions included: Patient had no medical history and no known allergies. The patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 05-AUG-2021 for prophylactic vaccination. Concomitant medications included methyldopa for stress, and blood pressure.  On 06-AUG-2021, the patient experienced lower back pain (still present but not as bad as it was). On 06-AUG-2021, the patient experienced severe muscle weakness and got worse with time. On 06-AUG-2021, the patient experienced chills. On 06-AUG-2021, the patient experienced severe body fatigue and got worse with time. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 07-AUG-2021, recovered with sequelae from severe muscle weakness and got worse with time on AUG-2021, was recovering from lower back pain (still present but not as bad as it was), and had not recovered from severe body fatigue and got worse with time. This report was non-serious.
my anxiety is pretty high; This spontaneous case was reported by a nurse and describes the occurrence of ANXIETY (my anxiety is pretty high) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) unknown. On an unknown date, the patient experienced ANXIETY (my anxiety is pretty high). At the time of the report, ANXIETY (my anxiety is pretty high) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported.  No treatment medication details was reported.