chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient fainted a few minutes after receiving the flu vaccine. She quickly recovered, remained in the pharmacy for 15 minutes, and then afterwards blood pressure (108/83) was taken and patient was determined to be stable and left the pharmacy. Patient followed up and confirmed she arrived home safely from pharmacy.
Had hives at arms & chest 2 hrs. after 3rd Gardasil vaccine on 1/3/08.
Pt received DTAP in left thigh, tolerated well. The following day parents noticed small area of surrounding redness that gradually increased over the following 24hrs to include entire anterior thigh with swelling and bruise. Pt without apparent pain. No gait disturbance or fever. No other rash, mucous membrane swelling, wheezing, dyspnea. No h/o similar reaction.
This spontaneous report was received from a healthcare worker and refers to an unspecified number of patients of unknown ages and genders. On an unknown dates in 2015 (reported as: since 20-MAY-2015), the patients were vaccinated with improperly stored PROQUAD (Merck) subcutaneous injection, lot # K021547, expiration date: 06-MAY-2016 (Dose not provided). No adverse effects reported. This is one of two reports received from the same reproter. Additional information has been requested.
Pt recvd vax 27MAR92 & devel t104 followed by 3 5-10 second episodes of "eyes rolled back" & "twitching of arms & legs"; Pt seen @ ER-CBC, UA, CXR done; tx APAP & bath; T persisted till 30MAR92 acting nl & exam nl x/for OM;
1022 Immunisation given, sat in chair with nurse until 1027. Walked with nurse and father - she felt lightheaded, legs buckled, escorted to chair, smelling salts used, assisted to bench in lying position, legs elevated, cold compress and cold drink given. BP 110/50, P 56, R 20 assessed by doctor. Color returned, sitting up for 5 min. Escorted out by father.
Severe muscle cramps and pain in left calf - started about 8 hours after vaccination - continued throughout night - pain continued for next several days - one week later - discomfort in leg
Unable to see things normally; Vision seriously blurred; This is a spontaneous report from a contactable consumer. A 62-year-old male consumer (patient) received bnt162b2, dose 2 via an unspecified route of administration, administered in left arm on 09Jun2021 16:00 as single dose for COVID-19 immunisation. Medical history included chronic bronchitis. There were no concomitant medications in 2 weeks. There was no other vaccine in four weeks. The patient previously took bnt162b2, dose 1, administered in left arm on 19May2021 at 04:00 PM for COVID-19 immunisation. The patient was not tested positive for COVID prior vaccination. The patient experienced vision seriously blurred and unable to see things normally; both after second dose of Pfizer vaccine on 12Jun2021 at 12:00 AM. Outcome of the events was not recovered. The patient was not tested positive for COVID post vaccination.
Pain in shoulders. Pain in arm.  Immediate dizziness. Immediately light headed. Next Day: Fatigue. I slept for 24 hours, 16 of those straight through. Some nausea.  Some vomiting. Light headache.
Moderna COVID-19 Vaccine EUA: presented to clinic with a new fever of 38.7 and ANC of 0. She was admitted to the hospital for management of neutropenic fever. Found to be COVID positive. Received remdesivir, antimicrobials, and anticoagulation. Discharged to home medically stable.
began 6/13 with chest pain and SOB, mild dizziness and sob.  Sx persisted -went to urgent care- EKG showed ST segment changes - sent to ED for eval .  In ED vital  stable, labs showed elevated troponin of 81 Echo in ED normal ventricular function- CXR nl - admitted sx myopericarditis
9 days after the vaccine,  I woke up with difficulty breathing. I went to numerous doctors and CAT scan and still unable to find the cause of breathing difficulties. I was put on steroids, inhalers, numerous chest x-ray, cat scan, PTF  pulmonary function tests and with little to no improvements.  I am still having difficulty but it has improved a little bit.
This spontaneous report as received from a licensed practical Nurse and refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 16-MAY-2016, the patient was accidentally vaccinated with two doses of M-M-R II 0.5 ml each dose, subcutaneously (lot #, expiration date and route of administration were not reported). Concomitant medications were not mentioned. Nevertheless, no adverse effects were reported and no product quality complaint was involved. Additional information has been requested.
Rash all over body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (Rash all over body) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (Rash all over body). The patient was treated with HYDROXYZINE HYDROCHLORIDE (VISTARIL [HYDROXYZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; FAMOTIDINE (PEPCID AC) for Adverse event, at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH (Rash all over body) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Patient went to the hospital on 01 Jul 2021 and 05 Jul 2021.  The lab test included some unspecified blood tests, whose results are not reported. Treatment also included Steroids.
1. first day swelling and pain 2. queasy, headache for 2 weeks,  3. Blisters reoccurring,  4.Inflammation in joint escalated. 5. Severe Angina (7) times 6. Tendonitis in knee, shoulder, elbow 7. Pressure in Back and hips then spread.
Pt recvd flu vax on 13NOV92; 15NOV92 exp pruritus, welts all over the body, red ears, diarrhea, vomiting, & bloating; adm to hosp; pt was found to have an elevated white blood cell count; 23NOV92 pt is recovering;
Narrative: 77-year-old male with past medical history of hypertension, hyperlipidemia, coronary disease status post coronary artery bypass graft x3, non-insulin dependent type II diabetes mellitus, squamous cell carcinoma of the lung status post chemoradiation, and recently COVID-19. Patient was admitted from 8/16-8/29 at a local hospital for COVID-19 and discharged on 2L at rest and 4L with activity. He was admitted at the Facility on 09/08/2021 for severe sepsis and acute on chronic hypoxic respiratory failure secondary to COVID-19 pneumonia. Patient's lactic acidosis responded appropriately to IV fluids. He was treated empirically treated for hospital acquired pneumonia with cefepime, later transitioned to oral levofloxacin. Patient's oxygen requirements waxed and waned throughout admission, at one point he required 10L via high flow nasal cannula. Patient was started on 40mg prednisone, which helped his respiratory status and oxygen requirements. Patient with history of poorly controlled diabetes and blood sugars were further uncontrolled when starting steroids. Sliding scale was initiated, as well as 10U NPH when the patient took his prednisone. Of note, patient experienced epistaxis due to the nasal cannula, which improved and was resolved using nasal spray and mupirocin ointment. He was on 2.5L  via nasal cannula at discharge. 6 minute walk test revealed patient requires 2L with rest and 6L with activity. He was discharged home with prednisone taper and insulin. Diabetes education provided to patient and family. Follow-up with PCP regarding insulin requirements going forward. He was discharged home in fair condition.
Left hand and middle finger hurt to the touch, tingly down arm, numbness in arm/hand. Hand and arm symptoms lasted approximately 48 hours from on-set. Also experienced fatigue, headache and arm soreness
Within the first 2 minutes, after the vaccine, I had to talk to my mom and stay on the phone with my mother because I couldn't see right; my speech was funny. I couldn't walk straight. I was walking into the isles of the store. I drove slowly and took back roads because of these symptoms. It lasted only a few hours and then it went away. Within two weeks of the vaccine, I had severe diarrhea. I have severe diarrhea and bad stomach pain ever since the second shot. To the point where I've lost 20 pounds. I have a gastro appointment next week. I've seen before because I thought I had COVID-19 last year in 2020 at the beginning of the year. I had diarrhea for three weeks during that time. This is almost like that was but now it's lasting forever. I have been taking Imodium and she told me to take IB Guard. I have been trying to eat a very bland diet and eliminating things with dairy. My brain has been foggy.
Manufacture's package: Dtap + Polio it is for children 4yrs to 6yrs of age. Vaccine administered to a child younger than 4 yrs.
Information has been received from a nurse practitioner concerning an 18 year old female with no medical history and no drug allergies, who on 07-DEC-2007 was vaccinated intramuscularly with a 0.5mL first dose of Gardasil (Lot# 655620/0171U).  There was no concomitant medication.  On 08-DEC-2007 the patient developed a "full body rash."  The patient reported that the rash was itchy.  No shortness of breath or difficulty breathing was reported.  The rash resolved within one week.  The patient recovered on 14-DEC-2007.  On 14-JAN-2008 the patient was seen in the office.  No laboratory diagnostics were performed.  No product quality complaint was involved.  Additional information has been requested.
Pt came to have arm checked on 10/14/2011 around 1600. Pt's arm was red and raised with swelling in the same location as varicella vaccine given. Pt's mother reported that her arm "had been this way" since the vaccine. Mom also reported that it was getting bigger and worse even though she had tried ibuprofen and ice.
before vaccination person reported that she had n/v everytime she had recived a flu vaccine. It was discussed with her and she insisted on taking the vaccine so she could keep working. 10 min after taking vaccination she had headache. Brought to observation area and progressed to n/v. Monitored for 30 min and then called for EMS. She was given Benadryl. She reported only 4 hours of sleep and not eating anything after waking up. transported via EMS for on site observation
continued to have joint pain after other effects resolved . I also had breakthrough menstrual bleeding which I have never had irregular cycle.
Information has been received from a physician concerning a pt who "a few years ago" was vaccinated with a dose of varicella virus vaccine live. On 11/04/03 it was reported that the pt "recently" developed chickenpox. Unspecified medical attention was sought.  There was no product quality complaint involved. Additional information has been requested.
Patient presented to her doctor's office on 4/28/21 stating she had been having myalgias since her second vaccination. She presented to the ED on 5/4/21 with abdominal pain. She presented to the ED and was subsequently hospitalized on 5/11/21 with acute gastroenteritis. These visits are within 6 weeks of receiving COVID vaccination.
Patient reported entire bicep being red and warm to the touch from site of injection to the elbow. It was a smaller area this morning and the redness grew throughout the day according to the patient.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Feb2021 at 12:00 as dose 1, single (Lot number: En6200), in left arm, on 20Mar2022 at 12:00 as dose 2, single (Lot number: Er2613), in right arm and on 15Oct2021 at 12:00 as dose 3 (booster), single (Lot number: Fh8020) at the age of 59 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Shellfish" (unspecified if ongoing); "Open heart to treat birth defect ALCA" (unspecified if ongoing); "Open heart to treat birth defect ALCA" (unspecified if ongoing); "Open heart to treat birth defect ALCA" (unspecified if ongoing); "possible auto immune" (unspecified if ongoing), notes: possible auto immune. Concomitant medication(s) included: VIVELLE [ETHINYLESTRADIOL;NORGESTIMATE], start date: 02Mar2018, stop date: 16May2022; METOPROLOL, start date: 02Feb2019, stop date: 16May2022; PROGESTERONE, start date: 01Mar2019, stop date: 16May2022. Past drug history included: Known allergies: augmentin ct dye, reaction(s): "Known allergies: augmentin ct dye". The following information was reported: VACCINATION FAILURE (medically significant) with onset 2022, outcome "unknown", COVID-19 (medically significant) with onset 2022, outcome "recovered" (2022) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) positive. Therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible. No further information is expected.
tightness in chest; Headache; dizziness; shortness of breath; nausea; itching; severe pain in both knees; numbness in both thighs; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 21Mar2021 14:30 (Batch/Lot number was not reported) at the age of 60 years old, as single dose for covid-19 immunization. Medical history included sleep apnea, history of breast cancer left side lumpectomy, chemotherapy, radiation, asthma, osteoarthritis, vestibular disorder, allergies to unspecified medications and food, and GERD (gastrooesophageal reflux disease). The patient was not diagnosed with COVID prior to vaccination. Concomitant medications included lisinopril (LISINOPRIL); hydrochlorothiazide; hydroxyzine; and meloxicam (MELOX); all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Mar2021 03:00, the patient experienced tightness in chest, headache, dizziness, shortness of breath, nausea, itching, severe pain in both knees, and numbness in both thighs. The events resulted in: doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The events were treated with Benadryl, solution medrol pf, sodium chloride. The patient has not recovered from the events. The patient has not been tested for COVID post vaccination. The events were reported as non-serious.   Information on the lot/batch number has been requested.
The pt received her 1st injection of Engerix-B on 11/30/92 and her 2nd injection on 2/28/93. She did not received the 3rd dose; no explanation provided. In April 1998, she was reportedly dx'd with multiple sclerosis. The pt reported that she currently has paralysis of her left arm, hand and leg. She is being treated with Copaxone 20mg SC daily, Ritalin 20 mg twice daily, Wellbutrin 150 mg twice daily, Prozac 20mg every other day, Tegretol 800mg daily and Tegretol-XR 200mg daily at bedtime. The pt stated that her current physician considers the multiple sclerosis to be possibly related to Engerix-B administration. The paralysis and multiple sclerosis persisted as of 12/28/00. The report is "Medically Serious".
woke up feeling horrible; had difficulty walking; felt weak; felt awful; nauseous; three episodes of very light vomiting; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (woke up feeling horrible), GAIT DISTURBANCE (had difficulty walking), ASTHENIA (felt weak), FEELING ABNORMAL (felt awful) and NAUSEA (nauseous) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes (for 26years.). Concomitant products included INSULIN for Diabetes.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Aug-2021, the patient experienced MALAISE (woke up feeling horrible), GAIT DISTURBANCE (had difficulty walking), ASTHENIA (felt weak), FEELING ABNORMAL (felt awful), NAUSEA (nauseous) and VOMITING (three episodes of very light vomiting). At the time of the report, MALAISE (woke up feeling horrible), GAIT DISTURBANCE (had difficulty walking), ASTHENIA (felt weak), FEELING ABNORMAL (felt awful), NAUSEA (nauseous) and VOMITING (three episodes of very light vomiting) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: mid to high 200s (High) High.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided.  Patient checked his blood sugar level before he ate and was mid to high 200s, which is too high for him. He stated that lasted for 14 days, no matter how much insulin he used. The blood sugar level returned to normal after 14 days but then is high again, mid to high 200s. He saw his endocrinologist who did not know what could have caused it. He stated that his diet and insulin regimen had not changed
felt a little dizziness; felt hot; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (felt a little dizziness) and FEELING HOT (felt hot) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No reported medical history.  The patient's past medical history included No adverse event (No medical history was not provided by the reporter). Concomitant products included LOSARTAN from 10-Sep-2016 to an unknown date and OMEPRAZOLE from 08-Jul-2016 to an unknown date.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced DIZZINESS (felt a little dizziness) and FEELING HOT (felt hot). On 15-Jan-2021, DIZZINESS (felt a little dizziness) and FEELING HOT (felt hot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information provided.   This case was linked to MOD-2021-088997 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Patient demography and concomitant drugs added.
Full trunk pink rash that grew to encompass thighs and shoulders over 24 hours. Then it evolved into  very irritating patches of raised bumps (batches of 20-30 per 6?x10? areas that were extremely itchy! Today. 4/27. Less bumps but they keep moving on back and front of trunk. Very very irritating itch.
Headache, Vertigo, Ibuprofen/ meclizine, symptoms improved with the mgt,
Extreme Soreness and inability to use the arm for activities of daily living. Over the last week arm was swollen, very black and blue and it looks like an extreme bruise over 16 inches long and 4 to 5 inches wide on the inside of the upper right arm.
went below freezing point; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis, DTPa (Infanrix) for prophylaxis, dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis, flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, Men ACWY-CRM NVS (Menveo) for prophylaxis, Men B NVS (Bexsero) for prophylaxis and meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation, Rotarix Oral Applicator Device, Infanrix, Infanrix Pre-Filled Syringe Device, Boostrix, Pediarix, Pediarix Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, FluLaval Quadrivalent, Flulaval Tetra Pre-Filled Syringe Device, Menveo, Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation, Rotarix Oral Applicator Device, Infanrix, Infanrix Pre-Filled Syringe Device, Boostrix, Pediarix, Pediarix Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, FluLaval Quadrivalent, Flulaval Tetra Pre-Filled Syringe Device, Menveo, Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable to this report. The nurse reported that, the several vaccines Bexsro, Menveo, Flulaval, Kinrix, Pediarix, Boostrix, Infanrix, Rotarix that went below freezing point was inadvertently administered to patient over a period of time, which led to incorrect storage of drug. The reporter consented to follow up. No details of patient or other vaccine details were available.
I started feeling achy, fever (101), headache, chills, heartrate rapid (twice as high as usual), cough, nauseated, itchy throat ... now today those sympt. are subsiding but I have bumps in throat and it is very sore and I am very hoarse when I talk. And I have some diarhea. 11/3/09 Medical records received from OB date 10/29/09 and 11/2/09. Pt called to OB office stated received H1N1 4 days ago then became very sick. Prev. OB OV date 10/29/09 indicate pt at that time was 10wks gestation, normal OB visit.
Headache, Myalgia, Arthralgia, NauseaVomiting,  Fatigue, cold toes  Narrative: