chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pulmonary embolism/blood clot in his lungs; Hiatal hernia; Hemoglobin was down to 5; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism/blood clot in his lungs) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   The patient's past medical history included Hip surgery and Blood transfusion.  On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism/blood clot in his lungs) (seriousness criteria medically significant and life threatening), HIATUS HERNIA (Hiatal hernia) and HAEMOGLOBIN DECREASED (Hemoglobin was down to 5). The patient was treated with APIXABAN (ELIQUIS) at an unspecified dose and frequency. At the time of the report, PULMONARY EMBOLISM (Pulmonary embolism/blood clot in his lungs), HIATUS HERNIA (Hiatal hernia) and HAEMOGLOBIN DECREASED (Hemoglobin was down to 5) outcome was unknown.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Haemoglobin: 5 (Low) hemoglobin was down to 5.  Concomitant product use was not provided by the reporter. The patient stated that he had a pulmonary embolism after his hip surgery and was placed on Eliquis. After 6 months while taking Eliquis he developed a blood clot in his lungs and was placed on Eliquis for life. This last week he went in for some blood tests and his hemoglobin was down to 5. He was given 3 units of blood by transfusion.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Thromboembolic events are one of the AESI in the use of the product  Patient will continue to be monitored. Further information is expected.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Thromboembolic events are one of the AESI in the use of the product  Patient will continue to be monitored. Further information is expected.
Client woke up with a headache @ 2:25p then developed inability to move was curled up in a fetal position this lasted approximately 2 1/2 hours. Client thought she had a temperature but did not check temperature had no difficulty breathing.
Information has been received from a consumer concerning her 60 year old husband with no pertinent medical history and no drug reactions or allergies who on 19-JAN-2009 was vaccinated with ZOSTAVAX (Lot # not reported). There was no concomitant medication. On 19-JAN-2009 after vaccination he experienced dizziness and headache. At the time of the report 19-JAN-2009 patient was not recovered. The patient did not seek medical attention. Additional information has been requested.
Patient felt pain and nausea right after receiving second dose vaccine.  Patient was throwing up and sweating. Blood pressure is in normal range but heart rate is 102. Patient was feeling better after. Following up with patient in afternoon, patient is feeling much better. Patient just feels tired.
pt tolerated vax well;returned to office crying inconsolably;thrashing in wave like fashion, bending @ wrist;given APAP & observe episode last 30-40min;had repeat episode w/inc irritability 3-4hr later lasting 15-20min;then no further episo
Flu vaccine given on 10/1/08 @ 15:00 pm.  Developed sob on exertion & left scapular back pain within 30 minutes of immunization.  Reported symptoms to supervisor @ 9:00pm.  Ambulance called to transport to local ER.
Swollen right arm, painful, could not lift it. Went to ER got abx.
This spontaneous report as received from a healthcare worker who reported that unknown numbers of patients might have received improperly stored VARIVAX (Merck) (dose, route of administration and lot # not provided), because a provider did not record the temperature of freezer since November-2012. No adverse effect reported. No PQC involved. Additional information is not expected.
patient suffered a heart attack after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (patient suffered a heart attack after the second dose) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYOCARDIAL INFARCTION (patient suffered a heart attack after the second dose) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDIAL INFARCTION (patient suffered a heart attack after the second dose) outcome was unknown.      No concomitant medications provided. No treatment medications provided. Patient was not diagnosed with myocarditis or pericarditis. Patient did not get hospitalized for myocarditis and pericarditis previously. Cardiac tests were not reported. Patient did not have history of Covid-19 infection.  Company Comment: This case concerns a 71 year old male with no reported medical history , who experienced Serious, unexpected event of Myocardial Infarction which occurred 21 days after vaccination with the 2nd dose of mRNA-1273 vaccine (Moderna Covid 19 Vaccine ) . The re-challenge for this case is not applicable since the event occurred after the 2nd dose and no additional doses would be given and also the outcome is unknown . The age of the patient can be considered as a confounder for this case ( Age, risk factor to cardiovascular events and Cardiovascular problems)/ The benefit-risk relationship of  mRNA-1273 vaccine ( Moderna Covid 19 Vaccine ) is not affected by this report.; Sender's Comments: This case concerns a 71 year old male with no reported medical history , who experienced Serious, unexpected event of Myocardial Infarction which occurred 21 days after vaccination with the 2nd dose of mRNA-1273 vaccine (Moderna Covid 19 Vaccine ) . The re-challenge for this case is not applicable since the event occurred after the 2nd dose and no additional doses would be given and also the outcome is unknown . The age of the patient can be considered as a confounder for this case ( Age, risk factor to cardiovascular events and Cardiovascular problems)/ The benefit-risk relationship of  mRNA-1273 vaccine ( Moderna Covid 19 Vaccine ) is not affected by this report.
Fever just under 101 in evening after 930AM GARDASIL #3 given felt achy. Today fever 99 this am. Slight dizziness, nausea.
Random uncontrollably sweating  Irregular menstrual  cycle  Sever back pain/sciatica  Cold sores
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a four-year-old female. Neither the patient's past medical history nor the concomitant medications were reported. The product expired on 15-Jan-2012. On 16-Jan-2012, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Additional information was obtained on 02-Apr-2012 and incorporated in the narrative: patient's information.
Pt. states that after receiving the 1st dose of Prevnar 23 01/20/2022, started experiencing symptoms 01/21/2022 of fatigue, pain in the Left arm, swelling at the injection site, nausea, blurred vision, and difficulty using Left arm. No noted Primary visit/communications. Pt. still continuing to experience symptoms.
Covid19 breakthrough.  1st vaccine 03/23/2021.  57 y/o with PMH of CIDP, CVA, Asthma, OSA, HF, DVT/Pulm emboli, pancreatitis presents with 2 day history of mult episodes of diarrhea, abdominal pain, nausea and hypotension.  Denies c/o fever, chills, SOB or cough.  Room air sat 99%, CXR -no acute process.  Started on IV steroids.
weakness; high heart rate; tachycardia; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), HEART RATE INCREASED (high heart rate) and TACHYCARDIA (tachycardia) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weakness), HEART RATE INCREASED (high heart rate) and TACHYCARDIA (tachycardia). At the time of the report, ASTHENIA (weakness), HEART RATE INCREASED (high heart rate) and TACHYCARDIA (tachycardia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Miscarriage (missed abortion) detected via ultrasound on 9/3.  D&C procedure carried out on 9/10. Light spotting continued until 10/3.
by mistake gave the Dtap/IPV part yesterday and did not give the AcHib part of the Pentacel to patient/NO AE; Initial information received on 06-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves patient of an unknown demographics who received only the Dtap/IPV part of the vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and was not given the AcHib part.  The medical history, medical treatment, vaccination and family history were not provided.  On an unknown date, the patient received a dose of only the Dtap/IPV part of the suspect vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (Box Lot number UJ124AAA, expiry date 29-Sep-2020; Datp/IPV Lot U6397AA, expiry date 29-Sep-2020; ActHIB- UJ124AA, expiry date 29-Sep-2020) via unknown route in unknown administration site without the AcHib part.  It was a case of actual medication error due to inappropriate reconstitution technique.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I had diarrhea for about 3 or 4 hours on May 17, 2023, chills and fatigue.  I had it again on May 25th and I went to the urgent care on the 27th for the diarrhea and ride side abdominal pain.  My doctor sent me to the emergency room on May 29th because he wanted imaging. I went to my gastroenterologist and was diagnosed with microscopic colitis and I am being treated with prescription medication, budesonide.  As of today, I am much better.
pt recvd vax & devel a poss allergic react; It is possbile states MD that pt may be reacting to the preservative or other ingredients in the vax;
Same day felt loopy and weak. Day 2, 3, 4 and 5, I felt heavier, loopier, body aches and dizzy and could just hang out in my pajamas and was extremely thirsty. Day 6 in the evening is when the worst hit. Sitting in a recliner acute pain and numbness with pins and needles started in my feet and traveled up my legs. It went up to my butt. By morning it was in my breast and by November 22nd it traveled up to the left side of face with numbness. I could not think or talk my brain wouldn't work. Everything was spinning and the acute pain and the pins and needles covered my entire body but worse on the left side due to the pinched nerves. I went to the Emergency Room. My muscles and tissues throughout my body had cramps and shooting pains and my body wouldn't and couldn't move because the tissues felt inflamed and pulsing and throbbing with electrical pains. I felt like I was burning up but didn't have a fever. I couldn't tell the difference between hot or cold. I'd try to move and my body was stuck even my fingers and wrists and I was so thirsty. My body shut down from normal feeling. Clothes hurt, tried to soak my feet and the water touching my ankle hurt. I couldn't touch my own skin because it would send shocks and pins and needles then pain.
pt recv vax & exp soreness @ the site of inj, erythema, swelling;area was size of a half dollar & noted area was warm to touch;
This spontaneous report as received from a clinic manager refers to an unspecified patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored doses of PEDVAXHIB (dose, route of administration and lot numbers were not reported). The reporter was not aware of an adverse experience. There was no previous temperature excursion. The call was made because of data logger. Administered vaccine experienced the temperature excursion of 32 to 35 degrees Fahrenheit for 15 hours. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA012739: US-009507513-1705USA012738: US-009507513-1705USA005716.
Almost sure I have  COVID; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (Almost sure I have  COVID) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SUSPECTED COVID-19 (Almost sure I have  COVID). At the time of the report, SUSPECTED COVID-19 (Almost sure I have  COVID) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were provided.
Pt in observation,  resting in chair with husband.  Pt had 1-2 minute LOC while sitting in chair and responded with touch and talk.  W/C to med eval. station and placed in supine position on cot.  VS 106/67 75P 18R.  Pale and diaphoretic.  Husband present with medical Hx. Fluids offered and ortho static BP done, stable with Gatorade and 16oz water.  VS  130/86 60P 20  100% sat, sitting & 136/93 70P 18R 100%sat  standing and discharged ambulatory with husband at 1215.  Educate pt for return visit for 2nd dose to be placed in med eval cot and recovery, verbalized understanding RS, NP.
No Adverse effect reported.  Patient's daughter, came in to report patient had received the wrong vaccine. On patient's CDC card the first and second dose read as Moderna and the third dose which was administered on site read as Pfizer. Record on RA site and on patient log records indicated patient received Moderna vaccine.
1st dose on April, 2nd on Octuber; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 24-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Previously administered products included Menveo (received 1st dose in April). Concurrent medical conditions included hiv infection (was HIV positive).   On an unknown date, the patient received the 2nd dose of Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 14-Dec-2022 Reporter's comment: The patient received 1st dose of Menveo in April but he missed the 2nd dose in July, then 2nd dose was administered in October. The reporter asked that they should take the October dose as the first dose and start and complete (2 doses) immunization series or the patient was covered with April and October doses. Unfortunately they did not had any other data such as patient's identifiers or exact administration date. Did not had opportunity to consent to follow-up Additional supportive information: The patient received the 2nddose of Menveo later than the recommended interval, which led to lengthening of vaccine schedule.
Tinnitus, fullness in ear, dizziness, lightheadedness, vertigo, imbalance started on 3/24. Urgent care visit (March 2021), ER visit( 4/1/21), ENT visit in April 2021 (initially diagnosed potential Meniere's). Fatigue and shortness of breath noticed. EKG and stress test done to rule out heart issues. After 2 months, the fullness in ear subsided. The lightheadedness, fatigue,  and dizziness continued (and still continues) upon any type of straining including sneezing, coughing, laughing, heavy lifting, etc. 2 MRI's and 2 CT Scans, most recent in April 2023 showed potential perilymph fistula.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Overweight" (unspecified if ongoing); "prehypertension" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL taken for nasopharyngitis, influenza, start date: 05May2022, stop date: 07May2022.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (12May2022) Negative; (17May2022) Positive, notes: Took home antigen test that was bright positive; (18May2022) Positive, notes: Test was positive but less bright than May 17; Weight: (unspecified date) Overweight. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2 weeks are reported as yes. Known allergies was reported as none.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Approximately 44hrs after vaccination hives near site of injection, arm, neck, trunk were noticed. BENADRYL was administered.
Patient called to report he has a rash, swelling, and tenderness at pneumo 23 inj site. Allergy list updated. Denies SOB, numbness/tingling in lips, mouth, tongue. Cool packs and BENADRYL. To ER if any SOB, tingling/numbness to mouth/lips/tongue. He voiced understanding.
fells like the flu; arm was sore; Body aches/aching all over; low grade fever/her temperatures were normal but sometimes 99.5; Sick to stomach, no vomiting; Cold Chills; Mild Headache; This spontaneous case was reported by a consumer and describes the occurrence of   in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.            Treatment medication was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2021: follow up received as Consumer stated that she is doing Fine and no further follow up required.
Itching in their hands; Widespread rash; Chills; Arm pain; This spontaneous case was reported by a physician and describes the occurrence of PRURITUS (Itching in their hands), PAIN IN EXTREMITY (Arm pain), RASH (Widespread rash) and CHILLS (Chills) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B2124 and 0021A) for COVID-19 vaccination.     No medical history provided.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm pain) and CHILLS (Chills). On 27-Mar-2021, the patient experienced PRURITUS (Itching in their hands) and RASH (Widespread rash). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (BENADRYL ALLERGY [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching in their hands), PAIN IN EXTREMITY (Arm pain), RASH (Widespread rash) and CHILLS (Chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with M-M-R II dose, route of administration, lot# and expiry date were not reported that were improperly stored. No adverse symptoms was reported. It was reported that the temperature excursion was unsupported with in-house stability data. This is one of several reports received from the same reporter. Additional information has been requested.