chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 2 hours after injection tongue started swelling, became difficult to breath, mouth and throat started tingling, started blacking out. Chewed 2 benadryl and went to emergency room. Was given more antihistamines there and monitored until reaction stopped.
Within a few days after receiving the vaccination I noticed a significant blurring of vision in my left eye.  Consulted my ophthalmologist, who diagnosed a central retinal vein occlusion, confirmed with an OCT., and referred me to a retina specialist.  Primary care physician started me on Xarelto and referred me to a hematologist.  I do not have any history of blood clots.
See # 12 above. The PVC condition had been monitored for several years, but over time had grown in frequency (approximately 25%) and echocardiogram history began to show a diminished percentage of lower chamber output. After consultation with Dr.  a decision was made to do a heart ablation procedure to attempt to significantly reduce the PVC frequency. The procedure was successfully performed on June 30, 2021. A few weeks after the procedure a 7-day monitor was worn to measure the post procedure PVC results. At the follow up visit on August 16, 2021, the test results revealed the PVC?s had been reduced to less than 2% in frequency, and it was assumed that the heart function percentage likely had increased as well, so to confirm this result a follow up echocardiogram was put on the schedule for September 9th. At that time I was encouraged by Dr. to go ahead and get the covid-19 vaccine. The covid vaccine (Moderna) was taken on Friday afternoon (8/20) and by Saturday morning (8/21) I noticed the PVC?s had returned at a much higher rate. I assumed this would probably diminish after a few days and did not even monitor it for about a week or so. Self-monitoring the PVC rate varied but averaged about 12-13%. When it persisted I contacted the Doctors office and they advised me to come in earlier for the echocardiogram, a 12-lead ECG, and an office visit. To date, the symptoms have not diminished and PVC rate has been monitored and remains above 9%.
Patient  begin to  experience on March 25, 2023 on Sat around 5 pm inflammation and minimal pain around the right breast area  and underarmpit on right . On Sunday, March 26, 2023, pt had to have surgery at 4:30 pm to remove implants on right and on the left .
This case was reported by a other health professional via sales rep and described the occurrence of sickness in a patient who received FLULAVAL QUADRIVALENT. On 2nd October 2015, the patient received FLULAVAL QUADRIVALENT. On 5th October 2015, 3 days after receiving FLULAVAL QUADRIVALENT, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: This is one of the 7 cases reported by the same reporter. The reporter indicated that FLULAVAL vaccines were administered to a group of individuals at a company or clinic. The sales rep stated that the reporter said six other individuals called out sick (possibly October 5th) after receiving the Flu vaccine but details were unknown and it was not known if related.
once she got home the arm that she received the vaccine started to burn, it began to have a tingling feeling, soon after her head felt like it had it's own heartbeat similar pounding to a headache or migraine but not the pain associated with it, she felt she wasn't here that her head was in a bubble, she hasn't taken any medication and is now feeling better since she has been sitting.
I had painful breathing in the upper right quad of my abdomen. The deeper I took a breath, the more it hurt. The onset was on that Thursday. I am a right side sleeper and I couldn't sleep on that right side. I went back to the surgeon who removed my gallbladder. No treatment was given because no cause of the pain could be found. I started feeling less pain while breathing while I was in the waiting room. Over the next 3 days, the pain got gradually less to a point where it was not hurting at all.
Hallucinations; Dizziness; Fatigue; Nausea; Vomiting; A spontaneous report was received from a consumer, concerning her husband, a 77-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hallucinations, dizziness, fatigue, nausea and vomiting.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On an unspecified date, the patient received their first of two planned doses of mRNA-1273 (Batch Number: unknown) via unknown route for prophylaxis of COVID-19 infection. On 01 Mar 2021, approximately three days prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch Number: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 03 Mar 2021, after second dose of vaccine, the patient experienced nausea and vomiting, fatigue, dizziness, and hallucinations. The event hallucinations were considered to be medically significant. The patient was also not been out bed for seven days. No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not applicable.    The outcome of the events, hallucinations, dizziness, fatigue, nausea and vomiting were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events (dizziness, fatigue, nausea, and vomiting), a causal relationship cannot be excluded. Very limited information regarding these event (hallucination) has been provided at this time. Medical history and concomitant medications are required for assessment. However, further information has been requested. However, fatigue, nausea, and vomiting are expected for mRNA1273.
Partial dose of vaccine (less than 1/2 dose) was given in error and repeat dose has been rescheduled per CDC Guidelines.  No adverse reactions reported per RN. Pt rescheduled for revaccination on 02-25-2021.
A patient received an expired dose of PROQUAD; No known adverse effects; This spontaneous report was received from a....regarding a female patient of unknown age. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.  On 25-APR-2019, the patient received an expired dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA)(PROQUAD) lot number N021727, expiration date 06-FEB-2019 (route of administration and dosage were not provided) for prophylaxis. No known adverse effects were reported.
Seven patients were administered an improperly stored dose of VARIVAX; No adverse effects were reported; This spontaneous report was received from a Registered Nurse concerning to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided.  On an unknown date, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose was not reported) lot # N034557, the expiration date: 05-DEC-2019, subcutaneous for prophylaxis.  The sterile diluent was properly stored. No adverse effects were reported.  The temperature of excursion registered was 5.5 °F, for 2 hours and 15 minutes. The call was made due to a data logger and there was no previous temperature excursion.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA013413: US-009507513-1904USA013414: US-009507513-1904USA013415: US-009507513-1904USA013416: US-009507513-1904USA013417: US-009507513-1904USA013418:
Patient experienced pain at the time of injection and has been feeling numbness/pins and needles in the left hand.
vertigo; chills; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo), CHILLS (chills), HEADACHE (headache) and NAUSEA (nausea) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: flu shot in December 2020. Concurrent medical conditions included Vertigo (due to barometer pressure changes and weather changes.) and Feeling cold.    On 22-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced VERTIGO (vertigo), CHILLS (chills), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, VERTIGO (vertigo), CHILLS (chills), HEADACHE (headache) and NAUSEA (nausea) had not resolved.            Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
did not feel so good; like low blood sugar; he whole jaw felt numb (like she had gone to the dentist); metal taste in her mouth; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (did not feel so good), BLOOD GLUCOSE DECREASED (like low blood sugar), HYPOAESTHESIA (he whole jaw felt numb (like she had gone to the dentist)) and DYSGEUSIA (metal taste in her mouth) in a 32-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 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced FEELING ABNORMAL (did not feel so good), BLOOD GLUCOSE DECREASED (like low blood sugar), HYPOAESTHESIA (he whole jaw felt numb (like she had gone to the dentist)) and DYSGEUSIA (metal taste in her mouth). On 12-Feb-2021, FEELING ABNORMAL (did not feel so good), BLOOD GLUCOSE DECREASED (like low blood sugar), HYPOAESTHESIA (he whole jaw felt numb (like she had gone to the dentist)) and DYSGEUSIA (metal taste in her mouth) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No information regarding corrective treatment was reported by the patient.
Denies any adverse reactions. FLUMIST expired 12/3/12 & was given on 12/10/12.
Patient missed the second dose of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (Patient missed the second dose of the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Patient missed the second dose of the vaccine). On 06-May-2021, INTENTIONAL PRODUCT USE ISSUE (Patient missed the second dose of the vaccine) had resolved.            Second dose was scheduled on 06 May 2021, and patient wanted to re-schedule the second dose.   Reporter did not allow further contact
Patient received: PNEUMO - VAX 06/09/2009 arm swelling and patient complained that it swelled up like Hercules, not documented in system, believe this was historical and data needed to compete form is not available. PNEUMOVAX 06/19/2015 Patient received this vaccination and had a similar but less severe reaction. He did not seek care, and no permanent damage was done. Documenting this one because there is information regarding the vaccine and the initial injection in 2009 can be seen nationally were the patient ever to transfer to another site.
Complaint-lightheaded, nausea, throat0chest tightness. to ED for evaluation-released home.
79 year old patient received Fluzone High Dose Quadrivalent on 03-Sep-2021 and again on 21-Sep-2021/no AE; Initial information was received on 22-Sep-2021 regarding an unsolicited valid  non-serious case received from a physician and health care professional via Agency - 00780734].  This case involves a 79 year-old female patient who was vaccinated with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] on 03-Sep-2021 and again on 21-Sep-2021 (Extra dose administered).  The patient's medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On 03-Sep-2021 and on 21-Sep-2021, the patient received first and second dose 0.7 mL of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (Strength: standard; lot UJ704AA and UJ741AB; expiry date 30-Jun-2022) via an unknown route at right and left deltoid respectively for prophylactic vaccination.  It was a case of an actual medication error due to extra dose administered (latency was on same day).   It was reported "Caller states that on 21-Sep-2021 a female patient age 79 received a dose of FLUZONE HIGH DOSE; after administration, staff realized patient had a dose of FLUZONE HIGH DOSE on 03-Sep-2021; caller would like to know of adverse effects to look out for. The caller states that this happened within the same practice but in two different locations".  At the time of report, no adverse event reported.   Outcome of event was unknown.   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 the 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.  Product used : Used  First time product used : No
Case number PHEH2013US018983 is an initial spontaneous report received from a nurse on 05 Sep 2013, with a follow up received from a nurse on 10 Oct 2013. This report refers to a 19-year-old female patient. Her medical history and concomitant medication were not reported. Her vaccination history included administration of meningococcal vaccine (manufacturer and batch number unknown) on 11 Oct 2005, which was well tolerated. She was vaccinated with MENVEO (batch number: X11077, expiry date: 01 Jun 2014) in the right deltoid at a dose of 0.5 ml intramuscularly on 07 Aug 2013 at 02:15 pm. It was reported that MENVEO which reached 31 Fahrenheit for 3 days was subsequently administered to the patient. No adverse event was reported following this medication error. Follow-up was received on 10 Oct 2013: Updated patient demographics, vaccination history, site and time of vaccination.
Information has been received from a physician concerning a 4 month old patient who was vaccinated PO with a second dose of Rotateq. Subsequently the patient experienced diarrhea that started 1-2 days after the vaccination. Unspecified medical attention was sought but no tests were performed. The patient recovered. The physician was uncertain if the diarrhea was related to the Rotateq. Additional information has been requested. Follow up information received from the physician indicated that the patient had "severe" diarrhea, 8-10 times per day for 48-60 hours. No additional information is expected.
Fever between 99-102, muscle/joint aches, extreme fatigue, all lasting 24 hours
Patient admitted to hospital with stroke like symptoms on 11/7/2021, LKW earlier 11/7/2021. Stroke work up positive for Acute Ischemic left middle cerebral artery stroke. Patient discharge home after 2 day hospital stay.
itching and burning throughout body; itching and burning throughout body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient. A female patient received bnt162b2 (COMIRNATY), administration date 08Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.   The following information was reported: BURNING SENSATION (non-serious), PRURITUS (non-serious) all with onset Nov2021, outcome "unknown" and all described as "itching and burning throughout body". Therapeutic measures were taken as a result of burning sensation, pruritus.  Additional information: After the first dose the patient immediately experienced itching and burning throughout body. The reporter stated that she was currently taking a 6-day regimen of steroids which will end on 11Nov2021 (reported as Thursday). She was scheduled for her second dose on 29Nov2021 (Monday). She wanted to know if the potency of the second dose the same as the first dose or is it different. There was no product quality complaint (PQC) present.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  The lot number for the vaccine was not provided and will be requested during follow up.
Initial information received on 09-Oct-2018 regarding an unsolicited valid non-serious case received from a health professional. This case involves a four-months old patient of unknown gender who received a dose of PENTACEL instead of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE. The patient also received a dose of IPOL and a dose of ACT-HIB. Patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant vaccinations given. On 24-Sep-2018, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE lot C5518AA expiry date: 15-Sep-2018 via intramuscular route in the left thigh. On 01-Oct-2018, the patient received a third 0.5 ml dose of ACT-HIB batch number: UI863AAA, exp date: 18-Feb-2019, intramuscularly in left thigh. On 08-Oct-2018, the patient received a third dose of 0.5 ml dose of IPOL batch number: N1G511M, exp date: 02-Aug-2019, intramuscularly in left thigh. It was reported that it was too early per schedule. Caller reported that the patient's parents did not want combination vaccines for the child. It was a case of actual medication error due to Wrong vaccine administered, inappropriate schedule of vaccine administered, expired vaccine used and extra dose administered. It was not reported that if any adverse event was experienced or not. 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. List of documents held by sender: none.
My right arm got really swollen and itchy and that lasted a few weeks. I did not contact my Doctor since it was listed as one of the reactions.
Patient received her vaccine at 5 PM and called the pharmacy around 7 PM saying her arm was red, swollen, and sore. I instructed her to use an ice pack and to take either Tylenol or Motrin. I called her at 8:40 PM and she said the ice had helped and her arm looked better.
Child had local reaction 5cm X 7cm raised area and hot to touch. Pt was treated with 5 days of Augmentin 400mg BID and Orapred 5mg BID.
COVID-19; acute respiratory failure with hypoxia' Pneumonia due to infectious organism, unspecified laterality, unspecified part of lung; Hyponatremia
Information has been received from a nurse practitioner referring to a 26 years old female patient. Information about concurrent condition, concomitant medication and medical history was not provided. In 2016, the patient received 1st dose in GARDASIL 9 series (dose, route, lot# and expiration date were not reported) for prophylaxis. On 28-MAR-2018, the patient received 2nd dose in GARDASIL 9 series (lot# N013276, expiration date 21-JAN-2020; dose and route were not reported) (Inappropriate schedule of vaccine administered). No adverse effects were reported. No product quality complaints was filed.
As the nurse put the injection in my arm it hurt more than usual. Then within hours it started hurting more and more. It hurt so bad that I had to take off work for two weeks, I couldn't even raise my arm up I couldn't hold a bottle of water with that hand this went on for over 2 weeks. Even after going back to work I had to alter my routines and make it easy on my shoulder. It's now been months and I still have pain in that shoulder I can't lift heavy things with that arm can't sleep on that arm it still hurts more than right after the average flu shot. Both my family doctor and a nurse at the health department said the shot was put way too high. My family doctor said if the pain continues after I have my baby that she will have x-rays and stuff done to see if she can help the pain at all. This is my fourth pregnancy I am due February 3rd. The pregnancy has been a normal healthy pregnancy.
MD ordered Diphtheria-Tetanus-acellular Pertussis vaccine (Tdap) and CMA gave the vaccine in left deltoid at 1240 on 10/7/16 (# GSK Lot # EC9A9, expiration 1/22/2019). Patient developed pain and swelling at the left arm injection site and returned to office on 10/10/16 for acute visit. MD assessed the patient and found mild swelling around the area of injection site. Patient stated that the pain is radiating to her left hand. Patient denied any erythema, fever or chills. Patient was advised to apply topical compress to the area, take acetaminophen or NSAIDS as needed and to return to office in one week for follow-up.
Injection site pain, swelling.  On Saturday noticed swelling in underarm and hardening of breast tissues.  Went to PCP on Monday 7/19 and was diagnosed with costochondritis and myalgia of the neck, chest and back.  Patient given meloxicam and sent home.
Sick; Slept on and off all day; Nauseous; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore), ILLNESS (Sick), SOMNOLENCE (Slept on and off all day) and NAUSEA (Nauseous) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore). On 11-Mar-2021, the patient experienced ILLNESS (Sick), SOMNOLENCE (Slept on and off all day) and NAUSEA (Nauseous). In March 2021, SOMNOLENCE (Slept on and off all day) and NAUSEA (Nauseous) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm was sore) and ILLNESS (Sick) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported. Treatment information was not provided.   This case was linked to MOD-2021-223978.
rt. hand fingers tingling, 15-20 minute later ears turned red, sinuses started aching, shaky week feeling