chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received from a patient in the USA on 18 July 2007. A 33 year old patient (with a medical history of allergies-PCN, egg, gluten, diary and mitral valve prolapse) complained of "shooting pains in the head and jaw", muscle and joint aches, malaise, lymph node swelling and weakness in legs after she received Adacel (lot number unknown, route and site of administration not reported) and a "TB test" (manufacturer, lot number, route and site administration not reported) "3 weeks ago". She denied any illness at the time of the vaccination. At the time of the report, some symptoms resolved but others persist. She has not been evaluated by a physician and her recovery status was not reported.
PATIENT WAS GIVEN AN ADDITIONAL BOOSTER SHOT OF MODERNA'S COVID-19 VACCINE. HIS ORIGINAL BOOSTER WAS GIVEN ON 12/10/2021. HIS SECOND BOOSTER WAS ADMINISTERED ON 02/03/2022. THIS MORNING, THE NURSE ON THE UNIT REPORTED PATIENT SAID "I FEEL WEAK".
10:00 - Flu mist given. 10:35am sl gag, coughing x 30 minutes. 2:30pm eyes puffy, hives over chest and back, mouth itchy, tongue fat, denies breathing difficulty. 3:45pm mouth stiff, "neck fat". 5pm to Dr. office received "shot" and oral prednisone. Follow up appointment 11/6/09.
She had fever 102-103 F one day after the vaccination, and seizure activity lasting about 20-30 minutes while she had fever (headache just before fever). She was sent to ER and received IV fluid and IV Ativan.
This case was reported by a nurse via sales repo and described the occurrence of pain in arm in a adolescent female patient who received BEXSERO. On an unknown date, the patient received BEXSERO (intramuscular) .5 ml. On an unknown date, the outcome of the pain in arm and fatigue were unknown. The reporter considered the pain in arm and fatigue to be almost certainly related to BEXSERO. Additional details were provided as follows: The patient was the physician's daughter. The age at vaccination was not reported. In 2016, the patient received BEXSERO on an unknown arm and was so fatigued and stays home in bed the next day. This case has been linked with case US2016161483 as reported by same reporter.
vaccines were out of the stability range with no reported adverse event; clinic already had given 4 doses of the vaccine out of stability with no reported adverse event; Initial information was received on 17-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2023SA323966, 2023SA323508 and 2023SA323592.  This case involves a 86 years old female patient to whom clinic already had given 4 doses of the influenza quadrival A-B high dose HV vaccine [Fluzone high-dose quadrivalent] that were out of the stability range with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 16-Oct-2023, the patient received a 0.7 ml, total, once dose of suspect influenza quadrival A-B high dose HV vaccine (unknown formulation) (lot U8162BA, expiry date: 30-Jun-2024 , strength: High dose) via intramuscular route in the right deltoid for Immunization and the time the clinic already had given 4 doses of the vaccine out of stability with no reported adverse event (poor quality product administered) (Latency: same day).  On an unknown date, vaccines were out of the stability range with no reported adverse event (product storage error).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the events.  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 and Regulatory Authority 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.
Erythema and tenderness with reactive lymph nodes left axillary area The size of erythema is 18x8 cm
Pt recvd 3 doses of Engerix-B 19APR90, 7NOV90, & 1JUN91 & 16AUG91 it was determined by titer result that pt did not respond to the vax series;
About two weeks ago from today 18Aug2021, he was diagnosed with COVID-19; lack of efficacy; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (About two weeks ago from today 18Aug2021, he was diagnosed with COVID-19) and DRUG INEFFECTIVE (lack of efficacy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In December 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 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 COVID-19 (About two weeks ago from today 18Aug2021, he was diagnosed with COVID-19) and DRUG INEFFECTIVE (lack of efficacy). At the time of the report, COVID-19 (About two weeks ago from today 18Aug2021, he was diagnosed with COVID-19) outcome was unknown and DRUG INEFFECTIVE (lack of efficacy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by reporter. He also mentions that he just had a Regeneron Infusion  . He wants to know how long he will be contagious for? How long does he have to quarantine?  Company Comment: This a drug ineffective report. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the causality of this event is assessed as not applicable. No further information is expected since there is no consent for safety follow up.; Sender's Comments: This a drug ineffective report. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the causality of this event is assessed as not applicable. No further information is expected since there is no consent for safety follow up.
6 in swollen, hot, tender arm w/flu-like sx; From correspondence received at manufacturer on 25-Apr-2000, it was reported that the patient recovered form this experience.  This case is closed.
This patient reports a lesion of unknown etiology to the suprapubic region two days after receiving his second dose of the Moderna vaccine. Dermatology workup included multiple biopsies, fungal cultures, and aerobic and anaerobic wound cultures. Diagnosis of skin infection of unknown origin with granulation tissue.
Information has been received from a nurse practitioner referring to a patient of unknown age and gender. Concurrent condition and medical history were not reported. On 26-OCT-2015 the patient was vaccinated with one expired dose of GARDASIL (lot #H021346, expiration 01-OCT-2015, dose and route were unknown). No adverse effects were reported. Additional information has been requested.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 29-FEB-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength: 0.5ml) (lot # L036245, expiration date 09-FEB-2018). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree) and the type of excursion (refrigerator/freezer) (R/F) for each time were 40, 34, and R; 136, 33 and R. The storage criteria was R. This is one of several reports received from the same source. Additional information has been requested.
Patient felt ill as soon as standing to leave vaccination room. Syncope episode (did not completely lose consciousness), blurred vision, shaking, chills, nausea, vomiting. This lasted about 15 minutes and the patient started to feel better.
upset stomach with intermittent nausea; fatigue; upset stomach with intermittent nausea; diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 11Mar2021 14:45 (Lot number: EN6203) at the age of 59 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "cancer - ovarian", start date: 2013 (unspecified if ongoing); "cancer - breast", start date: 2015 (unspecified if ongoing); "allergies: penicillin" (unspecified if ongoing); "allergies: sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: CENTRUM MULTIGUMMIES; CALTRATE [CALCIUM CARBONATE]; ARIMIDEX. Past drug history included: Vancomycin, reaction(s): "allergies: vancomycin"; Codeine, reaction(s): "allergies: codeine". Vaccination history included: Bnt162b2 (dose number: 1, administration time: 10:00 AM, vaccine location: Right arm, lot number: EL3247), administration date: 18Feb2021, when the patient was 59 years old, for COVID-19 immunisation, reaction(s): "constant runny nose", "Fatigue", "constant watering eye". The following information was reported: ABDOMINAL DISCOMFORT (non-serious), NAUSEA (non-serious) all with onset 12Mar2021 02:00, outcome "recovering" and all described as "upset stomach with intermittent nausea"; FATIGUE (non-serious) with onset 12Mar2021 02:00, outcome "recovering", described as "fatigue"; DIARRHOEA (non-serious) with onset 12Mar2021 02:00, outcome "recovering", described as "diarrhea". Therapeutic measures were not taken as a result of abdominal discomfort, fatigue, nausea, diarrhea.  Additional Information: Prior vaccination patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
So the day after I had some chest pressure and that lasted a couple days and it got less and less. I thought that was it but then I started getting heart palpitations around the holidays. I was due for a physical in March and mention to my doctor about that and shortness of breath at times, kind off and on flu like symptoms and been tested for COVID many times all resulted NEGATIVE. My provider had me wear a heart monitor for 2 weeks then it showed some abnormalities. SO then she had me do a stress test and echocardiogram. Results were lower then it should be so she sent me to a Cardiologist. First appointment was yesterday 6/30/2022. I was diagnosed with dilated Cardiomyalphay and the dr. is sending me for more labs and another echocardiogram plus a cardiac MRI. 2nd Cariology appoint. more labs and echo on 7/12/2022. No date for the cardiac MRI yet, waiting on call.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (sulfa), Vitamin D deficiency, Depression, Obesity, Anxiety and Migraine. Concomitant products included BUSPIRONE, ESCITALOPRAM, FAMOTIDINE, ATORVASTATIN and CYPROHEPTADINE for an unknown indication.    On 17-Sep-2021 at 4:31 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021 at 4:31 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 17-Sep-2021 at 4:31 PM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) to be not related.    There was no adverse reaction.   There was no acute illnesses at the time of vaccination and up to one month before. No treatment drug was reported.   This case was linked to MOD-2021-328706 (Patient Link).
dizziness, SOB, lightheadedness, lethargic, poss hyperventilation;
Patient stated the day after he received Shingrix he experienced nausea and a red sensitive injection site for  a few days. He recovered fully.
3-5 minutes after receiving Flu shot and Pneumonia Shot, one in each arm, I had severe pain in my lower back and hips and some pain extending down right leg.  I told the Pharmacist that gave the shots about the pain. All he said is "usually you don't have pain that fast".  So I told him I would wait to see if I got better.  In about 10 minutes the pain went away.
became really sick; bad virus; lost about 20 pounds; feeling bad; Initial information was received on 06-Oct-2020 regarding an unsolicited valid non-serious case from the physician via email..  This case involves a male patient (age in mid of 50's) who became really sick (malaise), feeling bad (feeling abnormal), viral infection (not corona) and lost about 20 pounds (weight decreased), while he received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2017 and expiration date was not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient became really sick (malaise) and feeling bad (feeling abnormal), 24 hours following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  On an unknown date, the patient developed non-serious viral infection (not corona) and lost about 20 pounds (weight decreased), (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  Details of laboratory data were not reported.  The patient treated with IMMUNOGLOBULINS.  At the time of reporting, the event outcome was not reported however, the patient returned to work after 1 week.
After 1st dose, delayed ovulation and period by 1 week; After 1st dose, delayed ovulation and period by 1 week; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 05Apr2021 (Batch/Lot number: unknown) at the age of 27 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: OVULATION DELAYED (non-serious), MENSTRUATION DELAYED (non-serious) all with onset 30Apr2021, outcome "recovered" (2021) and all described as "After 1st dose, delayed ovulation and period by 1 week". Therapeutic measures were not taken as a result of ovulation delayed, menstruation delayed.  Additional information: The Lot unknown reason was unable to locate or read the details. The facility type vaccine was school or student health clinic. No vaccine was administered to patient in four weeks. Patient did not take any other medications in two weeks. After 1st dose, delayed ovulation and period by 1 week. No change to daily routine. Patient did not have Covid prior and post vaccination. Patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Flu; I have full body chills and headache and fatigue; I have full body chills and headache and fatigue; I have full body chills and headache and fatigue; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu), CHILLS (I have full body chills and headache and fatigue), HEADACHE (I have full body chills and headache and fatigue) and FATIGUE (I have full body chills and headache and fatigue) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (Flu), CHILLS (I have full body chills and headache and fatigue), HEADACHE (I have full body chills and headache and fatigue) and FATIGUE (I have full body chills and headache and fatigue). At the time of the report, INFLUENZA (Flu), CHILLS (I have full body chills and headache and fatigue), HEADACHE (I have full body chills and headache and fatigue) and FATIGUE (I have full body chills and headache and fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.    Reporter did not allow further contact
blood in her eye, like it busted; This is a spontaneous report from a non-contactable consumer reported for herself. A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient got her first Pfizer covid vaccine this morning she was doing fine but when she came home and looked in the mirror, it looks like there is blood in her eye, like it busted.  It doesn't hurt or anything on unknown date with outcome of unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
MODERNA COVID VACCINE #3 GIVEN 10/27/21, LOT # 076C21A; 1/6/22 pt to ED with malaise, fatigue, generalized weakness; found to be in SVT requiring cardioversion; septic shock with bilateral pneumonia requiring intubation; able to be extubated; 1/14/22 found to be positive for COVID; treated with steroids, ABX, Vitamin D and zinc; pt suffered cardiac arrest, ROSC achieved; enterococcal bacteremia; UTI; placed on BiPAP; respiratory status worsened requiring reintubation with mechanical ventilation; pt expired in the hospital
Swollen, red and sore to injection site first night. Next day increased swelling, redness more and a lot more sore. I also had body aches that felt like authritis and a headache.
Patient presented to the pharmacy on 12.14 stating she developed a rash behind her neck the day after the vaccine. She reports itching where rash was located. She had not taken any medications at the time yet to relieve rash or itching. Therefore, advised patient to take Benadryl for relief. Followed up with patient on 12.19 and she said the itching and rash was resolved after taking Benadryl.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with the first dose of GARDASIL (Lot # not reported) in October 2011 and received her second dose of GARDASIL (Lot # not reported) in October 2012. No adverse effect was reported. Additional information has been requested.
Patient seen in the ED on 7/15 after testing positive for COVID at home. She reported coughing, headaches, and body aches. COVID-19 PCR swab also done in the ED and was positive. Patient did not feel safe being discharged home, so she was admitted from 7/15-7/18 and diagnosed with acute on chronic hypoxic respiratory failure due to COVID-19. She is vaccinated against COVID-19. This meets criteria for vaccine breakthrough case review.
Fever for over 48 hours, 101.8.. Chills during first 24 hours.
irritation in outer upper corner of left eye; eye infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 46-year-old male patient received BNT162b2 (BNT162B2), on 02Jun2022 at 16:00 as dose 2, single (Lot number: FJ4991) at the age of 46 years, in left arm for covid-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Single, Batch/Lot No: FM0173, Location of injection: Arm Left, Vaccine Administration Time: 06:00 PM), administration date: 06May2022, when the patient was 46-year-old, for Covid-19 Immunization. The following information was reported: EYE INFECTION (non-serious) with onset 03Jun2022 at 08:00, outcome "not recovered"; EYE IRRITATION (non-serious) with onset 03Jun2022 at 08:00, outcome "not recovered", described as "irritation in outer upper corner of left eye". The events "irritation in outer upper corner of left eye" and "eye infection" required physician office visit. Therapeutic measures were taken as a result of eye irritation, eye infection. Additional information: The patient had no other vaccine in four weeks and no other medications in two weeks. Day after dose 2, irritation in outer upper corner of left eye. over the next 5 days irritation persisted and developed an eye infection. Doctor or other healthcare professional office/clinic visited. The patient was treated with .prescription of antibiotics. The Patient did not have covid prior vaccination and was not tested for covid post vaccination. No Known allergies and no other medical history.
Immediate redness at injection site. Within 30 minutes, had developed a rash and had difficulty breathing (anaphylactic reaction). Within 1 hour, skin over majority of body (head, neck, torso, limbs) was itchy, red, and covered in hives (utricaria). Medical records state allergic reaction to vaccine. msv. Follow-up: Allergist suspects Latex, Neomycin Reaction.