chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This baby received vaccines on 12/20/00 at 3 PM. The mother states that a "rash" started at midnight and "came and went" ; the baby also did not sleep all night. The patient presented to the Health Dept Pediatrics 12/21/00 and was seen by 6:30 PM. The doctor sent the father to Osco to get Benadryl so a dose could be given and the baby observed. Hives progressed to the point that the doctor wanted the baby to go to the ER. 911 was called and the baby was transported before Benadryl was given.
pt recvd vax & exp severe allergic react hives; treated w/DPH;
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted 8 minutes after administration, came to after a few seconds. Patient was laid supine with legs elevated and EMS was called. Patient stated that he was fine, but was taken by EMS for further evaluation.
Headache, Arthralgia, UrticariaPruritus, NauseaVomiting, irst dose- sore arm with redness, severe headache, lethargy and joint pain. second dose- sore red arm, itchy site, severe headache, very lethargic, nausea, joint pain lasting for the week Narrative:  Other Relevant History:
About 50mm induration within 3 hrs of injection and broad patch of topical redness/erythema and bruised feeling lasting for about 3 weeks.  After second dose (sub-q) in right forearm about 30 days after first dose a small induration (~15mm) was observed within 1 hr of injection followed by large (~100 mm) erythema after about 1 day spreading along forearm with mild itching.  Second injection site is resolving slowly as of this report
Client sympathetic with itching, hives 1 1/2 hr post Zostavax injection. Took 50 mg Benadryl with relief of Sx. Took 50 more mg in 4 hrs with resumption of Sx. Sx resolved with further incident or need for additional Rx.
Have four vaccines and shocked that contracted COVID; Have four vaccines and shocked that contracted COVID; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  An adult female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Have four vaccines and shocked that contracted COVID".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information provided and temporal association, a causal relationship between BNT162b2, and the events covid-19, drug ineffective cannot be excluded.,Linked Report(s) : US-PFIZER INC-202300231829 different patient, same drug and event.;
pt exp persistent crying since vax administered & beyond 2 1/2hrs -3hrs;leg swollen & reddened @ inj site, warm to touch;
Initial information received on 26-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 64 years old female patient who received an expired dose of 0.5 mL FLUZONE HIGH DOSE lot UJ042AA expiry date: 19-May-2018 via unknown route in the right deltoid on 23-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is an actual medication error case due to expired vaccine used, inappropriate age at vaccine administration and overdose. It was reported that the patient received FLUZONE HD a few days before her 65 birthday. It was not reported whether the patient had any adverse event. 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.
Patient said her neck is very red from her collar bone up to almost her ear.  She has no other symptoms other than the redness, no itching or difficulty breathing
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 56-year-old female patient 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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. The reporter stated that, their facility had not been able to download the digital data logger, they had been put on hold by the state at the moment. There had been no power outages that would have impacted the Moderna vaccine. It was reported that, the facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. The reporter did not have any questions and wanted to report this to Moderna. The reporter stated that no adverse reactions were reported by any patients. No treatment medications were reported.
p/vax pt arm aching a lot w/swelling & redness; pain is worse in evening; redness & swelling noted w/warmth to the site & arm is stiff
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jul-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 EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No treatment and concomitant information was reported.   Reporter did not allow further contact
G. mom - Reports crying x 2/2 hrs after vaccine administration. G. mom "thinks child not breathing normal". Examined in office 5 hr > administration of vaccine. No local reaction @ vaccine site lmp: "crying reaction to immunization"
little murmur in [his] heart; This is a spontaneous report from a contactable consumer(patient). This 84-year-old male patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0158) on 01Jun2021 via an unknown route in right arm at 84-year-old for Covid-19 immunization. Medical history and concomitant drug were not provided. Historical vaccine included 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EW0150) on 11May2021 at 84-year-old for Covid-19 immunization.  Patient had an echocardiogram scheduled this Wednesday, 06Jun2021, and further reported had scheduled for an echocardiogram on 09Jun2021; due to a "little murmur in [his] heart", which his doctor noted during his physical exam a couple days ago.  The Patient stated that he heard from other people that they don't recommend any other scans after receiving the second dose of the vaccine, and inquired if it's safe in getting his scheduled echocardiogram. Outcome of the event was unknown.
small rash to rt arm chest & lt arm accompanied by itching;rash appears to be varicella like lesions;
Hives(that Itch) all over my body. Started in my arms and moved to everywhere.
two months with cramps in his legs he cannot even walk and go to school; He get cramps through the day on his legs; two months with cramps in his legs he cannot even walk and go to school; He get cramps through the day on his legs; he wakes up in the morning in pain he was too sleep in pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 12 year-old male patient received bnt162b2 (BNT162B2), administered in hand left, administration date 08Jan2022 (Batch/Lot number: unknown) as dose 2, single and administered in hand left, administration date 18Dec2021 (Batch/Lot number: unknown) 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: MUSCLE SPASMS (non-serious), GAIT INABILITY (non-serious) all with onset Jan2022, outcome "not recovered" and all described as "two months with cramps in his legs he cannot even walk and go to school; He get cramps through the day on his legs"; PAIN (non-serious) with onset Jan2022, outcome "not recovered", described as "he wakes up in the morning in pain he was too sleep in pain". Therapeutic measures were not taken as a result of muscle spasms, gait inability, pain. Additional Information: Patient had lab test but nothing shows up in his blood, nothing that, he is healthy, he was healthy, he used to play soccer he used to do karate and now he can do nothing he cannot even go to school.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Weak; Dizzy; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak), DIZZINESS (Dizzy) and PYREXIA (Fever) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     The patient's past medical history included No adverse event. Concomittant product usage was not included.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced ASTHENIA (Weak), DIZZINESS (Dizzy) and PYREXIA (Fever). At the time of the report, ASTHENIA (Weak), DIZZINESS (Dizzy) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. Patient has requested for the follow up.
Patient reports that since he  received his second Pfizer COVID-19 vaccine in his left arm on 8/2/21, he has  had left arm pain and tingling down to his fingers and radiating to his neck. He  states this pain began 3-4 days after the injection. He denies any CP or SOB. He  states that it feels like severe muscle pain and it keeps him awake at night. He  reports the pain is causing him problems with his everyday movements and  activities. Denies redness or swelling. He states he has tried cold compresses,  heat application, NSAIDs, and Tylenol with no effect. He did not have a reaction  with the first vaccine.
IN ABOUT 1 WEEK AFTER VACCINATION, ITCHING AND SWELLING BEGAN DEVELOPING ON MY LEFT ARM, A LITTLE BIT UNDER THE  VACCINE SITE, THE FOLLOWING DAYS, RASHES CAME OUT IN OTHER PARTS OF THE BODY, FIRST AROUND WRISTS AND ANKLES, THEN KNEES AND ELBOWS, THEN LEGS, UPPER BODY, THEN FINGERS, TOES, LIPS, EARS. THE RASHES ARE EXTREMELY ITCHY WHEN THEY ARE SWELLING. I WENT TO THE DOCTOR AFTER ONE WEEK OF SUCH SYMPTONS, I WAS GIVEN LORATADINE AND CREAM FOR SKIN. I HAD THE PILLS FOR ABOUT 2 WEEKS WHEN THE SYMPTON BEGAN TO IMPROVE. THEN I STOPPED TAKING THE PILLS, AND NO NEW RASHES CAME OUT TILL TODAY. I DIDN'T TAKE THE 2ND SHOT CONSIDERING THERE MIGHT BE MORE STRONG SIDE EFFECT.
Several days after vaccine woke with body aches, fatigue, shortness of breath, decreased endurance, inflammation, joint pain, lacy rash/hives on shoulders and chest, weight gain, increased fatigue
EXCRUCIATING BACK PAIN; MUSCLES WEAKNESS; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included back pain. The patient experienced drug allergy when treated with cefepime, and vancomycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029,expiry: 25-MAY-2021) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced muscles weakness. Treatment medications included: lidocaine, and paracetamol. On 17-APR-2021, the subject experienced excruciating back pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from excruciating back pain, and the outcome of muscles weakness was not reported. This report was non-serious.
The injection site is hot/warm; The injection site is swollen; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (the injection site is hot/warm) and VACCINATION SITE SWELLING (the injection site is swollen) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Feb-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 VACCINATION SITE WARMTH (the injection site is hot/warm) and VACCINATION SITE SWELLING (the injection site is swollen). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (the injection site is hot/warm) and VACCINATION SITE SWELLING (the injection site is swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       2 weeks after receiving the vaccine, the patient's injection site was hot/warm and swollen. The patient has been putting ice pack on it. Then she contacted her doctor and who prescribed aspirin/Tylenol and told her to use the ice pack.  Concomitant medications were not reported.
Instant swelling of the left lymph node ( visibly seen by witness and was compared to the size of a lemon) and swelling of right (minimal) closing throat, inability to swallow and challenge to breathe, tingling in hands, 90%  loss of muscle strength in legs, heart palpitations (over 90 bpm - avg. 62), loss of concentration and low Co2, and flushed/redness in skin on neck, face, hands, back.  I had many witnesses and 2 called 911 thinking it was anaphylactic shock with continuous throat swelling.   Paramedic said that it did not appear to be an allergic reaction but could clearly see my lymph nodes swelling. Provided  oxygen, Benadryl,  IV and blood tests. No infection was found and no food allergy in past.  I could not move my legs for a couple of hours but eventually had swelling, muscle strength decrease and return back to normal by the end of the evening.  My  first dose had no symptoms. However, I placed my hormone patch on the same arm of the second vaccine that week (*note -have used for over a year with no adverse reactions). Possibility of lymph node overdrive or anaphylactic shock with the combo? Should be looked into. Very serious, life threatening event.
Patient experienced nausea, then a seizure 5 minutes after receiving the vaccination. He was incontinent and postictal. He remembers his arms tingling and difficulty opening his right hand. Patient went to the ED.  His CT scan was negative for bleed. EKG showed sinus bradycardia 48.  Patient did have a head injury at the age of 18 but no prior history of seizures. He was discharged but told to follow up with neurology.
I had a really severe sore throat; I lost my voice for awhile. Water on my ears and 101 degree temperature. Runny nose really bad. There was drainage down my throat from runny nose. Feeling really weak and tired. Really deep down in my lungs cough. I was sick for about five days and then went to Urgent Care; Cough medicine and Z-Pak Antibiotic that helped with all except the water in my ears. That hasn't gone away yet so my hearing is a little off.  The cough lasted for about two and 1/2 weeks but is gone now. I cough every once in a while, but not bad. I may go back to the Urgent care for my ears.
pt devel severe h/a 9/98 lasting 1week; starting 11/1/98 pt has had h/a every day x 9mo; pain is 9 on scale of 1-10; to clinic numerous times for attempts to stop pain; test done; many drugs used; biofeedback; magnet therapy; Annual follow up states the pt has coordination problems.
Hospitalized (11.15-11.19);  COVID-19 positive (11.15.21);  fully vaccinated  Admission Date: 11/15/2021;  Discharge Date: Nov 19, 2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Weakness [R53.1] Hypoxia [R09.02] Fever, unspecified fever cause [R50.9] Pneumonia due to COVID-19 virus [U07.1, J12.82] HOSPITAL COURSE: 85 yo M hx Cad s/p CABG, Hx CVA, Depression, T2DM. He presented to ER on 11/15 with severe weakness, chills, rigors and cough for the past 10 days. He was found to be COVID19 positive, he is unvaccinated. He was placed on 2L oxygen for support and started on steroids. He labs were also notable for mild AKI, leukocytosis, elevated inflammatory markers. CXR without acute cardiopulmonary process. He was admitted to Medicine Service for further assessment and management. He was started on iv fluids. His kidney numbers improved. He was able to wean off of oxygen.  His symptoms resolved by the following day.  Physical therapy recommended acute rehab.  Patient was discharged to acute rehab at Blodgett on 11/19/2021.
Initial report was received 23 September 2011 from a health care professional which involved a cluster of 50-60 unidentified patients. This case represents one patient who experienced face swelling. A second patient who experienced axillary swelling axillary had been captured in case number 2011-09286. The remaining cluster of 50-60 unidentified patients have been captured in case number 2011-09280. An unidentified patient had received an injection of FLUZONE (unspecified; lot number, route, site and date of administration not reported) and an unspecified amount of time later, the patient developed face swelling. Outcome was not reported. NO additional information was provided at the time of the report. Documents held by sender: None.
Headache, body ache, fatigue for 24 hrs. Swollen lymph glands in left armpit still
Very sick; Shaking; His body was cold; Shivering; Headache; Throwing up even though there's no food in his stomach over night.; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ILLNESS (Very sick), TREMOR (Shaking), FEELING COLD (His body was cold), CHILLS (Shivering) and HEADACHE (Headache) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027CZ1A and 044BZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to animal.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced ILLNESS (Very sick), TREMOR (Shaking), CHILLS (Shivering) and HEADACHE (Headache). 11-May-2021, the patient experienced FEELING COLD (His body was cold) and VOMITING (Throwing up even though there's no food in his stomach over night.). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 11-May-2021, ILLNESS (Very sick), TREMOR (Shaking), FEELING COLD (His body was cold), CHILLS (Shivering) and VOMITING (Throwing up even though there's no food in his stomach over night.) had resolved. At the time of the report, HEADACHE (Headache) outcome was unknown.            Treatment and Concomitant medicines were not provided,     This case was linked to US-MODERNATX, INC.-MOD-2021-128524 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-128524:
2/13/2023 CLINICAL IMPRESSION: Hyponatremia, Shortness of breath, Bilateral edema of lower extremity Presents to the ED with chief complaint of shortness of breath, cough, congestion. The patient has had fatigue with bilateral lower extremity edema and a cough.  On arrival here, the patient was afebrile with heart of 92, respiratory 26, blood pressure 137/74, pulse ox 96% on room air. On exam, the patient had some tachypnea with increased work of breathing but clear lung sounds, bilateral lower extremity edema.  Principal Problem: Acute diastolic congestive heart failure (*) Active Problems: Peripheral vascular disease (*) Hypothyroidism due to acquired atrophy of thyroid (*) Chronic atrial fibrillation (*) Essential hypertension (*) Dual Chamber Cardiac pacemaker - Dr. [ 03/23/2014] Generalized anxiety disorder (*) Aortic valve stenosis, severe Resolved Problems: * No resolved hospital problems  Submitter does not have access to further medical records or information on hospital course. If further information is needed, please contact the admitting hospital: