chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever/flush, chills/pale, body aches, headache, sore arm day 1 3 large red bumps below injection site, pain from shoulder to wrist, swollen wrist (watch too tight), sore/swollen axillary glands & neck on injection beginning day 1 night (reported to Moderna phone line) worsening & spreading day 2 treated with ice at injection and bump sites, 500mg Tylenol about every 4 waking hours
Patient treated with antibiotic therapy for cellulitis.  reported 5/10/2022 to pharmacy
The second dose of hepatitis A vaccine was administered 24 weeks after the first dose instead of 6 calendar months.
I developed a rash the next day. The rash was on both arms on the elbow and the inside of my arm. on the inside of my legs.  Gastrointestinal bleeding and blood in my stool.
maculopapular rash starting along back of neck spreading to upper arms, drunk & legs over 2 days;+rhinitis;no coryza, cough, koplik's spots;low grade fever;
Patient received the first dose of Pfizer vaccine on 09/08/2021 and was due to get his 2nd dose of Pfizer vaccine. Patient was instead given the Moderna vaccine. Patient did not have any strong side effects other than fever on 10/19/2021 which patient recovered from on 10/20/2021 after taking Advil.
Approximately 2 weeks after my booster shot I developed chronic spontaneous urticaria and am still experiencing it 5 months later. I also had a fainting incident the day my symptoms started and had to go to the ER.
Chest pain ,  headache feverish with no fever , feels like the flu with no fever, achy all over
Within 5 minutes of vaccine patient became lightheaded, saw black spots, had muffles hearing, felt nauseous, and was having slight trouble breathing.  She started feeling better in about 15 minutes. EMTs arrived on site within 2 minutes of her symptoms and they evaluated her before leaving.
Pt stated that she had headache, cough, mouth sores, rash on chest area. The blood vessels of her eye were red, and had trouble hearing.
She took a test and her doctor told her the vaccine did not work; She took a test and her doctor told her the vaccine did not work; This is a spontaneous report from a non-contactable consumer or other non-health care professional. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution), dose 2 via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as single dose, dose 1 via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. Medical history included bone marrow transplant from 2019 (two years ago) and went through chemotherapy, and immunocompromised. The patient's concomitant medications were not reported. After the vaccination on unknown date in 2021, the vaccine did not work because she had low immunity after chemotherapy. She took a test on unknown date in 2021 and her doctor told her the vaccine did not work. Her doctor told her to wait until there was more information. Outcome of the events was unknown.   No follow-up attempts are possible. Information regarding the lot/batch number cannot be obtained.
COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 73-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing); "Fibromuscular dysplasia" (unspecified if ongoing). Concomitant medication(s) included: ARMOUR THYROID taken for thyroid disorder, start date: Jun1990. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13Dec2022, outcome "unknown" and all described as "COVID-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Dec2022) Positive; (18Dec2022) negative; (24Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient took Paxlovid from 13Dec2022 to 18Dec2022 for the treatment of COVID-19. The patient had COVID rebound. The patient tested positive for COVID on 13Dec2022 and started Paxlovid on 13Dec2022. Tested negative after treatment on 18Dec2022. Symptoms restarted on 23Dec2022. Tested positive on 24Dec2022. Reported rebound to my MD on 26Dec2022. The patient had no known allergies.    The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Swelling of hands, knees, feet with mobile rash and pain, with sensitivity to touch and movement. Diagnosis - urticarial rash/hives. Illness lasted 3 weeks. RX - prednisone, TYLENOL. Treated w/ ORAPRED and BENADRYL.
twitching; pain; A spontaneous report was received from a non healthcare professional who was 70 years old male patient who received Moderna's COVID-19 vaccine. Caller reported adverse event following Moderna vaccine on 16JAN2021. Symptoms included twitching and pain.   Patients medical history was not available. His concomitant medication included simvastatin for cholesterol,Tamsulosin for prostate and hydrochlorothiazide for water retention. The start date or stop date of these medications were not provided. Treatment provided was unknown.  Action taken with mRNA -1273 was not available.  The outcome of events ,twitching and pain are unknown.
Hep A given 0.5ml right deltoid on 9/3/04 at 10:30 AM. Developed sudden temp of 103 at 4:30 PM on 9/3/04. Patient was fatigued, exhausted, with decreased energy and increased sleepiness. These symptoms continued throughout 9/4/04 with anorexia included. On the morning of 9/5/04, he awoke and was back to his baseline of excellent health.
Day of shot slight pain at injection point which went away in 48 hrs. Then on day 8 post shot: 1.75 inch diameter swelling bump with itchiness and slight pain on bump area.  No other symptoms.
Several children, ages 6-16, vax w/ booster dose;  complained of stinging at inject site;  Stinging lasted 1 minute.
Information has been received from a licensed practical nurse concerning an approximately 5 year old patient who on 05-JAN-2004 and on 12-FEB-2007 was vaccinated with the first and second (lot# 656079/1306F) doses of VARIVAX (Merck). On approximately 27-MAR-2007, the patient developed small lesions scattered. At the time of the report, the patient's outcome was unknown. This is one of several reports received from the same source. No further information is available.
The area around my shot is extremely swollen, red and warm. It is getting bigger and now about the size of a hockey puck. It is sensitive to touch, however, I have no other symptoms other than the area of contact.
Lymphedema under the left arm - worst on day 2, and slowly resolving at day 6.
This spontaneous report as received from a pharmacist, via company representative, refers to a female patient of unknown age. On an unknown date, in the past, that patient received an unspecified dose of ZOSTAVAX (dose, route and lot number were not reported) and on an unspecified date developed "a rash up and down and inside and outside of her from top to bottom". Patient took no other medications. There were no other symptoms. The outcome of rash up and down and inside and outside of her arm from top to bottom was not reported. The relationship between ZOSTAVAX and event was not reported. Patient seek medical attention: contacted pharmacy. Additional information has been requested.
Within 5 minutes of vaccination patient developed hives on mouth and chest. Gave oral diphenhydramine. Patient recovered in 30 minutes.
A53 year old female inadvertently received an injection of Tetanus Toxoid Adsorbed, on 01/31/00, instead of PPD. That same day, she developed an injection site reaction characterized by redness and swelling. She was treated with Benadryl.
Pt called and told me that within an after his shingrix shot, he got a red rash and tingling on the left torso to left buttock. He said it felt raised like a big bump. An hour later th patch spread eventually leading growing to front quad and outside left hip in addition to the torso and buttock. All raised and all tingling. He said he saw a teledoc who told him he had shingles. He was told he had shingles by the health care provider. He called and wanted to let us know because the provider told him to do so. Overall his symptoms are relatively mild as he said he heard shingles are a lot worse than what he is feeling. He still wants to get the second vaccination.
pt recv vax & exposed to chickenpox in community;pt devel chickenpox which was dx in ER. This is in follow-up to report (s) previously submitted on 5/14/1999 28-month-old male patient with hypotonia and developmental delay and no known allergies who on 20-Jan-1998 was vaccinated with one dose of varicella virus vaccine live sc. The patient was subsequently exposed to chickenpox in teh community. On 13-Apr-1998 the patient developed chickenpox which was diagnosed in an emergency room. Subsequently, the patient recovered from the episodes. No further information is available. There is an amended report. the patient's address, history and recovery status were added and the narrative was updated accordingly.
Information has been received from a licensed practical nurse concerning a 66 yr old female pt with allergies to meperidine hydrochloride (Demerol), codeine, and procaine hydrochloride (Novocain), degenerative joint disease, hormone deficiency and dyspepsia who on 25Oct05 was vaccinated IM into the upper left deltoid with a second dose pneumococcal 23v polysaccharide vaccine (lot 651523/0604R). Concomitant therapy given IM into the left deltoid included a third dose of influenza virus whole virion 3v vaccine inactivated (Fluzone (influenza virus whole virion 3v vaccine inactivated)) (lot U1777AA), Iansoprazole (Prevacid) and omeprazole. There was no illness at the time of vaccination. On 25Oct05, the pt returned to the office because she experienced a more extreme reaction than usual to the vaccine which included possible cellulitis with redness, warmth, swelling at the site and severe site pain and tenderness. Unspecified medical attention was sought. The pt used ice packs and ibuprofen for two days for muscle aches and redness. On 29Oct05 after 4 days, the pt recovered. It was noted that the pt did not have a reaction to the initial vaccination of pneumococcal 23v polysaccharide vaccine. A investigation into the lot number was requested. No product quality complaint was involved. The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards and was released. Additional information in not expected.
Patient c/o itching at the site, 5min later started coughing. Mom stated he was having an asthma attack, but did not have inhaler. Dr. notified and nebulizer treatment started with pulse ox.
Heart palpitations and arrhythmia beginning on 2nd day after vaccine  Heart rate elevate 20+ bpm General ill feeling with body aches and fatigue
Patient called after getting 3 imz yesterday about some side effects/ reactions. Patient had received Shingrix, Fluzone HD, and Arexvy. He was fine after the vaccines, but later that night got chills, fever, muscle aches, lethargy, some dizziness. This morning he had some difficulty getting around due to the muscle aches and dizziness and had some difficulty with vision. He said he had glasses on but it was like he still didn't, was very blurry and unable to focus or read things. This was currently getting better. He called us to verify which vaccines he had received. I went over them with him and discussed how most of that are side effects that can happen with the vaccines but the change in vision is abnormal. I told him he could take some Tylenol to help with fever, chills, and body aches. He appreciated that. I told him if anything worsens or does not go away to go in to the doctor. He stated he would and would let his doctors know as well. I called patient 9/10/23 and patient was doing better.
Patient got vaccinated at 10:32 AM.   He called at 2:24 PM and said that his hand has been shaking "since 2 hours ago".  He said it's been like that for 1 hour.   He self-reports that he checked his blood glucose & blood pressure and they're all within  normal.  I told him to see MD ASAP.  Last I heard from him was that he's going to call an ambulance.
Large red, swollen,  itchy area near injection site developed about 9 days after injection.
Severe chills, myalgias, neuralgias, low-grade fevers, headaches.  Treatments, Aleve 440mg with feverfew 2 tabs.  After taking medication, diaphoretic episodes.  Symptoms began 9 hours after the vaccine.  Severe symptoms continued for 34 hours.
9 days after I got dose #1 I  got red, hot, itchy large bump by injection site. It grew and 36 hours later still here. Taking Benadryl, Ibuprofen and icing and it hasn't gone away. Some docs are saying it's COVID arm but going to see my regular doc tomorrow when the office opens back up.
Red swelling and sore but not at injection site, moved down the arm she received it in.
Pt vaccinated with Influenza c/o achiness & flu-like s/s first wk. Confirmed febrile - becomes febrile 3-4PM & as high as 102 by 6-7PM, nigh sweats, weakness, nausea.
COVID infection; COVID infection; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 04Jun2022 at 10:00 as dose 4 (booster), single (Lot number: FK9895) at the age of 44 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: METOPROLOL; AMLODIPINE; LOSARTAN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24Jun2022, outcome "recovered" (2022) and all described as "COVID infection". The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: (28Jun2022) Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical Course: Report was about covid treatment. More than 3 Doses received. Facility type vaccine was Hospital. No other vaccine in four weeks. Other medication in 2 weeks were metoprolol, amlodipine, losartan. No covid prior vaccination. Covid tested positive post vaccination.   No follow-up attempts are possible. No further information is expected.
Patient presented to emergency department from skilled nursing facility for shortness of breath and hypoxia. Patient also reported shoulder pain. Patient reported she tested positive for COVID-19 on 10/1/2021. Due to patient's current treatment for osteosarcoma, she was transferred to a different facility to be cared for by her current care team.
This spontaneous report was received from a medical assistant refers to a 66 years old female patient with hypertension, hyperlipidemia, allergy to doxycycline, tetracycline, LEVAQUIN and acetaminophen, PERCOCET and a history of deep vein thrombosis who on 07-NOV-2011, was vaccinated intramuscularly with a 0.65 ml dose of ZOSTAVAX (lot number not reported). No other co-suspects were reported. Concomitant medications included gabapentin, furosemide (manufacturer unknown). ZYRTEC, atenolol, LOVENOX, meclizine, COUMADIN, lansoprazole, alprazolam, and doxepin hydrochloride. It was reported that in July 2012, the patient developed shingles. Acyclovir was given as a treatment for the experience. No lab diagnostics studies were performed. At the time of the report, the patient was recovering, no longer had lesions. On 07-SEP-2012, the patient had an office visit because she continued to have pain. The relatedness for patient developed shingles was unknown for ZOSTAVAX. Additional information has been requested.
Pt. had shot yesterday (MENVEO vaccine). He asked for ADVIL this morning due to pain in (L) deltoid. This morning patient was training for wrestling and boxing and was on floor off and on. Rash started approx 12:30 PM. The swelling was worse prior to getting to the office. Treated with ice pack and told to take CLARITIN 10mg once daily.
This spontaneous report was received from a medical assistant and refers to a 15 month old patient of unknown gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 26-OCT-2016, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # L042267, expiration date 27-OCT-2017; site, dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as no further information is available.
This is a spontaneous report from a contactable Pharmacist via Pfizer sales representative. A 65 years old female patient of an unspecified age and ethnicity received on the same unspecified date PREVNAR 13 at single dose and influenza vaccine both via an unspecified route of administration for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced a little more tired and she felt like she was becoming sick on an unspecified date with outcome of unknown. No follow-up attempts are possible. No further information is expected.
Patient is under 18 years old (Moderna not approved for this age); received first dose from this location; administered second dose per Moderna dosing schedule
Seizure after Dtap. Seen at ED on 6/17/2013.
p/4mos immun (24-48 hrs later) had 5-10 mins of unusual different cry during which time pt was not consolable; no fever noted; APAP was given; the cry occurred every 4-6 hrs during that time;
FOIL WRAP OR CAP OF VACCINE VIAL WAS REMOVED AND STORED IN FRIDGE; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855835, expiry: UNKNOWN) dose was not reported, administered on 20-FEB-2022 for prophylactic vaccination. No concomitant medications were reported. On 20-FEB-2022, the patient experienced out of specification product use, and foil wrap or cap of vaccine vial was removed and stored in fridge. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the out of specification product use and foil wrap or cap of vaccine vial was removed and stored in fridge was not reported. This report was non-serious.
Myalgia, Arthralgia, chills/ fatigue; unable to lift arm Narrative:
Narrative: She reports having experienced mild nausea and dizziness about an hour after the initial vaccination. This lasted for a few hours prior to spontaneously resolving and was not associated with other common adverse effects including vomiting, abdominal cramping or diarrhea. She was able to tolerate oral intake while having nausea.
Slight redness for 2 days after shot. Redness disappeared, then 1 week later redness came back at site of injection. It was very hot (103.5 degrees skin temp at site of injection, 97.2 for the rest of the arm). It was itchy and very painful. Lasted 5 days.
After 2 minutes a lot of bitterness in the mouth that lasted 4 hours, burning in the tears in both eyes that disappeared a few minutes later and a strange sensation in the ear that still continues, on day 6 after having vaccinated inflammation in the armpit glands left that continues.
Information has been received from a RN concerning a 38 year old male pt, with no reported medical history, who on 02Jun2003 was vaccinated SC into the left deltoid with a dose of  measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation). The pt denied any illness at the time of vaccination. ON 15Jun03 (previously reported as 14Jun03) the pt developed a "rash" on his face, abdomen (stomach), right arm and right leg with itching and came to employee health on 16Jun03 at 14:45. There was no drainage or vesicles noted. It was reported that the pt did not develop a fever and he did not require hospitalization or treatment. It was noted that the pt recovered. The pt stated that his mother told him that he did have an adverse reaction to the vaccine when he was a child. Additional information is not expected.
This spontaneous report was received from a medical assistant and a nurse via company representative refers to a 6 month old female patient. No medical history or concurrent conditions were reported. Approximately on 01-OCT-2014 (reported as 2 weeks ago) the patient was vaccinated with 3rd dose of ROTATEQ vial oral suspension (dose, frequency, lot number unknown). No concomitant medication was reported. On an unknown date approximately in October 2014, the patient experienced intussusception (hospitalization) and was hospitalized on an unknown date approximately in October 2014 for an unspecified length of time. On an unknown date approximately in October 2014, the nurse thought that the child had surgery (medically significant). On an unknown date, the patient received treatment for the event. Patient also sought medical attention. The outcome of intussusception was reported as recovering. Outcome of the surgery was unknown. Causality of the events were unknown. No product quality complaint (PQC) was involved. Upon internal review surgery was considered to be medically significant. Additional information has been requested.
This spontaneous report as received from a female patient of unknown age reporting on herself. The patient did not have any known allergies or reactions. Information regarding concomitant medications was not provided. In approximately October 2015 (also reported as "about a year and a half ago"), the patient was vaccinated with VARIVAX (strength, dose, frequency, lot number and expiration date were not provided) subcutaneously for prophylaxis. The patient advised that after receiving the second dose, on an unspecified date, she developed what "seems like hives" on her legs which was very itchy (urticaria). The symptoms have been getting worse for a year and a half. Her physician referred her to an anonymous dermatologist and an anonymous allergist on unspecified dates. There have been unspecified tests performed on unspecified dates, but no diagnosis and treatment of her symptoms. She was prescribed steroid cream, but the hives go away and then have come back on unspecified dates. There was no product quality complaint (PQC) involved. At the reporting time the outcome of urticaria was reported as not recovered. The reporter did not assess the causality between urticaria and VARIVAX. Additional information has been requested.
Insomnia, I was not able to sleep after my 12hr shift which is highly unusual for me. I was awake for a total of 45-50hrs before I could fall asleep. I finally took Benadryl 50mg and Melatonin 40mg and was able to fall asleep.