chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The morning following the Dtap vaccine, patient screamed at 6:00 AM. I couldn't calm her and I noticed her eyes were arching up and over to the left. I noticed it a few times in the 2 weeks following the vaccine. Then, they started to appear in clusters. On the day of admission at the hospital, she had 11 clusters and 2 days before the admission, she had  approx. 4 to 5 clusters and I noticed that her legs were going limb (or at least she was losing control of her legs. The clusters were increasing. She was admitted overnight and the next morning they tested her. The EEG showed hypsarrhythmia. She got diagnosed with Infantiles Spams with no known etiology.
This is a prospective pregnancy case. This 36-year-old female subject was enrolled in an open label study. The subject received the 1st dose of BOOSTRIX .5 ml on 21st January 2015 16:00. The subject received BOOSTRIX at week 34 of the pregnancy and during the third trimester of pregnancy. On 21st January 2015 16:00, an unknown time after receiving BOOSTRIX the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing.
This spontaneous report as received from a consumer refers to a 66 year old male patient with hypertension. On JUN-2017 the patient was vaccinated with ZOSTAVAX, 1 DF for prophylaxis. Concomitant therapies included atenolol. On 07-JUL-2017 the patient experienced injection site pain. The outcome of injection site pain is unknown.
This case was reported by a healthcare professional and described the occurrence of increased liver function test in a female subject of unspecified age who was vaccinated with hepatitis A vaccine inactivated (Havrix) for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not reported. Previous vaccination included hepatitis B vaccine (manufacturer unspecified) which was administered on an unspecified date prior to 18 July 2006. On 18 July 2006, the subject received an unspecified dose of Havrix. At an unspecified time prior to 25 September 2006, after vaccination with Havrix, the subject experienced increased liver function test. No additional information was provided at the time of reporting. This case was assessed as medically serious by the manufacturer (OMIC). At the time of reporting the outcome of the event was unspecified.
COVID Vaccine Breakthrough Case  J&J dose 3/13/21 (180501) Moderna Dose 11/9/21 (076C21A) COVID Positive March 2020 COVID Positive 12/20/21  12/20/21: History is obtained from patient as well as the personal review of records. Patient is a 45-year-old with known history of class 3 obesity, BMI of 52.2, anxiety and depression, lung nodule, diabetes mellitus, sleep apnea, asthma, chronic respiratory failure, and other medical problems.  She has been having intermittent episodes of worsening shortness of breath and low pulse ox. She has oxygen concentrator at home and is supposed to use oxygen as needed.  On and off episodes of cough with small amount of white sputum.  She called her pulmonologist for worsening shortness of breath and low oxygen levels.  She was advised to come to emergency department. She was found to have fever on arrival at emergency department.  Her temperature went up to 101.2° F while undergoing evaluation in ED.  she felt better after oxygen supplementation. X-ray showed right-sided pneumonia.  She tested positive for SARS-CoV-2.  Patient previously tested positive for COVID-19 in March 2020. She required ventilatory assistance and was treated at Hospitals and Clinics.  She has chronic leukocytosis and follows with hematologist.  She follows with neurologist for memory problems.  12/22/21: Home with Home Health Care
Recently diagnosed with Sudden Sensory Hearing Loss in my right ear.  Loud, constant ringing in the ear. Hearing loss, unable to hear well.
Starting a couple of hours after the vaccine, all of my (severe) fatigue and joint pain completely disappeared.  The day after the vaccine I had no fatigue, nausea, etc. - Which I have had daily for months.  I attributed it to a Fibromyalgia flare, but I am unsure now.  The second day after the vx all fatigue and pain resumed.
No additional AE reported; PEDVAXHIB administered after a temperature excursion; This spontaneous report was received from a Health Care Professional and refers to a 15-month-old male patient.  Information regarding the patient's medical history, concurrent conditions, concomitant medications, and drug reactions or allergies was not provided.  On 16-DEC-2022, the patient was vaccinated with the third dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) intramuscular injection, in left thigh (LT), lot #W006596, expiration date: 11-OCT-2024, administered intramuscularly for prophylaxis (dose was not provided) administered for prophylaxis.   The administered dose of the vaccine had experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were previously stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.
EMS called to pt's home for SOB (in home close contact to COVID); intubated by EMS; when brought to ED, O2 sats were in the 80s; positive for COVID; decreased renal function; hypotensive, treated with Levophed drip; given dexamethasone; multi-focal pneumonia; developed ARDS; pt's condition suddenly declined due to a suspected mucus plugging; pt died in the hosp
Information has been received from a nurse practitioner concerning a 22 year old female patient with no pertinent medical history and allergic reaction to AUGMENTIN, CECLOR, and sulfonamide allergy who on 13-AUG-2007 was vaccinated with the first dose of GARDASIL (Lot # 658554/0928U) intramuscularly. On 29-FEB-2008 the patient received the second dose of GARDASIL (Lot # 660557/0072X). Concomitant therapy included LOESTRIN 24. It was reported that in December 2007 the patient developed mental illness which consisted of mood disorder after receiving GARDASIL. It was reported that the patient had not yet received the third dose. A serum level test for aluminum was performed (result not provided). It was reported that the patient had been hospitalized due to the disorder, but the reporter did not know the duration of the hospitalization. Additional information has been requested.
This case was reported by a consumer via sales rep and described the occurrence of injection site pain in a 61-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of nausea (1st dose received on 22nd March 2018, for events information refer case US2018120827). On 16th August 2018, the patient received the 2nd dose of SHINGRIX. On 16th August 2018, 6 hrs after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovering/resolving. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient experienced mild soreness in her left arm at the injection site and it presented 6 hours after receiving the injections and was resolving. She received the vaccine at 3:00 PM and the soreness presented that night. This case has been linked with case US2018120827 reported by the same reporter for the same patient (case of 1st dose).
Received vaccine 1/27/21, passed away in his sleep 1/29/21.
Started as red, raised round circle with tiny bumps inside. The circle?s circumference is larger than a half dollar. I immediately felt  pain and itchiness at the site, but did not see my left arm until I got home. Now, 3+ weeks after injection, round circle is not red, but is still itchy and noticeable (as of reporting).  There is a small, hard lump most likely where needle was inserted still.
Patient fully vaccinated for COVID (12/30/2021 and 1/20/2021). COVID exposure from co-habitant, tested positive for COVID on 4/28/2021.
Pfizer vaccine was administered outside of facility - reported by patient- ? NO LOT NUMBER WERE SUPPLIED  ALLERGIC REACTION, INIT 3/7/2022 PREGNANCY OF UNKNOWN LOCATION ALLERGIC REACTION, INIT 3/7/2022 PREGNANCY OF UNKNOWN LOCATION
Fever, Headache, Shaking Chills, Discomfort in the body.  I am taking Panadol every four hours.
Site: Pain at Injection Site-Mild, Additional Details: has persistent dry cough now for several day,not going away,told pt to contact md if persists
Copious Watery diarrhea. Extreme drowsiness. Wake up have diarrhea, sleep, slept all day 8/27, all that night, most of 8/28. Had to replenish electrolytes 8/28/16.
Erythma and edema of proximal (L) upper extremity. Tx with prednisone 1mg/kg burst x 3 days.
Information has been received from a physician concerning a 15 month old male who on 15-APR-2008 was vaccinated with a dose of VARIVAX (Merck) (lot # 659942/1797U) in his left arm. Concomitant therapy included vaccination with a dose of HAVRIX (lot #AHAVB200BA) in his right arm on 15-APR-2008. Within 15 minutes of vaccination the patient broke out in hives. The patient was given an unspecified antihistamine and fully recovered 15 minutes later. There was no product quality complaint involved. No further information is expected.
Information has been received from a registered nurse, for the Pregnancy Registry for GARDASIL, concerning a 19 year old female with no relevant medical history or drug allergies who on 04-NOV-2008 was vaccinated IM with a first 0.5 ml dose of GARDASIL (lot # not reported). Concomitant therapy included vitamins (unspecified). The patient sought an unspecified medical attention. The patient's LMP was estimated to 07-JUN-2008 and the estimated delivery date was 14-MAR-2009. It was reported that the patient had an uncomplicated pregnancy and delivered a health infant, at 36 weeks gestation. Follow-up information was received on 20-APR-2009 from a registered nurse who reported that on 04-NOV-2008 the patient was vaccinated with a first dose of GARDASIL (lot # 661764/0650X). It was unknown if the patient received concomitant vaccines on 04-NOV-2008. Follow-up information was received from a R.N. who reported that the lot # for the first dose of GARDASIL was 660553/0070X (not 661764/0650X as previously reported). It was reported that the patient also received a dose of influenza virus vaccine (unspecified) on 11-NOV-2008 that had a lot # of AFLUA375AA. Additional information has been requested.
Felt soreness in clavicular lymphnode near collarbone.  One felt tender and quite enlarged, another was smaller but also tender.  Both nodes located on right side of neck, close to collarbone, but not on the collarbone.  Felt less sore the day after, so it seems to be getting better and returning to normal, though the node is still enlarged.
Patient says about 1 week after shot got pain in shoulder-not sharp pain but ache.
This is 1 of 3 infants from this facility to devel fever,inconsolable crying & irritability p/vax.
VERTIGO; RUNNY NOSE; FEELING SICK; This spontaneous report received from a patient concerned a 61 year old not Hispanic or Latino, African American female. The patient's height, and weight were not reported. The patient's concurrent conditions included blood pressure, cholesterol, depression, and non smoker, and the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, expiry: unknown) frequency 1 total, dose was not reported, administered on 31-MAR-2021 to right arm for prophylactic vaccination. Concomitant medications included blood pressure pill, cholesterol pill and anti-depressant.  One week after vaccination, on 07-APR-2021, the patient was feeling sick and dizzy. She said that the ambulance picked her up that day she felt really dizzy and took her to the hospital. There they performed tests on her and kept her overnight. Doctor of Medicine (MD) diagnosed her with vertigo and told her to take some over the counter medications for it. She reported that her runny nose and sick feeling went away after about a day. One to two weeks after that emergency room (ER) visit, she again went to the ER. This occurred at around 1-2:30 AM she went to the ER and MD said she had vertigo but she just stayed until the morning. MD prescribed her medicine for the vertigo, but the vertigo had not gone away. The MD there, did tests for blood clots but did not find anything but told her to take Aspirin (acetylsalicylic acid). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from runny nose, and feeling sick on 08-APR-2021, and had not recovered from vertigo. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210544583-covid-19 vaccine ad26.cov2-Vertigo, Runny nose. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). V0:20210544583-covid-19 vaccine ad26.cov2-Feeling sick. This event(s) is labeled per RSI and is therefore considered potentially related.
PROQUAD - Red/raised area at injection 1/2 mL BENADRYL given per Dr order.
Myocarditis/pericarditis; Myocarditis/pericarditis; This is a spontaneous report from a contactable physician. A 18-year-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm Left on 18May2021 (at the age of 18-year-old) as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular, administered in Arm Left on an unspecified date for COVID-19 Immunization. The patient experienced myocarditis/pericarditis on 21May2021 17:30. The adverse event result in emergency room/department or urgent care. The patient received treatment for the adverse event included anti-inflammatory medication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.  No follow up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of myocarditis/pericarditis due to temporal relationship.  Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Overnight after 2 shot: Fever, chills, body aches and muscle cramps. About a week after second shot :strong metallic taste in mouth lasting over a week.. starting to fade.  About 2 weeks after second shot:   Light rash over entire body exept for face. First day it was itchy. by third day not as noticable. Taking otc allergy meds daily. On going as of thrid day.
day following vax pt reportedly devel runny nose w/small amount of blood in nasal drainage; pt began to have thick & foul-smelling vomit; 3/15 pt devel watery & foul smelling stools; MD dx an ear infection & prescribed cefzil
Woke up Thursday am with hives on right lower abdomen and leg getting progressively worse throughout the day.  By that afternoon had back pain in right back and continuing hives.  Woke up Friday with numbness to right leg, hives, and back pain all on right side of body.  Had numbness to foot, face but especially thigh, back and across upper buttocks.  Saturday hives subsiding, numbness receding to face, upper thigh and foot only on right side of body.  Sunday, back pain some improved, no hives or hives minimal, numbness persists upper thigh face and foot on right side of body.  Monday, Tuesday and Wednesday the same.  Woke up   Thursday   with shingles rash to upper thigh back, numbness to foot face and upper thigh persist only on right side of body. Darn!!!
Tinnitus - woke up and felt like my ear was clogged and it was ringing. Confirmed with a PA that my ear was not clogged when I got to work. When I tried to teach, there was an echo and a weird high pitched feedback sound. Ear consistently rang throughout the day.
Patient was awoken in her sleep by a significant amount of blood coming from her nose and mouth. She also reported nausea  and high blood pressure as well.
bad stomachache; terrible diarrhea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (bad stomachache), DIARRHOEA (terrible diarrhea) and CHILLS (Chills) 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.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (bad stomachache), DIARRHOEA (terrible diarrhea) and CHILLS (Chills). On 22-Apr-2021, DIARRHOEA (terrible diarrhea) had resolved. At the time of the report, CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
pain in the upper right arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose number unknown (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "two plates and numerous screws in the right humorous bone" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Nov2022, outcome "unknown", described as "pain in the upper right arm".  Additional information: A couple of hours after receiving booster and for the next three days, patient had pain in the upper right arm. She was asking clarifications regarding right arm pain, when the injection was placed in the left arm.   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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201356977 same patient, different vaccine dose/partial same event;
Mother reports to ER 5/17/08 in afternoon as had rash/hives on right thigh where vaccines were given, patient verbalized right leg hurt. Did receive BENADRYL, instructed to use warm compresses. Rash has decreased. Today - 5/19/08 at 1315 - area approximate 7 inch diameter is reddened, no induration noted. No pain with palpation noted.
gums red and extremely inflamed,  painful, dentist said my gums looked like an allergic reaction, dentist gave me RX for Periogard on April 11, 2021, Periogard hasn't helped the inflammation, I am to see him for recheck on April 5, 2021.  I am to see my regular doctor on March 31, 2021. My dentist sent my doctor a report on my gum condition.
No initial reaction. About 9 hours later she woke up from sleep with wheezing and itching of the throat, ears, and armpits. She developed three hives on her abdomen. She took diphenhydramine and Claritin then was able to go back to bed. She did not use the EpiPen but had it available. When she woke up in the morning she had swelling of the eyelids and face.
8/27/21 receive janssen vaccine. States next day developed b/l gluteus pain, h/a, gral malaise, myalgias. On 9/7/21 call Duty HS with arm pain at sight of jab and continued body aches. Order to take nsaid?s. 9/12 continued with myalgias, developed diarrhea, n/v and 100.7 temp. rapid antigen test 9/13: neg. seen at the clinic 9/17 with continued sx?s. no SOB, no chest pain, no skin rashes. Sent to ER for further testing and released w/o meds after work-up reviewed by MD. That night developed cough, yellow phlegm, fatigue (no SOB), h/a?s. diarrhea and n/v resolved. Seen by me 9/17 and stated no h/a, no n/v, diarrhea. Persistent pain on site of jab radiating to tricep. No lower limbs radiculopathy, loss of strength, unsteady gait, facial muscles abnormalities, dysphagia, double vision or b/b/dysfunction. On exam he does not looks acutely or chronically ill.
was vaccinated, still got them/ Suspected vaccination failure; was vaccinated, still got them; This case was reported by a consumer viainteractive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported. The patient received Shingles vaccine and still got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Hey why is my injection site magnetic why is my injection site magnetic" "Why is my injection site magnetic I can it'll hold paper clips and Staples; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE REACTION (Hey why is my injection site magnetic why is my injection site magnetic" "Why is my injection site magnetic I can it'll hold paper clips and Staples) 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 VACCINATION SITE REACTION (Hey why is my injection site magnetic why is my injection site magnetic" "Why is my injection site magnetic I can it'll hold paper clips and Staples). At the time of the report, VACCINATION SITE REACTION (Hey why is my injection site magnetic why is my injection site magnetic" "Why is my injection site magnetic I can it'll hold paper clips and Staples) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The patient asked why their injection site was magnetic and stated that it could hold paper clips and staples.  No treatment information was provided.
Pt c/o pain upper R arm at time of injection. Increase two days later, also c/o redness and heat-lasted one week. States pain continued called 1/6/03 health dept. Was told to take Motrin, if no relief. To see physician called again 2/25/03 c/o of continuing pain outer aspect length of upper arm, difficulty raising arm. Has not seen physician even though advised to do so. Referred to clinic for medical attention.