chrisvoncsefalvay/vaers-outcomes huggingface dataset:
High level or soreness in left arm Muscle and  joint soreness similar to what I experienced with having Covid 3 months prior especially fine motor muscles and joints Very tired  but unable to sleep the first night
My adverse reaction was that I had abdominal pain and severe diarrhea,  I waited a few days before I called the Dr. and they advised that I change my laxative so  I stopped taking the Linzess around 02/05/2021, and I went back to a different laxative.  The diarrhea stopped after that.
Pt developed abscess @ site of Varicella vaccination. Painful, red, indurated. Started antibiotics (SEPTRA x 7 days). May need incision & drainage.
Left shoulder burning pain x 1 month, started 2 days after getting the Pfizer vaccine.
Erythema multiforme. Had WCC and DTAP 04/21/12. A couple of annular lesions noted on face last night (4/21/12). Spread all over this A.M. (4/22/12). No meds given prior to rash. 4/22/12 started BENADRYL 4ml prn for every 6 hrs, ORAPRED 9ml once a day x 7 days if having mouth ulcers. Triamcinolone apply to affected area BID 14 days. Use wet compresses and oral antihistamine if itching.
Breakthrough COVID infection resulting in hospitalization.  Symptoms include fatigue, cough, chest tightness, and shortness of breath beginning 4/24/22.
Within few hrs of vaccination (L) upper arm sore, next morning red/warm. Patient felt ill, fever 101, myalgias - remained home from wk. Then developed unusual looking rash, pink slightly raised spots on dorsum of hands, going up his arms. Slightly itchy - rash spreading to upper B/L legs and ankles. Prednisone taper prescribed as well as TYLENOL when needed.
It was reported that a 50 year old female received Fluzone SV 98-99 USP vaccine on 10/22/1998. Reportedly on 10/24/1998 the pt developed distal vein thrombosis out left arm. Reportedly the pt recovered from this experience. From additional information received on 11/16/1998 it was reported that the date of the adverse reaction was 10/23/98 at 11:00 PM not 10/24/98 at 6:00am as previously reported.
PT REC'D VACCINE , FELT HOT  IMMEDIATELY AFTER - SAT IN A CHAIR NEAR OPEN WINDOW, REMOVED LONG SLEEVE OVER SHIRT, EPISODE APPROX 3 MIN, VSS, HX VASOVAGAL REACTIONS IN PAST. PT NEVER FELT SYNCOPE.  Adverse reactions or other concerns:  PT REC'D VACCINE AND IMMEDIATELY FELT HOT, DENIED FEELING NEAR SYNCOPE  Actions taken and other comments: PT WAS SEATED NEAR OPEN WINDOW, REMOVED LONG SLEEVE OVERSHIRT, OFFERED WATER, PATIENT DENIED NEED FOR FOOD, EPISODE IN TOTAL LASTED 3-5 min, VSS, NEVER SYNCOPAL, REPORTS HISTORY OF VASOVAGAL REACTION TO VACCINES & BLOOD DRAWS IN THE PAST.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 65 year old female of unknown race and ethnicity. The patient's weight was 170 pounds, and height was 60 inches. The patient's concurrent conditions included lymphoma type b, sarcoidosis of lungs, diabetes, non alcohol user, and non smoker, and other pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: Unknown) dose was not reported,1 total, administered on 08-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 26-MAY-2021, the patient had her blood work done and her antibody test came back negative (confirmed immunological vaccine failure). Type of antibody test was not known by patient. Laboratory data included: Antibody test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210747864-Covid-19 vaccine ad26.cov2.s-Confirmed Immunological vaccine Failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS.
Given Rubella and Flu vaccine and 1/2 hour, post vax, had a headache and itching which continued into facial swelling, chest tightness and wheezing. Returned to UHS with symptoms and was given epinephrine and Benadryl IM and sent to ER.
Patient administered undiluted Pfizer vaccine. Patient has not endorsed any adverse effects from receiving undiluted dose.
This spontaneous report as received from a licensed practical nurse, who reported that on 07-AUG-2013, one patient of unknown age and gender received one dose of GARDASIL (lot # reported as J004192, expiration date 27-NOV-2015) (dose and route were not reported) exposed to 31F for 84 hours over the past two months, since approximately June 2013. Concomitant medications were not reported. No adverse effects reported. This case is linked to cases 1308USA010552, 1309USA004745, 1309USA004746, and 1309USA004747 via same reported link. Additional information has been requested.
Initial report received from a non-health care professional on 19 December 2013. The patients, whose age, medical history and concomitant medications were not reported, had received a dose of influenza vaccine (flu shot) (lot  number, route and site of vaccination were not reported), on an unspecified date in 2013. On an unspecified date, the all four patients were very sick with flu shot. At the time of this report, the outcome of adverse event was unknown. No further relevant information reported.
Patient had a red, swollen, slightly warm to the touch area around the injection site.  Patient presented to the pharmacy 6/23/16 to show pharmacist her arm. Her arm was still somewhat red, and warm to the touch.
1st Pfizer vaccine on 04Jan2021. She then tested positive for COVID-19 on 18Jan2021; 1st Pfizer vaccine on 04Jan2021/returning for her 2nd vaccine dose today 06May2021; 1st Pfizer vaccine on 04Jan2021/returning for her 2nd vaccine dose today 06May2021; 1st Pfizer vaccine on 04Jan2021. She then tested positive for COVID-19 on 18Jan2021; This is a spontaneous report from a contactable pharmacist via medical information team. A 41-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration on 04Jan2021 (at the age of 41-years-old) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient underwent lab tests and procedures which included sars-cov-2 test positive: positive on 18Jan2021-positive. It was reported as the patient received her first Pfizer vaccine on 04Jan2021. She then tested positive for COVID-19 on 18Jan2021. She then received a "plasma transfusion on 28Jan2021. She is now returning for her second vaccine dose today 06May2021. The reporter asked if is this ok since it has been 90 days and does her first dose need to be repeated. Therapeutic measures were taken as a result of the event covid-19. The outcome of the events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE.   There is limited information provided in this report.  This case will be reassessed once additional information is available. 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.
Information has been received from a nurse concerning a female who was vaccinated with the second dose of GARDASIL vaccine on an unspecified date. Subsequently the patient experienced a rash all over the body. "The palms and soles of the feet were really bad and throbbing. Rash and throbbing went away after 48 hours." The patient did not have any problems after the first dose. At the time of the report, the patient had recovered on an unspecified date. Follow up information has been received from a nurse concerning a 23 year old female patient with allergy of clonidine patch allergy and no illness at time of vaccination who on 15-OCT-2009 was vaccinated intramuscularly with the second dose of GARDASIL (lot # 663454/0672Y) in right deltoid. In the morning of 17-OCT-2009 the patient called the office reported the on 16-OCT-2009 she experienced total body rash, palms of hands and feet burning. No medical attention had been sought. No relevant diagnostic test or laboratory test was performed. On 20-OCT-2009 the patient reported that complaint ceased after 48 hours. on 18-OCT-2009 the patient was recovered. No further information is expected.
Diffuse myalgia, anthralgia, fever, localized redness, warmth and tender.
Patient has swelling from mid arm down to elbow and redness. Patient has never reacted to flu vaccine before. RPh suggested tylenol and benadryl. Patient considering visit to clinic for exam.
1)m client got her vaccine and was monitored for 20 mins afterward with no  problem. 2) Aprox 10  mins after she left the clinic, she started having an itchy throat and trouble swallowing. She immediatly took Benadryl 50mg po.  3) at 2pm she started having the same symptoms, itchy throat and trouble swallowing, She took 50mg of Benadryl again and her dr was working with her and he gave her an Rx for steroid pack which she filled and took. 4) no problems since then.
feeling like this weird dizziness but its only like when I am sitting or I am at my rest; if I am at sitting still and reading it is like my head is spinning; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 as dose number unknown (booster), single (Lot number: 6H9693) at the age of 24 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 immunisation; Covid-19 vaccine (First Booster dose), administration date: 2021, for COVID-19 immunization. The following information was reported: DIZZINESS POSTURAL (non-serious) with onset 15Oct2022, outcome "unknown", described as "feeling like this weird dizziness but its only like when I am sitting or I am at my rest"; VERTIGO POSITIONAL (non-serious) with onset 15Oct2022, outcome "unknown", described as "if I am at sitting still and reading it is like my head is spinning". Therapeutic measures were not taken as a result of dizziness postural, vertigo positional.  Additional Information: Consumer stated, I got a Pfizer Vaccine last week at my Health Center and I start feeling like this weird dizziness but it is only like when I am sitting or I am at my rest. It is not like when I am walking around or some exercising, it goes away but like if I am at sitting still and reading it is like my head is spinning I guess but I do not have nausea and my vitals are okay. So, I do not know if that is from vaccine but that has been happening one day after I got the Vaccine and then it still happening like 7 days later, so. Consumer stated, Yes, it is like I am just wondering how long would the side effects last or also like. Prior Vaccination within 4 weeks consumer stated, No, the patient last booster shot was in 2021, this is his first one this year. Yeah, it is his second booster shot but the first one was last year. When again clarified the name of the product, consumer stated, I guess it is but the sheet that health center gave me says it is a Comirnaty and it is the Pfizer BioNTech. I am pretty sure that is the new one. The patient is not taking any medications and Consumer stated, no treatment received. Consumer stated, I just want to clarify on my report that these symptoms kind of go away whenever I am moving around. So, it is not the dizziness where I lose my balance or I am at nausea or any of that stuff. Consumer was informed that same will be added to the report.  No follow-up attempts are possible. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 72-year-old male patient who received SHINGRIX. Concurrent medical conditions included cataract (left eye surgery performed on 9th May 2018 and right eye surgery was scheduled on 23rd May 2018). Concomitant products included ADVIL, simvastatin, BESIVANCE, and PROLENSA. On 20th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 20th May 2018, less than a day after receiving SHINGRIX, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on the left arm. The patient's body temperature went as high as 100.7 degree F. The patient planned to follow up with his physician on an unknown date.
temp couple hrs p/vax; disoriented, abt wk, 10 days later not eating, became cranky, abt 2 wks later unusual high pitched crying, moaning, twitching, spasms; limp & unresponsive & staring;
Patient received flu shot on 8/25/21. On 8/29/21 she came to the pharmacy to report that she had an adverse reaction several hours after the injection. She said she had extreme shakes, described as seizure like but not as severe. She also had nausea/vomiting. These symptoms went away by the next day.  Patient said she did not go to the hospital or a doctor but just went to bed.
HAY FEVER; This spontaneous report received from a patient concerned an 8 decade old male. The patient's weight was 165 pounds, and height was 71 inches. The patient's concurrent conditions included: hay fever, and allergy (wigs him out terribly). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on APR-2021 for covid-19 prophylaxis. Age at time of vaccination 71 years old. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced hay fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hay fever. This report was non-serious.
pt recvd vax lt arm 15MAR94 returned to clinic w/a rash on the site 2x3" red and hot to touch;
Severe headaches for 5 weeks now diarrhea (caused dehydration and hospital stay for 2 days) numbness in both arms, tremors from back of head down spine to both legs with a feeling like an electrical current. Per annual report-She is still having headaches.
I've had shingles shots/Suspected Vaccination failure; shingles started/ bugs crawling feeling biting; bad itching; nerve wracking; burning; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 68-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I've had shingles shots/Suspected Vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles started/ bugs crawling feeling biting), pruritus (Verbatim: bad itching), nerve pain (Verbatim: nerve wracking) and burning sensation (Verbatim: burning). The outcome of the vaccination failure was unknown and the outcome of the shingles, pruritus, nerve pain and burning sensation were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pruritus, nerve pain and burning sensation to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pruritus, nerve pain and burning sensation to be related to Shingles vaccine.   Additional Information: GSK receipt date: 14-MAR-2023 The case was received from the patient interactive digital media. The patient had Shingles shots year ago and going 3 months ago shingles started and still had them right side, bad itching burning bugs crawling feeling biting , nerve wracking. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
This spontaneous report as received from a nurse refers to an 11 years  month old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, lot # K005881, exp. date: 14-JAN-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Information has been received from a health professional concerning a 13 year old female who on 26-FEB-2006 was vaccinated with a dose of Gardasil. Concomitant therapy included Abreva. On 27-FEB-2007, 24 hours after vaccination the patient experienced redness around mouth. On 28-FEB-2007, 48 hours after vaccination the patient cold sore around mouth. According to the nurse, the lesions resolved but returned again 3 weeks after the vaccination. Medical attention was sought. No product quality complaint was involved. Additional information has been requested.
No wheal formed on 1st attempt so 2nd dose administered; wheal formed on 2nd dose
I have a feeling at the bottom of my feet like I?m walking on marbles. It?s not painful but very uncomfortable. It?s hard to walk without feeling unbalance. You can?t feel anything under the bottom of my feet but it does feel like I?m walking on marbles at all times when I put pressure on it.
pt recv vax;was warm to touch,starry eyed & had sz for 40 sec;er technician called & pt taken to hosp;was noted to have fever of 104.4;tx w/ O2 & remained in er for 5 hr;CT scan,X-ray & blood work neg;
Patient was on his way out of the building when he fainted by the elevator. He stated that he remained conscious the whole time. He was placed in a supine position with his lower extremities raised by a pillow. Parents reported that he's had history of fainting spells after receiving vaccines, lab work, or any medications that require the use of needles. They also said that he had not eaten anything that day. A pouch of juice was given orally. A fan was turned on towared the patient. He got up after 10 minutes with no other problem noted and walked out with a steady gait.
This is a spontaneous report from a contactable consumer who reported for herself. A 75-year-old female patient received the first dose of  PREVNAR 13, intramuscular on 15Nov2016 at 4 pm at left upper arm for pneumonia prevention, and first dose of FLUZONE HD, intramuscular from 15Nov2016 at 4 pm at left upper arm to prevent the flu. Medical history included asthma and cough. Concomitant medication included  Q-40 inhalant at 1DF 2x/day for asthma, montelukast 1 DF 1x/day (at night) for asthma and benzonatate 100 mg as needed (at night) for cough, all from 2014 and ongoing. On 15Nov2016 at around 7-8 pm, patient  felt sick for a couple of day and she also had chills, fever, diarrhea, headache and shoulder pains; she felt like she had the flu. She felt really bad for 24 hours and then for 2-3 days. Patient recovered from all the events on 19Nov2016.
A report has been received from a Health Professional concerning a 4 year old, Female subject, who had been receiving nasal FLUMIST. FLUMIST started on an unknown date. The patient experienced EXPIRED FLUMIST GIVEN which started on 21-DEC-2012. The follow up reporter, stated the patient has not been back in the office and they have not heard from her. She was not re-dosed. The oucome of the event of EXPIRED FLUMIST GIVEN is unknown. The report was considered to be non-serious.
He past away on 28Feb2021 from a heart attack; A spontaneous report was received from a consumer concerning a 80 year old male patient who received Moderna's COVID-19 vaccine and the patient died due to heart attack.  The patient's medical history, as provided by the reporter, included diabetes, congestive heart failure, hypertension and high cholesterol. Concomitant product use was not provided by the reporter.  The patient received their first of two planned doses of mRNA-1273 (Batch number: 025L20A) intramuscularly in the right arm on 21 Jan 2021. On 26 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: 024M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 28 Feb 2021 the patient passed away due to heart attack. No treatment information was provided.  The seriousness criteria for the event passed away from a heart attack were death and medically significant.  Action taken with mRNA-1273 in response to the event was not applicable.  The outcome for the event, he passed away from a heart attack was fatal.; Reporter's Comments: This case concerns a 80 year old, male patient. who died due to myocardial infarction. Very limited information regarding this event has been provided at this time.  The patient's medical history of diabetes, congestive heart failure, hypertension and high cholesterol remains the risk factor for myocardial infarction. Further information has been requested. The cause of death is Myocardial infarction.; Reported Cause(s) of Death: Heart Attack
Fever, body aches, cough (viral syndrome, possible rx to immunization) erythema/swelling around vaccination area.
Pt developed varicella disease on 3/9/00. Vesicles on ankle, trunk, left arm, pt also experienced a headache, and a fever of 100.3.
Temp 102 Headache for 1 1/2 day. 3/29/17 AM - 3/30/17 AM resolved by afternoon.
patient received vaccine on 5/19/21.  Did not report what happened to pharmacist until 06/02/21.  Patient states he had " heart burn" after vaccine.  He states, " chest was hurting, felt really tired".  I asked if he had palpitations, pt responded " yes" . patient states symptoms happened day after vaccination and lasted one day and was over after 24 hours. Mother gave him tums for heart and it helped.   patient is feeling well and not reporting any symptoms. advised pt to contact MD for follow up and have md clear pt for second covid vaccine if any concerns.
I contracted Covid in September. I had a sore throat, a cough, head congestion, aching upper body, a fever of 102 and fatigue. I called my doctor, and he gave me Paxlovid which made the fever, and the aches go away the next day, the following symptoms within days, however the fever lasted a bit over a month.
Pt received ZOSTAVAX 11-19-14. Developed swelling from eyebrow to nose next am. Describes skin as swollen, puffy, bags under eyes - reddish/purple in color, skin warm and dry and feels like sandpaper. Injection site swollen, hard, sensitive; NKA to food or meds; hx of environmental allergies. Reported incident 11/24/14 because not improving. Used BENADRYL x2 11/28 without improvement. TC with pt 12/1 - totally resolved with OTC cortisone cream and BENADRYL. Also D/C new face cream.
Patches of vitiligo on skin overlying radius bone on same side of immunization, started about one to two weeks after vaccine administered.