chrisvoncsefalvay/vaers-outcomes huggingface dataset:
multiple, severe outbreaks of shingles across his body, including his face, which resulted in his eyes being swollen shut; multiple, severe outbreaks of shingles across his body, including his face, which resulted in his eyes being swollen shut; This spontaneous report has been received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On or around 06-NOV-2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered multiple, severe outbreaks of shingles across his body, including his face, which resulted in his eyes being swollen shut. These injuries were caused by zoster vaccine live (ZOSTAVAX). As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms resulted in physical limitations not present prior to using the vaccine. He also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, he suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The reporter determined the events to be disabling.  Upon internal review, the event of herpes zoster ophthalmicus was considered to be medically significant.
Injection site is painful / Injection site is tender; Injection site is sensitive; Red near the injection site; red, raised spot near the injection site; Tired; Easily distracted; Can't focus; Not sleeping well; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 25th August 2021, the patient received the 2nd dose of Shingrix. In August 2021, less than a week after receiving Shingrix, the patient experienced injection site pain, injection site hypersensitivity, injection site erythema, injection site papule, tiredness, distractibility, mental concentration difficult and poor sleep. On an unknown date, the outcome of the injection site pain, injection site hypersensitivity, injection site erythema, injection site papule, tiredness, distractibility, mental concentration difficult and poor sleep were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site hypersensitivity, injection site erythema, injection site papule, tiredness, distractibility, mental concentration difficult and poor sleep to be related to Shingrix.  Additional detail were provided as follows: The age at vaccination was not reported. The patient stated that, she had her first Shingrix shot on 25th June 2021 and had no side effects. She had got her second dose of Shingrix and was experienced the following side effects like tired, easily distracted, could not focus, was not sleeping well, injection site was sensitive, painful, and tender, and a red, raised spot near the injection site. The patient did not want to provide her HCP (health care professional) information. The reporter did not consent to follow-up.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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. Past drug history included: Citric acid, reaction(s): "Known allergies: Citric acid". The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 23May2022, outcome "recovered" (27May2022) and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19, drug ineffective included PAXLOVID.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
This is a spontaneous report from a contactable nurse who reported 10 cases for different patients. This is the 8th of 10 cases. A patient of unspecified age, race/ethnicity and gender received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at 0.5 ml single, for immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that the injection hurt a lot on an unspecified date with unknown outcome.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017083713 same reporter/drug/event, different patient.
I noticed that I had itchy bumps which I thought were possibly bug bites around mid May. I kept getting them on my right forearm. I was applying bug spray etc. I kept getting more. I also was getting them on my left forearm and my right thigh. SO I made an appnt with my PCD on May 27th 2021 and she referred me to a dermatologist which I went to see on June 8th 2021 and had a follow up on June 27th 2021. The dermatologist said it looks like folliculitis and has me using a prescribed skin cleanser and Clindamycin Phosphate Solution to all of the areas affected.
Diarrhea (26x/day), watery 3 days after receiving vaccine.
Headache, Myalgia, Bodyaches, Facial burning, Rigors, Fever/chills Narrative: Employee reports symptoms are controlled with Tylenol and are improving daily
abdominal pain, diarrhea, fatigue, pancolitis, elevated serum creatinine
I got a rash all over my stomach, back, neck.  I had same reaction from first Vaccine--this was my second.  first one happened 24 hours after vaccine.  It started itching on my stomach and back a couple days later  It took about a week for it to completely be gonel
Given vaccines at 10:30 a.m By 1:15 p.m extreme dizziness (room felt like it was spinning), extreme nausea, felt like fainting, ears felt like everything was far away, could feel heart pounding, next day tongue slightly swollen and sore.  Vertigo lasting more than 5 days.
expired Menactra vaccine administered; Initial information received on 11-Jul-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 17 years old female patient who was vaccinated with expired vaccine of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot number U5948AB (Expiry date 03-Jul-2019) via intramuscular route in the left arm, On 10-Jul-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) and MENINGOCOCCAL VACCINE B RFHBPA/FHBPB (TRUMENBA).   It was an actual medication error due to expired vaccine used.  At the time of reporting, no adverse reaction was reported.  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.
1 week after receiving Moderna booster, patient experienced difficulty moving her right arm. She does not have full range of motion. She cannot put her arm behind her back and has some pain in her right arm. Last week she asked about it and all the doctor said was maybe the pharmacist hit a bone.
Fever of 102.4; Started with Fever; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), PYREXIA (Started with Fever) and PYREXIA (Fever of 102.4) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028l20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, the patient experienced PAIN IN EXTREMITY (Sore arm). On 30-Jan-2021, the patient experienced PYREXIA (Started with Fever). On 21-Feb-2021, the patient experienced PYREXIA (Fever of 102.4). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 3 dosage form. On 30-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, PYREXIA (Started with Fever) and PYREXIA (Fever of 102.4) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Feb-2021, Pyrexia: 102.4 (High) 102.4.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
No adverse effects reported; multiple unspecified patient were probably administered improperly stored vaccines; This spontaneous report was received from an immunization official referring to multiple patients of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.     Since 24-MAY-2019, multiple unspecified patients were probably vaccinated with improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # S002639, expiration date 19-NOV-2020) (lot # R024025, expiration date 02-SEP-2020)(strength, dose and route were not reported), hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # R025726, expiration date 26-MAY-2021) (lot # R025730, expiration date 18-JUN-2021) (strength, dose and route were not reported) and rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (lot # R016790, expiration date 20-APR-2020)(orally; strength and dose were not reported) for prophylaxis (product storage error). It was not determined which lots had been administered or not. Temperature excursion was above 9 Centigrade Degrees (mainly at 10.2 Centigrade Degrees) for 15 minutes. Previous temperature excursion was above 9 Centigrade Degrees(mainly at 9 .1 Centigrade) for 15 minutes and above 9 Centigrade Degrees(mainly at 16.5 Centigrade Degrees) for 5 hours and 15 minutes. Data logger was involved. No adverse effects were reported.  This is a non-valid case due to lack of patients' identifier and number.
This spontaneous report was received from a registered nurse refers to unknown number of patients (gender and age unspecified). On an unknown date (reported as for the past 18 years), the patient were vaccinated with a dose of PROQUAD, (lot number, expiry date and route was not reported) in the leg of children under the age of 4 years rather than in the arm. No adverse effect was reported. This is one of three reports received from the same reporter. Additional information is not expected.
I had the second dose of Moderna at 11:30 a.m.  on April 5, 2021.  By 8:30 p.m. on April 5, 2021, I was running a temperature and had chills for hours.  At around 2 am., I got up, fainted and fell.  Had a blow to my head.   Fainted a second time and fell.  Went to the ER with a 101 temperature.  I was admitted to ICU.  The CT scan didn't show any brain bleeding.  Hurt my lower back when I fell.
This spontaneous report as received from a radiology technician refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies of medical history provided.  On 22-APR-2016, the patient was vaccinated with and improperly stored dose of VARIVAX injection (lot # L016123, expiration date 06-MAY-2017; dose, anatomical location and route of administration were not reported). No adverse events were reported. Temperature was 10.6 degrees Fahrenheit for 9 days. The data logger was involved and there was no previous temperature excursion reported. This is one of several reports received from the same reporter. Additional information has been requested.
This case was reported by a healthcare professional and described the occurrence of swelling injection site in a 26-month-old female subject who was vaccinated with KINRIX (GlaxoSmithKline). Previous and/or concurrent vaccination included HAVRIX; GlaxoSmithKline; unknown; unknown given on 10 May 2011. On 10 May 2011 the subject received 4th dose of KINRIX (.5 ml, unknown, left leg). Less than one week after vaccination with KINRIX, the subject experienced swelling injection site, injection site redness and injection site warmth. A 26 month old subject was given KINRIX and presented to the doctor's office two days later with red, warm and swollen leg where it was administered. No fever was reported. At the time of reporting the outcome of the swelling injection site, injection site redness and injection site warmth were was unspecified.
Eyes: Vision is a bit blurry, have difficulty focusing  Light sensitivity Eyes are sore  Pain at Injection site (left arm)  Extreme fatigue
Patient reported to us that she had a miscarriage on 5/13/21. At the time of her first shot she marked on our consent form that she was considering becoming pregnant.
rash at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE RASH (rash at injection site) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003821A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced INJECTION SITE RASH (rash at injection site). At the time of the report, INJECTION SITE RASH (rash at injection site) outcome was unknown. Not Provided      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.   Treatment information not provided. Concomitant medications were not provided.
Given an Injection of Heplisav-B Which Had Been Out of Temperature Range for Greater Than 8 Hours; Initial Report Received on 27-Feb-2023.  A registered nurse reported that a 41-year-old male patient (race and ethnicity unknown) received a dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization that was out of temperature range for greater than eight hours.  Medical history was unknown and concomitant medications at the time of vaccination were not reported. The patient had no known drug allergies.  On 08-Feb-2023, the patient received a dose of HEPLISAV-B vaccine (Lot # 937228, expiration date 30 Aug-2023, NDC # 43528-0003-05) intramuscularly in the left deltoid. The HEPLISAV-B dose that the patient received had been out of temperature range for greater than eight hours. No adverse effects were reported.  No further information was provided.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Info has been received from a health prof'l concerning a 52 y.o. female w/Hep C, and NKA who on 8/22/02 was vax'd w/Hep B vax recombinant. There was no concomitant medication. On 8/22/02 the PT developed "flu-like Sx's", nausea, light-headedness, stiff neck and fatigue w/in 1 hr post vax. The PT recovered from the Sx's of nausea, light-headedness, stiff neck and fatigue 12 hrs later and was reported to have been fine since then. Unspecified medical attention was sought. Add'l info has been requested.
General light dizziness. "Seeing was not right." This abated a few hours later.
Information has been received from a medical assistant, for GARDASIL, a Pregnancy Registry product, concerning a 15 years old female patient. The patient had no pertinent medical history, drug reactions or allergies. On 19-NOV-2012, the patient had her first dose of GARDASIL (lot #, expiration date, dose were not reported) injection intramuscularly for human papillomavirus (HPV) prophylaxis. The patient had no other co-suspects or concomitant medications. On 19-NOV-2012 (reported as "today"), the patient was seen at the nurse practitioner's office and had a human chorionic gonadotropin (hCG) urine pregnancy test that was originally negative, subsequently had her first and only dose of GARDASIL administered, then the pregnancy test might have turned positive. The patient might have been in first trimester pregnancy. The patient had last menstrual period (LMP) on an unspecified day in October 2012 (reported as "last month in October 2012"). The estimated date of delivery (EDD) would be on an unspecified date in 2013. No treatment was given to the patient. The patient sought medical attention and went to the nurse practitioner's office. Follow up information has been received from certified registered nurse practitioner on 26-FEB-2014. Reporter provided information that the patient delivered normal infant with no congenital anomaly on an unspecified date in 2013. Delivery type, infant's gender, length or head circumference (HC) were not reported. Additional information is not expected.
This spontaneous report as received from a physician refers to a 69 year old male patient. The patient had no pertinent medical history. The patient had no drug allergies. On 15-MAY-2014 the patient was vaccinated with ZOSTAVAX lot # K000726, expiration date 09-JAN-2015, (dose, strength and frequency were unknown) subcutaneous. There were no concomitant medications On 24-MAY-2014, the patient developed pain over the left chest area. The patient sought for medical attention by seeing the physician. No treatment was given. Lab diagnostics studies performed were reported as none. On 25-MAY-2014 the patient developed a rash in that same area. The outcome of the event was not recovered. The causality of the report was unknown. Additional information has been requested.
I was positive for COVID-19 on 05JAN2023, general respiratory symptoms. I was coughing, sneezing and sore throat. I saw my doctor, she prescribed me ZITHROMAX. I started feeling better right after after.
Lightheaded, short of breath, nausea, diarrhea, hot flashes
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 24-AUG-2016, the patient was vaccinated with incorrectly stored dose of M-M-R II lot # L026553, therapy type was not specified (dose and route of administration were not reported). This is one of several reports received from the same source. Additional information has been requested.
-Extreme lethargy for 24 hours -Could not eat for 24 hours -Fever for 24 hours
pt rcvd 3 doses of vax; admitted to hosp & dx w/ V-P shunt failure vs. pneumonia. BC was positive for H. influenzae, not able to be accurately typed; pt developed a v-p shunt infection & meningitis due to H. flu;
My brother had heart problems after his Moderna Covid-19 booster shot; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CARDIAC DISCOMFORT (My brother had heart problems after his Moderna Covid-19 booster shot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 21-Jul-2022, the patient experienced CARDIAC DISCOMFORT (My brother had heart problems after his Moderna Covid-19 booster shot). At the time of the report, CARDIAC DISCOMFORT (My brother had heart problems after his Moderna Covid-19 booster shot) had not resolved.            No Concomitant medications were reported.  Adverse Event cause patient to seek medical care. Adverse event outcome was reported as Ongoing.  Patient had to take blood thinners for the treatment   This case was linked to US-MODERNATX, INC.-MOD-2022-611900, US-MODERNATX, INC.-MOD-2022-611860 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-611900:MOD22-019253(reporters case) US-MODERNATX, INC.-MOD-2022-611860:(reporters case) 2nd booster dose
Bell's palsy on Right and weak right eyelid, decrease scotopic threshold response, asymmetric smile, able to follow brow bilateral seems to be improving. No treatment. 12/18/06 Received medical records from reporter which reveal patient seen 7/06 & dx w/strep throat, treated/resolved & then otitis media, treated/resolved.  Received flu shot at pharmacy on 10/11. Seen by reporter on 11/3/06 after being evaluated by eye dr who dx bells palsy.  Facial weakness had been present for approx 1 week. Right eyelid weakness, right corner of mouth drooping, able to wrinkle forehead bilaterally.  Temp 99.5. Final Dx: Bells Palsy.  Mother reported to reporter on 12/6/06 that all symptoms had resolved.
In between the 2nd dose being scheduled and administered, the guidance changed. The injection was given within the 4 day grace period, but was before the 28 day mark.
A serious report of a medically important event of spontaneous abortion in a 32-year-old pregnant woman who was administered FluMist was received from a nurse practitioner. No medical history nor concomitant medications were reported. The patient was in a shelter for the homeless. The patient received FluMist on 12-Nov-2007. At the time of FluMist administration, the patient denied pregnancy or any other contraindication. On 16-Nov-2007, the patient notified the reporter that she was pregnant and in the first trimester of her pregnancy. The pregnancy was confirmed by urine test on an unreported date. In December 2007, the patient experienced bleeding and when examined by an obstetrician-gynecologist (OB-GYN), it was determined that the pregnancy was non-viabe and the patient had experienced a spontaneous abortion. No causality assessment was reported for the pregnancy. The reporter stated that the patient's OB-GYN did not think that the spontaneous abortion was related to FluMist vaccine. The sponsor considered the spontaneous abortion an important medical event.
10/18/2004: Mother noticed the redness on her right arm where she received Varicella vaccine. No other symptoms. Check her right deltoid has redness and wheal 2cm in diameter. Told MOC to observe if worsen and have other rash to keep the child home and let us know. Mother of child stated rash disappear 4 days later and feeling fine.
Evening of 3/8/21 severe dizziness, nausea, vomiting, weakness: lasted several hours then gradually improved overnight
Severe full-body redness and itching, tightness in throat, swelling in tongue, tightness in chest, difficulty taking a full breath.  Happened 30 minutes after the shot, as of 10:25 on April 20th I am still having itchiness, and my throat is sore, still have tightness in chest.