chrisvoncsefalvay/vaers-outcomes huggingface dataset:
big red spot on arm; Spot not going away; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (big red spot on arm) and RASH MACULAR (Spot not going away) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Cholesterol.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced VACCINATION SITE ERYTHEMA (big red spot on arm) and RASH MACULAR (Spot not going away). At the time of the report, VACCINATION SITE ERYTHEMA (big red spot on arm) and RASH MACULAR (Spot not going away) had not resolved.            Concomitant medications include cholesterol medication and Blood pressure medication.  Treatment medications were not provided.
developed red eye Jan 07-txd with drops without response seen urgent care 2 days later dx'd scratched cornea tx'd with tobradex followed up with opthalmologist. Then develop red eye in 3/07 dxd with autoimmune uveitis.  Will receive methotrexate therapy.  8/17/07 Received opthamologist medical records which reveal patient initially evaluated 3/29/07 for bilateral eye irritation x 3 mos.  Had been seen at urgent care 12/06 & dx w/right corneal abrasion.  On eye drops & topical steroids w/improvement.  Then on 3/12 developed fever, nausea & itchy red right eye.  Dx at that time was iritis.  Treated w/minimal improvement then developed iritis of left eye.  Dx on 3/29 was acute bilateral iritis, viral vs immune.  Returned to office 4/6 w/continued irritation bilateral eyes but improved.  Lab w/u reported as neg.  Continued on topical steroids & oral steroids, tapered.  Returend to office 4/23.  Doing much better.  Dx chronic iridocyclitis, improving but w/mild inflammation & mild optic nerve hyperemia right eye.  Continued on topical & oral steorids.  Return to office 5/7, doing well but inflammation had increased on lower dose on oral steroids.  Oral steroid increased & continued topical steroids.  Returned 5/23/07 w/continued inflammation & increased IOP.  Meds unchanged & additional labs ordered.  Returned 6/1, improved but still w/ocular HTN both eyes despite meds.  Returned 6/15/07, IOP had improved but inflammation had increased.  Meds adjusted.  Returned 6/29/07, IOP improved but increased inflammation again noted.  Meds adjusted.  Returned 7/27/07, dx chronic iritis & possible vasculitis.  Meds unchanged.  Discussion of whether to start methotrexate. 8/28/07 Received pcp medical records. Included report from specialist out of state dated 7/30/07 for eval done 7/13/07 which revealed patient experienced clearing of eyes on 1/5/07 when received vax.  2 days s/p vax, right eye was red again w/blurry vision.  Eye cleared w/continued treatment.  Patient ill on 3/11 w/fever & by 3/13, right eye again inflammed & started oral steroids. Angiogram revealed vasculitis. FINAL DX: idiopathic intermediate uveitis, OU.
Post vax, mother called on 2/1/2000 and reported child had a golf ball sized maroon mark over the site of injection on right thigh. Started as blotches, then got dark maroon. Referred her to doctor who recommended Benadryl and hydrocortisone ointment but was not used. Later, on 2/14/2000, mom said child had eczema on both legs, knee and below and white spots at injection site which then disappeared.
Information has been received from a registered nurse concerning her 12 year old granddaughter who in February 2007, was vaccinated with a first dose of Gardasil (lot# unknown) injection.  In April 2007, the patient was vaccinated with a second dose of Gardasil injection and experienced dizziness.  Medical attention was sought.  The patient recovered from dizziness.  In August 2007 the patient was vaccinated with a third dose of Gardasil injection.  Approximately one week after receiving the third dose of Gardasil the patient had broken out in hives all over the body and since then the patient had developed rashes all over her body, hands were turning blue and swelling had occurred.  The patient was given (diphenhydramine hc1) BENADRYL and (montelukast sodium) SINGULAIR (MSD) to help with these symptoms, but they have not subsided.  The nurse reported that the patient had gone to the emergency room on 22-JAN-2008 and was placed on prednisone (manufacturer unspecified).  The nurse was not sure if the patient was admitted to the hospital.  The nurse reported that the patient had many unspecified diagnostic tests.  There was no further AE experience.  At the time of reporting the patient had not recovered.  Additional information has been requested.
Left arm swollen, red, warm to touch with 3cm in diameter. No Tx except ice and Motrin for pain if needed.
3 year old patient was given a Flublock vaccination /no AE; 3 year old patient was given a Flublock vaccination /no AE; Initial information was received on 23-Nov-2021 regarding an unsolicited valid non-serious case from pharmacist via call center via Agency (Reference number- 00870412).  This case involves a 3-year-old female patient who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (product administered to patient of inappropriate age and overdose).  The patient's medical history, medical treatments, vaccinations, concomitant medication and family history were not provided.  On 19-Nov-2021, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was an actual medication error case due to inappropriate age at vaccine administration and overdose (latency: same day).  It was reported "What would they watch for?"  At the time of reporting, no adverse event 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.  There will be no information available on the batch number for this case.
circumscribed rash w/pale center all over body appeared 3AUG98; 3 1/2wk p/vax erythema mult;
12 hours after receiving the first dose, I woke in the night with extreme dizziness and subsequently fainted. I was unconscious for about 10 seconds. When I regained consciousness, I was violently ill with vomiting and diarrhea. I had chills and sweating, and extreme dizziness that felt like a hallucination. We called 911 and I was taken to the hospital in an ambulance and admitted to the hospital for treatment.
Headache, Myalgia, NauseaVomiting, Coryza, chills, cervical node swelling Narrative: PCR (+) for COVID-19, 3/4/21
Information has been received from a physician concerning a patient who was vaccinated with Gardasil (yeast). Subsequently the patient experienced dry mouth. Additional information has been requested.
Blood clot to the brain resulting in massive stroke at home.   Suffered immediate paralysis from the neck down.  Bounced from hospital to nursing home to hospital over the next 3 months.  Never recovered from the paralysis or returned home.   Passed away from stroke complications on July 29, 2021.     Our mom, (VAERS ID# 1114718, ereport # 366759) also passed away approximately 30 days after her Janssen covid vaccination on 3/17/21.  She suffered a blood clot to the heart and died at home from a massive heart attack.   My mom and brother were vaccinated in March 2021 and both suffered catastrophic health events one month later in April 2021.
fever throughout the night with intense body aches & fatigue for present for about 24 hours following the injection; fever throughout the night with intense body aches & fatigue for present for about 24 hours following the injection; fever throughout the night with intense body aches & fatigue for present for about 24 hours following the injection; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 55-year-old female patient (not pregnant) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 01Apr2023 at 05:00 as dose 1, single (Batch/Lot number: unknown) at the age of 55 years, in arm for immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Thyroid" (unspecified if ongoing); "anemia" (unspecified if ongoing); "hypertension" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; GLIMEPIRIDE; BENAZEPRIL; LEVOTHYROXINE; PRAVASTATIN; TRULICITY. The following information was reported: PYREXIA (non-serious), PAIN (non-serious), FATIGUE (non-serious) all with onset 01Apr2023 at 21:00, outcome "recovered" (03Apr2023) and all described as "fever throughout the night with intense body aches & fatigue for present for about 24 hours following the injection". It was unknown if therapeutic measures were taken as a result of pyrexia, pain, fatigue. Additional information: The patient have no known allergies. Patient have no vaccine on the same date and other vaccine in four weeks.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
On Monday The next day I woke up with chills and crooked.  My sciatic nerve was pinched and i was so weak I spent all day in bed with no strength.  I was as weak as when I got Covid last year.  It hurts to stand straight as my sciatic nerve got pinched.
This spontaneous report as received from a Registered Nurse refers to unknown number patients of unknown age. The nurse reported that unknown number of patients had been vaccinated with improperly stored VARIVAX (lot# was unknown). The vaccines were stored between 10F and 24F for the past several months. No adverse effect reported. Additional information has been requested. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
5/1/07-Vomiting in evening; fever 103.2 5/2/07-6:00 a.m. Swelling (R) deltoid area 5-6 inches accompanied by redness (beet red) and warm to the touch. Fever controlled with Motrin and cool compress on deltoid area.
10 minutes after vaccine both legs became numbness and tingling. Numbness and tingling continue throughout the day on Thursday 10/25/18 until Friday morning. Later Thursday evening both legs broke out in rash. Rash continued until Friday evening. I also had to upset on Thursday a few hours after vaccine.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021 at 3:29 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Apr-2021 at 3:29 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported age 34.57. No concomitant medication was reported by reporter. Batch number 007C21A underwent temperature excursion on 28-Apr-2021 with temperature 33 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 19-Apr-2021 and beyond use date for the vial was reported as 19-May-2021. Product moved to clinic on 28-Apr-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. Temperature recordings were taken by using a Fisherbrand traceable temperature monitor at every hour. The vial was not in a frozen state at the time of vaccine administration. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. No treatment information was provided.
Developed atrial fibrillation with rapid ventricular response within 24 hours of vaccine administration. Symptoms progressed and he presented to hospital where heart rate brought under control with amiodarone drip and converted to flecainide. d/c to home following day.
Patient was administered vaccine in the left deltoid. A golf ball size hard bump immediately appeared.  Cold compresses were applied and patient remained in the pharmacy for observation for 45 minutes.  Patient was allowed to leave after 45 minutes when bump was significantly smaller in size
Pain in the injected arm; Nerve pain; shooting pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st December 2019, the patient received the 1st dose of Shingrix. On 22nd December 2019, 1 days after receiving Shingrix, the patient experienced pain in arm, nerve pain and shooting pain. On an unknown date, the outcome of the pain in arm, nerve pain and shooting pain were recovering/resolving.   It was unknown if the reporter considered the pain in arm, nerve pain and shooting pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced pain in the injected arm the day after receiving the vaccine.  The pain has improved but he still experiences a shooting pain when he moves his hand a certain way or makes a sudden movement.   He described it as nerve pain.   It goes away quickly but it was annoying. The reporter consented to follow up.
Ischemic Colitis - admitted to the hospital 3/31/21 - 4/13/21.
upper lip is swollen was reported as worsened; upper lip started to swell, is having difficulty talking/upper lip is swollen; This is a spontaneous report from a contactable consumer. A 54-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL8982), dose 1 via an unspecified route of administration, administered in right arm on 26Jan2021 14:30 (at the age of 54-years-old) as a single dose for covid-19 immunization. Family Medical History included high blood pressure. Medical history included blood pressure abnormal, fibromyalgia, cardiac disorder, anxiety, hypertension. Concomitant medication(s) included amlodipine besylate (10mg take once daily by mouth, taking for 4 years) taken for blood pressure abnormal; aspirin [acetylsalicylic acid] (81mg take once daily by mouth, taking for 4 years) taken for blood pressure abnormal, cardiac disorder; chlorthalidone (50mg take once daily by mouth) taken for blood pressure abnormal, taking for 4 years; duloxetine hydrochloride (20mg take once daily by mouth, taking for a year) taken for fibromyalgia, anxiety; lisinopril (40mg take once daily by mouth, taking for 4 years) taken for blood pressure abnormal. The patient had no other vaccine within four weeks. The patient had a bad reaction to the shot. He had it a couple of days ago and on 28Jan2021, his upper lip was swollen. Adds he was unable to take medication, clarified he was asking is there something he isn't supposed to take of his unusual medications. and what should he do. He was having a hard time talking. The event upper lip is swollen was reported as worsened. He is taking several blood pressure medications and is wondering if they are interacting with the vaccine or if they should be discontinued. He is scheduled for the second dose of the vaccine on 16Feb2021. The outcome of the upper lip is swollen was reported as worsened was unknown, while that of the upper lip started to swell, is having difficulty talking/upper lip is swollen was not recovered at the time of report.  Follow-up attempts are completed. No further information is expected.
Administered after temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 51-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number TR292, expiry date 3rd November 2025) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th August 2022, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 12-Aug-2022 Reporter's comment: The medical assistant stating that refrigerator temperature log indicated out of range temperatures for Boostrix.   The lowest recorded was 3.7 degrees Celsius and the highest was 9.2 degrees Celsius one day before the vaccination (for 48 minutes).   This case is for 3 out of 10 linked patients reported by same reporter. Additional supportive information: The patient received Boostrix after temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2022118568:Same reporter. US-GSK-US2022118569:Same reporter. US-GSK-US2022118572:Same reporter US-GSK-US2022118570:Same reporter. US-GSK-US2022118571:Same reporter. US-GSK-US2022118616:Same reporter. US-GSK-US2022118615:Same reporter. US-GSK-US2022118614:Same reporter. US-GSK-US2022118613:Same reporter.
DEATH; HEADACHE; This spontaneous report received from a health care professional via a company representative concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. 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: unknown expiry: unknown) dose, start therapy date were not reported, frequency time 1 total was administered for prophylactic vaccination The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, after receiving the covid-19 vaccine patient complained of a headache that day. The next day he died due to unknown cause of death. It was reported that the patient did not have anything else going on with him. Reporter did not know whether it was related to the covid-19 vaccine and was going to talk about it to his cousin. It was unknown if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died from an unknown cause on an unspecified date, and the outcome of headache was not reported. This report was serious (Death).; Sender's Comments: V0: 20211025751-COVID-19 VACCINE AD26.COV2.S-Death. 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).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Patient had 2nd dose of vaccine on 12/6/18. On 12/25/18, patient had weakness in left hand. On neurologic exam and  electrodiagnostic testing, he had pure motor nerve palsy of left ulnar and median nerve. Blood work revealed elevated anti-GM1 antibody. There is a working diagnosis of multifocal motor neuropathy. On 1/25/19 pt was re-evaluated and found to have slight improvement in weakness. He has not received any treatment yet, but was offered IVIG which he is considering.
This case was reported by a healthcare professional via a sales representative and described the occurrence of swelling of upper arm in a child subject of unspecified gender who was vaccinated with KINRIX. In February 2009 the subject received 1st dose of KINRIX in an unknown arm. At an unspecified time after vaccination with KINRIX, the subject experienced swelling of upper arm ( the arm where KINRIX was given). At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the event was probably related to vaccination with KINRIX. It was reported that 5 subjects in the age range of 4 to 6 years received KINRIX within the last week and developed swelling in the arm where the KINRIX was given. No specific details were known at the time of reporting. Linked cases include. A0770472A, A0770473A, A0770474A and A0770476A.
Pt reports awakening on the AM of 01/08/05 with paresthesia at right arm and right leg. Noticed right foot flopping during his exercise walk that AM. Continues to have intermittent right UE and LE paresthesia until present time. Approx 04/01/2005 developed generalized twitching of muscle in all 4 extremities.
patient received Pfizer covid vaccine on 4/12.  On 4/13 patient presented to ER with purple fingers and toes.  bilateral feet numb and tingling.  patient admitted to hospital.  by morning 4/14 patien resp status declined, ciwa score 15, afib rvr, ams, low bp.   septic shock.  source unclear.