chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 13-Nov-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 70 years old male patient who received 0.5 mL dose of vaccine FLUBLOK QIV lot number QFAA1815, expiry date-30-06-2019 via intramuscular route in the right deltoid on 06-NOV-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to incorrect product storage. It was reported that vaccines were exposed to a Max temp of 52 F for 27 hours- patient inadvertently received FLUBLOK QUADRIVALENT. It was unknown if any adverse event was occurred. 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. Documents held by sender: none.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 51 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 12Mar2021 as dose 1, single (Lot number: 010A21A) and on 16Apr2021 as dose 2, single (Lot number: 016B21A) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN, start date: Mar2022, stop date: Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Body temperature: (15Jul2022) 99.4; (16Jul2022) 100, notes: The next day fever was up to 100; SARS-CoV-2 test: (13Jul2022) Negative, notes: tested negative and went back to work on Wednesday the 13th; (15Jul2022) Positive, notes: I immediately went home that afternoon and tested and was positive; (18Jul2022) Positive, notes: Today, Monday, I am still positive with symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Patient had no known allergies.  No follow-up attempts are needed. No further information is expected.
ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN ACUTE DVT OF BILAT LEGS, UNSPECIFIED VEINS ACUTE DVT, UNSPECIFIED VEIN ACUTE DVT OF LEFT FEMORAL VEIN
Swelling, itching, redness at injection site.  Continued reaction over next 4 days: headache, neck pain, lower leg pain, increased redness, swelling, hardness at injection site about 2.5 inches in diameter. Swelling not significantly raised. Leg pain in right leg painful enough to interrupt sleep Friday night. Fatigue since Thursday morning.
High fever, seizure, febrile temperature 104, UA (+) WBC, Na: 134, Bun/Creatinine: 33.3.
Redness, edema, and swelling localized to injection site. Treatment consisted of local ice compress. Self-resolved.
Migraine behind the eyes; Pain in the teeth; nausea; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine behind the eyes), TOOTHACHE (Pain in the teeth) and NAUSEA (nausea) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Allergic reaction.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced MIGRAINE (Migraine behind the eyes), TOOTHACHE (Pain in the teeth) and NAUSEA (nausea). At the time of the report, MIGRAINE (Migraine behind the eyes), TOOTHACHE (Pain in the teeth) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment include Tylenol.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
after receiving 1st shot 14 days later i had blood clot of left eye resulting i loss of vision and i also was diagnosed with Afib !
Focal seizure approx 7:00 AM, tonic clonic seizure approx 12:00 PM and 1:30 PM. 12/10/2009 MR and DC summary for 9/19-9/21/2009, patient with staring episodes, eye deviation upwards and tonic-clonic movements. tx'd with Keppra and Diastat, DC DX new onset seizures
Swelling of the R eyelid started 5 days post-vaccine.  Initially thought to be a Sty. First tried conventional warm compress multiple times a day.  That did not help.  Started to use Raw Honey and Hot Black Tea bags on eye, that brought the swelling to a head (pimple),  and started to drain at week 2.  Then the docs prescribed erythromycin opthamolgic ointment and I had an adverse reaction to that which increased the swelling again.  Now going on the 4th week, the swelling is still present and not showing any improvement.  Is it possible it's related to the vaccine??
Pronounced swelling and redness from elbow to shoulder on vaccinated arm. Treated with higher-than-normal doses of ibuprofen and benadryl.
3 reports of "no response" after primary Engerix B series. Staff ages and sex: Male: 39; Male: 52; Female: 43;
headache; joint aches; This is a spontaneous report from a contactable non healthcare professional, the patient. A 67-year-old non-pregnant female patient received the unknown dose of BNT162be (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch Number: EL9264) via an unspecified route of administration in the left arm on 11Feb2021 at 10:15 A.M. (at the age of 67-year-old) as a single dose for COVID-19 vaccination. Patient Medical history not reported. Patient was allergic to molds, diesels products and bees. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patients concomitant medications included alegra, nexium, probiotic and scripts, all for unknown indications from unknown dates and unknown if ongoing. vaccine was administered in a hospital. The patient did not receive any other vaccine within four weeks prior to the vaccination. On 11Feb2021, at 7:30 P.M. patient experienced minor tolerable headache and joint aches. The patient did not receive any treatment for the events headache and joint ache. The clinical outcome of headache and joint ache was resolved. No follow-up attempts are needed. No further information is expected.
pt reported feeling nauseas and if she may vomit. took pt hx, took vs, assessed pt, gave pt 2 crackers, stayed with pt until she reported feeling better.
Pt recvd Engerix-B doses 18APR91 & 21MAY91 & 1 wk p/receiving both doses the pt devel a stiff arm & neck w/pain;
14 days after vaccine I started getting itchy in my groin and inner thighs after a walk. I itched all night and thought I had poison oak rash or something. Next day it was worse but on other parts of my body. Within 24 hours I was desperately itchy from head to toe, anything I touched or rubbed was incredibly itchy within a few minutes. I could draw lines and welts on my skin just by rubbing with my fingers. I took BENADRYL and it helped with the itching but the rash remained. Next day I went to my doctor and he prescribed me some antihistamines and prednisone if the itching got really bad or I developed hives. I continued to take antihistamines each day, sometimes twice a day. My condition aligns exactly with "dermatographia" or skin writing. Two weeks later I am still itching and get the rash at my waistline and anywhere that I rub or scratch, but it is completely manageable as long as I take ZYRTEC each day. The reactivity of my skin seems to be decreasing as time passes and I hope to be done with this in the coming weeks. My brother (same genetics) got hives and dermatographia, as well as anaphylaxis within 11 days of his booster shot in 2021. My brother and myself have never had an allergic skin reaction prior to this.
small rashes, itchy; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of rash (received shingle shot 5 years ago from time of reporting and received several rashes slightly bigger).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced itchy rash. On an unknown date, the outcome of the itchy rash was unknown.   It was unknown if the reporter considered the itchy rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but as per indication of the vaccine age group was captured as adult. The patient developed 3 small rashes, itchy, but did not spread. The patient inquired of everything was normal or not and asked if the patient should get the second dose or not.
On evening of day 8, 3/12  after receiving Moderna, 1st shot, Itchy red rash around injection site On evening of day 9 , 3/13 chills, nausea,, headache. Itchy rash a little bigger - applied Benadryl cream which helped Day 10, 3/14  Rash hot and itchy, applied Benadryl.  Feeling unwell but no chills Day 11, 3/15  Rash still there, headache
Increased FiO2 need; increase in periodic breathing accompanied by desafurations. Required change of tx from HFNC 2l/m. RA to 3iPap 5cm; 30%.
As a hospital employee, I got my first injection on January 4th at 9:30 am. For the next few days I had no reaction other than soreness at injection site. A week later, in the morning of January 11th, I felt the itch on the same arm next to injection site, and observed skin rash in an egg shape. I thought it was just an insect bite. The itch continued on Tuesday, which made me wonder if there is such a thing as delayed reaction to COVID-19 vaccine. I did a bit digging in the medical literature, which confirmed my suspicion of delayed reaction to vaccines in general. Today, Thursday, January 14th, the itch is minimum and the skin rash is still there. The skin rash area is approximately 5 cm from left to right and 6 cm from top to bottom. I took a few photos, and am happy to email them to you if interested.
Received AFLURIA vaccine 11:10am 10-12-10. Pt reports fever 102.4 orally w/chills, and joint aches. Lasted 2 days. Pt is an obstetrical pt. No long term issues. Pt notified office today 10-27-10.
Convulsions; Hallucinations; cramping; Chest pain; This is a spontaneous report from a contactable consumer or other non health professional (parent).  A female patient of an unspecified age received second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number was not reported, Expiration Date was not reported), via an unspecified route of administration on 25Jun2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 via unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. It was reported that, reporter daughter was given a second shot today (25Jun2021) of Pfizer and it's now about 4 hours since she was given the shot and she had reacted to the shot having convulsions, hallucinations and cramping, chest pains and all that. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Severe Burning about 2 inches above elbow. 4/15/2016  went to Emergency and was given Gabapentin.  Didn't help-only put me to sleep.  Went to Primary Dr 04/20/2016 and given TYLENOL 3 and told to keep taking Ibuprofen.  Went to Chiropractor for month of April-no help. Severe tingling in lower arm and last 2 fingers numb. Hurting so bad took 3 TYLENOL 3 in 2 days and in total fog so went back to Emergency May/9/2016 and given Prednisone. Still hurting so back to Primary 05/12/2016 for arm x-ray.  All good and given Acylovir, Folic Acid and inflammation cream.  Waiting to see how this works!
Pt presented with altered mental status related to UTI and Covid 19. treated with remdesivir and rocephin for uti. Pt discharged home once stable.
Patient was given a 5th dose of IPV and a dose of Tdap that she wasn't due for (last received 01/14/15).
Information has been received from a registered nurse concerning a 6 year old female with allergies to Augmentin and Keflex and a history of eczema who on 08-NOV-2006 was vaccinated SC in the left thigh with a second dose of virus vaccine live (Oka/Merck(Lot#654695/1055F). Concomitant therapy included a second dose of hepatitis A vaccine (inactive) (MSD) (Lot#655301/0741F) given IM in the left thigh. On 15-MAY-2007, the patient presented to the office with a rash and headache. The patient was diagnosed with chickenpox and pyoderma. The physician prescribed Zithromax and Bactroban. On 18-MAY-2007 the patient recovered. No further information was provided. Additional information is not expected. This is one of several reports from the same source.
Information has been received from a registered nurse referring to a female patient of unknown age. The patient's medical history, concurrent condition and concomitant therapy were not provided. In June 2008 and April 2010, the patient was vaccinated with her first and second doses of GARDASIL (lot #, expiration date, dose and route not provided) by unspecified physicians, respectively (inappropriate schedule of vaccine administration). On 06-OCT-2015 (reported as today), the patient received her third dose of GARDASIL (lot # reported as L023905 with expiration date 27-MAY-2017, dose and route not provided) (inappropriate schedule of vaccine administration). No adverse experiences had been reported. Additional information has been requested.
Patient developed was she considers extreme chills for 5 hours on 10/19. She states she slept all day long 10/20/21 and on 10/21/21 had heart palpitations that lasted about 12 hours and about 2 hours  also on 10/22/21.
Day 4 itchy rash on toes. Vesicular. Pinpoint red bumps. Mild. Treated with hydrocortisone.
Develop pneumonia diagnosed day after: could not breathe, cough, high fever, X-ray shows acute pneumonia.
irregular heartbeat; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient of unspecified age received the first dose of BNT162B2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 21Mar2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced irregular heartbeat last night (24Mar2021) and he took Dofetilide in order to normalize his heartbeat. He wants to know if this is a side effect of the vaccine and if it is a problem. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
The morning of June 18, 2021, began receiving chest pressure and pain. After consultation with a doctor, doctor recommended I check into the Emergency Room, where some irregularities were found in the EKG. I was then transported to a different Medical Center for further evaluation.
CV-19 vaccine: protein in urine has increased dramatically and seems to be getting worse; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; finerenone (KERENDIA), (Batch/Lot number: unknown) at 10 mg. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed but unknown manufacturer.), for covid-19 immunization. The following information was reported: PROTEIN URINE PRESENT (non-serious), outcome "unknown", described as "CV-19 vaccine: protein in urine has increased dramatically and seems to be getting worse". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for finerenone was unknown.  Additional information: Caller is calling about CV-19 vaccine, confirmed manufacturer is Pfizer. CV-19 vaccine: protein in urine has increased dramatically and seems to be getting worse: Had last shot a year ago in Aug, which was caller's 3rd shot. On Pfizer website lists a condition that the vaccine could cause kidney damage, kidney doctor noticed that protein in urine has increased dramatically and seems to be getting worse now. Doctor prescribed caller a special drug called Kerendia, which is very expensive. Caller is wondering if Pfizer will take care of the copayment of Kerendia because copay is very high. No report related to a study or programme.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
devel hives over entire body x/face; duration 1 day; treated w/DPH;
Patient developed extreme swelling, pain, and rash/itchiness on entire body close to a week after being vaccinated. Was prescribed prednisone, hydroxyzine, and valtrex for symptomatic relief on 2/2/19.
15 min after vaccine pt reports profuse sweating, nausea/vomiting and rash/hives to both arms, abdomen and back. Instructed to go to ER. receives BENADRYL IM and nausea med at ER. She continued BENADRYL as directed by ER. doctor at home by mouth and cream to rash areas. Pt reports was better next day.
shortness of breath; chest pain; injection site swelling; This is a spontaneous report from a non-contactable consumer (patient).   A 33-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 10Nov2021 (Batch/Lot number was not reported) as single dose (at the age of 33) for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No covid prior vaccination, or covid tested post vaccination. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced shortness of breath on 11Nov2021, chest pain on 11Nov2021, injection site swelling on 11Nov2021. The events resulted in Emergency room/department or urgent care. The events were not treated. The events outcome was recovering.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Ongoing symptoms similar from previous VAERS report (1694959). I have not recovered from the extreme headache, chest pain and shortness of breath as of 01/17/2022.
The day following vaccination I had very, very painful joint pain throughout my body.  In particular my hips were so painful that walking was difficult.  I've never had a hip  injury or problems with hip pain.  My doctor  eventually ordered x-rays of both hips and blood work to rule out other possible causes.   All tests showed that I was perfectly healthy.  The pain in most of my joints has subsided considerably, but my hips continue (now over two months following the vaccination date) to be painful.
Information has been received from a physician concerning a 25 year old female who was vaccinated with 2 doses as a child (dates unknown) of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). In 2005, she had positive antibody titers to measles, mumps, and rubella. Subsequently, she "recently", in 2007, had her titers checked due to pregnancy and the titer results were reported as negative. She contacted her physician via telephone. No problems were reported. Product quality complaint was not reported. No further information was available. Further information is not expected.
pt recvd flu vax 15OCT93 & devel weakness & couldn't get out of bed unassisted; pt had no power or strength in grip, had pains in knees, hips, shoulders & hands; had no use of lt arm for 3 wks; pt also limite use of rt arm; pt seen by MD;
Patient was given Pneumoccal PPV23 LOT#0380U LEFT LEG IM @ 9 AM ON 09/10/2008, THIS WAS REPORTED TO LOCAL HEALTH DEPT. AWAITING CALL BACK ON WHEN CORRECT IMM. SHOULD BE GIVEN
Patient 16 yrs old and received Moderna vaccine on 5/7/21. According to current CDC recommendations, patient also received second dose on 6/4/21. Patient tolerated well.
neuralgic pain; This case was reported by a consumer via call center representative and described the occurrence of neuralgia in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles outbreak 2 years ago from reporting date, before he received Shingrix).   On an unknown date, the patient received Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced neuralgia. On an unknown date, the outcome of the neuralgia was not recovered/not resolved.   It was unknown if the reporter considered the neuralgia to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received Shingrix vaccine 2 years ago from reporting date and had neuralgic pain that was wrapping around the right side of his back, similar to when he had an outbreak of shingles 2 years ago from reporting date (before he received Shingrix dates were unknown). The reporter consented to follow up
Hib was inadvertently given in a combination vaccine (PENtACEL) and given separately (PEDVAX HIB). I meant to give the PEDIARIX and PEDVAX HIB instead.
Approx 12 hrs post-vaccine; I had the expected flu-like symptoms. They subsided in about 3 days. Now I am on day 6 & the brain fog just will not go away. It's really bad & abnormal for me, it even affected my driving. I REALLY hope it goes away. I feel like a vegetable- filling this out now I'm staring off.