chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I got the shingles shot/Suspected Vaccination Failure; I got it three different times; SCORCHING; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I got the shingles shot/Suspected Vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: I got it three different times) and feeling hot (Verbatim: SCORCHING). The outcome of the vaccination failure was unknown and the outcome of the shingles and feeling hot were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and feeling hot to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles and feeling hot to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 11-MAR-2023 This case was reported by a patient via interactive digital media. The patient got the shingles shot. However, the following year, he/she got shingles three different times on face, lower spine and stomach.  The reporter stated that scorching was his/her word. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting.  The follow up would not possible as no contact details were available.
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, Fatigue Narrative:
dizziness; distorted vision; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 14 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Jun2021 12:00 (Lot number: ew0167) at the age of 14 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "hay fever allergies" (unspecified if ongoing); "If Covid prior vaccination: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 15Jun2021 08:00, outcome "not recovered", described as "dizziness"; METAMORPHOPSIA (non-serious) with onset 15Jun2021 08:00, outcome "not recovered", described as "distorted vision". The events "dizziness" and "distorted vision" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of dizziness, metamorphopsia.  Additional Information: No any treatment received for events. Prior to vaccination patient tested positive for covid-19. Patient did not tested for covid-19 post vaccination. No known allergies were reported.  No follow-up attempts are possible. No further information is expected.
"Restless" at night - toss & turn, wake frequently. Both hands intermittently "fall asleep" during night. Also 2" x 1" local reaction red, itchy - resolving.
Case number PHHY2011US45143 is an initial spontaneous report received from a nurse on 20 May 2011 with follow-up on 01 Aug 2011. This report refers to an 11-year-old male patient. He was given only CYW-135 liquid component MENVEO (batch number M10034) intramuscularly on 05 May 2011. No other adverse reaction was reported. The patient was revaccinated. Follow-up received on 01 Aug 2011: Updated patient demographic and vaccination date.
First pregnancy, low risk under midwife care, no genetic anomalies detected, due date oct 4 2021, spontaneous delivery on June 19 2021. Birth weight 790g, survived and receiving care at NICU.
Patient's arm got sore and red below the injection site. The red was hot to the touch and itched.
Days 1-3: Fatigue Day 4 (2/1/21): Fever of 100.5, shakes, and rash on left forearm
Symptoms overlapped, so reports are combined.  Dose 1 - I went to the store to get food and started to feel funny. I had a severe headache, was extremely tired and became nauseous. I took some Tylenol. I still felt funny the next day, but a little better. The headache persisted, so my neurologist scheduled an MRI.  Dose 2 - That evening, I still felt weird. I also developed chills, a fever and I still had the headache. The following morning, I was achy all over. I felt like I had COVID all over again. I took Tylenol repeatedly, but it wasn't until I took an Advil, did I get some relief. My fever broke and the pain eased. I went to my doctor and was told that they symptoms would last for a while. I had my MRI during this time and the results were normal. By Sunday night, I was fine. I'm still having headaches, but not as often nor as severe. I am also still dealing with fatigue.  I also experienced breathing issues, which has been a problem since I had COVID, so I had to  follow up with my pulmonologist during this time as well. I am currently on an inhaler.
None reported. 11-3-09 call to Daycare-spoke to owner (patient's daughter), she states patient is working and is doing fine. Patient did not have any adverse reaction; patient was contacted about one week later by clinic administrator and patient said she was fine.
Essential tremors began April 9, 2021. They were written off as stress from my doctor. I have an appointment with the neurologist in three weeks in a few days. They have become increasingly worse.
Administered GARDASIL .5cc IM to left deltoid on 5/10/12. Several moments later she became lightheaded. She was placed on a cot to rest. She did not lose consciousness.
BASED ON NOTES FROM STAFF (FLOATER): LEFT SHOULDER PAIN, LIMITED RANGE OF MOTION, PAIN (LASTING? DIFFICULT TO READ NOTE FROM STAFF) FROM SHOT OVER 6 WEEKS.
11-02-03 Palpable papular rash began, lower extremities with progression to trunck and head - rash became pink then red - masculopapular - no vesicles or pustules - puritic - knees - as is crawling - to doctor 11-03-03 for cough - was given Vistral x 3 doses - no change in rash - also taking pan cough D - Febrile 10-31-03 T 99.8 resolved with treatment
"45up to void min later sweat, 12hrs later when I woke up to void, I felt warm ,severe  fatigue ,  ,muscle  aches , pain  some  Syncope, nausea, sweating on and off, oral herpes  outbreak just like I  did when  I had Covid -19 in April"
COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose via an unspecified route of administration, administered in arm left on 21Jan2021 (Batch/Lot Number: EL3302) at the age of 34-year-old as single dose, 2nd dose via an unspecified route of administration, administered in arm left on 10Feb2021 12:00 (Batch/Lot Number: EM9810) at the age of 34-year-old as single dose for COVID-19 immunization. Relevant medical history and relevant past drug history was none. The patient was not pregnant. Concomitant medications included escitalopram oxalate (LEXAPRO); ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE); probiotics; paracetamol (TYLENOL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Reported event was tested positive for COVID on 03May2021. Treatment received for the adverse event was medicines and rest. The patient underwent lab tests and procedures which included Lumiradx Sars-Cov-2 AG: positive on 03May2021 (Nasal Swab). The outcome of event was recovering.   Follow-up attempts are needed. Further information is expected.
01/18/2021- Around 5pm I got chills, and shaking lasted until 10pm, I had a fever of around 102.0. Shaking subsided, but chills lasted all night, severe fatigue. I had fever chills, fatigue that lasted all day Tuesday and Wednesday, I slept a lot. I had loss of appetite and loss of thirst due to excessive sleepiness, during those 2 days. I had volunteered to work vaccine clinic the following Thursday, but I had still not eaten so I was dizzy and lightheaded, I worked 10 hours and 5 hours on Friday and 5 hours on Saturday, I went home and slept more on Saturday. I had a low grade fever at this point and then on Sunday or Monday my fever spiked, I still slept a lot. I was contacted by a tracer letting me know I had come into contact with someone infected on the previous Thursday. I began to have Covid-like symptoms started on 1/24/2021 which lasted 10 days until Feb 2nd, 2021.  I had very severe abdominal pain. I had a telehealth visit on 1/28/2021 in which they told me to go to urgent care but I was too sick to go. I still have some lingering fatigue where I did not have fatigue before all of this began.
Severe pain in arm, swelling in arm, ongoing fever, allergic reaction (itching that benadryl doesn't help), throat swelling, trouble breathing, visible rash on entire arm, weakness, fatigue, coughing, burning nose and throat, nausea, abdominal pain, diarrhea
Came to Clinic 18Oct17. Rt. upper arm had 11x7cm reddened, swollen, hot, painful, slightly itchy area where Flu shot was given 16Oct17. "It hurt 7/10 last night and I couldn't sleep."  Ice to area and recommended OTC pain reliever/anti-inflammatory, and anti-itch remedy to site.
Black and blue area. Pt said burning sensation also. Pt showed me 9/30/16.
Sweats/greasy oil sweats start halfway up head and drip down/getting worse and worse/starts 2 PM and lasts until morning; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweats/greasy oil sweats start halfway up head and drip down/getting worse and worse/starts 2 PM and lasts until morning) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Stent placement (Stent in heart). Concurrent medical conditions included Blood pressure abnormal. Concomitant products included CANDESARTAN for Blood pressure, ACETYLSALICYLIC ACID (BABY ASPIRIN) for Stent placement, ATORVASTATIN, METFORMIN, VITAMIN B12 [VITAMIN B12 NOS], VITAMIN D3, MULTIVITAMINS [VITAMINS NOS], FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced HYPERHIDROSIS (Sweats/greasy oil sweats start halfway up head and drip down/getting worse and worse/starts 2 PM and lasts until morning). The patient was treated with HYDROCORTISONE for Adverse event, at a dose of 25 milligram. At the time of the report, HYPERHIDROSIS (Sweats/greasy oil sweats start halfway up head and drip down/getting worse and worse/starts 2 PM and lasts until morning) had not resolved.            Patient started having a lot of trouble with sweats, greasy oily sweats that start halfway up the head and drips down. Its been getting worse and worse. It starts around 2 PM in the afternoon and lasts until the morning. The patient reports his regular physician has given up, his dermatologist has given up. He reports his HCP prescribed him Hydrocortisone HCL 25 mg, but it did not work much, so he stopped it.
Case number PHEH2014US003603, is an initial spontaneous report from a pharmacist received on 21 FEB 2014. This report refers to a 14-year-old male patient. Past medical history and concomitant medications were not reported. He was inadvertently vaccinated with FLUCELVAX 2013/2014 (batch number: 010031A, expiration date:  JUNE 2014) at a dose of 0.5 ml intramuscularly on 24 NOV 2013. No adverse event was reported following the maladministration (inappropriate age at vaccine administration).  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014: The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Diarrhea - Started on Monday, March 15. Escalated through Wednesday, March 17th. Used Pepto Bismal to alleviate.
Received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 17-year-old patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA713A) for prophylaxis.   On 13-JAN-2023, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced incorrect storage of drug (Verbatim: Received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Itching started at night on January 23, 2021. Itching continued the next morning with little bumps and redness measuring approximately 2" wide by 3" long around injection site. Applied hydrocortisone cream 2x/daily.  Resolved on January 26, 2021.
After vaccine was administered patient was seemingly fine until a loss of consciousness/mini stroke on Jan 16 (5 days after vaccine) causing a fall and massive stroke on Jan 22 (11 days after vaccine) that left patient unresponsive and on life support until family decided to stop services and begin hospice care with no fluids or food until death
Office Visit 3/27/2021   T, PA-C COVID-19 Dx Cough  ? Diarrhea ? Fatigue ? Covid-19 Screening Reason for Visit Progress Notes , PA-C (Physician Assistant) ? ? Family Medicine ? ? Encounter Date: 3/27/2021 ? ? Signed Cosigned by:  MD at 3/28/2021  9:14 AM Expand AllCollapse All    MDM Nontoxic-appearing 77-year-old female presents with 5 days of URI symptoms.  Rapid Covid testing house was positive.  Patient has had 1 dose of Pfizer SARS-CoV-2 vaccine and is due for his second and final in 1 week.  Patient was given strict supportive care and isolation instructions.  She is to follow-up with her PCP today when she leaves to discuss monoclonal antibody infusion.  ED precautions reviewed in detail with patient.  1. COVID-19       was seen today for cough, diarrhea, fatigue and covid-19 screening.   Diagnoses and all orders for this visit:   COVID-19 -     POCT COVID-19 Antigen      RN Registered Nurse  Progress Notes    Signed Encounter Date:  3/30/2021     Signed        Hide copied text  Hover for details Patient is here for MAB Infusion Consent for infusion prior to this visit reviewed and verified. O2 sats > or = 90% Signs of potential reaction reviewed with patient. Tolerated IV start and MAB infusion without complication. Pt has access to pulse oximeter and thermometer for home monitoring Provided fact sheet for patients, parents and caregivers- Emergency Use Authorization of BAM for Coronovirus Disease 2019 for pt to review. Discharge instructions reviewed. Patient denies any questions
no AE; expired vaccine and expired diluent administered; This spontaneous report was received from a medical assistant and refers to a patient of unknow age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 18-OCT-2023, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 0.5 milliliter, lot #U025200, expiration date: 13-AUG-2023, administered for prophylaxis (strength, and route of administration were not provided); and  sterile diluent (STERILE DILUENT) solution for injection/infusion, unknown, lot #T029530, expiration date: 10-MAR-2023 (strength, route of administration, and indication were not provided) (Expired product administered). Products had not experienced temperature excursion through date of administration. No additional adverse event was reported.
Patient developed palpitations after drinking coffee.  Also noted dyspnea on exertion.  He test positive for Covid-19 on 12/23/2021.
16 days p/ vax,mom reported redness/swelling/pain & fever in arm. MD dx as abscess, tx: heat.Seen at Hlth Unit-08/22/96. No redness or pain noted.Minimal T noted.Area about 1"x 3/4"-lower &more anterior than inj site.Felt muscle swelling.
24 hours after vaccine, temperature 101.8, chills, slight nausea, no appetite, sleepiness. 48 hours after vaccine just fine, health back to normal!!
Patient developed a rash on her upper arm, it was a big rash and had to take BENADRYL for several days. The rash is completely cured and gone now.
Fever of 100 for 2 days, muscle pain, chills 1.5 days after shot.  swelling and painful arm from shoulder to elbow, bruise a quarter large at injection site for 5 days. Lymph nodes swollen along left clavicle and under arm. Felt fluish. Severe fatigue beginning in evening first day thru morning of 2nd day after shot.
Member with c/o L arm discomfort since vaccination off and on.  Very itchy at times with localized swelling and erythema.  Follow up with patient provider if worsens.
The patient experienced nausea, dizziness, itching, heaviness in chest, hives at the injection site, some rash on her arms and a headache. The patient was treated with Benadryl, Prednisone and Vistaril.
chronic benign neutropenia; This spontaneous report was received from a registered nurse, who is also the patient's mother and refers to her 18-year-old son. There was no information regarding patient's pertinent medical history, drug reactions, allergies and concomitant therapies provided. On an unknown date, the patient was administered an unspecified meningitis vaccine (manufacturer unknown) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for vaccination.  On an unknown date (reported as after the vaccine administration), the patient had an unspecified blood test performed, which showed chronic benign netropoenia (date and details were not provided).  The outcome of the event was reported as not recovered. The causality assessment was not provided.  Upon internal review, the event of chronic benign neutropenia was determined to be medically significant.
COLD FOR 12 DAYS; SORE ARM; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. 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) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced cold for 12 days, and sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cold for 12 days and sore arm was not reported. This report was non-serious.
This spontaneous report as received from a 73 year old female consumer reporting on herself with bronchitis, drug hypersensitivity to tramadol and codeine. The patient's medical history included myocardial infarction, gallbladder operation and knee operation in 2013. On 20-JAN-2015, the patient was vaccinated with ZOSTAVAX 1 time vaccine in the left arm, triceps area. Concomitant therapies included aspirin 81 mg 1 time daily, levothyroxine sodium (manufacturer unknown) 50 mg, COREG 3.12 mg twice daily, "prevastatin", niacin, PLAVIX 75 mg, zenix, LASIX 20 mg, NEXIUM and unspecified stool softener once daily. On 20-FEB-2015, the patient developed a red area "1 1/2 inches by 3 inches", on her left insertion arm. The patient stated that it was warm, but not hot to the touch, and it was not painful. She also stated that the red area was subsiding. It was reported that the patient sought unspecified medical attention but did not receive treatment for the adverse events. No Product Quality Complaint (PQC) reported. Additional information has been requested.
A 49 year old male revaccinee was vaccinated against smallpox on 3/12/03.  He reported itching at the vaccination site 5  7 days post-vaccination but no fever and no other symptoms.  His take was "major" on 3/18/03.  On 4/8/03 patient experienced chest pain  while at work and reports he experienced similar symptoms the evening before which he attributed to indigestion.  While driving home the pain increased and he developed dyspnea and diaphoresis.  He was transported via ambulance to a local Emergency Department where he was found to have EKG (Q waves in V1 to V4, non-specific ST and T waves abnormalities, and poor R wave progression) changes consistent with anterior myocardial infarction. His BP was 139/75 mm Hg, pulse 84 and regular. His initial CK was elevated at 1285 and his initial troponin was also elevated at 12.7.  A cardiology consult resulted in cardiac catheterization on 4/8/03.  This procedure indicated an acute anterior myocardial infarction related to a complete occlusion of the left anterior descending artery involving the dominant right coronary artery; anterolateral, apical and inferoapical akinesia with a reduced ejection fraction; and elevated left ventricular end diastolic pressures. Successful PTCA and stent deployment in the mid and proximal LAD was performed. The impression was of moderate coronary artery disease.   He was also medically managed with heparin, Intravenous beta-blockers and aspirin.  Patient has no history of hyperlipidemia , no family history of premature coronary disease, no history of diabetes, no history of hypertention and patient is a nonsmoker. The only medications he took prior to 4/8/03 were Nasonex and Clarinex.  Patient was discharged from the hospital 4/12/03 and is now recovering comfortably at home.
Patient received first dose Pfizer vaccine (LOT#: EW0162 Exp: 7/2021) at 1556. Patients observation time had passed. EMT asked patient if she was feeling well to leave. Patient stated that she felt a tingling feeling in her hands to her legs. EMT told PHN who asked patient to stay another 30 minutes for further observation. PHN offered patient diphenhydramine. Patient refused medication at 1634. EMT took patients vital signs. BP: 106/58, pulse: 65, 02: 98%. PHN assessed patient again. Patient stated that the tingling feeling moved to her face around 1642. PHN offered patient Diphenhydramine once again. Patient agreed to medication. PHN gave patient adult dose of Diphenhydramine 50mg/mL at 1643. Patient assessed after 30 minutes were up. Patient stated that the tingling feeling in her hands, legs and face had gone away at 1700. Patient was picked up by her cousin. Patient left vaccination site unassisted and with a steady gait.
Mother states approx. 2 days after receiving vaccine patient had following symptoms similar to his sister that received vaccine on 5/2/21: Bell' Palsy type of symptoms: disfigured mouth pulled to right and one side of eyelid raise/and other side drooping. Mother states his getting a little better. Unable to talk to him/left msg.