chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I woke up at 3AM in the morning coughing choking with burning and pain, I had grey thick mucous this continued straight for six days. I had little lumps in my throat. I had loose bowels as well.
four children including my son went in with this illness; four children including my son went in with this illness/Suspected vaccination failure; This case was reported by a consumer via interactive digital media and described the occurrence of bacterial meningitis in a child patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced bacterial meningitis (serious criteria death and GSK medically significant) and vaccination failure (serious criteria GSK medically significant). On an unknown date, the outcome of the bacterial meningitis was fatal and the outcome of the vaccination failure was unknown. The reported cause of death was bacterial meningitis.   The reporter considered the bacterial meningitis and vaccination failure to be related to Meningococcal B vaccine.  Additional details were provided as follows: The age at the vaccination was not reported. The patient was given meningitis B vaccine and it did not protect from bacterial meningitis. The reporter reported children went in with this illness. The patient did not survive. This case was considered as suspected vaccination failure, since the details regarding dose number, time to onset and laboratory confirmation were not provided. This case is linked to the case US2020AMR232425, US2020AMR232424 and US2020AMR232267.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR232425:same reporter US-GLAXOSMITHKLINE-US2020AMR232424:same reporter US-GLAXOSMITHKLINE-US2020AMR232267:same reporter; Reported Cause(s) of Death: Meningitis bacterial
Large red rash appeared on upper left arm on Wednesday, April 7th around 5pm.  Slightly itchy, but mostly just very very hot.  It is raised up like a welt with the diameter of about 3 inches. There are a few smaller surrounding welts with diameters of 1/2 inch, all slightly connected.
beginning of kidney failure due to high creatinine levels most likely caused by her hormonal birth control mixed with the vaccine and it caused her body to create multiple blood clots, severely swollen leg; beginning of kidney failure due to high creatinine levels most likely caused by her hormonal birth control mixed with the vaccine and it caused her body to create multiple blood clots, severely swollen leg; beginning of kidney failure due to high creatinine levels most likely caused by her hormonal birth control mixed with the vaccine and it caused her body to create multiple blood clots, severely swollen leg; lower back pain; fever up to 103.7 degrees; This is a spontaneous report from a contactable consumer. A 19-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiry date not reported), via an unspecified route of administration in mid May2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiry date not reported), via an unspecified route of administration on an unspecified date, as dose 1, single for COVID-19 immunisation. It was reported that the patient was generally healthy. The patient received her second dose of Pfizer COVID vaccine on mid-May. The patient was hospitalized with 5 blood clots and lower back pain. The patient was initially given Aleve and a muscle relaxant thinking it was a back strain. The patient woke up three hours later with a severely swollen leg and immediately went to ER and the ultrasound confirmed blood clots with 4 clots reaching the lungs. The patient had fever up to 103.7 degrees. The patient was told at the hospital that she was in the beginning of kidney failure due to high creatinine levels. Doctors told her that it was most likely caused by her hormonal birth control mixed with the vaccine and it caused her body to create multiple blood clots. The events took place after the use of vaccine. The patient underwent lab tests and procedures which included body temperature: 103.7 degrees (Fever), ultrasound scan: blood clots on ultrasound confirmed blood clots with 4 clots reaching the lungs, blood creatinine: high. The outcome for the events was unknown.  Information about Lot/batch number has been requested.
Fever, vomiting, dehydration, flu-like muscle pain, headache, dizziness, swelling of upper (L) arm and pain.
Fever, body aches, severe headache, fatigue and pain at the injection site, muscle pain
I got the shot I got the shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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 6 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the Shingles six month prior to the reporting and got the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Patient stated just after receiving  vaccination, she felt dizzy and started  to fall. Staff was able to assist patient to. floor.
Goes to prove the vaccine is not 100%, still get/Suspected vaccination failure; Still get (shingles); Pain in back; Pain under arm; Rash/rash had gotten smaller; It feels more like Bee sting every once and while; Sometimes my back feels like sandpaper rubbing back and forth on it; Redness; This 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, back pain, axillary pain, erythema, rash, tingling sensation and abnormal physical sensation. On an unknown date, the outcome of the vaccination failure, shingles, tingling sensation and abnormal physical sensation were unknown and the outcome of the back pain, axillary pain and rash were recovering/resolving and the outcome of the erythema was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles, back pain, axillary pain, erythema, rash, tingling sensation and abnormal physical sensation to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-SEP-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient did not had itching. The patient had pain in back and under his/her arm. It was not as intense as it was when it started.  The patient felt more like bee sting every once and while.  Sometimes his/her back felt liked sandpaper rubbing back and forth on it.  After almost two months the redness was gone and the rash had gotten smaller.  The reporter went to prove the vaccine was not 100% effective and still got shingles. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available. This case has been linked with case US2022AMR139439 reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR139439:Same reporter
This is a 29y.o. male With history of previous pulmonary embolism Approximately 4 years ago.  Was treated with Xeralto for 6 months.  Underwent hypercoagulable workup at that time which, according to the patient, was negative.  Patient presented to the ER Today complaining of left calf pain.  Ultrasound reveals a DVT in the left popliteal vein
The patient sat down after receiving the vaccine.  After a few minutes she started feeling dizzy as well as having tingling on the left side of her body from head to legs.  She described it as similar to your leg falling asleep.  I recommended that she get someone else to drive her, and I recommended an NSAID like ibuprofen or naproxen in case there was nerve inflammation causing the symptoms she described.
Patient stated her right arm became tender and warm after receiving the Shingrix vaccine. She also felt super tired and had deep muscle tension.
Patient came into the clinic requesting the Pfizer Covid-19 vaccine. She stated that she received a Janssen Covid-19 vaccine but does not recall the date and was worried about the Delta variant. She stated that she and her PCP had discussed it and agreed that she should get the Pfizer Covid-19 vaccine. She received the vaccine 7/21/21
patient had vasovagal episode s/p covid-19 vaccination. patent received the vaccine at 10:40am and 3 minutes after the injection felt cool, clammy and pale, alert and oriented to self, place and date. Patient lower to the ground by medical staff with legs elevated., HR 67, B/P 116/60, R16 O2 98% ra. Orange juice and cookies provided. At 10:55am patient state feeling "much better" repositioned to the chair after 10 minutes laying on the ground and informed he's observation will be at least 30 minutes.  At 11:30am, patient states at his baseline, VS B/P 110/80, HR 70, R 16, O2 sats 98-99% ra, no complaints at this time, patient d/c home with steady gait, no distress noted.
No adverse event, Vaccine was freezed and then thaw before using. Per CDC that was incorrect so we need to report as not good and notify our patients.
Patient was given MMRV and Varicella on the same day.  She received 2 doses of varicella.
Less than 3 minutes after administration, I began having tingling in my throat. My heart began to race. I grabbed a medically professional who assessed me, she stated I was beginning to flush and then had EMS respond. Vital signs indicated a peak heart rate in the 160?s, O2 Sats were in the 80?s. I also had a metallic taste in my mouth and a tightness in my airway. Later in my hour observation I had a period of facial flushing and itching. I had ice packs placed on my skin, given a fluid bolus and monitored by an RN and EMS personal. A Doctor assessed me and contemplated transporting to the ED for management but I was slowly feeling improvement. I was monitored for an hour and felt okay when I left the clinic.
received an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 15-month-old male patient who received DTPa (Infanrix) (batch number 49TM3, expiry date 28th May 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th June 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 8th June 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 08-JUN-2022 Reporter's comment: The registered nurse reported that the patient received an expired dose of Infanrix. The reporter consented to follow up. Additional supportive information: The patient received Infanrix which was already expired, which led to expired vaccine used.
pt began w/being fussy immed following vax;this fussy behavior cont to inc throughout the day & the day ended w/pt screaming & crying for 4-6hr;the following 2 days were the same w/screaming & crying;t99.6;pt cont w/low grade temp & fussy
Site: Redness at Injection Site-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Hyperventilation-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium
The pt developed papular, vesicular rash in different stages more on back of neck, back, same on chest and extremities. Very itchy and few on back are crusted.
VERY SICK WITH COVID; This spontaneous report received from a parent via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced very sick with covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of very sick with covid was not reported. This report was non-serious. This case was associated with a product quality complaint:
3rd day after vaccine, I had severe sore throat on left side, teeth ached on left side, ear ache on left side, no fever, but severe fatigue. Two weeks after I had the 1st vaccine, I ate shell fish.  30 to 45 minutes later, I had a terrible reaction.  I had a bad back ache.  I felt like I was going to faint and felt very dizzy.  I had severe diarreha and had hot flashes and forehead sweats.  I barely made it to my bed and went to sleep.
administered with the vaccine which has been stored in the refrigerator for more than 30 days; administered with the vaccine which has been stored in the refrigerator for more than 30 days; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (administered with the vaccine which has been stored in the refrigerator for more than 30 days) and EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported).    On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jul-2021, the patient experienced PRODUCT STORAGE ERROR (administered with the vaccine which has been stored in the refrigerator for more than 30 days) and EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days). At the time of the report, PRODUCT STORAGE ERROR (administered with the vaccine which has been stored in the refrigerator for more than 30 days) and EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days) had resolved.        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.
Patient got vaccinated then immediately vasovagal happened she ended up on the floor and hit her left side forehead and got a golf sized knot. Took vitals, WNL, bilateral pupils 2mm, brisk, equal. Offered to called ambulance but she refused.
Pt. woke up Saturday with a swollen arm.  Hot and red in appearance.  3 days later (Monday) swelling was gone.  Antibiotics given.  Benadryl and ibprofin given as needed
Fever, shortness of breath  started 230pm. SPO2  75% on RA, O2 started 2L NC sats  uo to 84% then increased to 3LNC up to  sats 94%
Patient's face was flushed and c/o "crawling things" on her face and itching and started coughing. Pt stated her throat was "closing up" but was able to speak and breathe. Pt's legs were raised, cold packs applied and Benadryl was given (per standing orders 25mg, PO). 0922 BP was 170/104, HR 61, Alert and oriented X4, hoarse voice and cough persist, no signs of labored breathing, able to complete sentences. Pt stated she had an EPI pen " just in case."  At 0929 EMS arrived VS: 165/98, 88, 90%, at 0933 VS: 151/88, 86, 98% still alert and awake, no difficulty breathing noted. Patient declined to be transported to ED and stated "something similar happened when I got my flu shot " and when she received a "shot of antibiotics." VS at 0937: 128/76, 74, 98-99% Patient was assisted to car and she and Spouse drove away. No s/s of distress noted; pt was able to walk to her vehicle, denied other symptoms and stated she was "feeling better."
Difficulty taking a complete deep inhalation, hoarseness, coughing, chest and throat tightness. Onset 2.5 hours after vaccination, lasting 3 hours.  Similar simptoms when exposed to cat dander, however this experience was more severe.  Recovered on own, however had thoughts of having to go to ER, a place I've never been.
pt recv vax 14JAN97 & started getting sore & stiff @ site on 24JAN97;site became hard & more sore on 25JAN97;difficult to lft arm on 26JAN97;red streak noticed 4" below inj site-redness about 1 1/2 in wide from side to side across bic
Headache, Myalgia, Arthralgia, Soreness at site, fever, malaise Narrative:
RECEIVED HEPATITIS B VACCINE ON 03/05/07 AND WITHIN A DAY HAD SYMPTOMS OF STIFF NECK AND STIFF ARM.
CIRCULAR RED RASH WITH INJECTION SITE AT CENTER WITH 10.12 CM STARTED ABOUT 24 HOURS RESOLVED AT ABOUT 3 DAYS.
chest pain, headache, soreness, nausea, fatigue, high fever over 101, fuzziness missed 3 days of work went to doctor took painkillers, anti-inflammatories, and antihistamines
Chief Complaint   Arrived via EMS- per wife pt has been more confused than BL, febrile, incont of bowel and bladder. Denied pain. +cough, SOA. Got first dose of COVID shot wed.. A&Ox1. Has left sided weakness from prior CVA  History of Present Illness     89-year-old male who presents to the ER via EMS with confusion.  He has also reportedly had a cough and some fever.  There has been some report of incontinence of both bowel and bladder.  He received his first dose of the Pfizer Covid vaccine on Wednesday, 3/17.  He and his wife have returned to the home after wintering in another state.  According to his wife, with whom I have spoken this evening, last night he suddenly became confused.  The confusion continued throughout the day today, thus prompting the EMS called to the house and the subsequent journey to the ED for further evaluation.   In the ER this evening, a battery of testing was completed.  A Covid swab is indeed positive.  His wife is uncertain of any positive contacts.  He had some vascular congestion on chest x-ray.  He has a prior history of pleural effusion which is thought to be resolved.  He does have a history of lower extremity edema.  He had some urinary incontinence and his wife held his Lasix Saturday morning.  He was noted to be slightly hypoxic around 88% on room air.  He was around 85% or so on room air at home with their home pulse oximeter device.  He has been placed on 2 L of nasal cannula.
Patient reports adverse event 4 hours after vaccination with Fluzone HD. He described his throat swelling, labored breathing, sweating, nausea, diarrhea, and cramps.  Symptoms lasted for 9 hours after they began. By the next day after vaccination, the patient reports he felt better. He did not seek medical attention.
IMMEDIATELY AFTER RECEIVING THE SHOT, THE PATIENT SLUMPED. THE PATIENT REVIVED A FEW MOMENTS UPON CALLING HIS NAME. HE IDENTIFIED HIMSELF BY ANSWERING WHEN HE WAS CALLED BY NAME AND VERIFIED HIS ADDRESS AND DATE OF BIRTH. HE INSISTED HE WAS FINE AND PASSED OUT BECAUSE HE WAS ANXIOUS AND WAS HUNGRY AS HE HAD NOT EATEN. THE PARAMEDICS WERE CALLED TO THE SCENE.
THERE WAS A SMALL AMOUNT OF BLOOD WITH THE INJECTION AS I WIPED IT AWAY THE INJECTION SITE HAD ALREADY BEGUN TO SWELL. IT SWELLED TO ABOUT THE SIZE OF A PEA. WE APPLIED A COLD PACK TO PREVENT ANY FURTHER SWELLING.
Information has been received from a healthcare worker referring to an unspecified number of patients with unknown age and gender. On unknown dates in 2015 ("after 17-NOV-2015"), the patients were vaccinated with doses of improper stored VARIVAX (lot # K021487, expiration date 03-NOV-2016; lot # K005428, expiration date 15-APR-2016; lot # L023594, expiration date 26-JUN-2017; lot # L013826, expiration date 21-APR-2017; lot # L019124, expiration date 27-MAY-2017; lot # L026405, expiration date 15-JUL-2017) (dose and route were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Atrial fibrillation with RVR, admitted to the telemetry floor for further management and continued on a diltiazem drip overnight with good control of heart rate. The morning of 10/23/21, the diltiazem drip was weaned off. Toprol XL 150 mg daily was restarted.  Cardiologist recommended the addition of digoxin 0.125 mg daily for treatment of atrial fibrillation as well as the addition of aspirin 81 mg twice weekly for secondary prevention of stroke. The patient was stable for discharge and felt comfortable with this plan. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
FAINTED; LOW BLOOD PRESSURE; FEELING FUNNY; This spontaneous report received from a patient concerned a 51 year old female. The patient's weight was 72.7 kilograms, and height was not reported.  The patient's concurrent conditions included primary pulmonary hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. Batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. The patient received selexipag (form of admin and route of admin were not reported, batch number: 031491701) 800 ug, every 2 days, frequency, and therapy dates were not reported for primary pulmonary hypertension. Concomitant medications included ambrisentan, and riociguat.  On 09-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) Low blood pressure. On 09-MAR-2021 13:00, the patient experienced low blood pressure, felt funny and she fainted. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of selexipag was not changed. The outcome of the low blood pressure, fainted and feeling funny was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210342442-Covid-19 vaccine ad26.cov2.s-Fainted, Low blood pressure. These events are considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the events than the drug. Specifically: CONMEDS-OTHER SUSPECT DRUGS  V0 20210342442-Selexipag-Fainted. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY AND UNDERLYING DISEASE  V0 20210342442-Selexipag-Low blood pressure. This event is labeled and is therefore considered potentially related