chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BLOOD CLOT; This spontaneous report received from a consumer via a company representative and concerned a male 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 not reported, batch number: Unknown) dose, start therapy date were not reported 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, a week or so after the Covid-19 vaccination the patient passed away in his sleep. The patient had no underlying condition. An autopsy was performed on an unspecified date and the patient was found to have blood clot.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: A male patient of unspecified age passed away in his sleep an unspecified time after receiving the Janssen COVID-19 vaccine for prevention of COVID-19 infection. It stated that the patient had no underlying condition. A blood clot was found by autopsy; no further details are provided. There is insufficient information to make a meaningful medical assessment. Additional information is being sought.; Reported Cause(s) of Death: BLOOD CLOT; Autopsy-determined Cause(s) of Death: BLOOD CLOT
Light headed/dizzy, nauseated, body aches, chills, headache.  Lasted 24 hours.  First vaccine reaction lasted 48 hrs.
Red, raised area on skin approximately 1" in diameter appeared approximately 11 hours after injection. Diameter increased to about 4" by about 50 hours after injection. Symptoms: Initially painful to touch and warmer than surrounding skin.  At one day post-injection, clear inflammation and tightness of skin accompanied the redness. By 40 hours post-injection, itching  initiated and increased to present (55 hours post-injection).  Noteworthy that first shot (Moderna Lot# 040A21A) had zero side effects.
THE DAY AFTER THE INJECTION THE PATIENT EXPERIENCED DIZZINESS, NAUSEA, DIARRHEA, FEVER, TIREDNESS AND A 4 INCH CIRCLE RED RASH ON LEFT ARM. SHE SAID SHE DID NOT GET OUT OF BED THE NEXT DAY CAUSE SHE SAID HER BODY FELT LIKE SHE HAD THE FLU. SHE REPORTED THIS ON OCTOBER 16TH. SHE HAD BRUISING WHERE THE RASH WAS. SHE STILL COMPLAINED OF NO ENERGY AND DIZZINESS. BUT SHE WAS ABLE TO GO TO WORK. SHE WAS STARTING TO FEEL BETTER THAN SHE HAD THE DAY AFTER THE INJECTION.
This case was reported by a healthcare professional and described the occurrence of burning pain at injection site in an adult subject of unspecified gender who was vaccinated with (Fluarix, GlaxoSmithKline) for prophylaxis. The subject had received previous immunizations with influenza virus vaccine with no subsequent adverse events. On an unspecified date on or after 21 October 2007 and before 8 November 2007, the subject received 1st dose of Fluarix (.5 ml, intramuscular, unknown deltoid). Within 24 hours after vaccination with Fluarix, the subject experienced burning pain at injection site, pain radiating up arm and reduced range of motion. The healthcare professional reported there were no signs of cellulitis, no induration, no warmth or redness at the injection site. The subject was treated with Medrol Dosepak, muscle relaxants, pain medication and physical therapy. The healthcare professional considered the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with Fluarix.
Fever; chills; body aches; headache; loss of appetite; overall un wellness; diarrhea; received third dose; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 14Dec2021 16:00 (Batch/Lot number: unknown) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Location of injection: Arm Right, Vaccine Administration Time: 14:00), administration date: 12Feb2021, when the patient was 44 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 14Dec2021 16:00, outcome "unknown", described as "received third dose"; PYREXIA (non-serious) with onset 14Dec2021 22:00, outcome "recovering", described as "Fever"; CHILLS (non-serious) with onset 14Dec2021 22:00, outcome "recovering", described as "chills"; PAIN (non-serious) with onset 14Dec2021 22:00, outcome "recovering", described as "body aches"; HEADACHE (non-serious) with onset 14Dec2021 22:00, outcome "recovering", described as "headache"; DECREASED APPETITE (non-serious) with onset 14Dec2021 22:00, outcome "recovered" (17Dec2021), described as "loss of appetite"; MALAISE (non-serious) with onset 14Dec2021 22:00, outcome "recovering", described as "overall un wellness"; DIARRHOEA (non-serious) with onset 14Dec2021 22:00, outcome "recovering", described as "diarrhea". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, chills, pain, headache, decreased appetite, malaise, diarrhoea.  Additional information: The seriousness of the case was reported as non-serious. The patient did not receive any other vaccine in four weeks and did not receive any other medication in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 27-NOV-2015 at time- 14:50, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperatures at which the product was stored were 3.1 and 1.9 (units unspecified) respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Tested positive for Covid; Tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  An 8-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Nov2021 as dose 1, single (Lot number: Pfizer FK 5217), in left arm, on 26Nov2021 as dose 2, single (Lot number: Pfizer FL0007), in left arm and on 23May2022 at 16:15 as dose 3 (booster), single (Lot number: Pfizer FL 8095) at the age of 8 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "No" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 05Jun2022 at 22:45, outcome "unknown" and all described as "Tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jun2022) Positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical course: Facility type vaccine: Doctor's office/urgent care. Patient did not received other vaccine in four weeks, other medication in two weeks and If COVID Prior vaccination were reported as no. Patient did not have any other medical history. No known allergies were reported. AE resulted in none of the above.  Product investigation conclusion: The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot of the reported lot FL0007. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. PGS Puurs concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.
Immediate,  long lasting and  very strong heart palpations. Total weakness. Could not stand up for 10-11 minutes. Had to have assistance walking. Lasted for a day. Next 3 days trying to move or function as if I were walking through thick mud. As of 6/15 2021 am still weak with strong dizziness.
Patient is a 76 y.o. female presenting from SNF with c/o patient presents to the emergency department from nursing facility due to increased confusion/altered mental status.  Per report from nursing home patient has refused to eat all day and been altered.  Per report patient is positive for COVID.  Patient is full code.  At baseline patient is nonambulatory.  Per history patient has history of "renal issues and sepsis:" No family present at initial exam to give any additional history.  Patient is awake and answer some questions.  Many questions she does not answer.  History is extremely limited from patient.            Hospital course as below.  Patient improved with medical treatment.  Patient discharged back to SNF in stable condition.   1.  COVID, +1/10: -Chest x-ray without pneumonia -No hypoxia at this time, no indication for remdesivir -CRP elevated, start Decadron  -Home Eliquis DVT prophylaxis  2.  Bacteremia: -Infectious disease consulted -1/11 blood cultures 2 out of 2 positive for staph hominis -1/13 blood cultures no growth to date -antibiotics per ID, likely contamination no further abx  3.  UTI: -UA concerning for infection -Urine culture came back contaminated -abx completed  4.  AMS, baseline cognitive dysfunction: -CT head nonacute -Likely in setting of above -Delirium precautions  5.  Status post fall during hospital stay: -CT head nonacute, scalp hematoma present -CT C-spine nonacute -X-ray bilateral lower extremity no fractures, right lower leg with hematoma
2 SWOLLEN LYMPH NODES AT THE FRONT BASE(LEFT SIDE) OF NECK (ONGOING)
constant ache in lt arm where inject was administered; 2 mons p/returned to MD; told that there was nothing could do, offered pain pills;
Information has been received from a healthcare worker concerning a 61 year old male patient who on 16-FEB-2007, was vaccinated with a dose of Pneumovax 23 (Lot# 655592/1175F).  Concomitant therapy included ADVAIR, AVELOX, XOPENEX, prednisone and LIPITOR.  The healthcare worker reported that the patient had an injection site reaction with Pneumovax 23.  On approximately 16-FEB-2007 the patient developed redness, swelling and pain at the injection site.  The patient called the office on 19-FEB-2007 and reported that the injection site arm was painful, swollen and red.  He also reported that he had been "in bed all weekend", but the onset date was unspecified.  On 22-FEB-2007, the patient called the office and reported that his arm was still hurting with movement, swollen and red.  The patient took ADVIL, for the symptoms, as directed by the office.  The patient had reported pain through the next week that improved and resolved on 27-FEB-2007.  It was reported that the patient never had a previous reaction to Pneumovax 23 and his previous dose was given on 29-MAR-2000.  The reporter has requested a lot check.  A standard lot check investigation was performed.  All in-process quality checks for the lot number in question were satisfactory.  The lot met the requirements of the agency and was released.  Additional information has been requested.
Information has been received from a physician concerning a 60 year old female who on 13-JUN-2007 was vaccinated with a dose of Zostavax (Oka/Merck). On 14-JUN-2007 the patient developed redness at the injection site and it turned out a "blister like rash." The patient sought unspecified medical attention. Subsequently, the patient recovered. No other information was provided. There was no product quality complaint involved. Additional information has been requested.
Monovalent pfizer covid 19 vaccine was inadvertently given instead of bivalent pfizer covid 19 vaccine. Patient did not experience any adverse effects.
Joint pains, stiffness and aching which impeded movement.  This was new, as I was flexible and pain-free prior to the vaccine
Pain in the left arm; A spontaneous report was received from a consumer who was also a 69-years-old male patient who received Moderna's COVID-19 vaccine experienced pain from injection site.  Patient's medical history and concomitant medicines were not provided.  On 22 Jan 2021, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 23 Jan 2021, the patient experienced pain in the left arm where the vaccine was administered.   Treatment included two Advils to treat the pain.  Action taken with mRNA-1273 was not reported.  The outcome of the events of pain in the left arm was unknown.; 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.
Cold like symptoms, sore throat: coughing: stuffy noise: sore muscles. Bronchitis: fever: fatigue took PAXLOVID and it shortened symptoms.
8/30/04 Immunization administered around 2.21 pm. Mom started child on meds (see below) in later PM on same date, states noticed child's reaction around 9pm on 8/31/04 of upper left arm red, warm to touch, swollen with fluid filed blisters. Mom denies child having any fever and complaining of pain. Reports reaction to clinic 9/1/04. Went to clinic for assessment and culture of area. 9/1/04.
On 01/22/2022 on the day of vaccination at 11:30 at night I started coughing and I had an asthma attack about midnight. January 23-24th I woke up cold/shivering but my bed was wet as if I was sweating. I also had swelling in my lymph node near armpit, breast, and collarbone and was hot. The lump was a size of lemon that was in between armpit and breast. It wasn't moveable but it was hot. Lymph node armpit swollen/under collar bone size of lemon and was hot. I took Tylenol. I was feverish and I could not sleep I was in so much pain; my upper breast/side of breast was hot and in pain. 2am on the 24th I called the Emergency line for after hours for managed care and I was told to take Aleve and apply heat. I have not been able to wear a bra. I was just told to take Motrin 800mg continue to stay hydrated and rest. My breathing has not been same since. I can't tolerate the mask. I have to take it off for fresh air after 30 minutes. Also, my boyfriend noticed that I am snoring more. Things that I hadn't experienced before. The lump is gone and I do want to have a mammogram. I do not wish to do a 4th booster.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 16-AUG-2017 the patient was vaccinated with ZOSTAVAX lot # M041510 for prophylaxis. Other suspect therapies included STERILE DILUENT. On 16-AUG-2017, 1 day after onset of therapy the patient experienced expired product administered. On an unknown date the patient experienced no adverse event. The outcome of expired product administered and no adverse event is unknown. The reporter considered no adverse event to be not related to ZOSTAVAX and STERILE DILUENT. The reporter considered expired product administered to be not related to STERILE DILUENT and ZOSTAVAX. Additional information has been requested.
I was pretty lethargic all day , but just before bed around 10 PM (approximately 14 hours after inoculation) I started to experience a fever and body chills.
Patient is having no adverse reaction. She came in for flu shot on 10/31 but left before receiving the shot--per patient's own recollection. She actually received her shot on 11/9. After thinking about it, she is now unsure if she received the shot on 10/31. Reporting this incident just in case.
A total of 29 patients were given a dose of Moderna Bivalent that initially were after the BUD but a lot analysis completed by Moderna confirmed that the doses were still effective against COVID-19.
Patient had jerking of entire body for about 5-10 seconds just after patient left office.
Breakthrough case admission after 2 vaccines Moderna 3/17/21 Lot# 007B21A;  Moderna 4/14/21 Lot# 043B21A
Progressive weakness & numbness on extremities, increased SOB, beginning 2wks after vaccination. (Quadraparesis severe, loss of reflex SP about speed). On plasmapheresis x5 days in ICU (no ventilation needed).
patient received a 5th dose of PENTACEL instead of QUADRACEL/no AE; Initial information received on 22-Jul-2021 regarding an unsolicited valid non-serious received from other health professional via phone via Agency (Reference number- 00693083).  This case involves a 4-years-old (unknown gender) patient who received a fifth dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] instead of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (Wrong product administered).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  On an unknown date, the patient received a fifth dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE instead of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)( Wrong product administered ) (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  It was of actual medication error due to Wrong vaccine administered (latency: same day).  At the time of reporting, no adverse event 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 the 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.
Onset about three hours after injection.  Patient states injection site seemed too high on shoulder.  Developed local pain.  Pain in shoulder joint.  Spread down arm.  Unable to lift arm.  Ongoing pain for many months.
Pt recvd vax & 36 hrs p/vax had sudden onset of diarrhea & achiness in joints; felt feverish but had no fever; sx lasted for several days; no further details were provided;
cutaneous lymphoid hyperplasia; This is a literature report for the following literature source(s).  A male patient in his 50's received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Biopsy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: CUTANEOUS LYMPHOMA (medically significant), 28 days after the suspect product(s) administration, outcome "recovered", described as "cutaneous lymphoid hyperplasia". The patient underwent the following laboratory tests and procedures: CD30 expression: Positive; CD4/CD8 ratio: 3:1; Histology: revealed T-cell-predominant lymphoid infiltrates, notes: consistent with pityriasis lichenoides etvarioliformis acuta (n = 2), cutaneous T-cell lymphoid hyperplasia (CLH) (n = 2), and lymphomatoid papulosis type A (n = 2); T-cell receptor gene rearrangement test: Positive. Therapeutic measures were taken as a result of cutaneous lymphoma.; Sender's Comments: As there is limited information in the case provided, the causal association between the event cutaneous lymphoma with the suspect product BNT162b2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : PV202200028643 Same article/ drug and different patient/event.;US-PFIZER INC-PV202200028643 Same article/ drug and different patient/event.;
Fever, chills, body aches, neck pain, back pain, nausea, migraine, injection site extremely sore with redness/swelling, muscle pain, fatigue.
Patient developed 103.9, headache, and chills within 2 hours of vaccines.
rash in right arm; This spontaneous case was reported by a patient and describes the occurrence of RASH (rash in right arm) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AF7162B) for COVID-19 vaccination.     The patient had no allergies to medications,food and other products. The patient never had COVID positive test or diagnosis. The patient had no medical history related to mentioned AE and both acute and chronic illnesses at the time of vaccination.     On 04-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Oct-2022, the patient experienced RASH (rash in right arm). At the time of the report, RASH (rash in right arm) had not resolved.            It was reported that all previous vaccines she received were Moderna. The AE doesn't cause patient to seek medical care office visit, urgent care, ER, hospitalized.  The patient did not experienced a similar event in the past. The symptoms were same. Patient does not take any concomitant medication. No treatment information was provided.   This case was linked to MOD-2022-655104 (Patient Link).
Left cheek and left side of lower lip, numb, noticed pm of 10-11-08. Then noticed rash on waist and then lower back and groin area. Also swelling of penis foreskin for 2 days. Sunday 10-12-08 started noticing rash under arms. Swelling by left temple area on 10-14-08. Doctor visit on 10-15-08. Numbness on right cheek on the night of 10-14-08, this prompted me to call Doctor on the morning of 10-15-08. After exam in his office Doctor was fairly certain it was "Hives".
01/02/21 itching all over body -hives developed except for neck and face; Benadryl dose, resolves then returns 6 hrs later. Hives have not resolved, hives developed on neck and face 01/03/21 in PM. Benadryl treatment continues
Vasovagal Syncope 4 days after vaccine.  ER visit, IV fluids