chrisvoncsefalvay/vaers-outcomes huggingface dataset:
persistent, inconsolable crying for @ least 3 hrs; also very painful, swollen, & reddened @ area of DTP shot;
High fever approx 8:00pm 102.8 degrees. Severe chills, muscle aches, moderate headache. Fatigue, dizziness and confusion. All side effects approx 6:00pm to 8:00pm when started. Still continuing at current time of 10:12pm times.
immediate metallic taste, headache, elevation in BP reading 200's /100's (this is still occurring  diastolic number will not remain below 100 even with medication) systolic had leveled to below 130's) ; low grade temp for 2wks; heated swollen soreness to injection site (baseball size lasting 3wks) with pealing of surrounding skin. area remains sore after almost 5wks;  debilitating fatigue at around 2wks lasting 2-3 days still occurs but is intermittent
Clear Cell Renal Carcinoma, partial nephrectomy, asymptomatic found incidentally
Pediatric Pfizer Covid vaccine administered for pt 12 years old (outside of indicated age range 5-11 years)
I woke up today on 06/19/2021 with itchy, swollen, and stinging lips.
I was pregnant at the time of my first and second dose of the vaccine. My estimated due date was February 15th 2022. A half hour after my second dose I had a little bit of spotting and moderate to severe cramping. This was dismissed as gas pains. Later that night I went to the bathroom to find a substantial amount of blood in my underwear at which point I called a nurse line and was directed to go to the ER. They gave an ultrasound and ran blood work. Miscarriage was strongly suspected but not totally confirmed. I was also running a low fever and experiencing severe chills, muscle and joint pain and a severe headache. I was sent home and told to follow up with my doctor for more blood work to confirm the miscarriage. I continued to get severe cramping, bleeding and loss of uterine tissue vaginally. On Monday I saw my doctor had blood work and confirmed the miscarriage. I am still bleeding today.
devel swelling @ all joints & could no longer walk p/receiving vax;has devel polymyalgia rheumatica
PATIENT HAD HIVES ALL OVER (TORSO, FACE, ARMS)
15-month-old patient was inadvertently administered QUADRACEL instead of the intended PENTACEL with no reported AE; 15-month-old patient was inadvertently administered QUADRACEL instead of the intended PENTACEL with no reported AE; Initial information received on 14-Mar-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 months old male patient to whom inadvertently administered diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (VERO) vaccine [Quadracel (VERO)] instead of the intended pentacel with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  Concomitant medications included Varicella zoster vaccine (Varicella Vaccine) for Immunisation.  On 14-Mar-2023, the patient received a dose of 0.5 mL dose 4 (primary/booster) of suspect diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (VERO) vaccine, solution for injection, (strength: standard, lot number: U7564AA and expiry date: 08-Nov-2024) via intramuscular route in the left thigh for immunisation.  On 14-MAR-2023 the 15-month-old patient was inadvertently administered quadracel instead of the intended pentacel with no reported ae (wrong product administered) (product administered to patient of inappropriate age) (latency: same day) following the administration of diphtheria-15/tetanus/5 hybrid AC pertussis/IPV (VERO) vaccine.  On follow up it was reported that, "After receiving quadracel patient had no adverse reaction."   No lab data was reported.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the events.  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.  Additional information received on 04-Apr-2023 from other healthcare professional. Dose number 4 of suspect product was added. Clinical course updated and text amended accordingly.
This is my booster. I had j and j first. In my left hand I?m having joint pain and now my index finger is almost unusable at times. Also in the thumb joint. Additionally at the same time I?ve been feeling tight muscles and a stretching pain in lower back going into hips.
Developed fever up to 104 degrees and erythematous rash about 2 wk after MMR given.
First started with diarrhea then a fever of 101.4. The diarrhea stopped but there was uncontrollable chills/shivering. My fever went up to 103.9.
pt recv vax;flushing,SOB,pressure in chest;abd pain;dph & epi used
I received the 2nd shot and heart pains progressively got worse; I received the 2nd shot and heart pains progressively got worse; but this time it was accompanied by dizziness; This is a spontaneous report from a contactable consumer.     A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 05Jun2021 13:30 (Lot Number: EW0168) at age of 53 years old as a single dose for covid-19 immunisation. Medical history included allergies(Pollen, Mt Ceder) not 100% sure on what causes them.  The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 14May2021 11:30 (Lot Number: EW0167) at age of 53 years old as a single dose for covid-19 immunisation and experienced After the 1st shot I noticed sporadic heart pains throughout the 2week period between shots. The patient received the 2nd shot and heart pains progressively got worse, but this time it was accompanied by dizziness, both in Jun2021. No treatment received. The outcome of the events was unknown. The events were reported as non-serious.   Clinical course: After the 1st shot he noticed sporadic heart pains throughout the 2 week period between shots. At the 2nd shot he asked the nurse at the hospital if anyone else had experienced similar issues. They asked if he wanted the 2nd shot and he stated he was already committed at that point. He received the 2nd shot and heart pains progressively got worse,  but this time it was accompanied by dizziness. He went to the ER on Wednesday 09Jun2021 where they ran a battery of tests and immediately referred me to a cardiologist. The events were resulting in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient was not COVID prior vaccination. It was unknown that covid tested post vaccination.
Blood clots in leg and both lungs; shortness of breath.  Shortness of breath for 1 week before seeking medical attention on March 7th. Admitted to hospital through emergency room on March 8th. Hospitalized from March 8-14.  Put on Coumadin.  Sent home with supplemental oxygen.
patient who received TENIVAC that was expired on 24Jun2023 and was administered today, the 30Jun2023 with no reported adverse event; Initial information received on 30-Jun-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 51 years old female patient received diphtheria-2/tetanus-5 Adsorbed Toxoids No Preservative Adult [Tenivac] that was expired on 24jun2023 and was administered today, the 30jun2023 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 30-Jun-2023, the patient received a 0.5 ml dose of suspect diphtheria-2/tetanus-5 Adsorbed Toxoids No Preservative Adult (strength: not reported; expiry date: 30Jun-2023 and  lot U7092AA) via intramuscular route in the right deltoid for Immunization and received was expired vaccine with no reported adverse event (expired product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   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.
Information has been received from a medical assistant concerning a female patient who was vaccinated with a dose of Gardasil. It was reported that the patient after being vaccinated went into a seizure state. Unspecified medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Pt fainted about 5 min after admin. Had pt on the floor about 1/2 hour. He responded in a few seconds, but on multiple blood pressure checks he bp was low. Gave crackers and water. Took pulse which was normal. Had pt sit for additional 15 minutes. Eventually he was ok to lewave but mom was monitoring bp. Called pt at end of day and he was fine. Said he had fainted before with blood drawn in past.
Information has been received from a healthcare worker concerning a patient (age and gender unknown), who, on an unspecified date, was vaccinated with a dose of Pneumovax 23 (651401/0619F).  Subsequently, on an unspecified date, the patient developed redness all over the injection site down to the elbow.  At the time of this report, the patient had recovered.  No product quality complaint involved.  A lot check was requested by the reporter.  The records of testing prior to release of the lot in question has been rechecked and found to be satisfactory.  The lot complies with the standards of the agency and was released.  Additional information has been requested.
Urticaria Mom noticed rash upon awakening on the 14th of July after vaccine administered on the 13th of July. Pt. given Prelone x 3 days and Zyrtec
Both arms / injection sites were sore for about 1-2 days, which is about the extent that I have ever reacted to a vaccine. I am making this report because I had most if not all the symptoms/signs of an adverse reaction to the yellow fever vaccine. It was the first time I ever received that vaccine. The following day in the evening, I had sudden chills / fever by the time I was leaving work. Upon arriving at home in the evening, I had SEVERE joint pain, 103 F fever, and severe nausea. By 10 pm, my fever had reached 105 F. I couldn't eat due to nausea and I could barely move because of my joint pain. I did my best to control my fever switching between max doses of ibprofen and tylenol every 4-6 hours. My fever was 103-104 the following two days (Wed/Thurs). Next 101-102 (Fri/Sat). Down to 99 Sunday. Joint pain and nausea came and left with rises in my fever.
soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness at the injection site) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ORAL CONTRACEPTIVE NOS for Contraception.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (soreness at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details was not reported by the reporter.    This case was linked to MOD-2021-187207 (Patient Link).
A patient receieved first dose of ROTATEQ late; This spontaneous report was received from a nurse and refers to a 4-month-old male patient.  The patient's concurrent conditions, medical history, concomitant medications, drugs reactions or allergies were not provided.  On 15-JUL-2021, the patient was vaccinated with a first dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ), lot # 1707457 with expiration date: 23-FEB-2022 (dose and strength were not provided) for prophylaxis. The patient received the first dose to late.(inappropriate schedule of product administration).
STAFF COMPLAINED OF ITCHINESS UNDER SKN, FAST HEARBEAT, DIZZINESS, NAUSEA AND VOMITTING
Heart murmur; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 15 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17May2021 16:00 (Lot number: EW0172) at the age of 14 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC MURMUR (non-serious) with onset 17Aug2021, outcome "not recovered", described as "Heart murmur". The event "heart murmur" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of cardiac murmur.  Additional information: Patient did not take other vaccine in four weeks. Patient did not take any other medications in two weeks. There was no covid prior vaccination. Patient was not tested for covid post vaccination. There were no known allergies. Patient was a perfectly athletic healthy fit teenager. Follow-up attempts are completed. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 59-year-old male patient received BNT162b2 (BNT162B2), on 16Aug2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 58 years for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing), notes: HTN; "OSA" (unspecified if ongoing), notes: OSA; "GERD" (unspecified if ongoing), notes: GERD; "ED" (unspecified if ongoing), notes: ED; "Insomnia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (10Jan2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 30Dec2022 to 05Jan2023 to treat COVID-19. The patient completed Paxlovid, had improvement of symptoms and tested negative and was fine for several days but got symptoms again on 09Jan2023 and tested positive for COVID on 10Jan2023. The patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As per the available information the causality of the events drug ineffective,and covid-19 with the suspect can not be ruled out completely.
24 hours after vaccine, I had typical mild cold/flu symptoms. After 48 hours I had a lot of pain in my injection arm and my armpit lymph nodes were swollen. I treated the pain with Advil and a heating pad. 72 hours after the vaccine I felt faint, dizzy, and nauseous. I began to vomit and have diarrhea that entire night and next morning. I felt very weak and was unable to keep any foods or liquids down. I was unable to walk around. I took Zofran 8mg which helped with the severe nausea and weakness.  These symptoms are ongoing.
approx. 2 hours post injection. I suddenly felt lower abdomen pain and gurgling.  sat on toilet then got dizzy, pale, very clammy. I had diarrhea and ringing in my right ear.  Felt too weak to walk and talk. My husband helped me to a chair.  He called the nearest ER.  I was asked if my tongue was swollen or throat closing in.  I think that episode lasted about 40 minutes.  I slowly felt better, but had more diarrhea.  Stayed home.
2-3d aching pain in lt upper arm immed p/vax;this lessened to a dull ache sometimes radiating to neck & lt forearm;paresthesias in lt hand began 4/15/99 & progressed in severity;weakness in lt arm noted 4/15/99;neuro confirmed motor & sense
Injection site blistered next day and popped with puss. This happened two times within first week. Also had muscle aches, itching, nausea, severe fatigue. All symptoms resolved by 8th day for the exception of injection site is red with hardened lump and tender to touch.
Patient 63 years old was in the observation area and tells her daughter she's having palpitations after the 1st PFIZER vaccine administration. Daughter tells the EMT that she was anxious before coming to the vaccination clinic. Patient was taken to the incident observation area at 3:20pm to evaluate and to take her vitals: 67 pulse, 95 sat, 150/90 BP, 23 respirations, and palpitations 55. At 3:34 vitals are retaken: 150/90 BP, 97 saturation, 80 pulse, and 22 respiration.
SHE WAS PERFECTLY HEALTHY   91 YEAR OLD, ON NO MEDS, RECEIVED HER VACCINE ON TUESDAY AND WAS FINE THAT EVENING.  CALLED TO CHECK ON HER WEDNESDAY AT APPROX 9:30 AM, COULD NOT UNDERSTAND WHAT SHE WAS SAYING.  CALLED EMS, TRANSPORTED TO EMERGENCY ROOM AND SAID TO HAVE HAD A STROKE.
J12.82 - Pneumonia due to Coronavirus disease 2019 U07.1 - COVID-19
Right thigh with 5-6 inches of redness/swelling, warm to touch. Dr to evaluate. Benadryl q 6 hr, Motrin. S/s of infection. Mom denies fever.
Patient tested positive on 11/8/21.  Doses on 2/25, 3/18, of Pfizer and Booster on 11/3 of Moderna.
Information has been received from a physician concerning a 21 year old female with no known drug reactions or allergies and a history of papilloma viral infection and loop electrosurgical excision procedure (2005) who on 13-APR-2007 was vaccinated with Gardasil.  Concomitant therapy included NUVARING.  On 03-MAY-2007 the patient developed condyloma on her vulva and vagina.  A biopsy of the condyloma was taken (results pending).  The Gardasil was not reintroduced.  Additional information has been requested.
Left thigh edema and erythema 4cm x 6cm starting 24 hours post vaccination.
Patient called 2 days after vaccination & said injection site was red & swollen about the size of an apple. Reported no itching and minor pain when touched.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered with the Moderna vaccine, which were beyond the 30 days beyond use date.) and NO ADVERSE EVENT (No adverse event) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053c21a) for COVID-19 prophylaxis.  No Medical History information was reported.    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered with the Moderna vaccine, which were beyond the 30 day beyond use date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered with the Moderna vaccine, which were beyond the 30 day beyond use date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient administered with the Moderna vaccine, which were beyond the 30 day beyond use date.).          Most recent FOLLOW-UP information incorporated above includes:
Swelling - hard lump at injection site - bright red rash covering large area on upper arm.  Site of rash is still visible although very faded. Lasted about 5 days before it began to fade.
Pt was given Peds Hep A (Havrix) & Gardasil (HPV) in Right arm. Pt then had syncope & passed out. He lost color in his face as well. Pt recovered well, walked around a bit, had some juice, waited around for a short time, then was given the other 3 vaccines he needed (Menactra, Boostrix, & Varivax). See next page for actual shots.
12 hrs after shot  around midnight,   Dizzy when eyes open, Body ache , Joint pain ,  Fatigue, Chills,  Sinus pressure , Slight Headache and Thirsty,  5 glasses of water in 5 hours, lasted 24 hours.  Off work on Thursday 3-25-21.    Friday 3-26-21 at 1am symtoms  gone except for back pain.  Saturday 3-27-21  1am   Night sweats  x 3 till 5am.    Went to work Saturday
On the evening of vaccination 9 hrs later, had episode of emesis followed by pallor and limpness lasting 15 minutes.
Shingles outbreak approximately 2 weeks after vaccination. I had never had shingles before.
Arm has been hurting ever since her shot on 10/15/2015. Pt states arm was bruised and red and feels like her bone hurts.
rash that started 9 days after vaccination in Right upper thigh with MMR vaccine. Started on right foot and has now spread to BUE, BLE, abdomen, back, and chest. Mother states he is itching but responding well benadryl. She denies and drainage or crusting or the rash. Mother states the rash and itching is getting better.
Injected on right side of stomach Subcutaneous.   At site of injection, for 10 days after injection, erythematous and tender to palpation injection site.  roughly 2-3cm circular erythema.  Subcutaneously there was a large nodule under the skin.  Today is day 12 post vaccine and still a nodule.  no more erythema.
A couple weeks after second vaccine, I had a night where I could sleep the whole night-felt buzzy. Then a  week or two later, I had an episode of mt heart racing while lying in bed & went to the hospital. Soon I was diagnosed with high blood pressure and put on medication but the high blood pressure is mostly just at night and not responding well to beta blockers It seemed it had started to get better,  maybe responding to meds until I got my booster and  now it?s back again and I?ve had some sleepless nights with my blood pressure spiking  at night. I don?t know if the vaccine is the cause but it does correlate
No additional AE; patient was given an expired dose ofPNEUMOV AX 23; This spontaneous report was received from a office manager who was reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On 28-OCT-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) syringe (dose, route of administration, anatomical location and strength were not provided; lot number R033343 was confirmed to be valid, expiration date 03-AUG-2020 was confirmed) for prophylaxis. No additional adverse events were reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R033343; expirationdate: 03-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Days 1, 2 had chills, headache, aches.  Fine for Days 3, 4, 5, 6, Day 7 headache and chills returned