chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Passed away yesterday, found deceased in her apartment; This spontaneous report was received from a consumer which refers to a 91-year-old female patient who received the Moderna COVID-19 vaccine (mRNA-1273) and next day the patient passed away.   The patient's medical history was not provided. Concomitant medications were not reported.   On 19 Jan 2021, the patient received her first of two planned doses of mRNA-1273 intramuscularly (Lot number: not provided) for prophylaxis of COVID-19 infection.  On 20 Jan 2021, the patient passed away and she was found deceased in her apartment. No treatment medication was provided.  Action taken with mRNA-1273 in response to the events was not applicable as the patient passed away.   On 20 Jan 2021, the patient died, cause of death was unknown. Autopsy result was unknown.  The reporter assessed the causality as related between the event and Moderna COVID-19 vaccine.; Reporter's Comments: This case concerns a 91-year old female patient. The medical history and concomitant medication is not provided. The patient experienced Death. The event occurred approximately one day after receiving their first of two planned doses of mRNA-1273 (Lot unknown). Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded and the event is considered possibly related to the vaccine.; Reported Cause(s) of Death: Unknown Cause of Death
Right thigh became swollen red & hot to touch. Measured at 4x5cm. No cellulitis noted. Advised warm compresses & MOTRIN as needed.
Patient received Rotateq and Prevnar 13 vaccinations 12/31/2020. Developed frank blood in stools 01/03/2021. Presented to office for evaluation of continued bloody stools on 01/05/21. Patient sent for stat KUB which returned as highly suspicious for Intussusception. STAT ultrasound confirmed presence of Intussusception and patient transferred to pediatric ER. Upon arrival in ER, repeat ultrasound revealed Intussusception had resolved on its own. Probable cause of Intussusception was adverse event to Rotateq vaccine. The patient has recovered from the adverse event.
VACCINE WAS EXPIRED WHEN ADMINISTERED TO PATIENT - EXPIRED ON 5/2/22
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 37-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032m20a and 011l20a) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Live, full term birth), Pregnancy (1 pregnancy did not reach completion) and Alcohol use. Concurrent medical conditions included Breech presentation (Currently in breech position). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 19-Apr-2021. On 09-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The cesarean delivery occurred on 15-Apr-2021, which was reported as Full-term. For neonate 1, the birth weight was 3940 grams (8lbs 11oz). The outcome was reported as Delivered NOS. Breech at 36 weeks, version procedure successfully performed at 37 weeks breech again at 38 weeks C-Section Scheduled at Successful at 39 weeks. Head Circumference 36cm. length 55cm. On 09-Feb-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2020, Pregnancy test: positive (Positive) positive.         Patient stated infant had elevated bilirubin levels but still within normal range (7mg).  Pediatrician believed it's breast milk jaundice but recommended continuing breast feeding.  No treatment information reported.     Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Followup received on 18-MAY-2021contains reporter's address, updated patient's medical history, updated pregnancy outcome details, delivery notes and  infant details.
The pt became very faint, pale, diaphoretic, tachycardic. This episode lasted approximately 3-5 minutes.
Around December I had a rash in my left hand that appeared it was blistered that turned colors maybe the size of a dime. It kept growing. The doctors have no idea of what this is. Both hands started developed rashes. The left hand was worse than the right. I have rashes on both thumbs. I cannot see the lines in my left hand. I must apply medication to my hands every day and wear gloves. I have had to changes any fragrance in washing detergent, soap, and perfumes. I have been experiencing a lot of brain fog. I have been having issues remembering common things on my job. My blood pressure has been elevated and I was introduced to new medication. I have experienced extreme hair loss more than before on dose 2 and I am on Viton. I am told my hair will not return and the rash is currently present.
Patient started with a fever of 102.5 approximately 48 hours after receiving shot. She alternated taking Tylenol & Aleve. Two days later her lips starting swelling with development of numerous fever blisters in mouth. She also had nasal drainage that caused fever blisters on outside of upper lip. She contacted her PCP who prescribed Valtrex for 10days.
This spontaneous report was received from a 4 year old female patient's mother refers to her daughter. On unknown date the patient was vaccinated with the first dose of M-M-R II (dose, lot# not reported). On 15-JAN-2014 the patient was vaccinated with the second dose of M-M-R II (dose, lot# not reported). On 22-JAN-2014, the reporter experienced widespread facial rash in the form of large welts an the child experienced fever as high as 104 F, stuffy nose, cough, rash and overall malaise. The patient was treated with TYLENOL and MOTRIN. The reporter noted that a "more mild" and unreported reaction, in the form of rash and a lower grade fever, was also experienced by her daughter after the "first dose" of M-M-R II. That first reaction, however, lasted for a shorter duration. At time of reporting, the patient had not recovered from the events which occurred after second dose of M-M-R II. Action taken with M-M-R II was not reported. The patient had sought medical attention. Additional information has been requested.
2 hours after second dose had swollen throat, fever and body aches. Used own inhaler and Benadryl. Had premedicated before the second Moderna vaccine with Benadryl and Tylenol.
Patient has minimal redness at site (appropriate response) until the morning of encounter (roughly 36 hours after injection) when the patient developed swelling, redness and warmth in the ipsilateral upper arm. It was NOT associated with pain, tenderness, decreased motion, effect on distal circulation, or induration. Even though the affected arm circumference was 5 cm wider than the opposite arm, it didn't bother the patient at all. If anything it was less hard than when they first noticed it in the morning. It was the school who sent the patient here.
Foster mom brought client in for 2nd set of immunizations on 03/18/2005 reporting this info-client had a 4 minute seizure on Fri. 02/11/2005 after coming home from school. Client had 2 cupcakes at school and 1 cookie at home before this happened- Client does not eat many sugars. Went to Dr on 02/16/2005 for this, concerned about her sugar and testing was done. No seizures since then.
Site: Swelling at Injection Site-Medium, Additional Details: swelling at the injection site
Pt experienced hives, fever, dizziness with vomiting. Given Benadryl.
Patient received expired dose of vaccine (Adacel vaccine), NO AE; Initial information received on 21-Jan-2020 regarding an unsolicited valid non-serious case received from a consumer in the.  This case involves patient with unknown demographics who received expired dose DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  Medical history, medical treatment vaccination and family history were not provided.  On 21-Jan-2020, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [lot number not reported, expiry date: 17-JAN-2020] via an unknown route at an unknown administration site Prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used.  At the time of report no adverse event was 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 Directive and Module VI of the 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 on the batch number was requested.
Pain in deep in arm pit that radiates down to breast tissue; Pain in deep in arm pit that radiates down to breast tissue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date Mar2021 (Batch/Lot number: unknown) 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: AXILLARY PAIN (non-serious), PAIN (non-serious) all with onset Mar2021, outcome "unknown" and all described as "Pain in deep in arm pit that radiates down to breast tissue". The event "pain in deep in arm pit that radiates down to breast tissue" and "pain in deep in arm pit that radiates down to breast tissue" was evaluated at the physician office visit.  Additional information: The course of the event was as follows: Pain in deep in arm pit that radiates down to breast tissue. Patient experienced pain six days after first vaccine injection. Saw her physician on day two of pain. Her HCP explained that it could be an S/E of the vaccine. Vaccine injection site was on same side as patient reported pain. The patient also received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunisation.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
7/2 (Day 4) - 7/5 (Day 7) - Painful and warm red blotch above and below injection site spanning about 5" long 7/2 (Day 4) - 7/7 (Day 9) - One blotch with rash looking dots approx 1/2" diameter on the back of both hands, red and painful to the touch 7/8 (Day 10) - day of reporting (Day 14) - Blotch on the back of both hands still somewhat visible but no longer painful to the touch
Patient presented to the pharmacy in person to report a very large red circle upon where her flu shot was administered. Patient stated it has gradually gotten bigger and bigger since administered and is slightly warm to the touch as well as extremely sore. Shot was administered on 11/22/2017 (Wednesday). The site upon observation took up the majority of her deltoid.
Few minutes after 2nd vaccine given, pt. complained felt dizzy and like she was going to faint. Sat her back down in chair. Pt then fainted or blacked out or possible small seizure -> was unresponsive to my voice for 30 seconds. Called 911. Pt came to . Said felt hot and had nausea. Got cold compress for head. Pt vomited a little. Medics arrived and checked pt out. Pt feeling better and refused to go to hospital.
After receiving Covid vaccinations:  Biopsy proven Small Fiber Neuropathy, chronic pain/myalgia/paresthesia/fatigue and Tinnitus, muscle fasciculations,  Symptomatic Ventricular Bi and Trigeminy, Dry eyes, sharp facial and ear pain, blue feet
One day post vax pt developed measles.  Pt had one or two spots, and a fever of 102.2F.  Pts fever subsequently decreased. Pt had periods of irritability.
Constant pain in upper arm that is unresolved and does not dissipate even with Tylenol, unable to lift arm above 90 degrees, unable to carry a purse or bag on left shoulder without additional pain, unable to carry items with left arm, unable to drive with left arm. Since an Xray was ordered by my insurance instead of an MRI, I have more pain and now muscle spasms from raising my arm for an extended period of time for the images 4/1/22. This pain in my arm started the day of injection 10/1/21 and has not dissipated or lessened in any way. If anything it has continued to be more painful.
On the day of the vaccine, I felt very tired, fever, muscle pains, headache,  and nausea. I did not take any medication.  I improved over 3 days and almost all gone away.   About a month after the vaccine, I found a lump in my right breast (self exam during shower).   It was bigger and painful.  I went to the doctor and referred to specialist.  I did a mamogram and ultrasound.  I had a 10cm area infected tissue as well as a cyst.  I was put on 2 rounds of antibiotics (the only one I can remember is Augmentin).   The infection was resolved after I finished the 2nd round of antibiotics (Augmentin) and the size of the cyst is decreasing.   As I was recovering from the breast cyst, I started to notice pain in my pelvic area.  I went to see NP/PCP and I had a CT scan which showed an ovarian cyst and was referred to a gynecologist.  I  did lab work and pelvic ultrasound.  Right now just monitoring the size and following up periodically.
Fever 4 hours after shots 103 and screaming and crying for several hours. Fever lasted 4 days, per mom.
This spontaneous report was received from a medical assistant concerning a 45-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 28-APR-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # L035283, expiration date 15-DEC-2016 (dose, dose number, anatomical location and route of administration were not provided). The vaccine underwent temperature excursion of -13 degrees Celsius for 48 hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as all the data was already obtained.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 09Mar2021 as dose 1, single (Lot number: EN6204) and on 31Mar2021 as dose 2, single (Lot number: EP6955) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 29Sep2021 as dose 3 (booster), single (Lot number: 301558) and on 30Mar2022 as dose 4 (booster), single (Lot number: 048l21A) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: GABAPENTIN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (20Mar2022) Negative; (27Mar2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received treatment with COVID-19 antiviral treatment from 15Jul2022 to 19Jul2022. COVID rebound. The patient received other medication in 2 weeks was yes. The patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
Hospitalization: 9/14/2022 - 9/17/2022 Presentation to the ED: COVID-19 + date: 9/15/22.  Treatment: SUPPLEMENTAL O2. NO REMDESIVIR OR DECADRON.  Discharge to: Home or Self Care.
Participant had fever, woke early the next morning and couldn't feel the left side of her face. Participant called hotline and the nurse called ambulance, participant went to ER, test was done, stroke was ruled out. Symptoms resolved the next day.
Chest pain; Trouble breathing; This is a spontaneous report from a contactable consumer (patient). A 16-year-old female patient received bnt162b2, via an unspecified route of administration, administered in Arm Left on 21Sep2021 13:30 (Lot Number: 30135BA), at the age of 16-year-old, as dose 2, single for COVID-19 immunisation. The patient was not pregnant. Medical history was none. No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. There were no concomitant medications. No other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of bnt162b2 (Lot number: FC3181) on 31Aug2021at 01:00 PM, in left arm for COVID-19 immunization. The patient experienced chest pain and trouble breathing on 21Sep2021 22:00. Still having these issues 5 weeks later. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment was received for the events. The patient underwent lab tests and procedures which included EKG, X-ray, Blood work in 2021 with unknown results. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Hospitalized for 2 days (10/12/21-10/14/21) with covid pneumonia; symptoms of cough and shortness of breath which started 9/30/21.
The subject had no adverse experiences following receipt of prior Hep-B vaccine series (9/95 and 11/95 and 4/96). She subsequently, received Engerix-B on 7/23/01, 9/4/01 and 2/5/02. Ten hours after her 3rd injection of the 2nd series of Engerix-B, the subject experienced a fever of 103F and "severe" chills. She was seen in the ER, where UA and "flu test" ruled out both the "flu" and a UTI. She was told by the physician on call, that she had "a reaction to the Hep-B vaccination". The subject returned to the vaccine provider on 2/6/02. Reportedly, WBC and eosinophil count were normal. The events were reported to have resolved, 1 month later on 3/5/02. The reporter considered the events to be possibly related to the 3rd injection of Engerix-B.
Administration Error: Undiluted vaccine administered. Patient received one undiluted dose of Pfizer-BioNTech vaccine (0.2mL).  Provider who administered dose did not add the 1.3mL diluent to the vial. Therefore, administered dose was incorrect.  The error noted 5+ hours later. At the time of administration and prior to leaving clinic, patient asymptomatic.
SEIZURE; PASSED OUT; POSTURE CONTRACTED; DIAPHORETIC/ SUPER SWEATY; CONFUSED; AFRAID; IT WAS LIKE A DREAM; This spontaneous report received from a pharmacist concerned a 27 year old male. The patient's height, and weight were not reported. The patient's past medical history included chest burning, and concurrent conditions included seasonal allergy and non-alcoholic user and other pre-existing medical conditions included no previous medical history or conditions, no family history of seizures/epilepsy, no illness at the time of vaccination, no past history of similar event, no history of allergy to vaccine, drug, or food, no family history of any disease (relevant to vaccination) or allergy, no other suspected causes including co-administered vaccine(s)/risk factors. The patient had no drug abuse or brain surgery. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular and batch number: 1808609 expiry: unknown) dose was not reported, 1 total administered on JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On unspecified date in JUN-2021, Reporter stated that the patient had his head backwards, the patient posture contracted, passed out in the observe area, which was tight and small area. Reported did not see that patient fall to ground. Reporter assumes that patient must have had a fall to get from the chair to the ground when she was able to see. Reporter stated that the seizure was about 15 seconds, eyes rolled back, blank stare, eyeballs twitching, full blown seizure. Reporter stated that when patient came back, he was super sweaty, diaphoretic, and only remembers that his chest was burning prior to vaccine. Reporter mentioned that patient did not know that he passed out. Reporter stated that patient said it was like a dream and do not know how long he was out and stated that he just said his chest was burning. Reporter mentioned that the guy was afraid and did not know what happened. Patient was confused upon waking up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from seizure, passed out and it was like a dream and the outcome of posture contracted, diaphoretic/super sweaty, confused and afraid was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20210667371-Covid 19 vaccine-Seizure, Passed out. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Information has been received from a nurse concerning a 23 year old female who in September 2007, was vaccinated with the first dose of GARDASIL vaccine (yeast) (Lot No 0250X). Concomitant therapy included (LOESTRIN). In September 2007, the patient experienced pain in arm for 4 months. The patient sought unspecified medical attention. On an unspecified date in January 2008, the patient recovered. Since she had pain for four months she did not get the second dose of GARDASIL vaccine (yeast) until 14-JUL-2008. No AE reported after the second dose. Additional information has been requested.
Extreme chills. Uncontrolled violent shaking in my entire body for four hours during the night. Some slight nausea, no vomiting.  March 5, extreme chills. No violent shaking. Wearing sweat pants, 3 sweat shirts --- I put a heavy blanket in the clothes dryer to get hot and wrapped it over my head and around my body. Extreme fatigue. No desire to do anything. Muscle pain in my shoulders, back and stomach until Monday, March 8.  Diminish the incidence of crime --- THREATEN THE CRIMINAL-WANNA-BE with these effects instead of prison.
The patient was an athlete in peak condition. She was being treated for amenorrhea in Aug 2006 with PROVERA followed by YASMIN at the time of the first administration of Gardasil. After 10/16/06 administration of Gardasil she dropped from 120 lbs to 88 lbs by 1/15/07. She was hospitalized 2/14/07 for one week. Her condition was never diagnosed. Unexplained weight loss. 10/18/07-records received for DOS 2/12-2/26/07- DC DX: Weight Loss. Absence of Menstruation. 30 pound weight loss since October 2006, denies appetite changes. No nausea no vomiting, no abdominal pain, no headache. Denies being depressed.  Stopped taking pills in September 2006 and has had no periods since that day.
Inconsolable screaming that lasted over 4 hours. No amount of soothing helped calm he down. Baby Tylenol didn't work either.
Resident had swollen, hard, and reddened area of injection site, right deltoid and whole upper arm.
Headaches in morning when waking. Some priperal neuropathy. Lower energy level than normal
Headache started 24 hours after vaccine lasted 2 days,  diarrhea started about 36 hours after vaccine and lasted about 12 hours.