chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Clinician prepared vial with 1.3ml Normal saline diluent rather than 1.8ml Normal saline. This occurred with the vaccination of first dose on 12/28/21 & on second dose received 1/13/22. Pt reported after receiving her 2nd dose she has been experiencing headaches. denies changes in her vision. States rlieved with Advil PRN
PATIENT REPORTS HAVING PAIN IN LEFT ARMPIT AND A BUMP UNDER THE SKIN IN THE SAME LEFT ARM AS VACCINE WAS GIVEN.  PATIENT SAID IT STARTED MONDAY MORNING AROUND 9:30AM AND HAS NOT TAKEN ANY MEDICATION OVER THE COUNTER.
patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021; patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021 at 10:57 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 17-Feb-2021 at 10:57 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (patient was administered with vaccine that experienced more than 1 temperature excursion during 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 88.92 years . No concomitant medications were reported.  Batch number 022M20A underwent temperature excursion on 17-Feb-2021 with temperature 22 degrees Fahrenheit from 08:00 AM to 09:00 AM. This vial was moved to fridge on 11-Feb-2021 and beyond use date for the vial was reported as 13-Mar-2021. Product moved to clinic on 17-Feb-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a temperature monitor at every hour.  No treatment medications were reported.
Patient is a 67-year-old female with past medical history of hypertension, GERD, hypothyroidism, and MS who presented to the emergency department with a history of ongoing nausea vomiting and diarrhea after she received her COVID and flu vaccination and administered her glatiramer shot on Monday.  She took another shot on Wednesday and has not taken her shots for today.  She is following Dr. for neurology for MS.  He was consulted and advised against steroids at this time given this patient's diarrhea.  At this time this patient is reporting severe weakness, nausea improving, no vomiting, has not had a bowel movement since last night.  Patient was noted to have low potassium levels, elevated liver function and bilirubin levels, elevated creatinine levels, noted to have possible UTI on her UA.  Patient's past surgical history is otherwise negative, family history was noncontributory, socially patient does not smoke drink or use any drugs except for occasional THC.  She was also complaining of initial presentation with vertigo which is resolving now.
No adverse event-Medication error Moderna booster given too soon. Second dose was given 6/9/2021, so it had not been 6 months.
Fatigue on first day.  On second day, I started to experience pains and tightness around my heart area.  These pains continue to re-occur as of today, January 7, 2022.
Patient stated that she felt nauseated after her 15 min. observation check and vitals were taken.  Patient was given oxygen and some water.  Patients oxygen were low @ 78 when vitals were completed, but after the oxygen was administered they went up to 98.  Patient was observed for 15 more minutes and then stated that she felt fine.   Patient was called this evening @ 5:30pm and she stated that she feels fine and was home relaxing.
Chills, uncontrolled shaking, muscles aches?back and neck, headache, vomiting? lasted 6 hours. Weakness followed for 10 hours
caget the shotsse of them, I case of them, I got the shots/ suspected vaccination failure; case of them; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and 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 and Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, gone through a case of shingles only an isolated area again after the shots. The reporter stated that, was sure if did not get the shot, the shingles would be far worse. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided. This case was linked with case US2021AMR088540, reported for same patient.
Nose bleed today both sides; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Apr2021 at 14:00 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included bipolar disorder. Concomitant medications included lithium (MANUFACTURER UNKNOWN) and quetiapine (MANUFACTURER UNKNOWN). The patient had no past drug. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05May2021 at 09:00 the patient experienced nose bleed both sides. The clinical outcome of the event nose bleed both sides was recovering.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a LPN concerning a normal, healthy 13 month old female child with no significant past medical history, who on 3/7/2000 vaccines. Post vax, on 3/11/2000, the pt experienced a seizure (considered an other medical event). the pt sought unspecified medical attention. Follow-up information received from a LPN stated that as far as she knows, the child did not have any fever preceding or around the time of the seizure, so she does not believe this was a febrile seizure. The reporter indicated that the child has recovered from her seizure and has had no further seizure activity or after effects from the event. Follow up on 12/06/2000: "Follow up information received on 04/28/2000 from a physician indicated that the patient had 3 seizures on 03/11/2000, required an emergency room/doctor visit, and was hospitalized for two days.  The physician reported that the magnetic resonance imaging (MRI) and head computed axial tomography test results were normal and that on 03/12/2000, the patient recovered.  No further information is available."
Pfizer was given as a booster when Moderna was 1st dose - no adverse reactions
Patient fainted in her chair a few minutes after receiving the yellow fever vaccine. Reported feeling dizzy afterwards.
Severe painful movements in my stump - Had to pack it in ice for (3) three days.
patient received vaccine on 3/3/09 in the afternoon patient then had fever of 102.7 at 3am on 3/4/09 was given tylenol. patient then had a seizure at 3am on 3/4/09 lasting approx one minute temp at that time was 101.7
COULD NOT THINK; BRAIN FOG; CAN'T FOCUS; FORGETTING WORDS; AFFECTING BEHIND EYES; BRAIN FATIGUE; VERY TIRED AND PHYSICAL FATIGUE; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient had no prior health issues and patient did not take any medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: 07-AUG-2021) dose was not reported, 1 total administered in left arm on 08-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-JUL-2021, the patient experienced brain fog, forgetting words, affecting behind eyes, brain fatigue, very tired and physical fatigue and patient couldn't focus.  Patient was ok for few days. Symptoms started three days later of vaccination and it is progressing worse and worse. Patient stated that Friday was really bad and Saturday was horrible. On Saturday 17-JUL-2021 patient came home and slept for five hours because she could not think. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from brain fog, very tired and physical fatigue, can't focus, forgetting words, affecting behind eyes, and brain fatigue, and the outcome of could not think was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210755714-Covid-19 vaccine ad26.cov2.s-Could not think . 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).
Patient given 2nd dose of Pfizer vaccine  2 weeks after 1st dose. Advised to revaccinate per CDC recommendations at ;east 21 days after invalid dose.
A week or so after vaccine, I had a light cold, cold symptoms, those lasted for a few days. I started having yeast infection symptoms on May 29th and on June 8th, I started having eczema issues; was having rashes. I went to the doctor on the 7th of June for a yeast infection; gave me a Flazalone or something like that for the infection. June 10th, I went to the doctor for rashes on my leg and a lot on my face and chin, cheek, and behind my ears and on my hands. Topical cream was prescribed for that: Clobetasol propionate cream (gave this to me when the lesser strength one wasn't working - they told me not to use it much; triamcinolone Acetonide cream, the lesser strength. On my face I use cortisone cream. Yeast infection cleared up, but I still have the Eczema; it's still popping out a little but it's getting a bit better.
Pt received FLUZONE premeasured syringe injection in right deltoid at approximately 3pm on 10/25/10. Pt called pharm on 10/26/10 at 8:15 AM to report evening before experienced chills, fever, nausea/vomiting at about 8 PM on 10/25/10. Pt will follow up with MD.
postural orthostatic tachycardia; booster; This is a spontaneous report received from non-contactable reporter(s) (Physician) from a representative.  An adult female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Manufacturer: Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Manufacturer: Unknown), for Covid-19 immunization. The following information was reported POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (non-serious) with onset Dec2021, outcome recovered; IMMUNISATION (non-serious) with onset Dec2021, outcome recovered. The event postural orthostatic tachycardia was evaluated at the physician office visit. Therapeutic measures were taken as a result of postural orthostatic tachycardia syndrome, immunisation.  The lot number for bnt162b2 was not provided and will be requested during follow up.  Doctor's office/urgent care was facility type vaccine. Other vaccine in four weeks was unknown. The patient was on low dose beta-blocker and it was feeling much better. AE treatment was beta-blocker. Covid prior vaccination was unknown. Covid tested post vaccination was unknown.
About 24 hours after receiving the second dose, I experienced very mild joint pain, muscle aches, headache, and fatigue. I did not feel ill enough to stay home from work or discontinue my regular routine. Three weeks later I am still experiencing the same symptoms. On a few occasions I have felt dizzy as well. Although I am still working and going about my normal routine, I am taking Excedrin on a regular basis.
found on the floor by his wife/passed out; This is a spontaneous report from a contactable nurse (patient's daughter). A 79-year-old male patient received BNT162B2 (COMIRNATY, solution for injection, lot number: FF8839), via an unspecified route of administration on 08Oct2021 (at the age of 79 years old) as dose 3 (booster), single for COVID-19 immunization. Medical history was reported as none. There were no concomitant medications. The patient previously received BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration on 20Feb2021 (at the age of 78 years old; lot number: EL9269) as dose 1, single and via an unspecified route of administration on 13Mar2021 (at the age of 78 years old; lot number: EL3302, expiry date: 30May2021) as dose 2, single for COVID-19 immunization. The patient was found on the floor by his wife/passed out, weak on the floor and couldn't get up on 09Oct2021. The patient's daughter clarified this was her father's booster shot. He took the injection on 08Oct2021. On Saturday, 09Oct2021, his wife found him and said he was passed out, weak on the floor, he couldn't get up. On 10Oct2021, her father went to the bathroom on himself which was totally unlike her father. On 11Oct2021, he started coming back to his normal self. For the causality, the reporter stated she doesn't know, it could possibly be related but she doesn't know. She confirmed her father started no new medications; he has no other medical conditions. The events did not require ER visit or physician office visit. The patient's daughter also confirmed her father has not been to the doctor's. She highly encouraged her parents to take him to the doctor and tell the doctor exactly what happened. She informed them they should have brought her father to the ER immediately. The outcome of the events found on the floor by his wife/passed out and weak on the floor was recovering.; Sender's Comments: Considering the temporal association, a causal association between administration of bnt162b2 and the onset of event cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product 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.
This spontaneous prospective pregnancy report was received from a female patient reporting on herself. On 20-DEC-2013, the patient was vaccinated with VARIVAX (Merck) injection 1 shot. Approximately on 26-DEC-2013, 6 days after she had received the chicken pox vaccine, the patient had a positive ovulation and could potentially be pregnant. The last menstrual period (LMP) and estimated date of delivery (EDD) is not known. No adverse experiences were reported. The outcome of the events and causality assessment were not provided. Additional information has been requested.
I received my shot at appx 1300 hours. By 1700 hours I had a flare up of Vasculitis symptoms. I began to get little red dots on both of my lower legs a total of about 10. They began really light and over the night got brighter and bigger. I went to the doctor the next morning and was given a prescription for a steroid and antibiotic which I first took at 2000 hours on 12/31/2020. By the next evening my dots began to get lighter. As of today all but one have faded away. The one I have is really light. I did have some of the usually listed symptoms, slight headache, runny nose, hard to breathe.
After both vaccines I got extremely ill, issues sleeping - could not fall asleep, April at the age of 40 I had my first psychotic break, as of today I am in the hospital for ?monkeypox?  liaisons on and a rounding genitals ? the seepage smells like a warm penny
Clot blood; Heart attack; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Clot blood) and MYOCARDIAL INFARCTION (Heart attack) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Clot blood) (seriousness criteria death and medically significant) and MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria death and medically significant). The patient died in 2021. The reported cause of death was blood clots and Heart attack. It is unknown if an autopsy was performed.            No concomitant product reported by reporter. No treatment medication reported by reporter. Company comment: This spontaneous case concerns a male patient of unknown age, with no medical history reported, who experienced unexpected serious fatal and medically significant events of thrombosis (AESI) and myocardial infarction (AESI) that occurred after receiving a dose of mRNA-1273, which was the patient's unknown dose of COVID-19 vaccination schedule. Latency cannot be calculated due to vaccination and events onset dates being unknown. Both events were reported as cause of death however it is unknown whether autopsy was performed. Details regarding vaccination date and events onset dates, any clinical symptoms, concomitant medications and concurrent diseases, accompanying circumstances with potential alternative causalities, autopsy report are not available in the report. Events' outcomes were fatal at the time of the report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-695239.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-695239:2nd brother's case; Reported Cause(s) of Death: Blood clots; Heart attack
She became dizzy and hot 15 minutes after the injection. Later vomited and had nausea and vomited several times. Dr  came in to evaluate and pt was given Zofran. BP elevated in the 150's/ 90's.  States that BP usually runs okay. Does not have PCP. She will follow up as new pt in a week and will come in earlier if needed. She was kept for 2 hours and discharged home. Stated that she felt better and nausea/vomiting had resolved.
1-2 minutes post vax, pt developed red welt/hive like rash all over body and at the MMR injection site a 2 - 2 1/2 welt. Pt treated with Benadryl. Within 1/2 hour, rash and welts resolved.
Fever 102 with 45 second seizure. No treatment except TYLENOL.
on 30-MAR-2017 at age of 12 years, patient received GARDASIL 9/the patient received the second dose in the HPV vaccination series, GARDASIL 9, on 02-JUL-2019.; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, previous drug reactions, allergies and concomitant medications were not provided.  It was reported that on 30-MAR-2017, at age of 12-years-old, a patient was vaccinated with first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, dosage schedule and route of administration were not provided). Subsequently, on 02-JUL-2019, the patient received the second dose in the Human Papilloma Virus (HPV) vaccination series, HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (inappropriate schedule of product administration).  Lot number R032766 has been verified to be a valid lot number for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), expiration date reported as 03-AUG-2021 but upon internal validation established as 31-AUG-2021.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE TRANSIENT CEREBRAL ISCHEMIA HYPOTENSION 9/6/2022,  12/19/2022,  1/20/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Pfizer 3/17/21, 4/7/21. Positive on 2/9/23. (pos.)
Fever, Severe headache and body aches, Tachycardia 120-150, Shortness of breath, Hypertension 160/110
11/01/2012 patient is still sick with all possible flu symptoms such as: low grade fever, body aches, headaches, sinus congestion / stuffy nose, sore throat, chest pressure, and infrequent diarrhea.
blood clots in his right leg; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (blood clots in his right leg) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History was reported.  Concomitant products included ENOXAPARIN for an unknown indication.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced THROMBOSIS (blood clots in his right leg) (seriousness criterion medically significant). The patient was treated with APIXABAN (ELIQUIS) from 06-Apr-2021 to 24-May-2021 for Clot blood, at a dose of 10 milligram twice a day. At the time of the report, THROMBOSIS (blood clots in his right leg) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Ultrasound scan: confirmed blood clots (abnormal) confirmed blood clots in patient's in right leg.         Company Comment: 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. Further information has been requested   This case was linked to MOD-2021-220788 (Patient Link).; Sender'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. Further information has been requested