chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient has end stage renal disease and rapidly worsening dementia, family could no longer care for him at home, and he was admitted for 14-day quarantine prior to admission to inpatient hospice. Received vaccine on 1/12 without apparent adverse reactions. Patient started refusing oral intake on 1/16, and CMP on 1/17 showed hypernatremia 165 (new issue). His BUN 138 CREAT 6.93 K 5.2 were his baseline. He was found to be deceased on 1/18 at 11:18 pm.
Child brought in by parents due to 31/2" by 31/2" circumscribed area (L) deltoid. Area edematous and reddened, warm to touch. Seen by doctor: Children's Benadryl at bedtime recommended, compresses and follow up with PMD. To ER with any increase in symptoms.
at 12 hours:  Chills, muscle spasms and ache 12-36 hours: Fever (101), chills, sweating, extreme fatigue, muscle ache, general malaise, headache 36-48 hours: slept 48 hours: some fatigue and muscle aches.  No other symptoms.
This spontaneous report was received from a physician assistant and refers to a 22 year old female patient. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 12-APR-2018, the patient was vaccinated with the first dose of GARDASIL 9 lot number N019923, expiration date 28-APR-2018 (dose and route were not reported) for preventive of cervical cancer (prophylaxis). On 12-APR-2018, 4 hrs after onset of therapy, the patient experienced swelling of her eyes. Afterwards, she was seen in an unspecified emergency room for treatment of swelling with BENADRYL and an unspecified steroid. On the same date, the patient was recovered from the event. The causal relationship between the event and GARDASIL 9 was not reported.
Information has been received from a healthcare student concerning a 63 year old male patient. No relevant medical history was reported. On an unknown date, the patient was vaccinated with the first dose of PNEUMOVAX23 (lot#, dose, strength, route not reported). It was reported that the patient developed hives following administration of PNEUMOVAX23 on an unspecified date and recovered from the hives on an unspecified date. Then the patient forgot that he experienced the hives reaction and was administered the second dose of PNEUMOVAX23 (lot#, dose and route unknown) on an unspecified date. The patient developed hives following the administration again but they were worse than before. The outcome of the second episode of hives was unknown. Additional information has been requested.
Had soreness in arm in first few hours. About 12 hours later (next morning) had full body pain that lasted about 1.5-2 days. Arm at injection site swelled up about the circumference of a small grapefruit, was firm and was warm to the touch but was not red yet. About day 4 I noticed it was a bit red and still swollen about the same size. Was also slightly painful and occasionally itchy. By day 6 it was obviously red and swollen, same size in diameter. Still hot to the touch and occasionally itchy. I?m starting day 10 now (shot was afternoon of 4/12. Now midnight 4/22) and still have large, red swollen lump that?s warm to the touch and firm. Less itchy and painful but still mildly so.
red rash and itchiness at the injection site. the rash seems to be in the area where the alcohol wipe was rubbed prior to injection
vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 26Jul2022; No adverse event; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 26Jul2022) and NO ADVERSE EVENT (No adverse event) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 26-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 26Jul2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 26Jul2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 26Jul2022).    Concomitant medications were not reported.  Patient received half dose. They administered the vaccine to 346 patients after the 30 day by used and total Number of vials was 35. The vial did not undergo any temperature excursions. Treatment medications were not reported.
This spontaneous report was received from a nurse practitioner refers to multiple unspecified patients of unknown gender and age. Information regarding their medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On specified dates in 2016 (reported as between February 2016 and April 2016), the patients were vaccinated with improperly stored doses of VAQTA (lot # L046953, expiry date: 14-JAN-2017; lot # L015460, expiry date: 02-JUL-2017; lot # L045713, expiry date: 14-JAN-2017; lot # L018498, expiry date: 28-APR-2016; lot # L043209, expiry date: 17-SEP-2017; lot # L023936, expiry date: 15-MAR-2017). Nurse reported that the vaccine underwent a temperature excursion at 11 degree Celsius in a large refrigerator for a time frame of 1 hour 18 minutes which came back to its temperature range. She reported that the vaccine also underwent 2 temperature excursions previously on an unknown date: at 0.2C as minimum for 96 hours plus a second exposure at 1.5C for 7 hours 22 minutes (evaluating 0.2C for cumulative time of 103 hours, 22 minutes). No adverse events were reported. This is one of the eight reports received from the same reporter. Additional information has been requested.
Blood Pressure spiked 40 points to 170's, face and neck  got hot and flushed, heart palpitations (continuous), strong metallic taste.   I was rushed to the hospital by ambulance, monitored for several hours, givena benedryl, and sent home.  These symptoms are continuing (3+ weeks). I am now wearing a cardiac monitor and going for blood, urine and cardiac tests.
PAIN; SHORTNESS OF BREATH; HEADACHE; FEVER; This spontaneous report received from a patient 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: 202821A, and expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 15:30 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, treatment medications included: paracetamol. On 09-APR-2021, the subject experienced pain. On 09-APR-2021, the subject experienced shortness of breath. On 09-APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced fever. Laboratory data (dates unspecified) included: COVID-19 PCR test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, fever, shortness of breath, and pain. This report was non-serious.
8/19/21 pt met with PCP via telemedicine, diagnosed with UTI, started on Bactrim; later in week was transported to outside hospital and diagnosed with COVID and electrolyte abnormalities; later was transported to a local HCF for care; c/o nausea, vomiting, productive cough, SOB; AKI; bradycardic and hypotensive; O2 sats @ 92% on 2 L O2;  pt's condition rapidly deteriorated; placed on comfort measures; pt passed away in the hospital
Within 16 hours I suffered severe muscle weakness tesult Resulting in a fall and fracturing my ankle
Information has been received from a registered nurse concerning an outbreak of chickenpox in a child, between the ages of kindergarten to 4th grade, who had been vaccinated subcutaneously with a first dose of 0.5 mL of varicella virus vaccine (Oka/Merck). Subsequently, the child developed chickenpox. The child may have 50 lesions or more. Additional information is not expected. This is one of several reports received from the same source.
Reporting is for a vaccine administration error where an adult patient was administered the Pfizer-BioTech vaccine  5-11 years   formulation(Orange cap),resulting in a lower than authorized dose for a booster. There is currently no symptoms or adverse event. Patient has been called and correct age appropriate dose of Pfizer-Biotech vaccine has been given on 11/23/21, as per CDC and vaccine manufacturer guidelines
TRANSIENT ACHINESS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: 1805031, and batch number: 1805031 expiry: 13-MAR-2021) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the subject experienced transient achiness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from transient achiness on 14-MAR-2021. This report was non-serious.
Was well at time of vaccination with AVA #1 on 22 Feb 03. On 25 Feb experienced fatigue, myalgias, chills, sweats, light headedness, vertigo and "couldn't get out of bed". On 27 Feb 03 developed white coating on tongue and mouth ulcerations over surface of tongue, around upper and lower teeth and gums and on bilateral buccal mucosa. Was unable to eat and could drink only clear fluids for several days.On 1 mar 03 went to the Military Clinic and saw Dr. who subsequently contacted the VHC. On 2Mar 03 pt was worse and went to a civilian emergency room where he received IV fluids for dehydration and was perscribed valtrex, triamicin, motrin and magic mouthwash. Seen at military hospital on 11 Mar03.Oral lesions resolving , asymptomatic otherwise.
Miscarriage at 6 weeks gestational age. No prior medical history. Had 1 prior healthy live birth.  No high risk behaviors such as smoking, drinking, recreational drugs use.
Will be calling back with vaccination information. Dr. was the one who was there because the other doctor was out.  The appointment was on the 12/13 in the afternoon, we left the office, it was an annual check up and everything went well. They administered the vaccine. At 7:30pm he went to sleep normal. In the early morning at 4 am, i heard a loud noise, like someone who can't breathe. I go to him and his eyes are rolling and his whole body was twitching and moving. His mouth was shut with blood. He had that very quickly. He whole body was very soft. He went to go potty and then he slept most of the day. I called the dr's office. The nurse said it was possibly be reaction to one of the vaccine. If he had a temperature to give tylenol. Dr. advised to do a follow up with a specialist. Dr diagnosed him with epilepsy. I learned he had a seizure after receiving all those vaccine. the MMR, Varicella, and 2 FLU shots. Specialty Clinic.
Patients states she had seizure lasting less than 1 minute after she got home from getting Zostavax vaccine.  Pt was able to talk and was clear headed when she called us at 5 pm. Said she would contact Dr suggested. Pt has been diagnosed with seizure disorder from same doctor who prescribed Zostavax and said she had been compliant with primidone and gabapentin.  Had no history of seizures within last 2 years until now.
Headache, Sedation, Myalgia, Arthralgia, Fever, chills, felt mouth was swelling Narrative:
Coughing uncontrollably; Slurred speech.; This is a spontaneous report from a contactable consumer, the patient. A 63 -year-old non-pregnant female patient received first dose of BNT162B2 (BNT162B2; Lot Number: Unknown) via an unspecified route of administration in the Left arm on 16Mar2021 at 12:30 (at the age of 63-year-old) as a single dose for COVID-19 Immunization. Prior to vaccination, the patient diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 16March2021 at 21:00, the patient experienced coughing uncontrollably and slurred speech. Patient did not received any treatment for the reported events. The Clinical outcome of the events coughing uncontrollably and slurred speech was resolved at the time of report. Information about lot/batch number cannot be obtained. No further information is expected.
Severe tinnitus in both ears developed after the second shot. Has not resolved over a year later. If anything, it seems to be getting worse.
Patient developed a lipoma in his right arm after receiving the flu vaccine.  He has had numbness in his right arm, index finger and no feeling in his right thumb.  Patient has seen a general surgeon and a arm specialist and is awaiting surgery to remove the lipoma.
Client reported a high level of anxiety a few minutes after receiving the vaccine.  EMT monitoring clients post vaccination responded to client and determined that vital signs were within the normal range.  Client refused EMT transport to the emergency department for further evaluation.  Client waited 30 minutes post vaccine with an EMT at her side and then determined that she was over the anxiety episode and was safe to leave vaccine site.
Lips swelled,  no other adverse  conditions,  took Benadryl  and swelling went down , I did not take scheduled 2nd shoy
Event: In February, 2018 I received (in my right shoulder); my 5th anthrax shot.  The initial part of the day was typical (burning, soreness?) however, when I was traveling home my arm developed a fever. Around the injection site I developed severe swelling to the point that it looked like I had a golf ball under my skin. My arm was hot to the touch, itchy and painful. I had a large red area on my upper arm maybe the size of a softball. It remained swollen for more than 12 hours. I applied a cool rag to help with the fever. I assumed that this was not normal and I contacted the flight doc. He mentioned that it was a possible side effect and that I should continue to monitor without great concern. After about a week the area seemed to be back to normal but had a tightness to the skin. Although it was not sudden my right pinky was numb for some time and my right shoulder joint remained achy.  Fast forward 3 months later: Now at the location my arm randomly swelled up at the injection sight and became feverish again. I went and reported to the flight doc and he said again it?s normal to have reactions to the shot although it seemed odd that it was so long ago. After about 6-7 hours the sight subsided. I thought it was a one-time event.  Fast forward another 3-4 months, now post. I was at on leave and the sight became inflamed again. Although I have not been able to retrieve the picture; I remember taking a picture and sending it to the flight doc. He said it probably was not the shot but something else that I was having a reaction to.  Follow on: Pretty much 3-4 months sometimes a little longer my right shoulder will randomly get raised and itch. To the best of my knowledge I have not found any ?triggers?. The last time it happened it was a very small area maybe the size of a flat pea and the skin around the area got blotchy red and itched. Almost like when bitten by a bug. The duration was only for a matter of an hour or so.
This is a spontaneous report from a contactable consumer reporting for herself. This female patient of an unspecified age, race and ethnicity received pneumococcal PREVNAR 13 via an unspecified route of administration in the middle of Jan2017 at 0.5 ml single for immunization. The patient was allergic to penicillin, sulfa, codeine and KEFLEX. The patient's concomitant medications were not reported.  Since the vaccination the patient was sick. The patient felt that her sickness was due to the vaccination, because when she woke up the day after having received the vaccine, she was weak and she could not get out of bed. She was also coughing. Outcome was unknown.
platelet count bottomed out; debilitating migraines; stroke like symptoms; unknown neurological disorder; not be able to walk without falling; This is a spontaneous report from a contactable other healthcare professional (patient). A 31-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 25May2021 13:00 at age of 31-year-old (Lot Number: EW0173) at single dose for COVID-19 immunisation at facility pharmacy or drug store. The patient's medical history was not reported. There was no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient is not pregnant at the time of the vaccination. The patient's concomitant medications were not reported. There was no other vaccine within 4 weeks prior to the COVID vaccine. The patient previously took bnt162b2 dose 1 for COVID-19 immunisation. On 30May2021, her platelet count bottomed out, she had debilitating migraines that cause stroke like symptoms, she had an unknown neurological disorder that caused her to not be able to walk without falling, 2 hospital stayed. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, prolongation of existing hospitalization (vaccine received during existing hospitalization), life threatening illness (immediate risk of death from the event), disability or permanent damage. The patient was hospitalized for the events from May2021 for 5 days. It was unknown if any treatment was received for the events. The patient underwent lab tests and procedures which included platelet count: reduced, platelet count bottomed out on 30May2021, since the vaccination,  the patient had been tested for COVID-19 via nasal swab in 2021 with unknown result. The outcome of the events was not resolved.; Sender's Comments: Based on the available information in the case, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events platelet count decreased, migraine, cerebrovascular accident, nervous system disorder and gait disturbance.  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.
Right leg is completely limp.  Unable to stand, walk or put on a shoe. The follow up states pt has regained use of his leg and the ability to walk. We now have reason to believe the child's condition was not caused by an adverse reaction to the vaccine but rather an injury. The timing was just coincidental. Because initial x-rays were negative, we were concerned that the vaccine may have been the cause. *Follow-up received on 02/12/03: PT has fully recovered. We believe that the adverse condition may have been a result of a coincident injury. We appreciate the cooperation of the MD in helping resolve this.
Pt stated  he felt light headed, cloudy.  EMT informed to evaluate Pt.  VS BP 132/100, HR 86 regular, OxSat 96% on RA.  Pt stated BP runs high when he experiences anxiety which he was today.  D/t rushing to site to receive vaccine but he said once he was evaluated by EMT he was feeling much better.
Elevated heart rate; This spontaneous case was reported by an other health care professional and describes the occurrence of HEART RATE INCREASED (Elevated heart rate) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced HEART RATE INCREASED (Elevated heart rate). At the time of the report, HEART RATE INCREASED (Elevated heart rate) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product used was not provided by the reporter.  Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Follow-up information received on 23-Mar-2021 included no new information.
Vasovagal syncope several minutes after administration Patient transferred to the ER for cardiac evaluation and left against medical advice
Next day, soreness, swollen face, lump to injection site. 2 days after, headache, nausea, light sensitivity to eyes. BP 165/92. Temp only in 99 degree range. 7/21/04 Symptoms improved. Still sore; cheeks still swollen, headache improved.
tested positive for COVID,Fatique,Cough,Rhinorrhoea; tested positive for COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An 11-year-old female patient received BNT162b2 (BNT162B2), on 24Nov2021 as dose 1, single (Lot number: FK5618, Expiration Date: 28Feb2022) and on 15Dec2021 as dose 2, single (Lot number: FK5618, Expiration Date: 28Feb2022) at the age of 11 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: COVID-19 (medically significant), outcome "unknown", described as "tested positive for COVID,Fatique,Cough,Rhinorrhoea"; VACCINATION FAILURE (medically significant), outcome "unknown", described as "tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.
Narrative:  COVID infection following COVID vaccine series 01/14, Pfizer, dose #1 02/04, Pfizer, dose #2 08/31 pt cc: cough, loss of taste or smell, sore throat exposure: unknown 09/02 COVID swab, result detected
About 40 minutes after injection, patient developed one "hive" on the side of his neck.  Patient had stable vital signs, no itching, no spreading rash in visible areas, and no trouble breathing.  PHN administered 100mg of Benadryl PO.  Patient left in stable condition with no other signs of symptoms.
Rash and itching, general very light red with raised bumps.  On arms, legs, trunk and neck.  After 1 week she went to her doctor who prescribed some cream and antihistamine.