chrisvoncsefalvay/vaers-outcomes huggingface dataset:
anaphylaxis and allergic reactions; This spontaneous report was received from a consumer concerning herself. No concurrent condition, medical history, or concomitant therapy was reported.   On unknown dates, the patient was vaccinated with hepatitis a vaccine, inactivated (manufacturer unknown) (strength, dose, frequency, route, lot# and expiration date were unknown) and zoster vaccine live (manufacturer unknown) (strength, dose, frequency, route, lot# and expiration date were unknown) (reported as unspecified Hepatitis A vaccine and unspecified "shingles shot'') for prophylaxis.    She had anaphylaxis and allergic reactions to the vaccines. Unspecified Hepatitis A vaccine affected her for 6 months. Unspecified "shingles shot'' caused swelling and rash on unknown dates. The outcome of anaphylaxis and allergic reactions was unknown. The reporter considered the event to be related to the both vaccines.     Upon internal review, anaphylaxis and allergic reactions was determined to be medically significant.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2101USA013273: US-009507513-2101USA013252:
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, pertinent medical history and concomitant medications were not reported. On unspecified dates,  unspecified patients were administered with an improperly stored RECOMBIVAX HB (dose and route of administration were not provided; lot #J012520 and expiration date on 30-JAN-2016). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Passenger in car going home.  30-40 minutes after injection had pounding headache, warm feeling all over, shortness of breath, difficulty breathing, rapid heart rate, chest pain, numbness and tingling in legs and arms
I did not have an adverse reaction to the vaccine. I tested positive for COVID-19 on 03/28/2023. I was so tired for a week with a cough and cold symptoms. I contacted my doctor and got a prescription for Paxlovid. I did not take the medication as directed but I completed it. I felt better but around day seven, I had some minor symptoms return for a couple days. As of today, I still sound like I have a cold and a cough.
I felt as though I was going to faint several times a day; My heart fluttered, pounded, raced and skipped beats.; My heart fluttered, pounded, raced and skipped beats.; My heart fluttered, pounded, raced and skipped beats.; and the fluttering made me nauseous; My resting heart rate dropped; This is a spontaneous report from a contactable consumer (patient).   This 52-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number ewo0153), via intramuscular administered in the left arm, on 04May2021 (at the age of 52-year-old) at single dose for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number ewo151) administered in the right arm, on 13Apr2021 (at the age of 52-year-old) at single dose for COVID-19 immunisation. Relevant medical history included high blood pressure. No known allergies. Relevant concomitant medications included metoprolol, cyanocobalamin, folic acid (VITAMIN B12 & FOLIC ACID), VITAMIN D3 and valsartan. The patient verbally reported 'on 16Jul2021, my heart fluttered, pounded, raced and skipped beats. My resting heart rate dropped and I felt as though I was going to faint several times a day, and the fluttering made me nauseous''. The events required physician office-visit. The patient was not treated for the events. Pre-vaccination and post-vaccination COVID tests were not performed. The patient was recovering from the events.
Headache, Fever, CoughWheeze, fatigue, chills, night sweats Narrative:  Employee stated woke up saturday morning with fever 102, chills, headache, fatigue, progressed to night sweats, and cough. was taking tylenol over the weekend for the fever, employee tested for COVID this morning
Hot flushes; This spontaneous case was reported by a patient and describes the occurrence of HOT FLUSH (Hot flushes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 11-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2023, the patient experienced HOT FLUSH (Hot flushes). At the time of the report, HOT FLUSH (Hot flushes) outcome was unknown.     No concomitant medications were reported.  Caller was 99 percentage sure that patient hot flashes which had been experiencing from the time caused by the second booster on 11-May-2022 with 24/7 and the vaccine was administered from vial. This event not reported previously with Moderna or another agency.  No treatment medications were reported.   Reporter did not allow further contact
Narrative: 76 yo male with metastatic prostate cancer to various bones, CAD s/p CABG, HTN, HLP, OSA on CPAP, bilateral carotid artery stenosis (50-69% stenosis bilaterally), NAFLD w/ cirrhosis, T2DM with neuropathy, OA, depression, PVD, hx of pulmonary nodules present to the hospital with chest pain on 08/10/2021. He was found to have NSTEMI. He was medically treated and d/c'ed home Hosparice on 9/7/21. Pt died at home in home hospice care on 9/24/21. Pt has received covid vaccines 2/14/21 & 3/13/21. This death is likely not related to vaccinations due to comorbidities, age, and length of time from vaccine administration.
Two days after getting vaccine, I spotted/possibly started period 2 weeks into cycle (which has never happened) and I feel terrible/bloated/anxious typical PMS symptoms.  I also had soreness at the point of injection for one day after about 24 hours, but hardly a big deal.
Severe heart inflammation; Bodies with weak immune systems; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  An adolescent patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for Covid-19 immunization. The following information was reported: CARDIAC INFECTION (death, medically significant), outcome "fatal", described as "Severe heart inflammation"; IMMUNE SYSTEM DISORDER (non-serious), outcome "unknown", described as "Bodies with weak immune systems". The patient date of death was unknown. The reported cause of death was inflammation. Additional information: Two teenagers died from the second shot. Severe heart inflammation on autopsy. Bodies with weak immune systems often don't react as fiercely as stronger ones. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Severe heart inflammation
It was at 1pm the appointment. My arm didn't hurt but I felt a little exhausted. I went to my daughter's and I had no reaction. I came home and slept fine. After 7 days, I got hot spells and I keep taking my temperature. Sometimes it varies from 98.7-97.9. I started getting headaches and a lump in my neck after 3 weeks. I saw an ENT and he said these symptoms would go away. I was coughing and I asked my doctor to get a CAT scan. I had inflammation on my chest. It was last week that my PCP told me to see a pulmonary doctor. The disk that she had given him was not clear and that he couldn't determine anything. I have told my doctor about the weird headaches and acid reflux that I have been getting.
Myalgia & NauseaVomiting Narrative: dose 1 and dose 2 day 1 and 2 with nausea and body ache
Red, itchy rash on left arm at approximate location of injection site, starting 1/28. Still present 1/30/21. No other symptoms reported.
Fever of 99.5, req emergency medical action, vomited six times, and could not eat food next/following day.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No concurrent conditions or pertinent medical history were reported. On 02-AUG-1976, the patient was vaccinated with the first dose of M-M-R II (dose, lot number, expiration date and route were not reported). On 15-JUN-2015, the patient was vaccinated with an expired the second dose of M-M-R II (lot # J006954, expiration date 07-JUN-2015) (Inappropriate schedule of drug administration) dose and route were not reported). Concomitant medication was not reported. No adverse symptoms were reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Mom called office 10/17/2005, stated child had chicken pox vaccine and now broke out with pox and itchy.
Angio-edema; Bottom lip locked badly; This is a spontaneous report from a contactable consumer (patient).   A 67-year-old patient of an unspecified gender received the 2nd dose of bnt162b2 (BNT162B2, lot # E19267) at single dose on 12Feb2021 for Covid-19 immunisation, as work in healthcare on the operational side (not clinical).  Medical history included blood pressure high. Concomitant medication included levothyroxine (LEVOTHYROXINE), nebivolol hydrochloride (BYSTOLIC), nifedipine (NIFEDIPINE), azilsartan kamedoxomil (EDARBI).  On 13Feb2021 the patient had to go directly to the emergency room because the bottom lip locked badly and they called (incomplete sentence), they said it was angio-edema and it was due to the injection. Patient went through a ton of lab work. All blood work and everything were fine, everything was perfect. All the last blood work patient had probably the last one was 26Jan2021, investigation: unknown results. The outcome of events was unknown. Patient wished to know if he/she could take vaccine ever again. That's a little scary, patient did not want to end up in a hospital, that he/she did.
Fever, severe chills, severe aching, head pain, ear pain, vomiting, dizzy For about 12 hours then continued ear and head pain and dizzy for another 12 hours Arm very sore for about 7-10 days
Starting Sunday 1/2, a small, painful and itchy red area appeared on the left deltoid. By the next evening, it was larger, firmer, and more red. Circled area, and it has grown in size. Contacted employee health for work but have not heard back. Today, Wednesday 1/6, it is less firm and less red, but still larger, reaching my shoulder and about an inch below yesterday's mark.
Upon going to bed at approx. 11:30 p.m. on the day I received my second dose of the Pfizer COVID-19 vaccine I began to feel quite ill.  I was experiencing moderate shaking / shivering / rigors (although I did not feel cold).  After a period of time, I was able to get to sleep, but at approximately 2:00 a.m. I woke up and, while lying in the supine position, experienced a convulsive syncopal episode witnessed by my husband.  Upon reviving from the episode, I was overcome with more uncontrollable shaking / shivering / rigors and involuntary muscle contractions as well as several other symptoms including malaise, nausea, diarrhea, neck pain and stiffness, possibly a slight fever (didn't have a thermometer handy to use), and a strange feeling I can best describe as numbness on the right side of my face and the right side of my body.
On 4/19/2022, at 9:02 am, flu vaccine administered to patient, despite having received one October 2021. He was monitored for 15 minutes after receiving both the flu and Moderna vaccines. No signs of distress observed or reported. He was provided with education on what to expect, adverse effects, and when to seek care (both verbal and written) on both the flu and COVID-19 vaccine. Reviewed dates of flu season with all staff, and how to better view the records in the system. It was found most staff were using the wrong page, which doesn't reveal as easily which vaccines are due versus completed. Provided instructions to contracted staff to double check.
Pfizer Dose 1 4/15/21 (EW0153) Pfizer Dose 2 5/7/21 (ER8736) Pfizer Dose 3 11/16/21 (FH8028) COVID Positive 1/23/22  1/23/22: This is a 75 years old female presented to the emergency department because of nausea and vomiting.  The patient has a history significant for COPD, congestive heart failure, atrial fibrillation, coronary artery disease, hypertension, diabetes mellitus, chronic anticoagulation.  There is documentation that the patient is on Eliquis and previously was prescribed Coumadin.  Per record it seems that she is supposed to be on Eliquis per the most recent hospitalization course  The patient is not a very good historian and keeps looking at her daughter to provide answers to questions.  The daughter appears exhausted in the room and is sleeping during the encounter  Patient has been sick for the past week with nausea, vomiting, reduced appetite and decreased oral intake.  She is also complaining of abdominal pain associated with diarrhea and cough.  She denies chest pain, shortness of breath, changes in stool colors, headache, dizziness.  She was found in the emergency department to be dehydrated with resultant acute kidney injury.  She has a chronic indwelling Foley catheter.  Urinalysis suggestive of a possible urinary tract infection.  She does have a history of ESBL UTI for which she was given Invanz at the last hospitalization.  CT abdomen pelvis did not show anything acute.  She is up-to-date with COVID-19 vaccinations.  She was given IV fluid boluses as well as Levaquin prior to being admitted to the hospitalist service for further evaluation and treatment  1/31/22: Patient is a 75-year-old female history of neurogenic bladder with chronic indwelling Foley catheter and CKD stage IV admitted to the hospital for acute complicated UTI associated with chronic indwelling Foley catheter patient was treated with IV antibiotics, her hospitalization was noted for COVID-19 infection without any respiratory symptoms.  As time progressed patient clinically improved, prior to discharge patient completed IV antibiotics.  Patient was evaluated by therapy recommended skilled nursing facility, however on January 31st patient requested to be discharged to home with VNA. Patient will be discharged home with VNA recommended follow-up with PCP within 1 week.
Pt. received flu and ZOSTAVAX on 9-16-15 flu (L) arm ZOSTAVAX - (R) arm. 9-18-15 pt. stated reaction started night she received the vaccine. 9-16-15 she came in for apt - c/o red rash to (R) arm see by dr.
-Patient received undiluted Pfizer Peds 5-11 Vaccine -Patient contacted and denies any s/s of adverse reaction at this time
Headache; muscle aches; fatigue; chills; 102.2 fever; This is a spontaneous report from a contactable healthcare professional (patient).  A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EJ1685), intramuscular on the left arm on 08Jan2021 08:15 at SINGLE DOSE for COVID-19 immunization at the hospital.  Medical history included hypertension (HBP).  Concomitant medications included irbesartan (IRBESARTAN), ibuprofen (ADVIL 12 HOUR), and sumatriptan succinate (SUMATRIPTAN SUCCINATE). On 08Jan2021 12:00, the patient had headache, muscle aches, fatigue, chills, and 102.2 fever and was recovering from these events. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. The patient did not receive any treatment for the events.
This spontaneous report was received from a pharmacist referring to an unspecified patients of unknown age and gender In September 2015 (reported as between 10-SEP-2015 and 18-SEP 2015), the patients were vaccinated with improperly stored doses of ZOSTAVAX (dose, frequency and route of vaccination were not reported, lot # L011533 with expiration date: 08-JUL-2015). No adverse effect reported. Additional information has been requested.
dizziness; throwing up; This is a spontaneous report from a contactable consumer or other non-health care professional reporting for her mother.  A 95-years old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 03Aug2020 09:30 as dose 2, single (at the age of 94-years) for COVID-19 immunisation. Medical history included COPD, Congestive Heart Failure, Pulmonary Problems, is on oxygen and asthmatic from an unknown date and unknown if ongoing. Other than that, she cannot think of everything else. She also has Neuropathy in legs. She had all prior to getting first dose. She has been with these conditions for years. She uses inhalers for respiratory problems. No further details provided. Historical vaccine included first dose of bnt162b2 (COMIRNATY, solution for injection, Lot Number: was not reported), via an unspecified route of administration, on an unspecified date as dose1, single for COVID-19 immunization. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No Prior Vaccinations within 4 weeks. Family Medical History Relevant to AE(s) was reported as None. The patient's concomitant medications were not reported. Other products reported as unknown. On 03Aug2021 01:00 the patient experienced dizziness, throwing up. Caller stated side effects began several hours after vaccination. She was not at her home and needs to find out what to do. Patient received her second dose today. First was three weeks ago on Thursday. Doctor said very little muscle but patient did get it in the muscle. The outcome of the events was not resolved.  Follow-up attempts are needed. Information on the lot/batch number is expected.
12x16CM area on rt thigh which was red, swollen & tender; Placed on Keflix QID 1 week; No significant past hx;
This spontaneous report as received from a nurse refers to an 11 years old patient (unknown gender). No concurrent condition, medical history or allergy/drug reactions were reported. On 01-APR-2015, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, dose number 1, lot # K004204, exp. date: 12-JAN-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Fever of 102 degrees for approximately 36 hours & then days later rash/welts on upper thigh (where vaccine was administered).
About 24 hours after the patient received the PNEUMOVAX vaccination, her left arm got swollen with red blotchy patches from the top of her shoulder down to her elbow. Patient applied cool compresses and hydrocortisone cream on the areas. The red patches and swelling subsided after doing this. She still had some residual itching after.
It seems this 12 yo male received a pediatric dose of Pfizer, which is an under dose for pt.  I did speak with pts mom last week and obtained basic info including copy of vac card,.  However, at that time was not sure an actual error occurred, so mom was not made aware at that time.  I have contacted pts mom x 2 today but have not received a call back at this time.  But when/if pts mom calls me back I will inform her of error.
pt presented w/pain & limitation of movement to rt arm for about 5 days p/vax;
This is a spontaneous report from a contactable Nurse via a Pfizer sales representative. A 16-year-old male patient received TRUMENBA and MENACTRA, both via an unspecified route of administration on 28Aug2018 at 12:30 pm at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient did not have any documented allergies. The patient experienced shivering on 28Aug2018 after use of the product, with no fever or any other symptom and within two hours, symptoms improved and symptoms were gone for the most part. The outcome of the event was recovering. Information on the batch number has been requested.
Patient had previously received the Janssen (J&J) vaccine on 3/31/2021.  This violates the guidelines for both vaccine parameters.
I had swollen in my left knee for about 5 days. I contacted my doctor about this. They did x-ray, normal results. I was diagnosed with gait.
site of vax became very firm,& skin very red over whole deltoid region starting 2 days p/vax;similar rxn w/another pt w/same lot# of DTP-Acel
The line "booster dose only" on the label is causing confusion.; Circumstance or information capable of leading to medication error; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT LABEL CONFUSION (The line "booster dose only" on the label is causing confusion.), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (No Adverse Event) in a 7-month-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT LABEL CONFUSION (The line "booster dose only" on the label is causing confusion.), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT LABEL CONFUSION (The line "booster dose only" on the label is causing confusion.), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for PRODUCT LABEL CONFUSION (The line "booster dose only" on the label is causing confusion.) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error).    Concomitant medication information was not reported.  Label was available on the vial/pre-filled syringe or cartoon but the line "booster dose only" on the label had caused confusion. The patient was not previously vaccinated and need to get the first dose of Moderna COVID-19 Vaccine, bivalent dose. The HCP was confused about which dose they should be administering and wanted to confirm. The HCP stated that both boxes which they had (including Dark Blue Cap and a Label with Gray Border as well as Dark Pink Cap and a Label with a Yellow Box) stated that it is for booster doses only. This labeling caused confusion. HCP did not have any lot numbers on hand.  No further investigation was recommended as no lot number was provided and consent to follow up was declined the reporter. Medical information provided the information to the provider along with the fact sheet for the vaccine.  Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Oct-2023: Significant follow-up received contains reporter details updated, added PQC report, narrative updated and patient details added.
adipose necrosis 1x1cm <less;pt exp dimpling in thigh p/vax;dimpling is a result of necrosis of fatty tissue;