chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Varicella - Information has been received from a medical assistant in a doctor's office concerning a 7 year old female who on 07 Apr 2000 was vaccinated with one dose of varicella virus vaccine live lot 632370/1462J site unknown.  On 24 Apr 2000 the patient developed chicken pox with an unknown amount of lesions.  The patient sought unspecified medical attention.  Also reported was a male sibling who was vaccinated and experienced similar events (waes 000423367)
Case number PHEH2014US003789, is an initial spontaneous report from a consumer received on 24 FEB 2014 and a follow up report from the nurse received on 26 FEB 2014. This report refers to a 12-year-old male patient. Past medical history and concomitant medications were not reported. He was inadvertently vaccinated with FLUCELVAX 2013/2014 (batch number: 010021A) intramuscularly on 27 DEC 2013. No adverse event was reported following the maladministration (inappropriate age of vaccine administration. Upon follow-up, the nurse confirmed the maladministration.  Follow up report from the nurse received on 26 FEB 2014: Nurse confirmation regarding the maladministration was updated in the narrative.   Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 26 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration " changed from listed to unlisted and added second indication as "adult product administered to child".
This patient's booster dose was administered too early. He received his second dose on 5/8/2021 and was given his booster dose on 10/14/2021. The patient was informed of this administration error and counseled to expect routine vaccine side effects and that the dose does not need to be repeated.
Earache, nausea x several days. One day after shot had pain in (R) hip. Unresolved & very uncomfortable at this time.
pt recvd vax; 2 wks later exp diffuse papular erythematous rash which was non pruritic; tx w/ pred x 10 days
Chills and fever, nausea, headache, muscle and joint pain, headache lasting 36 hours after injection
Died shortly after receiving second dose and contracting covid; Died shortly after receiving second dose and contracting covid; This is a spontaneous report from a non-contactable consumer. An adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on an unspecified date in 2021, dose 1 via an unspecified route of administration on an unspecified date, both single for COVID-19 immunisation. The patient's medical history was not reported. It was unknown whether the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether there was list of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed as COVID-19. On 17Nov2021, the patient died shortly after receiving second dose and contracting COVID on 17Nov2021. The outcome of event was fatal. It was unknown if the patient received treatment. Since the vaccination, it was unknown of the patient had been tested for COVID-19. It was not reported if an autopsy was performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: Died shortly after receiving second dose and contracting covid
Pain in arm same day and couldn't raise arm, Dr suggested going to ER and did and was given ibuprofen and is doing better.
Itching; redness; 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, lot/batch number and expiration date were unknown), via an unspecified route of administration on 09Jan2021 at a single dose for COVID-19 immunization. Medical history was reported as none. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior to vaccination. She has no known allergies. The patient's concomitant medications were not reported. No other vaccines in four weeks prior to COVID vaccine. No other medication in two weeks. On 10Jan2021, the patient experienced itching and redness. Benadryl was given as treatment for the events. The events resulted in emergency room/department or urgent care. The patient has not been tested for COVID post vaccination. The patient is recovering from the events.   Information on the lot/batch number has been requested.
3/25: Approx 5 mins after injection, started breathing quickly and became lightheaded. Moments later, heart rate elevated north of 190 bpm and blood pressure went up to approx 180/100. Developed dry mouth (was very thirsty) and shaking/chills. Took about 60 minutes to stabilize. Went to ER for evaluation and tests around 2:30P. Received a liter of fluid. Both EKG and Bloodwork was indicated as normal. Released from hospital around 6P. Slept through most of the night.   3/26: heart rate was erratic all day. Would race and then stabilize throughout the day/night. Extremely lethargic. No trouble breathing (was able to breathe and take deep breathes) but took effort to breathe.  3/27: 1:40A woke up heart began racing at close to 200 bpm. Dry mouth, shakes. Similar to what I experienced immediately following the vaccine shot. Went to ER out of precaution. Symptoms stabilized after about an hour. Hospital did EKG, blood work and chest X-ray. all were normal, lungs were clear. However, glucose and bilirubin were both slightly elevated.  3/29: Still feeling lethargic. Heart rate has stabilized some but is still erratic. It  easily increases from simply walking around the house (much more than usual).   3/30: Scheduled appointment with primary care physician 3/31: Scheduled appointment with cardialogist
Extreme pain with every bone and joint. My spine and pevic bone hurt.  Every inch of my skin hurt. I could differentiate the difference between body parts. Dizziness barely able to use the restroom without falling. The pain stated to lessen around 8:30 pm the next night. The weird part is the pain started to lessen in parts. For instance a section of my upper leg then a section of my forearm. I woke up around 7:30 am two days later after the injection with no pain. Exhausted.
This spontaneous report as received from a nurse refers to a 71 year old male patient. The medical history, concurrent conditions and concomitant medications were not reported. On 23-MAY-2017, the patient was vaccinated with PNEUMOVAX 23 lot # N001007 19-SEP-2018, N011491 04-NOV-2018, M047519, 08-APR-2018  for prophylaxis. On 23-MAY-2017(reported as within 24 hours), the patient experienced redness, pain and swelling in the entire arm. The nurse reported that the pain radiated to the patient's shoulder. The patient was instructed to take an unspecified over the counter pain reliever and to apply warm compresses to the arm. The nurse reported that the symptoms lasted at least 3days and it resolved. The nurse was unsure which patient received which vaccine. Lab tests was not performed. The outcome of the events were reported as recovered/resolved. The patient sought medical attention. Additional information has been requested.
Aches, lethargy, exhaustion, dazed feeling, headache   Tylenol and rest
blood cloth form groin to their ankle on their right leg; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood cloth form groin to their ankle on their right leg) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient did not have Acute and Chronic illnesses at the time of vaccination.  Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], ENALAPRIL, PRAVASTATIN, PANTOPRAZOLE SODIUM SESQUIHYDRATE (PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]), PANCREATIN (CREON), ALLOPURINOL and RIVAROXABAN (XARELTO) for an unknown indication.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (blood cloth form groin to their ankle on their right leg) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (blood cloth form groin to their ankle on their right leg) had not resolved.            Patient reported two months after getting their Second dose of the Moderna covid19 vaccine he got blood clot form groin to their ankle on their right leg. still there at the time of reporting, patient had been put on blood thinner for a year, and the blood cloth was still there, he don't know how he get it, because he was very active and takes aspirin everyday.  Patient also received the first booster on Nov2021, but could not provided date or lot number of the vaccine he took.  The patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine.  Patient never experienced a similar event in the past.  Company comment: This Spontaneous case concerns a 74-year-old, male patient, with no reported medical history, who experienced the unexpected, serious (Medically significant) AESI of thrombosis after administration of the second dose of mRNA-1273 vaccine. He consulted to the emergency department and is under blood thinners. No further clinical information was provided for medical reviewing. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This Spontaneous case concerns a 74-year-old, male patient, with no reported medical history, who experienced the unexpected, serious (Medically significant) AESI of thrombosis after administration of the second dose of mRNA-1273 vaccine. He consulted to the emergency department and is under blood thinners. No further clinical information was provided for medical reviewing. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Soreness, fatigue, difficulty breathing, mild chest discomfort when inhaling, increased heart rate.
Patient received an extra dose of the Pfizer Bivalent Booster. Her original Bivalent was given on 10/4/2022 but was not entered on her CDC card
DIED; This spontaneous report received from a consumer via social media from company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the reporter stated that, "I have a friend who was young, took the Johnson shot and died two weeks later" (Dose number in series 1). On an unspecified date, the patient died from unknown cause of death.  It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0 20220100327-COVID-19 VACCINE AD26.COV2.S-Died. 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).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
This spontaneous report was received from a registered nurse via medical assistant and refers to a 13-month-old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, past drugs and drug allergies were not reported. On 18-SEP-2017, the patient was vaccinated with improperly stored M-M-R II (lot # M034387; expiry date: 19-JUL-2018) (dosing details were not provided) for prophylaxis. Temperature excursion details of the vaccine were not provided. This is one of the several reports received from the same source. Sender's Comments: US-009507513-1709USA008861: US-009507513-1710USA013424: US-009507513-1710USA013470: US-009507513-1710USA013465: US-009507513-1710USA013440: US-009507513-1710USA013468: US-009507513-1710USA013442: US-009507513-1710USA013445: US-009507513-1710USA013460: US-009507513-1710USA013463: US-009507513-1710USA013464: US-009507513-1710USA013438: US-009507513-1710USA013439: US-009507513-1710USA013450: US-009507513-1710USA013430: US-009507513-1710USA013469: US-009507513-1710USA013467: US-009507513-1710USA013435: US-009507513-1710USA013434: US-009507513-1710USA013432: US-009507513-1710USA013428: US-009507513-1710USA013437: US-009507513-1710USA013441: US-009507513-1710USA013443: US-009507513-1710USA013444: US-009507513-1710USA013446: US-009507513-1710USA013447: US-009507513-1710USA013448: US-009507513-1710USA013436: US-009507513-1710USA013449: US-009507513-1710USA013451: US-009507513-1710USA013452: US-009507513-1710USA013454: US-009507513-1710USA013455: US-009507513-1710USA013456: US-009507513-1710USA013457: US-009507513-1710USA013458: US-009507513-1710USA013459: US-009507513-1710USA013461: US-009507513-1710USA013462: US-009507513-1710USA013466: US-009507513-1710USA013427: US-009507513-1710USA013471: US-009507513-1710USA013472: US-009507513-1710USA013473: US-009507513-1710USA013474: US-009507513-1710USA013475: US-009507513-1710USA013476: US-009507513-1710USA013425: US-009507513-1710USA013433: US-009507513-1710USA013423: US-009507513-1710USA013040: US-009507513-1710USA013426: US-009507513-1710USA013429: US-009507513-1710USA013431: US-009507513-1709USA008666: Original Case: 1709USA008666: US-009507513-1710USA014650: Original Case: 1710USA014649: US-009507513-1710USA014651: Original Case: 1710USA014649: US-009507513-1710USA014649: Original Case: 1710USA014649.
Confirmed Break Through Case COVID-19 (Pfizer) 1 01/21/2021 HealthCare Pfizer EL9261   COVID-19 (Pfizer) 2 02/11/2021 HealthCare Pfizer EM9810   COVID-19 (Pfizer) 3 10/19/2021 Pharmacy Pfizer 30155BA
pt recv vax;exp sciatic herpes and intermittent swollen lymph nodes in thigh, throat and neck;
Pt received the 4th Hib on 9/2/94 and within 24 hours, was having tremors all over his body and a fever of 104F. We rushed him to ER and he was examined extensively and sent home with no other symptoms; (viral/bacterial).
I (the doctor) was signed out to another doctor. Neither of us witnessed event. Mother and father are both medically knowledgeable (cardiovascular technicians). Mother sent us a typed report of her observations and I am faxing her observations of the event. Patient had three shots on 9/4/03 around 10:30am. She had her first dose of Tylenol at 11:30am. She seemed fine at home. She nursed at 1:30pm and then she fell asleep from 2pm to 4:30pm when she woke up she didn't seem quite like herself. Around 5pm she didn't seem as alert as usual and she seemed a little pale. I didn't think too much about it. Then at 5:20-5:30pm, my dad was holding her and she raised her lets up and made three groans like I never heard before and I knew something was wrong. I went to get her and she was extremely pale, she was clammy, and her head was wet. She didn't have a fever. She was lethargic and above her lip began to turn blue. She seemed as if she was ready to lose consciousness. I was afraid for her life and the thought did cross my mind that I was going to have to do CPR. I called the doctors office immediately. 10-15 minutes passed and she seemed to be coming around. I called the office back because no one returned my call. I did tell them at that point that she was coming around, but I still needed to talk to the Doctor on call. Doctor returned my call around 5:50-5:55pm. At this point, patient seemed like herself again and she nursed fine. By 6:30pm I gave her another dose of Tylenol, her coloring was back to normal and she was smiling again etc. I was told to watch her through the evening and call doctor back in the am. Patient was fine all evening and she seemed fine today 9/5/03 according to my husband and my parents. I called the office in the am and doctor thought it would be best to eliminate the pertussis vaccination. I will continue to watch her closely.
I got the shingles vaccine & had no adverse effects. Three days after getting the shot, I saw my 4-yr. old *granddaughter* (who kissed me on the cheek). Two days later, she had shingles.
PATIENT PASSED OUT. SHE LOST CONSCIOUSNESS. THOUGH HAD NORMAL PULSE AND BREATHING. BUT WE GAVE SOME COLD WATER AND JUICE FROM THE MOM, USED COLD ICE PACK ON THE FACE AND NECK AND WE LAY THE PATIENT DOWN IN A SUPINE POSITION, MAINTAINED AIRWAYS AND RAISED HER LEGS. WE CONTINUED TO CHECK PULSE AND BREATHING WHICH WAS NORMAL AND WE FANNED THE PATIENT SO SHE CAN GET SOME VENTILATION. SHE GOT REVIVED IN ABOUT 20-25MINUTES
received her first dose of Moderna on Friday, 3/26/21, around 1:30pm.  She reports onset of chills, muscle aches and "just didn't feel good" starting around 12:30am on Saturday, 3/27/21.  At approximately 12:00pm on 3/27/21 she reports sudden loss of hearing in her left ear along with dizziness.  She continued to feel poorly (nausea, vomiting, dizziness and dry heaves) along with the hearing loss through Sunday, 3/28/21.  She reports she saw Dr. (ENT) on Monday, 3/29/21 for the hearing loss and dizziness.  A hearing test was preformed and steroids were prescribed.  She reports seeing Dr. again for a follow up appointment on 4/12/21 with another hearing test.
15 minutes after admin. of vaccine she began to have tingling/itchiness in the face and scalp followd by hands. 24 hours later scalp still itchy and red and has only been controlled by BENADRYL. Told to see doctor if persists.
Headache, Sedation, Myalgia, Arthralgia, Fever, NauseaVomiting, Swollen lymph nodes, Pain/Swelling/Redness/Rash @ injection site Narrative:
Headaches; fever; swelling; hoarseness; weakness; racing heart; sepsis shock.
Body aches, vivid dreams, nauseous, warm sensation at neck and down shoulder ,  stiff neck , I felt like I had to poop but could not go,  my mouth had more salvia then normal
This spontaneous report as received from a registered pharmacist refers to an unspecified number of patients of unknown ages. The patients were vaccinated with a dose of AFLURIA (Lot # not reported) on an unspecified date. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on an unspecified date, the patients experienced injection site pain. The pharmacist stated that the pain went away approximately 1 and a half days after administration of the vaccine. The relatedness for injection site pain was unknown for AFLURIA. Follow-up information has been received from the registered pharmacist concerning one female patient in her 40's who in October 2012 was vaccinated with a dose of AFLURIA (Lot # not reported) and a dose of PNEUMOVAX23 (Lot # not reported). The patient developed tendonitis after vaccination in approximately October 2012 and recovered 3 weeks later. The relatedness for tendonitis was unknown for AFLURIA and PNEUMOVAX23. This is one of several reports received from the same source. Additional information has been requested.
A few hours after receiving vaccine, she noted a firm red "bump" around the injection site.  Bump was slightly tender to palpation.  Felt itchy by the center.  A few days later indurated area is wider but not as firm or red.  Arm also felt "heavy."  Still had full mobility and strength to arm and shoulder.
19MAR97 pt devel fluid in the lungs;SEP97 exp signs of depression;pt also exp pain in lungs & muscle cramps;also exp two episodes of pneumonia;became manic;dx bipolar disorder;dx asthma;
Patient came to the pharmacy to have her flu shot but mistakenly pharmacist gave her  Covid19 Pfizer shot. Patient stats that she already completed her 2 Covid Moderna series at another pharmacy.
The patient's upper arm got all swollen on the side where she got the vaccine. She said it "swelled up to the size of her thigh". It was sore to the touch and had limited range of motion. She was instructed to watch it, and if it looked like the swelling was getting worse, or if she had fevers, to go see a doctor.  She started feeling worse, and had fevers up to 103 degrees. She went in to the Dr, and was not given an antibiotic, for they felt it was just a strong response to the vaccine. BENADRYL was prescribed, and helped to decrease the swelling and reaction. At the time she saw the MD, the injection site swelling was the size of a baseball, and they marked it with a pen. It didn't get worse, and today when she came to tell me about this, the site looked much better, and was not raised, nor fevered.
Coughing, running nose, sore throat, diarrhea, body aches, loss of voice.
About 6 papulovesicular lesions noted over 3 wks from the varicella shot, on scalp, trunk, and feet.
Initial unsolicited report received from a nurse on 21 December 2015. This case is linked to case id: 2015SA176376, 2015SA176377, 2015SA172486. This case involves a (age and gender unknown) patient who was vaccinated with a dose of FLUZONE) (batch number, expiry date was not reported) intramuscularly in left deltoid and also received PNEUMOVAX 23 (batch number L003188, expiry date 06 July 2016, route and site administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, following the vaccination patient experienced adverse reaction. Laboratory investigation and corrective treatment were not reported. The outcome of event was not reported. List of documents held by sender: none.
I developed acute onset hyperglycemia. On 11/21/21 I was diagnosed with type II diabetes with a fasting glucose of 369 and HbA1C of 9.9.  Subsequently I have also developed acute onset neuropathy of unknown etiology. Neuropathy has continued to worsen over the last year resulting in significant weakness that involve bilateral lower legs and arms resulting in difficulty with work.
3in. diameter red warm raised welt at injection site, extremely painful, lasted 6 days and site is still slightly painful.
dose 1 of Twinrix for 2nd dose was administered Engerix-B instead of Twinrix; This case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a patient who received HBV (Engerix B) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX VACCINE).   On 14th December 2021, the patient received Engerix B. On 14th December 2021, unknown after receiving Engerix B, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient received an Engerix-B instead of 2nd dose of Twinrix which led to wrong vaccine administered.  Reporter stated that the date of the Twinrix administration would had been at least a month ago and did not received 2nd dose of Twinrix till the date of reporting.  Reporter called on behalf of another pharmacist and did not had patient information, date of the Twinrix administration, or lot number /expiration date.  The pharmacist did not have lot number/expiration date of Engerix-B. The reporter consented to follow up. Note: Incomplete course of vaccination was not coded for twinrix 2nd dose as it could be given after 7-day post 1 months as per deviation.