chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shortly after getting the HPV shot (about 5-8 minutes), my daughter said the pictures on the wall looked strange and then she said she felt dizzy.  We walked her into a nearby patient room.  The nurse had her lay down.  My daughter's skin on her face turned a green color.  The nurse put a wash cloth on her forehead and had her lay still for a short while.  They then asked if we had any food to give her and I think I gave her a granola bar or apple to eat.  Within just a few minutes, the green color went away.  The nurse had her sit up and start eating and my daughter said she was feeling better. We then went to the waiting room and sat there for another 15 minutes to ensure my daughter was fine.  The nurse asked when the last time was that my daughter had eaten and it had been about 4-5 hours.  They then told me that with the HPV vaccine it is wise to eat a little bit before coming for the vaccine.  So, for the third dose of the HPV vaccine (on 5/21/11), my daughter ate a banana just before we arrived at the doctor's office and she was just fine and had no reaction.  I just wish that the doctor's office had informed me of this (to eat before the HPV vaccine) prior to my daughter getting the HPV vaccine in the first place. (My daughter has never had any reactions to any other vaccines before or since and she has received every vaccine available and a flu shot every year).
Pt. called 9/16/13 to clinic. Complained of (R) upper arm swelling and redness beginning 9/13/13, worse 9/14/13. Per pt 9/16/13 less redness but still a bit swollen and itchy. 99.5 temp on 9/13/13.
Screaming crying 2 hours after immunizations given.  Mother unable to soothe.  The crying lasted 2 hours and after that she was very fussy and would cry off and on.  The next day no crying or fussiness noted.
Patient reports swelling, redness, and itching in area near where the immunization was administered. The adverse reaction began 6 days after the immunization, prior to the patient said the area was sore.
One week after the vaccine the arm was very red and looked infected. He went to the doctor and was given Amoxicillin. But two days later he was feeling so ill he was in bed all day and had a horrible headache. He went back to the doctor 3-26. The doctor cut his arm open, drained it, flushed it and gave him an antibiotic shot in the rear end. He also prescribed Doxycycline and Linezolid because he believes its a MRSA infection. He did swab it but we don't have the results back yet. The wound is not as red today and my husband is feeling better. Should he get the second vaccine? the doctor said this was the second patient he saw that day with the same infection at the vaccine site. I received my vaccine the same time and had zero issues. The doctor thought maybe his arm was not sufficiently alcohol swabbed but I know he was swabbed as was I as we were in the same room. He has severe asthma so we wanted the protection from the Covid vaccine but want to know if it is safe to get the second vaccine? I have taken photos each day so I can share what his arm has looked like
Patient received Tdap on 8-16-2018 MCIR records when combined showed Tdap given at PCP on7/8/2015 and was UTD - did not need dose received in LHD.
Patient received his second covid dose (Moderna) 22 days from the first dose (Pfizer).
This spontaneous report was received from a medical assistant referring to a 13 month old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was reported. On 21-SEP-2016, the patients received improperly stored dose of VARIVAX injection, lot # M009768, expiration date: 23-FEB-2018 (dose, route of administration and anatomical location were not reported). It was reported that the administered dose of VARIVAX was improperly stored at -3.5 degrees Celsius (C) for 1 hour and 6 minutes on 29-AUG-2016. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments:  US-009507513-1610USA011133:
pt recvd vax 10NOV93; pt devel a Kawasaki-like synd that resulted in hospitalization, was felt to be life threatening; exp soreness, condition persisted;
stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criteria medically significant and life threatening). At the time of the report, CEREBROVASCULAR ACCIDENT (stroke) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported. No Treatment medication reported. He received the vaccination series from the Moderna COVID-19 vaccine and a month and, a half later, he had a stroke.  Company comment- Very limited information regarding this event has been provided at this time. No further follow-up information is expected.; Sender's Comments: Very limited information regarding this event has been provided at this time. No further follow-up information is expected.
Information has been received from a physician referring to multiple unspecified numbers of patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant therapy were not reported. From January 2016, an unspecified number of patients were vaccinated with an improperly stored dose of ROTATEQ (lot#, expiration date, dosage, frequency and route were not reported) for prophylaxis. No adverse effect reported. The vaccine was stored at unspecified high or low temperature excursions from January 2016. The reporter stated that one refrigerator experienced 2041 excursions and another experienced 230 excursions during this timeframe. There has previous temperature excursion. Data logger was involved. No product quality complaint was involved. No further information was provided. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA008490: US-009507513-1709USA004627: US-009507513-1709USA004633: US-009507513-1709USA004630: US-009507513-1709USA004631: US-009507513-1709USA004632: US-009507513-1709USA004629.
Pt vaccinated with MMR/HBCV developed seizure - MD felt the seizure was due to a high fever caused by a viral infection.
I was 4 weeks and 3 days pregnant at time of Covid Vaccination. On Saturday 4/10 I began to spot lightly, and  called my doctor on Monday morning, who recommended I come in for a blood test. I received a beta HCG blood pregnancy test Monday 4/12 and Wednesday 4/14. On Wednesday 4/14, I miscarried at 6pm.
Headache, dizziness, fatigue; Headache, dizziness, fatigue; Headache, dizziness, fatigue; This is a spontaneous report from a contactable physician.  A 50-years-old female patient  received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE): EJ1685, via an unspecified route of administration, in left arm on 18Dec2020 at 1845 (at the age of 50-years-old) as a single dose for COVID-19 immunization.  Medical history included asthma and an allergy to penicillin. Concomitant medications were not reported.  The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The  patient experienced headache, dizziness, fatigue on 19Dec2020 at 19:00. The patient was not treated for the events. The outcome of the events was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Shingles / Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Vaccination failure/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 22-JUL-2023 This case was reported by a patient via interactive digital media. The patient had the shots and had shingles right now. This case was considered as suspected vaccination failure as details regarding complete vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Rash at injection site that spread over upper arm. After two days (14th-16th April) has continued to spread.
I received the vaccine at noon on October 4th 2021, by 3pm I was sweaty and started to feel yucky.  By bedtime that day I was having muscle aches all over my body and my injection site and the arm pit of that arm felt swollen and painful.  I was in terrible pain all night and couldn't work the next day.  Tylenol did not help.  I felt alternatively hot and then cold.  I felt too ill to work until Friday the 8th, and I still didn't feel well but was able to work all day Friday.  It is now October 11th and I still have a headache and periods through out the day when I am covered in sweat and feel feverish.
There was excursion from the freezer; There was an excursion from their freezer/they were administered to 118 patients.; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (There was an excursion from their freezer/they were administered to 118 patients.) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (There was an excursion from their freezer/they were administered to 118 patients.). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (There was an excursion from their freezer/they were administered to 118 patients.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.
4 vesicular bumps on lateral right thigh, crusting over after about 1 week. Concurrent upper respiratory infection.
Patient experienced chest pain, dizziness, back pain and sweating.  Very pale and jittery.   told  she was unable to walk.  ER physician on site at clinic and brought Patient to the ER.    BP 140/90, Pulse Ox 98%, HR 64.    Upon interview with Patient she did not stay in the ED long due to increased anxiety and she felt like she as having a panic attack.  She said she was put into a small room, many people surrounded her, was sitting on a stretcher.  She said she had to leave and she went back up to her unit to see her supervisor where she had a panic attack.  Physical symptoms did subside.  Patient started with COVID symptoms on Saturday and was diagnosed on 1/11/22 with COVID.
#1 Anthrax- Fatigue, chills, subjective fever for 5 days, local nodule. #2 Anthrax- Local nodule only. #3 Anthrax- Large local reaction with approximately 10 cm erythema.
Fever, red eyes, lethargy, leg pain, face swollen. Received vaccines 8-5-13. Onset of symptoms 8-31-13. She went to medical office on 9-03-13. Symptoms lasted 6 days according to mom.
Received H1N1 vaccine on 11-7-09, L arm 0.5 ml-when removed band-aid on 11-9-09 noted approx 5mm blister at injection site (filled with fluid) which was mid posterior left arm. Was seen by PP-advised not to break blister, site dressed by P.P., to follow-up if any further problems.
heart palpitations; dying because of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart palpitations) and FEELING ABNORMAL (dying because of the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     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 PALPITATIONS (heart palpitations) and FEELING ABNORMAL (dying because of the vaccine). At the time of the report, PALPITATIONS (heart palpitations) and FEELING ABNORMAL (dying because of the vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: (abnormal) Abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported. Treatment information was not reported.
I began coughing 2 days after the 2nd dose of the covid-19 Pfizer vaccine. It is a constant cough that has not gone away in 6 months and it began 2 days after the 2nd dose . Sometimes it causes me to throw up due to the excessive coughing fits
Patient had hematuria and bilateral thigh pain for 2 days that started on the day the vaccine was given.
Case number PHEH2016US023344, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 45 years old patient of unknown gender. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml, intramuscularly, in left arm on 12 Jan 2016. On 12 Jan 2016, FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursions was administered to patient. The nurse stated that, no adverse event was reported following this administration error.
A large, painful, red area around the injection site showed up 8 days after the vaccine. It is hot to the touch.
Given 2 Doses of Heplisav-B; Initial Report Received on 03-Nov-2021  A nurse reported that a 60 year-old male (race and ethnicity not provided) was accidentally given two doses of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 03-Nov-2021, the patient received two doses of HEPLISAV-B (Lot # 934973, expiration date 24-Jul-2022m NDC # 43528-003-05 and serial number 492972497336.). One injection was given in the right deltoid and the other injection was given in the left deltoid. It was reported that this error happened when trying to give HEPLISAV-B with the adjuvant and another vaccine with recombinant, hence the reason for the double dose of HEPLISAV-B.   No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
On 03/18/2I, was having a real sore throat. I went into an emergency room on 03/18/2023. I was diagnosed with a strep throat.  The treatment antibiotics, Cephalexin. I have recovered.
My monthly menstruation came early. This month after my second vaccine I had severe painful cramps and a heavy flow with clots not a normal period for me.
Initial misuse report received from a healthcare professional on 19 JUNE 2013. It was reported that a 16-year-old male patient was given a dose of ADACEL on 17 JUNE (year not specified) and he had also received a dose of TDap on 04 APRIL 2012. No adverse event was reported. Documents held by sender: none.
shingles breakout each year/may had shingles after  1st dose also; This case was reported by a consumer and described the occurrence of shingles in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (In the past 20 years, the patient had a shingles breakout each year).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.   Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. In the past 20 years the patient had a shingles breakout each year so in the 1st dose of Shingrix also may have shingles breakout. This is 1 of 3 case reported by same reporter. Permission to follow up was denied.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR203694:Same patient, possible breakout 2020 post-1st dose
Severe stiffness in arm muscle, extending from shoulder down below elbow of right arm and associated pain. Complete spasm as lumping of area, lasted weeks.
Pt received Pfizer injection IM in Right Arm on 8/16. Pt came back on 8/18 with swelling in the lymph nodes under the right arm, with stiffness and discomfort in the right arm. Pt was advised that this may sometimes occur, but infrequently. Pt advised to take Ibuprofen or Naproxen OTC, and to see his Dr. if he has additional concerns.
Fever approx. 102' F. (Acetominophen given.) Vomiting two times.  Next day and for at least 5 days after, FIVE Large DARK PINK SPOTS approximately 2" diameter:  1 on each side of one (right?) elbow, 1 on back, 1 on lower torso front, 1 on thigh.  Not itchy, no liquid discharge or scaling, a little bit raised and marbled-looking. Recovery from  fever and nausea within 48 hours, so no doctor visit when workweek began again. Spots shrunk and "dried up" more pale over 5-10 days.  Patient was currently on very long course (11th week) of  Omnicef antiobiotic for massive sinus infection diagnosed June 20, 2003.  Sister (separate report) of 17 months had very similar reaction.
admitted to hospital 10/8/21 with covid. had fever, respiratory and GI symptoms
Information has been received from a registered nurse concerning a 5 year old female who was vaccinated subcutaneously with the second dose of varicella virus vaccine live (Oka/Merck) (lot#658373/1116U). Concomitant therapy included measles-mumps-rubella vaccine (MSD) and diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid. Subsequently the patient developed a red, warm, raised and swollen area at the injection site. The patient's mother had contacted the physician's office to report this event. This is one of several reports from the same source. Additional information has been requested.
Information has been received from a 60 year old female with high cholesterol, asthma and a sulfa allergy. The patient reported that she experienced chickenpox as an adult and the virus stays moment in her left ear. At the end of January or beginning of February 2008, the patient was vaccinated with zoster vaccine live (Oka/Merck). Concomitant therapy included atorvastatin calcium (LIPITOR) and levothyroxine Na (SYNTHROID). The patient reported on 22-MAY-2008 that she currently had shingles on her torso. The patient's shingles persisted. The patient sought unspecified medical attention. Additional information has been requested. This is in follow-up to report(s) previously submitted on 6/24/2008.  Information has been received from a 60 year old female with high cholesterol, asthma and a sulfa allergy.  The patient reported that she experienced chickenpox as an adult and the virus stays dorment in her left ear.  At the end of January or beginning of February 2008.  The patient was vaccinated with ZOSTAVAX (Merck).  Concomitant therapy included LIPITOR and SYNTHROID.  The patient reported on 22-MAY-2008 that she currently had shingles on her torso.  The patient's shingles persisted.  The patient sought unspecified medical attention.  Additional information has been requested.
pt states went to ER w/severe pain, swelling of rt upper arm;t102;pt given percocet for pain;Clinoril;pred also given sling for the arm & advised not to work until 19SEP97;pt exp pain, induration, erythema, ecchymosis;
Started to feel strange about 10 minutes after the vaccine. Dizziness, disoriented, foggy, high blood pressure that lasted about 11hrs. Monitored BP and then sent home to rest and checked blood pressure through out the day.  Body aches, chills, fatigue, headache the next day.
no additional AE reported; a 5 year old patient was administered GARDASIL 9; Spontaneous information has been received from a nurse referring to 5-year-old patient of unknown gender. Information regarding the patient's medical history, concurrent conditions, concomitant therapies and drug allergies or reactions were not provided.   On 01-MAR-2022, the patient received HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 mL (route, indication, were not provided; which had a lot # 1687293, expiration date: 30-APR-2023) (formulation,route of administration, vaccination scheme frequency and anatomical location were not reported) for prophylaxis. It was reported that the patient had not had any side effects associated with the administration. No additional adverse event reported.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 09-SEP-2009, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance and for the long-term prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 25-SEP-2016, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
I'm not sure if related still would like to report complications to CDC. On Wed May 26 I had episode of bleeding during night around 2am. I went to the ER me and the baby was monitored for 24 hrs. Since I had no additional bleeding sent home. On Fri June 4 had the same episode went to the ER I was 37 weeks my doctor decided to induce my labor. I delivered, baby was healthy then I started hemorrhaging. I got to a stage 3 hemorrhaging became more got different shots. I lost  a couple liters of blood now I'm doing fine now.
This spontaneous report was received from a medical assistant and refers to a 14 year old patient (gender unknown). No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On 14-SEP-2018, the patient was vaccinated with a dose of PROQUAD lot#R011802, expiration date 21-OCT-2019 (dose, route of administration were not reported) for prophylaxis. Other suspect therapies included sterile diluent (manufacturer unknown) (dose, route of administration, lot# and expiration date were not reported). No adverse effects were reported.