chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 23-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 19 years old male patient who received 0.5 mL dose of vaccine IMOVAX RABIES lot M13911M, expiry date: 24-Jul-2018 via intramuscular route in the right deltoid on 23-Oct-2018. It was actual medication error due to Expired vaccine used. It was reported that administering expired Imovax to patient. No reaction reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
sporadic flushing of the face and neck Increased flushing of the face and neck with wine/champagne
severe pain all over;bad head ache;fever 102 lasted for two days day three felt much better
After I received my shot I was waiting  the required 15 minutes when my throat became scratchy, thinking nothing about I left and while driving I notice I was having trouble swallowing and my mouth was dry. However, I could breathe easily so I just remained to relax and slowly swallowing my salia over and over again. Once home took a benedryl and was able to drink water without any problems. My throat is still somewhat scratchy after 2 hours.
This case was reported by a healthcare professional and described the occurrence of pruritic papular rash in a 65-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). The subject's medical history included allergy to morphine. Concurrent medical conditions included gastroesophageal reflux disease, high blood pressure, high cholesterol. Previous and/or concurrent vaccination included DECAVAC; Sanofi; unknown; left arm given on 28 February 2008. Concurrent medications included Atenolol, LIPITOR and PROTONIX. On 28 February 2008 the subject received 1st dose of HAVRIX (1 ml, intramuscular, left deltoid). On 9 March 2008, 10 days after vaccination with HAVRIX, the subject experienced pruritic papular rash. The subject received HAVRIX and DECAVAC injections one inch apart in the same arm. The subject was treated with BENADRYL. At the time of reporting, the injection site reaction was improved. The healthcare professional considered the injection site reaction as probably related to vaccination with HAVRIX since this was his first hepatitis A vaccine and the injection had never experienced a reaction with the tetanus vaccine. Follow-up information was received on 21 April 2008, via nurse, who reported the injection site reaction resolved on 13 March 2008. The reporting nurse considered the event possibly related to vaccination with HAVRIX.
This spontaneous report as received from a medical assistant refers to a 45 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 31-MAR-2016, the patient was vaccinated with an improperly stored dose of M-M-R II lot # L007216, expiration date: 03-MAR-2017 (exact dose, route of administration and therapy type were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Fever starting @ 8pm and vomiting, the next day in the morning his face was swollen. The facial swelling was improving within 24 hours. Child was "limp" for the first 12 hours of "reaction", but slowly improved each day.
Approx 24 hours after receiving the vaccine on I experienced joint pain that was not associated with the injection site. Within 48 hours I experienced flu-like symptoms (body aches, low grade fever of 100.1, chills) and then overnight experienced sweats . Woke up the following morning feeling better and now, 72 hours after receiving the vaccine, I am no longer experiencing any side effects.
The patient received Moderna COVID vaccine on 3/25/2021 at a different facility, then she received Pfizer COVID vaccine from our facility on 4/21/2021. The patient is not experiencing any side effects and feels normal. Recommeneded that she not receive any further covid vaccines since it has been ~28 days from her first vaccine and she received another mRNA covid vaccine (Pfizer). CDC suggests that she not receive any other COVID vaccines or the 2nd dose of Moderna or Pfizer at this time.
pt recvd vax & exp itching; tx w/ prednisone & hydroxyzine;
Shortness of breath, cough, chest tightness, dizziness, weakness,  shaky, took Benadryl and had took took take time off of work. The symptoms lasted for two weeks before relief began.
By 8:30pm on 01/15 (the day she received the vaccine) client experienced nausea, headache, localized swelling and redness at the site of the injection in her left arm. States that the site of the injection  "It looked like it had been punched."  Took Benadryl on the night of the 15th and slept until 10:30am on the 16th. She woke up with chills, headache, fatigue and nausea. Slept most of the day. Reports that she "took half a Vicodin. I am not sure how much I was prescribed." States this took away headache and the "horrible feeling." By the night of the 17th the nausea, headache, fatigue, disappeared but there was redness at the injection site. Redness gone by the 20th. Continues to have itching at the site.
Headache, Fever, Chills, Loss of Smell, diminished taste, Nausea & Vomiting, Diarrhea
Received Covid vaccination/injection in right arm on 2/2/21. For the 1st four days, had occasional heart palpitations that lasted first 4 days then stopped--heart returned to normal with no more episodes. On 2/4/21, that night when I went to bed, I noticed a ringing in my left ear that became louder & louder as the next several days went by.  I then noticed substantial hearing loss in my left ear.  Also 2 days later, I started having a dull ache around my left ear along with the loud, high pitched ringing. I kept thinking it would get better but a week before my next vaccine, I called my ENT  who monitors a small lesion & hearing in my left middle ear.  I already had slight conductive hearing loss from this lesion and my last appointment/check up with her was in September 2020.  Dr. had me come to the hospital on 3/11/21 and a hearing test was performed and my left ear hearing had declined 15 decibels since my last hearing test in Sept 2020.  I was prescribed a Medrol Pak (steroids) for 1 week and returned on 3/23 for a 2nd hearing test with no improvement in my hearing or the loud ringing (tinnitus).  The Dr. told me that my hearing test showed damage to the left ear nerve.  I had also developed an inflamed, painful large sore under the left side of my tongue & was prescribed Triamcinolone Acetonide Dental Paste to use 2 x daily on the sore.  The Dr. ordered an MRI of my brain & left ear to make sure the lesion in my ear had not grown.  I had the MRI on 3/29/21 and returned to my Dr. on 3/30/21 for results.  The lesion was stable, no growth.  I made my own decision and did not return for my 2nd Covid vaccine because it appears the 1st vaccine either inflamed the nerve in my ear or caused an auto immune response.
The morning after Mom's first dose of the Pfizer shot, Dad woke up and found Mom lying on the floor next to the bed.  Mom said, "I can't move my arm." Dad called paramedics who checked her.  They said her vital signs were normal and left.  On 2/9/21 in the morning my da awoke to see that Mom had large amounts of bubbly saliva pouring from her mouth onto her pillow.  Dad called paramedics, who said this was a diabetic reaction.  Mom had NEVER had anything happen like this before.  Mom was very sleepy, could not be aroused, and made only gurgling noises.  She was admitted to the hospital for care and therapy.  She pulled her own IV out.  Mom had to be restrained in the hospital and sedated, due to confusion and worsening dementia.  By 2/18 when we spoke by phone mom's speech was abnormally slow and very repetitive.  "I'm very tired today" was spoken many times.  In morning time mom was able to follow basic conversation.  Not so later in the day.  Mom came home from rehab on 2/26/21.  She was able to walk steadily and independently at home after her therapy.  After a week or so, Mom began hitting the in-home caregiver.  Dad's presence would calm her.  In a short time Mom seemed not to know dad anymore, and would hit him and the caregiver when they helped her.  She also pulled all covers off the bed and pulled clothes out of the closet, throwing them all over the room during the night.  Mom was usually walking around the house during each night.  On 4/16/21 Mom and dad were napping sitting up on the couch in the morning.  Mom fell forward and hit her head on the hearth.  Dad and caregiver gave first aid and called paramedics, who took her to the ER.  Mom came home on 4/17/21.  On 4/18/21 Mom pulled her catheter out in the early morning.  In the afternoon Mom's appearance was concerning, so Dad called paramedics.  They said that Mom's BP had dropped very low and took her to the ER. Mom was combative the next day in the hospital.  Dr. adjusted her medications periodically to ensure that mom's care would be manageable when she would eventually be sent home.  Minimal therapy was done due to dementia.  By 5/3/21 doctor said that Mom is bed bound and needing total care.  Her blood sugar spiked high despite special diet.  Staff waiting for insulin order from doctor.  5/4/21 Doctor called Dad to say that Mom had died during the night.
Rash appeared to upper neck (posterior) with two vesicle type appearances <10 minutes after vaccine administration. Instructed mother to use calamine lotion to area, give Benadryl if needed, and to report any further symptoms.
Information has been received from a physician concerning a 13 week old (reported as "14 weeks of age") female and her twin (WAES# 0802USA01252) who on 19-NOV-2007 was vaccinated with her first dose of ROTATEQ. The patient was not experiencing any known symptoms. There was no product quality complaint. This is one of several reports from the same source. Additional information has been requested.
On July 1, 2021, I felt chest pain around 6pm. 10 times, each lasting 1 second.  My heart rate was 95, higher than my normal 75. On July 2, 2021, I felt chest pain 3 times around midnight, 2 times around 2am, 2 times around 7am, 1 time around 9:30am. The above chest pain each lasting 1 second.  But at 6:10pm I felt chest pain once, lasting 2 seconds and more dull than previous ones. I have never had any chest pain before the Pfizer covid vaccine. I called my pediatrician's office in the evening of July 1 and was told to rest and observe. I saw my pediatrician  at 10:30am on July 2. My blood pressure is normal and heart rate is above 90. My doctor told me it was obvious the side effects of covid vaccine.
Patient describes an intense itching around injection site that started one day after she received the vaccine. There is no swelling, rash or redness. She reports the itching getting worse and its local to the injection site. It is not spreading.
2 days after immunization pt. developed rash, vomiting and diarrhea. Was seen in ED. F/U with PCP in clinic the following day (3 days after shots).
Pt. c/o soreness (R) arm, numbness and tingling "down to finger-Headache began within hours has gradually gotten worse-On 10-11-07 began having nausea/vomiting-had to leave school-Advised see MD. 10/15/07-Flu with mother-did not see Dr. states found out 2 people client was with over weekend had headache, MV also-mother now feels she had "a bug"
Red itchy few hours after injection. Increased red area (HA, muscle aches see 48 hours later - cellulitis & adverse reaction injection.
Pt became syncopal and appeared non responsive with pulse (60's) and BP 100/80. Diaphoretic. Pale. Episode lasted  Approx 1-2 minutes. Pt and husband stating "we should have told you she does this when she gets around needles."  She was able to walk on  her own out of the pharmacy. Telephone call later to Pt, "I'm much better and  thank you for calling."
On the evening that the vaccine was given, pt became "itchy" and was covered with hives on arms, legs and face. Mother gave him Benadryl around the clock for following 2 Days. Also had a couple of episodes of vomiting 2 days after the vaccine. Then recovered.
Wife called and complained about patient having headache, severe muscle pain, nausea, because of pain patient cannot move. Right now patient is admitted in hospital.
He had a ball in the left plantar arch; Pain was so great that he cannot work/had been intensifying, particularly after the second dose; Patient began to have pain in the plantar arch; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Pain was so great that he cannot work/had been intensifying, particularly after the second dose), PLANTAR FASCIITIS (Patient began to have pain in the plantar arch) and PLANTAR FASCIAL FIBROMATOSIS (He had a ball in the left plantar arch) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included INSULIN for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced PAIN IN EXTREMITY (Pain was so great that he cannot work/had been intensifying, particularly after the second dose) and PLANTAR FASCIITIS (Patient began to have pain in the plantar arch). On an unknown date, the patient experienced PLANTAR FASCIAL FIBROMATOSIS (He had a ball in the left plantar arch). The patient was treated with NAPROXEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain was so great that he cannot work/had been intensifying, particularly after the second dose) and PLANTAR FASCIITIS (Patient began to have pain in the plantar arch) had not resolved and PLANTAR FASCIAL FIBROMATOSIS (He had a ball in the left plantar arch) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: normal (normal) found nothing.         Treatment medication included Naproxen.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-101860 (Patient Link).
Fever. X 2 days  ( 101.0 to 101.9), body aches, headache on and off for a week, recurrent nausea. Leg weakness of day 3, legs giving up while standing. Generalized  weakness noticed after 2 weeks when resuming  weight training and new shortness of breath when going to private residence second floo
Circumstance or information capable of leading to medication error; No adverse event; This spontaneous case was reported by a patient family member or friend and describes the occurrence of 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 male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     Concurrent medical conditions included Immunocompromised.    In 2022, 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 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, 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 assessment was provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error).    No concomitant medications were reported. It was reported that reporter's Husband was immunocompromised and was wondering how often in between they should wait before having another booster for the 7th booster dose.  Caller's husband (patient) got the first Bivalent 6 months ago today until it's been a year. Patient was on an immunosuppressive medications and high risk. Agent asked for vaccination records, but patient only wanted to provide that their Bivalent booster dose was administered 6 months ago from today 21Mar2023. AE submitted in case doses were provided contrary to authorized vaccine schedule. Caller ended the call. Further AE information could not be collected.  No treatment medications were reported.   Reporter did not allow further contact
Fatigue, weakness hoarseness over pass over past 6 days since Tdap vaccine.
Fever and Rash-(torso and back) approx 10 days after MMR vaccine given
Pt. was administered Hep A in (RD) - approx. 2-3 minutes later - nurse was called to waiting room by pt.'s friend "that she didn't feel - well". Nurse arrived in waiting room pt fainted was lifted from chair to floor - pt. was not responsive for approx. 2-3 seconds awaken oriented x3 - appeared skin pale B/P 70/50 - P-58 - R-20 - observed for approx 45 min B/P remained low with c/o dizziness transferred by ambulance to ER for evaluation.
fever, chills, muscle pain, joint pain, malaise, sweat, loss of appetite, severe chest pain, shortness of breath, headache, drowsiness and slept all day. Severe symptoms and bedridden for 4 days.  Brain fog for a month. Took tylenol on day 3.
w/in 5 min p/vax pt became faint & had swelling & hives but no difficulty breathing; DPH IM was administered; pt recovered; pt had bronchitis 1 wk prior to immun;
UNCONTROLLABLE SCREAMING AND CRYING IN EXCESS OF THREE HOURS, COULD NOT CONSOLE INFANT WOULD NOT EAT, TEMP 101.4
Hospitalized 12/20/2021; COVID-19 positive 12/20/2021; fully vaccinated  BRIEF OVERVIEW: Discharge Provider: MD Primary Care Provider at Discharge: PA  Admission Date: 12/20/2021 Discharge Date: 12/27/2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Hypokalemia [E87.6] Hypoxia [R09.02] Pneumonia due to COVID-19 virus [U07.1, J12.82] COVID-19 [U07.1]   HOSPITAL COURSE:   The patient is a 58 y.o. female  who presented to hospital emergency department with worsening cough and shortness of breath and hypoxia. patient stated that symptoms started a week before last on Friday approximately 10 days ago with cough shortness of breath increasing dyspnea.  On Wednesday last week she called her pulmonologist who placed her on a Medrol Dosepak.  Over the next several days patient's cough on Friday 72 hours before arrival to the hospital she had increasing coughing severe paroxysms both Friday and Saturday and then yesterday on Sunday he improved slightly.  She complained of a dry hacking cough she had intermittent fevers and chills mostly always at noon she would have a fever take Tylenol or Motrin and would improve easily.  Patient also complains of body aches she did not lose taste or smell. She was tested positive for COVID 19.  Patient was treated with solumedrol due to reported decadron allergy. Over the next few days there was little improvement. She was started on Duonebs and inhaled steroids.  Macrocytic anemia being treated with B12 and folic acid.  The patient remained stable on 4L O2 via NC @ rest.   Her longstanding chronic obstructive pulmonary disease with multiple exacerbations complicated course. She was unable to be completely weaned off of O2 .  She was evaluated by RT for home oxygen and was found to require 2 L at rest and 3 L during ambulation. Patient was discharged home on supplemental O2 and medrol dose pack.
acuate shortnee of breath; weak and feeble/turned into a skeleton; cannot perform daily activities smoothly; suffering badly; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (acuate shortnee of breath), ASTHENIA (weak and feeble/turned into a skeleton), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (cannot perform daily activities smoothly) and EMOTIONAL DISTRESS (suffering badly) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No reported medical history.  Concomitant products included METFORMIN.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (acuate shortnee of breath) (seriousness criterion hospitalization), ASTHENIA (weak and feeble/turned into a skeleton) (seriousness criterion medically significant), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (cannot perform daily activities smoothly) (seriousness criterion medically significant) and EMOTIONAL DISTRESS (suffering badly) (seriousness criterion medically significant). The patient was hospitalized from 13-Apr-2021 to 17-Apr-2021 due to DYSPNOEA. At the time of the report, DYSPNOEA (acuate shortnee of breath), ASTHENIA (weak and feeble/turned into a skeleton), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (cannot perform daily activities smoothly) and EMOTIONAL DISTRESS (suffering badly) outcome was unknown.            Treatment information also included Levothyroxine, Lisinopril and Metoprolol. Patient was discharged from hospital without any improvement and there is no benefit in patient's health.  Very limited information regarding the event onset date has been provided at this time and is insufficient for causality assessment. A causal relationship cannot be excluded.; Sender's Comments: Very limited information regarding the event onset date has been provided at this time and is insufficient for causality assessment. A causal relationship cannot be excluded.