chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Seizure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A 72-year-old male patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SEIZURE (medically significant), outcome "unknown". The patient mentioned that he got Pfizer COVID-19 vaccine and his last dose was in Feb (unknown year).  He mentioned that after he took the last vaccine, he got seizure and he was afraid to get the new shot.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
pt recvd vax 26DEC92 & devel a fever on 27DEC & had a febrile seizure; paramedics were called & pt was taken to hosp; dx febrile seizure;
5 minutes after dose while standing and watching sister receive dose of vaccine, patient experienced presyncope.  Patient started to sway and lost muscle control.  I helped to the floor and laid him out.  Patient conscious whole time and never stopped breathing.  Did not lose cognizance.  Had momentary feeling of nausea that immediately passed.  Did not believe necessary to call 9-1-1 as patient did not exhibit any allergy symptoms of any distress during the whole episode.  Allowed to lay on floor for about 5-10 min.  Supplied patient with bottle of water to help with dry mouth and he drank and felt better.  After another 10 minutes patient was up on feet and feltmuch better.  Mother called an hour and a half later (about 5 min ago as I prepare this form) to inform me that he was back to 100%.
Received Pfizer COVID vaccines 02/10/2021 & 03/03/2021.  07/20/2022 - Admitted to Critical Care @ local hospital. Tested positive for COVID. 07/22/2022 - Discharged home with hospice.  07/24/2022 - Patient expired
I have been experiencing Tinnitus starting approx. 2 days after receiving the second dose.
she had a sore arm after the first dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 13Feb2021 (Batch/Lot number: unknown) at the age of 71 years as 1st dose, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Flu vaccine (she gets a sore arm when she receives her annual flu vaccine. She states that it is recurrent after each vaccine. Caller had no product information to provide in regards to the flu vaccines she received.), reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Feb2021, outcome "unknown", described as "she had a sore arm after the first dose".  Additional information: Patient did not visit emergency room or physician office for any AE(s). No other products, no patient history and no relevant tests. Family Medical History Relevant to AE(s): No. Caller stated that she was unsure of lot number. She stated that it was either EL9267 or EL9269. She said that the handwriting on the card was messy; her husband believed that it was EL9269. Sore arm with the first COVID-19 vaccine on 13Feb2021, she had no redness no spots or anything. Caller mentions that she gets a sore arm when she receives her annual flu vaccine. She states that it is recurrent after each vaccine. Caller had no product information to provide in regards to the flu vaccines she received.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Initial unsolicited report received from the literature on 22 April 2016. The following is verbatim from the article: Infections are a leading cause of morbidity in children following transplantation. It is therefore imperative to ensure that children are immunized before a transplant. Contrary to this recommendation, it has long been suggested that children with congenital nephrotic syndrome (CNS) not receive immunizations due to their perceived lack of response. We report a child with CNS who was immunized before transplantation per the routine pediatric immunization protocol and responded appropriately. The intent of this report is to encourage health care providers to immunize children with CNS, as the practice of withholding immunizations in these patients may have adverse health implications. At 33 week gestation to a 21-year-old (patient's mother) who had been noted to have an elevated serum and amniotic fluid alpha-fetoprotein level and carried a prenatal diagnosis of CNS. This case involves a 16-year-old male patient who was vaccinated with a dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DTAP) (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unspecified date. The patient had a medical history of congenital nephrotic syndrome. Concomitant medications were not reported. On an unspecified date, following the vaccination, the patient developed Antibody test abnormal. Lab data and corrective treatment were not reported. The outcome of the event was unknown. List of documents held by sender: none.
Patient was vaccinated on 09/11/2003 with 4 yr boosters.  Patient was seen back in our office on 09/13/2003 with reaction on the left arm.  Patient received DTaP and IPV on that arm. No pain, no allergies, swelling, redness.
A spontaneous non-serious report of administration of expired product was received from a certified medical assistant in a physician's concerning a child of unknown age and gender.  On 07-Jan-2009, the patient received FLUMIST which expired on 15-Dec-2008.  There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
On 09/30/2003, I visited my MD and had a complete physical with excellent results overall.  I do have controlled high blood pressure via 40 mg Zestril, 25 mg HCT, and 2 mg Cardura 1 day.  On 10/01/2003, I received the flu shot from MD, nurse at which time I did not receive a CDC Vaccine Info Statement-nurse in a rush at other patients in office at that time.  On 10/02/2003, I played 2 hours of Tennis (doubles) with (0) zero ill effects-felt a little muscle aches and another 2 hours tennis (doubles on Saturday, 10/04/2003), but, following that session I really felt ill.  Ie: I experienced intermittent high fever, was very hoarse (almost lost voice entirely) had chills, high heart rate and very high blood pressure (205/115), muscle aches (neck, back and legs), got dizzy each time I stood up or turned around.  I was very weak and each time I ate I broke out in a profuse sweat-also following taking a shower on relieving my bowels all these reactions (?) lasted on a slowly diminishing basis for approximately 7-10 days before I began to actually feel any where near normal again.  I was confused and concerned enough at 3 specific times (during this seige on the nights of 4,5,6 10/03), to consider calling 911, however, I did not.  I did call MD office and reported my plight to his nurse and also to another RN found at cardiovascular clinic (she had been my clinical nurse in an earlier high blood pressure study a couple years ago).  When I felt better I telephoned VAERS and reported this adverse event (using the telephone # indicated on the CDC info statement form my wife had received when she received her flu shot at the clinic. The follow up received on 11/11/3 states, I reported events (adverse) previously I felt too weak to go to emergency room for 2-3 days. My wife nourished me back to normal.
Appendectomy / Appendicitis  on 3/29  3/18 that night stomach irritation developed. 3/19 stomach irritation continued and difficultly sleeping due to irritation, pain continued. 3/28 Pain became severe and couldn't  sleep. 3/29 Went to urgent care, transferred to ER.  ER did a CT scan and determined appendicitis.  Emergency appendectomy performed.
patient received the first dose of Shingrix on September 19th 2023 and the second dose was administered on October 12th 2023.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number Y2229, expiry date 16-SEP-2025) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 12-OCT-2023, the patient received the 2nd dose of Shingrix. On 12-OCT-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: patient received the first dose of Shingrix on September 19th 2023 and the second dose was administered on October 12th 2023.). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 07-NOV-2023 The pharmacist reported that a patient received the 1st dose of Shingrix and the 2nd dose was administered on. The vaccine administration facility was the same as primary reporter. The patient received the 2nd dose earlier than the schedule, which led to shortening of vaccination schedule.  The reporter did not consent to follow-up.
On 10/17/22 Patient was exposed to shingles. On 10/22/22 he received his bivalent booster. On 10/24/22 we received a call from the pharmacist that Patient received an undiluted dose of the vaccine. On 10/25/22 Patient was diagnosed with a break through case of chicken pox. On 10/30 and 10/31 Patient suffered from vomiting and profuse diarrhea.
Pfizer COVID-19 Vaccine EUA  Patient received Pfizer COVID vaccine on 3/12/2021. Patient presented to outpatient clinic on 4/8/2021 for complaints of leg pain since Monday 4/5/2021.  Patient states that Monday he woke up with point tenderness in his left calf which went away after about 2 hours.  Tuesday, he woke up the same pain, which is persistent to this point.  Patient denies exacerbating or relieving features.  Patient denies trauma, no precipitating event and denies history of similar symptoms.  Patient has not presented for medical attention for this prior today. Patient had a venous doppler ultrasound which showed a clot in the posterior tibial vein. Patient started on apixaban
had vax 1JUn-every since had frequent crying, had temp 1JUN to 4JUN around 101, dec appetite & thirst, not sleeping much;pt doesn't seem himself;was not easily consoled;
Headache, Sedation, Myalgia, Fever, severe pain at injection site, chills Narrative:
Patient is a 37-year-old healthy gentleman who presented with chest discomfort on the early morning hours of April 28, 2010. Due to his elevated troponin he was evaluated with CAT scan showing no evidence of pulmonary embolism. He subsequently went to heart catheterization lab and underwent heart catheterization disclosing no significant obstructive coronary disease. The patient was seen by Infectious Disease due to abnormal left deltoid at the site of his recent smallpox vaccination. CDC was involved through Dr's conversations and evaluation of photographs of the deltoid lesion. The patient has done well. He will be discharged later today and will follow-up with Dr. within one week. He will follow-up me in the office in two to three weeks. At that time he will have an echocardiogram and plain treadmill stress test. If these are acceptable, then I think the patient can return to his usual activities including work without restriction. That decision will be made after evaluation of the patient following his echocardiogram and stress test. I believe the patient had myocarditis secondary to his smallpox vaccination. The timing is appropriate. The clinical picture is definitely consistent with myocarditis. This is definitely a known potential complication from a smallpox vaccination. The patient will be discharged later today.
felt weak; light headache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (felt weak) and HEADACHE (light headache) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Apr-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced ASTHENIA (felt weak) and HEADACHE (light headache). At the time of the report, ASTHENIA (felt weak) and HEADACHE (light headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided.  No concomitant medication was provided
1) Blood Glucose shot up from 80 at 4:40 AM to 402 at 9:50 AM  on a single bowl of cereal (35 carbs) 2) Unable to do my regular 3 mile run at 10 AM
I started PAXLOVID the same day that I tested positive for COVID-19. The date was July 22, 2022. On July 28, 2022, I tested negative for COVID-19. Three days later, I tested positive for COVID-19 again. I stayed positive for two weeks. I had mild symptoms. I was tired. I had a headache. I had a little bit of congestion and a mild cough. The cough lingered the longest. Approximately two months later, I had a heart attack. My Cardiologist thinks there may be a connection to COVID-19. I have three stents and have been under a cardiologist's care. I take blood thinners and another medication to keep my arteries dilated. I've been on medical leave this whole time. I go back to work this Monday.
Information has been received from a certified medical assistant referring to an unspecified number of patients of unknown age and gender. On 05-OCT-2015, the patients were vaccinated with improperly stored doses of GARDASIL (lot # K008931, expiration date 04-MAR-2017, dose and route not provided)(incorrect product storage). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
I started getting a rash a few days after the vaccine.  I wasn't convinced it was a rash at that point.  I thought it could be dry skin so I started treating it that way.  That didn't help so I started taking my seasonal allergy medication (Zyrtec generic brand).  The rash continues to expand.  It's on my breasts, arms, shoulders, and back.  It is red and feels rough.  It isn't itchy but is bothered by the contact of my bra on my shoulders.
Dizziness; Blood Pressure 155/66; Sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), HYPERTENSION (Blood Pressure 155/66) and VACCINATION SITE PAIN (Sore left injection site arm) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVETIRACETAM for an unknown indication.    On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jul-2021, the patient experienced VACCINATION SITE PAIN (Sore left injection site arm). On 03-Aug-2021, the patient experienced DIZZINESS (Dizziness) and HYPERTENSION (Blood Pressure 155/66). At the time of the report, DIZZINESS (Dizziness), HYPERTENSION (Blood Pressure 155/66) and VACCINATION SITE PAIN (Sore left injection site arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Aug-2021, Blood pressure measurement: 155/66 (High) blood pressure of 155/66.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Had a severe headache, dizziness, and chills, the symPtoms Lasted about 24 hours.
Immediate mild shortness of breath and arm soreness, worsening overnight. In addition, nausea and vomiting, melena Called EMS next day.  Required intubation en route to hospital.  Brief IV antibiotics.  Discharged on omeprazole with plans for GI following, B12 and iron supplements
Trouble breathing & hoarseness over next few days adm to hosp 26FEB92 for bronchiolitis; Pt recved DTP/OPV/HIB on 17FEB92; sx unrelated to shot;
Rash at injection site beginning five days after injection-redness and itchiness.  Also, abdominal pain beginning day after injection and lasting about four days.  It felt like someone had punched me in the stomach.  There weren't any gastrointestinal symptoms associated with the pain.
Soreness at the site - headache - tiredness - diarrhea; still experiencing all of these symptoms
Was tired; At the injection site there was a little burning, and it felt hot; At the injection site there was a little burning, and it felt hot; Patient got a little nauseous; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (At the injection site there was a little burning, and it felt hot), NAUSEA (Patient got a little nauseous), FATIGUE (Was tired) and VACCINATION SITE PAIN (At the injection site there was a little burning, and it felt hot) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M2DA) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included GERD (GERD described as acid reflux.), Kidney stones, Bladder discomfort (Bladder problems) and Spasms (Back spasms.). Concurrent medical conditions included COPD, Arthritis, Blood pressure and Anxiety. Concomitant products included BACLOFEN for Spasms, SALBUTAMOL SULFATE (PROAIR [SALBUTAMOL SULFATE]), MONTELUKAST SODIUM (SINGULAIR) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE WARMTH (At the injection site there was a little burning, and it felt hot), NAUSEA (Patient got a little nauseous) and VACCINATION SITE PAIN (At the injection site there was a little burning, and it felt hot). On 26-Feb-2021, the patient experienced FATIGUE (Was tired). On 25-Feb-2021, VACCINATION SITE WARMTH (At the injection site there was a little burning, and it felt hot), NAUSEA (Patient got a little nauseous) and VACCINATION SITE PAIN (At the injection site there was a little burning, and it felt hot) had resolved. At the time of the report, FATIGUE (Was tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Blood pressure medicine, acid reflux medicine, anxiety medicine, COPD inhaler were the concomitant medications provided.  No treatment drug details was provided.   This case was linked to MOD-2021-215265 (Patient Link).
Chills, fever, Severe muscle pain in arms, legs, back and eventually I had chest pain for about an hour
Movement in my right upper arm is painful; This is a spontaneous report from a contactable consumer.  A 66-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 03Feb2021 (Batch/Lot Number: en5318) as SINGLE DOSE for an unspecified indication.  Medical history included drug hypersensitivity from an unknown date and unknown if ongoing. There were no concomitant medications.  The patient experienced movement in my right upper arm is painful (movement disorder) (non-serious) on 08Feb2021 07:00. There was not treatment received for the adverse events. The events were considered as non-serious by the other healthcare professional. The outcome of the event was reported as not recovered.
Expired dose administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 52-year-old male patient who received HAV (Havrix) (batch number 3A22R, expiry date 24th May 2022) for prophylaxis.   On 6th June 2022, the patient received Havrix. On 6th June 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 06-Jun-2022 Reporter's Comments: The reporter was a medical assistant. The patient received a dose of expired Havrix. The reporter was consented to follow up. Additional Supportive Information: The patient received expired Havrix, which led to expired vaccine used.
Patient received Covid vaccine. During her 15 minutes of monitoring her boyfriend came to get us saying she fainted. When I touched her arm and said her name she was responsive to me. We got her an ice pack, she started drinking water and then told me she felt nauseous. I got her a trash can and she vomited. After she stated she felt better and she started to regain her color. We made her monitor for an additional 15 minutes after the incident.
Pt. received her first dose of COVID - 19 vaccine Pfizer 0.3 ml IM on her Lt. deltoid at 08:39 am on 07/28/21.Pt c/o Lt upper arm tingling at 8:41 am. Nurse did massage on her Lt. arm site area. Then pt. c/o dizziness at 8:42 am. Pt looked pale & conscious. Nurses assisted pt. lay on the examination bed. BP:97/57,P:47,SPO2:96%.at 8:47 am. Pt said that she did not eat her breakfast & did exercise for 1.5 hrs. before the vaccination. BP: 101/64, P:56, SPO2:96% at 08:50 am & pt. said that she had no more dizziness & no tingling on her Lt. injection site arm. Pt said that she was fine & other discomfort. Pulse:60 at 8:51 am. BP:101/64, P:56 at 8:58 am. Cont. monitor pt. Pt alert & conscious. BP:101/64, P 54, SPO2:97% at 9:02 am. BP:101/64, P:56, SPO2:97% at 9:12 am. Pt was monitor for 30 min., & left the facility at 9:14 am without distress noted & in stable condition.
J96.21 ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 6/7/2021 DIARRHEA
mom reports pt recvd vax 11AM @ 9PM w/bath had hives; mom describes pt as having big, swollen, round areas to tummy & on rt arm, w/one spot quite large, about 1 inch from MMR inj site; pt given DPH that noc & 2x next day; rash faded;
1. General malaise the day of the vaccination,  2. Local reaction at injection site: Redness, Swelling, and Pain.  Took Acetaminophen and applied ice pack to injection site.  Malaise improved by Day 2, but local reaction still active on Day 3.
This spontaneous report as received from medical assistant and refers to a patient of unknown gender and age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose (1DF) of (wistar ra 27-3) M-M-R II, subcutaneously, lot # N013296 (Albumin status rHA), expiration date 28-APR-2019 (dose, strength, batch number not specified) for prophylaxis. The (wistar ra 27-3) M-M-R II was stored improperly. Digital Data Logger reported the storage of the suspect vaccine in temperature 48F (degrees Fahrenheit) for 4 hours. There was no previous temperature excursion. No adverse events were reported and no further information was provided by the reporter.
pt c/o soreness of rt arm & swelling; sitff, rigid neck muscles; had lesion on face & lt leg; c/o numbness tingling lt leg; MD cultured open wound & tx for infection, temp 97.9;
22MAY91 pt recvd 1 dose of Engerix-B & immed p/inject exp a burning sensation inside the upper arm w/in a wk of inject devel weakness of the lt arm & aches & pain in the lt arm which dropped in intensity; 15JUL91 lt arm tired easily;
Arm extremely sore and happened quickly taking a walk. Patient started to change his walking gait and was leaning forward , wheezing and breathing heavily , and sweating profusely. He tried to sit down and feel on his knees missing the park bench.