chrisvoncsefalvay/vaers-outcomes huggingface dataset:
slight fever; Headache; Fatigue; Pain in her entire arm; This is a spontaneous report from a contactable consumer via Pfizer sales representative. A 18-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced slight fever, headache, fatigue, and pain in her entire arm with outcome of unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
PATIENT REPORTED THE NEXT DAY HER ARM WAS RED, HOT, AND SWOLLEN. SHE ALSO REPORTED FEELING FATIGUED. THIS IS A NORMAL VACCINE RESPONSE AND SHE WAS COUNSELED TO MONITOR THE EFFECTS AND TO SEE HER PHYSICIAN IF SYMPTOMS WORSENED AND PERSISTED. THE PATIENT DID NOT REPORT WORSENED SYMPTOMS FOR SEVERAL WEEKS. THE PATIENT SPOKE TO THE PHARMACIST ON 5/25/2018 THAT SHE STILL HAD PAIN IN HER ARM AT THE INJECTION SITE AND COMPLAINED OF ALL OVER BODY PAIN AND JOINT PAIN. SHE DESCRIBES FATIGUE WHICH WORSENS WITH WORK AND ACTIVITY AND CAUSES HER TO SLEEP WHENEVER NOT WORKING. THE PHARMACIST COUNSELED THE PATIENT TO SEE HER PHYSICIAN WHICH SHE SAID SHE WOULD DO.
Child was not due for TDap vaccine since she is only 3 years old. TDap vaccine was administered.
Mild reaction 1st day, less than annual flu shot.  7th day injection site sore; following morning soreness continues and red crescent appears as though fluid collected under skin. Slight itch. 9th day crescent had increased to shape of a circle, 3-4 inch diameter. Disappearing 11th day; nearly gone 12th day.
A spontaneous, non-serious report of H1N1 (intranasal) sprayed into eyes was received from a nurse concerning a six-year-old female patient. While receiving the vaccine on 21-Oct-2009, the patient jumped during administration and the vaccine sprayed into her eyes. There was no adverse event associated with the medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
L-ARM: SHOT GIVEN - RED, TENDERNESS, SWELLING; NOTICED THE NEXT DAY; GOT WORSE IN THE NEXT 24-36 HOURS. R-ARM: NOTHING GIVEN - BLISTERS (2) ON FOREARM HALF WAY UP; FULL BODY ITCHYNESS. PATIENT CHOSE NOT TO BE SEEN - CALL THE CLINIC TO REPORT INCIDENT.
rash 3 x 3 area; itching; A spontaneous report was received from a consumer concerning a 87-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events rash 3 x 3 area, itching.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 041L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   rash 3 x 3 area, itching.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), rash 3 x 3 area was unknown.The outcome of event(s), itching was unknown..
01/13/2022-Red around injection site, warm to the touch. 01/14/2022- Redness grew around injection site, still warm, and Pt reports feeling sore in her armpit.
Premature, severely painful and heavy menstrual period (4-6 days, pain was most severe the first 1-2) Following PMS was more intense/severe, unknown if cycles will continue this way
patient got nausea and vomiting 10  minutes after getting the vaccine ( she didn't eat anything prior vaccination per patient )
This spontaneous report was received from a medical assistant concerning to a 24 year old female patient. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On an unspecified date, when the patient was an infant, she was vaccinated with the complete series of RECOMBIVAX HB 2.5/0.5 (units not provided) (dose, route of administration, lot number and expiration date were not reported) as routine vaccine. Recently, on an unspecified date, the patient was tested for hepatitis B antibodies by her employer, and the titers were negative. The reporter stated that the patient was seeking revaccination, but she had not yet been revaccinated (also reported as no treatment was received). Additionally, the reporter said that the RECOMBIVAX HB could not be ruled out as the vaccine that the patient received as an infant. At the time of reporting the patient had not recovered from the event Hepatitis B antibody negative. The causal relationship between the event and the vaccine was not reported. Additional information is not expected because there was no consent to contact physician.
gave me some relief from my cancer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP), Program ID: The reporter is the patient.  A 74-year-old female patient received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; sirolimus (SIROLIMUS). The patient's relevant medical history included: "cancer" (unspecified if ongoing), notes: Patient was in remission from her cancer. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "gave me some relief from my cancer". The action taken for sirolimus was unknown.  Additional information: The patient noted that the vaccine gave some relief from cancer, which was elaborated as worked on the whole immune system, not otherwise specified.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On Thurs. 10/24 got FLUVIRIN @ 3pm. By 4:00 -4:15 Eye swelling, itching also palms of hand, awake all night itching all over body.  As the day went on I started swelling with red welts over my body I called pharmacist and he said to take benedryl which I did. I didn't sleep any, Thursday night I called 911 and had to go by ambulance to the emergency room where they gave medinigsone. Friday Am my husband drove me to the emergency as my B.P. Was high. they put more steroids into me and saw if my mouth started swelling to come back. My mouth was 3-4 times bigger. By Saturday I wasn't able to get out of bed. My B/P dropped by time paramedics got their I was going into shock.  I had FLUVIRIN year arm not allergies to eggs Prednizione has so many effects on me also. I've had terrible experience with this I would NEVER take another shot and would advise anyone that Flu wouldn't be as bad as this has has been. I have Medicare and blue cross secondary ins. I didn't know if they will pay, however if they don't I will be back in in forth with you. Fri AM face, eyes swelled shut call 911 went to emergency got shot, went home. Mouth swelling back to hospital on Sat. B/P dropped 53, going into shock back to hospital stayed overnight 10/25/2008 form attached from hospital.  11/18/08 Reviewed ER records that accompanied report. FINAL DX: allergic reaction to influenza vaccine. Records reveal patient seen in ER on 10/24/08 & again on 10/25-26/2008.  Tx w/steroids, antihistamine initially, released to home & returned next day.  Admitted overnight for observation.  D/c to home on continued steroids & antihistamine.
Chill, fever, wheezing, difficulty breathing, body aches.  Difficulty breathing lasted for 6 days.
This spontaneous report was received from a physician and refers to a 29 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant medications and medical history provided. On 16-MAR-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot# L042846, expiration date 15-SEP-2017) 1 ml, intramuscularly in unspecified deltoid. No adverse events were reported. Administered dose of vaccine experienced the temperature excursion of 49 degrees Fahrenheit. This is one of several reports received from the same reporter. Additional information is not expected as all the correspondence was returned by the post office.
Some of the vaccine spilled out and not all of it went into arm; Some of the vaccine spilled out and not all of it went into arm; Arm hurts big time, sore; A spontaneous report was received from a consumer concerning a 72-year-old, male patient who experienced some of the vaccine spilled out and not all of it went into arm/underdose, device connection issue and arm hurts big time and is sore/injection site pain.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 20 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (lot number 043L20A) intramuscularly in the right upper arm for prophylaxis of COVID-19 infection.   On 20FEB2021, the patient reported that he did not receive the full dose of the vaccine. He saw that the person dispensing it withdrew the needle with product still inside, which spilled out upon withdrawal. He also reported that his arm hurt big time and felt sore.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events, underdose and device connection issue were recovered/resolved.  The outcome of the event, injection site pain was unknown.; Reporter's Comments: This report refers to a case of underdose and device connection issue for mRNA-1273 (lot # 043L20A) with associated AE reported as injection site pain.
Fatigue, fever, body aches, chills, loss of appetite, nausea, dizziness  Treated with ibuprofen with some success.
Headache; Sore injection site; Nausea; Fever over 101 F.; This is a spontaneous report from a non-contactable consumer (patient). A 50-years-old (non-pregnant) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 04Feb2021 at 11:00 (Batch/Lot Number: EM9810) (at the age of 50-years-old) as 1st dose, single for COVID-19 immunization. The patient medical history was not reported. The patient did not had allergies to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included other medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 04Feb2021 at 17:00, the patient experienced headache, sore injection site, nausea and fever over 101 F. The patient underwent lab tests and procedures which included body temperature: over 101 Fahrenheit on 04Feb2021 (fever over 101 F). The patient did not receive treatment for the events. The outcome of the events was not recovered.   No follow up attempts are possible. No further information is expected.
Pt complained of left thigh swelling and redness at injection site, no fever. Pts mother advised to treat with ice and children's Motrin as directed. Also advised to seek further medical attention if symptoms worsened.
This case was reported by a healthcare professional and described the occurrence of injection site hives in a 6-year-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline) and FLUARIX. Concurrent medical conditions included allergies. Concurrent medications included Allergy medication. On 3 October 2012 the subject received unspecified dose of INFANRIX (unknown, unknown arm) and unspecified dose of FLUARIX (unknown, unknown arm). On 5 October 2012, 2 days after vaccination with FLUARIX and INFANRIX, the subject experienced injection site hives, injection site redness, swelling injection site and itching. The healthcare professional is also the subject's aunt, who reported the subject experienced hives wrapped around his arm at injection site, redness at injection site, swelling at injection site and itching. It was unknown if both INFANRIX and FLUARIX were given in the same arm. The healthcare professional inquired if soy was in INFANRIX and FLUARIX; she did not suspect soy as being the cause of this reaction but believed it is just related to the subject receiving in multiple vaccinations on the same day. At the time of reporting the injection site hives, injection site redness, swelling injection site and itching were unresolved. The healthcare professional considered the events were probably related to vaccination with INFANRIX and FLUARIX.
Developed shingles (ophthalmic) - started a couple weeks after vaccine with eye pain/irritation in one eye that lasted several days, one time discharge from that eye. About a week later developed pain/irritation in other eye.  Approx. a week later (~5/30),  developed a large red bump on my forehead that later erupted.  There were some additional very small skin bumps, but they disappeared on their own.  I waited a week to see the dermatologist and was initially prescribed a topical ointment pending the test results.  The test results  came back positive for shingles and an infection on my forehead.  I was prescribed and took medication for shingles and the infection.  I have a scar/indentation on my forehead where the large eruption occurred.    I also had  a dry cough that started right after receiving the vaccine.  The cough lasted over 4 weeks. I've never had a dry cough before.  As a result of these adverse events and concern that the vaccine negatively  impacted my immune system, I did not get the second dose. I  rarely get sick and have a very good immune system.
Balance problems; Fever after booster; Chills after booster; Headache after booster; Fatigue after booster; Body aches after booster; This spontaneous case was reported by a nurse and describes the occurrence of BALANCE DISORDER (Balance problems), PYREXIA (Fever after booster), CHILLS (Chills after booster), HEADACHE (Headache after booster) and FATIGUE (Fatigue after booster) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PYREXIA (Fever after booster), CHILLS (Chills after booster), HEADACHE (Headache after booster), FATIGUE (Fatigue after booster) and MYALGIA (Body aches after booster). On 01-Nov-2021, the patient experienced BALANCE DISORDER (Balance problems). On 27-Oct-2021, PYREXIA (Fever after booster), CHILLS (Chills after booster), HEADACHE (Headache after booster), FATIGUE (Fatigue after booster) and MYALGIA (Body aches after booster) had resolved. At the time of the report, BALANCE DISORDER (Balance problems) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported.  No Treatment information was reported.    This case was linked to MOD-2021-374915 (Patient Link).
expired PENTACEL vaccine was administered with no reported adverse event; Initial information was received on 28-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 months old male patient to whom an expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13) and rotavirus vaccine LIVE ORAL 1V (Rotarix) for Prophylactic vaccination.  On 28-Sep-2023, the patient received a 0.5 ml, once (dose 2) of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine (Suspension for injection) (lot UJ682AA, expiry date: 16-Sep-2023, strength: standard) via intramuscular route in Right thigh for Immunization and administered an expired vaccine with no reported adverse event (expired product administered) (Latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   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 the 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.
BLOOD PRESSURE FLUCTUATING; RIGHT EYE VISION BLURRINESS; BLOOD PRESSURE  DROPPED; RASH ON LEGS, BACK, AND IN PLACES; SWELLING AT SITE OF  INJECTION; HIVES; SORENESS AT SITE OF INJECTION; ITCHING ALL OVER BODY; IRREGULAR HEART BEAT; This spontaneous report received from a patient concerned a 78 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high risk heart patient, stage 3 kidney patient, penicillin allergy, all different kinds of erythro allergy and allergic to 37 different types of medications (unspecified), non alcoholic, and non-smoker, and other pre-existing medical conditions included she had no history of drug abuse or illicit drug usage. The patient experienced drug allergy when treated with codeine for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 14-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-JUL-2021, the subject experienced itching all over body. On 14-JUL-2021, the subject experienced irregular heart beat. On 14-JUL-2021, the subject experienced right eye vision blurriness. On 14-JUL-2021, the subject experienced blood pressure dropped. On 14-JUL-2021, the subject experienced rash on legs, back, and in places. On 14-JUL-2021, the subject experienced swelling at site of injection. On 14-JUL-2021, the subject experienced hives. On 14-JUL-2021, the subject experienced soreness at site of injection. Laboratory data included: Blood pressure (NR: not provided) dropped. On 15-JUL-2021, the subject experienced blood pressure fluctuating. Laboratory data included: Blood pressure (NR: not provided) fluctuating, and Systolic blood pressure (NR: not provided) went down below 100. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on legs, back, and in places, itching all over body, right eye vision blurriness, swelling at site of injection, hives, soreness at site of injection, and irregular heart beat, and the outcome of blood pressure dropped and blood pressure fluctuating was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as the case assessed as non-serious.
pt recvd vax & exp paralysis from the waist down & could not walk;currently, pt undergoing physical therapy;MD noted that this info was communicated to him third hand;no further details were provided;
received the first dose on Feb 2020 /April 1st 2021 he received second dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 54-year-old male patient who received HAB (Twinrix adult) (batch number 75C72, expiry date 13th June 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix adult (1st dose received on February 2020).   On 1st April 2021, the patient received the 2nd dose of Twinrix adult and Twinrix Pre-Filled Syringe Device. On 1st April 2021, unknown after receiving Twinrix adult and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The pharmacist was looking for guidance on Twinrix standard dosing because the patient received 2nd dose later then the recommended schedule, which led to lengthening of vaccination schedule. The reporter consented to follow up via fax.
After my first vaccine, I got my periods one or two days early, and after my 2nd dose, my periods are delayed for more than 25 days now... Experienced severe cramps in between...
Patient reports fatigue, hot and cold flashes within a day of vaccine administration. She also reports worsening of headache (light and noise sensitivity unrelieved by rest or over the counter medications) that resulted in a Primary Care Provider visit with an injection of sumatriptan and prescription for sumatriptan.
Extreme itching/burning on the palms of hands and soles of feet. This continued through the waiting period between dose 1 and 2 and became worse after dose 2. The itching/burning has since mostly subsided. The itching and burning became worse during the night hours.
pt recv vax 11JUL95 in rt arm; returned for eval w/redness, edema, erythema involving all of rt limb, circumference measurements r>L by 2cm;0 induration; +warmth, +tenderness afeb
HIVES OVER FACE AND NECK APPROX  HOURS AFTER VACCINATION WITH 1ST OF PRE-EXPOSURE SERIES RABIES PCEC VACCINE
Mother noticed child's upper Rt. arm was red and warm to touch when bathing him Friday night. Called Dad Sat. at 10 AM and informed him of this. He called Pediatrician. She told him to give BENADRYL. After no change with BENADRYL, he took child to Urgent Care. Saw PA there, she said was reaction to vaccine and to give CLARITIN. Arm still has redness (quarter size) and slight warmth today, but Dad said it is much better.
Injection was administered on August 30/ 2012. On September 1/ 2012 2 days after injection, patient developed intermittent  urticaria  with severe itching covered almost body area. Last episode of flaring was reported on September 5th. No anaphylactic reaction reported
PER PARENT - yesterday morning her right, upper arm started to hurt, itch and was reddened and very warm to touch. Patient complained that her arm felt stiff as well. We have been treating her arm with hydro-cortisone, an alcohol rub, and a warm compress and giving her ibuprofen for the pain.
Received shot at 2:15 pm and around 9:30 pm, I started to have the chills/shaking.  It then went between chills to sweating profusely.  I took Advil before going to bed.  I have a slight heading now (9:00 am, 3/10/21).