chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A nurse reported the occurrence of shortness of breath in a 43 y.o. female who received Hep B vaccine recombinant (Engerix-B) for prophylaxis. The subject had a history of blood clots while receiving unspecified birth control pills. She was allergic to penicillin, codeine, and ciprofloxacin hydrochloride (Cipro). She received no concurrent medications. She experienced no adverse events following 3 previous injections of Engerix-B and one injection of Hep A vaccine (brand unknown). In March 02, June 02, and Sept. 02, the subject received Engerix-B without adverse event. On 10/22/02, the subject received her 4th injection of Engerix-B (lot ENG5290A4; expiry, 9/19/03). 5 mins later, she started having dizziness. 1/2 hour later, she experienced pupil dilation, shortness of breath, fatigue, and muscle aches. The PT had to call the EMS to her house after she returned home from the physician's office. No add'l details were provided related to this home visit. The reporting nurse spoke with the subject on 10/23/02 and at that time, the dizziness, pupil dilation, and shortness of breath had resolved while the fatigue and muscle aches were "worse." The Engerix-B immunization series was discontinued.
pain from back of my hip and going down my leg all the way to foot; severe muscle pain/ pain from back of my hip and going down my leg all the way to foot; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (severe muscle pain/ pain from back of my hip and going down my leg all the way to foot) and BACK PAIN (pain from back of my hip and going down my leg all the way to foot) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Diabetes.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced MYALGIA (severe muscle pain/ pain from back of my hip and going down my leg all the way to foot) and BACK PAIN (pain from back of my hip and going down my leg all the way to foot). The patient was treated with ACETYLSALICYLIC ACID (BAYER ASPIRIN) on 08-Feb-2021 at a dose of 4 dosage form. At the time of the report, MYALGIA (severe muscle pain/ pain from back of my hip and going down my leg all the way to foot) and BACK PAIN (pain from back of my hip and going down my leg all the way to foot) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included high blood pressure medication, diabetes medication, Vitamins and cholesterol medication.
11:10 PT STARTED TO FEEL TIGHTENING IN THROAT, PT BROUGHT OVE TO VACCINATION STATION FOR FURTHER ASSESSMENT.  AIRWAY PATENT, NO STRIDOR OR S/S OF RESPIRATORYDISTRES NOTED AT THIS TIME. VSS B/P 152/90, HR 90, RR 18, SPO2 99%.  BENADRYL 50 MG PO GIVEN X 1.  PA OVER TO ASSESS PATIENT. PT STATES HE HAD A SIMILAR MORE MILD EXPRERIENCE WITH FIRST PFIZER DOSE. 11:30: PT STATES EVERYTHING STILL FEELS THE SAME, NO CHANGE OR WORSENING OF SYMPTOMS AT THIS TIME. 11:45 PT STATS LEFT SIDED CHEST PAIN 7/10 STABBING. MEDICAL PROVIDER NOTIFIED. PT BROUGHT BACK TO OBSERVATION ROOM. ASSESSED BY EMTS. 12 LEAD EKG PERFORMED. PT SR WITH 1ST DEGREE BLOCK. HR 70. B/P 149/94, SPO2 99% 11:50  PROVIDER IN TO SEE PT. PT TO BE TRANSFERED TO FACILITY FOR FURTHER TESTING AND TREATMENT.
Vax given 22JAN91 mom states child developed hives 23JAN91 appeared 1st @ joints, later seen on back, face, arms, legs, back - seen by PP - stated poss vax rxn (rash comes & goes).
Adverse event: Sore Arm Treatment: Rubbed it a few times Outcome: Went away after a few days
Anthrax #2 shot; severe swelling of upper R/arm, starting at 2" below elbow to shoulder, entire swelling, red, hot to touch. Area of injection was hard/knotted, difficulty bending arm & lifting.
On May 27, 1999 the pt experienced shingles with a maximum temperature of 99F. It was indicated that the pt had no history of chickenpox and there was no recent exposure to chickenpox.
no additional adverse event reported; temperature excursion for PROQUAD/doses were administered following the excursion; This spontaneous report was received from a physician referring to a 4 year old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 29-DEC-2020, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 0.5 milliliter for prophylaxis, lot number reported as T021642 and expiration date as 21-DEC-2020 (vaccination scheme, anatomical location, and route of administration were not provided) (product storage error). No additional adverse event reported.     The administered dose of the vaccine experienced a temperature excursion of max. 16.2 Fahrenheit (F) for a timeframe of 2 hours and 28 minutes, as recorded by a digital data logger. It was also reported there was not a previous temperature excursion.
11 days p/vax pt devel maculopapular rash on face which spread to torso & extretmites;
fluzone quadrivalent received during pregnancy with no reported adverse event; Initial information received on 13-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 35 years old female patient who who was at 16 weeks of pregnancy and was exposed to vaccine Influenza Quadrival A-B Vaccine [Fluzone Quadrivalent] during second pregnancy trimester.  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The date of last menstrual period was reported as 02-Jun-2023. The estimated due date is 08-Mar-2024. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.  On 13-Sep-2023, the pregnant patient received a dose 1 with unknown dose of suspect Influenza Quadrival A-B Vaccine (expiry date, strength: not reported and lot 4T80404A ) via intramuscular route in unknown administration site as prophylactic vaccination (maternal exposure during pregnancy) (latency: same day).   Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  Additionally, at time of reporting, the pregnancy is still ongoing.
same day: fatique,headache,fever, next day fever[101] redness at site, dizziness,headache next day ;fatigue,redness down to elbow next symptoms gone except for soreness at site and redness to elbow
pt recv vax & devel redness, swelling, warmth & itching site of inj;from f/u of 24JUN98 it was reported pt exp 15x8cm ovoid distribution of erythema & swelling plus warmth;tx w/zyrtec & elocon cream;
patient experienced partial paralysis of face, left face.  was taken to the hospital, ruled out a stroke.. diagnosed bell's palsy
24JUL92 t99.1, rash w/hives; urticaria; cause undetermined; pt also consumed new food items 12 hrs prior to onset of sx;
Patient began experiencing itchy rash on neck and palm of hands at 13:03 , approximately 30 min after her Moderna vaccination. Patient was given water at the time and moved to a private observation area where vital signs were recorded every 5 min3 times. Patient was took Benadryl 25 mg PO one time at 13:22. It 13:45 patient reported rash on hands less itchy and clinician noted rash on back of patient's neck resolved. Patient educated on worsening signs and symptoms and when to follow up with PCP. Patient left at 13:45 by herself and took a car service home.
Patient experienced a rash that caused his red corpusles to explode. Also, his blood sugars increased to 500-600.
Patient states he developed a dry hacky cough the day following the AFLURIA injection, cough is only mildly resolved by OTC treatment and continues to persist. Patient states he has not seeked medical attention at this time.
Rash papular lesions on body, scalp, behind ears and and palate. To use Aveeno and Dytan Q 12 hours.
I have already had COVID.  My symptoms, at the time of infection, were confusion due to brain inflammation, and nasal drip. It was very mild and easy to get over. No taste and smell as well, still at the time of writing. After the first vaccination, it made me bedridden for a whole day. No fevers or brain inflammation. It felt worse than COVID. The second vaccination caused an even more extreme immune response. Around 2 PM, I ended up feeling extremely fatigued and feverish. I had not developed a fever while infected with COVID, nor after the first vaccine. An hour later, I started getting extremely confused, and my head wouldn?t stop pounding. It was the exact same feeling of brain inflammation present when I was infected. I do not recollect how long I was in a completely disassociative state, but it is probably around 2 hours. I could not move to call 911. I should have been in an emergency room, but unfortunately I was alone. After that, I have had 101F fevers, fatigue, and aches.
expired ACT HIB vaccine was administered to patient with no reported adverse event; Initial information received on 17-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1 years old male patient who was administered an expired Hib (Prp/T) Vaccine [Act-Hib] was administered to patient 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 hepatitis a vaccine (hepatitis a) for immunisation; measles vaccine, mumps vaccine, rubella vaccine (mmr) for immunisation; and varicella zoster vaccine (varicella vaccine) for immunisation.  On 16-Oct-2023, the patient received 0.5 ml (Dose 4) of suspect HIB (PRP/T) VACCINE Powder and solvent for solution for injection (lot number: UJ784AB, Expiry date: 08-Oct-2023) (Strength: standard) (Frequency: once) via unknown route in unknown administration site for immunization.  On 16-Oct-2023 the patient was administered an expired Hib (Prp/T) Vaccine [Act-Hib] was administered to patient with no reported adverse event (expired product administered) (latency: same day).  It was reported, Compliance Specialist called from doctor`s office where an expired ACT HIB vaccine was administered to patient. This inquiry was submitted since an expired dose was given to a patient.  Action taken: not applicable.  Outcome: Unknown    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.
Developed joint pain following a 2nd vax; Condition cleared spontaneously in 1 month;
This is a spontaneous report by a contactable consumer (employee from sales department).  A 3-year-old male child received a dose of PREVNAR 13 via intramuscular injection once as a preventive measure for pneumococcal disease on 07Feb2011.  Relevant medical history, past product history and concomitant medications were not provided.  On 09Feb2011, the patient experienced red patch of 1.5 to 3 inches at the site of injection that was warm and painful.  There was no fever.  Relevant lab data was unknown.  At the time of the report, the patient had recovered from the events in Feb2011.  The caller was not sure whether PREVNAR 13 protein was purchased.
Ironically I just got COVID for the second time [after receiving the Pfizer/BioNTech vaccine]; Ironically I just got COVID for the second time [after receiving the Pfizer/BioNTech vaccine]; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Ironically I just got COVID for the second time [after receiving the Pfizer/BioNTech vaccine]".  Clinical course: The patients age was provided as 50 (no units provided).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Expired dose of Havrix was administered to patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 20-year-old male patient who received HAV (Havrix 1440) (batch number KM72C, expiry date 18-JUN-2022) for prophylaxis.   On 11-MAY-2023, the patient received Havrix 1440. On 11-MAY-2023, an unknown time after receiving Havrix 1440, the patient experienced expired vaccine used (Verbatim: Expired dose of Havrix was administered to patient ). The outcome of the expired vaccine used 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 Information: GSK Receipt Date: 11-MAY-2023 The expired dose of Havrix was administered to patient today, which led to expired vaccine used.  Address and email address were both shared for follow up Havrix formulation was confirmed by batch look up. The reporter consented to follow up.
Information has been received from a registered nurse concerning a male (age not reported) who was vaccinated with the "second dose" of varicella virus vaccine live (Oka/Merck) (lot # not reported). The registered nurse reported that "after receiving the second dose of varicella virus vaccine live (Oka/Merck), the patient developed a small rash on the stomach, which was transient and went away after one day. The patient also had five pox marks on his face and experienced diarrhea and fever". The patient sought unspecified medical attention. The patient's status concerning the five pox marks on his face, diarrhea, and fever was not reported. There was no product quality complaint. Additional information has been requested.
All my Lyme Disease symptoms returned after 19 months of absence. Tingling sensation in my left hand. Dropping and coordination issues has become a constant occurrence.
The patient became unwell a few minutes after receiving the vaccine, he informed me he threw up, felt dizzy and sweaty. I gave him some water and a cookie. He said he felt better after consuming the cookie. I had him sit in a chair outside my counseling room and to knock if he continued to feel unwell. After 10 minutes, the patient said he was feeling much improved. I had the patient wait another 20 minutes before leaving. The patient left feeling normal again.
2mo post vax pt still c/o soreness in her arm, bruising type discoloration in area where shot given & a palpable knot; Also not feeling well; Denies fever; Seen by MD was told rxn normal & the lump can be present for 14wks;
hardly even sore in my left arm after the first two doses.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Apr2021 (Lot number: EW0162) as dose 1, single and administered in arm left, administration date 10May2021 (Lot number: EW0179) as dose 2, single for covid-19 immunisation. Relevant medical history included: "No. Varicose Veins is all." (unspecified if ongoing), notes: No. Varicose Veins is all. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "hardly even sore in my left arm after the first two doses.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient had no known allergies. Prior to vaccination, patient was not diagnosed with COVID-19. Patient was Recovering. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no other medication in 2 weeks. On 22Nov2021, the booster dose (Dose 3, lot Number: 363080) was administered on left arm as vaccination anatomical location. She didn't really have any side effects and was hardly even sore in her left arm after the first two doses. On 23Nov2021, patient experienced the events. It was reported that the day after I got my booster, right on time, left breast has been achy and had pain for a month and a half. The left side of my breast, and what feels like inside my breast. It has hurt to sleep on that side to the point that I haven't - until recently, when getting a lymphatic drainage session helped. The discomfort hasn't been constant, but has been a lot of the time, and even me massaging that area hasn't resolved it. The lymph nodes seem to be swollen in my left breast area, and therefore things aren't moving along as they should and there is inflammation. It is concerning. It was treated by Lymphatic drainage. Covid test post vaccination by nasal swab was negative. Case was reported as, non-serious since, no seriousness criteria was met. Device Date was reported as 07Jan2022.  Follow-up attempts are completed. No further information is expected.
approx 24hr p/vax pt devel tactile fever & rash on both extremities & face;pt was seen by 48hr p/vax w/indurated red & purple blotchy rash on arms & legs diffusely & less on lower face & mid trunk;T100.4ax;erythema;
Recieved Varicella vaccine on 1 Oct 03. Sx began on 15 or 16 Oct with pruritis and rash on buttocks, spreading to chest, scalp, back and extremities by 18 or 19 Oct, accompanied with HA and rhinitis. Afebrile. Lesions are reported to be maculo papular. Admitted to hospital and currently recieving Acyclovir.
Incontinence; This case was reported by a other health professional via call center representative and described the occurrence of incontinence in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 23JK5, expiry date 13th April 2020) for prophylaxis.   On 21st May 2019, the patient received the 1st dose of Shingrix (intramuscular). On 21st May 2019, less than a day after receiving Shingrix, the patient experienced incontinence. On an unknown date, the outcome of the incontinence was not recovered/not resolved.   It was unknown if the reporter considered the incontinence to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix in left arm. The concomitant medication included diuretic. The patient experienced incontinence following a Shingrix dose.  The patient reported it to pharmacy on 22nd May 2019. The patient was still experiencing incontinence as of 23rd May 2019. The reporter gave permission to follow up. This case had been linked to the case US2019094040, reported by same reporter. As per sales data sheet reported batch number was changed from 23JKS to 23JK5.
Slight redness, warm, itch,   no treatment given or required, patient will advise if anything further. Stated it was a mild reactions, and was diminishing by the third day which was when it was reported.
itching; redness; wrist pain that radiates to forearm; hot; pain at injection site; A spontaneous report was received from a nurse concerning a 75-year-old, female patient, who received  Moderna's  COVID-19 vaccine (mRNA-1273) and experienced Redness expanding,  warmth, pain at injection site, wrist  pain that radiates from forearm, itching. The patient's medical history, was not provided by the reporter.  On 20 Jan 2021 , the patient received their first of two planned doses of mRNA-1273 (Lot number: 013L20A) intramuscularly in the  arm for prophylaxis of COVID-19 infection.   On 20 Jan 2021 the patient experienced the event pain at injection site and it got resolved on 22 Jan 2021. Again on 26 Jan 2021 she reported redness expanding, warmth, wrist pain that radiates  to fore arm, itching.  Treatment  information was not provided. Action taken with mRNA-1273 in response to the events was not reported.   The events,  pain at injection site got resolved on 22 Jan 2021. Redness expanding, warmth, wrist pain that radiates to fore arm, itching were considered unknown.
I had upset stomach, headache, confusion, fatigue, heart palpitation, depression, diarrhea, hot flashes.
No additional AEs or PQC reported; Caller states 1st dose was administered on 10/11/2022 and 2nd dose was administered on 1/18/2023.; This spontaneous report has been received from a medical assistant and refers to a 39-year-old male patient.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 11-OCT-2022, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 1 milliliter (ml). On 18-JAN-2023, being too early, the patient was vaccinated with the second dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 1 milliliter (inappropriate schedule of product administration) (lot number reported for both doses U036184 has been determined to be valid for hepatitis a vaccine, inactivated (VAQTA), expiration date reported and established as 02-MAR-2023), both administered intramuscularly for prophylaxis (strength was not provided).
pt recv vax 19OCT98 & pt exp typical soreness in lt arm & weakness;20OCT98 pt exp constant, severe joint pain;pt was seen in MD office & it was reported that everything was fine x/for joint pain;
About 5-10 minutes after vaccination, patient reported dizziness and blurred vision. Patient then started feeling nauseous and sweating. Patient in and out of consciousness until squad arrived
Headache next day after second vaccine.  It has lasted 7 weeks.  Also tinnitus has amplified so that I can?t stand it.  Had MRI of brain.  Went to ENT and went to allergist.  Nothing found.  Went to optometrist and my eyesight is fine
Headache; Tiredness; Muscle pain; Chills; I am so painful in my joints, all muscle ache; I was so tired and weak; I am not feeling well; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received second dose of bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Lot number: EW0167, Expiration date: Aug2021), via an unspecified route of administration, administered in Arm Left on 20May2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included diabetes mellitus from 26Apr2021 to 26Apr2021. Concomitant medications included metformin, lisinopril and glipizide. Historical vaccine included first dose of BNT162B2 (Lot number: EW0171) via an unspecified route of administration, administered in left arm for COVID-19 immunization. Patient got the vaccine second dose and patient was not feeling well. patient got the vaccine in the morning and midday patient was having like headache, tiredness, muscle pain and last night, patient was not shivering but patient was feeling chills inside her body like patient was under the layers of blanket, but patient did not have fever. My temperature patient kept taking it was last 98 to 97.9 something like that. Patient kept taking her temperature, but patient so painful in her joints, all muscle aches. Patient was so tired and weak on an unspecified date in 2021, for headache patient have taken Tylenol (Treatment) it comes in and goes. The outcome of the events headache, tiredness was not recovered while unknown for another events.  Information on Lot/Batch number was available. Additional information has been requested