chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a non-healthcare professional (Patient's parent) on 12 December 2016. This case involves a 24-months-old female patient who was vaccinated with doses of FLUZONE (batch number: U5399AA, expiry date: 30-JUN-2016, dose and dose in series were not reported) intramuscularly and HEPATITIS B VACCINE (batch number, expiry date, dose and dose in series were not reported) in an unknown site on 02 December 2016. Illness at the time of vaccination and Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as Reporter denied. Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On 12 December 2016, 10 days following the vaccination, the patient developed Purplish rashes, joint swelling random fevers, demographic urticaria and finally diagnosed serum sickness. The patient had previous dose of FLUZONE in 2014 and HEPATITIS B VACCINE unspecified 2-3 doses. The patient required emergency room (ER) and doctor visit on an unspecified date and was hospitalized. The patients' Laboratory investigations was reported as the patient had performed blood work and the fever was reported as 103 degree Fahrenheit. Corrective treatment was reported as unknown. The patient was discharge from the hospital on an unknown date with the hospitalization duration of one day and the outcome of event was reported as unknown. The reporter assessed the causal relationship with vaccines as related. List of documents held by sender: none. Sender's Comments: Patient had serum sickness and associated symptoms following FLUZONE AND HEPATITIS B VACCINE. Time to onset is unknown, additional information regarding patient medical history, allergic history, past vaccination history and its tolerance are needed to further assess the case. Based on available information the role of vaccine cannot be ruled, but role of each vaccine cannot be assessed.
Itching, feverish  tender, raised rash approximately 1.5 inches in diameter at injection site developed 9 days following the injection
Tachypnea, Palpitations, HYPERtension & Angina Narrative: 12 HOURS AFTER VACCINE PT DEVELOPS TACHYCARDIA, CHEST PAIN, AND SHORTNESS OF BREATH. TREATMENT AT ER/ HOPSPITALIZATION FOR TWO DAYS.
Fatigue (extreme), Headache, chills,  muscle aches (full body) numbness in arms and lower legs
Pt received her Moderna vaccine on 4/11/21 she then started experiencing swelling, redness, and pain at the injection site on 4/16/21. Reported it to us today to report it to the Vaers system.
A few days after receiving my Moderna booster, I started experiencing chest discomfort when I laid down in the evening. Doctor suggested that I take Advil. That helped for a few weeks, but the discomfort came back. I was then prescribed Colchicine. That helped for a number of months. When i tried to come off of the medication, the discomfort came back even worse. I was then prescribed Arcalyst. This caused side effects (numb feet and clammy feeling) and didn't help with the chest discomfort. I have since been taking indomethacin. It seems to help with the discomfort, but I continue to experience flare-ups on a regular basis.
shingles; Information has been received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age or gender. The pt's concurrent conditions, medical history and concomitant medications were not reported. On an unspecified date in 2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, lot number and expiration date were not provided) as prescribed and/or administered by a healthcare provider (HCP) for the long-term prevention of shingles and/or zoster-related conditions. Subsequently, the pt's was treated by a physician for shingles. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of shingles was not provided, and causal relationship was reported as related to zoster vaccine live (ZOSTAVAX).
MISCARRIAGE; This is a spontaneous report  received from a contactable consumer (patient). This is a maternal report. A 37-years-old female patient  received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 16Aug2021 10:00 (Batch/Lot number was not reported) at the age of 37-years-old as SINGLE DOSE for covid-19 immunisation. Vaccine was administered at Public Health Clinic/Military Administration facility. The patient's medical history was not reported. There were no concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not received any other medications within 2 weeks of vaccination. The patient experienced miscarriage on 08Sep2021. Event result in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event included Dilatation and Curettage (D&C). The mother reported she pregnant while taking bnt162b2. The mother was 8 Weeks pregnant at the onset of the event. The mother was due to deliver on 16Apr2022. The last menstrual period (LMP) was on 10Jul2021. The outcome of the event was not recovered. Prior to vaccination,  the patient was not diagnosed with COVID-19 and Since the vaccination,  the patient has not been tested for COVID-19.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Area of medium erythema centered on vaccine site on left deltoid induration in the center, less than 2 cm in diameter.  Small amount of warmth, no swelling, not painful.
Shingles attack of the face. Eye swollen shut. Forehead and scalp rash. Tingling of head. Eye pain and blurriness.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (slight hardness), VACCINATION SITE PAIN (slight pain) and PYREXIA (low grade temperature) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included METFORMIN and ALBUTEROL [SALBUTAMOL] for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced VACCINATION SITE INDURATION (slight hardness), VACCINATION SITE PAIN (slight pain) and PYREXIA (low grade temperature). At the time of the report, VACCINATION SITE INDURATION (slight hardness), VACCINATION SITE PAIN (slight pain) and PYREXIA (low grade temperature) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, Body temperature: 95.4 (Low) She was having lower than normal temperature and 96.2 (Inconclusive) One hour later it was 96.2 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication include OTC-Emergen-C.
SLE development and COVID-19 vaccination; This is a literature report for the following literature source(s):   A 54-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Sjogren's syndrome" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, (UNKNOWN MANUFACTURER)), for COVID-19 immunisation. The following information was reported: SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), outcome "unknown", described as "SLE development and COVID-19 vaccination". The patient underwent the following laboratory tests and procedures: Antinuclear antibody: Positive; Positive; Antinuclear antibody positive: Positive; Complement factor: Unknown result, notes: Hypocomplementemia; DNA antibody: Positive; Histone antibody: Positive. Therapeutic measures were taken as a result of systemic lupus erythematosus.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
The vaccine had expired on 5/4/2023. patient did not have any reaction to the vaccine
This case was reported by a consumer via call center representative and described the occurrence of injection site reaction in a 70-year-old male patient who received Shingrix (batch number 7X3EJ, expiry date 5th December 2020) for prophylaxis. On 29th August 2018, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 29th August 2018, less than a day after receiving Shingrix, the patient experienced injection site reaction and injection site pain. On an unknown date, the outcome of the injection site reaction was recovered/resolved and the outcome of the injection site pain was recovering/resolving. It was unknown if the reporter considered the injection site reaction and injection site pain to be related to Shingrix. Additional details were reported as follows: The reporter's husband experienced the above side effects. The patient received Shingrix on right arm. The patient experienced injection site stiffness and injection site pain. This case has been linked with US2018163082, reported by same reporter.
Tuesday AM had red raised welts around where shot was given, soreness, pain in area. Continued thru Wed. night. Saw RPh recommended ice and Ibuprofen. Stopped in Thurs AM was better. Continued treatment. Called Friday night was back to normal.
First week I had pain from the injection site (left shoulder)  to my  neck left side. Then 2nd week I started getting extreme itchy rash all  over my entire body. From neck to toe. My feet turned purplish and swollen. Even palms of hands itched at night.  About a week after that all started I had one night where I experienced rapid heart rate. It only lasted a few minutes.    Now it?s been 3 weeks since I total shot and I am still suffering from the rash.  (Was prescribed a prednisone for 5 days)
On 28DEC2020 my doctor had a TSH test done and my value was 1.23 ml UL within standard range. Upon changing doctors in 01JAN2023 a new TSH test was done and the value was les than 0.008mU/L. I was sent to an Endocrinologist who did a full thyroid workup and stated I have an overactive thyroid and graves disease. I have been prescribed methimazole to control my thyroid.
Moderna COVID-19 Vaccine EUA Itching, rash, redness and slight swelling approximately 3" long and 1.5" wide that developed on 10th day after vaccination (including the day of vaccination). I have smallpox scar on the same arm which got red, elevated and very itchy. All symptoms subsided overnight but returned in the morning. Lingering soreness and weakness of the left arm.
infect @ site of vax area;5cm round x .25cm deep, reddened draining serous fluid w/localized swelling;
Information has been received from a consumer concerning a 15 month old male patient, with food allergies to peanuts, eggs, soy and wheat, who was vaccinated with a diluted dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine (second generation) via pin prick, "NEAT F/S PRICK TEST".  There was no concomitant medication.  Subsequently, it was reported that the patient did have a reaction and developed facial swelling and hives all over his body.  It was reported that the patient was given medication and the symptoms went away.  Unspecified medical attention was sought.  Additional information has been requested.
This spontaneous report as received from a consumer via Clinic refers to a currently 15 month old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 10-OCT-2017, the patient was vaccinated with improperly stored dose of M-M-R II recombinant human albumin (rHA) 1 dose unit (lot # M044350, Expiry date was not reported) and PEDVAXHIB 1 dose unit (Lot # M047666, Expiry date was not reported), on 13-APR-2017, the patient was vaccinated with improperly stored dose of ROTATEQ 1 dose unit (Lot # M005733, Expiry date: 01-OCT-2017) for prophylaxis. There were no previous temperature excursions recorded. It was unknown if data logger was involved. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1801USA000166.
This case involves a 25-year-old female patient who had severe burning (burning sensation) and welts on arms (urticaria), after receiving INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2127, expiry date: 30-Jun-2022) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed non-serious severe burning (burning sensation) and welts on arms (urticaria) (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was reported "Nurse reports they received 50 doses of Flublok. They administered 6 so far and stopped using the product. She reports for 4 of the 6 administered to staff they have complained of severe burning and were even "jumping" with the injection. Two of the employees have had rashes and welts on arms at injection site the size of a baseball. The welts were hot to touch and raised."  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment for the events.  At time of reporting, the outcome was unknown for both the events.
patient reports red, hot area about 2 inches in diameter around injection site - no pain or itching, patient didn't notice any feeling different, told patient could take ibuprofen if becomes uncomfortable, if worsens was advised to see a physician
Flu      "I feel like I have the flu for the past few days." ? Syncope     "I passed out this morning and I think I hit my head."     Source of Information:  Patient and Available medical record   History of Present Illness:  This is a 64y.o. female with pmh of  Hypertension  H/o renal transplant in 2001,on immmunosuppresants  ckd following transplant  Presented to ed with c/o fever,malaise,which started last week, along with this symptoms she develop cough and sob with nausea,also feeling lightheaded.she is vaccinated for covid,but did not get her booster shot yet. V/s were normal and o2 sat 95 % on ra,at the time of arrival Admission labs were bun/cr of 45/4.09,bilirubin of 2.0,ua with wbc of 11 to 20 but with squamous cells of >50. Ct head shows no acute process Chest xray with rt basilar air space disease  covid -19 positive
Sensation of burning down entire arm to knuckles, as if a nerve was hit during administration of vax; Pt has had flu vax a/but never had this problem a/;
Left thigh- 1/2 dollar sized red rash. Not hot to touch. Child fussy-more than with other shots. Giving TYLENOL and MOTRIN.
I was diagnosed with covid on December 11, I got the vaccine on January 10 while I had no symptoms left from the covid infection . However, one day post vaccine I got all my symptoms back but milder including malaise, sinus pressure, ear ache, sore throat and cough burning sensation in my lungs. 6 days post vaccine still have some cough.
I woke up with a horrible headache the day after my second dose of the vaccine. It progressed to a low grade fever of 100.4, and at one point was 102 degrees. I had chills, muscle aches, and I was extremely tired. Tylenol brought the fever down.
Dizziness and headache which led to patient falling and bruising hip. Site of injection was painful and warm to touch. Pt used ice and OTC Nsaids to relieve pain. Pt stated this helped.
consumer having a possible allergic reaction with a Flu vaccine; Initial information received on 25-Sep-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves patient of unknown demographics who was having a possible reaction (hypersensitivity), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  The patient developed a non-serious consumer having a possible reaction (hypersensitivity), (Unknown latency) following the administration of INFLUENZA VACCINE.  It was reported that Hospital was looking to re-challenge a patient with Fluzone Quadrivalent by diluting the vaccine and administering a small portion and wanting to know what fluid would be compatible with the Fluzone Quadrivalent for the dilution. They would like to know if there was anything, they can use to dilute the flu vaccine. They stated that they have an order for vaccine for a 9-year-old patient from an allergy clinic and they want to challenge with flu vaccine. It was not known if the patient has taken the fluzone in the past and this is a re-challenge. It is not known if the patient has experienced any reactions.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  The outcome was not reported at the time of reporting.  There will be no information on the batch number for this case.
Patient received first dose of the Pfizer COVID Vaccine on 7/6/21. Patient returned today 7/21/21 to alert us that he still was having arm pain from his first dose and that it was tough to raise his arm. Pharmacist observed patient's arm where it was noticeable where the vaccination was given as there was a "rash" or slightly raised area that resembled the injecti-safe bandage. Based on observation, the vaccine was given in the correct location. Patient mentioned taking "pain pills" to assist with the pain but was unable to tell the pharmacist what medications he took. Pharmacist recommended patient to take ibuprofen and use biofreeze for the arm. Pharmacist and patient will follow up with each other in a week and patient will decide if he should go to see a physician.
Information has been received from a registered nurse concerning "many patients" who were vaccinated with a dose of Gardasil. Subsequently, the patients reported that the vaccination was painful. At the time of the report, the outcome was unknown. Additional information has been requested.
I had a miscarriage in December. After receiving my vaccine in February my period became very light. From February-May I only spotted. I didn't have a normal period. My period did not return to normal until June 2022. I also experienced pain my shoulders after receiving the vaccine. The pain felt like it was in my bones and not in the muscle. I am still experiencing pain.
Pt recvd HIB TITER/MMR/DTP/OPV on 26JUN91 2PM; Approx 27JUN91 12noon began to devel urticarial rash;
Vaccines that were administered beyond use date after thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 27-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient's age was reported as 25 years and 2 months. No concomitant medication was provided. It was reported that vaccine was administered beyond use date to the patients. There was no adverse reaction noted or reported regarding these administrations. Vaccine NDC code- 80777-0273-99 No treatment medication was provided.
Subject reports that she felt tired with headache and muscle aches, beginning 8 hours following immunization. Developed tender right neck lymph node on 2nd day following. Treated symptoms with rest and Ibuprofen 800 mg as needed.
HIGH BLOOD PRESSURE; DIFFICULTY BREATHING; DRY COUGH; PRESSURE ON CHEST (FELT LIKE SOMEONE WAS STANDING ON CHEST); This spontaneous report received from a patient concerned a 32 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user, and ex-smoker, and other pre-existing medical conditions included: The patient had no known drug allergies and no drug abuse or illicit drug use. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 08-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-SEP-2021, the patient experienced pressure on chest (felt like someone was standing on chest). On 22-SEP-2021, the patient experienced difficulty breathing. On 22-SEP-2021, the patient experienced dry cough. On an unspecified date, the patient experienced high blood pressure. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) High. The action taken with covid-19 vaccine was not applicable. The outcome of the dry cough, difficulty breathing, pressure on chest (felt like someone was standing on chest) and high blood pressure was not reported. This report was non-serious.
Patient complained of dizziness and drowsiness after vaccination. Vitals signs taken and patient monitored until discharged home. No hospitalization needed.
Vaccination site began to swell to the size of an egg on 5/13/10. No Fever, No Rash. Site itchy. 5/18 - site has large red circle, swelling has subsided. Pt applied ice and took ibuprofen.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 21-FEB-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB injection, lot # N031493 with expiration date on 03-OCT-2019 (dose and route of administration were not reported). The vaccine underwent a temperature excursion of 47 (46.9) to 77 degrees Fahrenheit for 10 minutes. Digital Data Logger was not involved in recording of the excursion. No previous temperature excursions were reported. No adverse effects were reported. This is one of several reports received from the same source. Sender's Comments: US-009507513-1803USA007590:US-009507513-1803USA013072:US-009507513-1803USA013073.