chrisvoncsefalvay/vaers-outcomes huggingface dataset:
with the second round, she couldn't tell she had a shot unless she pushed on it, like she got a bruise; Soreness around the injection site with very little swelling- like a mosquito bite,; she had a small bumps and it was sensitive to the touch; Very little bit of heaviness when lifting arm; Soreness around the injection site with very little swelling- like a mosquito bite,; This is a spontaneous report from a contactable consumer or other non hcp.   A female patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient's historic vaccine included bnt162b2 (BNT162B2, solution for injection), dose 1 on an unspecified date as single dose for covid-19 immunization. she experienced soreness around the injection site with very little swelling- like a mosquito bite, she had a small bumps and it was sensitive to the touch and little bit of heaviness when lifting arm. On an unspecified date, patient couldn't tell she had a shot unless she pushed on it, like she got a bruise. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
The patient received the vaccine, walked around the store after receiving it and started having an allergic reaction. We then gave her 2 tablets of 25mg Benadryl and contacted 911. Paramedics came and checked her out, suggested she go to the hospital but she declined.
pain, redness, swelling at injection site 1 week post vaccine with left axillary adenopathy
Patient has no history of cancer, one month after vaccination, he developed  squamous cell carcinoma skin cancer as well as a basal cell carcinoma skin cancer. Three weeks after his second vaccination, he developed a persistent sore throat which never improved. Upon endoscopy, tissue changes were seen on surface of epiglottis, which with biopsy revealed Squamous Cell Carcinoma.
Approximately 1 hour after receiving immunizations child experienced fever of 103, vomiting and rapid heart rate that lasted for the rest of the day.  Was treated with Tylenol and Motrin alternating for fever after seeing doctor.
Received Moderna vaccines on 2/25/21, 3/25/21; tested positive for COVID by PCR on 8/24/21 hospitalized for ileal perforation on 8/25/21; incidental finding of asymptomatic COVID infection.
Redness on arm where vaccination was given. Started at the size of a quarter and now the size of a fist.
This spontaneous report was received from an immunization coordinator and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown day in December 2015, the patient was vaccinated with an improperly stored dose of M-M-R II (lot # K002528, expiration date: 18-FEB-2016) (dose, route of administration and injection site were not provided). No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of 51.1 degrees Fahrenheit for 1 hour and 15 minutes. Data logger was involved. There were no previous excursions reported. Additional information has been requested.
38 y/o pt received primary SPV + AVA #3 1/11/2008; presented acutely with chest pain, diaphoresis, light-headedness on 4/21/2008; abn ECG (LBBB, age indeterminate); hospitalized at medical center 4/22-4/23/2008, diagnosed with non-ischemic cardiomyopathy, discharged to CONUS for continuation of care. Symptoms: Chest Pain, sub-sternal, Diarphoreis Comments: Onset of symptoms not temporally-related to receipt of vaccines listed box 13; vaccine causality assessment, using WHO criteria for AEFI: association with receipt of SPV and AVA is unlikely 8/13/08-records received-on 4/22/08 DX Idiopathic cardiomyopathy and LBBB. In early January C/O feeling tired, flu-like symptoms 2-3 days following vaccinations. Smallpox site erythema mild swelling and swollen tender lymph nodes. 3/08 became ill with viral infection and failed PT test, easy fatigability. Developed cellulitis of toe. On 4/21/08 developed mod-severe left anterior chest pain and diaphoresis and light-headedness.  Follow-up: Buf cardiac stable and controlled. Pt received inter cardiac defibrillator 10/2008; was medically boarded out of active Military Service to TDRL.  Status effective Aug 2009.
use to get the flu every year; Initial information was received on 26-Feb-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves a patient (age and gender unspecified) who use to get the flu every year (Influenza), when received INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications 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 not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was use to get the flu every year (Influenza) (unknown latency, non-serious event) following the administration of INFLUENZA VACCINE.  Reporter Comment: Consumer use to get the flu every year. Consumer have stopped flu shots and other medicines, health is wonderful. It was unknown if the patient experienced any additional symptoms/events. Medication Details and reason for taking the medicine: Product Name: Product name was not provided. Since this is a public post on the Sanofi flu shot campaign we are assuming the consumer is referring to the Sanofi flu vaccine. The patient had no medical history, concomitant disease or risk factor. There were no lab data/results available.   No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Received vaccine on Monday, had sudden Gall bladder attack on Friday. No prior symptoms at all, emergency gallbladder removal surgery done on Saturday Nov 12, 2022
Pt recvd MMR vax on 29OCT91; 10DEC91 recvd booster dose & w/in 5 to 10 mins following vax exp dizziness & vertigo; 20 mins later exp h/a; also nervousness & a feeling of impending doom;
Nausea, vomiting, diarrhea, fever, redness at site of reaction. Patient went to doctor who prescribed ZOFRAN.
some soreness in his left arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (some soreness in his left arm at injection site) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, the patient experienced VACCINATION SITE PAIN (some soreness in his left arm at injection site). At the time of the report, VACCINATION SITE PAIN (some soreness in his left arm at injection site) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication were reported. No treatment information was reported.   This case was linked to MOD-2021-320997 (Patient Link).
pt would lose consiousness, come back lose consiousness, come back lasted about 10-15 secs ea time;
Tested + with sore throat, body aches, headache, mild congestion.; Tested + with sore throat, body aches, headache, mild congestion.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19May2022 at 14:00 as dose 4 (booster), single (Lot number: FJ4991) at the age of 61 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested + with sore throat, body aches, headache, mild congestion.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive; (Jun2022) Positive; (Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Information has been received from a health professional concerning a 17 year old female with acne and no known drug allergies and a history of spinal meningitis at 6 months old who on 06-AUG-2007 was vaccinated with a second dose of Gardasil.  Concomitant therapy included ACCUTANE.  It was reported that RETIN-A, AMOXIL and a topical medication for acne were discontinued when ACCUTANE was started.  On 06-AUG-2007 the patient experienced generalized itching and hives over most of her body.  The patient sought unspecified medical attention.  It was noted that on 04-JUN-2007 the patient received her first dose of Gardasil  (Lot # 657868/0523U) and MENACTRA with no reaction noted.  No laboratory diagnostic studies were performed.  At the time of this report, the patient had not recovered.  No product quality complaint was involved.  Additional information has been requested.
Nausea, headache, vomiting within 24 hours following Anthrax injection. Fever, svere headache, nausea, vomiting, body aches, fatigue.  Pt. has been evaluated by a physician or health care provider for this event.  Pt received ANTHRAX shots since the reported event - same symptoms as described above. Shot 1 and 2, symptomns persisted for 72 hours. third shot, symptoms still reamin after 15 days.
Father called on 02/22/2019 to report his daughters arm hurt (unknown arm), fatigue, and generalized muscle pain. PHN suggested father call health care provider.
No adverse effects; patient was administered one dose of GARDASIL 9 on 8/14/2014, and one dose of GARDASIL 9 on 6/24/2016; This spontaneous report was received from a medical assistant and refers to a 24-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 14-AUG-2014, the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, site and route of administration, lot # and expiration date were not reported) for prophylaxis and on 24-JUN-2016, she was vaccinated with another dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, site and route of administration, lot # and expiration date were not reported) for prophylaxis. No adverse effects were reported.
Full body ache, chills, low grade fever, very sore arm on which injection occurred, extreme exhaustion, which lasted about 36 hours. Also seems to have delayed menstrual period by two days (which has started in the meantime with no other notable change).
during the noc mom noted pt to be having frequent recurrent gen twitching of all 4 extremities, lasting 3-4minutes; sucking @ breast irregularly & sporadically during episode;seemed dazed for few minutes afterward;nl, no fever
pt c/o chest pain p/vax;breath sounds present & clear;P80, R20, skin warm to touch, negative urticaria, hives, & cyanosis;
This spontaneous report was received from an office manager referring to a 1 month old patient of unknown gender. The patient's medical history and concurrent condition was not reported. On 09-JUN-2016 the patient received a dose of ROTATEQ (lot# L027726, expired on 10-MAY-2017) 2 ml, orally, which is outside the recommendations of the prescribed information (drug administered to patient of inappropriate age). No adverse effect was reported. Additional information has been requested.
My INR went up to 8 without any other changes. INR stayed stable with the second and third dose. My desired range is between 3 and 3.5.
Swelling, itching on left arm. Hives spreading to face with swelling, itching. Hives appearing on right arm, chest (itching). Neck pain, joint pain, headache, fatigue. Called Dr. after Benadryl and hydrocortisone not effective. Ibuprofen relieved headache. Rx:  Methylprednisolone initiated on afternoon of 3/15. Itching relief allowing me to sleep but hives on right arm (opposite of injection) has worsened. On second day of 5 day protocol.
Sore upper right arm, feels like a punch to the arm. Dull pain when lifting arm. Persisting for a few days
This spontaneous report as received from a registered nurse refers to a 7 months old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 07-NOV-2016, the patient was vaccinated with improperly stored PEDVAXHIB (dose and route not reported) from lot # M025192, expiry date: 21-MAR-2019 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140.
Started feeling chest pains approximately one week after second vaccination. Nothing noticeable after the first vac. Pain comes and goes, no connection to activity from what I can tell. Can feel sharp but is dulled. Lessens with mid-day rest. Symptoms come and go, and are either beginning to fade or I?m just getting used to it. Started taking aspirin just in case. Have not seen healthcare provider yet but have considered emergency and urgent treatment.
Patient experience a fainting episode onhis way from vaccination area to observation area. Parameddics were summoned and responded and checked patioent  Patient was "out" for approximately 15 seconds per EMT who witnessed event.
This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (she was quite fatigued) and VACCINATION SITE ERYTHEMA (Redness at the injection site that does not hurt but is quite large) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. No Medical History information was reported. On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced FATIGUE (she was quite fatigued) and VACCINATION SITE ERYTHEMA (Redness at the injection site that does not hurt but is quite large). At the time of the report, FATIGUE (she was quite fatigued) and VACCINATION SITE ERYTHEMA (Redness at the injection site that does not hurt but is quite large) outcome was unknown. No concomitant and treatment medications were reported. For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable.
PATIENT ANSWERED NO TO ALL QUESTIONS ON THE VARS FORM AND RPH CONSULTED WITH HER AB THE HIGHER RISK FOR THROMBTIC EVENT IN WOMEN IN HER AGE GROUP AND COUNSELED HER AN ALTERNATIVE MFG SUCH AS PFIZER, BUT PT WANTED THE JANSSEN MFG. IMMUNIZER TECH PROCEEDED TO IMMUNIZE PT AND PON COMPLETION OF THE ADMINISTRATION, PT SEEMED LIKE SHE WAS FAINTING AND TECH/RPH HELPED TO SLIDE HER TO THE FLOOR. AS SHE WAS SLIDING SHE SEEMED TO HAVE A TINY SEIZURE (JERKING MOVEMEN OF THE HEAD). JUST A FEW SECONDS IN AS SHE WAS ON THE FLOOR AND RPH WAS ASSESING HER ( TECH ON CALL WITH 911 ) SHE CAME AROUND AND ABLE TO SPEAK AND SAID THIS HAPPENS TO HER SOMETIMES AND SHE WILL BE FINE. SHE REFUSED RESCUE WHILE STILL ON THE PHONE. A FEW MINUTES LATER AS SHE WAS BETTER SHE WENT TO HAVE A SIT / LAY DOWN ON THE CHAIRS IN THE WAITING AREA WITH HER FRIEND AND TECH HELP. SHE WAS THERE FOR A FEW MINUTES STILL FEELING A BIT LETHARGIC SO 911 WAS CALLED BY STORE MANAGEMENT JUST TO MAKE SURE SHE WAS OK. FIRE RESCUE CAME AND CHECKED HER OUT AND SHE SEEMED BETTER AND WENT HOME WITH HER FRIEND AFTER FIRE RESCUE CHECKED HER OUT.
A non-serious spontaneous report of bloody nose has been received from a non-health professional concerning an eight-year-old male, subsequent to FLUMIST. Neither past medical history nor concomitant medications were reported for this patient. On unknown date, patient received FLUMIST. An eight year old patient reported bloody nose after receiving FLUMIST. Nurse who administered the vaccine believes that it was because the child was not cooperating with her. The outcome of event bloody nose was unknown.
discomfort and pain on his back; joint pain; chills; discomfort and pain on his back; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 04Mar2021 as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration for covid-19 immunisation and patient stated when he received the first dose of the vaccine he did not have any adverse reaction. On an unspecified date, the patient experienced discomfort and pain on his back, joint pain and chills. Outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Severe Chills; Fever; Muscle Aches; severe flu-like symptoms; This non-serious case was reported by a nurse via sales rep and described the occurrence of chills in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In JAN-2021, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced chills (Verbatim: Severe Chills), fever (Verbatim: Fever), muscle pain (Verbatim: Muscle Aches) and influenza-like symptoms (Verbatim: severe flu-like symptoms). The outcome of the chills, fever and muscle pain were unknown and the outcome of the influenza-like symptoms was resolved (duration 24 hrs).   It was unknown if the reporter considered the chills, fever, muscle pain and influenza-like symptoms to be related to Shingrix.     It was unknown if the company considered the chills, fever, muscle pain and influenza-like symptoms to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-APR-2023 The reporter reported an adverse event from an in-office staff member. The reporter did not consent for follow up.
Hives that started out as itchy bumps and spread across entire body within 24 hours. Required oral steroid and Benadryl course to treat.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient's pertinent medical history, drug reaction or allergies and concomitant therapies were not reported. On 05-MAR-2018, the patient was vaccinated with one shot of PEDVAXHIB (lot # N034006; expiry date: 01-FEB-2020) injection which had undergone a temperature excursion and was not supported. Dosing details were not reported. The temperature excursion occurred at 28.8 degrees Fahrenheit (°F) on an unknown date for a time frame of 35 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1803USA002448.
PATIENT RECEIVED BIVALENT DOSE BUT SHOULD HAVE RECEIVED FIRST DOSE IN PRIMARY SERIES
Patient developed dizziness and tachycardia 1 minute after receiving vaccination. Blood pressure was low. Full recovery after 10 minutes.
70-year-old male, with past medical history of hypertension and morbid obesity who presents with generalized worsening weakness and shortness of breath. Was noted and found to be COVID-19 positive yesterday by a home test. He has been increasingly weak and tired the last few days with worsening shortness of breath and audible wheezes. He does not use oxygen at home at baseline. As any chest discomfort or chest pain. He has not had lightheadedness or dizziness or presyncopal episodes and was urged to come in and be evaluated in the ED by his daughter who called EMS. EMS arrived at his house patient was noted to be hypoxic and he was placed on 5 L of oxygen via nasal cannula. Patient otherwise admits to normal by mouth intake with normal voiding and no blood. He does admit to having diarrhea about 3-4 times per day for the last week. He otherwise has no other complaints, negative PCR test her at facility x2 on 12/11/2021 and 12/13/2021
Patient reported burning at the injection site shortly after receiving vaccine.  She had a burning / swelling sensation of her tongue and otherwise felt unwell.  She was placed on a cardiac monitor which showed ST with a VR 142-155, no ectopy.  She reports that her HR is usually 130 or less.  She had a BP that ranged between 149-160/96-105.  She reports this is elevated for her.  Patient sent to ED and given Benadryl and prednisone for 3 days. On 1/4, patient contacted MD and stated injection site is red and raised. Continues to take Benadryl and prednisone and has a numb and swollen tongue.