chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mother reports patient stated he didn't feel well 5 minutes after vaccination. She assisted him off the exam table to the garbage can in case he needed to vomit. Mom reports his body stiffened, his eyes widened, so she laid him on the ground. She states his body felt stiff. He urinated wile laying on the ground. Mom called for help and staff immediately responded. He was pale, but started to speak when we entered the room asking what happened. BP 110/60, pulse 70. He was given a lollipop. After several minutes he was assisted to a sitting position. He had no complaints other than feeling tired. His lips were now pink. He was assisted to the chair where he sat for several minutes. He drank and retained a cup of water. He was then assisted to standing position, and took steps around the office. He stated he felt himself, just tired. After several minutes he was ambulated out of the office without incidence. Time in office, approximately 45 minutes.
Mild arm soreness the next day, no other symptoms. On day 7 had noticeable redness, induration at the site of injection. Site was hot, red, swollen, but not painful. No other symptoms. Redness spreading everyday, but the induration is less.
Initial report received 28 January 2009 from a consumer who is the patient's aunt. A four-month-old patient with a history of respiratory problems, had received a first dose of DAPTACEL, lot number C3000AA, a first dose of ACTHIB, lot number UF518AA (corresponding sanofi pasteur SA lot number B0030-2), and a first dose of PREVNAR (manufacturer Wyeth, lot not reported) on an unspecified date, and within 24 hours, he began to have seizures. The patient received treatment at the hospital (unspecified). According to the reporter, the patient, who was now six months old, was now home on an apnea monitor and their recovery status was unknown. The reporter declined to provide additional information at the time of the report. Documents held by sender: None
Vaccine expired on 2/1/2022 and vaccine given on 2/2/2022.  No adverse reaction occured.
No signs or symptoms. Pt is pregnant and received the H1N1 Flumist Vaccination. Pt is 21 year old, G2P1, 16 weeks normal IUP. No treatment. 11/19/2009 MD records, pregnant patient with no sx at this time
At 10 pm on the 5th I got chills, shaking, goose flesh and cramps quickly followed by nausea and then diarrhea and vomiting. By 3 am those had lessened and I had muscle aches, mild nausea and fatigue during the day on the 6th. By the morning of the 7th I was fine.
patient fainted while driving the car; This is a spontaneous report from a non-contactable consumer reporting for a patient. A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation, age at vaccination unknown. The patient medical history and patient's concomitant medications were not reported. 40 minutes after the application, patient fainted while driving the car. Outcome of the event was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, start therapy date was not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache. This report was non-serious.
light headedness & chills in 30';throat swelling feeling in 1hr, sx improved but not gone in 4hr;no hives or wheezing;
Information has been received from a consumer concerning her daughter current 22 year old daughter with migraine, asthma, fibroids and pertussis allergy, who in 2007 started therapy with GARDASIL (Lot # not reported). Concomitant therapy included TOPAMAX. Consumer reported that about a month to six weeks after her daughter received the 3rd GARDASIL shot, she started developing papillomas around her eyes. They were removed about this time last year in approximately November 2009 or in the beginning of 2010. Within the last 2 or 3 months, in approximately August 2010 they have come back and been multiplying. There were located just where the eyelash goes into the lid, and now there were some growing on the bottom section of the eye too. Consumer's daughter was never admitted to hospital, she had outpatient surgery. On an unspecified date a biopsy on papillomas and invasive Pap smears were performed (results not provided). At the time of the report the patient had not recovered. Additional information has been requested.
side effects after second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (side effects after second dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Past medical history not provided).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE DRUG REACTION (side effects after second dose). At the time of the report, ADVERSE DRUG REACTION (side effects after second dose) outcome was unknown.            Reporter did not allow further contact
After a life time and family history of normal to low blood pressure, my blood pressure skyrocketed and has remained high. I discovered this two days after the shot at a normal visit to my medical doctor.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Feb2021 as dose 1, single (Lot number: EL9265), in left arm, on 09Mar2021 as dose 2, single (Lot number: EN6205), in left arm and on 09Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cough-variant asthma" (unspecified if ongoing); "migraines" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: QVAR REDIHALER; FLOVENT; PANTOPRAZOLE, start date: 10Dec2021; POTASSIUM CITRATE, start date: 03Feb2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Symptoms resolved and I tested negative multiple times; (14Jun2022) Positive, notes: symptoms returned and I tested positive again. Reboundexperienced. Therapeutic measures were taken as a result of vaccination failure, covid-19. Anti-viral details Product: COVID 19 Treatment,Brand: Paxlovid Treatment start date: 04Jun2022, Treatment stop date: 08Jun2022.
PASSED AWAY; This spontaneous report was received from a partner, and concerned a 64 year old patient of an unspecified sex. The patient's height, and weight were not reported. The patient's past medical history included strokes; concurrent conditions included heavy smoker, caffeine consumption, unspecified heart issues, and felling unwell. The patient received Covid-19 vaccine Ad26.COV2.S (suspension for injection, route of admin, and batch number were not reported) dose, vaccination site, and start therapy date were not reported, for prophylactic vaccination. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient passed away. It was reported that the patient received Covid-19 vaccine in the morning and passed away later that day. The patient had felt unwell upon waking up that morning prior to vaccination. The coroner ruled out the vaccine as a potential cause of death due to the individual's past and concurrent medical conditions. It was unspecified if an autopsy was performed. Action taken with Covid-19 vaccine Ad26.COV2.S was not applicable. This report was serious (Death).; Sender's Comments: V0: A 64-year-old patient of unspecified sex received the Janssen COVID vaccine in the morning and died later that day. The coroner ruled out the vaccine as a potential cause of death due to the individual's past and concurrent medical conditions, although these conditions weren't specifically reported. Given the coroner's assessment and symptoms preceding vaccination, there is a plausible alternate explanation for the death.; Reported Cause(s) of Death: PASSED AWAY
PT WITH HEMATOSPERMIA, HTN AT 172/114,   SENT TO ER TO R/O ABNORMALITIES
Disease recurrence (Suspected COVID-19); Drug ineffective; Suspected COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 54-year-old female patient received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Lot number: EN O208) and on 09Apr2021 as dose 2, single (Lot number: EWU153) at the age of 53 years 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) with onset Jan2022, outcome "unknown"; SUSPECTED COVID-19 (medically significant) with onset Jan2022, outcome "unknown"; DISEASE RECURRENCE (medically significant) with onset 16Jan2023, outcome "unknown", described as "Disease recurrence (Suspected COVID-19)". The events "drug ineffective", "suspected covid-19" and "disease recurrence (suspected covid-19)" required physician office visit. Clinical Course: Patient stated she knew people got Bell's Palsy with reaction to Pfizer covid-19 vaccines, she did not have Pfizer shot since Apr2021. She did not have the boosters, her doctor thought that it was too long ago to be the reason for this. She did get covid herself in Janaury and her upper back and neck were in excruciating pain, then all of a sudden bam. She had covid twice after the second dose of the Pfizer covid 19 vaccine, second dose was in April, she got covid the following Jan2022, and again this 15Jan2023. Patient asked for any data that people who took Pfizer covid vaccine had bell's palsy, or got it at a later date. She got Covid on 16Jan2023 and woke up all nasally, woke up the next day and her upper upper trap muscles, neck and muscles on the right could not move without pain. Her doctor thought it was post viral neuralgia. She had been going to physical therapy 3 times a week since January. She just went down to 2 times a week because her body was feeling better and did not know if it was related. She was also under a lot of stress.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300182700 Same patient, different product, different event;
I have had no symptoms. I went in for my physical on the 25th of May. I was not fasting and had all my labs done. I have not had any symptoms at all. I was surprised quickly because my labs came back needing attention. I had elevated AST and GOT. She wanted to schedule me for an ultrasound, so I had that done on June 15, 2022. That was negative and showed nothing wrong with my liver. She referred me to a gastroenterologist, but I haven?t scheduled an appointment because we?re waiting to see if the steroids will help with the inflammation and elevated enzymes. I?m currently taking prednisone 40mcg for 10 days then tapering down to 20mcg then 10mcg then 5mcg for the next 10 days after.
This spontaneous report as received from a pharmacist refers to an unspecified patients of unknown age and unknown gender. On an unknown date, the unspecified patients were vaccinated with doses of improperly stored PNEUMOVAX 23. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 24-APR-2015, the patient was vaccinated with a dose of improperly stored VAQTA (10Pk 50U/1 mL) lot number K008984, expiration date of 21-OCT-2015 (route of administration was not reported), which was stored 1 time with the following lowest recorded temperature: 34F (1.11 celsius degrees) for 88 hours. No highest reported temperature was reported. The type of storage was refrigerator. No concomitant therapies were reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021 at 10:36 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Feb-2021 at 10:36 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 34.76.  Concomitant products were not provided.  On 13-Feb-2021, Excursion time was 09:00 AM, temperature was 32, total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Feb-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Numbness in right arm and leg almost immediately after the shot. Numbness is not constant but comes and goes. So far it has been a year with occasional numbness in right arm and leg.
Information has been received from a registered pharmacist concerning a patient who was vaccinated with ZOSTAVAX (Oka/Merck) about two weeks ago, and then within two weeks of receiving ZOSTAVAX (Oka/Merck) the patient had chickenpox like rash and it was itchy. No further information is available.
a mild kidney infection; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age (reported as 70; unit unknown) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration on 08Feb2021 at SINGLE DOSE for covid-19 imunisation. Patient's medical history and concomitant medications were not reported. It was reported that patient received first dose of the Covid vaccine yesterday (08Feb2021). Patient reported that it appears he has a mild kidney infection on an unspecified date in which his urologist has prescribed ciprofloxacin to take. Patient asked if an antibiotic will interfere with his vaccination. Outcome of the event was unknown.   Information about batch/lot number has been requested.
pt recv vax 23SEP97 family traveled to Colorado about 26SEP97 & child became ill was seen @ clinic 28SEP97 w/fever;dx OM;med prescribed;2OCT97 came to ofc w/sx rash-hive like rash;platelet count 52,000;3OCT platelet count 83,000;
Inflammation  lines lesions that come and go; Inflammation  lines lesions that come and go; chills; fever; immediate synthetic headache; Experienced brain fog; This is a spontaneous report from a contactable consumer (patient) for herself. This 56-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number were not reported), via an unspecified route of administration on 02Apr2021 as DOSE 1, SINGLE for COVID-19 immunization. Patient had no relevant medical history. The patient concomitant medications were not reported. On an unspecified date in Apr2021 after the vaccination, the patient experienced inflammation lines lesions that come and go, chills, fever, immediate synthetic headache and experienced brain fog. It was reported that, the patient reluctantly received first dose 02Apr2021, 7-10 days following first dose the patient reported inflammation, lines lesions that come and go. Not historical and blood clots. They occur again, resolve and experienced brain fog, an immediate synthetic headache, chills and fever. The patient did not take any medication and declined complete demographics. The HCP indicated to receive second dose and asked if adverse events was worse Potential Duplicate AE. Spoke from attached and Full EUA Prescribing Information Table 1: Study 2 - Frequency and Percentages of Participants with Solicited Local Reactions, by Maximum Severity, Within 7 Days after each dose - Participants 18-55 Years of Age-Reactogenicity Subset of the Safety Population. Refer to HCP numerous time. The patient asked about efficacy of vaccine and how long the patient be protected. When was the patient knowns that he was protected and if he get Sars-COV-2, it be less symptomatic and the patient safely went out. The outcome of the events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I was dizzy, loss of balance, sore all over that is getting better but still present.
FEELING FLUSH IN FACE FEELING DRYNESS IN MOOUTH AND THROAT FEELING THICKNESS IN THROAT ( CLIENT EVALUATED BY CLINIC DOCTOR AND SYMPTOMS SUDSIDED IN 15 MINUTES)
Patient scheduled for a vaccine update visit.  Patient was due for the #2 dose of Bexsero.  What was ordered and administered was Pfizer Bivalent, 0.3ml dose.  No reaction noted other than reporting of the error.  Patient has never received a COIVD vaccine prior to this incident.   It was reviewed and found on 4/17/23 that the incorrect vaccine was ordered and administered.  MA was addressed and required to complete additional training and support.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE NEUROPATHY 8/25/2022,  10/31/2022,  11/2/2022 -- RECURRENCE OF SAME SYMPTOMS
5 minutes after the 5 vaccines, She felt an abnormal feeling in her throat like it was maybe swollen, tingling sensation in both arms, lightheaded feeling, jittery. HR and BP was good, no fever, breathing sounds remained clear. Patient was laid down and within 5 minutes or less 50 mg of IM Benadryl was given. Within 5 minutes or less, she felt the swelling sensation in throat get better. She slowly got better over the next 1 to 1.5 hours and left feeling well, not excessively tired.
patient was given a 3 dose of vaccine.  he had tiredness and also soreness at the site of the injection
Patient received this at alternative Health Clinic on 1/6/2023.  Vaccine was not documented in EMR, so patient subsequently received vaccine on 2/21/2023
Patient experienced fever on Monday with fatigue. Tuesday she started to experience generalized joint pain, swollen cervical lymph nodes, diarrhea and nausea.
Soreness and red mark on right arm at injection site Soreness in left arm Slight fever (99.8 F), general achiness and headache
The first day I had pain in left arm around injection. Couldn't sleep on it. Next day it was itchy but pain had subsided. Next day itching was almost gone. By Wednesday January 27 I thought everything was gone. Getting dressed that night I noticed a red rash developed around or near injection site. About 1 inch by 2 inch oval, slightly raised, slightly warm, slightly itchy. This morning January 29, it is still there less itchy and less red, but still visible outline. I was being followed by vsafe up to wednesday afternoon the 27th. I thought I shouldn't wait til next week for the vsafe check in.
Information has been received from a provider concerning a consumer's female friend who on an unspecified date, was vaccinated with GARDASIL (lot # not reported). Subsequently the patient experienced seizures. At the time of report, the outcome was unknown. It was unspecified if the patient sought medical attention. Upon internal review, seizure was considered to be another important medical event. Additional information has been requested.
ITCHING OF EYELIDS; GLANDS ARE SWOLLEN BETWEEN TEMPLES AND EARS; INCREASED BATHROOM USE; HURT ALL OVER; TINGLING ON LEFT SIDE; ITCHING OF EYEBROW/ITCHING; FEEL LIKE EATEN A SOUR CANDY; GOT NAUSEATED; HEADACHE; TIRED; This spontaneous report received from a patient concerned a 63 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included neuropathy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: HT365, and expiry: 03/AUG/2021) dose was not reported, administered on 30-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-JUN-2021, the subject experienced itching of eyelids. On 30-JUN-2021, the subject experienced glands are swollen between temples and ears. On 30-JUN-2021, the subject experienced increased bathroom use. On 30-JUN-2021, the subject experienced hurt all over. On 30-JUN-2021, the subject experienced tingling on left side. On 30-JUN-2021, the subject experienced itching of eyebrow/itching. On 30-JUN-2021, the subject experienced feel like eaten a sour candy. On 30-JUN-2021, the subject experienced got nauseated. On 30-JUN-2021, the subject experienced headache. On 30-JUN-2021, the subject experienced tired. Treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the itching of eyelids, glands are swollen between temples and ears, tired, got nauseated, increased bathroom use, hurt all over, headache, tingling on left side, itching of eyebrow/itching and feel like eaten a sour candy was not reported. This report was non-serious.