chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt texted me "feels really crummy.; Body aches; Bones hurt; I'm radiating heat but freezing; Got home and temp was 99.8, it is usually around 96.5; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 24Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IUD NOS; BENADRYL; IBUPROFEN. Vaccination history included: Bnt162b2 (Dose 1, Lot number: Unknown), for COVID-19 immunization.  The following information was reported: FEELING ABNORMAL (non-serious) with onset 25Mar2021 20:00, outcome "recovering", described as "Pt stated "feels really crummy."; PAIN (non-serious) with onset 25Mar2021 20:00, outcome "recovering", described as "Body aches"; BONE PAIN (non-serious) with onset 25Mar2021 20:00, outcome "recovering", described as "Bones hurt"; FEELING COLD (non-serious) with onset 25Mar2021 20:00, outcome "recovering", described as "I'm radiating heat but freezing"; BODY TEMPERATURE INCREASED (non-serious) with onset 25Mar2021 20:00, outcome "recovering", described as "Got home and temp was 99.8, it is usually around 96.5". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of feeling abnormal, pain, bone pain, feeling cold, body temperature increased.  Additional information: It was unknown whether the patient receive any other vaccines within 4 weeks prior to the COVID vaccine or not. List of any other medications the patient received within 2 weeks of vaccination: Pt has an IUD and took OTC Benadryl and Ibuprofen. the patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The events did not result into death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect. This report was non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
She was diagnosed with appendicitis; This is a spontaneous report received from a contactable consumer (parent; patient's mother). A 19-year-old female patient (daughter) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 24Apr2021 at 11:00 (at the age of 19 years old) (Lot Number: ER8736, unknown expiration) as 1st dose, single for COVID-19 immunization.  Medical history and concomitant medication reported as none.  One week after the vaccine dose, the patient went to the ED with pain and vomiting on 02May2021. She was diagnosed with appendicitis after running some tests on 02May2021 and had her appendix has been removed on the same day she was admitted. The reporter asked if there was any further information about more patients getting appendicitis after the Pfizer vaccine and if the patient should get the second shot. One of her daughter's friends knew someone else who got the shot and got appendicitis, so the reporter wanted to know if it was a common side effect or coincidence. The reporter has no identifying information about her daughter's friend who knew someone that got the shot and had appendicitis. No additional vaccines administered on same date of the Pfizer suspect. They knew from the blood test something was wrong, the patient's WBC results were too high on 02May2021. The regular range was between 4.31-10.16 but the result was 22.03 units per microliter, she was not sure what the units mean. The patient's urine test results (unknown results) were not explained to the reporter and the CAT scan confirmed positive for appendicitis on 02May2021.  No prior vaccinations within 4 weeks. The patient was recuperating from it with no more complications. The events require emergency room visit. The patient was recovering from the events.  The events were assessed as serious (hospitalization from 02May2021 to 03May2021)  Information on lot/batch number was available. Additional information has been requested.
PATIENT COMPLAINED OF CHEST PAIN VSS: 140/100 (LEFT); 140/90 (RIGHT); 142/98 (LEFT)  PULSE OX: 98%; PULSE 100 REGULAR  EMS CALLED AND EVALUATED; PATIENT DECLINED TRANSPORT AND STATED SHE WOULD CONTACT HEALTH PROVIDER; SHE WAS TRASPORTED HOME BY A COWOKER
died Fr the shot; This case was reported by a consumer via media and described the occurrence of unknown cause of death in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the unknown cause of death to be related to Shingles vaccine.  Additional details were provided as follows The reporter was the patient's friend. The age group was not reported but was captured as an adult as per the vaccine indication. The age at vaccination was not reported. The reporter stated that, the patient died from the shot.; Reported Cause(s) of Death: Unknown cause of death
swelling in throat and mouth and lips  and then in left hand all the way up left arm to armpit over course of seven days
Late injection reaction.  Awoke to find a large rash (about 3 inches long, 1 inch wide) around the site of the injection.  I had not noticed it before that time.  It resolved by itself over the next few days.
Tenderness, Swelling, itching, denied fever, describes knot "as size of golf ball" at site of administration. Mother states took child to facility on 8/22/10. Was told she had an allergic reaction & to take Benadryl & Motrin.
10 cm x 4 cm, raised, red, hot, painful, rash . It started as two, round, red, raised areas that progressed over 18 hours to the previously mentioned dimensions. I took Tylenol, Benadryl and applied ice compresses. Day 2+ arm remains the same.
Information has been received from a pharmacist referring to a female patient of unknown age with rheumatoid arthritis. In approximately February 2014 (reported as "about a year ago"), the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route were not reported). Subsequently, on an unknown date, the patient developed shingles. The patient "was working with the Centers for Disease Control (CDC)" about the event. The patient had sought unspecified medical attention. The outcome of shingles was not provided. Additional information is not expected because the reporter had no patient information available and did not want to be contacted.
Patient received first dose of Moderna on 03/18/2021 and received second dose on 04/01/2021 - being too soon to receive second dose of vaccine.
3cm x 3cm wheal at injection site with erythema about 10 mins after injection. Varivax was given 7/13/06 in the right thigh. within 5 min pt had reaction. Pt was asked to wait 15 min before leaving office. Pt was doing better, given Benadryl at home. Reaction 3cm x 3cm hard round wheal.
Seizure - 5 minutes after receiving vaccine, patient stated, "I'm feeling faint." - then she slumped forward & sideways on exam table and had twitching - generalized tonic-clonic seizure lasting 10 seconds. Was post-ictal for 10 minutes the regained consciousness.
Arm/Shoulder are extremely sore.   Mainly at night  or when arm is at rest for period of time.  Been going on for a week and its not getting better.
Patient started to feel muscle pain at the upper part of the injected arm and it was getting worse till today (10/29) when she contacted the pharmacy. No treatment was done. She also noticed red raised rash on both sides of her neck about 10 days after the shot and the rash is getting better now.
Approx. 8 hours after Meningitis shot, developed pain, swell and erythema approx. 1" in diameter.
VACCINE WAS ADMINISTERED FROM A PUNCTURED VIAL 18 HOURS AFTER BEING USED INITIALLY.; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 07-AUG-2021) dose was not reported, administered on 24-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-JUN-2021, the subject experienced vaccine was administered from a punctured vial 18 hours after being used initially. On 24-JUN-2021, the subject experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine was administered from a punctured vial 18 hours after being used initially. and incorrect product storage was not reported. This report was non-serious.
patient is under the unauthorized age group; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient is under the unauthorized age group) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient is under the unauthorized age group). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient is under the unauthorized age group) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment drugs were reported.
Narrative:  COVID infection following COVID vaccine series 03/12, MODERNA, dose #1 outside facility 04/30, MODERNA, dose #2 outside facility 10/27 COVID swab, result: detected 10/27 pt cc: exposure: unknown
Noticed a few days afterwards and still to this day, both lower legs are tingling.     7/6/21 I went to the doctor office as then I started to development intermittent nerve or pains around both knees.   After  that I got blood work done, all good except slightly low on Vitamin D,  thought maybe Lyme, but then 2nd test came back negative.   Now am taking since 7/10 Vit Da, B6 B12.     7/13 or so now intermittent nerve pain is spreading sometimes now in my lower legs, back of knees, thighs, my foot and elbows are a bit sore.  Also know both knees are tight and sore if I bend them and sit on them, and they make crunching noises when I go up the steps like the joints or cartridge is making noise.     As of 7/30 this I still going on, and slowly getting worse.   My doctor said not to worry it is not the vaccine and probably just a Vitamin deficiency.   However all my blood work from 12/2020 was great, no issues, and all these symptoms started days and weeks following my J&J vaccine.   So I am very anxious and worried it could be something tied to the vaccine or that the vaccine brought out something dormant in my system.   After I pushed multiple times for more help, I have a specialist apt with another doctor on 8/12 where I will try to get more answers and maybe get new blood work done again to check all my current levels.
decay; patient received 2nd dose 41 days after the 1st dose; nauseas; This spontaneous case was reported by a consumer and describes the occurrence of DENTAL CARIES (decay), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received 2nd dose 41 days after the 1st dose) and NAUSEA (nauseas) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Hypertension.    On 30-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced DENTAL CARIES (decay), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received 2nd dose 41 days after the 1st dose) and NAUSEA (nauseas). On 30-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient received 2nd dose 41 days after the 1st dose) had resolved. At the time of the report, DENTAL CARIES (decay) and NAUSEA (nauseas) outcome was unknown.            No Concomitant medications were reported.  No Treatment information was reported.   This case was linked to MOD-2021-293254 (Patient Link).
This spontaneous report as received from a nurse refers to an 11 years 10 months old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, lot # K005881, exp. date: 14-JAN-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Information as been received from a physician via representative concerning a 7 month old patient. The concurrent condition and medical history were not reported. There was no concomitant therapy. On 28-OCT-2o15, 30-DEC-2015 and 25-FEB-2016, the patient was vaccinated with the first, second and third dose fo ROTATEQ, orally, respectively. On 19-APR-2016 the patient was administered with a fourth dose of ROTATEQ (lot # L038536, Expiration Date unknown) (extra dose administered). No treatment was given. The patient did not seek medical attention. Additional information has been requested.
This is a spontaneous report from a contactable nurse. A 75-year-old female patient received PREVNAR 13 (lot number J20348, expiry date 31May2016, NDC: 0005-1971-02) on 26Mar2015, intramuscular, in left deltoid, at 0.5 ml single. No other vaccines were given that day or within four weeks prior. Medical history included ongoing osteoporosis diagnosed sometime before 2013, ongoing hyperlipidemia diagnosed sometime before 2013 and allergies to sulfa. Concomitant medications included lovastatin tablets for cholesterol at 20 mg, 1x/day nightly and oral colestipol for cholesterol at 5 g, 2x/day. On 26Mar2015 the patient experienced migratory polyarthritis. Patient did not go to the Emergency room, but did call the doctor and was treated with medications including ibuprofen. On unknown date she experienced joint swelling/accompanied by swelling and redness, fever, chills, her arm was very sore at the injection site. On an unspecified date in Mar2015 she could barely move. The events were described as follows. The event migratory polyarthritis started off with intermittent migratory joint pain that began in the left shoulder two hours after receiving the vaccination. It was migratory to the right shoulder within 24 hours. The initial site (left shoulder) resolved with migration to the other (right) shoulder, then involved the left hand. The right shoulder resolved and then it went to the right hand. It has gone to the right foot and ankle. All joints accompanied by swelling and redness during the time of involvement. For the first seven days of the involvement she also had fever and chills, but no other symptoms. The patient called back on 30Mar2015 and talked about the injection site, that her arm was very sore all the way up to the shoulder and she could barely move. She was treated with BENADRYL and ibuprofen with little improvement of the pain. She was started on a MEDROL dose pack on 06Apr2015. The patient was going to perform the following investigations: uric acid, rheumatoid factor, sedimentation rate, and ANA panel comprehensive, but they still needed to be collected. The patient was not recovered from migratory polyarthritis. She recovered from fever and chills on unknown date. She was recovering from vaccination site pain. Outcomes of the other reported events were unknown at time of report. According to the reporter there was a reasonable possibility that migratory polyarthritis was related to PREVNAR 13.
Approximately 10 am fussy, inconsolable approximately 2 hours after vaccines.  2:30 pm right thigh somewhat swollen and reddened.  Mom stated child had red raised hives at 2:30 pm - (not seen in office approximately 3 pm).  Mom gave Tylenol, 6 ml at 12:30 pm.
FATIGUE AND RASH AT INJECTION SITE. VACCINE RECIVED ON 071919. FOLLOWED BY THE ADVERSE EVENTS WHICH OCCURRED FROM 072019-072319. SAME SYMPTOMS REAPPEARED ON 073019.
I began to bruise all over my body.  Later got little red dots on legs, arms, and back. I was hospitalized on November 17-21 because of low platelets.  They were at 6,000 at time of arrival.  They got as low as 2,000.  When I was discharged, I had a platelet count of 135,000.  I am on currently taking steroids.  I've been checked to see if I had Lupus or Leukemia.  Both those tests came back negative.  The doctor says that I have ITP.  Currently my platelet count is at 63,000.  I have to keep going to the doctor so that we can figure out how to treat this thing.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients who on unspecified dates were administered with GARDASIL (dose, frequency and indication not reported) that went through a supported temperature excursion. No adverse reported. This is one of several reports received from same source. Additional information is not expected.
Pt vaccinated with DTP/OPV/HIB had "high pitched cry" a "peculiar cry" neither parent had heard before for approx 1 hrs 630-730PM. Afeb-fine over one hour since report.
Patinet presented to the clinic with redness, warmth, tender, swelling to site of injection.
Developed nausea, projectile vomiting, low grade fever and next morning developed red macular rash to neck, anterior and posterior trunk and bil upper thighs.  Nausea, vomiting and fever resolved in 24 hours; rash still present on 3/15/12.
pt arm had extreme fever and chills, hot and bright red on most of arm, very swollen, got diarrhea and headache, - pt took tylenol and some benadryl to help- going to follow up with dr if doesnt reduce soon
swelling at injection site; pain, itching, redness, warmth at injection site; pain, itching, redness, warmth at injection site; pain, itching, redness, warmth at injection site; pain, itching, redness, warmth at injection site; body aches; fatigue; fever 100.2; This is a spontaneous report from a contactable Nurse.  A 27-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3249), intramuscular on 13Jan2021 10:45 at single dose for covid-19 immunisation. Vaccine location was left arm. Medical history included covid-19. Historical vaccine included first dose of BNT162B2 lot number EK5730 on 22Dec2020 10:15 AM. Concomitant medications included multivitamins, ascorbic acid (VITAMIN C), cetirizine hydrochloride (ZYRTEC). The patient experienced body aches on 14Jan2021 05:00, fatigue on 14Jan2021 05:00, fever 100.2 on 14Jan2021 05:00, pain, itching, redness, warmth at injection site on 15Jan2021. The patient underwent lab tests and procedures which included body temperature: 100.2 on 14Jan2021, and 99.8 on 15Jan2021. No treatment received. The events recovered in Jan2021.
a small rash at the vaccine site; a small rash at the vaccine site. It was warm, red, itchy, sore to the touch.; a small rash at the vaccine site. It was warm, red, itchy, sore to the touch.; a small rash at the vaccine site. It was warm, red, itchy, sore to the touch.; a small rash at the vaccine site. It was warm, red, itchy, sore to the touch.; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot Number: EP6955) via an unspecified route of administration in the left arm on 18Mar2021 at 19:15(at the age of 53-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, shellfish allergy,  pollen allergy, heart arrhythmia, atrial fibrillation and fatty liver. The patient received unspecified medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021 at 20:30 the patient experienced a small rash at the vaccine site approximately 3 inches across and about 1 inch down. It was warm, red, itchy, sore to the touch. It was also firm. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment herself with Benadryl ointment. The clinical outcome of the event a small rash at the vaccine site, It was warm, red, itchy, sore to the touch was recovered on 25Mar2021.   No follow-up attempts are needed. No further information is expected.
Patient had discomfort, swelling at site of ZOSTAVAX injection. A localized cellulitis was diagnosed - pt rec'd antibiotic injection and oral antibiotic.
This spontaneous report was received from a healthcare worker regarding unspecified number of patients of unknown age and gender. No historical or concurrent conditions were reported. On an unknown date, an unspecified number of patients received vaccination dose with improperly stored RECOMBIVAX HB (lot # L027733, expiry: 13-SEP-2017). The reporter reported a temperature excursion for the product. There was high temperature excursion at 9.5 degrees Celsius for a time frame of 31 minutes and low temperature excursion at 0.5 degrees Celsius for a time frame of 20 hours and 45 minutes. There was no previous temperature excursion. No concomitant medications were reported. No adverse effects were reported. No Product Quality Complaint (PQC) was reported. This is one of several reports received from the same reporter (# 1602USA006329). Additional information has been requested.
patient passed out; Information has been received from a physician via a company representative referring to a 11 years old female patient.  Concomitant therapies included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (TDAP) and meningococcal acyw conj vaccine (carrier unspecified) (MENACWY). The patient's pertinent medical history and drug reactions/ allergies were unknown by the reporter.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose number, dose, anatomical location and route of administration, lot number and expiration date were unknown) for prophylaxis.      The patient passed out after the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection and the patient was not not injured. The patient was observed and monitored for 30 minutes in doctor's office and then went home.   No product quality complaint (PQC) was involved. No treatment was given for the adverse event. Information about lab diagnostics/studies performed was unknown by the reporter. The outcome of event passed out was reported as recovered. The causality assessment between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Upon internal review, the event passed out was determined to be medically significant.