chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain; acheness; light headed; weak; nausea; severe pain in arm; cold; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 14May2021 at 15:00 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis. Concomitant medications included methotrexate (MANUFACTURER UNKNOWN), amfetamine aspartate; amfetamine sulfate; dexamfetamine saccharate; dexamfetamine sulfate (ADDERALL) and folic acid (MANUFACTURER UNKNOWN) all from unknown date for unspecified indications. The patient did not have a history of allergies to medications, food, or other products. 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 14May2021 at 17:45 the patient experienced pain, achiness, light headed, weak, nausea, severe pain in arm and cold. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcomes of the events pain, achiness, light headed, weak, nausea, severe pain in arm and cold was not recovered at the time of report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Localized redness & swelling noticed the next day which progressed to redness and swelling of most of right upper arm (circumferentia)l. Patient complained of pain and itching; Was seen in urgent care 12/11/02 and at our office on 12/12/02. Treated with Benadryl and Tylenol.
Fatigue, elevated heart rate (about 10 bpm higher than normal which lasted 2 weeks). I wear a smart watch that records my heart rate.
The patient experienced shaking, nausea, lighheadedness, and a fever of 104-105 degrees. She went to the emergency room approximately 10 hours after receiving the vaccination and was discharged approximately 16 hours later
WILD DREAMS; CHILLS; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow up to request batch number. No concomitant medications were reported. On 08-APR-2021, the subject experienced wild dreams. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills and wild dreams was not reported. This report was non-serious.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored VARIVAX (dose, frequency and route were unknown, lot # M049127, expiration date: 15-DEC-2018, lot # N010107, expiration date: 28-MAR-2019) for prophylaxis. Administered vaccine experienced the temperature excursion of -14 Celsius degree to -10 Celsius degree (-14.2 Celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of several reports from the same reporter. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from an other reporter concerning a 12 month old patient. On 02-OCT-2017, the patient vaccinated with improperly stored VARIVAX (dose, frequency and route were unknown, lot # N017698, expiration date: 09-JUN-2019) for prophylaxis. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA002098: US-009507513-1709USA002186.
This spontaneous report as received from a physician refers to a 70 years old female patient with a pacemaker for her heart condition and drug reaction/allergy to BETADINE. The patient's medical history included shingles and cancer. The patient was vaccinated with single dose, 0.65 ml ZOSTAVAX, product circular # 9989115, vaccination date reported as 21-SEP-2012. No other co-suspects were reported. Concomitant medications included COUMADIN, METOPROLOL and FLECAINIDE ACETATE. After vaccination (also reported as on 20-SEP-2012) the patient experienced she developed flu-like symptoms, fever, malaise, headache, diarrhea and extreme fatigue. The patient's husband felt the patient should not have received ZOSTAVAX, as she is a cancer survivor who has had chemotherapy and also has already had shingles. He also stated the patients symptoms have not improved and have actually become worse. The patient did visit an urgent care center where they did a viral swab of the nose which came back negative. The patient was provided a treatment of TYLENOL WITH CODEINE and PROMETHAZINE. The physician reported that the extreme fatigue, malaise and fever are still present at the time of the call, but the diarrhea (described as 5 or 7 occurrences, dates unspecified) has resolved as of 30-SEP-2012. The patient's husband reported that his wife is continuing to have problems following vaccination with the ZOSTAVAX. The patient's husband stated that his wife is in "dire straits" and continues to have a fever. The fever resolved at 05-OCT-2012 and on an unknown date the patient had pink eye in both eyes and immune problems. The patient's husband reports that the patient developed a circular, red rash on her chest and back on 05-OCT-2012. She was admitted to hospital on 05-OCT-2012 and treated with "unspecified antibiotics" and "hydration therapy". The patient was discharged from the hospital on 07-OCT-2012. She was prescribed a 5 day course of CEFPODOXIME 200 mg twice per day and an "unspecified topical ointment" for the rash. The outcome of circular, red rash on her chest and back, she developed flu-like symptoms, malaise, headache, is in "dire straits", pink eye in both eyes, immune problems and extreme fatigue was reported as not recovered/not resolved. The outcome of diarrhea and fever was reported as recovered/resolved. The relatedness for circular, red rash on her chest and back, she developed flu-like symptoms, fever, malaise, headache, diarrhea, is in "dire straits", pink eye in both eyes, immune problems and extreme fatigue was not reported for ZOSTAVAX. Additional information has been requested.
Ache to both sides of neck and the right side of the back of head.  Hurts to move head at night.  Pain in head and neck upon touch and when coughing.  Ache and pain minimally relieved by ibuprofen but getting better after 2 weeks.
p/vax c/o general malaise, swelling, tenderness & redness in arm p/vax;reporter concerned because had another pt w/rxn t tetanus w/same sx;p/2nd case reporter felt poss bad lot;
BRIEF OVERVIEW: Primary Care Provider at Discharge: DO Admission Date: 5/5/2021 Discharge Date:5/6/2021    Active Hospital Problems   Diagnosis Date Noted POA ? Essential hypertension 05/06/2021 Yes ? Pulmonary embolism on right (HCC) 05/05/2021 Yes ? Right flank pain 05/05/2021 Yes ? Hypokalemia 05/05/2021 Yes ? Uncomplicated alcohol dependence (HCC) 05/05/2021 Yes   Resolved Hospital Problems No resolved problems to display.   CONSULTS: None    INPATIENT PROCEDURES: None   DETAILS OF HOSPITAL STAY:   PRESENTING PROBLEM: Patient is a 83 y.o. male with Hx of HTN who presents today with complaint of right sided flank pain, with radiations into the right side of his back and right side of his chest. The pain is worse with movement and deep inspiration. He denies palpitations and shortness of breath. He has no previous HX of VTE. He denies fever, chills, cough, nasal congestion, and sore throat. He denies abdominal pain, N/V, and changes in bowel movements. The patient is a limited historian. He is oriented x4 on admission, but states that he has had difficulty with his memory over the past 2-3 years. He lives alone in an apartment.   In the emergency department the patient's vital signs were stable.  Labs revealed a potassium of 3.3.  AST was 52 and ALT 61. White blood cell count was 11.13.  Troponin was negative and BNP was within normal limits.  Lactic acid was 1.5.  UA showed trace blood.  EKG showed normal sinus rhythm with PACs.  CTA the thorax abdomen and pelvis showed acute pulmonary emboli involving the segmental subsegmental arteries of the upper and lower lobes.  There is no evidence of heart strain. He was admitted for observation due to severe pain, and was given IV fentanyl.  Echocardiogram showed: The left ventricular ejection fraction is 67%. No regional wall motion abnormalities noted. The right ventricular size, thickness, and function are normal. The estimated right ventricular systolic pressure is 36 mmHg. The inferior vena cava was not visualized during the exam. There is no comparison study available.    He was started on Eliquis 10 mg bid for 7 days, than 5 mg bid for total of 3 months.  He should follow up with PCP in 1 week and should check CBC and BMP on 5/10/21. He should also follow up with pulmonologist in 2-3 months.  He had Pfizer COVID-19 vaccine on 2/18/21 and 3/18/21. There is remote possibility that this PE could be related to COVID-19 vaccine, so this was reported to Vaccine Adverse Event Reporting System (VAERS). He had mild hypokalemia due to HCTZ, and required K-dur supplement. HCTZ was switched to Maxzide 25/37.5 mg daily. Rechecked K was normal 3.9. BMP should be checked in 1 week. Also he is drinking little bit too much alcohol, 4 alcoholic drinks every night. He was instructed to cut alcohol drinking to </=2 alcoholic drink a day.  His daughter was updated over the phone.
This case was reported by a physician to a sales representative and described the occurrence of jaundice in an adult male pt who received Twinrix. On 9/9/04, the pt received a dose of Twinrix. At an and unspecified time, post/vax, the pt experienced jaundice. The pt was seen at a physician's office. Laboratory evaluation revealed elevated liver enzymes. The events were ongoing at the time of initial reporting. The reporting pharmacist considered the events to possible be related to vaccination with Twinrix. Comment: Jaundice and elevated liver enzymes were assessed as medically serious by Mfr.
Severe body aches, fever of 103, headache, diarrhea and gassy stomach. Symptoms began approximately 24 hours after injection and have persisted since. They have decreased in severity.
received Menveo reconstituted with Pfizer Covid diluent; received Menveo reconstituted with Pfizer Covid diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA569A, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Menveo lyophilized powder portion after being reconstituted with pfizer covid diluent when the patient was supposed to get the covid pfizer, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. No reactions reported. The reporter consented to follow up. This case was linked with 12 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR243472:Same reporter US-GLAXOSMITHKLINE-US2021AMR243469:Same reporter US-GLAXOSMITHKLINE-US2021AMR243475:Same reporter US-GLAXOSMITHKLINE-US2021AMR243473:Same reporter US-GLAXOSMITHKLINE-US2021AMR243476:Same reporter US-GLAXOSMITHKLINE-US2021AMR243474:Same reporter US-GLAXOSMITHKLINE-US2021AMR243470:Same reporter US-GLAXOSMITHKLINE-US2021AMR243478:Same reporter US-GLAXOSMITHKLINE-US2021AMR243479:Same reporter US-GLAXOSMITHKLINE-US2021AMR243480:Same reporter US-GLAXOSMITHKLINE-US2021240689:Same reporter
Starting yesterday evening, Pt had pain and numbness throughout arm and chest. Pt complains of not being able to move her arm.
This claim is being reported as medication error.  Pfizer Bivalent Under 5 yrs given too soon. The guidelines changed from Pfizer Mono of 3 weeks interval to Pfizer Bivalent under 5 yrs. to 8 week interval.  Patient had first Pfizer Mono on 4/15/23. Patient was given Pfizer Bivalent under 5 yrs, 0.2ml IM, right deltoid too early. Pt. was observed for 15 minutes, without adverse effects. Discharged stable. Father was informed by RN that per CDC guidelines that this vaccine given today was invalid and to return in 8 weeks from todays date: 05/06/2023. Father understood and will return in 8 weeks for Pfizer Bivalent under 5 years.
Since my vaccine, I've had swollen glands in my neck and under my ear.  It is not getting better.  I went to my primary care doctor and got a prednisone pack (4 days), but it did not decrease the swelling.
arm hurt; This case was reported by a consumer and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Post vaccination the patient's arm hurted for a week which was a known side effect. The patient inquired about how long after the first dose can symptoms still occur. The patient also asked if need get the second shot in the arm or was there a less painful place to get the injection. This case was linked to another case US2019AMR225800 reported by the same reporter.
itching, hives several hours after dosing no dyspnea or angioedema  treatment with oral Benadryl x 3 doses and hives resolved but itching still
Pt received MMR,Varicella and PPD on 6/27/05. Pt grandmother called morning of 7/1/05 to report a rash over face of approximately 20 pin point/heat rash type bumps on face.  Felt warm on 6/29/05.  No treatment was necessary.
extreme fatigue; nausea; headache; chills on and off; headache; nausea; fever; extreme fatigue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Mar-2021 and was forwarded to Moderna on 19-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of the first episode of HEADACHE (headache), the first episode of NAUSEA (nausea), PYREXIA (fever), the first episode of FATIGUE (extreme fatigue) and the second episode of FATIGUE (extreme fatigue) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced the first episode of HEADACHE (headache), the first episode of NAUSEA (nausea), PYREXIA (fever) and the first episode of FATIGUE (extreme fatigue). On 12-Mar-2021, the patient experienced the second episode of FATIGUE (extreme fatigue), the second episode of NAUSEA (nausea), the second episode of HEADACHE (headache) and CHILLS (chills on and off). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 02-Mar-2021, PYREXIA (fever) outcome was unknown. At the time of the report, last episode of FATIGUE (extreme fatigue), the last episode of NAUSEA (nausea), the last episode of HEADACHE (headache) and CHILLS (chills on and off) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
sore arm from the injection; My wife got her 2nd dose of the Moderna Covid-19 vaccine 24 days after the 1st dose.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm from the injection) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (My wife got her 2nd dose of the Moderna Covid-19 vaccine 24 days after the 1st dose.) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced VACCINATION SITE PAIN (sore arm from the injection) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (My wife got her 2nd dose of the Moderna Covid-19 vaccine 24 days after the 1st dose.). On 24-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (My wife got her 2nd dose of the Moderna Covid-19 vaccine 24 days after the 1st dose.) had resolved. At the time of the report, VACCINATION SITE PAIN (sore arm from the injection) outcome was unknown.            Concomitant medication was not reported. Treatment information was not reported.   This case was linked to MOD-2021-302673 (Patient Link).
member complained of a large discolored area approx 4 x 2cm and raised at vaccine site. Member developed a rash to area on neck and face. Rash only on vaccination site. Red area started 24 hours post shot and inenaled over 48 hours. Rash started at 72 hrs post shot. Member took 50 mg oral Benadryl and good results. Member took 2 doses.
This spontaneous report as received from a nurse refers to a 1 month old patient. On 08-AUG-2014 the patient was vaccinated with VAQTA, .5 ml, intramuscular. Nurse reported that patient was administered VAQTA 0.5ml instead of RECOMBIVAX HB. The outcome of the event was unknown. No adverse event was reported. Additional information has been requested.
seizures, seizure every week for 5 weeks; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (seizures, seizure every week for 5 weeks) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     Concurrent medical conditions included Seizures (minor seizures twice a month).    On 02-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced SEIZURE (seizures, seizure every week for 5 weeks) (seriousness criterion medically significant). The patient was treated with CANNABIS for Seizures, at an unspecified dose and frequency. In October 2021, SEIZURE (seizures, seizure every week for 5 weeks) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Patient had minor seizures twice a month. When she got the first Moderna shot, she got a seizure every week for 5 weeks.  Company Comment:This is a spontaneous case concerning a 55-year-old, female patient with current condition of seizures, who experienced the unexpected serious event of Seizures on an unknown date after the first dose of mRNA-1273 vaccine. Patients current condition is confounder for the case. The outcome of the event was resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-415060 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 55-year-old, female patient with current condition of seizures, who experienced the unexpected serious  event of Seizures on an unknown date after the first dose of mRNA-1273 vaccine. Patients current condition is confounder for the case. The outcome of the event was resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Immediate tachycardia, diaphoresis, scratchy throat, light headiness.
Hoarseness. Severe stomach upset and feeling of fullness. Followed by nausea and multiple bouts of vomiting. Shaking and chills. No fever.
First vaccine given on 3/31/21 of Pfizer. Second vaccine administered Moderna on 4/21/21
This spontaneous report as received from a certified medical assistant refers to multiple patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. In August 2016, reported as dates starting on or after 04-AUG-2016, the patients were vaccinated with improperly stored dose of ROTATEQ, orally, lot # L028645, expiry date 25-MAY-2017 (strength and dose were not reported). No adverse effect was reported. Administered doses of vaccines experienced the temperature excursion of 35 degrees Fahrenheit for 6 hours and 25 minutes and 47 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous temperature excursions reported. This is one of several cases received from the same reporter. Additional information has been requested.
Patient reported a blister behind her left shoulder after receiving a flu vaccine in her left arm with pain leading from injection site to blister. Symptoms started the night of vaccination. The blister opened and patient was seen at an urgent care and received an antibiotic ointment to place on the open blister.  The blister has since healed but remains tender and itchy.
This spontaneous report was received from a registered nurse referring to an 11 year old female patient. The patient's concomitant medication, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 28-SEP-2017, the patient was vaccinated with either GARDASIL lot # N000326, expiration date 14-OCT-2019 or GARDASIL 9 lot # N000326, expiration date: not reported (strength, dose, dose number and route of administration were not provided) for prophylaxis which were improperly stored. This is one of several reports received from the same source. Sender's Comments: US-009507513-1709USA008666.
This spontaneous reports as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patient was vaccinated with M-M-R II (strength, dose and frequency not reported) (route, lot# and expiration date not provided). It was reported that M-M-R II was exposed to a supported temperature excursion on 06-OCT-2014 and had been administered to unspecified patients on unspecified dates since the excursion on 06-OCT-2014. No adverse effects had been observed or reported. This is one of several reports received form the same reporter. Additional information has been requested.
pt re-challenged w/DTP/HBOC/OPV on 11OCT94 had similar event-rhinitis
Insomnia 1 night, no appetite 48 hours,  terribly sore mouth 72 hours, shortness of breath 24 hours
Immediately after administration of vaccines patient had a generalized tonic-clonic seizure lasting approximately 10 minutes, requiring administration of Midazolam IM by paramedics and transport via ambulance to a pediatric hospital for further care.   Seizure stopped minutes after administration of midazolam.
Pt to ED 10/21 for fatigue and cough. Pt COVID+ 10/21. 10/22 pt is A&O x 4, on room air. 10/23 no new symptoms. 10/24 pt discharged.