chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vasovagal syncope approximately 3 minutes after injection.  No warning signs such as nausea or dizziness beforehand, she explained everything just went "black" slumped off table and I caught her before she hit floor.  She had rapid loss of blood pressure and her muscles were severely twitching in her arms and legs while unconscious for about 10 seconds (it looked similar to a seizure).  Her blood pressure remained low for 10 minutes or so before beginning to climb again, she also had nausea & dizziness after event.  She did hit her head during fall, but it caused only a small bump on the back of her head, and was not serious.  The doctor's refused to consider a link with vaccine, except possibly "nervousness" over getting a shot- which was NOT the case.  Another report will show my son also fainted immediately thereafter at the same time with a different vaccine----I asked if these new vaccines possibly have inactive ingredients that they could possibly have allergies to at the time and was told that he passed out simply because his sister did. (he is 17 and has never passed out)---but the reports of vasovagal syncope show a higher incidence among these 2 vaccines...and perhaps there is a link with a particular ingredient?  Or with a certain bloodtype? There is something about these vaccines that caused my children to have a very serious reaction.  The nurse told me that my daughter must have been hyperventalating without me being aware of it, which is totally ridiculous.  Both kids were calm and chatting pleasantly about the day ahead when my daughter suddenly slumped over and passed out.  This was NOT normal and they were NOT children having some sort of panicked reaction.
Body Aches, Arm Pain, HA, Fever of 102- 12/24/2020
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date between 15-JUN-2017 and 06-JUL-2017, the patients received unspecified doses of ROTATEQ (lot#: M044395, expiration date: 31-MAY-2018; lot#: M038744, expiration date: 26-APR-2018; lot# reported as: M041415, expiration date: 28-AUG-2018) (dose, frequency and route of administration were unspecified) for prophylaxis, in immunization series that were improperly stored. No adverse events were reported. It was stated that the vaccines were exposed to a temperature of 1 Celsius degree for a time frame of 65 hours and 5 minutes. There were no previous temperature excursions and a digital data logger was involved. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1707USA002262: US-009507513-1707USA003301: US-009507513-1707USA003302: US-009507513-1707USA003303: US-009507513-1707USA003298: US-009507513-1707USA003299:
left arm was swollen and pain, but it went away in 24 hours; left arm was swollen and pain, but it went away in 24 hours; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15May2021 (Batch/Lot number: unknown) at the age of 34 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 15May2021, outcome "recovered" (16May2021 23:00) and all described as "left arm was swollen and pain, but it went away in 24 hours". Therapeutic measures were not taken as a result of pain in extremity, peripheral swelling.  Additional information: Vaccine facility type was reported as other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Adverse event resulted in None of the above. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any treatment for the event. The patient also received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Expiry date: unknown), via an unspecified route of administration, administered on an unspecified date as dose 2, single for covid-19 immunisation and experienced low fever at around 100F. Lot numbers were reported as EW0164 and EW0173. Vaccination time reported as 12:30 pm and Adverse event start time reported as 11:00 pm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a consumer 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 date, the patient was vaccinated with GARDASIL 9 (dose, route and site of administration, indication, lot # and expiration date were not reported). On an unknown date, the patient was "sent to the hospital" after receiving the GARDASIL 9 vaccine due to unspecified reason. On an unknown date, the patient was on an oxygen therapy because of what the GARDASIL 9 did to them. The outcome of the events and the relatedness between the events and GARDASIL 9 were not reported. Upon internal review, the event of oxygen therapy was considered to be medically significant. Additional information is not expected due to lack of the reporter's contact details.
difficulty breathing; fluctuations in blood pressure /blood pressure ups and downs; Ringing in the ears; Heart palpitations; High Oxygen saturation; cannot do a whole lot of work after the vaccination; Sometimes arm is red; right ear and neck is sore; Arm swells sometimes; Arm red sometimes; right ear and neck is sore; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing), BLOOD PRESSURE FLUCTUATION (fluctuations in blood pressure /blood pressure ups and downs), TINNITUS (Ringing in the ears), PALPITATIONS (Heart palpitations) and OXYGEN SATURATION INCREASED (High Oxygen saturation) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (difficulty breathing), BLOOD PRESSURE FLUCTUATION (fluctuations in blood pressure /blood pressure ups and downs), TINNITUS (Ringing in the ears), PALPITATIONS (Heart palpitations), OXYGEN SATURATION INCREASED (High Oxygen saturation), FATIGUE (cannot do a whole lot of work after the vaccination), ERYTHEMA (Sometimes arm is red), EAR PAIN (right ear and neck is sore), PERIPHERAL SWELLING (Arm swells sometimes), ERYTHEMA (Arm red sometimes) and NECK PAIN (right ear and neck is sore). The patient was treated with PREDNISONE at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (difficulty breathing), BLOOD PRESSURE FLUCTUATION (fluctuations in blood pressure /blood pressure ups and downs), TINNITUS (Ringing in the ears), PALPITATIONS (Heart palpitations), OXYGEN SATURATION INCREASED (High Oxygen saturation), FATIGUE (cannot do a whole lot of work after the vaccination), ERYTHEMA (Sometimes arm is red), EAR PAIN (right ear and neck is sore), PERIPHERAL SWELLING (Arm swells sometimes), ERYTHEMA (Arm red sometimes) and NECK PAIN (right ear and neck is sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported by the reporter.   This case was linked to MOD-2021-225102 (Patient Link).
PATIENT RECEIVED COVID VACCINE ON 09/27/2021 AND HAD A SORE ARM AND ITCHING AT THE SITE, HE SCRATCHED A LITTLE SORE ON IT,. A SKIN LESION ON THE RIGHT ARM STARTED ON 10/16/2021 PATIENTS RIGHT ARM FROM SHOULDER TO HAD RED, SWOLLEN WITH LARGE AND SMELL BLISTERS NOTED TO RIGHT WRIST. PATIENT WENT TO THE ER ON 10/16/2021 AND WAS STARTED ON AZITHROMYCIN 500MG QD AND CLINDAMYCIN 300MG Q8 HOURS THE ER PHYSICIAN NOTED THAT IT DID NOT LOOK LIKE A DVT AT THE TIME OF THE ER VISIT ER DOCTOR THOUGHT THAT THE SCRATCH WAS THE SOURCE OF THE CELLULITIS
Fever of 101F; Sore arm; Shakes; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), TREMOR (Shakes), CHILLS (Chills) and PYREXIA (Fever of 101F) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), TREMOR (Shakes) and CHILLS (Chills). On 02-Apr-2021, the patient experienced PYREXIA (Fever of 101F). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), TREMOR (Shakes), CHILLS (Chills) and PYREXIA (Fever of 101F) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Body temperature: 101 (High) 101 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported.
One week after patient received second dose of COVID 19 vaccine, patient experienced irregular break-through spotting and cramping.
Within an hour severe headache started, pain level 8. Heart rate elevated to over 100 bpm. Fever started the next day 100+ for 3-4 days. Extremely lethargic for 5-6 days. Headache continued for 9-10 days. Ringing in ears described as a  tinnitus. Has continued for 7 months.
Headache Chills Fever Fatigue Slight dizziness  Side effects lasted about 36 hours
Tues AM shot.  Wed PM developed fever, chills & itchy red patches. took tylenol. Thu AM fever started to subside but the chills & giant red itchy patches worsened Thu PM fever gone. Per doctor consult, started prednisone (20mg 2x/day for 3 days then taper off) Fri-Mon despite prednisone full body chills + giant red itchy patches worsened. Mon afternoon, per in-person doctor visit, starting claritan + benadryl
felt like a soft ball size; migraine; intense ear pain; flu like symptoms; burning up; Sore arm; fever with temperature of 102; body ache; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (felt like a soft ball size), MIGRAINE (migraine), EAR PAIN (intense ear pain), INFLUENZA LIKE ILLNESS (flu like symptoms) and BURNING SENSATION (burning up) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036C21A and 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-May-2021, the patient experienced SWELLING (felt like a soft ball size), MIGRAINE (migraine), EAR PAIN (intense ear pain), INFLUENZA LIKE ILLNESS (flu like symptoms), BURNING SENSATION (burning up), PYREXIA (fever with temperature of 102) and MYALGIA (body ache). 20-May-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. At the time of the report, SWELLING (felt like a soft ball size), MIGRAINE (migraine), EAR PAIN (intense ear pain), INFLUENZA LIKE ILLNESS (flu like symptoms), BURNING SENSATION (burning up), PAIN IN EXTREMITY (Sore arm), PYREXIA (fever with temperature of 102) and MYALGIA (body ache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-May-2021, Body temperature: 102 (High) 102 temperature.         Concomitant products include other unspecified medication.  Patient was drinking plenty of fluid.   This case was linked to MOD-2021-162224 (Patient Link).
Pt was lethargic for about 72 hours. Described "sleeping almost all day Saturday following the vaccine". She also described a red nodule on her bicep that was warm to the touch that dissipated over the course of 72 hours including extreme soreness and inflammation.
Pharmacist gave shot intramuscular and patient feels as if shot was given incorrectly.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 72-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 at 13:00 as dose 5 (booster), single (Lot number: GJ2524) at the age of 71 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 14Oct2021 at 11:30 as dose 3 (booster), single (Lot number: FD0809), in left arm and on 20Apr2022 at 01:00 as dose 4 (booster), single (Lot number: FJ4989), in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "sulfa drugs allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid from 19Oct2023 to 25Oct2023.; Sender's Comments: Considering a plausible drug-event temporal association, a reasonable possibility that the events drug ineffective and Covid-19 are related to bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5) cannot be excluded. This case will be reassessed should additional information become available.,Linked Report(s) : US-PFIZER INC-202300356713 Same patient, different drug/event;
Information has been received from a physician concerning a 14 year old female who was vaccinated with Gardasil.  Concomitant therapy included tetanus toxoid in the same arm.  The patient developed a blister at the injection site.  The patient's sister also received the first dose of Gardasil and had the same adverse event (WAES #0801USA03560).  Subsequently, the patient recovered.  No further information was provided regarding this adverse experience.  This is one of several reports from the same source.  Additional information has been requested.
right cheek tingling/ right arm tingling; This is a spontaneous report from a contactable physician.  A 20-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date at the age of 20-years-old (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. 15 minutes after the first dose of the Pfizer Covid19 vaccine, the patient started having tingling in her right cheek.  Labs and CT were negative. The reporter did not see any deficit, the patient was just complaining of right cheek tingling, right arm tingling. The patient had no allergies, surgeries, or medical problems, no itchiness, no shortness of breath, no hives. It was  like the CT of brain was normal, then the MRI, and that they keep getting normal. CBC, CMP, urine, and drug screen were all normal. The patient did report that she was getting better - no more right arm tingling, and the right cheek tingling was almost gone. The event outcome was recovering.  No follow-up attempts are possible, information about batch number cannot be obtained.
HOT FLUSH, blood pressure Blood pressure was 156/81, heart rate 84 at 10:07. Blood pressure was 156/81 and pulse 88 at 10:30. Employee started feeling hot like hot flush two minutes after the injection but reaction was not severe.
approx 15 mins after pt received first dose of Pfizer COVID-19 vaccination pt had a seizure. He was initially observed slumped in chair with eyes rolling back and then began to seize and contract, he was lowered to the floor and 911 called. Pt remained unresponsive until EMS arrived, at which point he stated he has a history of seizures and has not taken his prescribed seizure medication for the past week. He was transported to the hospital with EMS.
Presented focal seizure , no lose of consciousness. Involved jerky movement of both arm and R leg., event lasted 15 seconds. Pt responded immediately, alert, oriented x4, stated was a little dizzy and was aware of soundings .  VS prior to incident B/P 109/72 P. 77 R. 18. After event  1.) B/P 83/51  P. 71 R.18.    2). 113/73 P. 79 R. 21 ;  ( patient was place safely in bed with legs elevated.  3) 105/68  P. 88. R. 20 .  VS was asses q 10'.
Patient received the COVID19 Moderna vaccine dose 1. Patient began to get nauseous and vomited 7 minutes after the vaccine was administered. Additional symptoms included sweating and chill. The patient remained under observation and left with symptoms resolved after approximately 30 minutes.
maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Pregnant. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 11-Sep-2020 and the estimated date of delivery was 18-Jun-2021. On 03-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twentieth week of the pregnancy.  On 03-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) 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 medication were provided No treatment were provided
NUMB RIGHT SIDE OF LIP, SWEATING PROFUSLEY, TIRED, COUGHING, CHEST HURTS, VOMITTING, CANT EAT OR DRINK, FREEZING COLD. tURNS OUT I GOT ACUTE BRONCIAL INFECTION AND PNUEMONIA, THEN PLUERSY
18 days p/MMR/DT pt devel an acute lt facial palsy; No assoc fever, h/a non OM; neuro exam otherwise nl; sx resolving but not completely resolved as of 18JUN92;
Lethargy, confusion, unsteady gait.  Decreased O2 saturation, difficulty swallowing.
c/o lt arm started itching yesterday area is warm & hot to touch & swollen to size of a baseball & hard to touch;might have scratched it because of itching;
I all ready jad flu be about 2week ago; Initial information was received on 17-Nov-2020 regarding an unsolicited valid non-serious social media case from a consumer.  This case involves a patient with unknown demography who already had flu be about 2week ago (influenza), while he/she received vaccine INFLUENZA VACCINE.  Medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number and expiration date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient had flu be about 2 weeks ago (influenza), unknown latency following the administration of INFLUENZA VACCINE.  It was not reported if the patient received any corrective treatment or not.  The outcome of the event was unknown.  There will be no information on the batch number for this case.
left lower back pain; very tired; arm started to be painful and stiff; This spontaneous case was reported by an other and describes the occurrence of PAIN IN EXTREMITY (arm started to be painful and stiff), FATIGUE (very tired) and BACK PAIN (left lower back pain) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for an unknown indication.     The patient's past medical history included UTI.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm started to be painful and stiff). On 26-Jan-2021, the patient experienced FATIGUE (very tired). On 27-Jan-2021, the patient experienced BACK PAIN (left lower back pain). On 29-Jan-2021, PAIN IN EXTREMITY (arm started to be painful and stiff), FATIGUE (very tired) and BACK PAIN (left lower back pain) had resolved.
pt recv vax 23AUG96 & 1hr later pt devel lesions (3);no further details were provided;
BRUISING, IT STARTED ON LEFT THIGH AND WENT TO LOWER LFT ABDOMEN WITH FIRST INJECTION.  AFTER 2ND INJECTION IT WENT TO THE RIGHT THIGH AND HAD SMALL BRUISES.