chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At 24 hours post injection, patient sustained 5 X 4 cm area of erythema with 1 cm area of soft induration over right thigh. No fever. No itching. No limp.  No tenderness
Patient was asked prior to leaving the office if he felt fine he said yes and commenced down the hallway where he got lightheaded. His mom helped him down to the floor, he was nauseated & pale. After approximately 20 minutes he was fine.
Significant soreness, pain lifting arm, tenderness to any touch, redness around 1 in in diameter around injection site for 7 days
BACK ACHE; HEADACHE; FEVER; This spontaneous report received from a consumer 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, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced back ache, headache, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient recovered from back ache, headache, and fever. This report was non-serious.
Left arm ached at injection site in the evening.; Felt extra warm from evening to morning; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 18May2021 13:30 (Batch/Lot number: unknown) 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: VACCINATION SITE PAIN (non-serious) with onset 18May2021, outcome "recovering", described as "Left arm ached at injection site in the evening."; FEELING HOT (non-serious) with onset 18May2021, outcome "recovering", described as "Felt extra warm from evening to morning". Therapeutic measures were not taken as a result of vaccination site pain, feeling hot.  Additional information: Unknown if any other medication patient received within 2 weeks of vaccination. Unknown if patient received any other vaccine within 4 weeks prior to the COVID vaccine. Unknown if prior to vaccination patient was diagnosed with COVID-19 and since the vaccination patient was tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
8/7/21 @5:30am woke with "quivering" of the heart immediately followed by chest pain/tightness, "squeezing", & difficulty breathing. Pain/distress 6 on a scale of 1-10, better when sitting up, worse when lying down. Low risk of cardiovascular disease, no pain in left arm (or any extremities). Symptoms lasted ~1 hour until fell asleep sitting up 8/8/21 ~8pm symptoms occurred again, 3 out of 10. Lasted ~1.5 hours. 8/9/21 @4am symptoms occurred again, 4 out of 10, lasted ~1 hour.  @3pm symptoms occurred and worsened; @ 5pm visited urgent care. Attending physician sent to the emergency room.  At the ER they performed an EKG, attached heart and oxygen monitors, and performed bloodwork.  Elevated D-dimer levels prompted a chest x-ray and iodine CT scan: no clots. All other tests in  normal range.  Administered aspirin and referred to a cardiologist.  Symptoms continued until ~11pm. Aspirin helped. 8/10/21 - 8/12/21 symptoms recurred intermittently, 4 out of 10, usually at night. Stopped Apri. 8/13/21 @7am symptoms worsened and lasted all day, 6 out of 10, causing incapacitation and a migraine.   8/14/21 - 8/15/21 symptoms lessened but continued. GP and cardiologists booked through Nov; depression & anxiety spiked;  suicidal thoughts.  Took 10mg Escitalopram, an anti-depressant used before with good result. 8/16/21 @330am woke to severe quivering, "a wave of adrenaline", and clenching/shaking/seizing that started in chest, spread to torso, stomach, intestines, legs, eventually arms, locking up the jaw.  Spouse called ambulance; taken to another ER.  Episode lasted ~45 minutes; disoriented intermittently thereafter. EKG showed normal. Given Ativan, brought on more shaking, lasted ~10 minutes.  Referred to GP, upper GI professional, Psychiatrist. Chest discomfort continued 3 out of 10 intermittently. 8/17/21 @4am another seizure episode, lasted 15 minutes, similar severity as  first.  Discontinued Escitalopram.  Seizures brought on a migraine which continued 8/17 - 8/19.  Intermittent chest discomfort, 3 out of 10, continued until 8/18. 8/20/21 @3:30am seizure occurred, milder than before, lasted ~ 15 minutes.   8/22/21 @2am another seizure, milder still 8/22, 8/24, 8/25/21 chest tightness for several hours, racing/pounding/quivering heart when waking up, much milder than onset.  8/29/21 saw cardiologist, implemented use of a heart monitor to be worn at home for 4 weeks.  8/30/21 mild heart racing.   9/10/21-9/14/21 mild chest discomfort/pain  9/15/21 saw GP's Nurse Practitioner, referred to neurologist.  @8pm chest pain began and worsened through 7am 9/16/21, 6 out of 10; some muscle spasms since.
Mixed series - 1st dose Pfizer and 2nd Moderna; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Mixed series - 1st dose Pfizer and 2nd Moderna) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer on 26-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer.    On 06-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Mixed series - 1st dose Pfizer and 2nd Moderna). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Mixed series - 1st dose Pfizer and 2nd Moderna) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported. No treatment information was reported. Pharmacist or reporter wanted to know if it would be right to give another mod shot on feb 2022.
About a week after the first vaccine pt started having numbness and tingling in the injected arm. He states it comes and goes and hasn't seemed to improve at time of second dose. He stated no previous issues with carpel tunnel or other nerve issues in his hand or arm. He did want to go ahead with the second injection.
Got vaccine around 12pm on 1/23/21 Woke up on 1/24/21 around 9am with very swollen eyes
severe swelling, pain, redness, and warmth to RIGHT wrist and hand hand is weak and he is unable to grip and functionally use the hand for 2 weeks
patient went into acute renal failure and presented to Hospital with a BUN/Cr 85/10.9.  she ended up having a kidney biopsy and had to have hemodialysis.  her biopsy was consistent with acute tubulointerstitial nephritis. she was seen by the nephrologist and she was started on prednisone 30mg daily.
Based on the additional information received on 02 March 2015, this case became medically confirmed. Initial unsolicited report received from a consumer (Patient) on 2 October 2014. A 72-year-old female patient, whose concomitant medications were not reported, had received a dose of FLUZONE HD (batch number and dose number were not reported, intramuscular in right deltoid) on 29 September 2014. It was reported that, the patient has a medical history of diabetes and has no illness at the time of vaccination. It was reported that on 29 September 2014, few hours after receiving FLUZONE HD vaccine, the patient experienced nasal congestion, sore throat and her eyes became blood red with a heavy yellow drainage. The physician prescribed eye drops and nasal sprays as a corrective treatment to the patient and has no laboratory investigations. The patient required ER/doctor visit. At the time of this report, the outcome was recovered. Documents held by sender: none. Follow-up information received from a Physician on 02 March 2015: No additional information was provided. The physician requested to contact the pharmacy that gave vaccine for details. Documents held by sender: none.
Given DTAP, IPV, HIB, Hep B, Prevnar on 09/05/2003.  First night had leg pain irritability, which resolved.  Since 09/08, unable to sleep at night, irritability, intermittent vomiting, legs weak.  Mom reported one episode of sudden closing eyes and going limp.  Suspect encephalitis/encephalopathy.
(L) upper arm - red, swollen, warm to the touch, 1.5cmX7cm.
soreness for about 5 days; light prick for about 5 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness for about 5 days) and PARAESTHESIA (light prick for about 5 days) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness for about 5 days) and PARAESTHESIA (light prick for about 5 days). At the time of the report, PAIN IN EXTREMITY (soreness for about 5 days) and PARAESTHESIA (light prick for about 5 days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-079326 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079326:First dose case
Received dose 1 on Wednesday, by Friday night and Saturday I noticed fatigue in my facial muscles. By Sunday and Monday the left side of my face was paralyzed. Monday evening I was diagnosed with Bell's Palsy. Was prescribed Valtrex and Prednisone. No tick exposure or herpes diagnosis.
PREVIOUS COVID INFECTION -6/2020, AND 10/2020- WITH SUBSEQUENT DIAGNOSIS OF POTT'S SYNDROME.  CHEST PAIN, SOB, SEVERE FATIGUE, DIZZINESS.  HAS HAD SEVERAL ABLATIONS  SINCE AND DX OF VENOUS INSUFFICIENCY.  SAME SYMPTONS DEVELOPED IN SAME SEQUENCE POST COVID VACCINATIONS.  POST THIS 2ND DOSE VACCINE- 2/28 STARTED WITH SOB AND DIZZINESS.  SYMPTOMOLOGY BEGAN ON DAY 16 POST 1ST DOSE VACCINE.
The patient stated that she woke up the day after getting the vaccine and was very dizzy. She said that she fell but did not have any injuries.  As of today she is no longer dizzy and has no other symptoms to report.
patient tested positive for SARS-CoV-2 after having received complete series of Moderna COVID vaccination
pt recvd vax; exp URI; devel rash w/ one lesion on stomach;
The patient was given a 0.5ml dose of Daptacel in the right arm  today, instead of Adacel with no AE; Initial information received on 03-Nov-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 11 years old female patient who received 0.5 ml dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number: not reported, expiry date: unknown) via unknown route on right arm on 03-Nov-2020 for prophylactic vaccination (wrong product administered).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included INFLUENZA VACCINE.  It was an actual medication error due to the Wrong vaccine administered (latency same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Feverish, very achy, arm where immunization given was very swollen and bright red, felt like I had been beaten all over, unable to do my work went to bed had sweats, woke up wringing wet. Applied ice pack to arm took Tylenol for pain and rested.
Vaccine was administered November 7th at 11:00 am. November 8th had mild arm soreness around injection site, mild muscle discomfort, and fatigue. November 9th upon waking had bilateral soreness along the cheekbone, patient has Allergan filler in this location. Other filler locations, chin (same filler type) and lips (softer type of filler) are not sore. There is no associated swelling of the face. Mild arm soreness around injection site, mild muscle discomfort, and fatigue has continued through the 9th.
restlessness in legs; soreness in left arm (injection site) & lower back; Fatigue; soreness in left arm (injection site) & lower back; This is a spontaneous report from a contactable consumer. A 38-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247), dose 2 via an unspecified route of administration, in left arm on 25Feb2021 09:00 (at 38-year age) as single dose for covid-19 immunisation and patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247), dose 2 via an unspecified route of administration, in left arm on 02Feb2021 10:00 (at 38-years age) as single dose for covid-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history and concomitant medications were not reported. The patient underwent lab tests and procedures which included post vaccination covid test nasal swab covid test on May2020 and result was negative. The patient experienced fatigue, restlessness in legs, and soreness in left arm (injection site) and lower back on 26Feb2021 03:30. No treatment received for reported adverse event. Patient not tested for COVID-19 after the vaccination. The outcome of the was resolving.
06/17/2022 I began to feel a terrible headache, chills, and a fever, and body aches that continued. I then reached out to my PCP and they provided me with Paxlovid, however the Paxlovid made me extremely nauseous and caused me to vomit frequently. Afterward I was given a anti nausea medication that helped out a lot but I did feel very tired and fatigued afterwards. I am just experiencing a small amount of tiredness however this is primarily it.
Initial and follow-up information has been received from a physician and office manager concerning a 2 month old male with no pertinent medical history or drug allergies who on 06-DEC-2007 was vaccinated PO with his first dose of ROTATEQ (no lot number given). Concomitant vaccinations administered "within the same visit" included a dose of Hib conj vaccine (OMPC) (manufacturer unknown), a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, a dose of poliovirus vaccine activated (unspecified) and a dose of PREVNAR. On 12-DEC-2007 the patient had "vomited five times" and was "admitted to the ER." The patient was not admitted to the hospital. No labs or diagnostic studies were performed. Subsequently, the patient recovered. There was no product quality complaint. Follow-up information from the reporting physician indicated that on 06-DEC-2007 the 9 week old male was vaccinated with a dose of Hib conj vaccine (tet toxoid) (ACTHIB) (no lot# available). Additional information has been requested.
Patient is a 28 year old male who has completed a 45-minute observation period with the following signs and symptoms of an adverse reaction: other - syncopal episode.  COVID-19 vaccine # 1 in series administered.  Patient complaints of syncopal episode witnessed  by other patients after received 1st dose of Covid vaccine. Patient states that he developed clammy skin, lightheadedness  10 minutes after he received his Covid vaccine, patient tried to get out of chair when he had a syncope episode and fell on the floor face down  witnessed by other patient in the Covid vaccine lobby area. Denies any head or facial injury. Patient states that he has needle phobia and he forgot to tell the nurse about his needle phobia. Treatment provided/action Taken: Vital sign @ 1325: blood pressure 114/44, heart rate: 71. SPO2: 98%, respiration : 16; Vital sign @ 1335: blood pressure 104/62, heart rate: 82. SPO2: 95%, respiration : 16; Vital sign @ 1352: blood pressure 102/68, heart rate: 90. SPO2: 99%, respiration : 16; Patient states that he didn't eat breakfast or lunch today, able to tolerated fluid and  intake well, eating chocolates. Action taken: Transferred to higher level of care ( urgent care ); Patient advised to discuss second dose considerations with a clinician.
rash; This is a spontaneous report from a contactable consumer. A 78-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in right arm at the age of 78 years old on 26Feb2021 15:30 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. Medical history was not reported. Concomitant medications included simvastatin (SIMVASTATIN), amlodipine (AMLODIPINE), carvedilol (CARVEDILOL), aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]), and ergocalciferol (VIT D). The patient previously took the first dose of BNT162B2 on 05Feb2021 for covid-19 immunization. On 27Feb2021, about 24 hours after receiving the second vaccine, the patient developed a rash on her feet and about halfway up to my knee but has not appeared on any other part of her body. The patient had no other side effects and the rash does not itch. No treatment was received. The outcome of the event was recovering.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
approx 21/2yrs p/vax pt exp breakthrough chickenpox w/approx 15-20 lesions noted.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, concurrent conditions and concomitant medications. On 28-JAN-2017, the patient was vaccinated with improperly stored dose of VARIVAX injection, lot # M033214, expiry date 13-JUL-2018 (site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1611USA011831.
Started to have widespread joint pains (ankles, buttocks, hips, hands, etc). It comes in flares where i can feel my joints burning and then i feel some pain. Joints do not swell, and are  not hot at touch  20 days after the second dose joint pains intensity increased
A report has been received from a health professional via medical representative concerning a female patient between the age of 20-30 years. The patient's concomitant diseases and concomitant medications were unknown. On an unknown date the patient started receiving nasal FLUMIST. During Jan-2013 the patient experienced Influenza B. The action taken of FLUMIST was unknown. The patient recovered from the event on an unspecified date. The report was considered to be non-serious by the reporter.
3:30 pm - 11:00 pm dizziness, no treatment went to bed.
Patient was given 4 doses of pediatric COVID Vaccine. Parents separately brought patient to both vaccine facility and clinic to recieve his doses. We believe they did not communicate with each other that they got the patient vaccinated at the other site. He has not had any complications from his vaccine at this time.
30 hours after injection pt developed redness at injection site.With slight elevation in temp. 99.1 3 hours later temp went to 101.7 approximately 48 hours after injection patient phoned clinic with complaints of weakness and malaise was advised to take antiinflamitories and report to Emergency room if experienced any shortness of breath
Pt  was vaccinated at 3:36pm; 3:42pm pt.  stated  "My head is hurting, and I feel hot".  Patient got vaccinated on left arm. RN assessed patient , vitals : BP 125/75, Temp 98.1, HR 77, Resp 20, Spo2 99%. on room air. Pulses noted on both arms strong and regular. Hearts sounds present. No respiratory distress, breathing through her nostrils mouth closed. Skin warm and dry.  Patient denies any other symptoms. Patient waited additional 15 minutes. RN reassessed and patient states, ? I feel fine now. I no longer have a headache, or feel hot?.  Vitals: BP 117/75, Temp 98.1, HR 74, Resp 20, Spo2 99% on room air, Patient cleared by clinical staff.  Clinical staff explained to  pt and the family member should she have any other reaction she may want to seek medical attention at a clinic. 4:10pm patient ambulated out of the clinic;  no distress gait steady and regular. Family member with her and family member drove her home. Cleared by Clinical Staff.
Rt arm is red warm to the touch 2 x 1" pt mother advised Tylenol and Ice.
expired tenivac vaccine was giving to a patient with no reported adverse event; Initial information received on 27-Sep-2023 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves a 24 years old female patient to whom expired diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] vaccine was giving to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.  On 27-Sep-2023, the patient received a dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection (lot- U7183AA) via intramuscular route in the arm nos (dose, strength, and expiration date: not provided) for Immunisation (expired product administered) (latency- same day).  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Swelling and redness of entire upper arm. 48 hours after vaccines given. No pain or fever.