chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At 1040 after vaccinating patient with Hepatitis A and Hepatitis B vaccines, patient sat down on one of the chairs and did not report any issues. At 1043, staff heard a thud sound and saw that the patient was lying with his back on the floor. Fall was unwitnessed by the staff. PHN assisted patient to sitting position and noted patient's skin was cold to the touch, pale and no bleeding, swelling nor discoloration were noted on the patient's head. Patient's father reported that the patient only had "root" to eat for breakfast. LVN and PHN assisted patient to the gravity chair. At 1044, PHN called for Interpretation service for language translation. PHN contacted Emergency Medical Services at 1047. PHN took vital signs at 1047 and were BP: 76/47, HR: 71 and RR: 20. Patient reported that he felt "better". LVN notifed Manager. Emergency Medical Services arrived on scene and assumed care at 1049. Paramedics provided patient's father with education. At 1101, patient's father signed AMA and Emergency Medical Services left the scene. Patient denied symptoms. At 1105 patient left the facility with steady gait accompanied by his family.
pt recv vax;seen at er for inc irritability, crying; inc T;was told to give sympathetic tx & released; to clinic 25apr95;
Swelling- knot on right side of of left arm at elbow. And is swollen a bit; This is a spontaneous report received from a contactable consumer (reporting for herself). A 68-years-old Non-Pregnant female patient received first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL9267 and Expiration date was not reported) via an unspecified route of administration in Arm Left on 19Feb2021 15:00 as single dose for COVID-19 immunization. Medical history included hypertension and drug hyper-sensitivity (Sulfa). Concomitant medication includes prescribed medicine. It was reported that on 21Feb2021 12:00 patient experienced Swelling- knot on right side of left arm at elbow. And is swollen a bit. Patient did not receive any treatment for event. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19 and did not test for covid Since the vaccination. The outcome of the event was not recovered.
accidentally gave a patient expired MENACTRA with no reported adverse event; Initial information received on 17-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional via call center  This case involves a 19 years old male patient who experienced accidentally gave a patient expired menactra with no reported adverse event while receiving meningococcal a-c-y-w135 (d conj) vaccine [Menactra].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 17-Jun-2022, the patient received a  0.5 ml dose of suspect meningococcal a-c-y-w135 (d conj) vaccine (batch lot number : U6952AA,Expiry date :09-Jun-2022)(unknown strength) via intramuscular route in the right deltoid.  On 17-Jun-2022 (latency :same day) the patient developed a non-serious event of  accidentally gave a patient expired menactra with no reported adverse event (expired product administered) following the administration of meningococcal a-c-y-w135 (d conj) vaccine.  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 guidelines. 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.
After patient was injected with Covid 19 Pfizer vaccine, her left hand swelled slightly and was sensitive to the touch. She refused EPIPEN - took 1 tablet of Benadryl. By evening, she was almost back to normal.
Pneumonia due to COVID-19 virus; Hypomagnesemia; Type 2 MI (myocardial infarction); Paroxysmal atrial fibrillation with RVR; Dyspnea on minimal exertion
tested positive for COVID 19; tested positive for COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 83-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 83 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 31May2022, outcome "unknown", COVID-19 (medically significant) with onset 31May2022, outcome "recovering" and all described as "tested positive for COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31May2022) Positive; (01Jun2022) Positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Clinical information: dose received: More than 3.product: COVID 19,brand name unknown:COVID19 Vaccine,lot unknown reason:Not available/provided to reporter at the time of report completion,dose number:4.Facility where the most recent COVID-19 vaccine was administered: Unknown.Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: Unknown.List of any other medications the patient received within 2 weeks of vaccination: multiple. Reported Event: My Mother and Father tested positive for COVID-19.Other medical history: multiple.Prior to vaccination, was the patient diagnosed with COVID-19. No. Since the vaccination, has the patient been tested for COVID-19. Yes.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200794255 same reporter/product/event, different patient
12-month-old was inadvertently administered a dose of QUADRACEL with no reported adverse event; Initial information received on 10-Apr-2023 regarding an unsolicited valid non-serious case received via practice manager. GMI number 01568765.  This case involves a 12-month-old female patient who was inadvertently administered a dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A) for Immunization.  On 27-Mar-2023, the 12-month-old was inadvertently administered suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE Suspension for injection at dose 0.5ml once (lot U7526AA, expiry date: 07-Sep-2024) via intramuscular route in the left vastus lateralis for Immunization with no reported adverse event (product administered to patient of inappropriate age) at same day latency.  Action taken: Not applicable.   At time of reporting, the outcome was Unknown for the event product administered to patient of inappropriate age.  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 guidelines. 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.
09/09/22 presents to Birth Center Triage for "contractions" "39w1d". PMHx of "depression ppd, eczema"
Everything locked up in my chest (the muscles) tightness of the pulmonary muscles (acute pulmonary distress) throat and pulmonary swelled, difficulty breathing-strange pressure type headache and irritability-(psychosis) felt like I had a knife in my chest-anaphylaxis-allergy type reaction. Still experiencing weakness-shortness of breath, Guillain-Barre syn., other problems. Patient prescribed diphenhydramine (BENADRYL); antihistamine and administered an EPI-PEN injection (myself), took ANAPROX meds (old presc.), packed ice on neck and chest, 4-5 days later took BENADRYL by presc.
Patient complaint of swelling and pain level 6/10 on scale of 0 to 10. Patient assessed no trouble breathing, lungs clear. Vitals WDL. Blood pressure: 114/74 temp: 98.7 F Oxygen- 97% Heart rate 87 RR- 16. Throat clear, no sign of obstruction. Patient given Tylenol 1,000 mg and ice pack. Told to report to ER if having any problems breathing.   Patient seen by MD at clinic.
Tested positive for covid; This spontaneous case was reported by a pharmacist and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for covid) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no relevant medical history reported).    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for covid). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for covid) 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.
anaphylaxis; allergic reaction; This is a spontaneous report received from contactable reporter (Other HCP). Other Case identifier(s): 2022NVX-US-000003400.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "anaphylaxis"; DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergic reaction".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on temporal association and known safety profile of the product, a causal relationship between the events or anaphylaxis, allergic reaction and can be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
May 16, 2021: Developed severe facial twitching and weakness. Early June: Experienced what was believed to be a stroke or a TIA, which was ruled-out; extreme tingling throughout my entire body (from head to toe), basically a feeling of getting splashed with ice cold water several times a week. Also, my blood pressure has been a constant roller coaster, ranging from 212/128 as low as 76/53 and everywhere in between while doing nothing.  I'm currently on 13 different medications.
PATIENT REPORTED THAT THE MORNING AFTER VACCINATION, A BRUISE/SWOLLEN AREA FORMED. THE INJECTION SITE WAS SWOLLEN, RED, AND WARM TO THE TOUCH. THE BRUISED SITE GREW IN DIAMETER. THE PATIENT REPORTED THE EVENT ON 3/14/20, AND WAS ADVISED TO WAIT 24 HOURS BEFORE SHOWING US THE BRUISE AGAIN. THE PATIENT PRESENTED AGAIN ON 3/15/20 AND WAS ADVISED TO MONITOR FOR PROGRESSION, BUT THE PATIENT SAID IT WAS BEGINNING TO GO DOWN AND RECEDE. THE PATIENT WAS CALLED TODAY, 3/18/20, BUT REPORTED THE BRUISED AREA IS STILL 2" ACROSS AND SEEMS TO BE CHANGING COLOR. PATIENT WAS ADVISED TO CONTINUE TO SELF MONITOR, BUT TO SEEK MEDICAL ATTENTION IN THE EVENT THAT THE SWELLING/BRUISING SPREADS. THE PATIENT VERBALIZED UNDERSTANDING.
Extreme swelling at least an inch and tenderness and redness in muscle. Very painful to move arm. Shivers and sick to stomach.
Recieved Booster Pfizer Vaccine on 9/29/21, on 9/30/21 had temp of 106.0, then 103.0, 102.0. CXR showed bilat infiltrates,  started on rocephin., temp down to 97.9 on 10/1/21. Multiple long standing chronic health conditions, active with Hospice Services. DNR/DNI. On Aspiration Precautions.
Was vaccinated in the evening of the 19th and symptoms started around 3pm the next day. All over body aches, severe right ankle/heel pain, headache, fever 101, chills, sweats. 1/22/2021  left axillary lymph node swelling and soreness.
Patient reported a rash on her lower back that appeared about week after 1st dose of shingrix. The rash looks like shingles. The patient has not been seen by MD for diagnosis yet. Advised patient to make an appointment with MD.
This case was reported by a physician and described the occurrence of swelling arm in a female subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). On October 2nd or 3rd, 2008 the subject received a dose of FLULAVAL in the right arm. At an unspecified time after vaccination with FLULAVAL, the subject experienced swelling in the right arm and heat and pain in the right arm. At the time of reporting the outcome of the events was unspecified.
THE SAME DAY I RECEIVED THE SECOND DOSE I STARTED TO HAVE INTERMITTENT TACHYCARDIA PULSE RATE SHOOTS UP ANYWHERE FROM 110 TO 140 WHILE AT REST. DOING NOTHING AND MY HEART STARTS TO SPEED UP AND SORT OF POUND. I ALSO HAD SOME OCCASIONAL CHEST PAINS WHICH WERE LIKE A SQUEEZING CRAMP IN THE UPPER MIDDLE OF MY CHEST THAT CAME AND WENT THROUGHOUT THE DAY X 3 DAYS.  THAT RESOLVED BUT THE TACHYCARDIA HAS NOT STOPPED.  IT EVEN HAPPENS WHILE I AM SLEEPING AND WAKES ME UP. I HAVE ZERO HEALTH ISSUES AND HAVE NEVER HAD THIS HAPPEN BEFORE.
On May 2, 2023, after receiving dose 4, I had a stuffy nose, chest congestion, wheezing and fatigue.  I began to cough up yellow mucus.  I called the doctor and had telehealth visit.  The coughing was so bad that I would lose control of bowels.  Saturday night after starting the prescriptions I couldn't taste or smell.  I tested negative for COVID-19.  But the tele-doctor diagnosed me with respiratory infection.  I am finally beginning to feel better today.  I was prescribed an Albuterol inhaler and a Z-Pack.
Both right and left middle fingers got swollen.  Both right and left middle fingers are painful to move.  Both right and left middle fingers feel as if they have a tight ring on them, but there is no ring on them.  Sometimes the pain goes to the palm of my hands.  I have had these symptoms for two moths now.
blood pressure started going up; the pain from the shot in her arm went down her arm and into her butt; and gave her a boil, and now getting boils all over her buttstocks; she saw gynecologist, for a pap smear,  who told her she had a yeast infection; the pain from the shot in her arm went down her arm and into her butt; her body is aching all over; This is a spontaneous report from a contactable consumer (patient) received via medical information team. A 40-year-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported), via unspecified route of administration, administered in arm on 14May2021, as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. The patient medical history included she got the shot is because her baby has asthma. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 on an unspecified date for COVID-19 immunisation and the patient experienced very very tired, sleepy and weak. The patient previously took Tylenol for an unspecified indication and had allergy. On an unspecified date in May2021, blood pressure started going up, the pain from the shot in her arm went down her arm and into her butt butt and gave her a boil, and now getting boils all over her buttstocks and her body is aching all over. The reporter stated that, after the second shot a week later her blood pressure started going up, the pain from the shot in her arm went down her arm and into her butt and gave her a boil, and now getting boils all over her buttstocks "like an infection is coming out of her body" she saw gynecologist, for a pap smear, who told her she had a yeast infection, because she was taking so many baths for the boils but after she was given the medication for the yeast infections, she saw another doctor and he said to see a skin doctor, caller states she knows when something is trying to come out of her body, it will do something like this, it will bring boils out, and she would have to sit on ice pack to help. The outcome of the events she saw gynecologist, for a pap smear, who told her she had a yeast infection was unknown and for other events were not recovered.  Information on Lot/Batch number has been requested.
Fatigue 12/1 3PM; dull headache 12/1 8PM - 12/2 4PM; Nausea 12/1 9PM, 12/2 1AM and 9AM. Felling faint 12/2 7AM worse 9AM - along with feeling clammy and sweaty
gasping air issues/ severe breathing issues; A spontaneous report was received from a consumer concerning a 66-year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced gasping air issues or severe breathing issues (gasping).  The patient's medical history was not reported. Concomitant product use was not reported.  On 19 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 20 Feb 2021, next day of receiving vaccine, patient experienced gasping air issues and had went to the emergency room because of severe breathing issues.   He was admitted into the hospital and on 22 Feb 2021, they had put him on a pacemaker. He also had a little bump on electrocardiogram (EKG). His second shot was scheduled on 16 Mar 2021.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event, gasping was recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
received a 100-mcg dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (received a 100-mcg dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Medical history was not provided.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (received a 100-mcg dose). At the time of the report, ACCIDENTAL OVERDOSE (received a 100-mcg dose) outcome was unknown.
Driving home on the 28th she started feeling dizzy, shaky. She says she feels fine when she is lying down, but not when upright. She called her doctor and they told her to monitor her symptoms and call if she got worse.
Information has been received from a registered nurse, concerning a patient's mother who on 21-APR-2010 was vaccinated with a dose of GARDASIL (lot # not reported).  (Mother experience reported in WAES # 1004USA03561).  The registered nurse reported that on 14-SEP-2010, at 26 gestational weeks, the mother had a baby.  The baby had been in the Neonatal Intensive Care Unit (NICU).  At the time of the report the gestational age of the patient at birth was unknown.  Additional information has been requested.
12 hours after vaccination (2am), awakened by chills, fever 102F, nausea, headache.   Used meclazine, benedryl, ibuprofen or Tylenol alternated for head and arm pain per doctors instructions. Arm swelling not significant, but sore as with any vaccinations.
Immediately after receiving IM flu vaccine pt has a seizure lasting 1 minute. Pt has sz disorder and has 0-20 sz/day.
Blurry vision. BP 114/60; HR 78; RR 16. Pt stable & released from vaccination site
had a decreased oxygen saturated levels where she had to increase her oxygen; fever; sweats; body aches; loss of appetite; numbness; tingling sensation in her left arm; productive cough; coughing up blood; doesn't have a lot of energy; This is a spontaneous report from a contactable nurse (patient herself). A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, the patient had a decreased oxygen saturated levels where she had to increase her oxygen, fever, sweats, body aches, loss of appetite, numbness, tingling sensation in her left arm, productive cough, coughing up blood and doesn't have a lot of energy. The reporter said normally she was on 2L but had to increase to 3L. The event of oxygen saturation decreased was considered to be medically significant. She heard that more people had a reaction with the 2nd dose than the 1st dose of the vaccine. With this, she wants to know the percentage of people who had a reaction with the 1st dose, and those who had it with the 2nd dose. The reporter wanted to know if she should still get the 2nd dose of the Pfizer-BioNTech Covid-19 Vaccine based on the symptoms that she had with the 1st dose. She told the health care professional (HCP) that there was no information about loss of appetite, coughing up blood, numbness tingling sensations, productive cough, and decreased oxygen saturated levels associated with the vaccine. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events fever, sweating, appetite lost, energy decreased and the suspect drug BNT162B2. As there is limited information in the case provided, the causal association between the event low oxygen saturation, general body pain, numbness, tingling sensation, productive cough, coughing blood and the suspect drug BNT162B2 cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient reported rash all over his entire body, nausea, weakness, confusion, tiredness. Patient was going home and if he felt worse then he would call an ambulance. 09:00 5-9-17 all resolved.
PATIENT RECEIVED VACCINE PAST BUD, CONSIDERED AS AN INVALID DOSE AND WILL COME BY NEXT WEEK FOR RE-VACCINATING  NOT EXPERIENCING ANY ADVERSE EVENTS FROM THAT DOSE
Information has been received from a physician concerning an 18 year old female who on 28-OCT-2008 was vaccinated intramuscularly with a first dose of GARDASIL (lot number and injection site not reported).  Subsequently the patient experienced fever, chills and nausea.  On 03-NOV-2008, the patient's mother called the physician's office to report the symptoms.  Subsequently, the patient fully recovered from the events without requiring treatment.  Additional information has been requested.