chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician regarding a 22-year-old female patient. Patient had no pertinent medical history, no drug reactions or allergies and was not on any concomitant therapy. On an unspecified date, prior to receiving vaccines, the patient underwent an unspecified HPV test that came back negative. On an unspecified date in February 2015, the patient was vaccinated with unidentified Merck HPV vaccine (either GARDASIL or GARDASIL 9 or another Merck vaccine). The patient completed the series of vaccination in May 2015. On 27-OCT-2015, the patient underwent an unspecified HPV test and that came back positive. Outcome of the positive HPV test was not known. Causality assessment was not provided. Additional information has been requested.
15 minutes after the vaccine, I started having muscle spasms/twitches. Today is 12/14/2022 and I still have these same symptoms.
WOKE UP WITH TERRIBLE MIGRAINE THAT MADE ME NAUSEOUS AND BODY ACHES WITH EXTREME FATIGUE.  MIGRAINE LASTED CLOSE TO 10 HOURS.  BODY ACHES AND FATIGUE LASTED 2 DAYS.
pt recvd vax;sterile abscesses or pos cellulitis;severe inject site reaction of swelling & erythema;
COVID-19 VACCINE  EUA;  MY ARM SWELLED  REAL BAD TURNED A DEEP RED, VERY PAINFUL, AND AS OF YESTERDAY 02/16/2021 HAD PURPLE SPOTS.
got covid 4 months after a second shot of vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (got covid 4 months after a second shot of vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic and Immunocompromised.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (got covid 4 months after a second shot of vaccine). At the time of the report, COVID-19 (got covid 4 months after a second shot of vaccine) outcome was unknown.            No Treatment informations were reported.
Low fever beginning on 1:00AM Monday 12Apr; Experienced nausea Monday 12Apr evening and seizure; Experienced nausea Monday 12Apr evening and seizure; This is a spontaneous report from a contactable consumer. A 58-year-old male patient received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration on 07Apr2021 (Batch/Lot Number: ENG201) as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced nausea monday 12Apr evening and seizure and low fever beginning on 1:00am monday 12apr at 01:00. The patient was hospitalized for experienced nausea monday 12apr evening and seizure and for low fever beginning on 1:00am monday 12apr for 4 days. Therapeutic measures were taken as a result of low fever beginning on 1:00am monday 12apr. It was unknown if therapeutic measures were taken for the events Experienced nausea Monday 12Apr evening and seizure. The outcome of the events was unknown.
profound Lethargy, difficulty ambulating and progression to DVT bilaterally(03/27/2021)
Pain in arm around injection site and arm immobility.  She claims to still have these difficulties now a month after the injection.  She has visited her doctor who advised she take Motrin and use warm compresses.
red rash outbreak on neck and chest; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 02Apr2021 at 14:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Medical history included kidney stones, gallstones and depression. Concomitant medications included venlafaxine (MANUFACTURER UNKNOWN), lamotrigine(MANUFACTURER UNKNOWN), valacyclovir (MANUFACTURER UNKNOWN). The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 12Mar2021 at 15:00 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was 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 03Apr2021 at 12:30 the patient experienced a red rash outbreak on the neck and chest. The patient did not receive any treatment for the event. The events did not result in doctor or other healthcare professional office/clinic visits, and the emergency room/department or urgent care. The clinical outcome of the event red rash outbreak on the neck and chest was not recovered at the time of the report.  No follow-up attempts are needed; information about the lot number cannot be obtained.
Second dose taste of copper is stronger; Second dose taste of copper is stronger; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 02May2021 12:15 (Lot number: EW0167) at the age of 40 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Obesity" (unspecified if ongoing), notes: other medical history: Obesity; "Anxiety combo/Anxiety" (unspecified if ongoing), notes: other medical history: ADHD/Depression/Anxiety combo; "ADHD/Depression/Anxiety combo" (unspecified if ongoing), notes: other medical history: ADHD/Depression/Anxiety combo; "Depression" (unspecified if ongoing), notes: other medical history: ADHD/Depression/Anxiety combo; "Chronic Inflammation" (unspecified if ongoing); "Testing for PCOS" (unspecified if ongoing); "known allergies: Sulfa / Bactrim" (unspecified if ongoing), notes: known allergies: Sulfa / Bactrim. Concomitant medication(s) included: VYVANSE; MAGNESIUM; TRINTELLIX; PROPRANOLOL. Past drug history included: Wellbutrin, reaction(s): "known allergies: Wellbutrin"; Bactrim, reaction(s): "known allergies: Sulfa / Bactrim", notes: known allergies: Sulfa / Bactrim. Vaccination history included: Bnt162b2 (lot number=EW0153,, administration date=11Apr2021,, dose number=1,, vaccine location=Left arm), administration date: 11Apr2021, when the patient was 40 years old, for Covid-19 Immunization, reaction(s): "I have a dirty penny in my mouth.". The following information was reported: DYSGEUSIA (non-serious), CONDITION AGGRAVATED (non-serious), outcome "recovering" and all described as "Second dose taste of copper is stronger". Therapeutic measures were not taken as a result of dysgeusia, condition aggravated.  No follow-up attempts are possible. No further information is expected.
first dose, two weeks after that a second dose; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   In May 2022, the patient received the 2nd dose of Shingrix. In May 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 12-SEP-2022 Reporter's Comment: The nurse reported that the patient received the second dose of Shingrix two weeks after the first dose. No more information could be gathered.  Consent to follow up could not be asked from reporter. Additional Supportive Information: The patient received the second dose of Shingrix earlier than the recommended interval, which led to shortening of vaccination schedule.
A nurse reported that a infant rec'd her 1st dose of Prevnar, Infanrix (GSK), Act-HIB (Aventis Pasteur SA) and IPOL (Aventis Pasteur SA) vaccines on 8/28/01. That same day, the infant experienced cyanosis of her legs and she screamed. The cyanosis resolved within 10 minutes. She was seen by the reporter and recovered. This report was rec'd from Glaxo Smith Kline (ref. #2001021044-1).
Intussusception 4/29/08  6/20/08 Reviewed hospital medical records of 4/29-5/1/2008. FINAL DX: Intussusception, surgically reduced Records reveal patient experienced restlessness, cramping intermittent abdominal pain, bilious emesis, constipation x 3-4 days.  Air contrast enema was initially successful then IS recurred overnight.  BE then was unsuccessful & taken to OR for laparoscopy.  Improved & d/c to home on oral antibiotics for recent OM.
C/O- Ringing in her ears  -Monitored, released from OBS area in 30 minutes
Site: Pain at Injection Site-Severe, Additional Details: patient came in and stated she has pain in her arm, it has been a month since her vaccines. other arm does not bother her
Hard, red knot about size of walnut formed at injection site after eight days. It is itchy and has slight rash around the hard knot. There was no initial reaction. It is not painful.
Information has been received from a physician concerning her 20 year old daughter who on 11-JAN-2007 was vaccinated IM with a 0.5 ml dose of GARDASIL vaccine (yeast) (lot#653938/0954F). Concomitant therapy included Yasmin. On 11-JAN-2007, fifteen minutes after the vaccination, welts appeared on the patient's neck and spread all over the body. Dermatographia resulted all over the patient's body, her hands and feet were swollen, and she experienced arthritic pain in her joints. It was reported that the patient was not able to walk because of the pain. The patient was treated with Zyrtec, dexamethasone and hydroxyzine. Unspecified blood tests were performed (results not reported). At the time of this report, the patient was not recovered. Welts, dermatographia, peripheral swelling, arthritic-like joint pain and the patient's inability to walk were considered to be disabling events. Additional information has been requested.
Started to have gastrointestinal issues. Never had any of these issues before the vaccine. I was subsequently diagnosed with ulcerative colitis via colonoscopy.
Moderna #4 given 5/6/22 9:30 am, in the afternoon patient was at his  daughters house feeling tired.  He went home to rest and later on that evening  reported by daughter she was acting strange, Yelling at family "get the f**  out", not responding to them to open the door.  EMS came over took patient to  hospital.  noted by reports was admited with  AMS/confusion. Hospital course vitals stable, blood work stable except for Na  126 that improved to 130 next day and normal CT of head. Patient was  discharged  next day AMA as he did not want to stay any longer.  Family took him home.
Forty eight hours later my right arm became extremely painful to the point of difficulty of lifting the arm, my right leg and jaw had shooting pain. and weakness lifting the right arm and leg.  Along with muscle atrophy.  A 10 lb. weight loss ar the time with sob and ankle edema. I have been in physical therapy for the past 4.5 months to regain the strength and mobility in the arm and leg. Today going up stairs is difficult and I have lived in pain daily since the vaccine. I still have shortness of breath, fatigue and difficulty sleeping due to numbness to right side.
Quarter-sized red, swollen and tender R thigh the night of vaccine administration. The next day, temperature up to 104. At ER, treated with antipyretics. The 2nd day, temperature still up to 103.5 + vomiting x 2. Examined on 3rd day, redness gone, irritable, clingy.
On Wednesday morning at 2 am I began to itch,   I have been itching from head to toe ever since.   Any friction on my skin will cause the skin to itch and burn.  If I scratch the itch I will break out in bumps and severe burning sensation.  All areas of my body itch including groin area( I itch and burn after wiping  when using toilet) except for my face.  The inside of my mouth itches at times when eating   my tongue will itch while talking.    My body will itch at times even without some sort of friction.  It is horrible.  I just want this vaccine out of my body.
9 days post vax status epilepticus x 2 hr; tx IV valium, Dilantin, Rocephin; No further sz p/2hr of status;
Per pt's wife - reported to pharmacy - 2 days after receiving vaccine - pt experienced shortness of breath, coughing, nausea. Patient was not feeling well in general. 2 days after this (so about 5 days after receiving the vaccine) - pt was COVID positive - and is at the moment in the ER.
Patient is a 74 year old male in good health with NO prior reactions to the annual flu, pneumonia, or shingles vaccinations. Because of a scheduled prostate biopsy in early April 2021, I wanted to complete the vaccination for COVID-19 in advance of this procedure. On Wednesday 2/24/21 at 11:00am, patient received Dose 1 Pfizer-BioNTech COVID-19 vaccine at the mass vaccination site. Within 5-10 mins of receiving the vaccination shot in left arm, left elbow and forearm began to swell into a large ball shape near the elbow joint. At the same time, left hand became noticeably swollen as well. Patient did not experience trouble breathing or have any numbness in fingers at that time. The observation staff nurses took patient to a separate room to check blood pressure and heart rate which were both in the normal range. They suggested that patient's wife go to the pharmacy and purchase Benadryl. Patient took 2-25mg capsules per manufacturer directions. Unfortunately, the swelling did not seem to be reduced by 6:00pm. Upon returning to our home, patient soaked left elbow, forearm and hand in an Epsom salt solution for about 45 minutes prior to going to bed. At 7:00am the next morning, Thursday 2/25/21, left armpit, elbow and forearm remain swollen but the hand appears to be normal again.
Information has been received from a licensed practical nurse concerning a 7 month old female with 3-methylcrotonyl-coenzyme A (CoA) carboxylase deficiency who on 05-MAY-2008 was inadvertently vaccinated PO with her first 2.0 ml dose of ROTATEQ (lot # 660377/0274X). The child was not experiencing any reaction to the vaccine at this time. The patient sought unspecified medical attention at the office. No other ROTATEQ will be administered to this child. There was no product quality complaint. No other information. Additional information has been requested.
Headache; Chills; Felt tired; Fever 101.3F; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), FATIGUE (Felt tired), PYREXIA (Fever 101.3F) and HEADACHE (Headache) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included EMTRICITABINE, TENOFOVIR DISOPROXIL FUMARATE (TRUVADA) for HIV pre-exposure prophylaxis, VITAMIN B2 [RIBOFLAVIN] for an unknown indication.    On 16-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced CHILLS (Chills), FATIGUE (Felt tired) and PYREXIA (Fever 101.3F). On 18-Apr-2021, the patient experienced HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 mg. On 17-Apr-2021, PYREXIA (Fever 101.3F) had resolved. On 18-Apr-2021, CHILLS (Chills), FATIGUE (Felt tired) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, Body temperature: 101.3 f (High) fever 101.3F.         This case was linked to MOD-2021-051612.
Pounding heart, fast breathing, warm/tingling in arms/hands, feeling like I might faint.
when administering vaccine "little to none" was actually injected with no adverse event; not attached properly to the prefilled syringe with no adverse event; Initial information was received on 01-Nov-2021 regarding an unsolicited valid non-serious case received from a pharmacist and non-healthcare professional via the Regulatory Authority (Regulatory Authority Number - 00836403).   This case involves a 61-years old male patient who was administered with suspect INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] had little to none was actually injected due to needle not attached properly to the prefilled syringe with no adverse event (Incorrect dose administered) (needle issue).   The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other concomitant vaccines were not provided.   On 31-Oct-2021, the patient received 0.5ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number UJ687AA and expiry date not reported) via intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate dose of vaccine administered and needle issue (latency was on same day).  At the time of report, no adverse event reported.  Events outcome was unknown.  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.
Shortness of breath that comes and goes. Lingers sometimes for two days. Feel tired and fatigued when shortness of breath occurs. Been to Emergency room since this has started. I have seen a primary care doctor, Seen Cardiologist , Seen a Pulmonoligist, seen GI doctor trying to figure out why this is occuring. It is very scary, debilitating feeling.
Extreme fatigue; body ache; dull headache; shakes; chills; swelling; itchiness at injection site; Lump; This is a spontaneous report from a contactable consumer or other non hcp.    A 61-years-old female Non pregnant patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 26Apr2021 09:15 (Batch/Lot Number: ER8735) as dose 2, single for covid-19 immunisation. Medical history included bronchitis chronic, hypertension from an unknown date and unknown if ongoing. Concomitant medication(s) included hydrochlorothiazide, triamterene (TRIAMTERENE HCTZ; salbutamol (ALBUTEROL HFA). The patient previously took bnt162b2 for covid-19 immunisation, percocet [oxycodone hydrochloride;oxycodone terephthalate;paracetamol] and experienced drug hypersensitivity.The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. the patient received within 2 weeks of vaccination Triamterene hctz. Albuterol, steroid.It was reported that, on 26Apr2021 the patient experienced Extreme fatigue, body ache, dull headache, shakes, chills, lump, swelling, itchiness at injection site. No treatment was received and patient was not hospitalized. On an unspecified date in 2021, the patient was recovered from the events   Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.
Patient came in 2 days after shot and had large bruise below shot site that was about 2 in x 5 in. Upon follow up; she said it dissipated a little, no pain, or itching.
This spontaneous case, initially received on 09-Jan-2017, was reported by a health professional and concerns a(n) 27-year-old male patient. Weight: not provided; Height: not provided. Concomitant medication: refer to appropriate report section. Administration of company suspect drug(s): The patient received AFLURIA from 04-JAN-2017 to 04-JAN-2017. Dose regimen: 0.5 ml, Route of administration: Intramuscular. Batch number: 13749221A. No additional suspect drugs. On 04-Jan-2017, the patient was administered AFLURIA from a multi dose vial that was punctured over 28 days. No adverse effects were noted. Special circumstances: Drug administration error without adverse event.
60 day follow up states: Pt recovered. She is doing very well. She has had  no further seizure activity and her EEG was normal after 3 months of phenobarbital. Her medication has now been stopped. Pt's parents have chosen to receive no further immunizations. An annual follow up report received 10/22/2003 adds: Thankfully this pt is doing well! The only residual poor outcome is pt's parents are no longer "pro-vaccine". Medical record states irritability, diarrhea, tremor, anorexia. msv
Fever of 102, chills, headache, body aches, nausea, sweats, lasting from 12 midnight until about 1-2 pm the next day. The symptoms were severe enough I could not work and 800 mg of ibuprofen did not take fever down enough to work or help much with the myalgia. Symptoms improved after about 14-16 hours of onset.
Irregular heart rate up to 180bpm in a resting state.; Lightheaded/Dizziness; palpitations; drop in blood pressure 80/60 sometimes unreadable.; diaphoretic; This is a spontaneous report from a contactable consumer (patient). A 35-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration at age of 35 years on 02Jun2021 12:00 (Batch/Lot Number: Unknown) as dose 2, single for covid-19 immunisation. Medical history included penicillin allergy, no other medical history. The patient's concomitant medications were not reported. No other medications the patient received within 2 weeks of vaccination. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 in 2021 (reported as other vaccine in 4weeks) at age of 35 years for covid-19 immunisation. The patient experienced Irregular heart rate up to 180bpm in a resting state. Lightheaded, dizziness, palpitations, diaphoretic, drop in blood pressure 80/60 sometimes unreadable, started since 03Jun2021 13:00, resulted in Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), hospitalization for 7 days, received treatment of Adenosine, Cardizem, Metroprolol. No COVID prior vaccination. COVID test post vaccination (Nasal Swab) on 04Jun2021 was negative. The outcome of the events was recovering.  The lot number for the vaccine BNT162B2, was not provided and will be requested during follow up.
fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) Fever of 102.         The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was Not Applicable. No Concomitant medication information provided. No treatment information provided.