chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Beginning day after dose 1, patient experienced diarrhea.; This is a spontaneous report from a contactable reporter (Consumer or other non HCP).   A 11-year-old male patient received bnt162b2 (BNT162B2), administration date 16Feb2022 (Lot number: unknown) at the age of 11 years as dose 1 (tris), single for COVID-19 immunisation. It was unknown whether the patient had any relevant medical history and it was unknown whether the patient was receiving concomitant medications. The following information was reported: DIARRHOEA (non-serious) with onset 17Feb2022, outcome "unknown", described as "Beginning day after dose 1, patient experienced diarrhea". It was unknown whether therapeutic measures were taken as a result of diarrhoea.  Additional information: It was unknown whether the patient had any known allergies. It was unknown whether the patient had received any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Spiked temp 2 hrs after vaccines, vomiting, ongoing fever, diarrhea for 2 days after - 9/16/11.
?Pfizer-BioNTech COVID-19 Vaccine EUA? Received second covid vaccine on 1/21 (17 days from first injection) and experienced fever, chills, nausea and body aches the following morning. Symptoms resolved by the next morning and pt felt fine all day Sat and Sun morning. Sun after noon around 1pm pt's lips started to swell and developed hives to right arm. This progressed throughout the evening despite antihistamines. At about 4am Monday 1/25 pt awoke with eyelid swelling, persistent lip swelling and more hives and presented to the ED. Pt was given prednisone. Pt followed up with PCP on Tues 1/26 as hives persisted through prednisone. Symptoms have improved over the next few days. No breathing or airway symptoms.
she does not have range of motion and can't use it; Fever; chills; Itching; ended up having severe pains in her left arm and shoulder; ended up having severe pains in her left arm and shoulder; shoulder injury; her arm is severely inflamed; This is a spontaneous report from a contactable consumer, the patient. A 54-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: ER8737; Expiration Date: Jul2021), via an unspecified route of administration in the arm left on 20Apr2021 10:30 as dose 1, single (at the age of 54-years-old) for covid-19 immunization. Medical history included ongoing hypertension from 2016 and covid-19. Patient family history was none. Concomitant medication included atenolol taken for hypertension from 2016. On 20Apr2021, she had the first dose of the vaccine and got the complications of fever, chills and itching and everything and these symptoms lasted three days and were completely resolved. Reportedly, after that she ended up having severe pains in her left arm and shoulder so in morning she ended up in the emergency room where the HCP said it could be a shoulder injury related to the vaccine administration and the acronym is SIRVA. The pain began on 20Apr2021 at nighttime and became worse on 21Apri2021. Her arm was severely inflamed and she did not had range of motion and could not use it. she was prescribed with prednisone 20mg and she had been taking three tablets daily for three days. The HCP also prescribed Volsarten 1 percent topical gel for pain and she has to rub it on her shoulder. Patient not yet had the 2nd dose of the Pfizer COVID Vaccine. Reportedly, the indication of the Pfizer COVID vaccine was that earlier in January, she, her husband and her daughter got the covid virus and it was pretty bad and had covid for two weeks straight and got over that and reportedly, her mother had a stroke. She went to the emergency room in morning because the pain was so unbearable and she was doing the over-the-counter CVS brand acetaminophen 500mg and CVS brand ibuprofen and that stuff was not helping her since last night, stated she knew this reported event was something more than how she was treating herself, also stated acetaminophen has lot 8JE2070C, expiry date Oct2021. Patient stated the Ibuprofen was 800 mg and she does not see any lot number on the bottle and did not. Patient did not receive any additional vaccines on same date of the pfizer suspect and no prior vaccinations within 4 weeks. The outcome of the events pyrexia, chills and pruritus was recovered and for rest of events it was unknown.  No follow-up attempts were needed. No further information was expected.
Tested positive for Covid-19 post vaccine, breakthrough case. Full symptoms (fever, body aches, chills, severe congestion, coughing, fatigue, etc.)
24 hrs p/getting vax pt started itching, swelling & erythema of lt deltoid area (size 4x3 inches); DPH given;
On the above-listed date, a vaccination clinic was held for staff to receive the COVID-19 booster vaccination. On this day we had Bivalent Moderna Booster dosed vials on hand to be given to those requesting the booster dose. At the time of the clinic, the vaccinator was operating on incorrect information that the Moderna Booster vaccination for the Bivalent vaccine was 0.25 mls rather than the new dosage of 0.5mls.  The error was not noticed until the end of the clinic.  Immediately the error was communicated to those affected. All patients requesting so were vaccinated with the remaining 0.25 mls within 24 hours in line with the FDA and CDC recommendations for this specific error.  Two patients were contacted but requested the full dosage of the booster vaccine in the coming weeks.  Three patients were contacted and chose not to be vaccinated further.  There were no reactions noted upon follow-up.  All patients were advised to communicate with their primary care doctors and follow up with them should there be any adverse reactions.  The entire department debriefed and confirmed all new information and rehabilitated the draw-up and delivery of for all vaccinations in the future. This error was taken very seriously and all means of ensuring this is to not happen in the future were implemented.
Hives, ear pain/pressure, sore throat, sinus congestion, tinnitus, hyperacusis
With the first dose, I had severe lethargy, body aches, and low-grade fever. Second dose just the lethargy and mild body aches.  Lethargy has persisted since that time. About a month ago, I developed an upper respiratory issue. It involved my ears, tonsils, throat, clusters of canker sores under my tongue, body aches, and still severe lethargy. That lasted about a month and just now getting over it. I tested negative for COVID in my doc office.
Syncope without warning at 6:00pm, "blacked out" for approximately 10 seconds. Rash at injection site approximately 3.5cm wide and 5cm tall, not noticed until 8:36pm same day. Blood pressure 144/85 mmHg Right arm, HR 84 bpm. Still dizzy and lightheaded at 9:05pm same day.
Vaccine not removed from freezer at 2 wk- at 3 wks and administered after consult with Dr. Notified pt offer repeat dose
Moderate fatigue, moderate body aches, mild chills, and mild headache beginning one day after injection and lasting 24 hours.
Misadministration (patient was supposed to receive Tdap not Dtap). No AEs following the injection.
increased my heart rate; arthritis; ENG showed carpal tunnel; I got a rash all over my arm from my elbow up same arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (increased my heart rate), ARTHRITIS (arthritis), CARPAL TUNNEL SYNDROME (ENG showed carpal tunnel) and VACCINATION SITE RASH (I got a rash all over my arm from my elbow up same arm of injection) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. he patient's past medical history included Radioactive iodine therapy (years ago I had to have radioactive iodine for goiter).Concurrent medical conditions included Thyroid disorder, Penicillin allergy, Drug allergy and Latex allergy.Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ATENOLOL and LISINOPRIL for an unknown indication. On 22-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (increased my heart rate), ARTHRITIS (arthritis), CARPAL TUNNEL SYNDROME (ENG showed carpal tunnel) and VACCINATION SITE RASH (I got a rash all over my arm from my elbow up same arm of injection). At the time of the report, HEART RATE INCREASED (increased my heart rate), ARTHRITIS (arthritis) and CARPAL TUNNEL SYNDROME (ENG showed carpal tunnel) outcome was unknown and VACCINATION SITE RASH (I got a rash all over my arm from my elbow up same arm of injection) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available):On an unknown date, Electronystagmogram: carpal tunnel (abnormal) ENG showed carpal tunnel.On unknown date patient went for X-ray for right hand.After receiving two injections, patient can not keep thyroid level normal.No treatment information were reported by the reporter company comment included,This case concerns a 67 year-old, female patient with a medical history of thyroid disorder, who experienced the non serious unexpected AESI of Arthritis. The event occurred after the second dose of mRNA-1273 vaccine, exact date not provided. The rechallenge was not applicable as the event was reported exclusively after the second dose. The medical history, of thyroid disorder remains as confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.This case was linked to MOD-2021-386036 (Patient Link).Sender's Comments: This case concerns a 67 year-old, female patient with a medical history of thyroid disorder, who experienced the non serious unexpected AESI of Arthritis. The event occurred after the second dose of mRNA-1273 vaccine, exact date not provided. The rechallenge was not applicable as the event was reported exclusively after the second dose. The medical history, of thyroid disorder remains as confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old male patient received BNT162b2 (BNT162B2), on 26Jan2022 as dose 4 (booster), single (Lot number: FJ1614) at the age of 53 years, in right arm 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. Concomitant medication(s) included: EMTRICITABINE, start date: 01Jan2022, stop date: 03Jul2022; TENOFOVIR, start date: 01Jan2022, stop date: 03Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Jun2022) negative, notes: I tested negative on antigen tests multiple times as of 30Jun2022; (03Jul2022) positive, notes: tested positive on two antigen tests on 03Jul2022; (unspecified date) Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Adverse event: fatigue, scratchy throat, head congestion, night sweats. Symptoms resolved, and I tested negative on antigen tests multiple times as of 30Jun2022, but rebounded and tested positive on two antigen tests on 03Jul2022.
suspected vaccination failure; had Shingles; painful; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient got shingles 2 times in less than a year and it was extremely painful. The patient had already received the Shingles vaccine and stated there would not be a third time.  This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Pt was here to receive 1st Hepatitis A vaccine and instead received a 4th Hepatitis B vaccine. Physician informed and pt's mother aware that no issue with receiving a 4th dose but will need to come back for the Hepatitis A at a later date
Complained of  right lower leg pain and swelling, shortness of breath, sent to hospital for Ultrasound of right lower leg, Ultra sound was positive for a DVT. Was then sent to the Emergency room for evaluation and treat for DVT. Complained of Shortness of breath. CT Scan Angiogram completed and found to have bilateral Pulmonary Embolism
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 03-FEB-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10 single Ds 0.5 ml Vls 10 SDV (lot number and expiration date: K007262 and 25-NOV-2015 respectively; route of administration was not provided). The vaccine had an excursion of 27 degrees Fahrenheit (-2.77 degrees Celsius) (lowest recorded temperature) for 828 hours (sum of hours in excursion). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Hives on my neck, collarbone, upper back, and a large raised welt on the arm of the injection (aside from swelling, redness, tenderness at site of injection.
HCP gave a patient TENIVAC on 19Oct2022 that expired on 08Oct2022 with no reported adverse event; Initial information received on 19-Oct-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 42 years old female patient to whom healthcare professional (HCP) gave DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC on 19-Oct-2022 that expired on 08-Oct-2022 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 19-Oct-2022, the patient received a expired second dose 0.5 ml of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT Strength: Standard (lot U6831AA, exp date:08-Oct-2022 ) via intramuscular route in the left deltoid for Immunization with no reported adverse event (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.
Patient passed out and fell to the ground; he then convulsed for 15 seconds before regaining consciousness. He was laid on an exam table under observation for 10 minutes. Pt recovered and walked out on his own accord without sequele.
PT dizzy immediately following shot. Checked out by staff.  BP low. PT hypotensive positive orthostatics.  Medic administrated fluids (0.9% Sodium Chloride Injection USP 1000 mL). Transfer of care to another group.  Transported to Medical Center.
A report received from a health care professional on 08Nov01 regarding a 61 year old male pt who died on 06Nov01 after receiving Fluvirin vaccine on 05November2001. Relevant medical history included right  CVA(hemiparesis), hypertension and coronary bypass surgery. The pt was taking acetylsalicylic acid, doxazosin mesilate, diltiazem hydrochloride, enalapril maleate, venlafaxine hydrochloride, isosorbide mononitrate, metoprolol tartrate, clopidogrel sulfate, lanscprazole, trazodone, glyceryl trinitrate, parecetamol and ranitidine hydrochloride. The pt was institutionalized in a nursing home and received a Fluvirin injection on 05Nov01. The next evening, the pt complained of chest pain and right hand pain. He was given sublingual nitroglycerin with marginal relief and experienced increasing shortness of breath. Subsequently, the pt was transported to the hospital and was pronounced dead upon arrival on 06Nov01. The reporter stated that the pt may have experienced a massive myocardial infarction. The reporter has assessed the relationship of study medication to the event as unk.
Patient complained of headache, upset stomach, diarrhea, very tired all day 1/8/21, left arm swelling with pain from forearm to shoulder.  Woke on Saturday, 1/9/21 with enlarged/swollen lymph nodes under left arm, had headaches throughout the weekend.  By Monday, 1/11/21 most symptoms had resolved with the exception of some arm soreness.
SORE THROAT; MILD SHORTNESS OF BREATH; MILD CHEST PAIN; DIZZINESS; CHILLS; INTENSE FATIGUE; FULL-BODY MUSCLE ACHES TO THE EXTENT THAT STANDING AND SITTING WERE PAINFUL; HEADACHE; FEVER; MILD SORENESS AT THE INJECTION SITE; NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced sore throat, mild shortness of breath, mild chest pain, dizziness, chills, intense fatigue, full-body muscle aches to the extent that standing and sitting were painful, headache, fever, mild soreness at the injection site, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore throat, mild shortness of breath, mild chest pain, dizziness, chills, intense fatigue, full-body muscle aches to the extent that standing and sitting were painful, headache, fever, and nausea, and had not recovered from mild soreness at the injection site. This report was non-serious.
Woke up in middle of the night. Got up to take medicine. Became nauseous and fainted
Within 24 hours of administration, the site of injection was tender to the touch and hot. There was about 2 inches of redness around the injection site. The patient went to a walk in care clinic about 48 hours after administration and received a 10 day course of oral antibiotic.
Inflammed red area about 3"x4" slightly hard to the thouch. "Patient was instructed to see doctor."
Patient admitted for severe sepsis, pneumonia - sepsis bundle module has been ordered. Serial lactates, Blood cultures, Broad spectrum antibiotics and IV fluids have been ordered or completed. Patient discharge to home. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
I had a perforated appendix follow an appendectomy follow by access on the side and pneumonia in both lungs at the same time. On March 15th, 2023. I had surgical drain implanted and April 7th I had the drainage removed.
Rash, fever, vomiting and lethargy occurred within 24 hours of shot. Symptoms subsided in 2 days.
On 04 February 2021 during our COVID-19 Vaccine Drive we vaccinated one of the clinic?s staff with a dose of Moderna COVID-19 vaccine. This is her 2nd mRNA COVID-19 Vaccine dose. She is a new Clinic employee who received the first dose of Pfizer/BioNTech COVID-19 vaccine in December prior to moving. Referencing the CDC guidance and consulting with our provider on site, the team determined that this situation falls under exceptional situation due to the following reasons: ? The Pfizer/BioNTech COVID-19 vaccine is not available in our footprint. ? The vaccine recipient belongs to the Phase 1a population, an essential healthcare worker. ? The vaccine recipient was in the window to receive her 2nd dose.   There has been no adverse reaction from the patient receiving the second dose. Submitting report for awareness.
Local reaction to injection, 2 inch redness around injection site. Red, warm and swollen.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 at 15:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 81 years, in left arm 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 included: "Hypertension" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient received Paxlovid for Indication treatment of COVID-19, treatment start date was 30Dec2022 and treatment stop date was 04Jan2023. Patient had no known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Cellulitis like reaction at injection site and extending to 10cmx14cm (erythema, tender to touch, and increased warmth) upper edge with harden area. No noted fevers but taking NSAIDS.