chrisvoncsefalvay/vaers-outcomes huggingface dataset:
High Creatinine; high nitrates; After her first Shingrix dose in January she developed urinary bleeding (hematuria); This case was reported by a consumer via call center representative and described the occurrence of hematuria in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th January 2021, the patient received the 1st dose of Shingrix (intramuscular). On 16th January 2021, less than a day after receiving Shingrix, the patient experienced hematuria. On an unknown date, the patient experienced creatinine increased and nitrite urine. On an unknown date, the outcome of the hematuria was not recovered/not resolved and the outcome of the creatinine increased and nitrite urine were unknown.   It was unknown if the reporter considered the hematuria, creatinine increased and nitrite urine to be related to Shingrix.  Additional details were provided as follows: It was reported as after her first Shingrix dose in January the patient developed urinary bleeding (hematuria) that had not resolved. It became less when the patient drank more water but it never went away. The patient seen a urologist and had a cystoscopy performed and no cause of the bleeding was found. The patient's urinalysis showed a normal levels of bacteria, not enough to cause bleeding. The patient underwent blood test and back with high creatine and nitrates. The patient had first Pfizer COVID-19 dose on 27th  February  2021 and second Pfizer COVID-19 dose on 20th  March 2021.  The patient received second of Shingrix on 3rd April 2021. All vaccine injections were in her right arm.  The patient will follow up with a new urologist next Friday on 14th May 2021.  The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR101259:
Patient experienced a mild/moderate anaphylactic rxn (SOB) for approximately 24 hrs post vaccine administration. Patient was monitored for 15 minutes post administration, per pharmacy's protocol. The rxn started after the pt had left the pharmacy.
Thursday evening, (2/4) after my 2nd shot, I began shaking with chills, fever, and the worst headache I ever experienced.  In addition, I threw up my very small dinner (rice & brussel sprouts).  All night, I whimpered in pain, but anytime I tried to take a Tylenol with water, I threw it up.   Friday (2/5):  I was able to keep water down and take Tylenol, but I had massive headaches, fever & chills. Saturday (2/6) - Monday (2/8):  Exhaustion, slight fevers, massive headaches throughout these days, although every day was a small improvement. Tuesday (2/9 - Wednesday (2/10):  Light headaches & exhaustion
Itching 4-5 hrs after injection on chest, back and arms. No hives just redness and itching. Became worse as time went on at it worst 48 hr after injection. Within 72 hr began to subside. By 12-28-05 completed gone.
Heavy vaginal bleeding beginning on cycle day 7  (period not due for 3+ weeks - very, very unusual for me).
Inquire about 3rd dose, 4 years after 2nd; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 25-year-old female patient who received HBV (Engerix B adult) for prophylaxis.   Previously administered products included Engerix B adult (1st dose received on 14th September 2017) and Engerix B adult (2nd dose received on 17th October 2017).   On an unknown date, the patient received the 3rd dose of Engerix B adult. On an unknown date, unknown after receiving Engerix B adult, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable to this report. Till the time of reporting the patient did not receive 3rd dose, which led to incomplete course of vaccination. Certified pharmacy technician called in to inquire about a third dose of Engerix. Since it had been years. The (Certified pharmacy technician) CPT did not to provide vaccine lot and expiration date. The reporter did not consent to follow-up.
I was diagnosed with Afib on March 1, 2023 I experienced high heart rate that only lasted for a few hours.
patient had received a dose of Dapatacel that was one day expired; Initial information received on 21-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a patient of unknown demography who received an expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].   The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site.  It was a case of actual medication error due to expired vaccine used.  It was unknown if the patient had any adverse 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 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.  Information on the batch number was requested  List of documents held by sender: none.
Information has been received from a registered nurse concerning an approximately 25 year old female who on 08-JUL-2008 was vaccinated with the first dose of GARDASIL in an Ob/Gyn office.  On 11-JUL-2008 the patient experienced severe allergic reaction, severe headaches, nausea, heart racing and slurred speech.  Per nurse, the patient also blacked out.  The patient was treated in the reporter's office.  The patient was referred to a neurologist and was brought to the emergency room.  It was unknown if the patient was hospitalized.  Additional information has been requested.
Patient reported no allergies to medications, never experienced seizures, Guillian-Barre Syndrome or any other neurological disorder, had not received a vaccination within 2 weeks prior to this vaccine.  Patient is currently 20 weeks pregnant.  Patient received vaccination around 8:00am and was waiting in pharmacy during 15 minute observation period.  Patient was seated and after about 10 minutes, patient became unconscious.  Eyes rolled back in head, faint pulse, 911 immediately called.  As 911 was called, patient was becoming conscious again.  Pulse still faint.  EMS arrived within 5 minutes of call.  EMS reported patient blood pressure very low and took patient to hospital for further observation.
Of note, I am the attending physician who saw this patient when he came in with chest pain. My summary is as follows:  He had some constitutional symptoms for a day or 2 following vaccinations. As those symptoms were improving, he began developing chest pain with a quality consistent with pericarditis. We obtained blood work, EKG, chest x-ray and CTA chest. He had negative cardiac biomarkers and a normal EKG. He also got a CTA chest and a TTE (no effusion) as a part of his chest pain work up. Both were unremarkable. After speaking w/ the on call cardiologist, we elected to treat him presumptively for pericarditis based on his symptoms and work up that excluded other potential causes. He was prescribed colchicine and NSAIDs. Note: he did not have classic EKG findings of pericarditis or a pericardial effusion that would have helped clinch the diagnosis.
Vertigo; Inner ear inflammation; vomiting; slight vision impairment; brain fog; This is a spontaneous report from a contactable consumer (the patient). A 51-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EK5730; Expiration Date: Mar2021), via an unspecified route of administration, administered in upper left arm on 11Jan2021 09:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation (reported as to protect himself). Medical history included ongoing ulcerative colitis. Concomitant medication included mesalazine (APRISO) taken for ulcerative colitis from an unspecified start date and ongoing. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EK5730; Expiration Date: Mar2021), via an unspecified route of administration, administered in upper left arm on 24Dec2020 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. No additional Vaccines administered on same date of the Pfizer suspect. No other vaccine within four weeks of getting COVID Vaccines. On 11Jan2021 22:00, the patient experienced vertigo, inner ear inflammation, vomiting. On an unspecified date in Jan2021, the patient experienced slight vision impairment, brain fog. He had an adverse reaction to the Pfizer shot. He had bad vertigo and inner ear inflammation. He got the second shot on 11Jan2021 at 9:30AM and that same day at 10PM everything started spinning and he started vomiting. He still has slight vision impairment, things are still slow, and he still has brain fog. It has gotten better, but very slowly. This has been a month now. It was reported that he went to a specialist an ENT after the fact. He was seen in the emergency room (ER) two days after the shot. When the hospital treated him they gave him anti-nausea medication and steroids for vertigo. He did not have the names of the medications. It was a seven day steroid course. When he went to the ER he was told that the Pfizer shot creates inflammation and it attacked the inner ear, so it is kind of same things as vertigo. On an unspecified date, the patient underwent lab tests and procedures which included tested his hearing: inflammation of the inner ear. Therapeutic measures were taken as a result of adverse events. The outcome of events inner ear inflammation and vomiting was unknown whereas the outcome of all other events was recovering.  No follow-up attempts are possible. No further information is expected.
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 73-year-old male patient received BNT162b2 (BNT162B2), on 09Jan2021 as dose 1, single (Lot number: EC3246), in left arm, on 30Jan2021 as dose 2, single (Lot number: EL9263), in left arm, on 19Sep2021 as dose 3 (booster), single (Lot number: E13184), in left arm and on 07Jul2022 as dose 4 (booster), single (Lot number: FP7150) at the age of 73 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Amphicilin, reaction(s): "Known allergies: amphicilin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Initial information received on 24-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 70 years old male patient who received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant medication received. On 24-Sep-2018, the patient received a 0.5 ml single dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ022AB via intramuscular route in the left deltoid. It was a case of actual medication error due to Syringe issue, Exposure via skin contact and underdose. the nurse administering the vaccine to the patient said that when she pulled needle came of patient's skin the bulk of it leaked out. Caller said the leak was around hub where the needle was attached to syringe and also from the patient's arm when it was pulled out. She is not sure how much of the 0.5ml the patient actually got. She said it ran down his arm and she thinks he probably did not get much of the FLUZONE HD vaccine. They used a 1 inch needle. It was unknown whether adverse event occurred or not. 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.
Arm mildly sore; headache and vomiting after 12 midnight.  Headache was positional .  Lasted about 36 hours. Ibuprofen
no adverese events; patient received an expired dose; This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient's concurrent conditions and medical history were not reported.  On 04-SEP-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # R027299, expiration date 09-APR-2020 (dose, route and site of administration were not reported) for prophylaxis. No additional adverse event was reported.  The vaccine did not undergo any temperature excursion prior to being administered.
the rash has return to the same area, to the area of the injection, it's a bit larger, it's a little bitsensitive, not itchy; woke up with the rash today /It's not as severe but it's larger, it covers a bigger area; a little bit sore; got what people are calling a COVID arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a little bit sore), HYPERSENSITIVITY (got what people are calling a COVID arm), INJECTION SITE RASH (the rash has return to the same area, to the area of the injection, it's a bit larger, it's a little bitsensitive, not itchy) and RASH (woke up with the rash today /It's not as severe but it's larger, it covers a bigger area) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. DOMZOA) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included METFORMIN, ATORVASTATIN and METHAQUALONE (TOQUILONE) for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (a little bit sore) and HYPERSENSITIVITY (got what people are calling a COVID arm). On 19-Feb-2021, the patient experienced INJECTION SITE RASH (the rash has return to the same area, to the area of the injection, it's a bit larger, it's a little bitsensitive, not itchy) and RASH (woke up with the rash today /It's not as severe but it's larger, it covers a bigger area). At the time of the report, PAIN IN EXTREMITY (a little bit sore), HYPERSENSITIVITY (got what people are calling a COVID arm), INJECTION SITE RASH (the rash has return to the same area, to the area of the injection, it's a bit larger, it's a little bitsensitive, not itchy) and RASH (woke up with the rash today /It's not as severe but it's larger, it covers a bigger area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
SOB, tachycardia - pt went to urgent care.   Two days later from Rx pt tested positive HCG, but tested negative day of administration
The first 3-5 days patient had redness and swelling at the injection site. Reports it got better, but then got "lumpy", swelling and redness started spreading, was up to 6 inches in diameter. The past few days it has been improving. Patient has been seen at urgent care on 1/29/21, told there is no cellulitis, most likely reaction to the vaccine.
Seen 11/4 in ER. End of October developed numbness in hands and feet (seen 11/5 sx x 1 wk). Returned 11/9 with paresthesia - unable to walk - sent to ER and admitted to Medical Center. Diagnosed with Guillain-Barre Syndrome. Discharged to rehab 11/16 and released 11/25. Seen in office 12/3.
I had the booster my arm was sore and flu like symptoms that lasted for 2 hours and I was due for the next shot and it got worse I thought I had allergies very congested and a cough and got test and found out I had COVID-19 on Tuesday and Thursday morning I started to have reaction.
administration of vaccines during temperature excursion; This spontaneous report has been received from a nurse regarding a 1-year-old female patient. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies was provided.  On 14-JUL-2022, the patient was vaccinated with the first dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) subcutaneous injection 0.5 ml for prophylaxis (strength, vaccination scheme frequency, anatomical location, route, lot number and expiration date were not reported) during temperature excursion (product storage error). Temperature and period of time of the temperature excursion were not provided.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA005211: US-009507513-2207USA005319: US-009507513-2207USA005196:
Vaccine placed 8/12/11. Presented 8/17 with pain/swelling, mild erythema & area of superficial abrasion centrally <1cm no pus. Tender but no warmth at site. Right deltoid.
Pt recvd 3 doses of Engerix-B following 2nd dose pt devel antigenemia & hepatomegalia; refused conventional therapies & was treated by a naturopath; took a leave of absence from work; c/o constellation of vague sx;
Almost immediate left arm pain and discomfort radiating from injection site to antecubital area. Redness formed at the injection site within 1 hour. Further progression of redness, swelling the size of a golf ball and pain followed by intense itching.
his is a 66-year-old male patient that arrives to the ER via EMS with complaints of diarrhea for 3 days along with shortness of breath.  The patient is hyperventilating on ER arrival.  He is very pale in appearance.  He denies any abdominal pain, chills, fever or vomiting.  He denies any urinary symptoms such as dysuria or frequency.  Patient does have a past medical history of Parkinson's disease, hypertension, hyperlipidemia, GERD, diabetes. Associated Symptoms: nausea, shortness of breath, vomiting
SEVERE PAIN AND SWELLING AT INJECTION SITE AND SHOULDER. ARM MOVEMENT PAINFUL.
Marked erythema and pain over left arm surrounding injection site, approximately 25 cm in diameter beginning approximately 2 days after vaccination and continuing to worsen/spread on day 9
Pain in arm after shot, numbness/tingling in arm. Pain persisted for > 2 wks. MD suspected bursitis and prescribed exercises.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt), PERIPHERAL SWELLING (arm was a little swollen) and PYREXIA (felt like having a little fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm hurt), PERIPHERAL SWELLING (arm was a little swollen) and PYREXIA (felt like having a little fever). At the time of the report, PAIN IN EXTREMITY (arm hurt), PERIPHERAL SWELLING (arm was a little swollen) and PYREXIA (felt like having a little fever) outcome was unknown.            No treatment medications were reported.
Metallic taste in throat w/in seconds of Hep B vax; lasted approx 2"; Recomvibax was only vax given when this occurred;
Fatigue and body ache Fever Stomach cramping Headache Excessive Sweating
Stevens-Johnson syndrome; skin on her hands began to peel; injection site reaction consistent with swelling; injection site reaction consistent with redness; injection site reaction consistent with tenderness; injection site reaction consistent with warmth; injection site reaction consistent with itchiness; Initial information received on 06-Dec-2021 regarding an unsolicited valid serious case received from consumer/non-healthcare professional via call center via Medical Information (Reference number- 00885626).  This case involves an 8-year-old female patient who experienced stevens-johnson syndrome, injection site reaction consistent with swelling, redness, tenderness, warmth and itchiness (vaccination site swelling, vaccination site erythema, vaccination site pain, vaccination site warmth and vaccination site pruritus) and skin on her hands began to peel (skin exfoliation) after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's medical treatments, concomitant medication and family history were not provided.  Patient had received flu vaccines before and had never experienced reactions like this with previous flu vaccines.  Patient did have other food allergies, but states she was not allergic to eggs.  On 02-Dec-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported) via an intramuscular route in the left deltoid for prophylactic vaccination.  On 02-Dec-2021 the patient developed a serious stevens-johnson syndrome and skin on her hands began to peel (skin exfoliation) same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant.  On 02-Dec-2021 the patient developed a non-serious injection site reaction consistent with swelling, redness, tenderness, warmth and itchiness (vaccination site swelling, vaccination site erythema, vaccination site pain, vaccination site warmth and vaccination site pruritus) same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  This injection site reaction measured 1.5 inch across.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment for the events.  The outcome was unknown for the events.  Information on the batch number was requested for this case.; Sender's Comments: This case concerns a 8-year-old female patient who experienced stevens-johnson syndrome, skin exfoliation, vaccination site swelling, vaccination site erythema, vaccination site pain, vaccination site warmth and vaccination site pruritus same day after vaccination with FLUZONE QIV. The time to onset is compatible. There is no further information regarding patient's medical condition at the time of vaccination and laboratory tests ruling out other alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Site of injection swelled to size of 1/2 of golf ball. red spot 3 inch in diameter appeared. Spot was very hot to touch. Arm from elbow to shoulder became tender to touch (day two) under arm from elbow to arm pit became swollen and tender to touch. Pain lasted 36 hours.
patient received undiluted Pediatric Pfizer 0.2ml IM to right deltoid. Monitored patient for 15 minutes after medication administration. No adverse reactions were reported at time of visit and patient verbalized "feeling fine" before leaving. At the time of this report (05:50PM 5/23/22) no known adverse reactions have been reported by this patient.