chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer concerning her 12 month old son with a history of wheezing who in March 2008, was placed on therapy with MMR II (dose, duration and indication not reported).  Concomitant therapy included VARIVAX.  On approximately 21-MAR-2008 the patient developed diarrhea and coughing.  On 23-MAR-2008 the patient experienced irritability, fever.  The patient was examined by a health care provider and was noted to have a red throat with white plaques and fluid behind his eardrums.  The patient was started on amoxicillin.  Later that evening, the patient experienced two twitching motions while feeding which progressed to a generalized seizure (lasting two minutes) with fever.  The patient was evaluated in an emergency department where he was noted to have slight rales in one area of his lungs on auscultation and a red throat with white plaques.  A rapid streptococcus test was negative.  Chest x-ray did not note pneumonia.  The patient improved with antipyretics and was discharged from the emergency department.  It was also noted that the family history was significant for a brother with a history of febrile seizures.  Upon internal review it was determined that febrile seizure was an other important medical event.  Additional information has been requested.
Severe kidney pain (left side) lasting one minute. Severe leg cramp (left) lasting one minute. Bladder pain and frequent urination (every 30 Min.) lasting 10 days. Pain beginning at left upper body, moving down left side of body over 6 week period. Early July, sudden severe pain in left knee with difficulty walking lasting 3 weeks. Still cannot run or jog due to pain in left knee.
feeling weak; sore all over; she is not feeling well/ feeling bad; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 48 year-old male patient received bnt162b2 (BNT162B2), administration date 23Jul2021 (Batch/Lot number: unknown) at the age of 48 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 23Jul2021, outcome "not recovered", described as "headache"; ASTHENIA (non-serious) with onset 24Jul2021, outcome "not recovered", described as "feeling weak"; PAIN (non-serious) with onset 24Jul2021, outcome "not recovered", described as "sore all over"; MALAISE (non-serious) with onset 24Jul2021, outcome "not recovered", described as "she is not feeling well/ feeling bad".  Additional information:Patient was is a 48-year-old consumer who got his first dose of the Pfizer BioNTech Covid-19 vaccine on Friday 23Jul2021. He reported that he had a headache the first day, but didn't feel bad. On the second day, he reported feeling weak and sore all over. Adds it seems like he feels better for a while and then get to feeling bad again. He is asking if that is normal and how long it lasts.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
acerbation of oral lichenoid mucositis/oral lichen planus; This is a literature report for the following literature source(s):  A 51-year-old male patient received BNT162b2 (BNT162B2), in May2021 as dose  2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Oral lichen planus" (unspecified if ongoing); "oral squamous cell carcinoma of the tongue" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. The following information was reported: LICHEN PLANUS (medically significant), 2 weeks after the suspect product(s) administration, outcome "recovered", described as "acerbation of oral lichenoid mucositis/oral lichen planus". The patient underwent the following laboratory tests and procedures: Clinical findings: include erythema and striations of the posterior, notes: buccal mucosal bilaterally. Therapeutic measures were taken as a result of lichen planus.; Sender's Comments: Based on the information given in narrative, the causal relationship between the reported events and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer drug 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.,Linked Report(s) : US-PFIZER INC-PV202200111251 Same article/ drug/event and different patient:;
Information has been received from a health professional concerning a 31 year old female who on 12-SEP-2007 was vaccinated with the first dose of GARDASIL.  On 12-Nov-2007, the patient received the second dose and on 11-Mar-2008 received the third dose IM (lot# 659182/1757U).  After the third dose the patient experienced "a little more soreness than usual".  It was unknown whether patient experienced any problems with first and second dose.  The patient was seen in the doctor's office.  At the time of report the patient had not recovered.  Additional information has been requested.
Patient fainted as he was leaving the vaccination clinic, hitting his head on a metal cart.  Patient was transported to ER by EMS.
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 44-year-old male patient received BNT162b2 (BNT162B2), on 18Dec2021 at 16:00 as dose 3 (booster), single (Lot number: F07218), in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 17Mar2021 at 11:00 as dose 1, single (Lot number: 031A21A), in left arm and on 14Apr2021 at 14:00 as dose 2, single (Lot number: 038B21A), in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient did not receive any other medication in 2weeks. Patient received antiviral treatment "paxlovid" from 14Aug2022 to 18Aug2022 for Treatment of COVID-19. No follow-up attempts are possible. No further information is expected.
Patient received MMR 6 days prior. Presented with angioneurotic edema and erythema multiforme rash, fever, arthralgia and joint swelling 3/26/07Received medical records from hospital which reveal patient experienced fever, rash & swelling including angioedema of lips.  Tx w/IV steroids, IVF, IV antibiotics, Benadryl & Atarax. Admitted to hospital from 2/21/07-2/24/07.  Edema improved but continued to have fever/chills up until 24 hrs prior to d/c.  Home on continued oral steroids FINAL DX: Erythema multiforme.
Experienced low grade fever; This is a spontaneous report from a contactable consumer.  A 21-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: was not reported), via an unspecified route of administration on 05May2021 as DOSE 2, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On unspecified date patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: was not reported), via an unspecified route of administration as DOSE 1, SINGLE for covid-19 immunisation. The patient experienced low grade fever on May2021. At the time of reporting, the outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt rec'd flu vaccine in office. Several hours later, he developed blurred vision, swelling of tongue. Went to ER for treatment. Prednisone and BENARDYL given.
Expired dose of Twinrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 59-year-old male patient who received HAB (Twinrix) (batch number X239D, expiry date 7th August 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th August 2022, the patient received the 1st dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 16th August 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 23-Aug-2022 Reporter's comment: The clinic director reported that the patient was administered a dose Twinrix which had an expiration date of 7th Aug 2022. This was the patient's first dose in the series. At the time of reporting, the dose has not been repeated. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Twinrix, which led to expired vaccine used.
Parent states they noticed the swelling redness to leg thigh states child flinched when area was touched referred to provider for further assessment.
Pt with 12cm by 16 cm erthematous, edematous swelling of lateral upper arm. This was the same arm that had received the Anthrax immunization 3 days prior.
p/vax pt shoulder & elbow both ache on & off; sl diminished energy level;
pregnant; abdominal cramps; its uterine pain; This is a spontaneous report from a contactable pharmacist. A 39-years-old pregnant female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that the pregnant patient had been having abdominal cramps after having the Pfizer BioNTech COVID19 vaccine. Patient was unsure if it due to the vaccine or if its uterine pain on unspecified date. The pain went away and she will be going to see her OBGYN. She was wondering if this was a reported side effect especially in pregnant woman. The outcome of abdominal cramps and uterine pain was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch cannot be obtained.
This spontaneous report was received from a physician referring to a 11-year-old patient of unknown gender. Pertinent medical history or concurrent conditions were not reported. On 22-AUG-2017, the patient was vaccinated with improperly stored dose of VAQTA (lot # N005274, expiration date 03-APR-2018) (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32°F and the higher was 54°F for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several cases from the same reporter. Sender's Comments: US-009507513-1709USA007325: Original Case: 1709USA007325: US-009507513-1709USA012768.
Discharge Provider: MD Primary Care Provider: DO Admission Date: 3/10/2023 Discharge Date: Mar 23, 2023  PRESENTING PROBLEM: Sepsis (HCC)  Severe sepsis (HCC) Septic shock (HCC)    HOSPITAL COURSE:  83 y.o. who has a past medical history significant for CKD, schizophrenia, bipolar disorder, previous CVA with residual weakness who presented on 3/10 with an acute onset of altered mentation, fever, hypoxemia and hypotension. Per family, she is slow to respond to questions at baseline and sleeps up to 20 hours per day. CT chest showed bilateral multifocal pneumonia. Labs were significant for AKI, mild lactic acidosis, transaminitis, elevated troponins and leukocytosis. UA with mild pyuria. She was given 4L IV fluids then started on vasopressors due to persistent hypotension. US of RUQ c/w fatty liver. Echo showed moderate concentric hypertrophy with assymetric severe septal hypertrophy (1.5 cm). No LV outflow obstruction at time of study. LVEF 66%. 1 of 2 blood cultures (+) for coag neg Staph - contaminant   Zosyn deescalated to Augmentin and completed 7 day course. In addition to pneumonia, found to be COVID+, She was started on remdesivir to complete 5 days with CMP monitoring.  Decadron 6 mg daily for 10 days.  Patient's acute kidney injury had resolved.   For her hypertrophic cardiomyopathy cardiology consulted and recommended non urgent outpatient visit in the next 1-2 months for re-evaluation and consideration of further testing such as cardiac MRI for her prior history of amyloidosis.   PTOT evaluation recommended skilled nursing facility placement. Doctor consulted and recommended dysphagia diet and outpatient ENT follow up. Psychiatry consulted and did deem patient mentally compensated and appropriate and no need for inpatient psychiatry.
I have a growing, 3-inch diameter circle that is bright red, hot and extremely sore. I had a fever for 48 hours. I still feel sick even 4 days later. The most concerning thing is the red, hot, large circle surrounding the injection sight.
Strong aches; Extreme chills; Moderate fatigue; Muscle cramping; Minor shakes; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 26Apr2021 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history and known allergies were reported as not applicable. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included hydrochlorothiazide (MANUFACTURER UNKNOWN); taken for unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. On 27Apr2021 at 10:00, the patient experienced strong aches, extreme chills, moderate fatigue, muscle cramping and minor shakes. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events strong aches, extreme chills, moderate fatigue, muscle cramping and minor shakes was resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Immediately after receiving a dose of flu vaccine patients right arm developed approximately quarter sized area of swelling with pain.  There was no redness or discoloration.
Pt. came requesting HPV vaccine on 8/1/16. Pt. stated LMP began 6/15/16. Pt. stated periods are irregular and denied any chance of pregnancy. Pt. returned to clinic on 9/8/16 requesting urine pregnancy test, which resulted positive. Pt. then stated LMP began 5/17/16.
Husband stated, after a shower at about 4:00 PM, patient had a cough, red eyes, her vision was "off" and she felt like a part of her throat was constricting. They went to the ER about 5:00 PM. ER MD determined either a virus or possible sensitivity to the FLUZONE HD VACCINE. Patient is not allergic to eggs and has successfully received the Regular Flu Vaccine for several years. MD gave a dose of BENADRYL and an albuterol inhaler and sent patient home. Patient was feeling better by 10/22/2016.
Hives that started 4 days after, originally in the arm only then progressed to full body
Metallic taste in mouth 5 min post injection.  Duration of about 5 minutes.; Feeling slightly dizzy 5 min post injection. Duration of approximately 5 min.; This is a spontaneous report from a non-contactable consumer, the patient. A 50-year-old female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration on 07Apr2021(at the age of 50-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 07Apr2021, within 5 minutes of receiving the vaccine the patient experienced metallic taste in mouth and felt slight dizzy for a duration of about 5 minutes. The metallic taste feeling was similar to what was experienced before vomiting, but without nausea. The clinical outcome of the event metallic taste and dizzy was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
I have felt really tired and weak since being vaccinated. The arm that my shot was in hurt really bad and it lasted for a long time. I had a headache for over a week. This lasted for about 2 weeks, but I still feel really weak.
changes in vision; a little bit of arm pain; She finds it weird that her head feels heavy and neck is sore; She finds it weird that her head feels heavy and neck is sore; she is nauseated; She is not feeling good; Dizziness; This is a spontaneous report from a contactable other health care professional, the patient. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on 11Feb2021 as dose number unknown, single for covid-19 immunization. Medical history included mild vision problems such as wearing glasses, history of slow allergic reactions to high blood pressure medications which included angioedema and She had vertigo years ago and an ear thing, but she hardly gets that now. The patient concomitant medications were not reported. The patient experienced dizziness, changes in vision, a little bit of arm pain. On and off symptoms but more profound today. Patient found it weird that her head felt heavy and neck was sore. The patient had just mild symptoms but started yesterday she began to experience a profound dizziness. She thought it would go away. The patient had no sinus symptoms. She woke up worsened. She had no teeth pain and no headache. Might be it was weather related. Patient had profound dizziness and she was nauseated. She has No Fever. The doctor had no idea about what to do. Even when sitting she felt dizzy, like the chair was moving, when she changed position it makes it worsened. She was playing with her cat and she had to stop because it was making it worse. She wanted to make sure could it be from the vaccine even though these symptoms started yesterday. The events were assessed as non-serious by the reporter. The outcome of the events was unknown.  Information on the lot/batch number had been requested.  Follow-up attempts were completed. No further information was expected.
recipient of the covid 19 vaccine received a positive antigen test within 10 days of getting the vaccine; recipient of the covid 19 vaccine received a positive antigen test within 10 days of getting the vaccine; This is a spontaneous report from a contactable nurse. This nurse reported similar events for two patients. This is the second of 2 reports. A female patient of an unspecified age (Age: 30, Unit: Unknown) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient received a positive antigen test within 10 days of the vaccine and wanted to know if the vaccine could cause a positive antigen test. There was no mention of exposure to a positive person. Outcome of the events was unknown.  Information on lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 antigen test positive and LOE due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.   This case will be reassessed once additional information is available.  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.,Linked Report(s) : US-PFIZER INC-2020519946 same reporter, drug, and events; different patients
arthralgia, stiffness, muscles aches p/the post exposure treatment; 14AUG92 abdo pains, migratory arthralgias, mild fatigue; went to ER on 1JUN & on 7JUN & 19JUN;
No reaction to first dose 12/16. I turned positive and recovered on 12/28 with only mild symptoms and received my second dose on 1/08. About 12 hours after started having rapidly evolving myalgia, high fever ( 104f) HR: 105 ( my baseline is 50-60) and RR 22 with SPO2 of 98-100%.
Lump at vaccination site; Expired vaccine used; This non-serious case was reported by a other health professional via call center representative and described the occurrence of injection site lump in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA933A, expiry date 30-JUN-2023) for prophylaxis.   On 11-JUL-2023, the patient received the 1st dose of Menveo. On 11-JUL-2023, less than a day after receiving Menveo, the patient experienced injection site lump (Verbatim: Lump at vaccination site) and expired vaccine used (Verbatim: Expired vaccine used). The outcome of the injection site lump and expired vaccine used were unknown.   It was unknown if the reporter considered the injection site lump to be related to Menveo.     It was unknown if the company considered the injection site lump to be related to Menveo.   Additional Information: GSK receipt date: 13-Jul-2023 A certified medical assistant called in to report that a patient developed a lump at the site of vaccination after receiving a dose of Menveo and wished to know how to proceed.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  Patient received a dose of Menveo which was already expired, which led to expired vaccine used. This case is linked with US2023096268, by same reporter.; Sender's Comments:  US-GSK-US2023096268:Same reporter