chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client came to our office for a Hep A, Menactra, and, HPV vaccination.  He passed out 2 years ago in our office when he received a Tdap vaccination.  His dad came prepared with a water bottle and an ice pack.  I had another nurse assist me with the vaccines.  We had the client lie down on the exam table and we both administed the vaccines at the same time.  The client was alert and talking during the vaccinations.  He stated he felt fine and he sat up about 2 minutes later and took a drink of water.  He then dropped the water bottle and his eyes rolled back into his head and he "shook" a little bit for about 2 seconds.  His dad, the other nurse, and all helped lay him back down on the exam table.   He was alert and oriented and was joking slightly and was engaged in conversation.  He was very pale.  We put an ice pack on his head, neck, and chest.  We continued to instruct him to take deep breaths and relax.  He continued to lay down for about 15 minutes, engaging in conversation the whole time.  Once he sat up he was pink in color and a few minutes later we moved him to a chair.  He sat in the chair for about 15 more minutes and drank 1 1/2 bottles of water.  He left with his dad and was instructed to call with any concerns.  Of note: a VAERS was filled out on him 2 years ago for a very similar incident, as well as for his brother last week.  His dad states they have this type of reaction with any medical procedure.
Headache, fatigue led to blood clot in the head and a seizure. _ diagnosis - Accute cerebral venous thrombosis (superior sagittal sinus{.
This spontaneous report as received from a registered nurse refers to 2 patients of unknown age and gender. The reporter stated that 2 patients received PNEUMOVAX23 (dose number, units, route of administration, anatomical location, lot number was not reported), that were exposed to 32F for 360 hours. PNEUMOVAX23 was a supported excursion with in-house stability data. No adverse symptoms reported. Additional information has been requested.
Around 4pm I began experiencing severe leg cramping. I felt cramps in my calves and thighs. So severe I could not walk or lift my legs more than a few inches. The cramps let off around 8pm but my legs were extremely sore after.
Flu; Initial information received on 02-Dec-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case involves a 74 years old patient of unknown gender who experienced flu (influenza), while the patient received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, (latency unknown) the patient had the flu (Influenza) following administration of INFLUENZA VACCINE. Patient stated that that was the only time patient had flu.    No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome was unknown for the event.     There will be no information available on the batch number for this case.
Patient received vaccine on 9/25/13 and the next day noticed a large, red, inflamed area on the arm near the injection site that covered a 2x2 area. it was also red and itchy.
I was hospitalized for the DRESS syndrome; This spontaneous case was reported by a consumer and describes the occurrence of DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (I was hospitalized for the DRESS syndrome) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 001A21A) for COVID-19 vaccination.     No medical history was reported.  Concurrent medical conditions included DRESS syndrome (day of dose 1 of vaccination patient had just completed 2 month course of treatment for DRESS syndrome after severe reactions to medications containing sulfa) and Sulfonamide allergy (severe reactions to medications containing sulfa). Concomitant products included PREDNISONE from 30-Nov-2020 to 29-Jan-2021 for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (I was hospitalized for the DRESS syndrome) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 18-Feb-2021 to 21-Feb-2021 due to DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS. The patient was treated with PREDNISONE (intravenous) from 18-Feb-2021 to 20-Feb-2021 for DRESS syndrome, at a dose of 750 mg twice a day and PREDNISONE (oral) ongoing from 21-Feb-2021 for DRESS syndrome, at a dose of UNK Tab. On 21-Feb-2021, DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (I was hospitalized for the DRESS syndrome) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, Blood immunoglobulin G: Negative. On 08-Apr-2021, SARS-CoV-2 antibody test: Negative.         Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.  Company Comment  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Product details updated. Patient gender updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Pt received Dtap R anterior thigh 3/5/07 he was seen in office 3/7/07 with warm erythematous, mildly elevated lesion R anterior thigh, + area of erythema/edema, patella.
When mixed, vial was only mixed with 1mL of diluent and 1 dose was given to patient. No other doses were given from vial. Patient was made aware. Patient was followed up with on 4/25 at 4:30pm and no issues reported at the time. Also called patient on 4/26 at 10am and patient stated he was having a low-grade fever and sore arm.
approx 1hr p/vax pt c/o h/a & dizziness;monitored child for 30min-sx were resolving;parent preferred to take child home & not cont to monitor @ home;
illness; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (illness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (illness). At the time of the report, ILLNESS (illness) outcome was unknown. Not Provided          This case was linked to MOD21-073867 (E2B Linked Report).; Sender's Comments:  MOD21-073867:Mother case
Got the shot last wk Thurs. By Friday arm had a large swollen area. Itched, it was red. Today a week later swelling is half way down, but area is real hard and still hurts and itches.
This is a spontaneous report from a contactable other hcp.   A 21-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) dose 2 via an unspecified route of administration, administered in Right arm on 12Jan2021 13:30 (at a age of 21-years- old) (Batch/Lot Number: EK3302) as dose 2, single for covid-19 immunisation. Medical history included none. There were no concomitant medications On 22Dec2020 historical Vaccine BNT162B2 dose 1 Lot number: EK5730 right arm. On 16Jan2021 06:30 the patient experienced stabbing chest pains, angina, heart spasms, difficulty breathing (hospitalization). The patient was hospitalized for stabbing chest pains (chest pain) for 1 days. The patient was hospitalized for angina (angina pectoris) for 1 days. The patient was hospitalized for heart spasms (cardiospasm) for 1 days. The patient was hospitalized for difficulty breathing (dyspnoea) for 1 days. The patient underwent lab tests and procedures which included blood test: unknown result computerized tomogram thorax: unknown result, sars-cov-2 test: negative on 19Mar2021, x-ray: unknown result. Therapeutic measures were taken as a result of stabbing chest pains (chest pain), angina (angina pectoris), heart spasms (cardiospasm), difficulty breathing (dyspnoea). On an unspecified date in 2021, the outcome of the events were recovered with sequelae.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Based on the information currently available, events with the suspected vaccine BNT162B2 in this patient cannot be completely excluded.    The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate
Information has been received from a physician concerning a female patient who in July or August of 2008, was vaccinated with her second dose of GARDASIL. In September 2008, the patient had NMDA antibody receptor and encephalitis. Drug treatment was required. The patient presented at the emergency room and was hospitalized for 2 months. At the time of reporting the patient was recovering from the NMDA antibody receptor encephalitis. The patient was told that she could have recurring episodes. It was unknown if there would be significant disability. Additional information has been requested.  4/24/09 Received hospital medical records of 9/29-11/25/2008. FINAL DX: NMDA receptor positive encephalopathy; delerium; g-tube placement; left brachiocephalic IVC clot associated w/PICC line placement; antiphospholipid antibodies. Records reveal patient symptoms noted in outlying ER in addition to aggression began approx 5 days prior.  Course waxed & waned w/intermittent decreased alertness & delerium, decreased O2 sats & was in/out of PICU.  Tx w/IVIG x 5 days, steroids, IV antibiotics/antivirals, plasmaphersis x 4 days, antineoplastics, feeding tube placement & anticoagulants.  Neuro, Rheum & Psych consult done.  Slowly improved & d/c to home w/PCP, Thrombophilia, Rheum, REhab & surgery clinic appts.  4/7/09 Received hospital medical records of 9/27-9/29/2008. FINAL DX: probable encephalitis Records reveal patient experienced acute confusion, mental status change, repetitive garbled speech then aphasia, excitable.  In hospital had alternating periods of quiescence & agitation, speech garbled, perseverating, neologisms & frequently aphasic.  ID & Neuro consults done.  Transferred to higher level of care.
This spontaneous report received from a pharmacist 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) .8 ml, start therapy date was not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the subject experienced overdose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of overdose was not reported. This report was non-serious.
Lower back symptom; Irritable; Could not focus on one thing at a time; Strange feeling; woke up with back pain; chills, other cold symptoms; leg achy so bad and cramping; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (leg achy so bad and cramping), NASOPHARYNGITIS (chills, other cold symptoms), BACK PAIN (Lower back symptom), IRRITABILITY (Irritable) and DISTURBANCE IN ATTENTION (Could not focus on one thing at a time) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ALPRAZOLAM (XANAX SR) for Anxiety, PARACETAMOL (TYLENOL) for Pain.    On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jun-2021, the patient experienced PAIN IN EXTREMITY (leg achy so bad and cramping) and MYALGIA (Body ache). On 06-Jun-2021, the patient experienced NASOPHARYNGITIS (chills, other cold symptoms). On 07-Jun-2021, the patient experienced BACK PAIN (Lower back symptom), IRRITABILITY (Irritable), DISTURBANCE IN ATTENTION (Could not focus on one thing at a time), FEELING ABNORMAL (Strange feeling) and BACK PAIN (woke up with back pain). The patient was treated with IBUPROFEN at a dose of 200 mg. At the time of the report, PAIN IN EXTREMITY (leg achy so bad and cramping), NASOPHARYNGITIS (chills, other cold symptoms), BACK PAIN (Lower back symptom), IRRITABILITY (Irritable), DISTURBANCE IN ATTENTION (Could not focus on one thing at a time), FEELING ABNORMAL (Strange feeling), BACK PAIN (woke up with back pain) and MYALGIA (Body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient received DTaP (5th dose) instead of Td (patient is 9 y.o.). 24 hours post vaccination, patient's father reported extensive limb swelling from shoulder to elbow, rash, heat, pain. No hives or symptoms of respiratory distress. Patient has history of food allergies but no reported contraindications or reactions to prior doses of DTaP.
patient was fine at first and her throat started itching and she had trouble breathing. She usually takes benadryl liquid. When that did not help we gave her an epi shot.
Patient had syncopal episode within 3 minutes of vaccination.  PO2 97%.  Pulse 88.  Glucose 80.  Taken to ER by EMS.
LITTLE WARM TO TOUCH; PAIN GOING DOWN AFTER RESTING; SORENESS ON INJECTION  SITE; SEVERE STOMACH ACHE; This spontaneous report received from a patient concerned a 23 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included consume alcohol sometimes, and non-smoker, and other pre-existing medical conditions included the patient have no known drug allergies and there was no history of drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced severe stomach ache. On an unspecified date, the subject experienced little warm to touch, pain going down after resting, and soreness on injection site.  Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe stomach ache, and the outcome of little warm to touch, soreness on injection site and pain going down after resting was not reported. This report was non-serious.
To date, 08/17/2001 the patient received a flu shot on 10/27/2000 and experienced several days of illness. The patient has had hives off and on to date. The patient never had hives prior to 11/16/2000.
Two hours after taking the first dose of Oral Vaccine developed a fever. Fever cycled in and out for 46 hours. At about 4 hours after taking the first dose of oral vaccine became nausous and began experiencing large amount of gas. Could not eat for the next 48 hours due to chills and nausea and could drink very little liquid. Second dose of oral vaccine produced gas but none of the other side effects.
On 2/5/21 I noticed a rash on the upper right portion of my back. I confirmed with Doctor that this was the shingles virus and he prescribed Valacyclovir HCL 1 Gram,1 tablet 3 times per day, which has now begun to clear up the rash.
Patient says she got rash that's itchy on the legs the next morning, then it eventually spread to whole body rash that is itchy, and some were blistering. It went away by itself after around 4 days. She contacted the doctor and doctor said to see him if it gets worse, but it got better until it self resolved.
pt recvd vax & had t 104.7 given meds & tepid bath; t spiked again ; to er;  20 min of screaming; L otitis media;
Chills; injection site swelling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 17-year-old male patient received BNT162b2 (BNT162B2), on 13Jul2022 at 16:00 as dose 3 (booster), single (Lot number: FP7139) at the age of 17 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Autism" (unspecified if ongoing); "Seizures" (unspecified if ongoing). Concomitant medication(s) included: TRILEPTAL. Past drug history included: Lamotrigine, reaction(s): "Allergy"; Fentyl, reaction(s): "Allergy"; Ativan, reaction(s): "Allergy". Vaccination history included: pfizer-biontech coviD-19 vaccine (DOSE 2, SINGLE, Batch/Lot No: FA6780, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 24Jun2021, when the patient was 16-year-old, for Covid-19 Immunization; pfizer-biontech coviD-19 vaccine (DOSE 1, SINGLE, Batch/Lot No: EW0191, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 03Jun2021, when the patient was 16-year-old, for Covid-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 14Jul2022, outcome "not recovered"; VACCINATION SITE SWELLING (non-serious) with onset 14Jul2022, outcome "not recovered", described as "injection site swelling". Therapeutic measures were not taken as a result of chills, vaccination site swelling.  Additional information:The patient was not tested prior to vaccination. The patient was not tested for covid after vaccination. The patient did not take any other vaccine in for weeks prior to vaccination.  No follow-up attempts are possible, no information is necessary.
lot of dry coughing; Initial information received on 07-Dec-2022 regarding an unsolicited non-serious case received from a consumer/non-hcp (non-healthcare professional) via social media.  This case involves a patient of an unknown age and gender who experienced lot of dry coughing after receiving  Influenza Vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor.    On an unknown date, the patient received an unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (with an unknown administration site, route, expiry date, batch number, formulation, strength) for immunisation.  On an unknown date, the patient developed lot of dry coughing (cough) (latency: unknown) following the administration of Influenza Vaccine.  It is unknown if there were lab data/results available.  It was reported 5 days after receiving my flu injection I can down with that RS thing. No aches, pains or fever. I really do believe the flu injection help make it a mild case. This was the 1st time I ever got a flu injection. Believe me I will be getting my next year as well.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (lot of dry coughing).  Outcome: Unknown
Site: Itching at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Nausea-Mild
This case was reported by a consumer via call center representative and described the occurrence of stomach cramps in a female patient who received RABAVERT. Co-suspect products included Rabies Vaccine, IMOVAX RABBIA. The patient's past medical history included automobile accident (16 years ago, the patient had a car accident). Concurrent medical conditions included muscle pain (experienced pain from a previous car accident 16 years before reporting date) and muscle weakness. On an unknown date, the patient received the 1st dose of RABAVERT and the 2nd dose of IMOVAX RABBIA. On an unknown date, 1 day after receiving RABAVERT, the patient experienced stomach cramps, appetite lost, muscle weakness, muscle pain, fever, condition aggravated and interchange of vaccine products. On an unknown date, the outcome of the stomach cramps, appetite lost, muscle weakness, muscle pain, fever, condition aggravated and interchange of vaccine products were unknown. It was unknown if the reporter considered the stomach cramps, appetite lost, muscle weakness, muscle pain, fever and condition aggravated to be related to RABAVERT. Additional details were provided as follows: The age at vaccination was not reported. The reporter declined to provide further limited demographic information beyond her first name and initial of her last name. The patient received one shot of RABAVERT in the emergency room (ER) around midnight. The next day, the patient had stomach cramps. The next shot, the patient received was another manufacturer's product IMOVAX, thus leading to interchange of vaccine products. She then had severe muscle pain and weakness on her left side, which she described as an exacerbation of pain from the previous car accident. Later, the patient had a low grade fever with loss of appetite. The patient said that she already had contacted the manufacturer of IMOVAX and was told that she should continue receiving IMOVAX instead of further RABAVERT injections. The reporter stated that she was calling to find out if the symptoms she was experiencing were due to RABAVERT or rabies as well as to inquiry if GlaxoSmithKline (GSK) recommended that she should continue with RABAVERT versus IMOVAX because most of her symptoms started after receiving IMOVAX. The reporter was provided a medical disclaimer and healthcare referral, and the call was placed on hold to further research for her product side effect inquiry. No further related details were provided.