chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from consumer on 20 April 2015. A male patient, whose medical history was reported as penicillin allergy and age, concomitant medication were not reported, had received a dose of FLUZONE batch number UH907AL, (expiration date, dose, dose cycle and route of administration not reported) in left deltoid on 18 October 2013. On an unspecified date, four weeks after vaccination patient had experienced symptoms of tingling in legs when stretching, numbness in the bottoms of feet and moving up legs progressively. Patient also experienced tingling in hand up arms and body, on April 2014. Patient was further diagnosed with Distal acquired demyelinating symmetric (DADS) version chronic inflammatory demyelinating polyneuropathy. It was reported that, in April 2014 patient did blood work up and Multiple Sclerosis Spinal Tap showed protein. The patient's laboratory investigation includes, cardiac workup and blood glucose levels, Electromyography (EMG) and Anti Mag test results were unknown, thyroid Magnetic resonance imaging (MRI) 3 levels was negative, Spinal tap result was Lymes ruled out. The patient had required ER/doctor visit. Illness at time of vaccination was reported as none. Upon internal review, company assessed the event of chronic Inflammatory Demyelinating Polyradiculoneuropathy, experienced tingling in legs when stretching/tingling in hand up arms and body and numbness in the bottoms of feet and moving up my legs progressively as serious and important medical event. At the time of this report, patient was not recovered from events. List of the document held by sender: None.
5/9  60y.o. male with a past medical history of ESRD on dialysis, CAD, CHF, CVA, GERD, pulmonary hypertension who presented for chief complaint of shortness of breath and cough. Patient was given emergent dialysis with improvement of his respiratory status. He also completed a course of remdesivir while in patient.  5/13 Stable for discharge at this time with recommendations to follow-up with his primary care physician and pulmonology as an outpatient.
A few days after getting vaccinated, I developed shortness of breath. The shortness of breath was without hypoxia. It felt exactly like I developed COVID 19 for a second time. It lasted a week. I went to urgent care and then the ER after it did not go away. I was tested twice for COVID 19 and both tests were negative.
Soreness around injection site. Swollen Lymph nodes of armpit of same arm of injection site.
Headache, Myalgia, Fever, inj site pain x1 day; severe body pain, fever, chills, HA, fatigue, loss of appetite x6 days Narrative:
On 3/2/00, the pt developed a stiff neck and a fever. She later developed lesions throughout her body and on 3/6/00 was seen by her physician and dx with chickenpox.
Breakthrough COVID infection. Pt fully vaccinated by April 10 2021. Pt tested positive July 8 2021
A 2-month-old patient was given Quadracel vaccine instead of Vaxelis. No adverse reaction at the moment.  Reported to the regional vaccination office (Regional Vaccination Coordinator) on 10/23/2023 at 4:30 pm.  Vaccine Administered: Quadracel Batch number U7656AA Expiration Date: 03/08/2025
This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient. An elderly male patient received BNT162b2 (BNT162B2), in Apr2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 68 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "pre-diabetes" (unspecified if ongoing), notes: pre-diabetes; "well controlled hypertension" (unspecified if ongoing), notes: well controlled hypertension. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Return of antigen test positivity after testing negative immediately after finishing Paxlovid 5 day course". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positivity, notes: antigen test positivity after testing negative; negative, notes: after finishing Paxlovid 5 day course. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Additional information: Return of antigen test positivity after testing negative immediately after finishing Paxlovid 5 day course. No other medication was received within two weeks. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever, chills, tiredness, fatigue, massive headache, body aches, sore and bump on my left arm. These have caused me to not come to work for two days.  I came back to work 1/16/21, still having headache, soreness on my left arm and feeling tired.
Medication error due to expired med. Pt was given injection of Moderna. Pt refused to wait 15 minutes. As medication QR code was scanned, it was revealed that vaccine was expired. There is no expiration date on vial or box that it comes in. Pt called and has had no adverse events at this time.
FATIGUE; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included smoker, non-alcoholic, and allergy, and other pre-existing medical conditions included the patient had no known drug abuse or illicit drug use. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1821286 expiry: UNKNOWN) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 18-MAY-2021, the subject experienced fatigue. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from fatigue. This report was non-serious.
Flaking of skin in ear conch area and at least part of the ear canal.  tried eucerin cream, aloe vera.
pt recvd vax; pt had small pustules at inject site; 1 day after lesions noted to be white & improvement;
Information has been received from a nurse concerning a 22 year old female patient with penicillin allergy who on 07-JAN-2009 was vaccinated with the first dose of GARDASIL (lot number not reported). The patient received the second dose on 12-MAR-2009 (lot number not reported) and the third 00.5 ml dose on 13-JUL-2009 (lot number 661044/0548X). Concomitant therapy included YAZ. Subsequently, the patient experienced shaking, sweating and quivering. The patient also had jerk movement with her legs and her hands, and she was not cognitive for about 20 seconds after she received the third dose of GARDASIL. Later, the patient was given food and water, and right after that the patient had vomiting. It was unspecified if lab studies were performed. The patient stabilized after 45 minutes. It was reported that the patient had an empty stomach at the time of vaccination. The nurse also reported that the patient did not experience any adverse events after the first and second dose. Follow-up information received from the nurse on 20-JUL-2009: The lot number for all three doses is 661044/0548X. There was no concomitant therapy with the third dose. The patient's jerky movements were not tonic-clonic movements. The patient did not lose consciousness. There was no seizure happened. The vaccine was administered after the patient had a gynecology (GYN) exam and she was highly anxious. According to the nurse, the event (probably vasovagal) was considered as disabling for the 45 minutes during which the event occurred. No further information expected.
Received Moderna vaccines on 2/26/21 and 3/26/21. Tested positive for COVID-19 by PCR on 6/11/21
Fever of 99.5 for approximately 2 hours muscle aches in back and legs for approximately 7 hours mental fatigue ?cloudy? thinking, still coherent and oriented, congruent with typical ?sickness? approximately 7 hours
Client received 5 vaccines. Immediately follow injection of last vaccine client passed out & started to slide from chair to floor. Slide client to floor when she regained consciousness B/P taken 122/82. Move client to exam table & 1st moving her to wheelchair. Placed in supine position after several minutes client felt better allowed to sit B/P 122/82 color good. Client stated she felt better allowed to leave with mother.
Extreme fatigue, hard to move, heavy legs and arms. Duration approx 8+weeks
Aprox 15-20 min after vaccination with Hepatitis B (Merck) pt reported feeling flushed with headache.  Rash appeared on neck and chest.
fully vaccinated (moderna; 3/3/21, 3/31/21); symptom onset 7/28/21
pain up into shoulder & neck & head then down into arms stingers which was assoc w/numbness;took Ibuprofen & sx gone p/2 days;
Arm redness became hot and extremely swollen. By midnight my muscles were cramping and my joints hurt to move for the next three days. I had a severe headache for three days. My arm is still red and swollen this morning.
Case number PHEH2016US020214 is an initial spontaneous report received from physician on 09 Aug 2016. This report refers to 54 year old female patient. Medical history and concomitant medication was not reported. The patient was vaccinated with influenza virus vaccine (Unknown seasonal or pandemic, manufacturer: unknown, batch number: not reported) on an unknown date. On an unknown date, the patient had flu vaccine allergies. Outcome, seriousness and causality of the event were not reported.
"I had neck and upper back pain for the 1st five days. That subsided and then pain is in right upper shoulder/tendon ever since. Limited range of motion, soreness and stiffness." Per patient.
Anything that was hot made him nauseas; Very hard bowel movements; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Anything that was hot made him nauseas) and CONSTIPATION (Very hard bowel movements) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011m20a) for COVID-19 vaccination.    Co-suspect product included non-company product CODEINE PHOSPHATE, METHOCARBAMOL, PARACETAMOL (MUSCLE & BACK PAIN RELIEF [CODEINE PHOSPHATE;METHOCARBAMOL;PARACETAMOL]) for an unknown indication.    No Medical History information was reported.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 an unknown date, the patient started CODEINE PHOSPHATE, METHOCARBAMOL, PARACETAMOL (MUSCLE & BACK PAIN RELIEF [CODEINE PHOSPHATE;METHOCARBAMOL;PARACETAMOL]) (unknown route) at an unspecified dose. On 14-Feb-2021, the patient experienced NAUSEA (Anything that was hot made him nauseas) and CONSTIPATION (Very hard bowel movements). At the time of the report, NAUSEA (Anything that was hot made him nauseas) and CONSTIPATION (Very hard bowel movements) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
accidentally administered an expired Pentacel vaccine to a patient with no reported adverse event; Initial information received on 18-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 3 months old and unknown gender patient who was accidentally administered an expired Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] vaccine to patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis b vaccine (hepatitis b [hepatitis b vaccine]) for prophylactic vaccination; and meningococcal vaccine (meningococcal vaccine) for prophylactic vaccination.  On 18-Sep-2023, the patient received 0.5 ml of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (lot number: V7331AA, Expiry date: 16-Sep-2023) (Strength:Standard, Frequency: Once) via unknown route in unknown administration site for Immunization.  On 18-Sep-2023, the who was accidentally administered an expired Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) vaccine to patient with no reported adverse event (expired product administered) (latency: same day).  It was reported, Nurse called in to report that they accidentally administered an expired PENTACEL vaccine to a patient and wants to know if it's considered a valid dose or if they should re-administer it. She declined to share the details for administering licensed practitioner.  Action taken: not applicable.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.
pt recv vax; T of 108; had febrile sz; seen in ER w/ inc T; no sz activity;
Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication were reported.  No treatment medication were reported.  The patient wanted to know if she is contagious to others in the house.
48 hours after DTaP vaccine R thigh seen in doctor's due swollen thigh, pain and itching. Could not walk. Recovering.
PATIENT RECEIVED FOLLOWING VACINATIONS:1) ANTHRAX 2) SMALLPOX 3) TYPHOID. PATIENT DID NOT KNOW AT THE TIME SHE WAS PREGNANT. LMP:12SEP07
Information has been received from a nurse concerning a 15 year old female with no drug reactions/allergies who was vaccinated with the first dose of 0.5 ml GARDASIL (lot # 670049/1261AA) on 20-AUG-2007 and he second dose of 0.5 ml GARDASIL on 24-JAN-2012 intramuscularly. There was no concomitant medication. Later on 24-JAN-2012 the patient had a urine test which showed she was pregnant. Her last menstrual period was in November 2011 and the estimated delivery date is in August 2012. No treatment was given to the patient Therapy continued. Follow up information was received. The office was called for pregnancy outcome information. The nurse was no longer there and they had no additional information to provide. All telephone attempts to obtain follow up information have been unsuccessful. This case is lost to follow up. Additional information is not expected.
After 1st vaccine frequent urges to urinate with an episode of blood.   After 2nd vaccine patient had panicky immediate frequent urges to urinate, which then subsided after a few days, no blood this time.  Symptoms have resolved.
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021355013 same reporter/drug/AE, different patients
erythema-8cm long x 5-6cm wide;very warm to touch;tx sterapred 6 day dominick;
12-24 hours after vaccination:  high fever 102+,  chills,  nausea, fatigue, headache, arm occasionally twitching near injection site,  very sore arm, irritability
8 days after receiving vaccine, area of injection began itching.  That area of the arm had areas of redness  covering an area of approx. 2-1/2 x 2-1/2 inches, but not solid.  A small hard lump can be felt under the injection site.
5th AVA vaccination received on 11 April 2006 to left tricep region (pointed to) with typical redness/soreness at site for one week.  Approximately day 10 (21 April) he noted a pulling sensation w/pain to this area.  Upon palpation of area there was a 'knot".  This discomfort worsened and mainly noticed with overhead lifting or doing PT. Currently there is no pain as is resting.  On 25 April he presented to clinic to discuss this outcome and was referred to HC. Systemic symptoms C/O nodule to left tricep region. Soft, mobile, 3-4cm length by 1/2-1cm height to side of left arm. Denies paresthesia, weakness.  C/o pulling sensation and pain with exersise to region.
joint pain; muscle pain; This is a spontaneous report from a non-contactable consumer or other non hcp. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on Jun2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on unspecified date as single dose for covid-19 immunisation. The patient experienced joint pain, muscle pain on an unspecified date. The clinical course was reported as she received second dose of the Pfizer covid vaccine one month ago. States one week after the second shot, she developed joint pain and muscle pain which is still ongoing. The clinical outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
has to go for surgery; This spontaneous case was reported by a consumer and describes the occurrence of ILL-DEFINED DISORDER (has to go for surgery) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILL-DEFINED DISORDER (has to go for surgery). At the time of the report, ILL-DEFINED DISORDER (has to go for surgery) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication were reported No treatment medication were reported
Administered expired vaccine by accident. Vaccine administered on 01/03/2023 and vaccine expired on 01/01/2023. No symptoms reported by the patient. Patient made aware of the mistake and does not have any additional questions or concerns. Patient will not be billed for this vaccine. Medical Director, Dr.  has been notified.
Mother called the clinic on Tuesday 9-29-2020 to report and seek counseling that her daughter (pt) had broken out in a rash Thursday afternoon. The rash started with a few red bumps on her face and slowly progressed down her arms/trunk/legs over the next day. States rash has stayed the same, it is not getting worse. Mother reports that rash is still present but there is no itching associated with it. States it is not hives, just generalized rash. States rash hasn't been treated. Encouraged to use Benadryl cream on rash or take Benadryl tablets and to call family doctor if rash gets worse or does not seem to be improving after taking several Benadryl for a couple of days. Supervisor also spoke with mom over phone using speaker phone. Reassured mom. We will follow up with phone call to mom on Friday.
12/30/2020 severe headache continuously worsened through the day, 6:00PM vomiting, weak and dizzy, heart racing, tingling and numbness all over face . Workplace clinic f/u contact-- advised to call ambulance or arrive at clinic. clinic administered IV, Zofran, solumedrol, Benadryl. Headache and vomiting stopped after treatment, tingling and numbness slowly subsiding with treatment, still very dizzy and weak. Ambulance called from clinic -- pt was feeling better, refused transport by ambulance at time of arrival. 12/31/2020 headache mild not as dizzy. Tingling and numbness have resolved.
Allergic reaction 5-6 days after getting Flu vaccine. Rash to neck and arms. Urticaria, DECADRON and BENADRYL given in ER.
Injection site is itchy; Has turned very red; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (Injection site is itchy) and ERYTHEMA (Has turned very red) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE (JANUMET), AMLODIPINE;OLMESARTAN, ATORVASTATIN, VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR HCL) and BIOTIN for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site is itchy) and ERYTHEMA (Has turned very red). At the time of the report, VACCINATION SITE PRURITUS (Injection site is itchy) and ERYTHEMA (Has turned very red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 01-Feb-2021, the patient received her allergy shot and her allergist said she could take diphenhydramine.
Initial report received from a consumer on 07 Dec 2009: This patient received FLUVIRIN on 05 Dec 2009. The patient was concomitantly administered with Nasal saline spray. The patient experienced nasal congestion, coughing, difficulty breathing and low grade fever (about 100 F) on 06 Dec 2009. The outcome of the event was reported as improving.
ONE OF FOUR PTS DEVELPD FEVER, CHILLS AND ARTHRALGIAS WITHIN 24 HRS AFTER IMMUNIZATION, NO RESIDUAL EFFECTS