chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Child's first dose in his COVID-19 series was Pfizer. The second dose given in August was an age-appropriate Moderna dose but should have been Pfizer. Parent notified and instructed to have child finish out series with the planned Pfizer 3rd dose at least 8 weeks from the last Moderna dose.  No adverse reactions noted.
Information has been received from a physician concerning a 17 year old female who on 22-JAN-2008 was vaccinated with her first dos eof GARDASIL (659055/1522U). Concomitant therapy included hormonal contraceptives (unspecified). On 25-JAN-2008 the patient experienced joint pain, abdominal pain, low grade fever and headache. The patient sought medical attention in the doctors office and she had unknown laboratory tests conducted which were normal. The patient's joint pain, abdominal pain, low grade fever and headache persisted. Additional information has been requested. This is in follow-up to report(s) previously submitted on 4/7/2008. Information has been received from a physician concerning a 17 year old female who on 08-JAN-2008 was vaccinated with her first dose of GARDASIL (659055/1522U). Concomitant therapy included hormonal contraceptived (unspecified). On 25-JAN-2008 the patient experienced joint pain, abdominal pain, low  grade fever, nausea, and headache. The patient sought medical attention in the doctors office. She saw her PCP, abdominal sonogram was within normal limits, a CBC and Chem 12 were within normal limits. Patient also saw an infectious disease specialist and is waiting on records. The patient's joint pain, abdominal pain, low grade fever, nausea, and headache persisted. No further information is expected.
Patient had menstrual bleeding 14 days after shot. No previous menstruation, no signs of menstruation about to start before the vaccine.
2/26 9:30 am: cold sweats, nausea, stayed home from work 2/27, 2/28: unable to perform normal elliptical cardio, could only do a few minutes than had to lay down due to extreme fatigue and shortness of breath 3/1: too fatigued to shower, change, or cook a meal.  Stayed home from work. 3/2: Went to work.  Too short of breath to walk across campus without sitting and taking breaks.  Went to urgent care at noon, took PCR test for Covid, was negative.
for my covid shot and I was in so much pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (002591). The reporter is the patient.  A 82 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "for my covid shot and I was in so much pain".  Additional information: Patient stated "I am out of medication I can be off of it for a couple of days but I had to be off of it for eight days for my covid shot and I was in so much pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Burned like area at the vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Burned like area at the vaccination site) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced VACCINATION SITE PAIN (Burned like area at the vaccination site). At the time of the report, VACCINATION SITE PAIN (Burned like area at the vaccination site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   No treatment information was provided.
Redness and swelling at vaccine site Rt Thigh. KEFLEX 200mg tid X 10 days/SYRUP 1/2 tsp tid
Approximately 6 hrs after the injection, I began to experience the following symptoms: fatigue, joint and muscle pain, fever, chills, severe headache and nausea. Treated with ibuprofen. Symptoms subsided completely after 24 hrs.
After receiving H1N1 nasal mist, child fell to the floor, crying I feel sick, with moderate amount of emesis noted. 9:15 am, Pt skin cool clammy to touch. BP- 70/48 (adult cup). 9:37 a.m. BP 68/42, P=96 drank sips of H2O, no emesis.
it was rpt fr pharmD concerning a pt who was vax & subsequently pt exp pock marks at inject site
As vax was being administered the needle became disconnected from the syringe & the vaccine went into the eyes of the hlth care professional & the staff member;12NOV97 staff member exp burning of the eyes;
54 yr old F pt was given Zostavax injection 4/10 at 1000 hr.  Pt called the facility at 4/11 0045 hr.  Pt c/o stiff neck and shivering.  Pt denied fever. Follow up call 4/11 at 1013 hr.  Pt was enroute to hospital.  Pt c/o severe stabbing h/a and max temp of 103.0 f.  Case was reviewed with Toxicologist and plan to f/u with pt & hospital.
first dose of Twinrix on 12Dec2020 and has not received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 46-year-old female patient who received HAB (Twinrix) 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.   Previously administered products included Twinrix (1st dose received on 12th December 2020 with batch number 75C72 and expirydate- 13th June 2022).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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 details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of the vaccine, which led to incomplete course of vaccination. The reporter did not consent to follow-up. VAERS details reported for 1st dose of Twinrix.
CoughWheeze, Syncope, TESTED POSITIVE WITH SURVEILLANCE MONITORING ON 1/23/2021 Narrative: POSITIVE RESULTS FROM SUVEILLANCE MONITORING ON 1/23/2021
pt recvd vax & had red; generalized; raised circumscribed rash; urticaria; tx w/ otc meds, resolving next am;
gave 2nd dose to a patient 2 weeks after patient received their 1st dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (gave 2nd dose to a patient 2 weeks after patient received their 1st dose) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (gave 2nd dose to a patient 2 weeks after patient received their 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (gave 2nd dose to a patient 2 weeks after patient received their 1st dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Information has been received from a pharmacist concerning an approximately 65 year-old female with a history of muscular weakness while taking LIPITOR who on 16-MAR-2010 was vaccinated subcutaneously with 0.65ml ZOSTAVAX (Oka/Merck) (lot # 664350/0957Y) in the right arm.  The pharmacist recently found out the patient felt faint and dizzy sometime post vaccination.  The pharmacist did not know when symptoms began.  The patient fell down the stairs on 23-MAY-2010.  She felt lightheaded when she stood up and then fell down steps.  She was taken to the hospital with a hematoma and broken ribs.  After a brain scan (no result reported) in the Emergency Room she was medically transferred by helicopter to another hospital.  She was admitted for 3-4 days.  She was discharged to home and then became lethargic, ill and not functioning.  She was taken to hospital and diagnosed with brain swelling and went into a coma.  She was transferred to the neurologic intensive care unit.  She was hospitalized for 3 weeks and was comatose most of time.  Since returning home she has experienced short term memory loss.  At the time of report, the outcome was unknown.  The patient took about 16 different unknown medications and was not taking LIPITOR at the time of the fall.  Additional information has been requested.
When patient returned to our office for her third Hepatitis B vaccine. She told us she had some facial swelling near her lips to the extent that it was noticeable by others after the second shot. When questioned further she admitted to minimal swelling near her lips after the first shot.
About 10 minutes after patient recieved the vaccine , she said her face and arm and legs felt itchy . She asked for benadryl. She took one tablet of benadryl. She waited another 20 minutes after taking the benadryl and said she felt fine then.
PAIN ON THE LEFT ARM, NO SIGNS OF FEVER, BRUISING, OR RASH. 9/30/2014 STILL PAIN AND CANNOT LIFT ARM UP
8hrs leg pain (weakness, decreased 6 days) bilaterally - brief SOB episode (6 hrs), 6 days bilateral weakness, hands, 6 days vertigo, 6 days sensation of wanting to pass out, 2 days headache, floaters both eyes.
I had a psychotic episode. I literally thought I was going to drive my self and my nephew to Heaven. I was going to Heaven and I was going to take him with me. I left the house without a phone and drove all the way to where my vehicle ran out of gas. I was apprehended by the highway patrol and taken to the local hospital. They ran all types of test and found nothing. The entire night I was out of my mind. My family came and I treated them badly. I refused to eat, drink, sleep, because I was fearful they would poison me or hurt me. It was awful. After they finally got me to take some sleeping pills, I woke up in my right mind. Why didn't you all have psychosis as a possible side effect? I would have never taken this vaccine had you all put this on the sheet of paper. Only thing you all had was "feeling unwell." What the heck is that? I was out of my mind and I was this hospital's third patient.  You all are dead wrong and psychosis should be added to the list ASAP. Who is going to pay this hospital bill plus two ambulance rides?
Flashing white light on the left side of left eye in dark environments.  Suspected detachment.  Made an immediate appoint ment with eye Doctor.  He could not find any detachments but suspected it.  Did not believe it was vaccine related since none reported.  Scheduled second appoint ment.  But the flashing went away by Dec 9, 2021.  So I suspect the vaccine effect on eye nerves.  Again the eye doctor strongly disagrees, but cannot figure out what else.
ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 73 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 19-SEP-2021) dose was not reported, administered on 21-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
Numbness in head; Pressure in head; This is a spontaneous report from a contactable other healthcare professional. A 39-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 15Mar2021 at 10:45 (at the age of 39-years-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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Mar2021 at 16:00, the patient experienced numbness in head and pressure in the head and lot of pressure in the head. 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 result of the events. Since the vaccination, the patient had not been tested for COVID-19.The clinical outcome of the events numbness in head and a lot of pressure in head was unknown at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is excepted.
This child had an approximate 8 x 5cm circle of erythema with a mild lump left anterior thigh.
Headaches/Migraine; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches/Migraine) and PAIN IN EXTREMITY (Sore Arm) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included Migraine and Seizure.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced HEADACHE (Headaches/Migraine). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore Arm). At the time of the report, HEADACHE (Headaches/Migraine) had not resolved and PAIN IN EXTREMITY (Sore Arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatments for the event included Ibuprofen.   Reporter did not allow further contact
Swollen Lymph node on left armpit (same arm as injection site). Swelling and moderate pain/discomfort.
Rash, UrticariaPruritus,  hives  Narrative: seen at UC, Rx prednisone, cetirizine, antibiotic (unknown), calamine...Sx worsened, PCP added fexofenadine, hydroxyzine,  famotidine, rash finally resolved 2/25
Received H1N1 Mist on 11/6/09. Trigeminal Herpes started 11/14/09. Diagnosed by MD on 11/17/09 and Antiviral started.
Excessive crying with temp 103.6, crying continuously x 4 hours onset of SX 12 hours after immunization.
Patient fell, sustaining a rib fracture; she subsequently developed, lethargy and dehydration requiring hospitalization, with admission on 09/28/2010
Shot adminstered at work. A week after shot, I began to have difficulty swallowing. The difficulty increased and visited doctor on 12/1.  On 12/2 was ordered to go to hospital for tests and feeding. Remained in Hospital for 23 days to test for cause. None diagnosed. After 3 weeks at home, went to clinic for second diagnosis. Again no set diagnosis, was given medication to take care of symptoms (double vision, facial tingle, and increased salivation.) Clinic decided to call it Cerebral Encephilitis. Said time was the only thing that would cure symptoms.  5/21/09 Received Neuro consult for 1/20-1/27/2009. FINAL DX: suspected brain stem inflammatory syndrome; hyperactive gag reflex due to same; dysphagia w/PEG tube; right trigeminal motor neuropathy; probable pseudobulbar palsy; fluctuating allodynia w/vomiting; diagonal double vision, normal neuro-ophtho exam. Records reveal patient experienced pain & tingling of right thigh w/raised rash.  Saw PCP 10/08 & dx w/zoster flare.  Tx w/antivirals.  Initially improved but the recurred about 6 wks later, tx again w/antivirals.  On 11/21 had choking spell that progressed in frequency & severity until by Thanksgiving very difficult to swallow.  On 11/30 while burning shrub, developed pain & tingling of head & neck, ear redness & nausea which subsequently became daily episodes when even a breeze was painful.  Developed facial rash w/o blisters in 12/08.  Saw PCP & tx w/antibiotic but was unable to swallow pill or even drink H2O.  Admitted to hospital on 12/3.  25# wt loss, hyperactive gag reflex, chills, sleeping sitting up due to choking sensation, anxiety, voice changes, phlegm, persistent double vision, ear fullness, recent thrush, 1 episode SOB.  Neuro-ophtho consult done & WNL.  EMG revealed right trigeminal motor neuropathy.  Facial reflexes very hyperactive c/w pseudobulbar dysfunction.  3/12/09 Received PCP medical records of 12/1/08-2/4/2009. FINAL DX: encephalitis of unknown cause affecting only brainstem; severe dysphagia. Records reveal that on 12/1/08 patient experienced sore throat, facial kin tingling, facial tightness/pressure, itching eyes/nose, difficulty sleeping, voice changes, HA & fever x 1 wk.  Was recovering from w/shingles pain although no vesicles.  RTC 2/4/09 s/p hospitalization x approx 1 mo where he received plasmapheresis.  Currently having facial tingling & difficulty swallowing, neck tension pain, generalized weakness, weight loss, feeding tube insertion & was going to swallow therapy & PT.  3/30/09 Received hospital medical records of 12/3-12/25/2008. FINAL DX: neurogenic dysphagia, unknown etiology; malnutrition requiring PEG placement. Records reveal patient experienced progressive dysphagia approx 12 days prior to admit, w/HA & facial pain/tingling after recent bout of presumed shingles(no rash).  Tx w/antivirals & steroids.  Feeling unwell x 2 mo.  No reactions to prior flu shots.  Neuro & ENT consults done, both of which were WNL.  Oropharyngeal video revealed aspiration.  Received plasmapharesis x 5 for possible GBS variant w/minimal improvement.  Able to manage secretions w/suctioning & d/c to home w/tube feedings w/Neuro & ENT f/u.
Information has been received from a company representative concerning a female who on an unspecified date was vaccinated with 2nd dose of Gardasil (lot# not provided).  Subsequently the patient experienced felt faint.  The patient outcome was not reported.  No further information is available.
pt recvd vax & devel paralysis in arms & one of leg; pt unable to make a fist or move leg;
This case was reported by a health professional in the United States on 21 June 2007. A 56-year-old female patient received an injection of Adacel (lot number, route, and site not reported) on 02 April 2007 after a "pencil jab". Approximately eight hours after vaccination, she began to experience fever, chills, muscle and body aches, cough, congestion, headache, and tiredness which lasted for one week. The patient recovered.
Infant was given 4mo vaccines on 1/25/23.  Was clinically well at that time. Returned on 2/2/23 with low-grade fever, vomiting, diarrhea, cough, congestion, tested pos for Flu A.  Also had dark mucous loose stools.  Treated w/ zofran and Tamiflu.  Went to ED 2/3/23 due to bloody stools and poor feeding.  Diagnosed with intussusception 2/3/23, failed air contrast enema and required surgical repair w/ ileocectomy.
administered 0.5 ml of Daptacel in the left deltoid by SS, the vaccine had expired prior to the administration with no AE; Initial information regarding this unsolicited valid non-serious case   This case involves a 63 year old female patient who received a 0.5 ml dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot: U6101, expiry date: 23-Oct-2020), via intramuscular route at left deltiod, on 19-Jan-2021 (expired product administered).  The patient's medical history, medical treatments, vaccinations, concomitant medication and family history were not provided.  It was an actual medication error due to the expired product administered.  At the time of reporting, the patient had no 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.
I noticed severe itching on my left upper thigh with bumps and after this shot; itching has spread to face and arms; This is a spontaneous report from a contactable other health professional (patient) reported for herself that a 40-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL0140), via intramuscular route of administration, administered in right arm (at the age of 40 years) on 08Jan2021 as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history included sinus tachycardia, panic disorder, depression, chronic fatigue syndrome, PCOS and allergic to Penicillin. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included Metformin 500mg, Metoprolol 50 mg, Paroxetine 50 mg and Vitamin D, which were received by the patient within 2 weeks of vaccination and all were taken for an unspecified indication, start and stop date were not reported. The most recent COVID-19 vaccine was administered at nursing Home/Senior Living Facility. On an unknown date, 2 weeks or so after first shot, the patient was noticed severe itching on my left upper thigh with bumps and after this shot, itching has spread to face and arms. Clinical course was reported as: On 20Jan2021, Joint and muscle pain and extreme fatigue that started on days 3+ (slept over 20 hours day 4, plus 12 day 5 and still exhausted). Congested with runny nose and itchy eyes and just generally feeling ill. 2 weeks or so after first shot, she noticed severe itching on her left upper thigh with bumps and after this shot, itching spread to face and arms. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient been tested for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test/ oropharyngeal swab test: negative on 01Feb2021. Patient did not receive treatment for the adverse event. The case was considered as non-serious as per reporter. Outcome of the events was not resolved.  Follow-up attempts are completed. No further information is expected.
Red itchy patch around injection site appeared four days after second injection (listed above). First injection was 2/24/21) Used topical steroid cream to reduce intching once on day 3 of rash. By day 4 rash is no longer itching and seems to be resolving.