chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm pain near injection site.; Body aches; Malaise; Tired; Slight brain fog; Diarrhea; stomach upset; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the right arm on 04May2021 at 11:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history was not provided. The patient received unspecified medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05May2021, the patient experienced arm pain near injection site, body aches, malaise, tired, slight brain fog, diarrhea and stomach upset. Patient didn't receive treatment for events. The adverse events didn't result in doctor or other healthcare professional office/clinic visit, or emergency room/department or urgent care. The clinical outcome of the events arm pain near injection site, body aches, malaise, tired, slight brain fog, diarrhea and stomach upset were unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: added information that patient didn't receive treatment for events.
This case was reported by a healthcare professional and described the occurrence of hair loss in a 40-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). On 20 July 2011 at 15:45 the subject received 3rd dose of ENGERIX B (1 ml, unknown route, left arm). On an unspecified date in 2011, approximately 1 month after vaccination with ENGERIX B, the subject experienced hair loss. The subject was treated with unspecified medications under dermatologist care. At the time of reporting the event was worse.
On the nights following the Vaccine, pt. began having very lucid strange dreams - sleep talking and jolted movements,  By the wee hours of April 19th at 3:14 am, pt. suffered a Grad Mall seizure.  it sounded like creaking glass as his body convulsed.  Paramedics arrived and while in route to the hospital he suffered another Grand mall seizure.
Patient presented to the ED and was subsequently hospitalized for abscess of left foot within 6 weeks of receiving COVID vaccination.
A  male patient received both doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown) via an unspecified route of administration on an unknown date (received second dose day before yesterday as per report) as a single dose for COVID-19 immunization. Medical history was not reported. Concomitant medication included clopidogrel bisulfate (PLAVIX) as an anticoagulant therapy. After both doses, the patient experienced sore arm. Patient was unaware at the time of his injections that he should mention taking an anti-coagulant. The outcome of the event was recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
A non-serious spontaneous report of received half dose of FLUMIST was received from a Registered Nurse concerning a 34 year-old male. The divider clip was not removed and the patient received  a half dose (0.1 ml) of FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
An apparent urticaria in & around the face, on forehead, cheeks, & chin; sx appear approx 48 hrs p/flu shot & continued 1 wk; sx subsided 7NOV91; tx wet soaks, hydrocortisone cream;
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per the vaccine indication. The patient had an out break of shingles after 1st dose of SHINGRIX vaccine. This was the only information available for this report. The pharmacist did not consent to follow up.
Patient saw PCP with  chief complaint of chest discomfort. on 2/7/22. after assessment EKG was negative and no other cardiac findings. Pt d/c'd from pcp  office with no new medications.  PCP called administrator to notify of patient's complaint potentially related to covid19 pediatric dose vaccine.
headache; This is a spontaneous report from a contactable consumer, the patient. This 38-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on 03Jan2021 (at the age of 38-years-old) as a single dose for COVID-19 vaccination. The patient's medical history and concomitant medication were not reported. On 03Jan2021 (reported as early today), the patient reported she feels fine, but has a little bit of a headache. She did not know if her headache was due to the vaccine or other reasons. The patient wanted to know if she could take ibuprofen. The clinical outcome of the headache was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
refrigerator was off for 8 hours with the highest temp 60.1 F/no AE; Based on information previously received with CSD: 02-JUL-2018, the following information [Listedness assessed for both suspects and seriousness criteria "Intervention required" was unticked and case was downgraded to non-serious] has been amended.  Based on information previously received with CSD: 02-JUL-2018, the following information [Reporter's State was updated ] have been amended.  Initial information received on 02-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an adult female patient (unknown age), who was tested with 0.1 ml dose of TUBERSOL (TUBERCULIN TEST) (lot - C5471AA, 09-Aug-2020, dose in series, route of administration was not reported) in the right arm and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (ADACEL) (batch number, expiry date, dose, dose in series, route and site of administration was not reported which was stored in the refrigerator that was off for 8 hours on an unknown date at Jun-2018.  The Patient's medical history and concomitant medications were not reported.  It was a case of actual medication error due to incorrect product storage. The test failed to show up for the reading of the test and has planned for other test in Jan-2018.  No other adverse events had been reported.  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.  Addendum: Based on information previously received with CSD: 02-JUL-2018, the following information [Reporter's State was updated] have been amended.  Addendum: Based on information previously received with CSD: 02-JUL-2018, the following information (Listedness assessed for both suspects and seriousness criteria "Intervention required" was unticked and case was downgraded to non-serious] has been amended).
On day 6 post-vaccination, I developed a raised, swollen, itchy rash around the vaccine site. The next day it flattened out and became larger and more red. It was about 2 inches x  3 inches. It took about another week for it to start fading. I still see a faint shadow of where the rash was.
1/16/22 13-year-old male with history of asthma presenting to the emergency department with upper respiratory symptoms for the past 3 days.  There has been cough, congestion and rhinorrhea.  There has been no wheezing or stridor noted at home.  There has been no labored breathing or increased work of breathing.  There has been no vomiting or diarrhea.  Appetite and activity levels have been normal.  Urine output has been normal.  No home treatment has been initiated.     ROS positive for cough, congestion and rhinorrhea, negative for vomiting or diarrhea, rash, labored breathing,  change in mental status, sore throat, eye or ear discharge; ROS o/w negative HEENT: TMs normal, oropharynx normal, mucus membranes moist. 1/16/22 Discharge: 13-year-old male presenting to the emergency department with chief complaint of upper respiratory symptoms for the last few days.  Exam reveals a healthy young man with occasional bronchospastic cough, rhinorrhea and congestion.  Dexamethasone x1 was given p.o. mother was advised to continue asthma regimen at home.  Benadryl to be taken at night.  Mother to allow rest and to push p.o. fluids.
headache; unsteady; can´t walk very well; nauseous; wobbly legs; This case was reported by a consumer via call center representative and described the occurrence of headache in a 11-year-old female patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On 9th August 2021, the patient received Tdap Vaccine. On 10th August 2021, 1 days after receiving Tdap Vaccine, the patient experienced headache, unsteadiness and walking difficulty. In August 2021, the patient experienced nausea and lower extremities weakness of. On an unknown date, the outcome of the headache, unsteadiness, nausea, lower extremities weakness of and walking difficulty were unknown.   It was unknown if the reporter considered the headache, unsteadiness, nausea, lower extremities weakness of and walking difficulty to be related to Tdap Vaccine.  Additional case details were provided as follows: The case was reported by patient's mother or father. The age at vaccination was not reported. The reporter asked how to treat minor symptoms of vaccine side effects. The patient received Tdap vaccine one day before of the reporting date and was complaining of a headache and was unsteady on the day of reporting. The patient also experienced nauseous and wobbly legs and a could not walk very well. Initially the reporter was confused if the vaccine was Meningitis or Tdap. Later confirmed that the vaccine administered was a Tdap vaccine and not a Meningitis, but he did not have the brand name.  Permission for follow up was not asked.
Pt was given the Pfizer 5-11 Orange top undiluted. Did not have an adverse reaction immediately after vaccination. Pt's mother was informed, and told to monitor. Was placed for a f/u visit tomorrow morning (10/7).
Pfizer COVID-19 Vaccine EUA Patient received 1st dose Pfizer at 1705.  Patient stood up and had vasovagal reaction, passed out and seized for 15 seconds.  Nurse performed sternal rub, patient was aroused.  Patient A&Ox3.  Physician arrived at 1708, vital signs obtained at 1711 (BP 113/68, O2 100%, HR 83 bpm.  Patient right ear started to bleed at 1712.  1725 obtained another set of vital signs.  BP 118/70, O2 96%HR 82 bpm.  EMS/Fire arrived 1732.
About 4 hours after the vaccination, patient developed mildly itchy rash over chest and abdomen.  Received Benadryl that evening but hives progressed to involve left arm up to face and swelling of left ear.  Benadryl given around the clock.  Doctor visit today only minimal hives on left upper arm evident.  No shortness of breath, trouble swallowing, no wheezing.
Practically fainted; Shortness of breath; Tingling in right hand; Numbness; Brain fog; Feels weak; Soreness; Itchiness; Fatigued; A spontaneous report  was received from a consumer concerning a 70-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced numbness, tingling in right hand, fatigued, practically fainted/Syncope, feels weak, itchiness, soreness, shortness of breath, brain fog.  The patient's medical history was not provided. Concomitant medications were not reported.  On 21 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number:028L20A) unknown route of administration in the left non-dominant arm for prophylaxis of COVID-19 infection.   On 18 Feb 2021, prior to the onset of the events, the patient received the second of two planned doses of mRNA-1273 (Lot number:031L20A) unknown route of administration in the left non-dominant arm for prophylaxis of COVID-19 infection.  On an unspecified date, the patient practically fainted, felt numbness, tingling in right hand, felt fatigued, feels weak, itchiness, soreness, shortness of breath and brain fog. Treatment for the events were not reported. The adverse event of practically fainted was assessed as medically significant.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of events of numbness, tingling in right hand, fatigued, practically fainted, feels weak, itchiness, soreness, shortness of breath, brain fog was unknown.; Reporter'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.
mild tenosynovitis of right hand Narrative: Patient is a 71 yo MALE with PMHx significant for nummular dermatitis, stroke (10/29/2020), HTN, and HLD. Per 2/10/21 secure message, patient experiencing swelling of his right hand w/ pain. His activity was reportedly a little more than usual--doing 6 hours of carpentry on Thursday (2/4/21) and yard work on Saturday (2/6/21), He also had a splinter in his thumb. Patient was seen by PCP on 2/11/21. Slight right hand erythema and mild diffuse swelling noted. Patient said pain and redness were "better today" and "other hand feeling well." Infection was ruled out d/t mild nature of presentation (neither cellulitis or cat scratch fever - patient has h/o of cat scratch fever 30 years ago) and blood work was ordered to rule out unlikely early RA; 2/11/21 labs resulted in: ESR =11 (WNL), CRP = 0.1 (WNL), rheumatoid factor = <10 (WNL), and CBC w/ diff = WNL. PCP's assessment was mild tenosynovitis. No medications were used /ordered per chart review. If not improving, PCP will refer patient to hand specialist and consider antibiotics. Unclear whether there is a correlation between the mild tenosynovitis presentation and recent Pfizer COVID-19 vaccine.
Patient was seen at hospital on 04JUN2021 for a Purpuric Rash at and was refereed to Medical Center on 04JUN2021 time 1704, upon arrival to the patients labs were collected. Lab results confirmed Thrombotic Thrombocytopenic Purpura due to platelet count of four. Patient has been hospitalized since that date receiving treatment.
Patient received J&J vaccine on 8/18/21. COVID positive on 5/10/22. PResented to ER on 5/11/22. Patient started to get sick last Wednesday with cough,  cold, and some chills and on Monday which is 2 days ago he was diagnosed with  COVID-19.  He comes to the emergency room because of worsening shortness of  breath and cough without any chest pain.  Mild nausea.  No vomiting.  No  diarrhea.  Denies any bleeds or melenic stools.  He was found to be quite  hypoxemic with a PO2 of only 61 on room air.  Chest x-ray did not reveal  anything acute except for some mild increased size in the cardiac silhouette.   The patient was given Lasix in the ER and then the hospitalist service called  for admission.  When I saw the patient, I discussed with him that he has  acute hypoxemic respiratory failure secondary to COVID-19 and that he would  benefit from Decadron, but the patient says he is "allergic to  corticosteroids" and he is vehemently denying receiving any Solu-Medrol or any  other oral or IV corticosteroids.  The patient will be admitted as an  inpatient to IMC unit with acute hypoxemic respiratory failure secondary to  COVID-19. REceived remdesivir 200 mg x 1 and doxycycline. Discharged on 5/12/22.
Patient presented for second dose of Moderna Vaccination. At 1300pm, patient stated he started to feel sweaty and weak. Vitals were taken, BP 134/82 P 74 R 18 O2 98%. Lungs clear on auscultation. Patient verbalized that he has a history of anxiety and only drank one cup of coffee today with no other fluid intake. Patient denied H/A, C/P, SOB and nausea at this time. Patient verbalized that he was starting to feel better. Patient was monitored by nurse during this time. Within a few minutes the patient started to get upset and stated that he felt like he was going to pass out and that his left leg felt weak. Patient was red, flushed, diaphoretic, and appeared anxious with increased respiratory effort. Cardiac monitor in use, normal sinus rhythm analyzed. O2 applied at 2LNC. Patient stated that he wanted to lay on the floor. Patient transferred to stretcher by EMS. BP 146/76 P 76 R 20 O2 99% 2L NC Patient verbalized that he wanted to be transported to the hospital.
redness on face,  arms, back, arms, legs and torso.  experiencing deeper breathing
18 days post vax pt devel t103-104 & joint pain (especially shoulder pain);21 days post vax devel rash on face w/mouth & tongue included;
DTap on 03/20/2002. Right thigh warm, red, swollen, tender on 03/22/2002. Pt afebrile.
Severe pain under right breast around into upper right back.  Was hospitalized 12Mar2020 for two days.  Pain is still very intense; Severe pain under right breast around into upper right back.  Was hospitalized 12Mar2020 for two days.  Pain is still very intense.; This is a spontaneous report from a contactable other health professional (HCP). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in right arm on 11Feb2021 at 13:00 (Batch/Lot number was not reported) as single dose, then second dose via an unspecified route of administration, administered in right arm on 04Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included Congestive heart failure (CHF), kidney stones, diabetes, penicillin allergy, drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medication included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) and vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), both for unspecified indication. The patient previously took statin [nystatin] for unspecified indication. On 05Mar2021 at 04:00, the patient experienced severe pain under right breast around into upper right back. The patient was hospitalized on 12Mar2020 for two days. Pain is still very intense. The patient underwent lab tests and procedures which included nasal swab: negative on 18Mar2021. The patient had bloodwork, x-ray, MRI and EKG as treatment for the events. The outcome of the events was not recovered.; Sender's Comments: The causal association cannot be excluded between the reported events of breast pain and back pain with BNT162B2 vaccine use due to strong temporal association. 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. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
NO ADVERSE EVENT OCCURED.  PATIENT IS 17 YEARS OF AGE AND WAS ADMINISTERED MODERNA VACCINE AT A OFFSITE CLINIC EVENT.  PER CDC 2ND DOSE SHOULD BE ADMINISTER AS "OFF-LABEL USAGE"
chest heaviness; throat spasms; racing heart; dizziness; This is a spontaneous report from a contactable consumer. This 70-years-old female consumer(patient) reported that:  A 70-years-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6200) via an unspecified route of administration in Arm Left on 01Mar2021 14:45 as dose 2, single for covid-19 immunisation. Medical history included 6 autoimmune, asthma, diabetes 2 celiac, environmental, genetic extra histamine production. Concomitant medications included certolizumab pegol (CIMZIA) taken for an unspecified indication, start and stop date were not reported. Patient known allergies: genetic extra histamine production. The patient receive other medications within 2 weeks of vaccination are cimzia (not enough space for all). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6200) via an unspecified route of administration in Arm Left on 08Feb2021 as dose 1, single for covid-19 immunisation. On 01Mar2021 at 15:00 patient experienced much milder with chest heaviness, throat spasm, dizziness, racing heart but no swelling of lips and jaw. Treatment patient received 20mg prednisone day before and day off vaccine and also took 50 mg benadryl 1 hour after vaccine. The clinical outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
patient was given second dose of Pfizer vaccine too soon (13 days apart from the fist dose)
Pt recvd vax & devel severe abdo pain; liver function tests were performed & all were nl x/Bilirubin which was 2 times nl values;
VOMITING; DIARRHEA; ACHY ALL OVER; BURNING PAIN IN LEGS; NAUSEA; ALLERGY SYMPTOMS; HIVES; This spontaneous report received from a parent concerned a female of unspecified age. 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: 202A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced allergy symptoms. On APR-2021, the subject experienced hives. On 08-APR-2021, the subject experienced vomiting. On 08-APR-2021, the subject experienced diarrhea. On 08-APR-2021, the subject experienced achy all over. On 08-APR-2021, the subject experienced burning pain in legs. On 08-APR-2021, the subject experienced nausea. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vomiting, nausea, diarrhea, burning pain in legs, achy all over, allergy symptoms and hives was not reported. This report was non-serious.
67 yo male hx of bronchietctasis, ILD, presents to ED for shortness of breath, found to have COVID PNA with hypoxia requiring 15L NRB mask  changed to 15L HFNC O2. Admitted to telemetry unit. Started on decadron and remdesivir 9/10/2021. Possible bacterial pneumonia.  Started on cefepime and levofloxacin, bronchodilators, BiPAP at night for sleep apnea.
12/3/16 pt fatigued in the afternoon and C/O mouth/cheek pain. Temp 99. 12/4/16 afternoon C/O cheek pain again. Was given TYLENOL then woke with (B) cheek swelling - By time of ER visit, (R) cheek nl, (L) still swollen at office visit today.
Vomiting until nothing was left in body 6 times. Sweating, body aches, sore neck, extreme headache. Felt really hot (103 temp.). Sensitive to sound and light. Had to be in dark and quiet. Swollen left arm with a lump 36 hours after vaccine.