chrisvoncsefalvay/vaers-outcomes huggingface dataset:
March 12, 2022 is my due date for my baby. I had one ultrasound done after my primary first two Covid vaccines with no abnormalities seen. My second ultrasound done after my third dose showed a heart defect, a hole in the heart. Not sure if it?s related or not to the vaccine.
The day after my first vaccination  at 3:15 PM I started getting visual auras and then migraine which lasted about 4 hours.  I have had up 7 more since then and after my 2nd vaccine.  Dr. thought it might be related since I have no history of chronic migraines.  All past were over 16 years ago and related to hormonal changes.
Site: Pain at Injection Site-Severe, Systemic: Joint Pain-Severe, Additional Details: Patient complains of shoulder pain severe enough that she cannot lift her arm. She claims the vaccine was administered high on the arm and to the back of the arm. However upon review of the video of administration, it appears the immunizer administered the vaccine in the right place.
Received First Dose Heplisav-B, Received Second Dose Engerix; Initial Report Received on 03-May-2023.  A pharmacist reported that a 31 year-old male (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for first dose of hepatitis B immunization and then received Engerix-B as the second dose.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 30-Mar-2023, the patient received the first dose of HEPLISAV-B (Lot # 941584, expiration date 31-Jan-2025 and NDC # 43528-003-05) in the left arm (route not reported) from a pharmacist.    On 30-Mar-2023, the patient was vaccinated with HEPLISAV-B as the first dose of hepatitis B immunization. On 01-May-2023 the patient came back to a different store location and received Engerix-B as a second dose, as this is the only brand they had at the location No adverse reactions was reported.  No additional information was reported.   Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Information has been received from a registered nurse concerning a 9 year old male who on 23-APR-1999 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (Lot # 627337/1057H). On 26-NOV-2007, the patient developed rash on back, arms and stomach. The patient had less than 50 lesions. A product quality complaint was not involved. Additional information has been requested. This is one of several reports from the same source.
Patient became dizzy and disoriented approximately 12 hours after receiving vaccine.  She fainted and hit her head.
apnea 10-15sec-several episodes, gagging episodes;had to rouse pt by gently shaking to get pt to breath each time;the episodes happened while pt was awake & also while sleeping;
Around 8pm the evening of my injection I began experiencing chills and fever.  Around 11pm I began feeling extremely nauseous and continued with the fever and chills.  By 1 am I began throwing up. I had about 3 episodes of throwing up/dry heaves. By this time, I also had body aches and the fever continued throughout the night. I would guess I got several 2 hour naps between being sick, but by 5am the nausea finally subsided. The next day the fever and chills continued throughout the day. I couldn?t eat much, so I wasn?t able to take anything for the fever. I did get some water down throughout the day, but I was dehydrated by the end of the day. I would say the worst of the symptoms lasted about 12 hours. The next 24 hours were manageable: minor soreness at injection site, body aches, headache, low fever. I needed to take a day off from work.
VARICELLA DISEASE FOLLOWING EXPOSURE TO MOM WITH SHINGLES 2 WEEKS PRIOR AND COUSIN WITH VARICELLA 1 WEEK PRIOR. URI SX WITH GREATER THAN 50 VESICLES BREAKING OUT TODAY. NO FEVERS. HE HAD 2 VACCINES WITH VARIVAX. THIS IS VACCINE FAILURE.
Patient presented with complaints of weakness on 11/3/21. Covid 19 booster was on 11/2/21. Patient was admitted due to mild CHF exacerbation and further workup. Discharged to rehab center 11/6/21.
Itchy scaling, psoriasis flaring of which not noted until covid vaccinations. Lab tests done after previous
I?m currently pregnant with my second baby. I?m 19 weeks pregnant due on 07/10/2021. My first dose of covid vaccine I had a tingling tongue and face and just took some Claritin and Pepcid. The second time around my entire mouth went numb and it felt like there was something in my throat. My airway was not impacted but it felt off. I was given 25mg of Benadryl and monitored for half an hour with vitals every 5 minutes. I?m 14 hours out from the reaction and I feel fine now.
Heart palpitations out of control. Lightheaded feeling and feeling like I was going to faint. Sitting on the couch and heart started pounding without any instigation.  Lasted at high rate for 1-2 hours. Palpitations continue to this day. Admitted to ER for three days. Triponin  levels were slightly high abnormal.  Discussion of myocarditis/paricarditis
Mother reports started crying inconsolably PM of 5/19, continued crying off and on all day with lower frequency through 6/22/03. No fevers at any time and no other symptoms. Mother gave Tylenol alternating with Ibuprofen every 8 hours. These symptoms resolved by 6/23/03. Also developed local reaction at injection site. Right upper thigh - "small knot" no redness or heat.
the redness came down to her elbow and it was a couple of inches wide; a week after the arm of the injection site was warm; week after the arm of the injection site was round; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (a week after the arm of the injection site was warm), VACCINATION SITE REACTION (week after the arm of the injection site was round) and INJECTION SITE ERYTHEMA (the redness came down to her elbow and it was a couple of inches wide) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE WARMTH (a week after the arm of the injection site was warm) and VACCINATION SITE REACTION (week after the arm of the injection site was round). On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (the redness came down to her elbow and it was a couple of inches wide). At the time of the report, VACCINATION SITE WARMTH (a week after the arm of the injection site was warm), VACCINATION SITE REACTION (week after the arm of the injection site was round) and INJECTION SITE ERYTHEMA (the redness came down to her elbow and it was a couple of inches wide) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
This is a spontaneous report from a RN referring to a male pt who received his 1st and 2nd doses of Lymerix on 6/25/99 and 7/27/99, respectively. Following the 2nd dose, the pt experienced unusual fatigue, sleeping several nights from 20:00 to 07:00. He was seen by a physician. No treatment was given. Lymerix was discontinued. The most recent information, received on 8/12/99, reports the condition of the pt is ongoing.
Patient received listed vaccines on Wednesday 8/23/2023. Vaccines were administered to both the deltoid (IM), as well as to the fatty tissue on the posterior aspect of the upper arm above the triceps (Subcutaneous). Patient presented to Health Dept. on Friday 8/25/2023 complaining of an adverse reaction in the right arm in the area of the deltoid muscle. On assessment, the area presented with diffuse but mild redness. The injection site did not appear swollen, but was firm to the touch. The site was not noticeably warm to the touch. The patient reported no pain on palpation of the affected site, but reported pain at 2/10 when moving the affected arm. The left arm, which also received vaccines on 8/23/2023, present no adverse reaction or complaint from the patient. The subcutaneous site of the right arm also presented without adverse reactions. After assessing the patient, this RN advised the patient and her family that the site should be assessed by a physician. The patient reported not having a primary care provider. This RN stated that if the injection site did not improve promptly, or if it worsened such as becoming more swollen, tender to touch, or the redness spread, that the patient should seek medical attention immediately. Patient and family expressed understanding and departed the Health Department.
Shot given too high and pain in arm so bad she cannot move it.  Received shot after night shift.  After sleeping, awoke in pain. Employee health recommended f/u with urgent care. Ice, ibuprofen and ROM exercises prescribed for over the weekend.  Symptoms improved and have now completely resolved.
Angioedema of the L upper lip was noticed at 10 am no other symptom associated. Improvement of angioedema after 50 mg of PO Benadryl. Will continue to re-evaluate and if needed with seek further  medical treatment.  (Pictures can be sent if needed)   Expected side effects occurred prior to angioedema.
7 days, post vax, child brought in by mom, secondary to being irritable and swelling in left thigh and pain upon movement and cellulitis; started on IV antibiotics and Benadryl in hospital for 2 days. Had a fever of 101.8F; indurated area of cellulitis in thigh 1cm X 1 1/2cm; responded to antibiotics. Discharged home.
Injection site swelling, redness, itching and warmth.  Symptoms lasted less than 24 hours.
Multiple state agencies collaborated to provide the Moderna COVID-19 vaccine to the staff and the men and women in custody who work and reside in state correctional facilities. The mass vaccination process began on 02/17/2021.    Quality assurance processes in place for this vaccination effort identified two concerns regarding the vaccination process that occurred at seven facilities between the dates of 02/24/2021 and 03/05/2021.  Based on the information obtained, seven sites varied from the recommended best practices during the first round of vaccinations. A total of 5150 doses were provided to correctional staff and inmates in these seven facilities.    Our observations: o Based on our estimates of the number of doses per vial, it is possible that some recipients of the vaccine in these seven facilities may have received a lower than authorized dose of the vaccine.  o At two specific facilities, vaccine pooling did occur.  o There were no adverse outcomes reported from any of these facilities.   We gathered detailed information from all our vaccination sites.  We reviewed and analyzed this information and reported these observations to both Moderna, and to the agency. The conclusion of these meetings was that these variations in vaccine administration will have no impact on the vaccine's ability to provide protection and pose no ongoing risk to vaccine recipients.   We implemented the following modifications to improve our process: o Provided staff education regarding COVID-19 vaccination best practices o Established centralized dose preparation by health care staff at each facility o Included additional in-service dose preparation training for nursing staff by staff who were trained by Moderna o Initiated additional data collection by health care staff o Analyzed and monitored collected data to determine effectiveness of modifications   We will complete the required Vaccine Adverse Event Report (VAERs) to the agency.  We will provide notification to vaccine recipients at the seven facilities potentially impacted.
Patient had  reduced mobility onsite EMS was called vitals 154/82   100% O2 HR 90. Patient refused evaluation and care, released againt medical advice.
patient get the flu shot and the flu every year; Initial information received on 29-Oct-2020 regarding an unsolicited non-valid non-serious social media case received from a consumer.  This case is linked to cases 2020SA306225, 2020SA306226, 2020SA306227, 2020SA306228, 2020SA306229, 2020SA306230, 2020SA306231, 2020SA306232, 2020SA306233 and 2020SA306234.  This case involves a patient who get the flu shot and the flu every year(influenza), while he/she received vaccine INFLUENZA VACCINE.   The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, patient got the flu shot and the flu every year (influenza) (Unknown latency) following the administration of INFLUENZA VACCINE.  Relevant laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.  There will be no information available on the batch number for this case.
Felt depressed from about 7 am to 6 pm the day after the vaccination.
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown ages and and genders. On an unknown date, the patients were vaccinated with GARDASIL (dose, route and lot number were not reported), vaccine had been exposed to multiple excursions with highest temperature reaching 57F for total time of 206 hours and these vaccines' stability could not be supported. No adverse effects reported. This is one of several reports from the same source. Follow up information was received with patient identifiers. This case reported that GARDASIL (dose and route not reported, lot# J009788,expired date: 17-MAR-2016) was administered to a 21 year old patient on 05-MAR-2014. This case was linlked to 1405USA00161, 1405USA001164, 1405USA001163, 1405USA001162, 1405USA001166 and 1403USA007265.
A few hours after the injection, I had a feeling in the lips - similar to when novocaine wears off from the dentist (not the pins & needles, more like the cold numbness tingling). 24 hours after the injection, became very tired, and vertigo (have had in the past) also set in. The fatigue & vertigo were helped after a few doses of meclizine.
Initial information received on 19-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 57 years old male patient who was vaccinated with 0.5 ml FLUBLOK QIV (batch number: QFAA1830, expiration date: 30-Jun-2019, route of administration was not reported) in left deltoid, on 19-Nov-2018. Some time later, the ordering department contacted the medical staff and informed them that this shipment took longer than the allotted 2 days. The patient's medical history was not reported. Concomitant medications included PNEUMOVAX 23 for Immunisation. It was an actual medication error due to incorrect product storage. It was unknown whether the patient had any 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. List of documents held by sender: none.
Information has been received from a consumer concerning her cousin's child who, on an unknown date, was vaccinated with a dose of MMR (lot number not reported). Subsequently, the patient developed autism. Unspecified medical attention was sought. The patient had not recovered. Autism was determined to be an other important medical event (OMIC). Additional information has been requested.
Attending Physician:    Date of Admission: 2/21/2022 Date of Visit: 2/22/2022   Chief Complaint:    Fatigue Source of Information:  Patient, Available medical record and sister-in-law   History of Present Illness:  This is a 68y.o. female  with a PMHx significant for Breast CA with metastasis, GERD, neuropathy presented to the ED 02/22/22 with complaints of fatigue, nausea, and vomiting. Patient reports that she had her last radiation treatment on 2/20. She states that she has been feeling fatigued with nausea and vomiting since. Patient reports that she had 2 radiation treatments back to back this week. She states that was supposed to have 5 treatments consecutively but she physically could not withstand. Patient reports that she has had over 3 episodes of nausea and vomiting. She states that her emesis is clear, nonbloody, and nonbilious. She reports that she has not been able to keep anything down and 3 days. She states her last bowel movement was 2/20. She states that her home pain regimen and antiemetics have not been helping her. Patient reports that she has increasingly worse generalized aching with back pain, epigastric abdominal pain, and bilateral feet pins-and-needles. Patient follows with the oncologist Dr. who works out of a HCF. Patient also reports that she has had difficulty with shortness of breath since she had Covid in January, patient wears 2 L of oxygen at all times at home At time of exam, sister-in-law's at bedside. Patient is feeling better. ED Course: Vital Signs: T 97.5, HR 103?115, RR 18, BP 144/82, and SPO2 98% on 3 L/nasal cannula Labs: Hyponatremia (129), elevated transaminases (ALP 152, AST 118, ALT 68), elevated beta hydroxybutyrate (2.19), normocytic anemia (H/H 10.8/32.8), UA positive ketones, UDS positive opiates and cannabinoids Diagnostics: EKG?ST, HR 117, nonspecific ST segments, no acute ischemic changes noted
Thrombotic stroke, Collapsed on June 21 with garbled speech and became unresponsive. Had second stroke with similar symptoms while in hospital next day. Had multiple tests and location of formation of blood clot could not be found. Had leg dopplers, carotid ultrasound, CT scans, echocardiogram, etc. Doctors could not find a primary source of clot. It appears to have simply formed in brain
Extreme fatigue and soreness in joints on left side only, worst for the ankle, knee and hip. Ankle pain persisting the longest.
Dizziness; nausea; full body itch; itchy red arm; itchy red arm; Swollen/painful lymph node under arm; Swollen/painful lymph node; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Oct2021 16:00 (Lot number: FF9941) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Yes" (unspecified if ongoing), notes: known allergies: Yes, many. Concomitant medication(s) included: SINGULAIR; ZYRTEC ALLERGY; CLARITINE; BENADRYL; PREVACID. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EP6955, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 22Mar2021, when the patient was 55 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0158, Location of injection: Arm Right, Vaccine Administration Time: 09:00 AM), administration date: 12Apr2021, when the patient was 55 years old, for COVID-19 Immunization, reaction(s): "Dizziness", "Nausea", "full body itch,", "Itchy red arm", "Swollen/painful lymph node", "Swollen/painful lymph node". The following information was reported: DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "Dizziness"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "nausea"; PRURITUS (non-serious) with onset 2021, outcome "unknown", described as "full body itch"; PRURITUS (non-serious), ERYTHEMA (non-serious) all with onset 2021, outcome "unknown" and all described as "itchy red arm"; LYMPHADENOPATHY (non-serious) with onset 2021, outcome "unknown", described as "Swollen/painful lymph node under arm"; LYMPH NODE PAIN (non-serious) with onset 2021, outcome "unknown", described as "Swollen/painful lymph node".  Additional information: It was reported that, the patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included Singulair, Zyrtec, Claritin, Benadryl, Prevacid. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 was reported as no. Stated that, Dizziness, nausea, full body itch, itchy red arm. Swollen/painful lymph node under arm after 2nd and 3rd shots (not the first), Fever esp after 2nd shot. The reporter seriousness for the events was classified as non-serious. The device date was on 25Oct2021.  No follow-up attempts are possible. No further information is expected.
Patient said he felt like he had swelling in his mouth and throat. He had a cough and had difficulty breathing, approx. 2 hours after vaccine was administered.
This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient. A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Dec2020 as dose 1, single (Batch/Lot number: unknown), in left arm, on 12Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 07Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Thyroid cancer" (unspecified if ongoing). Concomitant medication(s) included in 2weeks: LEVOTHYROXINE. Adverse event: Rebound COVID symptoms and + COVID test one week after completing Paxlovid. Had negative COVID test after completing Paxlovid. Known allergies: No. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative. Therapeutic measures were taken as a result of vaccination failure, Covid-19. Anti-viral details: Product: COVID 19 Treatment Brand: Paxlovid treatment start date: 19Apr2022 treatment stop date: 24Apr2022 indication: Treatment of COVID-19. No treatment for adverse events. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events cannot be totally excluded.