chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient experiencing a localized erythema, swelling, and blistering; patient experiencing a localized erythema, swelling, and blistering; patient experiencing a localized erythema, swelling, and blistering; This spontaneous report was received from a physician and refers to a 4-year-old female patient. The patient's concomitant medications and pertinent medical history were not reported. The patient had no known drug allergies.  On 12-JUN-2023, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 1 dose, lot #X011112 has been verified to be valid, expiration date: 18-JUL-2024, albumin status has been verified as recombinant human albumin (rHA), administered intramuscularly on right thigh for vaccination against measles, mumps, rubella, and varicella (strength and exact dose were not provided); and diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (KINRIX), at other body site (strength, formulation, dose, exact anatomical location, lot #, expiry date, route of administration, and indication were not provided).  On 13-JUN-2023, the patient experienced a localized erythema, swelling, and blistering after receiving measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). The patient had prescribed cefalexinum (KEFLEX) as treatment. At the time of report, events seemed to be improving. On 15-JUN-2023, polymerase chain reaction (PCR) test was ordered and bacterial cultures were negative.  The causal relationship between the events and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was not provided.
Hives covering legs and on wrist and lower abdomen.  Hives began within a week of injection and continued to spread for a week.  Began applying traimcinolone 2 weeks after injection on the affected areas.  Began taking 180mg of fexofenadine 2x per day, starting 15 days after the injection.  Spreading has stopped, but current hives are still swollen and itching.
Baby vomited one time, turned pale and was "unresponsive" for 5 minutes, according to mother. She then recovered. Parents did not seek medical attention at the time of the event. Notified MD's office 3 days later.
A PAIN IN THE HEART; LUMPS ON THE HANDS; LEG CRAMPS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, and batch number were not reported and expiry: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in OCT-2021, the patient experienced a pain in the heart, lumps on the hands, and leg cramps. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) up to 37 degrees. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lumps on the hands, leg cramps, and a pain in the heart. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20211137029-covid-19 vaccine ad26.cov2.s-pain in the heart.This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
got dose 1 on 13Dec2021. On 06Jan2022 she tested positive for covid; got dose 1 on 13Dec2021. On 06Jan2022 she tested positive for covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the parent. Other Case identifier(s): US-PFIZER INC-202200047512.  A 10 year-old female patient received bnt162b2 (BNT162B2), administration date 13Dec2021 (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 06Jan2022, outcome "unknown", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "got dose 1 on 13Dec2021. On 06Jan2022 she tested positive for covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Jan2022) positive. Description of complaint:  Patient was tested positive for covid and has NO symptoms. She was scheduled to take her 2nd dose on 16Jan2022 (10 days after testing positive), assuming she had no symptoms, reporter enquires if it safe for her to take it on this date or should she wait?  The lot number for bnt162b2 was not provided and will be requested during follow up.
Primary Care Physician at Discharge: MD Hematologist/Oncologist: MD Admission Date: 8/26/2022 Discharge Date: 8/27/2022  PRESENTING PROBLEM: Severe sepsis  Hepatocellular carcinoma, fibrolamellar   HOSPITAL COURSE: The patient is a 13 y.o. female with metastatic fibrolamellar hepatocellular carcinoma diagnosed March 2019.    She has had progressive disease in spite of multiple therapies with most recent therapy of IV Gemcitabine/IV Nivolumab/PO Lenvatinib/PO Quecertin + celebrex. She was admitted 8/15 with new onset dyspnea. Scans at that time noted interval progression. Patient's chemo regime was stopped and she stabilized from a clinical respiratory stand point. She began palliative radiation therapy 8/22. She was last seen in clinic 8/23 for Nivolumab and 8/24 for PRBC transfusion.    Prior to presentation, patient had been clinically well and attending school. Patient came to the ED early on 8/26 with new onset fever, cough and increased WOB. She required pain control and oxygen via nasal cannula in the ED. She received a fast break with cefepime. RVP returned positive for COVID and started on Decadron as she was inelgiable for other antivirals from her transmanitis.. She was admitted to the floor for oxygen supplementation that she was able to be weaned from shortly after admission. She was continued on rocephin daily while admitted. Her home penicillin was held while she received IV abx.    On admission, patient noted worsening pain that had not been covered by home regime. Pain and palliative was consulted. They were able to start a Fentanyl patch 12mcg to be changed every 72 hours with Oxycodone 15mg Q4 hours. Mom was instructed that if her pain was not controlled on this she could contact pediatric palliative care in order to increase the regimen.    At time of discharge, she is to continue Decadron 6mg QD to complete on 9/2/2022 and will have palliative radiation continued with next appointment on 8/29/2022.
This spontaneous report as received from a pharmacist refers to an approximately 54 years old male patient. The patient medical history included shingles approximately in 1965 (reported as when the patient was 27 years old). On 15-JAN-2013 the patient was vaccinated with ZOSTAVAX subcutaneously, 0.65 ml dose, lot # H018798, expiration date: 15-JAN-2014. Concomitant therapies included NAPROSYN. Two or three days after vaccination in January 2013 the patient developed a rash at the injection site that was noted as red, small, blotchy and raised. He also developed slight itching at the injection site a day later than rash in January 2013. No lab diagnostic studies were performed and there was no treatment given for the patient's adverse events. The patient did not seek medical attention. On an unspecified date in January 2013 (reported as within a week) the patient recovered from his adverse events. The relatedness between the patient's adverse events and the vaccination with ZOSTAVAX was not reported. Additional information is not expected.
12:00AM severe shaking chills, nausea, severe headache, fever  101.4 Tylenol and Motrin broke fever 3.30 AM ; headache still persists
Swelling the size of a goose egg at the site of Injection; This case was reported by a other health professional via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 11-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 43E4T, expiry date 1st October 2021) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced extensive swelling of vaccinated limb. On an unknown date, the outcome of the extensive swelling of vaccinated limb was unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb to be related to Boostrix.  Additional details were provided as follows: The batch number was updated from 43E47 to 43E4T as per sales data sheet. The health care professional reported that the patient had swelling the size of a goose egg at the site of Injection with Boostrix. Th reporter consented to follow up. This case linked with US2019160466, US2019160503, US2019160497 and US2019160491, reported by same reporter.
uncontrolled diabetes; Bell's palsy; hypertension; chest pain; raised area the size of a softball in her upper left arm that turned black and blue and hot to the touch.; raised area the size of a softball in her upper left arm that turned black and blue and hot to the touch.; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On or about 11-OCT-2016, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the prevention of shingles (herpes Zoster).  On an unspecified date, shortly after to the patient vaccination, the patient presented a raised area of the size of a softball in her upper left arm that turned black-blue and hot to the touch, facial droop, uncontrolled diabetes and hypertension. On an unspecified date, the patient was diagnosed with acute bell's palsy, hypertension, chest pain and diabetes with hyperglycemia. Additionally, the symptoms had been resulted in physical limitation not presented prior vaccination. The patient sustained severe and permanent injuries; the patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's conditions.  As a direct and proximate result, the patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.   The reporter considered all the events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the events of uncontrolled diabetes and bell's palsy was considered as medically significant.
Hives and pale skin, low blood pressure and rapid heart beat, light sensitivity, headache, shaking and vomiting.  Received oral antihistamines.
Diarrhea, NauseaVomiting, FATIGUE; CHILLS Narrative:
Received the 1 dose lil bit of chest tightness after 20 mins release to leave by 4pm my right eye started twitching, a Finally got home received the first dose of Pfizer yesterday morning and within hours I felt horrible got all the side effect of course and had to go to the hospital this morning. Having SOB  dry cough and horrible upper back pain. Dr and I?m wheezing a lot so I got a shot of steroids and two neb treatments X-ray showed inflammation the cause was the vaccination activated my asthma and the rest side effect nd within hours I felt horrible got all the side effect  and had to go to the hospital this morning. Having SOB  dry cough and horrible upper back pain. Dr and I?m wheezing a lot so I got a shot of steroids and two neb treatments X-ray the cause was the vaccination activated my asthma and the rest  was side effect
MBR STATES THAT HE HAS LOST ALL SENSE OF TASTE AND SMELL
This spontaneous report as received from a certified medical assistant concerning a patient (gender and age were not provided) who on 15-AUG-2012 was vaccinated with an expired dose of M-M-R II (lot number 668070/1059Z, expiration date 11-AUG-2012). (route was not provided). No adverse events were reported. Additional information is not expected.
Chills, body aches, and headache reported day after vaccination given via patient phone call to pharmacy.  Recommended to take Tylenol for symptoms.  Patient mentioned that she already has an appointment scheduled to visit her doctor.
hernia; stomach strangulation, extreme nausea; unable to eat; hospitalized on April 3; emergency surgery to repair hernia and put stomach in proper position on April 6.
nerve pain and could not move her arm; nerve pain and could not move her arm; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient. A 55-year-old female patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown) at the age of 53 years intramuscular for covid-19 immunisation.  The patient's relevant medical history included: "Hyperthyroid" (unspecified if ongoing), notes: Relevant Medical History and Concurrent Conditions (not including reaction / event): Hyperthyroid.  Concomitant medication included: METHIMAZOLE taken for thyroid disorder. The following information was reported: NEURALGIA (non-serious), JOINT RANGE OF MOTION DECREASED (non-serious), outcome "unknown" and all described as "nerve pain and could not move her arm".  Additional information: 1st vaccine, the vaccine was put in her shoulder capsule and had nerve pain and couldnt move her arm. She did make sure she has padding on her shoulder and not feeling like that. She couldnt tell she couldnt move her left arm till the next morning.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I had two days of a sore throat and on Tuesday I ran fever, sever congestion, nausea, dry heaving, couldn't sleep and I guess that was about it. It lasted till I contacted the Dr. on Wednesday morning. The doctor asked me questions about how I was feeling and he prescribed the Paxlovid and told me to stop taking my Lipitor while taking that medication. I still don't have no sense of smell or taste, runny nose, and a cough but not too bad.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium
Numbing and tingling of the four extremities, difficulty swallowing, unable to hold objects, unable to walk.
Pt started a fever of 101.6 the day after his 2nd dose of Moderna. Pt took 1 Ibuprophen for treatment. Pt wife reported he was ill feeling after his first dose and did have a rash with "welps" after the first dose. They contacted his primary provider to see if he should get the 2nd dose and they did not receive a return call so he went ahead and got the second dose.  Encouraged to seek evaluation from his primary provider is redness, rash, hives or any other adverse events occurs.
Pt reported having chills, diaphoresis, weakness, malaise with 1-2 hours post vax.  Felt he probably had a fever but took acetaminophen throughout the day to reduce discomfort.  Sx's persisted for 2 days.
2nd dose given from beyond use date vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2nd dose given from beyond use date vial) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2nd dose given from beyond use date vial). On 16-Jun-2021, EXPIRED PRODUCT ADMINISTERED (2nd dose given from beyond use date vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever. This report was non-serious.
Patient received her vaccine at 1:12pm. She went to check out. The check out man reported that she didn't feel well. I noticed that she started to slump over in her chair. I went to her. I asked if she wanted to lay on the hospital bed. She said she couldn't get up. She wanted cold rags. She was visibly sweating. I motioned another health care worker over so I could go get the rags. When I got back less than 30 seconds later, she was on the floor. My coworker reported she slumped out of the chair and was unconscious for about 10 seconds.   Security called 911 , and I called the emergency phone number to the hospital. She came back around and did not want to go to ER. Dr listened to her. Lungs were completely clear. She reports she has a history of dizziness with all vaccines. She has never gone totally unconscious before. She has no history of diabetes or hypertension. She did not eat lunch before coming. BP 123/80 at start of the event. 27 minutes after the event bp was 99/69 with pulse 66. 52 minutes later bp 109/86 with pulse of 71.  We did not want her to drive home. We had her call someone to be picked up. She was able to walk out of the building without assistance.
As a means of background, my first Pfizer-BioNTech Covid-19 injection was on May 22, 2021 (Lot No. EWO187).  The following morning and for a period of roughly 6 months thereafter, I experienced pain in my right bicep.  That pain eventually subsided in mid November 2021.    My second Pfizer-BioNTech Covid-19 injection was on June 12, 2021 (Lot NO. EWO217) on June 12, 2021.  From the following morning up until the present time I have experienced pain in my left underarm on a daily basis.
Hypertensive Emergency (BP 219/114) with no previous blood pressure issues; Radiating chest pain, left arm pain; jaw pain; This is a spontaneous report from a contactable other Health Professional (patient). A 40-year-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EX5170), via an unspecified route of administration on 16Dec2020 15:00 at single dose in left arm for covid-19 immunization. Medical history included symptomatic PVC's (Premature ventricular contractions), tachycardia, bradycardia, CVA (cerebrovascular accident) from 2018 to an unknown date, asthma and rhythm. Concomitant medication included flecainide, spironolactone, metoprolol for rhythm. The patient had known allergies included hydrocodone bitartrate, paracetamol (VICODIN), eletriptan and adhesive. Prior vaccination, the patient had no covid. On 22Dec2020 18:00, the patient experienced hypertensive Emergency (BP 219/114) with no previous blood pressure issues. Radiating chest pain, left arm pain, and jaw pain. Admitted to the hospital where an echocardiogram and angiogram was performed showing clear coronary arteries and no hypertensive remodeling of the heart. Issue has been ongoing since, despite interventions. The events result in emergency room/department or urgent care and hospitalization from an unspecified date for 1 day. The patient received the treatment for the events included frequent nitroglycerin, hydralazine and metoprolol. The patient underwent curative-SARS-Cov-2 Assay RT-PCR on 01Jan2021 with negative result. The outcome of the events was not recovered.; Sender's Comments: Based on the information available, contributory role of BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE,) to event "hypertensive emergency (BP 219/114) with no previous blood pressure issues" cannot be excluded. The events chest pain and pain in jaw are attributed to underlying medical conditions and assessed unrelated. BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE,). The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
2 hours after vaccines fever began.  Max 102.4.  Then swelling of Rt. thigh to the knee.  Hot to the touch.  Child will not bear weight on Rt leg X's 3 days now.  Swelling worse in office today.  Follow up Monday.  7/26/10.
UNCONTROLLABLE SHAKING; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (UNCONTROLLABLE SHAKING) 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 TREMOR (UNCONTROLLABLE SHAKING). At the time of the report, TREMOR (UNCONTROLLABLE SHAKING) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MODERNATX, INC.-MOD-2021-022839 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MODERNATX, INC.-MOD-2021-022839:Crosslinked (MOD21-021326)
09/03/22 ~2 AM (~8 hrs after shot): body aches, chills, fever (up to 102.1ºF), oppressive headache. 09/03/22 ~9 AM (~14 hrs after shot): add to previous symptoms an episode (~30 min?) of near-fainting (felt like vasovagal syncope, but lowering head to the floor stopped me from passing out completely) and nausea. Contemplate an ER visit if temp nears 103, but it does not. Aches, fever, chills persist for ~3 days before resolving. 09/20/22 ~4 PM (2.5 weeks after shot): Right thumb fractures while using tools with that hand. There was no obvious impact event that caused this fracture. Cause is still unknown. *Thumb fracture is the event I sought medical care for.* 09/20/22: Period expected, but does not come until10/10 (3 weeks late).
Broke out with a rash in middle of back and side of stomach around 08/06/2021. No cream would help as it became painful.  Diagnosed 08/13/21 with Shingles
At about 10am on Friday I had a really intense pain on my right abdomen. It kind of felt like a menstrual cramp but when I tried to move it didn't subside. At 11am I went to urgent care. I was told I had a cyst on y right ovary before which is why I went. At urgent care they couldn't do any imaging, so they sent me to the emergency room, and I was given a pain medication in my arm that helped the pain. I had vitals taken, an ultrasound, and a CT scan. On the CT scan they saw I had acute appendicitis. I was then admitted, I had surgery to remove my appendix.  I was discharged that flowing Saturday. I was prescribed oxycodone for the pain.