chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient called on October 6 said her arm was bruised and swollen. I told her that some swelling and bruising were normal and to put ice on the area. If arm gets worse or more evidence of bruising, call back or call doctor or go to urgent care.
Within half hour to 45 minutes my face was flushed and felt like a sunburn.
This case was reported in a literature article and described the occurrence on uveitis in a 12-year-old female subject who was vaccinated with hepatitis B vaccine recombinant (Hepatitis B vaccine, manufacturer unspecified). On an unspecified date the subject received unspecified dose of Hepatitis B vaccine (unknown). At an unspecified time after vaccination with Hepatitis B vaccine, the subject experienced uveitis. This case was assessed as medically serious by GSK. This is one of the 32 reported cases (B0662264A till B0662297A) of uveitis which occurred after hepatitis b vaccine between 1982 and 2009. It appeared that all subject's recovered, although the treatment for uveitis was not reported. The uveitis occurred in average of 3 days after vaccination in patients without other risk factors or disease that could cause uveitis. This could be consistent with immune complex deposition or nonspecific activation from vaccine adjuvants. Although there was a debate that uveitis occurred because of hepatitis B infection there was evidence that immune complex deposition diseases such as glomerulonephritis and cryoglobulinemia occurred during chronic hepatitis B infection. Furthermore it was possible the surface antigen of the vaccine and the hepatitis B antibodies of the immune response after vaccination formed  immune complexes which initiated the ocular response of uveitis.
Redness, warmth from injection site down to the wrist.  Patient did not feel well and went to the Dr.
pt recv vax 24JUN96 & 1JUL96 pt devel orchitis & fever;MD felt devel mumps;
I have been having headaches that been coming and going, they have funny patterns to them. They will last from ten days to fourteen days, I have a really bad cough that comes on at times, that is dry and very severe, it will cause the headaches to come on and I cannot stop the headaches from coming on. I went to my doctor to try and find out what is causing the coughing and headaches. He ordered an echocardiogram, stress test, bloodwork, MRI, chest x-ray. All tests came back normal, he did give me a prescription for an additional blood pressure medication to help keep my blood pressure normal as the coughing was raising my blood pressure.
pt recv vax 6JUN95 & exp a local rxn described as a welt the size of half dollar approx 5 mins p/vax; swelling, redness at site 30 min p vax;
Narrative: Per nursing note on 2/11: "Patient calling because he has a rash that appeared on his RUE/upper arm about 3 days after he received his 1stCOVID vaccine shot - patient stated that although vaccine note says he received shot in LUE- he said he received it in RUE. This reddened area started out about as big as a quarter. Since onset it has increased to about the size of a dollar. Patient said that it is not really "painful", but said that today it has been really burning. He said that it itches sometimes. He is aware of it with clothing touching it. Patient denied any other symptoms - no CP, no tightness/swelling of airways. Patient said he maintains ROM. He said that rash is red and there maybe some little bumps. "Per nursing note on 2/12: "Pt came to the clinic today for reaction to the Covid-19 vaccine on his left forearm. Pt reports he got the Covid-19 vaccine in the right arm on 1/26/21. He reports rash started five to six  days after as this size of a dime and keeps getting larger and spreading. Pt as area of redness on the right upper arm covering the bicept area. States "the rash burns" no drainage, no pain, minimal discomfort of burning rated at 1 on 0/10."
sore arm for 3 days at the site of injection; This is a spontaneous report from a contactable consumer. A 14-years-old male patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 21May2021 as single dose for COVID-19 immunisation. Medical history not reported. Concomitant medication included methylphenidate taken from 21May2021 to 23May2021. Past drug included that patient was received methylphenidate 36 mg tablets (PO, QD) for two years for ADHD without reported problems. On 21-May-2021, the patient received his first Pfizer COVID-19 vaccine. It was reported that the reporter had asked the patient physician about recommendations on interactions with methylphenidate and the COVID-19 vaccine and the physician had no information to provide to the reporter. Therefore, the patient held his methylphenidate doses starting 21-May-2021 to 23-May-2021. It was reported that patient only experienced a sore arm for 3 days at the site of injection. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Fatigue; Pain; This non-serious case was reported by a physician via call center representative and described the occurrence of fatigue in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced fatigue (Verbatim: Fatigue) and pain (Verbatim: Pain). The outcome of the fatigue and pain were unknown.   It was unknown if the reporter considered the fatigue and pain to be related to Shingrix.     It was unknown if the company considered the fatigue and pain to be related to Shingrix.   Additional Information: GSK receipt date: 23-Jun-2023 The medical physician informed that he received a dose of Shingrix 3 years ago and he had pain and fatigue, and for that reason he never got a second dose to complete the series.  No other information was provided to GlaxoSmithKline sales representative.  The reporter did not want to be contacted by GlaxoSmithKline. The reporter did not consent to follow-up.
PATIENT GOT VACCINE AND STARTED FEELING DIZZINESS AND VOMITING. PATIENT WAS HAVING DIFFICULTY BREATHING. CALLED 911 AND IN LESS THEN 5 MINUTES THEY ARRIVED. PATIENTS BP WAS 80/50 AND TOOK HER TO THE HOSPITAL
pt tested pos for COVID 19 on 10/18/21 and then was admitted on 10/21/21 for cough and dyspnea received oxygen, remdesivir and dexamethasone while in the hospital discharged on 10/23/21
Started on Friday morning with lower back pain, body aches, chills. Extreme pain in base of neck, down to shoulderblades. Treated with ibuprofen throught course of day. Extreme fatigue. Dry brushed in shower on back of thighs and buttocks.. Saturday morning, woke up with body rash, continued joint pain, body aches, no fever. Treated with ibuprofen until afternoon, Head discomfort. Saturday afternoon, switched to benadryl and tylenol, increase in chills, body aches and joint pain, swelling in extremeties. Slept for 14 hrs. Sunday morning, rash on hands, back- had spread further and struggling with mobility. Hard to move. Went to Urgent Care. Got  steroid shot and "some pills". Saw some improvements, continued with body aches and some rash and headache. By Tuesday morning, had not improved much so went to Family Practice. Stopped augmentin that she was on. Prescribed antihistamine, 8 days of steroids, only took antihistamine for 5 days. Rash had cleared by then. Returned to work on Wednesday 2-3-2021. Joints felt better.
Local symptoms : Pain -discomfort, General symptoms: Headaches, muscle pains, fatigue, nausea
No reactions until 12:30am when I awoke with severe chills/shaking and freezing.  Lasted about an hour.  Woke up every 2 hours.  Severe headache & muscle aches.  Took maximum dosage of ibuprofen and tylenol.  I was very tired the next 2 days.
Redness, pain, swelling. Seen in ER and though to be infection/possibly. Rx'd Augmentin.
Per mother, patient's legs began tingling, he began staggering, couldn't walk. He was taken to the ER and transferred to another ER. Hospitalized for transverse myelitis syndrome. Ongoing. Discharge summary states back pain. msv
expired dose of Twinrix was given to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 27-year-old male patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 01-JAN-2023) for prophylaxis.   On 07-JUN-2023, the patient received the 1st dose of Twinrix. On 07-JUN-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: expired dose of Twinrix was given to a patient). The outcome of the expired vaccine used 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 Information: GSK Receipt Date: 08-JUN-2023 A pharmacy operations manager called to report that an expired dose of Twinrix was given to a patient and wished to know how to proceed. Information about the event, vaccine and patient were provided. The vaccine administration facility is the same as primary reporter. The reporter consented to follow up. The patient received Twinrix beyond the expiration date, which led to expired vaccine used.
COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Psoriatic arthritis and Plaque psoriasis.    Concurrent medical conditions included Psoriasis and Psoriatic arthritis.   On 02-Sep-2021, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram every two weeks. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. In November 2021, the patient experienced COVID-19 (COVID). At the time of the report, COVID-19 (COVID) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medication was reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication was reported.  The reporter's causality for the event of COVID was not provided for Humira.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jan-2022: Significant Live follow up appended : updates to suspect drug information.
Body stiffened, sl TC movements, unresponsive, urinated in pants, episode lasted about 20 sec.
Patient presented to the ED and was subsequently hospitalized for Periprosthetic fracture around internal prosthetic left hip joint within 6 weeks of receiving COVID vaccination.
Approximately one week following inoculation, sore throat developed. Continued for another week.  Suspected strep. Presented to medical clinic, strep test negative, and final Dx thyroiditis/possible Hashimoto's Disease. Symptoms persisted for month and a half - thyroid gland and other nodes swollen, tender to touch, and extreme fatigue.
Information has been received from a physician concerning a male who's 5 year old son was vaccinated with VARIVAX (Oka/Merck) on an unspecified date.  Within 2 weeks, the child's father was diagnosed with shingles.  He was not immunocompromised prior to the outbreak.  At the time of reporting, the patient's outcome was unknown.  It was not specified if the patient sought medical attention.  There was no product quality complaint.  Additional information has been requested.
Rash on neck and clavicle bone; Diagonised with Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Diagonised with Shingles) and RASH (Rash on neck and clavicle bone) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced HERPES ZOSTER (Diagonised with Shingles). On an unknown date, the patient experienced RASH (Rash on neck and clavicle bone). At the time of the report, HERPES ZOSTER (Diagonised with Shingles) and RASH (Rash on neck and clavicle bone) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided. Treatment information includes Acyclovir but want to know before she takes it.
PT HOSPITALIZED  4/26/21 WITH COVID-19 AFTER BEING FULLY VACCINATED.  ACUTE ENCEPHALOPATHY DUE TO COVID-10.   TREATED WITH DEXAMETHASONE.  DISCHARGED FROM HOSPITAL, ON 4/29/21
Lower back pain with left side flank pain accompanied with left lower extremity weakness and foot drop, was diagnosed with transverse myelitis; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or around August 2013, the patient was vaccinated (inoculated) with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for routine health maintenance and for its intended purpose; the prevention of shingles (herpes zoster) (prophylaxis).Shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered lower back pain with left sided flank pain accompanied with left lower extremity weakness and foot drop. The patient was diagnosed with transverse myelitis (myelitis transverse). As a direct and proximate results of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations do not present prior to using zoster vaccine live (ZOSTAVAX). Also, experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. Also, the patient sustained severe and permanent personal injuries. Therefore, 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. Also, suffered and incurred damages, including medical expenses, the loss of accumulations, and other economic and non-economic damages.The outcome of the event was not recovered.  Upon internal review, the event myelitis transverse was considered to be medically significant and disability.
DEATH Narrative: Events surrounding patient's death are unknown- nothing is documented in medical record regarding event. Causality of death is unknown. This event is being reported due to the timing of the death in relation to the receipt of vaccine (4 days).
Systemic response of immune system and exacerbation of autoimmune symptoms. this included pain and burning in the legs to point of not being able to walk similar to multiple sclerosis flare up Seeing neurologist in March 2023 Changes in EKG for a PR interval seeing cardiologist in Jan 2023
Headache, Myalgia, malaise, stomach upset, sleeplessness, and night sweats Narrative:
High fever 103.7 with Tylenol 2.5 mg. Large painful swollen lump on leg.  Hospital visit for fever reduction.
Started at 430 am on the 13th of April, my stomach started hurting. It does not matter if or what I eat, it still hurts. I got headaches, those have also continued since the 13th.  The following week my mouth began to hurt, I started coughing more than normal. First a dry cough, now I'm coughing up phlegm with specks of blood. And I can not stop itching, and I'm getting tired of taking benadryl for it. I contacted my doctor, all I got was these are normal reactions to the vaccine. They last 2 to 4 weeks. I already get migraines, my gut is picky since that shot. I used to eat hot peppers, now if I use pepper on my dinner my stomach is in pain. These side effects should be gone by now. I am one pissed off person.
Had dose #1 at 1620 and started feeling itchy on her head and face about 1700. Face red. No difficulty breathing. Given 25 mg benadrly po. Observed and improved. Returned to clinical unit as a patient care tech about 1745.  At about 2200 she started having swelling in her face and lower lip and tingling in tongue and left upper and lower lip. Taken to ED in our Facility. Given benadrly 25 mg, famotidine 20mg, and prednisone 60 mg all PO x 1. No difficulty breathing, or swallowing, no wheezings or angioedema of mouth or throat. Sxs improved . diagnosed with allergic reaction. given instructions when to return. Given instructions for Benadryl and famotidine otc use. given script for prednisone 40mg x 5 doses.  DC at 12/19 /20 at 0144 to home.   12/21/20 1000 this rn called patient at home. She is doing much better with redness in her face and itching in her back and face. No swelling or rash.  Last had benadryl last night. has been taking multiple times a day for the itching. had famotidine x 1 on 12/19. She has not filled the script for prednisone.  I told her if she could tolerate itchiness tomorrow w/o use of benadryl she could work her 1600-2400 shift. I will discuss her taking covid vaccine #2 with Medical Director for Employee Health, Dr.
This is a spontaneous report from a contactable consumer. A 73-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), dose 2 via an unspecified route of administration, administered in right arm on 22Feb2021 14:15 as 2nd dose, single for covid-19 immunisation. Medical history included hyper/hypothyroid, cardiac arrhythmia. Concomitant medications included metoprolol; acetylsalicylic acid (ECOTRIN); atorvastatin (LIPITOR); levothyroxine sodium (SYNTHROID); cetirizine hydrochloride (ZYRTEC). The patient previously took codeine, compezine, sulfa medication, adhesives, all experienced allergies. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261) administered in right arm on 01Feb2021 14:15 for COVID-19 Immunization. On 31Mar2021 (20:00), the patient awakened by upper abdominal pain, rapid pulse, and sweating, experienced diarrhea. On 01Apr2021 the patient awakened with same symptoms, plus tachycardia, shortness of breath, clammy skin, lightheadedness, what felt like acid reflux/upper abdominal pain, and diarrhea. Upon walking, almost fainted. On 01Apr2021 17:00, the patient went to Urgent Care. She had abnormal bloodwork, rapid heart beat and shortness of breath/wheezing. EKG showed irregularities. Was told to proceed to the ER for more tests. On 01Apr2021 19:00, the patient went to Hospital. She completed ultrasound of abdomen, EKG, CT Scan, and other testing. Found evidence of cardiomegaly (1st time ever), elevated blood pressure, inflammation around the heart, liver, pancreas, and stomach. Also noted pulmonary edema. Told I could travel back to CA with compression socks and pain medication and Zofran. 05Apr2021, they ordered additional tests and referral to the Cardiologist. Still experiencing extreme fatigue. Events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received treatment (pain medication, zofran, referral to GI and cardio) for adverse event. There is no covid prior vaccination. The patient received covid tested post vaccination with Nasal Swab on 01Apr2021, result was negative. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has been tested for COVID-19. The outcome of the events was not resolved.
Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 05-MAR-2015, the patient was vaccinated at a clinic with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 16-MAR-2016, the patient was treated at a clinic for onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient was prescribed VALTREX for the management of his painful and persistent symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
This case was considered medically important. Information regarding Prevnar vaccine unspecified was received from an attorney who alleged that a male patient received a dose of Prevnar on an unspecified date and experienced meningitis. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. It is alleged that as a result of having not been given a dose of Prevnar during his doctor visit in March/May 2005, the patient developed meningitis (meningitis) (drug ineffective). The attorney noted that according to the CDC website, "there was a product shortage in 2004 and it said to decrease the number of doses given. "The patient's outcome is unknown. No additional information was available at the time of this report. OMIC. Case cancelled: Upon receipt of addiitonal information, it was discovered that the patient did not receive PREVNAR vaccine. This case was considered medically important.
Patient with longstanding bilateral tinnitus which worsened a few weeks following his second COVID vaccine. He has now found white noise and music to be helpful; however it is still present. He also notes some increased pressure to the right ear periodically
she is currently experiencing Headache and she took Tylenol for that; This is a spontaneous report from a Pfizer-sponsored program COVAX US support from a non-contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported. The patient got her first shot (COVID Vaccine) last Sunday and she is currently experiencing headache and she took Tylenol for that and she is asking if she could take probably an Ibuprofen or Aspirin instead because guessed the Tylenol is not working for her. She experienced headache after the first dose. The patient went to the Dentist and had some dental work then the patient wanted to take Advil and wanted to know when is it safe to take anti-inflammatory. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Site: Pain at Injection Site-Medium, Systemic: Pain/soreness from her shoulder to collar bone back down to her elbow.-Medium
Within 5 minutes patient with dizziness and fast heart rate (reported by patient as in the 80s). Patient also with worsening of her baseline essential tremor (R>L). No other signs of anaphylaxis or other symptoms. Vitals taken with BP 128/68, HR 68, RR 16. Patient observed for 30 minutes with no other side effects. Discarhge in stable condition with no medications administered.