chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Soreness in the injected arm; Very tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in the injected arm) and FATIGUE (Very tired) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia. Concomitant products included AMLODIPINE BESILATE (AMLODIPINE BESYLATE) for Blood pressure high, EZETIMIBE for Cholesterol high, LEVOTHYROXINE, PANTOPRAZOLE, VITAMIN D NOS and VITAMIN B COMPLEX (VITAMIN B-COMPLEX [VITAMIN B COMPLEX]) for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (Soreness in the injected arm) and FATIGUE (Very tired). On 21-Feb-2021, PAIN IN EXTREMITY (Soreness in the injected arm) and FATIGUE (Very tired) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment information was unknown.   This case was linked to MOD-2021-250515 (Patient Link).
Hospitalized 12/31/2021; COVID-19 12/31/2021; fully vaccinated  Discharge Physician: MD, MPH Primary Care Physician: MD   Date of Admission: 12/31/2021 Discharge Date: 1/3/2022 Room Number:  DETAILS OF HOSPITAL STAY:   PRESENTING PROBLEM: Weakness [R53.1] Acute cystitis without hematuria [N30.00] Complicated UTI (urinary tract infection) [N39.0]   HOSPITAL COURSE: 42-year-old female past medical history anxiety disorder, cavernous hemangioma of brain, neurogenic bladder, seizure disorder presents with progressive worsening dizziness.  UA positive for which blood cultures and IV antibiotics were initiated.  Patient afebrile with no leukocytosis or lactic acidosis did not meet sepsis criteria.  Hospitalist service consulted for admission further evaluation.   In the emergency department initial vital signs hypotensive.  Patient was initiated on IV fluid resuscitation and CT angiogram obtained with no evidence of acute abnormality.  Patient was continued on IV fluids and IV antibiotics.  Bladder scans and p.r.n. nursing straight cath were continued.  Patient had increased lethargy and confusion for which code stroke was activated.  CT head, CT P, CTA head and neck were negative.  Case was discussed with on-call stroke neurologist who advised multifactorial encephalopathy less likely CVA with no further neuro workup indicated.  Patient with chronic dysphagia was evaluated by SLP who advised dietary modifications.  Given that patient COVID-19 positive with no evidence of hypoxia and numerous comorbidities monoclonal antibody infusion clinic was contacted.  Patient provided fact sheet and discussed risks and benefits of medical antibodies which patient ultimately declined.  She was also unable to be evaluated with esophagram and VFSS while under COVID isolation. She continued to have significantly positive orthostatic vital signs in seated as well as standing positions.  She was initiated on midodrine and Florinef therapies with improvement of blood pressures, improved dizziness. 2D TTE Limited without significant abnormalities. PT/OT evaluated patient and advised home with assist and outpatient therapy services PT/OT. Patient clinically improved and hemodynamically stable for discharge. Urine cultures with E coli and E faecalis both sensitive to ampicillin. She was transitioned from IV to PO Augmentin without any side effect. She will complete 5 additional days of antibiotics. Discussed plan of care discharge with patient including outpatient follow-up PCP within 7 days.  He was recommended to patient follow-up outpatient Neurology and neuropsychiatry for further evaluation.  He was also advised patient follow-up outpatient psychiatry to review medications as they may be contributing to orthostatic hypotension.  She was also advised to continue outpatient GI and SLP evaluations for ongoing dysphagia. Patient voiced understanding was agreeable with plan of care discharge
It was reported that a 55 year old female patient received a Fluzone SV vaccination on 11/28/2000. Reportedly that same day, the patient complained of a rash on her neck and torso. Further information is requested.
Sore throat, severe abdominal cramps with profuse sweating, later changed to stuffy nose, runny eyes and headache at about 8pm.  Red eyes with discharge at morning 9/25/10 plus continued headache.
Devel abscesses 11SEP91 in both groins, p/immun; there had been no site rxn in the thighs; inginal nodes appeared 12 days later;
Pt reports development of hives on bilateral hands, chest and leg. Denies other contact. No prior reaction to vaccinations.
This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis. On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and meningitis (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and meningitis were unknown. It was unknown if the reporter considered the vaccination failure and meningitis to be related to Meningococcal B vaccine. Additional information was reported as follows: This case reported by the reporter's sister. The age at vaccination was not reported. The patient was fully vaccinated with Meningococcal B vaccine contracted this twice and the vaccines kill. This case was considered as suspected vaccination failure case since the details regarding laboratory confirmation and time to onset for target disease were unknown at the time of reporting.
faint; Dizziness; Nauseous; diarrhea; Tight throat; This is a spontaneous report from a contactable consumer reporting for herself. A 47-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Apr2021 17:15 (lot number Ew0161) on left arm at single dose for COVID-19 immunization. Medical history included Meningitis. Concomitant medications included unspecified birth control medication. The patient experienced dizziness, faint, nauseous, diarrhea and tight throat, all on 14Apr2021 17:15. All events were resulted in Emergency Room Visit. No treatment was received for the events.  Lab data included Blood Test on 22Dec2020 with unknown results. The outcome of the events were resolving.
This spontaneous report was received from a registered nurse refers to unspecified number of patients of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date unspecified number of patients were vaccinated with improperly stored VAQTA (Lot #, dosage regimen were not reported). No adverse effects were noted. This is one of the several reports received from the same reporter. Additional information has been requested.
pt brought to ED with lethargy, and agitation, unable to walk for past 3 days, usually ambulates with walker at home; positive for COVID; AKI; metabolic encephalopathy; required increasing O2; AHRF secondary to COVID pneumonia; steroids and baricitinib; IV nutrition and NG tube; DNR; pt's condition and he passed away in the hospital
While waiting 15 minutes following vaccination the patient experienced tingling in her left arm that descended to her fingers and travelled to her face.  She stated it felt like she bumped her elbow.  Patient stated she had no trouble breathing.  She later developed hives (within a couple hours), but they spontaneously resolved.
Appendicitis occurrence on 9/3/21, appendectomy on 9/4/21.  Symptoms were extreme pain on my lower right abdominal area, sudden onset that day, got worse as the evening progressed.  Surgery the next morning to remove appendix.
developed an itchy trunk; rash radiated to arms; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported for a 74-year-old male patient that received first dose of BNT162B2 (BNT162B2, Pfizer-BioNTech Covid-19 Vaccine), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for Covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced/developed an itchy trunk and then rash radiated to arms on an unspecified date with outcome of unknown. She wants to know if he can receive the second dose of the vaccine in a retail setting. The pharmacist reported that "is itchiness of the trunk and arms a contraindication to the vaccine?"  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Localized swelling and soreness at injection site. Headache began at noon on Sunday, aches and fever began around 4pm Sunday. Discovered purple ring around injection site around 5pm and redness extending through shoulder and bicep. Took TYLENOL. Sunday evening and morning was experiencing numbness in my fingertips and left hand. Stiff/swollen/sore shoulder, stiff elbow, stiff hands, and headache continue as of 11/5/2018 8:45am.
Blurred vision, weak legs, shaky feeling, chills only lasted on the afternoon after getting flu shot (24 hours later) and was gone by next day.
Leg pain and vaccine local reaction. Recommendations given include: warm compress and clean area well TID. Pt's mother was advised to call the office if there is no improvement or if new or worsening symptoms develop. Doctor prescribed TYLENOL, Childrens of pain.
Friday, Oct. 29 in the pm, I started feeling tired until Sunday early afternoon and then I felt fine.  On Monday around 4 p.m. I started feeling tired, my ears started to hurt .  I started to have a severe cough on Monday night.  I saw a physician's assistant to verify that I did not have an ear infection or any other infection.  She did not see anything.  I had severe coughing since and had to "sleep" in a totally upright position to get any rest for about a week.  I developed a hoarse throat around Saturday, November 6 and have been hoarse and coughing since.   Treated with Allegra, Ventolin inhaler, guaifensin with codeine, Flonase.  Mucinex started on 11/6 or 7 along with Ventolin inhaler.
Slight headache; Slight malaise; This is a spontaneous report received from a contactable consumer (patient himself) in response to the non-HCP letter sent reported that a 69-years old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EN8727 and expiration date: unknown), via Intramuscularly on 17Mar2021 14:00 (at the age of 69 years old) at Left shoulder as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Previously the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EL6200 and expiration date: unknown), via Intramuscularly on 24Feb2021 14:00 at Right shoulder as a single dose for COVID-19 immunisation. The patient has not taken any vaccines prior 4 weeks of vaccination. On 18Mar2021 at 06:00, the patient experienced Slight headache and slight malaise. The reporter considered the events as non-serious and no treatment was received. The outcome of the events was recovered on 19Mar2021. AE was milder than an average flu shot for me. My wife had no AE at all with either dose.  No follow-up attempts are needed. No further information is expected.
have now leg//knee problems; have now leg//knee problems.knee pain; drag right leg in home, and they fell like rubber as hard standing; in bed is worse as hard to get into position to get asleep; This is a spontaneous report from a contactable consumer (Patient). A 82-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), dose 2 via an unspecified route of administration on an unspecified date in Mar2021 (Batch/Lot number was not reported) as dose 2, single and dose 1 via an unspecified route of administration on an unspecified date in Feb2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, patient have leg, knee problems. Some times patient drag right leg in home, and they felt like rubber as hard standing. In bed it was worse as hard to get into position to get asleep for knee pain. Patient can not see a doctor as they only will talk on phone so this is hard. The outcome of events was unknown.  Information about lot/batch number is requested.
This spontaneous report as received from a nurse refers to the unspecified number of patients of unknown ages (reported as "about 5 patients but nurse could not be sure of exact number of patients"). On 16-OCT-2014, the nurse reported temperature excursion inquiry only and no adverse event was reported. On 06-JAN-2015, the nurse reported second temperature excursion for VARIVAX (Merck) doses and reported that improperly stored VARIVAX (Merck) (strength and lot# unknown, 0.5 ml, subcutaneous) doses had been administered to patients on unspecified dates since initial report of temperature excursion. Additional information has been requested.
Child received 0.5 cc of  pediatric Moderna vaccine that was labelled as a "single-dose vial" but should have received 0.25 cc
Started with full body sweats and dizziness, lost peripheral vision, extreme tinnitus but what I could hear was muffled like I had a pillow over my head. Almost lost consciousness. First to subside was the dizziness and loss of peripheral vision, muffled hearing after, tinnitus subsided around the same time of the body sweats. Only lasted 5 minutes, but was followed by a less extreme version of all the same symptoms an hour to two hours later. No episodes since.
Patient reported history of vasovagal response to 2020 COVID dose - mother was present on 10/6 for flu vaccination just in case.  RPH advised to lay down for vaccine -patient and mother refused this advisement since she had not had any issue with a flu shot in the past.  Approximately 30 seconds after vaccine, patinet reported "feeling it coming" and was lightheaded, sweating, and fainted for about 30 seconds.  When she came to, she was confused, sweating, BP 120/84.  Campus EMS was called at mother's request, patient observed & went home with mother about 30 min later.
Immediately following vaccinations patient felt dizzy. She lied to a flat position on the exam table. It took 2 to 5 minutes for patient to start to feel better. BP 95/58. She then sat up and her BP was 100/59. She then stood to her feet and walked a few steps, BP 98/58. Took a few more steps and drank some water, BP 99/84. Patient stated she felt better and was able to walk to car, and I followed her.
It's been too long since it happened and too much has gone on. My son died, my family members have died. The heart stuff has been happening for several months that's all I can tell you, and it's just not getting better. If you want all the information then go back to my little check-ins there from my phone that you send me. My heart rate is high, my numbers are just disturbing. I cannot get enough air. I wouldn't even know, I don't even know if it is vaccine related. It is hard to differentiate where it got worse. I had went to the heart DR on the 14th of Sept and he told me to go to the ER for tests but I cannot go to the ER I have too high of a deductible, I cannot afford that. Well I did, I went to the ER and they admitted me there.
A non-serious, spontaneous report of administered expired FLUMIST was received from a other health professional concerning a 31-year-old female. Neither medical history nor concomitant medications were provided. The product expired on 12-Dec-2010. On 13-Dec-2010, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information was received on 14-Feb-2011: Reporter confirmed that there was no late occurrence of adverse events.
mom called 24hr p/vax c/o elevated temp noc @ 1AM of 105;mom cont to alternate APAP & Motrin;@ time of call today temp was 103 but climbing;sent to ER
Couldn't get out the bed; Severe joint and muscle are aching; Severe joint and muscle are aching; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (Couldn't get out the bed), ARTHRALGIA (Severe joint and muscle are aching) and MYALGIA (Severe joint and muscle are aching) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GAIT INABILITY (Couldn't get out the bed), ARTHRALGIA (Severe joint and muscle are aching) and MYALGIA (Severe joint and muscle are aching). At the time of the report, GAIT INABILITY (Couldn't get out the bed), ARTHRALGIA (Severe joint and muscle are aching) and MYALGIA (Severe joint and muscle are aching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment was reported for the events.
Dose #1 Dec 11, 2020, got dose #2 until 8/26/2021; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 11th December 2020).   On 26th August 2021, the patient received the 2nd dose of Shingrix. On 26th August 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The patient was the reporter.  The age at vaccination was not reported. The patient received 2nd dose of Shingrix, 8 months 2 weeks after the 1st dose, which led to lengthening of vaccination schedule. The patient reported that due to circumstances his/her 2nd dose was late and enquired would this be effective given that was longer window between doses than was recommended. The patient asked to forward the email with package insert and asked for transcript.
This is a spontaneous report from a contactable consumer (patient) received via Pfizer sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER CVOID-19 VACCINE), via an unspecified route of administration on 10Jun2021 07:15 (Lot Number: EW0175) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced soreness arm on 10Jun2021 and enquired if she could take acetaminophen (TYLENOL). The outcome of the event was unknown.
Pt was given vaccine 3pm on 4/24/07. The next day leg was warm to touch and red. Mom brought pt in our office on 4/26/07. Diagnosed with cellulitis (L) upper thigh app-3 inch in diameter pt treated with Keflex.
Excruciating pain to right arm and severe right axillary lymphadenopathy; treatment is supportive, outcome to be determined.
This case was reported by an employee of a healthcare facility via a sales representative and described the occurrence of injection site redness in a subject of unspecified age and gender who was vaccinated with KINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of KINRIX (unknown). At an unspecified time after vaccination with KINRIX, the subject experienced injection site redness and swelling injection site. At the time of reporting the outcome of the events was unspecified. The sales representative had limited information. The sales representative was told that the adverse events were noticed with three separate subjects on different dates. The injections were given by different nurses. Please see A0877778A and A0877779A for the two additional reports of injection site redness and swelling injection site.
patient inadvertently received a dose of expired Twinrix.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 50-year-old male patient who received HAB (Twinrix) (batch number 2KE55, expiry date 22-SEP-2023) for prophylaxis.   On 20-OCT-2023, the patient received Twinrix. On 20-OCT-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: patient inadvertently received a dose of expired Twinrix.). 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: 24-OCT-2023 The pharmacist reported that the patient inadvertently received a dose of expired Twinrix which led to expired vaccine used. The reporter consented to follow up.
broken tooth; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program Support. A 67-years-old male patient received bnt162b2 (COMIRNATY), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient previously received first dose of bnt162b2 on an unspecified date for covid-19 immunisation. The patient experienced broken tooth in 2021 and had a dental implant today (06Oct2021). Outcome of event was unknown. The patient was prescribed with "Afrin for his right nostril because his dental implant was on the upper right side"; prescribed with Chlorhexidine mouth wash. The patient was scheduled for his booster or third dose of the Pfizer COVID-19 vaccine tomorrow and wanted to know if there would be an interaction with Afrin and Chlorhexidine mouth was with the vaccine. The patient was also prescribed with Naproxen Sodium 550mg 1 tablet every 12 hours as pain medication, and Cephalexin 500mg 1 capsule every 6 hours as antibiotic.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.
experienced a high fever (103.6 degrees Fahrenheit) for 6 hours; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as dose 2, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as dose 1, single dose for COVID-19 immunization. On an unspecified date, within 24 hours of receiving the second COVID vaccine dose, the patient experienced a high fever (103.6 degrees Fahrenheit) for 6 hours. Event took place after use of product. The patient underwent lab test and procedure include Body temperature with 103.6 degrees Fahrenheit for 6 hours. Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Received H1N1 12/11/09. States severe arm dysfunction beginning 2-3 days after injection. Arm totally useless for ADL, work. Pain in upper and lower arm without finger dysfunction.