chrisvoncsefalvay/vaers-outcomes huggingface dataset:
zoster related hearing loss; zoster related hearing loss; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant medications was provided. On or about 13-SEP-2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) as prescribed and/or administered by a pharmacist at a pharmacy for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a healthcare provider at an audiology center for zoster related hearing loss. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the events was considered to be not recovered. The reporter considered zoster related hearing loss to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of deafness was determined to be medically significant.
Possibly inadvertently injected with empty syringe with vaccine and Ml vanish point syringe
ITCHING, SWELLING, EDEMA, HOT  TREATED WITH SEPTRA DS FOR 14 DAYS
Patient is a 89 y.o. male admitted on 5/1/2021     Please refer to the History and Physical report for information on presentation. 89-year-old male with past medical history of CAD, recent cath done in January, known disease that is not amenable to intervention, hypertension, BPH, diabetes mellitus came to ED due to chest pain.  Patient had persistent chest pain despite nitroglycerin, however later reports relieved.  Troponin negative initially, however later trended up.  EKG unchanged.  Patient became asymptomatic during hospitalization.  Cardiologist Dr. evaluated patient, recommended no further management except for blood pressure control.  Blood pressure medications were adjusted.  Cardiologist said patient has known CAD, that is not amenable to any intervention.  He will have underlying some chest pain and troponin leak.  Patient needs to fllow up with cardiologist in the office.  He has known AV node block.  Sometimes heart rate went down to as low as 30.  Patient remained asymptomatic.  Lopressor dose was decreased from 50 mg to 25 mg daily.  Amlodipine dose increased.  Patient understands, and agrees for discharge.  Plan explained to family, wife present at bedside.  All the concerns were answered.
VACCINE GIVEN AT 8:07 AM; STATED HEART RATE WAS FAST; AT 8:19 AM.  ASSISTED TO EXAM TABLE TO LIE DOWN.  AT  8:20 AM, BP 138/78, PULSE 110/min, PULSE OX 99%, Temp 96*. ALERT + ORIENTED TO TIME, PLACE, PERSON, FULLY COHERENT. AT 8:30, PATIENT SITTING UP AT ABOUT 80*; BP 128/78, PULSE 88 bpm, PULSE OX 99%. TOLERATED JUICE + CRACKERS WITH NO PROBLEM. (CONTINUED) AT 8:40, BP 1263/76, Pulse 88 bpm, Pulse OX 99%, feels "better," PT also states, " I didn't eat anything This morning And I Think I was dehydrated." AT 8:45 , BP 124/78, Pulse 86 bpm, Pulse ox 99%,  ambulated to bathroom with steady gait. AT 8:55, BP 130/80, Pulse 88 bpm, pulse ox 99% PATIENT STATES   "I feel fine" Spouse arrived to drive patient home - patient agrees to call emergency for any further issues (allergic REACTIONS)
C/O dizziness approx an hour after nasal mist. Student also c/o hunger. Temp 97.9. No c/o SOB or difficulty breathing called mother to pick up student.
This spontaneous report as received from a physician and the patient's mother concerning a 3 year old female patient with delayed reactions and above average immune levels. The patient's medical history included unspecific reaction to PENTACYL. On 11-SEP-2013, the patient was vaccinated with M-M-R II dose 1 (dose route and lot number not reported). The physician stated that the patient was fine the day the MMR II was administered however within the next 24 hours. The patient's mother, reported that on 12-SEP-2013, her daughter experienced insomnia, as well as a stomachache (belly ache). The caller stated that her daughter generally sleeps 9-10 hours a night; however, after the M-M-R II dose, the child "wasn't hungry" and slept less than 7 hours that night. The mother stated that her daughter said that she "doesn't feel tired" and slept only short periods in the past 48 hours. The patient's mother informed that she herself has had reactions to drugs: drugs have "almost killed" her, and when she was in childbirth she was given PITOCIN and suffered hallucinations. As well, caller mentioned that her father died (unspecific death) after being on unspecified drugs. ON 12-SEP-2013 2 days after onset of therapy the patient experienced insomnia, the patient was generally "not feeling well" the child "wasn't hungry" and stomach ache. The outcome of insomnia, the patient was generally "not feeling well", and child "wasn't hungry" and stomachache was reported as not recovered/not resolved. ON 13-SEP-2013, the physician called in regard to the adverse event filed by the mother of the patient. The mother of the patient also stated that the patient was generally "not feeling well" since receiving M-M-R II dose 1. All time of reporting the patient had not recovered. This is one of several reports from the same source. No further information is available.
Extremely severe joint pain, particularly in my hands but also in knees, shoulder, elbows.  Very bad headaches.  Severe fatigue by mid-day.  Unable to sleep.
Stated itching on right side of neck, shoulder and back at 5:00 PM. It then moved quickly to full body. Took 50mgs of Benadryl. On 3/26/2013, took another 50mgs of Benadryl, this time it didn't work. Hives started on both sides of neck under ears. Called doctor at 10 AM and got 6mgs of Decadron. Helped itching a little bit and hives went away. Went to the Emergency Room at 4 AM 3/27/2013 because of itching on the tongue in addition to itching head to toe. Was administered DexaMETHAsone Phos inj at 20mgs. Was prescribed Pepcid and Prelone and am to take both twice a day for 5 days. Was told to go to doctor if not better by 3/28/2013 or 3/29/2013.
This spontaneous report was received from a registered nurse refers to unspecified patients of unknown age and gender. Concurrent conditions, medical history and concomitant medications were not reported. The reporter stated that, the patients were vaccinated with improperly stored doses (temperature excursion: 48.7 F, time frame: 3 hours) of PNEUMOVAX 23 with lot/batch # L014420, expiry date 23-FEB-2017 (dose, dose number, vaccination site and route of administration not provided) since 02-FEB-2016. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of two reports from the same reporter. Additional information has been requested.
On the light rail went into seizure a few hours after receiving MMR-actually felt this one coming on. My last seizure was last year in November. "My elbows and neck are injured as a rash" took a while"" ER I don't know how I got there.
Approximately 40 minutes after flu shot c/o feeling warm head tightness around entire head and dizziness. Nausea radiated into mid chest area and throat. Belching with acid reflux denied Hx of Acid Reflux. 10/10/14 appt cx per pt. "Working today and feel fine."
Area of induration, with surrounding red rash. Prescribed mupirocin ointment and steroid.
Loss of lower extremity strength, cervical spinal cord inflammation, possible myelitis.  5/16/08 Reviewed hospital medical records for 4/16-4/21/2008. FINAL DX: myelitis transverse Records reveal patient experienced bilateral leg weakness as noted from transferring hospital.  Continued IV steroids & then tapering oral steroids.  Improved & D/C to home f/neuro f/u & continued outpatient PT.   4/29/08 Reviewed hospital medical records for 4/14-4/16/2008. FINAL DX: lower paraplegia; lower cervical intramedullary swelling. Records reveal patient experienced falls w/o being able to get up x 4 days.  Was able to crawl.  Seen by PCP who suspected left knee injury.  Referred to ortho who suspected hip injury.  Was to f/u next week but no improvement & was unable to stand.  Noted to have bloody stool & returned to PCP.  Referred to neuro who admitted.  On exam, good strength in UEs & flaccid LEs.  Areflexic & sensation decreased.  Anal sphincter tone & reflex weak.  CT scan of spine revealed edema from C3 through T1.  Tx w/high dose steroids.  Transferred to higher level of care.
Severe chills with chattering teeth and high fever and very sore arm. Treatment was Motrin.
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Stroke-Severe, Additional Details: Patients husband came in to report patient had stroke about a week after getting covid booster and first shingrix shot and was hospitalized for a week
The patient was given the first dose of Pfizer COVID-19 vaccine and was instructed to wait in the waiting area for 15 minutes.  After waiting for about 15 minutes, he tried to exit the waiting area, but ended up collapsing.  When I went out to examine him, his eyes were open and he was breathing normally, but he was not immediately responsive.  I had to ask him if he was OK several times before I was able to get an answer.  He appeared to be disoriented, but otherwise appeared fine.  My technician helped him to a chair.  He was coming in and out of non-responsive/limp state several times before he asked us for a glass of water.  I had contacted 911.  They came in and examined him.  One of the paramedics told me that he appeared to be fine, but they were going to take him to ER.  The patient walked to the stretcher outside the pharmacy.
in bed for 3 days; throwing up; diarrhea; horrible headache; trouble sleeping with the sound; tinnitus,some days worse than others,hissing sound; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (in bed for 3 days), VOMITING (throwing up), DIARRHOEA (diarrhea), HEADACHE (horrible headache) and TINNITUS (tinnitus,some days worse than others,hissing sound) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Blood pressure high. Concomitant products included SALBUTAMOL SULFATE (INHALERIN) for Asthma, LOVASTATIN for Cholesterol.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced TINNITUS (tinnitus,some days worse than others,hissing sound). On an unknown date, the patient experienced MOBILITY DECREASED (in bed for 3 days), VOMITING (throwing up), DIARRHOEA (diarrhea), HEADACHE (horrible headache) and INSOMNIA (trouble sleeping with the sound). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency and LORATADINE (CLARITINE) for Tinnitus, at an unspecified dose and frequency. At the time of the report, MOBILITY DECREASED (in bed for 3 days), VOMITING (throwing up), DIARRHOEA (diarrhea), HEADACHE (horrible headache), TINNITUS (tinnitus,some days worse than others,hissing sound) and INSOMNIA (trouble sleeping with the sound) outcome was unknown.            Patient taking blood pressure pill as concomitant. Patient was on nose spray for tinnitus.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2022: Non Significant Follow-up received
Pt claims that she had hives 2 hours after the flu shot from left back shoulder to her left arm (elbow). Pt said she took 2 (BENADRYL 25 mg) 2 hours ago (7:00 PM 10/9/09) and she already feels better and she thinks it was an allergy. Pt said no spread of rashes anymore and sore injected area but it is getting better by taking BENADRYL. She had flu shot with the same manufacturer with no adverse effects.
Developed red streaking from vaccine site to axilla, Consistent with secondary cellulitis & lymphangitis
This spontaneous report as received from a healthcare student refers to a patient of unknown age and gender. On 01-OCT-2014 the patient was vaccinated with an expired dose of (Oka/Merck) VARIVAX (dose, route and lot # were not provided, expiration date : 10-SEP-2014). No adverse effect reported. Additional information has been requested.
Arm swollen, fingers tinkling, sharp pain in top of back across shoulders, (9 on a 1-10 scale). Fatigue where patient cannot stay awake, chills, 103 fever, cannot eat as stomach upset
No Adverse event noted at time of administration. Patient was given 2 doses of Pfizer vaccine during 7/23/2021 visit at approx. 7:45am . Patient did not suffer any ill effect at time of visit and up to an hour after administration.
ANAPHYLAXIS,,,,,,NAUSEA , VOMITING, THROAT TICKLING
Fever of 105 converted to oral from apical; fever reduced w/APAP @ hosp; had febrile sz; thought pt had concurrent ear infect contributing to fever;
Expired vaccine used; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 57-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-2021 at 9:26 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 26-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 26-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication were reported.
Pt was observed post Covid-19 immunization for 15 minutes .  During the observation period, she experienced an adverse reaction with the following symptoms:  tingling on L scalp, L Face, L tongue, L arm and L hand. She gave this information to observation nurse after 15 minutes of waiting after getting vaccinated. Pt informed this nurse that she had a migraine before coming in to get vaccinated and the symptoms that were presenting to patient (tingling) usually accompanied her migraines.  Pt was taken to an area to be assessed by paramedics. Pt was able to swallow water without difficulty. Per Paramedics, pt is okay to be discharged home.  Pt states her tingling in her tongue has gone away but she still has tingling in her L scalp, L hand, L arm.  Pt is alert and oriented at discharge and notified to call 911 if symptoms worsened. Pt verbalized understanding of instructions and husband was driving her home today. Pt stated she would take a benadryl at home after being offered benadryl at vaccination site.   VS: 140/76, 64hr, 100%02. 123/67, 58hr, 100%02     Assessment : Time of assessment 1548. Alert and oriented.   Actions taken:  Vitals sign taken  VAERS form completed     Medications administered: No medication administered.   Disposition: Reports no further symptoms of adverse reaction after observation for 15 minutes. Discharged home. Instructed to follow up with PCP  for evaluation for second dose. Instructed to call 911 for trouble breathing, rapid heart rate, dizziness, swelling of tongue or throat.
At 0803 employee complained of his throat tightening and he was placed on an AED and EMS was called and a non-rebreather and Anaphylaxis kit were brought 0805 HR 118 RR 22 employee breathing was not labored AED "no shock advised" employee now reporting centralized tight feeling chest pain 0807 HR 122 RR 20 employee breathing was not labored. AED "no shock advised" 0809 HR 118 RR 22 AED "no shock advised" 0811 HR 102 RR 18 employee breathing was not labored. AED "no shock advised" Employee reported Chest pain "less tight" still with dry mouth ,difficulty swallowing and now burning sensation in throat 0811 HR 104 RR 18  AED "no shock advised" employee breathing was not labored 0813 EMS arrived and care of employee handed over. 02 and pharmacy monitoring applied. They assessed and took  patient to ED Received Solu-Medrol, Pepcid, and Benadryl in ED
Diarrhea; Hives all up and down arms and hands, a few on legs; Itched head to toe; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 06Apr2021 at 14:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included polycystic ovarian syndrome, obesity, raynaud's syndrome and known allergy to sulfa drugs. Concomitant medications included escitalopram oxalate (LEXAPRO), colecalciferol (VITAMIN D3), ascorbic acid (VITAMIN C), silybum marianum (MILK THISTLE) and krill oil (KRILLA); all from unknown dates for unknown indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 20:00, 6 hours post vaccination, the patient experienced hives all up and down arms and hands, a few on legs and itched head to toe. On 07Apr2021 at 10:00, 20 hours post vaccination, the patient experienced diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events hives all up and down arms and hands, a few on legs, itched head to toe and diarrhea was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
REDNESS AT INJECTION SITE; LUMP AT INJECTION SITE; PAIN AT INJECTION SITE; This spontaneous report received from a patient concerned a 37 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug or non drug allergy.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, and batch number: 1805029 expiry: 14-MAR-2021) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced redness at injection site. On 11-MAR-2021, the subject experienced lump at injection site. On 11-MAR-2021, the subject experienced pain at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain at injection site, redness at injection site, and lump at injection site. This report was non-serious.
She received her vaccine, went to the restroom to urinate, and upon attempting to return to the exam room, fainted in the hallway.
Patient presented to the emergency room on 1/4/2022 with cough and fatigue that started approximately 10 days ago. She was found to be COVID-19 positive and was started on dexamethasone. Patient was discharged home on 1/5/2022.
Narrative:  Patient was hospitalized with severe COVID-19 infection in early December 2020 and is currently in rehab d/t dizziness while ambulating. No reports of ADR from first dose of vaccine noted, but with second dose, patient complained of chills and rigors. Symptoms:  & Chills/Rigors Treatment:
This spontaneous report was received from an office manager refers to an unspecified number of patients of unknown demographics. On an unknown date the patients were vaccinated with VAQTA (lot#, expiration date and route not reported) that underwent unsupported temperature excursions and no adverse effects reported. No adverse effects reported. This is one of the several reports from the same source. Additional information has been requested.
Admitted after missing dialysis, reporting weakness in early June 2021.  Guillian-Barre syndrome identified during admission.  Currently admitted and receiving IVIG and plasmapheresis.  Pt also with CMV colitis and hypotensive
Immediate massive fatigue, lightheaded, chills, higher than my normal blood pressure. I lied down at the facility for one hour. Fever, severe headache, 6 hours later, diarrhea and vomited. 24 hours after vaccine, extreme fatigue, fever, smaller headache.
This spontaneous report was received from a Registered Nurse concerning a 15 month old patient of unknown gender. On 08-OCT-2013, the patient ws vaccinated with a dose of VARIVAX (Merck), 0.5 ml, subcutaneous in an arm. Other suspect therapies included a dose of PROQUAD (Merck), 0.5 ml in a separate arm. The outcome of the events was unknown. Additional information has been requested.
In addition to major pain in left arm (shot arm), overall sick feeling, lethargy, couldn't read anything without head pain. Worsened, so went to lie down, whole-body chills every few minutes; sharp, sudden, intense stabbing pains in head, as if a sharp large knife was jammed into my head, at left temple, and behind my right lower ear - super intense pain, repeatedly. Occasional shortness of breath and difficulty breathing. All Sunday day and night. Since I couldn't even fall asleep due to the sharp, sudden stabs of pain, I tried a naproxen (Aleve).  By Monday, the sudden sharp stabs in Head had lessened, (less frequent, and not as painful), and a deeper, constant headache filled the whole left side of my head.  Whole left arm still very painful, and super sensitive to touch.  Deep, sometimes throbbing, constant headache on left side, arm pain, and occasional difficulty breathing continue this whole week. (Today, Saturday, is Day 8 from first vaccine shot.  ). Still.  Also note: I have no smell or taste, since Jan.1,2021.
Fever 100.4 followed by uncontrollable full body tremors lasting 30 minutes.