chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This medically confirmed spontaneous report (initial receipt 26-Aug-2015) concerns a 63 year-old female patient who had no history of bleeding and was not on any blood thinning medications. On 26-Aug-2015 at 11:00 AM, the patient received AFLURIA (batch number U54806) 0.5mL via the intramuscular route on the right deltoid/arm. AFLURIA was stored correctly. On 26-Aug-2015 at 11:00 am, the patient experienced profuse bleeding at the injection site after the AFLURIA was administered and the PFS was pulled out of the right deltoid. Some blood spilled onto the floor. After the bandage was placed onto the injections site on the right arm (site of injection) started to swell and became swollen. Patient then became nauseated. Ice pack was placed onto the swollen arm for fifteen minutes and the patient rested for the duration until the swelling subsided. The bleeding discontinued upon bandage placement. The outcome was recovered on 26-Aug-2015. Reporter's comments: The reporter insisted that the vaccine was administered properly into the muscle.
Information has been received from an approximately 50 year old female with acquired immunodeficiency syndrome (AIDS) and codeine allergy. In 2017 (reported as "sometime last year"), the patient was vaccinated with ZOSTAVAX (lot number, dosage and route of administration not provided) for the prevention of shingles. ZOSTAVAX had been reconstituted with sterile diluent (lot number not provided). The patient reported she was administered the ZOSTAVAX at a pharmacy when she had "full blown AIDs." On an unknown date in 2017 (reported as "sometime last year"), the patient broke out in lesions which covered her entire body. The patient sought medical attention and was admitted to a hospital (length of stay unspecified) and was given unspecified treatment. She was reported to have been "at death's door." A biopsy of the lesions determined the lesions to be chickenpox. The outcome of the chickenpox was reported as recovered. The patient was requesting compensation for her pain and suffering. Chickenpox was considered to be life-threatening. Additional information is not expected.
Patient fainted 5 minutes after receiving the vaccine.  Laid down with her legs up.  She drank a bottle of water and felt better.
Fifteen minutes after leaving  I was experiencing dizziness. During the night while trying to fall asleep I was hallucinating like someone was in my room but no one was there. The next day I felt like I had the flu, and just arm pain. Following days I felt tired and had a headache on the top of my head ranging from a seven to a ten in pain. I tried Tylenol but no help because body rejected it. I tried Excedrin migraine for headaches but still no let up. I am still experiencing headaches and Fatigue.
Fever over 100F Severe headache  Fatigue  Body aches  Dizziness brain fog  Impatience  Onset - Approximately 4 hours after 2nd dose. Getting worse over the next 12 hours then persisting for the next 36 hours.  Headache is less severe and fever has reduced now that its 48 hours past.  Still not feeling well. Dizziness, brain fog, fatigue, Body aches and mild headache persists.
This spontaneous report was received from a 64 years old female reporting on herself with no pertinent medical history, drug reactions or allergies. The patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported) on 29-OCT-2012. No other co-suspects were reported. Concomitant medications included BENADRYL and prednisone (manufacturer unknown). The consumer stated that since 30-OCT-2012, she had experience a rash that covered different parts of her body at different times but had since spread all over her body. She stated that they would cover an entire portion of her body at a time then move to a different part of her body. She stated that since the rash had gone away, she had also experienced difficulty breathing starting on 04-NOV-2012. She stated that the effects caused her to stay home for about a week. Unspecified treatment was given for the events. The patient sought unspecified medical attention and no lab diagnostic tests were performed. The patient received unspecified treatment for the event. The outcome of difficulty breathing was reported as recovering. The relatedness for the reported events was not provided for ZOSTAVAX. The reporter considered the events to be disabling. Additional information is not expected.
48 hours later, I know have a rash all over my body and breaking into hives.; 48 hours later, I know have a rash all over my body and breaking into hives.; 4 hours after getting the vaccine, I started to feel nauseous; Dizzy; Horrible migraine; Can't move out of bed. I felt like that for two days.; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 09Apr2021 at 13:30 (at the age of 21-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy and sulfonamide allergy (sulfa). The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine.  The patient previously took erythromycin (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19Mar2021 at 13:30 (at the age of 21-year-old) as a single dose for COVID-19 immunisation. 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 09Apr2021 at 17:30, 4 hours after getting the vaccine, the patient felt nauseous, dizzy, horrible migraine and "can't move out of bed". The patient felt like that for two days. On 11Apr2021, 48 hours after vaccination, the patient experienced rash all over body and breaking into hives. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown whether therapeutic measures were taken as a result of the events. The clinical outcome of the events feeling nauseous, dizzy, horrible migraine, can't move out of bed, rash all over body and breaking into hives was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Dec2021 at 13:00 as dose 3 (booster), single (Lot number: FJ1620) at the age of 47 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing); "heart disease" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN, start date: 04May2010; CELEXA [CELECOXIB], start date: 04May2010; AMLODIPINE, start date: 04May2010; VICTOZA, start date: 04May2010; ISOSORBIDE MONONITRATE, start date: 04May2010. Past drug history included: Lisinopril, reaction(s): "Known allergies: Lisinopril"; Morphine, reaction(s): "Known allergies: morphine"; Fentanyl, reaction(s): "Known allergies: fentanyl". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events Covid 19 and Drug ineffective and suspect BNT162B2 cannot be excluded.
Please see physician records; acute onset of headache, dizziness, general malaise followed by acute bilateral upper extremity paresthesias (numbness and tingling, mild component of weakness).  Symptoms listed first were gone within 48 hours of the vaccine administration time.  However, upper extremity paresthesias persisted- very intense for about 1-2 weeks with a gradual decrease in symptoms at 2-3 weeks and minimal symptoms after 3-4 weeks and nearly complete resolution of symptoms about 5-6 weeks later. Also caused anxiety and depression, secondary to symptoms.
Five minutes after 1st dose patient had SOB, left after 30 minutes observation with SOB and back pain. She did not report symptoms. at 10pm that night, she had wheezing, noticed a red rash on left arm and chest. Used inhaler, no antihistamines. Hives resolved in 36 hours. Have to clear throat and intermittent wheezing for 2 weeks (mild globus sensation).
This spontaneous report as received from a pharmacist refers to a 49 year old female patient with no pertinent medical history, drug reactions or allergies. At the time of this report the patient was not pregnant. On 13-OCT-2014 the patient was vaccinated with PNEUMOVAX 23 (0.5 ml once, subcutaneous, lot number was not reported). On 13-OCT-2014 (reported as later the same day) the patient experienced redness and swelling at the injection site. None concomitant medication was reported. No treatment was given for the adverse events. None lab diagnostics studies were performed. The patient sought medical attention via speaking with the pharmacist. The outcome of redness and swelling at the injection site was reported as recovering/resolving (reported also that the patient's symptoms were starting to resolve as of today 15-OCT-2014. The relatedness between events and PNEUMOVAX 23) was not reported. Additional information has been requested.
This case was reported by a physician via sales rep and described the occurrence of adverse event in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, immediately after receiving SHINGRIX, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. This case was reported from emergency room for the patient that had just received SHINGRIX. The patient had multiple tests done to rule out other issues before emergency room provider ultimately agreed it must be from the vaccine.
My arm was sore where I got the shot and I had extreme fatigue lasted for 36 hours. I took Tylenol for my symptoms.
Redness with hives itching and heat and soreness in deltoid are of left arm  started 1 week after injection. Started approx. 1pm in the afternoon.  No current treatment started.
Day following immunization patient reported that she developed fever, chills, body aches. Pain, swelling and redness at injection site. PT reported dizziness and imbalance. Pain and chills worsened over next day so she came to our urgent care for evaluation on 6/29/18. SHe had an elevated heart rate at time of evaluation. She was treated with 1 Liter of Normal saline IV fluid in office at time of exam. She had labs drawn. She was sent home on a steroid course and allergy medications. Patient had improvement of heart rate and some symptoms following IV fluids. On 7/3/18 due to ongoing pain, she underwent an ultrasound of the injection site to evaluate for blood clot. this test was negative.
Janssen COVID-19 Vaccine EUA Woke up at midnight with chills which last approximately 4 hours and restless sleep throughout the night.  Woke up at 5am with aches and pains all over, soreness at the injection (upper left arm) and a headache.  Took Excedrin at 9am and felt better until around 3 when the aches came back.  Took my temperature and was running a slight fever at 99.0 degrees.  Took Tylenol extra strength as a fever reducer.
Rash/spots appeared on his back, the back of his neck, and in his hair line. They appeared to be small pimple-like bumps but he said they itched. They were most prominent when he got out of the shower. I put hydrocortisone on them Sunday and Monday evening and they improved.
pt recv vax 6JAN98 & on 21JAN98 broke out w/4 chickenpox like lesions;mom reports low grade fever for wk prior to breakout (approx 99);
Developed shortness of breath, chills, diarrhea, abd pain, fatigue, chest pressure, body aches, sore throat on 1/13/2021. Continues to have sob, chest pressure, abd pain, and fatigue. COVID test neg on 1/17.
2O MINUTES FOLLOWING INJECTION PATIENT SWELLING OF TONGUE AND THROAT, TASTE CHANGE, DIZZINESS AND RAPID HEART RATE.  IMMEDIATELY TOOK BENADRYL TOOK 2 HOURS TO DECREASE SYMPTOMS.
This spontaneous report was received from a registered nurse and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 24-APR-2018, the patient may have received an improperly stored dose of ROTATEQ, orally, lot# N004811 and expiration date: 29-SEP-2018 (dose was not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion from 9 to 25 degrees Fahrenheit for 45 minutes. Data logger was involved. There were no previous excursions reported.
I have fever 38.5C,  2.5 weeks after taking vaccine.; This is a spontaneous report from a contactable consumer or other non hcp. This consumer (patient) reported for himself that a 28-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: EN6200), dose 1 via an unspecified route of administration, administered in Arm Left on 18Feb2021 12:00 as 1ST DOSE, SINGLE dose for covid-19 immunisation. Medical history included Diamond Black fan anaemia; Hepatitis C (Cured). Concomitant medications included ashwagandha (ASHWAGANDHA); bacopa monnieri (BACOPA [BACOPA MONNIERI]). Patient had no known allergies. On 10Mar2021, the patient experienced fever 38.5c, 2.5 weeks after taking vaccine. Patient did not received any treatment. The patient underwent lab tests and procedures which included nasal swab test: unknown on 10Mar2021; Body temperature 38.5C on 10Mar2021. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. Patient did not visit to physician office. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Didn't sleep all night; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Didn't sleep all night) 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 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced INSOMNIA (Didn't sleep all night). At the time of the report, INSOMNIA (Didn't sleep all night) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Initial unsolicited report received from the literature on 14 September 2015. This case is linked to 2015SA146032, 2015SA146044, 2015SA146045, 2015SA146046, 2015SA146047, 2015SA146048, 2015SA146049, 2015SA146050, 2015SA146051, 2015SA146052, 2015SA146053, 2015SA146054, 2015SA146055, 2015SA146056, 2015SA146057, 2015SA146058, 2015SA146059, 2015SA146060, 2015SA146061, 2015SA146062, 2015SA146063, 2015SA146064, 2015SA146065, 2015SA146066 and 2015SA146067 (Same literature). The following is verbatim from the article: Background. Reporting of adverse events (AEs) following vaccination can help identify rare or unexpected complications of immunizations and aid in characterizing potential vaccine safety signals. We developed an open-source, generalizable clinical decision support system called Electronic Support for Public Health-Vaccine Adverse Event Reporting System (ESP-VAERS) to assist clinicians with AE detection and reporting. Methods. ESP-VAERS monitors patients' electronic health records for new diagnoses, changes in laboratory values and new allergies following vaccinations. When suggestive events are found, ESP-VAERS sends the patient's clinician a secure electronic message with an invitation to affirm or refute the message, add comments, and submit an automated, prepopulated electronic report to VAERS. High-probability AEs are reported automatically if the clinician does not respond. We implemented ESP-VAERS in December 2012 throughout the System, an integrated healthcare system. We queried the VAERS database to determine System's baseline reporting rates from January 2009 to March 2012 and then assessed changes in reporting rates with ESP-VAERS. Results. In the 8 months following implementation, 91,622 vaccinations were given. ESP-VAERS sent 1385 messages to responsible clinicians describing potential AEs. Clinicians opened 1304 (94.2 percent) messages, responded to 209 (15.1 percent), and confirmed 16 for transmission to VAERS. An additional 16 high-probability AEs were sent automatically. Reported events included seizure, pleural effusion, and lymphocytopenia. The odds of a VAERS report submission during the implementation period were 30.2 (95 percent confidence interval, 9.52-95.5) times greater than the odds during the comparable preimplementation period. Conclusions. An open-source, electronic health record-based clinical decision support system can increase AE detection and reporting rates in VAERS. Keywords. Vaccine; immunization; adverse reaction; reporting; adverse event. This case involves a patient (age and gender not reported), who was vaccinated with a dose of INFLUENZA VACCINE (IIV) (Manufacturer: unknown, batch number, route, dose in series and site of administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date following the vaccination, the patient had developed eosinophilia. Laboratory tests and corrective treatments were not reported. The outcome of event was not reported. List of documents held by sender: none. Follow-up information received from physician on 19 October 2015. No additional information was provided.
Pfizer-BioNTech COVID-19 Vaccine EUA: Injection site pain, woke me up whenever I tried to move my left arm for the whole night. I didn't sleep well because of that.
This spontaneous report as received from a medical assistant via a company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot#, strength, dose, frequency and route unspecified). On an unknown date the patient experienced rash and pain after receiving the vaccine. The patient sought medical attention via office visit on unspecified date and no treatment was given for the events. The outcome of pain and rash was reported as recovering. Additional information is not expected as the physician did not want to be contacted.
Smelling metal everywhere I go. I can still smell but 80% of the time I am smelling metal or like the smell of coins; This is a spontaneous report from a contactable other healthcare professional, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration on an unknown date in Oct2021 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medication. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) for unknown indication and experienced drug allergy. On an unknown date in Oct2021, the patient experienced smelling metal everywhere she went. She could still smell (at the time of this report) but 80% of the time she was smelling metal or like the smell of coins. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event smelling metal everywhere she went, she could still smell but 80% of the time she was smelling metal or like the smell of coins was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
This spontaneous report as received from a physician via a company representative refers to a 16 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. In approximately 2002 (reported as about 15 years ago), the patient was vaccinated with a dose of VARIVAX (dose reported as 1 dose; route of administration, lot # and expiration date were not reported) for prevention of chickenpox. In approximately 2017 (reported as 15 years after receiving VARIVAX), the patient experienced shingles that were localized on the right thigh. The patient sought medical attention via the physician's office visit and received an unspecified treatment for the adverse event. The outcome of the adverse event was unknown. The relatedness between the adverse event and VARIVAX was not provided. Additional information has been requested.
I began suffering excessive sweating, dehydration and heat exhaustion in early June when the weather pattern changed to 90+ degrees and high humidity. This feeling is still happening after 2-1/2 months and I have never had any issues with heat or humidity before now. I suddenly cannot drink enough water in these conditions as I sweat profusely (never been a sweater) and develop brain fog and headaches. I wish I had never taken the vaccines and let myself be exposed to the virus to allow a natural immunity to build up. I look forward to hearing if other healthy people are experiencing anything like am. I hope not.
Achy; tired; This case was reported by a consumer via call center representative and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain and tiredness. On an unknown date, the outcome of the pain and tiredness were unknown.   It was unknown if the reporter considered the pain and tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not provided but selected as an adult as per vaccine indication. The reporter stated that, one of her friend experienced achy and tired after 1st dose of shingrix. No additional information was provided. The reporter did not consent to follow up. This case has been linked with case US2020000907 and US2020000905, reporterd by same reporter.
On 25DEC90 became cranky, feverish, holding head as if a headache, achy. Was given Panodol or Tylenol q 4 hrs; On 28DEC90 sx continued, temp to 103.6, cheeks blotchy red w/ 1 red spot on arm. Child taken to MD 28DEC90.
Dose administered past the expiration/beyond-use date.  Pt received vaccine dose from multidose vial that was opened on 10/11/22 1300
Patient presented to the ED on 3/5/21 and 3/11/21. She was subsequently admitted on 3/12/21. She also presented to the ED on 3/20/21 but left before being seen.