chrisvoncsefalvay/vaers-outcomes huggingface dataset:
infection in the eye; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer reported for herself.  A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiry date was not reported) as single dose for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced infection in the eye after taking the 1st dose. The patient received treatment with Valacyclovir for the event infection in the eye. Outcome of the event infection in the eye was reported as unknown.  Follow-up attempts completed. No further information expected.
PT SAID SHE WOKE UP WITH EXTREME DIZZINESS AND FELT LIKE SHE WAS HUNGOVER BUT THE DIZZINESS WAS THE WORRISOME PART FOR HER.  NOT ABLE TO OPEN EYES WITHOUT HAVING EXTREME DIZZINESS
This spontaneous report was received from a physician, referring to a patient of unknown age and gender. The patient's medical history included Hodgkin's lymphoma in approximately 1996 (reported as about 20 years ago), that the physician thought it was cured. No information about the patient's concurrent conditions was provided. On an unknown date, the patient was vaccinated with ZOSTAVAX (route, strength, dose, frequency and lot number were not reported). Concomitant medications were not reported. On an unspecified date a year and a half after vaccination, the patient developed Hodgkin's lymphoma. At the time of the report, the outcome of the event and the action taken with the therapy were unknown. The relatedness between the event and the therapy was not provided. No product quality complaint was involved. Upon internal review, Hodgkin's lymphoma was determined to be medically significant. Additional information has been requested.
Headache; Feeling extremely dizzy/dizzy all day; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Feeling extremely dizzy/dizzy all day) and HEADACHE (Headache) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Hypercholesterolaemia, Gout, Arthritis and Vertigo.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIZZINESS (Feeling extremely dizzy/dizzy all day). On an unknown date, the patient experienced HEADACHE (Headache). The patient was treated with TRAMADOL for Headache, at an unspecified dose and frequency. At the time of the report, DIZZINESS (Feeling extremely dizzy/dizzy all day) had not resolved and HEADACHE (Headache) outcome was unknown.            Patient is on medications for high blood pressure, cholesterol, gout and arthritis.  It was reported that the patient had done some exercises for vertigo but they only helped a little.   This case was linked to MOD-2021-370207, MOD-2021-370192 (Patient Link).
Received shot about 9 a.m. on 4/5/2021. Indicates started having excruciating arm pain about 4p.m. States the entire arm and hand ached . She also felt dizzy and nauseated and could hardly walk.  Relates she was better in about 24 hours.
extremely sick; dizziness; This is a spontaneous report from a contactable consumer (patient). A 51-year-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN5318), via an unspecified route of administration on the left deltoid on 29Jan2021 at a single dose for COVID-19 immunization. Medical history included patient was asthmatic diagnosed around 8 or 9 years old. Concomitant medication included albuterol [salbutamol] for asthma. On 29Jan2021, the patient had first dose of the COVID vaccine and ended up getting extremely sick. The patient was taken by ambulance to the hospital on the same day. As reported, "so I was in ambulance dying just put me on there, but I got 2 doses of the "Aefrom" and I ended up of another dose of "hawdapil." The patient still had a little bit of dizziness which was not bad and has improved. The doctor instructed the patient to report and find out if patient was going to be able to get the second dose because they were saying not to. The patient got the vaccine at an hospital, in a line. Outcome of the event "extremely sick" was unknown and of dizziness was recovering.
Injection site is red, painful, itching and a large lump; Injection site is red, painful, itching and a large lump; Injection site is red, painful, itching and a large lump; Injection site is red, painful, itching and a large lump; This is a spontaneous report from a contactable consumer, the patient. A 38-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 in the right arm on 20Apr2021 at 00:15 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no known allergies to medications, food, or other products. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021, 4 days later the vaccination, the patient's injection site was red, painful, itching and a large lump. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site was red, injection site painful, injection site itching and injection site large lump was not resolved at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
1st vaccine 02/02/2021 tender left arm from day one  2nd vaccine 03/03/2021 soreness on arm throughout part of the days. Can not lay on nor apply pressure on the arm which will cause numbness throughout the arm to the thumb pad of the hand.  No Treatment.
Patient mentioned she had a small rash on first dose, but this time the rash was big as the size of palm, warm to touch, painful, chills, fever, and pain in stomach. She had to return back to home from work yesterday. She took ADVIL for pain. All her symptoms today are gone except the rash.  Pharmacist suggested to report it to primary care doctor. We reported to Glaxo as well. Patient was also advised to seek medical attention if the symptoms resume or worsens.
Information has been received from a physician concerning an 18 year old male who on 15, Aug 1003. 17, Sep 1993  and 24, Feb 1994 was vaccinated with a first, second and third dose of hepatitis B virus vaccine rHBsAg (yeast). "Recently", in approximately February 2006, the patient was treated and found to be positive for hepatitis B. Unspecified medical attention was sought. No product quality complaint was involved. Follow-up information from a nurse in the physicians office indicated that the patient went to donate blood and was told that he tested positive for Hepatitis B. The following lab test findings were reported: Anti HB core positive, HB surface antigen positive, and Anti Hep C negative. The physicians office ordered testing and received the following lab test results: HB surface antigen positive, HB e antibody reactive, HB e antibody negative, and HB e antigen non-reactive. The nurse was unable to provide any details regarding symptoms experienced by the patient as he had not been seen by the office.
Fever of 104.3 degrees; chills; dizziness; exhaustion; headache.
Reddness at site, hives to elbow, numbness to fingers lasted approx 24 hours.
This spontaneous report was received from a healthcare worker and refers to multiple patients of unknown demographics. The patients' concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patients' were vaccinated with improperly stored doses of VAQTA lot # M009377 with expiration date of 17-JUN-2017 (dose, strength, and route unknown) (improper product storage). The vaccine was exposed to temperature of 71.2 Fahrenheit (F) for 7 hours and 31.8 for 106 hours. Data logger was involved. It was unknown if there was any previous temperature excursion. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Immediate burning in the injection area, dizziness, and nausea 15 min after injection. Consecutive vomiting 2 to 20 minutes after the injection and strong stomach pain. About an hour later confusion to come up with words and lethargic when I went to bed. The next day I had severe diarrhea, Since that day I have felt fatigued, tachycardic, muscle aches and joints, and extreme fatigue. On the night of August 3rd, during the night I felt short of breath and did not sleep due to strong muscle pain that persisted, neck are and back pain.
Informed of event on 5/9/2013. Pt initially had a bump at injection site then developed an itchy rash. She called her PCP and was instructed to take BENADRYL and use hydrocortisone.
My vaccine was done on 1/5/2021.  My arm was sore but that went away.  Today, 1/15/2021, I noticed I had a red area around my arm where the vaccine was given.  I couldn't tell if it was hot as my hands were cold.  A nurse in our office looked at and said it did feel warm. I am having no other problems...just thought it was strange it would appear 10 days later.  I do want to get the 2nd shot when I am able.
PATIENT STATED SHE WAS IMUMNOCOMPROMISE BUT WAS GIVEN MODERNA 0.25ML INSTEAD OF 0.5ML
Sore arm that it was mildly, when raise arm feel a little bit the day of the first doses; This spontaneous case was reported by a consumer and describes the occurrence of   in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028a21a and 012a21a) for COVID-19 vaccination.     No medical history reported.  Concomitant products included CHOLESTEROL, ACETYLSALICYLIC ACID (BABY ASPIRIN) and VITAMINS NOS for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.            Concomitant medication also includes blood pressure, and anti reflects medications. No treatment medication reported.   This case was linked to MOD-2021-392078, MOD-2021-392066 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 66-year-old, male patient with relevant medical history of experiencing pain in extremity after the first dose of mRNA-1273 vaccine who experienced the unexpected non serious event of pain in extremity. The event pain in extremity occurred the same day with the second dose of mRNA-1273 vaccine administration. The rechallenge is positive. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Gradual onset tinnitus in left ear over the following 48 hours after the vaccine, worsening to current level over about 7 days. Has been constant since then. The level is moderate and interferes somewhat with sleep and quality of life. Also headaches on that side. No treatment has been attempted as of yet.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in her arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014c21a) for COVID-19 vaccination.     No medical history was provided by reporter.    On 23-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (soreness in her arm). At the time of the report, PAIN IN EXTREMITY (soreness in her arm) outcome was unknown. Not Provided          No treatment and concomitant medications were provided.
Pt recv vax & exp runny eyes & nose. 12Oct97 pt exp diarrhea,fever lasting 2-3 day.Morbilliform rash w/>50 lesions on trunk,face & lower extremities.MD unsure if sx R/T vax.
Drank coffee within an hour after taking third dose of Vivotif; Spontaneous report received on 14JAN2020.  A nurse reported that a 49-year-old male consumer "drank coffee within an hour after taking third dose of Vivotif" (PT: Product administration error). He was receiving Vivotif for immunisation. The consumer took first two doses of Vivotif on an empty stomach on 10JAN2020 and 12JAN2020 respectively. On 14JAN2020 he drank coffee less than an hour after taking the third dose. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer drank coffee within an hour of taking his third dose of Vivotif (drug administration error). Vivotif should be taken on an empty stomach with cold or luke warm water and the person should not have a meal for at least one hour after taking Vivotif dose. Considering the nature of the event, the causality of drug administration error is assessed as not applicable to Vivotif.; Sender's Comments: A consumer drank coffee within an hour of taking his third dose of Vivotif (drug administration error). Vivotif should be taken on an empty stomach with cold or luke warm water and the person should not have a meal for at least one hour after taking Vivotif dose. Considering the nature of the event, the causality of drug administration error is assessed as not applicable to Vivotif.
Immediately after injection I had a sore arm in a warm spot. And the following days I had a headache and felt very under the weather with a low-dose fever. On Saturday 3/20, I started to get achy muscles and joints. On 3/21, I had around five incidents of diarrhea. Today, 3/22 I called my doctor about the joint and muscle pain. We decided constantly taking ibuprofen for a few dates is the course of treatment for now.   I would consider it moderate pain, I?m struggling doing daily activities without pain intervention. Most of the pain is in my hips, knees, ankles, toes, and hands.
Per patient report- For the vacation adverse effects report, I've had excessively heavy, long periods with clotted blood coming out since early 2022, so it corresponds with the third dose of the Covid vaccine I received in January 2022. The heavy periods are not monthly, some months they are light and more like spotting. However, when I get heavy periods, the bleeding continues for two weeks or more and some days it's so heavy that I'm constantly in the bathroom changing pads, washing and changing underwear & clothes, and even needing to put something underneath me where I sit to prevent blood staining things. The latest one that started on May 23rd has not stopped yet (3 weeks and counting!) and I'm getting dizzy and feel palpitations because of all the bleeding and heavy clots that come out continuously.
(R) deltoid pain, pain down (R) arm, tingling in (R) hand, tender area (R) arm just below acromion. Shot given 4/21/08. Pt called 4/30/08. Pt seen back in clinic 5-1-08. Pat given a Medrol dose pak.
I already did.  Face itching/burning and nausea  I had no red face and no discernible hives or rash.
1 day after vaccine admininstered, patient exhibited swelling, redness, and soreness to touch. Pt reports maximum swelling diameter was about 1-1 and half inches. Patient reported to Medical 5 days after vaccine administration. Swelling and redness and drastically decreased when Patient reported to Medical with initial measurement of 1 inch diameter in swelling. Pt. has afebrile and has no other symptoms today, 16Oct18.
1/13/03 - received anthrax vaccine #1 along with SPV- about a week later, noticed rash on left inner thigh- c/o moderate pruritus- was dx'ed with "poison ivy"- sxs fully resolved after receiving a 'steroid shot'- no other medical complaints. 2/24/02 - received anthrax vaccine #2 (alone)- about a week later, again noticed a similar rash on the same area- same intensity- sxs fully resolved in 3 days after using OTC topical "steroid' cream- no other medical complaints. 3/10/03- received anthrax vaccine #3 (alone)- about a week later, similar rash on left inner thigh and right inner thigh/right popliteal fossa area- again used the topical cream mentioned above- full resolution in one day- no other medical complaints. 8/20/03- anthrax vaccine #4- similar incident noted as with anthrax vaccine #3- no other medical complaints. 2/17/04- anthrax vaccine#5- 6 weeks later, awoken from "burning sensation" in his back- noticed "hives all over my back"- c/o severe pruritus- was given BENADRYL PO for his sxs- urticaria fully resolved after three hours- no other medical complaints. Week after the above incident, pt. started to noticed similar hives appearing every morning in different areas of his body (back, calves, arms, hands; dorsal radial)- lesions appear 'early every morning around five and resolve within 2 to 3 hours" without any interventions- c/o moderate pruritus- also c/o "lip tingling" sensation- incident x2- lasted "only few minutes"- "just half of my lower lip"- resolved without any intervention- no c/o respiratory problems or angioedema. 12/08/04-seen by allergist- was given CLARITIN, ZANTAC; and BENADRYL for his sxs- CBC with diff and ESR all WNL- pt. referred to clinic. Patient seen by his Case Manager- c/o persistent hives appearing every morning- denies any relation to physical stimuli- no meds taken for sxs- denies any sx/sx of systemic problems when rashes appear- h/o 'really bad" asthma as a child- denies any h/o skin problems/conditions- no FH of skin problems/conditions- denies allergy to meds or foods. Hives Start: 2/7/2003 - Occurs every morning since receiving anthrax vaccine #5
Swollen red itchy sore and hot to the touch in area of vaccine shot and down my arm to my elbow. Lasted for 2 weeks. Took Acetaminophen. Symptoms have resolved
This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a adult patient who received 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 injected limb mobility decreased, injection site pain, sleep disturbance, muscle soreness and activities of daily living impaired. On an unknown date, the outcome of the injected limb mobility decreased, injection site pain, sleep disturbance, muscle soreness and activities of daily living impaired were unknown. It was unknown if the reporter considered the injected limb mobility decreased, injection site pain, sleep disturbance, muscle soreness and activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: This case was reported to VAERS by the reporter. This case was reported by the patient's friend. The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient said that the initial SHINGRIX injection was much more painful. Within an hour after vaccination with SHINGRIX, his muscle became sore. The evening after it interfered with his sleep. The next morning after vaccination, the patient only had use of about 25 percent of that arm and had to cancel activities that morning. The reporter asked what did GlaxoSmithKline thought the issue was. This case was linked with the case US2018GSK194103, reported by the same reporter.
Fever, extremely tired, chills, body aches, dizzy, light-headed, intermittent ringing in ears. Headache for 48 hours.
Pt reported "severe muscle pain" at injection site first. Then dizzy/lightheaded. Resulted in car accident on 10/5/16.
VACCINE DOSE ADMINISTERED AFTER VIAL PUNCTURED FOR MORE THAN 6 HOURS; This spontaneous report received from a pharmacist concerned a 56 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: 21/JUN/2021) dose was not reported, administered on 06-MAY-2021 17:40 for prophylactic vaccination. No concomitant medications were reported. On 06-MAY-2021, the subject experienced vaccine dose administered after vial punctured for more than 6 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine dose administered after vial punctured for more than 6 hours was not reported. This report was non-serious.