chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm swollen; Arm hot to touch in area where vaccine was implemented; Arm red in area where vaccine was implemented; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Arm swollen), VACCINATION SITE WARMTH (Arm hot to touch in area where vaccine was implemented) and VACCINATION SITE ERYTHEMA (Arm red in area where vaccine was implemented) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Arm swollen), VACCINATION SITE WARMTH (Arm hot to touch in area where vaccine was implemented) and VACCINATION SITE ERYTHEMA (Arm red in area where vaccine was implemented). At the time of the report, VACCINATION SITE SWELLING (Arm swollen), VACCINATION SITE WARMTH (Arm hot to touch in area where vaccine was implemented) and VACCINATION SITE ERYTHEMA (Arm red in area where vaccine was implemented) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.   Reporter did not allow further contact
administered to an 8 year old; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number M442P, expiry date 27th October 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th July 2022, the patient received the 1st dose of Boostrix and Boostrix Pre-Filled Syringe Device. On 25th July 2022, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: 25-Jul-2022 Reporter's comment: The certified medical assistant stated that the Boostrix was administered to 8 years old patient. The reporter consented to follow-up via postal. Additional supportive information: The patient received a dose of Boostrix vaccine at inappropriate age, which led to inappropriate age at vaccine administration.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2012, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 02-SEP-2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. On or about 09-SEP-2016, the patient sought subsequent treatment from a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Patient could not move her arm the next day and has pain to this day. Patient is worried of a long term problem and prevent mobility.
pt recv vax 18AUG98 & began having swelling & redness in rt deltoid were DTAP given;mom brought child to hlth dept 20AUG98 for nurse to see arm;rt deltoid extremely swollen, hot & red;
Nose bleed 3/17 Nose bleed 4/28 Never had a nose bleed before then ever
Pt was given two doses of Typhoid vaccine instead of 1 Typhoid and 1 Meningococcal vaccine. Mixed up the vaccine and
Breakthrough COVID at healthcare facility. Pt fully vaccinated and boostered on 10/27/21. Pt admitted to ED on 1/20/22 for syncopal episode. ED workup included sinus rhythm on EKG, significantly positive orthostatic vital signs, normal chest XR, positive COVID test. Pt admitted for cardiac workup.
Beginning Tuesday April 13, 2021, the right side of my face begin to swell. As the week went on, I started breaking out into hives on the right side of my head, face and  my upper back. I started feeling throbbing pain in my head and the swollen area of my face. On Sunday, April 18, 2021, I started to feel better with the help of taking 2 Tylenol 500 mg every 6 hours. As of today, the top of my head hurt and when I scratch my head on the right side it feels like Im scratching with razors. Also, I still have a little swellen under my earlobe on the right side. I was scheduled to take my second dose today, but I am afraid that I will have the reaction that I had with the first dose. Please advise
fibromyalgia and it caused a flare up; fibromyalgia and it caused a flare up; Vertigo; Joint pain; Joint swelling; Hot flashes; Brain Fog; Headache; Fatigue extreme; severe nausea; full body itching; This is a spontaneous report received from contactable Health Care professionals (included patient). A 33-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via unspecified route of administration on the left arm on 13Mar2021 at 03:30 PM (at the age of 33-year-old) as single dose for COVID-19 immunisation. Medical history included fibromyalgia, irritable bowel syndrome (IBS), attention deficit hyperactivity disorder (ADHD), major depression disorder (MDD). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included dextroamphetamine (MANUFACTURER UNKNOWN), lamotrigine (MANUFACTURER UNKNOWN), duloxetine (MANUFACTURER UNKNOWN), loratil (MANUFACTURER UNKNOWN). The patient was not allergic to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 13Mar2021 at 04:30 PM, the patient had fibromyalgia and it caused a flare up, vertigo, joint pain and swelling, hot flashes, brain fog, headache (feels like an ice pick hitting the top of head) and extreme fatigue. Initially, the patient had severe nausea, but it resolved itself in less than 24 hours. She also had been experiencing full body itching that only goes away if she take allergy medicine. Therapeutic measures were taken as a result of full body itching and included treatment with allergy medicine, no treatment for the other events. On an unknown date in Mar2021 patient was recovered from the event nausea. The clinical outcome of the other events was not recovered.  No follow-up attempts are possible. No further information is expected.
pt recvd 2 doses of Engerix-B & following 2nd dose had hives rt under arm;
Started with nausea. Then omitting (without GI disturbances). Around noon, symptoms included severe body pain, feet swelling, headache, light and noise sensitivity, foggy thought process, and facial rash with noticeable hair loss comparable to a Lupus flare prior to treatment several years ago. Low grade temperature of 99 for a few days. The symptoms have improved, however, thinking is very foggy. Physician ordered Phenergan for nausea and vomiting; as well as: hydration and rest. Ibuprofen for headache and joint and body pain. Ambien to sleep. This has been going on for four days.
Case number PHEH2015US026928 is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 37 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501 and expiry date: May 2016) into left deltoid on 12 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and  when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information provided. Follow up information received from the nurse on 26 Jan 2016: Reporter's comment updated.
Itchy throat; Itchy tongue; Ears itch; Eyes itch; allergic reaction; Rash; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (Itchy throat), TONGUE PRURITUS (Itchy tongue), PRURITUS (Ears itch), EYE PRURITUS (Eyes itch) and HYPERSENSITIVITY (allergic reaction) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Seafood allergy and Allergy to nuts.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, the patient experienced THROAT IRRITATION (Itchy throat), TONGUE PRURITUS (Itchy tongue), PRURITUS (Ears itch), EYE PRURITUS (Eyes itch), HYPERSENSITIVITY (allergic reaction) and RASH (Rash). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at an unspecified dose and frequency. At the time of the report, THROAT IRRITATION (Itchy throat), TONGUE PRURITUS (Itchy tongue), PRURITUS (Ears itch), EYE PRURITUS (Eyes itch), HYPERSENSITIVITY (allergic reaction) and RASH (Rash) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.
CONSIDERABLE SWELLING AT INJECTION SITE, WELTS, ITCHING, PAIN, KNOT, RASH ON LEGS & BACK.
This spontaneous report was received from a Registered nurse regarding a 15 year old patients of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 22-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Shortly after receiving vaccine, patient looked very pale.  He was still sitting in the chair and lost consciousness for 1-2 seconds.  He regained color immediately and said he felt fine.  He remained on site another 20 minutes to make sure he was okay.  Patient was called 3 hours after incident and reported to be doing great.
Resident became unresponsive after bath. unable to get O2 stats P76  B/P 116/70. Very lethargic all am did not get out of bed all day continued to be very lethargic all day.
flu-like symptoms; Dizziness; Diarrhea; very sick; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), DIZZINESS (Dizziness), DIARRHOEA (Diarrhea), ILLNESS (very sick) and VOMITING (Vomiting) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03F2117, 026L20A and 029L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), DIZZINESS (Dizziness), DIARRHOEA (Diarrhea), ILLNESS (very sick) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL 8 HOUR) for Adverse event, at a dose of 1 dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), DIZZINESS (Dizziness), DIARRHOEA (Diarrhea), ILLNESS (very sick) and VOMITING (Vomiting) had not resolved.            Concomitant medication included unspecified stomach medicine. Treatment medication included cold and flu medicine.
06/30/14 Pt was seen at the walk-in clinic today, reported red, itchy rash the next evening of the vaccination - bilateral rib area below both breasts, bilateral armpits, underarms, bilateral thigh and groin. Continues to worsen and spread.
Presents today for vaccinations. Needs Meningitis  No complaints. Received vaccination in the past with no reaction.    After receiving the injection, began feeling light headed and dizzy. Patient appeared pale. Did not appear to have an seizure like activity. Respirations were easy and unlabored. However, blood pressure was 70's/40's. Patient was still awake and alert. Room was hot. Patient did have food to eat prior to coming to clinic.    After resting and ice pack placed on the back of the neck, patient blood pressure was 80's/50's, heart rate was high 40's. Still awake and alert.    Repeat blood pressure began climbing to normal levels, 90's/50's and heart rate was 64.    Last blood pressure was 116/54; heart rate was 65. Patient still awake and alert and in no acute distress.    Advised mom that this is not a normal reaction after receiving vaccine. Gave parent number to report to VARES regarding.    Also advised the he not receive Menactra in the future. Mother verbalized understanding and agreement.    This provider will report this reaction as well.
Crohn's Disease; the patients Hepatitis B titers were low; This spontaneous report was received from a nurse and refers to a female of unknown age.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown dates in 2013, the patient received 2 doses of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection, lot #0569AA, expiration date: 01-NOV-2013, lot # 0893AA, expiration date: 17-MAY-2022, administered for prevention of hepatitis B (strength, exact dose and route of administration were not provided).  On an unknown date, the patient was seen by an allergy and immunology doctor, who said the patient's hepatitis B titers were low and they recommended she received another manufacturer's hepatitis B vaccine. The patient was being seen by a gastrointestinal (GI) doctor as well and it was also reported that "nobody really knew what's going on with her, but that her doctors seemed to think she might have Crohn's Disease."   At the time of reporting, the outcome of the events was not known.  The causal relationship between the events and hepatitis b vaccine (recombinant) (RECOMBIVAX HB) was unknown.   Upon internal review, the event of Crohn's Disease was determined to be medically significant.
SARS-CoV-2 test; This is a spontaneous report from a contactable consumer or other non hcp (patient) via Pfizer spon-sored Program (CEP 159558).  A female patient of an unspecified age received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration on 05Mar2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 15Mar2021, the patient had her sars-cov-2 test, and she was positive to it. The patient is concerned about taking 2nd dose of the vaccination. The outcome of the event was reported as unknown at the time of report.  No follow-up attempts are possible. No information about lot/batch number cannot been obtained.
Stomach upset/nausea - started 10/6/18 - Fever/body aches - started 10/6/18 - Local reaction - inflamed, even with ice - started 10/7/18 - Joint pain - mostly knees - started 10/8/18 - Headache - started 10/6/18.
Nausea, dizzy, headache, body ache, metal taste in mouth, feel like I have diarrhea. No treatment yet. Called family dr to report symptoms.
Approx 1 minute after vaccine administered to L arm pt stated was itchy hives were noted at that time no respiratory sypmtoms no wheezing sat 100% on RA benadryl given.  Approx 5 minutes after which hives and itching resolved Pt observed for another 20 minutes and was noted to be asymptomatic.
Tested positive for COVID-19 after receiving first vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Tested positive for COVID-19 after receiving first vaccine) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced COVID-19 (Tested positive for COVID-19 after receiving first vaccine). At the time of the report, COVID-19 (Tested positive for COVID-19 after receiving first vaccine) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Apr-2021, SARS-CoV-2 test positive: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications and treatment information were reported.   This case was linked to MOD-2021-089851 (E2B Linked Report).; Sender's Comments:  MOD-2021-089851:Husband's case
Severe spasticity c/w dystonia. Unable to maintain pt in wheelchair. Unable to control pts body while on floor. Pt remained alert and talking during incident. Incident lasted greater than 15 minutes
Morning on 3/11 awoke with fever and body aches, breathing became difficult over the next several days, along with light headedness.  ED visit on 3/14 diagnosed with COPD flare advised to follow up with PCP.  3/22 follow up with PCP,  discovered blood in stool sent to ED.  Admitted on 3/22 with low hemoglobin and blood in stool. Endoscopy on 3/23 and coloscopy on 3/24.  Source of bleed undetermined. Released on 3/23.  4/1 returned to ED as symptoms continued.  D-dime blood test and CAT found blood clots in lower right lung.  Prescribed Eloquis and released.  Returned to ED on 4/5 admitted with low hemoglobin (7.1) bleeding, breathing difficulty.  Endoscopy repeated on 4/6 not bleeding found.  Released on 4/9.
I have been developing bad bruising in places I have no injuring or had any impact to. I have the in multiple places in my body. I went to a walk in clinic today for bloodwork.
On 11/14/00, the pt had a temperature of 101.5F, nausea and vomiting. On 4/23/01, gave pt Pediatric DT in right arm and pt developed a raised whelp with redness.
A report has been received from a Health Professional concerning a 5 year old, Male subject, who had been receiving Nasal FLUMIST QUADRIVALENT (Intranasal). FLUMIST QUADRIVALENT (Intranasal) started on 19-Dec-2013. The reporter stated that inadvertently expired FLUMIST QUADRIVALENT administered which stared on 19-Dec-2013. The outcome os the event of expired FLUMIST QUADRIVALENT administered is unknown. The report was considered to be non-serious by the reporter.
Her husband got a bad covid outbreak after first dose; Her husband got a bad covid outbreak after first dose; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients (herself and her husband). This is second (husband) of two reports. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The reporter stated that on an unspecified date her husband (patient) got a bad Covid outbreak after first dose and the location closed. The patient does not know where to get second dosage. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Chills Fever 102.1 degrees lasted 12 hours Fatigue Headache Dizziness  Red @ Swollen around injection site. A border of 2 inches Took aspirin and drank fluids
After 24 hours of receiving the vaccine, I developed fever of 99.8 F, Had chills, muscle and joint pain. for at least 2 days.
Within 10 secs after injection patient said his body started having some adverse reaction.  He said he didn?t say anything  until his eyes were black and couldn?t see then he said he didn?t feel so good.  The color drained from his body and he went limp.  Luckily a nearby paramedic caught him and he was wheeled to a recovery room to be monitored. Patient felt better after 15 Mins but it was so scary.  We didn?t expect any reactions as hes gotten all of his immunizations and never had any reactions.  I was really traumatized by this whole event.  The staff there were very nice and helpful and helped us ease thru his recovery.  I wanted to report this incident so that way you have a log of adverse side affects from getting the vaccine.  I hope the 2nd shot will be ok.... I?m very scared at this point. TBD
developed severe left sided bells palsy after 2nd shot. symptoms mostly resolved after about 6 months with mild residual, then residual symptoms worsened some after booster shot october of pfzeizer
Raised welts, redness and itchy around the injection site. Treatment: none. Outcome: does not interfere with ADLs continue to work.
3 days post Dose #1 developed myalgias, joint pain, headache, fever. One labial ulceration - not sexually active. ADVIL, TYLENOL - then taper Prednisone 30 x 2, 20 x 2, 10 x 2. Symptoms lasted 2 weeks.
Shingles; shingles, including any and all of its sequelae; This spontaneous report was received from a lawyer and an approximately 63 year old female patient regarding a case in litigation on 18-MAR-2021. The patient's concurrent conditions, concomitant medications, medical history, drug reactions or allergies were not reported. On 04-FEB-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, anatomical location not provided) as prophylaxis. On an unspecified date in October 2013, as a result of her receipt of zoster vaccine live (ZOSTAVAX), plaintiff was caused to suffer shingles, including any and all of its sequelae. As a result of her receipt of zoster vaccine live (ZOSTAVAX), she had been caused to suffer severe personal injuries, pain, suffering and emotional distress. At the reporting time, the outcome of shingles, including any and all of its sequelae was considered as not recovered. The reporters considered the events to be related to Zoster Vaccine Live (ZOSTAVAX).     The reporters considered the events of shingles, including any and all of its sequelae to be disabling.