chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On Sunday evening I began feeling ill, mainly congestion and minor sore throat. Monday morning woke up feeling worse and took at home test, testing positive. Called provider and was set up with APRN the following day. Monday I also began running low grade fever. Tuesday woke up feeling the same. Attended telehealth appointment and was prescribed Paxlovid. Began taking the medicine immediately and started feeling better on Wednesday. Symptoms resolved rapidly and the worst part was having to come off of my medicines while I took Paxlovid.
No fever, prolonged soreness, muscle ache - that extended into left arm pit. Tightness at injection site along with swelling. Lasting over 2 weeks in left arm. Follow up on 05/15/2000: "Patient did no recover from the adverse event.  Localized pain at immunization site.  Achiness in upper arm.  Tingling arm."
Breakthrough case admission after 4 vaccines Moderna 3/13/21 Lot# 002B21A;  Moderna 4/10/21 Lot# 025B21A;  Moderna 11/27/21 Lot# 027H21B;  Moderna 4/12/22 Lot# 065K21A
entire lt upper arm was red swollen & painful 11AM 19NOV92; pt has had temp of 100-101; had been giving APAP; advised mom to contact pt's MD for advice & poss treatment; seen by MD 19NOV92 put on PCN for poss infection from shot;
pt recvd vax was given on 18NOV93 react started 20NOV93; erythema 1x2 hard movable lump;
Malaise started a few hours of getting the vaccine, along w/ 102.5 fever for 24 hours and 100-101 fever for 12 hours. Fatigue, dizziness on standing, bedridden essentially for a total of 36 hours. Super sore arms for 5 days. This was similar to dose 1 and 2. What was different about dose 3 was cold sores on Day 5 of vaccine.
- approx 5 minutes after administration of the vaccines, patient had abrupt onset of facial and lip swelling, lethargy, paleness with perioral cyanosis, and tachypnea - epinephrine was administered SQ immediately and she was placed on 100% O2 by facemask and EMS was called - EMS arrived within 7 minutes and transported her to hospital; prior to arrival to EMS, patient was pale, and lethargic with occasional outbursts of agitation - she had impressive lip swelling, pale appearance and hives noted on upper thighs; she was drooling but there was no stridor - she had clear breath sounds - tachypnea and mild retractions were also noted; she was also tachycardic but this was noted approx 3 min after the administration of SQ epinephrine. - contact by ER - patient received another dose of epi in ER along with Benadryl and steroids - stable and doing well - BP a little low - considering PICU vs IMC admission.  10/1/09 ED records received DOS 9/24/09 to 9/25/09. Assessment: Acute Anaphylaxis. Patient developed immediate oral swelling, lip edema, and emesis. Presents with general weakness, decreased level of consciousness, lightheadedness, rapid respirations, coughing, wheezing. Pale, tired. Erythematous splotches legs. Observe overnight.
He reports that yesterday afternoon/evening he had a red spot  in his right groin that was sore to touch.  He reports after 6-7 hours the  redness moved around his right hip towards his right buttock.  He reports the top of his left foot was also red.  He reports this morning when he woke up all of the sx went away.  He denies redness, pain, blisters, hives, fever, or other sx.  He reports "I feel great," and he wanted to let PCP know what happened.
Parent reports softball sized lump at injection site. Mom did not specify which side. Area was reported to be hot to touch. Gave Motrin and next morning size of lump had decreased markedly. Afebrile
Slight headache/headache/bad headache; I had cracking sensation in my head, its almost like in my brain or something and especially I noticed when I looking at the cell phones its worst; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Aug2021 (Lot number: FC3183) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing), notes: Prior medical history: No. There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 03Sep2021, outcome "not recovered", described as "Slight headache"; FEELING ABNORMAL (non-serious) with onset 03Sep2021, outcome "unknown", described as "I had cracking sensation in my head, its almost like in my brain or something and especially I noticed when I looking at the cell phones its worst". Therapeutic measures were not taken as a result of headache, feeling abnormal.  Additional Information: It was reported that I had the covid shot, the Pfizer on Tuesday and I had slight headache when I did this but it was like something I usually have before every month you know, so and then it have went away, but now for the past like yesterday evening and today I noticed like I had cracking sensation in my head, its almost like in my brain or something and especially I noticed when I looking at the cell phones its worst so I was wondering if anybody have those side effects." When probed for the when did the patient experience the problem, Consumer stated, "I had headache, as I told you like I had slight headache when I took the vaccine. So, let me tell you from the beginning. I had bad headache on Monday. I went to take the vaccine and the pharmacist  actually told me better not to do if I had really bad headache and then next day I went and I had the slight headache and its my usual headache, I had like every month and then it lasted like couple days but I mean it lasted one day after the shot and yesterday I noticed it's the night time, especially when I using my phone, those wired like sensation in my head  and it's not a headache it something like more different you know how it is, I mean may be from the cell phone but I never had these from cell phone." Prior vaccination  was reported as "No, this the first one." Prior medical history for the same problem you have now was reported as no. When probed for still experiencing the problem, Consumer stated, "Its like not constant, throughout whole day its just like come and go. But I noticed when I had, like right now also  I am using this phone it went from time to time more when I am using the phone. I am not sure." When probed for the event is worsened, improved or persisting, Consumer stated, No, it  didn't worsened it is constant, like it is same throughout the day so far. It started yesterday, when I noticed yesterday morning and today.  Follow-up attempts are completed. No further information is expected.
Initial misuse report received from a healthcare professional on 25 June 2013. A patient (No information was provided regarding the patient) had received an intradermal 0.1 ml dose of Tetanus toxoid vaccine (Manufacture unknown) instead of Tubersol. No adverse event was reported. List of documents held by sender: none.
Where I had major leg surgery with cadaver and metal the was attacked.  Till this day almost 3 months later I still have the feelings of just after the surgery took place. Both legs are so shaky I can not walk my daily walk routine.  It is slowly getting better but just before the shot I had just started snow skiing again on expert slopes and now I can not walk 2 miles.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 as dose 5 (booster), single (Lot number: GJ6739) at the age of 68 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; desvenlafaxine succinate monohydrate (PRISTIQ), (Batch/Lot number: unknown); fexofenadine hydrochloride (ALLEGRA [FEXOFENADINE HYDROCHLORIDE]), (Batch/Lot number: unknown); fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]), (Batch/Lot number: unknown); buspirone (BUSPIRONE), (Batch/Lot number: unknown); naproxen (NAPROXEN), (Batch/Lot number: unknown). The patient's relevant medical history included: "Cardiac arrhythmia" (unspecified if ongoing); "allergic rhinitis" (unspecified if ongoing); "Depression with anxiety" (unspecified if ongoing); "Depression with anxiety" (unspecified if ongoing); "perennial allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had no known allergies. She received Paxlovid for COVID-19 treatment, started from 25Dec2022 to 29Dec2022.; Sender's Comments: As per the available information the causality of the events drug ineffective, covid-19 with the suspect can not be ruled out completely.
Shots given around 11:00am.  Fever started around 17:00.  Convulsions around 05:00am that night.
SORE ARM; A spontaneous report was received from a Consumer concerning a 84-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm.  The patient's medical history was not provided. Concomitant medications reported were clonidine, carvedilol, amlodipine, atorvastatin calcium, levothyroxine sodium, sodium bicarbonate, synthroid for drug use for unknown indication.  On 14 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 012120A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 14 Jan 2021, the patient experienced the events sore arm.  Treatment details included NONE  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events include, sore arm was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Aggravated neck pain; Coughing; itching at injection site; Pain at the injection site; Chills; Her torso had super itchy; extreme over reaction to mosquito bites; widespread rashes that looked like cellulitis; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Aggravated neck pain), COUGH (Coughing), PRURITUS (Her torso had super itchy), HYPERSENSITIVITY (extreme over reaction to mosquito bites) and RASH (widespread rashes that looked like cellulitis) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cellulitis and Breast cancer in 1998. Concurrent medical conditions included Asthma.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-May-2021, the patient experienced PRURITUS (Her torso had super itchy), HYPERSENSITIVITY (extreme over reaction to mosquito bites) and RASH (widespread rashes that looked like cellulitis). On an unknown date, the patient experienced NECK PAIN (Aggravated neck pain), COUGH (Coughing), VACCINATION SITE PRURITUS (itching at injection site), VACCINATION SITE PAIN (Pain at the injection site) and CHILLS (Chills). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) at an unspecified dose and frequency. At the time of the report, NECK PAIN (Aggravated neck pain), COUGH (Coughing), PRURITUS (Her torso had super itchy), HYPERSENSITIVITY (extreme over reaction to mosquito bites), RASH (widespread rashes that looked like cellulitis), VACCINATION SITE PRURITUS (itching at injection site), VACCINATION SITE PAIN (Pain at the injection site) and CHILLS (Chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.    This case was linked to MOD-2021-015278 (Patient Link).
Mild itching first night, developing gradually to intense itching in one week, feeling sick, rash appearing on 6th day, hives, welts, raised rash over much of the body by 10th day throat closing, hoarse voice. Treatment, BENADRYL taken over the counter, trip to ER, treatment of steroids, BENADRYL, transfer by ambulance to hospital, drugs and prednisone begun, blood tests performed, unknown results.
had a fever of 105 degrees (rectal reading); This spontaneous report has been received from a physician via field-based employee (FBE) referring to a 11-week-old (also reported as 2 months, conflict information) male patient. The patient's medical history included umbilical hernia. The patient's concurrent conditions and concomitant therapies were not reported. There was no other vaccine within 4 weeks prior to the suspect vaccines. The patient had no illness at time of vaccination.  On 06-JUL-2023, the patient was vaccinated with the first dose of diphtheria toxoid (+) hepatitis b virus vaccine rhbsag (yeast) (+) hib conj vaccine (ompc) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (vero) (+) tetanus toxoid (VAXELIS) injection, lot #U7536AA, expiration date: 30-SEP-2025, administered intramuscularly (IM) at left thigh for prophylaxis (strength and dose were not provided); the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #X002251, expiration date: 03-JUN-2024, administered orally (PO) for prophylaxis (strength and dose were not provided); the patient was vaccinated with pneumococcal vaccine conj 13v (crm197) (PREVENAR 13), batch# GH6086, expiration date reported as 31-MAY-2025, administered intramuscularly at right thigh for prophylaxis (strength, formulation, and dose were not provided). The patient was given the vaccines appropriately at private doctor's office/hospital by a registered nurse (RN) who was trained, and the vaccines were used according to the instruction leaflet. The vaccines were purchased with private funds. There was no temperature excursion occur as a result of a reading from a Data Logger. There was no product quality complaint.  On 07-JUL-2023, the baby had fever of 105 degree Fahrenheit (rectal reading). He continued with lower temperatures on the same date. The fever went down and resolved within 24 hours, and the patient did not spike to 105 degree Fahrenheit again. The patient had sought for medical attention. The vaccines were not available for return or evaluation as they were disposed after administration.   It was reported the event fever was attributable to the suspect vaccines.
Bad reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Bad reaction) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 VACCINATION COMPLICATION (Bad reaction). At the time of the report, VACCINATION COMPLICATION (Bad reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No treatment medication was provided.   This case was linked to MOD-2021-370484, MOD-2021-370485 (Patient Link).
Slight swelling at site of facial dermal fillers that lasted about 2-3 days. Swelling of lymph node under left arm that started about 1 week after injection and lasted about 5 days
It started on 06/16/2021, I started experiencing mild abdominal pain on the right side both above and below the naval. It was gradually becoming more severe, but never excruciating. On 08/16/2021, I went to the ER, a few days before that it was getting worse, I thought I was have appendicitis. Ultimately they did a CT scan of the abdominal area-- large cyst on my liver, 10 cm. I had a previous CT scan in 2008 and at the time it was something like 2 cm. The CT scan also showed fat deposits on my ascending colon. They didn't see any infection and referred me to the gastroenterology dept. The symptoms have not varied a lot but they have not gotten any worse.
Pt returned to office at 9:25- pt started coughing and sneezing at CK out- went to parking garage - pt starting spitting up thick mucus, stated to mom that it was hard to breathe-mom brought him back up to the office- 106/58, pulse 109, O2 97, pt having some redness on Lt leg - cool pack applied to area- Dr. notified and checked pt's vitals, listen to chest- 10:08- more redness on Lt leg- pt irritable. EPIPEN JR given at 10:10 am right leg - lot # 0GK526, exp 1/12. 10:15 am -redness improved- pt more alert - pt states feeling better. CLARITIN 5 mg given at 10:30. 10:18 am P 105, O2 98. 10:24 am O2 98, p 105, 10:50 pt D/C to home- EPIPEN JR faxed to pharm- if needed mom will give to child and call 911 for hospital transport- mom to give CLARITIN 5 mg tomorrow and the next day- mom states understanding.
Information has been received from a physician concerning a female patient who on unspecified dates was vaccinated intramuscularly with three 0.5 mL doses of GARDASIL. On an unspecified date, "recently", the patient had an abnormal Papanicolaou (PAP) test that was positive for HPV 16. The physician was questioning vaccine failure. The physician did not know how much time there was between the completion of the series and the abnormal PAP test. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. Follow up information indicated that the approximately 27 year old patient was vaccinated with a first dose of GARDASIL on 07-DEC-2007, a second dose on 07-FEB-2008 and a third dose on 18-JUN-2008. On an unknown date a "PAP test" revealed atypical cells of undetermined significance and could not exclude high grade squamous intraepithelial lesions (SIL). ON 11-AUG-2009 an HPV DNA test returned "high risk 16". On 03-SEP-2009 a colposcopy and a biopsy test revealed no dysplasia or malignancy. No further information is available.
a lot of the volume of the vaccine came out of the arm after the needle was drawn out; a lot of the volume of the vaccine came out of the arm after the needle was drawn out; a lot of the volume of the vaccine came out of the arm after the needle was drawn out; a lot of the volume of the vaccine came out of the arm after the needle was drawn out; This is a spontaneous report received from a contactable pharmacist. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration in the arm, on an unspecified date, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The pharmacist reported that the patient received the first dose of the vaccine on an unspecified date and mentioned that a lot of the volume of the vaccine came out of the arm after the needle was drawn out. The patient wanted to get revaccinated and the pharmacist wanted to confirm if this is recommended as she has not seen anything on the website. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Shoulder soreness for most of the week, but nothing more uncomfortable than sleeping wrong. Pain was mainly in lifting my arms at work (I unload and load trailers on an LTL cross-dock, using a forklift but often having to do physical placement and strapping).
Patient called at 5pm 12/22 to let pharmacy know about his illness. Patient said that 12 hours after getting the nasal mist he had vomiting and diarrhea. He also had a fever as high as 102. Patient said the symptoms went away after 24 hours.
This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. On an unknown date the patients were vaccinated with PROQUAD (Lot# M044020 with expiration date 01-MAY-2018, Lot# reported as M013865 with expiration date 31-OCT-2018, Lot# M044575 with expiration date 04-MAY-2018, Lot# M049122 with expiration date 13-JUN-2018) for prophylaxis which were reconstituted with diluent. On an unknown date the patients were vaccinated with the vaccines that were improperly stored between 6F to 14F (9F) with the time frame of 3 hours and 45 minutes. There was no previous temperature excursion. No data logger was involved. No adverse effects were reported. Diluent was not involved in the temperature excursion. This is one of several reports received from the same source.  Sender's Comments: US-009507513-1707USA009490: US-009507513-1707USA009511:
When I got the injection, I had a sore arm and in the middle of the night around 12:00AM, I stared to feel sick. I could not get out of bed. I felt this for a week and could not get out of bed. I had a scratchy throat and was coughing like I had COVID-19. I also had nausea, stomach cramps and diarrhea with lethargic feeling. I had chest pain as well. I felt like this with all 3 of my vaccines. Then on 05/27/2022, I developed COVID-19 symptoms. I started coughing. Then I took an at home COVID-19 test that was positive. My symptoms progressed to dizziness, lost my voice, severe coughing. I took cough medication with codeine that has helped suppress my cough. I feel very fatigues and stayed in bed. I get exhausted easily doing simple chores. I have diarrhea and stomach cramping. I have severe headaches and body aches and even my eyeballs hurt. For 4 days, I had severe runny nose and watery eyes. I have a lack of appetite and just now starting to eat again. I called the nurse and was told to take a decongestant which does help.
Dr. accidentally administered a 3rd dose of HPV (Guardasil) to pt. Per Dr., only two doses should have been administered. These two doses were already administered previously. The Doctor's office accidentally scheduled an appointment and administered a 3rd dose.
adm to hosp 18JUN97 w/ hx of weakness, wobbly, lying in bed-not walking 3wk-fussy +, hypotonia, DTR+ w/some ankle clonus;dx post inj myelopathy vs acute cerebellar ataxia;schedule MRI cerebellum/cervical spinal cord;
I had knee surgery and fainted after it. I had to get a CAT scan to rule out blood clots and they found I had a mass on the right side of my thyroid. It was about 5.7cm and it grew to like 6.4cm by the time it was taken out. I had the surgery on Monday 10/4/2021. They also did blood work to figure out to see if the rest of my thyroid is functional. Right now I am on pain management.
About 20 minutes after the vaccine was administered my Mother's speech became garbled and she was unable to speak understandably. I thought she was having a stroke so rushed her to the emergency room. They examined her and her speech returned to normal in about an hour. They kept her overnight for tests and after an MRI they said she had a TIA. We wanted to report it in case there were others who had a similar adverse affect. No one can say for sure if the vaccine caused it or not but we wanted to let you know what happened to her.
For the first two days after the vaccination, I experienced a very sore arm, body aches all over, and fatigue.  Also, on the first day after, I had a tempurature of 100.4 for several hours.  For 4 days after, the lymph nodes under my left armpit swelled and hurt.  I took two Advil tablets 2 to 3 times per day and that helped the symptoms.