chrisvoncsefalvay/vaers-outcomes huggingface dataset:
EMS called after patient displayed a heart rate of 160, a little over an hour after vaccine administration. Patient was taken to the hospital and diagnosed with an episode of RVR Afib; she was admitted to the hospital.
almost 2 weeks post second dose, patient developed vestibular neuritis and significant positional vertigo.
Mild case of shingles, bothering me; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 15-APR-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine and experienced mild case of Shingles. The patient stated that the shingles was bothering him/her. The patient asked that could he/she get his 2nd vaccination now as he/she was experiencing the virus. Additional supportive information: The follow-up would not possible, as no contact details were available.
Seizure; Fever; Inadvertently given a dose of Pediarix instead of Infanrix; This case was reported by a nurse via call center representative and described the occurrence of seizure in a 16-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number D93B4, expiry date 14th June 2021) for prophylaxis.   Co-suspect products included Hib (Hiberix) (batch number S000355 ?, expiry date 10th October 2021) for prophylaxis and PNEUMOCOCCAL VACCINE (PREVNAR) for prophylaxis.   On 15th January 2020, the patient received Pediarix, Hiberix and PREVNAR. On 15th January 2020, unknown after receiving Pediarix and not applicable after receiving Hiberix, the patient experienced wrong vaccine administered. On 16th January 2020, the patient experienced seizure (serious criteria GSK medically significant) and fever. On an unknown date, the outcome of the seizure, fever and wrong vaccine administered were unknown.   It was unknown if the reporter considered the seizure and fever to be related to Pediarix and Hiberix.  Additional case details were reported as follows: The patient was inadvertently given a dose of Pediarix instead of Infanrix, which led to wrong vaccine administered.  This should have been dose 4 of DTaP for the patient. The patient also administered Prevenar and Hiberix. The patient experienced a seizure the next morning after vaccination, had fever and taken to the ambulance. It was unknown if the reporter considered the seizure and fever to be related to Prevenar. No further details were provided during the call. The reporter consented to follow up.
COVID-19 vaccine on 2/8/21. Next day had redness and swelling of one side of face. No other reaction. No fever. No pain.
Deep Soar and bruise in arm for 3 months. Severe pain in arm, tingling from elbow to finger tips for 5 months. Taking 6-8 tylenol daily. pain rating 1-10 pain level is 13
Temp 100; Headache; Chiils; Body aches; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 13Mar2021 at 15:15 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, high blood pressure and COVID-19. The patient had unspecified allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had unspecified concomitant medication. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Mar2021 at 11:00, the patient experienced temperature (Temp) 100, headache, chills and body aches. On 14Mar2021 at 11:00, the patient underwent body temperature test and result was 100 (unspecified unit). The events 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 events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events temperature (Temp) 100, headache, chills and body aches was not recovered at the time of this report.  No follow up attempts are needed. No further information is expected.
MACULARPAPULAR RASH ALL OVER BODY (ARMS, LEGS, BACK, NECK, AND CHEST) ITCHINESS AND REDNESS. WENT TO CLINIC 06OCT04 GIVEN CREAM ARISTOCORTA 2X A DAY. 12OCT04 GIVEN CREAM TRIAMCINOLONEACETONIDE 2X A DAY/ZYRTEC PILLS. 18OCT04 GIVEN CREAM ACTICIN ONE TIME A DAY LEAVE ON FOR 10-12HOURS, RUB ALL OVER BODY, THEN WASH OFF (PERMETHRIN) HYDROXINE PILLS FOR ICHING/TWICE A DAY, ONE/TWO PILLS (ATARAX). 20OCT04 GIVEN PRENEZONE PILLS 20MG TAPERED OFF 60MG FOR DAYS 1-2 60MG/DAYS 3-4 40MG/DAYS 5-6 20MG/DAYS 7-8 1/2 TAB/HYDROXINE (ATARAX) 25MG TWICE A DAY/TWO TO THREE PILLS. 28OCT04 GIVEN PRENEZONE PILLS 20MG TAKEN ONCE A DAY/HYDROXINE 25MG/TWO TO THREE PILLS TWICE A DAY 01NOV04. 20MG PRENEZONE TAPER OFF OVER 2 WEEKS IN NOVEMBER(2st-19th). 60MG DAYS 1-3. 40MG DAYS 4-12. 20MG DAYS 13-19 CREAM FLUOCINONIDE .05%  15 GRAMS TWICE A DAY HYDROXINE (ATARAX) 25MG  2x A DAY (TWO OR THREE PILLS)
11:20 onset of L arm itching, numbness and tingling down to hand.  Immediate evaluation by onsite EMS and NP. (vaccination time 11:05);  11:22 Benadryl 25mg PO administered. Ice pack applied to injection site. VS 125/90; P 76; O2 Sats on RA 99%.  Symptoms resolved by 11:50.  No changes in VS.  Discharged home.
Developed necrotizing lymphadenitis in axillary right arm and all the biopsies suggest is vaccine related.
I developed a headache and body aches around 8:00 pm. In the middle of the night, I woke up feeling nauseous and had a fever. I checked it three times over the course of several hours: It was 100.4, then 101, and then 100.8. I am taking Aleve and plan to take Tylenol.  I have been sleeping & resting.
cyst in my neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 74 year-old male patient received bnt162b2 (BNT162B2), administration date 31Jan2021 (Batch/Lot number: unknown) as dose1, single and administration date 21Feb2021 (Batch/Lot number: unknown) as dose2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CYST (non-serious) with onset 2021, outcome "unknown", described as "cyst in my neck". Therapeutic measures were taken as a result of cyst.  Additional information: Patient stated that  "Yesterday his  HCP prescribed antibiotics: sulfamethoxazole-tmp dx (generic for Bactrim) to treat a cyst in his neck would antibiotics detract in anyway the vaccine"  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Immediately after administration I had heart palpitations and sweating. The area on my arm grew to a golf size ball lump.  I had horrible anxiety and my depression pills felt like they were not working.
Week after vaccination broke out in itchy red hives all over body.  Taking Benadryl and steroids for 6 days and symptoms have not improved. Hives come and go throughout the day and are worst at night.
Aching from the inside out all over, fever up to 102, headache, nausea and awful fatigue for 3 days. The fatigue continued for 3 more days.
soreness; little tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness) and FATIGUE (little tired) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included Autoimmune haemolytic anaemia, Gaucher's disease type I, Kidney stones, Gallbladder removal, Arthrodesis and Shoulder replacement (both shoulders replaced). Concurrent medical conditions included Drug allergy.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced PAIN (soreness) and FATIGUE (little tired). At the time of the report, PAIN (soreness) and FATIGUE (little tired) outcome was unknown.        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.   Concomitant medication information was not reported. Treatment information as not reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-114568 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-114568:Dose 2
ADMINISTRATION ERROR: ADMINISTRATOR GAVE CHILD 2ND DOSE AFTER 2 WEEKS INSTEAD OF 3 WEEKS
An immunization coordinator is reporting an AE on behalf of a patient. The HBP reports that a nurse in the clinic drew up MMR-II and VARIVAX for a patient but the patient was not scheduled to receive those products. The HBP reports that the nurse cau; An immunization coordinator is reporting an AE on behalf of a patient. The HBP reports that a nurse in the clinic drew up MMR-II and VARIVAX for a patient but the patient was not scheduled to receive those products. The HBP reports that the nurse cau; This spontaneous report has been received from a other reporter and refers to a patient of unknown age.   The patient's concurrent condition, medical history and concomitant therapies were not provided  On 25-JAN-2023, it was reported that a nurse in the clinic drew up measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and varicella virus vaccine live (oka/merck)(VARIVAX) for a patient but the patient was not scheduled to receive those products. It was reported that the nurse caught the mistake prior to administration and administered the correct product to the patient. The reporter  did not know what product the patient was supposed to receive (wrong product administered and intercepted product administration error). No additional adverse event  details were provided . The outcome of wrong product administered and intercepted product administration error was unknown.
04/23/2021 13:00 Cardiac arrest from ventricular fibrillation. Collapsed, had immediate bystander CPR and EMS arrived quickly.  His initial rhythm was VF.  5 shocks were delivered as well as 2 rounds of epinephrine and 2 boluses of amiodarone.  ROSC was achieved
1st shot only moderate soreness next day. 2nd shot in approx 5 hours I had chills, headache, body aches, extreme exhaustion, swollen throbbing ears, fever, nausea,  and stomach ache went to bed woke up a 9 pm 102.5 fever barely able to function. Took Vicks 44 tried to sleep completely miserable. Took Tylenol to try to get fever down. Still so miserable I couldn't swollen because my ear pain was bad. My friend drove me to the nearest minor med. I couldnt tolerate any light, barely walk, dizzy and hurting all over.  My lymph nodes started swelling up all over my body. I am still in pain and hurting , exhausted 5 days later. I have kept a constant headache, still exhausted, and can rest with pain meds.
An expired dose was unintentionally given to the pt. This event was discovered at around 5:30pm when staff was salvaging vaccines as part of store-closing tasks, a few hours after the pt received 3rd dose. Pt had 1st dose in 2/9/21 and 2nd dose on 3/7/21. Pt showed no adverse effects/symptoms before leaving the pharmacy after administration. Unknown if something happened afterwards to pt. Pt will be notified of situation once upper management finalizes reviewing clinical Pfizer Covid vaccine data stability; revaccination is a possibility. Pharmacy workflow changes were immediately made to decrease risk of expired-dose administration reoccurrences such as ordering template expiration labels and incorporating the date of vaccine reconstitution as part of the label. Staff were all made aware of incident.
Minor AE's: Pain at the injection site and Fatigue. I took Tylenol for the pain.
Information has been received from a 53 year old female physician concerning herself who in March 2002 ("5 years ago"), was vaccinated with a dose of Pneumovax 23 (Lot# not reported).  Subsequently, in March 2002, the patient developed a huge injection site reaction with redness/erythema and swelling of the upper arm.  The physician reported that she recovered (date unspecified).  Additional information has been requested.
Pain - swelling at site of vaccine (L) deltoid. Pain in muscles of shoulder - back and chest persistent after 5 weeks. Range of motion decreased - pain all down (L) arm to wrist.
The vaccine did not prevent shingles as intended; persistent strain of herpes zoster or shingles; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a male patient of unknown age. His concurrent conditions, medical history and concomitant medications were not provided. On or about 16-SEP-2014, the patient was vaccinated with the zoster vaccine live (ZOSTAVAX) (strength, lot # expiration date, dosage, injection anatomical location and route of administration were not provided) at a clinic as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 31-DEC-2015, he was treated by a physician at a clinic, for a severe vesicular outbreak, which was diagnosed as herpes zoster. The patient was prescribed famciclovir for management of his painful symptoms and chronic pain. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (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, he had suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Therefore, the outcome for herpes zoster was not recovered, and for vaccination failure was unknown. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
About 4 pm, started feeling tired, rundown, by 6:30 had a fever and severe chills, got worse.  Went to bed at 8 pm, chills, fever, weak, achy, could hardly move.  Chills stopped about 10:30 pm, then slowly got hot, woke up sweating about 4:30 am.  Got up about 6:30 am feeling better but still weak, achy and tired.  Went back to bed about 9:30 am, got up at 11:30 am feeling better, just achy, tired and slight headache.  Reactions gone by 3 pm 3/26/21.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2008, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX 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 an unknown date in 2016, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe shingles. The outcome of the events is unknown. As a direct and proximate result of the 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. Additional information has been requested.
Erythematous macular papular rash involving face and trunk to a lesser extent arms.
pt recv vax 10JAN97 & on 12JAN97 pt exp a hive-type rash;
Patient states they had a shingles outbreaks approx. 5 weeks after the vaccine. The disease has resolved but he now has post-herpetic neuralgia
This spontaneous report as received from a nurse refers to 2 patients of unknown age. No concomitants were reported. On 15-MAY-2014, the patient was vaccinated with ROTATEQ inj, lot J015062, expiration date 13-OCT-2015 (dose, frequency, route of administration and indication were not provided) that was exposed to 8.8C for 10 days. No adverse effects reported. No product quality complaint (PQC) was involved. The outcome of events was unknown. On 02-JUN-2014 a phone call was placed to reporter. The receptionist stated they do not have any one by that name employed at this facility. No further information is available at this time. This report is linked to 1405USA013915 and 1405USA013916, 1406USA004906, 1406USA004908, 1406USA004909, 1406USA004913, 1406USA004914, 1406USA004915, 1406USA004863, 1406USA004881, 1406USA004891, 1406USA004896, 1406USA004897, 1406USA004900, 1406USA004901, 1406USA004814, 1406USA004830, 1406USA004831, 1406USA004832, 1406USA004833, 1406USA004835, 1406USA004837 by the same reporter link. Additional information is not expected.
Pt experienced fever for 4 days of 101 + and a rash for 3 days.
Patient received a seasonal influenza vaccine and fainted a few minutes after. She was pale and fatigued with low blood pressure for about 30 minutes and vomited after receiving a snack. Her color returned over the next hour and she was more alert, but fatigued for the rest of the day.
injection site swelling (size of dime); TThe one at the injection site itself, was an injection site swelling about the size of a dime, "a red area"/at the site where the shot was administered he has some red streaks; red streaks running from the site up to his neck and shoulder. It is very small. It looks like if he took a ball point pin and drew some lines; This is a spontaneous report from the Medical Information Team. A contactable consumer reported that a 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Batch/lot number: ELO142, via an unspecified route of administration from 13Jan2021 11:00 at SINGLE DOSE for COVID-19 immunization. Medical history included haemochromatosis diagnosed in the mid 90's and wa reported as hereditary it was too much iron in the blood, he goes once a month for therapeutic phlebotomy to reduce the iron in the blood; very rare bacterial infection called Arupense from an unknown; he has a slight case of asthma but mentioned that it was related to living on the coast with the mold and moisture and also has a little wheezing. Concomitant medications included ethambutol, montelukast, pravastatin, amlodipine; hydrochlorothiazide, lisinopril; colecalciferol (VITAMIN D), acetylsalicylic acid (ASPIRIN (E.C.) and rifampin for infection and blood pressure medications.  Patient had the first dose of the vaccine yesterday 13Jan2021. He has no discomfort, but at the site where the shot was administered, he has some red streaks running from the site up to his neck and shoulder. It was very small. It looks like if he took a ball point pin and drew some lines. However, the patient's wife said it was bigger than a ball point pen. It was jagged lines. The one at the injection site itself, the injection site swelling was about the size of a dime, a red area. He only discovered the red streaks about an hour ago on 14Jan2021, so there has not been no radical change. Patient has concerns; he wanted to know if he should seek medical advice. "Is it just a rash?", he asked. His doctor doesn't know about this yet.   No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
Post vax, the pt had lymph node swelling for 5-6 weeks and he was extremely tired.
Patient felt dizzy patient was placed supine , blood pressure measured. after 30minutes patient was feeling normal
Patient was inadvertently administered a booster dose from an expired batch/lot. Expiration date 12/21/2021; administration date 12/28/2021. Per routine procedure, patient monitored for 15 minutes after receiving the vaccine; no adverse effects noted.
Pt became pale, bluish in color & lethargic w/t102.8; 3 hrs post vax seen by MD in office; APAP given as per MD x 24 hrs; t99.8 p/2doses of APAP;
Patient given pediatric dose (5-11) when the age-appropriate dose was the adult dose (12+). This resulted in a lower-than-authorized dose administration error. Per guidelines, do not repeat dose and continue with schedule. No adverse reaction reported at this time.
Information has been received from a doctor of pharmacy and from a 56 year old female patient with rheumatoid arthritis who on 01-SEP-2010, was vaccinated SQ with 0.65 ml once dose of ZOSTAVAX (Merck) (Lot#: 664628/1018Y). Concomitant therapy included methotrexate. The patient stated that she was going to undergo RITUXAN procedure for arthritis in the future. The doctor of pharmacy reported that on 02-SEP-2010, the patient developed an injection site reaction after ZOSTAVAX (Merck). It began as swelling and redness along with a headache. On 03-SEP-2010, it became more red and swollen. The patient also stated that she had a "large rash that was red and inflamed around the injection site". The shot was given by the doctor of pharmacy. The patient did not seek medical attention. At the time of the report, the patient had not recovered. Follow-up information was received from other health professional who stated that the 56 year old female patient with no pre-existing allergies, no birth defects and no medical conditions, no illness at time of vaccination and no adverse event following prior vaccination, was vaccinated on 26-AUG-2010 (reported previously as 01-SEP-2010), SQ in the left deltoid with the first dose of ZOSTAVAX (Merck) (lot# 664628/1018Y) at 14:30. On 27-AUG-2010 (reported previously as 02-SEP-2010) the patient developed rash extending to elbow, redness, painful, hot, fever and itchy. There was no relevant diagnostic test and laboratory data. On approximately 02-SEP-2010, the patient recovered. No further information is expected.
Pt got hives and full body itching. To ER x 3 over 4 day period. Given Prednisone.
Rash occurred on (L) arm near the injection site; rash covered underside of (L) upper arm, persisted x 1 week, treated with oral antihistamine and topical steroid cream.
NauseaVomiting, MUSCLE TWITCH ON LT ARM AND SIDE Narrative:
Rash on left arm, appeared about one week after the Moderna shot.  Rash about 4 inches long, 1 - 2 inches wide on upper arm.  Slightly itchy.  Tender to the touch or in shower.
pt refused to move (walk, sit up) screamed when they tried to bend; ER administered pediaprofen & observed till pt showed signs of recovering;