chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Per mom- legs red swollen rash at the injection sites. Crying in pain, fever, imbalance according to the mother (Telephone message).
This spontaneous report as received from a consumer refers to his 51 year old female wife with latex's allergy. The patient's medical history included leukemia and bone marrow transplant. On 18-OCT-2012, the patient was vaccinated with a dose of PNEUMOVAX23 (dose, route and lot number were not reported). Concomitant therapies included TACROLIMUS. The husband's consumer indicated that his wife on an unknown date, experienced redness and swelling in the arms, tingling feet, respiratory failure, double vision and difficulty walking. At the time of the report, the patient's outcome for the adverse events was unknown. The relatedness for the adverse events with PNEUMOVAX23 was unknown. Upon internal review respiratory failure was considered to be an other important medical event. Additional information has been requested.
Son starting acting strange, uncontrollable babbling, yelling, crying.  Could not relax, wouldn't stop moving his hands and legs.  Glazed over look in his eyes, eyes were dilated.  Wouldn't sleep or calm down for almost 24 hours.  Excessive drooling, strange breathing, trouble walking, weakening in legs.
The most most adverse and extreme event occurred 4 days after the first dose and my neck pain in ongoing up to and including today (7/16/2021): constant NECK PAIN radiating from neck to upper left shoulder and back.  Some days  the neck pain is worse than others.  Most extreme when turning to the left.  1st Dose: for approx. 6 hours felt achy. 2nd Dose: Extreme thirst the following day and sweating. Right side of neck hurt for a couple of days.  For the next 3 months I could not focus on work. Easily distracted.  Unusual event on the morning of July 14 that lasted a couple hours: Sharp pain radiated from roof of mouth to the nose .
I started feeling extreme weakness in both of my thighs and I was not able to walk as far as I could the day before.
Ongoing shoulder/ top of arm pain in left arm following flu shot. Pain began upon injection and has been a problem since for three plus weeks now. I have been back to my PCP and to the Neurologist. Starting physical therapy for pain and having additional testing coming up. Range of motion problems with left arm. Sharp night time radiating pain.
The main concern is that this is the one and only time that his monitor alarmed, oxygen saturation read 78%. This event happened at 2:35am 10/8/2020. He was also very upset, inconsolable at times off and on for approximately 48 hours.  Please note- we did not immediately notify our doctor, we watched him closely. Discussed event with her months later. However, I feel this should be submitted.
Rash developed on wrists and upper shoulders on 04/12/2003.  Visited doctor for initial evaluation that night.  Rash spread by 04/13/2003 to face, neck, and back.  Small blisters and pimples characterized outbreak, symptoms spread to arms and legs by 04/15/2003.  Began to taper off by 04/17/2003.  Most visible symptoms gone by following week.  Was given Benadryl.
This spontaneous report as received from a healthcare worker refers to 4 unspecified patients of an unknown age. The patients' relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patients were vaccinated with improperly stored dose of GARDASIL 9 lot # L025737 (expiry date: 28-JUL-2017) (start date and dosage not reported). No adverse effect reported. The nurse reported a temperature excursion for the GARDASIL 9. No further details provided. This case is linked to case # 1603USA005930 and 1603USA003817 via same reporter link. Additional information has been requested.
1st dose on Oct/Nov2021, 2nd not received; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received intramuscularly in October or November of 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 26-SEP-2022 Reporter's comment: The case was reported by the patient's husband. The reporter stated that the patient not yet received her second Shingrix vaccine. The reporter did not give permission to contact HCP (Health Care Professional). The reporter did not consent to follow-up. Additional Supportive Information: Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to Incomplete course of vaccination. This case had been linked with case US2022137995, reported by the same reporter.; Sender's Comments:  US-GSK-US2022137995:Same reporter/ husband case
area on her arm where the vaccine was give that has a 3-4 inch diameter round red area that is is warm; area on her arm where the vaccine was give that has a 3-4 inch diameter round red area that is is warm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (area on her arm where the vaccine was give that has a 3-4 inch diameter round red area that is is warm) and VACCINATION SITE ERYTHEMA (area on her arm where the vaccine was give that has a 3-4 inch diameter round red area that is is warm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced VACCINATION SITE WARMTH (area on her arm where the vaccine was give that has a 3-4 inch diameter round red area that is is warm) and VACCINATION SITE ERYTHEMA (area on her arm where the vaccine was give that has a 3-4 inch diameter round red area that is is warm). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (area on her arm where the vaccine was give that has a 3-4 inch diameter round red area that is is warm) and VACCINATION SITE ERYTHEMA (area on her arm where the vaccine was give that has a 3-4 inch diameter round red area that is is warm) outcome was unknown.
Positive erythema 3 1/2 cm x 3 1/2 cm x 2 days pain to area - Tx with ice packs, ADVIL for pain.
This spontaneous report as received from a Medical Assistant refers to a patient of unknown gender and age. The patient was vaccinated with dose first GARDASIL 0.5 ml, intramuscularly on 22-SEP-2009. No other co-suspects were reported. No concomitant medications were reported. On 30-NOV-2012 the patient was in the office to receive the second dose of GARDASIL. No adverse effects were reported. No treatment information was reported. Additional information is not expected.
Administered adult dose of Hep B vaccine to client in error vs. adolescent dose. No adverse event noted at time of administration of vaccine.
Dizziness, severe Shaking, headaches, weakness, confusion, chest pain in lung area, worse arrhythmias, trouble urinating w/ yellow / orange pee, lung spasms (much more than before), abrupt waking at night. Small arm pain where shot was given, very tired.
whole body aches, bones and skin, everything hurt, HA fatigue, hands and head cold but body burning up.
2 episodes of shaking with fever within 24 hours of vaccination that sound like may have been febrile seizure.
7AUG93 mom reported 3 hrs p/immun; pt face got swollen, eyes watering, runny nose; called MD given DPH & doing better 9AUG93 pt is alot better;
STOMACH ACHE, PASSED BRIGHT GREEN STOOL Narrative:  Other Relevant History:
Information has been received from a consumer concerning, the patient's mother, her son (a twin, who also had the same experiences reported in WAES# 0905USA01034) with penicillin allergy who some time in 1999 was vaccinated with MMR II (dose, route and lot number not reported). There was no concomitant medication. The mother stated that after receiving the vaccine the patient had 104 degree fever, was making no eye contact, excessive activity, did not speak, had stomach issues and the in May-2000 at the age of 2 1/2 year old, was diagnosed with autism. The mother reported that the patient had genetic blood work done which came back negative and he was allergic to penicillin (manufacturer unspecified) and she also reported that the patient had made progress with 40 hours of therapy a week and she was unsure if the patient received any other vaccine at the time, he received MMR II. It was unspecified if the patient sought medical attention. Upon internal review, autism was determined to be an other important medical event. Additional information is not expected.
Vaccine was administered to patient on 11/1 patient then came to the pharmacy on 11/9 with her arm black, swollen, red, hot, and infected. Patient first spoke with Pharmacist and then myslef. Patient stated that her arm was hot and red and inflamed in the days following the shot. It spread to the point that she went to the doctor. The doctor informed her that the shot likely caused an infection in her arm that spread to her blood stream and moved down her arm. She was placed on a sling and antibiotics. She wanted me to understand that this was caused by the shot. She stated that if she had known a technician was giving the shot she would not have decided to get it. I informed her that this is a risk of a vaccination because bacteria can get under the skin whenever we break it. I also informed her that technicians receive the same training that pharmacists do and that we swab the injection site with alcohol for this reason. I told patient I would report this event and she agreed that was alright.
Shortness of breath, rash appeared on skin, chills, faint feeling, pain at injection site.
Temperature Excursion. Vaccine was stored refrigerated (2-8 degrees Celsius) for greater than 10 weeks.  Vaccine was stored for a total of 4 days past its beyond use date in the refrigerator.  Patient did not experience any adverse events at this time.
1/7 : 1 inch in diameter knot, very red, itched like crazy 1/12: 3 in diameter red spot, no knot, did not itch
Two cases of endocarditis after the vaccine; A spontaneous report  was received from a consumer concerning two unspecified patients who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event endocarditis after the vaccine.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the event the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patients experienced the event endocarditis after the vaccine. The event endocarditis, was considered medically significant.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event, endocarditis after the vaccine was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
After 20 mins after receiving the vaccine, Pt was sitting with his family when he started seizing. Seizure lasted no longer than 10 seconds. Pt was standing when he started decorticate posturing and drooling while being held by the mother. After the seizure, Pt was post ictal and was having difficulty realizing where he was. Pt was breathing normally, pale, and was A&Ox2. Pt started regaining consciousness and noticed his mother and started calming down. Pt vitals were taken on scene. Pt BP: 60/24, HR: 60, and 97 % on room air. 911 was contacted. Upon arrival, report was given to EMS and EMS did a full assessment and placed the Pt on the monitor. After Pt was evaluated, and vitals were taken, Pt parents opted from transporting their son to the ER via ambulance and decided drive him to the hospital on their own.
Pt became lightheaded and dizzy with BP 99/50, perioral cyanosis. Initial BP was 107/73, after lying down for approx 10 min, then sat up, and ate crackers 7 min after eating, BP 104/58 and asymptomatic. Pt developed hypotension after varicella was administered.
Horrible headache, naucious, dizzy, fever/chills. Slept from 3pm to 8am.
Headache.   Low grade fever.   Body aches.   Exhaustion.       Started 24 hours after shot.   And lasted less than 24 hours.    Symptoms are totally gone now.
smelling mild cigarette smoke smell; This is a spontaneous report from a contactable consumer, the patient. A non-pregnant female patient of an unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EJ1686) via an unspecified route of administration in the left arm on 01Mar2021 at 12:15 as a single dose for COVID-19 immunisation. Medical history included GERD and sulfonamide allergy (Sulfa drugs). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient received other medications within two weeks of vaccination, names were unspecified.  On 12Apr2021, the patient experienced smelling mild cigarette smoke smell. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event smelling mild cigarette smoke smell was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Information has been received from a registered nurse concerning her 10 year old daughter who in approximately 2000, at three years of age, was vaccinated with varicella virus live (Oka/Merck). On 20-February-2007, the patient developed a mild case of chickenpox, with less than 50 lesions and no fever at that time. Unspecified medical attention was sought. The nurse reported that chicken pox was going around at the local school. There was no product quality complaint. It was also noted that the patient's two sisters developed an adverse event after vaccination with varicella virus vaccine live (Oka/Merck) (WAES#0702USA04089 and WAES#0703USA06659). Additional information has been requested.
Pt received series of immunizations on 4/16/08 (immunizations listed below).  On 4/20/08, mother noted some redness developing of the right thigh at the site of an immunization.  She was taken to Hospital and evaluated.  The diagnosis of an early cellulitis was made.  Attempts to lance lesion failed and pt was started on augmentin.  I saw the pt on 4/21, 4/22 and 4/23 for follow up.  The lesion continued to develop with a margin of approx 2.5 cm with a central crater.  On 4/23, another attempt was made to retrieve purlent material.  No purulent material was obtained but serosanguinous fluid was obtained and sent for culture.  The culture grew 4+ pseudomonas aerugenosa, pure culture.  Pt was subsequently admitted on 4/24 for treatment.  Lesion has resolved with antibiotics.  Immunodeficiency workup was done and was negative for findings.  5/14/2008 MR received for DOS 4/24-5/1/2008 with D/C DX: Neutropenia, R Leg Cellulitis.  ER visit of 4/20/08 also sent. Pt initially presented on 4/20/08 with redness on the R thigh at one of the immunization injection sites (either Pediarix or Prevnar), as well as fever to 102'F. PE (+) for 2 cm of erythema with a central fluid filled pustule. DX R leg cellulitis. D/C home on abx.  Returned to ER 4/23/08 with increasing erythema and induration. Antibiotic changed to Septra with development of a red splotchy rash. Area now with induration 2.5 cm with a central area of white material in the middle of the lesion. Erythema 4.5x3.5cm. (+) warmth, tenderness and beefy redness. (+) abcess.  Lesion was I&D-cx (+). Abx changed to Fortaz and gent.  Wound improvement noted by HD#5. Given GCSF for continuing neutropenia. D/C home to f/u as outpt on Cipro po.
2nd day after vaccine muscle spasms all over. Especially legs and sciatica. Feet spasm. During night time waking up with numb hands and feet. This is day 10 post vaccine and I am still exhibiting these symptoms.
I awoke with pain in every joint in my body one 11-9-22 . As the day went on the pain was more intense. I had taken some  in the morning. So around 2 p.m. I took two Aspirin.  Around 2:30 P.M. I experienced  diarrhea which was very watery. I also had  a fever of  99.3 degrees.  and a slight headache.  During that night I awoke with  joint pain all over my body.
8SEP92 fever x 2 days up to 103.5; intermittent screaming episodes x 2 days; rash on lt hand & inside of arm; MD called advil ordered for pt; mom notified hlth dept 16SEP & pt doing OK x/ a little irritable;
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Nov2021 as dose 3 (booster), single (Lot number: 32030bd) at the age of 37 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer survivor (Nov2020)", start date: Nov2020 (unspecified if ongoing); "asthma" (unspecified if ongoing); "Known allergies: Tree nuts" (unspecified if ongoing); "Known allergies: soy" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was treated with Paxlovid for COVID-19. Treatment start date was 16Jul2022. Treatment stop date was 20Jul2022. Patient received no other medications in two weeks. Paxlovid rebound after 11 days from starting the medicine. Adverse event start date was 26Jul2022.  No follow-up attempts are possible. No further information is expected.
large red patch on skin around where vaccine was administered. Patient states it has been getting larger and is itchy.  about 6in in diameter
Not sure if coincidence, but ever since vaccine, my periods have been super erratic, super heavy, unpredictable, super painful, and have been skipping periods. This is very unusual for me, and although it could be age related, I have many other friends who noticed similar issues coinciding with the vaccine. Almost like the vaccine spurned me toward menopause at a faster rate. Again, could be coincidence, but thought it would be useful information if others are reporting it as well.
Pt began with itching about 1/2  to 1 hour, post vax, and within 2 hours, pt had tiny raised red rash on chest and stomach. 16 over body. By next evening (Wed) rash had extended to left ear and nose; acne-like rash. Pt's MD contacted by family (Wed) AM and he ordered Benadryl. By Thursday, 3/16/00 at 17:00, pt's rash and itching was abated.
Shaking, chills, headache, muscle aches, gums and teeth hurting, joints aching. After 24 hours symptoms receded but joints aching and patient tired.
Adult patient received pediatric dose; Adult patient received pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a patient who received HAV (Havrix) (batch number EP478, expiry date 6th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th March 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 9th March 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced accidental underdose and adult use of a child product. On an unknown date, the outcome of the accidental underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that adult patient received inadvertently a pediatric dose of Havrix, which led to accidental underdose and adult use of a child product. The reporter asked that we could administer another pediatric dose to make up an adult dose. The demographics from patient weren't available at the moment of the reporting. The reporter consented to follow up.
On second day after second dose (2/22/21) lump on arm below injection site, and enlarged lymph node on left side of neck.
After giving both vaccines in each arm. Pt went to have a seat in the waiting area, moments later the person with him came to the pharmacist window and stated they were fainting. I went out and assessed and they did seem pale but were coherent and lucid and stated they were not having trouble breathing and did not want to be administered an epipen. I stood by observing and gave some candy and water the pharmacy had and they started improving within 30 minutes. They stated they previously had a phobia of needles and were not sure if they had completely overcome the phobia yet. I suggested emergency services and they declined insistently.
Information has been received from a medical assistant referring to a 69 year old female patient with drug hypersensitivity for AUGMENTIN. The patient's medical history included myocardial infarction, osteoporosis, dyslipidaemia and diverticulum. On 22-APR-2015 the patient was vaccinated with PNEUMOVAX 23 lot # K019386, expired date 09-JUN-2016, intramuscular in the left deltoid as part of well-check visit (dose and dose number were not reported). Concomitant therapies included PLAVIX, ZESTRIL, metoprolol, CRESTOR, aspirin and NITROSTAT. On an unspecified date in April 2015, the patient developed left arm swelling. The patient called to the office on 23-APR-2015 to report the symptom, she visited the office on 24-APR-2015 in order that the physician could examine on her arm and was instructed to put moist compresses on her arm. No lab diagnostic studies performed. The outcome of event was unspecified by reporter. The causality between PNEUMOVAX 23 and the event was unknown. Additional information has been requested.
Sore and tender right arm, chills, muscle ache, joint pain, some nausea, fatigue starting at about 6 PM EST on 1/13/21, worse on 1/14/21 until around 5 PM EST, better on 1/15/21 with some fatigue, but all symptoms recurring again that evening starting around 7 PM EST. I took Tylenol 325 mg around 10 PM EST and went to bed and feel normal so far today 1/16/21.
I got my second covid shot October 14th 2021 and on Monday October 18th 2021 about 1100am my right ear starting ringing by 1300 I couldn't hear anything out of the right ear. By 1800 i could bearly stand up I went to the walk in clinic where i came really close to passing out BP was 190/100.  Got an appointment about the last week of October to see Dr E.N.T did hearing test that showed there was no form of sound being heard in right ear, had and MRI that showed no reason to not be able to hear anything in right ear. November 26th 2021 i was having surgery with Dr to get a cochlear implant to get some form of nomral hearing back