chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Varicella vaccine given 03/19/2001. Developed vesicular rash on pt lower extremity 10/04/2001. Pt very fussy with it and was scratch in it. Seen at urgent care 10/07/2001 and diagnosed varicella and given Acyclovir and Benadryl. On 10/09/2001 has excoriated vesicular rash confined to pt thigh, primarily anterior knee and one spot on pt lower back near spine.
Redness and rash at injection site.  Itchy, tightness, and dull pain.
A report has been received from a Health Professional concerning a Child, Male subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on an unknown date. The licensed practical nurse reported that fifteen days expired FLUMIST QUADRIVALENT was given to two patients. Neither patient has reported any adverse event symptoms. The outcome of the event of gave FLUMIST QUADRIVALENT that was 15 days expired is unknown. The report was considered to be non-serious by reporter.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. NO information regarding the patients' medical history, concurrent conditions or concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored doses of M-M-R II (lot # L015279 with expiration date 30-APR-2017, Lot # L024267 with expiration date 01-JUL-2017, and Lot # L027591 with expiration date 23-JUL-2017)(therapy type, dose, route of administration, and anatomical location were not provided). No adverse effect were reported. This is one of two reports received from the same reporter. Additional information has been requested.
The patient presented with symptoms similar to chilblains, a lymphocytic dermatitis.; This literature-non-study case was reported in a literature article and describes the occurrence of CHILLBLAINS (The patient presented with symptoms similar to chilblains, a lymphocytic dermatitis.) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   Concurrent medical conditions included Asthma.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLBLAINS (The patient presented with symptoms similar to chilblains, a lymphocytic dermatitis.) (seriousness criterion hospitalization). The patient was treated with CORTICOSTEROIDS (oral) for Chilblains, at an unspecified dose and frequency. At the time of the report, CHILLBLAINS (The patient presented with symptoms similar to chilblains, a lymphocytic dermatitis.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Biopsy skin: superficial and mid-dermal perivascular cuffed lym (Inconclusive) Superficial and mid-dermal perivascular cuffed lymphocytic infiltrate. Mild superficial dermal edema is present. No interface changes are present. There is no evidence of vasculitis or vasculopathy. Initial and multiple deeper sections were examined. Direct immunofluorescence of the skin showed no specific immunoreactants detected. In 2021, Blood immunoglobulin G: positive (Positive) Present one month post-vaccine. In 2021, Blood test: normal (normal) normal. negative inflammatory markers and autoimmune serologies. In 2021, SARS-CoV-2 test: negative (Negative) Negative and negative (Negative) Negative.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered CHILLBLAINS (The patient presented with symptoms similar to chilblains, a lymphocytic dermatitis.) to be possibly related.    It was reported that the patient will not get the second COVID-19 vaccine dose.  Furthermore, it was made known that the chilblains-like lesions suggest an antibody response from either 1 vaccine dose or a previous PCR-negative COVID-19 infection.  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.; Sender'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.
Pt presented with 2-3 days of right-sided chest pain and dyspnea.  CT demonstrates bilateral PE.  Pt prescribed apixaban.
Injection site hurt; Red rash covered her arm and  groin area; This case was reported by a pharmacist and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site pain and red rash. On an unknown date, the outcome of the injection site pain and red rash were recovered/resolved.   It was unknown if the reporter considered the injection site pain and red rash to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient received the 1st dose of Shingrix at the beginning of October and then her injection site hurt and she developed a red rash that covered her arm and groin that only lasted for 2 days. Pharmacist said that the patient experienced it after the 1st dose and just told her day before reporting. She did not have many details because she called from home but agreed to follow up via email. The reporter consented to follow up.
I got so sick; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 04-Dec-2020.  This case involves a patient of unknown demographics reported got so sick as got the flu shot and got the flu (influenza), while the patient received Influenza Vaccine.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was unknown.  On an unknown date, the patients received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, the patient reported got vaccine two times and got so sick (Illness), stayed in bed three days in misery, both times (influenza) unknown period of time after the administration of influenza vaccine.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.
Janssen COVID-19 Vaccine EUA. Mild body aches and chills. Injection site tenderness. Three 200 mg ibuprofen taken around 10 pm relieved symptoms
I started having a very mild, intermittent, dry cough throughout the day along with tiredness.
Slept 11 hours, woke up to shaking hands, body and joint pain, nausea, vomiting, muscle weakness, fatigue, fever. Not able to go to work.
Received vaccines 3/22/07, developed hives on stomach and back 3/25/07. On 4-3-07 saw a dermatologist and was diagnosed with pityriasis rosea.
Severe pain in both hands; This is a spontaneous report from a contactable nurse, the patient.  A 41-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: el0140) via intramuscular route of administration in the arm left on 09Jan2021 at 10:00 as a single dose for COVID-19 immunisation. Medical history included graves' disease. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ej1685) via intramuscular route of administration in the arm left on 18Dec2021 at 10:00 as a single dose for COVID-19 immunization. On 18Mar2021 at 08:00 the patient felt severe pain in both hands for the past month. The patient had no history of this. The event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe pain in both hands was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
march 13th -first covid vaccine (moderna)  march 3/25:  abdnormal movements noted Right arm followed by right leg...hospitalized from 3/25 to 3/29.  Neuroimaging negative for acute changes (records requested for review but not received by me yet)  Seen by me in telemedicine 4/1; he exhibited choreatheoid movements of right upper extremity and to a lesser extent, his right leg.  These seemed lower in amplitude than typical hemibalismus movements.  He was unable to control these movements (they were involuntary in my assessment) and followed commands with left side without problem.  Neurology consult was requested at the 4/1 visit but has not been completed as of today (4/15).  On follow up (4/15) patient and daughter inform me that these abnormal movments gradually decreased  and had grossly resolved as of april 9th 2021
Information has been received from a nurse practitioner concerning a 12 month old female who on 19-FEB-2009 was vaccinated with a dose of MMR II. 4-5 days post vaccination, the patient developed a fever and measles symptoms. At the time of reporting, the patient did not recover. The patient sought unspecified medical attention. Additional information has been requested.
I was diagnosed with a bladder stone that they were going to go in and get and when they went to do it, it was attached to a tumor in the bladder. Dx'd with Bladder Cancer. Then they did some testing on that and I have had a couple of surgeries. They went in twice to do the TURB procedure. The first time, they didn't take enough to get to the muscle of the bladder so they had to do it again. I start BCG treatments - I start those the 12th of this month for six weeks, once per week.
Swelling, redness, and hot injection site, fever, chills, vomiting, locked jaw, headache, muscle aches.
Started as a low grade fever, sluggish and lethargic after waking from afternoon nap-gave Motrin and he seemed much better. Then, during his bath 8:00 PM that evening, we noticed red circles about half in I diameter on his torso. They blanched when touched and were not raised but rather flush with his skin. Called dr; he said could be viral, allergic reaction or combination. No fever at this time. Recommended Benadryl. Did not have any, and child did not seem bothered, so we chose not to give meds. Next morning, 12/21/2011, tons more spots and they've changed in appearance. Some are still small red dots, se have tripled in size and joined together. Child again lethargic and clingy unlike himself. Gave Benadryl. He soon fell asleep. When he woke, he was still whiny and cranky. Gave Motrin and soon was playing and acting normal. Next morning, 12/22/2012, child covered in spots head to toe. Child very irritated and itchy now. Spots on back of head and neck and ears are bothersome to child. Ears dark red. Many of the spots on sides and underarm are raised and look like welts. They also appear to be more of a red raised ring instead of the whole spot being red as they had started. Chose to go to ER. Diagnosed with allergic reaction probably to vaccine.  Ran fever again through that night. Ongoing as this reaction is still active in my son.
Redness at the site, swollen eyelids, was also on a new prescription for Macrobid.
Pt was transported to the ED 9/2/21 for hypoxia and hypotension per her report.  She actually denied shortness of breath or cough but reported throat pain for the last few days which she attributed to thrush. Per EMS report, BP was 70/40, and SPO2 mid 80% on 2L. She received 1.5 L IV fluid in ED which corrected her blood pressure and was placed on NRB initially then weaned to HFNC but became hypoxic and was placed back on NRB.  Her ABG showed hypercapnia. Pt required admission to ICU.
Fever, achey body, foggy head, nausea, began at 8 am and continued throughout the day
Increased heart rate (resting between 100-110, moving and during activity 120-130) - normal heart rates between 55-70 Elevated blood pressure (155/100, 160/98)  - normal around 120/80 always
Severe back pain in September 2021, one week after contracting COVID-19. Got progressively worse despite treatment and hand tremors began in October 2021. Tremors in back and spine beginning November 2021.
Extreme dizziness, fatigue and lethargy with headache. Lasted for 18 hours.  Then general fatigue and slight headache lasted for another 24 hours.
The day after the 2nd vaccine, there was widespread rash over trunk of body - front and back.  This started about one week after the first vaccine, with a few areas on the abdomen; I did not connect this with the vaccine, until after the 2nd dose.  The areas started as round, crusty areas (almost like a ringworm look); no blisters or oozing.  within the week after the 2nd dose, my full torso was covered in this rash.  It was not itchy, unless I got overheated or sweaty;  my entire skin became severely dry and flaky.  The rash spread beyond the trunk to the arms and upper legs.  I received a steroid injection, after several weeks.  There was a biopsy done of one area; it returned as being  guttate psoriasis.  I have NEVER had any rash this severe.  I did not fit the causes of this diagnosis (strep throat for most); I did not even have a slight sore throat, and I certainly am not in the adolescent or young adult category. I have mostly recovered, but not fully.  I also developed pronounced vertical double vision.  With regular hydrating eye drops, this is being corrected.
Shingles after the first dose of Shingrix; He received the first dose 4 years ago; This case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, 4 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient needed to ask many questions about Shingrix. He received the first dose 4 years ago and now was developing Shingles. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient was transferred to the Patient Assistant department. The reporter mentioned he did not want to spend any more money until he get the information he needs.
Gave expired MMR to patient; This spontaneous report was received from a specific reporter, referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication and drug reactions/allergies were not provided.     On 02-SEP-2020, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, frequency, route were not provided; lot # R024907, expiration date 30-AUG-2020) for prophylaxis. The outcome of expired product administered was unknown.
24 hours post vaccination experienced intermittent mid sternal chest pain with short of breath lasting 2 days.  ? diaphoresis.  Did not seek medical care.  No return of c/p since then.
Patient reported back to the pharmacy on 10/15/2020 that ever since she received the adacel vaccine,  she has been experiencing "pins and needles" in hand (same arm as vaccine). She states its mainly in the evening when she lays down. However, she it "comes and goes during the day in her arm as well". It started the same night she received the vaccine, and has continued to persist. She also stated that she had bleeding at the injection site for several days after she received the vaccine. At the time of the vaccine, she had some bleeding as well, which prompted me to ask " are you taking fish oils or vit. e"?, which she replied "yes" to vit. e
had metal taste in mouth within the two hours my L Arm started to hurt more, it was burning / itching / feeling like it was stiffning, looked at sight and noticed something was wrong went and showed MA, she took me to show Dr. was advised that I was A having an reaction take some BenadryL go home f/u with
Information has been received from a nurse referring to an unspecified number of patients of unknown demographics. On an unknown dates the patients were vaccinated with improperly stored ROTATEQ lot # L027719, expiry: APR-2017 (dose and route were unknown). No adverse effects were reported. No further information was provided. This is one of several reports received from the same source. Additional information has been requested.
This case was reported by a other health professional via call center representative and described the occurrence of petechial rash in a 17-year-old female patient who received BEXSERO. On 8th April 2016, the patient received BEXSERO .5 ml. On 13th April 2016, 5 days after receiving BEXSERO, the patient experienced petechial rash. In April 2016, the patient experienced headache. On an unknown date, the outcome of the petechial rash and headache were recovering/resolving. It was unknown if the reporter considered the petechial rash and headache to be related to BEXSERO. Additional details provided were as follows: This case was reported by a other health professional, who herself was the patient's mother. The patient experienced petechial rash on her upper back which has spread to spinal column and on the same day the patient was taken to emergency room, but was not admitted. In April 2016, less than a week after vaccination, the patient also experienced slight headache. At the time of reporting, the side effects were better, but have not completely resolved.
became symptomatic 07/02/2021, rapid antigen positive 07/06.
pt recvd vax; unconsolable crying for 3-4 hrs; Lt leg red & swollen;
A non-serious spontaneous report of administration of expired medication was received from a health professional concerning a pediatric patient. Neither relevant medical history nor concomitant mediations have been reported for the patient. The product expired on 22-Nov-2010. The patient was administered the expired FLUMIST between 23-Nov-2010 and 03-Dec-2010. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
By midnight my husband had severe chills (he could not get warm no matter how many blankets he covered himself in) - severe headache - lethargic flu like - body aches - he was nervous and checked on me and my mom-  as we all got the in home vaccine together . We were both fine but he had side effects on the higher/ more severe end. Lasting about 24 hours where it then began to break into cold clammy sweats (he did use Tylenol starting about 3-4:00pm on the 25th and by the morning of the 26th he felt much better. The Vaccine did not write our lot number on our vaccine cards - I have to call and attempt to find out. I am reporting this in case it is helpful for others.  He did not have to be admitted anywhere but he would say that for those first 24 hours he was having side effects more on the severe side.
injection site pain - just mild from 3 pm 4/2 to present (1 am 4/6)  tiredness/fatigue - severe from 4 am 4/3 to 10 am 4/4  headache - mild in the evening on 4/2  muscle pain - severe from 4 am 4/3 to 10 am 4/4  chills - severe from 4 am 4/3 to 2 pm 4/3  fever - mild from 4 am 4/3 to 10 am 4/4  nausea - severe from 11 pm 4/4 to 1 am 4/5, resulting in vomiting   feeling unwell -  severe from 4 am 4/3 to 10 am 4/4  swollen lymph nodes (lymphadenopathy) - excruciating pain from 4 am 4/3 to 6 am 4/3, then severe to 10 pm 4/3, then mild on left side persisting to present (1 am 4/6)
Inner cranial pressure followed by migraine the following day. . Loud hi frequency squealing in both ears, still persists.
STROKE; BLOOD CLOT; FELL  DOWN; This spontaneous report received from a health care professional( Nurse) concerned an 86 year old male, The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes mellitus type 2. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 28-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  Post vaccination 2 week patient experienced symptoms. On(unspecified date) JUN-2021, the patient fell down and was and brought to the hospital via ambulance. On 12-JUN-2021 patient  was diagnosed with Stroke and was hospitalized 3 to 4 days. On (unspecified date) JUN-2021 patient for profound left sided weakness was in the nursing home. On (unspecified date) JUN-2021 patient had blood clot and it was reported stroke might had due to Blood clot but it was unsure was that due to Janssen Covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stroke, blood clot, felt down and profound left sided weakness was not reported. This report was serious (Hospitalization Caused / Prolonged) .; Sender's Comments: V0-20210705027-COVID-19 VACCINE AD26.COV2.S-Stroke, blood clot, fell down. These events are considered not related. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There are other factors more likely to be associated with the events than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE.
Information has been received from a medical assistant concerning a male who was vaccinated with a dose of Zostavax. Subsequently, the patient developed a non-painful rash on the neck, that the physician identified as shingles. Unspecified medical attention was sought. No product quality complaint involved. Additional information has been requested.
Started off with extreme fatigue the morning after the vaccine, then throbbing intense migraine started around 11 am that lasted until the next morning after which a dull headache lasting till Friday, 102.3 fever, EXTREMELY painful body aches, metallic taste in mouth, thirst that could not be quenched, dizziness, blurred vision, confusing, nausea.