chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received from a healthcare professional on 23 October 2012. A 6-month-old male patient, who had no medical history and whose concomitant medications were not reported, received a dose of FLUZONE (lot number: U4488EA) intramuscularly in the right deltoid and PENTACEL (Lot number: C4299AA) intramuscularly in the left deltoid on 16 October 2012. On 19 October 2012, 3 days after vaccination, the patient began shaking his head. The patient was taken to ER and was diagnosed to have ear infection. There were no laboratory investigations done. The patient received Amoxicillin as the corrective medication. The patient is also referred to neurologist, however the appointment is pending. On 22 October 2012, the patient was seen by MD and the ear infection had resolved, however the patient is still shaking the head. As of 23 October 2012, the patient had not recovered. List of documents held by sender: none. Follow up information received on 25 January 2013. On 27 October 2012 patient had developed coxsackie vesicles in oropharynx, rash on B/L legs and feet. Next visit after that 14 January 2013 no report of any issue or neurological deficit. Initial visit on 23 October 2012 no record of that specialty visit ever done.
Presented for HD need from missing due to illness; + Covid in ED; Admitted to tele for Covid PNA and hyperkalemia; tx with merrem, remdesivir, actemra, vancomycin, Zithromax, Rocephin, Vi D3, steroids, singulair, Zosyn, zinc, supplemental O2 initially; to HF O2 within 24 hours after arrival; Decadron started 9/20/21, increased to 6 mg bid 9/21/21 and 10 mg bid 9/22/21             - Remdesivir started 9/20/21             - Actemra dosed 9/21/21  9/24 pt with increased dyspnea; code blue called, intubated & transferred to ICU, multiple codes, ultimately leading to bradycardia and PEA.
Breakthrough COVID 19 infection not requiring hospitalization. Note:  This patient received 2 doses of Moderna as primary series and a Pfizer booster.
Pt recvd MMR on 25JUN90; 2 days later pt devel fever & achiness; pt recovered from exp;
Dad left office after checking out approximately 5 minutes after vaccines were given.  States that patient started sneezing,runny nose, face red, with c/o throat being dry.  Dad returned to office immediately. Benadryl was administered at approximately 2:20 p.m.
pt recvd vax;devel low grade fever;devel gen rash & more & more than 30 spots on legs & legs;spots turned into small red bumps,possibly chicken pox;RN stated mom was informed to treat pt's exp as a mild case of chicken pox;
pt reported swelling & soreness  @ inj site;onset was approx 4-6hr p/inj, soreness cont approx 5 days, swelling lasted approx 7 days;tx included ice for swelling & APAP for pain;
About 5 minutes into his post-vaccination observation, patient felt unwell and tried to get up to get help. We are on-site pharmacy located inside the Health Center. At the time, a nurse is monitoring patients at the observation area. He noticed the patient was pale and he reached over to grab the patient as he was about to fall/faint. The nurse took him back into one of the patient's room. His blood pressure was very low. Patient was given 2 boxes of apple juices and some Gatorade. He rested for another 30 minutes and he felt better. Then he left.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 27-AUG-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL with lot number: K010215, expiry date: 05-MAY-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
schizophrenia; cardiac arrest; This spontaneous case was reported by a consumer and describes the occurrence of SCHIZOPHRENIA (schizophrenia) and CARDIAC ARREST (cardiac arrest) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE and COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE and COVID-19 VACCINE.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In August 2022, the patient experienced CARDIAC ARREST (cardiac arrest) (seriousness criteria death and medically significant). On an unknown date, the patient experienced SCHIZOPHRENIA (schizophrenia) (seriousness criterion medically significant). The patient died in August 2022. The reported cause of death was Cardiac arrest. It is unknown if an autopsy was performed. At the time of death, SCHIZOPHRENIA (schizophrenia) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was reported. It was reported that, patient died of a cardiac arrest ,on the streets, some time in Aug 2022. No treatment medication information was reported.  Company Comment: This is a Spontaneous case reported by a consumer, concerning a male patient (age not specified), with no medical history reported, who experienced the unexpected Fatal serious (medically significant) event of Cardiac Arrest and unexpected serious (medically significant) event of Schizophrenia. Latency cannot be properly assessed, since vaccination date was not disclosed; however, the events occurred in the context of a dose (reported as initial booster) of mRNA-1273. It was reported that in August 2022, the patient experienced CARDIAC ARREST and the patient died in August 2022, on the streets. The reported cause of death was Cardiac arrest. The exact course of events which led to the fatal outcome was not disclosed. It was unknown if an autopsy was performed. At the time of death, outcome of schizophrenia was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704425:Child case; Reported Cause(s) of Death: cardiac arrest
Sore arm; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events a sore arm.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unspecified date( 7 or 9th Feb2021) prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event a sore arm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, sore arm was unknown.
Within about 4 hours, injection site was very sore. The following day it was a strain to lift that arm. On Tuesday (3 days after) around 12 pm I started having severe diarrhea and stomach cramps
pain on legs; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain on legs) and NAUSEA (Nausea) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included OLANZAPINE, ROSUVASTATIN, VENLAFAXINE, GABAPENTIN and CICLOSPORIN (RESTASIS) for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced PAIN IN EXTREMITY (pain on legs) and NAUSEA (Nausea). At the time of the report, PAIN IN EXTREMITY (pain on legs) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD21-076433, US-MODERNATX, INC.-MOD-2021-077818 (E2B Linked Report).; Sender's Comments:  MOD21-076433: US-MODERNATX, INC.-MOD-2021-077818:daughter
Pain in calves, feet, quads, hamstrings, lower and upper back, neck and head ache. Swelling in the shot location.
pt now seeing another MD since JAN96 had cerebral convulsion 2DEC96;mom also claims sz since vax;
Stung during injection, injection site itchy during 30 minute observation, tricep pain unable to lift arm above head about 6 hours after injection and last 48 hours. Slight headache started next morning. Went away with 600 mg dose of Ibuprofen. Day 3 thru 6 no visible reaction, pain or itching Day 7 injection site in afternoon was tender, swollen, warm and red (dime size) by 7PM deep red, warm, nectarine size inflammation, sore right triceps and armpit.
Headache: lasted ~48 hours, treated once with ibuprofen Muscle pain, joint pain: lasted 48+ hours Fatigue: lasted 24 hours Inflammation and soreness at injection site: lasted 48+ hours
On February 26, 2021 I received my first COVID Moderna vaccination. On Monday, March 1, 2021 I started having difficulty getting a deep breath. I went to the doctor three weeks later and she gave me an albuterol atomizer. I started feeling a little better. She advised me to go ahead and get my second COVID Moderna vaccination. On Friday, March 26, 2021, I received my second COVID Moderna vaccination. On Monday, March 29, 2021, I started having an increasingly harder time getting a deep breath again.
fever, chills, edema, rash, joint pain see Dr.'s dictation from office visit 2/3/2020 Patient here this morning to talk about a reaction that she believes is secondary to her Shingrix injection. She had her first shot in October and her second 1 at pharmacy on Thursday night. She said that evening she began having chills and fevers and by the next day she started noticing some swelling in her face and eye area. She says when she woke up Saturday morning her eyes were completely swollen shut. She says she feels like there is some fullness in the throat. She says now the swelling in her face is getting better but she has the swelling in  her lower legs and her joints ache. She also thinks she has a little bit of a new rash on her face. She has been taking some Benadryl but all that is doing she says it makes her sleepy.
11/2/16-Pt reported site symptoms: (L) arm soreness, tender, hot to touch, pain radiating to shoulder, sign bicep swelling, temp 100.3F, (R) flank pain, urinary frequency.
Patient reported one day post immunization moderate body aches, headache, severe throbbing injection site.
Approximately 20-30 seconds after receiving the shot, my blood pressure dropped, my heart rate accelerated, my face was pale while the rest of my body was flushed and I broke out in a cold sweat. I instantly felt light headed and my ears felt plugged. I was instructed to lay my head down and was given a juice and cookie.  At the time, I was told it was syncope and it was ?normal.?  The symptoms resided after approx 5 minutes, but I continued to feel very out of it for the rest of the day. Since then, I?ve been told those are signs of cardiac anaphylaxis and my doctor encouraged me to report it to VAERS and not get the second dose.  I give blood samples regularly and get my flu shot and have never had this reaction, so I know this was not a ?fear of needles.?
Patient reported fever, headache, swollen red hot to touch  left arm with several blister that itched real bad, itchy fluid filled blisters to mid area on left side of torso.
PATIENT COMPLAINED TO PARENT THAT SHE COULDN'T HEAR ANYTHING, THAT SHE COULDN'T "FEEL HER EARS" WITHIN 5 MIN AFTER BEING VACCINATED. PT SOON AFTER BECAME UNSCONSCIOUS AND FELL ON THE FLOOR. RPH WAS CALLED TO THE SITE AT THIS TIME. PT GAINED CONSCIOUSNESS ~2-5 MIN AFTER RPH WAS PRESENT. PT THEN HAD A SEIZURE THAT LASTED ABOUT 5 MIN; PT WAS SCREAMING, ASKING MOM "TO MAKE IT STOP." SHE LATER FELT BETTER BUT WAS FEELING TIRED.
Fever (high of 102), body aches, nausea, diarrhea, Covid Arm rash, rash on chest area up left side of neck and ear and across forehead, overall feeling of anxiousnesd
I felt very Dizzy and head spinning off balance.  Mainly the main problem as of now is have a rash all over my face and neck  and itchy all over my face and neck. I am also very bright red and in spot in my face is burning.
NAUSEA; HEADACHE-MIGRAINE ON THE RIGHT SIDE OF THE HEAD; PAIN DOWN THE NECK; SORENESS AT INJECTION SITE; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's past medical history included low blood sugar, and concurrent conditions included migraines, and other pre-existing medical conditions included half-se asian,  half white woman. The patient had no known drug allergies. Patient reported that she usually has lots of bruising with injections but in this case there was no bruising at all. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,) dose was not reported, administered on 22-MAR-2021 in left arm for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On 22-MAR-2021, the subject experienced headache-migraine on the right side of the head. On 22-MAR-2021, the subject experienced pain down the neck. On 22-MAR-2021, the subject experienced soreness at injection site. On 25-MAR-2021, the subject experienced nausea. Treatment medications (dates unspecified) included: ibuprofen, acetylsalicylic acid/caffeine/paracetamol/salicylamide, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness at injection site on 22-MAR-2021, and nausea on 25-MAR-2021, and had not recovered from headache-migraine on the right side of the head, and pain down the neck. This report was non-serious.
This spontaneous report as received from a nurse practitioner via a company representative refers to a 13 year old female patient. On an unknown date the patient was vaccinated with the first dose of GARDASIL (dose, route, frequency, lot# and expiration date were unknown). The patient did not receive the second dose of GARDASIL until a year later. Additional information has been requested.
I experienced a breakthrough case of COVID-19 with runny nose, cough, chest congestion and body aches.
Rash on upper arm-same as injection arm. Stinging and soreness.  Treated with analgesic cream.
sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Seven days after shot, left arm injection site became swollen and tight. Red circular rash and painful to touch.  Arm itched and skin felt dimpled if touched. Fever at the injection site. All symptoms Lasted about a week.
The patient experienced left-side chest pain 2 weeks post-vaccination. In the 3rd week, the patient experienced coughs and body aches. Referred the patient to go see her primary care doctor.
Same day post vax, the pt became clammy, complained of abdominal cramps, vomiting, diarrhea, and extreme weakness. Took a suppository with relief.
She had that with the first two vaccines at the injection site in the arm. With the first two vaccines she had pain in left arm.; She had that with the first two vaccines at the injection site in the arm. With the first two vaccines she had pain in left arm.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single and administered in arm left, administration date May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 2021, outcome "recovering" and all described as "She had that with the first two vaccines at the injection site in the arm. With the first two vaccines she had pain in left arm.". Therapeutic measures were taken as a result of vaccination site pain, pain in extremity.  Additional information: It was reported, the patient was calling about Pfizer COVID vaccine booster shot. She had it last done last Monday, 15Nov. She woke up two days later and her left toe and the bones on the front of her foot were swollen. She didn't know she would get that side effect. She had been in and out of a headache. She would have a headache for a few minutes and it would come and go. She had a swollen tongue and tightness of chest. She could hardly breathe. She had shortness of breath, runny nose, and a slight decrease in appetite. The hardest thing was the big fat swollen tongue and the swelling of left big toe and the bone structure on the front of the foot. She got severe pain in her arm at the injection site. She had that all day on Tuesday and thought it was normal. She had that with the first two vaccines at the injection site in the arm. She thought that would go away. She took tablets and was getting better. She could hardly breathe on Wednesday. Her big toe was swollen and she had wicked sore bone and joints. She is ok now and it went back to normal. In April and May caller got the first two vaccines.  Follow-up attempts completed. No further information is expected.
Pt states at site of injection, left deltoid, she is experiencing red, raised bump, swelling in he rlymph node under her arm pit and headaches.
mom called 20OCT93 10AM & stated pt started running fever last noc 19OCT93; was fussy & not eating or taking bottle; dx pt w/ear infection w/no rxn to vaxs;
Acute pain at injection site 4 weeks after getting 2nd vaccine, experienced normal injection site pain of 48 hours then pain returned 4 weeks later and it was triggered by moving my arm and is not tender to the touch. Seems to happen more in the am
Most people don't complain about flu like symptoms / that last more than 24 hours; Most people / referring to body aches; Most people / referring to / chills that kind of thing; This case was reported by a nurse via call center representative and described the occurrence of influenza-like symptoms in an unspecified number patient's who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, general body pain and chills. On an unknown date, the outcome of the influenza-like symptoms, general body pain and chills were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, general body pain and chills to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable. Nurse reported that most people did not complain about flu like symptoms following Shingrix that lasted more than 24 hours. Most people got over with it in a day or so, about 24 hours.  The nurse referred to body aches, chills that kind of thing. The reporter consented to follow up.  No additional details are available. At the time they didn't even report it because we had told them what to watch out for. This case is linked with US2021AMR139399, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR139399:Same reporter. Case for: Maybe 15 people. US-GLAXOSMITHKLINE-US2021AMR139611:Same reporter. Invalid case for 1st dose.
Mother states patient developed "staring spells" 1-2 weeks after vaccine (GARDASIL) given. Episodes happened after 1st and 2nd vaccine. Refused 3rd injection.
Information has been received from a medical assistant for GARDASIL, a Pregnancy Registry product, concerning a 19 year old female patient with no allergies or drug reactions and no pertinent medical history who on 01-MAR-2011, was vaccinated with the first dose of GARDASIL 0.5 ml, subcutaneously (lot number 666121/1778Y, Exp:19-AUG-2012). Concomitant therapy included prenatal vitamins (not specified), fish oil and ZOFRAN. It was reported that the patient did not receive any concomitant vaccinations at that time. On 02-MAR-2011, the patient became pregnant her EDD (estimated delivery date) was estimated to be on 07-DEC-2011. On 11-MAY-2011, the patient experienced "spotting", the patient was assessed in the emergency room and an ultrasound confirmed a viable fetus with an audible heartbeat. The medical assistant reported that the patient came to the physician's office on 13-MAY-2011, because the patient was experiencing continued "spotting" and the patient "miscarried". The medical assistant stated that no treatment was commenced for the miscarriage. At the time of the report the patient was recovering, it was stated that the patient had recovered from the miscarriage. Upon internal review, miscarried was determined to be an other important medical event. Additional information has been requested.
Fever/body ache on day 4; Fever/body ache on day 4; Headache on day 2 and 3; This is a spontaneous report from a non-contactable consumer (patient). A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686) via an unspecified route of administration at left arm on 06Jan2021 14:45 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced headache on day 2 (reported as 08Jan2021) and 3, fever/body ache on day 4 (10Jan2021). Patient received Ibuprofen as treatment for the events. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. The outcome of the events was not recovered.   No follow up attempts are possible. No further information is expected.
Teeth chattering; 103 fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Teeth chattering) and PYREXIA (103 fever) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced CHILLS (Teeth chattering) and PYREXIA (103 fever). At the time of the report, CHILLS (Teeth chattering) and PYREXIA (103 fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 degree Celsius (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported. Treatment details included Not provided