chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 08-MAY-2012, the patient was inoculated with ZOSTAVAX by a healthcare provider to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided). On an unknown date, the patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of patient's injuries. The patient was treated by a physician for shingles on or about 27-DEC-2016. The lawyer reported that as a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death - aggravation of preexisting conditions and activation - of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
Child received separate doses of DTaP, IPV, Hib, Prevnar and HBV. Child cried vigorously and then described as "very quiet." Became pale and diaphoretic within 2 minutes after injections. I examined the infant approximately five minutes after the symptoms began. The infant had mild pallor and diaphoresis. Held in mother's arms and appeared to be staring, not responsive. Infant began to cry and move spontaneously immediately upon being placed on exam table. Heart rate 110, respiratory rate not recorded. Was breathing without distress. BP 92/36. Extremities were warm and pink with brisk capillary refill. Infant's pallor resolved within minutes. Began breastfeeding without difficulty within approximately 15 minutes after event began. Vital signs remained stable and WNL. Infant was discharged from the office after observation time of approximately 30 minutes. Follow-up phone call to mother was made approximately six hours after event. Baby described as "a little sleepy" but otherwise appeared well, back to usual activity and normal feeding.
Rash appeared at the injection site couple days after the injection.  A week later, about an inch below the injection spot, a large egg size spot showed up, it was red, swollen. It was very itchy also painful when touching. It lasted about 2-4 day. Now sometimes, I feel a little itchy on that arm, but no redness.
Large local reaction - 4 x 4.5 inches 2 days after vaccine.  Progressed to include elbow so became concerned about septic joint vs cellulitis vs local reaction.  MRI negative for septic joint. Treated with Keflex. No fever.  Contracture of elbow developed as erythema/swelling resolved.  Contracture resolved without intervention over next few weeks.
Patient c/o of tingling in the legs about 15 mins after receiving the vaccine. Patient also c/o of warmst in the chest area
Rash to face, chest and back, also upper respiratory symptoms (cough, runny nose.)
Urinary tract infection; More than 36 days have passed since first dose given (6Mar2021), still hasn't had 2nd dose; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of URINARY TRACT INFECTION (Urinary tract infection) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced URINARY TRACT INFECTION (Urinary tract infection) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced INCOMPLETE COURSE OF VACCINATION (More than 36 days have passed since first dose given (6Mar2021), still hasn't had 2nd dose). The patient was hospitalized on 02-Apr-2021 due to URINARY TRACT INFECTION. At the time of the report, URINARY TRACT INFECTION (Urinary tract infection) and INCOMPLETE COURSE OF VACCINATION (More than 36 days have passed since first dose given (6Mar2021), still hasn't had 2nd dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use was not reported.   Treatment information was not reported.   It was noted by the reporter that the event "urinary tract infection" was not due to the vaccine but due to something that the patient ate.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, 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 events, a causal relationship cannot be excluded.
A spontaneous report has been received from a consumer. The report concerns a male patient (age not provided) of Unknown ethnic origin. No medical history was reported. No concomitant products were reported. During 2009, the patient received the H1N1 FLUMIST (intranasal) once/single vaccine and died from reaction. It is not known whether an autopsy was performed. The cause of death was vaccination adverse reaction. The case was considered as serious due to fatal outcome. Sender's Comments: The fatal event of vaccination complication is not listed in the company core data sheet for FLUMIST. Due to limited information on patient's demographics, medical history, exposure to specific risk factors, concomitant drugs, dose and start date of the suspect drug, onset date and circumstances of the event, diagnostic and aetiologic workup and the absence of autopsy report it is not possible to make a conclusive assessment of the causal relationship between the event and suspect drug. Reported Cause(s) of Death: RECEIVED THE 2009 H1N1 FLUMIST VACCINE AND DIED FROM REACTION.
104 fever; chills; headache; swollen lips; blisters; felt something happen inside her chest; lips started getting red and kind of hurting; lips started getting red and kind of hurting; sick; This is a spontaneous report from a contactable consumer (patient). A 46-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EW0151), via an unspecified route of administration, administrated in left arm, shoulder on 09Apr2021 11:45 (age at the time of vaccination 46-years-old) as a single dose for COVID-19 immunization. The patient's medical history included migraines, thyroid, and Covid last year patient did have Covid last year and was not as bad as the vaccine. Patient's family medical history included Mom had thyroid, and Dad had migraines. The patient's concomitant medications included Eletriptan, as 40 mg, (lot number PA03110, expiry date: 20Nov2022), takes when she has headaches of Migraine; Ajovy [Fremanezumab Vfrm], as 225mg injection, once a month from Feb2021, first one and from 16Mar2021, which was the second shot, for Migraine; and Methimazole as 2.5 mg (2.5mg, half of a 5mg tablet), Has been taking over 10 years for thyroid. On 09Apr2021 23:00, the patient experienced 104 fever, chills, headache, swollen lips, blisters, felt something happen inside her chest, lips started getting red and kind of hurting, and sick. On an unspecified date, the patient underwent lab tests and procedures which included antibody spike, Antibody test: 250 Uml, Positive; Nichler antibodies, Antinuclear antibody: Positive, reactive positive; and on 09Apr2021 Body temperature: 104 Fahrenheit, Positive; and on an unspecified date 2021 had Covid, SARS-CoV-2 test: Positive, Caller also reports that she had a positive antibody test, but she also had Covid before getting her first vaccine dose. Treatment was received as a result of adverse events which included Tylenol, took it every 4 hours because the fever was not going lower than 100; Benadryl; Got a little cream, does not know the name, thinks it is Abreve, it is a little cream in a very small tube. They say to use it for sore throat and lips and all that, does not have the tube with her so does not have the exact spelling of the medication; and Bags of ice and Tylenol, also has pills that she usually takes for migraines, to make the headache go away, but it didn't work. No prior vaccination within 4 weeks. The outcome of the events 104 fever was recovered on 13Apr2021; swollen lips recovered on an unspecified date; and other events chills, headache, blisters, felt something happen inside her chest, lips started getting red and kind of hurting, sick was unknown.  No follow-up attempts are possible. No further information is expected.
Racing heartbeat (143-157 bpm) waking from sleep.which lasted approximately 30 min. Consulted primary Dr office. They did EKG and sent me to hospital emergency room. I was admitted for overnight stay. Ultrasound and catheterization procedure was done. No blockages or issues found. No previous issues know. Last nuclear stress test was done in 2017 with no issues found. Currently on 24 hr heart monitoring.
Mild typical symptoms  happened 15mins after the shot-Patient felt a sense of a pulse inside their head-  felt pressure their head. Sore arm the next day, lasted for a few days. Actual Symptoms began 7 months after the shot. October 1st - got flu shot- PVC disc appeared on right arm. Aches and Pain- 6:30pm bruising. Distorted vision -lasted 2mins. Blurry vision still exist. Day 2 after vaccine, i got a one sided headache- happens around the back of the head, body ache, Burning tongue Got ill for almost a week. In august 2021, I got shingles at the back of my ear.
Breakthrough case admission after 3 vaccines Pfizer 2/27/21 lot# EL3248;  Pfizer 3/20/21 lot# EL9265;  Pfizer 12/16/21 lot# 33130BA
pain and inflammation was greatly reduced on left knee (osteoarthritis); difficulty falling asleep.; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: ER2613), via an unspecified route of administration in the left arm on 20Mar2021 at 14:30 (at the age of 71-years-old) as a single dose for COVID-19 immunization. Medical history included osteoarthritis of both knees, and aortic stenosis. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included apixaban (ELIQUIS), metoprolol, losartan, loratadine (LORTADINE), calcium. The patient did not receive any other vaccine within 4 weeks of the vaccination. The patient previously took erythromycin and experienced allergies, and previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6198) in the left arm on 27Feb2021 at 14:30 for COVID-19 immunization. On 20Mar2021 at 20:15, the patient had difficulty falling asleep (that night only). It was also reported that on 20Mar2021 at 20:30, 6 hours after vaccination, the patient's pain and inflammation of the left knee (osteoarthritis) was greatly reduced, and 48 hours later, still greatly reduced pain. The patient was not treated for the event difficulty falling asleep. Since the vaccination, the patient was not tested for COVID-19. The clinical outcome of difficulty falling asleep was resolved on 21Mar2021, while of "pain and inflammation was greatly reduced on left knee (osteoarthritis)" was unknown.
The patient was mistakenly given COVID 19 Pfizer|BioNTech bivalent booster (gray cap) 0.3ml which is recommended for ages 12 years old and older. The patient reported tenderness around the vaccine injection site lasting for one day and has had no further complaints and is feeling well.
rash-sibling dx w/chickenpox yesterday erythematous macules over trunk & extremities;vesicles on toe;
PT received the JEV the afternoon prior. PT returned to the immunizations clinic about 24 hours later stating nausea and vomiting that started the next morning when he woke up. PT stated he was unable to keep food down but was able to hydrate. PT stated he will wait 24 hours prior to seeing a physician unless symptoms become worse.
COVID Positive on 30May2022; COVID Positive on 30May2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Lot number: EL9264), in left arm, on 22Feb2021 as dose 2, single (Lot number: EN6200), in left arm, on 19Aug2021 as dose 3 (booster), single (Lot number: EW0186), in left arm and on 21Jan2022 as dose 4 (booster), single (Lot number: 330368D) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Autoimmune Hepatitis" (unspecified if ongoing); "Primary Billiary Cirrosis" (unspecified if ongoing). The patient took concomitant medications. Patient had not received any other vaccine in four weeks. Patient did not had covid prior to vaccination nor been tested post vaccination. Patient had no known allergies.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30May2022 at 15:30, outcome "recovering" and all described as "COVID Positive on 30May2022". The event "covid positive on 30may2022" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30May2022) Positive, notes: COVID Positive on 30May2022; (20Sep2021) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
Painful rash and pruritus. Described as erythematous, inflamed and itchy. Onset: 1 day ago. Location is right leg. Denies relieving factors. She received the MMR/VARIVAX yesterday in that leg.
Approximately three weeks after immunizations had dizziness, itchiness, flu like symptoms 2/6/03 mild urticaria noted in both upper arms abdomen and both inner thigh area.
Moderna COVID-19 Vaccine EUA: patient presents to clinic for follow-up for all-over body rash that developed nine days after second vaccine dose. Patient also reports myalgias, sore arm, and chest tightness after vaccination that resolved. Patient initially seen  12 days after vaccination and reports they tried topical cortisone, diphenhydramine, and loratadine and states topical cortisone provided some temporary relief. Patient advised to continue oral antihistamines and topical steroids. Three days later patient returned to clinic and prescribed prednisone and will follow-up with allergy clinic.
Significant morbiliform rash noted to bilateral arms, abdomen, back, and proximal legs with erythromelagia to hands and feet, including the palms and soles (accompanied with significant pain which caused inability to ambulate)
Around the time of receiving the first dose, I began experiencing hives in a linear pattern. I have been getting hives everyday since I got the shot in my thighs, chest, abdomen, arms, and back. Begins by feeling the urge to itch and once I start itching, raised bumps in a linear pattern will appear every where. Symptoms are only alleviated by taking Zyrtec daily. If I go more than one day without taking a Zyrtec, I begin to break out in hives at random time throughout the day every day. I have no previous allergies to food, no changes in my lifestyle or diet either.
No adverse event occurred, other than administering the wrong vaccine to the patient.  Patient remained on site for 15 minutes after injection with no adverse reaction or event.
PATIENT WAS ADMINISTERED AN UNDILUTED DOSE (0.3 mL) OF PFIZER VACCINE BY EMT VOLUNTEER VACCINATOR FROM FIRE DEPARTMENT DURING OUTREACH CLINIC. HEALTH DEPARTMENT PROVIDED VACCINE AND SITE COORDINATION.
Intense pain in toe and bottom heel of one foot.  2 months later it still there and now is starting to have same symptoms in other foot.  Like glass crystals where can't walk.  Almost a gout experience (never have had gout).  Also arthritic symptoms in 2 fingers on right hand.  Never had arthritis. Symptoms have not gone away.
Headache, Myalgia & Arthralgia Narrative:  dose 2-day 2-4-arm pain; day 2-3-jointpain; aches; chills; ha
Child had rash for 10 days.  Fever for 1 day that reached 100 degrees.  Advil was given for 1 day.  No complications, no pre-existing conditions.  Had less than 50 pox.
EVENT: Patient reported being hospitalized due to having a drug reaction to the Moderna COVID-19 vaccine booster shot
Severe drop in blood presure leading to waterfall stroke and seizure.  According to neurologist brain damage is permanent and non reversible.
Tested positive for covid after being vaccinated for greater than 2 weeks.  With symptoms of cough, chest tightness, headache, stuffy and runny nose, loss of smell and taste
Diarrhea; Lethargy; Queasy stomach; This spontaneous case was reported by an other health care professional and describes the occurrence of DIARRHOEA (Diarrhea), LETHARGY (Lethargy) and NAUSEA (Queasy stomach) in a patient of an unknown age and gender who received mRNA-1273 for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2022, the patient received third dose of mRNA-1273 (unknown route) 1 dosage form. On 10-Jan-2022, the patient experienced DIARRHOEA (Diarrhea), LETHARGY (Lethargy) and NAUSEA (Queasy stomach). At the time of the report, DIARRHOEA (Diarrhea), LETHARGY (Lethargy) and NAUSEA (Queasy stomach) had not resolved.        For mRNA-1273 (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment details were reported.
evening p/vax, pt refused to walk-seemed d/t more than pain from shot-dead weight & would collapse;refused to eat only wanted to sleep;no fever;by morning the next day was walking w/limp & eating much better;?hyporesponsive or circulatory
Approximately 11 hours post injection awoke from sleep with severe bone and joint pain and chills. After one hour, developed skin sensitivity and muscle aches. At this time temperature reading 100.4. After two additional hours of rest and hydration all symptoms intensified and temperature now reading 100.6. Symptoms and fever persisted for a total of roughly 12 hours with fatigue lasting the entirety of the following day.  Was not able to attend work due to severity of symptoms.
Right side facial swelling and right eye twitching sensation. Given Benadryl 50mg.
Pain injection site/Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Pain injection site/Soreness at the injection site) in a 78-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 02-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced INJECTION SITE PAIN (Pain injection site/Soreness at the injection site). At the time of the report, INJECTION SITE PAIN (Pain injection site/Soreness at the injection site) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) was unknown.       No concomitant medication was reported.,  Pain and soreness at the injection site, its been almost 4 weeks since injection and getting worse It was unknown if the patient experienced any additional symptoms/events.  No treatment information was reported.
Had flu shot at same time as Shingles shot, one in each arm.  May never have had chicken pox (that may make a difference). Severe itch and pain on neck and all the way down the back. Pain and itch is worse on the left side of the neck, but is all over the back.  Severe dizziness and nausea (including vomiting). Constant headache.
Myalgia, Arthralgia, Fever, Chills Narrative:  Took Advil
Hives , itching on various parts of the body. Went to the ER and got a steroid shot and 3 days of 20 mg. of prednisone
Child's mom noted child had flushed face on 4/7/01 and child complained of stomach rash (not visible to mom). Mom gave child Benadryl and symptoms have since, faded. Fraternal female twin complained of more severe symptoms: redness, large bumps on abdomen and back with itching. Mom denies that children have had new clothes, food, or soap in the last few weeks. Mom stated that she did just start back to using Downy fabric softener on 4/1/01, after not using it for several months. She stated that she had used different scents in the past, was using the green label now (? mt. spring scent).
Patient got the first dose more than 36 days ago and has not got the second/second dose beyond 42 days; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient got the first dose more than 36 days ago and has not got the second/second dose beyond 42 days) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient got the first dose more than 36 days ago and has not got the second/second dose beyond 42 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient got the first dose more than 36 days ago and has not got the second/second dose beyond 42 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.  Patient took the first dose of the Moderna COVID-19 vaccine and was unsure about date, he was confused it being mid of March 2021 but in his calendar he has 17-Feb-2021 and the date was not recorded in the vaccination card, only that his second dose was supposed to be on ??-Apr-2021 and he has not got his second dose as patient was outside of the 42 days window.   This case was linked to CASE  MOD21-122483 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow-up information received on 03-AUG-2021 contains non-significant information.