chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a patient's father via a company representative and refers to his son -a male patient of unknown age. No information regarding the patient's pertinent medical history, concurrent conditions and drug reactions or allergies was provided. On an unknown date, the patient was enrolled in an unknown clinical trial and was vaccinated with VARIVAX (dose, route of administration, lot# and expiration date were not reported). On an unknown date, the patient developed Crohn's disease. The patient was diagnosed at the age of 17 but the father reported that he noticed issues prior the official diagnosis. The outcome of the event was unknown. The relatedness between Crohn's disease and the suspect drug was not reported. The reporter was wondering whether the event could potentially be related to the patient receiving the vaccine. The reporter mentioned that both of his sons participated in the unknown clinical trial involving VARIVAX. Upon internal review, the event of Crohn's disease was determined to be medically significant.
Member called stating that he was running a fever up to 101 on day 10 of small pox vaccine and was complaining of discomfort under the arms from swollen lymph nodes and also complaint of discomfort in the xyphoid process under the left rib cage. It felt like it was pushing out. Member was instructed to take motrin and if pain worsened to go to the emergency department.
got his grandma a covid-19 vaccine and she died /she's not the first i have heard about that died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (got his grandma a covid-19 vaccine and she died /she's not the first i have heard about that died) in a female patient of an unknown age 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) (Intramuscular) 1 dosage form. Death occurred on 23-May-2021 The patient died on 23-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant medication was reported.  It was reported that the reporter grandma received a covid-19 vaccine and died yesterday. Reporter also stated that it's not the first he has heard about that someone died from the covid-19 vaccine. The reporter did not specify it was the morderna Covid-19 vaccine he was referring to.  Company comment Very limited information regarding this event/s has been provided at this time.  Further information has not been requested since reporter did not share any personal information.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has not been requested since reporter did not share any personal information.; Reported Cause(s) of Death: unknown cause of death
Localized erythema on RIGHT thigh at site of injection, progressing to worsening erythema with discharge concerning for secondary bacterial infection.
Dizzy, felt very tired throughout the day.  About 1 am 12/20/2013 I woke to him in seizure like activity.  He was unconscious and needed to be intubated as his respirations were very low. He was sent from medical center to another hospital PICU.
This spontaneous case reported by a nurse, describes the occurrence of administered expired product (318 patients received dose from vials beyond 30-day use by date) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 037C21A) for COVID-19 immunization. No medical history reported. On Jun 16, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jun 16, 2021, patient administered expired product (318 patients received dose from vials beyond 30-day use by date). On Jun 16, 2021, administered expired product (318 patients received dose from vials beyond 30-day use by date) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. Date of vaccine refrigeration: May 7, 2021.
loss of protective titers; This literature marketed report has been received from the authors of a published literature article, titled as stated below, and refers to a 17-year-old male patient with germline heterozygous nonsense mutations in IKZF1 primarily affecting dimerization by haploinsufficiency, demonstrating reduced IKAROS expression. The patient was diagnosed at 9 years of age with immune thrombocytopenia (ITP). His concurrent conditions included mild leukopenia, thrombocytopenia and hypogammaglobulinemia. He did not have a history of recurrent or severe infections. His family history was remarkable for his father reporting one episode of pneumonia in adulthood, and pernicious anemia. On unspecified dates, the patient was receiving IgG replacement therapy. On an unknown date, the patient's laboratory results showed immunoglobulins IgG 1001 mg/dL, IgA 49 mg/dL (low result), IgM 14 mg/dL (low result), anti-platelet antibodies test was positive and Coombs test was negative.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown)(dose, frequency, lot number and expiration date were not reported) and with haemophilus b conjugate vaccine (meningococcal protein conjugate)(manufacturer unknown)(dose, frequency, lot number and expiration date were not reported), both for prophylaxis.     On an unknown date, he experienced progressive loss of protective titers towards pneumococcal and Haemophilus influenzae b (Hib) antigens. The outcome of the event was unknown. The authors considered antibody test negative to be related to the suspect vaccines.  A copy of the published literature article is attached as further documentation of the patient's experience.
Has low iron/She said she found out her iron was so low; She was just worn out, and fell asleep at a red light; She couldn't think straight at the time.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 85 year-old female patient received bnt162b2 (BNT162B2), administration date 26Jan2021 (Lot number: EK9231) at the age of 85 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetic" (ongoing), notes: she had been Type 2 diabetic for about 8 years.she was pre-diabetic now. No further details.; "Blood pressure high" (ongoing), notes: Stated she hadn't had high blood pressure for very long. No further details provided. The patient's concomitant medications were not reported. The following information was reported: BLOOD IRON DECREASED (non-serious) with onset 2021, outcome "unknown", described as "Has low iron/She said she found out her iron was so low"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "She was just worn out, and fell asleep at a red light"; CONFUSIONAL STATE (non-serious) with onset 2021, outcome "unknown", described as "She couldn't think straight at the time.". The events "has low iron/she said she found out her iron was so low", "she was just worn out, and fell asleep at a red light" and "she couldn't think straight at the time." were evaluated at the physician office visit. Therapeutic measures were taken as a result of blood iron decreased, fatigue, confusional state. No follow-up attempts are possible. No further information is expected.
Patient received vaccines on afternoon of 4/2/08. Developed symptoms the following day - erythema, swelling at right anterior thigh. On 4/4/08, mom noted increased swelling, erythema, heat and child complained of pain at site. Child brought to clinic for evaluation. Large area of erythema, edema, and heat noted across right anterior thigh with complaint of tenderness with palpation. Advised mom to take child to emergency room.
Approximately 20 hours after receiving vaccine started to complain of tenderness, progressed over the next 24 hours to red, hot, hard and measured 15 cmx12.5 cm when seen in clinic 48 hours after given, on the day mom called about the reaction.
TD give on 8-26-05. Given in the R Delt muscle in the R upper arm. Came to Employee Health today, 8-29-05 with a conplaint of discomfort at vaccine site. Area red, swollen and warm to touch. Recommended ice to area and to take one Benadryl capsule 25mg PO every 6 hrs as needed for swelling and itching. May take 2 capsules if one doesn't relieve the symptoms. Instructed not to drive a car or operate machinery while take this medication because it can cause sleepiness. Instructed to return to be rechecked in the morning if vaccine site has not improved.
(1) Fever 2 days 100.3 - 101.1 (took tylenol every 6-8 hours). (2) Fatigue (slept most of day after injection). (3) Heart rate elevated (woke up 7hrs after injection with feeling of heart pounding in my chest; heart rate over 90 while trying to sleep; believe reducing fever with tylenol helped settle heart rate).  (4) Muscle aches 2 days (previously injured muscles/joints became very sore 1-2 day after injection [left hip, right foot, left quad, lower back] - believe tylenol reduced inflammation) --symptoms ended 3-4 days after injection; slight fatigue remains 7 days later.
Within  the first hour of administration I felt nauseous. Then vomited 3 times within a few hours after the shot. Was nauseous and clammy for the rest of the day Saturday . By 2pm I felt drained and exhausted and had a headache which  carried over to most of the next day. My injection site was hot and inflamed as well but has gone down over the last 12 hours.
Within 24 hours of these two vaccines, my 15 year old son's personality was completely different. He went from being a happy, independent, confident person to being severely depressed, crying for hours at a time, as well as having separation anxiety, severe OCD, and recurrent panic attacks. He was also barely able to eat for several days, and was very restrictive with his food and drink choices.
Booster shot injected in left arm on 11/24/21 around 4:00 pm.  On 11/28/21 around 9:30 pm, patient's caregiver noticed that his left arm was swollen.  Swelling went down (but not away) and then on 11/30/21 the morning caregiver noticed left was swollen and tight and patient was experiencing discomfort in arm.  A pillow was propped under the arm to aid in reducing swelling.
Development of serum-sickness-like reaction w/hives, erythema multiforme-type rash, fever and arthritis day after receiving vaccine. Resolved after 1 week. Also was on antibiotic.
8 days after vaccination, site became red and swollen and itchy. Also have a headache, chills, and flu like;  chest wall following double mastectomy 6 years ago suddenly became painful and itchy. Not sure if this delayed reaction is because I had an injury on my hand on day 8?
Temp 102.4; chills; numbness in hands; body aches. Frequent vital signs done until resolved. MD notified.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 75-year-old male patient who received SHINGRIX for prophylaxis. On 29th August 2018, the patient received the 1st dose of SHINGRIX. On 5th September 2018, 7 days after receiving SHINGRIX, the patient experienced injection site erythema and erythromacular rash. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved and the outcome of the erythromacular rash was unknown. It was unknown if the reporter considered the injection site erythema and erythromacular rash to be related to SHINGRIX. Additional details were provided as follows: The reporter was wife of the patient. At 16:00 hours, the patient received SHINGRIX on left arm. The patient experienced redness at the injection a week after receiving the injection. It was a red spot above, below and on the sides of the injection site. The patient had denied permission to contact their physician.
2 months later / only administered the lyophilized powder mixed with normal saline; Inappropriate dose of vaccine administered; received the 1st dose of adjuvant suspension only / 2 months later / only administered the lyophilized powder mixed with normal saline/ HCP mixed the adjuvant portion with saline solution; received the 1st dose of adjuvant suspension only / 2 months later / only administered the lyophilized powder mixed with normal saline; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In April 2021, the patient received the 1st dose of Shingrix. In June 2021, the patient received the 2nd dose of Shingrix. In April 2021, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. In June 2021, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered, wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received the 1st dose of adjuvant suspension only, and came back 2 months later and only administered the lyophilized powder mixed with normal saline. No adverse events reported by patient. This was 5 of 9 linked cases reported by same reporter for different patients. The reporter consented to follow up.   Follow up information received from sales representative on 25 June 2021: The reporter stated that, the health care professional mixed the adjuvant portion with saline solution and administrated it as a first dose and later reconstituted the powder portion with saline solution as second dose. The event inappropriate preparation of medication for 1st dose updated to wrong solution used in drug reconstitution as stated that the health care professional mixed the adjuvant portion with saline solution. The reporter did not know exact date, patient's involved and outcome.  No further events were reported. The reporter consented to follow up; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR138554:Same reporter US-GLAXOSMITHKLINE-US2021AMR138546:Same reporter US-GLAXOSMITHKLINE-US2021AMR138552:Same reporter US-GLAXOSMITHKLINE-US2021AMR138553:Same reporter US-GLAXOSMITHKLINE-US2021AMR138556:Same reporter US-GLAXOSMITHKLINE-US2021AMR138557:Same reporter US-GLAXOSMITHKLINE-US2021AMR138558:Same reporter US-GLAXOSMITHKLINE-US2021AMR138559:Same reporter US-GLAXOSMITHKLINE-US2021138628:FU1-deleted
Initial information received on 09-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a four months old female patient who received second dose of vaccine ACTHIB lot UI803AA, expiry date: 21-SEP-2018 via intramuscular route in the right thigh on an unspecified date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ROTAVIRUS VACCINE for Immunisation; and KINRIX for Immunisation. It was an actual medication error due to expired vaccine used. It was reported that no reported issue or complaints by the mother. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning a 69-year-old, elderly patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUCELVAX QIVc vaccine exposed to temperatures in the range of 47F to 50.9F (explicitly coded as incorrect product storage). On 15-Sep-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported] which underwent temperature excursion (explicitly coded as drug administration error). The patient did not experience any adverse reaction after the vaccination. The reporter assessed the case as non-serious. This case 201804110 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up report received from reporter on 14-Nov-2018: The med info number (SEQ18-02667) was added in additional information tab. No new information was received. Hence, no changes were done in the narrative.
The day after vaccination of Prevnar and Hepatitis, child showed evidence of decrease muscle tone.  He was unable to sit upright.  Referred to medical center.
Patient received the Pneumovax 23 vaccine at the pharmacy. The first day she started to report redness on her arm from her elbow to her hands and itching, which has improved in the last day.
This manifested initially in the afternoon as a pain down the arm, through the arm pit, into back and neck on right side.  Sought lymphedema treatment and this is clearing up fast, but not gone away.  Feels 90% better
Patient reported R facial swelling tongue swelling,sore throat , tightness and dizziness. she later experience pruirities and head ache. she denied  SOB,difficulties breathing,rash,. patient has multiple drug sensitivit ies including narcortic. She took zysol before comPatient reported R facial swelling tongue swelling,sore throat , tightness and dizziness. she later experience pruirities and head acing to get vaccination. patient was brought to the medical tent for evaluation. BP 179/73,HR80,0xygen sat 95%,when  BP was recheckd it was 161/82, lung CTA 25mlags including  SOB, difficulty breathing,throat swelling,rash,unresolved pruirities,. patient left the vicinity with  husbandg posterior. benadryl was given at 0855am, patient was under observation till 1011am. patient reported symptom resolution. provider recommend  emer
Patient stated that she felt nauseated for a few days after taking vaccine. Patient stated second week in June she felt like she had COVID. she had alot of fatigue soreness and headache. Those symptoms only lasted a few days.  A week after that she had extreme pain that goes from her jaw to her ear to her head. Patient has been to dentist and they said they do not see anything going on inside the patients mouth.
On the morning of the 14th my mother was keeping my child and noticed some jerking movements.  AT 12:10PM she saw my daughter start jerking all over her body and she was not acting right.  I called my doctor and he sent us to the ER.  When we got there her fever was 102.5.  They gave her Advil for fever, a double dose to get the fever down.  We were later told it was a febrile seizure due to the vaccines she received.
Information has been received from a nurse practitioner concerning a female between 16-20 years of age, who on an unspecified date was vaccinated with GARDASIL vaccine (yeast). The nurse practitioner reported that within the last 4-6 months the patient had experienced fainting and dizziness after receiving GARDASIL vaccine (yeast). It is unclear it the fainting occurred after all three dose or not. At the time of the report the patients had recovered; she was fine before leaving the office after receiving the vaccine. The patient did not seek medical attention. This is one of several reports received from the same source. Attempts are being made to obtain additional identifying information to distinguish the individual patients. Additional information has been requested.
First vaccine given 2/22/2017 at age 4. Since then patient has developed staring spells and sharp brief pain in head. Referred to Pediatric Neurologist for evaluation.
swollen lymph node; Chills; headache; body aches; This is a spontaneous report from a contactable Nurse (patient). A 28-year-old female patient received BNT162B2 (lot number: Eka231) second dose on 14Jan2021 08:00 AM intramuscularly on left arm at single dose for Covid-19 immunization. Medical history included Hypothyroidism. Concomitant medications were none. No COVID prior vaccination. No COVID tested post vaccination. Known allergies to Sulfa. Patient previously received BNT162B2 (lot number: Elo140) first dose (age 28-year-old) on 24Dec2020 08:00 AM intramuscularly on left arm at single dose for Covid-19 immunization. Patient is not pregnant. No other vaccine in four weeks. No other medications in two weeks. Patient had Chills, headache, body aches, swollen lymph node on 15Jan2021 02:00 PM. The outcome of the events was Recovering. No treatment for events.
LITTLE PAIN IN ARM; RED DOTS ON LEGS LIKE PURPURA; This spontaneous report received from a patient concerned an 80 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included cigarette smoker, and non alcoholic, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. The patient experienced drug allergy when treated with azithromycin, and clindamycin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 21-MAY-2021, the subject experienced red dots on legs like purpura. On an unspecified date, the subject experienced little pain in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little pain in arm, and had not recovered from red dots on legs like purpura. This report was non-serious.