chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 03-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA279741, 2018SA279748, 2018SA279744, 2018SA279747, 2018SA279742, 2018SA279746, 2018SA279740, 2018SA279743 and 2018SA277209 (same reporter). This case involves a patient of an unknown demographics who was vaccinated with a dose of FLUBLOK QIV lot QFAA1829; expiry date: 30-Jun-2019 via intramuscular route in the left deltoid on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage. It was reported that the patient did not experience any adverse event. 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 Good 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. List of documents held by sender: none.
Welts on bilateral upper and back. both legs have  welts, but not as much as my arms. See other doc.
Shivers, incredible bone chilling cold that lasted for an hour before I went to sleep.  Couldn?t warm up.  Woke in the morning with pressure sensation soreness, in both eyes.  Took Motrin 800 and the rest of the following day was fine. No negative reactions since.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient said she was lightheaded 15 minutes after vaccine. I had her sit in chair head between her legs and she drank Gatorade while fan blew on her. Started feeling tingling as well from knees down. Took BP and pulse both were normal. Called paramedics she chose not to go with them.
Body aches; Fatigue; Headache; Low grade fever; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, administered in the right arm on 07Mar2021 at 08:45 (Lot Number: En6204) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. The patient had no known allergies and did not have COVID-19 prior to vaccination. Concomitant medication includes unspecified birth control. The patient was not tested for COVID post vaccination. The patient previously received the first dose of BNT162B2 on an unknown date for COVID-19 immunization. The patient experienced body aches, fatigue, headache and low grade fever on 08Mar2021 at 03:00. The patient did not receive treatment for the events. The outcome of the events was recovering.    No follow-up attempts are possible. No further information is expected.
Headache, fatigue, right arm pain, progressing to fever, chills, body aches, and night sweats for approximately 2 days.
I received the Moderna booster 10 months after 2 shots of the Pfizer COVID vaccine. Mild fever (99.7), very weak, extremely drowsy, throbbing headache,  aches and pains in almost all my joints. It began Saturday late morning (22 hrs after I got the booster) that lasted 3 days.  About 1 day into it,  I also got completely congested and sore throat. Sore throat lasted 1 day. Weak and congested for a total.of 6 days. Then was better.
106 fever for hours, violent chills vomiting, headaches, body aches, oxygen levels 85-91
Immediately after, tingling in lips.  Day after, HS exacerbation. Large sores on inside of thighs that created a burning sensation and weeping wounds. Have been present for 3 days
Low grade fever to 101.5 started afternoon of 8DEC, followed by appearance of pink bumps AM of 9DEC.  Eval by pediatrician around 10:30 AM, rash consistent with mild varicella rash, pink maculopapular lesions, no vesicles.  T=101.1 in clinic.
I feel sick, I have problems with my stomach.; I feel sick, I have problems with my stomach.; This is a spontaneous report from a non-contactable consumer (Patient reported for self). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date, as a single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, the patient has had to get second vaccine 'today', but the patient cannot go because, the patient was feeling sick, had problems with stomach. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
My father died of a blood clot; Pulmonary Embolism on December 15th, 2022. The clot brought extreme pain in his lower back Monday the 13th. He was sent home from the hospital, then we re admitted him on the 15th, and he died.
Rash on lower arms (right and left) as well as the back of both calves.  The rash is more like red sores that itch.  Also developed peeling splotches on both palms that are extremely itchy.  There are also spots of thinning, red skin by the nail beds on numerous fingers on both hands.  These areas on the hands are also sensitive to hot water.  Began appearing on 3/3/21.    I was prescribed a  regimen of Methylprednisolone 4 mg DosePack on 3/10/21 to alleviate itching.
swelling or knot at the injection site after a couple of days, diarrhea, nausea, vomiting, constant headache, runny nose, abdominal pain
death of patient's father from subdermal hematoma; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUBCUTANEOUS HAEMATOMA (death), outcome "fatal", described as "death of patient's father from subdermal hematoma". The patient date of death was unknown. Reported cause of death: "death of patient's father from subdermal hematoma". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: death of patient's father from subdermal hematoma
Hospitalized 10/26/2021; COVID-19 positive 10/27/2021, fully vaccinated  BRIEF OVERVIEW: Discharge Provider: DOCTOR Primary Care Physician at Discharge: DOCTOR Admission Date: 10/26/2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Septic shock   HOSPITAL COURSE: Patient is a 60 year old male with PMH of HTN, HLD, DMII, super morbid obesity who initially presented to outside hospital with a 2-3 day history of right groin rash and found to have necrotizing fascitis. Patient underwent his initial debridement at outside hospital prior to transferring to Butterworth SICU. Of note, patient was hypoxic prior to intubation and found to have COVID-19 pneumonia which was treated with steroids and Remdesivir. Patient was intubated and sedated upon transfer and had pressor requirements due to septic shock from the necrotizing fascitis. Patient underwent IV abx therapy, resuscitation with fluids and pressors, and ventilator support. Patient underwent a second debridement for source control the following day. Patient's ICU course was also complicated by Diabetic ketoacidosis for which he was on endotool with DGMS following, AKI, and SVT with RVR. During his ICU course, source control was obtained from his infection, however patient's respiratory status continued to decline with ARDS. Patient on high ventilator requirements of 90-100% Fi02 with hypercarbia due to large body habitus with chest wall restrction, COVID-19, and volume overload due to resuscitation for septic shock. Patient was paralyzed during his course to assist with ventilation however this did not improve his respiratory status. Pulmonary critical care was consulted however patient not a candidate for ECMO given his BMI. Discussion was held with family (sister) on 10/31/21 given poor prognosis even with aggressive therapy. Comfort care was ultimately decided upon per family. Paralyzation was stopped and patient was subsequently extubated and expired on 10/31/2021 at 1354
Post Varivax pt had rash on posterior LE (thighs) itching. Also itching at hands and feet.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 19-AUG-2013, the patient was vaccinated with ZOSTAVAX (dose strength and route was not reported) (lot # J001700 and expiry date: 08-MAY-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting ZOSTAVAX, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for ZOSTAVAX. This is one of the several reports from the same reporter. Additional information has been requested.
Day 1 he had pain in injection arm and felt like he was "speeding". He developed a fever of 101 with a headache. He treated this by alternating  2 Aleve 220mg  and Tylenol during the evening and the next afternoon. On the second and third day he felt a little off, but stayed in bed.  His arm hurt and he had a headache. On the 4th day he said he felt better that morning when they talked to him, but was found deceased that evening and coroner placed the death around 4 o'clock.  He was by himself and was found around 8 pm.  They said it looked like he spit up and fell face forward and that's how they found him.  He had received his first two Moderna shots in April and May 2021.
symptomatic COVID-19 11/12/21: present to ED with generalized weakness ( beginning 11/7/21) IV remdesivir and PO azithromycin and zinc
Drug ineffective; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4536227-00.  A 66-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), at (citrate free), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SUSPECTED COVID-19 (medically significant) with onset 30Aug2022, outcome "unknown", described as "COVID-19"; DRUG INEFFECTIVE (medically significant) with onset 30Aug2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. The action taken for adalimumab was unknown.  Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for Humira (Adalimumab): The reporter's causality for the event(s) COVID-19 was not provided. Causality for BNT162b2: The reporter considered "drug ineffective" and "covid-19" related to BNT162b2.   The lot number for [BNT162b2], was not provided and will be requested during follow up.; Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics, severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
Covid19 breakthrough.  1st vaccine received on 08/02/2021.  2nd vaccine on 08/24/2021.  56 y/o male presents to ED after being found wandering around with Left facial droop and c/o left leg pain, trouble ambulating and weakness.  Pt lives at group home and has a PMHx of Autism, Bell's palsy, depression, anxiety, Hypothyroidism, AVF for renal dialysis and schozophrenia. No specific treatment for Covid19.
Very heavy period.  Normal period lasts 5 days and is light with no other symptoms.  My first period after my first shot was so heavy i was having to change my pad and tampon 3-5 times in a day.  After 7 days of heavy bleeding, I started passing large blood clots along with the bleeding.  I would pass a large blood clot roughly once an hour.  I got the second vaccination on the 11th day of this bleeding.  After 14 days, the period stopped only to start again after one day.  I am currently on the 16th day of bleeding.  There is also intense cramping associated with the blood clots.
Pt report arm soreness/stiffness in left arm still at 1 yr after vaccine. She has used MOTRIN off and on as treatment.
AFTER RECEIVING 3RD DOSE PATIENT DEVELOPED MILD RASJH/ATOPIC DERMITITS ON RIGHT HAND ABOUT 10 MINUTES AFTER RECIEVING THE DOSE. PATIENT WAS A/Ox3 AND WAS GIVE 25MG DIPHENHYDRAMINE TO TAKE. SHE SAID SHE WOULD TAKE IT WHEN SHE GOT HOME. NO THROAT OR SOFT TISSUE SWELLING OBSERVED AND WAS RELEASED TO HOME. NOTE: PREVIOUS DOSES ON 2/4/21 AND 3/4/21 AND HAD A SIMILAR REACTION THEN ALSO.
Information has been received from a nurse practitioner a 19 year old white female with a history of "CIN1" (cervical neoplasm) and "HR HPV" who on 15-DEC-2006 was vaccinated IM in the left deltoid with 0.5mL of Gardasil vaccine (yeast) (lot # 654741/1208F) at 16:00. On 15-DEC-2006 the patient experienced mild nausea 1 hour after receiving vaccination and the nausea lasted 2-3 days. On 16-FEB-2007 the patient was vaccinated, second dose, IM in the left deltoid with 0.5 mL of Gardasil vaccine (yeast) (lot # 656049/0187U) at 16:00. The patient experienced nausea and vomiting 1 hour after vaccination and it lasted approximately 1 week. The nausea and vomiting would occur after eating or attempting to eat. The patient sought unspecified medical attention. No further information is available.
On July 23, 2022, I woke up with a blood shot eye and numbness in my arm as well.  My arm was numb from the top of my shoulder to my fingertips.   I went to the ER and the intake nurse asked some neurological questions to ensure I was not having a stroke.  I was told that my eye would selfheal in a few weeks.  I was referred to a neurologist and was diagnosed with carpal tunnel syndrome on August 22, 2022.
This spontaneous report as received from a healthcare worker refers to two unspecified patients of unknown age and unknown gender. The two unspecified patients pertinent medical history was not reported. Since 02-MAR-2015, the two unspecified patients were vaccinated with (Oka/Merck) VARIVAX which underwent supported temperature excursions. No adverse effects were reported. No product quality complaint (PQC) was reported. Additional information has been requested.
Pt started having pain in left arm afternoon after shot was given in the AM. By the next day Pt noticed redness, swelling and increased pain in mid left arm.
The patient was to receive Meninge B and received a 3rd dose of Menactra approximately 1 year after the 2nd dose of Menactra with no reported adverse event; The patient was to receive Meninge B and received a 3rd dose of Menactra approximately 1 year after the 2nd dose of Menactra with no reported adverse event; Initial information received on 06-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves Adolescent female patient who was to receive meninge b (MENINGOCOCCAL VACCINE B) and received a 3rd dose of menactra (MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA]) approximately 1 year after the 2nd dose of menactra with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE Solution for injection (strength, dose and lot number not reported) via intramuscular route in unknown administration site instead of MENINGOCOCCAL VACCINE B, for prophylactic vaccination.  On an unknown, (latency: same day) date the patient developed a non-serious the patient was to receive meninge b and received a 3rd dose of menactra approximately 1 year after the 2nd dose of menactra with no reported adverse event (wrong product administered) and (inappropriate schedule of product administration).  Action taken was not applicable with both the suspects.  At time of reporting, the outcome was Unknown for both the events.  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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 71-year-old male patient received BNT162b2 (BNT162B2), on 02Jun2021 at 15:45 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 71 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "DM" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "BPH" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (unspecified date) Positive; (19Jul2022) Negative; (20Jul2022) Negative; (21Jul2022) Negative; (22Jul2022) Negative; (23Jul2022) Negative; (24Jul2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication administered in 2weeks was unknown. Anti-viral details: Product=COVID 19 treatment, brand= paxlovid, treatment start date= 13jul2022; treatment stop date= 17Jul2022; indication=treatment of covid-19; administrator route= oral. Adverse event: Rebound infection following negative antigen test. Patient tested negative for Covid on 19Jul2022 following 5 day course of Paxlovid which ended on 17Jul2022. No treatment was received. No known allergies. Other medical history= DM, hypertension, BPH.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on information in the case provided, the causal association between the Reported events and the suspect drug cannot be excluded.
Two days after receiving vaccination, developed 1/4 inch sized welts on abdomen and both legs
A lump, about the size of a large grape, and a rash, about 4" x 4",  developed at the injection site a few days after the shot.  The rash was puffy and warm to the touch but neither the rash nor the lump were painful or itchy.  Both subsided within about 10 days.
having symptoms/She tested positive to COVID-19; having symptoms/She tested positive to COVID-19; This is a spontaneous report from a contactable nurse (patient). A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient started having symptoms on Thursday. On Friday, her supervisor had her get tested for COVID. She tested positive to COVID-19 in Dec2020. Outcome of the events was unknown. The patient wanted to know if she is symptom free, should/can she still get the 2nd dose as planned.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the single dose and short duration
Pt called 10/1/03 to state she was having a reaction on her right arm. States it's red, itchy, sore and warm. No other problems with vaccination noted. Encouraged cool compress and Benadryl. If no improvement to seek medical care. Pt went to physician 10/1/03 PM, hydrocortisone ointment applied and continuation of cool and Benadryl ordered. Physician reported "local reaction".
pt had fever for 2 days (mom couldn't give degree of fever); On 2nd day 12APR91 pt taken to MD w/cellulitis from inject site to elbow; placed on Keflex x 10 days;
Patient was given the Pfizer vaccine at 17 years of age before it was approved for this age
Headache, Fever, NauseaVomiting,  Body numbness Narrative:  Other Relevant History:
Administered expired vaccine. Expired 09/18/2023 given 09/19/2023. No signs or symptoms as of yet.
Constant stable musculoskeletal pain to right bicep with decreased mobility and nocturnal awakening with pain. Prednisone x5 days. Continues to have achy pain that is worse with use or pressure. Denies numbness, tingling, or weakness.
Blisters in throat, sore throat and low grade fever.  The next day I had fever, body aches and nasal congestion.  Congestion and fever has now subsided but still suffering SEVERE body/muscle aches on 10/21/2010.  Taking Advil.  All sleep interrupted during this time due to pain.
This spontaneous report as received from a physician assistant refers to a patient of unknown age and gender. On 05-SEP-2014 the patient was vaccinated with an expired dose of RECOMBIVAX HB (5/0.5 microgram/ml injection, lot # 1741AA, expiration date 27-JUN-2014, 0.5 ml) intramuscularly. No adverse effect was reported. The patient did not seek for medical attention. Additional information has been requested.
Started to have palpitations with some dizziness  prior to second dose of the vaccine on 1/10/21,  and then night of vaccine 1/11/2021,  had chest pressure and palpitations. On 1/12 had worse symptoms , on 1/13 still had those symptoms but less. Came back to work on 1/14 and same symptoms . Came to ED on 1/13/21  had full work up neg EKG, neg CT scan, neg labs. Has Holter now.   ( H/O covid in April 2020 had chest pressure when had covid. ) needs to follow up with PCP. No other PMH
High fever, 101.5, chills, upset stomach, headache, body aches, joint aches, fatigue.   Onset of symptoms was 7 hours after vaccination, escalated to it's worst by midnight, consistent high fever with all symptoms through 11:00 a.m. next day, then symptoms began to subside and were gone 7 hours later.  Sore arm and fatigue lasted through the next day.
Patient developed SVT (supraventricular tachycardia) approximately 29 hours after receiving the COVID vaccine.  Patient has no prior history of SVT or any other cardiac related events.  Patient was engaged in a basketball game when the SVT occurred.  Patient has been involved in multiple competitive sports since the age of four without any prior incident related to exercise.  He felt like he could not breathe, his heart was racing, he became dizzy, began to lose his vision and I took him to the local fire station for evaluation.