chrisvoncsefalvay/vaers-outcomes huggingface dataset:
POTENTIAL MECHANICAL ISSUE WITH THE REFRIGERATOR. Max/Low Temperature reached: 31.5° FAHRENHEIT. Vaxelis administered. These vaccines were administered to 40 patients over a span of 1 week, starting on 15Jun2023 till stopping at 22Jun2023.; This spontaneous safety report, with reference number 2023SA238007 (Inquiry #, Parent Inquiry #) was received by the partner on 03-AUG-2023 and forwarded to agency on 04-AUG-2023, from a health professional.    Due to the nature of the event, the causality between the event "POTENTIAL MECHANICAL ISSUE WITH THE REFRIGERATOR. Max/Low Temperature reached: 31.5° FAHRENHEIT. Vaxelis administered. These vaccines were administered to 40 patients over a span of 1 week, starting on 15Jun2023 till stopping at 22Jun2023." and Vaxelis was not applicable.   This case is linked to other temperature excursion cases: MCM-005121, MCM-005127, MCM-005128,  MCM-005135, MCM-005136, MCM-005138, MCM-005140.   Further information is expected.
This is a 79y.o. male with a pmh of HFpEF, COPD, obesity, vertigo, and HTN who presented to the ED for complaint of "feeling off". He states that last night he had difficulty sleeping because he could not get comfortable and he knew "something was wrong" and decided to seek further intervention at our facility. He states that he is SOB but this is unchanged over the past 2-3 months. He admits to a cough for the past 2-3 months. He states his SOB has not been worsening over the past few days.States his chronic cough is non-productive.  Admits to b/l LE swelling with R>L which has been an ongoing issue for months. He states he tripped and hit his right knee but denies head trauma. He denies any fevers, chills, chest pain, sob, adominal pain, nvd.  He states he was vaccinated for covid 19 in 03/2021. Cannot recall which vaccine. He did not get his booster. He has a history of COPD but is not on home O2 or any inhalers. He denies any fevers, chills, chest pain, sob, nvd, orthopnea. Denies tobacco, etoh, or illicit drug use.    In the ED, BP 141/88, HR 106, RR 22, spo2 90% on RA. Afebrile. CXR revealed left sided parenchymal reticular and groundglass densities suggesting pneumonia. ECG revealed sinus tachycardia with 108 with PVC and no ST changes. Labs significant for Plt 132, BG 105, PT/INR 14.5/1.3. BNP wnl. Troponin neg x1. Patient was started on 2L NC with improvement of sp2 to 96%. He was administered albuterol inhaler x1, duoneb x1, and decadron 6 mg IVP x1. Patient was admitted with consult to ID placed for management of covid 19.
Pt contacted clinic on the morning of the day following injection. Patient reported localized reaction to the PVX injection recieved 9/10/09. Patient states this is the second time he has had a localized reaction, arm very sore this time and painful to move, redness and swelling. Patient encouraged to use acetaminophen and apply ice pack to site intermittently. Patient reports that he will NEVER take another pvx injection.
Anaphylactic reaction; She is going to pass out; Sweating; threw up; she couldn't stand up because she was so dizzy; she couldn't stand up because she was so dizzy; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the parent.  A female patient received BNT162b2 (PFIZER COVID-19 VACCINE), on 30Jun2022 as dose 1, 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: ANAPHYLACTIC REACTION (medically significant), outcome "unknown"; PRESYNCOPE (non-serious), outcome "unknown", described as "She is going to pass out"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "Sweating"; VOMITING (non-serious), outcome "unknown", described as "threw up"; DIZZINESS (non-serious), DYSSTASIA (non-serious), outcome "unknown" and all described as "she couldn't stand up because she was so dizzy". The events "anaphylactic reaction", "she is going to pass out", "sweating", "threw up" and "she couldn't stand up because she was so dizzy" required physician office visit and emergency room visit. Clinical course: Reporter stated that reporter just wanted to ask a question, okay so the daughter received her first Pfizer vaccine on 30Jun2022 (Thursday) and she had an anaphylactic reaction, she was sweating, she was going to pass out and she threw up and she couldn't stand up because she was so dizzy. So, reporter called her doctor and her doctor said she didn't recommend getting the second dose unless it had done in half without studying because her reaction was so bad. The paramedics came because the person regarding they called the paramedics just to make sure she was okay. So reporter asked if Pfizer recommended her getting the second dose because reporter didn't know what to do and reporter didn't want to jeopardize her health. Reporter was requested to visit emergency room and consulted with doctor in case of emergency. Reporter further stated that patient was okay now.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt received COVID19 vaccine and was observed for 15 minutes afterwards and no immediate reaction occurred. As pt was walking to her car to leave she noted that she was very thirsty and she attempted to drink water in her car but felt a constant need to swallow with a feeling of PND. She returned to the observation area in the health dept. Vital signs obtained and elevated BP 204/99, HR 104, R 20 even and unlabored. Denied tongue swelling and no facial edema noted. Denied difficulty breathing. Continued to swallow water successfully but still had a feeling of PND. No coughing noted and denied having any illness prior to injection. Does have a history of chronic sinusitis and asthma but no recent problems noted. Pt given Benadryl 50mg p.o. and friend was called for transport. Continued to monitor for 1 hr before leaving with friend.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 63-year-old male patient received BNT162b2 (BNT162B2), on 07Oct2021 at 10:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 11May2022 at 10:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 03Jan2020 at 11:00 as dose 1, single (Batch/Lot number: unknown), in left arm and as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "DM" (unspecified if ongoing); "HTN" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "HL" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment; Negative, notes: negative PCR test. Therapeutic measures were taken as a result of covid-19.  Clinical course: Patient was under treatment for COVID-19 with Paxlovid from 29May2022 to 02Jun2022. Covid rebound occurred after completing five day paxlovid course and negative PCR test. He had minor symptoms of nasal congestion, headache and malaise.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective and covid 19 cannot be ruled out.
Had J&J covid vaccine today. Contacted the help line and ultimately spoke with the FDA who recommended she to go ER to r/o blood clot. She has minimal pain around bruising. Bruising is in forearm, distal to where her shot was given. Not consistent with DVT.
Pt states after she and husband rec. flu vaccination - they fell very ill 4 days later. Horrible diarrhea with horrible smell, coughing, couldn't get out of bed. She just wanted us to know. Had flu vac. before - no problems before - she reported this on 10-17-12 - still sick but better. Got antibiotics.
Ringing in ears / tinnitus has occurred ever since I received the Moderna booster.  The ringing is constant and interrupts my sleep.
This spontaneous report as received from a registered nurse (R.N) refers to a 12 month old patient. On 14-MAY-2013 the patient was vaccinated with (Merck) VARIVAX (lit # H018782, expiry date 15-OCT-2014) (1350 U, 0.5 ml, subcutaneous in the right thigh, strength not specified) and MMR II (lot # not reported) (in the left thigh, strength and total daily dose not reported). It was reported that the patient developed swelling in the groin lymph nodes bilaterally which lasted for 5 days. On 22-MAY-2013, the patient developed red swelling on the right thigh, and a little rash on arms by elbow but nowhere else. The patient was afebrile. The patient was examined by a physician on 23-MAY-2013. And no treatment was prescribed. The outcome of red swelling on the right thigh and a little rash on arms was unknown. This is one of several reports received from the same source. Additional information has been requested.
13 month old male with rash - possible measles. Plus fever to 101.6. Had MMR vaccines 3 one week ago - broke out in rash yesterday evening after bath. Began on chest/neck and spread to entire body - less on arms/legs- rash not bothersome. Also has red/watery eyes.  ____ok ______ activity.
Patient presented to the ER with c/o altered mental status, confusion and fall. Symptoms thought to be multifactorial given the Covid-19 infection and underlying dementia. Patient received Remdesivir, IV abx. Neurosyphilis also suspected but family declined further testing and decided to transition patient to hospice. Patient discharged home with hospice care.
Previously healthy 13 yo old boy presenting with chest pain and vomiting. Symptoms started Sunday night with myalgias and generalized body aches. Received 2nd COVID19 vaccine on Sun. Post vaccine complained of generalized body aches, malaise, until Tuesday morning, when the patient returned to feeling  at baseline. Tuesday night complaints of new onset substernal chest pain. Pain was worse when laying down and when raising hands. Sitting up helped with pain but walking around made pain increasingly achy. EMS was called who performed EKG, which was reportedly read as normal and at that time did not pursue further treatment.  The patient only slept about 3 hours and the next morning,  experienced multiple episodes of vomiting that worsened pain. The patient was subsequently brought to the ED.
mild redness, swelling-induration;bruising-middle-soreness 50 cm x 60cm in diameter;mom had called MD a/calling clinic;told mom no reason for concern;
Pt called this office on 12/8/17 and reported episodes of upper left back and left chest/breast pains since getting PREVENAR 13 on 11/29/17. She went to Urgent Care and was worked up. Pt C/O some residual head and rib pains. Will see PCP to address.
Pt noted redness and swelling in left arm. Seen at urgent care. Culture done. On Sat 8/30/03 swelling increased. Increased fever, red, pain and hot to touch. Seen at ER and given IV antibiotics and now on oral antibiotics.
No adverse event; a patient was administered an expired MMR Il vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 11-SEP-2019, the patient was vaccinated with an expired dose of with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # N027779 has been verified to be a valid lot number, expiration date 08-AUG-2019, recombinant Human albumin (exact dose, dose number, route and site of administration were not reported) for prophylaxis. No adverse event was reported. The outcome of the events was unknown.
Patient received expired Moderna Covid-19 vaccine; Patient received expired Moderna Covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) and PRODUCT STORAGE ERROR (Patient received expired Moderna Covid-19 vaccine) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received expired Moderna Covid-19 vaccine). On 26-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Patient received expired Moderna Covid-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication was  not reported. Relevant concomitant medications were not provided by the reporter.  One dose was given 24AUG2021, second expired dose given 26AUG2021, and the last 3 doses were given on 27AUG2021.
A 41 year old female reported that she received Flu Shield ('00-'01) on 11/28/00. On that day, she reported being approx. 2 weeks pregnant. Follow-up information has been received on 2/1/02 from the now 42 year old female who reported that she "had a miscarriage". The date of the event was not reported. The event was considered to be an "Other Important Medical Event".
tightness in throat & under jaw, h/a, very weak x 3 days-fast heart beat;BP 163/89, P109, dizzy called MD office;
late for the second dose of Shingrix / first dose was administrated on 2018; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: No patient's identifiers provided. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. No adverse event was reported. No exact vaccination date provided. No lot number and expiration date provided. The reporter did not consent to follow up.
Information has been received from a physician concerning a patient who on unknown date, was vaccinated with a first dose of ROTATEQ (dose, route and lot number not reported). On an unknown date, the patient developed intussusception. The patient was hospitalized. The physician considered intussusception to be immediately life-threatening and an other important medical event. At the time of the report the outcome of the patient was unknown. The physician indicated that the intussusception had been previously reported to VAERS. Additional information has been requested.
Patient called today stating that her arm is still sore at the site where she got the vaccination over 1 month ago. The pain isn't severe but she still feels it when she touches the area.
in three days, developed macular truncal rash, conjunctivitis, slapped-cheek appearance, scleral icterus, jaundice,elevated liver fxn tests.
I went to bed Friday night around 10:00PM.  I woke around 12:30AM with a throbbing headache, sore throat, post-nasal drainage, body aches, chills, fever, sweating, weakness and nausea.  I went down to use the bathroom and then back to bed but could not sleep due to the throbbing headache and chills.  I got back up around 2:30AM and soaked in a warm bath.  I went back to bed around 4:30AM.  I was able to go to sleep.  I slept until around 8:30AM.  At that time, I drank some water and went back to sleep.  I slept until approximately 10:30AM and started drinking Powerade Zero.  The Powerade was taken to bed and sipped on when I would stir and change positions.  I slept until approximately 2:30PM, when I got up to use the bathroom.  I urinated, washed my hands and went to walk out of the bathroom when everything went black.  I remember yelling for my husband but then nothing else until I heard him yell my name several times and I was lying on the floor in the doorway of the bathroom.  I passed out.  I was sat up in the recliner and monitored.  Above symptoms continued.  Tylenol and Motrin were alternated every 4 hours for the fever.
Information has been received from a physician concerning a 41 year old female with a history of negative varicella titer who in 1999 was vaccinated SC with a 0.5 ml dose of varicella virus vaccine live. There was no concomitant medication. In 1999, within 24 hours of receiving the vaccine, the patient experienced hives around her joints. Soon after this, in approximately 1999, she broke out in a chickenpox like rash for which she was treated with cetirizine hydrochloride (ZYRTEC). Since then the patient has had 3 episodes of "zoster" (type unspecified) per year for which she is treated with cetirizine hydrochloride (ZYRTEC), montelukast sodium (MSD) and albuterol. The zoster lesions most recently appeared on her face and previously on her hip. She also has post herpetic neuralgia. It was noted that she is presently being treated with medications. No product quality complaint was involved. Additional information has been requested.
This case was reported by a nurse via sales rep and described the occurrence of injection site rash in a patient who received PEDIARIX. On an unknown date, the patient received PEDIARIX. On an unknown date, an unknown time after receiving PEDIARIX, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was unknown. It was unknown if the reporter considered the injection site rash to be related to PEDIARIX. Additional details were provided as follows: This case was not previously reported to anyone. The age at vaccination was not reported. The patient had denied permission to contact their physician. The nurse had not requested any follow up and declined to provide details for the report. The details of injection site and patient name were not available. This case has been linked to case US2016073720 and US2016073723, reported by the same reporter.
5 days after administration, blood pressure spiked and started having numbness in his fingers. the numbness went to his legs and could no longer walk.  Patient went to ER and decided that he had developed Guillain-Barre from one of the vaccines.
MMRV and Varicella given on same date. No adverse event or abnormal signs or symptoms occurred.
Infant was given routine 2 month IZ on 6/6/00 and on 6/9/00, the infant was found in his crib at 06:15 AM and was not breathing. Maternal grandmother found infant. She states infant was fine after receiving IZ but was fussy but no fever. She reported that she gave the infant o.4 ml of infant acetaminophen to ease soreness in infants legs. She denies any problems, no fever, etc. On 6/7/00 and 6/8/00, child took formula well. On 6/8/00, she fed baby a bottle of formula with cereal and rocked him to sleep. She placed infant in his crib on his stomach. Mother of baby checked on him at midnight and placed baby on his side. At 06:15 AM, grandmother got up, put a bottle of formula in hot water for feeding infant and then went in to check on infant. She states that she thought he was asleep but then noticed infant was not breathing (when she went in the room baby was found on his stomach, face down, in middle of baby crib; covers at waist.) She states she called out to the infant's mother and to grandfather of baby that infant was not breathing and to call 911. Paramedics arrived and attempted to revive infant, then transported infant to hospital, where staff attempted life saving efforts but were unsuccessful. Autopsy has been performed and per death certificate, cause of death was Sudden Infant Death Syndrome, undetermined circumstances. Health Dept not aware of child's death until 6/29/2000.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2 (BNT162B2), on 11Apr2021 as dose 1, single (Lot number: ew0158) and on 02May2021 as dose 2, single (Lot number: ew0173) at the age of 38 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 07Nov2021 as dose 3 (booster), single (Lot number: 039fzia), in right arm for covid-19 immunisation. The patient's relevant medical history included: "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing). There were no concomitant medications. The patient had no known allergies.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: Treatment of COVID-19; (17Jul2022) Positive, notes: Rebound with symptoms and positive testing. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient had taken Paxlovid, from 08Jul2022 to 13Jul2022 for the treatment of Covid-19.  No follow-up attempts are possible. No further information is expected.
Pt went to ER c/o nausea and vomiting onset just prior to arrival.
Information has been received for the pregnancy registry for GARDASIL from a physician concerning a 15 year old female who on 23-OCT-2008 was vaccinated with a third dose of GARDASIL (lot # 659184/0843X). It was reported that the patient was pregnant since August 2008 (LMP: August 2008). An ultrasound test was performed on 08-DEC-2008, which showed gestation of 22 weeks and 1 day. The physician reported that the patient had an elective termination of her pregnancy. The patient had no previous pregnancies. Upon internal review, elective termination of pregnancy was considered to be an other important medical event. Additional information has been requested.
Multiple boughts of vomiting yellow bile and diarrhea for 2 hours beginning  around 10 10:30 am