chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA294589 (same reporter). This case involves a 60 years old female patient who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE in error (lot UJ042AA and Exp. Date not reported) via intramuscular route in the left deltoid on 22-Oct-2018. The patients medical history and concomitant medications were not reported. It was an actual medication error due to inappropriate age at vaccine administration and overdose. It was reported that patient did not have any bad reaction and have not had treatment. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. List of documents held by sender: none.
Received vaccine at 4pm.  Lost appetite by 6pm .  Teeth chattering chills and high fever 103 by 9pm.   Vomiting by 10pm.      Called Primary Dr. at 11pm.   Dr. prescribed  Ondansetron HCL 8mg tablet for nausea and vomiting.  Fever throughout the night and next day. Day 2  Still had fever, vomiting,   Day 3 fever was gone.
I experienced a headache at the base of my skull the night of 5/3/21.  On 5/4/21 around 11 am I began feeling dizzy, nauseous and had an extreme headache.  I began throwing up and was unable to stand.  An ambulance was called and the EMS checked me out.  They told me I was probably experiencing Covid vaccine side effects and they should resolve.  After 2 days I was able to stand and eat normally but I experienced right-sided weakness.  I went to the ER on 5/6/21 and was admitted after a CAT scan and MRI revealed I had a cerebellar stroke.  I am currently in treatment (PT, OT, neurology) but the doctors have told me they think I had Covid and that mixed with the vaccine hypo-coagulated my blood leading to the stroke.  I currently cannot use my right side.
This case was reported by a physician and described the occurrence of shortness of breath in a 29-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). Relevant medical history included a latex allergy and no history of adverse events to previous vaccinations. On 7 April 2008 at 13:05 the subject received 1st dose of BOOSTRIX (.5 ml, single dose vial, left arm). On 7 April 2008, within 20 minutes after vaccination with BOOSTRIX, the subject started to experienced shortness of breath, wheezing, coughing, itching, skin blotches and dizziness. The subject was treated with BENADRYL and Epinephrine in the office. The symptoms improves some and the subject was taken to the emergency room where Solumedrol was administered. The subject was released from the emergency room and was not hospitalized overnight. The subject also experienced a vaccination error as BOOSTRIX is recommended for 10 through 18 years of age. The physician considered the events were disabling, life threatening and clinically significant (or requiring intervention). At the time of reporting the events were improved. The physician considered the events were probably related to vaccination with BOOSTRIX. Additional information received on 08 April 2008 from a nurse. She reported that the subject had no concurrent medications. She reported that no other vaccinations were given on the same day as BOOSTRIX. She reported that the subject experienced an anaphylactic reaction and BOOSTRIX was mis-administered per the indicated age range. She noted that the subject also had an adverse reaction to the vaccine that was initially local and then became systemic. The nurse reported that the subject received Solumedrol, epinephrine and Pepcid in the healthcare professional's office and then was transported to the hospital by emergency medical services.
Dusky discoloration of face, floppy muscular tone and obtended alertness which developed immediately after the appearace of scattered maculopapular rash with vesicles over the back. All three signs and symptoms developed within 10 minutes (approx). Given immediately EPI 1:1000 SC of Benadryl with persisent rash, sent patient to hospital.
headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administration date 11Feb2021 14:00 (Batch/Lot number: unknown) at the age of 69 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: penicillin" (not ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose of vaccine, Fatigue, headache, chills.), for COVID-19 Immunisation, reaction(s): "chills", "Fatigue", "headache". The following information was reported: HEADACHE (non-serious) with onset 20Mar2021, outcome "not recovered", described as "headache". The event "headache" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of headache.  Additional Information: Headache after 2nd shot and reoccurred two weeks after getting 2nd vaccine and have not gone away. No covid prior vaccination. No covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Narrative:  Positive covid test in fully vaccinated patient admitted for SOB 2/2 volume overload due to missed dialysis
While I was waiting during the 15 minute window, I started to feel light headed and saw black spots. I told the nurse I didn't feel well and wanted to wait a little longer. Within 10 minutes or so, I started to experience tingling sensation all over my face and then it spread to my neck and then to the rest of my body. My face started to feel stiff and I became really hot. My tongue felt swollen and my entire jaw felt very stiff. I lost my ability to speak and then eventually had full body paralysis. I could not move any limb. I could hear and see, but I could not verbalize a response or move any part of my body. I remained in this state for about 1.5 hour. Afterwards, I regained my motor skills and my speech.
This spontaneous report was received from pharmacist regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # N004564, expiry date 22-OCT-2018) (dose and route not reported) for prophylaxis. The vaccine was exposed to temperature of 47 degrees Fahrenheit to 77 degrees Fahrenheit (49.1 Fahrenheit) for 1 hour and 45 minutes. No previous temperature excursion was reported. The call was not because of a data logger. No adverse effects and no product quality complaint (PQC) was reported. No further information provided. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1709USA000688: US-009507513-1709USA000689.
I got the booster in the Apr2022, that was almost an years ago, I still have a migraine headache from it; it messed up my right eye busted the background of my eye now I am seeing like feathers in my eye/migraine with aura; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Apr2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: Oct2021, for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), administration date: Nov2021, for COVID-19 immunisation. The following information was reported: MIGRAINE (non-serious), outcome "not recovered", described as "I got the booster in the Apr2022, that was almost an years ago, I still have a migraine headache from it"; MIGRAINE WITH AURA (non-serious), outcome "not recovered", described as "it messed up my right eye busted the background of my eye now I am seeing like feathers in my eye/migraine with aura".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Child got his shots Monday. He went swimming last night. After swimming noticed left upper arm red, swollen, and warm to touch. Size of adult palm hand almost.
Pt developed swelling and redness with streaks at DTAP site, 1 hour, post vax. It was tender to touch. Had onset of fever on 9/12/01 AM, 99F (oral).
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 19Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: RISPERIDONE, start date: 01Jun2019; BABY ASPIRIN; ZYRTEC ALLERGY; FLONASE ALLERGY RELIEF; MELATONIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: Patient was given antiviral drug Paxlovid from 07Jul2022 to 11Jul2022 as a treatment for Covid-19. It was reported that the patient does not have any known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient. A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22May2022 at 10:30 as dose 4 (booster), single (Lot number: FK9894) at the age of 68 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 was not pregnant at time of vaccination. The patient's relevant medical history included: "Osteoarthritis" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL, start date: 01May2002; CELEBREX, start date: 08Jan2018. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: The patient received other medication in 2 weeks. Product-COVID 19 Treatment, Brand-Paxlovid, Treatment start date- 01Jun2022, Treatment stop date- 06Jun2022, Indication: Treatment of COVID-19. The patient received other medication in 2 weeks product=Estradiol Patch, start date=01May2002, Celebrex, start date=08Jan2018. Adverse event: Covid Rebound-developed nasal congestion, mild chest congestion, body aches, fatigue and headache, event start date: 10Jun2022, event start time: 07:00 AM. The patient had no Known allergies: no. The patient other medical history: osteoarthritis, osteoporosis. No follow-up attempts possible. No further information expected. Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events drug ineffective and Covid-19 and BNT162B2.
bumps under his lips; This is a spontaneous report received from a contactable reporter (Consumer) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 20Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIP DISORDER (non-serious) with onset 20Apr2021, outcome "unknown", described as "bumps under his lips".  Additional Information: The patient got his first dose today (20Apr2021), he had bumps under his lips and wasn't sure if it's from the vaccine or not.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt returned for U/A dip. Left arm redness and swollen. Pt was seen through urgent care at site of DTAP vaccine. Pt had a reaction.
Patient had some fussiness, sleeping more and decreased appetite, 24 hours after vaccine. Spoke with mother to see how patient was doing. Mother stated he was doing better.
Start Date/Time: [Pfizer] 8-JAN-2021 12:15 PM/ Start Date/Time: [Pfizer ] 21-DEC-2020 09:30 AM; Left arm at site has been tender since shot.; This is a spontaneous report from a contactable nurse (patient). A 61-years-old female patient received bnt162b2 (BNT162B2 solution for injection, Lot Number was EL32119) dose 2 via an unspecified route of administration, administered in Arm Left on 08Jan2021 12:15 as single dose for covid-19 immunization at Hospital. The patient was not pregnant at the time of vaccination. The patient had known allergies with streptomycin. Medical history included. synthetic ascending aorta and an aortic pig Valve replacement. Patient previously took first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number was EL0140), via an unspecified route of administration, administered in Arm right on 21Dec2020 09:30 as single dose for covid-19 immunization. The patient's concomitant medications included Toprol XL (METOPROLOL SUCCINATE), losartan (LOSARTAN), Advil (IBUPROFEN), Tylenol (PARACETAMOL), asa (ASA), multi v. The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with covid. Post vaccination patient was not tested for covid. On 15Feb2021, patient experienced Left arm at site has been tender since shot. But over last week it has become very tender. At times when arm moved just right feels a knife at that spot. Outcome of Left arm at site has been tender since shot was not recovered, and inappropriate schedule of product administration was unknown.    Follow-up (14May2021): Follow-up attempts completed. No further information expected.
died within 24 hours of the vaccine; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), via an unspecified route of administration, on an unspecified date (Batch/lot number and expiration dates unknown), as dose number unknown, single, for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date, the patient died within 24 hours of the vaccine. The patient never had a problem in his life. The reporter stated that the patient died from the vaccine. It was unknown if an autopsy was done.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: died within 24 hours of the vaccine
Came to clinic today with varicella like blisters (4) and redness about 3 cm diameter around blister. Mom stated child develop redness on site of injection on 10/25/2001 then develop fever on 10/26/2001 and 2 blisters came out on site of vaccination. Two days after 2 more blisters came out.
DIED; SUFFERING; This spontaneous report received from a consumer via a company representative concerned multiple patients of an unspecified age, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 in total, dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patients were suffering (unspecified). On an unspecified date, the patients died from an unknown cause of death. It was unknown if an autopsy was performed. It was reported that, "I can tell you so many people I personally know are suffering or died from this shot. Yet there are others everywhere trying to stifle stories like yours. Maybe others will learn something if they read some of the suffering". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suffering was not reported. This report was serious (Death).; Sender's Comments: V0-20221259339-Died. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Started with numbness in left cheek, tingling in arms and legs. 10 months later had the same symptoms lasting for 2 weeks. I am currently having the same symptoms again. Also tingling around lips.
Case number PHEH2014US021783 is an initial spontaneous report received from a health care professional (clinical coordinator) on 28 Oct 2014. This report refers to a female patient whose age was not reported. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 14581P) intramuscularly at a dose of 0.5 ml on 23 Oct 2014. On the same day after vaccination, she developed hives and her throat airway closed. She went to the emergency department for treatment of symptoms after which they were resolved on an unknown date. The seriousness and causality of the events were not reported.
This spontaneous report was received from a pharmacist refers to a 42 year old male patient. The patient's relevant medical history and past drug history are unknown. On an unknown date in August 2013, 1 month and 2 days ago the patient was vaccinated with a dose 1 of GARDASIL (lot#, expiry not reported) one injection once for an unknown indication. On 14-SEP-2013, this pharmacist reported that a 42 year old male would receive his second dose of GARDASIL. It was unknown if there was any laboratory data. As of 14-SEP-2013, the patient was planning on getting the second GARDASIL today and the outcome of a 42 year old patient getting the GARDASIL was unknown. Additional information has been requested.
Patient inadvertently give 0.15 mL dose instead of required/recommended 0.3 mL dose. CDC contacted and advised to have patient return ASAP fto receive correct dosage. No adverse affects reported per patient. Patient returned 9/28/2021 and received 0.3 mL. dosage.
Information has been received from a physicians assistant concerning a 17 year old female who in approximately August 2007 was vaccinated with a first dose of Gardasil. Subsequently the patient had a lot of back pain. On approximately 23-SEP-2007 was vaccinated with a second dose of Gardasil. On approximately 24-SEP-2007 the patient ended up going in the hospital the next day for severe back pain. After seeing a Rheumatologist and having an x-ray it was discovered she had a lumbar fracture. At the time of the report the patient's outcome was unknown. It was determined that the mother and the patient seem to feel that the lumbar fracture was still due to Gardasil. Additional information has been requested.
Less than full dose given; This spontaneous report as received from a nurse referred to a unspecified child of an unknown age and gender. The patients concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the nurse reported that at least one patient received less than a full dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II), .5 milliliter, subcutaneous. The unspecified child moved and some of the dose might have squirted out (incorrect dose administered). Nurse reported that, the nurse in the practice that administered the dose routinely only withdrawn and administered 0.5 ml of  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) instead of all contents as directed in the prescribing information so they believed that the less than full dose was given. No further information was provided.
no AE; MMRII with a labeled expiry of 5/29/2022 was administered to 6 patients on various dates; This spontaneous report was received from an office manager via employee, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug allergies, and concomitant therapies were not reported.  On 09-JUN-2022, the patient was vaccinated with one dose (quality: 1) of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (therapy type: recombinant human albumin (rHA)) subcutaneous injection, 0.5 milliliter, lot #T018669, expiration date: 29-MAY-2022 (strength, route of administration and anatomical location were not provided) administered for prophylaxis (expired product administered). No additional adverse event was reported (no adverse event).  This is the one of six reports received from the same reporter.; Sender's Comments:  US-009507513-2207USA007188: US-009507513-2207USA007049: US-009507513-2207USA007041: US-009507513-2207USA007043: US-009507513-2207USA007052:
This spontaneous report as received from a registered nurse refers to a 11 week old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 21-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706:
Moderate dry mouth  began 1 wk after vaccine & persists to 02/24/2021
I have had tinnitus and an an amount hearing loss since my early 40's. Ocassional hearing tests yielded: This was at a level deemed "not unusual for my age", but not optimal. Over the course of years, the tinnitus has slowly increased little by little.  Within a month after the vaccine, the tinnitus (and some associated hearing loss) became NOTICIBLY worse in a short time. After 6 months, it has not subsided.
patient experienced severe dizziness, lightheadedness, nausea, diarrhea & chills.  She was unable to work for 3 days due to the mentioned side effects
Uncontrollable shaking; Fever; Vomiting; Achiness; This is a spontaneous report from a contactable consumer(patient).  A patient of unspecified age and gender received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Jan2021 08:30 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously received first dose BNT162B2 for COVID-19 immunization. Patient had second dose on 22Jan2021 about 08:30 AM and around 10 PM, patient had uncontrollable shaking for a couple of hours, just seem like patient couldn't get body to stop shaking and also experienced other side effects fever, vomiting, achiness, all in Jan2021. Outcome of events was unknown.  Information on the lot/ batch number has been requested.