chrisvoncsefalvay/vaers-outcomes huggingface dataset:
non cardiogenic pulmonary edema, metabolic acidosis (severe) & intractable hypotension about 3hr p/vax;requiring mechanical ventilation, vasopressor;similar case of ARDS in MAY97 w/o etiology;No known vax given then;plumonary edema
Immediate chest pain following shot subsiding after 10 min..  following 3 weeks after shot : consistent and very prevalent shortness of breath, feeling of someone sitting on my chest, heart fluttering, anxiety, light-headed ness, irregular chest pain for short intervals, fatigue.
Random single itchy hives that come and go within a few hours on different areas of the body; This is a spontaneous report from a contactable other healthcare professional. A 38-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2813) via intramuscular route of administration in the left arm on 19Mar2021 at 15:15 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. The patient had pollen allergy and had no other medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Mar2021, on day 3 after first vaccine, the patient experienced random single itchy hives that came and went within a few hours on different areas of the body and was lasting for about a week. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measure was taken for the event. The clinical outcome of the event random single itchy hives that come and go within a few hours on different areas of the body was unknown at the time of this report. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via intramuscular route of administration in the left arm on 09Apr2021 at 16:15 as a single dose for COVID-19 immunisation.   No follow-up attempts are needed. No further information is expected.
bell's palsy; Inappropriate schedule of vaccine administered; Information has been received from a lawyer referring to a 58 years old male patient. Information about concurrent condition, history condition and concomitant medication was not reported. On or about 03-MAR-2009 the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for the long-term prevention of shingles and zoster-related conditions (Inappropriate schedule of product administration). As a result of the receipt of zoster vaccine live (ZOSTAVAX), the patient was caused to suffer Bell's palsy on or about 04-MAR-2009, including any and all of it sequelae. Subsequently, the patient was treated by a provider for the following injuries resulting from Zostavax (ZOSTAVAX): Bell's palsy. As a result of the receipt of zoster vaccine live (ZOSTAVAX), the patient has been caused to suffer severe personal injuries, pain, suffering and emotional distress, as well as to incur substantial economic damages. As a direct and proximate result of zoster vaccine live (ZOSTAVAX)'s failure to warn, the patient suffered severe and permanent physical injuries, including but not limited to Bell's palsy, as well as other severe and permanent health consequences. The patient has endured substantial pain and suffering, has incurred significant expenses for medical care and treatment, and will continue to incur such expenses in the future. The patient has lost past earning and has suffered a loss of earning capacity. The pt had suffered and will continue to suffer economic loss, and has otherwise been physically, emotionally and economically injured. The patient's injuries and damages are permanent and will continue into the future. The outcome of the event Bell's palsy was considered to be not recovered and causal relationship was assessed as related.    The lawyer considered the events Bell's palsy to be disability.   Upon internal review, Bell's palsy was determined to be medically significant.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date in 2014 (reported as since 08-AUG-2014), the patients were vaccinated with (Merck) VARIVAX which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received from the registered nurse who stated that it will take some time to get the (Merck) VARIVAX information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she may send the information at a later time. Follow up information has been received from the registered nurse concerning a patient (age range reported as 13-18, units not reported) of unknown gender. On 17-OCT-2014, the patient was vaccinated with a dose of (Merck) VARIVAX which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Patient was administered second dose for Moderna COVID vaccine. During 15 minute waiting period patient fainted while sitting. He was accompanied by his two companions whom caught him and placed him on the ground. 911 was called. Checked patient was breathing and there was a pulse. Smelling salts were provided to help bring consciousness back to patient. He was placed back on the chair and blood pressure and pulse monitored while waiting for EMT. Water was provided. EMT arrived and checked BP, glucose levels, and Ox. Patient denied to go to the hospital and went home with his companions.
Patient stated that initally there was a red line horizontally underneath the injection and then the next day the patient noticed bruising at the site of injection approximately the size of a half dollar.  Bruise has lasted for a week and patient also stated that there was "numbness down to the bone".
7.5 hours after receiving the Covid19 Vaccine, my nasal passages started burning. After about 30 min of my nasal passages burning (they continued to burn), I had a sudden onset of severe pain across my face in my sinus's. My upper teeth were also in pain. I could not drink anything hot or cold because it would cause a sharp shooting pain through my sinus's and would take several mins to subside. The pain continued the next day, so I went to immediate care but they refused to give me an antibiotic. They gave me a Covid test which was negative. 4 days after the extreme pain in my sinus's and teeth, I still had severe pain on the left side of my face, ear and teeth. I called my primary care physician and she prescribed a 10 day Augmentin antibiotic.  Finally my pain subsided 7 days after my vaccine (3 days after the start of antibiotics). 2 days after I finished the antibiotics, I had a sudden onset of severe pain in my hips and lower back, the pain persisted for a week. I went for acupuncture treatment and this eased my pain.  I just had my 2nd dose of the Covid19 vaccine and did not have any side effects.
C/o red rash all over her body. Mother stated it look like "welts". Mother called 12/9/02 and reported rash. Examined rash on student 12/9/02. Student stated "rash fading", no fever or other symptoms noted.
FLUBLOK had been administered to 10 year old patient with no adverse event; Initial information was received on 04-Jan-2021 regarding an unsolicited valid non-serious case from an other health professional (Nurse) via Medical Information (Reference number- 00413997).  This case involves a 10 year old female patient who had been administered with Influenza Quadrivalent Recombinant Vaccine (Flublok QIV) (Product administered to patient of inappropriate age). Reporter would like to know if patients were "covered" for influenza vaccination for the season.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was not reported.  On 22-Dec-2020, the patient received a once dose of suspect influenza quadrivalent recombinant vaccine (Prefilled Syringe) at a dose of 0.5 mL via intramuscular route in the right deltoid (lot number: UJ509AA, expiry date: 10-May-2021) for prophylactic vaccination.  It was a case of actual medication error due to Inappropriate age at vaccine administration. (latency- same day)  At the time of report, no adverse event was reported. (Adverse event (AE) symptoms: None reported )  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.
This spontaneous report as received from a 75 year old female patient with no pertinent medical history and no drug reactions or drug allergies refers to herself. On 27-SEP-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot number, dose, frequency, route and site of administration were not reported). Concomitant therapies included levothyroxine sodium (manufacturer unknown) an simvastatin (manufacturer unknown). On 30-SEP-2013, the patient felt her mouth was very dry and her tongue burned, especially when she drank or ate. The patient reported she was experiencing side effects since getting ZOSTAVAX. The patient did not seek medical attention. There was no treatment given for adverse events. No lab diagnostics studies were performed. The patient did not recover from adverse events. The relatedness between vaccination with a dose of ZOSTAVAX and adverse events was not reported. Additional information is not expected.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 26 year old white female of unknown ethnicity. The patient's height and weight were not reported. The patient had no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 2110210, expiry: UNKNOWN) dose was not reported, 1 total administered to right arm on 20-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-NOV-2021, patient reporter her first symptom of cough. Patient also reported being symptomatic with congestion and loss of taste. Patient also experienced confirmed covid-19 infection and confirmed clinical vaccination failure. On 07-NOV-2021, patient was tested positive for covid-19 with a home test kit. Patient later went in to a hospital place and got tested again and test results from the hospital were pending. She was exposed through her husband who showed the symptoms first. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure was not reported.  This report was serious (Other Medically Important Condition). This report was associated with regulatory authority.; Sender's Comments: V0: 20211119185-Covid-19 vaccine ad26.cov2.s- Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Took all the Pfizer Covid shots said to take and went to doctor today and told has Covid.; Took all the Pfizer Covid shots said to take and went to doctor today and told has Covid.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 14Feb2023, outcome "unknown" and all described as "Took all the Pfizer Covid shots said to take and went to doctor today and told has Covid.". The events "took all the pfizer covid shots said to take and went to doctor today and told has covid." required physician office visit. Clinical course: Patient took all the Pfizer Covid shots said to take and went to doctor on the day of reporting and told has Covid.  Then was given a medicine to take called Paxlovid. Patient asked if Paxlovid is the same thing as the Pfizer Covid shot was. Patient wants to take medicine. Has got a sick one at home, clarified he is also taking care of somebody else. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was revaccinated. She requested and was administered the first dose of Pfizer COVID-19 because her PCP told her to get it to give her better protection from the Delta variant. She had already received Janssen COVID-19 vaccine five months earlier at a different facility. The first vaccine was not in the  database. No adverse effects have been reported.
Redness, swollen lump, pain, bruising at injection site 1 day post injection. Fever of 101-102 degrees F for 4 days, starting 2/15/20 through 2/20/20 post injection. On 2/21/20, approx. 8 small, red pinpoint bumps/rash noted across arms, abdomen, and back. Rash resolved by 2/23/20.
Tested positive for COVID-19; Tested positive for COVID-19; This is a spontaneous report received from a contactable reporter (Physician) from medical information team.  An 86-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Parkinson's disease" (ongoing); "blood pressure" (unspecified if ongoing); "prostate" (unspecified if ongoing). Concomitant medication(s) included: SINEMET and medication for prostate and blood pressure. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: Glomerular filtration rate: (2022) 94; SARS-CoV-2 test: (2022) Positive, notes: tested positive for COVID-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: A contributory role of BNT162B2 to event Tested positive for COVID-19 cannot be excluded based on temporal association and available information.
Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. I am a deployed soldier. I have several concerns about the anthrax vaccination. I have been forced to take four shots since 2001 as a reservist. Each time, I have pain for about two weeks per shot. I am a 29 year old male with no prior major injuries. Now, I have weakness in my hands and tend to sprain my ankle often since I have been taking the anthrax vaccination. I was due  for my fifth vaccination, until the judge ruled against the DOD in forcing the shots to service members. I feel like a guinea pig. Now, I will have joint problems the rest of my life. Please stop these unnecessary vaccinations.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6202), in left arm, on 18Mar2021 as dose 2, single (Lot number: ER2613), in left arm, on 26Oct2021 as dose 3 (booster), single (Lot number: 30155BA), in left arm and on 13Jun2022 at 13:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Reduced kidney function as a result of kidney donation in 2004, Latest GFR 49" (unspecified if ongoing), notes: Reduced kidney function as a result of kidney donation in 2004, Latest GFR 49; "Reduced kidney function as a result of kidney donation in 2004, Latest GFR 49" (unspecified if ongoing), notes: Reduced kidney function as a result of kidney donation in 2004, Latest GFR 49; "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin"; Suphedrine, reaction(s): "Known allergies: Suphedrine".  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: Glomerular filtration rate: (unspecified date) 49, notes: Reduced kidney function as a result of kidney donation in 2004, Latest GFR 49; SARS-CoV-2 test: (unspecified date) Unknown Result; (08Jul2022) Negative, notes: Rebound of COVID after previously testing negative. Negative test July 8, 2022; (10Jul2022) Positive, notes: July 10; tested positive July 10; (18Jul2022) Positive, notes: Retest July 18 also positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Severe spasticity started at 7:00pm 3/31 - couldn't move - all cramped.  By midnight started vomiting which lasted until 7:30am.  Spasticity lasted about 8 hours.  SHINGLES outbreak noticed Sunday at 5:30am on the left side of my trunk.  Full outbreak by Thursday the 8th which wrapped around to the front side of my left side.  Went to the doctor at 7:30 on the 9th.  Started Valacyclovir at 10:00am - 7 day dose.  Tons of pain.  Have been out of work since diagnosis so far.
This case was reported by a nurse and described the occurrence of anaphylactoid reaction in a 5 year old male subject who was vaccianted with a hepatitis A vaccine inactivated Havrix, plus a separate injection of measles, mumps and rubella virus vaccine, strain not specified MMR II vaccine, for prophylaxis. The subject had no pre existing medical conditions. There were no concurrent medications. On 5/25/2006 at 12:20pm, the subject received 1st dose of Havrix (lot AHAVA305AA) and the 2nd dose of MMR II vaccine lot 1048R. On 5/25/2006, 10 minutes after vaccination with Havrix and MMR II vaccine, the subject experienced itching, cough, wheezing and hives. The nurse described the events as an anaphylactoid reaction. The patient was treated with adrenaline Epi Pen, dexamethasone Decadron, salbutamol sulphate Xopenex and diphenhydramine hydrochloride Benadryl at the physicians office. After a 4 hour observation, on 5/25/2006 at the physicians office, the events had improved. The vaccination course with Havrix was discontinued. The nurse considered the events to possibly be related to vaccination with Havrix and MMR II vaccine. Anaphylactoid reaction was assessed as medically serious by manufacturer (OMIC).
Mother called 7/25 am to report client c/o nausea, fatigue, fever starting, 7/24 pm. Talked with mother 7/27 pm stated client had nausea didn't eat or drink 7/25 fainted 5:30am 7/26. Went to Dr no treatment, Symptoms resolved 7/26 pm.
After verifying patient's name and DOB and making sure the dose, route and medication were correct, attempted to administer the vaccine to the patient in his left deltoid. The needle entered the patient's muscle; however the vaccine leaked out of the end of the syringe. The amount administered was undetermined but not much.
Right thigh 2x2in red swollen, no fever slightly sore and itchy. Administer ibuprofen for pain, warm compress, Benadryl for itching.
Rashes; hives; allergic reaction; This is a spontaneous report received from a contactable reporter(s) (Other HCP). Other Case identifier(s): LUS21-00448 .  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown", described as "Rashes"; URTICARIA (non-serious), outcome "unknown", described as "hives"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "allergic reaction".  Additional information: The patient has had allergic reaction to the vaccine, has suffered rashes and hives. No additional information can be provided at this time. This report will not be submitted to the FDA by another company.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (20Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 17May2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 06Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 24 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "common variable immune deficiency" (unspecified if ongoing), notes: common variable immune deficiency; "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical Course: The patient received Paxlovid from 21May2022 to 25May2022 as treatment of COVID-19. The patient reported to had, Covid symptoms rebounded and tested positive after completing the 5-day course. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Nausea, Body aches,  Given Tylenol and ginger ale. Feeling better
CNS/neurological symptoms with nausea and sleepiness Symptoms consistent with drug crossing blood brain barrier similar to atropine
Fever, chills, night sweats -- lasted about 48 hours Mild headache, background noise in ears (possibly tinnitus) has not ended -- 14 days, so far