chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer reporting for the daughter. A female patient of an unspecified age and race/ethnicity received the first dose of TRUMENBA on 10Jul2017, at 0.5 ml single, for immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Since 10Jul2017 and on 11Jul2017 throughout the day the patient experienced fever (at 101.5), was very achy all over the body, had nauseous feeling off and on and her head hurt. The events had not yet resolved at the time of report.
Dementia seems to worsen; Patient who received the Pfizer-Biontech Covid19 vaccine, and contracted Sars-CoV-2 a few days later.; drug ineffective; This is a spontaneous report received from a contactable physician.A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EM9809), via an unspecified route of administration on an unspecified date as 1st dose, single for covid-19 immunization.Medical history included covid-19 and dementia.The patient's concomitant medications were not reported.The physician reported that patient who received the Pfizer-Biontech Covid19 vaccine, and contracted Sars-CoV-2 a few days later.The patient was also treated with antibody therapy, and the second dose of vaccine has been deferred for the 90 days after this therapy. The reporter would like to know if the patient should receive the second dose or re-start the series. The person contracted Covid at a couple days so assumed the first dose did not work at all. The patient had Covid infection then given the vaccine, the dementia seems to worsened with Covid. The reporter stated that having a Sars-CoV-2 infection has been shown to worsen dementia and asked what the effects would be if the patient were to then receive a Covid vaccine. The reporter would like to know if the first dose of the vaccine was efficacious, since the patient tested positive for Sars-CoV-2 shortly after receiving it and what reporter have seen as far as efficacy if patient contracted Sars-Cov-2 in between doses and how does it affect immunity. Therapeutic measures were taken as a result of covid-19. The patient underwent lab tests which included sars-cov-2 test: positive. The outcome of the events were unknown.; Sender's Comments: As there is temporal relationship in the case provided, the causal association between the event and the suspect drug cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Ocular Palsies ( Third Cranial Nerve Palsy - Strabismus) Misalignment of the left eye, weakness of cranial nerves. LE started drifting inward, not working with the other eye. Worsened over time. Palsy refers to paralysis, number one cause of Ocular Palsies is pressure on the Cranial Nerve, which likely came from Encephalitis (inflammation of the brain) which is another known and listed vaccine side affect (adverse event). Adverse event caused permanent damage, needs surgery to correct it. Has been in glasses since diagnosis. Will need to do a thorough detox to remove the heavy metals and toxins from her body that caused the Encephalitis which caused the Ocular Palsies.
IMMEDIATLY I BROKE OUT IN HIVES ALL OVER, MY RIGHT ARM SWELLED UP, AND HOT TO THE TOUCH, COULD NOT SWALLOW, AND LOST MY VOICE. IT STARTED CALMING DOWN AN HOUR AFTER I WAS GIVEN STERIODS.
Symptoms-Bad headache, body aches for several days, low grade fever off and on for several days, nausea and vomiting, sore throat
I had a rash temporarily and then on 11/14/2021 I had a stroke out of nowhere. I had no previous ssues.
Pt developed pain and swelling in his leg on 2/8/21. Sent to the emergency room on 2/10/21 and found to have DVT. No history of clots in the past.
I started with flu like symptoms and took a COVID-19 test. I had sinus congestion, head ache and chills. I was prescribed Paxlovid and on my last dose today. Symptoms today are almost gone minus some lingering fatigue.
I was seen by the Medical Center Emergency Room on Saturday, January 15,2022 for paralysis of the left side of my face.  The condition was diagnosed as Bells Palsy.
Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain at the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Pain at the injection site). At the time of the report, VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided.  No treatment information was given.   This case was linked to MOD-2021-075367 (Patient Link).
chronic diarrhea; This is a spontaneous report from a contactable consumer (patient's grandson). A male patient of an unspecified age received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history was not reported. Historical vaccine included patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. Patient received unspecified concomitant medications. On an unspecified date, after Pfizer COVID vaccine second shot, patient had 80+ days of chronic diarrhea. The outcome of chronic diarrhea was unknown.  Information on the lot/batch number has been requested.
pt recvd vax & 16 hrs later, pt devel tingling in the lt arm; 2 wks later devel pain & weakness in the arm; pt was referred to a neurologist who found the ulnar & medial nerve to be affected & dx post vax neuropathy; tx Dexamethasone
2/9 I notice a sharp pain in the right ear. I did experience vertigo at the same time and went to urgent care on 2/10 to determine what caused the vertigo. In one ear I had ear wax and they removed it to get a better look at my ear drum. There was no ear infection and it was determined that it was an instance of my off and on vertigo issue. This lasted about a week or less and after there was no more sharp pain in my ear. I have fully recovered.
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 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 50 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 18Jan2021 as dose 1, single (Lot number: 071856), on 10Feb2021 as dose 2, single (Lot number: 004M20A) and on 20Sep2021 as dose 3 (booster), single (Lot number: 048F2A) for covid-19 immunisation. The patient's relevant medical history included: "Mitral valve prolapse" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: PREMARIN, start date: 31Dec2019, stop date: 19Jun2022; PREMPRO, start date: 01Aug2021, stop date: 19Jun2022.  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: Positive, notes: Positive home test day 10; Negative, notes: Negative home test on day 7.
This spontaneous report was received from a registered nurse referring to a 11 year-old patient of unknown gender. The patient's pertinent medical history and concurrent conditions were not provided.    On 13-DEC-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # N004799, expiration date on 15-NOV-2019 or lot #N021475, expiration date on 21-JAN-2020, for prophylaxis (strength and route were not reported). The vaccine was stored at a temperature of 50°F for a time frame of 2 hours. No adverse effects neither previous temperature excursions for the improperly stored vaccine were reported. The call was because of a data logger. This case was one of several reports received from the same reporter. ; Sender's Comments: US-009507513-1801USA002510: US-009507513-1801USA002511: US-009507513-1801USA002512: US-009507513-1801USA002513: US-009507513-1801USA002515: US-009507513-1712USA010085: US-009507513-1801USA002517: US-009507513-1801USA002518: US-009507513-1801USA002519: US-009507513-1801USA002520: US-009507513-1801USA002521: US-009507513-1801USA002522: US-009507513-1801USA002509: US-009507513-1801USA002508: US-009507513-1801USA002514:
Patient states that she is unable to lift her arm above her shoulder, grasp or carry anything with that arm, or carry anything heavy. She also states that she has shooting pain in that arm sometimes. She visited her dr who told her when the vaccine was given it probably hit a nerve and it should resolve sometime in next 6 months.
Reports left sided numbness that comes and goes, perhaps 20 minute episodes over the last several weeks. First reported these symptoms three weeks after vaccination. Has been evaluated several times with no neuro deficit. Continues to be evaluated periodically by physician and APP with no observable deficits.
Began with swollen cheek, swelling spread to lips and other cheek, subsided after  3 days. This was PREVNAR-23; No previous reaction to PREVNAR-13 administered March 2016.
This case was reported by a physician via sales representative and described the occurrence of injection site reaction in a subject of unspecified age and gender who was vaccinated with KINRIX, (GlaxoSmithKline).  On an unspecified date, the subject received unspecified dose of KINRIX (unknown).  At an unspecified time after vaccination with KINRIX, the subject experienced injection site reaction.  At the time of reporting the outcome of the events was unspecified.  The sales representative was told that the physician's office had four major injection site reactions (from four different subjects) over the course of a month.  No additional information was provided.  Additional cases see A0796720A, A0796722A, and A0796724A.
Pain at injection site started the day after vaccination (1/23).  On 2/1, she noticed a bullseye rash to injection site along with intense pain and itching.  She then noticed elevated heart rate and began to feel light headed.  She was instructed to go to the emergency department at our local hospital .  Her heart rate was 107 and blood pressure was 162/112.  An IV was started and IV Solumedrol and Benadryl were administered.  Chest X-Ray revealed pneumonia.  Bloodwork is pending.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient received bnt162b2 (BNT162B2), on 21May2022 as dose 4 (booster), single (Batch/Lot number: unknown), 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: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of "COVID 19 Treatment" included Paxlovid from 29Aug2023 to 02Sep2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
fatigue, body aches, sore throat, headache, wheezing  lasted around 36 hours
Extreme fatigue, unable to  go about my day, constantly falling asleep. Started at 5am on 3/5,  arm also sore at injection site, no skin reaction, started about an hour after the injection
Parent spoke to after hours provider 9/8/23, c/o severe arm pain, dizziness, ringing in the ears. Was advised to continue icing the arm, use tylenol or ibuprofen for pain, rest, fluids, preferably with electrolytes.  Patient will be seen in clinic this afternoon for recheck. Mom reportd this morning that the dizziness and ringing in her ears stopped. Patient was still having a sore arm and a little swelling.
Information has been received from a physician concerning a female patient who on an unspecified date, was vaccinated with a dose of GARDASIL vaccine (yeast). The physician reported that the patient fainted and hit her head after receiving the dose of HPV vaccine. The patient sought medical attention at the physician's office. Additional information has been requested.
Severe fever blister outbreak consisting of 5 sores developing simultaneously. Very atypical for me. Not sure of anything else that it could be connected to.
Swelling, redness at injection sight, numbness and tingling in hand; treated with ice and BENADRYL and ibuprofen, large welt 2 inch in diameter, swollen/sore for 4 days.
This spontaneous report as received from a physician, via market research (TPSI), refers to a immunosuppressed female patient in her 80's with leukemia. In December 2013 or January 2014, the patient was vaccinated with ZOSTAVAX (dose, route and lot number were not reported). Concomitant medications were not reported. On an unknown date the patient experienced skin reaction that clinically looked to be disseminated zoster. The outcome of skin reaction and disseminated zoster was reported as recovered/resolved. On an unknown date patient underwent biopsy of skin lesion: results not provided. The relationship between ZOSTAVAX and the events was not reported. Physician suspected that immunosuppression and concomitant leukemia were the reason for skin reaction. Additional information has been requested.
Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: Pt recievd vaccine and fainted while in the observation area.  Pt was not unconscious when i arrived. Pt was disoriented.  Had patient lay down. Called 911.  Pt stated he was warm, and nauseous. Provided patient with water. 911 came. Pt refused transport to hospital. Pt felt better. Friend came to tajke patient home. Pt again felt week and had tingling in the arms.  Asked if he wanted  911 or if he wanted friend to take hime to the ER. Pt did not want 911.  Stressed need to go to the ER.
12/9/21 COVID Positive.  Admitted for generalized weakness on 12/9/21.  12/11/21 patient was positive for C-Difficile with ongoing diarrhea.  Started on Vancomycin.  Stable on Room Air. Currently hospitalized (12/15/21).
DID NOT TAKE THE LAST DOSE; This spontaneous case (PVX2019-719) was received from a consumer on 25-Mar-2019. It describes a 21-year-old adult female consumer who "did not take the last dose", while being on Vivotif for an unknown indication.   Case report: The consumer took 3 doses of Vivotif on 18-Mar-2019, 20-Mar-2019, and 22-Mar-2019 respectively. After that she went out of town and did not carry the last dose. It was reported that she would not return home until 29-Mar-2019 and thus she missed her last dose, which was due on 24-Mar-2019.   Action taken with Vivotif was not applicable.   The clinical outcome of the event "did not take the last dose" was unknown.  Company's Comment: The causality of the event "did not take the last dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "did not take the last dose" was considered as not applicable.
Patient fell (did not sit down completely for vaccine), and lightly hit forehead. On Pradaxa. No visible head trauma. BP 160/100 (pulse 56), O2 sat 97%. Final BP 132/62.
No other AE reported by HCP; an expired dose of PNEUMOVAX 23 was administered; This spontaneous report was received from a pharmacist and refers to a 67-year-old patient of an unknown gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 22-OCT-2021, the patient was vaccinated with expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) formulation vial, dose/frequency reporter as 0.5 ml (miilliliter) one time, lot # T021329, expiration date 03-OCT-2021 (dose number and route of administration were not reported) for prophylaxis (expired product administered).  The vaccine had not experienced a temperature excursion. No other adverse events was reported by the pharmacist (no adverse event). The pharmacist additionally inquired how long after expiration the product was good for.
Pain at the injection site; Itching; Small blisters; Scabbing; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose in September 2021).   In December 2021, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced injection site pain, pruritus, blister and scab. On an unknown date, the outcome of the injection site pain, pruritus, blister and scab were unknown.   It was unknown if the reporter considered the injection site pain, pruritus, blister and scab to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received Shingrix a week before reporting at the end of December 2021, since then she had noticed pain at the injection site.  The patient had itching, small blisters, and scabbing on her right wrist.  The patient was inquiring how to confirm if that was Shingles.  The reporter consented to follow up. The patient provided permission to contact health care professional.  No additional details were provided.
Chills; migraine; inflammation throughout entire body; tingling and numbness in hands and feet.; tingling and numbness in hands and feet.; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FR8736) via an unspecified route of administration in the right arm on 03May2021 at 13:15 at the age of 37-years-old as a single dose for COVID-19 immunisation. The medical history included fibromyalgia, lupus, and allergic to sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included IBUPROFEN for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FR8731) via an unspecified route of administration in the right arm on 12Apr2021 at 13:15 at the age of 37-years-old as a single dose for COVID-19 immunisation. On 04May2021 at 01:00, the patient experienced chills, migraine, inflammation throughout entire body, and tingling and numbness in hands and feet. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the reported events which included treatment with unspecified pain medication and anti-depressant. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, migraine, inflammation throughout entire body, and tingling and numbness in hands and feet were resolved with sequelae on an unknown date in May2021.    No follow-up attempts are needed. No further information is expected.
I sat the duration of the 5 minutes in the lobby to make sure I had no reaction. I was fine so I drove to work. Took about ten minutes to get there and I noticed that my left hand was tingly and it was getting hard to hold on to an object. Then I started feeling tingly pins and needles in my left arm and hand. I called the clinic back and they advised that I come back to the clinic. I drove back and by the time I got there the pins and needles where down my left leg as well and a little in my right hand. They checked my vitals and they were good. I was getting light headed and dizzy. The nurse called her boss and it was advised that I needed to go to the ER, so they called an ambulance. Took about an hour to get an ambulance there, Once inside the ambulance they did a diabetes test, that came back negative. Listened to my heart and took my blood pressure that was also fine. Got to the ER and they took me into the triage nurse to get evaluated. Once I went over everything they pushed me to the lobby and I was told if I get worse to let the front desk know. I sat there for about 20 minutes and I could not move my left leg or arm, therefore could not go to the front desk to let her know. They finally called me back in and I let them know that I was worse and that my face was now turning numb.  All results came back normal. I was given no treatment and to this day the nerve damage limits what I can do at work and in my personal life. Just typing this I am in severe pain. I do not sleep at night as the pain and numbness is so much worse. I can only hold an object for about 30 minutes before the weakness and pain gets worse. Driving used to be my favorite thing to do and now this pain and using my hands makes it difficult and hard to enjoy anymore. I have no insurance so I have not gone to the doctor as this bill is costing me over $6000.00
On Oct 8, 2014 noticed increasing numbness left side of face which progressed to left facial paralysis; transient fever and sweating, went to ED. On Wed night 10/8/14 - diagnosed Bell's palsy; will f/u with PCP on 10/13/14.
NONE- PATIENT IS 17 YEARS OLD AND WAS ADMINISTERED FLUBLOK THAT IS INDICATED FOR PATIENTS 18 AND UP.  PATIENT TOLERATED VACCINE WELL AND HAS NOT HAD ANY ADVERSE EVENTS OR REACTIONS
Severe redness at site of injection 2 weeks afterwards as well as itching over entire body. A mild headache accompanied by fatigue.  This was the first dose of the vaccine.  Has been going on for over 24 hours.
Headache, Fatigue, Fever, Chills, Generalized muscle aches, especially the neck.
low temp begin evening 14JUN;dec sleep, dec appetite;seen 19JUN;?otitis;-amox given-devel v,d, inc fever, rash-to ER-IVSF, CBC, blood cult;21JUN lethargic-still rash;24JUN t100.9 still rash, vomit;better 27JUN seen in office still rash;
temp 102 the evening of vax mild facial & upper extremity flushing, nausea & dry heaves;localized rx 5mm in diameter;sx lasted 4hr;resolved w/DPH & APAP;temp today 100;
Patient developed chest pain and was found to have elevated troponins with ST changes on EKG, concerning for perimyocarditis. Currently in the cardiac ICU at hospital with improving values at this time.