chrisvoncsefalvay/vaers-outcomes huggingface dataset:
seizure; This is a spontaneous report from a contactable consumer (patient).  A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 16Feb2021 14:00 at the age of 65-years-old (Batch/Lot Number: EN6201) as 1ST DOSE, SINGLE for covid-19 immunisation.  Medical history included Stage 4 cancer from an unknown date, known allergies: Sulfa, Emcin. Concomitant medications included osimertinib mesilate (TAGRISSO); levothyroxine sodium (SYNTHROID) and paracetamol (TYLENOL) all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not Pregnant at time of Vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient stated 10 days after vaccine (as reported) she had a seizure on 21Feb2021 19:30. She was not saying it was related to vaccine but she had heard other people have had this happen and she should report it. The patient was hospitalized for seizure for 3 days. The event resulted in emergency room/department or urgent care. The patient underwent lab tests and procedures which included Brain EEG (electroencephalogram), Brain MRI (magnetic resonance imaging) with unknown results on an unspecified date. Therapeutic measures were taken as a result of seizure. The outcome of the event was resolved in 2021.
Very fatigued for 4 days+, joint aches for approx. 7 days, headache on and off for 4 days, Brain fog on and off for 3 weeks or more. Arm soreness. Lethargic on and off for a week or more.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2011, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (strength, route, dosage schedule, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster on an unspecified date. Later in 2015, the patient was treated for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, pain, suffering and other damages. The outcome of the events was unknown. Vaccination failure, emotional distress, injury and herpes zoster were considered to be related to ZOSTAVAX.
Sciatica and neck pain on right side. Headaches. Fatigue. Memory issues. Anxiety and Depression flareup. Nightmares. This has lasted for three weeks.
Information has been received from a registered nurse concerning a 66 year old patient who on 04-FEB-2011 was vaccinated with a dose of VARIVAX (Merck) (lot number 666854/0163Z) instead of ZOSTAVAX (Merck) due to a human error. There was no adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
This spontaneous report was received from other health professional refers to an unspecified number of patients of unknown age. The patient's past medical history and concomitant medications were not reported. On unknown dates the patients received improperly stored PNEUMOVAX 23, lot # M037533 with expiry date 07-MAY-2018(Dose, frequency route unknown) for prophylaxis. No adverse effects reported. This is one of the 3 reports. Additional information has been requested.
Patient was given 0.3 ml of vaccine to left arm by nurse in office, undiluted from vial
1 day after vaccination developed dizziness, ataxia, left upper and lower extremity weakness that has persisted at least to today (7 days later).   Today's exam reveals left arm and leg weakness throughout with normal patellar and brachialis reflexes, but with mild cogwheel regidity at left elbow. Cranial nerves intact and respiratory musculature appears to be functioning normally.
About 4 hours after the first vaccine, numbness and tingling all over the body. Left arm went completely numb and tingling. Scalp tingling and numb. Felt like circulation was cut off. Severe Shortness of breath. Extreme feeling of adrenaline. The next day on March 14th, had extreme vaginal bleeding on day 14 of cycle. Bled for another 7 days which led to extreme anemia. The shortness of breath is every day since the first dose. Heart palpitations (heart rate went up to 190!). After the second dose on 4/03, all symptoms got worst. Left leg went completely numb the same day which I went to the emergency room for. The neurological tingling and numbness was spreading to my whole body. Arms, legs, face, ears, scalp, inside my head. I was worried for a heart attack since all of my symptoms of left arm and shoulder pain and numbness etc. I was released from the emergency room 12 hours later. I continued to have severe symptoms. The shortness of breath was so bad that I didn't sleep for 2 nights straight because my oxygen would drop. I also had severe insomnia and no appetite and lost 5 pounds in 1 week. Major adrenaline feeling. I went back to the emergency room 2 more times this week to check out my heart and lungs. All of my doctors recommended ER since they couldn't help me. My neurologist said he is getting lots of these symptoms from people post vaccine.  My shortness of breath and elevated heart rate and numbness and tingling are still here and I can barely go up and down stairs without being out of breath and having a 130-140 heart rate and super low blood pressure and night sweats. It is awful.
Migraine, extreme fatigue, nausea, fever, chills, aches, joint pain, shot site swelling and sensitivity.  Basically, I felt like crap for around a day. My wife and I have received the same vaccines and experienced identical, terrible side effects every time. This was the first time that I felt so terrible I thought I?d have to go to urgent care if my Tylenol and advil combo didn?t help my migraine.
Lightheaded with emesis & short of breath. Seen @ urgent care @ 3:15pm. Hypertensive on admission with headache.
significant occipital & partial h/a w/in 1hr of 2nd dose in series;also lightheadedness & very distracted;tx w/Ibuprofen;resolved by next morning;severe h/a, dizziness;
on Sept 8, Reported to ER painful Rush ,Blistering, purpuric,  weeping. On 9/9/2021 Saw me, Family Doctor, Rash + pain getting worse- Blisters, Splolches worse, weeping clear fluid.
Feeling a little tired; Fever; This is a spontaneous report from a contactable consumer (reported for his wife) from a Pfizer-sponsored program.  A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the second dose yesterday (unspecified date), and she was feeling a little tired and had a fever. The reporter wanted to know if she can take ibuprofen. The outcome of the events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
I had a severe case of vertigo. It woke me out of my sleep. I felt like the room was spinning, I tried to stand, and I fell over. I have never had this happen to me before and I am still having problems but not as bad. I talked to my doctor through telehealth. She prescribed me Meclizine and a Z-pack.
Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 77-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: ep6955, Expiry date was not reported ), via an unspecified route of administration, administered in Arm Right on 05Mar2021 12:00 (age at vaccination 77-years-old) as dose 2, single for COVID-19 immunization.The patient medical history and concomitant medications were not reported.Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: ENS318, Expiry date was not reported), via an unspecified route of administration, administered in Arm Right on 12Feb2021 as dose 1, single for COVID-19 immunization. Patient received other vaccine in four weeks. Prior to vaccination, patient was not diagnosed with COVID-19. On 06Mar2021 12:00, patient experienced diarrhea. Event results in doctor or other healthcare professional office/clinic visit. Patient received treatment foe event. Patient stop metformin. Since the vaccination, patient tested for COVID-19. The patient underwent lab tests and procedures which included sars-cov-2 test: unknown on 17May2021 Nasal swab. The outcome of the event was recovering.  Follow-up attempts completed. No further information is expected.
Came into the ER for left side cramping chest pain radiating into his left arm starting 1 hour 15 minutes prior to arrival to ER. Pain 7/10. Sitting in chair but had just worked out with light weights and cardio.
Pt is a 15-month-old male brough in my mom for a rash.  Mom is concerend that is may be due to one of his immunizations.  He was in for a 15 month well child check on 08/25/2008 at which time he received his MMR and DTaP.  At that point, he had a diaper rash that looked like yeast, otherwise his examination was completely unremarkable and he was not ill in any way.  The day following his immunizations, he developed a fever and ran a fever for fice days and it did get up to 103.  After the fifth day, his fever did go away; however, then on 9/3 in the evening mom noticed just a slight rash on his stomach.  She describes it as samll, red dots that were light in nature.  She put him to bed and when he awoke the next morning, the rash was gone; however yesterday on 9/7/08, he developed a rash once again on his stomach and back that seems to bother him.  He seems to be scratching and rubbing at his skin and it has now progressed and is starting to creep up onton the back of his head.  He seems more irritable.  He has not had any further fevers.  He has not had any redness to his eyes or drainage from his eyes.  He has not had any runny nose and has not had any cough.  He continues to eat well.  No one else in the home has been sick and he only goes to a drop-in daycare one day a week while mom works out.   Exam reveals erythematous papules covering his entire trunk ranging in size from a few pinpoint, mainly 3 millimeters in diameter, and some are confluent.  They cover his entire abdomen, back, up onto the back of his neck and into the hairline, and a few on his cheeks.  A few of them also go down onto his legs and arms, but definitely not as prevalent as on his trunk.  There are no pustules and there are no vesicles.  These are dry lesions.
little pain on his arm after the first; 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 male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 04Apr2021 (Batch/Lot number: unknown) at the age of 50 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Allergic to motrin for allergy, reaction(s): "lip swells", notes: Verbatim: allergic to Motrin. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "little pain on his arm after the first".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
both arms heavy;could not hold a pen;numbness & tingling in arms w/some tingling in legs;
Swelling, red blotches, itchy( on arm where the vaccine was given)severe headache, pain in left side by hip bone, sharp pain, cotton mouth(extremely thirsty) and tightens of chest
Headache. Myalgia & Arthralgia Narrative: severe weakness, body aches. ha , insomnia
second moderna vaccine was given 3 months after first dose for health reasons not related to Covid; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second moderna vaccine was given 3 months after first dose for health reasons not related to Covid) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COPD and Asthma.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second moderna vaccine was given 3 months after first dose for health reasons not related to Covid). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second moderna vaccine was given 3 months after first dose for health reasons not related to Covid) had resolved.            No concomitant medications were reported.  Patient reported that her second moderna vaccine was given 3 months after first dose for health reasons not related to covid.  No treatment details were reported.   Reporter did not allow further contact
Seizure at home and in the emergency room. Still in hospital receiving medications and tests.  Nurse follow up on 11/01/04 states: "Drowsy." Per annual report-Pt. has epilepsy, first seizure was after immunization listed above.
Vials used that were more than 30 days in refrigerator administered to patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vials used that were more than 30 days in refrigerator administered to patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vials used that were more than 30 days in refrigerator administered to patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vials used that were more than 30 days in refrigerator administered to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported.  No treatment information was reported by reporter.  Crosslinked to MOD21-136212, MOD21-136213, MOD21-136214, MOD21-136215, MOD21-136216, MOD21-136217, MOD21-136218
Red circle, ~2" at injection site.  It's sore, hot to the touch, and hard to the touch.
Patient claims to have black and blue arm and bad dreams. Reported 9/21/16.
A report has been received from a physician concerning a 3 year old, male subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. The patient reported administered expired FLUMIST QUADRIVALENT which started on 08-Sep-2014. The outcome of the event of ADMINISTERED EXPIRED FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Persistent soreness and tenderness in the arm muscle where the injection was given. It worsens when I use the muscle.  I also feel like a "heaviness" there, like something is present in my muscle. I had a cyst - like lump for about 2 weeks post shot that eventually went away.
Initial unsolicited report received from a nurse on 04 November 2015. This case involves a 07-year-old male patient who was vaccinated with 0.5 ml dose of FLUZONE QUADRIVALENT multi-dose vial (batch number: UI443AC, expiry date, dose, route of administration were not reported) in left deltoid on 29 October 2015. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had developed severe swelling of entire upper arm with warmth and redness. It was reported that, reaction was seen on 02 November 2015. The patient's laboratory data and corrective treatment were not reported. The outcome of event was not reported. List of documents held by sender: none.
pemphigus vulgaris (trunk and back) and mouth; This is a literature report for the following literature source(s).   A 40-year-old female patient received BNT162b2 (BNT162B2), as dose 2, 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, experienced events after 5 days after vaccination), for covid-19 immunization, reaction(s): "Pemphigus vulgaris". The following information was reported: PEMPHIGUS (medically significant), 3 days after the suspect product(s) administration, outcome "recovering", described as "pemphigus vulgaris (trunk and back) and mouth". Therapeutic measures were taken as a result of pemphigus.  Clinical information: Consumer reported treatment for reported event as oral prednisone and azathioprine. Clinical outcome was remission without reported relapse (unspecified timeline).; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event PEMPHIGUS and BNT162B2.  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.,Linked Report(s) : US-PFIZER INC-PV202200065086 Same article/ drug/ patient and different event;
This case was reported by a physician via a sales representative and described the occurrence of drug effect incomplete in a female subject of unspecified age who was vaccinated with (Flu vaccine, manufacturer unspecified) and received TREXIMET (GlaxoSmithKline) for migraines. On an unspecified date the subject took an initial dose of TREXIMET 85/500 (oral). Pain relief was achieved, but not complete resolution. On an unspecified date, the next day approximately 24 hours after ingestion of TREXIMET, the subject received unspecified dose of Flu vaccine (unknown). At an unspecified time after TREXIMET and after vaccination with Flu vaccine, the subject complained of dizziness and unsteady gait. The physician considered the events were clinically significant (or requiring intervention). At the time of reporting the outcome of the events was unspecified. On 16 October 2009, the sales representative reported that the subject was referred to a local neurologist. No additional information was provided. Follow up information was received on 19 October 2009 via a sales representative who reported that the subject took one dose of TREXIMET and then about 24 hours later received flu vaccine  (and thought this was on 15 October 2009). That same day, the subject experienced both dizziness and unsteady gait, both of which resolved on an unspecified date. The subject required referral to the neurologist. The subject took only one dose of TREXIMET. TREXIMET was discontinued and was not reintroduced.
Initial information received on 02-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA306289 and 2018SA306332. This case involves a 6 months old male patient who experienced received expired PENTACEL, while he received vaccine PENTACEL. Patient has received PREVNAR and Rotavirus vaccine (also reported as Rhodavirus) as concomitant medications. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 01-Nov-2018, the patient received a 0.5 ml once dose of suspect PENTACEL lot C5439AA, expiry date- 29-Oct-2018 in right thigh. It was a case of actual medication error due to expired vaccine used. It was not reported whether the patient had any adverse event or not after receiving the expired vaccine. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the 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.
About 30 minutes after vaccination, patient notiched itchiness which progressed to hives on her bilateral arms and face. Around two hours after the vaccination while on the phone with our covid vaccine team, she developed tachycardia and shortness of breath. She called EMS and was evaluated at home at which time her symptoms were improving. They advised that she was not having anaphylaxis and could stay at home. She went to urgent care and received PO Benadryl.
Rib pain consistent with costochondritis starting the day of vaccination, and continuing for a week. Treated with OTC Alleve (naproxen sodium) without complications
Pt developed intermittent epigastric abdominal cramping, diarrhea, and fever on 10/15/21.  Encouraged to take PPI daily (has esomeprazole at home) and to add Pepcid 40 mg BID
Contracted Covid; Contracted Covid; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 58-year-old male patient received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL3247), on 17Feb2021 as dose 2, single (Lot number: EL3247), on 30Sep2021 as dose 3 (booster), single (Lot number: FF2589) and on 04Apr2022 as dose 4 (booster), single (Lot number: FL3197) at the age of 58 years 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) with onset 16Jun2022, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset 16Jun2022, outcome "recovering" and all described as "Contracted Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Jun2022) Unknown results.  Clinical course: Unknown if covid prior vaccination. Covid tested post vaccination. Covid test type post vaccination was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available
As an amputee all my nerves started firing after the vaccine. My face swelled up as if I?d been beaten. My residual limb has had hives and blisters and nerve pain since the vaccine. Pain I haven?t had in 3 years since losing my leg.
pt recvd flu vax 1NOV93 & approx 1-2 wks p/vax pt broke out in herpes zoster;
Screaming, irritability and holding abdomen as if in pain, from approximately 2 hours after immunization until two days later. Medical Records received on 1/12/2005 state gastroenteritis.