chrisvoncsefalvay/vaers-outcomes huggingface dataset:
05/15/2010 tired, headache. 05/16/2010 migraine, blurred vision, vertigo, ear ache/buzzing and eye pain, high blood pressure, tired and muscle pain, nausea, went back to clinic they gave 2 anti migraine pills (Zomig). Migraine improved for some hours. 05/17/2010 neck pain, migraine, vertigo, blurred vision, muscle pain, hard to breath, nausea, low fever. 05/18/2010 severe muscle pain and migraine, vertigo, and nausea, low fever, hard to breathe. 05/19/2010 severe muscle pain, hard to breathe, vertigo, low fever. 05/20/2010 went to other doctor, got steroid shot, started to improve regarding muscle pain, fever, vertigo and migraine. 05/21/2010 still muscle pain and tired, neck pain and hard to breathe. 05/22/2010 return to work but with dizziness and muscle pain and low fever.
Mental confusion/ difficult to remember numbers; Mental confusion/ difficult to remember numbers; This spontaneous case was received on 07-Oct-2022 from pharmacist via Communications (reference number: SEQW22-04179) and concerned an 85-year-old, female patient.  The patient had no relevant medical history. The patient was using concomitant medications, however it was not reported which one.   On 01-Oct-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; route of administration: intramuscular, dose: 0.5 ml, anatomical location: not reported) for prevention of influenza disease. The batch number reported was 346361 and expiry date: 19-May-2023.  On 02-Oct-2022, one day after receiving Fluad Quadrivalent, the patient experienced mental confusion and it was difficult to remember numbers for about six days. No treatment was associated with the event.  At the time of initial report on 07-Oct-2022, the patient had not recovered from the events.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: An 85-year-old, female patient of unknown age and gender was vaccinated with the suspect product influenza vaccine. One day after vaccination the patient experienced mental confusion and it was difficult to remember numbers for about six days. Information regarding the related diagnostic findings and concomitant medications has not been provided. Advanced age confounds causality. Causality is assessed as not related based on biological implausibility.; Sender's Comments: An 85-year-old, female patient of unknown age and gender was vaccinated with the suspect product influenza vaccine. One day after vaccination the patient experienced mental confusion and it was difficult to remember numbers for about six days. Information regarding the related diagnostic findings and concomitant medications has not been provided. Advanced age confounds causality. Causality is assessed as not related based on biological implausibility.
4 hours after immunizations, fever 104.1, decreased appetite, crying inconsolably, waking dozily.
Dizziness; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0171), via an unspecified route of administration in left arm on 26Apr2021 at 10:00 (at the age of 50-year-old) as dose 1, single for COVID-19 immunisation at pharmacy/drug store. The patient's medical history and concomitant medications. It was reported that day of 1st dose, no ailment, no medications, "exceptional" rating for health insurance every year, never ever had and never will have a single addiction, never an injury or hospitalization, fit and mindful of nutrition never overweight. After 1st dose, began slight dizziness and reported via "V-safe" coc website and weekly text check-ups. The patient did not receive any treatment for the events. The outcome of the event was reported as not resolved.   Follow-up attempts are completed. No further information is expected.
Pt exp an ax t103 2hrs post vax, mom administered tempra, exp excessive crying for several hrs; Was seen by MD on 23MAY91 dx w/chest cold placed on ATB; Advised to receive DT in future;
nauseous; threw up; chills; This spontaneous case was reported by a nurse and describes the occurrence of NAUSEA (nauseous), VOMITING (threw up) and CHILLS (chills) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NAUSEA (nauseous), VOMITING (threw up) and CHILLS (chills). At the time of the report, NAUSEA (nauseous), VOMITING (threw up) and CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2021-302868 (Patient Link).
Patient complained of feeling "woozy", stated, "I'm going to pass out", patient seated in passenger seat of car.  Level of consciousness continued to decline, bp low at 104/64. 911 called. Patient responding to verbal cues but stated "I'm so tired, I'm going to fall asleep".  Transported to ER via ambulance.
Side Effects; This case was reported by a consumer and described the occurrence of adverse event in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown.   It was unknown if the reporter considered the adverse event to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per vaccine indication. The reporter wanted to know were side effects different after second dose.
Patient came to the health department on 10/3/23 to show her arm. Below the injection site approximately 1-3 inches there was a large red, warm, hard area. It was 3 inches wide and 6 inches long. Patient has she just noticed it that morning.  She denied any pain or discomfort. She was told to contact her provider to notify them of her reaction to the Tdap that they requested her have. 10/6/23 I called Patient to check on her arm. She reported that the area has gotten smaller and she still does not have any pain or discomfort. The area is improving.
Pt woke up the morning after vaccine and could not use his legs. This lasted approximately. 2 hours then he regained movement.
Itching, swelling, redness, headache, and hot to the touch at injection site.  Provider prescribed cephalexin 250mg.
Infanrix administered to a 17 year old patient in error; This case was reported by a nurse via sales rep and described the occurrence of adult use of a child product in a 17-year-old patient who received DTPa (Infanrix) for prophylaxis.   On an unknown date, the patient received Infanrix at an unknown dose. On an unknown date, unknown after receiving Infanrix, the patient experienced adult use of a child product. On an unknown date, the outcome of the adult use of a child product was unknown.  Additional details were received as follows: The reporter stated that the Infanrix administered to patient in error, instead of Boostrix, which led to adult use of a child product. The reporter asked dose the patient need to be revaccinated with Boostrix.
Approx 10 hours after injection - noted swelling at injection site. No redness, no itching. Injection site tender to touch. No lump at injection site. At same time noted redness, hives with itching and skin warmth on skin behind ears, neck and upper chest. No difficulty breathing. No treatment of symptoms. Next a.m. noted same symptoms. Referred to next level of care at clinic.
pt went to bed 8PM 16SEP w/o problems; woke up 11PM whimpering APAP given; 17SEP93 noon t102 ax; all day fever between 101-102; 18SEP fever 104.5 ax;
Patient developed a fever that persisted for nearly 48 hours.  During the first hour of the fever, patient had a one-hour long seizure that required hospitalization.
Information has been received from a Registered Nurse, through the Merck pregnancy registry, concerning a 24 year old female patient who in March 2007, was vaccinated with a first dose of Gardasil and in May 2007 received the second dose of Gardasil. On 25-JUN-2007 Methotrexate was given for treatment of the ectopic pregnancy. Pregnancy was confirmed 1 week before 25-JUN-2007. No further information was available. Upon internal review, ectopic pregnancy, spontaneous abortion was determined to be an other Important Medical Event. Additional information has been requested.
CARDIAC ARREST AND WAS WITHOUT A HEARTBEAT, AND EFFECTIVELY DEAD FOR 18 MINUTES; 2 MASSIVE BLOOD CLOTS TO THE HEART; COMA; EXTENSIVE BRAIN DAMAGE THAT OCCURRED WHEN BRAIN WAS WITHOUT OXYGEN; FEELING REALLY UNWELL; This spontaneous report received from a consumer via a company representative via social media concerned a 51 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 total, administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On JUL-2021, the patient experienced feeling really unwell and for which patient went to the emergency room. On an unspecified date, the patient experienced 2 massive blood clots to the heart. Due to a number of events, patient went into cardiac arrest and was without a heartbeat, and effectively dead for 18 minutes and was hospitalized (for unspecified duration). Followed two weeks in a coma, the patient faced many months of intensive therapy seven days a week to heal and strengthen patient brain to combat the extensive brain damage that occurred when patient brain was without oxygen. In addition to the daily physical, occupational, and speech therapy the patient would be getting hyperbaric oxygen therapy to accelerate patient brain function and healing. The patient was working so hard every day at improving physical and mental abilities and for which patient already had made amazing progress. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from coma, was recovering from extensive brain damage that occurred when brain was without oxygen, and the outcome of 2 massive blood clots to the heart, feeling really unwell and cardiac arrest and was without a heartbeat, and effectively dead for 18 minutes was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211139814-covid-19 vaccine ad26.cov2.s-cardiac arrest and was without a heartbeat, and effectively dead for 18 minutes;  2 massive blood clots to the heart;  Coma;  extensive brain damage that occurred when brain was without oxygen. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).  20211139814-covid-19 vaccine ad26.cov2.s-feeling really unwell. This event(s) is labeled per RA and is therefore considered potentially related
Systemic: Other- Patient mildly panicked and had some mild shortness of breath 15 minutes after injection of 2nd dose. Pt monitored for full 30 minutes after which symptoms quickly resolved. No epinephrine given. -Mild
lips are swollen along with other areas on his face where he has fillers; lips are swollen along with other areas on his face where he has fillers; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (lips are swollen along with other areas on his face where he has fillers) and SWELLING FACE (lips are swollen along with other areas on his face where he has fillers) 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 19-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, the patient experienced LIP SWELLING (lips are swollen along with other areas on his face where he has fillers) and SWELLING FACE (lips are swollen along with other areas on his face where he has fillers). At the time of the report, LIP SWELLING (lips are swollen along with other areas on his face where he has fillers) and SWELLING FACE (lips are swollen along with other areas on his face where he has fillers) outcome was unknown.      No treatment information was provided. No relevant concomitant medications reported.
no adverse effect; The following 10 patients were administered the VAQTA Lot # S009943 that had undergone temperature excursion; This spontaneous report was received from an office manager concerning a 20-months-old male patient. The patient's concurrent conditions, medical history and drug reactions or allergies were not reported.  On 10-OCT-2019, hepatitis a vaccine, inactivated (VAQTA) experienced temperature excursion at -1.49ºC for a timeframe of three days. On 29-OCT-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) (lot # S009943 and expiration date: 26-JUL-2020) as prophylaxis (strength, route of administration and anatomical location were not reported) (incorrect product storage). On 31-OCT-2019, hepatitis a vaccine, inactivated (VAQTA) experienced another temperature excursion at 11.49ºC for a timeframe of fifteen minutes. There was no previous temperature excursion. The call was due to digital data logger.  No adverse effects were reported.  This is one of several cases received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; deviceage and unit: 0 ; malfunction: No; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-1911USA007567:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 78-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had taken Paxlovid from 23Jul2022 to 28Jul2022 for Indication of Treatment of COVID-19. Paxlovid alleviated COVID symptoms but upon completion of 5 day regimen, though milder, symptoms returned. Patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch and lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced arm soreness. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of arm soreness was not reported. This report was non-serious.
This spontaneous report was received from a Medical Assistant referring to an unspecified number of patients of unknown age and gender. Information about the patients' medical histories and concurrent conditions was not provided. Starting on 14-JAN-2016 and on unspecified dates after, the patients were vaccinated with improperly stored doses of LIQUID PEDVAX HIB (administration routes, lot numbers and expiration dates were not provided). The details of the temperature excursion were as follows: Temperature/time frame: 32.9F for 15 hours and 74.6F for 15 hours. There were no previous temperature excursions. No adverse effects were reported. This is one of two reports from the same reporter. Additional information has been requested.
Elevated BPs in 190-200's. BP came down quickly in ER. CT head negative for acute changes 5/18/2022. Brain MRI obtained due to symptoms of vertigo and disequilibrium 7/12/2022 showed chronic, small infarct in L cerebellum.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored GARDASIL (dose, route and lot # not reported). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Patient experienced numbness from shoulder to finger tips starting 5 minutes after the injection. 15 minutes later, numbness decreased and pt feels tingling in hand and fingers. "It's like I fell asleep on my hand."
Increased heavy menses with debilitating cramping pain. Took 2 Advil liquid gel 200mgs to help with pain. About 2 hours later I felt better. Pain continued for a total of 2 days.
10/26/21 patient received 3rd dose (booster) of pfizer covid-19 vaccine. 11/10/21, patient presented to ED after syncopal event while eating, had been feeling unwell for a few days prior to admission.  Upon arrival to ED, during PIV placement, patient vagal'ed and was in complete heart block, bradycardic, this degenerated into asystole and cardiac arrest. Concurrent with the arrest was loss of consciousness, posturing, upward gaze and deep erratic respirations, ROSC ensued. Post arrest ECG showed Sinus tachycardia with ST elevations, Troponin elevated to 108, patient brought emergently to cardiac cath lab. There she received PCI to LAD for 100% occlusion (drug eluting stent x 1), transvenous pacemaker placement for complete heart block, and had an intra-aortic balloon pump placed for acute heart failure EF 27%.  She was hospitalized until 11/18/21, when she was discharged home on heart failure medications with presumed ischemic cardiomyopathy.  Follow up outpatient ECHO on 12/22/21 showed worsening Ejection Fraction to 15% and a moderate to large pericardial effusion with tamponade physiology and she was re-admitted to the hospital. She was taken emergently to the OR for cardiac tamponade on 12/26/21 and remains admitted.
Fever of 103 degrees for roughly 3 hours followed by fever lowering to 100 degrees for roughly 16 hours with severe headache, nausea, and vomiting. Strong soreness in joints from shivering with fever.
Patient is a 62-year-old male with history of diabetes on metformin, Hypothyroidism on Synthroid as well as a pituitary abnormality at birth on hydrocortisone 20 mg daily presenting to the emergency department via EMS from home for nausea, vomiting and generalized weakness.  Patient lives at home with mom, she states last night he felt nauseous and had multiple bouts of vomiting throughout the night.  She notes this morning he slept until approximately 10 AM, normally he gets up around 5 AM.  When he woke up he felt very weak and had no energy.  She states she tried to have him drink fluids, however he vomited them up, and he was too weak to pivot from the chair, so she called 911.  He has had no falls or injury.  He has not really eaten or drinking anything since yesterday.  Upon arrival to the ED, patient is somewhat slow to answer questions, however denies any pain, denies chest pain, abdominal pain or headache. Associated Symptoms: diarrhea, nausea, vomiting
Hi, I had the Janssen vaccine around noon time. From around before 7pm the same day evening, I started having chills and fever for two hours, I didn't do anything but just lying there and feeling really cold with a fever. Then around 9pm, the temp went up becoming a high fever and I had a severe "temple ache" for the next 3 hours on both sides. I felt dizzy during those hours. Then around midnight my fever slightly went down but the aches on my temple remained there. For the next 10+ hours, I suffered a fever and temple pain.  Until around the early afternoon the next day, I finally felt I was back to 70% normal but still weak.  But I didn't feel I was fully recovered until around the noon time the following day-- which was about 1.5 to 2 days later after my vaccination.
Extreme hives all over/full blown hives that itch and hurt; itchy; This is a spontaneous report from a non-contactable 72-year-old female consumer reporting herself. A 72 years-old female patient received first dose of BNT162b2 (BNT162b2, PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot number: EL9264) via unspecified route of administration in the right arm on 31Jan2021 at 11:15 as a first single dose for COVID-19 immunisation (age at vaccination was 72 years). The patient's medical history includes atrial fibrillation. Concomitant medications included warfarin (WARFARIN, 5mg), metoprolol tartrate (METOPROLOL TARTRATE) and terazosin hcl (TERAZOSIN HCL). The patient was other medications received within 2 weeks of vaccination included Warfarin 5mg. Metoprolol Tartrate. Terazosin HCL. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Feb2021 the patient experienced extreme hives all over, concentrated in my midsection. she started feeling itchy about 3 days before my second shot and once her got that it turned into full blown hives that itch and hurt. Patient was not diagnosed with covid prior to COVID-19 vaccination and Since the vaccination, patient not tested for COVID-19. Patient was not received treatment for the event. The case classified as non-serious. The outcome of the event was reported as not recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.
The first I got the vaccine I coughed up blood for about two weeks. And I was having bad anxiety attacks that I didn't realize was heart problems. I also was having bad headaches.