chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID Vaccine Breakthrough Case  Pfizer Dose 1 2/23/21 (EN6200) Pfizer Dose 2 3/17/21 (EN6204) COVID Positive 12/7/21 COVID Positive 12/16/21  12/7/21: A 90-year-old woman with a history of hypertension, colonic diverticulosis who presented to the emergency room with complains left-sided facial facial droop and weakness which was noticed today.  Family had noted weakness in the right upper extremity.  No prior history of stroke.  No history of coronary artery disease. No loss of consciousness.  On presentation to the emergency room, vital signs revealed elevated blood pressure with systolic of 184/80 mmHg.  Laboratory workup is unremarkable.  EKG done reveals sinus rhythm with first-degree AV block with supraventricular complexes. Chest x-ray reveals no acute abnormality.  CT scan of the head does not reveal any acute intracranial process which shows bilateral chronic use to me changes.  In the emergency room patient received aspirin neurologist was consulted who recommended admission to the hospitalist service.  Patient is being admitted to the hospitalist service to rule out CVA  12/17/21: Possible TIA  - with gait instability. MRI brain: no acute infarct. Currently on aspirin and high-intensity statin.  No focal deficits appreciated during course of exam.  Patient appears to be baseline continue meds as ordered optimize blood pressures noted below.  COVID-19 infection  - with intermittent fever, but no respiratory symptoms. Continues to be on room air, remains afebrile for greater than 24 hours.  Mild leukopenia, trend.  Chest x-ray negative CRP 2.5.   Supportive measures currently. COVID-19 precautions to be provided for dispo.  suspected acute bronchitis: improved clinically  - did receive short course of antibiotics no coughing congestion or coarse sounds noted room air symptomatic management as noted will need to mobilize Acapella.  Uncontrolled hypertension: improved  - On  BP meds: Atenolol, Losartan, Isosorbide, Hydralazine.  Does periodically have some high readings, medications have been titrated.  Suspect may need further titration have strongly advised to follow-up with PCP within 7 days of discharge from skilled for further management titration of blood pressure.  chronic systolic dysfunction- CHF-not in acute exacerbation  - Echo: EF:35-45% On Atenolol and Losartan.  Continue monitor fluid status  Deconditioning with gait instability  PT/OT. social service for placement to SNF when bed is available    All ED in RTC precautions have been provided patient, she endorses understanding and is agreement with plan as outlined.  She patient will need to follow PCP within 7 days of discharge for longitudinal management.
Rash on arms, bilaterally on 7/12/01; fever 100-102.8 F, 7/15/16/17. Fever down with cool bath and Tylenol. Rash appeared on stomach on 7/19/01 and still present on 7/20/01. Mother reported this to PCP as well as JCHD.
This spontaneous report as received from a medical assistant refers to a 11 month old patient of unknown gender. On 08-OCT-2013 the patient was vaccinated with M-M-R II (lot# and expiration date not provided) (dose not reported). No adverse effects were reported.  Additional information has been requested.
This spontaneous report as received from a male patient of unknown age with high blood pressure and cholesterol refers to himself. No allergies were reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot#, expiration date not reported). Concomitant therapy included unspecified medications for high blood pressure and cholesterol. On an unknown date, reported as "6 months after the shot" the patient got shingles. The patient stated that he discovered a lump on his abdomen (date unspecified). On an unknown date the patient went to the hospital, where he received several tests and X-ray that did not show anything in the lump. The patient was not admitted to the hospital. For the treatment the patient was given steroids (unspecified name and manufacturer) and TYLENOL. The outcome of adverse events was reported as not recovered. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Patient complained of pain down the arm with swelling and redness. When examined there was minor swelling and no noticeable redness.  Patient claimed the intense pain kept her from sleeping.
Immediately following vaccine patient felt nauseous, dizzy, and complained of arm soreness.  Approximately 20 minutes post vaccine patient did vomit. He was monitored in office given a snack and water.
This spontaneous report as received from a healthcare professional refers to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with doses of M-M-R II (dose, route, lot # and expiration date were not provided) which were exposed to temperatures of outside of the recommended range (incorrect product storage). No adverse effects had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
bone and joint pain, muscle aches,lethargy, no temperature, no respiratory distress, no rash, no local reaction
Sore arm day 2-3 post does. Day 5 post dose, severe Axillary lymphatic pain on injection arm. Still persisting and radiating into arm day 8. Also, breastfeeding and day 8 (post vaccine) experiencing possible  clogged duct on injection side as well (related?).
Received booster on 1/21/22, followed by malaise, mild fever and three instances of vomiting from 1/22/22  through 1/24/22.  Appeared normal until hives presented throughout upper legs to neck area on the afternoon of 2/2.  Treated with  OTC Benadryl, to no effect, with hives worsening each day and becoming much denser.  Treated at urgent care on 2/10, with a prescription antihistamine and OTC lotion.  Hives resolved on 2/16/22.
Child received DPT & MMR & OPV at 9:30 am at Co. Health Dept. at 1:00pm child's eyes rolled back, "shook", became unconscious, suspect seizure.  Had similar episode last summer not assoc. /w immunization.
Redness on upper arm around the place that took the dose after take the vaccine for around 9 days. Didn?t take medicine. The redness disappear after two days. The lymph is swollen (and pain if I touch it) on the side that take the vaccine after 9 days after taking vaccine. Then, it recovered after gradually.
The adverse event was that the Td (tenivac) was administered after the dose expired (vaccine administration error). Td vaccine expired 10-8-22 and was administered 10-13-22. Error was discovered right after administration and reason for error was misreading the small printed expiration date on label. When documenting administration, error discovered. The manufacturer was contacted and advised re-vaccination as soon as possible. Ordering provider called patient and informed of error, encouraged re-vaccination. Patient declined revaccination, despite acknowledging that the Td dose  he received 10-13-22 is not considered a valid dose.  Patient has no signs/symptoms of any negative physical effects.
Pt reported having palpitations after receiving the first dose of COVID vaccine. Pt states she began feeling a little light headed. Pt was taken to the triage area and assessed by EMS and this ED Nurse. There were no s/s of anaphylaxis.  4 lead cardiac monitor was placed by EMS. Sinus tachycardia was noted with at rate of 117. Blood pressure was 191/125. Spo2 was 100% without oxygen supplementation. Repeat blood pressure was 202/92 with a heart rate of 104. Pt remained in the observation area for 30 minutes. Pt declined staff and EMS request for hospital transport. Pt left observation area ambulatory with friend who agreed to stay with the patient and assist her home. Pt was instructed to call 911 for any worsening of symptoms or cause for concern. Patient agreed.
Reactive arthritis got a lot worse after receiving the second dose; Reactive arthritis got a lot worse after receiving the second dose; UTI; This is a spontaneous report from a contactable healthcare professional. An 80 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date, as the second single dose, for COVID-19 immunisation. The patient received the first dose of BNT162B2 vaccine on an unknown date experiencing reactive arthritis. Other medical history and concomitant medication were not reported. The patient came in the emergency room with severe arthritis and joint pain and was diagnosed with reactive arthritis due to BNT162B2 vaccine. It started with first dose and got a lot worse 2 days after receiving the second dose. Patient was given prednisone and was treated for UTI. The case was reported as non-serious. Reactive arthritis worsened had not yet resolved. The outcome of UTI was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the available information and the strong drug event temporal association, a possible contributory role of suspect product BNT162B2 to development of event reactive arthritis, condition aggravated and UTI 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.,Linked Report(s) : US-PFIZER INC-202101127267 Same reporter/patient/vaccine, different dose/events
Patient became warm-temperature rose rapidly during night, became limp, eyes rolled back, she had flem coming out of her mouth-non responsive for about 5-10 minutes until emergency medical services arrived.  Febrile, seizure, rose.
This spontaneous report as received from a healthcare worker (also reported as administrator) refers to a identifiable patient of unknown age. On 25-JAN-2018, the patient was vaccinated with improperly stored PNEUMOVAX 23 from lot N014946 expiry date 01-FEB-2019 for prophylaxis. No adverse effect reported. Temperature was reported as 52 degrees Fahrenheit. Time frame was reported as 4 hours. There was no previous temperature excursion involved. The call was because of a data logger. No product quality complaint was involved. This is one of the two reports linked via same reporter link. Sender's Comments: US-009507513-1804USA008339.
like being disoriented, like you are drugged or something; fuzzy headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (like being disoriented, like you are drugged or something) and HEADACHE (fuzzy headache) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DISORIENTATION (like being disoriented, like you are drugged or something) and HEADACHE (fuzzy headache). At the time of the report, DISORIENTATION (like being disoriented, like you are drugged or something) and HEADACHE (fuzzy headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
PATIENT PRESENTS WITH C/O FEELING DIZZY WITH VOMIT/NAUSEA. PATIENT SLIGHTLY DIAPHORETIC . NO PAIN NOTED. NO SOB. PATIENT BEING EVALUATED BY EMS. VITALS ASSESSED. ADVISED TO HYDRATE. REFUSES TRANSPORT TO ER. FOLLOWING FURTHER ASSESMENT STATES FEELING MUCH BETTER.
Swelling and pain left armpit for >3 days. Fever and body aches for 1 full day. Both starting about 18 hours following vaccine.
Right arm swelling and redness, shoulder to elbow, Started 2 days after injections. Swelling equal to 2X original size of right arm. (?)
Screamed and cried non-stop for 4 hours.  (only stopped when exhausted to rest/sleep only for a few minutes and then woke up screaming again.)
jaw tightness; right jaw tenderness; little tired; right jaw stiffness; This is a spontaneous report from a contactable consumer or non-health care professional (patient) via medical information team and from a sponsored program  Support. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was not reported), via an unspecified route of administration, administered in right arm on an unspecified date in Feb2021 10:30 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in Feb2021, after the first dose of the vaccine, the patient felt a little tired. The following day patient woke up and patient had some jaw tightness and jaw tenderness which occurred the morning after patient got vaccinated. Her right jaw was the one that felt tender when patient opened the mouth, patient could feel that it got affected. Patient also stated that felt like it was just hard to open her mouth and that lasted for about 12 hours and it was resolved or maybe 8 hours and that was resolved by Thursday night (unspecified date). Patient also had jaw stiffness on the side of the where the patient received vaccine. Patient wanted to know if what patient had experienced would increase patient's possibility of having Bell's palsy. Outcome of the events jaw tightness and right jaw tenderness was recovered on an unspecified date in Feb2021 and outcome of rest of other events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Several episodes of vomiting and one single episode of black tarry stool with specks of blood, patient was fussy and unable to keep liquids down. Advised to go to local ER by primary physician upon exam patient was transferred to another Hospital. Labs and an obstructive series Xrays were obtained along with an abdominal ultrasound and upper and lower GI fluoroscopy which showed there was a 4 cm intussusception of left small bowel. Patient was prepped for an air bolus to reduce the intussusception and admitted to surgery at this time patient is still admitted to Hospital.
Diarrhea, NauseaVomiting, Lightheadedness Narrative:
Day of shot- arm muscle soreness Day after shot- Tiredness and arm soreness 3rd day- Felt better but that night discovered I had rash around entire torso and some itching. 4th day- redness dissipated but itching continued for several days.
Immunization given about 4:00PM. At approximately 6:30PM, eyes began to swell; called triage. Instructed to given Benadryl. At 8:00 PM, face, eyes, and tongue were swollen. Went to ER.
This spontaneous report as received from a physician via a company representative refers to a patient of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX 23 for prophylaxis. On an unknown date the patient experienced antibody test negative. The outcome of antibody test negative was reported as not recovered/not resolved. Additional information is not expected.
Flu like symptoms lasting 2 days from the time of vaccination: headache and aches.; This is a spontaneous report from a contactable consumer. An adult male patient of unknown age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the vaccination. It was unknown whether the patient had any concomitant medications. On an unknown date, the patient developed flu like symptoms which lasted for two days from the time of vaccination with headache and aches. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event flu like symptoms lasting 2 days from the time of vaccination: headache and aches were recovered on an unknown date.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
pt had high fever ?104 p/vax & had sz;taken to ER via amb;given APAP suppository & got fever down;has had 2 more febrile sz since one in 9/98 & in 12/98 or  1/99 mom can't remember;pt hosp  p/9/98 episode;EEG done & OK;
1st dose 5 months ago, no 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received Twinrix first dose 5 months ago).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose 5 months ago, no 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 14-Apr-2023 The pharmacist did not want to provide any other information on this case. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive the second dose of Twinrix, which led to incomplete course of vaccination.
Initial unsolicited report received from a health care professional on 01 October 2014. A 75-year-old male patient, had received an intramuscular dose of FLUZONE HD vaccine (lot number: U5017BA, expiry date- 07 Apr 2015, dose number not reported) in left deltoid on 10 September 2014. The patient illness at the time of vaccination was not reported. The patient pre-existing physician diagnosed allergies, birth defects, medical conditions was not reported. On an unknown date since after vaccination patient had experienced high blood sugars. Corrective treatment and laboratory details were not reported. At the time of this report, patient outcome was unknown. Documents held by sender: None. Follow up report received from a health care professional on 07-APR-2015: No new information was reported. Corrected the coding of event high blood sugars to blood sugar increased from hyperglycaemia
Arm of injection site was more sore than expected. Last 6-8 weeks - painful to lift upward. Injection was given too high.
Pink-red erythema L deltoid - itching  - MCD.  Pink-red erythema L deltoid - itching - Hep A.  Cold compresses & MOTRIN.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included Heart attack (Patient had 3 heart attacks) and Stroke.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced MYALGIA (sore arm). At the time of the report, MYALGIA (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   No Treatment information was provided.  Patient was vegan for 10 yrs now. And use no oils in his diet   This case was linked to MOD-2021-302658 (Patient Link).
lt deltoid area 5x4cm redness & swelling & soreness;cold compresses, DPH;
Maculopapular rash on face, body, fever 6 hours (low grade). Symptoms of cold 6 days after MMR #1.
Discharge Provider: MD Primary Care Provider: MD Admission Date: 10/1/2022 Discharge Date: Oct 4, 2022  PRESENTING PROBLEM: Acute hypoxemic respiratory failure COVID-19   HOSPITAL COURSE: "Patient is a 22-year-old male with past medical history of anxiety, migraines, celiac disease, hypoplastic left heart syndrome status post Norwood, hemi Fontan, and Fontan completion w/ associated liver disease who presented on 10/1 with septic shock in the setting of COVID. He was fluid resuscitated with 1.5 L IVF and remained hypotensive so was then started on norepinephrine. Further IVF not given due to pt's R ventricular failure. He was started on 5 day course of remdesivir. CAP coverage with azithromycin for total of 3 day course. He was not hypoxic initially so steroids were not started. Pt's BP improved and norepinephrine was discontinued. He did have desat on RA to 89% on morning of 10/2 with new O2 requirement of 2L via NC. Due to this, decision was made to keep pt for observation and to complete course of remdesivir. However, pt no longer required pressor support or ICU level care so transferred to general medicine." ICU transfer summary    After transfer out of the ICU, pt continued to do well and was weaned to RA. He was continued on Remdesivir and completed day #3 of Azithromycin. Congenital heart continued to follow him until discharge and given recent hypotension his Lisinopril/Spironolactone have been held. Asa was held for thrombocytopenia. For his cytopenias with thrombocytopenia Congenital heart recommended Heme consult. Heme felt pt with chronic thrombocytopenia at baseline which likely exacerbated from COVID-19 illness and checking labs with blood path, haptoglobin, LDH, folate/b12. Haptoglobin was normal, LDH normal, b12 399, folate 5.6. Blood path showed possible viral etiology. Pt discharged on 10/4/2022. Plt level day of discharge was 54.    He will follow up with hematology.
problems regarding my memory; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 85-year-old female patient received bnt162b2 (BNT162B2), as dose number unknown, single (Lot number: EL9269) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "problems regarding my memory".
Blister at injection site. Blister had light pink thin liquid, it was tender to touch. blister is almost gone but had a hard lump under the injection site.