chrisvoncsefalvay/vaers-outcomes huggingface dataset:
walking and talking in my sleep; walking and talking in my sleep; mental things, something would run through my mind that happened years ago; two stents put in her arteries; blood pressure went up to 200-something; A spontaneous report was received from a consumer concerning a 77-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced blood pressure went up to 200-something/blood pressure increased, walking and talking in her sleep/somnambulism/sleep talking, two stents put in her arteries/stent placement, mental things, something would run through my mind that happened years ago/emotional distress.  The patient's medical history included hasimoto's. No concomitant product use was reported.  On 04-FEB-2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013M20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 06-FEB-2021, post vaccination, the patient's blood pressure increased up to 200 and taken to emergency room and hospitalized. During her hospitalization, the patient reported on either the second or third night, she experienced walking and talking in her sleep with no memory. Per the patient, she had never done this before. On the third day of her hospitalization, she reported she had two stents placed in unspecified arteries and that evening had bad anesthetic and sleep walking. Thoughts of things that happened years prior would run through her mind, this happened twice. The patient stated she was prescribed clopidogrel 75 milligrams and acetylsalicyclic acid/dipyridamole 25-200 micrograms.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events, blood pressure went up to 200-something/blood pressure increased, walking and talking in her sleep/somnambulism/sleep talking, two stents put in her arteries/stent placement, mental things, something would run through my mind that happened years ago/emotional distress, were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Mouth, gums, tongue and lips swollen, broken out, and sensitive with a burning sensation. I'm therefore I'm unable to eat, drink, tast or talk comfortably. Situation has been worsening daily.
Information has been received regarding a case in litigation, from a lawyer, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. In 2014, the patient was vaccinated with ZOSTAVAX, due to health care professional recommendation, for permanent prevention and protection against shingles and zoster-related injuries (prophylaxis) (strength, anatomical location, dose, route of administration, lot # and expiration date were not provided). In 2014, the patient was treated by an advanced practice registered nurse for shingles, as the patient was diagnosed with shingles or other related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient had and would continue suffer ongoing injuries, included but not limited to: mental and physical pain and suffering, extensive medical care and treatment for these injuries; significant medical an related expenses as a result of these injuries, included but not limited to medical losses and cost include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions. At the time of report, the patient was not recovered from emotional distress, injury and pain. The outcome of vaccination failure, quality of life decreased, herpes zoster and the pre-existing unspecified conditions aggravated was unknown. The reporter considered the events to be disabling, life-threatening and medically significant.
gave a dose of the Moderna Covid-19 vaccine to a patient from a vial which has been punctured for more than 12 hours.; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave a dose of the Moderna Covid-19 vaccine to a patient from a vial which has been punctured for more than 12 hours.) 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 08-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave a dose of the Moderna Covid-19 vaccine to a patient from a vial which has been punctured for more than 12 hours.). On 08-Dec-2021, EXPIRED PRODUCT ADMINISTERED (gave a dose of the Moderna Covid-19 vaccine to a patient from a vial which has been punctured for more than 12 hours.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.
Left arm at site of injection - redness 7cm x 6cm - no induration, temperature 96.4, sore to touch.
12-24 hours after the Covid -19 vaccine the patient had a seizure like event: eyes wide open, moaning, unresponsive for 2-3 mins.   Patient had reported occurences of blacking out.    These are new events.  The patient does not have any history of seizures or seizure like symptoms. Patient was placed in isolation at the hospitial for 03/13/2021 thru 03/16/2021
This case was considered medically important (OMIC). Information regarding Prevnar was received from a healthcare professional via a manufacturer (A0560864A) regarding a 24 month old male patient who was diagnosed with autism. The patient received a dose in 2005. The patient previously experienced no reaction on previous exposure to drug while taking Engerix B. Indication for Prevnar was immunization. Product was administered in 2005. Dose regimen was 1 dose. Additional suspect medication included Haemophilus influenzae type B, Tripedia, Infanrix, and Engerix B. Concomitant medications were not reported. A physician reported that the patient was diagnosed with autism on an unspecified date in 2005 (on or before 5/26/05). No additional information was available at the time of this report.
Treatment of COVID-19; Treatment of COVID-19; Dose Number: 4/Moderna; Dose number: 3/Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Jan2021 as dose 1, single (Lot number: EL0140), on 18Feb2021 as dose 2, single (Lot number: EL9261), in left arm and on 11Oct2021 as dose 3 (booster), single (Lot number: 30135BA) at the age of 71 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 26Apr2022 as dose 4 (booster), single (Lot number: 049L21A), in left arm and on 29Oct2022 as dose 5 (booster), single (Lot number: 014H22A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "Type II Diabetes" (unspecified if ongoing); "known allergies: Wool" (unspecified if ongoing); "known allergies: trees" (unspecified if ongoing); "known allergies: grass" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 26Apr2022, outcome "unknown", described as "Dose Number: 4/Moderna; Dose number: 3/Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 28Mar2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Mar2023) Positive, notes: home test. Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid.
received the first dose of vaccine in a hospital on 18Dec2020/tested positive for COVID on 01Jan2021; received the first dose of vaccine in a hospital on 18Dec2020/tested positive for COVID on 01Jan2021; This is a spontaneous report from a contactable nurse (patient) via Pfizer-sponsored program, Pfizer First Connect. A 43-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EK5730, expiration 31Mar2021) , via an unspecified route of administration in left arm, on 18Dec2020 at 15:00, at 0.3 mL, single, for COVID-19 immunization.  Medical history and concomitant medications were reported as none.  The patient received the first dose of vaccine in a hospital on 18Dec2020 at 15:00 as she works in emergency room and tested positive for COVID on 01Jan2021. The patient stated that the second dose is scheduled this afternoon (08Jan2021) and wants to know if she should proceed with the vaccine. The patient is looking for guidance on whether or not to get the second dose or wait. The patient has been directed to receive second COVID vaccine. No additional vaccines administered on the same date. The event required a visit to urgent care. The patient did not have prior vaccinations within 4 weeks. No events prior to vaccination. The patient underwent lab tests and procedures which included COVID 19: positive on 01Jan2021. Outcome of the events was unknown.  The event was assessed as serious (medically significant). The event "Tested positive for COVID" was assessed as unrelated to COVID vaccine as her husband was COVID positive before her.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available.
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Mild, Systemic: WAS CLOSE TO FAINTING BUT DID NOT.-Mild, Systemic: Hypotension-Severe, Systemic: Shakiness-Severe, Additional Details: COMPLAINED OF DIZZINESS, VISION DISTURBANCES.  STORE CALLED EMS BUT BY THE TIME THEY GOT TO STORE THE PATIENT WAS ALERT AND RESPONSIVE. PATIENT ALSO COMPLAINED OF THURST AND WE GAVE HER WATER TO DRINK.    THEY DID A FULL WORKUP ON HER BUT DID NOT TRANSPORT HER TO HOSPITAL.   SHE LEFT WITH HER MOTHER , EVENT LASTED ABOUT 45 MINUTES .
swollen red area @ inject site; increasing in size over 2 days (going down arm) w/inc pain;
injection site pain; headache; chills; tiredness; sensitive skin/hair follicles; muscle pain; joint pain; This is a spontaneous report from a contactable consumer, the patient. A 17-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26May2021 at 15:15 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Patient had no relevant medical history. Patient had no known allergies reported. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Apr2021 at 16:00 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27May2021 at 08:00, the patient experienced injection site pain, headache, chills, tiredness, sensitive skin/hair follicles, muscle and joint pain. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events injection site pain, headache, chills, tiredness, sensitive skin/hair follicles, muscle and joint pain was unknown at the time of this report.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
I had body aches and I had pain in my right wrist. After my second dose on 2/25/2021 I had pain in my left groin joint and cannot walk.  2nd dose of Pfizer received in my left arm lot#EL9266 on 2/25/2021
Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Comorbidities include diabetes, HLD, HTN, aortic stenosis, kidney stones, smoking. He was found deceased in his bed on 4/2/21 with unknown cause of death. Medical examiner listed possible causes of death as 1. Natural causes 2. possible due to hypertensive heart disease 3. Probable diabetes mellitus 2
Patient is complaining of a shingles like rash on his left rib cage. He states that it is burning.
muscle spasm at the injection site; This information has been received from a Licensed Practical Nurse and an administrator concerning a patients of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # M038359 and expiration date on 13-MAY-2018 (dose, dose number, route of administration and anatomical location were not provided), administered for prophylaxis. On an unknown date, the patient experienced muscle spasm at the injection site. The outcome of muscle spasm at the injection site and the causal relationship between the event and therapy with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) were not reported. This is one of several reports received from the same reporter.  Additional information has been requested.
Pain in the left arm and reflected in the axilla, neck and face. Period not normal, with pain and lasts more than 7 days.
Started out with a headache and dizziness within a few minutes of the vaccine, along with nausea. I stayed put laying down with a lollipop and water bottle along with ice packs on me for about an hour until I was well enough they thought for me to drive back to my dorm. Once I started driving the headache was back but I was driving so I couldn?t do much. Almost pulled over because I was getting over whelmed but ended up making it back to my dorm. Once I got back I changed and laid down in bed hoping to fell better. Things started getting worse from there. Throughout the rest of the day my head ache and dizziness got worse to the point where I was pretty unsteady on my feet. Chills and body aches also started and progressed rapidly despite no fever.  My nausea was present in waves but eventually dissipated around 8 PM.  I tried to go to bed around 11 hoping to sleep off the symptoms. I began tossing and turning. My chills were really bad and it got to the point where my skin was so sensitive that the clothes I was wearing touching and rubbing against my skin were hurting me. I was so dizzy and light headed to the point where it didn?t matter if I was laying down or sitting up, I felt the same, extremely dizzy and lightheaded as if cotton were in my brain or as if it were working too slow. It was like trying to process thoughts through molasses. Then around 1:30 I couldn?t take it anymore and thought maybe a quick shower would help me to at least feel better so I could sleep. When I got in the shower I immediately knew things were worse.  My vision started going black at the edges and black spots in the middle to the point where at certain moments I couldn?t see. I was fighting to stay on my feet and conscious and it was hurting to breathe. I knew I needed to get help so I stumbled to my dorm and collapsed when I got in the doorway to my room. My vision was spotty, my chest was hurting and I could barely breathe.  My hands and feet went numb as well, I was shivering, and my body temperature was a little down to about 98.1 degrees Fahrenheit.   I was transported to a hospital via ambulance my vitals were normal except elevated heart rate and O2 and  was admitted at 2:40 in the morning. I received a chest x ray and  my heart rate was better.  The dizziness was under control by then. I was discharged at 4:50 in the morning.
Woke up at 4:30am and thought I should go to bathroom.  However, I could barely get out of bed.  Could not get my balance, head was spinning. Tried to hold on to wall and doorjamb but could not make my legs work to standup or my hands grip. I slept  until 10:00 next morning which I am usually up by 7.  Was very incapacitated the whole day.  This is  Friday and I thought I would feel better by today but my legs are still wobbley.
Backache; This is a spontaneous report from a contactable consume, the patient. A 26-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9269), dose 1 via an unspecified route of administration, administered in arm right on 10Feb2021 17:15 as first dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced backache on 11Feb2021 08:00. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not treatment received for the adverse event. Patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient has not been tested for COVID-19. Case reported as non-serious. The outcome of the event was recovered.   Follow-up attempts are completed. No further information is expected.
Adverse Reactions; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Adverse Reactions) in a female 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 COMPLICATION (Adverse Reactions). At the time of the report, VACCINATION COMPLICATION (Adverse Reactions) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
pt. received the vaccine greater than 12 hours after it was drawn up. No adverse event. Declined revaccination. MD contacted pt.
Severe peri-orbital edema, migraine headaches resulting in diplopia, blurred vision, and increased pain levels. Symptoms occured bilaterally, and have persisted greater than 5 months. The second shot was administered 12/16/10, and symptoms worsened. Treated in the ER and by primary care physician with a course of steroids, prednisone to decrease the peri-orbital edema. Additionally, ice packs for 10-15 min increments several times daily and ibuprofen up to 600-800mg every 6 hours.  Demerol was prescribed for pain management as well.
BURNING AND ITCHY RASH OVER THE BODY (ARMS AND LEGS).  HEAT ESCALATES THE RASH (PATIENT CANNOT EVEN TAKE WARM/HOT SHOWERS) OVER TIME RASH IS SPREADING INTO THE FACE AND HEAD.  SYMPTOMS STARTED 2 DAYS AFTER SECOND DOSE OF SHINGRIX AND HAS BEEN ONGOING FOR 3 MONTHS AND IS WORNSENING. DERMATOLOGIST ATTRIBUTED DERM ISSUES TO SHINGRIX VACCINATION.  PT IS BEING TREATED WITH TOPICAL STEROIDS.
Patient admitted as inpatient on 2/18 due to acute respiratory failure with hypoxia. Patient was tested for COVID-19 and was positive on 1/31 and again on 2/17. history of recurrent multiple myeloma on chemotherapy who presented to hospital with complaint of shortness of breath.  She reports that she initially developed fevers on the evening of 2/15/22, measured 100.5° with subsequent diaphoresis.  This continued although with less severe diaphoresis over the last couple days.  Additionally noted to be very weak at rest with worsened DOE yesterday, ultimately prompting ED visit. Diagnosed with covid 19 infection on 1/31/22, 18 days ago, which was reportedly a mild case with only slight worsening of chronic "tickle" in her throat, sinus congestion, cough. Receiving chemotherapy with teclistamab/dara/Pom, most recently on 1/17/22 with daratumumab.
Became positive after receiving the Moderna vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Became positive after receiving the Moderna vaccine) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Became positive after receiving the Moderna vaccine). At the time of the report, COVID-19 (Became positive after receiving the Moderna vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment related information has been reported.; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
LARGE BLOOD CLOT; SWOLLEN BALL ON SIDE OF KNEE; This spontaneous report received from a female patient of unspecified age reporting on self. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: Unknown) dose was not reported, 1 total administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced large blood clot and swollen ball on side of knee. The swollen ball on side of knee was going on for a couple days now. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The patient had not recovered from large blood clot, and swollen ball on side of knee. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This is a report of a female patient, unspecified age, unknown ethnicity, who experienced a large blood clot and swelling on the side of the knee (laterality not reported) on an unspecified number of days after receiving the cobid-19 vaccine ad26.cov.2. The information provided precludes a meaningful medical assessment. Additional information requested.
Auto inocculation (not satellite) to self apprx. 1 1/2 in from primary site