chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt readmitted from 10/16 - 10/21 stay for AKI & falls; returned d/t worsening creatinine of 5.0; admitted for AKI, acute bronchitis; pt COVID+ & xray showed pneumonia; tx w/Azithromycin, Cefipime, Vit C, steroids & zinc; 10/20 - started 5 day course of remdesivir; O2 status  & creatinine worsened and pt started dialysis 10/30; Hgb dropped to 5.7 w/ no evidence of bleeding; 2 U PRBCs transfused; pt did not improve w/ dialysis & oxygenation status continued to deteriorate and required OptiFlow & BiPAP. Pt made DNR, went into asystole 11/4 and subsequently passed away.
I have had serious reactions to things in the past and wouldn?t so much say this was serious. So I do disagree but just wanted to give you both the heads up.  I got vaccinated about 1500 (give or take 20 mins). About 1640 I felt my jaw/cheeks feel tight like they were swollen, my hands felt clammy and my heart felt like it was racing. They all happened within minutes of each other. I felt a little extra phlegmy in my throat but no itching or difficulty swallowing. No rashes, hives, difficulty breathing, etc. I took 1 Benadryl at around the 2hr mark post vaccine and about an hour later I improved drastically. I took another Benadryl at that the 3.5 hour post vaccine mark (this would make 2 total). I
No symptoms reported via Clinic. Patient was given the adult dose of Hep B prior to 20th birthday at the age of 19.
High fever 102 degrees started day after shot. Treated with TYLENOL. Temp did go down to 100 degrees.
Shortness of breath, heart palpitations, lower back pain, a feeling of exhaustion, and headaches.
Left arm pain at injection site 4pm on 4-8-21 Low grade fever 3am- 8pm on 4-9-21 Chills 6am-8pm on 4-9-21 Body Aches 3am 4-9-21 to 830am on 4-10-21 Headache 3am on 4-9-21  and currently still have
This spontaneous report as received from a registered Nurse refers to a female patient of unknown age. On 03-JAN-2014 the patient was vaccinated with single dose of ZOSTAVAX route reported as injection (dose, dose number and lot were not reported). On 04-JAN-2014, the patient woke up at 2 am and experienced headache and gastrointestinal issues (also reported as "G.I."). The patient did not receive any treatment. The patient did not see medical attention. On unspecified date in January 2014, the outcome of gastrointestinal issues and headache was reported as recovered/resolved. Additional information has been requested.
Patient died on March 10th 2021 and received the vaccine on February 23 2021. Patient had health issues. Spoke with coroner and patient did die at home. Patient was taken straight the the funeral home afterwards.
Emotional distress; Headache; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of EMOTIONAL DISTRESS (Emotional distress), HEADACHE (Headache) and FATIGUE (Tiredness) in a 19-year-old male patient who received mRNA-1273 for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   On 07-Feb-2022, the patient received dose of mRNA-1273 (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In February 2022, the patient experienced HEADACHE (Headache) and FATIGUE (Tiredness). On an unknown date, the patient experienced EMOTIONAL DISTRESS (Emotional distress). In February 2022, HEADACHE (Headache) and FATIGUE (Tiredness) had resolved. At the time of the report, EMOTIONAL DISTRESS (Emotional distress) had not resolved.        The action taken with mRNA-1273  (Intramuscular) was unknown.       No concomitant medication provided. No treatment information mentioned.  On an unknown date, patient reported not feeling well emotionally. In FEB2022, patient experienced a headache and felt tired but that resolved.  Reporters causality of events with Humira was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
pt recvd vax & shoulder, elbow to wrist became sore & achy;  pt took APAP, pt thumb & entire fingers are tingling & numb; mvt cause pain;
Information has been received from a company representative concerning his healthy 15-month-old son with no allergies who on 11-OCT-2005 was vaccinated subcutaneously with a 0.5 ml dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live.  There was no concomitant medication.  On 19-OCT-2005 the patient developed a rash all over his body, low grade fever and runny nose.  It was reported that no medical attention was sought and no laboratory or diagnostic tests were performed.  At the time of the event the patient was also teething with 2 new teeth.  It was reported that the patient was recovering.  No product quality complaint was involved.  Follow-up information has been received from a physician indicating that he did not see the patient for the reaction and no information exists in his outpatient chart.  Additional information is not expected.
This spontaneous report as received from a certified medical assistant refers to a multiple unspecified patients of unknown age and gender. No information on patients' medical history, concurrent conditions or concomitant medications was provided. On an multiple unspecified dates, the patients were vaccinated with improperly stored unspecified doses of GARDASIL injection, lot # K011562 with expiration date 08-APR-2017 (dose and route of administration were not reported). No adverse effects were reported. This is one of the several reports from the same source. Additional information has been requested.
Pt c/o dizziness, taken to room for observation, VSS. BP 105/73, HR 101, RR 16 -- > 106/67, 75, 16.  Pt given fluids.  Upon reassessment, pt denied nausea and dizziness, assisted pt to sitting position.  No distress noted.  Pt stable and discharged from vaccination site in mother's care.
Pt stated arm was red, swollen, and painful. Went to ER and was told to go to the health department. States she began taking Benadryl on day of immunization and continued for two days. Seen at Health Department on 10/07/2010. Arm was slighly swollen and slightly flushed.
Heart palpitations. Insomnia.  Debilitating anxiety. Brain fog. Night Sweats. Insatiable appetite. Diarrhea. Weight loss.  All of these constant since 5/23.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 62-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Sep2023 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Lot/batch number: En6199, Anatomical location: Left arm), administration date: 09Mar2021, for Covid-19 immunization; bnt162b2 (DOSE 2, SINGLE, Lot/batch number: Fp7534, Anatomical location: Left arm), administration date: 30Mar2021, for Covid-19 immunization; bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Lot/batch number: Wag7386, Anatomical location: Left arm), administration date: 02Oct2021, for Covid-19 immunization; moderna covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, Lot/batch number:066k21a, Anatomical location: Right arm), administration date: 31Mar2022, for COVID-19 immunization; bnt162b2 (DOSE 5 (BOOSTER), SINGLE, Lot/batch number: Gj2524, Anatomical location: Left arm), administration date: 24Sep2022, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 07Nov2023 to 12Nov2023. Clinical course: Patient had no known allergies.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300381302 Same patient, different product, different dose/event;
Initially-red arm. 1 Week later-his leg developed red bumps and they spread. He went to his dr and he said that it was shingles.
Information has been received from a physician via a company representative, referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. The physician mentioned that the patient might have been vaccinated with PNEUMOVAX 23 (strength, dose, route, lot# and expiration ate were not reported) on an unknown date, and might have subsequently received another dose of PNEUMOVAX 23 on an unknown date approximately 3 months later. No adverse symptoms were reported. Additional information is not expected as the physician did not wish further contact.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 13-SEP-2018, the patient was vaccinated with an expired dose of M-M-R II (lot # M035935 exp date 09-AUG-2018) (dose and route not reported). No adverse effects were reported.
07-21-09 Given vaccines.  Started with rash on right thigh that mom says is slowly getting bigger.  No fever or no other symptoms
No reaction occurred from time of administration (0830) to 1600.  Intense emesis and stomach pain then began. Patient self-administered 100mg IM hydrocortisone.  Blood pressure monitored via home monitor quickly decreased and heartrate increased. At 2000 on 3/2 EMS was engaged and brought patient to Hospital Emergency Department. At emergency room patient was diagnosed with acute adrenal crisis and given multiple doses of hydrocortisone 50mg and promethazine 12.5mg. At least three 1000ml NS boluses were provided in ED. Blood pressure continued to drop; lowest noted was low 80s/30s. Admitted to cardiology unit for continued observation and steroid/antiemetic support.  Patient remained admitted 3/3 and was discharged 3/4 following adequate fluid resuscitation and transition to PO steroids.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 63 year old female. Initial information was processed along with additional information on 27-MAY-2021. The patient's weight was 175 pounds, and height was 63 centimeters. The patient's past medical history included high cholesterol, and concurrent conditions included alcohol user, and non-smoker. The patient had no known drug allergies and no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and expiry: UNKNOWN) 1 total, dose was not reported, administered on left arm on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 26-MAY-2021, the patient had negative (1.00 index) SARS-CoV-2 IgG antibody test (confirmed immunological vaccine failure).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint 90000180894. The suspected product quality complaint has been confirmed to be not voided (meet PQC criteria) based on the PQC evaluation/investigation performed.; Sender's Comments: V0:20210551579-COVID-19 VACCINE AD26.COV2.S -confirmed immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Narrative:  She received the vaccine in 2/11 and then felt fevers, chills and myalgias on 2/12. She noted that her neck and shoulder were slightly swollen. She took some tylenol and felt a little better. She notes when she has taken her temperature at home it has read normal. 2/14 her systemic symptoms were improving but when she woke up this morning 2/15 she noticed increased swelling and pain on her neck and shoulder only on her left side. Given Toradol x1 and discharged from ED with Diclofenac Gel.
Mild throat swelling, itchy lower half of face, time of shot. Next day rash on chin
#1 dose recv'd on 02-13-2021:  symptoms:  headache x 1 day,  muscle soreness x 1 week, fatigue x 5 days, vertigo x 15 days,                                                                         very sore right arm x 3 days,  all gone by #2 dose.  #2 dose recv'd on 03-13-2021: symptoms:  headache, right arm very sore, nausea, fatigue within 3 hrs. of #2 dose.
(My Symptoms, Signs, Time Course, ETC) Approximately three (3) weeks after my second shot, I developed a rash. It started on arm's and leg's then my back and chest, shoulders and then to the face. I was advised by oncologist to see a dermatologist. I then went to see a dermatologist. I was prescribed a cream of Fluocinou .057 for four weeks twice a day. And return in four weeks for follow up. The rash was getting worse. He did additiona four more scrapings, showing no results. Another cream Triamcinolone Acetonide oil. I was to return on Nov. fourth for follow up. No improvement, breaking out in other locations of the body. Another cream mometasone oil cream 45gr. Apply twice a day and return in four weeks. Upon return I asked the question if the rash could be related to my vaccine because it started 3 weeks after my second shot. Their reply was yes they had heard of this. I need to return again on Dec 2nd I would appreciate any feed back you can suggest; need to get to the bottom of this after seven months and the experience.
resident began to experience stroke like symptoms at approximately 0300, resident noted with slurred speech, left arm and leg flacid, facial drooping to left side of face. B/P 193/116. transferred to ER for evaluation
6MAR92 c/o fever, chills, vomiting, low back pain, t103; 7MAR92 seen in ER t100.6, generalized aching; No SOB or cough, pharynx not inflammed, no rash;
The following morn I woke up with pain in my hips and legs. Lasted all day.; The following morn I woke up with pain in my hips and legs. Lasted all day.; By after dinner I was freezing, nauseous and weak.; By after dinner I was freezing, nauseous and weak.; By after dinner I was freezing, nauseous and weak. The next 2 days I was very weak.; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 29Apr2021 at 12:15 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 and allergy. The patients past drug was reported as no. Concomitant medications taken within two weeks prior to vaccination included Multi vitamin (unspecified), allergy pill (unspecified), vitamin d nos (VITAMIN D) and calcium (MANUFACTURER UNKNOWN), all from unknown date for unknown indication. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The following morning, on 30Apr2021 at 07:00, the patient woke up with pain in hips and legs. Lasted all day. By after dinner she was freezing, nauseous and weak. The next two days the patient was very weak. On the day of report, 04May2021, was the first day she felt fine since getting the shot. The clinical outcome of the event woke up with pain in hips and legs, by dinner was freezing, nauseous and weak was resolved on 04May2021.  No follow-up attempts are needed. No further information is expected.
Pt developed a rashy and red area at the site of injection that moved down the arm 4 inches.  It was raised and hard and hot at the reaction site and patient described it as very itchy when it appeared that has since subsided.  I would best describe the skin reaction as angioedema and erythema with the inability to determine if it is an allergic reaction or a mere injection site reaction so to err on the side of caution, I am advising the patient to not get the second dose and to keep an eye on the reaction in case it starts to get worse and to also take benadryl to keep it from getting worse.  I am also advising her to call her doctor and see what they would like her to do.
Fever of 101; headache; This is a spontaneous report from a contactable consumer (patient). A 68-years-old non-pregnant female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: unknown) via an unspecified route of administration on 04Mar2021 at 03:00 (at the age of 68-years-old) as a single dose for covid-19 immunization. Medical history included systemic lupus erythematosus and sulfa allergies both from an unknown date and unknown if ongoing. The patient did not receive any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with covid-19. Post vaccination, the patient had not been tested for covid-19. The patient's concomitant medications were not reported. The patient experienced fever of 101 and headache on an unknown date in Mar2021. The patient underwent lab tests and procedures which included body temperature: 101 on an unknown date in Mar2021. The patient did not receive any treatment. The outcome of both the events was resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Body aches, extreme fatigue, dizziness, severe headache, and fever over 2 days so far and used Ibuprofen and Tylenol and rest to treat symptoms.
Moderna vaccine was administered outside of clinic - reported by patient   ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/4/2022 HEARING PROBLEM  HYPOXIA 4/12/2022 HEARING PROBLEM  ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/4/2022 CARDIOMYOPATHY, UNSPECIFIED  HYPOXIA 4/12/2022 CARDIOMYOPATHY, UNSPECIFIED
Severe Left upper arm pain that affects movement of Left arm and prevents normal function to do daily ADRs. The pain even affects driving due to pain when turning steering wheel.
Tachycardia, shortness of breath, nausea, abdominal pain. Symptoms lasted for about two months and were temporarily disabling.
shot was broken up in a 10% and 90% dose.  he had mild stomach pain after the first dose.  After the second shot, he had increasing stomach pain and vomited.  As his allergist, I treated him for an allergic reaction with epinephrine auto-injector and he did well.
per patient, on 12/29/2019 he developed left shoulder pain went to the "hospital medical center", and was prescribed Ibuprofen 800 mg and generic Norco 5/325 mg on 12/31/19. On 01/02/20 patient got "Adacel ( lot: c5609aa)" vaccine  on his right deltoid. Per patients wife, patient developed severe shoulder pain on left side and admitted to ICU on 01/03/20. Per patient family, attending clinicians said he developed "Septic arthritis" and Staphylococcal infection. Patient went for left shoulder surgery on 01/10/20.
Fever, headaches, vomiting 10 times in 12 hour period, diarrhea 16 times  36 hour period
pt reported dizziness and disorientation, states she became lost on her way home and did not recognize where she was for 30 minutes. also reported body aches.
Woke up in am with left side of face drooping. Left eye will now not close.  Has since developed numbness/tingling in fingers of both hands and toes of both feet.
GENERALIZED RASH; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: 207AD1A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced generalized rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from generalized rash. This report was non-serious.
p/vax pt awoke & could not sleep;devel fever 100.6 to 102.0;pt not eating but is drinking okay;pt crabby & fussy;sl erythema;dec mobility;mild pharyngitis secondary to fever & vax;pt screaming, stiff, T104;snoring;can't swallow;sz;
PATIENT FELT LIGHT HEADED AND FAINT APPROX 10 MINUTES AFTER RECEIVING THE VACCINE. WE CALLED 911 AND THE PARAMEDICS WERE SUMMONED AND THE PATIENT WAS TAKEN TO THE HOSPITAL.
This spontaneous report as received from a healthcare professional refers to two unspecified patients of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patients were vaccinated with improperly stored VARIVAX injection, lot # L020004, expiry date: 02-JUN-2017, lot # L006384, expiry date: 25-FEB-2017 or lot # L01912, expiry date: 27-MAY-2017 (strength, dose and route unspecified). No concomitant medications were reported. No adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No further information was provided. Additional information has been requested.
pt recv vax 27DEC96 & 23JAN97 pt devel a mild rash consisting of 4-5 lesions;
This nurse removed opened vial of Moderna from storage. Placed in cooler with ice packs along with two other unopened vials of Moderna. This nurse then transported and gave the three vials to the agency nurse. Agency nurse administered open vial of Moderna to persons who had signed up for the Booster vaccination of the Moderna Vaccination 0.25ml. Once completed updated Manager that the bottle given to her was open and was going to open another vial. This nurse confirmed with the manager that the bottle had been opened previously, 1/19/2022. This nurse had mis read the storage information regarding Moderna to be stored unopened and unused for 30 days. This nurse made telephone call to each person affected by this opened vial. Per Medical Director, offered everyone a dose of 0.25ml out of the new unopened vial.