chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Admit for fall, hip fx. No other COVID related complaints aside from recent weakness. Hx of CKD, s/p kidney transplant on immunosuppression, CAD, HTN.  COVID+, CXR shows COVID PNA. On RA, supportive care with abx. Acute resp fx resolved at time of DC. DC to SNF.
Patient's husband reported severe pain post-injection in shoulder/upper arm in arm where injection was given.
Pain to left arm and elbow immediate (10/8) - "feeling sick, nausea) not and painful left elbow and arm next day (10/19) - 10/10 to ER - fever > 101 - hot/red/swollen. Cellulitis difficult to bend elbow - 10/10 antibiotics BACTROM and KEFLEX.
Rash-red sports all over body including hands, feet and head. Seen at ER that night of vaccine administration. Two days rash disappeared.
Extreme fatigue for two days Saturday and Sunday; very "fuzzy" headed and unable to concentrate on anything important. Chills - I was hot, then cold.  Seemed to be over by Monday morning.
=Rash - started 3/25/10. Started on face spread to trunk & limbs in 24 hours.
Sore arm; Metallic taste in mouth; This is a spontaneous report from a non-contactable consumer. A female 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 and concomitant medications were not reported. On an unknown date, the patient experienced sore arm and metallic taste in the mouth after the shot. The clinical outcome for the events sore arm and metallic taste in mouth were 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.
ED to Hosp-Admission Discharged 9/2/2021 - 9/4/2021 (2 days)   Acute on chronic respiratory failure with hypoxia COVID-19 virus infection  Acute on chronic systolic heart failure   Presenting Problem/History of Present Illness/Reason for Admission COPD exacerbation [J44.1] Acute respiratory failure with hypoxia [J96.01] Acute on chronic respiratory failure with hypoxia [J96.21] Pneumonia due to COVID-19 virus [U07.1, J12.82]     Hospital Course Pt. is an 70 y.o. female from home with history of CAD, O2 dependent COPD, CAD with stents, CVA, hypertension, hyperlipidemia, tobacco abuse, who presented to the ED via EMS with progressive d
administration of two doses of Fluarix; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 17-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number T9HA2, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number T9HA2, expiry date 30th June 2023) for prophylaxis and flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th October 2022, the patient received Fluarix Quadrivalent 2022-2023 season, Fluarix Tetra Pre-Filled Syringe Device, Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. On 13th October 2022, unknown after receiving Fluarix Quadrivalent 2022-2023 season, Fluarix Tetra Pre-Filled Syringe Device, Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced overdose. On an unknown date, the outcome of the overdose 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: 13-OCT-2022 Reporter's Comments: The nurse asked for information regarding the administration of two doses of Fluarix on same day with same lot number and expiration date on same day. The reporter asked how to proceed with patient. The reporter consented to follow up. Additional Supportive Information: The patient received two doses of Fluarix on same day, which led to overdose.
Left upper arm swelling, tenderness, redness, started evening after receiving PREVNAR vaccine earlier that day. Seen 3-6-15 and 3-9-15 in office, tx with antihistamines, NSAID then abx.
On the last visit...after he received pneumovac...5th of Feb...saw local MD on Feb 7th...because swelling...sore and redness...was transferred to orthopaedic specialists...they thought it to be cellulitis and was given KEFLEX. States in one week ... it was almost cleared. States they thought his infection had spread to his chest...he began to have trouble breathing...productive cough/green sputum...no blood/wheezing was heard. Left ear pressure. Had chest pains with cough. Persistent short of breath. Had course of doxycycline. No GERD type symptoms. Scheduled to see lung specialist in April 2nd chest x-ray...2-28-2007...negative/also started on steroids and oral inhalers. Cephalexin unrecorded.
This spontaneous report as received from a licensed practical nurse (L.P.N.) refers to multiple unspecified patients of unknown demographics. On an unknown dates, the patients were vaccinated with improperly stored (wistar ra 27-3) M-M-R II lot # L041455 and expiration date: 30-NOV-2017; lot # L043703 and expiration date: 03-NOV-2017; (route, therapy type and dosage unspecified). No adverse effects were reported. It was reported that therapy was not discontinued. No product quality complaint was involved. No further information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Inpatient admission on 9/1/21 with new onset shortness of breath. Multiple pulmonary blood clots discovered on CT scan.
Sore arm at injection site; High resting heart rate (just over 100, normal heart rate is round 60); Blisters in mouth; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Oct2021 14:15 (Batch/Lot number: unknown) at the age of 28 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Major depressive disorder" (unspecified if ongoing); "generalized anxiety disorder" (unspecified if ongoing); "bursitis of hips" (unspecified if ongoing); "PTSD" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE. Vaccination history included: Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Pfizer ,, prev dose brand unknown=False,, prev dose lot unknown=True,, prev dose lot unknown reason=Misplaced/discarded,, prev dose administration date=25Mar2021, prev dose dose number=2,, prev dose vaccine location=Left arm), administration date: 25Mar2021, when the patient was 28 years old, for Covid-19 Immunization; Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Pfizer ,, prev dose brand unknown=False,, prev dose lot unknown=True,, prev dose lot unknown reason=Misplaced/discarded,, prev dose administration date=04Mar2021, prev dose dose number=1,, prev dose vaccine location=Left arm), administration date: 04Mar2021, when the patient was 28 years old, for Covid-19 Immunization.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 30Oct2021, outcome "not recovered", described as "Sore arm at injection site"; HEART RATE INCREASED (non-serious) with onset 30Oct2021, outcome "not recovered", described as "High resting heart rate (just over 100, normal heart rate is round 60)"; ORAL MUCOSAL BLISTERING (non-serious) with onset 30Oct2021, outcome "not recovered", described as "Blisters in mouth"; FATIGUE (non-serious) with onset 30Oct2021, outcome "not recovered", described as "Fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, heart rate increased, oral mucosal blistering, fatigue.  Additional information: The patient not had COVID prior vaccination. The patient was not tested for COVID post vaccination. Patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Lightheadedness, inability to focus, lose track of thoughts in the middle of conversations, feeling mentality disconnected, disassociated feeling
This spontaneous report as received from an office supervisor  medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not provided. On unknown date in 2017, reported as since March 2017, the patient was vaccinated with an incorrect storage dose of GARDASIL 9, lot M036059 with an expiration date on 03-JUN-2019 (strength, dose and route of administration were not reported) for prophylaxis. The vaccine was exposed from 47°F to 77°F for 12 hours. There were no previous temperature excursions. The call was made because there was a "data logger". No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1707USA006643.
Slight nausea and headache within hour one, sore arm within hour two, body aches and diarrhea  started around hour 9, fever and swollen lymph node started around hour 12, severe body aches  started around hour 13.   Ibuprofen resolved the headache but I had to take regular doses or it came back. Tylenol resolved the fever but again I had to take tea gulag doses or it came back. I go back and forth between severe chills and burning up.   I'm at hour 45 and I still have diarrhea and headache with a low grade fever, fatigue, sore arm (it is better) and slight body aches.
Vaccine was fine when I got it.  What I reported yesterday was that I tested positive for COVID in mid-February after returning. I had no symptoms and called my doctor. She told me to isolate 5 days, then wear a mask. My sinuses have also been bad for the last month or so, as I reported.
PAIN IN ARM STARTING 3 DAYS AFTER INJECTION PAIN 8/10
Mom reported shaking/trembling 2-8-06 couldn't stand for 30 sec. Lethargic, sleeping a lot.
The patient is a 38 yo male with a history of MS. He reports He received post exposure rabies vaccine on 20 Dec 2016 due to puncture wounds from a cat attack. He states he did not have a bite, but had multiple claw wounds to his right bicep area. He had been wearing long sleeves. He was treated with rabies immunoglobulin (RIG) and received rabies vaccine #1 in addition to antibiotic. About 12 hours later he developed a profoundly severe headache 'worst of his life.' He was released from work to his room, and went to sleep. He self-treated with ibuprofen which did not help. He states the duration was about 24 hours and then symptoms resolved. He states he had the same headache experience after each subsequent rabies vaccine dose with the same 12 hour onset, profound severity and 24 hour duration, and only effective treatment was sleep. The pt reported his events to our clinic due to clinical onset of MS 76 days post vaccine receipt. It is unlikely his MS is vaccine related due to limited evidence in the literature associating MS with vaccine receipt and delay in onset is not consistent.
PT FELT FLUSHED AT TIME OF INJECTION OF FIRST DOSE OF ENGERIX-B
They gave her the shot and about 30 seconds after she started shaking loss conscious legs started shaking and she had trouble breathing. Treatment was just to let her come to and sit there for about 15 minutes.
Nausea; Vomiting; Back muscle spasm on and off from his shoulder to his waist; Has a good pain tolerance but he is almost in tears; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Back muscle spasm on and off from his shoulder to his waist), PAIN (Has a good pain tolerance but he is almost in tears), FATIGUE (Fatigue), NAUSEA (Nausea) and VOMITING (Vomiting) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Fatigue, Hypercholesterolaemia, Anxiety, Depression and Arthritis. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Anxiety, CELECOXIB for Arthritis, PRAVASTATIN for Cholesterosis, BUPROPION HYDROCHLORIDE (WELLBUTRIN) for Depression, SERTRALINE HYDROCHLORIDE (RETALIN) for Fatigue.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced MUSCLE SPASMS (Back muscle spasm on and off from his shoulder to his waist) and PAIN (Has a good pain tolerance but he is almost in tears). 19-Feb-2021, the patient experienced FATIGUE (Fatigue). On 22-Feb-2021, the patient experienced NAUSEA (Nausea) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form; CANNABIDIOL (CBD OIL) for Sleep problem, at a dose of 1 dosage form; Bed rest for Muscle spasms; Bed rest for Pain and Bed rest for Fatigue. On 05-Mar-2021, MUSCLE SPASMS (Back muscle spasm on and off from his shoulder to his waist) had resolved. On 06-Mar-2021, PAIN (Has a good pain tolerance but he is almost in tears), FATIGUE (Fatigue), NAUSEA (Nausea) and VOMITING (Vomiting) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MUSCLE SPASMS (Back muscle spasm on and off from his shoulder to his waist), PAIN (Has a good pain tolerance but he is almost in tears), FATIGUE (Fatigue), NAUSEA (Nausea) and VOMITING (Vomiting) to be possibly related.    Treatment information also included Icing.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Additional information received contact information updated. On 23-Jul-2021: Updated additional reporter information, patient demographics (Height, weight, race, ethnic group), relevant history information, first dose information and second dose site changed to Right arm. Added vaccine facility information, concomitant medications, event (pain), event stop date, duration and outcome of the event. Added non-drug treatment and updated causality as reported.
Patient with systemic lupus erythematosus and lupus nephritis experienced a significant flare in disease activity and also new myositis.   Prior to the immunization he had trace proteinuria, normal complement levels; normal muscle enzymes.
Information has been received from an office manager referring to an unspecified number of patients. On unknown dates the patients were vaccinated with GARDASIL 9 (lot # M017983, expiration date 30-MAY-2018) which was improperly stored at 48.9 F for 48 minutes. Data logger was involved. There was no previous temperature excursion. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to 2 patients of unknown age. On 20-MAY-2013 the patients were vaccinated with expired dose of GARDASIL, 0.5 ml, intramuscular (lot # 668261/1397AA Exp. 09-APR-2013). No adverse effect reported. This is one of several reports from the same reporter. Additional information has been requested.
Nursing administrator reported to this writer new onset confusion on 12/16/22, but facility staff and this pharmacist (vaccinator) can report that confusion was present even before vaccination was given. It was unknown to the pharmacist who provided the vaccine that this was a new symptom. Facility administrator also reported that nausea, and diarrhea presented themselves on 12-16-22, and that patient required 4L O2, rather than normal 2L O2, to achieve an oxygen sat of 92.
PATIENT DAUGHTER STATED FATHER HAD REACTION. HE WAS NOT ABLE TO SPEAK, IT LOOK LIKE HE HAD A STROKE. WENT TO HOSPITAL BUT NO STROKE OR TIA WAS DETERMINED. HOSPITAL BELIEVES IT WAS REACTION TO VACCINE
Information has been received from a registered nurse concerning a teenage female who on unspecified date was vaccinated with a dose of GARDASIL. After receiving GARDASIL, the patient was lightheaded. The outcome of the patient was not reported. This is one of several reports from the same source. Additional information has been requested.
Acute Eczematous Reaction on Left Lower Leg, anterior; Left forearm; posterior neck.  Seen today, Oct 5, 2015 in the office and was prescribed Triamcinolone Acetonide 0.1% Cream, apply to affected area BID.
patient was given monovalent Pfizer 6mo-<5yr for the 3rd dose instead of Pfizer bivalent 6mo-<5yr.  No treatment needed parent informed of given monovalent as the 3rd dose instead of bivalent to child
This spontaneous report was received on 12-OCT-2016 from a licensed practical nurse who reported that multiple unspecified patients (gender and age not specified) received improperly stored vaccines on either 11-OCT-2016 or 12-OCT-2016. The patients' pertinent medical history, current conditions and concomitant medications were not reported. On 11-OCT-2016 or 12-OCT-2016, the patients received improperly stored ROTATEQ (Lot number M007298, expiration date 19-NOV-2017) (Lot number M007298, expiration date 19-NOV-2017). Temperature was reported as 34.8 degrees Fahrenheit. Time frame was reported as 5 hours 22 minutes. The vaccines were reported as administered. There was no previous temperature excursion. The Call was because of data logger. No adverse effects was reported. No additional information was available. No product quality complaint involved. This is one of several reports received from same reporter. Additional information has been requested.
Dizziness when laying down, and sitting up; headaches; chills; body aches; in the fog; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), FEELING ABNORMAL (in the fog), DIZZINESS (Dizziness when laying down, and sitting up), HEADACHE (headaches) and CHILLS (chills) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included CALCIUM from 01-Jan-2013 to an unknown date for Calcium supplementation, MAGNESIUM from 01-Jan-2013 to an unknown date for Magnesium supplementation, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) from 01-Jan-2013 to an unknown date for Supplementation therapy, ZINC from 01-Jan-2013 to an unknown date for Zinc supplementation.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced DIZZINESS (Dizziness when laying down, and sitting up). On an unknown date, the patient experienced PAIN (body aches), FEELING ABNORMAL (in the fog), HEADACHE (headaches) and CHILLS (chills). On 29-Mar-2021, DIZZINESS (Dizziness when laying down, and sitting up) had resolved. At the time of the report, PAIN (body aches), FEELING ABNORMAL (in the fog), HEADACHE (headaches) and CHILLS (chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On an unknown date, Blood pressure tests and EKG's were performed. Blood work was done. Ears were inspected and lung and heart were listened to. Patient's blood pressure for 2 weeks and the ranges were normal most of the time with some elevated readings. Everything was normal, there were no findings.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Patient characteristics have updated. Concomitant drugs includes vitamin D, calcium, mag, zinc have been updated. Outcome of the event dizziness has updated
Pt got flu shot at outlying clinic 10/9/07. Presented to our facility 11/1/07 w/ lower extremity weakness and transferred to hospital - hospitalized there  and w/u was consistent with Guillain-Barre syndrome - treated w/ IVIG w/ improvement.  12/7/07 Reviewed ER medical records which reveal patient experienced ankle swelling & pain, bilateral LE weakness, difficulty walking & fever.   W/u for rheumatic fever & tx w/penicillin & high dose ASA w/o improvement.  Transferred to higher level of care for further w/u of systemic inflammatory process, felt to be unlikely GBS due to (+) DTRs. 12/7/07 Reviewed hospital medical records which reveal patient experienced bilateral leg pain.  Saw PCP, dx w/UTI & started antibiotics.  Leg pain worsened & developed SOB, warmth & bilateral LE edema, weakness & flat red rash over the next 10 days.  ER dx w/possible rheumatic fever.  Tx w/penicillin & ASA.  Had some imiprovement but when stopped ASA fever returned.  Continued w/tingling of bilateral LEs.  Returned to ER & transferred to higher level of care.  Admitted 11/1-11/8/2007.  Neuro consult obtained.  Tx w/IVIG x 5 days.  Improved & d/c to home. FINAL DX: Bilateral LE weakness, suspect Guillain-Barre syndrome; elevated transaminases; vitamin B12 deficiency; hyperlipidemia; elevated sed rate. CDC's CISA staff has reviewed VAERS 298327 and concluded it is not GBS. Follow-up Information 16-DEC-2008: By chart review, no persistent neuro symptoms. I do not see this patient personally. Follow-up Information 18-DEC-2007: Pt was seen for problem on 1/1/07 - symptoms started several days prior.
This spontaneous report was received from a healthcare worker refers to a patient of unknown demography. On an unknown date, the patient was vaccinated with unspecified number of doses of VARIVAX (Merck) which were administered to the patients which were exposed to the temperature outside of range. The patient was vaccinated with VARIVAX (Merck) Lot # J00891 (Expiry: 19-JUL-2015) which was exposed to 26F for 82 days. No further information was provided. This case is linked to the case 1404USA002681 and 1404USA002682 (same reporter link). Additional information has been requested.
Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Seizure-Mild, Systemic: Tinnitus-Mild, Additional Details: Patient received 2nd dose and withing approximately 5 minutes, her eyes rooled back and her body went limp.  She came too withing 1 minute and was ok for approximately 2-3 minutes.  Then her eyes rolled in the back of her head and she experienced slight convulsions of her extremities.  she came too once again within 1 minute.  she was confued initailly when she came too, but pretty quickly was fully awae of her surroundings.
c/o SOB, cough, fever, +covid X 10 days ago. sats 86 on RA, placed on 5L O2.  acute resp failure due to COVID Pneumonia, PE, DVT, prolonged hiccups (5 days), on dexamethasone, zinc,  and vit C. no remdisivir due outside of window.  on heparin drip for PE and DVT. O2 needs increased, pt requiring 15 L NRB. Toci given. on 10/18 pt requiring 15 L NRB plus 100% HFNC to increase sats from 86 to 91%.  PT a DNR, does not want intubation.  pt continued to declined, transferred to inpt hospice.
Outdated Varivax given to pt on 9/9/03, lot #9971L 1/7/03 (3 other patients this happened to as well).