chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On July 7th it was discovered that when the Pfizer vaccination was taken out of the fridge and mixed it was dated with the incorrect date. It was dated as the 7th however was actually supposed to be the 6th.  It was also discovered that the staff had not thrown the Pfizer vaccination away when they left on the 6th. This resulted in a patient receiving the Pfizer vaccination that had set out all night.  Pfizer vaccination had actually been taken out of fridge at 8:54am and then mixed at 9:01am then drawn into syringes and was dated the 7th however was actually the 6th. One vaccination was given that day then the next day the 7th a staff member looked at the dates and times and then gave the injection to a patient. When I discovered the error I contacted Pfizer to see what next steps need to be done.
it is itchy; rashes broke out on her arm, stomach, back, down to her knees then to both of her legs; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-May-2021 and was forwarded to Moderna on 03-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (it is itchy) and RASH (rashes broke out on her arm, stomach, back, down to her knees then to both of her legs) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Multiple sclerosis. Concomitant products included FUROSEMIDE (LASIX [FUROSEMIDE]) for Hypertension, ALPRAZOLAM, PROPRANOLOL HYDROCHLORIDE (PROPRAZOLAM) for Multiple sclerosis.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced PRURITUS (it is itchy) and RASH (rashes broke out on her arm, stomach, back, down to her knees then to both of her legs). At the time of the report, PRURITUS (it is itchy) and RASH (rashes broke out on her arm, stomach, back, down to her knees then to both of her legs) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included Benadryl and rubbed Vaseline cream for the rashes.
VanishPoint spring-retractably syringe (Lot G200712) malfunctioned during (R) deltoid IM administration. Unable to depress plunger on administration so nurse pulled out a little and was able to administered. Minimal leakage noted from injection site simultaneously as plunger malfunctioned after being fully depressed. Site lead notified for further assistance.
Pt received vaccine and was waiting in a chair for the required 15 minutes with her dad. after 10 minutes, she told her dad she was feeling dizzy and wanted a water. He left to get water. Another RPH saw pt. falling over in her chair. Patient's eye were open and tears were coming down but she could not speak. Her eyes began to close and she kept trying to pass out. We took pts mask off and fanned her and kept talking to her. After about 3 minutes, she was able to focus her eyes and could say her name. After about 3 more minutes, she was able to count to 10 backwards. Her dad returned. She drank water and was feeling much better after about 20 more minutes.
lost her voice; could not keep food down; dehydration; Initial information received on 19-Jul-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves female patient (age not reported) who lost her voice, could not keep food down and dehydration, while she received vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious lost her voice (aphonia), could not keep food down (movement disorder) and dehydration (unknown latency) following the administration of INFLUENZA VACCINE.  Other relevant tests not reported.  Final diagnosis was dehydration, movement disorder and aphonia.  It was not reported if the patient received a corrective treatment.  The outcome was unknown for dehydration, movement disorder and aphonia.  Information on the batch number was requested.  List of documents held by sender: none.
Fever of 104 degrees x 2 days, lump at injection site. Screaming q 15 minutes for 24 hrs after injection.
Pt recv vax on 8/27/97; on 8/29/97 pt exp fever (102) x24 hr; tx=Rocephin; pt imp 9/2/97.
she is getting Chemotherapy on 16Mar2021; she is getting Chemotherapy on 16Mar2021; neck started to hurt; my neck started to hurt, got stiff; shoulder and neck started turning  red; breaking out look on the skin; This is a spontaneous report from a contactable consumer (patient). A 81-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EN6200; Expiration Date: Jun2021, NDC number: 592671000-1, patient was 81-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Right on 23Feb2021 at 02:00 PM as DOSE 1, SINGLE for covid-19 immunisation. Medical history included bladder cancer, Kidney cancer, Allergy, Allergies: Sulphur or Sulfa. There were no concomitant medications. On 28Feb2021 is when she had the stiff neck as well as the redness and breaking out look on the skin, she looked in the bathroom, and pulled her shit down and looked on the shoulder, by the neck, it was red as if it was like welts, however she did not have welts it was smooth skin on the shoulder, she felt her skin and on the neck she a welt, she states that maybe it is an allergic reaction, she did not feel any temperature. She put a hot water bag on the neck. Caller adds that back on the early part of Feb2021 before the covid vaccine, she had a nuclear medicine test, with that she broke out with welts on the neck, she does not know the name of vaccine used during the test. She is getting ready to have chemo because of her bladder and they needed the Nuclear medicine test for a biopsy, all of this happened before first dose. The patient previously took codeine, aspirin and experienced allergy, the patient previously took bactrim and experienced her stiff/bones stiff. On an unspecified date, the patient experienced she is getting chemotherapy on 16mar2021, breaking out look on the skin, on 28Feb2021, the patient experienced neck started to hurt, my neck started to hurt, got stiff, shoulder and neck started turning red. The patient underwent lab tests and procedures which included biopsy, blood test which included unknown result in 2021, Nuclear Medicine Test: unknown result on Feb2021. Reported that patient does not know if patient was having an allergic reaction to the medicine. Caller has called her oncology doctor because she is getting Chemotherapy on 16Mar2021. Patient was told to take Benadryl. It was reported that after vaccination, yesterday last night she was sitting in the chair and felt that her neck was getting stiff on the right side. She looked in the mirror and saw that her skin turned red, as if it like broke out into something. The outcomes of events (my neck started to hurt, got stiff, shoulder and neck started turning red) were not recovered and the outcome of event (breaking out look on the skin, she is getting Chemotherapy on 16Mar2021) was unknown.  No follow-up attempts are possible. No further information is expected.
pt presented to ED with altered mental state and coughing up bloody secretions; left pneumothorax, right lung mass; positive for COVID; given IVFs, ABX, dexamethasone; intubated, Chest tube placed; transferred to ICU; pt's condition declined; DNR; pt went into asystole and never recovered; death certificate and medical records sent per VAERS request
new eosinophilic esophagitis 13 d after dose one of pfizer vaccine Pain in her esophagus, dysphagia,  felt like throat was swollen. Heartburn.
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. No medical history was reported. On an unknown date, the patient was vaccinated with a dose of RECOMBIVAX HB (lot #, expiry, dose, route not reported) outside of the administration schedule in the prescribing information. No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
Heavy legs, knees felt like they were buckling and slight headache all within 15 minutes after getting the vaccine then itchy bumps (3) on the right side of my face developed a few days later; Heavy legs, knees felt like they were buckling and slight headache all within 15 minutes after getting the vaccine then itchy bumps (3) on the right side of my face developed a few days later; Heavy legs, knees felt like they were buckling and slight headache all within 15 minutes after getting the vaccine then itchy bumps (3) on the right side of my face developed a few days later; Heavy legs, knees felt like they were buckling and slight headache all within 15 minutes after getting the vaccine then itchy bumps (3) on the right side of my face developed a few days later; This is a spontaneous report from a contactable consumer (patient). A 64-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 30Jun2021 13:15 (Age at vaccination 64 years old) as DOSE 1, SINGLE for covid-19 immunisation. No medical history reported. Concomitant medications included levothyroxine sodium, rosuvastatin, cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]), biotin taken for an unspecified indication, start and stop date were not reported. Not pregnant at time of vaccination. If covid prior vaccination, If covid tested post vaccination, Known allergies, other vaccine in four weeks were not received. On 30Jun2021 the patient experienced heavy legs, knees felt like they were buckling and slight headache all within 15 minutes after getting the vaccine then itchy bumps (3) on the right side of my face developed a few days later. The patient did not received treatment. The clinical outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Body aches, chills, fever of 102.1 starting about 1:00 am lasting all night. Fatigue the next day with a fever of 101.7 until approximately 48 hours after the shot. Diarrhea several times a day starting about 24 hours after the shot lasting approximately a week. Dry nonproductive cough starting about one hour after the shot and lasting approximately two weeks.
PATIENT WAS IN OFFICE FOR 9 YEAR WELL CHILD EXAM - HEALTHY ON EXAM, LUNGS CLEAR AT TIME OF EXAM. IMMUNIZATIONS GIVEN AT CONCLUSION OF APPOINTMENT.  FIFTEEN (15) MINUTES AFTER VACCINES GIVEN TIGHT COUGH WAS NOTED.  COUGH BECAME TIGHTER, MORE FREQUENT.  WHEEZE WAS NOTED ON PHYSICAL EXAM, R > L WITH SCATTERED WHEEZE NOTED THROUGHOUT ALL LUNG FIELDS.  RESPIRATORY RATE 28, NO RETRACTIONS NOTED. PHYSICIAN ORDERED ORAL ORAPRED 30 MGM, ORAL BENADRYL 25 MGM AND ALBUTEROL AEROSOL 2.5 MGM STAT.  AFTER AEROSOL IMPROVEMENT WAS NOTED BUT STILL COUGH AND SCATTERED WHEEZE ON EXAM. TO CONTINUE ALBUTEROL AEROSOLS AT HOME EVERY 4 - 6 HOURS AS NEEDED.  HOME ON ORAPRED 15 MGM TWICE DAILY X 3 DAYS.  PHONE CALL FOLLOWUP IN A.M., SEE IN ER TONIGHT IF ANY CONCERNS OR IN OFFICE IF PROBLEMS IN NEXT 1 - 2 DAYS.
Light headed, sore throat, joint pain, frequent urination, shortness of breath, periodic fast heart rate, fatigue, sore legs
pt recvd vax 24JAN95 & lt shoulder is swollen, red-warm to touch; pt c/o soreness in area; has full ROM of lt shoulder; inst pt's teacher to tell mom to take pt to MD;
Head pressure; Pain in arm (LEFT); Spine ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm (LEFT)), SPINAL PAIN (Spine ache) and HEAD DISCOMFORT (Head pressure) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer since 2012 and Rheumatoid arthritis. Concomitant products included UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm (LEFT)) and SPINAL PAIN (Spine ache). On 11-Feb-2021, the patient experienced HEAD DISCOMFORT (Head pressure). On 11-Feb-2021, PAIN IN EXTREMITY (Pain in arm (LEFT)) and HEAD DISCOMFORT (Head pressure) had resolved. On 12-Feb-2021, SPINAL PAIN (Spine ache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
8 days after the ProQuad was given in the right thigh she had a pink raised indurated eye shaped lesion a little below the shot site.
PT was observed post Covid-19 immunization for 15 minutes .  During the observation period, he experienced an adverse reaction with the following symptoms,  feeling flushed, clammy..   Assessment : Time of assessment 1049. Alert and oriented and Clammy. Patient was in observation for 15 minutes and he says after about 8 minutes he started feeling flushed, clammy and says he was hot and needed a drink. He was given a soda which he drank with no issues. He walked to the triage area without any problems. He says this happens anytime her receives a vaccine, such as a flu shot, and anytime he goes to the doctor's office. 1051: BP 120/82, P 77, Oxygen sat 100% RA; 1058: BP 123/96, P 70; 1059: Standing BP 12/90, P 71. Patient reported feeling better, ambulatory out.Actions taken:  Vitals sign taken  VAERS form obtained and completed by RN.   Medications administered: No medication administered.   Disposition: Reports no further symptoms of adverse reaction after observation for additional 15 minutes minutes. Discharged home. Instructed to follow up with PCP  for evaluation for second dose. Instructed to call 911 for trouble breathing, rapid heart rate, dizziness, swelling of tongue or throat. The Patient was provided with Vaccine Information Sheet and instruction to access the V-Safe system.
Positive COVID Test; A Spontaneous report was received from a Physician and concerns a 95-year-old male patient who experienced positive COVID test.  The patient's medical history included chronic obstructive pulmonary disease, arthritis, chronic kidney disease, hyperlipidemia, hypertension, atrial fibrillation (A-Fib), chronic heart failure, benign prostatic hyperplasia (BPH), hydronephrosis, chronic low back pain, hematuria, Alzheimer's, essential tremor, peripheral vascular disease and heart valve replace.  No relevant concomitant medications were reported.  On 19 Dec 2020, the patient had negative COVID-19 PCR test.  On 25 Dec 2020, the patient received his first of two planned doses of mRNA-1273 (batch no: unknown) intramuscularly, for prophylaxis of COVID-19 infection.  On 25 Dec 2020, the same day of receiving vaccination, the patient tested positive for COVID-19. Symptoms included sore throat.  No relevant treatment information was provided.  Action taken with mRNA-1273 in response to the event, positive COVID test was not provided.  The outcome for the event, positive COVID test was not reported.; Reporter's Comments: This case concerns a 95 year old male with medical history of COPD, arthritis, CKD/hydronephrosis, hyperlipidemia, hypertension, A-Fib, CHF/heart valve replacement, BPH, chronic low back pain, hematuria, Alzheimer's, essential tremor, PVD. Baseline COVID-19 test was negative on 19 Dec 2020. On 25 Dec 2020, the same day as first dose mRNA-1273 administration, he tested positive for COVID-19. Symptoms included sore throat.  Based on available evidence at the time of this report and the temporal association of positive COVID-19 test occurring the same day as the mRNA-1273 first dose, the nonserious event of SARS-CoV-2 test positive,  a causal relationship cannot be excluded.
This is a spontaneous report from a contactable consumer reporting for himself from a Pfizer-sponsored program. A 78-year-old male patient received second dose of PREVENAR 13 via an unspecified route of administration, in Nov2017, single dose, for immunization. Relevant medical history included logging accident years ago, operation on his neck (before receiving the second dose), and the patient also can't lose weight (but that was because of his other meds) before all of this. Concomitant medications included injections for cholesterol (unspecified drug). The patient previously received PREVENAR 13 in 2016 (last year) for immunization. It was reported that the patient already received a dose of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) one year ago and he received second dose of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) about a month ago. On 19Dec2017, the patient has been having some chest pain and tightness of chest. It was also reported that his sleep has not been on key lately and that the patient has been having trouble sleeping lately and was tired. It was reported that the chest pain comes and goes, sitting makes it better but the patient doesn't know if it's just his chest muscles because he didn't sleep properly. Outcome of the event sleep has not been on key lately/ has been having trouble sleeping and fatigue was not recovered while it was unknown for the other events.
The patient is unable to extend his left arm fully at the shoulder. When he moves the arm he experiences shooting pains down the arm.
At first 2 red places which later merged into a large red area. Hard knot beneath skin at injection site. Warm to the touch, swelling in same area. Pain to the touch similar to bruise. Headache on day 2. Red area became 8" before antibiotic started working.
A report has been received from a Health Professional concerning a female subject who had been receiving Nasal FLUMIST (intranasal), 0.2 Millilitres, Unknown. FLUMIST (intranasal) started on an unknown date. The patient received FLUMIST when she was 4 weeks pregnant (did not know). She just found out she was pregnant. FLUMIST (intranasal) was continued. The outcome of the event of PREGNANT is unknown. The report was considered to be non-serious.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 25Sep2023 at 15:15 as dose 1, single (Lot number: H09835) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "sleep apnea" (unspecified if ongoing); "sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Azythromicin, reaction(s): "allergies". Vaccination history included: Covid-19 vaccine (DOSE 6 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for Covid-19 immunization; Covid-19 vaccine (DOSE 5 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for Covid-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for Covid-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, UNKNOWN MANUFACTURER), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, UNKNOWN MANUFACTURER), for Covid-19 immunization; Covid-19 vaccine (DOSE 1, SINGLE, UNKNOWN MANUFACTURER), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 05Oct2023, outcome "unknown", COVID-19 (medically significant) with onset 05Oct2023, outcome "recovered" (15Oct2023) and all described as "Treatment of COVID-19". The patient became ill and tested positive for COVID on 05Oct2023. He contacted his doctor and began a 5 day course of Paxlovid on 06Oct2023 and completed it on 10Oct2023 at which time he felt he had recovered from COVID. On the morning of 14Oct2023, he tested negative, but later the day, after getting his first vigorous exercise in over a week, he began feeling feverish, had a runny nose and felt fatigued. On 15Oct2023, these symptoms continued and he tested positive for COVID. Today, 17Oct2023, he still feel very fatigued, still have a runny nose, but he do not have a fever. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Oct2023) Positive; (14Oct2023) Negative; (15Oct2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Information has been received from an office manager concerning a 79 year old female patient with asthma and allergic to morphine, penicillin and sulfonamide who on 14-JAN_2009 was vaccinated with a dose of PNEUMOVAX 23 (lot #662785/1124X) intramuscularly in the left arm. Concomitant therapy included vitamin D (unspecified), metformin, ADVAIR, AZMACORT, albuterol, SPIRIVA, COUMADIN, LASIX (furosemide)), potassium (unspecified), LIPITOR, VICODIN, captopril, carvedilol and meclizine. Subsequently the patient developed an injection site reaction. Her left arm became red, swollen and painful. Patient sought medical attention via office visit. No lab diagnostic studies were performed. Patient was given BENADRYL and the symptoms resolved. This is one of several reports received from the same source. Additional information has been requested.
Immediately sore at injection sight, worsened over the next day and two weeks later I am in more pain with limited use of my right arm - due to the shoulder pain. (Shot was given high by my shoulder).
This is one case out of a cumulative total of 23 cases solicited from the Electronic Disease Surveillance System during the surveillance period from 01 January 2010 to 14 July 2011. These 23 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP-combination vaccines from other manufacturers are not reported as per study protocol. Initial report was received on 14 July 2011 from the Investigator participating in the above-mentioned post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a two-year-old female subject (initials not collected) was identified by the investigator based on review of data from the electronic database. The subject's vaccine history included three doses of PENTACEL; dose one lot number C3243AB received on 23 April 2009, dose two and three lot number C3293AA received on 22 June 2009 and 20 August 2009 and one dose of DAPTACEL; lot number C3191AA on 11 May 2010 (routes and sites of administration not reported). Approximately one year after the last dose, on 16 May 2011, the subject developed cough. Eight days later, the subject developed a paroxysmal cough with whoop. The subject also experienced cold-like symptoms, post-tussive vomiting and sleep disturbance (onset dates not reported). Laboratory testing included positive PCR on 31 May 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 02 June 2011 for five days. The subject was not hospitalized. At the time of final contact on 06 June 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 21 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Patient is currently pregnant and followed up with her OB.  Symptoms started with scattered rash that "spread all over body and down to her toes" itching began on left arm then on entire body.  Physician ordered Benadryl & OTC hydrocortisone cream.  the following day after little relief she contacted her physician again and received order for steriods.