chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a RN concerning a 5 year old Hispanic/Native American male with no medical history and no known drug allergies who on 07/12/03 at 12:30 was inadvertently vaccinated SC in the right thigh with an expired first dose of varicella virus vaccine live (Lot # 640071/1317L; expired on 03/18/03).  On 07/21/03 at 12:30 the pt was also vaccinated SC in the left thigh with a second dose of MMRII (Lot # 643390/0771M), a fifth dose given IM in the right arm of DTAP (Infanrix, Lot # 572A2) and a fourth dose given SC in the left arm of IPV (Lot # T14462).  There were no other concomitant medications. There was no illness at the time of vaccination. The pt's mother stated that he had a slight fever the day of the immunizations and that she gave him Tylenol. It was also reported that the pt had no adverse side effects. Unspecified medical attention was sought. No diagnostic studies were performed. On 08/14/03 it was reported that, "at this time", the physician had not decided whether to revaccinate the pt and was awaiting more information. No product quality complaint was involved. On 08/26/03 it was reported that the physician had decided not to revaccinate. No further information is expected.
Infant was behind on immunizations. Mother gave a negative history for previous adverse reactions. Infant was put to bed for the evening and expired. Cause of death is undetermined. Autopsy states cause of death as asphyxia.
The patient was administered 0.5 mL Influenza shot instead of 0.25 ml for 1st dose. And 2nd dose was not given after consultation with the drug (vaccine) company.
Developed swelling, bruising, pain at site of anthrax injection within 24 hours of receiving the shot.  Edema at injection site 50-120mm, ecchymosis, erythema, swelling, pain.
Severe allergic reaction; BP of 170/104; felt like his whole body was on fire; chest tightness; HR elevated at 110bpm; Severe allergic reaction with symptoms that include/ rash all over his body including his throat, chest, and inner legs.; Right side of neck was swollen and sore; Right side of neck was swollen and sore; his neck was stiff to turn; he feels "really weak and tired"; he feels "really weak and tired"; This is a spontaneous report from a contactable other healthcare professional. A 46-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date unknown) via an unspecified route of administration, on 29Dec2020, at a single dose, for COVID-19. The patient's medical history and concomitant medications were not reported. Patient is a 46y/o male certified nursing assistant (CNA).  He received his first dose of Pfizer-Biontech Covid19 vaccine, yesterday 29Dec2020. On an unspecified date in Dec2020, patient experienced severe allergic reaction with symptoms that include: felt like his whole body was on fire, chest tightness, BP of 170/104, HR elevated at 110 bpm, rash all over his body including his throat, chest, and inner legs. Right side of neck was swollen and sore. Both sides are swollen, today, and his neck was stiff to turn, he feels "really weak and tired".  Patient was taken by ambulance to the emergency room.  Patient then asked if he should get the second dose of the vaccine. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of severe allergic reaction with multiple symptoms cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Asthma; Sinusitis; Hypertension; Vaccination failure; COVID-19; Unspecified illness; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Unspecified illness), VACCINATION FAILURE (Vaccination failure), COVID-19 (COVID-19), ASTHMA (Asthma) and SINUSITIS (Sinusitis) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Prophylactic vaccination: influenza (influenza vaccine for flu). Past adverse reactions to the above products included Ill feeling with influenza. Concurrent medical conditions included Penicillin allergy, Drug allergy (tetracycline and sulfa), Shellfish allergy and Asthma.    On 12-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced ILLNESS (Unspecified illness). On 06-Feb-2022, the patient experienced VACCINATION FAILURE (Vaccination failure) and COVID-19 (COVID-19). On an unknown date, the patient experienced ASTHMA (Asthma), SINUSITIS (Sinusitis) and HYPERTENSION (Hypertension). On 06-Feb-2022, VACCINATION FAILURE (Vaccination failure) had resolved. At the time of the report, ILLNESS (Unspecified illness) and SINUSITIS (Sinusitis) outcome was unknown and COVID-19 (COVID-19), ASTHMA (Asthma) and HYPERTENSION (Hypertension) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 170/90 (High) 170/90 mmHg..         No concomitant medication information was provided.  No treatment medication was provided.  Company comment: This is a spontaneous case concerning a 60-year-old female  patient with asthma, who experienced the non-serious unexpected event of COVID-19 (AESI), more than 8 months after the administration of second dose of mRNA-1273 vaccine. Patient had COVID-19 rapid test and PCR with positive results. Patient did not specify any symptoms but reported that she not had fever. Vaccination failure was also included  as an event. Seven months after primary vaccination with mRNA-1273, patient received a dose of COVID-19 vaccine ad26.cov2.s Janssen.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-509055 (Patient Link). Sender's Comments: Company comment: This is a spontaneous case concerning a 60-year-old female  patient with asthma, who experienced the non-serious unexpected event of COVID-19 (AESI), more than 8 months after the administration of second dose of mRNA-1273 vaccine. Patient had COVID-19 rapid test and PCR with positive results. Patient did not specify any symptoms but reported that she not had fever. Vaccination failure was also included  as an event. Seven months after primary vaccination with mRNA-1273, patient received a dose of COVID-19 vaccine ad26.cov2.s Janssen.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
This spontaneous report was received from a registered nurse who was referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On unknown dates, the patient was vaccinated with the first and second doses of GARDASIL 9 (route, concentration, anatomical place of vaccination, lot # and expiration date were not reported). Concomitant therapies were not reported. Then, on 01-APR-2016 (reported as "today"), the patient went to the office and was vaccinated with the third dose of the aforementioned vaccine, which according to the reporter was "two weeks earlier than the recommended schedule". No adverse effects were reported and no product quality complaint was involved. Additional information has been requested.
Vaccine received on 2/27/01 and had 2.5 cm red area with induration. Temperature was 104F on 3/2/01 and then 100F (R), that day. Treated with Tylenol and cold compresses to the area. No more DTAP.
not doing very well; bad reaction; high fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not doing very well), IMMUNISATION REACTION (bad reaction) and PYREXIA (high fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination.    Co-suspect products included non-company products INFLUENZA VACCINE for Prophylactic vaccination, PNEUMOCOCCAL VACCINE for Prophylactic vaccination and DUPILUMAB (DUPIXENT) solution for injection for Atopic dermatitis.    The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor.    In May 2021, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 300 milligram. On 13-Oct-2021, the patient received dose of INFLUENZA VACCINE (unknown route) 1 dosage form and dose of PNEUMOCOCCAL VACCINE (unknown route) 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced MALAISE (not doing very well), IMMUNISATION REACTION (bad reaction) and PYREXIA (high fever). At the time of the report, MALAISE (not doing very well) and IMMUNISATION REACTION (bad reaction) outcome was unknown and PYREXIA (high fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Oct-2021, Body temperature: High Fever. On an unknown date, Body temperature: Temperature was then back to normal.. On an unknown date, Influenza virus test: (Negative) Flu test was negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  On 13-OCT-2021 the patient experienced high fever, was not doing very well and had bad reaction same day following the administration of Influenza vaccine and Pneumococcal vaccine, (unknown latency) following the dose intake of with Dupilumab and administration of Moderna COVID-19-19 vaccine.  On an unknown date, the patient recovered from high fever (temperature was now back to normal).  It was unknown if the patient experienced any additional symptoms/events.  Treatment medications were not provided. It was not reported if the patient received a corrective treatment for the events (high fever, not doing very well, bad reaction).  Patient stated she was tested for flu and COVID and had a blood culture drawn her flu test was negative and SARS-CoV-2 test results were not received yet.  It was unknown if there were other lab data/results available.  This case was identified as part of retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
MA administered Men B vaccine instead of Menactra. I did explain to MA that patient still indeed needed the menactra vaccine before she leaves our office. Patient received 4 vaccines on Dec. 2, 2019.
Throw up; i got sick; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 01Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VOMITING (non-serious) with onset Apr2021, outcome "unknown", described as "Throw up"; ILLNESS (non-serious) with onset Apr2021, outcome "unknown", described as "i got sick".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sick; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick). At the time of the report, ILLNESS (Sick) outcome was unknown.             AE submitted via chatbot  "Dose the moderna make you sick for a week' "yes I been sick for 4 days now'   Reporter did not allow further contact
I woke up with chills, body aches, hurting all over, injection site was sore, lethargic, fatigue. The next day the inflammation in the right arm from shoulder to elbow, with whelps, redness, hot to the touch, itchy.
Diarrhea; Vomiting; Muscle ache; Feeling bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Apr2021 (Lot number: EW0172) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Back ache" (unspecified if ongoing), notes: I have a bad back. I have 4 bulging disc and 1 herniated; "4 bulging disc and 1 herniated" (unspecified if ongoing), notes: I have a bad back. I have 4 bulging disc and 1 herniated. Concomitant medication(s) included: NORCO taken for back pain; PERCOCET-5. The following information was reported: DIARRHOEA (non-serious) with onset 01May2021, outcome "recovering", described as "Diarrhea"; VOMITING (non-serious) with onset 01May2021, outcome "recovering", described as "Vomiting"; MYALGIA (non-serious) with onset 01May2021, outcome "recovering", described as "Muscle ache"; FEELING ABNORMAL (non-serious) with onset 01May2021, outcome "recovering", described as "Feeling bad". Therapeutic measures were not taken as a result of diarrhoea, vomiting, myalgia, feeling abnormal. Additional information: When paraphrased the above concern patient stated, "It got the vaccine first dose on Wednesday (Confirmed as 28Apr2021) and last Wednesday and Saturday night when it went to bed it started feeling bad." When paraphrased the above concern consumer stated, "It got the vaccine first dose on Wednesday (Confirmed as 28Apr2021) and last Wednesday and Saturday night when it went to bed it started feeling bad."  No follow-up attempts are possible. No further information is expected.
Rec. shingles 2nd dose and flu shot at the same time. 6 hours later Nauseated/ vomiting, shivering, shaking. 4am went to ER, there 5 hours  Pharmacy has last name as married name.  Madien name used at ER
Patient states about 10 days ago started with bilateral lower extremity pain.  Severity of pain can be 6 out of 10.  This morning the pain was left anterior thigh pain up by the hip.  The pain starts after she gets up and walks.  Pain has been below right as well as left knee area shooting down the to ankle.  Patient experience sudden pain lasting hours.
Breakthrough case admission after 2 vaccines Pfizer 4/2/21 Lot# EW00172;  Pfizer 5/12/21 Lot# Ew017
1st dose on 13Jun2022, 2nd dose on 27Jun2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 299J9, expiry date 1st July 2023) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 27th June 2022, the patient received the 2nd dose of Shingrix. On 27th June 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 09-SEP-2022 Reporter's Comment: The patient was not immunocompromised.  At the time of reporting, the dose had not been repeated.  The reporter consented to follow up. Additional Supportive Information: The patient received the 2nd dose of Shingrix earlier than the recommended schedule, which led to shortening of vaccination schedule.
19 y.o. male fell and fainted about 3 min. after receiving a flu shot. Pt had chills and cold sweat but awake and was confused. Medics were called and pt was taken to the hospital. No treatment was given by administer.
Patient got vaccine; waited onsite 15minutes then left and had a cigarette.   Returned, stating she feels a lump in throat.   Waited onsite & reported feeling of lump resolved.  Left to return to work @home.
This case was reported by a nurse and described the occurrence of headache in a 58 year old male patient who received hepatitis A inactivated and hepatitis B recombinant vaccine (Twinrix) for prophylaxis.  The pt has no known history of drug or food allergies.  The pt received no concurrent medications.  On 09/25/03, the pt received his first dose of Twinrix w/out incident.  The same day, the pt also received inactivated poliomyelitis virus vaccine (IPOL, AP), tetanus and diphtheria toxoids adsorbed (manufacturer unknown), and typhoid vaccine (manufacturer unknown).  The pt received his second dose of Twinrix on 10/27/03.  On the evening of 10/29/03, the pt reported that he consumed alcohol (wine).  On 10/30/03, at 3:00am the pt awoke with a "severe headache" and nausea.  The nurse stated that the pt reported he "got up and took an aspirin and felt confused and depressed, and later vomited."  The pt went back to sleep and upon wakening continued to experienced mild nausea and headache.  The confusion, depression, and vomiting resolved on 31oct2003. The immunization series with Twinrix was discontinued. The nurse considered the events to be related to vaccinationwith Twinrix.
sick for two days after 2nd vaccine - lethargic, headache, stomach cramps, nausea, night sweats, low grade fever  I am still experiencing tinnitus in right ear.
THERE WAS AN ORANGE-SIZED SWELLING ON THE RIGHT DELTOID THAT WAS ERYTHAMATOUS AND FIRM THAT LASTED APPROXIMATELY 10 DAYS. THE PATIENT NEVER EXPERIENCED PAIN, BUT IT REMAINED SORE UNTIL IT RESOLVED ON ITS OWN.
patient received an expired dose of TENIVAC/no AE; Initial information regarding an unsolicited valid non-serious case was received on 21-Apr-2021 from a health care professional via Medical Information (Reference number- 00571113) and transmitted to Sanofi on 21-Apr-2021.  This case involves a 56 year-old female patient who was vaccinated with expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (Expired product administered).  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) on 21-Apr-2021 for prophylactic vaccination.  On 21-Apr-2021, the patient received 0.5 mL (total) dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot U6265AA and expiry date 19-Apr-2021) via an intramuscular route at the right deltoid for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency was on same day).  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Information has been received from a consumer concerning his approximately 36 months old grandson with amoxicillin, DIFLUCAN, "Kamet" and environmental things allergy and a history of high toxin levels of mercury and vitamin D deficiency who at his 18 months old, in approximately October 2001, was vaccinated with the first dose of MMR II and other 18 month old vaccines (names and manufacturer unspecified). The consumer reported that about a year and a half after vaccination, in approximately April 2003, the patient stopped talking completely and was diagnosed with autism. The patient sought unspecified medical attention. No lab tests were performed. The consumer reported that the patient had been improving with his speech but he was not fully recovered. It was reported that therapy with MMR II was not reintroduced. Upon internal review, autism was determined to be an other important medical event. Additional information has been requested.
HEMATOMAS ON BOTH LEGS ONE LEG LOOKS BIGGER AND TO THE OTHER LEG BEGINNING TO FORM HEMATOMAS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On MAY-2021, the subject experienced hematomas on both legs one leg looks bigger and to the other leg beginning to form hematomas. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from hematomas on both legs one leg looks bigger and to the other leg beginning to form hematomas. This report was non-serious.
Patient received adult dose of vaccine (1mL) instead of pediatric dose (0.5mL). Patient is asymptomatic, and no treatment was needed.
15 minutes after vaccines became dizzy when she stood up. B/P elevated 158/85.  Was extremely fatigued and localized site redness, swelling and pain.
Swollen eyes, upper respiratory symptoms.  Diagnosed as Ocular respiratory reaction, self-limiting, better in 48 hours
8/17/22-Pt and husband in for scheudled clinic. Pt ambulatory with cane, feeling well, no dyspnea. Volume stable, .9 above TW, tx scheduled for later today. Meds and labs reviewed, K remains slightly low at 3.6, discussed with pt and she will increase K food intake slightly. Hgb stable, adequacy in goal. Bone/mineral stable. albumin improved from 2.8 to 3.2. Pt had been complaint free and sudenly c/o feeling dizzy. feet up and took BP which was syst 75. Pt diaphoretic. Palpated a regular pulse in 90s. Pt denied any pain-no chest, jaw, armor abd. Denied feeling short of breath. O2 placed at 3L/min per NC. Obtained glucose by finger stick and resulted at 94. Pt verbalized she had not taken am 9/21/22Pts husband cPts husband called to report pt had similar episode of hypotension and dyspnea as last clinic visit upon returning home today. Stated he called EMS and sent her to ER. Discussed feel Heplisav could be issue. Called ER and spoke with pts nurse, informed that pt had first 2 doses which were uneventful, however likely a reaction at this point.  Called Dr and informed and listed Heplisav as allergy in system.
mild rash on and near site injection that lasted about 5-7 days, used cortisone cream at recommendation of physician (already taking OTC allergy meds) and self resolved, no medical appt needed
Pain, which initiated within few days after vaccination and still present a few week out after vaccines were administered. (Pain/soreness on arm which they were given). (Left and right).