chrisvoncsefalvay/vaers-outcomes huggingface dataset:
In April I had my second dose, in May I tried to do my usual blood donation and my iron was too low. Also in May I went for my physical and told him I had been tired (falling asleep early at night and requiring naps) and short of breath when climbing stairs. Blood tests were ordered and all my counts had plummeted. Started taking more vitamins and snacking on kale chips, prunes etc. In June I went for more blood work and my CBC had come back up, but my hemoglobin and Hematocrit not enough. I had just my iron checked in August and they were below normal still. Also retested Hemoglobin and hematocrit and RBC, while up, not up enough.
Patient woke in AM of 12 Feb 13 finding "red spots" on chest and back.  As of 13 Feb 13, "red spots" have started to resolve.  Smallpox site itself is within normal limits.  Exam showed multiple (50-100) 2-3 mm in diameter, faint macules on chest and back.  Less than 10 showed tiny pustule without discharge.  Patient reports macules are resolving.
None. Until the next day starting with a dry cough, continued into throwing up & a fever. I thought it was the flu. I was bed ridden for a whole week; could not move or eat. It just hit me today what may be caused by this after reading the possible risks after this vaccine. I broke the fever last night but currently still have a very bad cough. Im not sure if my illness is from this but it is quite ironic and have never been so sick in my entire life.
This is a non-serious spontaneous case, initially received from other non-health professional on 14-Nov-2018, concerning a female patient of unspecified age. On an unspecified date, the FLUCELVAX QIVc vaccine under first temperature excursion with maximum temperature (Tmax) 8.2 degree centigrade for 4 minutes. On 22-Oct-2018, vaccine underwent second temperature excursion with Tmax 9.8 degree centigrade for 23 minutes. On an unspecified date, two temperature excursions were identified after an audit. On 06-Nov-2018, the patient was inadvertently administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right deltoid batch number: 252672 and expiry date: 30-Jun-2019) which underwent temperature excursion. The patient did not experience any adverse events after vaccination. This case is linked to 201805262 (same reporter).
Itching, rash on arm (vaccine site R arm initially), rash now on torso and Left arm. No fever. Slightly raised, circular (about 7mm in diameter) reddish rash.  Still present.
Patient received dose of COVID19 (Pfizer-BioNTech) past the vial BUD (Beyond Use Date) of 32 days from transfer of deep freeze to refrigeration temperature. BUD date of dose was 1/7/22 at 0900, patient received vaccination on 1/07/22 at approximately 09:30am. When error discovered facility contacted for course of action. At direction of the, patient contacted regarding occurrence to offer re-vaccination of dose. Patient accepted revaccination on 1/28/2022. No adverse side effects or event as result of dose.
Absolute number of lymphocytes came out high; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHOCYTE COUNT INCREASED (Absolute number of lymphocytes came out high) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included CLL (Normal), Penicillin allergy (Penicillin allergy), Allergy (Allergic to Sulphur.), Anxiety since 2010, Hypercholesterolemia since 2010 and Hypertension since 2000. Concomitant products included DESVENLAFAXINE and ALPRAZOLAM for Anxiety, AMLODIPINE for Blood pressure, ROSUVASTATIN and EZETIMIBE for Cholesterol.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced LYMPHOCYTE COUNT INCREASED (Absolute number of lymphocytes came out high). At the time of the report, LYMPHOCYTE COUNT INCREASED (Absolute number of lymphocytes came out high) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Jan-2021, Lymphocyte count: 14857 (High) 14857. On 24-Jan-2021, Lymphocyte count: 11623 (High) 11623 H.         Concomitant medications DESVENLAFAXINE, ALPRAZOLAM, AMLODIPINE , ROSUVASTATIN , EZETIMIBE . Treatment details were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Added patient demographics, medical history, lab tests and concomitant medications.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
A nurse wanting to know can a dose of Daptacel be counted as valid after it was reconstituted with and diluted with sterile water and administered to an 8-month-old child; Initial information received on 29-Oct-2020 regarding an unsolicited valid non-serious case received from healthcare professional (nurse).  This case involves an 8-month-old male patient for whom nurse wanted to know could a dose of diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel] be counted as valid after it was reconstituted with and diluted with sterile water and administered to an 8-month-old child (unevaluable event).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were none.  On 23-Sep-2020, the patient received a dose of suspect diphtheria-15/tetanus/5 ac pertussis vaccine (lot number: C5643CA and expiration date: 16-July-2021) 0.5 ml once via intramuscular route in the left thigh for prophylactic vaccination.  On 23-Sep-2020, on the same day nurse wanted to know a dose of diphtheria-15/tetanus/5 ac pertussis vaccine be counted as valid after it was reconstituted with and diluted with sterile water and administered to an 8-month-old child (unevaluable event).  No laboratory data was not reported. It was not reported if the patient received any corrective treatment. At the time of reporting, outcome of the event was not resolved.
I contracted COVID-19 while traveling outside the country on 06/07/2022 fever, shortness of breath, upper leg pain, headache, cough, sore throat, congestion, and fatigue. I was ill for 5 to 6 before my symptoms started resolve. I was prescribed an antiseptic mouth wash, cough medication, and fever reducers while abroad. I still have lingering symptoms of fatigue, cough, and sore throat.
Patient given undiluted dose of pediatric vaccine - no side effects reported as of 12/16/21 6:630pm
pt recvd vax & devel pruritic raised bumps b/w wrist & elbow;
Patient came to emergency department with complaints of midsternal chest pain radiating to the back that started on 6/13/21.  Patient discussed pain as severe sharp chest pain that worsens with taking a deep breathe, movement, and coughing,  Patient was diagnosed with pericarditis.  Patient was admitted to the hospital for observation, monitoring, and evaluation.  Patient was given Toradol 15mg IV and monitor chest pain.
I took the first shot and my psoriasis started to act up and inflamed. I was very ill and I also went to see the doctor and he was concerned that my liver was inflamed.
Patient presented to immunizations clinic on 21 MAY 21 requesting Typhoid and Hepatitis B#3. Patient received Hepatitis B #3 and HPV#2 - both at the proper intervals. Patient then returned to clinic on 26 MAY 21 for Typhoid vaccine which was missed on appointment 21 MAY 21. At this second appointment, patient received Typhoid and HPV dose#3. Dose was given only 4 days after dose #2 when minimum interval is 12 weeks between doses. This was an administration error. No adverse events reported.
This case was reported by a pharmacist via other manufacturer and described the occurrence of allergic reaction in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to SHINGRIX. Additional details were provided as follows: The age group of the patient was not reported, however it could be adult as per package insert. The age at vaccination was not reported.
55 patients received a dose of a vial after 12 hours of initial puncture; 55 patients received a dose of a vial after 12 hours of initial puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED and PRODUCT STORAGE ERROR in a 35-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, the patient experienced PRODUCT STORAGE ERROR. On 03-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 03-Sep-2021, EXPIRED PRODUCT ADMINISTERED and PRODUCT STORAGE ERROR had resolved. Not Provided.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided. No treatment information was provided.  Vial punctured 01-Jun-2021. Vial stored in refrigerator once punctured, in freezer prior to puncture.   This case was linked to MOD-2021-418964 (Patient Link).
GARDASIL shot given 3/18/19. Involuntary movement per mom 3/19/19 -> not seen mom refuse to follow up.
pt recv vax 24JUN96 & pt devel a lacy red rash on face, forehead, arms;pt was described as having pinpoint red spots, a puffy face & feverish that lasted a couple of days;
Funny smell when inhaling , smells like salon patch; This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (Funny smell when inhaling , smells like salon patch) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAROSMIA (Funny smell when inhaling , smells like salon patch). At the time of the report, PAROSMIA (Funny smell when inhaling , smells like salon patch) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Migraine; This spontaneous case was reported by an other and describes the occurrence of MIGRAINE (Migraine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced MIGRAINE (Migraine). At the time of the report, MIGRAINE (Migraine) outcome was unknown.            NO concomitant medication details were not provided. NO treatment medication details were not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-103955 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-103955:first dose case
infection in his mouth; This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (infection in his mouth) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Immunocompromised. Concomitant products included INSULIN for Diabetes.   In January 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFECTION (infection in his mouth). At the time of the report, INFECTION (infection in his mouth) outcome was unknown.        Concomitant medication was not provided Treatment information was not reported  Patient is going for his booster shot on 01SEP2021. Patient reported that he may have to take an antibiotic for an infection in his mouth, he is going to the dentist tomorrow.
mom gave pt APAP when they returned home & pt went to sleep; slept through the next 24 hrs; vomited & did not arouse; mom was not able to get pt to drink formula; t104 R; was wheezing; trouble breathing;
Dry mouth and difficulty swallowing felt like my throat swelled up . palpitations and sob ..within 5 -10 minutes resolved . Weakness within 20 minutes and   dizziness later that night into next day . Itchy injection site at night .
Her son has died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Her son has died) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            No relevant concomitant medications were reported.  No treatment information was provided.  This is a case of death in a male subject who died after receiving first dose of vaccine Very limited information has been provided at this time.; Sender's Comments: This is a case of death in a male subject who died after receiving first dose of vaccine Very limited information has been provided at this time.; Reported Cause(s) of Death: unknown cause of death
Patient complained of itching @ injection site(Right Deltoid), approximately 15 minutes after administration of Fluvirin Vaccine.  Noted mild redness & rash at injection site.  Patient denied shortness of breath. Diphenhydramine 25mg(2 tabs) given P.O. with good results. Rash and redness resolving in 15 minutes. Patient dismissed to home at 9:35am
About 7 hours after the Moderna booster, I felt a tingling sensation in my left eye. I never felt that before. I ignored it first because it was not very disturbing. a few minutes later it came back. I thought it might be due to my high blood pressure condition. I never experienced that before though. Just to be sure, I checked my blood pressure and it was normal (120/73). The issue wasn't a big deal after all. The second reaction, the same as the one described above happened the next night. On 12/12/2021 at around 4 am while asleep, this time it was sharper than the previous one, but it lasted shorter. I just thought that it might be something to do with the booster shot I just received hours earlier. I am reporting this just in case my reaction might help science.
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX, GlaxoSmithKline. In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site. At the time of reporting the outcome of the events were unspecified. For the other 79 linked subjects please see cases: A0756483A - A0756531A, A0756533A - A0756562A. The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in stated AFLUA3508A. With a possibility of coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA): AFLUCA320, AFLUA320A, and AFLUA320B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA): AFLUCA350 and AFLUA350B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
Please note that we do not know the manufacturer of the influenza shot received, so we selected one at random.  Patient experienced body-wide small-fiber neuropathy (pain, tingling, pins and needles), myalgia, headache, severe fatigue. Diagnosis, treatment, and outcome have not yet been determined.
KIDNEY FAILURE; AFIB; BRAIN SWELLING; MYOCARDITIS; PARKINSONS; LEWY BODY DEMENTIA; This spontaneous report received from a consumer via social media concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had been a private pilot for 20 plus years. On an unspecified date in OCT-2021, patient had passed intensive flight physical. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered on an unspecified date in DEC-2021 for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, 3 days after the vaccination, the patient collapsed and was diagnosed with myocarditis, kidney failure, AFIB (Atrial fibrillation), and brain swelling. Laboratory data (dates unspecified) included: Laboratory test diagnosed with myocarditis, AFIB, kidney failure, brain swelling. On an unspecified date in JUN-2022, the patient experienced Parkinsons, and Lewy body dementia. Laboratory data included: Laboratory test diagnosed Parkinsons and Lewy Body Dementia. It was reported as "Husband has been a private pilot 20 plus years.10/21 passed intensive Flight Physical. 12/21 had Vax. Collapsed 3 days after and diagnosed myocarditis, AFIB, kidney failure, brain swelling. 6/22 diagnosed Parkinsons and Lewy Body Dementia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the myocarditis, AFIB, kidney failure, brain swelling, Parkinsons and Lewy body dementia was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230258813- kidney failure, AFIB, brain swelling, Parkinsons and Lewy body dementia . The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the Causality is considered indeterminate. The company causality is considered unassessable.  20230258813-Myocarditis. The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.
Fatigue; Smell smoking burning metal; Bizarre metallic taste in my mouth; Clammy; This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (Smell smoking burning metal), DYSGEUSIA (Bizarre metallic taste in my mouth), COLD SWEAT (Clammy) and FATIGUE (Fatigue) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced PAROSMIA (Smell smoking burning metal), DYSGEUSIA (Bizarre metallic taste in my mouth) and COLD SWEAT (Clammy). On an unknown date, the patient experienced FATIGUE (Fatigue). At the time of the report, PAROSMIA (Smell smoking burning metal), COLD SWEAT (Clammy) and FATIGUE (Fatigue) outcome was unknown and DYSGEUSIA (Bizarre metallic taste in my mouth) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.
pt recvd Typhoid vax 22nov & 23nov pt c/o tightness & pain in chest & arms;25nov call MD, better; sxs did last for 2 days; did not seek med help;
Event occurred after 2nd Dose. Patient was diagnosed with COVID Tylenol, Zinc sulphate, Remdesivir IN-patient
Not able to swallow full dose; Tasted very bad, appeared oily; SWALLOW FULL DOSE DUE TO SPITTING OUT; This non-serious case was reported by a nurse via sales rep and described the occurrence of regurgitation of medication in a 5-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number SKBYL9YN) for prophylaxis. This case was associated with a product complaint.   On 12-APR-2023, the patient received Rotarix lyophilized formulation. On 12-APR-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced accidental underdose (Verbatim: Not able to swallow full dose) and pharmaceutical product complaint (Verbatim: Tasted very bad, appeared oily). In APR-2023, the patient experienced regurgitation of medication (Verbatim: SWALLOW FULL DOSE DUE TO SPITTING OUT). The outcome of the regurgitation of medication was not reported and the outcome of the accidental underdose and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.     It was unknown if the company considered the regurgitation of medication to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.   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: 21-APR-2023 The patient was not able to swallow full dose of Rotarix liquid due to spitting out. It was observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth. The patient did not receive a second dose.  The patient made face as if it tasted too bad to swallow. The patient previously had used Rotarix vial presentation and had no problems. The reporter agreed to follow up from GlaxoSmithKline.  The patient was not able to swallow full dose of Rotarix liquid due to spitting out and observed that the vaccine tasted very bad and appeared oily as it dribbled out of the corners of the mouth, which led to accidental underdose and pharmaceutical product complaint. This was 1 of 12 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR058971:Same reporter US-GSK-US2023AMR059644:Same reporter US-GSK-US2023AMR059645:Same reporter US-GSK-US2023AMR059807:Same reporter US-GSK-US2023AMR059808:Same reporter US-GSK-US2023AMR060400:Same reporter US-GSK-US2023AMR060460:Same reporter US-GSK-US2023AMR060463:Same reporter US-GSK-US2023AMR060476:Same reporter US-GSK-US2023AMR060491:Same reporter US-GSK-US2023AMR060497:Same reporter US-GSK-US2023AMR060497:Same reporter US-GSK-US2023060947:Same reporter. FU1 - deleted US-GSK-US2023AMR058971:Same reporter