chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt attempted to receive second dose of COVID vaccine at  location.  Upon review of record after updated with  information from outside, record revealed pt already completed pfizer vaccine two dose series at another location ( Stadium) At Stadium he received: EL9269 on 2/6/2021 EM9809 on 2/27/2021  At he came for "first dose" and received ER8791 on 4/22/2021  -Pt felt that based on what he heard on the news, he needed to get a booster dose.    He denies any reaction or side effects after receiving a third dose.   Pt teaching with patient to ensure that he understood that he already completed the series and that there is NO approved or recommended booster dose at this time.  Pt repeated back verbal understanding that he is not to try and get a fourth dose unless specifically recommended in the future.  Reinforced that patients will have the expected protection after the two authorized doses, and a third dose is NOT authorized or recommended at this time.
Information has been received via a company representative from a 52 year old female patient, who was a nurse, referring to herself. There was no medical history or drug reaction/allergies reported. On 03-FEB-2016 the patient was vaccinated with a dose of VARIVAX (Merck) (subcutaneous injection, dose and lot# were unknown) required for employment. No concomitant therapy was reported. On the same day, after the vaccination, the patient experienced headache. The patient did not seek medical attention. The outcome of the event was unknown. Additional information has been requested.
Headache, Myalgia, Arthralgia, chills, fatigue, numbness/tingling Narrative:
Vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) in a 34-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not experience any adverse event.  No concomitant medications were reported. No treatment drug was reported.   This case was linked to MOD-2021-395985 (Patient Link).
More than 36 days after the first dose without receiving the second dose.; high blood pressure,(blood pressure)  like 170; I am still having palpitations a little bit sometimes; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (high blood pressure,(blood pressure)  like 170), PALPITATIONS (I am still having palpitations a little bit sometimes) and PRODUCT DOSE OMISSION ISSUE (More than 36 days after the first dose without receiving the second dose.) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included Supraventricular tachycardia (she was diagnosed by 5 years before), Palpitations and Blood pressure high.    On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jul-2021, the patient experienced BLOOD PRESSURE INCREASED (high blood pressure,(blood pressure)  like 170) and PALPITATIONS (I am still having palpitations a little bit sometimes). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 36 days after the first dose without receiving the second dose.). At the time of the report, BLOOD PRESSURE INCREASED (high blood pressure,(blood pressure)  like 170) outcome was unknown, PALPITATIONS (I am still having palpitations a little bit sometimes) had not resolved and PRODUCT DOSE OMISSION ISSUE (More than 36 days after the first dose without receiving the second dose.) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jul-2021, Blood pressure measurement: 170 (High) Reported as blood pressure really high, like 170.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reported as patient takes medicines for her stomach, but stated that that doesn't cause palpitations. And also wanted to know if she can get Pfizer as the second dose. No medication treatment was taken.   Reporter did not allow further contact
On 01/08/07 looser stools, fever 101.5 x 4-5 days, crying, inconsolable x 2 days, stools foul and mucousy.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Jan2021 as dose 1, single (Lot number: EL3249), in right arm, on 20Feb2021 as dose 2, single (Lot number: EN6200), in right arm, on 28Sep2021 as dose 3 (booster), single (Lot number: FF2578), in right arm and on 04Apr2022 as dose 4 (booster), single (Lot number: FJ5682) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Sleep apnea" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "shellfish allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Jul2022) Positive, notes: Tested positive again 6 days after finishing Paxlovid prescription. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical information: Patient received anti-viral Paxlovid (Lot number: 1917017A) from 11Jul2022 to 16Jul2022 for COVID 19 treatment. Rebound of virus after Paxlovid. Tested positive again 6 days after finishing Paxlovid prescription.; Sender's Comments: Based on the available information in the case, the causal association between the events Vaccination failure, COVID-19 and the suspect drug cannot be excluded.
This spontaneous report was received from a registered nurse refers to a patient of unknown age who on 06-APR-2009, was vaccinated with the first dose GARDASIL and today, on 26-JUL-2012, was in the office to receive the second dose of GARDASIL (doses, routes and lot numbers not reported). No adverse effects were reported. Additional information has been requested.
Pt was vaccinated for covid 19 on 1/22 and 2/24 with moderna. Diagnosed with new onset rapid atrial fibrillation/flutter on 7/9/21 and admitted to the hospital. Took no medications chronically. No hx HTN, no PE found, normal weight, TSH normal, no hx of OSA or alcohol use. Pt physically fit and active. was readmitted for the same on 8/9/21.
Pt states vomited x2, dizziness, and chest discomfort after vaccinated for influenza. Pt laying - resting in exam room 45 min later - pt stated feeling better.
Raised itchy bumps appeared on left hand. Over the next several days, more appeared on fingers of both hands, right elbow, forehead, and bottom of left toe. Bumps on fingers and bottom of hands turned into blisters.  Taking Benedryl for  itch.
8 days after 2 mos immunizations (DTaP, IPV, PCV, HepB-Hib, Rotavirus) baby found prone after 4 hour sleep, floppy, pale, not breathing-ER and admitted for 24 hrs ECG, EEG, urine, blood, nasopharyngeal WNL-ALTE.  3/16/07 Received medical records from hospital which reveal patient experienced floppy, pallor & unresponsiveness & possible respiratory absence on 2/15/07 which lasted approx 15 min.  Parental stimulation produced respirations but continued floppy, pale & unresponsive in prone position. Taken to ER & admitted for overnight observation & ALTE work up including ID, cardiac & neuro investigations.  Progressed well w/o further incident & was d/c home next day.  F/U visit on 2/21/07 revealed  FINAL DX: Apparent life threatening event in infant.
SEVERE TOTAL BODY RASH WITH HIVES TO ALL CONTACT SURFACESNG INTERCOSTAL NERVES AND SKIN CREASES  WITH SEVERE ITCHING AND STINGING PAIN.
Narrative: Patient received two doses of COVID vaccine. Patient died on hospice, on hospice related to respiratory failure/PE. Patient developed covid within one week of first vaccine dose. No further reports of death documented.
A spontaneous, non-serious event of muscle aches was received from a pharmacist (who was the patient) concerning a 39-year-old patient subsequent to FLUMIST administration. Medical history included that the patient "works out" a lot. Concomitant medications were not reported. On 28-Sep-2009, the patient received FLUMIST. This was the first time he had received FLUMIST. On 26-Oct-2009, the patient awoke during the night in response to achiness; his forearms "really hurt". The next night, 27-Oct-2009, the patient's legs began to hurt. On 28-Oct-2009, the pain continued. The patient also reported that it was difficult to grab and squeeze things; he said that he had difficulty pumping gas on 29-Oct-2009. Treatment included ibuprofen. He went to the doctor on 29-Oct-2009; laboratory tests were done and most of the tests were normal; however creatine kinase was "a little elevated". His physician prescribed diazepam and the patient took a dose that night to relieve the pain. The outcome of the event was not reported.
Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 11-MAY-2022; Patient received an expired vaccine on 11-MAY-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine on 11-MAY-2022) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 11-MAY-2022) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 016M20A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine on 11-MAY-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 11-MAY-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine on 11-MAY-2022) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 11-Jan-2022 and was administered to patient on 11-MAY-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The pharmacist stated that they inadvertently administered expired dose of the Moderna Covid-19 vaccine to 18 patients - 9 doses administered on 09-May-2022 and 9 doses administered on 11-May-2022.   On 17-May-2022, the pharmacist reported after doing further research, she stated the actual total number of patients that received expired doses after the 30 day use by date was 82 patients total and not 18 patients.  The pharmacist identified an additional issue that staff were not dating the boxes of vaccine when placing them in the fridge for storage. This lot number (084J21A) was received and placed in the fridge on 11-Jan-2022 which meant that all doses administered more than 30 days after 11-Jan-2022 which was not in accordance with the EUA. This included 84 doses administered to 82 patients (as 2 patients received 2 doses from the same lot more than 30 days after it was in the fridge). The vaccine was administered between 16-feb-2022 and 11-May-2022.  Total number of doses/vials- HCP reported 84 doses  Date the vial was initially stored in the refrigerator was 11-Jan-2022. The vial did not undergo any temperature excursions. No patients had reported any adverse reactions  No treatment medication were provided.
Hives and extremely swollen lips.  Hives off and on for 7 days.  Swollen lips subsided in 2 days. Prednisone taper from 60 mg-10 mg, ranitidine 150 mg twice a day, Benadryl 50 mg every 4 hrs.  1st vaccine 8-21-2006 2nd vaccine 8-24-2006 3rd vaccine8-28-2006
Patient received a vaccine has was beyond the BUD. The vaccine was punctured at 8:50 am on 8/3/2021. The vaccine expired at 8:50 pm on 8/3/21.
Chills hit me suddenly 6hrs after getting the shot. I was freezing. Two hours later, extremely tired and sore. I feel groggy. 3hrs later, I cannot sleep although I am so tired. Chugged water and took a hot bath but was so tired had to get out of bath. Zero appetite.
Mother came to school to have reaction checked.  Left deltoid swollen and red at injection site.  Warm to touch.  Patient states he feels fine except that his arm hurts.
pt recv vax 23APR95 & 18JAN96 nurse reports pt does not have adequate protective levels against hep A;
CMML cases that have undergone clinical progression; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of CHRONIC MYELOMONOCYTIC LEUKAEMIA (CMML cases that have undergone clinical progression) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Chronic myelomonocytic leukemia.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHRONIC MYELOMONOCYTIC LEUKAEMIA (CMML cases that have undergone clinical progression) (seriousness criterion medically significant). At the time of the report, CHRONIC MYELOMONOCYTIC LEUKAEMIA (CMML cases that have undergone clinical progression) outcome was unknown.        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.   This is an invalid case due to no identifiable patient. Also, very limited information regarding the event has been provided at this time.; Sender's Comments: This is an invalid case due to no identifiable patient. Also, very limited information regarding the event has been provided at this time.
Patient at home around 7:45 experienced racing heart, Pulse 145 per patient. No shortness of breath, no chest pain. Went to ER Pulse was 156 or higher.
ill; temperature was 102.4 /fever; legs didn't feel like they were strong enough to stand up; chills /periods of violent chills; weakness; large fever blisters on my lip; trembling violently for half an hour to forty minutes; sore neck; brief headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (ill), PYREXIA (temperature was 102.4 /fever), GAIT INABILITY (legs didn't feel like they were strong enough to stand up), CHILLS (chills /periods of violent chills) and ASTHENIA (weakness) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced ILLNESS (ill), PYREXIA (temperature was 102.4 /fever), GAIT INABILITY (legs didn't feel like they were strong enough to stand up), CHILLS (chills /periods of violent chills), ASTHENIA (weakness), ORAL HERPES (large fever blisters on my lip), TREMOR (trembling violently for half an hour to forty minutes), NECK PAIN (sore neck) and HEADACHE (brief headache). At the time of the report, ILLNESS (ill), PYREXIA (temperature was 102.4 /fever), GAIT INABILITY (legs didn't feel like they were strong enough to stand up), CHILLS (chills /periods of violent chills), ASTHENIA (weakness), ORAL HERPES (large fever blisters on my lip), TREMOR (trembling violently for half an hour to forty minutes), NECK PAIN (sore neck) and HEADACHE (brief headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2021, SARS-CoV-2 test negative: negative (Negative) negative.     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.
Chest discomfort, shortness of breath; head buzzing; extreme fatigue; body aches; unable to sleep more than 6 hours per night
Case number PHEH2013US013248, is an initial spontaneous report received from a nurse on 14  JUN 2013, with a follow-up received from a nurse on 09 JUL 2013. The case refers to a 17-year-old female patient. Her medical history and concomitant medication were not provided. She was vaccinated with MENVEO (batch number: M12025 and expiry date: 31 DEC 2014) at a dose of 0.5 ml intramuscularly into left deltoid on 07 JUN 2013. Reporter stated that, un-reconstituted MENVEO reached -1 degree Celsius for at least 30-minutes before going back up to 6 degree Celsius on 07 JUN 2013 (vaccine did not freeze). No adverse event was experienced following this administration error.  Follow-up was received on 09 JUL 2013: Patient demographics, vaccination site and date were updated.
Lymph Node swelling under left arm along with swelling bellow lymph node on side of body with redness as with injection site on left arm.
PERSISTENT PAIN AND POINT TENDERNESS AT THE INJECTION SITE 6 MONTHS LATER
Received shot on 11/11/09 - 12 noon received shot - Started to feel ill later that evening 6 or 7 pm - Chills, fever, vomiting, body aches, diarrhea. This lasted Friday - Monday - Returned to work Wednesday. Afebrile on Monday. Went to MD on Monday - 11/16/09.
swollen arm and itching; swollen arm and itching; This is a spontaneous report from a contactable consumer (patient) via medical information team. An 83-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for immunization. The patient's medical history and concomitant medications were not reported. The patient wants to know if there is any content on the Pfizer COVID 19 vaccine that is similar to the pneumonia vaccine before taking the vaccine. She had the pneumonia shot few years ago can't remember exactly the brand was, she had swollen arm and itching on unspecified date. The outcome of the events was unknown.   Pfizer is a marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
mild body aches; very sore arm/sore arm and tired after first dose; felt tired/sore arm and tired after first dose; This is a spontaneous report from a contactable other healthcare professional. A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EH9899), via an unspecified route of administration, administered in Arm Left on 28Dec2020 (at the age of 67-year-old) as dose 1, single for covid-19 immunisation. Medical history included Heart condition, rheumatic fever (When she was 10 years old since then she had been taking the flu shot), hypertension from 2006 to an unknown date, impaired mitral valve (diagnosed at 10 years old). The patient concomitant medications were not reported. Historical vaccine included flu shot (I had rheumatic fever when I was 10 years old since then I been taking the flu shot). The patient reported the on 28Dec2021, she felt tired, very sore arm and had mild body aches after getting the first dose of the vaccine but had zero symptoms not even a sore arm after the second dose. The patient was worried that the dose was ineffective either it was left out for too long and not kept cold or it was a bad dose. She wanted to know if she needs to repeat the dose. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Itching and burning at site of injection. Stinging also and redness light headache. Headache could be due to sinus infection as well though?
Severe  fatigue, to the point that I could not keep my eyes open. I also have the chills, to the point I could not keep warm.
Narrative:  Patient admitted to the hospital for other reasons. Tested positive for COVID 19 despite vaccination. The patient has been asymptomatic for COVID infection.
2nd dose of Moderna COVID Vaccine administered 22 days after 1st dose to prevent wastage of expiring dose. No adverse reaction noted.
mild GI upset; This is a spontaneous report from a Pfizer sponsored program. A contactable nurse and consumer reported that a 67-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Mar2021(Batch/Lot number was not reported) at the age of 67-years-old as single dose for covid-19 immunisation; bosutinib (BOSULIF), via an unspecified route of administration from 26Mar2021 (Batch/Lot number was not reported, expiration date: 31Dec2023) at 400 mg, once daily for chronic myeloid leukaemia. Medical history included acute sinusitis, allergic rhinitis, anemia, chronic myeloid leukemia, cough, depression, elevated white blood cell count, gastro-esophageal reflux disease, anxiety, osteoarthrosis, fatigue, pleural effusion, postanasal drip, allergies: sulfa, doxycycline, morphine, stadolol, vytorin. Concomitant medications included atorvastatin taken for an unspecified indication, start and stop date were not reported; furosemide taken for an unspecified indication, start and stop date were not reported; montelukast taken for an unspecified indication, start and stop date were not reported; escitalopram taken for an unspecified indication, start and stop date were not reported, dasatinib monohydrate (SPRYCEL) taken for an unspecified indication, start and stop date were not reported. Patient was not pregnant. Patient recieved covid vaccination yesterday on 25Mar2021 and the patient experienced mild GI upset this morning on 26Mar2021. The action taken in response to the event for bosutinib was unknown. The outcome of the event GI upset was unknown.  No follow-up attempts are needed. No further information is expected.