chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Starting getting ?fluttering? heart episodes ,  first they started (5/3/21) about once a week. But then they gradually got worse, to the point now, where I get them every day, and sometimes several times a day. These episodes last for about 20 sec or so.
Anaphylactic shot; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic shot) in a female 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic shot) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC SHOCK (Anaphylactic shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported. The patient reports that the vaccine has made the life to be living in pure hell.  Company comment:  This case concerns a female patient with no reported medical history who experienced serious unexpected event of anaphylactic shock, that occurred after the dose of the mRNA-1273 .  The rechallenge was not applicable due to unspecified number of doses administered. The symptoms were facial angioedema  and hives all over her body. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a female patient with no reported medical history who experienced serious unexpected event of anaphylactic shock, that occurred after the dose of the mRNA-1273 .  The rechallenge was not applicable due to unspecified number of doses administered. The symptoms were facial angioedema  and hives all over her body. The benefit-risk relationship of mRNA-1273 is not affected by this report.
I noticed an increase in blood pressure within a week of taking the second shot.  Other symptoms were a general unwell feeling with soreness at the injection site.
heart rate increased to 150 and continued to remian this high rate throughout the night; was in afib; Initial information received on 05-Oct-2022 regarding an unsolicited valid  serious case received from a consumer/non-hcp.  This case involves a 66 years old male patient who was in afib (atrial fibrillation), after receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past  medical treatment(s), vaccination(s) and family history were not provided. The patient had no medical history, concomitant disease or risk factor.    On 28-Sep-2022 at 02:00 pm, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE , suspension for injection in prefilled syringe, (lot: UT7714AA ; expiry date: not reported) via intramuscular route for flu vaccination (influenza vaccination).  On the same day at 3:30pm following the administration, heartrate increased to 150 and continued to remain at this high rate throughout the night (heart rate increased) and went into afib (atrial fibrillation). These events were assessed as medically significant. The patient went to my local emergent care in the morning, where they gave me last dose aspirin and intravenous (iv) diltiazim. Heart rate decreased, but was still in afib. The higher heart rate and afib resolved on evening of 30-Sep-2022. Patient did not experience any additional symptoms/events.  There were no lab data/results available  Relevant laboratory test results included: Heart rate - On 28-Sep-2022:  [heartrate increased to 150]  Action taken: not applicable.  Corrective treatment: ACETYLSALICYLIC ACID (ASPIRIN [ACETYLSALICYLIC ACID]) and DILTIAZEM (DILTIAZEM) for atrial fibrillation and its symptom.  Outcome:  Recovered / Resolved on 30-Sep-2022 for the event of atrial fibrillation and its symptom.; Sender's Comments: Sanofi company comment date 10-Oct-2022:  This case involves a 66 years old male patient who experienced atrial fibrillation after receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT]. The time to onset (same day) is suggestive of a relationship with the vaccine. However, a detailed clinical course was not provided. Limited information was also provided regarding circumstances leading to and patient's health status directly preceding the reported events. Further information is needed to fully assess the case.
PATIENTS ARM WAS SWOLLEN AND RED. CALLED PATIENT ON 04012018 AND PATIENT SAID HER ARM WAS MUCH BETTER/FINE BUT WOULD CONTINUE TO TAKE ANTIBIOTICS FOR THE 7 DAY THERAPY.
h/a, malaise, numbness & tingling of fingers, redness @ site 20x23cm diameter, warm to touch; many yrs since last Td;
Beginning within a week of getting the vaccine, I started experiencing extreme fatigue, and my left arm swelled up to about 2x the size of the right arm. I had chills, vomitting, fever, joint pain, body aches and a rash at the injection site. Then, the injection site started to peel and eventually it progressed to other parts of my body. I developed rashes all over and then they progressed to peeling. As soon as this started, I called my doctor and they told me to monitor, and if it got worse to go to the ER. I may have gone to the ER but I am unsure. I was unable to work for a few days and the symptoms lasted for about 2 weeks. The rash lasted a little longer than 2 weeks. As of 09/13/2021, I had still been experiencing rashes and peeling skin. It eventually went away on its own. I eventually contracted COVID on 01/03/2022 after being fully vaccinated and now have "long covid"
Headache onset 12 hours later, lasting approx. 36 hrs.;  nausea and fatigue over same period;  some diarrhea beginning 24 hrs after vaccination and lasting about 24 hrs.
diffuse joint pain & edema;myalgia, fever to 101;abd cramping;
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (arm has become red), VACCINATION SITE SWELLING (arm has become swollen) and VACCINATION SITE INDURATION (hard around where my shot was administered) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (arm has become red), VACCINATION SITE SWELLING (arm has become swollen) and VACCINATION SITE INDURATION (hard around where my shot was administered). At the time of the report, VACCINATION SITE ERYTHEMA (arm has become red), VACCINATION SITE SWELLING (arm has become swollen) and VACCINATION SITE INDURATION (hard around where my shot was administered) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication reported. No treatment information reported.
Guillain-Barre Syndrome with motor weakness.  Nurse follow up on 07/27/04 states: "otitis media
Headache, Fever, NauseaVomiting, Inj site pain, change in taste, congestion, sore throat and ear ache Narrative:
Covid test result: Positive; Covid test result: Positive; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date Jan2021 (Lot number: 8982) at the age of 42 years as dose 2, single and administration date Dec2020 (Lot number: el1284) 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Jan2022, outcome "unknown" and all described as "Covid test result: Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (12Jan2022) positive, notes: Nasal Swab.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect drug BNT162B2 (COMIRNATY) to the reported events drug ineffective/COVID-19 cannot be ruled out.
This spontaneous report was derived from an article published in a local newspaper and refers to a group of female patients of unspecified age. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with GARDASIL (dose, route of administration, lot number and expiration date were not provided) and CERVARIX. Based on the information published, in the group of patients described above, the rate of infertility problem was higher when compared to the group that did not receive the human papilloma virus (HPV) vaccine. The reporter considered the events to be related to the administered vaccines. Sender's Comments: US-009507513-1809USA001053.
vomitted once 22APR92; fever 105 22APR92; fever 103-104 20APR to 21APR92; lethargic 20APR to 22APR92;
skin sensitivity; Muscle and joint aches; muscle and joint aches; slight headache; This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 22Apr2021 at 12:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had known allergies to anise. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included ethinylestradiol/ norgestimate (SPRINTEC) for birth control from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. On 23Apr2021 at 03:00, the patient experienced muscle and joint aches, skin sensitivity and slight headache. The events did not result in a visit to the doctors or other healthcare professional office/clinic, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events muscle and joint aches, skin sensitivity and slight headache was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Severe muscle and tendon pain, chills, moderate headache, chest pressure and pain, trembling, fever of 99, fatigue, pronounced pain in arm and shoulders
Was vaccinated and still got and has never been the same; Was vaccinated and still got and has never been the same; Very sick to this day; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), meningococcal infection (serious criteria GSK medically significant) and sickness. On an unknown date, the outcome of the vaccination failure and meningococcal infection were unknown and the outcome of the sickness was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, meningococcal infection and sickness to be related to Meningococcal B vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter mentioned that, the patient was vaccinated and still got the disease and had never been the same. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation of meningococcal infection (specific serogroup) were unknown at the time of reporting. The reporter stated that, the patient was 18 years old and graduating and got bit by a mosquito and almost died. Till the time of reporting, the patient was very sick. No further information was available.
Redness on arm with golf ball size knot. Friday 1/4 experienced shortness of breath, nausea and heart rate between 105-110. Wed 1/9- My son, which was a perfect pregnancy was born stillborn at 32 weeks -his heart just stopped.
pain and swelling at the injection site; pain and swelling at the injection site; This spontaneous report was received from a field employee referring to an unspecified number of unknown patients. The patients' pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions or allergies were unknown by the reporter.  On unknown dates in November 2019 (also reported as "within the past month"), the patients were vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) intramuscularly (strength, dose and anatomical site of vaccination were not reported; lot number and expiration date were unknown by the reporter) as routine immunization.  On unspecified dates in November 2019,  the patients experienced pain and swelling at the injection site (vaccination site pain and vaccination site swelling). It was unknown by the reporter if any treatment was given for the adverse events or if any laboratories or studies were performed.  The outcome of vaccination site swelling and vaccination site pain was reported as recovered. The causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the aforementioned events, was not reported.  This case has been considered as non-valid due to the lack of patient's identifiers.
Polymalgia rheumatic developed with mild symptoms beginning one week after vaccine and progressed for the next 1-3 weeks after that.
Customer called and reported that a 9 month old baby received ROTATEQ. She reports that the baby received the 1st dose at 2 months old, the 2nd dose at 5 months old, and the 3rd dose at 9 months old. No additional AE reported. No PQC reported. No add; Customer called and reported that a 9 month old baby received ROTATEQ. She reports that the baby received the 1st dose at 2 months old, the 2nd dose at 5 months old, and the 3rd dose at 9 months old. No additional AE reported. No PQC reported. No add; Customer called and reported that a 9 month old baby received ROTATEQ. She reports that the baby received the 1st dose at 2 months old, the 2nd dose at 5 months old, and the 3rd dose at 9 months old. No additional AE reported. No PQC reported. No add; This spontaneous report was received from a nurse referring to a 5-month-old of unknown gender. Information regarding the patient's concurrent conditions, medical history, or concomitant medications was not provided.  On an unknown date in November 2021, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2ml, administered for prophylaxis (route of administration, vaccination scheme frequency, anatomical location, lot number, and expiration date were not reported). On an unknown date in February 2022, at the age of 5 months, the patient was vaccinated with the second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2ml (route of administration, vaccination scheme frequency, anatomical location, lot number, and expiration date were not reported) (inappropriate schedule of vaccine administered). On 22-JUN-2022, at the age of 9 months old, the patient was vaccinated with the third and last reported dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2ml (route of administration, vaccination scheme frequency, and anatomical location were not provided; valid lot number W004501 with an expiration date of 20-APR-2023) (inappropriate schedule of vaccine administered). No adverse event was reported.
When the pt was four months old, he was limp and unresponsive (shock collapse) for most of the day. I don't think it was ever reported. This report recently became known to me because of my son got pertussis on 11/27/2001. (After DTP 2, I declined future pertussis part of the shot).
Information has been received from a nurse manager concerning a 25 year old female who on 08-MAR-2009 was vaccinated with GARDASIL. There was no concomitant medication. Subsequently the patient developed hives and felt the sensation of the right nostril closing up throughout the night of vaccination onto the next day. She was seen on 09-MAR-2009 at her primary care and was prescribed a (MEDROL DOSEPAK). Patient is inquiring about continuing the GARDASIL series. At this report time the patient had recovered. Follow up information has been received from this nurse manager: Their office did not perform any lab/diagnostic tests. The events did not require hospitalization, and were not disabling or life threatening. Additional information is not expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 16Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 2 Diabetes" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: No other medications in 2 weeks and no known allergies reported. Adverse event: dysgeusia within a few hours of first dose on 09Jun2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
To ER 10-25-10 at 2200 with itchy, red, watery eyes, congestion, pale face, & rash on inside of arm at bend down on opposite arm -R.A. - Albuterol treatment at home before ER; BENADRYL in ER & in A.M. 10-26-10 - 1430 - spoke to Dad states no s/s or problems now.
As per hospital death on 8-5-08. 10/15/08-autopsy report received-cause of death:Sudden Infant Death Syndrome.
mom called and came into pharmacy on 6/3/2021 to inform us that daughter was having limited mobility in arm and was not able to raise arm unless assisted by using other arm. mom brought in article and picture of arm marking where vaccine was possibly given
infantile spasms onset 2 days p/vax;pt father reports pt frequently dropped head x 2mo;pt devel sudden drop of head 2 days p/vax;pt ran high temp & had local rxn d/t vax;MD referred pt for further eval & management of poss sz disorder
Wheezing in evening, relieved with inhaler, chills and fever onset app. 11 PM, continued through Sunday with low fever, body aches, sweats and chills.
Had covid after 2 Moderna shots; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Had covid after 2 Moderna shots) 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) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced COVID-19 (Had covid after 2 Moderna shots). At the time of the report, COVID-19 (Had covid after 2 Moderna shots) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.  Company comment:  This regulatory authority case concerns a patient with no reported medical history who experienced non-serious unexpected AESI of COVID-19, that occurred after the 2nd dose of the mRNA-1273 . The exact time to onset was not provided. The rechallenge was not applicable due to occurrence after the 2nd dose and nature of the event. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This regulatory authority case concerns a patient with no reported medical history who experienced non-serious unexpected AESI of COVID-19, that occurred after the 2nd dose of the mRNA-1273 . The exact time to onset was not provided. The rechallenge was not applicable due to occurrence after the 2nd dose and nature of the event. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Arthralgia, Fever, fatigue, injection site discomfort Narrative:  symptoms relieved with tylenol
Onset of rt hand parakensia "fell asleep" while typing on computer.  Sx's progressed to entire arm and to rt foot and leg.  Pt also experienced expressive aphasia.   Sx's lasted 30 minutes and severe headache followed, lasted 8-12 hours then resolved.  No recurrance.  No Hx of similar Sx.
Initial report received on 10 September 2007 from a health care professional. A four-month-old infant with no concurrent illnesses, no known allergies, and who had no pre-existing medical history, had received a second intramuscular dose of ActHib, lot number UF160AA (Sanofi Pasteur SA lot number A0122-2) in the left thigh; a second intramuscular dose of Daptacel, lot number C2650AA in the right thigh; a second intramuscular dose of IPOL, lot number Z0872-2 (reported as Z0872), in the right thigh; and a second intramuscular dose of Prevnar (manufacturer Wyeth), lot number B97283B, in the left thigh. The patient had not experienced any adverse events following prior vaccinations. Later that evening the patient was "found expired." Reportedly, an autopsy will be completed.  3/19/08 Reviewed autopsy report which states COD as complications of congenital pulmonary malformation.  3/19/08 Autopsy states pathologic diagnoses as: I. Congenital Pulmonary malformation with     A. Microscopic characteristics most c/w congenital cystic adenomatoid malformation, Type I     B. lymphocytic & macrophage peri-bronchial inflammation, mod to marked     C. Intraalveolar hemorrhage, marked     D. pulmonary edema, marked III. Abnormal 17 hydroxyprogesterone study w/o microscopic abnormality of adrenal glands.