chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had both shots for shingles, still got them/suspected vaccination failure; Still got them (shingles); They hurt like heck; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 3-Nov-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had both shots for shingles and still got them even through they were not to severe, they hurt like heck. The patient's friend texted her that she was diagnosed with shingles. She could not believe how painful and uncomfortable the rash was. The patient mentioned that she was at a chapter in her life where she should be enjoying it to the fullest, date nights, brunch with friends, playing with grandchildren, traveling. All the fun things. The patient did not want to be on the sidelines because of shingles. The reporter did not consented to follow-up. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
I am experiencing neurological/nervous system symptoms that are not conclusive with the migraines. I've had in the past. For the past three weeks, I have been experiencing intense head pressure, sharp pains in the back of my head (completely unlike my migraines), brain fog, vision issues (blurriness), and vertigo. On April 3, 2022 I had fainted twice in my bathroom and had to be rushed to the ER. In the last week alone, I have had to go to the ER three times for the intense head pressure and dizziness, with each time being referred to a neurologist. I was immensely sick after receiving the first dose but after those flu/Covid-like symptoms subsided, I started to have these other issues with my head. Furthermore, I had tested positive on January 5, 2022 for Covid-19 and the hospital (my place of employment) forced me to get the vaccine with the threat of firing me; however, they did not wait the three months to make me get the shot like what the CDC recommends. There was not the full three months lapse between having Covid-19 and getting the Moderna shot. When I had Covid-19, I was asymptomatic but tested positive numerous times.
CHIEF COMPLAINT:   Covis + SOB diarrhea   HISTORY OF PRESENT ILLNESS:     76-year-old female with history of coronary artery disease, heart failure, high cholesterol, anticoagulated Secondary to atrial fibrillation, comes to the ER for evaluation of shortness of breath extreme fatigue related to COVID-19 infection.  The patient was vaccinated for COVID-19.  Patient was positive for COVID-19 towards the end of December 2021, approximately 10 to 15 days ago.  At home she has had mild coughs and thought she was recovering well.  Over the past 24 to 40 hours she says that she is become extremely fatigued and unable to walk even a short distance without having to stop.  At this time, while she is at rest, she denies shortness of breath denies chest pain.  To be very hypoxic in triage.
CHILD'S DOB WRITTEN AS 5/4/2009 AND AGE WRITTEN AS 12 ON CONSENT SIGNED BY INDIVIDUAL IDENTIFYING AS MOTHER. CHILD IDENTIFIED IN IMMTRAC (226954620) WITH DOB AS 7/4/2009. CHILD TOO YOUNG FOR VACCINE IN 6/2021. THIS IS SECOND DOSE. FIRST DOSE GIVEN 5/15/2021 (VAERS FILED #740899).
Approximately 2 months after my vaccination I had the following symptoms: I started having my menstrual cycle again after not having it for 3 years. No other symptoms experienced, and when I called my doctor she said that she has been seeing a lot of patients who got vaccinated that were experiencing the same thing. Up until this day (04/11/2022) I still have my regular menstrual cycle despite having birth control.
Child was given an adult dose of Pfizer COVID 19 vaccine,  instead of the pediatric dose
Moderna EUA Patient reports after she left the site and drove about thirty minutes away, she had to pull into  parking lot because she felt bad and confused. States she has passed out x2 that same day. Reported feeling lethargic and a strain on her heart.
fever, chills, upset stomach x 6 hrs followed by fatigue x 6 hrs (unable to carry out normal activities)
Alopecia areata starting in June 2022 and still unresolved - no treatments, osteoarthritis in left hip starting in  August 2022 and worsening - no treatments.
every one I know who got the flu shot is sick; Initial information received on 18-Jan-2022 regarding an unsolicited valid Social Media non-serious case was received from the consumer.  This case involves an unknown age and unknown gender patient who reported that everyone he/she knew who got the flu shot was sick, while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, dosage regimen, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination. Information on batch number was requested.   On an unknown date, the patient developed a non-serious event 'everyone i know who got the flu shot is sick' (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "everyone I know who got the flu shot is sick. And those of us who didn't never died or went to the hospital. Im done with them."  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (everyone I know who got the flu shot is sick).  At time of reporting, the outcome was Unknown for the event (everyone i know who got the flu shot is sick).
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Joint pain.    No Medical History information was reported.   In 2021, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced COVID-19 (COVID-19) (seriousness criterion hospitalization). In 2021, COVID-19 (COVID-19) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. Patient started Rinvoq in 2021 and already feels huge improvement with joint pain. He was hospitalized with covid and released. No pain still with his joints, he attributes to Rinvoq. No treatment medication were reported. It was reported that there is no reasonable possibility that the event of COVID is related to RINVOQ(UPADACITINIB). This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This is a spontaneous case concerning a 62-year-old male patient with no reported medical history, who was hospitalized due to the unexpected, serious adverse event of special interest of COVID-19, after receiving a dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the event, clinical course, diagnostic tests and treatment details were not provided in the case. The event had resolved within the same year. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 62-year-old male patient with no reported medical history, who was hospitalized due to the unexpected, serious adverse event of special interest of COVID-19, after receiving a dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the event, clinical course, diagnostic tests and treatment details were not provided in the case. The event had resolved within the same year. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Covid; Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Oct2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 37 years for covid-19 immunisation. The patient's relevant medical history included: "shellfish/ citrus allergy" (unspecified if ongoing), notes: shellfish/ citrus allergy; "shellfish/ citrus allergy" (unspecified if ongoing), notes: shellfish/ citrus allergy. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Covid". Therapeutic measures were taken as a result of covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
body aches; Incomplete course of vaccination; Fatigue; Fever; This case was reported by a physician via call center representative and described the occurrence of fatigue in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 7447A, expiry date 25th April 2020) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced fatigue, fever, general body pain and incomplete course of vaccination. On an unknown date, the outcome of the fatigue and fever were recovered/resolved and the outcome of the general body pain and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the fatigue, fever and general body pain to be related to Shingrix.  Additional details were provided as follows: The reporter stated that after vaccination the patient had fever and fatigue for 7 to 10 days. The health care professional asked how to proceed with the second shot. Till the time of reporting, the patient did not received 2nd dose of Shingrix, which led to incomplete cours eof vaccination. The health care professional stated that the patient received the first dose in the facility where she works. The health care professional  was calling to ask if the patient should receive the second dose taking into account the adverse reactions developed, but did not realize the late dose issue until the first line agent mentioned her the recommended schedule for Shingrix. The reporter consented to follow up. The VAERS details were not provided. This case 1 of 3 linked cases, reported by same reporter.
Vaccine was in thaw state (2 to 8 degree Celsius) from about 20-Dec-2021; Received its 30-days Exp date; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received its 30-days Exp date) and PRODUCT STORAGE ERROR (Vaccine was in thaw state (2 to 8 degree Celsius) from about 20-Dec-2021) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2022 at 5:53 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 28-Jan-2022 at 5:53 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received its 30-days Exp date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was in thaw state (2 to 8 degree Celsius) from about 20-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received its 30-days Exp date) and PRODUCT STORAGE ERROR (Vaccine was in thaw state (2 to 8 degree Celsius) from about 20-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter.  Vaccine was in thaw state (2 to 8 degree Celsius) from about 20-Dec-2021. No treatment medication was reported by reporter.
PATIENT RETURNED TO THE PHARMACY ON 08/27/2021 AND PRESENTED WITH A RED RASH AROUND THE INJECTION SITE (APPROXIMATELY 4" X 6").  SHE SAID THAT IT ITCHED, AND THAT IT HAD STARTED OUT AS A SMALL RED CIRCLE AROUND THE INJECTION SITE, AND GRADUALLY SPREAD TO ITS PRESENT SIZE AS DESCRIBED ABOVE.  PHARMACIST MARKED THE PERIMETER OF THE RASH WITH A MARKER WITH DATE AND TIME (08/27/21, 5:27PM), AND TOLD THE PATIENT TO ADD ICE, AND TAKE DIPHENHYDRAMINE 25MG AT 1 PO Q4-6H PRN.  ALSO TOLD THE PATIENT THAT IF THE RASH SPREAD OUTSIDE OF THE PERIMETER ONCE SHE HAD STARTED THE ICE AND DIPHENHYDRAMINE, TO SEEK MEDICAL ATTENTION FROM HER DOCTOR.
This spontaneous report was received from a physician via a company representative, referring to a female patient of unknown age. The patient's medical history or concurrent conditions were not reported. On an unknown date, the patient was vaccinated with the 3rd dose of GARDASIL 9 (strength, dose, route and lot number were not reported). The patient's concomitant medication was not reported. On an unknown date, after vaccination with GARDASIL 9 vaccine the patient fainted, fell off the table and bumped her head. Additionally, she lost consciousness for 30 seconds. Then the patient was advice to go to the emergency room. It was reported that the patient received an unspecified treatment for the adverse events and she sought medical attention. At the time of the report, the outcome of loss of consciousness was recovered. The outcome of fainted, fell and bumped her head was unknown. Additional information has been requested.
Still having redness, swelling and soreness at injection site. Has itching all over body.
SHORTNESS OF BREATH, IRREGULAR HEART BEAT, FEVER, MUSCLE ACHES, WHOLE BODY SWOLLEN, NAUSEA, FATIGUE, NECK AND BACK STIFFNESS
arm red, hot @ site of vax;went to acute care & had MD examine;given antihistamine & ice pack, improvement noted;pt denied discomfort or pain;
received expired Pentacel vaccine,with no reported adverse event; Initial information received on 22-May-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 15 months old female patient who had received expired pentacel vaccine,with no reported adverse event after receiving vaccine diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine [pentacel (vero)].  The patient had no medical history, concomitant disease or risk factor   On 12-May-2023, the patient received a unknown dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(vero)/hib(prp/t) vaccine Suspension for injection, lot UJ664AA via unknown route, strength, expiration date in unknown administration site for Prophylactic vaccination(Immunisation).  On 12-May-2023 the patient developed a non-serious received expired pentacel vaccine,with no reported adverse event (expired product administered) (latency: same day).  Patient did not experience any additional symptoms/events  There were no lab data/results available.  Action taken was not applicable.  Outcome: Unknown for the event received expired pentacel vaccine,with no reported adverse event.  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 the 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.
Fever x 3 days, treated with TYLENOL 10 little dots all over body, became fluid filled, then crusted over.
Patient reported Dizziness, lightheadedness. In private observation area patient had an episode of emesis.
Pt started feeling ill the evening after receiving the vaccine. Reports feeling fatigue, chest pain and sore throat. Pt was unable to check temperature.
Developed itchy rash on wrists and buttocks later in the evening the day of the vaccine, no unique local reaction.  Treatment with OTC creams/steroids.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 01/13/21pfizer,Lot#EL3248 2nd dose: 02/03/21 Pfizer,Lot# EL9264 Diagnosed covid positive:07/27/21 Symptom onset:07/27/21 Exposure:Home Symptoms:Muscle aches,runny nose, congestion
01/02/22 presents to ED for "nausea, diarrhea, shortness of breath, cough, headache and fever 102". PMHx of "HTN"
I got this shot in Oct. The next day I got the shingles & still have pain & no strength in my right hand. Blisters were all along the right arm & between fingers; fever of 102 degrees F resolved in 2-3 days; blisters for approx 1 mo.
Fever of 104 and feeling faint the evening after TRUMENBA. The next day, symptoms resolved.
OFF LABEL USE; VACCINE ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; This spontaneous report received from a health care professional concerned a 14 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A expiry: 21-SEP-2021) dose was not reported, administered on 20-SEP-2021 for prophylactic vaccination. No concomitant medications were reported.  On 20-SEP-2021, the patient experienced off label use. On 20-SEP-2021, the patient experienced vaccine administered to patient of inappropriate age. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and vaccine administered to patient of inappropriate age was not reported. This report was non-serious. This case, from the same reporter is linked to 20211217833, 20211217956, 20211218548, 20211218297 and 20211221204.
patient was sweating profusely, stated he was very dizzy and his heart felt funny.  Provided patient with a cold, wet paper towel, checked blood pressure at 11:10 was 127/86 and pulse was 91.  Provided patient with cold water to drink.  Re checked blood pressure at 11:40 am 111/77 and pulse was 74.   Patient stayed for almost one hour before he felt well enough to drive.  I called the patient to check on him at 1:05 pm and he stated he was feeling ok but his arm was sore.  I recommended he apply ice to the sore arm.
A physician reported that a 12 month old male received his 2nd Prevnar on 9/27/00. Two days, post vax, the child was seen in the clinic after developing angioedema and hives/urticaria. The child recovered. Both the investigator and the medical monitor considered the events to be 'possibly' related to Prevnar administration. Follow up information received 03/09/2001 clarified that the  patient did not experience angioedema as originally reported. The patient experienced hives/urticaria only. Therefore, this report has been downgraded to non-serious.
no adverse effect; administered improperly stored vaccine; This spontaneous report was received from a medical assistant referring to refers to a 6-month-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 17-OCT-2019, the patient was inadvertently administered improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R029814 with expiration date 05-JUN-2020) (strength, exact dose, route of administration and anatomical location were not reported) for prophylaxis. Administered dose of vaccine experienced a temperature excursion of 51.62 degrees Fahrenheit for 10 hours. It was reported that digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. There were no adverse effects reported. No product quality complaint (PQC) was involved.  This is one of the several reports received from the same reporter.
Had large welt at injection site, then broke out in hives and bouts of eczema between April-August 2021, until I took a series of steroids.
Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease; Transverse Myelitis; This is a literature report for the following literature source(s).  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYELIN OLIGODENDROCYTE GLYCOPROTEIN ANTIBODY-ASSOCIATED DISEASE (medically significant), outcome "unknown"; MYELITIS TRANSVERSE (medically significant), outcome "unknown", described as "Transverse Myelitis".  The lot number for [generic name], was not provided and will be requested during follow up.; Sender's Comments: Based on the information available and temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available   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.,Linked Report(s) : US-PFIZER INC-PV202200013127 Same drug and different event/patient;
Presented 3 days after Covid vaccination with ongoing chest pain since then.  He was found to have elevated troponin and elevated ST segments consistent with pericarditis.  He was also found to have be Covid positive by PCR. No medications initiated. ECHO normal.
Body aches, fever - 99.1 - 100.5 - one day only. Upset stomach - belching and loss of appetite. One watery stool on second day. Digestive upset lasted several days and slight upset lasted about one week.
Between February and April of 2022 I visited the ER 4 times because my breathing was suffering and my oxygen was low.  The first time it happened I realized I was short of breath and the next day I went to the ER in February 2022.    They said it was COPD which I've never had.  I then visited the Pulmonologist on April 23 2022 and was diagnosed with Asthma.