chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After episode in the clinic parents stated That patient when crying  holds his breath.  He  becomes slightly blue and then the episode rapidly resolves and he goes back to  his normal self.  Discussed with parents this can be normal at his age but that  we should monitor closely.
PT FELL AND HIT FOREHEAD ON CLINIC FLOOR ABOUT 2-3 MINS AFTER VACCINE WAS ADMINISTERED. PT BEGAN TO HAVE A HAVE SPASMS AND JERKING IN ALL FOUR EXTREMITIES.
This case was reported by a healthcare professional and described the occurrence of arm numbness in a 66-year-old male subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 18 October 2009 the subject received unspecified dose of FLULAVAL at 0.5 ml in the left arm. At an unspecified time after vaccination with FLULAVAL, the subject experienced left arm numbness, left arm redness, swelling of the left arm, cold hand and possible blood clot. The healthcare professional considered the events were disabling. The subject was treated with two different pain medications. At the time of reporting the outcome of the events was unspecified. In the reporter's opinion, all of the events with the exception of possible blood clot (which was unknown) were considered possibly related to treatment with FLULAVAL.
Vaccine administered at 22 days interval from the first dose, instead of at 28days.
Fever 102 degrees started the day after shots vomiting and diarrhea on and off for three days.
A non-serious spontaneous report of sore throat has been received from a consumer concerning an adult female herself, subsequent to FLUMIST. Neither relevant past medical history nor concomitant medications had been reported for this patient. On 06-Oct-2011, the patient's received FLUMIST. After receiving FLUMIST, the patient had sore throat which lasted for four days. The patient also had a son, who too received FLUMIST on the same day. He had a non-productive cough in his chest for four days. The outcome of the event sore throat was recovered.
received doses of menactra in 2017, 11NOV2020, extra dose vaccine menquadfi on 31JUL2023 with no reported AE; Initial information received on 01-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 18 years old female patient who received doses of menactra in 2017, 11NOV2020, extra dose vaccine menquadfi on 31JUL2023 with no reported adverse event.  The patient's past vaccination(s) included menactra in 2017 and on 11-Nov-2020. The patient's past medical history, medical treatment(s) and family history were not provided.  Concomitant medications included meningococcal vaccine B RFHBP/NADA/NHBA OMV (Bexsero) for Immunisation.  On 31-Jul-2023, the patient received a dose 3  of suspect meningococcal A-C-Y-W135 (T CONJ) vaccine, Solution for injection lot U7675DC, expiry date:30-Sep-2025  via intramuscular route in the left deltoid for prophylactic vaccination (strength, dose: unknown), received doses of menactra in 2017, 11NOV2020, extra dose vaccine menquadfi on 31JUL2023 with no reported adverse event (extra dose administered) (latency same day).  Action taken: not applicable.  Reportedly, patient had previously received doses of MENACTRA in 2017 and on 11NOV2020. The patient received a third dose of MENQUADFI on 31JUL2023. The dose of MENQUADFI was administered 2 years and 8 months after the last dose of MENACTRA  At time of reporting, the outcome was Unknown for the event extra dose administered.  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 guidelines. 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.
100-degree fever for 24 hours; all-over aches, fatigue for 48 hours.
Normal variant-satellite lesions around vaccine site likely-cultures pending. Back lesions c/w pass diss varicella vx folliculitis gotyp em biopsy P pt well.
nausea; POTS flare ups not experienced for years. So bad over past months since May vaccine  that we have explored every gastro possibility to no avail.; POTS flare ups not experienced for years. So bad over past months since May vaccine  that we have explored every gastro possibility to no avail.; This is a spontaneous report from a contactable consumer. A non pregnant 19-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE ; Lot number and expiration date were not reported), via an unspecified route of administration, administered in Arm Right on 04May2021 14:45 (at the age of 19-years-old) at dose 2, single for covid-19 immunization. Medical history included known allergies to penicillins and POTS (Postural orthostatic tachycardia syndrome). The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE ; Lot number and expiration date were not reported), via an unspecified route of administration, administered on 13Apr2021 15:00 at dose 1, single for covid-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination has not been tested for COVID-19. Patient did not receive any other vaccines in four weeks. Patient had POTS which was managed at time of Covid vaccine. After 2nd vaccine patient symptoms became much worse on 05May2021. She has not experienced POTS flare ups for years. It was so bad over past months since second vaccine that they have explored every gastro possibility to no avail. Nowshe has to withdrawfrom her first college classes due to this worsening of her POTS illness. The most recent covid-19 vaccine was administered at Pharmacy or Drug Store. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Patient was given Fluids in ER  and nausea prescriptions. The outcome of the event POTS was not recovered, outcome of nausea was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Hospitalized with COVID pneumonia after seeming recovery and MAB treatment.  Nausea and diarrhea
Vaccine drawn up into syringes 6-16-2021 at 10:20am. Administered dose into left arm at 04:40 pm. Immediately after administration discovered vaccine doses had expired. Per recommendation of clinical coordinator administered dose of newly prepared vaccine into right arm at 04:50 pm. Pt monitored for 15 minutes following administration.
Patient presented to the office and according to MR was due for HPV. HPV was administered.  Upon charting the vaccine, it was noted that there was already an HPV vaccine ordered from 8/17/2022, but not charted, this vaccine from 8/22/2022 was given, and was his last dose, however, was not charted, thus not transferring to MR.  He ended up getting a third dose of HPV that was not needed.
NO KNOWN ADVERSE EVENTS HAVE BEEN REPORTED TO FACILITY.  HAVE TRIED TO CONTACT INDIVIDUAL BY PHONE AND EMAIL TO VERIFY DOB UNDER 16 YEARS AND HAVE NOT BEEN SUCCESSFUL.  WILL CONTINUE TO TRY TO CONTACT.  SECOND VACCINATION HAS BEEN CANCELED UNTIL DOB CAN BE VERIFIED.
arm  tenderness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm  tenderness". Additional information: after 1st dose had little bit arm tenderness. After 2nd dose had little arm tenderness and a slight headache. Want to know if its ok to take Advil or Tylenol. Has not taken anything. patient was also wondering about a possible test we can suggest to take to check efficacy of vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Soreness in my left tricep 12 days after. Next day itchy rash on left scalpula where I have a tattoo. Not sure if related to shot but girlfriend wanted me to report just in case.
2 days after injection , the injection site become painfull and resilve un 48 hours, but on 1/2/2021 started to get swollen redness and very hard and firm , also the ventral aspect of the arm felt swollen
PATIENT DID WELL UPON IMMEDIATE RECEIPT OF VACCINE.  MOVED PATIENT TO OBSERVATION AREA. WITHIN 10 MINUTES PATIENT FAINTED ONTO FLOOR,HIT HEAD AND BECAME NONRESPONSIVE.  WE CALLED 911.  WITHIN SECONDS HE BECAME RESPONSIVE AND DID NOT WANT EMS TO COME. WE GOT ICE PACKS FOR THE BACK OF HIS NECK AND FOREHEAD AND MADE HIM COMFORTABLE ON THE FLOOR. HE CONTINUED TO SAY HE WAS FEELING BETTER AND THAT IT JUST CAME ON VERY QUICKLY.  AFTER 20MINUTES HE WANTED TO SIT UP IN THE CHAIR. AFTER A FEW MINUTES WE MOVED HIM TO A MORE COMFORTABLE CHAIR.  PATIENT CONTINUED TO TALK AND RESPOND. AFTER 15 MORE MINUTES HE  DECIDED HE WAS GOOD ENOUGH TO LEAVE.
Patient complained about redness and itching on injection site. Patient went to the doctor and got antibiotics for 5 days. Doctor advised patient to seek medical attention if symptoms worsen.
Initial literature report received on 01 Nov 2010: This patient with medical history of heart failure participated in a prospective cohort study to evaluate T cell responses as correlates of protection against influenza following vaccination in older adults. The patients were vaccinated with Influenza virus vaccine 2007/2008 (manufacturer unknown, batch number: unknown) during the fall of 2007. The influenza surveillance was initiated at two study sites at the start of the influenza season in Jan 2008. The mean age of the study subjects was 74 years (range 60-92). Patients started reporting influenza-like illness symptoms. When reported symptoms met the ILI criteria and were within 5 days of onset, a nasal swab for detection of influenza virus was obtained during a home visit or a clinic visit. A laboratory diagnosis of influenza illness was confirmed by the detection of influenza virus in a polymerase chain reaction assay of the nasal swabs or a 4-fold or greater rise in the antibody titer after the illness. Subjects that met both clinical and at least one of the laboratory criteria were identified as laboratory-confirmed influenza. This patient, who had a history of heart failure, had an antibody titer value of 80, 80, 57, and 160 after 0 weeks, 4 weeks, 10 weeks and 20 weeks of vaccination respectively. The patient did not have 4-fold increase in titer value and tested negative for seroconversion but tested positive for PCR of B strain. Therefore this patient was considered as an LCI case of Influenza B. The outcome was not reported.
Continuous under eye twitch that I noticed the evening after getting the vaccine. As of today, it has been 2 weeks. I have not experienced this symptom before and it does not appear to be subsiding.
Immunization provided for employer group as part of an onsite immunization clinic. Employees were invited to receive flu shots sponsored by employer. I do not have many specifics because I did not speak to the patient. Instead, the employer is working with the patient and they only indicated that the patient "got ill after the flu shot and eventually had some type of partial paralysis." I do not know the timeline of this occurence, the severity, or whether it still exists. The employee received the flu shot in Oct 2010 and we were notified by the employer yesterday, 4/10/2012 (approx 1.5 years later).
RED, BUMPY, ITCHY RASH APPEARED FIRST ON ARMS, HAS THEN SPREAD TO FACE, TRUNK, BACK.
Feel sick; Stomach ache; My stomach's upset. I haven't thrown up, but my stomach is upset; Patient received  first dose as Moderna Bivalent Vaccine; Headache; I have 100 degree temperature; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Feel sick), ABDOMINAL PAIN UPPER (Stomach ache), ABDOMINAL DISCOMFORT (My stomach's upset. I haven't thrown up, but my stomach is upset), WRONG PRODUCT ADMINISTERED (Patient received  first dose as Moderna Bivalent Vaccine) and HEADACHE (Headache) in a 51-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 09-Aug-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 09-Aug-2023, the patient experienced MALAISE (Feel sick), ABDOMINAL PAIN UPPER (Stomach ache), ABDOMINAL DISCOMFORT (My stomach's upset. I haven't thrown up, but my stomach is upset), WRONG PRODUCT ADMINISTERED (Patient received  first dose as Moderna Bivalent Vaccine), HEADACHE (Headache) and PYREXIA (I have 100 degree temperature). At the time of the report, MALAISE (Feel sick), ABDOMINAL PAIN UPPER (Stomach ache) and HEADACHE (Headache) had not resolved and ABDOMINAL DISCOMFORT (My stomach's upset. I haven't thrown up, but my stomach is upset), WRONG PRODUCT ADMINISTERED (Patient received  first dose as Moderna Bivalent Vaccine) and PYREXIA (I have 100 degree temperature) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Aug-2023, Body temperature: 100 degree Celsius.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported that patient mom was elderly, and she was not well and patient just wanted to make sure that his mother can't contract it. No treatment medication was reported.
Fatigue; Tender lymph nodes near site of injection; This is a spontaneous report from a non-contactable other health care professional reporting for herself. A 36-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in right arm on 04Mar2021 09:00 (at the age of 36-year-old) as single dose for COVID-19 immunization. The patient medical history included diabetes mellitus and Sjogren's syndrome from an unknown date and unknown if ongoing. Patient had not any allergies. Concomitant medications included metformin, ibuprofen and paracetamol (TYLENOL)-all taken for an unspecified indication, start and stop date were not reported. Patient did not have COVID prior to the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. On Mar2021 (as reported: 02Mar2021 21:00) the patient experienced fatigue, and tender lymph nodes near site of injection. The patient did not receive the treatment for adverse events. The outcome of events was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
misplaced their vaccination cards which are needed for their cataract surgery; This is a spontaneous report from a Non contactable consumer via Pfizer-sponsored program.  A patient of unknown age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. On unknown date, the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunisation. The patient misplaced vaccination card which was needed for cataract surgery. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot been obtained.
PATIENT EXPERIENCED SWELLING IN ARM ABOUT 5 MINUTES AFTER VACCINATION.
Congestion; dizziness; headaches; incontinence; severe lower leg pain; numbness in feet; tingling on face; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the right arm on 07Jun2021 at 13:00 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included 2 heart mitral valve surgeries, Raynaud's disease, deviated septum and arthritis. The patient had allergies to sulfa drugs. Concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Jun2021 the patient experienced congestion, dizziness, headaches, incontinence, severe lower leg pain, numbness in feet and tingling on face. It happened within an hour of vaccine. Got better 2 days in between and on 3rd now having same side effects as the first day. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events congestion, dizziness, headaches, incontinence, severe lower leg pain, numbness in feet and tingling on face were not recovered at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning a female who on 24-JAN-2007 was vaccinated with a dose of RECOMBIVAX HB.  Subsequently the patient experienced severe abdominal pain and low ferritin levels.  The patient was seen by the physician and was then referred to the clinic.  The patient was diagnosed with Dunbar's compression and was being treated for low ferritin levels.  As of 02-Oct-2007, the patient was recovering.  No product quality complaint was involved.  Additional information has been requested.
Received immunization left deltoid on 01/12/04.  On 01/13/04 mom noted swelling at injection site.  Mom called office today because swelling was spreading lg 10cm (4 inch) erythematous area left aspect.
At the injection site bruised very badly. Two inches below the injection site was a big red circle which developed to a rash and was hot to the touch.
This spontaneous report as received from a medical assistant refers to a 4 year old patient who on 24-JUL-2014, was vaccinated with a dose of (Oka/Merck) PROQUAD (lot number K005648, Exp. Date: 17-OCT-2015)(dose and route not reported) that ws improperly stored. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
spinal stenosis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 01Mar2021 (Lot number: EM9802) as dose 2, single and administration date 08Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SPINAL STENOSIS (non-serious) with onset Mar2021, outcome "not recovered", described as "spinal stenosis".  Additional information: He got two vaccines from Pfizer shortly there after he had a spinal stenosis and still has it. He is wondering if its a coincidence or if its related. He clarified as the covid 19 vaccination and wants to know if that could be a symptom or related to getting his Pfizer vaccine.  No follow-up attempts are possible; No further information is expected.
Client was vaccinated with Moderna vaccine for Covid on 4/7 and 5/7/2021.  Covid symptoms started 9/5 (fever, nasal congestion, cough, headache).  Tested + with PCR on 9/8 for Covid.  Reported as a case of breakthrough Covid disease in fully vaccinated person.
RN administered 3 vaccinations. Client stood up shortly after vaccinations were administered and went to waiting area to sit with parents and 2 siblings. RN heard yelling, looked out in waiting room and visualized client laying back in dad's arms. RN grabbed anaphylactic kit and was to client in seconds. RN yelled for help immediately when visualized client laying in dad's arms. When RN with client, client waking up and started conversing. This episode lasted no more than 20-30 seconds. When client awoke stated, "Why is everyone around me?" States, "I sat down, got dizzy and that is all I remember." Client alert and oriented to person, place and time. BP and assessment completed. EMT called per parents request. No further treatment completed. Followed up with family following day and mom states, "He is back to his normal self."
Left upper arm swelling from elbow to shoulder, "Zig-zag" rash on left arm, sore throat, trouble swallowing.
This serious spontaneous case was initially received on 11-Apr-2018, reported by other non-health professional, concerns a male patient of unspecified age. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2017 (reported as September or October of 2017), the patient was administered with INN flu vaccine seasonal (dose, anatomical location, route of administration, batch number, expiry date, manufacturer, trade name was not reported). On an unspecified date in Jan-2018, about 3 months after vaccination, the patient became paralyzed from the waist down. The reporter did not know if the event was related to the vaccine. It was reported that, the patient was seen at hospital due to event. The outcome of the event paralysis was not reported.
A few weeks after my second shot I?ve developed tinnitus. I wasn?t sure what it was, it just seem like white noise in my head. I had an appointment with a hearing specialist and they told me what it was. I didn?t know if it was a side effect of the vaccine until I saw other reports that people had developed this condition. I just thought it was age related but I?ve never had anything like this before
Information has been received from a Registered Nurse concerning a 28 year old female with hypothyroidism, polycystic ovary syndrome, hypercholesterolaemia, ZITHROMAX and nonsteroidal anti-inflammatory drugs allergies who on 25-SEP-2006 was vaccinated subcutaneously with a 0.5 mL dose of MMR II (lot# 654543/0699F). Concomitant therapy included FLONASE, CALTRASE, SYNTHROID, vitamin B-12 and GLUCOPHAGE. It was reported that the patient had a negative mumps titer. It was unknown if the dose given on 25-SEP-2006 was the patient's first dose of vaccine. The outcome was unknown. The patient sought medical attention by visiting the physician's office. Additional information has been requested.
The day after my vaccination, 02/21/2021, I was on a walk with my dog, and my knee swelled up and was it was very painful. It has never swelled up like that. It took weeks for it to get better, but it hasn't been good since then. I had a telehealth 02/23/2021. He told me to let him know when I wanted to have surgery. He ordered x-rays- showed I had bone on bone. The vaccines worsened  the arthritis in my knee. The doctor said it would get better, but it has never been like it was before. He treated it with Synvisc, a series of injections. It's better than it was in 3 or 4 weeks, but it has never been better than it was before. It would be dramatic to say No, I have not recovered from the AE, but it certainly has worsened it.
Pt reported itching at injection site on the day following the injection. By the next day, she had generalized itching. No rash/hives. Pt. reported taking BENADRYL to relieve itching. She also received PREVNAR at another clinic on 4/11/16.