chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Since 2nd shot, pt got very ill for about a week, but after the week continued have issues with dizziness, weakness in the legs, and blood pressure issues that were not present before hand.
Next morning, patient had episode of dizziness, disorientation, nausea, and fever of 103.0. Patient went to bed and slept most of the day. Felt back to normal Thursday.
WEDNESDAY ; Arm started hurting right away , more than when the first dose was administered . Tired that night . Arm got more painful with each hour passing, could not sleep on it, very painful every time I moved. THURSDAY :  by morning , severe unbearable pain in my arm, , could not use it at all, had to keep it braced against me, never been in so much pain after an injection ! Bad chills , shaking, cold, skin hurting, achy all over, and terrible headache. Could not function and went to bed. FRIDAY : arm still painful , pain not as acute, not using it much at all. Still dealing with chills and headaches, coming  in waves. SATURDAY : arm getting less painful, still chills and headaches. SUNDAY :  pain almost gone in arm , still chills and headaches
Patient got shot, two days later arm became hot and red then two days later arm was sore and this lasted around a week, then for 1 more week arm became itchy and warm but redness went away the reaction lasted till 7-17-19
Headaches and dizziness starting roughly 1 week after vaccination, and continued until eventual hospitalization. Experienced first time ever seizure (tonic-clonic) at midnight, March 29th. 2nd seizure approximately 12 hours later. 3rd seizure on May 2nd, at approx. 5 am.   Patient is currently taking 500 mg levetiracetam (Keppra) twice daily. Doctors are still yet to identify the cause of seizures.
About six weeks after receiving my second Moderna COVID-19 vaccine dose I started experiencing irregular menstrual cycles. It started with spotting in between cycles and progressively worsened to having multiple menstrual cycles in a month.
swollen lymph nose in left armpit. never have had anything like this happen to my body.
accidentally left refrigerator door open too long; due to human error,low of 1.85C for 30 min with no reported adverse event; opened ipol was administered to patient with no reported adverse event; Initial information was received on 22-Jul-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves 11 months old male patient who reported that accidentally left refrigerator door open too long; due to human error,low of 1.85c for 30 min with no reported adverse event and opened ipol was administered to patient with no reported adverse event after receiving ipv (VERO) [Ipol].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 17-Jul-2023, the patient received a dose of 0.5 ml of suspect ipv (VERO) (Suspension for injection) (lot V1A021M, Expiry date: 27-Feb-2024) (strength was unknown) via intramuscular route in unknown administration site for and developed a non-serious event of accidentally left refrigerator door open too long; due to human error,low of 1.85c for 30 min with no reported adverse event (product storage error) and opened ipol was administered to patient with no reported adverse event (poor quality product administered) (latency : same day) following the administration of ipv (VERO).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event accidentally left refrigerator door open too long; due to human error,low of 1.85c for 30 min with no reported adverse event and was Unknown for the event opened ipol was administered to patient 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.
1402 BLOOD PRESSURE 162/70, HEART RATE 60, OXYGEN SATURATION 98%, RESPIRATIONS 18. COMPLAINTS OF LIGHT HEADED, FLUSHED , HOT, DRY MOUTH. STATES SHE HAD A HEADACHE BEFORE INJECTISON. FLUID GIVEN BY MOUTH, ACCEPTED. 1415 PATIENT STATES SHE IS FEELING BETTER. FLUID  BY MOUTH HELPED. INSTRUCTED TO CALL EMS IF SYPTOMS RETURN OR GETS WORSE. PATIENT VERBALIZED UNDERSTANDING 1440 PATIENT STATES SHE IS BETTER, DROVE HOME
10-24-07 Pt Rt arm is red, swollen, tender to touch. Fever 100-102. Area is red about size of 9 1/2 tall, 6 1/2 wide redness. Very painful.
Death; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant products were reported.  On an unknown date, patients mother reported that her son died suddenly three months ago after taking the second dose of the Moderna vaccine and she has been devastated.  No treatment information was reported by the reporter.  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 spontaneous case concerns a male patient, of unknown age, with no medical history reported, who experienced the unexpected, serious event of death. The event occurred unknown number of days after receiving the second dose of the mRNA-1273 vaccine. Of note, the vaccination date and the event onset date were not provided, hence, the onset latency could not be assessed. No information was available regarding the first vaccine dose. It was reported that the patient suddenly died after receiving the second dose of the Moderna vaccine. No further details were provided. The cause of death was not provided. It is unknown if an autopsy was performed. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient, of unknown age, with no medical history reported, who experienced the unexpected, serious event of death. The event occurred unknown number of days after receiving the second dose of the mRNA-1273 vaccine. Of note, the vaccination date and the event onset date were not provided, hence, the onset latency could not be assessed. No information was available regarding the first vaccine dose. It was reported that the patient suddenly died after receiving the second dose of the Moderna vaccine. No further details were provided. The cause of death was not provided. It is unknown if an autopsy was performed. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: unknown cause of death
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2022 at 10:56 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Feb-2022 at 10:56 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 'vaccine administration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication reported. The patient had received the vaccine dose number as booster. It was reported that a series of approximately 540 patients had received lot 066H21A past its 30 days of an expiry date. The vaccine was administered up until its manufactured expiry date of 04-Apr-2022 and this lot number was no longer possessed. No Treatment medication reported.   This case was linked to MOD-2022-542869 (Patient Link).
The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 1-year-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the vaccines hepatitis a vaccine, inactivated(VAQTA) (lot # S019435 with expiration date 23-AUG-2020, lot # S026003 with expiration date 17-OCT-2020, and lot # S032056 with expiration date 09-NOV-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) 25/0.5 dosage form at a dose of 0.5 ml (route not provided) for prophylaxis. No adverse events were reported.  This is one of several cases from the same reporter.  combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S019435; expirationdate: 23-AUG-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004521: US-009507513-2005USA004522: US-009507513-2005USA004523: US-009507513-2005USA004524: US-009507513-2005USA004525: US-009507513-2005USA004526: US-009507513-2005USA004527: US-009507513-2005USA004528: US-009507513-2005USA004529: US-009507513-2005USA004531: US-009507513-2005USA004532: US-009507513-2005USA004533: US-009507513-2005USA004534: US-009507513-2005USA004535:
TOOK 4 UNREFRIGERATED DOSES; This spontaneous case (PVX2019-1094) was received from a nurse on 03-May-2019. It describes a 20-year-old female consumer who "took 4 unrefrigerated doses", while receiving oral Vivotif (one dose every other day) for typhoid fever prophylaxis.  Case report: The consumer took 4 unrefrigerated doses of Vivotif. The doses were taken from 30-Mar-2019 to 05-Apr-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event "took 4 unrefrigerated doses" was unknown.  Company's Comment: The causality of the event "took 4 unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took 4 unrefrigerated doses" was considered as not applicable.
Patient came in on 10/21 and claims she has been having repeated occurrences of diarrhea since she got her flu shot.  No dark, tarry or bloody stools reported.  Counseled patient on taking imodium and eating high fiber food and if not resolved to discuss with doctor.
Approximately 20 minutes after receiving the vaccine my arm began itching really bad at injection site. Ten minutes later my vision was blurred and I felt dizzy and weak, within an hour my head began to hurt and gradually got worst. By 9:30pm my fingers were swollen on the arm I got the injection and through the evening twitched. Body aches, headache got worse  The blurred vision, swollen fingers weakness and dizziness last through 02/25/21. Issues did not resolve until the morning of Saturday 02/06/2021 7am.
I developed dizziness about 10 hours after the vaccine was administered.  It lasted for about 3 minutes.  The dizziness returned 24 hours after the initial dizziness began, so about 34 hours after the vaccine was given to me.  The second dizzy spell also lasted a few minutes.
Pt presented for 1st dose of COVID-19 vaccine at . Pt completed COVID Vaccine Consent Form which was reviewed by immunizer prior to administration. Pt reported hx of syncope >10 yrs ago after blood work. ~2 mins after vaccine administration pt reported not feeling well and became unconscious. Seen by immunizer who called for help and caught pt prior to falling from seated position. O2 Sat ~99% and HR 60 bpm and BG 140 mg/dL. Pt  was addressed while she regained consciousness (able to state name and location). 911 was called and onsite within 5 mins. Pt's husband alerted and she was taken to Hospital for further testing.
Knot on arm that turned into blister looking growth that has now scabbed over. Itches and has some irritation
Dizziness and tinnitus about 2 1/2 weeks after first dose.  I definitely got worse after second dose.   I have had my ears checked and a hearing test.  All of that is good.
13hr p/vax pt began to have severe chills @ 0200hr that lasted 1hr  followed by fever that lasted 36hr;low grade fever & fatigue persists today;
Fever stayed up to 102 to 104 even w/APAP; sz occurred-pt went to ER;
MULTIPLE PAPULAR AND VESICULAR LESION ALL OVER HIS BODY WITH SOME SCABS AND SECONDRY BACTERIAL INFECTION , LESION STARTED TO APPEARE ONE WEEK AFTER ADNINISTRING THE VACCINE.
pt recv vax & 2 to 3 days post vax pt exp inc BP 210/110;pt inc BP persisted & pt MD had inc the dosage of BP med;
Immediately after administering vaccine patient's face was pale with cyanosis around her mouth.  Medical Assistant noted her arms were stiff and head was shaking with eyes rolled back.  Few seconds later patient was awake with "funny feeling" in her chest and dizziness.  Blood pressure was low at 88/54 and heart rate was in 60's.  Glucose was 145.  After 30 minutes of observation patient felt well and walked out with her parents.
Fever, muscle pain, headache, nausea - started 12 hours after vaccine and continuing for >12 hours
Very swollen lymph nodes under armpit raised; armpit raised and red lump 2 inch on length and 1 inch in width; This is a spontaneous report from a contactable consumer, the patient. A male patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: FC3180) via an unspecified route of administration in the left arm on 03Aug2021 at 16:30 as a single dose for COVID-19 immunisation. Medical history included autism and COVID-19. The patient had no known allergies to medications, food, or other products. Concomitant medications included lisdexamfetamine mesilate (VYVANSE), lithium (MANUFACTURER UNKNOWN), duloxetine (MANUFACTURER UNKNOWN) and risperidone (MANUFACTURER UNKNOWN); all taken for unknown indications from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Aug2021 at 10:00, the patient experienced very swollen lymph nodes under armpit raised and red lump 2 inch on length and 1 inch in width. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events very swollen lymph nodes under armpit and raised and red lump 2 inch on length and 1 inch in width were not resolved at the time of this report.
Period came two days after the shot, which was earlier than expected; Usually the flow is light at the first half day. But this time, it is very heavy at the very beginning. This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Apr2021 at 09:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medication. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 24Apr2021 at 23:00, two days after the shot, the patient experienced her period, which was earlier than expected and there was no cramp feeling at all this time. The patient used to experience some sort of cramp feeling before and during the first half day and her body tells that period was coming. But this time, it came very silently and had no feelings at all and usually, the flow was light at the first half day, but this time, it was very heavy at the very beginning. The events did not result in doctor or other healthcare professional office/clinic visit, 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 period came two days after the shot, which was earlier than expected and usually, the flow was light at the first half day, but this time, it was very heavy at the very beginning was resolved on an unknown date in Apr2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt. reported loss of consciousness approximately 10 minutes after vaccination.  Pt. alerted observation staff immediately.  Pt. reported he had not eaten or had anything to drink this morning.  Pt. was given pack of crackers and juice.  Pt. was A&Ox3 with no confusion and reported anxiety only.  Heart rate-58, P02-98%.  Pt. was observed for 30 additional minutes with no additional complications.
This case was reported by a consumer (subject's grandmother) and described the occurrence of autism in a 17-month-old male subject who was vaccinated with Hep A (manufacturer unspecified), dtpa-polio-hib (non-gsk), MMR (non-gsk), varicella virus vaccine (non-gsk) and PREVNAR (non-gsk). A physician or other health care professional has not verified this report. The subject's medical history included constipation, drug reaction and thrush. Concurrent medical conditions included celiac symptoms nos, flour sensitivity and sensitive to chemicals. Historic vaccination included Hib; manufacturer unspecified; unknown given on 16 December 2008; DTaP; manufacturer unspecified; unknown given 16 December 2008; IPV (non-gsk); non-GSK manufacturer; unknown given on 16 December 2008; and live attenuated human rotavirus vaccine; manufacturer unspecified; unknown given on 16 December 2008. On 23 March 2010 the subject received 1st dose of Hep A (unknown), unspecified dose of DTPa-Polio-HIB (Non-GSK) (unknown), unspecified dose of MMR (Non-GSK) (unknown), unspecified dose of Varicella virus vaccine (Non-GSK) (unknown), unspecified dose of PREVNAR (unknown). In 2010, less than one week after vaccination with DTPa-Polio-HIB (Non-GSK), Hep A, MMR (Non-GSK), PREVNAR and Varicella virus vaccine (Non-GSK), the subject experienced high grade fever up to 105, not eating properly. The subject's physician recommended treating the fever with TYLENOL and sponge baths. About 2 to 3 weeks after vaccination with DTPa-Polio-HIB (Non-GSK), Hep A, MMR (Non-GSK), PREVNAR and Varicella virus vaccine (Non-GSK), the subject experienced chicken pox and "about" 1 month after, the subject experienced weight loss, loss of fine motor skills, non communicative, dysphagia and loss of making eye contact. The grandmother explained that the subject lost about 50 percent of his weight, lost 80 percent of his fine motor skills. According to the grandmother, prior to these vaccinations, at the subject's last physical he was noted as normal growth and development. About 4 months after vaccination with DTPa-Polio-HIB (Non-GSK), Hep A, MMR (Non-GSK), PREVNAR and Varicella virus vaccine (Non-GSK), the subject experienced autism. At the time of the report, the grandmother explained that the subject had recovered to about 90 percent and now attended a school for special education students. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the events was unspecified except the autism was considered as improved. After the next vaccination with Hep A the events recurred. On 09 March 2012, the subject was vaccinated with HAVRIX and experienced some of the same events plus different events. See case A0970857C for details. Prior to these vaccinations, the subject was vaccinated with DTaP on 16 December 2008 and experienced some of the same events plus some different events. See case A0970857A for details.
Patient complained of urticaria, rash over his whole body, pain with chewing, itchy eye lids, and his R arm hurting, which all started on the next morning, a Friday. The itching and rash kept him up during the night time and he got little sleep afterward. He contacted the clinic Monday morning when it felt worse. On 3/28/19, spoke with him to prepare this report, and he stated he was doing much better, after starting treatment with BENADRYL and ADVIL on 3/25/19.
Soreness x2 days.  Subsequently 6 days after had deep arm pain followed by severe pain and loss of range of motion.  Pain woke patient from sleep.  Patient underwent steroid course for arm pain with some improvement.  Continues to be followed by orthopedics and PCP for arm pain and some residual loss of function.
COULDN'T TAKE A DEEP BREATH; FELT COLD; WHOLE BODY ACHY; DIZZINESS; WEAKNESS; CHILLS; EXTREMELY TIRED; NAUSEATED; EYES GOT HEAVY; This spontaneous report received from a patient concerned a 41 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included type2 diabetes. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 206A21A, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. Concomitant medications included metformin for type2 diabetes. On 18-MAY-2021, the subject experienced whole body achy. On 18-MAY-2021, the subject experienced dizziness. On 18-MAY-2021, the subject experienced weakness. On 18-MAY-2021, the subject experienced chills. On 18-MAY-2021, the subject experienced extremely tired. On 18-MAY-2021, the subject experienced nauseated. On 18-MAY-2021, the subject experienced eyes got heavy. On 19-MAY-2021, the subject experienced couldn't take a deep breath. On 19-MAY-2021, the subject experienced felt cold. The action taken with covid-19 vaccine  was not applicable. The patient recovered from nauseated on MAY-2021, was recovering from couldn't take a deep breath, had not recovered from extremely tired, whole body achy, weakness, and chills, and the outcome of dizziness, eyes got heavy and felt cold was not reported. This report was non-serious.