chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Atypical febrile seizure, intubated, ICU stay.  Now epilepsy, behavioral problems, developmental delay.  10/20/2008 MR received for numerous ER visits and one admission beginning 3/14/2007 with DX: Status epilepticus, possibly 2' to meningitis.  Respiratory Failure. Fever. Pt presented after having a seizure at daycare.  EMS found infant unresponsive with decreased respirations.  Responding only to pain, lethargic with poor gag reflex, tachycardic and with mottled skin. Temp 102.5"F. Tonic-clonic activity bilaterally of upper and lower extremities. R TM erythematous. Pt intubated and transfered to higher level of care, txd with abx and d/c Returned 3/22/03 with repeat febrile seizure.  Numerous ER visits for Febrile seizure 3/2003-2008.  10/30/2008 MR received from transfer hospital DOS 3/14-16/2003 with D/C Dx:  Anticonvulsant induced apnea.  Immunization Fever. Seizure with fever.  URI/apnea. Intubation < 24 hrs.  Sepsis w/u.  Antibiotics x 48hrs. DOS 6/18/03 D/C Dx:  Complex Febrile seizure.   PCP records also received from 2003-2008. Speech delay noted 12/15/04. Behavior problems and repetitive behaviors, developmental delay and Autism like tendencies noted 12/7/05. Behavior problems worsening after seizure 3/2008. 1/27/2010 Has ongoing epilepsy and developmental delays.
On the day following vaccination, patient developed confluent pruritic maculopapular rash on elbows and knees which spread to buttocks and upper arms and ear pinnae over the next two days.
Within 20 to 30 minutes after vaccine, a feeling of sinus pressure, mild to moderate; still feeling it more than 6 hours after vaccine; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Mar2021 at 15:30 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history included lumpectomy in 2018 and mild hypertension. Prior to vaccination, the patient was not diagnosed with COVID -19. Concomitant medications included spironolactone (MANUFACTURER UNKNOWN), colecalciferol (VIT D3), anastrozole (MANUFACTURER UNKNOWN) and acetylsalicylic acid (ASPIRIN); all taken for unknown indication from an unknown date and unknown if ongoing. The patient previously took acetylsalicylic acid; caffeine; paracetamol (FIORINAL) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Mar2021 at 15:45, within 20 to 30 minutes after vaccine, the patient experienced a feeling of sinus pressure, mild to moderate. The patient felt it for more than 6 hours after vaccine. 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event feeling of sinus pressure, mild to moderate was not recovered at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Patient received incorrect 3rd dose. Immunocompromised patient received 0.25ml booster for 3rd dose instead of the intended 0.5ml  full 3rd dose .
crawling on her hands and knees as well; horrific neck issue; This is a spontaneous report from a contactable physician (Specialty: Obstetrics & Gynecology). This physician reported for a patient (Reporter's friend) that: A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), via an unspecified route of administration on an unspecified date in Jan2021 at single dose for COVID-19 immunization.  Medical history included minor lower back issues from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported. Historical Vaccine included first dose of BNT162B2 for COVID-19 immunization with no adverse events. The patient has a horrific neck issue in Jan2021. She got the second dose of the Pfizer COVID19 vaccine on Friday and over the weekend in Jan2021 she was crawling on her hands and knees as well. The outcome of the events was unknown  Information on the lot/batch number has been requested.
Vaccine give Saturday PM.  Sunday evening (24 hours after the vaccine) patient noticed the injection site was starting to get raised, swollen, warm to the touch.  Over the next 36 hours the area continued to get larger and not until Tuesday afternoon patient noticed swelling was decreasing.  As of this morning-Wed 8/26/20, area is looking more normal with just some mild bruising.  Patient did not use any NSAIDS, ice, ect...just watched area.
5 minutes after injection I experienced light headedness. An hour after it turned into a brain fogginess feeling where I feel like I am high constantly. It feels like I am not as alert, pressure on forehead, unbalanced/dizziness, slight headache, major fatigue, eyes feel strained, etc.
Two minutes post flu vaccination, patient stated she felt dizzy, flushed and had tingling in her arms. A red rash appeared on her face. Patient complained of tightening in her chest and throat. On-site nurses had her lie down. Coached her to slow down her breathing as she appeared to be hyperventilating. Vital signs were taken and monitored. 0.5 ml of epinephrine administered. 911 was called. After EMS arrived, Patient appeared to be in stable condition. Rash had dissipated and tightening was resolving. This writer contacted patient on 11/15/16 to follow-up. Patient reported that she was transported to ER where they administered a steroid and monitored her for a few hours. She was discharged to home with steroids to take for the next 2 days.
This spontaneous report as received from a Medical Assistant refers to a 69 year old female patient with drug reactions/allergies to MEDROL. The patient had no pertinent medical history. On 24-SEP-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (injection, intramuscular, 0.5 ml, lot# was reported as K00773, expiration date 01-MAY-2015) as required. Concomitant therapies included FLONASE, BIEST, estriol, OTEZLA and metoprolol succinate. On 26-SEP-2014, the patient experienced red rash at the injection site and extreme muscle ache after taking PNEUMOVAX 23. The patient had been still feeling unwell and "sore" since 26-SEP-2014. The patient had sought for medical attention. Treatment included BACTRIM was given for the adverse event. No lab diagnostics study was performed. The outcome of the events was reported as not recovered. Additional information has been requested.
Breakthrough case after two vaccines ; Pfizer 4/26/21 Lot# EW0171;  Pfizer 5/17/21 Lot# EW0168
After receiving my second Covid vaccine Phizer, my blood sugar started rising into uncontrollable levels. I ultimately went to the emergency room and was admitted to the ICU with diabetic keto acidosis believed to be caused by the vaccine.
Aches all over my body, tiredness; lasted only one day. Got  some sleep no symptons the following day
He had a cough; has not been feeling good; Tested positive for COVID19 after receiving Moderna vaccine/came down with COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID19 after receiving Moderna vaccine/came down with COVID), COUGH (He had a cough) and MALAISE (has not been feeling good) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Jul-2021, the patient experienced COVID-19 (Tested positive for COVID19 after receiving Moderna vaccine/came down with COVID). On an unknown date, the patient experienced COUGH (He had a cough) and MALAISE (has not been feeling good). At the time of the report, COVID-19 (Tested positive for COVID19 after receiving Moderna vaccine/came down with COVID) and MALAISE (has not been feeling good) outcome was unknown and COUGH (He had a cough) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jul-2021, SARS-CoV-2 test: positive (Positive) tested positive.         Concomitant medications were not reported.  Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Added Start date for both the doses of Suspect vaccine, New event Feeling unwell was added, Verbatim for the event Covid 19 was updated and outcome of the event Cough updated from unknown to Not recovered.
Pfizer vaccine was administered - reported by patient  I95.9 HYPOTENSION 6/7/2021 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION R09.02 HYPOXIA 7/18/2021 SEVERE SEPSIS W ACUTE ORGAN DYSFUNCTION I95.9 HYPOTENSION 6/7/2021 BACTEREMIA R09.02 HYPOXIA 7/18/2021 BACTEREMIA I95.9 HYPOTENSION 6/7/2021 CANCER METASTATIC TO LIVER R09.02 HYPOXIA 7/18/2021 CANCER METASTATIC TO LIVER
Headache; Tired; Arm soreness; This is a spontaneous report from a contactable consumer, the patient. This 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3247),  dose  1, single dose via an unspecified route of administration in the left arm on 14Jan2021 at 20:30 for COVID-19 vaccination. There was no relevant medical history. There were no known drug allergies. The patient was not pregnant. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included colecalciferol (VITAMIN D), estradiol (VIVELLE) patch .05 estrogen only and famotidine (PEPCID). On 04Feb2021 at 12:00, the patient had headache, tired and arm soreness. No treatment was received for headache, tired and arm soreness. The clinical outcome of headache, tired and arm soreness was recovered.
Headache & Myalgia Narrative:  employee had body aches for a day but has had daily headaches since vaccination. Severity of 2/10. She normally does not experience headaches.
The next morning I went to urgent care because I was experiencing really bad chest pains and body aches where an EKG and chest X-Ray were perform and I was released and advised if the symtoms got any worse to come back or got to the ER.  For the next week the chest pain persist and got worse. I experienced severe chest pains, struggled with breathing at night, was extremely tired and felt worn out.  I had sharp pains throughtout my body so I went to the ER where a EKG and D-Dimer test was perfomed and was advised it was elevated and I left.  I went to the ER later that day who checked the D-Dimer who advised it was normal and was I  was released from there as well after monitoring.  The next day I began having sharp pains in my stomach and diarreah which prompted me to now go to hospital where a CT scan, X-Ray and EKG was perfomed there also which all results came back normal and advised I reach out to a Cardiovascular Specialist for the Chest pains and I have an appointment scheduled for 4/21/21 for further followup on that
Woke feeling achy- got worse as morning progressed. By 12 or 1pm I felt very achy and was sure I had a temp- I did not have it taken. I took ibuprofen. Aches lessen and by about 6pm I felt as if the temp had passed and I felt good. I slept well last night and woke feeling fine. I am NOT sure this was related to the vaccine but I thought it quite possible. In any event, any signs of fever and all over achiness passed in about a 12 hrs time period.
It started with a numbing feeling in my left arm and somewhat of cramping in that same wrist. About 2 minutes later, I felt extremely dizzy and lightheaded. My boyfriend realized that I stopped responding to him and my eyes rolled back. I ended up passing out, falling to the floor, and having convulsions for about 45 seconds before waking up extremely confused.
Patient tested positive for COVID on 7/29/2021, symptoms started on 7/28/2021. Admitted to hospital on 7/29/2021 Received Pfizer vaccine on 1/23/2021 & 2/13/2021
extrapyramidal syndrome from vaccine; shaking uncontrollably/ body tremors; uncontrolled convulsions/ seizure type activity; jaw was locked; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of EXTRAPYRAMIDAL DISORDER (extrapyramidal syndrome from vaccine), TREMOR (shaking uncontrollably/ body tremors) and SEIZURE (uncontrolled convulsions/ seizure type activity) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced TREMOR (shaking uncontrollably/ body tremors) (seriousness criterion hospitalization), SEIZURE (uncontrolled convulsions/ seizure type activity) (seriousness criterion medically significant) and TRISMUS (jaw was locked). On 30-Mar-2021, the patient experienced EXTRAPYRAMIDAL DISORDER (extrapyramidal syndrome from vaccine) (seriousness criterion hospitalization). The patient was hospitalized on 30-Mar-2021 due to EXTRAPYRAMIDAL DISORDER and TREMOR. At the time of the report, EXTRAPYRAMIDAL DISORDER (extrapyramidal syndrome from vaccine), TREMOR (shaking uncontrollably/ body tremors), SEIZURE (uncontrolled convulsions/ seizure type activity) and TRISMUS (jaw was locked) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electroencephalogram: Diagnosed Extrapyramidal syndrome from vaccine. On an unknown date, Magnetic resonance imaging: normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient has always been healthy. She was prescribed high strength Benadryl and Vistaril. These treatment medications did not help her and she went back again to emergency room.  She was a college student and got vaccinated so she could continue her education in person. Concomitant medications were not reported.  Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Right arm soreness Dec 24 , Fatique on Dec 25 , Severe Chills DEC 26 and fever of 101.5
not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced MALAISE (not feeling well). At the time of the report, MALAISE (not feeling well) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow up TCR report received included no new information.
very slight low grade fever; This is a spontaneous report from a contactable consumer (patient) via Regulatory Authority. A 62-years-old 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 on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter mentioned that she had a very slight low-grade fever on an unspecified date. The event outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
EXTREME fatigue,body aches,no appetite,felt out of it,mild HA,NO energy,slept
Information has been received from a registered nurse and a 64 year old male consumer, reporting on himself, with no pertinent medical history, drug reactions or allergies reported, who on 19-APR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot #, dose and route not reported). Concomitant therapy included allopurinol. Consumer reported that on 20-APR-2011 he experienced swelling and a rash at the injection site which went away. He reported that on approximately 22-APR-2011, a couple of days later, a bug or flu developed where he felt nauseous and his bones hurt. Registered nurse confirmed that on 19-APR-2011, patient was vaccinated with ZOSTAVAX (Merck) (lot #, dose and route not reported). She reported that on 22-APR-2011, three days later, patient called the doctor's office to report he experienced flu-like symptoms: nauseous, bone aches, chills, feeling hot and cold. Nurse stated consumer never said he had a rash. No treatment was given for the events. No lab/diagnostic studies were performed. On an unspecified date, patient recovered. Additional information has been requested.
24 hours after shot: blister at site of vaccine lasting 1 week 1 week after shot: blood blister at site of vaccine, lasting a few days 4 weeks after shot: dizziness/vertigo, lasting 4 months (until present) 2 months after shot: vision problems, lasting 2 months (until present) 3 months after shot: paresthesia in foot and hand, lasting 1 month (until present)
no adverse effects reported; 33 year old male patient was administered dose one of GARDASIL 9; This spontaneous report was received from a pharmacist and refers to a 33-year-old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date in December 2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), on an unknown date in February 2020, he was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and on 18-SEP-2020 (reported as today), he would be vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (site and route of administration, lot# and expiration date were not reported for any) for prophylaxis. No adverse effects were reported.
Red itchy rash on my left arm near the vaccination site -- about 6 inches long and 3 inches wide. Treated with over-the-counter Cortizone creme
Extreme dizziness; Vomiting; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Extreme dizziness), NAUSEA (Nausea) and VOMITING (Vomiting) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016m20a) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 02-Mar-2021, the patient experienced NAUSEA (Nausea). On 04-Mar-2021, the patient experienced DIZZINESS (Extreme dizziness) and VOMITING (Vomiting). On 03-Mar-2021, NAUSEA (Nausea) had resolved. On 04-Mar-2021, DIZZINESS (Extreme dizziness) and VOMITING (Vomiting) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient believes that dizziness and vomiting were caused by another medication he was prescribed. No concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Stroke  complete left side paralysis and weaknesses  first pregnancy completely normal  vaginal delivery 6lbs 10 oz
This spontaneous case was reported by a patient family member or friend and describes the occurrence of DIZZINESS (Felt dizzy all day long), MALAISE (Not feeling well/feels unwell), PRESYNCOPE (Almost fainted, she felt like she would pass out), PYREXIA (103.5 Fahrenheit degrees fever/99-100 Fahrenheit degrees fever) and VACCINATION SITE SWELLING (This morning (13Sep2022) her arm on the site of injection is double its size) in a 20-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. A57145B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Patient was never tested positive for Covid-19. Concurrent medical conditions included Adhesive tape allergy. Concomitant products included ELAGOLIX SODIUM (ORILISSA) and ESTROGENS CONJUGATED (PREMARIN) for an unknown indication. On 10-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Sep-2022, the patient experienced PRESYNCOPE (Almost fainted, she felt like she would pass out) and PYREXIA (103.5 Fahrenheit degrees fever/99-100 Fahrenheit degrees fever). On 11-Sep-2022, the patient experienced DIZZINESS (Felt dizzy all day long). On 12-Sep-2022, the patient experienced MALAISE (Not feeling well/feels unwell). On 13-Sep-2022, the patient experienced VACCINATION SITE SWELLING (This morning (13Sep2022) her arm on the site of injection is double its size) and INJECTION SITE INDURATION (Site of injection swollen and hard). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, DIZZINESS (Felt dizzy all day long), MALAISE (Not feeling well/feels unwell), PRESYNCOPE (Almost fainted, she felt like she would pass out), PYREXIA (103.5 Fahrenheit degrees fever/99-100 Fahrenheit degrees fever), VACCINATION SITE SWELLING (This morning (13Sep2022) her arm on the site of injection is double its size) and INJECTION SITE INDURATION (Site of injection swollen and hard) outcome was unknown.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Sep-2022, Body temperature: 103.5 103.5 Fahrenheit degrees fever. On 12-Sep-2022, Body temperature: 99-100 Fahrenheit degrees fever. Patient took Moderna first dose on 16-Feb-2021 (lot number 011M20A), Moderna second dose on 16-Mar-2021 (047A21A), Moderna 1st booster dose on 12-Nov-2021 (lot number 033F21A). Concomitant medication reported as Hormonal IUD with description Progesterone. The patient visited the hospital, where some tests were conducted. The tests were normal. The patient was released midnight from the hospital. This case was linked to MOD-2022-645021 (Patient Link).
This is a spontaneous report obtained from a contactable consumer. This consumer reported similar adverse event for three different patients. This is the second of three reports.  A male patient received PREVNAR 13 on an unspecified date. Relevant medical history and concomitant medications were unknown. ON an unspecified date, in NOV 2013, while on PREVNAR 13 the patient experienced rash on arm, swelling on arm, inflammation on arm, fever and sores. Relevant laboratory data was unknown. Therapeutic measures taken in response to the events were unknown. At the time of this report, the patient recovered from the event, sores (lasted for two days) while clinical outcome of the events was unknown.   Follow-up (16JAN2014): Follow-up attempts completed. No further information expected.