chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 19-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 55 years old female patient for whom incorrect product storage happened while she received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had no concomitant medication. On 19-Nov-2018, the patient received a dose of suspect Diphtheria-2/Tetanus/5 Ac Pertussis Vaccine lot lot number: U6103AA; EXP date: 25-oct-2018 via intramuscular route in the left deltoid. It was reported that the ADACEL shipment received was not viable as it was too long in transit and One ADACEL immunization was already given to a patient with the vaccine that was determined to be not viable. It was a case of actual medication error due to incorrect product storage issue.  Final diagnosis was vaccine that was determined to be not viable as it was too long in transit. 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 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.
Narrative: 63 yo female patient with the following problem list: PROBLEM LAST MOD PROVIDER Diabetes mellitus (SCT 73211009) (ICD-10-CM 08/14/2019 E11.8) Hyperbilirubinemia (SCT 14783006) (ICD-10-CM 09/15/2017 R69.) Needs follow up CT of possile obstruction Dec, 2017. Depressive disorder (SCT 35489007) (ICD-10-CM 09/02/2017 F32.9) Alcohol withdrawal-induced seizure (SCT 08/29/2017 308742005) (ICD-10-CM R69.) Autoimmune hepatitis (SCT 408335007) (ICD-10-CM 05/17/2017 K75.4) Homeless single person (SCT 160700001) 04/11/2017 (ICD-10-CM Z59.0) (ICD-10-CM Z01.20); ENCOUNTER FOR DENTAL 03/20/2017 EXAMINATION AND CLEANING WITHOUT ABNORMAL FINDINGS Heavy tobacco smoker (SCT42871000124103) 03/09/2017 (ICD-10-CM F17.200) Alcohol withdrawal syndrome (SCT 191480000) 03/06/2017 (ICD-10-CM F10.239) Adjustment disorder with mixed disturbance of 02/06/2017 emotions AND conduct (SCT 66381006) (ICD-10-CM F43.25) Alcohol dependence (SCT 66590003) (ICD-10-CM 02/06/2017 F10.99) Obstructive sleep apnea of adult (SCT 02/06/2017 1101000119103) (ICD-10-CM G47.33) Borderline personality disorder (SCT 20010003) 02/06/2017 (ICD-10-CM F60.3)  Alcohol abuse (SCT 15167005) (ICD-10-CM F10.129) 02/03/2017 Had made a call to suicide hotline on 12/16/2021. Pt was found deceased on 12/17/2021 by officer of welfare check. Coroner confirmed that the official cause of death was natural passing with HTN and chronic etoh abuse. Pt had received one J&J covid vaccine on 8/13/2021. This death is not related to covid vaccine.
COVID 19 contracted in July, 2022, hospitalized for 3 days, received oxygen part of the time, ambulatory throughout
Intense nausea (thought I would throw up), headache, fever, chills, sore arm (hot to touch). I have never had adverse reactions to a vaccine before.
Patient describes having a metal taste and smell two weeks following her vaccination on 05/22/2021.
swelling and rash started on arm 2 days after vaccine then spread to face, slight itching
Red, burning, itchy left eye where she had previously (years prior) had a shingles outbreak. Reaction not confirmed as shingles.  Also had significant flu-like symptoms that lasted 7 days and fatigue still at day 10.  No reactions to first shot in series.
Almost immediately after this patient had her shot her arm became sore, swollen, hot, and itching. It got worse and she went to the ER. She was given Prednisone, Benadryl, and Motrin. The patient also used ice, she was told not to take another Pneumonia shot unless made differently.
hair loss; This spontaneous case was reported by a patient and describes the occurrence of ALOPECIA (hair loss) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     The patient's past medical history included Fever. Concomitant products included INFLUENZA VACCINE for an unknown indication.    On 07-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALOPECIA (hair loss). The patient was treated with MINOXIDIL (ROGAINE) at an unspecified dose and frequency. At the time of the report, ALOPECIA (hair loss) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Thyroid function test: Normal.     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.   It was reported that patient hair was very long at one point, but now it's very thin. She stated that it started after  the Moderna vaccine. Then patient had her flu shot the next week. She wonders if she took them too close together. Patient states she didn't have a reaction before the Moderna. Patient felt it was overnight that she started losing hair. Patient did not have this issue with the other shots. Did not get any reaction. She did have a small fever last spring.
Within 5-7 minutes after injection, throat started to close up and heart started to race (elevated from upper 60?s to about 135-140 - checked on Apple Watch).  Having reaction Reported to pharmacist who offered ambulance and inquired if I was anxious (wasn?t until my throat started to close). It didn?t close further but stayed very scratchy and uncomfortable, HR remained elevated 90?s ish). Finally one hour after shot, I purchased and took a dose of Benadryl which helped; at 530 PM took another dose of Benadryl as throat became increasingly scratchy /uncomfortable which again helped. Woke at 230 am finally feeling that reaction had passed. Pharmacist encouraged returning for next shot despite reaction. I participated in V-safe and reported reaction same day as vaccine. Researched on own to try and figure out 2nd dose or no as did not feel pharmacy was equipped for anaphylaxis. Finally called and spoke with Moderna on 4/5/21 and they indicated this was definitely an acute allergic reaction and should be reported to VAERS and 2nd dose was contraindicated     Spoke with pharmacist on 4/6 (date scheduled for 2nd dose - my husband was getting his 2nd dose) and she did not discourage 2nd dose but I elected to follow up with my allergy testing as recommended by CDC which is now pending
On 10/16/08 at approximately 10:30 a.m. I started to feel light headed and dizzy. I went home at 11:30 a.m. and by the time I got home I felt dizzy, light headed, I had the chills and felt weak. I had to lay down and did not start to feel better until the next morning. I have never had a reaction to the vaccination before.
significant bruising still 2.5 weeks after injection. joint pain, low back pain, stiff neck on side of injection.
third covid 19 vaccine caused chills and diarrhea increased; third covid 19 vaccine caused chills and diarrhea increased; This spontaneous case was reported by a non-health professional and describes the occurrence of DIARRHOEA (third covid 19 vaccine caused chills and diarrhea increased) and CHILLS (third covid 19 vaccine caused chills and diarrhea increased) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis and Crohn's disease.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced DIARRHOEA (third covid 19 vaccine caused chills and diarrhea increased) and CHILLS (third covid 19 vaccine caused chills and diarrhea increased). At the time of the report, DIARRHOEA (third covid 19 vaccine caused chills and diarrhea increased) had not resolved and CHILLS (third covid 19 vaccine caused chills and diarrhea increased) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Colonoscopy: unknown.         No Concomitant medications were reported. No treatment medications were reported. 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.
3 weeks of fatigue, chills, night sweats, no fever, general malaise, sore throat, "odd" headache, loss of appetite
tested positive for herpes.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HERPES ZOSTER (non-serious) with onset 2021, outcome "unknown", described as "tested positive for herpes.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Called in because his sexual partner recently got the Pfizer covid-19 vaccine 6 or 8 months ago and tested positive for herpes. He wants to know if vaccines trigger dormant herpes in somebody's body.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Approximately 1-2 minutes post vaccine injection, pt collapsed, fell into mother's arms from standing position (? stiff ? shaking per mother), lost consciousness 2-3 seconds, I arrived in room took child (limp, pale, waking up), placed her supine on exam table -> immediate return of color & alertness BP nl (100/60) Pulse 80 neg T 97.3, remained well immediate post event minutes, observed at home - event most consistent with vasovagal syncope.
My father passed away on February 10th, 2021. On Monday, January 25th 2021, he said he is feeling very uncomfortable in his chest area. He thought it was severe acid reflux. He took Gas X for Acid Reflux and told us that he does not want to go to the hospital. On Tuyesday, January 26th, he felt that his Acid Reflux symptoms got worse, he still did not want to go to the hospital. He took Tums. On that evening, he started having shortness of breath. We took his BP at home and it was very low. We begged him to go to the hospital, he still did not want to go. On Wednesday, January 27th, his shortness of breath got worse and we convinced him that he has to go to the hospital. We took him to ER. Doctor said that he had a heart attack on Monday morning and that is why he was not feeling well since Monday morning. While at the hospital, while the cardiologists were monitoring him, his heart condition got worse.  By Friday, February 5th, cardiologists said that he is very fragile, his heart condition is very fragile and he won't survive any procedure. They said that something triggered the heart attack. We told them about the vaccination on 1/13/2021. They sent him home on hospice on Friday, Feburary 5th, 2021. He was on supplemental oxygen when he came home. He passed away due to a heart attack on February 10th, 2021 around 9pm.
1025 22 y/o new hire employee had change in level of consciousness. He  was  alert to self but slow to respond to verbal  command and tactile stimuli , On  presentation he was pale and diaphoretic and hypotensive  VS  88/45 HR 54 94% on RA  Oral  hydration  given .1035  107/55 HR 68  92% on RA . His vital signs improved after hydration and rest .1045 VS 110/65 HR 61 100% on RA. 1100 Employee was discharged and transported out to his care via a wheelchair assist x 1.
Patient complained of very sore arm the day after vaccination. Low mobility. She called it "dead arm." Improving about 10% per day. Pt consulted MD & was told he has seen this before w/ flu shot.
PENTACEL was administered without reconstituting with the acthib portion of the vaccine/No AE; Initial information received on 29-Sep-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 6 months old female patient who received a 0.5mL dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] without reconstituting with the HIB (PRP/T) VACCINE [ACT-HIB] [lot number: U6395AB, expiry date: 03-May-2021] portion of the vaccine via Intramuscular route on right vastus lateralis site on 29-Sep-2020.   The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE, PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ).   It was an actual medication error due to inappropriate reconstitution technique (latency same day).  At the time of report, no adverse event was reported.  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 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.
Pt called hospital call center on 10/27/21 to report side effects w/ vaccine.  PT received 2nd dose on 10/19/21.  C/o  headache, body aches, runny nose, cough that hurts and occasional sob. Denies chest pain or other emergency symptoms. Taking Mucinex for symptoms relief.  Pt schedule for visit with urgent care provider on 10/28/21AM. Pt advised for ER precautions in the intermin. She verbalized understanding
On 3/22/22, patient received Moderna COVID vaccine booster dose (0.25mL) lot # 013H21B, but this lot # expired on 3/19/22 (per manufacturer's expiration date). Moderna was contacted and they confirmed that: "The vaccine administered on March 22, 2022 from lot number 013H21B maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration." Thus, we did not need to repeat the booster dose.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 at 15:45 as dose 2, single (Batch/Lot number: unknown) at the age of 56 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "no chronic conditions except year round allergies" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (21Aug2023) Positive, notes: tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course:  The patient received COVID-19 treatment from 14Aug2023 to 18Aug2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Severe body aches, headache, mild sore throat, site of vaccine red, hard, hot to touch, swollen to about the size of a baseball.  Fevers from 101.5 to 103.1 over three days that would not break with Tylenol or Motrin.  Nausea and vomiting for one day.
Fever 101.1, body ache, lethargy. After tylenol was given at 6:30 a.m., the fever went away, but the body ache and lethargy remained.
since receiving the vaccine she has experienced premature aging./ her skin has aged and looks like that of a 90 year old.; also experiencing hair loss.; scared to take the 2nd dose/ first dose on 17MAY2021.; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Jul-2021 and was forwarded to Moderna on 14-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PREMATURE AGEING (since receiving the vaccine she has experienced premature aging./ her skin has aged and looks like that of a 90 year old.), ALOPECIA (also experiencing hair loss.) and PRODUCT DOSE OMISSION ISSUE (scared to take the 2nd dose/ first dose on 17MAY2021.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included RISPERIDONE for an unknown indication.    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PREMATURE AGEING (since receiving the vaccine she has experienced premature aging./ her skin has aged and looks like that of a 90 year old.), ALOPECIA (also experiencing hair loss.) and PRODUCT DOSE OMISSION ISSUE (scared to take the 2nd dose/ first dose on 17MAY2021.). At the time of the report, PREMATURE AGEING (since receiving the vaccine she has experienced premature aging./ her skin has aged and looks like that of a 90 year old.), ALOPECIA (also experiencing hair loss.) and PRODUCT DOSE OMISSION ISSUE (scared to take the 2nd dose/ first dose on 17MAY2021.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment drugs included
Complaint of cough, sore/scratchy throat, headache, runny nose/congestion, and myalgia
Daughter noticed day after vaccination, that area 2-3 inches below vaccine site was warm, red, raised in "U" shape. The next morning it became painful and after being assessed at pharmacy, pt was seen at Urgent Care and thought to have possible cellulitis/reaction to vaccine. Given KEFLEX and clear within 48 hours.
This spontaneous report as received from a nurse refers to a unspecified number of patients (unknown age and gender). In unknown date in 2014 the patients were vaccinated with GARDASIL dose, route of administration and lot# were not reported. On 23-MAY-2014 doses of GARDASIL was exposed to -1C for 2 hours. Reporter stated that there other excursions that were below 2C, and she did not have that information organized presently in order to report it. Reporter would "run a report" of the patients who received these improperly stored doses and she would provide the full details of the excursions. There were no adverse experience to report at the time of report. Case linked with MARRS # 1406USA010046 (Same Reporter Link). Additional information has been requested.
Shingles that began May 17, 2021; Cold sore that began April 13, 2021; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 30Mar2021 at 10:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient previously took sulfa drugs and experienced sulfonamide allergy. Concomitant medications taken within two weeks of vaccination included estradiol (MANUFACTURER UNKNOWN) and progesterone (MANUFACTURER UNKNOWN) both from unknown date for unknown indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 09Mar2021 at 10:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced cold sore that began on 13Apr2021 at 04:00. The patient experienced shingles that began on 17May2021. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of shingles and included treatment with Valtrex from 21May2021. The clinical outcome of the events cold sore that began on 13Apr2021 and shingles that began on 17May2021 was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Approximately 20 minutes after vaccine administration patient indicated swelling and "tingling" on right cheek.
Alleged episode of clonic contractions of arms and head. Lasted approx. 30 seconds. No alt LOC.
Motor tics began within 48 hrs of immunization causing minor symptoms of blinking and head movement.
Patient felt just fine the day he got the vaccination.  The next day he had high fever, myalgias, anorexia.  He lost consciousness and had to go to the hospital and was hospitalized for five days.  9/19/21 US R arm revealed a DVT in his R brachial artery requiring 3 months of Eliquis.
Breakthrough case admission after 3 vaccine pfizer 4/29/21 lot# Ew0150;  Pfizer 5/20/21 lot# Ew0158;  Pfizer 11/2/21 lot# FF2590
Patient felt dizzy, hot, and described his vision as "everything went black." Patient passed out but was caught by his mother and lowered to the floor. He was given cool washcloths, BP monitored, pulse ox and pulse monitored. First vitals: BP 104/63, pulse 72, POx 99; Second vitals: BP 108/72, Pulse 103 (moved to a sitting position), POx 99; Third vitals 117/76, Pulse 77, POx 99; BP 120/74 (standing), Pulse 88, POx 98. Patient reported last eating a meal at noon. Patient was given water and a Coca-Cola to drink.
drooping face on tight side, diagnosed as Bell's Palsy in the ER; Numbness of lips; This is a spontaneous report received from a contactable other non-Health Care Professional (Patient). A 64-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: En6201 and expiry date was not provided), via an unspecified route of administration, in Arm left, on 12-MAR-2021 10:45 AM (at the age of A 64-year-old) as a single dose for COVID-19 immunization. Medical history included Diabetes, high blood pressure and Allergies to medications, food, or other products Tetanus Shot. Concomitant medications received within 2 weeks of vaccination were Magnesium 500mg, Lisinopril 20mg, Chlorthalid 25mg. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. It was reported that numbness of lips, drooping face on tight side. Diagnosed as Bells Palsy in the ER. CAT scan to rule out other causes on 19Mar2021. Patient went to Emergency room/department or urgent care, where the patient put on Prednisone for 5 days and anti-viral for 7 days for the adverse events. Outcome of the events was Not recovered.