chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Narrative: 74yo male died of unknown causes on 12/3/2021 at outside hospital. Last note dated 10/22/21 so no info about pt's condition near death timeframe available. Pt had the following problem list: PROBLEM LAST MOD PROVIDER Neck pain (SCT 81680005) (ICD-10-CM M54.2) 03/09/2021 CAD - Coronary artery disease (SCT 53741008) 05/05/2020 (ICD-10-CM I25.10) CHF - Congestive heart failure (SCT 42343007) 04/29/2020 (ICD-10-CM I50.9) Pneumonia (SCT 233604007) (ICD-10-CM J18.9) 04/29/2020 Subdural hematoma (SCT 95453001) (ICD-10-CM 04/23/2020 S00.80XA) Kidney stone (SCT 95570007) (ICD-10-CM N20.0) 01/13/2020 Solitary nodule of lung (SCT 427359005) 01/13/2020 (ICD-10-CM R91.1) Depression (SCT 35489007) (ICD-10-CM F32.9) 03/12/2019 Knee pain (SCT 30989003) (ICD-10-CM M25.569) 08/21/2018 Shoulder pain (SCT 45326000) (ICD-10-CM M25.519) 08/21/2018 Vertigo (SCT 399153001) (ICD-10-CM H81.10) 11/20/2019 Carotid artery stenosis (SCT 64586002) 12/13/2016 (ICD-10-CM I65.29) Nonspecific (Abnormal) Findings on Radiological 04/08/2014 and other Examination of Musculoskeletal System (ICD-9-CM 793.7) Chronic airway obstruction, Not Elsewhere 01/13/2020 Classified (SCT 13645005) (ICD-10-CM J44.9) (ICD-9-CM 780.57); SLEEP APNEA NOS 09/24/2012 (ICD-10-CM F33.9); Depression (SNOMED CT 12/07/2015 35489007); Orthostatic hypotension 09/25/2018 (SNOMED CT 28651003) (ICD-10-CM H90.5); Hearing loss (SNOMED CT 10/07/2021 15188001) (ICD-9-CM 724.2); Chronic low back pain 03/30/2010 (ICD-9-CM 719.41); Pain in joint involving 03/30/2010 shoulder region (ICD-9-CM 719.41) (ICD-9-CM V67.9); Unspecified Follow-up 10/16/2007 Examination (ICD-9-CM V67.9)(ICD-9-CM 790.29); Hyperglycemia * (ICD-9-CM 10/16/2007 790.29) (ICD-9-CM 592.0); Nephrolithiasis * (ICD-9-CM 08/29/2006 592.0) (ICD-9-CM 702.0); Actinic Keratosis 10/05/2005 (ICD-10-CM E66.3); Overweight (SNOMED CT 12/07/2015 238131007) (ICD-9-CM 709.9); Skin Diseases (ICD-9-CM 709.9) 02/08/2005 (ICD-9-CM 211.3); Colon Polyp (ICD-9-CM 211.3) 08/02/2004 (ICD-9-CM 793.1); Multiple nodules of lung 08/02/2004 (ICD-10-CM Z72.0); Tobacco Use (SNOMED CT 12/07/2015 110483000) (ICD-10-CM E78.2); Hyperlipidemia (SNOMED CT 12/07/2015 55822004) (ICD-9-CM 607.84); Impotence of organic origin 02/05/2003 (ICD-9-CM 607.84) Benign neoplasm of colon (ICD-9-CM 211.3) 11/16/2001 Essential Hypertension (SCT 1201005) (ICD-10-CM 12/07/2015 I10.) Pt had record he has received one J&J covid vaccine on 3/9/21 from outside provider. This death is likely not related to the vaccinations due to the patient's comorbidities, advanced age, and length of time from vaccine administration.
Pt. noticed on 10-21/11 - 50 cent sized red circle around injection site, no swelling, itches a little bit.
Given Tdap (L) deltoid on 6/16/15. Revisit 6/17/15-blister (bleb) noted at injection site-0.8 x 0.2 cm. No itching/burning/pain/redness.
This spontaneous report was received from a pharmacist and refers to a 20 year old female patient. The patient's pertinent medical history and concurrent conditions were not provided. On 18-AUG-2016, the patient was vaccinated with the first dose of M-M-R II lot # L027591, expiration date 23-JUL-2017, intramuscularly. Concomitant therapy information was not provided. In 2016, the patient experienced injection site pain. It was reported that at the time of the report, the patient was still experiencing pain at the injection site from the M-M-R II administration, so the outcome of injection site pain was reported as not recovered. The pharmacist did not assess the relationship of the injection site pain to M-M-R II. A product quality complaint was not involved. Additional information has been requested.
The vial was first punctured on 06-Jul-2022 and was stored in fridge post puncture; Patient was administered with the dose more than 12 hours of post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with the dose more than 12 hours of post puncture) and PRODUCT STORAGE ERROR (The vial was first punctured on 06-Jul-2022 and was stored in fridge post puncture) in an 80-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 060A22A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jul-2022 at 7:25 AM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 07-Jul-2022 at 7:25 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with the dose more than 12 hours of post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was first punctured on 06-Jul-2022 and was stored in fridge post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with the dose more than 12 hours of post puncture) and PRODUCT STORAGE ERROR (The vial was first punctured on 06-Jul-2022 and was stored in fridge post puncture) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that the vial was initially stored in the refrigerator on 29-Jun-2022 and the date and time vial was first punctured was on 06-Jul-2022 at 7:49.The vial had not undergone any temperature excursions and the total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was Less than 30/45 minutes  No treatment medications were reported.  This case contains information for the 1st patient out of 2 patients described by the reporter.   This case was linked to MOD-2022-615591 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD-2022-615591:2nd patient
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021 at 4:21 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Nov-2021 at 4:21 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   There was no concomitant list was provided by the reporter. No treatment medications were provided.  The patient was administered vaccine that was stored at temperature between minus 80 degree F to minus 84 degree F. It was unknown if patient had allergy to medications, food and other products. It was unknown if the patient was ever diagnosed with or tested positive for COVID-19. Patient's acute illness at the time of vaccination and up to one month before was unknown. Chronic or long-standing health conditions were unknown. Prescription, over-the-counter medications, dietary supplements, or herbal remedies being taken at the time of vaccination and or at the time of the adverse event was unknown.
neuropathy amplified; uncomfortable; This case was reported by a consumer via call center representative and described the occurrence of neuropathy in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th August 2021, the patient received the 1st dose of Shingrix. In August 2021, 24 hrs after receiving Shingrix, the patient experienced neuropathy (serious criteria GSK medically significant) and discomfort. On an unknown date, the outcome of the neuropathy and discomfort were recovered/resolved.   It was unknown if the reporter considered the neuropathy and discomfort to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The age at vaccination was not reported. The patient had received her first dose of Shingrix and after about 24 hours the patient experienced being uncomfortable and neuropathy which might had been amplified.  This had lasted for about 2 weeks. The reporter did not consent to follow-up. This case was linked with US2021192008, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021192008:same reporter
Patient felt very sick the evening the vaccine was given.  She felt dizzy,severe flu like symptoms.
fever; chills; achiness; sore arm; feeling swelling; pressure around her eyes; This case was reported by a consumer via call center representative and described the occurrence of fever in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 4ME42, expiry date 14th November 2021) for prophylaxis.  On 27th February 2020, the patient received the 1st dose of Shingrix (intramuscular). On 2nd March 2020, 4 days after receiving Shingrix, the patient experienced periocular swelling and sensation of pressure in eye. On an unknown date, the patient experienced fever, chills, pain and pain in arm. On an unknown date, the outcome of the fever, chills, pain, pain in arm, periocular swelling and sensation of pressure in eye were recovered/resolved.   It was unknown if the reporter considered the fever, chills, pain, pain in arm, periocular swelling and sensation of pressure in eye to be related to Shingrix.  Additional case details were reported as follows: This case was reported by patient herself. Less than 2 weeks after receiving Shingrix, the patient experienced fever, chills, achiness, and sore arm for a couple days. The patient also experienced feeling swelling and pressure around her eyes. The reporter consented to follow up.   Follow up information received from health care professional on 21st April 2020: The patient demographics details were updated. The batch details and expiry details of the suspect vaccine were updated. Generally healthy adult. Concurrent medical conditions included allergy to neomycin (rash), nickel sensitivity and allergy to metals. The patient had allergy of adhesive patches. The patient received the Shingrix 0.5ml. The patient did not report side effect to ours office. The VAERS details were updated.
Tiredness, chills, headache, body aches, loss of appetite, vomiting
Information has been received from a physician concerning a male infant who on 12-AUG-2008 was vaccinated with a dose of RECOMBIVAX HB.  The reporting physician reported that the patient tested positive for Hepatitis B core antigen ("Hepatitis B Core IgM") after receiving the vaccine at another hospital.  The infant's mother tested negative for Hepatitis B and the reason why the infant received the RECOMBIVAX HB at birth was unknown.  At the time of this report the infant was hospitalized in the neonatal intensive care unit.  The patient developed unspecified hepatic dysfunction symptoms and a test for Hepatitis B core antigen was positive.  No other symptoms or treatment reported.  The patient had not recovered.  Additional information has been requested.
An expired vaccine was given on 3/12/2023. Vaccine expired 3/11/2023
Patient stood up after vaccination and asked for water. The Pharmacist  was getting water and he passed out. She went over with emergency kit and helped patient off the floor. He had a pulse and was breathing the entire time. She did not have to administer any medications. She called 911 and paramedics were here within minutes. He told the pharmacist after the shot that he passes out with shots , even though he put no on the form.  Patient was fine and denied to go to hospital.
Hives and ithcing starting a day or two post vaccine, which persisted for 3 weeks.
Pain in left elbow and in anterior muscle from elbow to mid arm.  Started day after receiving second COVID vaccine.  Bruise remains at injection site, lite purple and tender to touch.
1 week after injection I developed superficial blood clots in my Left Calf, that still have not resolved.  Left arm and shoulder pain and headaches.
RED RASH ON RIGHT INNER DELTOID (NOT AT INJECTION SITE). RASH IS WARM TO TOUCH. PATIENT FEELS TIRED AND RUN DOWN.
Mild headache began 2 hours before the adverse event. At time of event, while seated, suddenly entire face went cold/numb, blood pressure seemed to drop significantly (did not have ability to monitor it), face and lips were pale, fingertips were cold. Felt like fainting, could not move or send a text message / call for help for about 10 minutes. I was afraid I was going to faint or fall off the seat but was able to prop myself against a box. The rest of my body was not cold and I had to remove a sweatshirt because it felt too warm. I have had a few vasovagal reactions in the past 20 years (very rare events, about 1x per year at most and usually much less frequent than that). I felt dehydrated despite drinking water throughout the day. After I was able to move again, I lay down for about 30 minutes with monitoring and gradually felt normal again. The injection site has felt very mildly sore but nothing unusual for a vaccination.
4 days after 9-18-10 injection - cramping (L) increase arm, lifting arm causes pain + hurts to lower arm - pain increasing, (L) forearm darker + cooler. No redness or inflammation at injection site.
Patient was on waiting area after vaccine administration, when suddenly he stood up and voice to that he was feeling lightheaded. We proceeded to seat him down and loosen his clothing and provide cold packs on his head and neck. While seated, loss consciousness for 30-60 seconds.  Nurses were working, one taking Vital Signs, one holding his head and the last one was talking to Soldier and  asking to express symptoms.  While working with patient, doctor came to further asses.
one of the children did not receive the ACT-HIB portion of the vaccine, with no reported adverse event; Initial information received on 04-Jan-2022 regarding an unsolicited valid non-serious case was received from the health professional.  This case involves a 5 months old male patient who did not receive the act-hib portion of the vaccine, with no reported adverse event while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), and family history were not provided.  Concomitant medications included rotavirus vaccine (Rotavirus Vaccine) for prophylactic vaccination; and hepatitis b vaccine (Hepatitis B Vaccine) for prophylactic vaccination.  On 15-Dec-2021, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (Strength : 0.5 ML; form, dosage: unknown; lot/batch number: UJ569ABA) via intramuscular route in unknown administration site for immunization.  On 15-DEC-2021 the patient developed a non-serious event 'one of the children did not receive the act-hib portion of the vaccine, with no reported adverse event' (product preparation error) (latency: same day) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  It is reported 'Caller reporting that two children received the PENTACEL vaccine on 15Dec2021 but one of the children did not receive the ACT-HIB portion of the vaccine. Caller stated they do not know which one of the patient did not receive the ACT-HIB portion. Caller is wanting to find out what to do'.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable.  At time of reporting, the outcome was Unknown for the event one of the children did not receive the act-hib portion of the vaccine, with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Resident tested positive for COVID on 01/11/2021. Resident received out patient monoclonal antibody treamtent on 01/12/2021.
Pt received a Tdap immunization in the R deltoid on 2/5/07. She had no reaction until 2/11/07. At that time she started itching and noticed two 3x3 inch area of erythema with a 1/2 inch area that connected them. Seen by Dr. No apparent infection. Spoke with pt today and it is itching and is fading. Not itching 2/13/07 and decreased erythema.
Received a Moderna's Pediatric Monovalent dose instead of the Bivalent Booster; No Adverse Event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received a Moderna's Pediatric Monovalent dose instead of the Bivalent Booster) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Received a Moderna's Pediatric Monovalent dose instead of the Bivalent Booster) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received a Moderna's Pediatric Monovalent dose instead of the Bivalent Booster) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Received a Moderna's Pediatric Monovalent dose instead of the Bivalent Booster).    No concomitant medications were reported.  It was reported that total 3 Adult patients received Moderna's monovalent Pediatrics for primary series 6 to 11 years instead of Moderna's Bivalent booster dose.  No treatment information was reported.  This case is for 1st adult patient.   This case was linked to US-MODERNATX, INC.-MOD-2022-662909, US-MODERNATX, INC.-MOD-2022-662904 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662909:Adult 3 US-MODERNATX, INC.-MOD-2022-662904:Adult 2
Pt reports arm pain that has been present since injection 43 days ago.  Pt. says that pain has been inhibiting her left arm rotation.  Pt says that pain has been steadily decreasing but suddenly was worse in the past two days.  Pt. has taken oral pain relievers (IBN/TYLENOL) but neither has relieved pain completely.
After the second dose of the Moderna mRNA vaccine, I became amenorrheic for two months, followed by a three-week period. Prior to the vaccine, I was completely regular with a 28 day cycle. My cycle is still inconsistent and I had my hormone levels tested in an attempt to restore balance.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 19-MAR-2016, the patient vaccinated with an improperly stored dose of ZOSTAVAX lot # L034724, expiration date 09-DEC-2016 (dose and route of administration were not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Rash below injection site; A red rash below injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE RASH (Rash below injection site) and VACCINATION SITE ERYTHEMA (A red rash below injection site) 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 28-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced VACCINATION SITE RASH (Rash below injection site) and VACCINATION SITE ERYTHEMA (A red rash below injection site). On 06-May-2021, VACCINATION SITE RASH (Rash below injection site) and VACCINATION SITE ERYTHEMA (A red rash below injection site) had resolved.        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.   No concomitant medications were provided. No treatment medications were taken by the patient.    Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Follow-up information received on 02-JUN-2021 contains non-significant information.
24 hours of fever between 100 and 101, muscle ache, joint pain, fatigue
Information has been received from a health professional concerning a 14 year old male who on 18-SEP-1998 was vaccinated with a 0.5 mL. dose of varicella virus vaccine live (Oka/Merck) (lot# 627337/1057H) once. On 07-JAN-2008, the reporter indicated that he developed breakthrough varicella. Unspecified medical attention was sought. No laboratory or diagnostic studies were performed. The reporter indicated that the physician had assumed that the patient recovered since they had not heard from the patient since the initial contact. A product quality complaint was not reported. Additional information has been requested.
14MAY97 140PM mom reports pt has rash, red w/white raised area pimple like on stomach, & back;tx w/DPH;
CDC reports: 16 mo child experienced screaming episode for > 3hrs & was "floppy" following DTP/OPV/MMR immun. Report states: NCVIA reportable event.
First he started with dizziness, lower extremity weakness,the metallic taste & smell; then progressed to palpitations, the SVT w/HR up to 180 lasting for about 20 seconds. All events resolved 6 hours later Narrative: He did not go to ER
Case number PHEH2015US020158, is an initial spontaneous report received from a nurse on 07 Oct 2015. This report refers to a patient of an unknown age of female patient. Past medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN (batch number: 1514601 and expiry date: not reported) intramuscularly on 07 Oct 2015. On the same day after vaccination, she experienced ill, burning, redness and swelling around the injection site. The outcome, seriousness and causality of the events were not reported. No further details provided.
08:05 am Nurse administrator vaccine too posterior on the arm. Numbness in right hand noticing around 10am.  Seek medical treatment at 410pm
Patient was waiting in observation after her shot when the nurse noticed swelling and redness of hands and face. Patient was immediately given 50 mg benadryl. Patient was given an ice pack and nurse assessed vitals. Patient was observeed for 30 more minutes and the symptoms subsided. W e gave her benadryl told her to take in 8 hours. Slight hives on face none on hands.