chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient, 60 yrs old, was given Fluzone High Dose, NO AE; Patient, 60 yrs old, was given Fluzone High Dose, NO AE; Initial information received on 17-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 60 years old male patient who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot number not reported via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to inappropriate age at vaccine administration and overdose.  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.  Information on the batch number was requested.
Shingrix :late for2nd dose; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (more than 1 year ago received 1st dose ).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Shingrix :late for2nd dose).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 19-SEP-2023 The physician reported that a patient who had 1 of 2 doses more than 1 year ago.  The reporter asked did she only need to had the 2nd dose of Shingrix or needed to start the vaccine sequence all over again. Till the time of reporting the patient did not receive the 2nd dose, which led to incomplete course of vaccination. Follow-up not possible as no contact details provided.
post herpetic neuralgia; herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient (pt) of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unknown date, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not specified) for routine health maintenance and the prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving zoster vaccine live (ZOSTAVAX) the pt suffered outbreaks of herpes zoster and post herpetic neuralgia. As a result of these symptoms, the pt was seen and treated by medical providers and still was under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms resulted in physical limitations not present prior to using the vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the vaccine, the pt suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The patient did not recover from the reported events. The lawyer considered the events to be related to zoster vaccine live (ZOSTAVAX).   The events of herpes zoster and post herpetic neuralgia were considered to be disabling.
Pain in the left arm at the injection site. More painful when moved certain directions (putting on clothes or taking clothes off). Pain doesn't get better with Aleve and pain has been there for 1 month now without going away.
STROKE; This spontaneous report received from a patient concerned an 80 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had always good cholesterol and was physically active. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on 30-MAR-2021 to left deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 24-JUN-2021, the patient experienced stroke and had weakness on the left side of body (left arm and left leg). The patient was recovering from the symptoms but it was slow and was still doing physical therapy and occupational therapy for the stroke. The patient attributed the stroke to the Janssen Covid-19 vaccine. The patient was in therapy at the hospital for 29 days. On 24-JUN-2021, the patient was admitted and discharged on 22-JUL-2021. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stroke. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211025160- COVID-19 VACCINE AD26.COV2.S- Stroke. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
I was not coherent, losing consciousness. I would act like I was high, my speech was slurred. I had swelling in my hands, legs, and feet, I went to the ER on June 2nd. I had a blood clot that disappeared. I had pain throughout my body. I now have high blood pressure and have been put on a medication
Days 2-5 following vaccine extremely painful pulsing pain type headache on same side as shot, with localized scalp soreness.  Pulses of pain would last for only 1-2 seconds, and were irregular in occurance, every 10 seconds to several minutes in between pulses.  Pain not eased by tylenol or motrin.  Also had accompanying nausea.
Information has been received from a registered nurse concerning a 36 year old female who on 2/17/99 was vaccinated with Hep b vaccine. Approximately 20 minutes post vax, the pt experienced nausea, dizziness, and headache. The pt recovered in 24 hours. It was also noted that the nurse used 2 5mcg doses instead of one 10 mcg dose. Follow up was received which indicated "not our patient".   No further information is available.
People that died; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DEATH (People that died) in a patient of an unknown age and 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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            The concomitant medications were not reported. The treatment information was not provided.   Company Comment : This case cannot be evaluated, it seems invalid. More info has been required to assess its validity.; Sender's Comments: This case cannot be evaluated, it seems invalid. More info has been required to assess its validity.; Reported Cause(s) of Death: Unknown cause of death
Headache, fatigue, joint pain (major joints), malaise lasting 36 hours post, diminishing to no s/s 48-72 hours post.
Pt experienced syncopal episode at vaccine table. According to vaccinator, episode lasted only "a few seconds". Pt was assisted to wheelchair and was taken to medical evaluation room for observation. Vitals were regularly obtained and Pt was observed for 15 minutes; during this time, Pt was administered water. After observation, Pt was assisted to observation area, where family was met, and Pt left without further incident.
Painful arm (Left arm), extremely large rash (Left arm), difficulty breathing, and hives/rash/itching spreading to entire body.
Redness, swelling, tenderness and slight itching of left thigh.  Trial of Benadryl.
Fever; Induration; This case was reported by a physician via sales rep and described the occurrence of fever in a 17-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Bexsero (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, 7 days after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced fever and induration. On an unknown date, the outcome of the fever and induration were unknown.   It was unknown if the reporter considered the fever and induration to be related to Bexsero and Bexsero Pre-Filled Syringe Device.This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient had fever at day 7 and not sure if it was related to the vaccine or not. The patient also had induration at day 9.
Hospitalized 11/12/2021-still admitted currently; COVID-19 positive 11/11/2021; fully vaccinated.  ASSESSMENT / PLAN:  56 y.o. female admitted to the ICU for status epilepticus that COVID-19. Assessment and Plan Pneumonia due to COVID-19 virus Assessment & Plan COVID-19 COVID Status: COVID confirmed  Lab Results Component Value Date   COVID19PCR Detected (A) 11/11/2021 Isolation: Severe Respiratory Isolation plan if COVID-19 negative: continue severe respiratory isolation Testing plan if COVID-19 negative: none  Decadron 6 milligram daily for 10 days.  Remdesivir for 5 days  Empiric antibiotics with clindamycin due to penicillin allergy and due to possible aspiration. Check sputum Gram stain and culture 11/18/2021 note: A/P Acute hypoxemic respiratory failure Airway protection d/t AMS after multiple seizures ETT 11/12 - current Goal fluid negative, lasix q8h Bronch 11/15 +burkholderia gladioli, ID consult Prop/Fentanyl/ versed for sedation Failing SBT's d/t tachypnea with profound weakness No PE COVID-19 +/- aspiration pneumonia S/P Moderna 3/21, no booster Steroids: Decadron 6mg 11/12-present Remdesivir 11/12-11/15 Toci not available Trend d-dimer Abx to complete 11/17
Information has been received from a registered nurse concerning a patient who on 16-OCT-2008 was vaccinated with VARIVAX (Merck) (LOT# 660897/0788X) instead of ZOSTAVAX (Merck). No adverse event complaints at this time. It was not reported whether the patient sought medical attention. Additional information was received from the nurse stating that vaccination error was human mistake- she was exhausted and pulled the wrong vaccine. Further information has been requested.
Vaccine was administered 3 days post Beyond use date. Moderna was contacted with no further actions needed.  Per Moderna, the lot number AS7148B maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration.
Took the Shingrix vaccination yesterday. They warned me of arm/muscle pain and possible flu-like sx. But I was not prepared for the significant malaise that developed. Injection site pain 6/10, pain with elevation of that arm enough to make me have to switch arms. Systemic body aches. Fever, persistent, even with ibuprofen - 100-101. Today, woke unable to go to work due to fever and malaise. Just thought I would let you know. I know these sx are WNL, but they are far more than I bargained for.
Noted pain in both arms, stiffness, burning sensation down arms and palm and itching mainly in arm. Noted stiffness of joints.
Dyspnoea; Fatigue; Pharyngeal Inflammation; Infusion Site Pain; Pain; Infusion Site Bruising; Chills; Asthenia; Feeling Hot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; macitentan (OPSUMIT) (Batch/Lot number: unknown) for pulmonary arterial hypertension; treprostinil sodium (REMODULIN) (Batch/Lot number: unknown) for pulmonary arterial hypertension; treprostinil (TREPROSTINIL) (Batch/Lot number: unknown) for pulmonary arterial hypertension; warfarin (WARFARIN) (Batch/Lot number: unknown) for pulmonary arterial hypertension; macitentan (MACITENTAN) (Batch/Lot number: unknown) for pulmonary arterial hypertension. The patient's relevant medical history was not reported. Concomitant medication(s) included: SILDENAFIL CITRATE. The following information was reported: DYSPNOEA (non-serious) with onset 2021, outcome "unknown", described as "Dyspnoea"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Fatigue"; PHARYNGEAL INFLAMMATION (non-serious) with onset 2021, outcome "unknown", described as "Pharyngeal Inflammation"; INFUSION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "Infusion Site Pain"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "Pain"; INFUSION SITE BRUISING (non-serious) with onset 2021, outcome "unknown", described as "Infusion Site Bruising"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "Chills"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "Asthenia"; FEELING HOT (non-serious) with onset 2021, outcome "unknown", described as "Feeling Hot". The action taken for macitentan, treprostinil sodium, treprostinil, warfarin and macitentan was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Developed erythema multiforme w/in 96' of DTaP, Hep A, PREVNAR and MOTRIN.
Dizziness. Intermittent at first, but always in the morning. As time has gone on, the dizziness last longer. Most prevalent when waking up or when changing positions. Orthostatic  hypotension rules out.
rash near the injection site; Hives (mild) near site; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL9264; Expiration Date: May2021), dose 1 via intramuscular, administered in Arm Left on 06Feb2021 10:50 (at the age of 28 years old) as 1st dose, single dose for COVID-19 immunization. Medical history included asthma, eczema, high cholesterol (It is Hereditary. She was not on medication), attention deficit hyperactivity disorder, depression. Family medical history included: Mother had High blood pressure, high cholesterol, obesity, sleep apnea, kidney stones, heart issues. Concomitant medication(s) included hydroxyzine (HYDROXYZINE) taken for eczema from Jun2017 and ongoing; albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]) taken for an unspecified indication, start and stop date were not reported; ethinylestradiol, norgestimate (TRI-PREVIFEM) taken for contraception from Oct2019 and ongoing; bupropion (BUPROPION) taken for depression from Jun2020 to Apr2021. Prior vaccinations: None. The patient stated that she was fully vaccinated with the COVID-19 vaccine. After the first dose, on 06Feb2021 15:00, she experienced a rash near the injection site and Hives (mild) near site.She specified she has eczema thus she was not concerned about it then. She asked for what to do and should she consult her HPC or dermatologist.  She also asked how long the rash lasted post vaccination. The patient had allergy medicines, lotions (Unspecified Medications) but nothing was really helping  The patient had been taking Benadryl but that hasn't been doing anything and about take Zyrtec. The patient do suffer from eczema (Medical History) so I am very familiar with kind of stuff so I have things with me, I have allergy medicines, lotions (Unspecified medications) but nothing was really helping. And don't if it really required me to go to the emergency room because the patient don't know what they will tell . The patient feel like they would be like to take the lotion.The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN6200; Expiration Date: Jun2021 ), dose 2 via Intramuscular, administered in Arm Left on 03Mar2021at 11:10 as second dose, single dose for COVID-19 immunization.The patient did not receive any treatment for the adverse events. The patient underwent lab tests and procedures which included COVID-19 test: negative on 10Nov2020, COVID-19 test: negative on 21Jan2021, COVID-19 test: negative on 17Feb2021. Investigations Nor.The reported assessed the vent as non serious.The clinical outcome of the events was resolved on 07Feb2021.
Extreme dizziness; This is a spontaneous report from a contactable consumer. A 36-years-old female patient received 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 DOSE 1, SINGLE for covid-19 immunisation (at the age of 36-year-old). The patient medical history was not reported. Concomitant medication(s) included buspirone (BUSPIRONE) 15 mg, one tablet twice a day and fluoxetine hydrochloride (PROZAC) 60 mg taken for an unspecified indication. On an unspecified date, since her last injection the patient experienced extreme dizziness. On 09Feb2021, the patient underwent lab tests and procedures which included magnesium: normal, Thyroid Panel: normal, CBC: normal, B12: normal. The patient taken Meclizine, Zofran. The outcome of event was unknown.  Follow-up attempts completed. No further information expected.
Partial facial paralysis right side first observed 12/13 is general muscle weakness in lips and eyelid, diagnosis of Bell's Palsy at urgent care on 12/14. Prescribed steroid 60mg/day for 7 days and antiviral. Some improvement in facial muscle control as of today 12/21.
Information has been received from a school nurse concerning a child who on an unspecified date as a baby/toddler was vaccinated with a 0.5 ml dose of varicella virus live (Oka/Merck). Subsequently the patient developed a "less severe" case of chicken pox (also reported as small rashes of chickenpox). There was no product quality complaint involved. No further information was provided. Additional information has been requested.
upon vaccination  vaccine leaked outside of the needle where it was screwed on to the syringe.  most of the vaccine leaked out of the syringe.  vaccine was re-adminstered to ensure patient is fully protected
feels tired; had a craving for salt; nausea; vomit breakfast; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Jan-2021 and was forwarded to Moderna on 20-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), VOMITING (vomit breakfast), FATIGUE (feels tired) and SALT CRAVING (had a craving for salt) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: TRAMADOL since an unknown date.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced NAUSEA (nausea) and VOMITING (vomit breakfast). On an unknown date, the patient experienced FATIGUE (feels tired) and SALT CRAVING (had a craving for salt). At the time of the report, NAUSEA (nausea), VOMITING (vomit breakfast), FATIGUE (feels tired) and SALT CRAVING (had a craving for salt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
Swollen eye lids, lower lip swollen Benadryl given. Occurred 3 hours after mins not seen until 3 days after. And occurred to lesser amount age after 2m, but not at 4m.
They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053c21a and 027C21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.).    No concomitant drug information was provided.  The beyond use date for lot no 027C21A was 21May2021 and lot no 053C21A was 01Jul2021.  No treatment medication information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Non-Significant Followup; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case