chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Got original vaccine and second two dose/ Suspected vaccination failure; Tough shingles case; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (Original vaccine).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got original vaccine and second two dose/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Tough shingles case). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 05-MAR-2023 This case was reported by the patient via interactive digital media. The reporter stated that the he/she had could attest, as one who got the original vaccine and then later, the second two dose, he/she was just getting over a case of pretty tough shingles.  He/She could only imagine how bad it might had been without the vaccine. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
arm hurt; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (arm hurt) 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) dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm hurt). At the time of the report, PAIN IN EXTREMITY (arm hurt) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided/unknown.  Treatment medication were not reported/unknown.
Injection site seems worse this morning; Injection site itchy; Injection site started hurting; Injection site got red; Swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Injection site seems worse this morning), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE PAIN (Injection site started hurting), VACCINATION SITE ERYTHEMA (Injection site got red) and VACCINATION SITE SWELLING (Swollen) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062G20A) for COVID-19 vaccination.     Concomitant products included LOSARTAN for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE PAIN (Injection site started hurting), VACCINATION SITE ERYTHEMA (Injection site got red) and VACCINATION SITE SWELLING (Swollen). On 03-Feb-2021, the patient experienced VACCINATION SITE REACTION (Injection site seems worse this morning). At the time of the report, VACCINATION SITE REACTION (Injection site seems worse this morning), VACCINATION SITE PRURITUS (Injection site itchy), VACCINATION SITE PAIN (Injection site started hurting), VACCINATION SITE ERYTHEMA (Injection site got red) and VACCINATION SITE SWELLING (Swollen) outcome was unknown.        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.
The patients were administered an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patients were administered an expired vaccine) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patients were administered an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patients were administered an expired vaccine) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information were provided. The vial was initially stored in the refrigerator was on 04-Nov-2021. Dates of administration of vaccine was 05-Nov-2021 and 12-Nov-2021. The vial didn't undergo any temperature excursions. In total 60 doses were administered.
pt recv vax 28SEP98 & reported that pt rt anterior thigh swollen & moderate redness from knee tot he groin area;30SEP98 415PM pt examined the area was smaller @ this time only covering 2/3 of thigh;
This spontaneous report as received from a medical assistant refers to a 5 years old Child, gender was not reported. On 21-AUG-2014, the patient was vaccinated with VAQTA lot # K007791, expiration date 22-AUG-2014 (dose, strength, route and frequency were not reported. Patient received improperly stored VAQTA exposed to 49F for 35 minutes. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
no other AE; PEDVAX HIB was administered after a temperature excursion; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 27-DEC-2021, the patient received 1 dose of incorrectly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB), lot #t042014 with expiration date on 23-JUL-2023, administered for prophylaxis (site and route of administration were not provided).   The vaccine underwent temperature excursion of 35.4 Fahrenheit degrees for 5 hours, 34.5 Fahrenheit degrees for 17 hours, 34.3 Fahrenheit degrees for 10 hours and 34.8 Fahrenheit degrees for 2 hours. No adverse event was reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2112USA010220:
I've had this neck pain and heel pain in the past. But it was exacerbated after the vaccine and new pain: joints - both of my knees and my hips - generalized achiness that has persisted since then. I had a heel spurt in my right foot treated in 2009 with steroid injections and no problem whatsoever  for years until last two months - constantly. Right hip and right knee - I have never had had pain there before and now I'm having consistent pain there in those places. No testing on that. I have taken a dose pack of steroids to see if that would help. I have taken two rounds of that for my neck and for my foot. It helped my neck but the pain is still there - it just made it less and it hasn't really helped my foot. I've also been in physical therapy for my neck and shoulder. I really feel like it's gotten worse after my vaccine. I did get COVID between between my two vaccines - it was two weeks after the first dose.  I am wondering if this is a long term affect of COVID or the COVID vaccination. I am still am dealing with the pain.
On 5/7/09 patient reports almost immediately after receiving vaccine nausea and dizziness, then in the evening fever of 102.8, mom gave EXCEDRIN, temperature decreased. Next day dizziness, nausea and fever returned in morning. Made appointment to see physician, patient at that time also report tongue "felt funny, tightness in throat.
From about 11 hr following injection, experienced a few hours of chills without elevated temperature followed by general muscle aches for approx. one day, returning to normal health by 24 hrs post-injection. No fever or elevated temp. throughout.
3 doses of PNEUMOV AX-23 were given yesterday which had expired; This spontaneous report was received from an administrator who was reporting on patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On 05-OCT-2020, the patient was vaccinated with expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route of administration, anatomical location and strength were not provided; lot number S026366 was confirmed to be valid, expiration date 17-SEP-2020) for prophylaxis. The vaccine has not undergone temperature excursion, and was supported up to one month after expiration. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S026366; expirationdate: 17-SEP-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
pt recvd vax 15FEB93 & devel fever & discomfort in arm; No further details were provided;
Information has been received from a medical assistant, who did not administer vaccines, concerning a 12 year old female patient. The patient had no pertinent medical history, and no known drug allergies or reactions. On 10-JAN-2002, the patient was vaccinated with a dose of live (Merck) VARIVAX (dose and route were not reported) (Lot # and expiration date were not reported). On an unknown date, the patient developed chickenpox. The patient sought medical attention through office visit. No treatment was given for the event. The medical assistant reported that in approximately February 2013 last week some "titers test" was drawn with negative results. At the time of the report, the patient had recovered from chickenpox. The relatedness for live (Merck) VARIVAX and chickenpox was unknown. Additional information has been requested.
Case number PHEh2014US021405, is an initial spontaneous report received from a nurse on 23 Oct 2014, with a follow up report received from the nurse on 15 Dec 2014. This report refers to a 44 years old female patient. Her medical history and concomitant medication were not reported. Her past vaccinations were well tolerated (no further details). She was vaccinated with the initial application of FLUCELVAX (batch number: unknown) intramuscularly at a dose of 0.5 ml in right deltoid on 02 Oct 2014. On 04 Oct 2014 (2 days after vaccination), she experienced intense headache which triggered migraines for 3 days. She also experienced fever, chills, muscle ache and fatigue that lasted for 4 days. The outcome of headache and migraine was reported as complete recovery after 3 days of onset and outcome for rest of the events was complete recovery on 08 Oct 2014. These events were reported as serious (permanent disability). Causality of these events was not reported. Follow up report received from the nurse on 15 Dec 2014: Updated patient demographics (height and weight), vaccination site, added new event (headache), updated outcome details and seriousness (serious).
Pt was lighted and dizzy about 10 mins after vaccine. Vitals were all normal and after we changed him from N95 to surgical mask, laid him down and gave him water he recovered fully.
Initial report received from a heath care provider on 24 September 2007. A 27-year-old female had received a left deltoid intramuscular injection of Adacel (Lot number reported as C2822AA) and a right deltoid intramuscular injection of Hepatitis B vaccine (manufacturer and lot number not reported) on 12 September 2007. The following day, the patient experienced left deltoid injection site swelling and redness. The swelling and redness then extended down to the forearm. The left deltoid area became a deeper red and the skin was peeling. The patient complained of pain in the whole arm. The event required a visit to the doctor's office. Treatment included a five day course of prednisone and placing the patient's arm in a sling. Outcome was reported as "not recovered". No additional information was provided at the time of this report.
pt recv vax & devel redness & swelling @ inj site & hand on the same side followed by welts across neck,down the other arm & @ the top of the gluteal area where 2 welt,3 inches in diameter devel;27SEP95 inner canthus rt eyed swelled;ached
PATIENT RECEIVED INCORRECT VACCINE FOR AGE GROUP. AT TIME OF VACCINATION, PATIENT WAS 11 YEARS OLD AND PFIZER 0.3ML DOSE IS INDICATED FOR 12 YEARS AND OVER. NO SYMPTOMS OF REACTION OBSERVED OR DOCUMENTED. ERROR DETECTED IN AGENCY.
COVID 19 Treatment; COVID 19 Treatment; BNT162b2 on 21Feb2021, EVUSHELD on 21Feb2022, Janssen COVID-19 vaccines on 14Aug2021 and 07Jul2022; BNT162b2 on 21Feb2021, EVUSHELD on 21Feb2022, Janssen COVID-19 vaccines on 14Aug2021 and 07Jul2022; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Feb2021 at 10:00 as dose 1, single (Batch/Lot number: unknown) at the age of 54 years, in left arm for COVID-19 immunisation; cilgavimab, tixagevimab (EVUSHELD), on 21Feb2022 at 10:00 as dose 3 (initial EVUSHELD dose), single (Batch/Lot number: unknown), in left gluteus medius for COVID-19 immunisation; Janssen COVID-19 vaccine (Janssen COVID-19 VACCINE), on 14Aug2021 at 11:00 as dose 2 (initial Janssen dose), single (Batch/Lot number: unknown), in left arm and on 07Jul2022 at 12:00 as dose 4 (second JANSSEN dose), single (Batch/Lot number: unknown), in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Auto Immune" (unspecified if ongoing). Concomitant medication(s) included: ARMOUR THYROID; CALCIUM & VITAMIN D3 (brand: Kirkland); FOLATE (brand: Solgar); MACUGUARD OCULAR SUPPORT (brand: Life Extension); MAGNESIUM (brand: Natures Way); ZENPEP; VITAMIN-A (brand: Solgar); VIT B12 (brand: Solgar); ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Other concomitant therapy included Evening Promrose Oil (brand: Life Extension). The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 14Aug2021, outcome "unknown" and all described as "BNT162b2 on 21Feb2021, EVUSHELD on 21Feb2022, Janssen COVID-19 vaccines on 14Aug2021 and 07Jul2022"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, COVID-19. Clinical course: Anti-viral details: COVID-19 Treatment (Paxlovid) was started from 27Jul2022 and stopped on 01Aug2022. COVID rebound 3 1/2 days after completion of 5 day Paxlovid treatment (rebound from 4Aug2022 12:00 PM and not recovered).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Considering a plausible drug-event temporal association, a reasonable possibility that the events drug ineffective and Covid-19 are related to BNT162b2 (COMIRNATY) administration cannot be excluded.  The vaccine efficacy varies from one patient to another and can be affected by different factors. This case will be reassessed should additional information become available.
Treatment of COVID-19; Treatment of COVID-19; Paxlovid rebound two days after negative test, 11 days post initial symptoms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 10Mar2021 at 08:00 as dose 1, single (Lot number: EN6199), in left arm, on 31Mar2021 at 08:00 as dose 2, single (Lot number: ER8732), in left arm, on 06Oct2021 at 08:00 as dose 3 (booster), single (Lot number: FC3184), in left arm and on 13May2022 at 08:30 as dose 4 (booster), single (Lot number: FK9893) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "PROSTATE CANCER" (unspecified if ongoing), notes: Other medical history: Prostate Cancer; "Gleason 6" (unspecified if ongoing), notes: Other medical history: Gleason 6, on active surveillance Protocol. Concomitant medication(s) included: DUTASTERIDE, start date: 01Jun2022, stop date: 25Aug2022. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 24Aug2022, outcome "not recovered", described as "Paxlovid rebound two days after negative test, 11 days post initial symptoms"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication for treatment of COVID-19; Negative, notes: Paxlovid rebound two days after negative test; Positive, notes: Paxlovid rebound two days after negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19, disease recurrence.  Clinical information: COVID 19 treatment, treatment start date 26Aug2022, treatment stop date 01Sep2022, Paxlovid rebound two days after negative test, 11 days post initial symtoms, adverse event start date 24Aug2022, adverse event start time 07:00 PM, Other medical history: Prostate Cancer, Gleason 6, on active surveillance Protocol.
Fever, chills, nausea, pain in arm, increased resting heart rate, heart palpatations, disoriented
Possible blood clot in L knee, appears to be superficial.  I get these frequently (about once a year).
This spontaneous report as received from a nurse via a field representative refers to a female patient of unknown age. No information regarding the patient's medical history was provided. On an unknown date the patient was vaccinated with GARDASIL injection. No concomitant medication was reported. On an unknown date the patient experienced vaccine failure. The result of a Papanicolaou (PAP) smear (date not specified) was positive. No outcome was reported. No causality assessment was provided. Additional information has been requested.
Since 2 February she has complained of recurrent episodes of generalized itching and rashes described as raised, red, itchy whelts which can occur anywhere on her body, especially at sites of pressure or where her skin is scraped or scratched. Lesions last less than 24 hours, affects her palms and soles, and resolve without post-inflammatory changes. She denies laryngeal, pulmonary, GI, neurologic, and cardiovascular symptoms with these episodes. Episodes not associated with heat, exercise, sweating, cold, foods, medications, NSAIDs, IV contrast, latex exposure, known infections, or insect bites/stings. She received her Moderna COVID-19 vaccine booster dose on 21 January, 12 days prior to onset of her symptoms. She has used oral antihistamines and oral corticosteroids with benefit. She denies constitutional symptoms. UCT score today is 11 (0, 1, 0, 3, 0, 3, 2, 2). No history of adverse reactions to prior vaccines.
Mother called office to report child "not feeling well" and that he was able to attend school as per normal routine
26OCT 245PM a/5PM c/o dull h/a & nausea; by 5PM exp diarrhea; c/o inc h/a & vomited all rest of 26OCT all of 27OCt; t101 x 2 days; slept most of 27OCT & 28OCT; felt better by 29OCT but still c/o h/a, queasy stomach & diarrhea;
vaccine related ITP; started having a rash 4 days after vaccination, seen in clinic today (3/29/20220), 5 days after receiving vaccine with purpura and petechiae and platelet count of 2,000.
This spontaneous report as received from a vaccine professional refers to multiple unspecified patients of unknown age and gender. On 15-AUG-2017, the patients were vaccinated with improperly stored doses of VARIVAX lot # N000682, lot #N008077 and N014369, as prophylaxis. Concomitant therapies included sterile diluent (manufacturer unknown).
Patient received Moderna dose #1 on  4/27/21. Janssen was given on 6/25/21.
Vaccine brand other= Moderna, Vaccine administration date= 04Oct2023,; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Lot number: EL9269), in left arm, on 04Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 21Aug2021 as dose 3 (booster), single (Lot number: EW0191), in left arm and on 31Mar2022 as dose 4 (booster), single (Lot number: FM0698), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Oct2023 as dose 6 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: tylenol, acedemetaphen" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 04Oct2023, outcome "unknown", described as "Vaccine brand other= Moderna, Vaccine administration date= 04Oct2023,"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Paxlovid treatment from 29Oct2023 to 03Nov2023.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300357541 same patient, different drug and event;
She got the vaccine, told her to wait 3 minutes and to let them know how she felt and then she could go home.  She told them she was fine and she left.  She went home, was fine, no events.  On the third morning she went up to go to the bathroom to go to work and her right knee collapsed underneath, and she looked at it and it was all swollen up.   She had a stem-cell injection in her knee 10/10/19 and she was able to get around with absolutely no problems following this, and has had no further problems until she got this vaccine.   Since then she is not able to walk like she used to and has to be very careful when she is walking, and is sore like it was before the stem-cell, and is walking like she has an uneven gait.  The knee is extremely painful now, which it had not been since the stem-cell injection.    She has had no improvement since waiting after the vaccination.