chrisvoncsefalvay/vaers-outcomes huggingface dataset:
developed small fiber neuropathy; her skin is on fire; first dose of Shingrix in June 2019 / never received the second dose; fever; headache; nausea; exhaustion; was on the couch for a week; This case was reported by a consumer via call center representative and described the occurrence of small fiber neuropathy in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Hepatitis B vaccine with an associated reaction of fever (received the Hepatitis B vaccine (manufacturer unknown) in the 90's, refer case US2021AMR056382 reported for same patient) and Typhoid vaccine.   In June 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced small fiber neuropathy (serious criteria GSK medically significant), burning skin, fever, headache, nausea, exhaustion, bedridden and incomplete course of vaccination. The patient was treated with gabapentin and pregabalin (Lyrica). On an unknown date, the outcome of the small fiber neuropathy and burning skin were not recovered/not resolved and the outcome of the fever, headache, nausea, exhaustion and bedridden were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the small fiber neuropathy, burning skin, fever, headache, nausea, exhaustion and bedridden to be related to Shingrix.  Additional details provided as follow: The patient reported that she received the first dose of Shingrix in June 2019. She experienced a fever, headache, nausea, and exhaustion after taking the vaccination. She claims that she was on the couch for a week but all of her symptoms resolved after the week. A month later, she developed small fiber neuropathy. She started Gabapentin in September 2019 and now she takes Lyrica because her skin was on fire unless she takes the medication. Her neuropathy was still unresolved and she never received the second dose of the Shingrix, which led to incomplete course of vaccination.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR056382:same patient (hepatitis B case)
No additional AEs or PQC reported; Caller reported VARIVAX was administered after temperature excursion.; This spontaneous report was received from an office manager referring to a patient of an unknown age and gender. The patient's pertinent medical history, concurrent conditions, drugs reactions or allergies and concomitant therapies was not provided.  On 06-JUL-2022, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliters (ml) lot #U030161 has been verified to be a valid lot number with expiration date on 28-SEP-2023, administered subcutaneously (SQ) for prophylaxis (strength, vaccination scheme frequency and anatomical location were not provided).  The administered vaccine experienced the temperature excursion of 41.5 degrees Fahrenheit (F) for a timeframe of frame 2 hours and 45 minutes. There was no previous temperature excursion. No adverse events (AEs) were reported.
Large, red, raised area around the vaccine area that is warm to the touch.  I noticed it the next day and it is still present three days later.
uncomfortable/druggy; achy; could not sleep; throwing up; really tired; real bad headache; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (uncomfortable/druggy), PAIN (achy), INSOMNIA (could not sleep), VOMITING (throwing up) and FATIGUE (really tired) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced FEELING ABNORMAL (uncomfortable/druggy), PAIN (achy), INSOMNIA (could not sleep), VOMITING (throwing up), FATIGUE (really tired), HEADACHE (real bad headache), CHILLS (chills) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. On 11-Apr-2021, FEELING ABNORMAL (uncomfortable/druggy), PAIN (achy), INSOMNIA (could not sleep), VOMITING (throwing up), FATIGUE (really tired), HEADACHE (real bad headache), CHILLS (chills) and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.7 100.7.         Concomitant medications were not provided.   This case was linked to MOD21-170135 (Patient Link).
Patient should have received Pfizer 12+ vaccine. RN miscalculated his birthday and patient received a 5-11 Pfizer vaccine. Mother notified that when the patient returns for his second dose he is to receive Pfizer 12+vaccine. Mother was agreeable to plan. Patient had no reported side effects while being observed or since receiving vaccine.
history of pulmonary sarcoidosis currently on the heart-lung transplant list.  Presents with COVID-19 a was diagnosed on September 15th presents with increasing dyspnea on oxygen required up to 5 L. Chest x-ray demonstrates a right suprahilar opacity in left mid lung opacity.  His pCO2 is 56. Due to his marginal lung function and oxygen requirement increasing he will be admitted to the hospital for further workup evaluation and management
Rash at the injection site, swollen lymph node under armpit on the same arm.
Vasovagal syncope in the 15 minute waiting period. Response by staff was great: laid me down, brought a cot, regularly checked my heart rate, blood oxygen, and blood pressure until it returned to normal and waited to make sure the symptoms did not return.   Later that night, I started experiencing some of the typical COVID vaccine side effects: sore arm, chills, nausea, and fever-like symptoms; in addition to the symptoms I was warned was possible, I also experienced periods of dizziness and an uncomfortable sense of balance. Three days later, the dizziness and other common symptoms have gone away, but my sense of balance still feels off, although I do not know if related to the vaccine. It?s not so bad that I?m at risk of falling over, but I have a semi-regular feeling of unsteadiness which I cannot explain.
Case number PHEH2014US024987, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 75-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 30 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration.
First dose / on 12Mar2019 / second dose had not been given at time of report; This case was reported by a pharmacist 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 (1st dose received on 12th March 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked for recommendation regarding the administration of a late 2nd dose of Shingrix. The reporter refused any patient or other AE information and wanted only the dosing recommendations. The reporter consented to follow up.
ANAPHYLAXIS; INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; OFF LABEL USE; This spontaneous report received from a consumer via other company (Pfizer Inc.) concerned 4 patients. No past medical history or concurrent conditions were reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, patients experienced anaphylaxis, inappropriate age at vaccine administration, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the anaphylaxis, inappropriate age at vaccine administration and off label use was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 ;20210756606-JANSSEN COVID-19 VACCINE-Anaphylaxis. This event(s) is labeled per RSI and is therefore considered potentially related.
Apr 6-Swelling and pain around injection site. Fever of 100 degrees for 5 hours. Tired. Apr 7-Short low-grade fever 99 degrees for 30 minutes.
After receiving GARDASIL vaccine, left arm went numb to touch for approx. 30 minutes.
injection site pain, tiredness, headache, muscle & joint pain, chills, nausea, feeling unwell, swollen lymph nodes, decreased appetitie, diarrhea, could not concentrate, restlessness, increased heartbeat at times.  Lasted about 28 hours.  Better this morning.
Diarrhea, Sweating, Chills, Feeling very Bad, Body Aches, Cough, not being able to work.
This case was reported by a physician and described the occurrence of rash in a 4-month-old subject of unspecified gender who was vaccinated with Pediarix (GlaxoSmithKline) for prophylaxis.  On an unspecified date on or after 01 November 2006 and before 08 November 2006, the subject received 2nd dose of Pediarix.  On the same day, the subject received Prevnar (Lederle Labs).  Approximately 2 hours after vaccination with Pediarix, on an unspecified date on or after 01 November 2006 and before 08 November 2006, the subject experienced "a rash on the abdomen which faded and then goes to other areas."  The subject was seen by a physician.  The outcome of the event was not reported.  The physician considered the event was probably related to vaccination with Pediarix.
PAIN, REDNESS AND SWELLING AT INJECTION SITE NAUSEA, HEADACHE, MUSCLE PAIN, FATIGUE, FEVER
A report from a Pharmacist via medical representative concerning a patient of unknown age and gender. Relevant history and concomitant drugs were not reported. The patient received nasal FLUMIST Quadrivalent on an unknown date. The patient experienced a neurological adverse event. The outcome of the neurological adverse event was unknown. The reporter assessed the event of neurological adverse event to be serious as an important medical event.
EYES OPEN BUT PHYSICALLY UNRESPONSIVE TO LIGHT, SOUND AND TEMPERATURE. JAW IMMOBILE WHEN I TRIED TO OPEN IT, TONGUE PUSHED AGAINST FRONT TEETH BUT NOT BLUE/PURPLE.
Exhaustion; Aching joints/was very achy in joints; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Exhaustion) and ARTHRALGIA (Aching joints/was very achy in joints) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to UNK, Citrate free. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In September 2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In September 2021, the patient experienced FATIGUE (Exhaustion) and ARTHRALGIA (Aching joints/was very achy in joints). In 2021, FATIGUE (Exhaustion) and ARTHRALGIA (Aching joints/was very achy in joints) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2020, SARS-CoV-2 test: (Positive) Positive. In November 2020, SARS-CoV-2 test: (Positive) Positive. In February 2021, SARS-CoV-2 test: (Negative) Negative.   No concomitant medication details were provided. No treatment medication details were provided.   It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for all the events was no reasonable possibility with HUMIRA.  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.   This case was linked to MOD-2021-623818 (Patient Link).
Local skin reaction, measuring 7.5x11cm red, firm, warm. Treated for cellulitis due to exam (Augmentin). Problem on left leg (Dtap/Comvax)
Woke up at 3am with the chills took my temp was 99.8.  Took my morning medicines and then some ibuprofen, was having body aches and severe chills.  Went back to bed and took my temp an hour later was 101.0.   Had body aches, chills, thirst, weakness, headache for the rest of the day.  Temperature went from 99.0 to the highest of 102.0.  Got ahold of covid 19 hotline at work, they said it was a reaction to the shot and should be gone within 72hrs.  If not then I would need to get covid tested.  Got ahold of my pcp and they ordered a covid test but I told them what the hotline had said and that I would wait to get one done.  It has been 24 hour since and now I no longer have a fever and am feeling better just tired.
Patient passed out for multiple seconds. The person accompanying the patient alerted the  pharmacist that the patient was doing well. the pharmacist found the patient incoherent/ pale/ warm/ sweaty. The pharmacist offer the patient cold water and a cold cloth. the patient came to and stated he has passed out there after her left the vaccination room to wait in the waiting room. the patient completely recovered from this episode and left the pharmacy area after 15 minutes of observation.
Moderna COVID-a9 Vaccine EUA - Woke from sleep about 15-16 hours after vaccination with continuous sharp cutting sensations in arm pit of arm which received the vaccination.   Upper  portion of breast also was just tender to touch.  The cutting sensation continued for about 24 hours with improvement continuing but  2.5 days later the upper portion of the breast presented bruising/bleeding signs.  Picture was taken.  Some tenderness.
On 4/25/03 AM started breaking out with red bumps all over body "scattered papulovesicular lesions" - tx with Benadryl and Zovirax.
Due to malfunction in syringe, patient only received 0.2ml of 0.3ml of Pfizer COVID19 vaccine dose
Narrative: Slight mid abdominal pain 4/14, lessening. 4/15 light headedness; fingers cold/stiff
Patient 16 years of age received first dose Moderna vaccine. Day care was informed of Moderna vaccine and age restrictions. Second dose was administered on 5-5-21 for off-label use.
Sudden onset of positional vertigo. Have never had vertigo before. Multiple short vertigo events throughout the night and morning of 7/31/21, especially when tilting head upward.  Additionally, the week prior had one vasovagal episode that lasted about 10-15 seconds. Stopped in hallway, vision blacked out and all sounds felt far away, disoriented after the event.
This spontaneous report was received from a physician via a company representative referring to a female patient in her 70's. On an unknown date in July 2008 the patient was vaccinated with ZOSTAVAX (lot# not provided) (dose not reported) for prevention of shingles. On an unknown date in December 2013the patient developed shingles after receiving ZOSTAVAX. The company representative reported that the physician stated to her that this was the second ZOSTAVAX failure that he had seen. The patient sought medical attention-visited the office. There was no PQC involved. Additional information has been requested.
tingling in left side of left hand (the side of hand and leftest 2 fingers) and leftmost part of left palm.  It started right after the shot and still continues as of today.
8/13/2021.  Breakthrough COVID 91 y/o female brought to ED for worsening mentation. Stated the patient's partner was hospitalized with COVID.   8/22/2021: patient Discharged home with home O2. Note: patient previously vaccinated with Pfizer COVID-19 vaccine in January 2021.
I was exposed to covid the same week I was given rhe 1st vaccine; tested positive for covid on Jan. 11th and my 1st vaccine was Jan 6th; This is a spontaneous report recieved from a contactable other hcp.   A 31-years-old female patient (non pregnant) received bnt162b2 (PFIZER COVID 19 VACCINE,Solution for injection, Batch/Lot Number: EK9231) intramuscular,administered in Arm Left on 06Jan2021 12:00 (at the age of 31 years) as dose 1, single for covid-19 immunization. Medical history included varicose vein and drug hypersensitivity from an unknown date and unknown if ongoing. Concomitant medications included buprenorphine hydrochloride and naloxone hydrochloride (SUBOXONE) and buspirone taken for an unspecified indication,start and stop date were not reported. The patient was exposed to covid the same week she was given the 1st vaccine and she tested positive for covid on jan 11th and 1st vaccine was on jan 6th. The patient underwent lab tests and procedures which included sars-cov-2 test positive positive on 11Jan2021. Therapeutic measures were taken as a result of tested positive for covid. The outcome of events were unknown.  Information on lot/batch number was available. Additional information has been requested.
pt had been playing on the floor, then climbed upon the couch w/dad & began to twitch & drool;was immed taken to hosp, t101.7;had been taking APAP earlier in the day;pt recv ativan in ER & was intubated & transferred to another hosp;
PATIENT RECEIVED JANSSEN VACCINE AND FELT FINE BUT WHILE WAITING FOR THE 15 MINUTE TIME PERIOD AFTER SHE PASSED OUT AT 11:57 AM AND FELL FROM THE CHAIR TO THE FLOOR AND HIT HER HEAD CAUSING A WOUND ABOVE HER LEFT EYEBROW WITH SIGNIFICANT BLEEDING. 911 WAS CALLED AS WELL AS THE PATIENTS MOTHER WHO WAS STILL IN THE STORE.  HER MOTHER CAME OVER IMMEDIATELY AND EMS ARRIVED AT 12:15 PM AND TOOK HER TO THE HOSPITAL FOR EVALUATION.  WHILE WAITING FOR EMS WE GAVE THE PATIENT MOIST AND DRY PAPER TOWELS UPON REQUEST AS WELL AS SEVERAL SMALL CONE CUPS OF WATER AND THEN A WATER BOTTLE.  EMS LEFT WITH THE PATIENT AT 12:24 PM.
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 72-year-old male patient 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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at this time. It was reported that no adverse reactions were reported by any patients. No treatment medication was provided.
IMMUNIZATION GIVEN 10-28-04. PT REPORTS PAIN @ INJECTION SITE BY 6:00PM SAME DAY AND WAS ACHEY FEELING "ALL OVER" BY BEDTIME.  TOO TENDER TO TOUCH SITE 10-29-04, AND NOT RELIEVED BY 800MG IBUPROFEN.
This spontaneous report as received from a registered nurse refers to a 16 year old male patient. Concurrent or medical conditions were not reported. On 17-MAR-2015, the patient was vaccinated with (Oka-Merck) PROQUAD subcutaneous (dose, strength and lot number were not reported). Secondary suspects and concomitant therapies were not reported. The nurse reported that the patient was supposed to received the second dose of (Oka/Merck) VARIVAX, but the patient inadvertently was administered a dose of (Oka-Merck) PROQUAD. No adverse effects reported. No product quality complain reported. Additional information has been requested.
severe cardiac and neurological ae; severe cardiac and neurological ae; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 6 year-old female patient received bnt162b2 (COMIRNATY) (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: NERVOUS SYSTEM DISORDER (non-serious), CARDIAC DISORDER (non-serious), outcome "unknown" and all described as "severe cardiac and neurological ae".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101631180 same reporter and vaccine, different patient and AE
11/20/2009 Gave 4 vaccinations-DTaP + Hib left thigh; PCV and Hep-A Right thigh. Parent states patient had redness, hard knot and pain at site of DTaP for 2 days following shots. Improved, but still tender.
Migraine, fever, chills, muscle aches, pain, exhaustion, swollen lymph nodes, cough
The day after the shots he was acting weird..Couldn't walk or give steps like he was trying and doing it before, showing disinterest in me (mommy), looking like he was daydreaming , not smiling or being happy as he is usually all the time, he just was acting disinterested in anything or anybody and these symptoms lasted for a week.