chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was given a second bivalent vaccination.  Patient showed no symptoms or signs of distress at time of discharge.
PT C/O ABDOMINAL AND CHEST PAIN WHILE WAITING IN WAITING ROOM FOR RECOMENDED 15 MINUTE POST VACCINE WAITING PERIOD. BP CHECK REVEALED HYPOTENSION 70/40. 911 CALLED, EMS TRANSPORTED PATIENT TO MEDICAL CENTER.
pt recv vax 5NOV98 approx 1130AM & late afternoon felt tingling all over & began to itch;used alcohol & had burning sensation, some swelling & then used calamine lotion;to hosp ER dx probably hives from vax;
Pentacel has been administered to a 5 year old boy in place of Dtap Ipv combination vaccine, no AE; Initial information received on 05-Oct-2020 regarding an unsolicited valid non-serious case from a physician.  This case involves a 5 years old male patient who in place of DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE combination was vaccinated with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number and expiration date were not reported for both the vaccines) via unknown route in an unknown administration site for prophylactic vaccination (PT: wrong product administered) on an unspecified date.  Medical history and concomitant medications were not reported.  It was an actual medication error case due to wrong vaccine administered (same day latency).  No adverse event reported at the time of reporting.  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.  There will be no information on the batch number for this case.
Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included DIAZEPAM (VALIUM) and VITAMIN D NOS for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced DIARRHOEA (Diarrhea). On 30-Jan-2021, DIARRHOEA (Diarrhea) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reported Concomitant medications including Blood pressure and Allergy pill.  It was reported that, the diarrhea was not severe enough for the patient to report to physician. It lasted for only one day. She was not sure if it was from the vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Event description was updated.
Rash - belly, back, legs.  Dec. 7th - doctor office.  Hydrocortisone.  Rash and hives on whole body.  Dec. 9th, called doctor.  Doctor called in Zyrtec.
Lt arm swollen, site sore, warm to touch, neck itchy, h/a, swollen lips & eyes;
This case was reported by a nurse via sales rep and described the occurrence of injection site lump in a 19-year-old male patient who received BEXSERO (batch number 16D401, expiry date 28th February 2019) for prophylaxis. On 30th May 2018, the patient received BEXSERO .5 ml. On an unknown date, less than a week after receiving BEXSERO, the patient experienced injection site lump, injection site pain and injection site erythema. On an unknown date, the outcome of the injection site lump, injection site pain and injection site erythema were unknown. It was unknown if the reporter considered the injection site lump, injection site pain and injection site erythema to be related to BEXSERO. Additional details were provided as follows: The patient also received a Hepatitis A vaccine the day of vaccination but in a different arm. The patient came in 2 days later for an unrelated follow up appointment and it was noticed that he had a painful lump and it was still red where he had gotten the BEXSERO shot 2 days earlier. They had not seen him back since so not sure if it resolved. The patient would be gone on a vacation after.
Child developed Alopecia Areata in December 2017, 2 months after  injections. Visited dermatologist on 2/26/18 who determined diagnosis. Prescribed Lidex to apply to area to help with irritation since child was pulling at the hair.
He has collapsed on site; seizures; memory loss; confusion; difficulty talking, eating; difficulty talking, eating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hashimotos" (unspecified if ongoing), notes: Caller provided previous history for patient of hashimotos. The patient's concomitant medications were not reported. The following information was reported: SYNCOPE (medically significant), outcome "unknown", described as "He has collapsed on site"; SEIZURE (medically significant), outcome "not recovered", described as "seizures"; AMNESIA (non-serious), outcome "not recovered", described as "memory loss"; CONFUSIONAL STATE (non-serious), outcome "not recovered", described as "confusion"; SPEECH DISORDER (non-serious), EATING DISORDER (non-serious), outcome "not recovered" and all described as "difficulty talking, eating". The events "he has collapsed on site", "seizures", "memory loss", "confusion" and "difficulty talking, eating" required physician office visit.  Clinical course: Reporter Inquired that there brother in law had been ill since he took the covid shots. He had memory loss, confusion, seizures, difficulty talking, eating, and many other symptoms. No doctor can pinpoint what was wrong. He was not getting better. Is there any study or program he can join to help him and my sister figure out what is going on? He had seen cardiologists, endocrinologists, neurologist s, and others. Caller provided previous history for patient of hashimotos and stated patient did not want to get the vaccine but was required by his workplace. Caller stated this had been happening for the excess of a year he can barely work and when driving to work one day, stated patient had a seizure behind the wheel of a car. He has collapsed on site, he stands up and it was a mess. Caller also stated kept a log everything he has eaten for the past 11 months.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I was having lower right hip pain. I thought that it might be my kidney. I went to the Emergency Room, and they told me that it was Sciatic Nerve pain. I was not prescribed medications. She told me to take Motrin for pain and to use a heating pad. It is slowly getting better.
That night and the next morning I had hot flashes severe enough to cause me to change tshirts.; Since then, even sminimal exercise has also brought unusual amount of perspiration; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (That night and the next morning I had hot flashes severe enough to cause me to change tshirts.) and HYPERHIDROSIS (Since then, even sminimal exercise has also brought unusual amount of perspiration) 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 09-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced HOT FLUSH (That night and the next morning I had hot flashes severe enough to cause me to change tshirts.) and HYPERHIDROSIS (Since then, even sminimal exercise has also brought unusual amount of perspiration). At the time of the report, HOT FLUSH (That night and the next morning I had hot flashes severe enough to cause me to change tshirts.) and HYPERHIDROSIS (Since then, even sminimal exercise has also brought unusual amount of perspiration) outcome was unknown.            Concomitant medications were not reported  No treatment information was provided.
First vaccine, had a delayed reaction. It took exactly 1 week before a small red hot welt show on the site on injection and it kept getting bigger as days progressed. Was sent to urgent care by nurse's advice and they gave me Vistaril 3x day for 6 days and Deltasone 2x day for 4 days. Within a day I felt much better and my arm is much better. Second vaccine took about 12 hours and the welt showed up bigger than the first time, I immediately took Benadryl as soon as I saw it and kept taking it every 6 hours the first 24 hours.
got vaccine / shingles/suspected vaccination failure; shingles in my mouth; total teeth loss; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and loss of teeth. On an unknown date, the outcome of the vaccination failure, shingles and loss of teeth were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and loss of teeth to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the Shingle vaccine and got shingles in a year in mouth total teeth loss. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule and laboratory test confirming shingles were unknown at the time of reporting.
50 x 40mm red induration. Flu-like symptoms, temp 98.8.
MOM STATES PATIENT DEVELOPED SITE REDNESS AND SWELLING 3/12/2020, SHE WAS SEEN IN OFFICE BY DR. 3/12/2020, SHE STARTED HER ON CEPHALEXIN FOR CELLULITIS. SPOKE WITH MOM TODAY AND SYMPTOMS HAVE RESOLVED 3/17/2020.
developed fever of 100 degrees F by 3:00AM the day following the injection.  developed all over body aches, severe headache, nausea and stomach pains resulting in severe loss of appetite, and deep exhaustion.  pain and sensitivity at the injection site, but no redness or other warning symptoms listed on the handouts.  the symptoms lasted for 24 hours.
Vaccine given in tricep instead of deltoid (believe to have been 1 inch needle). Normal redness, localized tenderness.
I had my vaccination on 11/04/2022. I have a history of Neuropathy. Forty eight hours after vaccination I had a flare-up that has yet to go away as of 12/06/2022. The Neuropathy has spread to all of my toes ankles and feet. I saw my nurse practitioner mid November 2022. She recommended TYLENOL acupuncture. I cannot get in to referral to neurologist until 02/2023. I did have COVID-19 positive in 06/2022.
Pain, redness, bruise and nausea onset evening after shot was given. Patient reported to pharmacy two mornings later and redness/soreness still present.
lump; redness; chills; muscle pain; Fatiguability and been lying on bed the whole afternoon; Itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), MASS EXCISION (lump), ERYTHEMA (redness), CHILLS (chills) and MYALGIA (muscle pain) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and LIOTHYRONINE SODIUM for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced PRURITUS (Itching). On 20-Feb-2021, the patient experienced MASS EXCISION (lump), ERYTHEMA (redness), CHILLS (chills), MYALGIA (muscle pain) and FATIGUE (Fatiguability and been lying on bed the whole afternoon). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 500 milligram twice a day. At the time of the report, PRURITUS (Itching), MASS EXCISION (lump), ERYTHEMA (redness), CHILLS (chills), MYALGIA (muscle pain) and FATIGUE (Fatiguability and been lying on bed the whole afternoon) outcome was unknown.            This case was linked to MOD-2021-019056 (Patient Link).
3 hrs after shot:  chills, fever 100.7, joint pain, muscle aches, headache pain in upper left arm
My 4 year-old son, with no medical history and on no medications, was given the KINRIX DTaP-IPV injection from GSK (lot# AC20B213BA) on 9/27/2012 at 4:37 PM in his left arm. At the same time, he was provided the VARIVAX vaccine (lot# H010559) in the same arm and the MMR combined vaccine (lot# H012139) in the right arm, both from Merck.  Also at the same time he was given the FLUMIST vaccine by MEDIMMUNE (lot# AJ2108).The injection site in the left arm was painful and hard to the touch the morning of 9/28/12.  My son was also lethargic and not eating well.  At 9:00 PM, when we removed my son's shirt for his bath, we noticed that his left arm was swollen to more than twice the size and the swelling was extending to his left should blade.  The information sheet on the DTap noted a "minor" reaction of arm swelling that could last for 1-7 days in the arm where the injection was administered.  I called the nurse on duty, the practice that administered the vaccination and was advised to visit the Emergency Room.  The doctor who examined him advised us that this was probably a vaccine reaction, but if the swelling did not improve by the next to start him on the antibiotic prescription that he provided for a possible infection.  The swelling did not get worse, but appeared to improve.  Within 3 days, the swelling was resolved.  I called his pediatrician on 10/2 and asked what could have caused the extreme swelling and was advised that it was probably the pertussis element in the vaccine and the swelling meant that my son had sufficient immune response to the vaccine.  I responded that this response was not normal and he should not have received the vaccine if he had sufficient immune response.  This is a severe reaction and something should have been done to prevent this.  I am very disturbed that we are being required to administer vaccinations to our children when there might be "sufficient immune response".  I also noticed in the literature that the Flumist vaccine that my son received is not supposed to be provided along with other vaccines and could this have probably been the cause.
Mother had called Pediatricians office the day after immunizations to report reaction that patient had red, hot swelling, and itching of deltoid region on left arm, later in day swelling extended to around arm region. Told by peds office to take Benadryl & cool packs.
This prospective pregnancy case was reported by a consumer and described the occurrence of vaccine exposure during a pregnancy in a 35-year-old female subject who was vaccinated with BOOSTRIX, (GlaxoSmithKline). On 17 September 2014, the subject received an unspecified dose of BOOSTRIX (unknown route and injection site, batch number not provided). Her last menstrual period was not provided but her estimated date of delivery was on 22 November 2014. The subject was exposed to the vaccine during the third trimester. No adverse event was reported. At the time of reporting, the pregnancy was ongoing. (Pregnancy Notes) On 26 January 2015, this case was considered lost to follow-up. Follow-up information received from the consumer on 23 February 2015. The consumer provided Healthcare professional details and reported that the pregnancy and the delivery were normal.
NOSE BLEED; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced nose bleed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nose bleed. This report was non-serious.
Received standard dose influenza vaccine but uncertain of which specific one. New onset of intermittent stuttering speech and difficulty with swallowing and chewing occurring 7 days after vaccine. Speech stuttering peaked 10 days after vaccine. Returned to clinic and sent to ER to rule out stroke. Brain CT without stroke or tumor. Brain MRI performed 1 week later also without stroke.
Patient became dizzy approx 2 hours after receiving flu shot. Patient passed out and was taken to ER. Patient was told it could have been a vaccine related side effect.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021 at 11:37 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Jan-2021 at 11:37 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 65.26 years. No concomitant medications were reported. Batch number 041L20A underwent temperature excursion on 12-Jan-2021 with temperature 34 degrees Fahrenheit from 8 AM to 9 AM. This vial was moved to fridge on 08-Jan-2021 and beyond use date for the vial was reported as 07-Feb-2021. Product moved to clinic on 12-Jan-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
PT given 1 dose - Hepatitis B vaccine IM, RD. Vaccine had expired 01/25/07.
3OCT93 unable to walk, h/a, aching all over, no appetite, nausea; unable to sleep due to pain in joints & muscles; episodies of SOB & confusion; taken to ER; abn reflexes; 6OCT93 viral infect; shaking, poor memory, twitching, sound & light
Received anthrax #2 on 1/13/03, 1st anthrax was 1999 (no adverse effect with #1). The following day, she had pains swelling at injection site and later welts below breast, stomach, both elbows, hands, legs, both knees, tops of feet. L arm problems, received Typhoid on R.
Around 2am I woke up with a rapid heartbeat (around 110 a my normal is about 70). This same symptom carried out for about 5 days. After the first 2 days, it seemed to be more in and off vs. just a steady rapid heartbeat.
This case was reported by a consumer via call center representative and described the occurrence of chest burning in a male patient who received SHINGRIX for prophylaxis. On 14th August 2018, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced chest burning. On an unknown date, the outcome of the chest burning was recovered/resolved. It was unknown if the reporter considered the chest burning to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter said that her husband had the shot with SHINGRIX and later one he told her that he experienced a burning chest. The reporter would not provide initials nor additional details on her husband. This case was 2 of the 2 cases, reported by the same reporter.
tingling in hands and feet; This is a spontaneous report from a non-contactable other healthcare professional. A 48-year-old female patient receives first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: HE9899), intramuscularly on 18Dec2020 12:45 at single dose for immunization. vaccine location provided as Right arm. Medical history included fibromyalgia, rheumatoid arthritis. The patient's concomitant medications were not reported. No history of vaccine or medication reaction previously. During her 15-minute waiting period after the injection, the patient began to experience tingling in hands and feet on 18Dec2020. She denied rash, hives, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, lightheadedness, dizziness and tongue swelling This provider was notified of patient reaction and she was then assessed in the emergency bay area. Review of Systems included: Constitutional: Negative for chills and fatigue.  HENT: Negative for congestion, facial swelling, rhinorrhea, sinus pain, sneezing, sore throat and trouble swallowing. Respiratory: Negative for cough and shortness of breath. Musculoskeletal: Negative for back pain, myalgias and neck stiffness. Skin: Negative for rash. Neurological: Tingling in hands and feet bilaterally. The outcome of the event was unknown. All events reported as non-serious.   No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a healthcare worker refers to an unknown number of patients of unknown age and gender. No concurrent condition or medical history was reported. It was reported that since 24-JUL-2015, the patients were vaccinated with improperly stored doses of M-M-R II (lot # J014876, Exp. 21-NOV-2015, dose and route of administration not provided). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. Additional information has been requested.
Monkeypox vaccine #2,  awoke in AM with radiating induration, itch and 1 streak from forearm to upper arm