chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Kinrix administered as 1st dose for dTap serie catch-up; Kinrix administered as 1st dose for dTap serie catch-up; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 9-year-old female patient who received DTPa-IPV (Kinrix) (batch number 24T2m, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th October 2022, the patient received the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 6th October 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate schedule of vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate schedule of vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-OCT-2022 Reporter's comments: Medical assistant had reported on 10 October 2022 that a 9 years of age patient had received Kinrix on 6th October 2022. Patient had not received any previous vaccines (including previous dTap immunization)  The vaccine administration facility is the same as primary reporter. The reporter did not consent to follow-up. Additional supportive information: At the time of reporting, the patient was 9 years old and had received Kinrix as 1st dose in the series, which had led to Inappropriate schedule of vaccine administered and Inappropriate age at vaccine administration.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Sep2022 at 12:00 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08Jul2023, outcome "not recovered" and all described as "Treatment of COVID-19". The event "treatment of covid-19" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jul2023) Positive; (09Jul2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19, patient was treated with Paxlovid from 08Jul2023 to 13Jul2023. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Hyperalgesia and mild edema in the ipsilateral axilla that persisted for ~36 hours and self-resolved.  *Note: Currently breastfeeding; ~2.5 weeks postpartum.
I had a cramp in my leg (thigh). It got worst and worst.  I got up.  I feel to the floor and passed out.  I don't know how long I was out.  I could not catch my breath.  I keep feeling like I need to go to the bathroom.  My husband helped me to the bed.  I was passing out again.  He had to help me left my feet up because it hurt so bad.  I still was having difficulty breathing.  I asked my husband for some aspirin.  I keep feeling like I was going pass out.  It take about a hour before I could get up.  I had a doctor appointment 3 days later.  He wanted to scan my leg because he believed that I had a blood clot.
Breakthrough case admission after 3 vaccines  Pfizer 4/16/21 lot# EW0161;  PFizer 5/7/21 lot# EW0176;  Pfizer 11/22/21 lot# FK8028;
Little bumps on left shoulder blade; Bumps on elbows as; Rash after the second dose.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE NODULE (Little bumps on left shoulder blade), NODULE (Bumps on elbows as) and RASH (Rash after the second dose.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE NODULE (Little bumps on left shoulder blade), NODULE (Bumps on elbows as) and RASH (Rash after the second dose.). At the time of the report, VACCINATION SITE NODULE (Little bumps on left shoulder blade), NODULE (Bumps on elbows as) and RASH (Rash after the second dose.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.   Reporter did not allow further contact
This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Flu seasonal QIV Dresden. Concomitant products included THERAFLU. On an unknown date, the patient received Influenza vaccine quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving influenza vaccine quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza (serious criteria death). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza was fatal. The reported cause of death was influenza. It was unknown if the reporter considered the vaccination failure and influenza to be related to influenza vaccine quadrivalent unspecified season. Additional details were reported as follows: The age at vaccination was not reported. The consumer posted on social media about 8 flu deaths of which, 7 had the flu shot and all 8 took THERAFLU. The consumer asked what's your take on who is to blame? It was unknown if an autopsy was performed or not. This case was considered as suspected vaccination failure since time to onset and the lab test confirmation for the event was unknown. This case is one of the 7 cases, reported by the same reporter for same event.
Right thigh became inflamed on Saturday night.  Seen in Local ER and treated with keflex.
Her arm is sore and unable to move it very well; Her arm is sore and unable to move it very well; This spontaneous case was received on 08-Sep-2020 from a physician via Agency (reference number SEQW20-01365) and concerned a 77-year-old, female patient.  The patient's concurrent conditions included diabetic, high cholesterol and heart disease. The patient's concomitant medications were not reported.  On 08-Sep-2020, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, dose: 0.5 ml, indication: influenza prophylaxis, route of administration: intramuscular, anatomical location: right deltoid). The batch number reported was 279794, expiry date: 29-May-2021.   On the same day, the patient's arm was sore and she could hardly move it. The patient was placing ice and did not take any over the counter medications.  At the time of initial reporting on 08-Sep-2020, the patient did not recover from the events.   The reporter did not provide a causality assessment.  The reporter assessed the events as non-serious.  Company comment: The patient developed movement disorder and pain in extremity on the same day after vaccination with the suspect product, Fluad Quadrivalent. Chronology is suggestive. No alternative aetiology was provided. Based on provided information, causal relationship between the suspect product and both events is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).; Sender's Comments: The patient developed movement disorder and pain in extremity on the same day after vaccination with the suspect product, Fluad Quadrivalent. Chronology is suggestive. No alternative aetiology was provided. Based on provided information, causal relationship between the suspect product and both events is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).
developed burning pain and then rash on abdomen 1-3 days after vaccine.  rash was erythematous patches with vesicles suggestive of shingles outbreak. visit over the phone on the holiday weekend ( 7/4) . patient did send photos via our secure patient communication portal.
Rash, Cough - Information has been received from a pharmacist concerning a 14 month old female relative, with no known allergies and a history of heart murmur.  who on 22 feb 2001, was vaccinated with mealses virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live second generation lot 630638/0140k.  On approximately 02 Mar 2001 the patient developed a servers hacking cough.  On 07 Mar 2001 the patient developed a total body rash.
Unable to get the second/It is now 7 weeks since first shot; Patient received the 1st dose 05May2021 still has not received the 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Unable to get the second/It is now 7 weeks since first shot) and PRODUCT DOSE OMISSION ISSUE (Patient received the 1st dose 05May2021 still has not received the 2nd dose) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Unable to get the second/It is now 7 weeks since first shot) and PRODUCT DOSE OMISSION ISSUE (Patient received the 1st dose 05May2021 still has not received the 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Unable to get the second/It is now 7 weeks since first shot) and PRODUCT DOSE OMISSION ISSUE (Patient received the 1st dose 05May2021 still has not received the 2nd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product was not provided by the reporter.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Follow-up received contains significant information. The primary reporter details has been updated. The patient demographics ( age, gender ) has been added. The dose 1 start date has been added. The event has been updated.
Was administered vaccine around 3:30 p.m. on 11/11/2005.  Approximately 3 hours after receiving vaccine had sudden tightness of chest, which worsened rapidly - similar to severe asthma attack.  Took Primatene tablet, and conditions graduadally lessened until I was able to breathe more freely in about 3 hours.  Was very surprised as the suddenness of the attack, as was feeling fine.  This episode included, in addition to severe tightness in chest, extreme difficulty breathing, and wheezing. (I was a childhood asthma sufferer, with occasional attacks as an adult, but haven't had one for over 10 years.  Also had severe allergies when infant through age 5, including dairy products and eggs, but outgrew those and have no current adverse reaction to eggs or dairy products.)
Caregiver/Partner reported patient had surgery but did not make it and passed. No other details provided at this time.
Right after patient received her shots she did not cry, held her breath became pale. Did not respond to stimulation, had pulse, was breathing. Kept eyes shut for 1/2 hr looked like was sleeping. After long period of time became alert & recovered.
bunch of energy; This is a spontaneous report from a contactable consumer or other non-hcp. A male patient of an unspecified age received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced bunch of energy on an unspecified date. Caller reported that, he had both doses of COVID vaccine and said he did not have any side effects. The vaccine gave him a bunch of energy and he was calling to report that. The outcome of the event was unknown.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Small bumps appeared under the skin on left upper arm with more bumps on right upper arm, chest & upper back (shoulders). These bumps did not blister, but after a few days the skin broke and began to peel. Dermatologist prescribed steroid cream 3 times per day. After 10 days, some of the bumps are still visible and may leave scars.
Pt vaccinated 8-5-09.  Onset 8-6-09 with headaches sore throat, nausea and congestion.  On 8-11-09 seen at local walk-n clinic now complaining of dizzyness, and other symptoms described.  No fever, Negative Step.  Encouraged ACETAMINOPHEN and fluids.
9 days after injection of first of two shots, the area where the injection was given became red and inflamed. It continued to get more red and painful with terrible itching. I contacted the pharmacist and was told it was called Covid arm/ Moderna arm. I began cortesone topical cream and benadryl tablets. It lasted 11 days, then began to get better. It's still slightly itching and red. My next injection is on Monday October 4, 2021. I'm moderately concerned about getting the second shot.
Nausea High fever up to 102.4 lasting about 4 hours Fever lasting over 24 hours Cold sweats Loss of appetite
Worse than a cold but not like the flu.  No fever, body aches not like the flu, felt weak and wanted to sleep.  I felt a little better everyday.  By Monday I felt better but by the afternoon felt weak and went home.  I started taking Paxlovid on Monday.  Didn't lose taste or smell.
patient stated that starting at the injection site and moving down her arm about halfway to elbow, the area is red and warm to the touch; she stated that she only noticed it today (1/30/2021).
Exactly a week later, my arm at the injection site felt very warm. It was red and actually looked like I had a hive (raised whelp). It was 3in in diameter. It was itchy, red, and hot. I called my Dr. and he said for now to put some Benadryl cream on it. My husband had an appointment at the doctor 2 days later and I had him look at the whelp. He told me to keep using the cream and it started helping. He told me to be careful and watch for anything odd. He was afraid that after the 2nd dose I would have a worse reaction, but I didn't have any reaction at all. Within a few days it was gone and everything was fine.
A little less than 5 weeks after my last Moderna vaccination, I noticed irritation on scalp and doctor diagnosed Shingles on my scalp on April 2, 2021.  Had Shingles 3-4 weeks.  Even after no visible lesions or blisters, still  have nerve  issues.
Raised, red nodule at site of injection appeared/noticed by patient roughly 3 weeks after injection. Nodule is non-painful and has remained and possibly increased in size over the last 14 days.
Red streak in arm to elbow; Feels like bunch of little ant bites; Little bumps all over that itch; Welts; Arm swells up huge; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE STREAKING (Red streak in arm to elbow), VACCINATION SITE PARAESTHESIA (Feels like bunch of little ant bites), VACCINATION SITE PRURITUS (Little bumps all over that itch), VACCINATION SITE URTICARIA (Welts) and VACCINATION SITE SWELLING (Arm swells up huge) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE STREAKING (Red streak in arm to elbow), VACCINATION SITE PRURITUS (Little bumps all over that itch) and VACCINATION SITE URTICARIA (Welts). 03-Feb-2021, the patient experienced VACCINATION SITE PARAESTHESIA (Feels like bunch of little ant bites) and VACCINATION SITE SWELLING (Arm swells up huge). At the time of the report, VACCINATION SITE STREAKING (Red streak in arm to elbow), VACCINATION SITE PARAESTHESIA (Feels like bunch of little ant bites), VACCINATION SITE PRURITUS (Little bumps all over that itch), VACCINATION SITE URTICARIA (Welts) and VACCINATION SITE SWELLING (Arm swells up huge) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications was reported. treatment medication was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Additional information was received on 22 -Apr-2021 no new information updated.
Felt heart pounding, irregular heart rate, faint feeling overall bad, ended up in hospital. I had 5 other episodes following over the next 4 months which was pounding heart in the middle of the night for no reason and feeling off-could faint feeling.
First dose of Shingrix vac in November 2020 / Do I need to start over; This case was reported by a consumer via media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on an unknown date in November 2020).   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: This case was reported by the patient himself/ herself. The age at vaccination was not applicable for this report. The patient had not received the second dose for more than 8 months, which led to incomplete course of vaccination. The reporter enquired if he/ she had to start over and get two more doses.
Onset of menstruation cycle 30 mins after receiving second dose of Moderna COVID-19 vax. Period was 7 days early. Menstruation cycle now occurs every 15 days for 7 days. Previously occurred every 24 days for 5 days. Heavy blood clotting and bleeding. Extreme cramps and backache. Increased migraines. Severe mood swings.
Pt recvd a series of 3 Engerix-B vax about 2 yrs ago & is a non-responder;
Swelling redness and tenderness 2 days after vax administration. Treated with antibiotic (oral Keflex).
Woke up around 3 am with splitting headache. This continued through the night/day. Had diarrhea around 6:45am, felt nauseated. Started getting worse through the morning. Dizzy, unfocused, exhaustion. Developed low grade fever
pt recvd vax & exp later exp h/a, fatigue, sore arm, & a rash;
Fatigue for 2-3  weeks.  Sore arm for 10 days.  Shortness of breath for 2 weeks.  All symptoms have resolved.
fever, vomiting, diarrhea, dizziness 4/28, 4/29, 4/30; The patient subsequently developed a fever of 103 to 104 deg F which lasted 2 days, body aches, stiffness and abdominal pain. The patient was seen by a nurse on 30-APR-1999 who stated that the abdominal pain may be due to gastroenteritis. Complete blood count and serum hepatitis A tests were performed: results were not provided. The patient was rehydrated with IV fluids. As of 04-MAY-1999, the patient was feeling better. This is 1 of 2 patients from this facility who experienced an adverse event following receipt of Tetanus and Diphtheria Toxoids Adsorbed, Ultrafined lot 4998113. This report was received from Medeva (MPI-1999-01848). Follow-up information received from the physician on 10-MAR-2000 provided patient information, lot numbers and stated that the patient recovered.
Client asked for high dose influenza vaccine and was given it. RN verified her DOB but not her exact age at time of vaccination. Client was not eligible for the high dose as she is not yet 65 years of age.
Child was brought in by mother for fever and raised redden area on right tricep, mother stated she (child) received immunization Thursday 5/1/08 at school by Public Health nurse, fevers, and redness started 5/2/08. See by doctor in Emergency room on 5/4/08.
Fatigue, very tired, getting worse daily, hot flashes, several times a day, no energy, just keep getting worse, get up, very tired, take naps, does not help much. Symptoms started after first shot and still going down hill. I am so tired. I just do not feel good.
SPENT 12 DAYS IN BED; FEVER OF 102° F OR HIGHER; This spontaneous report received from a patient via a representative concerned a patient of unspecified age and sex. 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced spent 12 days in bed, and fever of 102° f or higher. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102° F OR HIGHER. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever of 102° f or higher and spent 12 days in bed was not reported. This report was non-serious.
ADMINISTERED EXPIRED VACCINE; OFF LABEL USE; This spontaneous report received from a health care professional concerned a 57 year old of unspecified sex. 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: 202A21A expiry: 21-SEP-2021) dose was not reported, administered on 08-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-NOV-2021, the patient experienced administered expired vaccine, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered expired vaccine and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20220310363, 20220309987, 20220309972, 20220310548, 20220310590, 20220309858 and 20220310631.
Received flu shot on 10/01/10 and became very ill after. Had a high fever and severe aches and pains - just like with the flu! It lasted about 4 days. Dose was: FLUVIRIN Multidose vial 2010-11, 5ML at pharmacy.