chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 21-OCT-2015 09:19, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 8.5 and -2.7 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Two calcifications were seen in CT scan; Headaches 3 days after shot; Dose 1: 22Jan2021; Dose 2: 02Feb2021 (as reported); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), intramuscular, administered in left arm, administration date 02Feb2021 18:00 (Lot number: EL9266) as dose 2, single for covid-19 immunisation. Relevant medical history included: "IBS", start date: 2019 (ongoing); "Anxiety", start date: 2013 (ongoing). Concomitant medication(s) included: COLESTIPOL taken for irritable bowel syndrome (ongoing); XANAX taken for anxiety (ongoing). Vaccination history included: BNT162B2 (DOSE 1, SINGLE (Lot No: EL9262) intramuscular in left arm, at 18:00), administration date: 22Jan2021, when the patient was 40 years old, for COVID-19 immunisation, reaction(s): "Headache", "extreme dizziness", "heart palpitations", "Vertigo". The following information was reported: HEADACHE (non-serious) with onset 05Feb2021 18:00, outcome "not recovered", described as "Headaches 3 days after shot"; CALCINOSIS (non-serious) with onset 23Mar2021, outcome "unknown", described as "Two calcifications were seen in CT scan"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 02Feb2021, described as "Dose 1: 22Jan2021; Dose 2: 02Feb2021 (as reported)". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Pt received 65+ dose of vaccine. No advise side effects. Physician and pt aware at time of administration.
No further information is available; a patient received an expired RECOMBIVAX; This spontaneous report was received from a pharmacist referring to a female patient of unknown age. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.   On 03-JUL-2021, the patient was vaccinated with an expired hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (0.5 ml, once, lot # R028384, expiration date 08-JUN-2021; strength and route of administration were not reported) for prophylaxis (expired product administered). No further information was available (no adverse event). No product quality complaint (PQC) was reported.
stroke after vaccine; burning feet; pin needles; zapping pains, also the pain move towards tummy and chest area; zapping pains, also the pain move towards tummy and chest area; zapping pains, also the pain move towards tummy and chest area; itching skin; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0150, Expiry date: Unknown), via an unspecified route of administration, administered in the left arm on 07Apr2021 at 13:15 (at the age of 43-years-old) as dose 1, single for covid-19 immunization. Medical history included heart surgery before vaccine on an unknown date and cerebrovascular accident from unknown date. It was reported that no covid prior to vaccination and no covid tested post vaccination. No known allergies. There were no concomitant medications, no other vaccines in four weeks and no other medications in two weeks. On an unspecified date in 2021, after vaccination, the patient experienced stroke after vaccine, burning feet, pin needles and zapping pains, also the pain move towards tummy and chest area, itching skin. Adverse events resulted in doctor or other healthcare professional office or clinic visit. No treatment received for events. The clinical outcome of events was not recovered at the time of report.    Follow-up attempts are completed. No further information is expected.
HOSPITALIZED BREAKTHROUGH CASE VACCINATED WITH MODERNA ON 3-24-21 AND 4-21-21. SYMPTOMS-FEVER, RUNNY NOSE AND COUGH. COMMUNITY ASSOCIATED CONTACT WITH A POSITIVE CASE.
Patient returned to pharmacy 10/6/16 to report continued pain at the site of injection. She reported a burning sensation as vaccine was administered and she is going to see doctor for continued arm/shoulder pain. Reports no other problems with previous flu vaccines.
- Day after shot: headache. Advil relieved it. (Also  had  sore throat and hoarse voice beginning a few hours after shot, but probably unrelated; had slight throat itch day prior.) - 48 hours after shot: headache. Advil relieved it. RASH on chest, stomach and back.  Took 2 Benadryl. Rash was gone the next morning.  (Still have sore throat and cough.) - NOTE:  I had this same reaction to the first dose of Shingles Shot that I had in early Sept. 2019.
Large local reaction vs secondary infection (cellulitis) at (L) thigh injection site (DTaP and IPV) 3 days prior. Patient treated with BENADRYL and cephalexin.
right eye swelling and aching and draining in first 24 hours. treatment by eye doctor
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On an unknown date in August 2013 the patient received a first dose of GARDASIL (intramuscular, dose unknown) (reported as GARDASIL INJ 120Y). Pertinent medical history and concomitant medications were unspecified by the reporter. The reporter stated that the patient now (approximately in August 2014) wants to received a second dose. No adverse symptoms reported. The outcome of the events was unknown. No further information provided. Additional information has been requested.
Blurred vision paired with a TERRIBLE headache (?blinding? headache), upset stomach. Started within an hour of the shot, came and went off and on (quickly onset and quickly disappeared, numerous times) for about 4-5 hours
The next day or so I was very tired. I experienced insomnia after the first 2 vaccine but it went away with melatonin. The tiredness from the booster. I also felt pain in vocal cords when attempting to speak or sing. It was more intense when singing. I am still having symptoms. I took homeopathic remedies that are helping. One is Arsenicum and Rhustox which are helping. Milk thistle helped overcome the fatigue. I started taking it 2 weeks ago and its helped a lot. The doctor advised me to take it for 3 weeks. I am continuing to do saline water gargles. The doctor did bloodwork to make sure there was no inflammation. All the test results were normal.
Narrative:  59yo male pt died on 9/1/2021 after self-presented to community emergency facility for chest pain. Pt had a Cardiac Arrest & died at the ER in non-agency community hospital ER on 9/1/2021. Pt had received covid vaccines on 3/22/21 & 4/19/2021. Pt's death is not related to covid vaccines.
Major major facial breakout that hurts and feels hard to touch; Major major facial breakout that hurts and feels hard to touch; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 22Jun2021 10:00 (Batch/Lot number: unknown) at the age of 31 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA. Vaccination history included: Bnt162b2 (Dose 1, Lot No: Unknown, Location of injection: Arm Right, Vaccine Administration Time: 10:00 AM), administration date: 01Jun2021, when the patient was 30 years old, for COVID-19 immunisation. The following information was reported: PAIN (non-serious), RASH (non-serious) all with onset 23Jun2021, outcome "not recovered" and all described as "Major major facial breakout that hurts and feels hard to touch". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain, rash.   Additional information: Patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt. c/o of tingling and tightness in the back of the throat and a warm feeling over her body. Alert and oriented Narrative: Pt. c/o of tingling and tightness in the back of the throat and a warm feeling over her body. 126/77, P 81, R 18 O2 sat at 96.1% at 1420; @ 1435 106/67, P. 65, R 16, O2 sat 99%; @ 1444 BP 115/63, P 67, R 17, O2 sat 100%.Symptoms resolved ay 1435 and denied any c/o. D/c'd in stable vs.
This spontaneous report as received from a nurse refers to a female patient who was in her 70s. The patient was vaccinated with live ZOSTAVAX (lot # not reported) in December 2012 ("within the last month"). Concomitant medications were many but unspecified. The nurse saw the patient broke out into hives one week after receiving the vaccine. The patient sought medical attention by visiting healthcare professional (HCP). The patient was given medication for the itching. The outcome was unknown at the time of this report. Additional information has been requested.
13 hours lost injection was awoken by strangers sensation in throat/neck.  I moved my head around to decrease the sensation but it persisted.  This occurred over around 15 minutes. I was attempting to improve ability to swallow, and my tongue felt slightly thick. It was difficult to swallow and the muscles in my throat felt stiff. I felt like I couldn?t swallow properly. I was able to drink water, was able to breath deeply in and out but still didn?t feel right and was frightened.  I took 25 mg of Benadryl and  I decided to call 911 for advise. Paramedics arrived in about 5 minutes. My blood pressure  and my heart rate were reported to be slightly elevated with a HR of 84 (my resting heart rate is 58). My ECG had a normal rhythm.  I was advised to go to the hospital if my symptoms worsened, which they did not.
two years old patien was receiving routine vaccines and inadvertently received Quadracel/ No AE; Initial information was received on 28-Feb-2020 regarding an unsolicited valid non-serious case received from an  other health care professional.  This case involves a 24 months 27 days old male patient who inadvertently received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot C5532AA) via intramuscular route in the right thigh for prophylactic vaccination while receiving routine vaccines (product administered to patient of inappropriate age).  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACT HIB) and HEPATITIS A VACCINE (HEPATITIS A) for prophylactic vaccination.  It was also a case of actual medication error due to inappropriate age at vaccine administration.  At the time of reporting no adverse reaction was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
diarrhea; vomiting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 73 year-old female patient received bnt162b2 (COMIRNATY), administration date 05Feb2021 (Lot number: EL9262, Expiration Date: 31May2021) at the age of 73 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (ongoing), notes: Verbatim: Arthritis; "Psoriatic arthritis", start date: 2001 (unspecified if ongoing), notes: Diagnosed around 2001, Psoriatic arthritis with Osteoarthritis..; "Osteoarthritis", start date: 2001 (unspecified if ongoing), notes: Diagnosed around 2001, Psoriatic arthritis with Osteoarthritis.. Concomitant medication(s) included: METHOTREXATE taken for psoriatic arthropathy (ongoing). Past drug history included: Clindamycin for allergic to clindamycin; Levaquin for allergic to Levaquin. The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; VOMITING (non-serious), outcome "unknown", described as "vomiting". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
patient fainted twice and lost consciousness twice for about 15 seconds. upon 2nd fainting episode, started having full body shakes/possible seizure
Pt vaccinated with MMR developed erythematous rash, c/o itching, Seen in ER; BP 108/74 Given Epinephrine then BP 110/68 given Bendryl.
My cousin got the booster and she is not immunocompromised or anything; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (My cousin got the booster and she is not immunocompromised or anything) in a 73-year-old female 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (My cousin got the booster and she is not immunocompromised or anything). At the time of the report, OFF LABEL USE (My cousin got the booster and she is not immunocompromised or anything) had resolved.            Concomitant medication use was unknown Treatment information was unknown
pt recv vax 18APR96 & 11AUG96 a titer revealed that no antibodies could be seen;
2 months in shingles after vaccinated/ suspected vaccination failure; Shingles; 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: 2 months in shingles after vaccinated/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was resolved (duration 2 months).   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 18-MAR-2023 This case was reported by a patient via  interactive digital media. The patient reported that he or she experienced shingles for two months after received shingles vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
headaches, bodyaches, vomitting, dizzy, sore throat, fatigue, blurry vision and eye fatigue
Pt reported a metallic taste in his mouth several minutes after receiving the shigrix vaccination. He was able to speak normally, exhibited no signs of shortness of breath. Lips and tongue were normal size, no difficulty swallowing. Pt monitored for 15 additional minutes. Reported no further symptoms. Denies dizziness. Pulse was at 71, and oxygen level at 96.
Pt was given a additonal booster of .25 in the L Delt. She had received one almost two months before.
Covid Arm: Lump, warm, redness, and itch around injection site on days 8-12
4 days after 2nd vaccine dose woke up with a bruising feeling on face and when she came home she noted red and swelling on right cheek. Improved with some topical corticosteroids and antihistamine and then seemed a bit on the left later that night.
Mild erythema, muscle soreness to leg - do not feel allergic reaction - more muscular.
A 15 year old male was given a Pfizer shot and 5 minutes later had a seizure for about a minute and then passed out for a few seconds and then woke up.  He was very pale and dizzy.  A nearby customer and pharmacy tech called 911.  The patient did mention that he hadn't eaten or drink anything before he got the shot.  The patient refused to go to the hospital.
Patient at approximately 1315 had post vaccination syncope with seizure like activity. After vaccination he stood up and went to trade chairs with his sister and fell face forward hitting his head and busting his chin on the fall. His left arm stiffened up and he began shaking. Nurses rolled him on his side and then to his back. He regained consciousness shortly after. 911 was called. Patient guardian refused transport to the ER and stated he would take them. Per my observation patient will require 1-3 stitches in his chin.
I began feeling noticeably dizzy approximately 3 hours after injection (first shot).. It is now 7 days post vaccination and the dizziness has not decreased AT ALL.
Lightheaded, dizzy, fever of 101, fatigue, aches, chills - lasted less then 24 hours.  Took 1 Tylenol before going to sleep at 9:00 PM
Extremely dizzy; Elevated heart rate; Some trouble breathing; Body aches; Joint pain; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Extremely dizzy), HEART RATE INCREASED (Elevated heart rate), DYSPNOEA (Some trouble breathing), MYALGIA (Body aches) and ARTHRALGIA (Joint pain) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced DIZZINESS (Extremely dizzy), HEART RATE INCREASED (Elevated heart rate), DYSPNOEA (Some trouble breathing), MYALGIA (Body aches), ARTHRALGIA (Joint pain) and NAUSEA (nausea). At the time of the report, DIZZINESS (Extremely dizzy), HEART RATE INCREASED (Elevated heart rate), DYSPNOEA (Some trouble breathing), MYALGIA (Body aches), ARTHRALGIA (Joint pain) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Approximately a few minutes after my booster shot I experienced the following symptoms: Left shoulder pain, Unable to move. The doctor said it might have been an injury with how the vaccine was administered to me. I took ibuprofen for treatment and physical therapy.
Possible powder reconstituted with another diluent; Possible powder reconstituted with another diluent; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number 424JG, expiry date 28th July 2023) and (batch number FA95N, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, the dose was an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 21-SEP-2022 Reporter's comment: The reporter was clinical coordinator.  The reporter stated that they had found 3 vials of Shingrix diluent and were doing an investigation, was unsure if three patients were given the powder reconstituted with another diluent.  The reporter had asked if there was any safety information provided or any harm to the patient.  The reporter had asked what he could do for it. The reporter was unsure and did not had a specific person/patient involved at that moment due to Healthcare professional investigating back from 15th August 2022 to 29th August 2022. The permission for consent to follow-up was denied. Additional Supportive Information: The patient was given the powder reconstituted with another diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case was linked with US2022135794 and US2022135797 reported by same reporter; Sender's Comments:  US-GSK-US2022135794:Same reporter US-GSK-US2022135797:Same reporter
This spontaneous report as received from a physician assistant refers to a male patient of unknown age. No information about medical history concurrent conditions and concomitant medications was reported. The reporter stated that the patient received of RECOMBIVAX HB (dose strength, route, indication was not reported) first dose on 19-JUN-2013 and the second dose on 18-JUL-2013 but missed the 3rd dose when scheduled. No adverse effects reported. The outcome of events reported is unknown. No product quality complaint was involved. Additional information has been requested.
Two hours after vaccine patient experienced hoarse voice, reported that she felt her airway was narrowing, and increased work of breathing.