chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired Boostrix administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 58-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number GC5NG, expiry date 01-APR-2023) for prophylaxis.   On 03-APR-2023, the patient received Boostrix. On 03-APR-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: Expired Boostrix administered). The outcome of the expired vaccine used was 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: 6-Apr-2023 The office manager called to inquired that how to proceed, the dose was still good. The reporter did not consent to follow-up. The patient inadvertently received an expired dose of Boostrix in reporter's facility, which led to expired vaccine used.
Information has been received from a physician concerning a 53 year old male who on 20-DEC-2006 was vaccinated SC with a dose of Zostavax> on 20-DEC-2006 the patient experienced a tingling sensation in the arm, down the arm and into the finger tips in the same arm the vaccine was given. On 13-FEB-2007 the patient was seen for an office visit and the tingling sensation has not gone away. There was no product quality complaint involved. Additional information has been requested.
Fissure on tongue, Lesions on the tongue around the fissure which was recently diagnosed as Oral Lichen planus. Horribly burning and sensitive tongue. Topical steroids prescribed but not helping much
Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient fainted, body stiffened, eyes rolled back.  Epi-pen was administered and patient regained consciousness.  911 was called after epi-pen was administered.  Paramedics arrived and assesed patient.  He decided to go home with parents and not be trasported to the hospital.
Patient immunization record from registry indicated that patient received first dose of Pfizer COVID-19 vaccine on 2/3/2021. No second dose was listed. Infection Prevention RN from the facility where she is currently admitted for rehabilitation requested second dose of Pfizer COVID-19 Vaccine to be given on 7/30/2021. Upon entering data into patient record it was discovered that a late entry was added to Registry for a missed record of second vaccination having been received on 3/3/2021. Patient was monitored for 30 minutes to ensure no adverse reaction from additional dose received today.
Extreme pain radiating to her neck; Extreme pain radiating to her neck; Left arm weakness and pain; Left arm weakness and pain; This spontaneous case was received on 01-Oct-2020 from other health professional via Health Authority (reference number: SEQW20-02728) and concerned a 42-year-old, female patient.  The patient had no relevant medical history and was not taking concomitant medications.  On 31-Aug-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent, dose: 0.5 ml, anatomical location: left deltoid and route of administration: not reported) for influenza prophylaxis. The batch number reported was 279827, expiry date: 18-Jun-2021.   On the same day, two hours after receiving Flucelvax QIV, the patient developed left arm weakness and pain.   On 01-Sep-2020, within 24 hours, the patient experienced extreme pain radiating to her neck.   On 03-Sep-2020, the patient came to pharmacy and it was noted there was no redness, swelling or sign of infection at the injection site and the site appeared to be fine.   On an unspecified date in 2020, at a later time (as reported), she was seen at an Urgent Care and given a high dose of steroids and Advil (ibuprofen).   On an unspecified date in 2020, all cleared up and the patient recovered from left arm pain, 'neck pain' and 'radiating pain', except the weakness in left arm.    At the time of initial reporting on 01-Oct-2020, the patient had not recovered from weakness in left arm.   The reporter did not provide a causality assessment.  The reporter did not provide a seriousness assessment.  Company comment: The patient developed pain in extremity, muscular weakness, pain and neck pain within one day after vaccination with the suspect product, Flucelvax QIV. Chronology is plausible. No information about concomitant medications and medical history was provided. Considering all above mentioned, causal relationship for all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).; Sender's Comments: The patient developed pain in extremity, muscular weakness, pain and neck pain within one day after vaccination with the suspect product, Flucelvax QIV. Chronology is plausible. No information about concomitant medications and medical history was provided. Considering all above mentioned, causal relationship for all events is assessed as possibly related. (defaults to ''related'' in the safety database for reporting purposes).
Around 11pm, I started getting fever and felt very sore everywhere.  I took two Tylenol and went to bed.  I woke in the night to find that the injection site was swollen to golf ball size.  By morning, it was hot, red, and the size of a softball.  I also had a migraine.  The knot is now the size of a grapefruit and it hurts.  I called the clinic and was told that a reaction is normal.  This is not normal.  The skin is stretched so thin it's almost translucent.
On Tuesday, February 16, 2021 pt received the Pfizer COVID vaccine (LOT # EN6201, EXP 6/20/21) at approximately 2:10pm. Pt approached EMT stating she is "feeling itchy" on her left arm and on her face. Pt said that scratching did not relieve the itchiness she felt. Pt said she received her shot on her right arm however that arm wasn't itchy. EMT did not obverse any signs of distress or indication including hives or redness on skin however pt appeared slightly diaphoretic as she was fanning herself with papers. Pt stated she has never had allergies to any food, medications or vaccine previously. Pt stated she was not experiencing any SOB and upon observation by EMT her breathing appeared unlabored and within normal limits. Pt also stated she felt a bit dizzy after receiving the vaccine. Pt declined a health assessment from EMT at this time and no further vitals were taken. EMT gave 10mL Diphenhydramine HCl oral solution and a water bottle at approximately 2:25pm. Pt stated at approximately 2:30pm she was no longer feeling itchy. Pt said she felt better when she left the vaccine site with a steady gait at 2:45pm-her husband drove her home.
Information has been received from a health professional concerning a patient (30 out of 40) who was vaccinated with Pneumovax 23 (lot number 651406/0620F).  It is unknown if the patient was vaccinated with the influenza virus vaccine (unspecified) on the same day.  Subsequently the patient experienced fever, pain at injection site, redness at injection site, swelling at injection site and red streaks on injection arm.  Subsequently, the patient recovered from fever, pain at injection site, redness at injection site, swelling at injection site and red streaks on injection arm.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot complies with the standards of the agency and was released.  Additional information has been requested.
fatigue that lasted one day/was in bed all that day; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue that lasted one day/was in bed all that day) in a female patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue that lasted one day/was in bed all that day). At the time of the report, FATIGUE (fatigue that lasted one day/was in bed all that day) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were not provided.
Severe nasal congestion Post-nasal drip Severe chills Severe Coughing (keeping me awake) Severe exhaustion Diarrhea Itchy/burning Scalp, palms, and feet Sensitive skin  Sore throat (No fever or loss of taste or smell) All symptoms were severe and lasted for 3-4 weeks after the second COVID-19 Pfizer Vaccine.  I was diagnosed with COVID on August 6, 2021, and these symptoms were just as bad, if not worse.
Acute renal failure  necrosis of skin with permanent injury  lost her job now disabled despite meds Basically fired because she was unable to return to work due to open sores
Narrative:  Patient reports no side effects from 3rd dose. No hospitalizations or exacerbations of current disease states
experienced "significant swelling, redness, and severe pain in her arm" at the injection site; experienced "significant swelling, redness, and severe pain in her arm" at the injection site; experienced "significant swelling, redness, and severe pain in her arm" at the injection site; This spontaneous report was received from an unspecified reporter via company representative and refers to a 65 year old female patient. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medication were not provided. On an unknown date, the patient was vaccinated with a dose pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (strength, dose, route of administration, lot # and expiration date were not provided), for prophylaxis. On an unknown date the patient experienced "significant swelling, redness and severe pain in her arm" at the injection site, for a couple of weeks before it subsided. The outcome of of the events was considered as recovering/resolving. The causality assessment was not provided.
vomiting x 4 (day p/vax);crying/fussiness-fever 100;APAP given per mom;
Site: Pain at Injection Site-Mild, Systemic: Chills-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Mild, Systemic: Shakiness-Medium, Systemic: Weakness-Medium, Additional Details: Pt received vaccine, spoke to her shortly after and decided to shop around the store. Shortly after walk pt started feeling light headed, and dizzy and fainted. Mom stated that this had happen to her before. Monitored patient for 30 min, gave water and a snack. Mom decided against calling 911.
pt recvd vax;inconsolable crying,lasting 30 hrs w/ break of 4 hrs of sleep;began 3 hrs after dose given;not high pitched cry,no shock like state;no fever;recovered on 19dec by 11am;
This spontaneous report as received from a health professional refers to a 5 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 05-NOV-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX lot # L024256, expiration date: 01-JUL-2017 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20.3 degrees Fahrenheit for 72 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
I had the Pfizer-BioNTech vaccine on 4/6 and felt dizzy 30 minutes later. The dizziness continued for the next 84 hours. On 4/9 (three days after vaccination), I fainted on my  driveway as I was heading home around noon time. I felt dizzy the whole afternoon but were trying to help out the groceries from the car. I fell down on the concrete driveway with two bags of groceries on my hand. I did not blackout, but were not able to get up for 10 seconds due to the dizziness. I eventually recovered from the dizziness 84 hours after the first dose of vaccine. I injured my knee as I fell, but the wound were treated at home immediately.  As for the sore arm, I could not hold any items heavier than 1 lb. The arm soreness went away after 48 hours with ice pack applied on upper arm(injection area).
Pt reported feeling dizzy and light headed.  He laid down with feet up with cold pack.  He felt better after about 10 minutes and he sat up.  He then fainted within about 5-10 minutes.  We again got him safely to the ground with feet up and cold pack. He remained pale and dizzy for about 10 minutes.  He then sat up and left after about 20 more minutes after reporting that he felt better.
On 6/13/01, DTAP, IPV, Prevnar and Comvax was given and within 48 hours, post vax, child had 2 seizures. Temperature maximum of 100F. Admitted to hospital with EEG and full septic work-up which were negative. Placed on phenobarbital. Plan to wean off in 3 months.
Started convulsive seizures about 10 minutes after dose administered. Had his own dose of diazepam 5mg oral concentrate that his companion administered. Seizure lasted less than 1 minute. Was able to get laid down and protected from any head injury or trauma.
weakness, body aches, headaches, increased BPs (checked by wife at home), chills, sweats at night, yellowing of eyes, nausea, intermittent cough
According to mother: Rash began this a.m. (4/10/03) and spread, "little blisters and pimples". Ran low grade temp. No appetite. On 4/11/03 rash has not increased, no temp, appetite remains decreased.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; HEART PALPITATION; THROBBING; RINGING OF EARS; TERRIBLE HEADACHE; FEVER; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non-alcohol user, and non-smoker. The patient had no known allergies, no history of drug abuse or illicit drug use and she did not had any medical history nor she was taking any medications prescribed by a physician/doctor. Patient was not pregnant. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 20-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  On 20-MAR-2021, the same day after vaccination the patient had fever of 101.8 degree fahrenheit and terrible headache which was throbbing and because of which patient was unable to stand up. The patient also experienced ringing of ears and throbbing. The patient said that she did not felt any symptoms until 11-AUG-2021 when the patient again reported having fever of 102.9 degree fahrenheit, chills, body aches, heart palpitations, and headache which was ponding, all of which lasted for 4 days. The patient also experienced cough, congested, and was extremely tired. The patient said that she could not do much whenever she tried to get active. On 12-AUG-2021 the patient took BinaxNow Covid-19 Antigen Swab Test which came negative. On 16-AUG-2021 the patient experienced loss of taste and smell and again took BinaxNow Covid-19 Antigen Swab Test which came out to be positive(suspected covid-19 infection and suspected clinical vaccine failure).     The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart palpitation on 14-AUG-2021, and terrible headache, and fever on 24-MAR-2021, had not recovered from ringing of ears, and throbbing, and the outcome of suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210835629- covid-19 vaccine ad26.cov2.s - Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically:SPECIAL SITUATIONS
107 patients who were administered with the vaccine past the published expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (107 patients who were administered with the vaccine past the published expiry) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (107 patients who were administered with the vaccine past the published expiry). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (107 patients who were administered with the vaccine past the published expiry) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was reported. No concomitant medications were reported.   This case was linked to MOD-2021-405476 (Patient Link).
This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient. A 64-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 05Jan2022 at 13:15 (Lot number: unknown) at the age of 64 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: high blood pressure; "Sulfonamide allergy" (unspecified if ongoing), notes: Known allergies: Sulfa and "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19? : Yes. The patient received unspecified concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EN6208, Anatomical site: Left arm, Administration time: 13:15, Route of administration: Unspecified), administration date: 16Mar2021, when the patient was 63 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: EN6206, Anatomical site: Left arm, Administration time: 12:15, Route of administration: Unspecified), administration date: 06Apr2021, when the patient was 63 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 05Jan2022 at 13:15, outcome "unknown", described as "Dose received: 3"; SWELLING (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 07Jan2022 at 08:00, outcome "not recovered", and all described as "Swelling underarm and below arm where shot was given". Therapeutic measures were not taken as a result of swelling and peripheral swelling. Additional information:  Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The lot number for BNT162b2 was not provided and will be requested during follow up.
Fever, chills, body aches, headache, diarrhea, muscle pain at injection site, whole left arm was sore.
S/S swelling/redness/warm to touch/pain and discomfort, decrease mobility of L arm. Tx'd with antihistamines and ice packs.
Abdominal cramps, diarrhea, dry heaves, nausea, fever and chills over 102 degrees
I was diagnosed with Guillain Barre Syndrome on 05-2015. I was extremely weak in my legs for a month before I was diagnosed. I was paralyzed from my waist down for a month and my hands were very curled. I was in the hospital for 1 month and inpatient rehab for 3 weeks. I currently go to physical therapy 2 times a week. After being paralyzed and learning how to walk again I NEEDED to be in a wheelchair for 6 months due to not being able to withstand the pain in my back. After the wheelchair I have needed to use a can, I currently can't stand for more than 2 minutes without getting extreme shooting nerve pain in my back, hips and legs. I am currently taking Lyrica, oxycodone, Flexeril and Elavil for the excruciating pain I have EVERY day.
Started with a dull pain in my right side.  After Dinner on that Friday (3-25-21) I  threw up.    Thought I had food poison(ate fish). running a low grade fever fell asleep an woke up feeling better however a sore stomach (like if stillsick).  Saturday evening the pain started to get worse/running high fever and a tenderness in my stomach. Went to Emergency. After being admitted and doing testing turns out I had appendixsitis.  Surgery was Sunday afternoon and turns out was a preforated appendix.  I am not sure if this is related at all to my getting the vaccine however too coincidental that I received the shot on the 15th and this happened so suddenly within 2 weeks.
Atrial fibrillation; Tested positive for COVID; Minor Aches like he was getting a cold; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation) and COVID-19 (Tested positive for COVID) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced MYALGIA (Minor Aches like he was getting a cold). On 25-Mar-2021, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criterion hospitalization) and COVID-19 (Tested positive for COVID) (seriousness criterion hospitalization). At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation), COVID-19 (Tested positive for COVID) and MYALGIA (Minor Aches like he was getting a cold) outcome was unknown.   She said they had been very careful, but had met with some friends and 2 of their friends also tested positive.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.      The day after he received the vaccine he felt minor aches, like he was coming down with a cold. On that Thursday he went into a fib. She took him to the ER and it took several hours to regulate his heart rate. While making arrangement to transfer him to a new hospital they did a COVID test and it was positive. They were shocked as he had not been showing any symptoms. He spent the night in the hospital.  Very limited information regarding the even tof A fib has been provided at this time.  Further information has been requested. However the event of Covid 19 and myalgia is unlikely related to vaccine. Covid 19 is  a confounding factor for the event of myalgia and base of the available information, the vaccine is not known cause of Covid 19.; Sender's Comments: Very limited information regarding the even tof A fib has been provided at this time.  Further information has been requested. However the event of Covid 19 and myalgia is unlikely related to vaccine. Covid 19 is  a confounding factor for the event of myalgia and base of the available information, the vaccine is not known cause of Covid 19.