chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Numbness on left arm; Hard to move around; Dose number: 3; This is a spontaneous report from a non-contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 28 year-old male patient received bnt162b2 (BNT162B2), administered in left arm, administration date 17Dec2021 at 14:30 (Lot number: FH8027) at the age of 28 years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history was not reported. The patient did not take any concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: ER8729; Route of administration: unspecified), administration date: 09Apr2021, when the patient was 27 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: EW0192; Anatomical site: Left arm; Route of administration: unspecified), administration date: 07May2021, when the patient was 27 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 17Dec2021 at 14:30, outcome "unknown", described as "Dose number: 3"; HYPOAESTHESIA (non-serious) with onset 17Dec2021 at 21:00, outcome "not recovered", described as "Numbness on left arm"; MOVEMENT DISORDER (non-serious) with onset 17Dec2021 at 21:00, outcome "not recovered", described as "hard to move around". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of hypoaesthesia and movement disorder.  Additional Information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had been tested for COVID-19 and the result was negative. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  No follow-up attempts are possible. No further information is expected.
My breakthrough Covid infection symptoms began Tuesday.  Went from a bad headache, day one.  On  day two it moved into my chest with sore throat and congestion.  I briefly had trouble breathing. while I was talking with my doctor on telehealth.  As of now I have a cough.
Jerky generalized seizure-like episodes occuring 3-4 times 5-15 seconds duration, starting approximately 36 hours after vaccination, until approximately 48 hours after vaccination.  No associated fever.
fever of 103.3 Fahrenheit; This is a spontaneous report from a contactable consumer(patient). A male patient of an unspecified age received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced a fever of 103.3 Fahrenheit on an unspecified date with outcome of unknown. Information about lot/batch number has been requested.
Blurred vision Headaches Leg cramping Dizziness  Body aches Chills Falling
2 days after vaccine employee had hands swelling , blisters on both hands and hands were very puritic, has improved but lasted 10 days
Horizontal Nystagmus next day following vaccine administration, pt did have Nystagmus week following 1st administration,  received Neuro w/u done then EEG neg MRI brain Neg.
FLUBLOK had been administered to 11 pediatric patients (with no adverse event); Initial information was received on 04-Jan-2021 regarding an unsolicited valid non-serious case from an other health professional.  This case involves a 16 years old male patient for whom it was reported that Flublok had been administered to 11 pediatric patients (with no adverse event) (Product administered to patient of inappropriate age), while he received vaccine influenza quadrivalent recombinant vaccine (Flublok QIV).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication was not reported.  On 22-Dec-2020, the patient received a dose of suspect influenza quadrivalent recombinant vaccine at a dose of 0.5 mL once via intramuscular route (lot number: UJ509AA, expiry date: 05-Oct-2020) as prophylactic vaccination in the right deltoid.  On an unknown date (latency unknown) after taking the suspect, it was reported that Flublok had been administered to 11 pediatric patients (with no adverse event) (Product administered to patient of inappropriate age) (intensity: not applicable).  No laboratory test was reported.  Action taken was reported as not applicable. Corrective treatment was not reported. Outcome was reported as not applicable for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.    No further information was reported.
itching, redness @ superior positon radiating to the elbow; spreading around the circumference of arm; sl swollen & warm to touch;
patient completely fainted, what I believed was a syncope, patient fail and hit his head badly, had nausea, numbness in his upper body, headache, pain in the neck, difficulty breathing
doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 4:20 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 4:20 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient age was reported as 63.83 years.  Concomitant products were not provided.  On 03-Apr-2021, Excursion time was 9 AM, temp was 34, total doses given for the day was 210, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vial was moved to clinic. Vaccine BUD date was 29-Apr-2021.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34- or 35-degree F.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken by using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. No treatment information was provided.
Initial and follow up information has been received from a physician concerning a 12 year old male patient with allergic rhinitis and skin test positive to multiple molds who on 22-SEP-2006 was vaccinated with a first dose of Pneumovax 23.  One hour later, the patient developed hives.  He was treated with an antihistamine.  The physician indicated that there were no other symptoms and that the hives were self-limiting with no major treatment needed.  On the same day, the patient recovered.  Additional information is not expected.
This is a spontaneous report from a contactable consumer. It was reported that a a male patient (the reporter's father) of unknown age and ethnicity, received the second dose of PREVNAR 13 on an unknown date at single dose in the arm for immunization. Patient medical history and concomitant medications were not reported. Past drug history included the first dose of PREVNAR 13 for immunization. The reporter stated that patient's arm was extremely sore, and the patient developed body aches all over. At the time of this report, the patient was feeling better but the arm was still extremely sore. The information on the batch number has been requested.
Left upper arm, is feverish, pain to touch, day after I ached all over, bones hurt. Took TYLENOL and ibuprofen. Approximately 12 hours later aching stopped but started again this morning.
Constant tinnitus since 3 days after the vaccine. So far it has lasted from 4/12 to now (5/18). Never had this tinnitus before the vaccine.
The lady?s technique was to put needle in with one hand. Switched the hand she was holding the needle with, then plunged the vaccine into my arm. I could feel the needle moving in my arm. It has been sore since!
I started with a cough that got severe and couldn't sleep. I went to the doctor and was prescribed a medication which I took. The cough is finally slowly going away. I have felt at times for a long time was exhausted after COVID-19 last year. I also have COPD.
The day after I received my 2nd Pfizer COVID vaccine (Day 1), I experienced sore muscle at the injection site and I noticed that the skin in my left flank, left back and Left abdomen felt numb. On Day 2 1/12/21, the numbness got progressively worse and it was noted that there was a marked difference while showering, my upper left hip and thigh were also beginning to get numb. I went into the ED where they took x-rays, gave me steroids (Decadron) and sent me home for follow up within the next 3-5 days. Today, Day 3-1/13/21,My skin still feels numb and less, and the tingling in my left thigh is no longer present. dx"paresthesia," no other concerns as it has not affected my movement or ability to work.
sleepy; Arm hurt; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleepy), PAIN IN EXTREMITY (Arm hurt) and FATIGUE (fatigue) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced SOMNOLENCE (sleepy), PAIN IN EXTREMITY (Arm hurt) and FATIGUE (fatigue). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (sleepy), PAIN IN EXTREMITY (Arm hurt) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.
on day 8, observed a red swelling around the injection site. no itchiness, just red and swollen
Sore teeth and gums starting  30 hours after shot so that chewing, brushing teeth and drinking cold liquids are painful.  Has continued for more than a day now.
Elevated temperature up to 101.3°F. Chills and bodyaches that were bad enough that I would've had to call off sick from work, and continued until 2/9/2021 evening, and despite taking doses of Tylenol 1000mg.
Headache, Myalgia, Fever, NauseaVomiting, Localized pain, redness, swelling; chills, fatigue Narrative:  Other Relevant History:
approx 1 hr p/vax mom came back to ofc; pt had petechiae noted around eyes; 2 days later pt returned to ofc w/more petechia & papules noted mainly on extremities; the rash cleared over a period of approx 1 wk;
Patient reports headache and tightness to chest (mild). Reports headache went away almost immediately but tightness to chest remained. Cleared by EMS
feeling tired, stiff jaw. patient went to urgent care and was told pt only needed over-the-counter ibuprofen.
Patient received 2nd dose of Pfizer Covid vaccine 1 week early- 1st dose  04/10/2021 and second dose 04/24/2021
Weakness that started in extremity (legs) and spread to all extremities over a 3 to 4 week period. Patient has received medical care, but has not returned to her previous normal, prior to vaccination date.
Hasn't gotten the second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Hasn't gotten the second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Hasn't gotten the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Hasn't gotten the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications have not been specified. The patient travelled out of state and has not received the second dose yet. Treatment information was not given.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Attached document contains no new information.
This case was considered medically important (OMIC). Information regarding Flumist was received from a pediatrician regarding a 14 year old male pt who experienced acute disseminated encephalomyelitis. At 14 years of age, the pt received a dose on 12/19/03. The pt's concurrent illness includes asthma. Indication for Flumist was immunization. Product was administered on 12/19/03. Dose regimen was one dose. Pt was not taking concomitant therapy. On 12/21/03, 2 days post-immunization, the pt experienced acute disseminated encephalomyelitis. No additional info was available at the time of this report. Follow-up information obtained via telephone from the physian provided specific symptoms, diagnostic tests performed, treatment and event outcome (patient recovered). Information regarding Flumist (2003-2004 formula) (influenza virus vaccine, live intranasal solution (frozen) was received from a pediatrician regarding a 14-year old male patient who experienced acute disseminated encephalomyelitis. Medical History: The patient's concurrent illness includes mild excercised induced asthma. He presented with slight upper respiratory infection symptoms on day of vaccination "but was essentially well". On 21-Dec-2003, 2 days post-immunization, the patient presented to the emergency room with confusion and uphasis. He was transferred to a nearby hospital and admitted to the pediatric intensive care unit. On 22-Dec-2003, he had hyperrflexia, eloqua, meningisma and confusion on exam. An MRI of the head revealed a diagnosis of acute disseminated ancephalomyelitis. He was treated with steroide (not specified) and improved dramatically within 24 hours. On 29-Dec-2003, the patient was discharged from the hospital. He was seen for follow-up on 06-Jan-2004, and was "completely recovered". Of note, the patient's sister was diagnosed with acute disseminated encephalomyelitis after a viral infection in March 2000.
stroke; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "stroke".  Clinical information: The patient had a stroke within a couple months after getting the Pfizer vaccine at a pretty young age when they had no health issues earlier.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (05Apr2023): This is a spontaneous follow-up report received in response to the mail trail sent regarding the confirmation of below mentioned query: Removed patient's details (age group, gender and non-Study Pt ID).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (18Apr2023): This is a follow-up report to notify that the case  are duplicates.  All subsequent follow-up information will be reported under Manufacturer report number 202300161917. Sender's Comments: Linked Report(s) : US-PFIZER INC-202300145035 Same reporter/ drug/ AE, different patients;US-PFIZER INC-202300145036 Same reporter/ drug/ AE, different patients;
got a pain in my left side of my neck right after shot. Had some headaches and chills and feeling fatigued for two days. The noticed the pain in my neck increase and my vein protruding. Went to get a neck ultrasound. they found many swollen lymph nodes and a blood clot. Diagnosis Thromophlebitis superficial.
irregular heart beat/afib; Chills; fever; headache; body ache; upset stomach; irregular heart beat/afib; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Apr2021 08:15 at single dose for COVID-19 immunisation. The patient's medical history included hypertension and afib. Concomitant medications included lisinopril, acetylsalicylic acid (ASPIRIN), both taken for an unspecified indication, start and stop date were not reported. The patient had no COVID prior to vaccination and was not tested for COVID post-vaccination. The vaccination facility type was Urgent Care Center (reported as Doctor's office/urgent care). On 08Apr2021 at 02:30, the patient experienced irregular heart beat/afib, chills, fever, headache, body ache, and upset stomach. No treatment was received for the events. The patient underwent lab tests and procedures which included heart beat: irregular on 08Apr2021. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Vaccinated at 0820. Around 1800 same day, felt very tired suddenly and developed mild headache and malaise. Went to bed early around 2030. Woke up feeling better next day. Still had a mild headache. Some soreness when lifting arm that vaccine was received in. Ate breakfast at 0730 and immediately felt very hot, like flushed. Lasted around 20 minutes, mainly subsided now. Took acetaminophen.
EVERYTHING TASTES LIKE DIRT; COUGH; NAUSEA; BODY ACHES; SHORTNESS OF BREATH; LIGHTHEADED; JOINT PAIN; ARM PAIN; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's past medical history included respiratory syncytial virus, and concurrent conditions included irritable bowel syndrome, fibromyalgia, osteoarthritis, osteoporosis, kidney tumor, duct closures in liver, penicillin allergy, Sulfonamide allergy, abstain from alcohol, and cigarette smoker, and other pre-existing medical conditions included the patient did not had drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018 and expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination in right arm. No concomitant medications were reported. On 13-MAR-2021, the subject experienced body aches. On 13-MAR-2021, the subject experienced shortness of breath. On 13-MAR-2021, the subject experienced lightheaded. On 13-MAR-2021, the subject experienced joint pain. On 13-MAR-2021, the subject experienced arm pain. On 14-MAR-2021, the subject experienced everything tastes like dirt. On 14-MAR-2021, the subject experienced cough. On 14-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from shortness of breath, had not recovered from body aches, nausea, lightheaded, everything tastes like dirt, cough, and arm pain, and the outcome of joint pain was not reported. This report was non-serious.  Additional information was received from patient on 16-MAR-2021. the following information was updated and incorporated into the case narrative: Patient information (date of birth, age, age group, race and ethnicity) added, patient medical history was added, New events everything tastes like dirt,cough,body aches were added.
Patient had second Moderna on 5/3/21, and next day was feeling achy, tired, headache. Today she stated she woke up with a sore arm at injection site that is also swollen and about 3" round.
Notified 11/30/2009 by mother - seizure activity on 11/26/09. Seen in ER. Releases after a few hours. Temp. at time of seizure 101 as stated by mom. Returned to school as of 11/30/09.
Hot in her muscles; Sore and painful arm; Fever; Anxiety; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Hot in her muscles), PAIN IN EXTREMITY (Sore and painful arm), PYREXIA (Fever) and ANXIETY (Anxiety) in a 60-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING HOT (Hot in her muscles), PAIN IN EXTREMITY (Sore and painful arm), PYREXIA (Fever) and ANXIETY (Anxiety). At the time of the report, FEELING HOT (Hot in her muscles), PAIN IN EXTREMITY (Sore and painful arm), PYREXIA (Fever) and ANXIETY (Anxiety) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Information was received on 11-JUL-2017 from a certified medical assistant who was reporting on a patient of unknown gender. No medical history or concomitant medications were reported. On an unspecified date 6 years ago, the patient was 10 years of age and received the first dose of GARDASIL (no lot, expiration, dose or site reported) for prophylaxis. On 11-JUL-2017, the patient was administered dose two in the serious with a dose of GARDASIL 9 (no lot, expiration, dose or site reported) six years later. No adverse effects reported. No other information was provided. Additional information has been requested.
A non-serious spontaneous report of arms and legs hurting badly has been received from a patient parent involving a 7.5 year old male subsequent to FLUMIST. The patient's medical history and concomitant medications were not reported. The patient received FLUMIST on 11-Oct-2009. On 12-Oct-2009, the patient reported that his legs and arms were hurting badly. The outcome of the event was not reported.