chrisvoncsefalvay/vaers-outcomes huggingface dataset:
he noticed there was a total absence of discomfort of his normal pain that he was in, in his leg, and back, and with his joint issues; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EK4176) intramuscularly in left arm on 19Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient states that this would seem a little unusual, because he was not calling to tell Pfizer about an adverse reaction, but rather, a positive reaction to a product. Patient stated that this was extremely odd, and he had not heard this before, so Pfizer might be interested to know, that the patient received his COVID 19 Vaccine at his VA office on 19Jan2021, and within 24 hours, he noticed there was a total absence of discomfort of his normal pain that he was in, in his leg, and back, and with his joint issues (also reported as within 24 hours that his normal pain and discomfort were relieved). Patient stated that the product acted as an anti-inflammatory for him. Patient stated that this side effect was still ongoing at this time, but that it was starting to wane. Patient stated that he did not take any anti-inflammatories, no Advil, no Tylenol, so this was a totally raw experience. Patient received no other vaccines on the same day. Patient stated that he did not know if this was relevant, but he had blood type O Negative. The outcome of the event was unknown.
Patient experienced severe elevated blood pressure and a hemorrhagic stroke a few days post receiving 2nd dose of Moderna Covid vaccine. Patient was hospitalized and then moved to care facility. In care facility, patient experienced UTI and sepsis, which led to re-hospitalization. Due to issues swallowing, patient suffered aspiration pneumonia. Patient could not swallow properly post stroke, and directive was no feeding tubes. Thus, patient moved to hospice and subsequently passed away on 9/10/21.
Flu Vaccine - adverse reaction: swollen left arm, warm to touch, pain and soreness, redden.
9:30 PM- headache, chills 11:30 PM- projectile vomiting, chills, fever, headache 12:00 AM- projectile vomiting 4:30 AM- projectile vomiting, 101 fever, uncontrollable chills, headache 8:30 AM-headache 11:30 AM-present- lethargic, dizzy, soreness at injection sight
Fever, irritability within 24 hours of receiving vaccines ER visit 7/8/12 T 103 (R) 1918 pm OTC ADVIL/TYLENOL OV 7/9/12 T 104.5 degrees (R) Increased WBC 20,600 manual diff. Pt. admitted by Dr. 46 Neutrophils 8 Bands 35 lymphocytes 1 monocytes.
LOW BLOOD PRESSURE; HEADACHE; FEELS SORE TO MOVE HER ARM; LEFT ARM SORENESS AT AND AROUND INJECTION SITE; NUMBNESS ALL OVER HER BODY BUT MOSTLY IN HER LEGS; TROUBLE SLEEPING; This spontaneous report received from a patient concerned a 45 year old female. The patient's weight was not reported and height was 65 inches. The patient's concurrent conditions included high blood pressure, alcoholic, and smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978) dose was not reported, administered on 30-MAR-2021 10:00 on Left Arm for prophylactic vaccination. No concomitant medications were reported. On NOV-2020, Laboratory data included: COVID-19 virus test (NR: not provided) positive, Negative. On 30-MAR-2021, the subject experienced numbness all over her body but mostly in her legs. On 30-MAR-2021, the subject experienced trouble sleeping. On 30-MAR-2021, the subject experienced feels sore to move her arm. On 30-MAR-2021, the subject experienced left arm soreness at and around injection site. Treatment medications included: paracetamol. On 30-MAR-2021 16:00, the subject experienced headache. On 31-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) 110/68 mmHg. On 31-MAR-2021 10:30, the subject experienced low blood pressure.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from trouble sleeping, had not recovered from headache, numbness all over her body but mostly in her legs, and feels sore to move her arm, and the outcome of left arm soreness at and around injection site and low blood pressure was not reported. This report was non-serious.
Information has been received from a physician referring to a female patient in her 70's. The patient's concurrent or historical condition was unknown. On an unknown date in 2016 (reported as "over 30 days ago"), the patient was administered ZOSTAVAX (lot#, expiration date, dose and route unknown) on an unspecified pharmacy. Concomitant therapy was not provided. The patient experienced a hard-red-lump injection site reaction on an unspecified date after administration of ZOSTAVAX. The patient saw the physician on 29-JUN-2016 because of the lump. The patient also complained of a "metallic taste in her month". The physician indicated that the redness was not a rash. The outcome of adverse events was reported as not recovered. The causality was not provided. Additional information has been requested.
Tender, raised, red, hot-to-touch lesion on the thigh where the vaccine was given; about the size of a 50 cent piece; overall irritability that lasted about 2 hours but resolved once acetaminophen was given.
ED Discharged  2/21/2021 (3 hours)  Hospital ED   DO Last attending ? Treatment team Upper respiratory tract infection, unspecified type Clinical impression Cough Chief complaint ED Provider Notes  DO (Physician) ? ? Emergency Medicine Expand AllCollapse All      HPI      Chief Complaint Patient presents with ? Cough     Presents to the emergency department with cough, fatigue, headache for the last 4 days.  Called her PCP 3 days ago and was prescribed erythromycin for possible upper respiratory illness.  She was told to come to the ER if she did not feel better in 3 days.  She still feels ill.  She has not taken anything for the headache.  Has been taking Coricidin for the cough which does not help much.  Has a history of asthma, used her inhaler this morning for wheezing.  Complains of some dyspnea with exertion.  Denies any leg swelling.  No history of CHF.    ED Discharged  2/27/2021 (1 hours)  Hospital ED  , DO Last attending ? Treatment team COVID-19 +1 more Clinical impression Weakness - Generalized Chief complaint ED Provider Notes DO (Physician) ? ? Emergency Medicine Expand AllCollapse All      HPI      Chief Complaint Patient presents with ? Weakness - Generalized     Patient presents to the emergency department with a complaint of "I just feel so rundown."  Started with cough, dyspnea, fatigue, headaches on February 17 a few days after receiving her Covid vaccine.  Seen here in the emergency department 6 days ago and tested positive for COVID-19.  Has been at home.  Has been checking her pulse oximetry daily which has been no lower than 95%.  However, she is complaining of intense fatigue.  States that today, she could barely get out of bed because of feeling so tired.  Cough is still present, productive of only a scant amount of clear sputum.  No fevers.  Decreased appetite, but no vomiting.
9 days of severe joint and muscle pain beginning two days after the 2nd dose (shot on 2/17, pain 2/19).  Left hip pain began in March when I started playing golf.  Pain increased as the season progressed until it became unbearable on August 10.  I saw Dr. in Orthopedics on 8/13.  Following xray, he diagnosed moderate to severe arthritis in the left hip.  I believe the second Moderna shot accelerated exacerbated the arthritis.
sore throat; flu-like syndrome; fever (99.8F); fatigue; Headache; body aches; nausea; chills; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), INFLUENZA LIKE ILLNESS (flu-like syndrome), PYREXIA (fever (99.8F)), FATIGUE (fatigue) and HEADACHE (Headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), INFLUENZA LIKE ILLNESS (flu-like syndrome), PYREXIA (fever (99.8F)), FATIGUE (fatigue), HEADACHE (Headache), MYALGIA (body aches), NAUSEA (nausea) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) for Fever, Headache and Chills, at an unspecified dose and frequency. On 04-Apr-2021, OROPHARYNGEAL PAIN (sore throat), INFLUENZA LIKE ILLNESS (flu-like syndrome), PYREXIA (fever (99.8F)), FATIGUE (fatigue), HEADACHE (Headache), MYALGIA (body aches), NAUSEA (nausea) and CHILLS (chills) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products details not provided.
Teen suffered Loss of Consciousness that occurred less than ten minutes after vaccination, while teen was talking with front office staff.  She fell and was unconscious on floor for less than one minute.  Afterwards she regained consciousness, walked to exam room and recovered fully.
48hr p/vax c/o site swelling, red, & hot;area was elevated & excoriated from scratching (d/t itching);reddened area -1 1/2" x 1/2" entire upper arm tender to touch-limited ROM shoulder;pt guarding upper portion
Patient went from healthy to 104 fever within 5 hours of vaccination. He had high fever, chills, headache, sore throat, runny nose, body aches, fatigue, loss of appetite. Background: 3 children, oldest is the one with the adverse reaction. The youngest is 5 months old and was born with a Congenital Heart Defect, corrected at 4 days old. Despite asking many different people on different occasions if the nasal mist would negatively affect them OR the baby as it is a live but weakened virus, we were given the OK. As everything online states, we were reassured that the vaccine itself would not cause the virus. 5 Hours after the vaccination was given-- patient (4) starts becoming ill. I called the doctors office the next morning, the doctor called me about an hour later to inform me she had called Infectious Disease and they all had the same conclusions: there was no need to actually test him for influenza as it would come back positive due to the nasal mist vaccination anyways, but that he did indeed have influenza caused from the vaccination. We were told to separate both patient and our middle child (who also received the nasal mist, although she had only a runny nose and a 'normal' reaction) from our baby to hopefully prevent him from contracting it as well, as it may be very bad for him being so young and with his history. Both Dr. and Infectious Disease recommend we start our infant on TAMIFLU to prevent him from developing influenza. Patient was sick for 4 days with high fever and influenza symptoms. We did separate our family during the time; my niece whom he was exposed to once contracted the illness as well.
inflamed gums from eye tooth to eye tooth; This case was reported by a consumer via call center representative and described the occurrence of gingival inflammation in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th September 2020, the patient received Shingrix. On an unknown date, between 1 and 3 weeks after receiving Shingrix, the patient experienced gingival inflammation. On an unknown date, the outcome of the gingival inflammation was not recovered/not resolved.   It was unknown if the reporter considered the gingival inflammation to be related to Shingrix.  Additional details were reported as follows: The reporter was the patient.  The age at vaccination was not reported. She reported that she got the Shingrix shot and about a week or two later, she got all inflamed gums from eye tooth to eye tooth. She visited her doctor regarding this and neither she nor her doctor knows if the Shingrix was responsible for causing the gum inflammation. She told that her doctor took bloodwork to help determine the cause.
Six pt exp inject site rxn @ the DTP site; rxn described s hot to touch, induration, fever & sterile abscess dx in some cases;
On April 16, I noticed tiny red spots on both lower legs.  Covering the fronts and lower sides of both legs.  Since then, I have noticed the spots fading away, then coming back.  No treatment yet.  I sent an email to my PCP today for advice, because they are still there.
She states she did well with prior Pfizer vaccines.  She noted from 11/10-11/14 she had: ? Fatigue ? Felt ?sickly? ? Hands felt painful ? Hip joints hurt   Later she noted from 11/14-11/20: ? Loss of taste ? ?mouth feels like its been burned? ? no sores noted ? ?things taste bad? ? Joints no longer painful   Hx of multiple ?joint impact? and arthritis. She states she is over 70 years old and never had issues with other vaccines before.  No reported treatments.
dizziness , monitored vitals for 30 minute advised to drink water.   pt is alert and responds appropriately. per pt felt dizziness subsided.
My daughter was given the Quadracel vaccine in her upper thigh (closer to her butt) and not in the muscle. She had swelling with redness and the vaccine injection site was hard and hot. The redness started the following day and increased over the next 3 days.  It has slowly gotten better.
Information has been received from a female consumer of unknown age, concerning herself. On an unspecified date, the patient was vaccinated with a dose of ZOSTAVAX injection (dose, route and frequency were not reported) (lot # and expiration date were unknown). On an unknown date the patient experienced "some side effects from it". At the time of the report, the patient's outcome was unknown. Additional information is not expected.
All began 9 hours after injection (around 8 pm) and extended into the next day., lasting a full 30 hours. Symptoms lessened with 1000mg Tylenol. Drank lots of water and slept a lot.  Fatigue Fever 101.6 Body aches  Headache Severe Chills Nausea Loss of appetite  Sore arm
She got her vaccine in her left arm that evening, she felt fine.  The next morning she got up, felt a little off but she went to work.  About 2:00 PM she knew that she had developed a fever. Came home, took her temp it was 101.5, and that lasted almost for the next 24 hours. She had the body aches, joint pain.  She took Tylenol and over the 24 hours it relieved her symptoms.  She also had a slight headache.    After that 24 hour period she felt fine (Thursday).  On Friday she went to work and sat down in a chair, and when she got up from there she had numbness and tingling down her left leg into her foot.  She has had some lower back issues and some hip issues before, but she had not done anything since she had gotten the vaccine.  She does not know whether this is part of the vaccine or unrelated, but felt she should report it.  She is still having the numbness and tingling in the left leg and foot today.    She also had the pain almost like a lymph node pain under her left arm with this one and with the 2nd dose as well.    She did have a mammogram that was OK.   She is going to a doctor today to see if it's related to the vaccine or not.
Pain between the breasts on the ribs. Started out as seconds of slight pain the day after shot until about 9:30pm when the pain became consistent but was a slight pain. I woke up at 2:30am and my chest hurt really badly. It was a constant pain but the amount of pain was back and forth. It hurt more to lay down and if I bent down it was very painful. I stayed up for an hour and a half until the pain went away. When it did I had sweat a lot and was very hot.  I then woke up with little discomfort until an hour after I woke up with slight pain. The pain then has gone off and on but not as painful as it was during the night.
Got what at first felt like bug bites on my head. 2 months later started bolding and bumps turned to lesions, eye swell up and rash on my neck. Had a very low WB count. Dermatologist diagnosed with possible cutaneous Lupus (autoimmune disease).
Pt developed Reddish/tender rash around injection site that a physician deemed "allergic" on 1 day after administration.
chills, loss of appetite and weakness started 2 pm 7/29- used advil and benadryl diarrhea started 7/31 itching over  area of injection site -soreness / lymp nodes swollen under armpit of left hand large wheals and hives to two areas on lt hand and one area to rt hand-saw pharmacist who encouraged to keep hydrating and to use hydrocortisone ointment
I had severe nausea throwing up and diarrhea for a whole day and a half. I experienced severe dehydration. I am nursing my newborn I was not able to nurse him for two days due to the severe dehydration and diarrhea. I had fever around 102. I called the nurse line at my doctor office to see if I needed to come in for an appointment or go to the ER and I was told if I did not urinate for 8 hours to go to the ER but I was able to urinate after 7 1/2 hours.  I was told to drink pidilite and do the BRAT diet. I also had a bad headache and achiness. I felt like I got him with the flu.
Muscle and joint aches, headaches, rash on hands. My joints ache a lot. I get headaches and had a CAT Scan done. Rash on hand, my skin cracks, tender to heat and cold. Muscle and joint aches after 1st vaccine. Rash after 5th vaccine, headaches after 5th.
10 days after vaccine I developed hives all over my body. I have had chronic hives since then (6 weeks, now) that I need to take daily antihistamines for to keep at bay. I have dermatographia as well which still occasionally worsens despite antihistamines.
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 37-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm, as dose 2, single (Batch/Lot number: unknown), in left arm and on 01Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "PCOS" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test negative: (unspecified date) Negative; SARS-CoV-2 test positive: (unspecified date) Positive, notes: Treatment COVID-19; (2023) Positive, notes: Covid symptoms and positive test 4 days after negative test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Course of events: Patient experienced rebound Covid symptoms and positive test 4 days after negative test and no symptoms. Patent received Paxlovid (Lot number GG2523) as antiviral COVID 19 treatment from 21Feb2023 to 25Feb2023. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
This spontaneous case reported by a healthcare professional, describes the occurrence of administered expired product (room temperature for more than 12 hours) and product temperature excursion issue in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 002C21A) for COVID-19 immunization. No medical history reported. On Jun 2, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jun 2, 2021, patient administered expired product (room temperature for more than 12 hours). On an unknown date, patient experienced product temperature excursion issue. On Jun 3, 2021, administered expired product (room temperature for more than 12 hours) resolved. At the time of the report, product temperature excursion issue outcome: unknown. The reporter did not provide any causality assessments, concomitant medications or treatment information.
fluzone administered to adult patient after product experienced an excursion with no reported adverse events; fluzone administered to adult patient after product experienced an excursion with no reported adverse events; Initial information received on 16-Feb-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves Adult and unknown gender patient to whom influenza quadrival A-B vaccine [Fluzone QIV] was administered after product experienced an excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient was administered unknown dose of suspect influenza quadrival A-B vaccine, suspension for injection (dose, strength: not reported; lot UT7683NA; UT7683NA: expiry date: 30-Jun-2023) via unknown route in unknown administration site for immunization after product experienced an excursion with no reported adverse events (product storage error) (poor quality product administered) (unknown latency).  Action taken : not applicable.  Outcome was Unknown.   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 the 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.; Sender's Comments:  US-SA-2023SA057309:01495347 US-SA-2023SA055890:01495388
A non-serious spontaneous report of gave 1 1/2 year old twins FLUMIST was received from a health professional concerning a 22-month-old female. The patient's past medical history includes twin birth. The patient's concomitant medications were not reported. The patient received FLUMIST on 22-Dec-2010. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Additional information was received on 23-Mar-2011: Reporter confirmed that there was no late occurrence of adverse events.