chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Neuropathy in both legs; Premature start of scheduled drug administration; Body aches/Aching; Chills; Fever; Headache; This spontaneous case was reported by a physician and describes the occurrence of NEUROPATHY PERIPHERAL (Neuropathy in both legs), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Premature start of scheduled drug administration), PAIN (Body aches/Aching), CHILLS (Chills) and PYREXIA (Fever) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (Neuropathy in both legs), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Premature start of scheduled drug administration), PAIN (Body aches/Aching), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, NEUROPATHY PERIPHERAL (Neuropathy in both legs) had not resolved, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Premature start of scheduled drug administration) had resolved and PAIN (Body aches/Aching), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: fever (High) Fever. In 2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PAIN (Body aches/Aching), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Headache) to be probably related. No further causality assessments were provided for NEUROPATHY PERIPHERAL (Neuropathy in both legs) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Premature start of scheduled drug administration).    Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was no change.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded for fever, chills, pain and headache. The events of Peripheral neuropathy is assessed by an HCP as reasonably related to Humira.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded for fever, chills, pain and headache. The events of Peripheral neuropathy is assessed by an HCP as reasonably related to Humira.
have noticed a definite loss of hair .  will be given blood work for thyroid and iron deficiency  atorvastatin used since 2017 without this side effect hair is noticeably and suddenly shedding ...seems to nave started post injection
Local Reaction, redness around injection site quarter size with 2 small whelps inside red area each the about 1/2 size of a dime in diameter
Persistent lightheadedness/dizziness; vertigo; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the right arm on 24Mar2021 at 02:45 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient did not receive any medication within two weeks of vaccination. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021 the patient experienced Persistent light headedness, dizziness, vertigo. Patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events vertigo, light headedness was not recovered at the time of reporting.  No follow-up attempts are needed. No further information is expected.
A little bit raised heart beat; felt like Anxious; Felt jittering inside body; Left arm was red at the injection site; Left arm was sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (A little bit raised heart beat) and VACCINATION SITE ERYTHEMA (Left arm was red at the injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L2019) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced HEART RATE INCREASED (A little bit raised heart beat) and VACCINATION SITE ERYTHEMA (Left arm was red at the injection site). On 08-Feb-2021, VACCINATION SITE ERYTHEMA (Left arm was red at the injection site) outcome was unknown. At the time of the report, HEART RATE INCREASED (A little bit raised heart beat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
PAIN IN TEETH TOWARDS THE HEAD; PAIN IN GUMS TOWARDS THE HEAD; PAIN IN CHEEKBONE TOWARDS THE HEAD; EYES ACHE; UNCONTROLLABLE SHAKING; MUSCLE PAIN AT INJECTION SITE; CHILLS; DULL HEADACHE; FEELING WASHED OUT / TIREDNESS; This spontaneous report received from a patient concerned an 81 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 15:00 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced pain in teeth towards the head. On 06-APR-2021, the subject experienced pain in gums towards the head. On 06-APR-2021, the subject experienced pain in cheekbone towards the head. On 06-APR-2021, the subject experienced eyes ached. On 06-APR-2021, the subject experienced uncontrollable shaking. On 06-APR-2021, the subject experienced muscle pain at injection site. On 06-APR-2021, the subject experienced chills. On 06-APR-2021, the subject experienced dull headache. On 06-APR-2021, the subject experienced feeling washed out. On 06-APR-2021, the subject experienced tired. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in teeth towards the head, pain in gums towards the head, pain in cheekbone towards the head, eyes ached, dull headache, feeling washed out, and tired on 07-APR-2021, uncontrollable shaking, and chills on 06-APR-2021 22:35:00, and muscle pain at injection site on 06-APR-2021. This report was non-serious.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Mild, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient experienced small pitchea on arms. Given 25 mg benadryl. Monitored additional 5 minutes, temperature increased, began to complain of bumps around neck. 0.3 mg epinephrine administered and BP monitored. Red rash began to form on face and neck. BP recorded as 99/39 mmHg. Paramedics arrived within 7 minutes of administering epinephrine.
Today on November 8th at 1:30 pm my two-month-old son had an appointment at the Dept of Health. My child's father took our son to get vaccines. He was supposed to receive four immunizations. At 6:09 p.m. I received a call from the Assistant Director informing me that my child did not receive his first dose of the HIB but instead received the INCORRECT immunization, Hepatitis B that is supposed to be received at nine months of age. My child is only two months old. Staff administered the wrong immunization to my child. She also printed the certification of immunization that listed all the supposed vaccines even though he did receive the HIB 1.
Pfizer COVID-19 Vaccine EUA  Patient received 2nd dose of Pfizer 11 days after first dose  Pfizer EUA administration of second vaccine is 17 days after the first dose.
Complaints of headache & dizziness while waiting 15 minutes after receiving the nasal spray.
Pt devel a t102, vomiting & pain in rt upper quad 2 days p/2nd inject w/Hep B vax; sx resolved spontaneously;
Was diagnosed with the flu/the same thing happened to them; This spontaneous case  was received on 02-Nov-2020 from other non-health professional (consumer) via Med Communications (reference number: SEQW20-04654) and concerned a patient of an unreported age and gender.  The patient's medical history and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with influenza virus vaccine polyvalent (brand not specified; dose, route of administration, anatomical location and indication not reported). The batch number was not reported.  On an unspecified date, an unknown amount of time after receiving with influenza virus vaccine polyvalent, the patient developed flu.   The outcome of the event was not reported.  The reporter did not provide a causality assessment.  The event of flu was considered to be medically significant by a Physician within Seqirus' Pharmacovigilance and Risk Management Department.  The case is linked to case 202005984 and 202005985 (the same reporter).  Company comment: A patient of an unreported age and gender was vaccinated with influenza virus vaccine polyvalent. An unknown amount of time after receiving with influenza virus vaccine polyvalent, the patient developed influenza. Chronology needs more clarification. Causality is unassessable.; Sender's Comments: A patient of an unreported age and gender was vaccinated with influenza virus vaccine polyvalent. An unknown amount of time after receiving with influenza virus vaccine polyvalent, the patient developed influenza. Chronology needs more clarification. Causality is unassessable.
Pain,swelling,red blotchy rash at injection site. Fever(102.2F), severe headache,body(muscle) aches,light headedness, disorientation and perfuse persperation.Treatment was bed rest, hydration and Vicodin 750/500 every 6 hrs.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 15-OCT-2014, the patient was inoculated at a health center with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. Between the dates of 26-DEC-2014 and 31-JAN-2015, the patient was treated by a Nurse Practitioner for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster. The patient was prescribed prescription topical ointments for management of her painful outbreaks. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
I began having pounding and vice-grip headaches three hours after injection. I am more than 11 weeks in now with daylong headaches. My treatment when I saw my PCP.  We tried Advil, then Sumatriptan, and then Tramadol -- with each bringing no relief. I then went to neurologist. We've been trying nortriptyline for a number of weeks, and that took away the pounding but nothing else although some days were better than others. I just last night started with Topiramate. My headaches are aggravated by screen time and loud noises, but they also come get worse anytime. I am in a lot of pain, but I can sleep at night. Thank you. I am hopeful you have seen this in others and can provide guidance to my neurologist and me.
had a seizure in the office; the patient fainted; This spontaneous report has been received from  a physician via a company representative a 21-year-old female patient. Information about concomitant medication, medical history and drug reactions /allergies were unkown by the reporter.  On 05-AUG-2019, the patient was vaccinated with a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), by intramuscular route indicated to prevent Human Papillovirus (HPV). (concentration, indication, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not reported). On the same day, she was vaccinated with meningococcal b rfhbp vaccine (e. coli) (TRUMENBA). (concentration, indication, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not reported).  The causality assessment between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and meningococcal b rfhbp vaccine (e. coli) (TRUMENBA) and the reported events was not reported.  Upon internal review, Syncope and Seizure were determined to be medically significant events
Muscle pain; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ZINC, VITAMIN C [ASCORBIC ACID] and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain). At the time of the report, MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) outcome was unknown.            Treatment information was not provided.  The action taken with mRNA-1273 in response to the event was not applicable.
First noticed half-dollar-sized red ?rash? on left arm Thursday 3/25/21. The ?rash? grew in size  each day, and now covers half of the outer facing portion of my upper left arm. The edges are slightly raised. The ?rash? is feverish and the edges are sometimes sensitive to touch.
Approximately 30 minutes after vaccination: shooting pains in right side of chest and down right arm.   Approximately 5 hours after vaccination:  numbness in right pinky and palm of hand: spreading up arm over the course of 1hour.  Approximately 6 hours after vaccination: severe headache. Took Aleve for pain.  10 hours after vaccine (midnight) injection site pain increased in right shoulder. Very uncomfortable, but bearable. Placed heating pad on before bed. Next morning: woke at 9:30am. Felt pain in upper arm. No medication.  Monday evening: pain in shoulder/arm. Sharp pain in elbow radiating up and down arm.  This pain/numbness in right arm, shoulder, hand, chest and back has been coming and going for over 2 weeks.  - [ ] Over a week and a half later, (Tuesday) awful sharp pain in right index finger.  Came on suddenly.  Lasted about an hour or two.  - [ ] Wednesday, felt sudden neck/arm/back/chest pain on right side. Not when I woke up, but later in the day. Came on suddenly.  Felt shooting pain in chest. Whole arm felt sore and stiff.  - [ ] Arm/neck/shoulder/back pain on right side still lingering on Friday. Feels more dull and achy most of the day with sudden flare ups at times.  Friday night: 2 weeks after vaccination, pain was so intense I was unable to sleep. Placed heating pad on arm and back shoulder. Numbness in arm/hand continues.
Patient had swelling, redness, itching around injection site. Patient was advised to take OTC BENADRYL and return to clinic if reaction persists or worsens, right subq area.
congested on right ear clogged; vertigo; This is a spontaneous report from a contactable physician. This Physician reported for the patient in response to HCP letter [sent to physician] via follow-up letter which included that: A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6208), via intramuscular route of administration in left arm on 12Mar2021 at 14:30 (at the age of 55-year-old) as dose 1, single for COVID-19 immunisation. Medical history included lichen planus from 27Oct2011 to an unknown date in 2012 (topical steroid for scalp- lichen planus on to of head.), auto immune from 27Oct2011 to an unknown date in 2012, alopecia from 27Oct2011 to an unknown date in 2012 (topical steroid for scalp- lichen planus on to of head. Hair loss). There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Mar2021, a week after from vaccination, the patient experienced congested on right ear clogged/ pressure/ felt like water in ear and vertigo. The outcome of the events was unknown at the time of reporting.
Achy; Feeling feverish with 101.2 fever. And this morning 99.4; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy) and PYREXIA (Feeling feverish with 101.2 fever. And this morning 99.4) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013LZ0A and 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Feb-2021, the patient experienced PAIN (Achy) and PYREXIA (Feeling feverish with 101.2 fever. And this morning 99.4). At the time of the report, PAIN (Achy) and PYREXIA (Feeling feverish with 101.2 fever. And this morning 99.4) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Feb-2021, Body temperature: 101.2 Fever. On 08-Feb-2021, Body temperature: 99.4 Fever.         Other concomitant medication included unspecified Ace Inhibitor and Inhaler.   Treatment medication included Tylenol.   This case was linked to MOD-2021-092480 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Reporter contact information and weight updated.
knee pain in her right knee; pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (knee pain in her right knee) and VACCINATION SITE PAIN (pain at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-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 ARTHRALGIA (knee pain in her right knee) and VACCINATION SITE PAIN (pain at the injection site). At the time of the report, ARTHRALGIA (knee pain in her right knee) and VACCINATION SITE PAIN (pain at the injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported.  The patient  received her second dose of the Moderna Covid-19 vaccine on 09-Apr-2021, lot number 031B21A, in her left arm. She had no adverse reactions to her second vaccine.  The patient received her first booster Moderna Covid-19 vaccine dose on 31-Oct-2021, lot number 789905, in her left arm shoulder deltoid muscle. She had no adverse reactions or side effects.  The patient had to see her physician and get fluid drained from her right knee and also had gel injected into her knee.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2022: Follow up document contains no new information.
Treatment of COVID-19/ tested positive for covid; Treatment of COVID-19/ tested positive for covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Feb2021 at 09:30 as dose 1, single (Lot number: EL9265), in right arm, on 25Feb2021 at 09:30 as dose 2, single (Lot number: EN6201), in right arm and on 27Sep2021 at 11:30 as dose 3 (booster), single (Lot number: FC83ifn) at the age of 76 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 05Apr2022 at 12:00 as dose 4(booster, single) (Lot number: O48L21A), in right arm for covid-19 immunisation. Patient had no known allergies. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE, start date: 16Sep2019, stop date: 30Jun2022; ROSUVASTIN, start date: 16Sep2019, stop date: 30Jun2022; MELOXICAM, start date: 16Sep2019, stop date: 30Jun2022; HYDROCHLOROTHIAZIDE, start date: 16Sep2019, stop date: 30Jun2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19/ tested positive for covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jul2022) Positive, notes: still tested positive for covid on 08Jul2022, 9 days after my first positive test. Therapeutic measures were taken as a result of vaccination failure, covid-19.
He had a varivax booster on Monday July 13,2009 and yesterday he felt sore. His R arm is swollen, red and sore. He is c/o HA and backaches too. He denies a fever but feels feverish. He feels weak and dizzy today.
couldn't lift my arms for 2 days,stabbing pain,sometimes i wake up in pain; my shoulder has been killing me,My shoulder aches to touch it; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (couldn't lift my arms for 2 days,stabbing pain,sometimes i wake up in pain) and ARTHRALGIA (my shoulder has been killing me,My shoulder aches to touch it) in a patient of an unknown age and gender 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (couldn't lift my arms for 2 days,stabbing pain,sometimes i wake up in pain) and ARTHRALGIA (my shoulder has been killing me,My shoulder aches to touch it). At the time of the report, PAIN (couldn't lift my arms for 2 days,stabbing pain,sometimes i wake up in pain) and ARTHRALGIA (my shoulder has been killing me,My shoulder aches to touch it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. No treatment information was provided.