chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Blood clot in the calf; Swelling/pain behind the knee; Swelling/pain behind the knee; A 62-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included vitamin d3 (VITAMIN D3). The patient experienced blood clot in the calf and swelling/pain behind the knee on 10Apr2021. The events resulted in emergency room visit. The patient underwent lab tests and procedures which included nasal swab: negative on 17Apr2021. Therapeutic measures were taken as a result of thrombosis, joint swelling and arthralgia included anticoagulation medication. The patient did not have COVID prior vaccination. Outcome of the event was recovering.   Information on the lot/batch number has been requested.
Patient developed bilateral lower leg pain 4 days after vaccination.  No swelling or lesions noted.  Pain runs down backs of calves.
After getting the vaccine, my left arm was sore for few days. However, I noticed the swelling going away but I am itchy around the spot where I got vaccinated after 6th day of getting my 1st dost of the Moderna COVID shot. The spot that is itches is sore and hurts when I touch it.
hives; soreness at the injection; This spontaneous case was reported by an other health care professional and describes the occurrence of URTICARIA (hives) and VACCINATION SITE PAIN (soreness at the injection) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], METOPROLOL, LEVOTHYROXINE, OXYBUTYNIN and BUPROPION HYDROCHLORIDE (WELLBUTRIN).    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness at the injection). On an unknown date, the patient experienced URTICARIA (hives). At the time of the report, URTICARIA (hives) and VACCINATION SITE PAIN (soreness at the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       unspecified topical antihistamines were used by patient as treatment.   Reporter did not allow further contact
high fever x 3 nights (night only) (highest 104.5) slight rash all over body, not much appetite, no breathing difficulty
Extreme dizziness with weakness and nausea started about an hour after I got home. I felt so ill I did not think to call the doctor or go to the doctor's office since I was home alone. I laid down on the floor for awhile before managing to get to the bedroom. I stayed in bed for several hours before attempting to get up; the symptoms were not as severe but still felt weak and dizzy when standing. Today symptoms have improved but still feel uncomfortable.
I missed my period the month I got the vaccine, which is very bizarre because my period is very regular.
nausea, severe headaches and bodyaches, extreme weakness, vomit, cough, fever, chills, unable to perform daily activities,  took bonine and tylenol
I had a headache and took Tylenol to help.   When headache kept coming back, I blamed my ears since a had an infection in them.  Ears were cleared but headache returned.  Now I was tired all the time, then in November I could not recognize numbers and I could not talk right.   Called 911, thought I was having a stroke but instead I had a brain bleed.
High fever, shivering, swollen at site of injection, redness to injection site, hard to touch.
This spontaneous report as received from a 26 year old female consumer refers to herself. The patient's pertinent medical history included sickle cell. There were no concomitant medication and drug reactions/allergies reported. In August 2013 the patient was vaccinated with the first dose of GARDASIL (lot#, strength, dosage and route unknown) because she had HPV. And the patient got a little sick after vaccination. In October 2013 the patient was vaccinated with the second dose of GARDASIL (lot#, strength, dosage and route unknown). The patient also missed a menstrual period in "May". The patient got bloated, she got real big, she got rashes, she was getting fat and getting water in her leg and she was throwing up real bad. She got real sick one time, she was so sick that she tried to get out of bed she actually fell out of the bed. She was shaking real bad like she was having a seizure, her back was hurting so bad like someone was stabbing her, she had headaches, migraines, dizziness, the whole nine yards. The patient took a ton of pregnancy tests because she thought she was pregnant but they all came back negative. The patient kept going to the hospital and the doctors' office, almost every day, because she did not know what was going on. She never stayed there though. She also missed a menstrual period in "May" (probably May 2014). The patient did not receive treatment for the adverse events. The outcome of the events was reported as not recovered. Additional information is not expected.
Chills; Headache; fever; skin rash; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE,Batch/Lot Number: EN6203) via an unspecified route of administration on 18Feb2021 (at the age of 74 year old) as dose number unknown, single for COVID-19 immunisation.  Medical history included high blood pressure from an unknown date. Patient has no known allergies. The patient's concomitant medications were not reported. Prior vaccination, patient did not receive any other vaccines within four weeks. Patient was not pregnant at the time of vaccination. On 28Feb2021, patient experienced chills, headache, fever and skin rash. The event resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included, on 02Mar2021, post vaccination, nasal swab (SARS-COV-2 test), was found negative. Therapeutic measures were taken in response to the events included Triamcinolone cream. The outcome of the events was recovering.  No follow-up attempts are Possible. No further information is expected.
Information has been received from two registered nurses concerning a 4 year old female with no known drug allergies or past medical history, who on 03/02/1998 was vaccinated with the first dose of varicella vaccine SC in the left arm. On 03/02/1998, concomitant vaccinations included the first dose MMR which the pt received SC in the right arm and the third dose of oral polio vaccine. Originally the one nurse reported that on 03/31/2001, the pt experienced 50 or more lesions over his body. Unspecified medical attention was sought. No treatment has been ordered. In follow-up, another nurse reported that the pt experienced 50 plus lesions on her abdomen and back on 04/01/2001. This nurse reported that the pt recovered. The registered nurse also reported on the pt's sibling who had an experience following vaccination with varicella vaccine. No further info is expected.
This spontaneous report as received from a Medical Assistant refers to an adult patient of unknown age and gender who on 13-APR-2015 was vaccinated with an improperly stored dose of GARDASIL lot # K006960 (exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent a temperature excursion for 72 hours. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
01/06 -Upon waking: generalized body ache, more intense left arm ache -12PM: intermittent chills without rigors -4PM: diffuse tension headache rated 1/10 -No other signs and symptoms   01/07: no change compared to 01/06.
Pt. c/o anxiety, "feeling funny, not herself" this morning, about 17 hours after receiving first Hepatitis B vaccine and MMR.  Pt. seen by P.A. who elicited a prior hx of "panic attacks". Pt. referred to EAP.
He feels his veins around his heart are trying to collapse, it is constantly going on and off; This spontaneous case was reported by a consumer and describes the occurrence of VEIN COLLAPSE (He feels his veins around his heart are trying to collapse, it is constantly going on and off) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced VEIN COLLAPSE (He feels his veins around his heart are trying to collapse, it is constantly going on and off). At the time of the report, VEIN COLLAPSE (He feels his veins around his heart are trying to collapse, it is constantly going on and off) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient experienced events after couple of drinks. Concomitant products include Blood pressure pill and Thyroid medication. Treatment information was not provided.
Chills; Headache; Congestion nasal; Stiff neck; sore legs; generalized soreness; Off Label Use; Drug Use for Unapproved Combination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Nov2022 at 17:30 as dose number unknown (booster), single (Lot number: GJ6665) at the age of 47 years, in left deltoid for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII taken for influenza, on 06Nov2022 as unk unk, single. Vaccination history included: BNT162b2 (dose 1,, Lot: EL3247 , Expiry date: May2021, Site: Unknown), administration date: 24Feb2021, when the patient was 46-year-old, for Covid-19 vaccinations; BNT162b2 (dose 2, Lot: EN6203 , Expiry date: Jun2021 , Site: Unknown), administration date: 17Mar2021, when the patient was 46-year-old, for Covid-19 vaccinations; BNT162b2 (3rd dose:, Lot: FE3592 , Expiry date: Unknown), administration date: 01Oct2021, when the patient was 46-year-old, for Covid-19 vaccinations. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 06Nov2022, outcome "unknown", described as "Drug Use for Unapproved Combination"; OFF LABEL USE (non-serious) with onset 06Nov2022, outcome "unknown"; CHILLS (non-serious) with onset 07Nov2022, outcome "recovering"; NASAL CONGESTION (non-serious) with onset 07Nov2022, outcome "not recovered", described as "Congestion nasal"; HEADACHE (non-serious) with onset 07Nov2022, outcome "not recovered"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 07Nov2022, outcome "not recovered", described as "Stiff neck"; PAIN (non-serious) with onset 07Nov2022, outcome "not recovered", described as "generalized soreness"; PAIN IN EXTREMITY (non-serious) with onset 07Nov2022, outcome "not recovered", described as "sore legs".  Additional information: Got the injection at about 17:30 and sometime at night the chills hit him with the headache along with everything else. This was in the early morning hours of 07Nov2022. Caller clarified that he had nasal congestion. Also reported that he had sore legs and generalized soreness. Chills are improved, he is still cold, but is not shivering anymore. He had no problems with the other 3 injections, but for some reason this one got him. He received the flu vaccine at the same time, but in the right deltoid.
COVID-19; COVID-19; Urinary tract infection; Vertigo; Tinnitus; Feeling unwell; Fall; Dizzy; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (not provided).  A 50-year-old female patient received BNT162b2 (BNT162B2), on 30Jul2021 as dose 1, single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation; adalimumab (HUMIRA), first regimen (Lot number: 1159928) at citrate free and second regimen (Lot number: 1160838) at citrate free, all subcutaneous for hidradenitis; hydrochlorothiazide, triamterene (TRIAMTERENE AND HYDROCHLOROTHIAZID), (Batch/Lot number: unknown) at (1 in 1 d), oral; venlafaxine (VENLAFAXINE), (Batch/Lot number: unknown), oral. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Amoxycillin, reaction(s): "Allergy: amoxycillin". The following information was reported: DIZZINESS (non-serious) with onset Dec2021, outcome "not recovered", described as "Dizzy"; FALL (non-serious) with onset Feb2022, outcome "recovering"; MALAISE (non-serious) with onset 06May2022, outcome "unknown", described as "Feeling unwell"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19"; URINARY TRACT INFECTION (non-serious), outcome "recovering"; VERTIGO (non-serious), outcome "not recovered"; TINNITUS (non-serious), outcome "not recovered". The patient underwent the following laboratory tests and procedures: Computerised tomogram head: (Feb2022) unknown results, notes: okay. The action taken for adalimumab, hydrochlorothiazide, triamterene and venlafaxine was unknown. Therapeutic measures were taken as a result of vertigo, dizziness.  The reporter's causality for the event(s) of Dizzy, Vertigo, Tinnitus, COVID, fell after going to bathroom/due to vertigo and urinary tract infection with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of feeling unwell was not provided.The reporter's assessment of the causal relationship of "covid-19", "urinary tract infection", "vertigo", "dizzy", "tinnitus", "fall" and "feeling unwell" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.
THE PATIENT HAD NUMBESS AND PRESSURE  IN THE FACE AND LIPS AND SHE ALSO EXPERIENCED COLDNESS OF HER EXTREMETIES(HANDS AND FEET) ) WHICH OCCURED ABOUT 15 MINUTES AFTER THE VACCINATION. SHE WAS GIVEN BENADRY 50 MG ( 2 OF THE 25 MG CAPSULES) AND SOME WATER AND SHE WAS OBVSERED FOR ABOUT AN HOUR BEFORE THE PATIENT DECIDED THAT SHE WAS FEELING BETTER AND LEFT THE PHARMACY
Patient received the expired fluzone dose with no reported adverse event; Initial information received on 21-Oct-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2022SA442254 and 2022SA443423(CLUSTER).  This case involves a 17years old female patient to whom expired fluzone dose with no reported adverse event while receiving vaccine influenza quadrival A-B vaccine [Fluzone Quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On 20-Oct-2022, the patient received suspect INFLUENZA QUADRIVAL A-B VACCINE at a total dose of 0.5 ml (lot UJ776AA, expiry date: 30-Jun-2022) (strength: standard) via intramuscular route in the left deltoid for immunization.  On 20-Oct-2022 the patient developed a non-serious patient received the expired fluzone dose with no reported adverse event (expired product administered) (same day latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken: Not applicable.  Outcome: 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.
Within 2 hours flu-like symptoms.  Worse the next day.  Chills, sweats, fever, headache, temples hurt when I coughed.  Spoke to pharmacist almost daily and was told these were side effects from Shingrix vaccine and should subside by the next day.  By day three my lungs were being affected.  Breathing became difficult, I became very weak, hallucinated and was shaking the chills were so bad. The only reason I did not seek medical assistance earlier was because pharmacist repeatedly told me side effects would subside.  The last time I called told him I was being poisoned and his response was "no you are not".  Oh yes I was!!!!!!!!!!!
arm swelled 13cm x 10cm w/erythema & induration 12-24 hrs p/inject;
tinnitus sometimes unbearable louder than the planes during travel louder than car noise when driving severely interfering with my career.
This is a spontaneous report from a contactable consumer. A 52-years-old female Non pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection; Lot Number: EL3247) dose1, via an unspecified route of administration in Arm Right on 27Jan2021 11:00 as 1ST DOSE, SINGLE for covid-19 immunization. No prior vaccination and did not tested after post vaccination. Medical history included drug hypersensitivity, known allergies penicillin. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced continue chronic pain in right upper arm where 1st dose vaccine was administered, limited range of motion a large bruise at injection site, a large bruise at injection site, Upon follow-up on 18Mar2021, it was reported that arm pain, lack of mobility occurred about 6 hours after the vaccine was administered on 27Jan2021. Therapeutic measures were taken as a result of continue chronic pain in right upper arm where 1st dose vaccine was administered, limited range of motion, a large bruise at injection site. The clinical outcome of the events were not recovered and arm pain, lack of mobility of the outcome was unknown. Follow-up (18Mar2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation below mentioned query. The response included: Additional events were updated (arm pain, lack of mobility) and updated event onset date. No follow-up attempts are needed. No further information is expected.
Atrial fibrillation; Heart rate increased; This serious case was reported by a consumer via regulatory authority and described the occurrence of atrial fibrillation in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   The patient's past medical history included atrial fibrillation. Concurrent medical conditions included blood pressure high. Concomitant products included apixaban (Eliquis), dofetilide, metoprolol, losartan, amlodipine and atorvastatin.   On 03-NOV-2023, the patient received Arexvy. On 03-NOV-2023, several hours after receiving Arexvy, the patient experienced atrial fibrillation (Verbatim: Atrial fibrillation) (serious criteria GSK medically significant) and heart rate increased (Verbatim: Heart rate increased). The outcome of the atrial fibrillation and heart rate increased were not resolved.   It was unknown if the reporter considered the atrial fibrillation and heart rate increased to be related to Arexvy.     It was unknown if the company considered the atrial fibrillation and heart rate increased to be related to Arexvy.   Additional Information: GSK Receipt Date: 9-NOV-2023 The patient went into atrial fibrillation, it happened on Friday a few hours after patient got the vaccine.  Then it happened again at 5:15 am on the morning of reporting day, and patient was still in atrial fibrillation at the time of reporting. The patient checked and the heart rate was at 117, when checked on Friday, it was about 120.  Normally the medication controls that, but it was not doing it now. It just seemed odd that patient had the vaccine on Friday and then was getting atrial fibrillation. The patient had no prior vaccinations for those events. Follow-up would not be possible, as no contact details were available.
7-year-old female inadvertently administered a pfizer 6 months to 5 year old dose instead of the correct 5 to 11 year old dose.
Fever 101 - 8-6 to 8-7. Right arm red warm and swollen at injection site 8-6 to present. Instructed to notify MD if fever persists, use ice to injection site, notify agency with any further symptoms.
persistent headache; This is a spontaneous report from a contactable 64-year-old female consumer reported that. A 64-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3Z47), via an unspecified route of administration in the left arm, on 11Feb2021 09:00 AM, SINGLE DOSE for covid-19 immunisation. Medical history was none. The patient's concomitant medications were unknown. The patient did not have any allergies to medications, food, or other products. 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 was not received treatment. The patient was not pregnant at the time of vaccination. On Feb2021 at 6:00 PM, the patient experienced persistent headache. Outcome of the event was recovering.
Headache and back pain within an hour of getting the second dose of the vaccine. Fever within 3 hours of getting the vaccine. Fever lasted for 13 days in a row despite round the clock tylenol and ibuprofen. Then I would get a fever for a few hours about every other day. Dizziness, lightheadedness, severe headaches, nausea, exhaustion, rash, extreme itchiness, heaviness on my head that radiated down both arms
Chest Pain, shortness of breath, fever, chills (9:00pm-3:00am) chills, body aches (April 4th-April 5th)
Patient said she had a fever of 99 degrees and severe joint pain.  She was also extremely tired.
Patient on the night of vaccines, had fever x 8 days.  On last 3 days of fever also developed red diffuse splotchy rash.
Patient received flu vaccine in September she returned back to the pharmacy in late January stating that her arm still hurts where she received the vaccine.
I started getting symptoms of fatigue and tiredness and sore throat. Received a positive COVID-19 test at the urgent care. My symptoms progressed to tiredness and achy flu like symptoms. I got an appointment for the microsomal antibodies 01/18/2022. The fatigue lasted several weeks.