chrisvoncsefalvay/vaers-outcomes huggingface dataset:
discomfort in her stomach, like nausea; Weakness; severe headache; This is a spontaneous report from a contactable Nurse. This 74-year-old female Nurse (Patient) reported that: A 74-years-old female patient received bnt162b2 (BNT162B2; solution for injection; Batch/Lot number was not reported)), dose 1 via an unspecified route of administration, administered in arm right on 08Mar2021 11:00 (at a age of 74-year-old) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included mycobacterium tuberculosis complex test positive from an unknown date and unknown if ongoing Verbatim: Positive for tuberculosis, ongoing blood cholesterol increased Verbatim: elevated cholesterol  from nine years, ongoing atrial fibrillation Verbatim: Atrial fibrillation from four years, parathyroid gland operation from an unknown date and unknown if ongoing Verbatim: surgery for a parathyroid gland tumor  seven years ago , heart rate irregular from an unknown date and unknown if ongoing patient taking. The patient experienced severe headache on 09Mar2021. On 10Mar2021 discomfort in her stomach, like nausea, weakness. Patient reported that, Monday morning she received the first dose of the Pfizer COVID 19 vaccine on 08Mar2021 at 11:00AM in the right arm. The next day she had a severe headache at night in the right side of the head only. She took aspirin and it helped the headache. Wednesday, she noticed discomfort in her stomach, like nausea, but she didn't throw up; and weakness; and the headache off and on. Adds the discomfort was more general, it was not exactly in her stomach, she ate and everything. She is concerned if she should get the second dose or not. Adds she is most concerned about the headache and she doesn't know if it is related to the vaccine or not. She was scheduled to receive the second dose on 29Mar2021. The patient underwent lab tests and procedures which included tuberculosis: positive on Tested positive 44 years ago. Therapeutic measures were taken as a result of severe headache. does not have vaccination card or information to provide , lot or expiration date. Outcome of the event headache was recovering, discomfort in her stomach, like nausea was recovered on 11Mar2021, weakness was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous case was reported by a nurse and describes the occurrence of DYSPEPSIA (Heartburn) and PAIN (Bee Sting Sensation from Chest and Nipple line, up to the top of his head) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced DYSPEPSIA (Heartburn) and PAIN (Bee Sting Sensation from Chest and Nipple line, up to the top of his head). The patient was treated with CALCIUM CARBONATE (TUMS ANTACID) at a dose of 1 dosage form. At the time of the report, DYSPEPSIA (Heartburn) and PAIN (Bee Sting Sensation from Chest and Nipple line, up to the top of his head) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. Treatment also Included Patient had 2 Glasses of Milk after event begins. Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Follow-up information received contains non-significant information. On 03-Jun-2021: Follow-up information received contains non-significant information.
shingles/ looks like shingles; vesicles of red below injection site; vesicles of red below injection site; This case was reported by a physician via sales rep and described the occurrence of shingles in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 2 days after receiving Shingrix, the patient experienced shingles, injection site vesicles and injection site erythema. On an unknown date, the outcome of the shingles, injection site vesicles and injection site erythema were unknown.   It was unknown if the reporter considered the shingles, injection site vesicles and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient came into physician office 2 days after receiving Shingrix at pharmacy. The reporter stated that adverse reaction seem to be what looks like shingles which was right below the injection site and it appeared like vesicles of red below injection site. The patient told the doctor that it did not itch. The physician seem to think that it was a coincidence and believed it was shingles.
30 minutes after administration of vaccine, Pt experienced a burning sensation on the right side of his body.  It was extraordinarily painful and he was trying to tear his clothes off.  He was given high dose benadryl and ibuprofen.  Pain subsided after one hour.
Pfizer-BioNTech COVID-19 Vaccine EUA: three days after vaccination patient reports nausea, vomiting, and abdominal cramping, Presents to oncology clinic with fever (temp 38.5 Celsius), rigors, and chills. Patient admitted to oncology service for fever and rigors while on immunosuppression.
This case was reported by a physician and described the occurrence of Bell's Palsy symptoms in an adult subject of unspecified gender who was vaccinated with TWINRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of TWINRIX (unknown). Within 48 hours after vaccination with TWINRIX, the subject experienced Bell's Palsy symptoms and had to report to the emergency department. The subject was hospitalised.  At the time of reporting the outcome of the event was unspecified.
5:11 mom states pt was given vaccine on 8/16/04 and leg left was later swollen by injection site. 4x3 area left leg thigh swollen and erythmatose. Benadryl 12.5-5cc PO 9. Rx: Keflex 250-5cc PO every 6 hr x 10days. Return to Dr Friday 7AM-9AM.
sleep more & had flu like sx; lost all verbal abilities & toilet training;the past three years going down hill fast d/t recent neurodegeneration;Annual follow-up dated 02/21/01 states the pt also received an MMR vaccine on the same day as the DTP.
Rash to scalp, neck, right shoulder.  Feet were "on fire" right foot red and desquamation of right heel epidermis unable to walk on feet for 2 weeks. Resolved.
patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received dose from vials beyond 30-day use by date) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received dose from vials beyond 30-day use by date). On 09-Jun-2021, EXPIRED PRODUCT ADMINISTERED (patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medication were reported No treatment medication were reported  Date of refrigeration:07May2021  318 patients received dose from vials beyond 30-day use by date
Immediately after receiving shot,severe pain in injection arm.Had to rest for 10mins in office.Beginning the next day, had a painful knot in back, pain in left lung if deep breath is drawn, muscle weakness on left side from shoulder to fingertips all the way down to toes, muscle weakness, nausea, headache,rash on neck and itchiness on chest.These symptoms progressed and got worse and by Friday. Call Dr's office. Was told the symptoms I described had nothing to do with the Gardasil Shot. After I pressed the issue, the doctor returned my call, stated their office could do nothing and suggested I should see my primary care physician. The primary care doctor was booked solid so went to urgent care center. The doctor on duty did not know much about gardasil and suggested we go to the emergency room at another hospital if symptoms got worse. I took my daughter home and watched over her. She did begin to feel better and as of today the symptoms have subsided. This was her 2nd gardasil shot, the first was given 7/2008. She is scheduled to receive the 3rd shot on 2/3/2009. I am very afraid to have the 3rd shot administered because of the difficulty she experienced with the 2nd shot and the lack of support she received from her doctor and the urgent care doctor.
Mom reported pt began to cry & c/o could not hear then became pale & sweaty; was thirsty & was given a drink of 7-UP did not lose consciousness & event resolved quickly;
3-13-21 C/O RT UPPER ARM IS RED, SWOLLEN & HOT TO THE TOUCH FROM THE SHOULDER TO THE ELBOW.  3-15-21 11:50AM : STATES  RT ARM IS BETTER - NO LONGER SORE AND THE SWELLING IS LESS; BUT NOW IT FEELS 'ITCHY'.  YESTERDAY THERE WERE 'HIVES' ON HER ARM, BUT THEY ARE GONE TODAY.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 036B21A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol and Hypertension since 2010. Concomitant products included CHLORTHALIDONE for Blood pressure, EZETIMIBE for Cholesterol, OMEPRAZOLE for Indigestion, VITAMIN D3 and CYANOCOBALAMIN (B12-VITAMIN) for an unknown indication.   On 06-Jan-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 18-Apr-2021: Follow-up was received included Medical History was updated and Concomitant Medicines were added.information regarding dose 2 has been added
THE MORNING FOLLOWING THE IMMUNIZATION I WOKE UP WITH EXTREME DIZZINESS, NAUSEA, CHILLS, SWEATS. I WAS UNABLE TO STAND AND TO WALK. I WAS TRANSPORTED BY AMBULANCE TO HOSPITAL WHERE MANY TESTS WERE PERFORMED AND NOTHING WAS FOUND. I WAS TREATED WITH IV'S TO COUNTERACT NAUSEA AND DIZZINESS. I WAS DISCHARGED FROM ER THE SAME DAY. I SLEPT THE REST OF THE DAY AND ALL NIGHT. I WAS FINE THE NEXT MORNING.
Brain Aneurysm; This is a spontaneous report from a contactable consumer. A 50-year-old female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm right on 08Apr2021 16:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing, no known allergies. Concomitant medication in two weeks included fluticasone propionate, salmeterol xinafoate (ADVAIR), and patient had birth control. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient previously received first dose of bnt162b2 on 18Mar2021 04:00 pm at the age of 50-year-old at right arm as single dose for covid-19 immunisation. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced brain aneurysm on 11Apr2021 13:00 with outcome of recovering. Patient received aneurysm coil as treatment. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event).  Information about lot/batch number has been requested.
tightness in his abdomen; constipation; This is a spontaneous report from a contactable consumer or other non-HCP (patient himself) via Medical Information Team. A male patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 22Jun2021 as dose 1, single for COVID-19 immunization. Patient medical history included blood pressure. The concomitant medications included blood pressure pills. Patient received the first dose of the Pfizer COVID vaccine around 22Jun2021 and within that same day he had a tightness in his abdomen on 22Jun2021. He stated the only thing he can compare this to was the sensation of overeating and feeling that tightness and when you take a full deep breath you cannot get full expansion without feeling resistance. He stated it increased the next day and lasted for maybe a total of three in a half four days and he also had constipation on an unspecified date in Jun2021 that lasted the same time frame. He stated he would like to know if this had been reported previously and he had asked other people and they said no but the proximity of the COVID vaccine is something that he could not ignore. He stated he spoke to his doctor and he already waived him off saying this was nothing. He stated could his side effects been an interaction although he was not really taking much medications but he takes a blood pressure pill and he was already told that would not been a problem. He was informed that Pfizer cannot assess causality between what he has experienced as being directly related to the vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Pt recv vax on 9/14/98; on 9/16/98 pt exp grand mal seizure; tx=Dilantin, dx=epilepsy
use of fluzone high dose to a 58 year old patient with no reported adverse event; Initial information received on 14-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 58 years old female patient and reported that there was use of fluzone high dose to a 58 year old patient with no reported adverse event, it involved vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were reported as none   On 14-Oct-2022, the patient received a  dose of 0.7 ml once of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE , with an unknown formulation and strength, (lot: UJ924AC ; expiry date: 30-Jun-2023)via intramuscular route in the left deltoid for immunization.  It was reported that on 14-Oct-2022, there was use of Fluzone high dose to a 58 year old patient with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  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.
Child had MMR & IPV in right arm on 7/19/06.  Mom called 7/20/06 said child had swelling & redness on his right arm.  Discussed to use ice packs and to call Dr. if it got any worse.  7/21/06 Mom took child to the Dr.  R. arm was red & swollen from shoulder to elbow.  Child was given an antihistamine and a steroid for relief.  7/25/06, spoke with Mom by phone.  States his arm is much better.  No sign of his reaction is left.  Immune records were sent to doctor.  Mom aware of which shots were given in each arm.
Site: Pain at Injection Site-Medium, Additional Details: patient states that he cannot lift his arm above his shoulder without pain. states that he notices it all the time with arm movement, but particularly bad when he lifts his arm that high.
Red Bumps all over her cheeks.; This case was reported by a consumer via call center representative and described the occurrence of localized erythema in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th January 2020, the patient received the 1st dose of Shingrix. On 29th January 2020, 3 days after receiving Shingrix, the patient experienced localized erythema and local swelling. On an unknown date, the outcome of the localized erythema and local swelling were unknown.   It was unknown if the reporter considered the localized erythema and local swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but may be 60 or 61 years. The patient received Shingrix vaccine on sunday and on wednesday woke up with red bumps all over her cheeks. No further details were provided. The reporter did not consent to follow up.
Acute osteomyelitis of metatarsal bone of right foot. Procedures: Wide excisional debridement with repeat washout and Stravix grafting with wound VAC. Repeat washout right foot, possible grafting possible wound vac placement.   Patient with acute on chronic anemia likely secondary to surgical losses and anemia of chronic disease given infections and occult negative.  Patient started on oral iron supplementation and was already on multivitamins.  Patient to follow-up with primary care physician within 1 week, vascular surgery in January, podiatry discussed appointment, and infectious diseases team in 2 to 4 weeks for monitoring of labs while on IV antibiotics.  Patient eventually accepted to swing bed facility for continuation of care and rehab with assistance of care management. Hospital admission within 6 weeks of receiving the COVID vaccine.
Child passed out twice after vaccines administered. Ammonia was swept in front of nostrils and child came out of it, placed flat on floor with feet elevated, juice administered, child kept in office for twenty minutes.
Information has been received from a physician concerning a 14 year old female with no previous medical history and no known drug allergies, who on 04-APR-2008 was vaccinated with the first dose of GARDASIL (lot# 6596551486U).  There was no concomitant medication.  The patient had three syncopal episodes beginning 24 hours after receiving the vaccination.  The patient sought treatment for the syncopal episode in the emergency room.  The episodes were described as lasting 10 seconds in duration with full loss of consciousness.  The patient was evaluated in the physician's office on 07-Apr-2008 and had fully recovered with no need for treatment.  Additional information has been requested.
Information has been received from a registered nurse concerning a 94 year old female nursing home resident with congestive heart failure and allergies to penicillin, metal, iodine, valium and vitamin K who on Oct 25 2004 at 2:30 was vaccinated intramuscularly in the right deltoid with a second dose of pneumococcal 23v polysaccharide vaccine (lot 649913/0577P). There was no illness at the time of vaccination. Concomitant therapy included nitroglycerin (Nitro patch), acetaminophen (Tylenol) and warfarin sodium (Coumadin). On Oct 25 2004 at 8:30 the patient developed a red, raised area on her right upper arm, that was swollen, warm to touch, and very tender and painful to touch. On Oct 26 2004 the patient was treated with dexamethasone 10mg IM and diphenhydramine hydrochloride (Benadryl) prm. No diagnostic lab test were performed. On Oct 31 2004 the patient recovered. No further information is expected.
I attended a wedding reception and later found out that multiple people in attendance tested positive for COVID-19. The last date I was around someone who tested positive was 05/30/2022. The first time I noticed any symptoms was 06/02/2022 and I felt like I was getting a cold. I had runny nose and congestion, and mild fatigue. The next day symptoms got really bad and I started losing my voice, but I was testing negative for COVID-19 until 06/04/2022. On that day, I had a virtual telehealth appointment. My doctor was concerned about a reaction between Paxlovid and the medication I currently take so I received a monoclonal antibody infusion on 06/07/2022 around 9AM and by that evening, I was already beginning to feel better and each day my symptoms continued to improve.  I continued to test positive for COVID-19 until 06/10/2022.
got hair growing; got hair growing; This is a spontaneous report received from a contactable consumer (patient). This 89-year-old patient of unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date at single dose for COVID-19 immunization. Medical history included the top head of the patient was bald. The concomitant medications were not reported. Patient called about good side effect of Pfizer Covid vaccine. The top head of the patient was bald and getting hair on there since patient got the shot. Patient got hair growing. The patient was going to be 90 and this was best side effect for patient's birthday. The outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Patient received flu vaccine and the next day developed papular rash to hands, legs, across  trunk.  Very pruretic. Was treated with diphenhydramine 50mg by mouth with no relief.  Next day developed spread over entire body.  Given two IM dexamethasone shots that day.  Elected not to give dexamethasone dose pack as patient HIV +, did not want to lessen immunity any further.
INJECTION BURNED; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to pine trees and other pollen producing trees and grass, runny nose, cough, and watery eyes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included diphenhydramine hydrochloride for seasonal allergies. On 2021, the subject experienced injection burned. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of injection burned was not reported. This report was non-serious.