chrisvoncsefalvay/vaers-outcomes huggingface dataset:
skin got so dry and looks like burn; skin got so dry and looks like burn; broke out with rash on face, cheeks and neck; This spontaneous case was reported by a consumer and describes the occurrence of RASH (broke out with rash on face, cheeks and neck), DRY SKIN (skin got so dry and looks like burn) and SKIN BURNING SENSATION (skin got so dry and looks like burn) in a female patient of an unknown age 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 21-Feb-2021, the patient experienced RASH (broke out with rash on face, cheeks and neck). On an unknown date, the patient experienced DRY SKIN (skin got so dry and looks like burn) and SKIN BURNING SENSATION (skin got so dry and looks like burn). At the time of the report, RASH (broke out with rash on face, cheeks and neck), DRY SKIN (skin got so dry and looks like burn) and SKIN BURNING SENSATION (skin got so dry and looks like burn) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication were reported.  No treatment medication were reported.
He has had two febrile seizures after the immunization. One in August and one in December.
No adverse event; GARDASIL 9 vaccine was inadvertently given to a 6 month infant; This spontaneous report was received from a Medical Assistant, referring to a 6 month old patient of an unspecified gender. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications were not provided.      In August 2020, the patient was inadvertently vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R020200 with expiration date in 05-MAY-2021 (route of administration, strength and dose were not provided) for prophylaxis. No other adverse effect was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R020200; expirationdate: 05-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcp rep rationale: Case information does not meet the criteria for Reportability
Moderna vaccine administered to a 17 year old patient.  Due to age of the patient they should have been given a Pfizer vaccine.
This spontaneous report was received from a office manager refers to a 13 year old female patient. There were no pertinent medical history or drug allergies or reactions. On 23-AUG-2012, the patient was vaccinated with first dose of 0.5 ml GARDASIL, (lot # 0459AE, 13-DEC-2014, route was intramuscular in the left arm). Concomitant medications were none. On 23-AUG-2012, the patient experienced tingling in the left leg for 2 weeks. The patient did not notify the office until 25-OCT-2012. There was no laboratory tests performed. Approximately on 05-SEP-2012, the outcome of tingling in the left leg was reported as recovered. The patient did not seek medical attention. Additional information has been requested.
Information has been received from a registered nurse concerning an 8 year old female who 27-OCT-1999 was vaccinated with a first dose of Varivax. The registered nurse reported that on 05-JAN-2007, the patient reported to the office with a 2 day history with a lesion under the nose that was spreading and itchy. The patient had 4-5 lesions on the face that were crusted over. The patient also had a couple of lesions on her arms. The total number of lesions was reported as 20 on the torso, arms, and legs. The outcome was reported as recovered. It was also noted that the patient's sibling had an AE after vaccination with varicella virus vaccine (WAES # 0701USA04732). Additional information has been requested.
Fever, chills, facial rash, nausea, vomiting, lethargy, muscle soreness, headache, all over body aches. Three days later I felt better. It hurt to walk, move, stand. Lymph-node under my left arm (same arm shot was given in) was swollen and painful to move/touch for three days.
w/in 4hr of vax pt devel fever 102 w/chills, nausea, h/a, cold sweats & swelling of the inj arm;pt collapsed 3x;pt taken to ER where dx dehydration made;pt still exp fatigue;
FOLLOWING ADMINISTRATION OF PFIZER VACCINE PT DEVELOPED SWOLLEN TONGUE. HX MULTIPLE ALLERGIES AND MULITPLE INCIDENTS OF ANAPHYLAXIS. CARRIED EPIPEN. EPI-AUTO INJECTOR 0.3MG IM X 1. TRANSFERRED TO HOSPITAL ED IN THE BUILDING FOR EMERGENCY MEDICAL ASSESSMENT. NO SOB OR DIFFICULTY BREATHING. NO ITCHING OR RASH. PT CALM.
Redness and swelling around injection site (11x13cm) on Right anterior thigh - 2 days after vaccine. Treatment- BENADRYL 12.5-25mq Q6h, Prednisolone 22.5 mg BID x 4 days.
Edema, redness, warmth, pain; Patient given Keflex 500mg three times daily for 10 days.
Within weeks of the Lymerix vaccine I began to feel stiff and experience joint pain.I began having headaches and found it difficult to concentrate.These symptoms have persisted and increased over the years so that I find it difficult to get through my day at work , as I constantly feel fatigued. Due to joint swelling,pain and arthritis  my activity levelis greatly reduced.I sleep alot.I have problems remembering things and have short attention span.I find myself feeling agitated,impulsive frustrated and moody with shortness of breath. I suffered a long period of sexual dysfunction that required the medical attention in 2000. After blood tests and MRI scans I was found to have developed a very uncommon hormonal imbalance hyperprolactinemia and now take Dostinex regularly.I developed arthritis and am under the care of a doctor who found that I had a certain positive genetic marker HLA. My immune system now seems compromised and I have almost constant sinus infections and/or colds. Testing has found no particular allergies and prescriptions for antibiotics,anti-inflamatories,antihistamines,pseudoephedrines have not helped. The 2nd dose of Lymerix was received in the four weeks after vaccination 10/09/1999. Medical records on 04/28/04 states: pituitary microadenoma, confusion, hyperlipidemia. Severe arthritis, hyperprolactinemia, fatiuge, short attention span, allergy like symptoms, headache.
RN administered 5.0cc of the Flu Vaccine to number of individual who are employees at a care center. The facility knowingly allowed RN with multiple complaints, medication error history reported to the State multiple times the direction to administer flu vaccines unsupervised. She administered 5cc instead of the usual dose of 0.5cc. The individuals do not know what to expect from this serious medication error.
Information has been received from a 65 year old male consumer, who is legally blind, in whom "ibuprofen caused vision problems, and SUDAFED caused his vision to become blurry", who "approximately six weeks ago" on approximately 15-JUN-2007 was vaccinated with a single dose of Zostavax. Concomitant therapy included COSOPT and XALATAN. On approximately 18-JUN-2007 ("three or four days after vaccination") the patient developed "pin pricks all over his body" that were not severe. His eyesight became even worse and was "foggier" than normal. Medical attention was not sought. No lab studies were performed. At the time of this report, the patient had not recovered. No further information was provided. There was no product quality complaint involved. Additional information has been requested. Upon internal review, the patient's worsening eyesight/blindness was determined to be an other important medical event.
Pain in arm after flu shot-couldn't lift arm above head or out to side. Not able to do anything with left arm. Happened one day after shot. Reported to Family Doctor immediately- he sent me to Dr-who told Family Doctor I needed physical therapy. Couldn't get in therapy till Dec 29, 16, 2 month therapy-75% use now-no more therapy-only at home.
Generalized erythematous, papules scattered through - out face, neck, trunk & bil upper & lower extremities. Resolved with conservative Tx x 48 hr.
Cellulitis on L arm; Keflex 200mg PO q 6 hrs x 10 days (45mg/kg/day)
Pt complained of nausea and feeling dizzy immediately after vaccination. Patient became diaphoretic, pallor to face, patient assisted to wheelchair and taken to stretcher and laid flat since unable to stand. BP 108/67, HR 57, RR 14, o2 sat 99%. Patient later reported she left better, color returned to face and diaphoresis ceased. Updated vitals: BP 109/71, HR 52, RR 16, o2 sat 100%.
Approximately 2.5 hours after vaccinations, patient returned to clinic with bilateral hand discoloration (purple) and cool to touch.  Delayed capillary refill time ~ 4-5 seconds.  Patient sent to urgent care and was then referred to local emergency room.  Physician in the Emergency Department believes the symptoms are Raynaud's Phenomenon triggered by vaccinations.
At injection site: Swollen, hardness, hot area, itching, rash, pain, swelling and pain in my right armpit Other: Headache
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 23-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Anti-viral treatment received as paxlovid started on 28Jun2022 and stop date was 02Jul2022. Covid rebound symptoms and positive test days after paxlovid treatment. Tested negative last week and now symptoms are back with positive test. The patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
At least once daily heart palpitations and fluttering heart starting 1 week post vaccine and lasting 1 month.  A few instances of chest pain during month following vaccination. At least twice weekly heart palpitations and fluttering heart starting 1 month post vaccine and lasting 3-4 months.
Severe heart palpitations; Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Severe heart palpitations) and DYSPNOEA (Shortness of breath) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Aug-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 PALPITATIONS (Severe heart palpitations) and DYSPNOEA (Shortness of breath). At the time of the report, PALPITATIONS (Severe heart palpitations) and DYSPNOEA (Shortness of breath) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 84 (abnormal) sitting down her heart rate was 84 and 136 (High) standing up it was like 136.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was provided by the reporter.  The patient experienced the events 4 days after receiving the vaccine. The symptoms lasted for 2.5 days where they were consistent but have not gone away completely. Patient went to Doctor on 14-Sep-2021, said it was probably stress and anxiety but the patient thought it was from the vaccine. The patient was scared to get the second shot.
drop in blood pressure; fever; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE DECREASED (drop in blood pressure) and PYREXIA (fever) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced BLOOD PRESSURE DECREASED (drop in blood pressure) and PYREXIA (fever). At the time of the report, BLOOD PRESSURE DECREASED (drop in blood pressure) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact
14 year old patient received Flublok by mistake/ NO AE; Initial information received on 21-Sep-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 14-years-old patient (gender not reported) who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number: QFAA2014 and expiry date: 30-Jun-2021) by mistake (product administered to patient of inappropriate age) on an unknown date via unknown route in unknown administration site for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to inappropriate age at vaccine administration (latency: same day)  At the time of reporting, no adverse event was reported.  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 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.
Patient reported throat tightness, voice change, dizziness, SOB shortly after receiving vaccine.
Swelling of lips, tongue, throat and face, tightness in throat and chest, trouble swallowing and breathing and wheezing. Feeling dizzy and Faint, muscle aches and joint pain. rash and hives. fast pounding heart and chest pains
SEVERE SWELLING; AFFECTING DAILY LIFE; LYMPH NODE SWOLLEN LEFT SIDE OF BODY; CAN NOT BEND LEGS; REACTION FROM VACCINE; This spontaneous report received from a patient concerned a 68 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient don't have blood clots. The patient had ruling out orthopedic issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, and expiry: 22-FEB-2022) dose was not reported, administered on 25-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-AUG-2021, the patient experienced reaction from vaccine. On 25-AUG-2021, the patient experienced can not bend legs. On SEP-2021, the patient experienced lymph node swollen left side of body. On an unspecified date, the patient experienced severe swelling, and affecting daily life. Laboratory data (dates unspecified) included: Lab test (NR: not provided) not a blood clot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from reaction from vaccine, can not bend legs, severe swelling, lymph node swollen left side of body, and affecting daily life. This report was non-serious.
Pt got hives and a low grade fever mom gave pt Benadryl and the hives went away.
Stroke, 3 day hospitalisation, tpa and Plavix pills for the rest of my life.  I did the vaccine..
fever 102 w/APAP; chills, shrill cry, jerking, pale, did not attempt to move at all; thighs swollen;
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical histories, drug reactions or allergies and concomitant medications were not reported. On unspecified dates, between 17-NOV-2016 and 13-DEC-2016, the patients were vaccinated with improperly stored doses of PNEUMOVAX23 injection, lot# M018624, expiration date 28-MAY-2017 (dose, route and site of administration were not reported). The administered doses of vaccine were stored in the temperature of 0.1 degrees Celsius for 6 hours and 48 minutes, in the temperature of 0.8 degrees Celsius for 3 hours and 36 minutes and in the temperature of 0.5 degrees Celsius for 5 hours and 24 minutes. The temperature excursions took place on 17-NOV-2016 (also reported as "reported on 17-NOV-2016"). On 13-DEC-2016, another temperature excursion was reported with a temperature of 10.4 degrees Celsius for 1 hour and 10 minutes. However, no doses of PNEUMOVAX23 were administered following the recent temperature excursion. Digital data logger was involved. No adverse effects were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA007250: US-009507513-1612USA007251: US-009507513-1612USA007248: US-009507513-1612USA007121.
patient was incorrectly given bivalent vaccine ad dose 1; patient received 0.3ml undiluted 5-11 Pfizer COVID vaccine; patient received 0.3ml undiluted 5-11 Pfizer COVID vaccine; patient received 0.3ml undiluted 5-11 Pfizer COVID vaccine; is pregnant: Yes; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 24-year-old female patient (pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Feb2023 at 13:45 as dose 1 (orange cap), 0.3 ml single (Lot number: GK1657) at the age of 24 years intramuscular, in left arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history included: "Anemia" (unspecified if ongoing). The patient was 23 weeks pregnant at the event onset. The patient took concomitant medications. Vaccination history included: flucelvax (DOSE NUMBER UNKNOWN, SINGLE; Lot number: 942413), administration date: 11Jan2023, when the patient was 23-year-old. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 09Feb2023 at 13:45, outcome "unknown", described as "is pregnant: Yes"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), PRODUCT PREPARATION ERROR (non-serious), UNDERDOSE (non-serious) all with onset 09Feb2023 at 13:45, outcome "unknown" and all described as "patient received 0.3ml undiluted 5-11 Pfizer COVID vaccine"; WRONG PRODUCT ADMINISTERED (non-serious) with onset 09Feb2023 at 13:45, outcome "unknown", described as "patient was incorrectly given bivalent vaccine ad dose 1". Therapeutic measures were not taken as a result of maternal exposure during pregnancy.  Additional information: Other medication in two weeks were prenatal vitamins.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I am the husband and I am reporting this for my wife. We are not sure this is considered an adverse reaction. However, we want to report that my wife got a Shingles Vaccine (Zostavax) on June 25 and got a rash on her abdomen on July 5th. On July 9, it has been confirmed as a case of Shingles.
arm continues to hurt; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (arm continues to hurt) in a 67-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm continues to hurt). At the time of the report, PAIN IN EXTREMITY (arm continues to hurt) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  The patient's arm continues to hurt more than a month ago. It was unknown if the patient experienced any additional symptoms/events.
Had an influenza vaccine. Not sure of type/brand.  Broke out with shingles days after getting the vaccine.
Patient received a 3rd dose of Moderna. 1st dose on 2/12/21, 2nd dose on 3/17/21, 3rd dose on 4/30/21.
This spontaneous report as received from a registered nurse referring to multiple patients of unknown age and gender. No pertinent medical history, concurrent conditions or drug allergies were reported. On an unknown date the patients were vaccinated with improperly stored doses of PEDVAXHIB lot # L051123, expiry date : 13-OCT-2018 (dosing regimen and frequency unknown) for prophylaxis. No concomitant medications were reported. No adverse effects were reported and no additional information was provided. There was no product quality complaint reported. Temperature of 30.2 F for 56.47 hours. There was no previous excursion. Data logger was reported as yes. This is 1 of 3 reports from the same reporter source. Additional information has been requested. Sender's Comments: US-009507513-1701USA003860: US-009507513-1701USA003863: US-009507513-1701USA003860.
Ocular migraine, first I've ever had. Started with vaseline-like spots in my vision, became 2 in. fishhook-shape in neon colors with a jagged black line around the fishhook. Could not read, could not see through the image but could see around it. Went to eye dr. within 1 hour of first symptoms. Dr. diagnosed Ocular Migraine and suggested it could recur. Rest advised during episodes, advised it would last about 20-30 minutes. Have had 4 of these total since that day. No more occurred since mid-last year.
pt recvd flu vax & devel leg numbness & difficulty walking; now required a walker;