chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I was fully vaccinated September 6, 2021. I had Covid-19 in April 2021. After being fully vaccinated, I experienced an abnormal period in September and in October during my period I developed a large mass of 2 ovarian cysts merging together and creating a giant cyst behind my uterus. I nearly lost my ovaries, I spent 2 days in the hospital and visited 2 different ERs before they realized I needed surgery. I was internally bleeding from this as well. I had an ultrasound 6 months before this incident and the cysts were not severe and did not require surgery. I believe this is a reaction to the covid shot and should be looked into.
Initial misuse report received from a healthcare professional in 04 September 2013. It was reported that 8-week-old patient received both ACTHIB and PENTACEL (No other information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none. Addendum 29 October 2013: Upon internal review of this case the event coding was changed to overdose and no adverse event was added in the event screen.
Expired dose administered to 7 patients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 7 patients) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077C21B) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 7 patients). On 19-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to 7 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patients were not under any concomitant or regular medication. It was reported that there were 7 doses from 1 vial. The vial was initially stored in the refrigerator on 19-Jan-2022. The vial did not undergo any temperature excursions. The reporter mentioned that no adverse events were observed in any of the patients and no treatment was given.
This is a spontaneous report from a contactable other HCP. A 66-year-old male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN5318), via intramuscular route on 04Mar2021 (age at vaccination: 65 years) as DOSE 1, SINGLE; via intramuscular route on 25Mar2021 (Batch/Lot Number: EN5318) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was administered vaccine in a workplace clinic. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Oct2021, the patient experienced tested positive on 0october after being exposed to his granddaughter who also tested positive. On 19Oct2021, the patient underwent sars-cov-2 test (nasal swab) which was positive. It was unknown if the patient was diagnosed with Covid-19 prior to vaccination. The outcome of the events was recovering. The device date was 21Oct2021. No follow-up attempts are needed. No further information is expected. Sender's Comments: Based on the reported information, a causal relationship between the events Covid-19 and Vaccination failure and suspected drug cannot be excluded.
diluent that came with it was frozen with no adverse event; Initial information received on 14-Dec-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 24 years old male patient who experienced diluent that came with it was frozen with no adverse event after receiving vaccine rabies (hdc) vaccine [imovax rabies].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Dec-2022, the patient received a 1 dose of suspect rabies (hdc) vaccine Powder and solvent for suspension for injection (unknown strength, dose and expiration date) lot V1B591M via intramuscular route in the left deltoid for immunization.  On an unknown date the patient developed diluent that came with it was frozen with no adverse event (product storage error) (unknown latency).  Lab data was not reported.  Action taken: not applicable.  Outcome: Unknown for the event diluent that came with it was frozen with no adverse event.  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 guidelines. 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.
ADHD; obsessive compulsive disorder; slightly autistic & tourettes syndrome. Her son's academic ability is at approx 4th grade level, but he is in high school special education.
On 7/1/04 at 8PM pt mother observed one red bumps on right leg and redness on inside of right calf. The bump burst after forming a blister ad has now burst. ON 7/2/04 , had same type of bump on left.
Initial solicited report received from a consumer (online market research respondent) in the below mentioned study on 09 September 2015. The subject (gender and age were not reported) experienced bad reaction on an unspecified date, after receiving a dose of Influenza vaccine (manufacturere was unknown also date of vaccination, site and route of administration and batch number were not reported). Medical history and concomitant therapies details were not reported. The subject experienced last year for the first time in 30 years, a bad reaction to the flu shot. The patient found out that there were 3 levels. He was given the medium shot which made the patient sick therefore the patient decided to not get the flu shot that year. The patient rather had a chance on getting the flu. The lab data and corrective treatment details were not reported. The outcome of the event was not reported. Relationship to investigational product according to company: not associated. Relationship to investigational product according to reporter: not reported. List of documents held by sender: none.
done on infant in uterine showed for the first time: Liver calcification noted measuring 5.9 x 4.2 x 1.7 mm. I git pregnant post ablation done in November 2019. The pregnancy was pretty normal. I have been considered hi risk due to my age, having an ablation and the throbophilia. At that point I had an done every 4 weeks since I was 18 weeks pregnant. Due date is 08/05/2021. The calcification of the liver has been seen in every since. I was scheduled to see a Neurologist on 03/18. On 03/16 baby stopped moving. Went to ER. Heart rate of fetuses was declining. An emergent C-Section was done. When baby came out she was in DIC due to acute hepatic failure. She received multiple different blood products along with Antibiotics, IVIG, IV Dopamine drip, IV lasix, and TPN. She was on the ventilator, had a central line, art line, multiple IV?s and NG tube. Birth weight was 1770 grams.
Vaccine error -- per internal reporting system, "Patient's daughter had alerted our office that patient had received COVID bivalent booster on 9/27/22. Nursing did not respond asking for verification of vaccine (I believe nursing is directed to only document vaccine administration when we have proof/documentation that vaccine administration occurred) and it was not documented in data by the individual (unsure where patient received vaccine) who administered. Patient came in for office visit and was asked if she wanted the COVID bivalent booster which was administered because there was no documentation that she had already received. "  Patient received duplicate COVID bivalent booster dose, RN informed patient's daughter that there are no concerns with the double dose. No noted health concerns since that time.
Mother of child states, after vaccines about 2pm, she noticed child's face swelling to eye & mouth by the time she got home from our office. Child was irritable and itching all over. Came back to clinic about 1650. Presented to clinic with eye swelling, lips swelling, croup sounding cry. Irritable. No red or welt rash noted. Pt give epinephrine 0.1 ml SQ & BENADRYL 2 mg IM then transferred to PER.
Chills, headache, fever. Chills began 3 hours after shot, were severe overnight, unable to get warm, shivering, teeth chattering, plus feverish, sweating. Lasted about 12 hours. Headache began 3 hours after shot, strongest during first 24 hours, lasted 48 hours total. Woke in a cold sweat day 2 post shot.
improperly stored vaccine administered after temperature excursion; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies and drug allergy or reactions were not reported.    On 10-SEP-2021, the improperly stored vaccines rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength and dose were not reported; lot # 1707460 and expiration date was 14-MAR-2022; orally) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength, dose and route were not reported; lot # T026961 and expiration date was 02-APR-2023) were administrated for prophylaxis after temperature excursion (product storage error). These vaccines experienced temperature excursion of 48.7 fahrenheit (F) for 10 minutes. There were no previous temperature excursions.
local arm tenderness/tenderness of the arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received BNT162b2 (BNT162B2), on 29Sep2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer", start date: 2016 (unspecified if ongoing), notes: Breast cancer had breast cancer like 7 years ago. There were no concomitant medications. Vaccination history included: BNT162b2 (dose 1, Pfizer covid vaccine with lot EL9262 with expiry date 31May2021), administration date: 24Jan2021, when the patient was 67-year-old, for COVID-19 IMMUNIZATION, reaction(s): "local arm tenderness/tenderness of the arm", "Chills"; BNT162b2 (dose 2 with lot EM9810 and expiry date 30Jun2021), administration date: 14Feb2021, when the patient was 67-year-old, for COVID-19 IMMUNIZATION, reaction(s): "local arm tenderness/tenderness of the arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "local arm tenderness/tenderness of the arm". Therapeutic measures were not taken as a result of pain in extremity. Additional information: Patient did not have any significant reaction to any of them regarding her Pfizer covid vaccines and stated she had no reactions just some local arm tenderness and thought the tenderness of the arm she had that from all of the Pfizer Covid vaccines.; Sender's Comments: Linked Report(s): US-PFIZER INC-202300271774 Same reporter/patient, same drug/different dose, different AE.
seizure; twitches jerks; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 73-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EW6205), via an unspecified route of administration on 25Feb2021 at SINGLE DOSE for COVID-19 immunisation. Medical history included high blood pressure, cholesterol, diabetes, seizure disorder, and was put on continuous positive airway pressure (CPAP) machine. Concomitant medication included unspecified medication for high blood pressures. Patient stated that her blood pressures are normal but she was on medication for it. The patient previously took phenobarbital for seizure. The patient got the first dose of the vaccine on 25Feb2021 and later that day, the patient had a seizure and was in the hospital for days. The patient was put back on seizure medication, Keppra. It was further reported that patient was diagnosed with a seizures disorder when she was 20. She haven't had a seizure probably in 40 years and she was put on a CPAP Machine and she started getting good sleep and she was able to go off all seizure medicines about 10 years ago. The patient got the first shot on the 25Feb, she sit around for 15 minutes and no adverse reactions. She went to lunch with her sister and started having like what she call twitches jerks (not clarified) and she went home and little bit later that afternoon she had a major seizure and had to be taken to the hospital and there she stayed about 4 days. Now she was home and back on her seizure medication (further clarified as Keppra). The patient was hospitalized for seizures on 25Feb2021 and was discharged March 1st or 2nd. Additionally, it was reported that patient had a bunch of laboratory test (unknown results) in the hospital. Electroencephalogram (EEG) and magnetic resonance imaging (MRI) were performed with unknown results. Therapeutic measures were taken as a result of seizure which included Keppra. The outcome of the events was unknown.
Red and itchy at the injection site for over a week.  Still red and itchy as of today, January 28, 2021.
This spontaneous case was reported by a patient and describes the occurrence of PARAESTHESIA (Started getting tingling below my knees, started around my knee caps, then makes it's way down to my ankles and toes, sometimes goes away but comes back) and THERAPEUTIC RESPONSE UNEXPECTED (I had a lot of energy after my 2 shots, I was cleaning my house like crazy) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048F21A and 939902) for COVID-19 vaccination. No Medical History information was reported. On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milligram. On 14-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milligram. On an unknown date, the patient experienced PARAESTHESIA (Started getting tingling below my knees, started around my knee caps, then makes it's way down to my ankles and toes, sometimes goes away but comes back) and THERAPEUTIC RESPONSE UNEXPECTED (I had a lot of energy after my 2 shots, I was cleaning my house like crazy). At the time of the report, PARAESTHESIA (Started getting tingling below my knees, started around my knee caps, then makes it's way down to my ankles and toes, sometimes goes away but comes back) had not resolved and THERAPEUTIC RESPONSE UNEXPECTED (I had a lot of energy after my 2 shots, I was cleaning my house like crazy) outcome was unknown. The patient had no allergies to medications, food and other products. The patient had no acute and chronic illnesses at the time of vaccination. The patient had never been tested or diagnosed with COVID +. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. The patient did not had any concomitant medications for any condition. It was reported that about one to two months after receiving the 2nd dose, patient started experiencing tingling just below her knees. The tingling sensation started in her knee caps, and traveled down to her legs, ankles, and toes. Three days later, the tinging went away but it came right back. Patient said that this sensation comes and goes and had never completely gone away since it first started. Patient had been experiencing this in both her legs. At first patient thought it could be neuropathy related, but after reading online she did not thought it was neuropathy as it did not felt like it. Patient believed more in herbal remedies than medications. Additionally, patient stated that she had a lot of energy for 2-3 days after receiving each dose and she got a lot of house cleaning done at that time. No treatment medications were reported. This case was linked to MOD-2022-647616 (Patient Link).
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 17-JAN-2017, the patient was vaccinated with an expired dose of VARIVAX subcutaneously (lot # L000453 with expiry date of 06-JAN-2017, site of administration was not reported). No adverse effects were reported.  Additional information has been requested.
Left arm and arm pit swollen, red, severe pain, could not move arm. Pain also in shoulder.
Patient states throat closed about 2 hours after vaccine administered, couldn't take deep breath. Went to ER - treated her for flu.
Site: Pain at Injection Site-Severe, Systemic: Hypotension-Severe, Additional Details: Caregiver also reported decreased heart rate and could not move arm.
A mass was first noticed 14SEP2022 through a regular exam. I had a mass on my ovary after a few months of follow up imaging. My oncologist recommended total removal  removal 12JAN2023 I had a total hysterectomy.  Stage 1A serous adenocarcinoma was diagnosed.
He came to the hospital with a chief complaint of abnormal lab from the rehab.  According to him the hemoglobin this morning was 6.5 when the blood draw was done at the Flagler Health and Rehab.  He was sent to the hospital for further evaluation and treatment for probable GI bleed.  Patient reports that he has been having black tarry stools for the last couple of days.  He denies any significant abdominal pain but does have some discomfort and reports that he is due for his paracentesis.  Denies any fevers, chills or cough.  Has not had alcohol since he has been in the rehab.  Otherwise continues to smoke cigarettes.  Denies any chest pain, shortness of breath, palpitations, burning or painful urination.  Patient admitted for GI bleed.  Was tested for transfer back to Rehab and was found to be COVID positive on 1/20/22.  Patient had been vacccinated with Janssen on 11/2/21.  Pt was asymptomatic and discharged to rehab on 1/21/22.
This spontaneous report received from a patient concerned a 95 year old Asian female. The patient's height, and weight were not reported. The patient's concurrent conditions included macular degeneration. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the patient experienced tiredness. On 01-APR-2021, the patient experienced blurry vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blurry vision, and the outcome of tiredness was not reported. This report was non-serious.
pt recv vax OCT96 & 18DEC96 pt started to ache all over & had a fever, drainage & blood from the sinuses & had a lump in throat (swollen gland);saw MD who said bronchial tubes were closed & lungs were swollen;sore throat & swollen gland;
presented to ED complaining of R neck pain x 2.5 days. Described as sharp shooting pain, thought was due to back pain, tender to touch, Tried ibuprofen, doans (ibuprofen with mag) ice/heat , flexeril without improvement -- > ED. No fever, chills, toothache, sore throat. Had dental work 3 months ago, redofilling of wisdom teeth (left lower), Had similar neck pain ~ 3 weeks ago, however involving left neck went away after 1.5 day), Used headset for work, No trauma to neck  CT soft tissue neck  IMPRESSION 1.  Inflammatory changes involving the deep soft tissues of the right neck located deep to the right sternocleidomastoid muscle and posterior to the right carotid space with prominent lymph nodes measuring up to 8 mm. findings concerning for a deep cellulitis. The inflammatory changes extend from the level of the thoracic inlet up to the angle of the mandible. No discrete organized fluid collection to suggest an abscess. There are prominent jugular chain lymph nodes. Correlate clinically. 2.  Retropharyngeal haziness measuring up to 4 mm in thickness on coronal images concerning for retropharyngeal inflammatory changes/phlegmon formation. Correlate clinically. Follow-up evaluation is recommended to document resolution and exclude abscess formation. CT soft tissue of neck showed findings concerning for deep cellulitis involving deep soft tissues of the right neck deep to R sternocleidomastoid musckle and posterior righ carotid space with prominent LNs, also noted retropharyngeal haziness concerning for retropharyngeal inflammatory changes/phlegmon formation. Given cefepime 2 g IV x1, clindamycin 900 milligrams IV x1. LR x 2L, toradol 15 milligrams IV x1. Medicine
tenderness lt deltoid;10cm x 6cm erythema, 19.5cm diameter vs 19.0 of rt deltoid;
NauseaVomiting Narrative:  skin hypersensitivity, chills, night sweats
pt recvd vax 22JUL94 & devel fever the same day; temp 38-40C Tuesday, swollen rt leg or between legs poss groin;
Information has been received from a registered pharmacist concerning a 63 year old female patient. On 12-OCT-2012, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX, just one shot (route and dose was not reported) (lot # 672675/0068AE; Expiration date: 03-APR-2013). On 12-OCT-2012 the patient developed a red, swollen, hot area at the injection site, after the ZOSTAVAX was administered. It was reported that the patient events lasted for 4 or 5 days and then resolved. At the time of the report, the patient had recovered from all of the events. The relatedness for red area at the injection site, hot area at the injection site and swollen area at the injection site was unknown for ZOSTAVAX. Additional information has been requested.
Patient states she is experiencing nerve pain,still from the shot given on 9/11/2020 over 30 days ago. I recommended patient contact prescriber to be since
This spontaneous report was received from a nurse refers to a 01-year-old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 27-SEP-2017, the patient was vaccinated with improperly stored M-M-R II (dosing details were not reported) (lot # M045401, expiry date: 14-NOV-2018) for prophylaxis. All lots of M-M-R II were reconstituted with properly stored sterile diluent (MRK). No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054: Original Case: 1709USA000054.
Swelling L thigh 7cm x 7 1/2cm, which is indurated, redness also on overlying. No fever.
Vaccine given to outside of recommended age. Patient was age 11 at time of vaccination. No adverse events
Pt came to office 9/15/03 for a physical. Mother stated pt started with rash yesterday, worse today. MD diagnosed rash as chickenpox, over 50 lesions, had Varivax 8/14/2000.