chrisvoncsefalvay/vaers-outcomes huggingface dataset:
from dc summary 12/7/2021  i do not have lot number for her covid vax above  Patient is a 83 y.o. with a PMH of hypertension, nonobstructive coronary artery disease, moderate to severe aortic insufficiency, unresectable pancreatic adenocarcinoma, s/p history of breast cancer, Status post esophageal cancer status post gastric pull-through who presented to the ER with acute onset shortness of breath and chest pain. CTA chest revealed acute bilateral upper lobe subsegmental pulmonary emboli without evidence of right heart strain. Due to her age and history of cancer she was "high-risk" on the PESI so she was admitted and started on IV heparin.    She quickly improved symptomatically and was transitioned to PO Eliquis to complete 7 days of 10 mg BID followed by transition to 5 mg BID. She will discuss ongoing anticoagulation with her oncologist.    With her esophageal cancer she currently has intermittent melena. We discussed the risk of worsening melena and transition to bright red blood per rectum. She will get a repeat CBC ~3 days after discharge to be sure bleeding has not picked up significantly. Her hemoglobin was stable after starting heparin gtt while inpatient.
Pt received her first Gardasil injection and became pre syncopal shortly thereafter.  Pt was assisted in lying down for 10-15 min, VS were stable.  She was given juice and crackers once sitting and was able to leave the department safely about 15-20 min after the injection.
Chronic spontaneous urticaria, dermatographia Chest tightness, itching, welts
Chills; Bright red rash; Entire area is swollen and is about the size of a hamburger; Injection site itching; Injection is a little sore; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of CHILLS (Chills), INJECTION SITE PAIN (Injection is a little sore), INJECTION SITE RASH (Bright red rash), INJECTION SITE PRURITUS (Injection site itching) and INJECTION SITE SWELLING (Entire area is swollen and is about the size of a hamburger) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical reported history).    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Dec-2020, the patient experienced INJECTION SITE PAIN (Injection is a little sore) and INJECTION SITE PRURITUS (Injection site itching). On 30-Dec-2020, the patient experienced CHILLS (Chills), INJECTION SITE RASH (Bright red rash) and INJECTION SITE SWELLING (Entire area is swollen and is about the size of a hamburger). At the time of the report, CHILLS (Chills), INJECTION SITE PAIN (Injection is a little sore), INJECTION SITE RASH (Bright red rash), INJECTION SITE PRURITUS (Injection site itching) and INJECTION SITE SWELLING (Entire area is swollen and is about the size of a hamburger) outcome was unknown.        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.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Lt upper arm pain x3 months (started after vaccine administered per pt.) Decreased ROM of arm per patient. Referred to health department for further details.
According to Admitting physician,  "Pt c/o multiple neurolgic findings and MRI changes consistent with a CNS demyelination syndrome. He reported receiving the influenza vaccine in the weeks prior to symptom onset." Pt received IV steriods.  Brand of IM influenza vaccine unknown.
Approximately 2-3 minutes following influenza and pneumococcal vaccine, pt. developed itching, throat tightness, tongue swelling diaphoresis, nausea, pallor and drooling.  EMS called and transported to hospital.
On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced DIZZINESS (Dizziness) and HEART RATE INCREASED (Increased Heart Rate). On 07-Mar-2021, DIZZINESS (Dizziness) and HEART RATE INCREASED (Increased Heart Rate) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided. Lab details were not provided.
Patient came in for her second shot and informed me that she had issues with her first shot not being placed correctly which caused a red area. Patient saw her MD for this reaction and told her it was due to bad shot placement, she showed me a picture and it was placed about 5-6 inches below the bicep and more midline then it should have been and there was about a 4 inch area of redness around the injection site. When giving the second shot I examined this area and it had minimal to no muscle tone. She reported that the redness took "some time" to clear up but was not painful or itchy.
Information has been received from a physician concerning a patient who on an unspecified date was vaccinated orally with a second dose of ROTATEQ. On an unspecified date the patient experienced a breakthrough case of ROTATEQ and was hospitalized. At the time of the report the patient's status was recovering. On an unknown date the patient had diagnostic studies performed to confirm rotavirus. A product quality complaint was not involved. Additional information has been requested.
MIGRAINES; This spontaneous report received from a consumer concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced migraines. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of migraines was not reported. This report was non-serious. This case, from the same reporter is linked to 20211203554.
Patient developed redness which progressively increased and pain at left arm injection site as well as fevers managed with motrin and Tylenol. Symptoms began a few hours after vaccination earlier that day on 10/2/2020 Patient seeked medical care at ED on 10/4 evening due to worsening redness, warmth, pain and fevers.  Findings concerning for cellulitis of left arm and patient was started on IV antibiotics in the ED, which was transitioned to narrowed spectrum and then oral antibiotics on 10/6 due to significant improval of symptoms.
pt stated she started having like an anaphylaxis reaction about 15 minutes after getting the booster shot.  Her throat was closing up and she was light headed.  After about half hour she decided to drive home.  Her vision was blurry and she had a tempurature of 102.  She contacted her PCP and she was told to her eye doctor which she had seen recently.  She saw her Eye physician and he compared the condition of her eyes from the last visit.  She was told there was drastic change from the last visit to this visit.  Her eyes were burning and were painful.  There are dry patches on them.  She had some vision loss.  She was advised not to use her eye drops at the time due to the condition her eyes were in. She will try Sustain gel when her eyes are better to help them heal.  She is using a mask at night which helps a little and also using a cool cloth. She will have to FU for further treatment.
The patient presented a rash over his chest, back, and both arms. No respiratory distress. He was given a Benadryl 20 mg around 04:15 pm and was then taken to the ER for further evaluation. He has been prescribed Prednisone 20 mg to be taken as follows: 2 tabs (40 mg total) PO, one time each day for 5 days.
Full body itching, rash (moving around my body) - still to this day. Trying to track down whether it is due to the vaccine, a current medication prescribed, or random Eczema occurrence.
PAIN/BURNING SENSATION IN THE ARM AT INJECTION SITE RIGHT AWAY FROM INSERTION OF THE NEEDLE TO PULLING OUT OF THE NEEDLE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included unspecified allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 20-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 20-MAY-2021, the subject experienced pain/burning sensation in the arm at injection site right away from insertion of the needle to pulling out of the needle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain/burning sensation in the arm at injection site right away from insertion of the needle to pulling out of the needle on 20-MAY-2021. This report was non-serious.
Upper administration of MMR.  Local reaction resulting in uriticarial rash with 1.5 x 1.0 cm and red 5 x 5 cm.  No respiration distress, no other problems.
Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: drop in blood pressure and blurred vision and feeling weak - called 911 and patients father -   patients recovered quick and left without going to er or seeking care -  felt slight chest pain next day she stated too
A nurse from Hospital called to say patient was just admitted with a symptom of barely being able to walk. She said the doctor wanted to know when the flu shot was given and the lot number/exp. date.
Client reported to another staff member of feeling hot and throat tightness approximately 10 minuets after receiving Pfizer vaccine. Client in the ladies room with her preschool age son. Client told writer she felt "hot" and had to get out of the clinic for "some air." When writer encountered client she denied difficulty breathing and went outside and sat on a bench with her husband. B/P 120/80. Writer discharged from clinic in the company of her husband. Writer instructed client to activate emergency response system for difficulty breathing. Client verbalized understanding of teaching.
Noted onset of some irregular heart beats about 4 hours after admin.  Infrequent not symptomatic(have had PVC's in past rarely and with fatigue/stress/caffeine combination, never treated, never diagnosed self-limiting, asymptomatic). Did yardwork and had normal evening.  Awoke and noticed occasional full feeling in throat and some irregular beats (a chest thump and correlated pause in radial pulse,  that decreased with a cough or valsalva maneuver.   The frequency and persistence increased throughout day so that I was uncomfortable lying down to try to rest.  I took an aspirin worrying about possible prolonged atrial fibrillation.  At nearly 24 hours from onset, all was back to normal.  No palpable irregular beats, no throat fullness, no other issues.
Itchy at the  injection site; Redness at the  injection site; Sore arm at the injection site; Itching under belly button and arm pit; Arm felt warm; Body ache; Fever; Headache; Arm soreness; A spontaneous report was received from a other health care professional, concerning herself, a 26-year-old female patient, who received Moderna's COVID-19 vaccine and experienced arm soreness/ pain in extremity, body ache/ pain, itching under belly button and arm pit/ pruritus, arm felt warm/ feeling hot, itchy at the  injection site/ vaccination site pruritus, redness at the  injection site/ vaccination site erythema, sore arm at the injection site/ vaccination site pain, fever/ pyrexia and headache.  The patient's medical history was not provided. No relevant concomitant medications were provided.   On 27 DEC 2020, the patient received their first of two planned doses of mRNA-1273 vaccine (batch# 037K20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.   On 27 Dec 2020, immediately after vaccination, the patient developed an arm soreness. On 28 Dec 2020 patient also experienced body ache, fever, headache and her arm felt warm. On 31 Dec 2020, additionally patient experienced itching under her belly button and arm pit. On 04 Jan 2021 she developed sore arm, redness and itchy at the injection site. No treatment was taken as of now and symptoms are ongoing at the time of this report..  The outcome of events arm soreness, body ache, itching under belly button and arm pit, arm felt warm, itchy at the injection site, redness at the  injection site, sore arm at the injection site, fever and headache were not resolved at the time of this report.; Reporter's Comments: Based on the information provided which includes a strong temporal association between the reported events and administration of mRNA-1273 vaccine, an excluding any other etiology, a causal association cannot be excluded. itchy at the injection site, redness at the injection site, sore arm at the injection site, fever and headache are consistent with the known safety profile of the vaccine.
Global profound weakness, receptive aphasia, echolalia.  Currently admitted and being treated for guillain barre.
Right side of lower face and lip began feeling numb. No drooping or issues with movement. Numbness continued from about 830p on 12/20 and is still present at the time of this report.
Information has been received from a registered nurse concerning an 18-year-old male with mild asthma and no allergies, who on 23-AUG-1995 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Concomitant therapy included albuterol. On 01-AUG-2007, the patient tested negative, with a titer value of 0.48 for chickenpox. Unspecified medical attention was sought. No outcome was reported. No product quality complaint was involved. Follow-up information indicates that the patient is a student who did not seroconvert from the primary varicella virus vaccine live (Oka/Merck). The vaccination was not administered by the reporting facility. On 30-Jul-2007 (previously reported as 01-Aug-2007) the patient tested negative, with a titer value of 0.48 for chickenpox. On 01-Aug-2007, he had a CBC drawn that was normal except for his red blood cell count which was 5375 million/uL. Vaccination history includes: a dose of Hib conj vaccine (OMPC) (manufacturer unknown) on 03-Oct-1990, a dose of diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (manufacturer unknown) on 05-Jun-1989, 07-Aug-1989, 09-Oct-1989, 03-Oct-1990 and 20-Sep-1993; a dose of measles virus vaccine live (Enders-Edmonston) (manufacturer unknown) on 08-Aug-1994; a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar 27/3) (manufacturer unknown) on 16-Jul-1990; a dose of poliovirus vaccine live oral (manufacturer unknown) on 05-Jun-1989, 07-Aug-1989, 09-Oct-1989, 03-Oct-1990, and 20-Sep-1993 and tuberculin purified protein derivative (manufacturer unknown) on 29-Mar-1992 and 08-Aug-1994. This is one of several reports from the same source. Additional information is not expected.
was accidentally given Pentacel with no AE; given an extra dose of ActHIB with no AE; Initial information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 15 months old female patient who received vaccines HIB (PRP/T) VACCINE [ACT-HIB] and DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and reported that was accidentally given Pentacel with no AE (inappropriate schedule of product administration) and given an extra dose of ActHib with no AE (extra dose administered).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 20-Sep-2019, the patient received 3rd dose of suspect 0.5 ml DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ013AA and expiry date: 10-Oct-2020 via intramuscular route in the left thigh.  On an unknown date, the patient received a dose of suspect HIB (PRP/T) VACCINE lot UI957AA via unknown route in unknown administration site.  It was a case of actual medication error due to inappropriate schedule of vaccine administered and extra dose administered.  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.  List of documents held by sender: none.
This case was reported by a consumer and described the occurrence of drop in platelet count in a 43-year-old male subject who was vaccinated with Influenza vaccine (unspecified) (manufacturer unspecified). A physician or other health care professional has not verified this report. Concurrent medical conditions included ITP since 2007. On 2008, 2009, 2010 and 2011, the subject received a dose of Influenza vaccine (unspecified) (administration site and route unknown, batch number not provided). At an unspecified time after vaccination with each doses of Influenza vaccine (unspecified), the subject experienced drop in platelet count for 6 months. All of these years, his platelet count was above 50000. He believed that he was taking prednisone in 2012 when he received the flu vaccine. At the time of reporting, the event was resolved.
BLOOD CLOTS IN BRAIN; This spontaneous report was received concerning a female patient of unspecified age. The patient's weight, height, and medical history were not reported. The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of administration not reported), administered on an unspecified date in MAR-2021. The batch number was not reported. No medical history or concomitant medications were reported.  On an unspecified date in MAR-2021, the patient was ill for a few weeks with a headache and was subsequently hospitalized with blood clots in her brain. The outcome of blood clots in brain was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: 20210425372 V0:  This is a spontaneous report of a female of unspecified age who experienced a headache and reportedly blood clots in her brain (cerebral thrombosis), a few weeks after receipt of the Janssen COVID-19 vaccine. No medical history, concomitant medications or additional details were reported. No laboratory results were provided. Additional information has been requested. The blood clot could represent cerebral venous sinus thrombosis (to be clarified).  The case will be assessed further when additional information is received.
Rash on chest and stomach. chills, night sweats, runny nose, stuffy nose, body aches, fever
Patient is a 40 y.o. female who received the Pfizer-BioNtech Covid-19 Vaccine, mRNA, BNT162b2 (PF) 30 mcg/0.3 mL IM Susp, Lot ER2813 on 3/18/2021. The patient experienced the following reaction(s) during the immediate   of observation: Pt notified staff of feeling faint. Site Lead attended to pt before pt fainted.  Patient was treated/managed as follows:   At approx. 2:50pm pt was given ice pack and gatorade. VS BP 86/50, HR 92, RR 20, O2 sat 97% on room air. Pt taken to treatment area and laid down on mat with legs raised. 3pm VS BP 122/81, HR 85, RR 18, O2 sat 99% on room air. EMT called. 3:20pm EMT arrived. Pt refused hospital transfer for further evaluation. Patient reports feeling better. Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. 3:45pm Pt escorted to car by RN
The pt states at night time legs started feeling weak and then for like 2 hours or maybe a little more he could not walk. He stated he felt completly paralyzed. He came in the next day and he could walk but he spoke to his dr and he  told him to report to us.
gave a FluBlok to a 15 yr old patient/no AE; Initial information received on 26-Aug-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 15 years old male patient who received a dose 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot QFAA1901, exp date: 17-May-2020 via intramuscular route in the right arm on 21-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant therapies were given.   It was a case of actual medication error due to inappropriate age at vaccine administration. It was reported that a 15 year old patient received Flublok.  It was not reported if the patient experienced any adverse event.  Outcome: not applicable.  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  List of document held: none
W/in 24 hours of receiving vaccine he had low grade fever, some nausea, swelling, redness, heat, soreness which got worse over 48 hours. Redness and heat was from elbow to shoulder. By 12/22 - it was getting better but not completely clear.
Patient came to the pharmacy on 9-19-11 and showed red spots & blotches all over her body. They are very itchy and seem to be spreading. Claims this started after the flu shot. Advised BENADRYL & cortisone, then go see doctor.
PATIENT ALMOST FAINTED, LOW HEART RATE ON VITALS CHECK COMPLETED BY STORE MANAGER, CHEST PAIN, TINGLING SENSATION IN ARM
that night her arm was really sore and swollen at injection site. by the next day her arm was puffy like a bump under the skin and red and splotchy around injection site and her arm is very sore.