chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PT recvd vax on 7JUL92 &  on 11JUL92 pt devel obscuration of peripheral vision in both eyes assoc w/photophobia; presented to ophthalmologist for an eye exam which was nl;
The child received his first injection with Havrix for prophylaxis on 5/10/2000. By that evening, he reportedly became febrile to 100 degrees and had some wheezing. Treated by his mother included Albuterol which relieved his wheezing. He remained mildly febrile for 3 days, but was active. On May 14, 2000, his mother noticed her son appeared to be jaundiced. By May 16, 2000 she thought his jaundice was improving, but on the advice of the health clinic, she brought him to an ER for evaluation. The mother reported her son did not have a tender or palpably enlarged liver during this exam. No blood work was drawn for laboratory analysis at that time. the information received on May 19, 2000 reported the child was not admitted to the hospital and was sent home from the ER.  This report is considered SB medically serious because of the jaundice. Additional information has been requested.
Local redness at LVL post vaccination KINRIX. Noted at baseball sixe w/(+) redness and hot to touch. Seen 3 days post vaccine. Home tx: ice; TYLENOL and BENADRYL as needed.
p/vax pt devel a rash of unk type;pt sought unspecified medical attention;
3d after receiving vaccine he was sitting in chair-he fussed, nanny picked him up. His left side twisted and stiffened for approx 15 sec and then he went limp for a few seconds. Since then (48 hrs) he has low energy (but with URI).
I got the dose in my arm and my arm still has not stopped hurting and it's in the muscle that I received the vaccine. About 3 weeks ago I started having trouble breathing, I thought I had to do with my lung disease and went to see my PCP she said that I should go see my cardiologist they did a stress test the came back negative with no blockage. And I had a blockage test done that I am waiting to get the test back for. This past Friday i woke up with the chills, diaherra I didn't feel good, and I went to bed instead of going to work and woke up feeling better and Saturday i felt okay working better but out of nowhere I got the chills and the shakes and the shakes would not stop. I went to the ER and they admitted me for 3 days they did a CAT Scan and Chest Xray they sent back blood cultures i don't have back nothing, they did a mercer test that came back negative along with COVID-19, Flu.
cardiomyopathy; LBBB; sleep apnea; CHF; Afib; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 25Sep2020 at 14:45 as dose number unknown, single (Batch/Lot number: unknown) at the age of 66 years, in left deltoid for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BUNDLE BRANCH BLOCK LEFT (hospitalization) with onset Sep2020, outcome "unknown", described as "LBBB"; CARDIOMYOPATHY (hospitalization, medically significant) with onset Sep2020, outcome "unknown"; ATRIAL FIBRILLATION (medically significant) with onset Oct2020, outcome "unknown", described as "Afib"; CARDIAC FAILURE CONGESTIVE (medically significant) with onset Oct2020, outcome "unknown", described as "CHF"; SLEEP APNOEA SYNDROME (non-serious) with onset Jan2023, outcome "unknown", described as "sleep apnea". The patient was hospitalized for cardiomyopathy, bundle branch block left (start date: 30Sep2020). The patient underwent the following laboratory tests and procedures: Ejection fraction: (2020) 10. Therapeutic measures were taken as a result of cardiomyopathy, bundle branch block left, cardiac failure congestive, atrial fibrillation.  Additional information: The patient reported, "I have CHF and Afib, use pacemaker/defibrillator for left branch bundle block. Recent diagnosis of severe sleep apnea. Heart issues diagnosed in Oct2020, after I had a dose of Prevnar 13 along with COVID, flu, and shingles shots, 25Sep2020. I was admitted to hospital on 30Sep2020 with chest pain and diagnosed with LBBB and cardiomyopathy- at that time my ejection fraction was 10. Pacemaker/defibrillator was implanted 12Nov2020. Wanted to let you know as I had neglected to mention the events that were subsequent to the Prevnar 13 dose."  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Pt vaccinated with Pneumovax 23 one wk following vaccination developed a cough & laryngospasm which lasted for 3 wks.
about 2 weeks after 2nd vaccination patient reported excessive heartburn and vomiting.  No prior history of heartburn.  Reports her daughter who had J&J vaccine had a similar experience.  Heartburn continues approx. 5 months after vaccination.  Also experienced lower stomach pain and has seen GI provider.
This spontaneous report was received from a medical assistant, regarding an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, drug allergies, or concomitant therapies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD subcutaneous injection as a single dose (strength was not reported) (lot # M041507, expiration date 09-APR-2018; lot #: M037652, expiration date: 28-FEB-2018) for prophylaxis. The patients were also administered sterile diluent (strength, lot number and expiration date were not reported). According to the reporter, PROQUAD doses were exposed to the following temperatures excursions: 22 degrees Fahrenheit (F) for 1 hour daily during defrost cycle. No adverse effects were reported. A digital data logger was involved. This is one of two reports from the same reporter. Additional information is not expected as the reported refused additional contact. Sender's Comments: US-009507513-1703USA006881.
DISCHARGE SUMMARY:   MRN: private Name: private Age: 60 y.o. Birthday:  private Admit Date: 7/14/2022  1:30 PM Discharge Date:  7/19/2022 Unit: 3A115/3A115A Admitting Physician: Dr. Discharge Physician: MD   Discharge Diagnosis: Principal Problem:   COVID-19 Active Problems:   Type 2 diabetes mellitus with hyperglycemia, with long-term current use of insulin   Benign essential HTN   AICD (automatic cardioverter/defibrillator) present   DM2 (diabetes mellitus, type 2)   Dilated cardiomyopathy   Chronic systolic CHF (congestive heart failure)       HPI AND HOSPITAL COURSE   History of Present Illness:  As per admission H&P, "The patient is a 60 y.o. male, presented on 7/14/2022 with the above. . The symptoms/labs were thought to be marked in severity and unstable. Onset several days ago. Associated symptoms include fatigue and fever . Alleviated by none. The patient has a history of chronic diastolic and systolic CHF with an EF of 40-45% in January of this year. He has an ICD in place as well. The patient states that he has had a chronic nagging cough starting around in his lower throat. This has been going on for 3 months. Nothing seems to make it better or worse. Cough suppressant does not seem to improve it. The cough is non productive. Over the last 3 days he has been having fevers and felt weak and tired. He came in today due to this and was found to be COVID 19 positive. He has never had COVID before. He is on room air as I am seeing him. He has no chest pain. He has been admitted for further management. "   Hospital Course: Patient, is a 60 y.o. male who presented with cough, shortness of breath.  He was managed for the following:   * COVID-19 COVID-19 infection - patient presented with cough, SOA.  He completed 5 days of remdesivir during admission.  He was stable on room air.  He felt improved, discharged home in stable condition.     Acute on Chronic Systolic Heart failure - Patient improved with IV lasix.  Resume po lasix and entresto on discharge.  AICD in place.    Chronic cough - CT thorax was unremarkable. Refer to ENT.   AKI on CKD IIIb - Cr improved, stable at baseline.             Physical Exam on the Date of Discharge: Blood pressure 118/74, pulse 62, temperature 97.6 °F (36.4 °C), temperature source Oral, resp. rate 18, height 5' 9" (175.3 cm), weight 101.7 kg (224 lb 3.2 oz), SpO2 98 %. General - NAD, appears stated age, obese HEENT - EOMI, PER, MMM,  Chest - lungs clear bilaterally,  Heart - RRR, NS1S2,  Abdomen - Soft, non-tender, Extremities - warm, no edema Psych - AAOx3,  Skin - no rash, dry   Discharge Condition: improved   Disposition: home
Combine initial and follow up information received from the health care professional on 19 Jan 2011 and 24 Jan 2011: This patient with unknown medical history vaccinated with FLUVIRIN (batch number unknown), on an unknown date. The patient experienced the flu-like symptoms on an unknown date. The outcome of the event was not reported. Combined following an internal review for the data received on 19 Jan 2011 and follow up report received from a nurse on 20 Jan 2011: This was also a quality complaint. This patient was vaccinated with 0.5ml of FLUVIRIN (batch number 11625A01) intramuscularly on 16 Nov 2010. Vaccination was uneventful and no adverse reactions were detected after vaccination. On 13 Jan 2011, she became sick with flu-like symptoms and tested positive for influenza A. Outcome of event was reported as condition unchanged. She was also vaccinated with another dose of FLUVIRIN on 20 Jan 2011.
Chills,  fatigue, headache,  trouble concentrating or focusing, sore throat. Lasted for about 24 hours. Days later still fatigued, but less so.
Narrative: PATIENT REPORTED HAD CHEST PAIN AND CHILLS FOR ABOUT 8 HOURS AFTER FIRST DOSE OF THE MODERNA VACCINE.
recent test positive for COVID with symptoms; recent test positive for COVID with symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03May2021 as dose 1, single (Lot number: EW0182) and on 24May2021 as dose 2, single (Lot number: EW0187) for covid-19 immunisation. The patient's relevant medical history included: "experienced covid prior vaccination" (unspecified if ongoing). There were no concomitant medications. No known allergies and no other relevant medical history.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19Jul2022, outcome "recovering" and all described as "recent test positive for COVID with symptoms". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Jul2022) Positive, notes: Adverse event: recent test positive for COVID with symptoms. Therapeutic measures were not taken as a result of vaccination failure, covid-19. No follow-up attempts are possible. No further information is expected.
I had diarrhea, nausea, tingling in fingers which lasted 2 to 3 days. I felt like a tendon was out of its groove on the left hand, center finger which became an annoyance and discomfort. This spread to my right center finger and then eventually to both hands. The tingling is on all the fingers of my left hand at this point and on the pointer and center finger. I went to my doctor who completed a blood panel and saw raised inflammation markers and slightly elevated white blood count. My doctor referred me to a rheumatologist.
Flu shot is administered at 10:40 A.M. Patient called back next morning said at about 4 P.M. he started throwing up. Has to be hospitalised and not able to walk right now.
fever on and off; coughing; a little congestion; tired; sore; woken up in the night because of her fever, because of being hot; feels burned out; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: ER2613), via an unspecified route of administration, administered in Arm Right on 09Apr2021 at 09:30 AM (at the age of 63-year-old) as DOSE 1, SINGLE for covid-19 immunisation (to prevent the Covid 19 virus). Medical history included high blood pressure, asthma. The patient's concomitant medications were not reported. Historical vaccine included flu vaccine taken several years ago before 2017 for immunization which made her very ill. No history of previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date with the Pfizer vaccine considered as suspect. No prior Vaccinations within 4 weeks. On 16Apr2021, the patient experienced fever on and off, coughing, a little congestion, tired, sore, woken up in the night because of her fever, because of being hot, feels burned out. The patient underwent lab tests and procedures which included body temperature resulted as fever on 16Apr2021. Patient asked if it's ok to take Tylenol and Theraflu at night so she can sleep. The coughing is keeping her up. Reported that her symptoms started last Friday on 16Apr2021. When she wakes up in the morning, she experienced some events. The symptoms fade away throughout the day and then she's fine. Then after 6:00PM, in the evening time, her symptoms come back. Reported that this has been going on for 5 days. Patient called her doctor on 21Apr2021, and she is waiting on a call back to see if the doctor is going to prescribe her anything or tell her what to do. Therapeutic measures were taken as a result of coughing, a little congestion, patient reported that she uses a nebulizer and a CPAP machine at night. The outcomes of events were not recovered.  No follow-up attempts are possible. No further information is expected.
There was no adverse reaction, vaccine expired on 08/31/2021 and vaccine was administered on 09/03/2021. This lot number expiration date was not extended.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (There was no adverse reaction, vaccine expired on 08/31/2021 and vaccine was administered on 09/03/2021. This lot number expiration date was not extended.) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus, Hypertension, Ex-smoker, Hyperlipidemia and Obesity. Concomitant products included METFORMIN, LISINOPRIL, AMLODIPINE, HCTZ and LOVASTATIN for an unknown indication.    On 03-Sep-2021 at 11:09 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021 at 11:09 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (There was no adverse reaction, vaccine expired on 08/31/2021 and vaccine was administered on 09/03/2021. This lot number expiration date was not extended.). On 03-Sep-2021 at 11:09 AM, EXPIRED PRODUCT ADMINISTERED (There was no adverse reaction, vaccine expired on 08/31/2021 and vaccine was administered on 09/03/2021. This lot number expiration date was not extended.) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (There was no adverse reaction, vaccine expired on 08/31/2021 and vaccine was administered on 09/03/2021. This lot number expiration date was not extended.) to be not related.    The patient had no known drug allergy. There were no any other potential causes of this event.   This case was linked to MOD-2021-328706 (Patient Link).
a patient received only the liquid component of Menveo; a patient received only the liquid component of Menveo; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA975A, expiry date 20-JUL-2024) for prophylaxis.   On 11-SEP-2023, the patient received Menveo. On 11-SEP-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: a patient received only the liquid component of Menveo) and inappropriate dose of vaccine administered (Verbatim: a patient received only the liquid component of Menveo).The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 12-SEP-2023  The reporter was a medical assistant. The reporter stated that the day before reporting a patient received only the liquid component of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter declined to provide more information. The reporter did not consent to follow-up.
27OCT recvd vax in rt deltoid; 12NOV began exp join pain rt shoulder, hand elbow; 25NOV consulted w/MD dx rheumatoid arthritis; 28NOV retunr to MD c/o sore throat-typ B step throat-tx w/PCN x 10 days;
No additional AE reported.; the vaccine was administered while out of recommended range, Temperature 89 F; This spontaneous report was received from a registered nurse and refers to a 14-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 15-MAY-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 milliliter, lot # 1687292, expiration date 25-AUG-2022 (route of administration and anatomical location were not reported) for prophylaxis. The vaccine was administered while out of recommended range. Temperature excursion was 89 degrees Fahrenheit (F) which lasted 24 hours, there was no previous temperature excursion. A digital data logger was involved in recording the excursion. No product quality complaints or additional adverse events were reported, and no further information was provided. 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: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; operatorofdevice: Nurse; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Patient experiencing itchy, swollen tissue around site of injection. Area measured 2 inches x 4 inches approximately.
Noticed slight itchy feeling, looked in mirror at back of left arm and it was the color of the wine rose' was 2" x 3" around the site of injection.  Next day redness continued to enlarge and had an orange peel effect(09/02/2013); next day it began to ache in the upper arm (L) and began to fade to the shade of white zinfandel; 09/03/2013 (today) arm still aches, armpit aches, injection site has grown to 7" x 3" but orange peel effect has decreased and the color remains about the same, but the area seems to be flattening out.  This is relieved by moist cool compresses and taking Benadryl 25 mg at night. I am a registered nurse and have sent my FNP a note about this on-line this a.m. I did not report this to the pharmacist yet.
Fever in mouth; Scabs; Blisters in mouth; This non-serious case was reported by a physician via sales rep and described the occurrence of fever in a 62-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number EP5FD) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE for prophylaxis.   On 07-SEP-2023, the patient received Arexvy and INFLUENZA VACCINE. On 08-SEP-2023, 1 days after receiving Arexvy and INFLUENZA VACCINE, the patient experienced fever (Verbatim: Fever in mouth) and blistering of mouth (Verbatim: Blisters in mouth). In SEP-2023, the patient experienced oral mucosal scab (Verbatim: Scabs).  The outcome of the fever and oral mucosal scab were not reported and the outcome of the blistering of mouth was resolving (duration 4 days).   It was unknown if the reporter considered the fever, blistering of mouth and oral mucosal scab to be related to Arexvy.     It was unknown if the company considered the fever, blistering of mouth and oral mucosal scab to be related to Arexvy.   Additional Information: GSK Receipt Date: 26-SEP-2023 It was reported that patient experienced fever and blisters in mouth that started the day after receiving Arexvy and Flu vaccine which was persistent for 4 days and turned to scabs by day 7. The physician saw patient and had reported through VAERS. Flu vaccine was giving by providers office and Arexvy was given by across the street.  Information was provided when contacted the pharmacy. It was unknown if the reporter considered the fever, blistering of mouth and oral mucosal scab to be related to Influenza vaccine.
Day of the second vaccine felt fine. Woke up with my left arm sore and injection site very sore (left upper arm). Started feeling very sluggish in the morning and then it progressed to high fever (over 100), fatigue, stuffy nose, severe headache. Took Tylenol for headache & fever.
Local erythema and some induration. Systemic effects with fever and mild aching, headache.
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received BNT162b2 (BNT162B2), on 28Feb2021 at 14:00 as dose 1, single (Lot number: en6202), in right arm, on 21Mar2021 as dose 2, single (Lot number: en6206), in right arm and on 22Oct2021 as dose 3 (booster), single (Lot number: Fh8020) at the age of 37 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Patient had no known allergies The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Jul2022) Positive, notes: I took two at home tests, both of which came back positive; (23Jul2022) Positive, notes: I took two at home tests, both of which came back positive; (17Jul2022) Negative, notes: first negative COVID test was on Sunday. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 13Jul2022 to 18Jul2022. It was reported that the first negative COVID test was on Sunday, 17Jul2022. Today (Saturday, 23Jul2022) patient began to feel allergy-like symptoms (stuffiness, runny nose). Out of an abundance of caution, patient took two at-home tests, both of which came back positive. Patient had also been more tired than normal, which he attributed to heat and physical exertion but now suspect could be connected.
This spontaneous report as received from a nurse regarding patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On 22-DEC-2016 the patient was vaccinated with ZOSTAVAX (dose, frequency, route of administration and indication were not reported), which expired on 16-DEC-2016. No side effects were reported. Additional information has been requested.
Patient described her eye watering and feeling like there were pins and needles poking her eye. This occurred in the evening on the day she received the vaccine. The discomfort has continued unchanged until now, the day after, at which she reported to me. She made an appointment with a eye doctor.