chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from the literature on 14 September 2015. This case is linked to 2015SA146032, 2015SA146043, 2015SA146044, 2015SA146046, 2015SA146047, 2015SA146048, 2015SA146049, 2015SA146050, 2015SA146051, 2015SA146052, 2015SA146053, 2015SA146054, 2015SA146055, 2015SA146056, 2015SA146057, 2015SA146058, 2015SA146059, 2015SA146060, 2015SA146061, 2015SA146062, 2015SA146063, 2015SA146064, 2015SA146065, 2015SA146066 and 2015SA146067 (Same literature). The following is verbatim from the article: Background. Reporting of adverse events (AEs) following vaccination can help identify rare or unexpected complications of immunizations and aid in characterizing potential vaccine safety signals. We developed an open-source, generalizable clinical decision support system called Electronic Support for Public Health-Vaccine Adverse Event Reporting System (ESP-VAERS) to assist clinicians with AE detection and reporting. Methods. ESP-VAERS monitors patients' electronic health records for new diagnoses, changes in laboratory values and new allergies following vaccinations. When suggestive events are found, ESP-VAERS sends the patient's clinician a secure electronic message with an invitation to affirm or refute the message, add comments, and submit an automated, prepopulated electronic report to VAERS. High-probability AEs are reported automatically if the clinician does not respond. We implemented ESP-VAERS in December 2012 throughout the System, an integrated healthcare system. We queried the VAERS database to determine System's baseline reporting rates from January 2009 to March 2012 and then assessed changes in reporting rates with ESP-VAERS. Results. In the 8 months following implementation, 91,622 vaccinations were given. ESP-VAERS sent 1385 messages to responsible clinicians describing potential AEs. Clinicians opened 1304 (94.2 percent) messages, responded to 209 (15.1 percent), and confirmed 16 for transmission to VAERS. An additional 16 high-probability AEs were sent automatically. Reported events included seizure, pleural effusion, and lymphocytopenia. The odds of a VAERS report submission during the implementation period were 30.2 (95 percent confidence interval, 9.52-95.5) times greater than the odds during the comparable preimplementation period. Conclusions. An open-source, electronic health record-based clinical decision support system can increase AE detection and reporting rates in VAERS. This case involves patient (age and gender not reported), who was vaccinated with a dose of INFLUENZA VACCINE (IIV) (Manufacturer: unknown, batch number, route, dose in series and site of administration were not reported) on unspecified date. Medical history and concomitant medications were not reported. On unspecified date following the vaccination, the patient experienced local immunization reaction. Lab tests and corrective treatments were not reported. Outcome of event was not reported. Documents held by sender: none. Follow-up information received from physician on 19 October 2015. No additional information was provided.
Erythematous 1.5cm well circumscribed papules - trunk, posteriorly/anteriorly. Non-pruritic, non-painful. Given steroid cream (1%) and diphenhydramine.
received an invalid dose of 0.25 mL instead of 0.5 mL/no AE; Initial information received on 15-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2019SA288673 (same reporter).  This case involves a 17 years old male patient who received 0.25 ml single dose instead of 0.5 ml dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] on 01-Oct-2019 (lot U6653BD via intramuscular route in the right deltoid).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included TETANUS VACCINE TOXOID (TETANUS TOXOID).  It was of actual medication error due to vaccine underdose.  It was unknown whether adverse event was experienced or not.  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.
Within a week of routine vaccinations for infants, my child had intusseption. Extreme crying, extreme pain, extreme lethargy.
This spontaneous report as received from a nurse practitioner refers to an unspecified number of patients of unknown age and gender. No pertinent medical history or drug reaction/allergies were provided. The nurse practitioner reported that, on unspecified dates, 25 patients were inadvertently administered PEDVAX (lot numbers, doses and routes not provided), and another two vaccines, that had been improperly stored. No adverse effects were reported. This case is linked to cases MARRS # 1408USA001066 and MARRS # 1408USA001206 (same reporter link). Additional information is not expected because there was no consent to follow-up.
Dose was given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose was given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that there was a confusion between the expiration date printed in the carton the expiration date when the QR code was scanned. No adverse events were reported. Vial did not undergo any temperature excursion. Vial was placed in refrigerator on 05-Nov-2021.  No treatment medications were reported.
Pt rec'd Dtap #4, Hib #4 and varicella #1 on 3/14 am. Throughout that day developed worsening swelling of eyes and then face. Called on call MD. Went to ED but was not evaluated. Mom gave BENADRYL and on 3/15 was fine.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Rash Generalized-Mild, Additional Details: Pt reported hives 2 days after vaccine
w/in 12 hr of vax pt devel hives & rash lasting 48hr;
Starting Friday Oct 14th: Sore/ rough/ itchy throat; cough (started mainly dry and painful, and it became a bit more productive; fatigue; neck/ head pain Saw Dr. on Monday October 17th at 8:45am at ARC Round Rock:  tested negative for COVID, flu, strep; set up chest X-ray (2 view) Treatment: took some OTC pain reliever and cough suppressant/ expectorant  On morning of Wednesday Oct 19: talked with 24/7 nurse working for Clinic due to ongoing but slightly changing symptoms: nasal congestion, runny nose, sneezing; sore throat and upper nasal passage; cough ? sometimes dry but production is yellow phlegm; (watery eyes), headache; fatigue; body aches; feverish. Took home covid test during call: negative. Treatment: take OTC meds on a more regular schedule, added saline nasal spray; had chest xray done and awaiting the results (which should be in later today)
On evening of vaccines increased irritability then turned blue. Parent called 911. Continued pallor when EMTs arrived, oxygen administered en route to hospital. Low grade temperature. No intervention required on arrival at ER.
No adverse event; Patient was administered with Moderna Covid 19 vaccine 15 days after expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered with Moderna Covid 19 vaccine 15 days after expiration date.) and NO ADVERSE EVENT (No adverse event) in a 31-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 015B22A) for COVID-19 prophylaxis.     It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 27-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 27-Feb-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered with Moderna Covid 19 vaccine 15 days after expiration date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered with Moderna Covid 19 vaccine 15 days after expiration date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient was administered with Moderna Covid 19 vaccine 15 days after expiration date.).    Concomitant medication was not provided.   Treatment information was not provided.
uveitis; Eye pain evaluated by a dr.; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 6 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: UVEITIS (medically significant), outcome "unknown", described as "uveitis"; EYE PAIN (non-serious), outcome "unknown", described as "Eye pain evaluated by a dr.". The event "eye pain evaluated by a dr." was evaluated at the physician office visit. Eye pain was reported "weird and had never happened before.: Eye pain evaluated by a dr. For uveitis, but did not have.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
It was reported that a female patient (4 of 4) was vaccinated with Fluzone SV 2001-2002 vaccine, lot number U0682AA on 10/16/2001. Reportedly the patient developed a local reaction of redness and swelling at the injection site. Patient was evaluated by a physician and no therapy was prescribed. This case is linked to reports U200101061, U200101278 and U200101279.
Two days post vax, mother noticed rash on abdomen. This spread to her arms and legs on 02/16 and temperature was 103. At physician's office, mom reports, symptoms due to bacterial infection or possible allergy. Not related to IZ. Rash is still present.
Diagnosed with Herpes Zooster (Shingles) as a result of reaction with second dose of Pfizer vaccine.
Chills, fever, headache, increased B/P, dizzy, fatigue. 4/30/16 Ambulance to ER (hospital) x 7 hours then 2 days later (L) arm red, swollen, hot to touch, painful.
THE EVENING OF MY FIRST SHINGRIX VACCINE MY ARM FELT QUITE SORE AND I WAS TIRED AND A BIT ACHEY. WITHIN A DAY (OR MAYBE A COUPLE OF DAYS) I BEGAN TO FEEL VERY ACHY. I HAVE HAD RHEUMATOID ARTHRITIS SINCE 2003. FOR SEVERAL YEARS I HAVE BEEN IN COMPLETE REMISSION, WTH MINOR SYMPTOMS THAT WERE HANDLED WITHOUT RA MEDICATION, ONLY TYLENOL. WE MOVED IN 2016 AND I NEVER SOUGHT CARE FROM A NEW RHEUMATOLOGIST.  AS THIS FLARE CONTINUED I GOT A RECOMMENDATION FROM MY CURRENT PERSONAL PHYSICIAN FOR A RHEUMATOLOGIST. I HAVE AN APPOINTMENT TO SEE THAT NEW RA DOCTOR, FOR A COMPLETE WORK-UP. THE FLARE CONTINUES, SO I AM EAGER TO SEE THE DOCTOR. I DO NOT KNOW IF THIS NEW AND TROUBLESOME RA FLARE IS MERELY A COINCIDENCE.
Information has been received from a medical assistant referring to a 15 months old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 11-JUN-2015, the patient was vaccinated with an improperly stored dose of MMR II (lot # K021151 with expiration date 02-NOV-2016; dose and route of administration were not reported). No adverse effects were reported. This is one of several cases received from the same source. Additional information has been requested.
pt recv vax 8APR98 & 9APR98 pt devel dizziness, eyes & face pressure & h/a;A MD visit was required;tx w/antivert;
Felt anxious and nervous 5 minutes after Pfizer vaccine. Patient drank 2 bottles of water and rested. BP 119/80, pulse 77, O2 sat 100%. Patient started feeling better. No new anxiety and nervousness. No other symptoms. Stable to go home.
My lips are red, swollen and peeling above the lip line.  Given medication for the reaction. It worked and the reaction subsided.
This spontaneous report was received from a pharmacist concerning a 62 year old female patient. The patient's medical history included headaches, drug reactions/allergies included redness to other vaccinations, allergic to penicillin and sulfa. On 12-NOV-2016, the patient was vaccinated with a dose of ZOSTAVAX 19400 plaque forming units (PFU), lot # M030140, expiration date: 18-AUG-2017, via subcutaneous, as prophylaxis (Dose was not reported). On 12-NOV-2016, immediately after vaccination with ZOSTAVAX the patient developed redness at the injection site. The pharmacist monitored the patient for 20 minutes after receiving the dose of ZOSTAVAX and the redness at the injection site did not develop into a rash. The pharmacist advised the patient to apply an unspecified cortisone cream (manufacturer unknown) topically to the injection site. The patient reported to the pharmacist that she took an unspecified amount of ALLEGRA, which helped to alleviate her injection site redness. During this report, the pharmacist reported that "it was not uncommon for patients (unspecified) to developed redness at the injection site of any vaccine (unspecified)". The pharmacist reported that none lab diagnostics studies were performed to the patient. The patient sought medical attention consulting the pharmacist. The outcome of injection site erythema was recovering. The reporter did not assess the causality between ZOSTAVAX and injection site erythema. Additional information has been requested.
It was a mild allergic reaction. I was experiencing itching and hives. Got a steroid cream prescribed by the doctor at the clinic.
Had the shot still got shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the shingle shot and still got shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
right side of face affected as well as her hearing; right eye redness; dark under the right eye; vision in right eye impaired; right side of face affected as well as her hearing; extensive swelling of right arm; Initial information received on 14-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional  This case involves a female patient of an unknown age who experienced extensive swelling of right arm, (PT Peripheral swelling), right side of face affected as well as her hearing (PT Swelling face), right side of face affected as well as her hearing (PT hypoacusis), right eye redness (PT Ocular hyperaemia), dark under the right eye (PT Dark circles under eyes) and vision in right eye impaired (PT Visual impairment), while she was immunized with influenza quadrival a-b vaccine [Fluzone quadrivalent].  The patient past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 26-Sep-2019, the patient was immunized with influenza quadrival a-b vaccine at a dose of 0.5 ml (batch number unknown).  On an unknown date, latency unknown, it was reported that there was extensive swelling of right arm, right side of face affected as well as her hearing, right eye redness, dark under the right eye, and vision in right eye impaired.  Action taken was not applicable.   It was not reported if the patient received a corrective treatment.  At the time of this report, outcome of events were not resolved.  Batch number was requested.  No further information was reported.
radiating pain along her arm/it was even more intense after the 3rd shot; it was even more intense after the 3rd shot; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 22Oct2021 (Lot number: EW0185) at the age of 66 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing); "cardiovascular disease" (unspecified if ongoing). Concomitant medication(s) included: ISOSORBIDE MONONITRATE. Vaccination history included: Bnt162b2 (first dose), when the patient was 66 years old, for Covid-19 immunization, reaction(s): "radiating pain along her arm"; Bnt162b2 (second dose), when the patient was 66 years old, for Covid-19 immunization, reaction(s): "radiating pain along her arm". The following information was reported: IMMUNISATION (non-serious) with onset 22Oct2021, outcome "unknown", described as "it was even more intense after the 3rd shot"; PAIN (non-serious) with onset 23Oct2021, outcome "not recovered", described as "radiating pain along her arm/it was even more intense after the 3rd shot". The event "radiating pain along her arm/it was even more intense after the 3rd shot" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of pain.  Additional information: The patient had no other vaccine within four weeks and no other medications received within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not have any allergies.   Follow-up attempts are completed. No further information is expected.
Pt slept 1st 24 hrs, on awakening 24 hrs later began high pitched, unconsolable crying; medicated w/APAP & seemed more comfortable; APAP advised;
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 28-NOV-2006, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 07-NOV-2016, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
ACUTE HYPOXEMIC RESPIRATORY FAILURE 12/15/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
NO other issues or concerns noted.; A 10 months old was administered GARDASIL 9; This spontaneous report was received from a nurse via company representative and refers to a 10-month-old patient of unknown gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 26-OCT-2022, the patient was vaccinated with a dose of 9-valent Human Papillomavirus (types 16, 18, 31, 33, 45, 52, 58, 6 and 11) recombinant vaccine (GARDASIL 9) (strength, dosage regimen, anatomical location, route of administration, lot #, and expiry date were not reported) as prophylaxis (Inappropriate age at vaccine administration). No adverse event was reported.
Itchiness and diffuse rash on arms, legs and trunk starting the evening of receiving vaccine. Denies all other s/s of allergic reaction.  Continues to have rash and itching 9 days after vaccine. Does not resolve with OTC ointments/creams.
flu like symptoms; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 047B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication were reported. Treatment medication was not provided.
Syncopal episode. Vital signs, blood sugar, hemoglobin, pt. monitored.
4 year old girl presented with 4 x 4 cm area of redness Left thigh 2 days after receiving DTaP. Exam consistent with localized cellulitis vs allergic reaction.
I experienced two days after, my joints felt real aching and felt inflamed, all my joints were hurting in my elbows, feet and back. I also a little nauseated and felt like I was trying to walk through sand. I felt very lethargic and had a really bad headache. I did see a doctor at a hospital ER and lab work was done. They gave me some IV's and started to feel better after that and felt more alert, felt a little more rested. I did not feel so tired after the IV administration. After I went to the hospital, my symptoms went away in about one week.
Bursitis of left shoulder. Diagnosed by primary care md and now having physical therapy that is ongoing for last month and still continuing.