chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 06-MAR-2014, the patient was vaccinated with PROQUAD (dose strength and route was not reported) (lot # J014235 and expiry date: 07-MAY-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting PROQUAD, nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for PROQUAD. This is one of the several reports from the same reporter. Additional information has been requested.
Mother reports swelling and inflammation right arm with small bumps present around injection site and also on left thigh. Running low grade temp 99.
This is not an adverse event per se; however, it is being reported as a vaccine administration error that was committed on 11/04/2019 by giving the patient these two vaccines on the same day. Even though they are not live vaccines and should not cause undue harm if given together, it is against CDC guidelines and our store policy to have given these vaccines on the same day. We realized this error recently as we reviewed documents to follow up patients who were due for subsequent vaccines in their schedule. The patient was contacted with no success, and the doctor was also contacted concerning the patient. He states that his office has only one record of vaccination for the patient on file, and the patient has never complained about an adverse event following the day these vaccines were administered. However, we had to report this error to the doctor and felt we should report it here as well.
Severe shivers, sweating, nausea, fatigue and headache.  Lost 4 pound over night.  Initial 12 hours the worst.  Then 24 hours of fatigue, headache and nausea.  Symptoms resolving on day 4.
pt recv vax 3NOV96 & 3NOV96 pt devel an inj site rxn approx 2" x 1: that was reddened w/itching;the area inc to the size of a grapefruit w/the skin raised & arm was sore;pt used Lanacane for the itching which provided temp relief;
GI upset; diarrhea; extreme abdominal cramping; bloating; gas; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 24-year-old female patient received BNT162b2 (BNT162B2), on 14Jan2021 at 16:00 as dose 1, single (Lot number: EL0142) at the age of 24 years intramuscular, in right deltoid for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: ABDOMINAL DISCOMFORT (non-serious) with onset 15Jan2021, outcome "recovered" (16Jan2021), described as "GI upset"; ABDOMINAL DISTENSION (non-serious) with onset 15Jan2021, outcome "recovered" (16Jan2021), described as "bloating"; DIARRHOEA (non-serious) with onset 15Jan2021, outcome "recovered" (16Jan2021), described as "diarrhea"; ABDOMINAL PAIN (non-serious) with onset 15Jan2021, outcome "recovered" (16Jan2021), described as "extreme abdominal cramping"; FLATULENCE (non-serious) with onset 15Jan2021, outcome "recovered" (16Jan2021), described as "gas". Therapeutic measures were taken as a result of abdominal discomfort, diarrhoea, abdominal pain, abdominal distension, flatulence.  Additional Information:On 04Feb2021, 16:00, Dose 2, Anatomical site of injection: R deltoid, Route of Administration: Intramuscular, Lot number: ZM9809. On 07Dec2021, 18:00, Anatomical site of injection: R deltoid, Route of Administration: Intramuscular, Lot number: Moderna: 058H21A, exp: 26Mar2022. COVID Shot 1: Received from as an employee. Felt no symptoms the day of, but almost exactly 18 hours later suffered from quick onset, intense diarrhea, extreme abdominal cramping, bloating, and gas for approx. 12 hours. Simethicone was taken but did not provide relief. With both initial doses, the side effects were so bad I was unable to carry on daily tasks.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200115252 same patient, different vaccine doses.;US-PFIZER INC-202201344425 same patient, different vaccine doses/events;
This spontaneous report as received from a pharmacist refers to a 68 years old female patient. The patient's medical history was not reported. On 30-OCT-2014 the patient was vaccinated with ZOSTAVAX 0.65 ml, subcutaneous in left deltoid, lot # K003598 and expiry date: 13-MAR-2015. On approximately 30-OCT-2014 the patient developed "a blister with a fluid oozing out of it." The reporter believed that the blister might have developed on the day the patient received ZOSTAVAX but she was not certain of the time the blister appeared. The pharmacist was also not certain where specially the "blister" was located, but she believed it might have been at the patient's injection site. The pharmacist did not observe the blister but she stated the patient sought physician's attention who referred the patient to the pharmacy. The patient also sought attention in unspecified pharmacy. There was no treatment prescribed for the event. By the time of the report the patient did not recover. Relatedness between the event and ZOSTAVAX was not specified. Additional information has been requested.
Sore throat/nasal condition; Body aches; Fever; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL DISCOMFORT (Sore throat/nasal condition), MYALGIA (Body aches) and PYREXIA (Fever) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included GABAPENTIN for an unknown indication. On 19-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced OROPHARYNGEAL DISCOMFORT (Sore throat/nasal condition), MYALGIA (Body aches) and PYREXIA (Fever). At the time of the report, OROPHARYNGEAL DISCOMFORT (Sore throat/nasal condition), MYALGIA (Body aches) and PYREXIA (Fever) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Treatment information was provided.
cellulitis and palpable induration. bed side US at ER (local hospital) shows deep abscess that may need surgical drainage
1/30/2022 - sudden, unexplained, extreme hair loss. Consulted doctor, labs were performed: Platelet=591, only out of range result. Hair continues falling out daily and 2 weeks later, 3/4 of my hair is gone.
funny taste; tongue is blue; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (funny taste) and TONGUE DISCOLOURATION (tongue is blue) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No medical history was reported.     On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced TASTE DISORDER (funny taste) and TONGUE DISCOLOURATION (tongue is blue). At the time of the report, TASTE DISORDER (funny taste) and TONGUE DISCOLOURATION (tongue is blue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant  information was  provided. No Treatment information was  provided.
pain and weakness in my left elbow joint and in the muscles above and below the elbow/Sore elbow joint; weakness in my left elbow joint and in the muscles above and below the elbow/weak elbow joint; pain and weakness in my left elbow joint and in the muscles above and below the elbow; weakness in my left elbow joint and in the muscles above and below the elbow; This case was reported by a consumer and described the occurrence of joint pain in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st September 2020, the patient received the 1st dose of Shingrix. In September 2020, less than 2 weeks after receiving Shingrix, the patient experienced joint pain, joint disorder, muscle pain and muscle weakness. On an unknown date, the outcome of the joint pain, joint disorder, muscle pain and muscle weakness were unknown.   It was unknown if the reporter considered the joint pain, joint disorder, muscle pain and muscle weakness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was in good health. The patient received the first Shingrix shot on 21st September 2020 in my left arm. Ever since the patient experienced continuous pain and weakness in the left elbow joint and in the muscles above and below the elbow. The patient contacted his primary care physician but did not seemed alarmed. The patient questioned what was going on and should he be concerned.
I went to the emergency room with kidney stones and they discovered a liver mass. The doctors put me on nausea and pain medication. Lomax to help pass the stones and an antibiotic. I was referred to a Urologist for follow up for an MRI to evaluate my liver.
temp, h/a, measles like rash on stomach, back, legs, sore throat;
Pt received standard 2-month immunizations on 9/2/2022. The next day, the patient developed a rash at the site of injection - the rash continued to spread to all extremities & chest/back/abdomen. Rash diagnosed as erythema multiforme vs urticaria multiforme vs vasculitis. Pt became febrile on 9/5/2022 and re-presented to the emergency department. Unknown if immunizations vs fever/viral illness are the cause of the rash; doubt immunizations are cause of fever
Initial information received on 26-Jul-2018 regarding an unsolicited valid non-serious case received from Nurse. This case involves a 63 years old male patient who was vaccinated with an expired dose of ACT-HIB. The patients past medical history included Asplenia. Concomitant medications included MENACTRA; PNEUMOVAX 23; and BEXSERO. On 26-Jul-2018, the patient received a 0.5 ml single dose of suspect HIB (PRP/T) VACCINE (lot number: Diluent Lot: U5859AB, vaccine lot: UI803AA) Expiry date: 01-July-2018 via intramuscular route in the left deltoid. It was a case of actual medication error due to inappropriate age at vaccine administration and Expired vaccine used. On 26 Jul 2018, patient visited physician. It was unknown whether adverse event occurred or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
At 4:30 am she stopped breathing and turned blue and went limp. They said she had a febrile seizure. She woke up and was awake at 4am and all of a sudden it happened out of no where.
Pt arrived at the store with warm rash and red rash that was sore at the site of injection, patient said it appeared the even after receiving FLUZONE and PREVNAR 13.
SWELLING OF FACE; SWELLING OF TOP LIP/UPPER LIP; FEELING LIKE THERE IS A FEVER WITHOUT A FEVER (FEELING ICKY); MALAISE; MILD HEADACHE; WHEEZING IN BREATHING; HANDS WERE SWOLLEN/SWELLING OF HANDS; VERY LITTLE SORENESS ON THE INJECTION SITE/MILD SORENESS ON THE INJECTION SITE; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included: shingles, and concurrent conditions included: undifferentiated connective tissue disease, severe osteoarthritis, iodine allergy, alcohol user, non-smoker, and antibiotic allergy, and other pre-existing medical conditions included: The patient was not pregnant at the time of reporting. The patient was on an antiviral drug that patient cannot remember but given for shingles and had no history of drug abuse or illicit drug use. The patient reported that she had fillers on her face. The patient took pain medicine (an OTC). The patient experienced drug allergy when treated with codeine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982 and expiry: UNKNOWN) dose was not reported, administered on 09-SEP-2021 for prophylactic vaccination on left deltoid. No concomitant medications were reported. On 09-SEP-2021, the patient experienced very little soreness on the injection site/mild soreness on the injection site. On 11-SEP-2021, the patient experienced hands were swollen/swelling of hands and wheezing in breathing. On 12-SEP-2021, the patient experienced swelling of face, swelling of top lip/upper lip, feeling like there is a fever without a fever (feeling icky), malaise and mild headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from wheezing in breathing on 11-SEP-2021, and had not recovered from very little soreness on the injection site/mild soreness on the injection site, mild headache, malaise, feeling like there is a fever without a fever (feeling icky), hands were swollen/swelling of hands, swelling of face, and swelling of top lip/upper lip. This report was non-serious.
has it listed as a monovalent not a bivalent dose; Circumstance or information capable of leading to medication error; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (has it listed as a monovalent not a bivalent dose), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (No adverse event) in a 79-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (has it listed as a monovalent not a bivalent dose), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (has it listed as a monovalent not a bivalent dose), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (has it listed as a monovalent not a bivalent dose) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Circumstance or information capable of leading to medication error).    No concomitant and treatment medications were reported
Edema, erythema - left UE near inject site. Resolved with Prednisone.
I had a severe flare in my arthritis; This is a spontaneous report from a contactable consumer (Patient) or other non-HCP, who reported for herself.  A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was EW0153) via an unspecified route of administration on an unspecified date in May2021 as a DOSE 2, SINGLE for COVID-19 immunization. Relevant medical history included Rheumatoid arthritis from an unspecified date. The condition had been stable for several years. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination was tested for COVID-19. Previously, the patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number was not reported) via an unspecified route of administration on an unspecified date as a DOSE 1, SINGLE for COVID-19 immunization. On an unspecified date in May2021, exactly 6 days after 2nd dose, the patient experienced I had a severe flare in my arthritis. An unspecified treatment was received for the adverse event. The patient underwent lab tests and medical procedure on an unspecified date in Aug2021 which included SARS-CoV-2 test negative. The clinical outcome of the event was Not recovered.  Follow-up attempts are completed. No further information is expected.
Employee complained of difficulty breathing, nausea, heart pounding, feeling jerky all over. Employee stated I think I am having a reaction to that shot. Employee examined by physician, documented no reaction to hep B vaccine.
Developed deep lowerchest/upper abdomen pain on right side 4 days after vaccine was administered.  Pain got progressively worse and a rash developed on right thorax in the Thoracic rib 5 region; Visited Army doctor on 12 MAY.  Based on visual exam of multiple, tiny water-filled blisters only on right side of thorax + description of pressing pain in chest similar to feeling of a heart attack, both doctors on shift diagnosed shingles.  Forgot I received COVID vaccine 4 days before symptoms started so I never mentioned it to the doctor.  TRX= 800mg acyclovir 5x/day x 7 days.  Rash continued to get worse and spread more before finally subsiding and starting to crust over.  Nearly 3 weeks later, rash is now a combo of scabs and open wounds.  Pressing deep pain in right chest is persistent and only relieved partially with 800mg ibuprofen q 8 hours.
From initial information received on 1/24/04 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 78 year old female patient received a dose of FLUZONE, lot number U1410BA, administered IM in an unspecified site on 10/11/04. Reportedly, within two weeks, the patient developed fatigue. She was diagnosed with a viral illness and hospitalized. Subsequently, the patient developed thoracic pain, spine pain, optic neuritis, and ataxia. Reportedly, the ataxia had worsened and the patient developed paralysis of bilateral lower extremities. The patient was diagnosed with transverse myelitis and sent for rehabilitation treatment, where she also developed a fever. The patient was once again hospitalized. A lumbar puncture was performed and was negative. The patient's family then transferred the patient to another facility. The physician's office was later informed that the patient expired in January of 2005. The patient's pre-existing medical conditions included high blood pressure, high cholesterol, and diabetes. Concomitant medications include Diovan, Glyburide, and unspecified cholesterol medications at the time of vaccination. Discharge Summary received on 2/17/2005 states apnea.
PT STATES STARTED AS LITTLE RED BUMPS ON L ARM, SPREADING TO BILATERAL ARMS AND BACK. IRRITATION AND ITCHING STARTED A COUPLE DAYS AFTER VACCINATION.  PT WAS PRESCRIBED HYDROXYZINE. RETURNED TO CLINIC A COUPLE DAYS AFTER INITIAL REACTION, WITH NO IMPROVEMENTS. NO HX ADVERSE REACTIONS IN THE PAST AND NO ALLERGIES TO EGGS, GLUTEN, LATEX, ETC. NO TROUBLE BREATHING. PT WILL BE PRESCRIBED MEDICATION DURING THE REMAINDER OF DEPLOYMENT AND VERBALIZED UNDERSTANDING TO REPORT TO THE CLINIC UPON ANY OTHER SYMPTOMS.
Injection at 2 PM left arm Around 5:30 PM that same evening I developed a migraine, then shortly after that I felt shaky nausea vomit Feverish with no fever chills entire body achyLeft arm severely painful unable to lift loss of strength with opening anything these Symptoms went on for about five days then I developed left arm weakness two days after the symptoms went away and neck pain only to the left side
no adverse event; Administered on the same day; This spontaneous report was received from a nurse regarding a patient of unspecified age and gender. The patient's concurrent condition, pertinent medical history, drug reactions, allergies and concomitant therapies were not reported. On 08-APR-2020, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (therapy type: rha) (lot number and expiry date reported as S002495 and 23-JUL-2020 respectively) and a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot number and expiry date reported as S004862 and 18-FEB-2021 respectively) for prophylaxis on the same day (Inappropriate schedule of product administration) and also other suspect therapy included sterile diluent for prophylaxis (dose, route and strength not reported) (lot number and expiry date reported as N029293 and 25-APR-2020 respectively). The patient experienced no symptoms. There was no product quality complaint reported. Outcome of the event was unknown.
Patient has history of being scared of shots. She received shot and was fine so nurse turned and gave shot to mother.  When she turned back around to check daughter her eyes fluttered and she slumped over in chair. She became diaphoretic and pale. Moved her to floor and called me to come help.  Checked respirations and heart rate which were good. Applied cool cloth and ice pack. She stabilized quickly.  Patient was given something to drink and remained in waiting area 15 minutes and then took her to her car and asked her to wait another 15minutes. Mom was driving. Patient may have reported also.
My daughter had the Johnson and Johnson.  she had externe headache, nausea, faintness, tempt of 101.  Soreness