chrisvoncsefalvay/vaers-outcomes huggingface dataset:
EXPIRED VACCINE ADMINISTERED; UNCONTROLLED PEEING; UNCONTROLLED POOPING/DIARRHEA; This spontaneous report received from a patient concerned a 73 year old male. The patient's weight was 160 pounds, and height was 185.42 centimeters. The patient's past medical history included: arthritic pain (went away when took Orgain), dizziness (went away when took Orgain), eye surgery (done in both eyes and now have 20/20 vision.), and vision issues, and concurrent conditions included: type 2 diabetes (using medications from 5-6 years ago), cipro allergy, alcohol use (a beer every few months), and non-smoker, and other pre-existing medical conditions included: The patient was using medications for the heart attack 5-6 years ago. The patient have never gotten COVID. The patient was previously treated with carbohydrates nos/fats nos/minerals nos/proteins nos/vitamins nos.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 18-FEB-2022) dose was not reported, administered on 06-MAY-2022 for covid-19 prophylaxis. The drug was associated with Drug taken beyond expiry date. Age at time of vaccination 73 years old. Concomitant medications included ascorbic acid, ergocalciferol, and zinc.  On MAY-2022, the patient experienced uncontrolled peeing, and uncontrolled pooping/diarrhea. On 06-MAY-2022, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from uncontrolled peeing, and uncontrolled pooping/diarrhea, and the outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20220861185.
Redness, warmth, pain at injection site 8 x 13 cm (Right deltoid only) Fever.
Right arm swelling, redness, tenderness at immunization site within 24 hrs of immunization. Pt mother gave tylenol. Physician orders of over the counter benadryl. Resolved at site.
It was reported a 2 year old female pt received an Act-Hib vaccination on 9/22/98. Reportedly on 5/24/00, the pt was admitted to the hospital for a duration of 10 days. Diagnosed with H flu Meningitis serotype 4. Further information has been requested. FOLLOW-UP correspondence received 04/23/2001, it was reported patient treated with cefotax and Ceftriaxone for ten days (IV). "Patient returned to our clinic post hospitalization only once on 06/05/2000, at that time progress note indicates. Patient has only fever from an unrelated illness, a cold most likely. Patient has not been seen here since june 2000. Mailed follow-up correspondence received on 06/13/2001 stated the route and site of the administered vaccines are not available.  FOLLOW-UP correspondence received on 10/29/2001, it was reported, "The patient has not been seen since 06/05/2000 as previously noted Upon review of copy of vaccination record, patient appears to have been admitted to hospital by primary care attending. Current status of patient is unknown.
pt recv vax 29MAR99 & pt presented w/bronchospasms & cough & was prescribed oral pred;the bronchospasms were considered an other medical event;
9 days and 6 hours after receiving shot, left arm started itching and swelling at injection site.  Area swelling is oblong in shape, 1-1/2 inches wide x 1 inch tall. Currently being treated with over the counter hydrocortisone cream.
Cellulitis of left upper arm developed about 2 days after administration of the pfizer vaccination.
Information has been received from a registered nurse concerning a 14 month old female patient with no pertinent medical history or drug allergies who on 17-MAR-2008 was vaccinated intramuscularly into the left thigh with her third of 0.5 ml dose of RECOMBIVAX HB (lot# 656876/0874U). Concomitant therapy included DTAP (Lot # AC14B069AA) and PREVNAR (Lot # C56540). On 08-DEC-2006 and 28-FEB-2008 she received her first and second dose of RECOMBIVAX HB. It was reported that she did not have any difficulties with either of the first or second dose. On 17-MAR-2008 in the evening after vaccination, the patient experienced hives on her left leg. No labs or diagnostic studies were performed. The patient was given BENADRYL as per the physician's request when he spoke with the patient's mother that evening. The patient recovered on 18-MAR-2008. It was also noted that the patient's twin sister was vaccinated with doses of RECOMBIVAX HB and did not have any difficulties. There was no product quality complaint. No further information is available.
1. At 1:30 AM, I had to urinate; I went back to bed and slept, only to wake up every hour after that to urinate. 2. 8:00 AM-I had severe edema.  My neck, shoulders, arms, thighs, and back were swollen;  I had difficulty moving from one side to the other because of pain and swelling;  3. Ibuprofen did nothing.  I took two every four hours.  4. By 8:30 AM, today, Saturday, I began to feel better. I took three Ibuprofens instead of two. Edema went down; only my back is a little swollen and achy. I was able to eat breakfast and walk around a little.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On 17-DEC-2014, the patient was vaccinated with an improperly stored GARDASIL (lot # K004204, expiry date 12-JAN-2017) (dosing regimen, route and frequency unknown). No concomitant medications were reported. No adverse effect was reported. This is one of the several reports from the same reporter. Additional information has been requested.
Information has been received from a PA concerning a 70 year old retired female pt with PCN and sulfa allergies and a history of immunization, osteoporosis, hypercholesterolemia, gastroesophageal reflux disease, degenerative joint disease, recurrent urinary tract infection and Raynaud's syndrome who on 11/17/03 at 12:00 was vaccinated SC in the left upper arm with a second dose of pneumococcal 23v polysaccharide vaccine (Lot # 645853/0256N). There was no illness at the time of vaccination and there were no adverse events following prior vaccinations. Previous vaccination included a dose of pneumococcal 23v polysaccharide vaccine six years ago without adverse symptoms. Concomitant therapy included alendronate sodium, folic acid, calcium supplement, raloxifene hydrochloride (Evista), vitamin E, vitamin C, multivitamin, oxybutyninCl (Ditropan XL), vitamin B12, aspirin, colesevelam hydrochloride (Welchol), rabeprazole sodium (Aciphex) and selenium. Subsequently on 11/14/03, the pt had bleeding into soft tissue from the injection site to the elbow and pain. Hematoma and ecchymosis at the injection site were also noted with an onset of 11/15/03 at approximately 08:00. On 11/18/03, the pt spoke with the medical office and was seen. The pt was healing well and no treatment was required. Lab tests were not performed. Subsequently, the pt recovered. "48 hours" was noted as the date of recovery. A product quality complaint was not involved. Additional information is not expected.
inappropriate schedule of vaccine; flu like symptoms; body aches / felt achy; painful to the touch; This case was reported by a other health professional via call center representative and described the occurrence of influenza-like symptoms in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 17th January 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 18th January 2019, 1 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced general body pain. On an unknown date, the patient experienced influenza-like symptoms, tenderness and incomplete course of vaccination. On an unknown date, the outcome of the influenza-like symptoms, general body pain and tenderness were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the influenza-like symptoms, general body pain and tenderness to be related to Shingrix.  Additional details were provided as follows: The caller was a pharmacy intern calling on behalf of a patient. The patient experienced flu like symptoms, body aches and her entire body was painful to the touch. These symptoms lasted for approximately 8 hours. The day after receiving the vaccine, the patient felt achy. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Patient was vaccinated 4/2007 for Zoster but developed herpes zoster rash in 9/2009.
swollen glands in her throat; dizzy/lightheaded; heart palpitations; inflammation on both sides of the back of her tongue; This is a spontaneous report from a contactable consumer (patient herself). A 40-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number ENG203) intramuscularly on 25Feb2021 (at the age of 40-year-old) at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient reported that the first day and a couple of days after (not clarified further) she had swollen glands in her throat, inflammation on both sides of the back of her tongue and lightheaded. These symptoms lasted a couple of days. The following week she was dizzy and had heart palpitations. She informed that "heart stops sometimes" (as reported) and she was experiencing that on and off. The caller was apprehensive about the second dose and wanted to know if her symptoms were an allergic reaction. The patient did her normal routine blood work with her doctor, unsure whether it was before or after the shot: it was normal. Tongue and throat were improving, reported to be resolved (not clarified further). Outcome of the other events was unknown.  No follow-up attempts are possible. No further information is expected.
Dizziness, weakness and fainting. Also experienced a high fever, chills, body aches, chest pains, and headache. I fainted at 9:30 a.m. on Friday, May 7, after walking into the kitchen to try to feed myself. I experienced all the symptoms, beginning at 2:30 a.m. on Friday, May 7, 16 hours after the second dose. The symptoms lasted until 8:00 a.m. on Saturday, May 8. I was not able to get back to the kitchen to feed myself or my dogs until 2:00 p.m. on Friday, May 7, as the nausea, weakness and dizziness were so severe. I was totally incapacitated. I have never been so sick in my entire life.
product=COVID 19 Treatment; product=COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 46 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Viral related asthma" (unspecified if ongoing); "chronic migraine" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "product=COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical course: Symptoms were nearly absent, only had some fatigue on day 10 with no sinus congestion. Woke up on Day 11 to severe Nasal congestion, sore throat, increased fatigue. No known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the given information , the possible contributory role of the suspect for the events drug ineffective and covid-19 cannot be excluded.
About 2 hours after receiving the vaccine, patient developed a "hive-live rash" per mom.  It is now 3 days later, and the rash persists.  It is itchy.  The rash is on the patient's chin, extremities, and abdomen.  No fever or other symptoms.
who presents with complaint of rash , itching minutes after COVID vaccine. Also notes nausea and fatigue. Pt notes no throat swelling , pain , voice change , shortness of breath , abdominal pain , vd or other concerns. Pt has known allergy to flu vaccine and other medications as noted
An area of erythema and edema that measured approximately 5x7 cm directly distal to the injection site.
Moderna COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Moderna Vaccine on 2/27/21, 3/27/21, 10/30/21. Presented to ED 1/30/22 c/o SOB, sent home with augmentin & doxycycline, Covid+. Contiuned to decline at home, admitted 2/2/22 to ICU for hypoxic respiratory failure with ARDS due to COVID PNA. Urology placed foley 2/5/22 2/2 penile urethral stricture required dilation over guidewire for placement. Overall mentation continued to decline w/increasing O2 requirements. Tx'd with dexamethasone, remdesivir, cefepime, vancomycin. Transitioned to comfort care/DNAR and expired 2/21/2022.
ED  Discharged  10/18/2021 (3 hours) ER Patient presents with ? Weakness - Generalized     HPI 71-year-old male with history of diabetes who presents ED for evaluation of recurrent falling.  Over the last couple days he has felt more fatigued with cough and warmth and chills.  He fell multiple times most recent being this morning, fell off the commode landed on his knees and his back.  Has an abrasion to his right posterior shoulder.  Did not strike his head.  No loss of conscious.  No neck pain.  No chest pain.  No abdominal pain.  No vomiting.  No diarrhea.  10/21/2021 COVID-19 virus infection    Dx Medication Infusion  Reason for Visit
DTaP/IPV/MMR/VARIVAX/FLUMIST given on 10/14. Fevers began 10/8, lasted 3-4 days associated with malaise and fatigue. No sick contacts, no URI/cough. Normal exam 10/15/14.
12/7/99:Pt. rcvd. pneumo & flu shot.Pt. complained of a burning sensation around a reddened area that is approx. 4 1/2" long and 1 1/2" wide.Pt. also complains of pain from her shoulder to her elbow on her right arm.
FLUBLOK administered to pediatric patients with no reported adverse event; Initial information received  on 27-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2022SA402510(CLUSTER), 2022SA402530(CLUSTER), 2022SA402436(CLUSTER), 2022SA402500(CLUSTER) and 2022SA402443(CLUSTER).  This case involves a 5 years pediatric male patient who administered vaccine Influenza Quadrivalent recombinant vaccine [Flublok] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included covid-19 vaccine and diphtheria vaccine toxoid, pertussis vaccine acellular 5-Component, Polio vaccine Inact 3V (MRC 5), tetanus vaccine toxoid (Quadracel).  On 12-Sep-2022, the patient received a 0.5 ml dose of suspect Influenza Quadrivalent recombinant vaccine (Frequency: once) (Strength: standard) (form was unknown) (lot number: UJ887AA) (expiry date: 09-Jun-2023) via intramuscular route in the left deltoid for Immunization.  On 12-SEP-2022 the pediatric male patient administered vaccine Influenza Quadrivalent recombinant vaccine [Flublok] with no reported adverse event (product administered to patient of inappropriate age) (Latency: same day).  It was reported Caller reported FLUBLOK administered to 15 pediatric patients and is requesting validity information.   Action: not applicable.  It was not reported if the patient received a corrective treatment  outcome : Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
Emergency Department visit on 09/22/23: related to fever, lethargy, rash on face/lower abdomen/ labia that started on 09/20/23.
About 2-2 1/2 weeks after immunization pt developed a few vesicular lesions. A few days before had fever. Late reg. signs/symptoms (wheezing) & was covered with lesions in first statges- macular & vesicular & crusted lesions.
This case was reported by a consumer and described the occurrence of erythematous rash in a adult patient who received SHINGRIX for prophylaxis. On 10th October 2018, the patient received SHINGRIX. In October 2018, less than a month after receiving SHINGRIX, the patient experienced erythematous rash, painful rash and pain burning. On an unknown date, the outcome of the erythematous rash, painful rash and pain burning were unknown. It was unknown if the reporter considered the erythematous rash, painful rash and pain burning to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccine the week before the reporting date and developed a rash under both the arms, it was red, burning, stinging and somewhat painful. The patient was wondering if this could be a side effect of the vaccine or something else and requested to advise if this was something that's needed to be shown to doctor or will it go on its own.
This case was reported by a consumer, the patient's mother, and described the occurrence of fever in a 2-month-old female subject who was vaccinated with Pediarix for prophylaxis.  A physician or other health care professional has not verified this report.  Concurrent medical conditions included healthy infant.  Previous and/or concurrent vaccination included HIB given on 19 December 2006; Prevnar, given on 19 December 2006.  There were no concurrent medications.  On 19 December 2006 the subject received 1st dose of Pediarix (.5 unknown, unknown).  On 19 December 2006, less than one day after vaccination with Pediarix, the subject experienced fever of 100.4 for 24 hours after the vaccination and injection site reaction.  An unspecified time after vaccination with Pediarix the subject experienced bilateral leg swelling with a "hard knot" that lasted for approximately four weeks.  The reporter did not know in which leg the subject received the vaccination.  She was treated with acetaminophen (Tylenol) for the fever.  At the time of reporting, the events were resolved.  According to the reporter, the physician had delayed the subject's next dose of Pediarix until the six month visit.
After dose one, my period arrived 8 days early; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 35 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Type 2 diabetic" (unspecified if ongoing); "Mild allergy to asparagus (facial hives)" (unspecified if ongoing), notes: facial hives. Concomitant medication(s) included: LANTUS; HUMALOG. The following information was reported: MENSTRUATION IRREGULAR (non-serious), outcome "unknown", described as "After dose one, my period arrived 8 days early".  Additional information: Patient did not take any other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Swollen right shoulder and right side of neck  after first vaccine; Sore right shoulder and right side of neck  after first vaccine; Sore right shoulder and right side of neck  after first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swollen right shoulder and right side of neck  after first vaccine), NECK PAIN (Sore right shoulder and right side of neck  after first vaccine) and ARTHRALGIA (Sore right shoulder and right side of neck  after first vaccine) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jul-2021, the patient experienced SWELLING (Swollen right shoulder and right side of neck  after first vaccine), NECK PAIN (Sore right shoulder and right side of neck  after first vaccine) and ARTHRALGIA (Sore right shoulder and right side of neck  after first vaccine). On 13-Jul-2021, SWELLING (Swollen right shoulder and right side of neck  after first vaccine), NECK PAIN (Sore right shoulder and right side of neck  after first vaccine) and ARTHRALGIA (Sore right shoulder and right side of neck  after first vaccine) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient got the first dose of the vaccine on the right shoulder.  Patient visited her doctor and blood works were done. The doctor told her that what she had was not an allergic reaction, and recommended to receive the second vaccine.  No concomitant medication information provided.  No treatment medication information provided.   This case was linked to MOD-2021-396388 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Dec-2021: Follow-up received on 19-Dec-2021 contains Non significant information: Patient demographic details added, On 19-Dec-2021: Follow-up received. New reporter information added.
(R) thigh bruising and mild erythema. Treating with Augmentin 400mg 3/4 tsp BID.
I experienced dizziness, blood pressure 130/80, nausea, migraine, difficulty breathing, and tightness in my chest.
Pt reported within 10  minutes of recieving vaccine that their throat felt a little tight and asked for some water. Asked patient to stay and gave them 50mg diphenydramine. Patient stayed and was observed for 40 more minutes and stated they weren't any worse  or better but tired and wanted to go home. Called patient about 2 hours later and they stated they were okay but still a bit swollen. He put ice packs on for 20 minutes and it went down. Called patient 2 hours after that and they stated their symptoms completely resolved. He also stated that he works with various viruses at work.
pt. returned back to vaccination site; c/o difficult swallowing and a headache.  care immediately transferred to medics on site; vitals stable.  pt. reported improvement prior to leaving.
Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized for shortness of breath and chest pain. Vaccination took place on 10/22/2007 and hospital admission was on 2/25/2008. According to the physician, relationship to treatment is 'None'. We would be happy to forward the Study's SAE Report Form upon request.
while driving home after receiving 2nd COVID-19 vaccination experienced palpitations & dizziness so proceeded to an ED. He has a history of supraventricular tachycardia (SVT). hypertensive & lab work within normal limits. Given adenosine with conversion and improved BP. Observed and then discharged to home.