chrisvoncsefalvay/vaers-outcomes huggingface dataset:
nurse administered PENTACEL to a patient without mixing the powder form (HIB) with no adverse event; Initial information received on 22-Nov-2021 regarding an unsolicited valid non-serious case from nurse and physician via The Regulatory Authority (under reference 00867952).  This case is linked to case 2021SA393946 (Cluster).  This case involves a 2 months old female patient who received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] without mixing the powder form (hib) [product preparation issue].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE LIVE ORAL 1V (ROTARIX), HEPATITIS B VACCINE and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVENAR 13) [lot number and expiration date were not reported] via unknown route in an unknown administration site for Prophylactic vaccination.  On 19-Nov-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (TOTAL, lot UJ504AAA and expiration date: 29-May-2022) via intramuscular route in the right thigh for prophylactic vaccination.  It was a case of an actual medication error due to Inappropriate reconstitution technique (same day latency).  It was reported "The caller stated that a nurse administered PENTACEL to a patient without mixing the powder form (HIB). The caller would like to know how to care for the patient. The caller stated that she was reading online that Sanofi will send them a diluent to mix with the other portion to administer to the patient."  At time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.
Vomited after 2nd dose; This spontaneous case was reported by a patient and describes the occurrence of VOMITING (Vomited after 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VOMITING (Vomited after 2nd dose). At the time of the report, VOMITING (Vomited after 2nd dose) outcome was unknown.            Concomitant medications were not reported. Treatment medications were not reported.   This case was linked to MOD-2022-529319, MOD-2022-528692 (Patient Link).   Reporter did not allow further contact
Nausea, achy, chills, fever, headache, tiredness  All lasted approximately 24 hours
Information has been received from a licensed vocational nurse concerning a 13 month old female with no known history and allergies who on 20-Jul-2006 was vaccinated with SQ with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live (lot#654042/0663F).  There was no concomitant medication.  The patient was seen in the office on 02 Aug 2006 with fever and maculopapular rash on trunk and hands.  She was seen again on 08-Aug-2006 with itching, urticaria and a lesion under her eye.  The patient was treated with diphenhydramine hcl (BENADRYL), CETAPHIL CREAM, and hydrocortisone cream 2.5%.  The patient's fever, maculopapular rash, itching, urticaria and lesion under eye persisted.  Additional information has been requested.
Pt returned to clinic on Oct 2nd complaining of a severe headache ever since the day after receiving the influenza vaccine-no previous headaches except in puberty.
presented to the ED with numbness and tingling in the toes on the plantar aspect for the past 4 days. Today the tingling extended to the back of the knees. The tingling is constant and without any pain. No back pain that radiates down in the legs. No problems with walking or gait. No weakness in the lower limbs. Denies any headache, vision changes, speech difficulties. the patient recently returned from Thaiti after a 1 month trip. She did receive hep A, B and typhoid vaccine before her trips. Never had any reactions to any immunizations in the past. Had some diarrhea on her return and now it is improving. No fever or chills. Has been having some achiness in the hips and the wrists. No insect bite. No new medications. Has been trying new foods in Thaiti.  11/13/09 Hospital records, discharge records received, service dates 10/28/09 to 10/29/09. Assessment: Mild distal sensory polyneuropathy with diminished sensation to light touch, temperature and vibration, both feet. History of foreign travel - rule out B12 deficiency, rule out neurotoxicity. Patient presents with 4 day hx of neuropathy. Numbness started in toes and is progressing up legs to calf. Sensation slightly deminished to light touch and temperature noth feet. Recent travel to Haiti. Taking Chloroquin. Diarrhea since returning from Haiti, took Cipro. Dizzy. Achiness in hips and wrist.
Patient passed out after receiving her first dose of Pfizer. Total time passed out (sitting in chair) was about 30 seconds. During that time 911 was called and patient's pulse was checked. After a pulse was found, the patient came to and was able to stand on her own. We took her to the immunization room where patient was monitored until EMS arrived. Patient threw up while waiting. Patient was able to leave on their own without being taken to hospital. Patient had marked on VAR form that they had been dizzy with other immunizations, so we encouraged them to stay for the full 15-20 minutes.
COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient received BNT162b2 (BNT162B2), on 09Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 59 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 was not reported. No known allergies. Concomitant medication(s) included: SYNTHROID; OZEMPIC. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Positive antigen test on day 3 after initial negative test (day 10 of first having symptoms); negative, notes: Positive antigen test on day 3 after initial negative test (day 10 of first having symptoms). The patient received Paxlovid as treatment of COVID-19 from 23Jun2022 to 27Jun2022. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Soreness at the site (expected). chills and fever the following day but then fine. 5 days post injections, have a large circular, red, itchy rash on upper arm near injection site. Arm still sore and now itchy and rashy.
Dose 3 of the series was administered in less than the minimum interval of 16 weeks from dose 1 to dose 3. It was administered at 13 weeks from dose 1. The administration error was discovered upon entering the vaccine into the Immunization Information System which flagged the dose as invalid. The patient was informed of the error and agreed to return for a valid dose.
Administered MMR 5/10/2007, Had painful gland swelling began on 5/17, right posterior auricular adenopathy, R wrist swelling and warmth. LFT's mildly abnormal with ALT of 83, AST of 530
Bell's Palsy type of reaction, sagging on left side of face primarily at the chin line.  some puffyness. Tingling sensation from chin to temple.  Tightness around the face.   Blood pressure elevated.  No adverse effects prior to this.  Have read that others having this reaction have had facial injections of Botox or fillers.  I have never had this.  No treatment was given.  I used a warm compress and exercised my muscles by trying to whistle.  Facial symptoms went away in 48-72 hours.  Still working on the blood pressure.
Immediately after adm injection of HPV child fainted. Child did not respond for seconds, his face was pale; BP 109/68; P 70. Observed pt and child was able to respond to questions. Oriented to person and place.
Horrible Hives, all over body, papoulas of hives large areas all cluttering together, headache, fever, extreme fatigue, 5 to 6 days after the second dose of the Pfizer vaccine. The first dose gave only an itchy redness patch around vaccine site about 10 days after vaccine. Second dose gave me these horrible Hives all over body now like chronic not curing today with antihistamine.  I'm very scared this could turn to be chronic as its not going away. This is giving me terrible anxiety and depression. I will NEVER take this vaccine again!
Pr had a generalized rash over the trunk of the body, pink, pinpoint macules with no crusting or drainage. Afebrile. Resolved <4 days.
Weakness (whole body), Voice changing,  Sleeplessness, Rib cage hurts since 4/11/2021
Racing heart, tightness in chest, increase blood pressure: began after 18 hours still happening today but not as severe aches :began after 28 hours still happening but lesser degree fever up to 102 began after 24 hours finally broke after 48 hours Insomnia at night from aches and rapid heart.  Hard to get comfortable from leg and hip aches. began first night and each night since.
Information has been received from a other health professional referring to a patient of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On 20-APR-2016 the patient was vaccinated with the first dose of  (Merck) VARIVAX (lot# L026405, expiration date 15-JUL-2017, dose and route unknown). The vaccine was improperly stored under 11 F for 4.5 hours without previous excursion. No adverse effects reported. The call was because of a data logger. Additional information has been requested.
89 yo female received J&J COVID-19 vaccination on 3/9/21. Patient with history of SMA thrombosis presenting with 1 month history of abdominal pain, nausea, and vomiting, found to have SMA stent thrombosis.  Stopped antiplatelet therapy several months prior to admission without consulting vascular team. Admitted and stable on heparin drip. GI was consulted, as her symptoms are not a classic presentation of mesenteric ischemia.  On 4/21 she underwent EGD. EGD was read as normal stomach and duodenum, Schatzki ring (widely patent) and regular Z-line. After this patient was able to resume PO intake in increasing volumes without nausea, vomiting or abdominal pain. Pt discharged on 4/23 with prescription for apixaban.
Narrative:  PATIENT REPORTS VERTIGO X 2 WEEKS - STILL OCCURING
Patient was administered Moderna Covid-19 vaccine, given a bottle of water, and asked to sit in the observation area for 15 minutes. Approximately 4-5 minutes later, the patient was observed to be slumping in the chair, and fell to the floor. It was not clear whether he hit his head. The patient was incoherent, and was asked to lie on his back. He tried to get up, and was positioned to a sitting position on the floor.  called 911, and conveyed all necessary info. A paramedic who happened to be shopping in the store intervened and tried to make an assessment of the patient. He asked several questions to determine patient awareness,(year, date, president). When Fire & Rescue arrived, they performed a general assessment including cardiac monitoring. After roughly 15 minutes, the patient appeared to have regained his faculties. Although it was strongly suggested that he be transported to the hospital for further observation, the patient declined, and left the store of his own accord with his mother.
Patient given immunizations-about 2-5 min afterwards slumped in chair arms and head began to twitch.  Upon touching arm calling name child-said what, assisted to chair vitals stable BP102/80-no knowledge of event.  Kept in office for
I had  sore throat, cough, chills. I used the at home COVID-19 test that came back positive. After it came back positive, I called my doctor and he prescribed Paxlovid. In a day or two I was still tired but the chills did go away, the cough went away and my sore throat subsided. I do feel much better now.
Pain in arm where shot was given, worsening a week later, upper arm is swollen and hot, shooting pains over 24 hours
Pfizer 5/17/21 lot# EM9810;  Pfizer 6/8/21 lot# EN6202
(17x14cm) injection site and surrounding area became pink, warm, swollen and tender.  Discomfort extended beyond the site (left triceps) down the lateral left arm to just above the wrist.
Sore shoulder at site of injection; This is a spontaneous report from a contactable consumer. A non-pregnant female patient of unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via an unspecified route of administration in the left arm on 22Mar2021 at 17:30, as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Mar2021, the patient experienced sore shoulder at site of injection. The patient did not receive any treatment for the adverse event. The adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not received any treatment for events. The clinical outcome of sore shoulder at site of injection was unknown at the time of reporting. No follow-up attempts are needed. No further information is expected.
Patient developed a painful, red, warm, hard, and sharply circumscribed patch below the injection site (not at the injection site) next day after the vaccination. She was seen by her dermatologist 3 days after (9/19/19) - it was felt it is cellulitis vs injection site rxn vs reactive skin eruption. She was treated empirically for cellulitis with  cephalexin 500 mg PO tid x 10 days. The red area started to get better within hours after the 1st dose of antibiotics, and resolved on 9/23/19.
Arm hurt/back of left arm where got the shot of first vaccine; Lethargic/first vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 25Mar2021, outcome "recovered" (Mar2021), described as "Arm hurt/back of left arm where got the shot of first vaccine"; LETHARGY (non-serious) with onset 25Mar2021, outcome "recovered" (2021), described as "Lethargic/first vaccine".  Additional information: The reporter stated that his left arm, where he got the shot, on the second day hurt(25Mar2021), also mentioned that he had pain in his arm after the first vaccine, but that was to be expected. He was lethargic after both vaccines, under his left elbow, there was a sharp pain for 5 days, that was not killing him, but was persistent, still present and not going away. He stated that everyone told him that his arm was uncomfortable, and felt off for a couple of days, after the vaccine. Everyone he knows, his age or older, said the same thing. No further details were provided by him. The patient history and other product information was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
A non-serious, spontaneous report of gave expired FLUMIST in a four-year-old male patient was received from a nurse practitioner. The patient's medical history included constipation and ear infections. Concomitant medications included: taking MIRALAX one daily for constipation; coadministration of three other vaccines with FLUMIST (DTAP, POLIO, MMR/Chicken Pox). On 11-Feb-2009, the patient received expired FLUMIST. The office called the parent and explained that the child may not be fully protected; however, the parents decided not to return to the office for re-dosing. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. This is in follow-up to report(s) previously submitted on 02/11/09. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 04/09/2009: Product Complaint Investigation results. 03/12/09 On 12 Mar 2009, the nurse practitioner confirmed that no adverse event occurred. Additional information received on 12-Mar-2009 and added to the narrative. No adverse event occurred.
4 incidents of light headedness, almost dissociative in nature accompanied by ?seeing 3 figures.? This occurred for each incident. Once in the morning, 2 mid day and one at night.
11:20 AM 3-6-14 I gave the immunizations listed below at approximately 11:20 then wrote down the lot numbers on paper so I could then enter in computer immediately after that (4 min later) mom said both legs red - nurse practitioner immediately examined him then doctor examined him, he also had multiple red blotches arm, legs, chest, back which all faded away.
Information as received on 16DEC2014 from a pharmacist regarding herself. The pharmacist (who was pregnant at the time- gestation unknown) reported that while preparing ZOSTAVAX on 15DEC2014 for administration to an unspecified patient, a drop of the vaccine fell onto her own hand. It was unspecified whether the unspecified patient received less than a full dose due to the pharmacist's exposure. No adverse effect was reported for the pharmacist's exposure or the unspecified patient. The pharmacist does not want to be contacted for follow-up. No further information was provided. No further information is expected. This is a corrected report. The term of "Exposure during pregnancy" was added to the case.
given an extra dose of Menquadfi to a patient with no reported adverse event; Initial information was received on 03-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 16 years old female patient who received an extra dose of meningococcal a-c-y-w135 (t conj) vaccine [Menquadfi] to a patient 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 meningococcal vaccine b rfhbp/nada/nhba omv (Bexsero) for Prophylactic vaccination (immunisation).  On 02-Aug-2023, the patient received an extra dose of dose 3 suspect meningococcal a-c-y-w135 (t conj) vaccine Solution for injection (strength: standard) at dose of 0.5 ml (lot number: U7616AA, expiration date: 11-Apr-2025) via intramuscular route in the left deltoid for Immunization (immunisation) with no reported adverse event (extra dose administered) (latency: same day).  No lab data reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event given an extra dose of menquadfi to a patient with no reported adverse event.  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 guidelines. 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.
Patient complained of immediate pain in right arm after flu shot. No numbness or tingling. Range of motion of right arm was limited due to pain, however, she now has almost full range of motion without pain most afternoons. She still complains of intermittent swelling and pain in morning; relieved by rubbing arm, Ibuprofen, and ROM exercises.
periorbital edema;mild transient dyspnea;rash on forehead spreading down neck;generalized pruritus;lightheadedness;diarrhea;saw PMD given kenalog & claritin;
I have a Mirena IUD and I started my period (for the first time since I got my IUD) 3 days after I received the vaccine.
DIZZINESS; EAR POPPING SENSATION WITH SWALLOWING; FEELING SLEEPY; VERTIGO; LEFT ARM PAIN; CHILLS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.     No concomitant medications were reported. On 15-MAR-2021, the subject experienced chills. On 15-MAR-2021, the subject experienced left arm pain. On 17-MAR-2021, the subject experienced dizziness. On 17-MAR-2021, the subject experienced ear popping sensation with swallowing. On 17-MAR-2021, the subject experienced feeling sleepy. On 17-MAR-2021, the subject experienced vertigo. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the left arm pain, dizziness, ear popping sensation with swallowing, feeling sleepy, chills and vertigo was not reported. This report was non-serious.
We received on 14 NOV 2007 via regulatory authority from a consumer the following information: A 67-year-old male patient with known coronary artery bypass graft in 2006, born on 29 OCT 1940, was vaccinated i.m. with 0.5 ml Fluvirin (batch no. unknown) on 04 NOV 2007. The patient experienced 45 minutes later increased heart rate and increased blood pressure (170 mmHg). The patient was hospitalised on 04 NOV 2007. The outcome is unknown Company assessment: Seriousness criterion: hospitalisation. Causality: not related. There is no association between Fluvirin vaccination and increased heart rate and blood pressure. It must be seen in connection with her cardiac disease. Expectedness assessment according to regulatory authority and product information: The described symptoms are unexpected after vaccination with Fluvirin. No change in benefit-risk-ratio. No measures necessary. Regulatory authority no.: NA07-006431
Vaccines given 6/18/03, that night temp up to 101, miserable, congested. Mother/father thought they saw some left-sided facial paralysis too. At 6/19/03 appt. MD states exam WNL. Mother questioned if at times still facial symptoms. Scheduled to see neuro.
S/S STARTED AFTER ABOUT 3-4 HOURS AND LASTED 24 HOURS.  FEVER OF ABOUT 100 DEGREES, JOINT PAIN AND STIFFNESS