chrisvoncsefalvay/vaers-outcomes huggingface dataset:
medication error occurred due to vaccine being administered to the wrong patient; increased sleep; decreased crying; irritability; Decreased PO intake; Initial information received on 01-Dec-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves a 2 months old female patient who reported medication error occurred due to vaccine being administered to the wrong patient, increased sleep, decreased crying, irritability and decreased po intake after receiving  INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for Prophylactic vaccination; DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL) for Prophylactic vaccination; and PARACETAMOL (TYLENOL).  On an unknown date, the patient received unknown  dose of suspect INFLUENZA QUADRIVAL A-B VACCINE ( with unknown strength, form, route, batch number and expiry date ) at  unknown administration site for Immunization.  On 29-NOV-2022 the patient had  non-serious events of medication error occurred due to vaccine being administered to the wrong patient (wrong patient received product) , increased sleep (hypersomnia),  decreased crying (emotional poverty) ,  irritability  and  decreased po intake (hypophagia) .  Action taken : not applicable.  It was not reported if the patient received a corrective treatment for the events (medication error occurred due to vaccine being administered to the wrong patient, increased sleep, decreased crying, irritability, Decreased PO intake).  Outcome : Unknown for all events.   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.
Shingles rash began less than 24 hours after vaccine. Area was (L) upper chest, (L) shoulder, (L) scapular area and (L) neck. Very painful. It has taken 1 month for rash to subside. Area is still painful.
About 10:30 today, Meredith's teacher noticed she was breathing heavily after a trip to the restroom. She was taken to the school clinic with a seat heart ate of around 110.  She was seen by her pediatrician and came home.  She slept much of the day with her heart rate while laying down reaching up to 136.  She reports feeling hot at times, but does not have a fever.  She also is very thirsty.
On 04Feb, was at work and was rushed to the emergency room having suffered a seizure / I experienced a 2nd seizure on 16Jul; skin peeling at the injection site and on lower part of the arm and several fingers; skin peeling at the injection site and on lower part of the arm and several fingers; Continued to feel extreme burning sensations at these skin peeling sites; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2022 at 10:00 as dose 2, single (Lot number: Fl3209) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; AMLODIPINE. Past drug history included: Clindomycin, reaction(s): "Known allergies: clindomycin". Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. FC3180, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM), administration date: 28Aug2021, when the patient was 50-year-old, for COVID-19 Immunization. The following information was reported: SKIN BURNING SENSATION (non-serious) with onset 23Jan2022 at 10:00, outcome "recovered with sequelae", described as "Continued to feel extreme burning sensations at these skin peeling sites"; VACCINATION SITE EXFOLIATION (non-serious), SKIN EXFOLIATION (non-serious) all with onset 23Jan2022 at 10:00, outcome "recovered with sequelae" and all described as "skin peeling at the injection site and on lower part of the arm and several fingers"; SEIZURE (medically significant) with onset 04Feb2022, outcome "recovered with sequelae", described as "On 04Feb, was at work and was rushed to the emergency room having suffered a seizure / I experienced a 2nd seizure on 16Jul". The events "on 04feb, was at work and was rushed to the emergency room having suffered a seizure / i experienced a 2nd seizure on 16jul", "skin peeling at the injection site and on lower part of the arm and several fingers" and "continued to feel extreme burning sensations at these skin peeling sites" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Sep2022) Negative, notes: Nasal Swab. Therapeutic measures were taken as a result of seizure, vaccination site exfoliation, skin exfoliation, skin burning sensation including painkillers and ointment. Clinical course: After taking 2nd dose on 22Jan2022, the patient went to the emergency room the next day (23Jan2022), with skin peeling at the injection site and on lower part of the arm and several fingers. Continued to feel extreme burning sensations at these skin peeling sites. On 04Feb2022, the patient was at work and was rushed to the emergency room having suffered a seizure. First one she ever had. The patient experienced a 2nd seizure on 16Jul2022. The patient has no covid prior to vaccination.
Initial and follow-up information has been received from a nurse practitioner concerning a 12 month old male patient who on 28-DEC-2006 was vaccinated intramuscularly into the right thigh with a 0.5 mL dose of Pneumovax 23.  No problems have been reported.  In follow-up it was reported, that the patient should have been given the 4th series vaccine of PREVNAR but was mistakenly given Pneumovax 23.  The patient did not experience any adverse event and was doing fine to date.  The vaccines were stored next to each other in the refrigerator and the wrong vaccine was picked out.  The nurse practitioner stated that since this episode occurred the Pneumovax 23 and the PREVNAR have been moved/separated, so this mix up doesn't occur again.  Additional information has been requested.
Information hsa been recieved from a registered nurse concerning an 81 year old male with high blood pressure, type II diabetes mellitus, hypothyroidism, chronic renal failure and osteoarthritis who on 10/12/04 was vaccinated in the left arm with a second dose of pneumococcal 23v polysaccharide vaccine (lot # 647359/0740N). On 10/12/04, the patient was concomitantly vaccinated with a dose of influenza virus split virion 3v vaccine inactivated in the right arm. COncomitant therapy included terazosin hydrochloride, benazepril HCl, amlodipine besylate, iron, levothyroxoine Na, atorvastatin calcium, torsemide, warfarin sodium, allopurinol, acetaminophen (+) propoxyphen napsylate, pantoprazole sodium, folic acid, vitamin E, xanthophyll, epipen shots, and pyenogenol. Less than 24 hours later, on 10/13/04, the patient's left arm from his armpit to his elbow became red, hot, tender, and patchy/blotchy cellulitis like. The nurse confirmed that the reaction was not true cellulitis, and that all symptoms were considered injection site reactions. He also had chills and fever. Unspecified medical attention was sought. The patient was treated with an unspecified antibiotic and ice packs. It was reported that the patient's first vaccination was approximately 10 years ago. At the time of this report, the patient had not recovered. The nurse reported that the patient was scheduled for a follow up re-evaluation on 10/20/04. The patient's fever, chills, and injection site erythema, warmth, pain and blotchy/cellulitis like reaction, not cellulitis were considered other medical events (OMIC). Additional information has been requested.
01/14/22 presents to ED for "increased leg swelling and shortness of breath". PMHx of "hypertension, diabetes, heart disease, congestive heart failure"
developed sores in his mouth a few days later - Had note from CNP stating he should not receive varicella vaccine due to having a case of shingles in past. Note was presented after child's appointment.
Hospitalized for syncope, shortness of breath, fatigue and diarrhea.  On 2 L of nasal oxygen.
had some soreness for 3-4 days noc p/the vax;7JUN98 (p/about 2-3hr drive noticed) tightness & numbness & dull ache in upper arm where vax given;also feels a small knot in area; until 19JUN;
About 8 days after the shot I started to experience itching at the injection site and had a large red spot around the shot area.  It is still itching a lot.
One week after shot, both hands became very painful and numb, which began to travel up my arms and into my feet. I have lost coordination and legs and arms have gone weak. I am having brain fog, difficulty walking and managing my life, and difficulty with my fine motor skills.
mom states pt woke up w/hives on 1JUL98;advised pt bring pt to MD office;pt currently on med for hives;
Client denying pregnancy at time of vaccination discovered she was pregnant 10 days later.  Client notified of the obstetrical risks placed on varicella in pregnancy registry.  Client has follow-up maternity appointment with the gynecologist.
3 days after my first vaccine my tongue started to feel like it was burnt. The Sunday after my first vaccination I woke up with the right side of my face was numb and not functioning.
This was a booster after a J&J first dose in March.   I had what looked like strawberry tongue?  The edges of my tongue very suddenly went numb and were covered with small very painful bumps (blisters?  swollen taste buds?  no idea...), my tongue looked gray, and I felt like I was having a little bit of trouble breathing because my mouth and throat felt swollen, but they didn't look swollen other than the bumps.  I also started getting feverish.  I drank a lot of water and went to sleep and felt fine by morning other than fatigue and a bit of RA joint pain.
This spontaneous report as received from a healthcare worker (medical assistant) refers to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates, since 24-SEP-2015, the patients were vaccinated with doses of VARIVAX (Merck) lot # K018961, expiry date: 15-OCT-2016 and lot # L013068, expiry date: 14-APR2017 (strength, dose and route of administration were not reported), which had been exposed to temperatures outside of the recommended range. No adverse events were reported. Additional information has been requested.
74 year old female She was Admitted to ICU for DM II, Hyperglycemia, Nausea, Vomiting, Altered Mental Status, UTI, Leukocytosis, Dehydration, Epilepsy, Hypernatremia, Hyperosmolality, and Hypertension. I was Consulted by Dr. for Medical Management. Unable to get any history from the patient. She is confused. Patient was sent to the emergency room for abnormal labs. Patient was found to be severely hypernatremic sodium was 162. CT of the brain was negative for acute stroke. Patient was started on IV fluids nephrology id as well as Nephrology were consulted patient was admitted to ICU for further workup. Patient was also started on Glucommander. First vaccine given 1/6/2021
Pain and swelling at vaccine site, redness 1 and 1/2 inches in diameter, headache day after vaccine, itching on day of vaccine
Dizziness, numbness in left arm, heart palpitations, nausea, blurred vision. Began within the hour of the dose. Dizziness, arm numbness, blurred vision lasted less than 24 hours. Heart palpitations lasted 3 days.   Breastfed twins also fussy, irritable, trouble sleeping, smaller appetites for three days.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 21-Jul-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not reported.    This case was linked to MOD-2021-363766 (Patient Link).
This spontaneous report as received from a physician assistant refers to her son(age not reported). On 07-JUL-2011 the patient was vaccinated with GARDASIL for vaccination. It was reported that the patient might have received two doses of GARDASIL that were expired (lot# and expiration dates were unspecified, dates expired GARDASIL was administered was unspecified). No adverse event reported. Additional information is not expected.
Bloody stools 24 hours after vaccine, otherwise well. Resolved with removal of milk protein. Stool studios (culture, cdiff, Rotazyme) all negative. Symptoms resolved.
Nausea, vomiting, fever 100.3, pounding headache, weakness, chills
Initially, rash on abdomen noticed. Today, generalized macular erythematous patches seen over the trunk and forearms, 2-3 cm in size, profuse over the abdomen.
SEVERAL MINUTES AFTER GETTING THE VACCINE THE PATIENT FAINTED AND SEEMED TO BE HAVING A SEIZURE. THIS HAPPENED 4 TIMES AND EACH EPISODE LASTED ABOUT 10 SECONDS. AMBULANCE CAME RIGHT AWAY. PT HAD SEVERLY LOW BLOOD PRESSURE, SWEATING, NAUSEA. MOM CAME AND PICKED UP PATIENT, HE REFUSED TO GO TO HOSPITAL.
Pt presented about 2 months following vaccine stating she started feeling internal pain in her (L) upper arm around the site of injection about a week for following the shot and it still continues regularly when she raises her arm. Pt is going to f/u w/PCP the week of 11/20/11.
Patient experienced loss of voice, and a red, swollen, tender 5cm area at the injection site.
headache, left arm quite sore, nausea on-going.  took 2 tylenol and drinking some sprite
DEVELOPED FEVER,MYALGIAS- RESOLVED AFTER 4 DAYS- TOOK PAXLOVID
Hives/Rash, so far 4x's. Dr.  is prescribing a steroid medication trying to stop the re-occurrence.
Swelling, fever, chills, vomiting, diarrhea 2 days-3days post.  site infected per ER MD- got antibiotics
High blood pressure readings; This is a spontaneous report from a non-contactable consumer Pfizer-sponsored program Support. A male patient of an unspecified age received second dose of BNT162B2 (COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date (Lot number and expiry date was not reported) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took BNT162B2 for Covid-19 immunization. Caller had his second shot and since had high blood pressure readings. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I had a stronger reaction to the vaccine than my mom or husband who also got Moderna at the same location and time as me. I started to feel sick a few hours later. I ended up being sick for about 4-5 days. I was on a rollercoaster of getting a fever, sweating it out, and then getting another for at least 2 days straight. What concerns me, however, is that I had what I am assuming is a neurological reaction to the vaccine. I could feel jolts in my brain and throughout my body. It felt like I had electricity in my teeth. Those symptoms went away after maybe the 3rd day.
Information has been received from a nurse concerning an approximately 16 weeks old patient who on 18-JAN-2011, 01-FEB-2011 and 24-MAR-2011 was vaccinated PO with the first, second and third dose of ROTATEQ (lot # and expiration date: the first dose 668359/0987Z, 06-MAY-2012; the second dose 668967/1201Z, 12-AUG-2012; the third dose 668824/2528Z, 08-JUL-2012), respectively. No adverse effect was reported. Additional information has been requested.
after 2 hours of receiving the shot, I developed hives all over my body, itching on the inside of my body it felt like...including my mouth, and rashes.  I immediately called the pharmacist and he said to take 2 Benadryl which helped to subside the symptoms. 3 days later I was also sent to the ER for rapid heart rate in the 140s, shortness of breath, and palpitations, irregular to my health.
internal itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (internal itching) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (internal itching). At the time of the report, PRURITUS (internal itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information was provided.
Site: Pain at Injection Site-Severe, Systemic: Abdominal Pain-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Diarrhea-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Severe, Systemic:  throat felt dry and scratchy -Severe, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Joint Pain-Severe, Systemic: Nausea-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Unable to Sleep-Severe, Systemic: Weakness-Severe, Additional Details: pt received 2nd dose on 5/2/21 at pharmacy (did not get first dose here). pt had severe pain in right arm, numbness and tingling in hand, severe pain from wrist to upper shoulder to neck. pt had weakness as well and couldnt move arm. pt did see her pcp today. he diagnosied her with brachial neuritis which he states is a direct adverse reaction from vaccine. he did confirm not an administration error.
Patient received two of the same vaccine - Pfizer dose 3 (booster). Patient intended to receive one COVID booster and one influenza vaccine, but after getting the first vaccine he sat down at another COVID vaccine table instead of the influenza table.
pt recv vax; exp lymphadenopathy, bruised easily, & had a fever & arthralgia;
Fever of 103.2, vomiting, irritability, swelling to L) leg, unconsolable crying.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Jul2022 at 13:00 as dose number unknown, single (Lot number: 077b22a) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Minor heart valve regurgitation" (unspecified if ongoing); "Known allergies" (unspecified if ongoing), notes: Known allergies: Yes. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Dec2022) Positive, notes: Tested positive 3 days after finishing the Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid.  Clinical Course: Patient had known allergies. The patient not received other medication in 2weeks. Received COVID 19 Treatment with Paxlovid (Lot number 1919256A) treatment start date on 21Dec2022 and stop date on 26Dec2022.
HYPOTENSION 1/21/2023 --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
PT Covid + last wed. C/o increased sob and low O2 sat at home. 87 on room air.   HISTORY OF PRESENT ILLNESS:     Patient is a 51-year-old female with no significant past medical history presents emergency room with complaints of hypoxia and shortness of breath.  Patient reports she tested positive for Covid last Wednesday.  States over the past 3 days she has been having worsening shortness of breath.  States she is been monitoring her oxygen at home and this morning her oxygen dropped down to 85%.  Patient reports she has been vaccinated.  Has not been taking anything for the symptoms.  States she has been having fevers, last dose of Tylenol was yesterday.  Denies any chest pain, nausea, vomiting, diarrhea, weakness
Pharmacist on duty incorrectly mixed 3.6ml of Sodium Chloride with the vaccine instead of 1.8ml. Patient was contacted, and no adverse reactions were reported.
Awakened at about 5 am , approximately 18 hours after the injection. Got  out of bed to go to the bathroom   and passed out.  I am not sure how long I was unconscious,. but when I came to I was on the floor and unable to move.  I called out to my husband and he got me up, but I could not walk. He got me back into bed. Several hours later he assisted me in walking  and I am walking ok now.
(2) syncope events, severe migraine, loss of vision, loss of feeling in all extremities (legs/feet, hands), throat swelling, and excessive sweating, dizziness, incoherency
Death; This is a spontaneous report from a non-contactable consumer. This is one of 5 reports      A patient of unspecified age and gender received bnt162b2 (BNT162B2) dose number unknown, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation  .  The patient medical history and concomitant medications were not reported.  The patient died on an unknown date from an unknown cause.    It was not reported if an autopsy was performed. The reporter stated that the vaccine was kept in ice box for like 5 hours.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100944572 same reporter/drug/event, different patient; Reported Cause(s) of Death: Death