chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lightheaded; dizzy; heart palpitations; shaking; headache; unable to take deep breaths; This is a spontaneous report from a contactable consumer or other non hcp. A 58-years-old non -pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6199), via an unspecified route of administration, administered in arm left on 06Mar2021 16:45 as 1st dose, single dose for COVID-19 immunization. Medical history included crohn's disease and known allergies Sulfa from an unknown date and unknown if ongoing. Concomitant medications included multivitamin, ergocalciferol (VIT D), curcuma longa (TURMERIC (CURCUMA LONGA), camphor, cymbopogon schoenanthus oil, menthol, panax pseudoginseng, zingiber officinale oil (GINGER CITRONELLA) , ascorbic acid (VIT C) , ibuprofen (ADVIL), paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. The patient was not had Covid prior vaccination, and the test was not performed post vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced lightheaded, dizzy, heart palpitations, shaking, headache, unable to take deep breaths on 06Mar2021 16:45. Treatment was not received for the events. The outcome of the events was reported as recovered on an unspecified date in 2021.  No follow-up attempts are Possible. No further information is expected.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a female patient who received FLUARIX QUADRIVALENT (batch number 5GC54, expiry date 21st May 2018). Previously administered products included Influenza vaccine (received on an unknown date and had no reaction with flu vaccines). On an unknown date, the patient received FLUARIX QUADRIVALENT. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT, the patient experienced injection site erythema, injection site induration, injection site itching and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site induration, injection site itching and injection site swelling were unknown. It was unknown if the reporter considered the injection site erythema, injection site induration, injection site itching and injection site swelling to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced red, hard, swollen and very itchy area, about 3 inches in diameter around the injection site. This case was linked to case US2017GSK152158, as reported by same reporter.
4 weeks to the day after I got the second shot, my left arm got very sore at the injunction site and I got a horrible metallic taste in my mouth.  That was yesterday.  Both are still there today.; 4 weeks to the day after I got the second shot, my left arm got very sore at the injunction site and I got a horrible metallic taste in my mouth.  That was yesterday.  Both are still there today.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14May2021 12:30 (Lot number: EW0175) at the age of 50 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZYRTEC-D taken for hypersensitivity. Vaccination history included: Bnt162b2 (lot number ER8736, lot unknown False,  administration time 12:30 PM, dose number 1, vaccine location Left arm.), administration date: 22Apr2021, when the patient was 50 years old, for Covid-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), DYSGEUSIA (non-serious) all with onset 14Jun2021 09:30, outcome "not recovered" and all described as "4 weeks to the day after I got the second shot, my left arm got very sore at the injunction site and I got a horrible metallic taste in my mouth.  That was yesterday.  Both are still there today.". Therapeutic measures were not taken as a result of vaccination site pain, dysgeusia.  Additional information: facility type vaccine: Public Health Clinic. No other vaccine was taken in 4 weeks. No covid prior vaccination. No covid tested post vaccination. Other medical history was nothing significant.  No follow-up attempts are possible. No further information is expected.
The time of the schedule appointment was for 3:00pm at the local Pharmacy).  Once the vaccine was injected into my left arm, I was placed into a different seating placement, to be observe for any signs of side-effects that may occur form the injection.  This seating area also displayed a digital clock to notify how long each patient must be stationed for (each station is registered for each patient to wait approximately 15 minutes after injection).  Once placed in the seating area and the clock was started to examine my treatment, within the six minutes of observation, the following signs occurred:  Rapid-Heart Rate, Short and Shallow Breathing, Sweaty Palms including Hot Flashes (lasting 4 seconds).
Date of Admission  01/08/2022   Date of Discharge  01/13/2022   Reason for Hospitalization   Pt COV+ yesterday, presents w/ c/o vomiting and states that he will just "throw up" without even being nauseous; states that he's craving water.  Hospital Course       Patient is a 32yo man with PMHx of depression, hx suicide attempt, methamphetamine & marijuana abuse, who was admitted on 1/8 for management of COVID-19, methamphetamine intoxication, and suicidal ideation. He was cleared by psych from an SI standpoint. Medically remained asymptomatic. Was accepted to house after 5d of isolation per their guidelines, so patient discharged there.  Discharge Diagnoses      1. Suicidal ideation  COVID 19  - Symptomatic 1/5/2022; Positive 1/7/2022; will not be cleared from isolation until 1/15/2022 per infection control  - on room air  - Currently asymptomatic  Stimulant use disorder: H/o Meth amphetamine abuse  Suicidal ideations  MDD  Possible malingering  - Psych consulted    -- continue sertraline 50 daily    -- Cleared for discharge by psychiatry when medically stable. Recommending continue sertraline 50 mg daily however patient is refusing prescription stating he will not take it.       Orders:   sertraline, 75 mg = 3 Tablet(s), Oral, Daily, # 90 Tablet(s), Refill(s) 0, Pharmacy: HOSP, bedside delivery please. Dsch ~1000, 178, cm, 01/09/22 1:05:00, Height (cm), kg, 01/09/22 1:05:00, Weight (kg), 85.2  Discharge Patient  Other Diagnoses   Ongoing  Abdominal pain  ADHD  Depression  H/O psychoactive substance use disorder  Marijuana use  Methamphetamine abuse  Schizophrenia  Symptomatic cholelithiasis  Historical  No qualifying data    Consultants  Psychiatry       Medications  New, Changed, or Refilled Medications  sertraline (Zoloft 25 mg) 75 mg, 3 Tablet(s), Oral, Daily, 90 Tablet(s), 0 Refill(s)      Medications to be Continued  None    Discontinued Medications  escitalopram (Lexapro 10 10 mg, 1 Tablet(s), Oral, Daily, 30 Tablet(s), 0 Refill(s)       Physical Exam at Discharge  Vitals & Measurements  T: 36.4 °C  TMIN: 35.8 °C  TMAX: 36.5 °C  HR: 75  RR: 16  BP: 102/58  SpO2: 96%      Constitutional: Patient laying in bed in no acute distress. Alert & oriented x4. HEENT: Oral mucosa moist. Conjunctiva without injection. Pulm: Regular respiratory rate & effort. Breath sounds clear in all anterior lung fields. No rales, rhonchi, wheezing. CV: RRR. Normal S1/S2, no murmurs appreciated. No pedal edema. GI: Normoactive bowel sounds. Soft, non-tender, non-distended. MSK: moves all extremities Skin: Warm, dry, intact. Neuro: No focal deficits Psych: Cooperative. Appropriate mood & affect.  Time Spent   32 minutes spent. 50% or greater of time spent counseling and/or coordination of care.   Collaborating physician agreement: Dr.
Woke up morning after vaccine injection with fever of 102° Did not immediately respond to Tylenol within first hour. By 12 noon, fever subsided Normal body temperature by 1pm.
Patient was inadvertently administered the bivalent Pfizer bivalent COVID-19 immunization instead of the monovalent immunization. Patient had not received their primary series.
FluMist administered 8 Jan 05 at 10:30 AM . On 11 Jan 05 cold symptoms began. Went to ER 14 Jan 05 with pain and swelling on stomach. Admitted to hospital for 4 days with Gastroenteritis leading to ileus. Discharge summary states enlarged abdomen, Medical records state diarrhea, hypovolemia. msv
excessive crying-unable to pacify x 24 hrs; disorientation unable to recognize x 12 hrs; walking into walls x 12 hrs;
Initial information received on 29-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a female patient (age reported as early 40's) who received a dose of FLUZONE QUADRIVALENT (batch number U5958AA, expiry date 30 June 2018, route and site of administration were not reported) on an unspecified date. Patient had no concomitant medication. It was a case of actual medication error as expired vaccine used. No adverse event was 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 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. Documents held by sender: none.
doctor ordered Trumenba and Menactra but the tech administered Trumenba and Bexsero with no reported adverse event; Initial information received on 04-Aug-2023 regarding an unsolicited valid non-serious courtesy case received from a other health professional.  This case involves patient of age 16 (units unspecified) who was administered trumenba and bexsero by the tech but the doctor ordered trumenba and meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] 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 RFHBPA/FHBPB (Trumenba) for annual physical (Immunisation).  On 28-Jul-2023 at 12:05 pm, the patient was administered trumenba and bexsero (expiry date: 31-Jan-2027) (dose, formulation; strength; lot number unknown) by the tech but the doctor ordered trumenba and meningococcal A-C-Y-W135 (D CONJ) vaccine (Solution for injection) (dose, strength, lot number; expiry date not reported) via unknown route at unknown administration site for Prophylactic vaccination with no reported adverse event (wrong product administered) (latency: same day).   It was reported, "The patient has had no reactions. It w as their annual physical for the patient and at certain times according to age you give certain vaccines and the doctor decided since the patient is age 16, wanted to prescribe for the patient the Trumenba and Menactra for the yearly annual physical."  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the 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 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.
On 10/25/10 child was given an adult Hep. A instead of the pediatric dose. Parent was informed of the error, child was in the office for over an hr. due to other services. Child did not have an signs or symptoms at this time. VIS was gone over with parent in Spanish & informed to watch child for any high fever or breathing problems for the next 24 hrs. Parent did not mention any problems of past vaccinations.
Daily fever over 101 and fatigue starting the day after the vaccine and persisted for over 10 days. fever of unknown origin work up was negative.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 at 13:00 as dose1, single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Nov2023) negative. Therapeutic measures were taken as a result of vaccination failure, Covid-19 with Paxlovid from 31Oct2023 to 04Nov2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300370083 Same reporter/patient, different drug, different AE;
This spontaneous report was received from a medical assistant and refers to a patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD, subcutaneous, lot number N014948 with expiration date on 11-NOV-2018 (strength, dose and anatomical location were not reported) for prophylaxis. The administered dose of the vaccine experienced a temperature excursion of 8.8°F for 51 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions. There was no adverse effect reported. No product quality complaint was involved.
fever, diarrhea, running nose for 2 days, 3rd day covered w/rash, 4th day rash worse, took to MD who dx rubella, 5th day rash, 6th day faded;
About 24 hours after vaccination, patient experienced diarrhea, vomiting and severe chills (hands were shaking uncontrollably) with about 103 fever. Pt took 3 tablets of ADVIL 200 mg and went to bed. All the symptoms were resolved by morning.
9:10 AM Patient to Covid Vaccine for second dose of J&J per Dr. post allergic reaction to first dose. Patient states she started experiencing itchy throat, cough and feeling like her throat was tightening, cough and her tongue felt like rubber. Patient states this was after observation period post vaccination with Moderna approximately 45 mins after and had to return to Urgent care for treatment. Patient is here now for second dose to increase dose coverage. Patient aware she may have a reaction and brought her epi pen in case. Patient made aware to notify us of any changes in status.  9:15 AM patient started coughing, complaints of difficulty breathing. Transferred to holding room for assessment.  9:20 AM stat MD called.   9:25 Am Skin prepped with chloraprep swab. Tourniquet applied. 22 guage saline lock started to right AC, on 1st attempt, blood return observed. Saline lock secured with tegaderm. Tourniquet removed. SL flushed with 10 mL 0.9% NaCl without difficulty, no redness, swelling or drainage noted to saline lock insertion site. Two DR's here for evaluation, orders for allergy placed.   9:30 am 50mg Benadryl iv push given per providers orders: diphenhydrAMINE Inj 50 mg (BENADRYL) 50 mg ONE TIME 8/5/2021 8/5/2021 -- Class: Back Office Route: intraVENOUS Order: 957070890 Associated Diagnoses   ADVERSE EFFECT OF CORONAVIRUS COVID-19 VACCINE, INIT [T88.1XXA, T50.B95A]    9:35 AM Patient has persistent coughing causing constant retching and dry heaving with very little output on vomitus. Dr. ordered Zogran IV to aid with vomiting. ONDANSETRON (ZOFRAN) given IV push.  Dosage: 4mg  Volume: 2ml  Start time: 9:35  Stop time: 9:36 AM  Ondansetron (PF) Inj 4 mg (ZOFRAN) 4 mg ONE TIME 8/5/2021 8/5/2021 -- Class: Back Office Route: intraVENOUS Order: 957070892 Associated Diagnoses   ADVERSE EFFECT OF CORONAVIRUS COVID-19 VACCINE, INIT [T88.1XXA, T50.B95A]    9:51 AM patient reports improvement with breathing, still a little tingling on tongue and rubbery feeling to tong 10:49 AM patient evaluated by Dr. and cleared for discharge.  IV infusion completed. Flushed with 10ml 0.9% Normal Saline.  IV DC'd w/cath intact. Pressure held to site w/ 2X2 gauze X 1 minute:hemostasis acheived: secured w/tape. Pt  tolerated well. Pt. DC'd home in stable condition with all belongings.
On 8/6/2013 pt recv'd a Rabies vaccine. On 8/14/13 pt. started to experience tingling in left leg and nausea. Right arm was very sore and swollen as well.
Injection site 8 days after injection hot to touch, hugely swollen, itchy, pain, hard time lifting arm
Pt called the pharmacy saying that she had to go ER with a severe allergic reaction in the injection site that spread to all over her body, was told by health care provioders there thats its reaction to the vaccine and was advised to report to the pharmacy, been taking BENADRYL.
No sings or symptoms reported; Temperature excursion; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.   On 09-APR-2021 and 23-APR-2021, a Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (lot # T035379 has been verified to be a valid lot number for Pneumococcal Vaccine, Polyvalent (23-valent), expiration date 31-MAY-2022) was exposed to a temperature of 49.0 and 48.7 Fahrenheit degrees respectively  for a time frame of 1 hours and 15 minutes cumulative.  On an unspecified day between 09-APR-2021 and 12-MAY-2021, the  patient was vaccinated with 1 single dose of  the previous mention Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength and administration route were not provided) (product storage error). No digital data logger was involved, non previous excursions were reports and no sing or symptoms were reported (no adverse event).  This case is linked with several same reporter cases. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T035379; expirationdate: 31-MAY-2022; deviceage and unit: 0 ; operatorofdevice: Unknown; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2105USA002866: US-009507513-2105USA002935: US-009507513-2105USA002943: US-009507513-2105USA002938: US-009507513-2105USA002939: US-009507513-2105USA002940: US-009507513-2105USA002941: US-009507513-2105USA002942: US-009507513-2105USA002934: US-009507513-2105USA002933: US-009507513-2105USA002936: US-009507513-2105USA002932:
on the evening of January 28,2021, I experienced mild itching on right arm and when I looked it was a light blotchy pink. It is the same this morning. I reported it to my doctor.
Arm red, swollen,  warm to touch and painful. Achy body down to the bones, fatigued, headache, SOB,  symptoms improving, but not gone
VASOVAGAL- Treatment cold packs - laid supine with feet elevated - hydration 20 fl oz water.
Confusion fatigue, injection site pain, chills, fever, brain fog for 2 days-off work for 2 days Narrative:  Other Relevant History:
This pharmacist reports that a 66 year old male patient was given PNEUMOVAX 23 injection, in the right arm on 28Oct2012. The patient's relevant medical history, concomitant medications are unknown and his past drug history includes, he may have gotten the PNEUMOVAX before but does not remember. On 29Oct2012 the patient came into the pharmacy to show the pharmacist that his right arm was swollen. It is unknown if there is any relevant laboratory data. As of 29Oct2012 it is unknown if the patient will have another PNEUMOVAX and his right arm is swollen today.
Headache, Myalgia, Arthralgia, Diarrhea, NauseaVomiting, fatigue, twitching in arm both doses Narrative:
ADULT OBSTRUCTIVE SLEEP APNEA, MODERATE CHRONIC RESPIRATORY FAILURE CHRONIC HYPOXEMIC RESPIRATORY FAILURE
So, 4 days later at 9pm my left arm went completely numb. No strength couldn't wiggle my fingers or anything. I called the advice line and they told me to go to the ED. and they did a CT scan, EKG, bloodwork. They told me I had a TIA, a miniature stroke. After 4 hours I got my feeling back. About 3 am they sent me home. It happened the following day for about 2-3 hours, but I didn't go back to the ER because I was just there the day before. And I currently still get a burst of soreness, numbness, tightness in that same arm and location. Occasionally, my fingers still tighten and tingle, numbness, and soreness, which happens every couple of times a week.
Itching and swelling in eyes, lips swelling, red raised rash on arms, stomach.
Information has been received from a physician concerning an 18 year old male patient who on 11-AUG-1994 was vaccinated with the first dose of MMR II. On 08-SEP-1997, the patient was vaccinated with the second dose of MMR II. On 15-NOV-2009 the patient experienced parotitis on the left side. The patient also experienced fever, cough and headaches. The patient sought unspecified medical attention. On 08-NOV-2009, the patient was diagnosed as mumps. At the time of the report, the patient's status was unknown. Follow up information has been received concerning the 18 (also reported as 17) year old patient who on 14-NOV-2009 experienced mumps. On 16-NOV-2009 (previously reported as 08-NOV-2009), the patient was diagnosed with mumps. The patient was afebrile and had right parotitis. At the time of the report, the patient's outcome was unknown. No further information is available.
This spontaneous report as received from a Registered Nurse refers to herself a 66 years old female patient with hypothyroidism, asthma and GERD and a medical history of drug allergies to: Penicillin, Erythromycin, SULFA, INAPSINE. On 11-OCT-2012, the patient was vaccinated with ZOSTAVAX (lot 1098533N exp not reported) (dose, and route not reported). Concomitant medications included SYNTHROID, ascorbic acid, multivitamins (unspecified), probiotics, chondroitin sulfate sodium, glucosamine sulfate, PRILOSEC, PRAVACHOL, gemfibrozil, calcium (unspecified) and magnesium (unspecified). The retired nurse reported that on 11-OCT-2012, she developed a red raised rash around the injection site as well as all over her body, she also mentioned the rash itches and burns. The patient was put on treatment with BENADRYL and CLARITIN. The nurse stated that VZV packed was offered and declined. At the time of the report the patient's outcome for adverse events was reported as not recovered/not resolved. The relatedness for adverse events was unknown for ZOSTAVAX. Additional information has been requested.