chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Only liquid component of Menveo; only liquid component was administrated; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number amra677a, expiry date 30th April 2023) for prophylaxis.   On 5th August 2022, the patient received Menveo. On 5th August 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.      Additional Information: GSK Receipt Date: 24-Aug-2022:  Reporter's comments: The registered nurse reported that a patient was administered with only the liquid component of Menveo.  No adverse event was reported. The reporter did not consent to follow up. Additional Supportive Information: The registered nurse reported that a patient received only the liquid component of the Menveo vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Patient received 4th dose of 0.25 ml.  Patient had already received a 0.25 ml booster dose in Nov 2021
For 2 day, I did not feel like myself.  In the end of Nov, I had SOB. I contact my son who is a doctor. He said that my afib heart. I was in two different hospital. I had Echo cardiogram, anagram, and a EKG. They try to shock my heart to get it back in rhyme. I am now seeing two different cardiologist about this. I also have to wear a life vest so it is monitoring my heart.
This spontaneous report as received from a medical assistant refers to a pediatric patient of unknown age. On 12-JUN-2013, the patient was given the first dose of VAQTA, injection(lot#, expiration date, dose, route and indication not reported). On 12-AUG-2013, the patient was given the second dose of VAQTA, injection(lot#, expiration date, dose, route and indication not reported). No adverse effect reported. It was not reported if the patient had sought medical attention. Additional information has been requested.
This spontaneous report was received from a physician via an unspecified reporter referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history was not reported. On 25-FEB-2016, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 "10 PK 0.5mL SD-PFS LLokwTip 10PK" and lot number L014876 with expiration date of 13-JAN-2017 (route of administration and anatomical location were not reported), which was stored at a lowest recorded temperature of 27F (-2.7 Celsius) for 1764 hours. The vaccine status was reported as excursion and the storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No concomitant therapies nor adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
ROTATEQ admin 1330. Mom called at 1700 saying there was blood in his stool. Seen in office that evening by MD. (+) Guaiac/mucus stool. Monitor at home.
Immediately after injection I felt a tingling in my back that went away within 25 minutes. My left arm started tingling/feeling numb in small areas starting days after injection from vaccine site up to my neck. Days later it spread down to my left hand. It has now been over a month straight of my entire left arm and left hand tingling/feeling numb, with my hand and fingertips being the worst. The symptoms affect me all day every. I?ve also had very bad headaches with the pain behind my eyes multiple times a week since the injection.
Had the booster on 15-OCT-2021; Had the booster last Friday and 2-3 days later the eczema just erupted; The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on [03Nov2021], this case now contains serious adverse reaction.  This is a spontaneous report from a contactable consumer (patient). An 84-year-old male patient received bnt162b2 (BNT162B2), dose 3 intramuscular, administered in Arm Left on 15Oct2021 15:00 (Lot Number: 301358A) as dose 3 (booster), single for COVID-19 immunization. The patient previously received the first dose of BNT162B2 via intramuscular, administered in left arm on 21Jan2021 3:22 PM (at the age of 84-year-old) as dose 1, single and the second dose of BNT162B2 (lot number: EL9266) intramuscular, administered in left arm on 16Feb2021 3:40 PM (at the age of 84-year-old) as dose 2, single for Covid-19 immunization. He got the 2nd Pfizer shot on 16Feb2021 and about 3 weeks after that he developed eczema, also he experienced red bumps, patches of dry skin with the second dose. Medical history included mild case of asthma and maybe allergies to cats. Family medical history included father had a psoriasis and mother had asthma. Concomitant medications included unspecified statin.  The patient had the booster last Friday and 2-3 days later (on unspecified date in Oct2021), the eczema just erupted. He got the booster and it's better to not get Covid than not get the booster. He is going crazy and is up at 1-3am. His wife told him to call Pfizer and see if there's a connection for the rash or skin outbreak. He is going crazy with what to eat or not and some doctors say it has nothing to do with it and some say it's a drug reaction. The latest thing is to stop his statin which will make his cholesterol increase. The caller states there seem to be a correlation between the vaccine and the emergence of a bout with eczema as he has never had any kind of skin problem ever, bottom line. On 29Oct2021 the patient still has eczema- head to toe, he had seen 4 dermatologists, an allergy doctor and his primary. The last dermatologist will start him on phototherapy on 04Nov2021. Also, he just got a steroid injection and new stronger ointment- Halobetasol propionate .05% The reporter assessed the event as seriousness (Persistent/Significant disability/Incapacity). Eczema was treated with Ointments, Steroid shots, lotions. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Pt phoned 10/11/2002 at 10:30 am. Pt states on 10/08/2002 around 12:30 - 1:00 pm she received Flu vaccine; on 10/08/2002 around 4-4:30 pm she noticed shortness of breath, throat felt swollen, scratchy, she took Benadryl 25mg PO at 4:30 pm.  with in 20 min. Symptoms decrease, 4 hours later took another Benadryl all symptoms gone. on 10/09/2002 took her allergy injection around 9-9:30 am at MD's office; 1-1:30 had same symptoms as 10/08/2002. Went to ER but had taken Benadryl 25mg at 1:30pm. Was in Er from 4:30-6 observed. Only sent home.
Information has been received from a physician concerning a approximately 48 months old male patient who on an unspecified date was vaccinated with a dose of VARIVAX (Merck) (dose, route and lot# unspecified). Subsequently, several months post vaccination the patient developed severe herpes zoster in the arm in which VARIVAX (Merck) was administered. The patient recovered from the initial episode but subsequently experienced a recurrence of the herpes zoster. The patient had an immunologic work-up and was found to be immunocompromised, specifically he was found to have adenosine deaminase deficiency (ADA deficiency), which was likely present but undiagnosed at the time of vaccination. It was unknown if the patient sought medical attention. At the time of the report, the outcome of the event was unknown. Additional information has been requested.
@ 3 AM on 3/18/2009 pt. awoke with temperature of 105.4 degrees @ 11 AM after waking up c/o entire body twitching, and increased crankiness.  3 hrs after shot (s) temperature was 101 degrees.
Small reddish lession about 5-6 mm on both sites of immunizations, with a hx of itching on site?.  Hx. of same reaction to flu vaccine administered on 11/2/07, scar present approximatelly 10 mm with no induration or colloid at site.  No other adverse reactions reported from patient.
pressure movement headaches; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on Feb2021 as 2nd dose, single for COVID-19 immunization; exemestane (EXEMESTANE), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 25 mg, daily for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization. The consumer reported that she was taking generic exemestane 25 mg daily manufactured by for 3 years as of this August. The consumer reports she had experienced a frozen shoulder in the neck while taking generic exemestane. At the beginning of Feb 2021, the consumer received her second dose of the Pfizer covid-19 vaccine. For about the past two months, the consumer had been experiencing pressure movement related headaches, described as getting a headache when she coughs, bends down, or strains. The consumer thought that the pressure movement headaches might be due to exemestane or perhaps even the Pfizer covid-19 vaccine, although she felt it was more likely to be due to exemestane. She also felt it was also very possible the pressure movement headaches are not related to exemestane or the Pfizer covid-19 vaccine at all. The consumer asked that the Pfizer covid-19 vaccine can cause headache and how long do the headaches last. The clinical outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: To delete the event headaches "might be due to exemestane or perhaps even the Pfizer covid-19 vaccine".
This spontaneous report as received from a registered pharmacist refers to a 65 year old female patient with atrial fibrillation, cardiac arrhythmia and no listed drug reaction/allergies. On 12-AUG-2013 the patient was vaccinated with a dose of ZOSTAVAX lot # J001694, expiring 08-MAY-2014, 0.65 ml, subcutaneous in the left arm. Concomitant therapies included digoxin, metoprolol and sotalol hydrochloride. On 14-AUG-2013, the patient reported to the pharmacy with an elevated blood pressure and heart rate increased. The patient's heart rate was 102 and irregular. The pharmacist measured the patients blood pressure and it was 162/88. The patient demonstrated a reddened area at the injection site, which the pharmacist stated had no evidence of being rash-like. The patient was not short of breath or exhibiting any sign of distress. No treatment was given for the adverse events. No other lab diagnostic tests were performed. The patient consulted the pharmacist for medical attention. The outcome of the events was reported as not recovered. The causal relationship was not reported. Additional information has been requested.
pt recvd vax prior to travel to China; next day had a large local reaction treated by MD ; swelling resolved in 2 days;
Chills/cold sweats, headache, fatigue, extreme soreness at injection site, body aches and pains
Injection of DTaP given on 04/23/02. Parent noticed rxn on 04/24/02. Right deltoid swollen 2"x4" with redness and itching.
Pt was a 14yo girl who was scheduled for her first COVID19 vaccine at one of our COVID19 clinics aimed at 5-11yo.  Even though we had a plan to identify anyone who showed up >11yo and vaccinate them appropriately, our catches missed this patient and she was immunized with a 10mcg dose instead of a 30 mcg dose.  This was not caught until a few days later during an audit.  We contacted her family and explained that the CDC recommend he not repeat dose 1 but make sure he gets 30mcg of dose 2.   Our team met internally to do a quality improvement causal analysis and have put additional safe guards in to make sure appropriate doses are delivered to patients.
Migraine evening of vaccine and day after. Nausea , vertigo and dizziness everyday since
Really, really sore, swollen arm and headache; Really, really sore, swollen arm and headache; Really, really sore, swollen arm and headache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown (Consumer stated, "cannot even read this, Is it GN6202. do not know if it is an E or G, GN6202)), via an unspecified route of administration on 24Feb2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced really, really sore, swollen arm and headache on an unspecified date. Are these normal? Can she take Tylenol to treat? Second dose scheduled for the next shot for 24Mar2021 and now that was 4 weeks away and she know that the second dose was supposed to be 3 weeks apart. She wanted to know why that was? The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Hospitalized 01/20/2022-still currently admitted; COVID-19 positive 01/21/22; fully vaccinated  ASSESSMENT / PLAN: Principal Problem:   Cardiogenic shock (HCC) Active Problems:   SVT (supraventricular tachycardia) (HCC)   Lactic acidosis   Single subsegmental pulmonary embolism without acute cor pulmonale (HCC)   Ischemic cardiomyopathy   Coronary artery disease without angina pectoris Patient is a 60 y.o. male with a past medical history of ischemic cardiomyopathy, left bundle blanch block/left fascicular block, alcohol abuse, coronary artery disease s/p angioplasty and stenting of the LAD & right PDA 2018, type 2 diabetes, hyperlipidemia who was admitted to the intensive care unit for cardiogenic shock. COVID-19 pneumonia without hypoxia Developed symptoms last Friday on 14th of January including fatigue, diarrhea and muscle aches.  Patient was exposed to coworkers who were COVID positive.  Has been isolating since then.  Is vaccinated with the Johnson Johnson.    Plan - not a candidate for steroid therapy as the patient is not hypoxic - not a candidate for remdesivir as the patient has AKI and shock liver (elevated LFTs)  01/24/2022 notes: COVID-19 Pneumonia Symptom onset 12/24. Tested positive at home 1/4. Vaccinated with J+J. PCR positive 1/21. Currently on 2L nasal cannula, likely secondary to cardiogenic shock rather than acute covid infection  Plan: - Holding steroids as patient's oxygen needs are unlikely from covid  Concern for Bacterial Pneumonia Febrile with leukocytosis and worsening bibasilar opacities on CXR 1/22. Blood cultures NGTD, strep/legionella Ag negative. Antibiotics stopped yesterday. Afebrile with down-trending leukocytosis. Plan: - Continue holding antibiotics 01/31/2022 notes: Combined Cardiogenic and septic shock (due to COVID) -status post milrinone and epi gtts -status post vasopressin gtt  -eventual GDMT  Acute on chronic combined systolic and diastolic heart failure -will add low dose diuretic- lasix 20 mg po bid -fluid and Na+ restricted diet, daily wts., I&Os COVID pneumonia -not requiring oxygen -continue zosyn x 5 day total course per MICU-> 2/1
Redness, swelling, fever, knobs under skin. Swelling goes down after aspirin and ice applied. Swelling returns after aspirin wears off. Started 15 days after shot
products were not good and needed to be returned with no reported adverse event/ Poor quality vaccine administered with no reported adverse event; Initial information was received on 19-Apr-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves Infant and unknown gender patient who reported that products were not good and needed to be returned with no reported adverse event/ poor quality vaccine administered with no reported adverse event after receiving hib (prp/t) vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a unknown dose of suspect hib (prp/t) vaccine (Powder and solvent for solution for injection) (lot VO7074844) (strength, expiry date unknown) via unknown route in unknown administration site for prophylactic vaccination(Immunization).  On an unknown date the patient developed a non-serious event of products were not good and needed to be returned with no reported adverse event/ poor quality vaccine administered with no reported adverse event (product storage error) (unknown latency) following the administration of hib (prp/t) vaccine.  It is unknown if there were lab data/results available.  Action taken with haemophilus type b (hib) vaccine (ACT-HIB) was not applicable.  At time of reporting, the outcome was Unknown for the event products were not good and needed to be returned with no reported adverse event/ poor quality vaccine administered 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 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.
Narrative: Patient reported nausea and vomiting and all over muscle  fatigue/myalgias starting 3 days after vaccine and lasting aprox. 24 hours.  Patient self-treated with acetaminophen and recovered completely.
Dizziness in observation area; vital signs stable and monitored for 15 minutes. Stable for discharge.
He got the vaccine, he had no issues at all.  Then on Friday evening 4/16/21 around 6:00 PM he started having no appetite, he's having delusions/awareness of what's going on, headaches, light headedness.  He still having soreness of the arm.  He is having difficulty walking due to the dizziness.  He is also having some coughing and congestion issues.  He has a history of alcoholism and smoking.   Has not taken anything for these symptoms, no insurance and trying to deal with it on his own to see if it would go away.
large local injection site reaction that started the day after vaccination. Redness/swelling/warmth/itching
So I had a headache, muscle and joint pain, and I had intense pain, lack of appetite, weight loss, fever, this lasted for a little over three months.  I had a video chat with the Dr. the symptoms just went away on their own after three months. Dr. thought it was cancer but it just went away and all other test results came back fine. Realized it was just an adverse reaction to the vaccination, it felt like I had a bad case of the flu. I also had Tinnitus and ringing in my ear for the whole three months that I was sick, it has happened with all my vaccines for about a week but this one lasted the longest. Also had the flu shot with this vaccine but I do not remember the info of the name of the shot given at that time.
Rash (wheals) developed at injection site and adjacent area slightly less than 1 week later than vaccine. No pruritus or pain.
Significant swelling under arm in armpit area and into the distal of the right breast with pain/tenderness; severe nausea and dizziness, some vomiting and diarrhea
Patient had fever and a period of decreased mental status in which he responded only to painful stimuli. Parents called 911 and patient was admitted. Recovered well. 12/19/08-records received on 9/19/08-presented with new onset of fever and lethargy and excessive sleepiness. 1/12/09-records received for DOS 9/20-9/21/09-DC DX: Fever possible vaccine related. Presented to ED with C/O difficult to arouse and increased sleepiness.
Fever started at hour 26 after injection and lasted roughly 5-6 hours. Max temp observed at 101 through ear thermometer. Severe fatigue corresponded to fever
Systemic: Just felt unwell and wanted to lay down.  Could not pinpoint any one thing as pt wanted to close his eyes and rest. Dad did report that pt gets anxious when getting shots.-Mild, Additional Details: Patient wanted to lay down & didn't feel well.  Vitals 104/61,pulse 60.  Patient father said that bp/pulse were pretty normal for patient.  He said for 1st dose pt was able to lie on a cot. Father said pt gets anxious with shots.I gave patient a chair to prop his feet up, a wet paper towel for his forehead &for his hand to hold.  Patient was closing his eyes leaned up against his father.  After about 1/2 hour patient felt better & was able to get up to leave
Night of the shot left arm swollen and hurt for the next 4 days.  One week and one day after a red itchy rash appeared at the same site and has continued for two days as of 3/13/21.
Injection site is swollen to size of pancake and itches at 48 hours after administration.
fever; Chills; Arm pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (Chills) and VACCINATION SITE PAIN (Arm pain at the injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PYREXIA (fever), CHILLS (Chills) and VACCINATION SITE PAIN (Arm pain at the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (fever), CHILLS (Chills) and VACCINATION SITE PAIN (Arm pain at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications information was reported For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments
This spontaneous report was received from a nurse and refers to a 6 year old female patient. The patient's medical history, drug reactions or allergies and concurrent conditions were not reported. On 19-MAR-2009, the patient was vaccinated with the first of RECOMBIVAX HB, on 20-MAY-2009, the patient received the second dose of RECOMBIVAX HB and on 29-JUL-2009, the patient received the third dose of RECOMBIVAX HB, (inappropriate schedule of drug administration), (dose, route, anatomical location, lot number and expiration date were not reported for all the therapies above described). No adverse effect was reported. There was no concomitant medication reported. Additional information has been requested.