chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a 12 years old patient was given a dose of Daptacel and the doctor had ordered Adacel; a 12 years old patient was given a dose of Daptacel and the doctor had ordered Adacel; Initial information received on 05-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2019SA216854 (same reporter).  This case involves a 12 years old patient who was given a 0.5ml dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot C5523aa, expiry date: 20-Sep-2020 via intramuscular route in the right deltoid on 01-Aug-2019 and the doctor had ordered DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) and HPV VACCINE (HPV VACCINE).  It was an actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered.  It was unknown if any adverse event occurred.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  List of documents held by sender: none.
Whole arm went numb a few minutes after injection (not 100% sure if that's abnormal). My first shot had flu like symptoms and cold sweats shivering/shaking very hard, extreme pain in right arm, nausea, couldn't sleep, migraine Diarrhea all lasted 24 hours then it was just nausea, migraine and pain in right arm, diarrhea and slight symptoms of the rest. Day 2 after vaccine had symptoms of UTI and yeast and still had other symptoms. Then went to doctor I think 4 days after. They said I had a severe UTI and severe Yeast to the point I almost had kidney failure. Took 2 weeks of antibiotics did not get second shot. Ever since i still get randomly nauseous and feeling sick. I have bad reactions to certain foods and drinks I didn't have before. I also have more weakness in my body and numbness random days. I have not seen a doctor due to money and lack of insurance. I also still have a mark from injection.
Moderna COVID-19 Vaccine EUA  Immediate taste of medicine in the mouth, treatment: None, Outcome: After a short period it went away Ear pain, treatment: None, Outcome: Periodically throughout the day Face throbbing, treatment: None, Outcome: Periodically throughout the day Stomach Cramps,  treatment: None, Outcome: Periodically throughout the day Light headed/dizziness,  treatment: None, Outcome: Periodically throughout the day
Patient reported that a few hours after the day of her COVID vaccine, she had numbness and tingling in her arm, which spread all over her body. She stated it felt like pins and needles and worsened with activity. She stated she sees a physical therapist and after some exercises it started to feel worse. She continues to have tingling all over her body at this time. The RN asked her to also inform her primary care doctor as he knows more about past history, surgeries, etc.
Pt had weakness and sweating shortly after vaccination with Afluria PF 2016-17.  Ambulance called, most symptoms resolved prior to EMT arrival, pt declined hospital care.
Within 1 hr had site tenderness, erythema, swelling, paresthesia proceeded down left arm and into shoulder & face, fever, nausea, vomiting, dizziness, "drunk feeling" ensued. Presented to urgent care & treated with prednisone & cephalexin.
Was no "adverse event" Patient was given vaccine too early. Patient only 13 and no supporting diagnosis to explain the need to get this early.
COVID 19 positive on 29May; COVID 19 positive on 29May; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26May2022 at 16:00 as dose 4 (booster), single (Lot number: FK9729), in left arm 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 had no relevant medical history. There were no known allergies. The patient did not take any other vaccine in four weeks. Patient did not have covid prior vaccination. Patient tested for covid post vaccination. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29May2022 at 12:00, outcome "recovering" and all described as "COVID 19 positive on 29May". The event "covid 19 positive on 29may" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29May2022) Positive, notes: Nasal Swab, 12:00. Therapeutic measures were not taken as a result of drug ineffective, covid-19.
Pregnancy ending in missed abortion at 16 weeks fetus death based on measurements at 13 weeks same week booster was administered. 12 week ultrasound WNL. Estimated due date 9/1/2022
Rash. Additional comments: outside L thigh, x3 days, same spot MMRV was given 8/28/18, no itching, no discharge, no fever, has not spread.
High pitched crying & constant crying would not calm down until 2AM next morning p/inject; inc temp 103 seen by MD in ER:
Developed Bell's Paulsy with mild symptoms presenting 15 days after 2nd dose. (5/19)  Went to ER, but eye droop and numbness subsided.  Awoke 5/23 with full numbness on left side of face and went to ER.   Left side entirely numb unresponsive/paralyzed from hair line down through tongue/gum. Started Prednisone 60mg daily and antiviral; both for 7-days.
Fever 102.2F fatigue Chills Body aches Nausea Headache
itching underneath of where I had the vaccine; kind of big rash; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching underneath of where I had the vaccine), VACCINATION SITE RASH (kind of big rash) and VACCINATION SITE SWELLING (Swelling) in a  patient of an unknown age and gender who received mRNA-1273 for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On 11-Jan-2021, the patient received first dose of mRNA-1273 (unknown route) at an unspecified dose. On 12-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itching underneath of where I had the vaccine), VACCINATION SITE RASH (kind of big rash) and VACCINATION SITE SWELLING (Swelling). At the time of the report, VACCINATION SITE PRURITUS (itching underneath of where I had the vaccine), VACCINATION SITE RASH (kind of big rash) and VACCINATION SITE SWELLING (Swelling) outcome was unknown.        The action taken with mRNA-1273 (Unknown) was unknown.       Upon in internal review on  21 -May 2021, the age was corrected to unknown  years.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient presented with what looked to be a breakout of Shingles on her trunk area. She said that there was also pins and needles / pinching feeling along her waistband line. She called her MD and they put her on a therapy of anti-viral and steroid.
This spontaneous report as received from a nurse refers to a 13 (reported as 14) year old patient of an unknown gender. On 15-JAN-2015, the patient was vaccinated with improperly stored GARDASIL (lot # K007264 and expiry date: 02-MAR-2017). No adverse events were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
Pt complained about soreness, redness & swelling in arm & feeling achy all over.
Patient developed following Sxs approximately 5 1/2 hours after receiving flu vaccine - sore throat, runny stuffy nose, aches, pains and exhaustion. Went to bed, slept for 12 hrs and felt fine when she woke up.
Two months after second shot my arm has a sore 4 day flareup in the exact location the vaccine was administered. My arm will have smaller intermittent  flareups. I have also noticed unusual intermittent joint flareups around the same time post vaccine where I have never had them before.
Information has been received from a woman in a medical office and a physician concerning a 8 year old white male student who on 18JUL1997 was vaccinated in the left arm with a first dose of varicella virus vaccine live. On 28MAY2003, the patient broke out with chickenpox. On 28MAY2003, the patient was seen by a physician in the office and was treated with acyclovir 1000mg per day for 5 days. Subsequently, the patient recovered. A product quality complaint was not involved. Additional information is not expected.
Information has been received from a physician concerning a 4 year old female with a history of recurrent sinus infections who on 03-JAN-2007 was vaccinated with the first dose of Pneumovax 23, IM in the arm.  Concomitant medication was not reported.  On 03-JAN-2007, the physician reported that the patient developed a fairly severe local reaction after receiving Pneumovax 23.  The evening after the patient received the Pneumovax 23 the injection site became edematous and erythematous which involved her entire arm.  The patient sought unspecified medical attention.  This was the patient's first vaccination with Pneumovax 23 but the patient had received PREVNAR in the distant past with no problem.  The patient's severe local reaction and injection site edematous and erythematous persisted.  Additional information has been requested.
Two weeks after the 1st dose of the Pfizer vax, heart started to flutter. Went to Urgent Care, then to the ER. They diagnosis him with Bundle Branch Blockage. Then came back to home location where he started to see (Cardiologist). Ran a bunch of tests, which turned out to be all clear. They couldn't find anything, that was making his heart flutter. (no clots, no artery blockage, etc.) Dr. put him on Cartia XT ER 120mg and saw him every 2 to 3 months. Heart still was fluttering after taken the medicine prescribed.  On February 24, 2023, went out mtn. bike riding and his heart just stopped. Paramedics were able to get his heart going again, then they transported him to the hospital, where he then past away 2 days later, 02/26/2023.
pt recvd vax 22SEP95 & small red nodule developed @ site & resolved p/1-2wks;then had sl fever lasting a few days;since then rt arm hurts;MD confirms event
The symptoms  came on quickly at 12:30 a.m.  5/13/20.  I had chills/shivering, 100 degree temperature by mouth,  severe headache, dizziness, nausea, achy joints and muscles, tired, difficulty concentrating.    I still had these symptoms until about 2:00 p.m. 5/13/20  and then started feeling better.  It is now 5:00 p.m.  I have a mild headache, a little dizzy and still have difficulty concentrating.  I've taken Xtra strength Tylenol and Advil for headache and body aches.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  ACUTE ST ELEVATION MI, UNSPECIFIED ACUTE NON ST ELEVATION MI
3FEB93, 3 1/2 hrs p/vax pt had been crying for 3 hrs straight & had fever; pt was taken to ER & given Ibuprophen for fever; MD told parent the pertussis had caused the react, vomitting occurred also;
Bad headache that Tylenol was able to handle, drained feeling the next day, arm sensitive at site. Fine later next day and into the next no problems.
4 days after shot I got shingles stabbing pain in right leg. Went to emergeny twice, clinic, and family doctor talked to on phone 3 times for horrible pain. Lasted 6 weeks. Day after pain subsided I got a rash over my whole body. Doctor prescribed more antibiotics. When that went away my lets started swelling.  Had many tests and utra sound on lets stomach and many blood tests. My legs still swell at times.
Narrative:  68yo male patient was discharged from inpatient admission on 11/4/21 to home. Pt died at home on 11/14/2021. Pt's DISCHARGE DIAGNOSIS: Iron deficiency anemia, POA Acute exacerbation COPD with history of chronic hypoxic respiratory failure, POA CAD s/p PCI, POA Insulin Dependent T2DM, POA Diabetic neuropathy, POA PAD s/p stent, POA AAA s/p EVAR, POA Anxiety, POA Peptic ulcer disease, POA Hyperlipidemia, POA Debility, POA Dementia, POA Pt had received covid vaccines on 2/14/21 & 3/13/21. This death is likely not related to the vaccinations due to comorbidities, age, and length of time from vaccine administration.
N30.01 - Acute cystitis with hematuria R31.9 - Hematuria, unspecified type D68.32 - Hemorrhagic disorder due to extrinsic circulating anticoagulants
Fever for 4-5 days; swelling, redness and pain at injection site; flu-like symptoms.
Generalized hives like rash developing 3-5 days after vaccine and lasting for one week
Ct scan that was for my breast caner, detected something on her lungs.  A bacterial infection of the lungs.
DRUG ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE; OFF-LABEL USE; This spontaneous report received from a patient concerned a 17 year old male. 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced drug administered to subject of inappropriate age, and off-label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the drug administered to patient of inappropriate age and off-label use was not reported. This report was non-serious.
Patient developed a fever, body aches, nausea the evening of vaccination administration. These symptoms resolved after two days. Patient also developed redness, hardness, and soreness at site of injection that has gotten better but not yet completely resolved.
1ST VAX fever, weakness,   2nd vax began sleeping  15 hours a day ,  problems with walking, nerve problems, formerly diagnosed with MS, was on road to recovery. Vax has caused relapse.
Redness, swelling, heat, mild pain, mild itchiness approximately one to two inches below site of injection twelve days after receiving first Moderna COVID19 vaccination.  Approximately five inches long and two inches high with an irregular shape.  The following day (Day 13 from the vaccination) the "rash" continues to grow.  It is now approximately six and a half inches long and three inches high.
joint pain; inability to move knees and fingers; This is a spontaneous report received from a contactable reporter (consumer or other non HCP).  A female patient in her 60's received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), on 01Aug2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; tetanus vaccine (TETANUS VACCINE), on 01Aug2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: JOINT RANGE OF MOTION DECREASED (non-serious) with onset 01Aug2022, outcome "unknown", described as "inability to move knees and fingers"; ARTHRALGIA (non-serious) with onset 01Aug2022, outcome "unknown", described as "joint pain".  Additional information: Patient received Apexxnar (PCV20) vaccine (as reported) on August 1st, began experiencing joint pain and the inability to move knees and fingers. Patient is mid-60s, female. Patient received tetanus shot and Apexxnar at the same visit. Event took place after use of product.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Severe shoulder pain lasting over 5 months now.   Lots of PT and ibuprofen did not completely remove pain.   Better now, but still hurts.   MRI done 3/8/2012 revealed bursitis.  Not sure what to try next.
CHILLS; MILD FEVER; DULL HEADACHE; FATIGUE; This spontaneous report received from a consumer concerned a 60 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid type symptoms. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced mild fever. On 08-APR-2021, the subject experienced dull headache. On 08-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, mild fever, and dull headache on 09-APR-2021, and fatigue on 10-APR-2021. This report was non-serious.
c/o feeling sore and achy night of shot.  Fever of >100 started 07/03/2008, ill for 2-3 nights with fever and body aches.  Painful blisters on hands and feet at points of contact developed on 07/05/2008 and have not resolved.  Achyness and fever resolved on 07/06/2008
I woke up in the middle of the night after having my vaccination completed, at that time I was suffering from a fever of 102.0 and I also had chills and fever. I went to see my doctor and was advised that my heart rhythm was in A-fib. I knew that this was what it felt like to me as I had had it before except it was something that affected me during specific seasons. My doctor placed me on blood thinners and sent me home with a cardiogram. He then shocked my heart back into normal sinus rhythm which only lasted for 7 hours. The provider completed a 2nd procedure which caused my heart to go into and stay at normal rhythm.
Patient received his high dose flu vaccine from another registry on 10/11/19. On 10/13/19 he was taken to ER for altered mental. status and rash. Patient spend 1 week  in hospital and 1 week in rehab with no dx  of why this happened. Pt and his wife feel that it was due to the flu vaccine and asked us to report.
Chills, full and deep bone & body aches, site of shot swelling,(6 X5 inches) red and hot X 5 days so far.  Nausea X 4 days.  Unable to sit up longer than 2 hours at a time.  Light headed. blurred vision.  Malase. unable to eat or drink much due to the nausea.
For several weeks after the vaccine, she felt more fatigued but did not make anything out of it. On February 22, she developed a very severe fatigue associated with the right leg heaviness and numbness. Over the next 3 days, the right leg became weak to the point that she needed to use a cane to ambulate. She also felt heaviness and numbness in the right hand but no clear weakness.  She was then treated with 5 days of high dose steroids (1250 mg of prednisone on day one or early followed by 4 days of 1000 milligrams IVMP. The right hand symptoms improve most, the leg weakness moderately improved but she still required a cane to walk especially the latter half of the day even 2 weeks after the infusions. The fatigue remains an important symptom for her.
Rash all over face, macular rash, peeling all over, slightly with rough skin . Erythema faintly ran all over.
Patient quit talking for 6 months after the 5 shots.  Then 7-07 was diagnosed with autism.  He had a fever and just didn't seem the same.  Like he was just not there anymore.  6/27/08 Reviewed PCP office records 12/13/04 pt w/cough, sneeze, thick green nasal drainage x 7 days & dx w/URI.  Otherwise developmentally appropriate.  Speech unintelligible 4/17/07.  8/5/08 Reviewed psychological evaluation of 9/18/2007. FINAL DX: autistic disorder; PDD; & mental retardation Records reveal patient experienced difficulty interacting w/others; avoiding eye contact; failure to make friends; difficulty communicating; stereotypical repetitive behaviors; difficulty adapting to changes in environment or routine; & delayed self-help skills.  Was receiving counseling; was in developmental disabilities program; & ST/OT & behavioral therapy were recommended.
Rash - chicken pox type on legs, trunk, underarm, ear, blister type and red splotch.
This is a spontaneous report from contactable other Health Care Professional and contactable consumer. A other Health Care Professional and 50-year-old female consumer reported that, A 50-years-old female patient received vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), first dose via an unspecified route of administration on an unspecified date as a DOSE 1, SINGLE and second dose (Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a DOSE 2, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, "I don't feel good right now." Post vaccination of her first dose patient experienced worsening symptoms of rheumatoid arthritis flare-ups. MD was unaware. after receiving the covid-19 vaccine last month (date unspecified), noted "mild flare-ups#" however, the 2nd dose of the covid-19 vaccine caused "strong flare-ups' of rheumatoid arthritis. no missed doses while receiving the vaccine. MD was aware. Outcome of the event was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on the known safety profile and a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Rheumatoid arthritis flare-ups. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Red, sore, swollen, itchy puffy eyes; Red, sore, swollen, itchy puffy eyes; Red, sore, swollen, itchy puffy eyes; Itchy puffy eyes; Puffy eyes; Puffy face; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 26Jul2021 at 10:45 (at the age of 60-years-old), as a single dose for COVID-19 immunisation. Medical history included leg and knee pain. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient received unspecified medications in two weeks of vaccination. The patient previously took levofloxacin (LEVAQUIN) on unknown date for an unspecified indication and experienced drug allergy. On 26Jul2021 at 23:00, the patient experienced red, sore, swollen, itchy puffy eye and puffy face. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events red, sore, swollen, itchy puffy eye and puffy face were not resolved at the time of this report.    The lot number for BNT162b2 was not provided and will be requested during follow up.