chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient received an unnecessary hib dose as well as an extra IPV dose; patient was inadvertently given PENTACEL instead of the ordered DAPTACEL; Initial information received on 18-Aug-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 years old female patient who experienced patient was inadvertently given pentacel instead of the ordered daptacel and patient received an unnecessary hib dose as well as an extra ipv dose while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and VARICELLA ZOSTER VACCINE (VARICELLA ZOSTER VACCINE) for Immunisation.  On 18-Aug-2022, the patient received a  0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE once (lot UJ651AAA; expiry date: 25-Feb-2023) via intramuscular route in the left thigh for prophylactic vaccination.  On 18-AUG-2022 the patient reported  patient was inadvertently given pentacel instead of the ordered daptacel (wrong product administered) and received an unnecessary hib dose as well as an extra ipv dose (extra dose administered) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken: not applicable.   At time of reporting, the outcome was Unknown for the event wrong product administered and extra dose administered.   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.
Within 24 hrs of immunization, (L) thigh became sore, warm, red. On 7/21 erythema decreasing but still (in intensity) 13x8cm. Indurated centrally. No pain.
Seasonal flu vaccine was being administered to patient from a pre-filled syringe. Product was Flublok. After administering vaccine, noticed that some of the vaccine serum had leaked from the connection point of the needle to PFS. Therefore patient did not receive the complete dose of the vaccine. Patient was notified of event.
Patient received 1st dose Moderna vaccine on 12/29/2020. Reports some soreness noted the next day. Reports redness and tenderness developed last evening (1/5/2020) and still present today. Site measured. 4 cm x 3 cm induration noted. Not warm to the touch. Denies fever or other symptoms. Reaction did not develop until 1 week post vaccination.
Initial information received on 27-Aug-2018 regarding an unsolicited valid non-serious case received from an-other healthcare professional. This case was linked with the case 2018SA244411 (Siblings/ Same reporter). This case involves a 3 years old female patient who was vaccinated with a 0.5 ml dose of DAPTACEL (lot C5202BA and expiry date: 16-May-2019) via intramuscular route in the right thigh. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Patient's concomitant medications included PREVENAR 13. It was a case of actual medication error due to Inappropriate schedule of vaccine administered because DAPTACEL given too early. It was unknown if any adverse reaction was occurred or not following the vaccination. 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 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 the sender: None.
during days noc vax given, pt had frequent episodes of uncontrollable crying; family stated these lasted 30-45 mins; tried riding in car everything they knew w/o success; by next day, much better, irritable 3-4 days; legs, tender;
This spontaneous report as received from a medical assistant refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies were not reported. Concomitant therapies included properly stored sterile diluent (STERILE DILUENT). On an unknown date, the patient was vaccinated with improperly stored dose of VARIVAX lot # N017700, expiration date: 09-JUN-2019 (concentration and route of administration were not reported).  Administered dose of vaccine experienced the temperature excursion of 15 degrees Fahrenheit to 46 degrees Fahrenheit for 1 hour 9 minutes. Previous temperatures excursions: 6 degrees Fahrenheit to 14 degrees Fahrenheit for 76 minutes and 15 degrees Fahrenheit to 46 degrees Fahrenheit for 1 hour and 23 minutes. The patient did not experience any adverse effects. Data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1711USA002012: US-009507513-1711USA004383: US-009507513-1711USA004384: US-009507513-1711USA004385: US-009507513-1711USA004386: US-009507513-1711USA004387: US-009507513-1711USA004388: US-009507513-1711USA004389: US-009507513-1711USA004390: US-009507513-1711USA004391: US-009507513-1711USA004392: US-009507513-1711USA004393: US-009507513-1711USA004394: US-009507513-1711USA004395: US-009507513-1711USA004396: US-009507513-1711USA004397: US-009507513-1711USA004398: US-009507513-1711USA004399: US-009507513-1711USA004400: US-009507513-1711USA004401: US-009507513-1711USA004402: US-009507513-1711USA004403: US-009507513-1711USA004382: US-009507513-1711USA004381: US-009507513-1711USA004379: US-009507513-1711USA004380.
Child developed poor appetite with associated vomiting, sudden in onset, worsening over a few hours. Child evaluated at office exam consistent with intussusception. Referred to medical center - air enema cured and diagnosed.  6/3/09 Hospital records received DOS 5/22/09. FINAL DIAGNOSIS: Intussusception Post vaccination not feeding well, fussy, projectile vomiting. Abdominal distension. Air enema reduction sucessful.  6/22/09 ICD-9 codes received. 560.0, 789.09
pt recvd vax & devel fever of 106.3; pt had convulsion; foaming at the mouth; gasping & gasping for breath; pt stopped breathing & turned blue; convuls lasted several mins.Had ear & throat infection. Hospitilized 2 days.
This spontaneous report was received from a medical assistant refers to an adult patient of unknown age. The patient was vaccinated IM with an expired 0.5 ml dose of the pediatric formulation of RECOMBIVAX HB (lot #:666029/1456Y, exp date on 06-AUG-2012) on 15-AUG-2012. No adverse effect reported. Additional information has been requested.
I became extremely tired and my legs were so sore. I had a very hard time getting out of bed, putting my shoes and socks on and bending over. It is so painful that i shake when I bend over. I have also had a headache on and off since then. I called the CDC, Health Dept, amd my doctor and was told that was normal. When I went for my secoond shot the nurse who administered the shot said it was my lymph nodes. I went to my doctor who ordered some bloodwork. My SED Rate West was 38, CRP Extended range was 59.62 and my RBC was 4.15. These are not typos! These were completed on March 11, 2021.
had sz w/fever w/in 24 hrs of vax hospitalized for observation, complications, problems; doing well;
This spontaneous report was received from a nurse practitioner, via company representative, referring to a 67 year old male patient. The patient's historical drugs, drug allergies/reactions, medical history and concomitant therapies were not reported. The patient's medical condition included other comorbidities related to lung function. On an unknown date, the patient was vaccinated with one dose of PNEUMOVAX 23 for prophylaxis (strength, dose, route, frequency, lot# and expiration date were not reported). On the same date, after the patient got home the day he received the PNEUMOVAX 23, the patient began experiencing shortness of breath. On an unspecified date, the reporter stated that the patient went to an unspecified emergency room after receiving the vaccine for treatment of shortness of breath (dyspnoea). The patient came back to physician office after going to the emergency room and was seen by a separate unspecified physician in the same practice for an unspecified reason (adverse event). At the time of reporting, the outcome of dyspnoea and adverse event was unknown. Additionally, the causality assessment between dyspnoea and adverse event with PNEUMOVAX 23 was not provided.
Patient called the CDC Clinician Information Line on 5-9-03 to ask about some symptoms since receiving the Smallpox vaccination. They told her to fill out a VAERS report. Patient states that she has been recently diagnosed with degenerative arthritis. It has been affecting her first digit of her little finger on her right hand. She began having some minor discomfort in it about a month after getting the smallpox vaccination. States she has very little cartilage left. A couple of weeks ago she noticed that the nail bed was white. States she has good circulation to the finger but that the joint is swollen and painful with movement. Patient states that this is the only joint affected at this time. Patient is a diabetic but has no history of cardiac problems. Patient states that her arm still aches at times where her vaccination was given.
At times extreme pain in left arm but always a continued pain. Unable to move my arm in a regular way without receiving sharp pain & followed by involuntary movement. Can not lift arm above head without sharp pain.
This case concerns male who had had influenza vax 48 hours prior to chemotherapy. On day 3, after the carboplatin based tridrug chemotherapy with blood brain-barrier disruption (vertebral artery), he experienced respiratory arrest and rapid progression of quadriparesis. The pt remained quadriparetic and ventilator dependent and died 75 days after chemotherapy treatment. The authors conclude that the pathophysiology of the complication seen in the 7 pts is multi-factorial but may be related to vascular streaming and an atypical inflammatory toxic reaction to carboplatin or etoposide. The complication has not recurred during a 6 month period following modification of the protocol. Date of vax and onset not specified and therefore assumed to be associated with the 1999/1999 influenza season.
Up to 11 hours post injection substantial arm pain. At 11 hours sudden onset of severe chills, muscle aches and headache, preventing sleep for 10 hours. After 24 hours post-injection symptoms completely gone.
Immediate sharp pain shortly after injection when moving arm to put on coat. Over the next few days there was what seemed to be typical soreness/tenderness after a flu shot and then over the next weeks the shoulder hurt more and more with sharp pains whenlifting arm above head or twisting arm. Weakness is arm and feeling of heat in the shoulder. Pain in shoulder when lying on left side and pain down the arm into the elbow after waking up.
Pfizer-BioNTech COVID-19 Vaccine EUA  Approx 7.5 hours after the injection, I began to experience significant fatigue and moderate injection site pain.  That night, the arm pain became more severe such that anytime I moved the pain would wake me.  I could not lift my arm without severe pain until around 1800 the following day.  On 11 Feb, I began to have a low fever around 1000.  The fever stayed between 99.0F - 99.8F and persisted until around 1800 that evening.  After 1800 on 11 Feb, all symptoms rapidly resolved and I was only left with very minor injection site pain by the morning of 12 Feb.
Second dose of Jynneos was given 21 days not 28 days between first and second doses.
30AUG face blue, eyes rolled back, arms back & head arched, saliva; Inject site red & firm, clean, t106.4; Dx febrile sz secondary to DTP;
Pemphigus; This is a spontaneous report from a contactable pharmacist. This reporter reported for 9 patients. A 94-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pemphigus on an unspecified date with outcome of unknown. The event was assessed as non-serious by the reporter.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information, a possible contributory role of BNT162B2 to the development of pemphigus cannot be excluded. 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.c,Linked Report(s) : US-PFIZER INC-2021615628 same reporter and drug, different patient and AE
Redness, itching, swelling, heat at injection site started afternoon after shot was given (within a few hours) it has lasted 4 days swelling, temperature has decreased, will follow up with pt.
PT STATES THAT AT 9 PM ON 9/28/23 CHEST PAIN BEGAN AND PERSISTED FOR DAYS. PT WAS SEEN IN THE ER ON 10/6/23. ECHO WAS PERFORMED AND SHOWED PERICARDITIS. PT WAS TOLD THERE WAS NO VIRAL ILLNESS PRIOR THAT COULD HAVE CAUSED THIS CONDITION. PT WAS STARTED ON COLCHICINE 0.6MG BID AND IBUPROFEN (UNKNOWN STRENGTH AND FREQ). PT WILL HAVE REPEAT ECHO IN 1 MONTH
Less than 6 hours after vaccination, patient felt intense body aches all over, profound malaise/fatigue, and fever (Tm 103.7).
oain, redness at injection site Narrative: Patient and wife called seeking evaluation for rash around injection site (right arm) x 3 days. Admits to tenderness upon palpation, itching. Denies drainage, arm swelling or weakness, fever, n/v. Received first Moderna covid vaccination on 1/19/21, second scheduled on 2/16/21. Please follow-up. Thank you.
Non painful mouth sores; This non-serious case was reported by a consumer via call center representative and described the occurrence of sores mouth in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10-SEP-2023, the patient received the 1st dose of Shingrix. In SEP-2023, 1 week after receiving Shingrix, the patient experienced sores mouth (Verbatim: Non painful mouth sores).  The outcome of the sores mouth was unknown.   It was unknown if the reporter considered the sores mouth to be related to Shingrix.     It was unknown if the company considered the sores mouth to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-OCT-2023 The reporter reported that the patient received Shingrix vaccine and 1 week later experienced 2 or 3 mouth ulcers that were painless on the inside of her bottom lip. The reporter asked if this could be a side effect from her Shingrix vaccine.   The patient was referred to her healthcare professional.  The reporter stated that her dentist believed that they are just normal oral mucosa damaged by trauma biting or nicotine tablets. The reporter consented to follow up.
pt recvd vax; 24 hrs later,felt achy,low grade t;30 hrs p/ shot devel high fever, severe aches; cold sx; n; sl red rash chest;
Swollen right lower leg. Doppler study revealed multiple blood clots. Stared on Eliquis. Continues on Eliquis at this time and leg still swollen
RESIDENT TESTED POSITIVE FOR COVID 19 ON NOVEMBER 4, 2020 PER ANTIGEN TEST. RECEIVED BOTH COVID 19 MODERNA VACCINES, FIRST DOSE ON DECEMBER 30, 2020 AND SECOND DOSE ON JANUARY 27, 2021. RESIDENT TESTED POSITIVE PER PCR TEST ON MARCH 8, 2021.
rt arm w/numbness, swelling from inject site to fingers; dx immun rxn Td r/o infect;
Vaccine was expired at time of administration.  It was past bud of 10 weeks in the fridge.  It expired on 3/30/22.  Called patient to discuss cdc recommendation for re-vaccination.  Patient is considering re-vax and will call us back when she decides.
Woke from an unusually long 3 hour nap at above time with fever of 102.3 F. Administered 0.8 ml infant Acetaminophen, fever reduced in one hour to 99.9. Awoke this morning and fever back to 101.6; administered more Acetaminophen around 8:00 AM (same dose) and fever reduced to 99.6 F. This afternoon, fever is back to 101.3, again gave same dose at 2:45 PM (few minutes ago).
received Twinrix / 6-8 years ago / had a test / has no antibodies; This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a 68-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Twinrix about 6 to 8 years ago from the reporting date and had a test that shows she had no antibodies. The health care professional did not know if the patient received the full Twinrix series and did not had the lot and expiry date of Twinrix. No symptoms reported.  The reporter consented to follow-up. This case had been linked with US2021AMR087423, reported for the same patient, by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR087423:same reporter
I had fever, chills and nausea throughout the night (after midnight) after receiving the vaccine that morning. Definitely flu like symptoms.  The next day, I felt like I had jabbing sensations in my right eye.  That eye also had some drainage (similar to what you would feel with a bad cold) and itchy.  That afternoon, I had the weird sensation of being able to "feel" the right side of my face. It felt like something was going to happen. It reminded me of how it felt when I had shingles in that area years ago. By the 3rd day, things seem to have resolved themselves.
Woke up around 7 am with headache and nausea/ vomiting.  Took Tylenol for headache, continues with headache
Systemic: anxiety, nervousness, shortness of breath-Severe, Additional Details: patient presented to pharmacy next day following janssen covid vaccine. presented with shortness of breath, anxiety, nervousness, cough. patient states symptoms started around 2AM. Ambulance was called. EMT took patient to hospital
The baby died under suspicious conditions this morning. 7/23/09 Medical records and DC summary received. Assessment: Multisystem organ failure, severe traumatic brain injury, acute respiratory distress syndrome, metabolic acidosis, rule out nonaccidental trauma. Patient presents with frontal traumatic brain injury, bilateral pneumothoraces, decreased hemoglobin and hematocrit. Pupils are 4 mm and fixed. Does not move face or extremities. GCS of 6T. Bruising to frontal scalp area, left knee. No corneal (reflex) no gag (reflex), no movement to pain. Diffuse hypotonia. Preretinal hemorrhage. Corneal edema. Anoxic encephalopathy. Depressed brain stem reflexes.
my left arm hurt; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of   in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 20-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   Treatment  information was unknown  Action taken with mRNA-1273 in response to the events was not applicable.   Reporter did not allow further contact
COVID-19 TEST POSITIVE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-JAN-2022, the patient experienced covid-19 test positive. Laboratory data included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 test positive was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000210186.
This case was reported by a physician via a sales representative, and described the occurrence of hepatitis B antibody negative in an adult male subject who was vaccinated with TWINRIX, GlaxoSmithKline.  On unspecified dates between approximately 2005 and the time of reporting in October 2007, the subject received the first and second doses of TWINRIX (unknown).  At an unspecified time after vaccination with TWINRIX, the subject experienced hepatitis B antibody negative.  According to the physician, the subject had been vaccinated with TWINRIX "twice in the past two years" and hepatitis B titers continued to be negative.  At the time of reporting the events were unresolved.  The physician considered the events were unrelated to vaccination with TWINRIX.
Started to bruise right after shot and was very sore, was red and hot to touch that night. Next day red spot was bigger, swollen, and very hot to the touch. Drew line around spot and was bigger the next day, still red, hot to touch, and swollen. I have had fatigue since shot, a slight fever today, and yesterday was nauseated for a couple hours.
Patient reports that she has been experiencing muscle pain and stiffness that  persisted for the past 4 weeks. The muscle stiffness has spread from her arm to her neck. Recommended patient contact her provider for further evaluation.