chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expired Daptacel was given to a patient/no AE; Initial information received on 03-Feb-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 3 year 7 month old male patient who was vaccinated with an 0.5 mL expired dose (fourth dose) DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number C5367AA and expiry date: 30-Jan-2020, frequency once) via an intramuscular route in the left vastus lateralis on 03-Feb-2020.  Medical history, medical treatment, vaccination and family history were not provided. Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation.  It was a case of actual medication error due to expired vaccine used. It was reported that patient was given the DAPTACEL vaccine, which was expired on 30-Jan-2020.  At the time of reporting, 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 and Module VI of the 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.
Pt. c/o neck pain at noon on 12-2-10 at school, no fever, has lg. swollen lymph nodes bilaterally.
According to her husband, approximately 3 hours after vaccine, patients clasped and was instantly unconscious.  She was pronounced dead upon arrival to hospital and physician told husband that she had suffered a burst abdominal aneurysm and passed immediately.  Nothing was out of ordinary during vaccination and during 15 minute wait time after.
had two temperature excursions; Initial information received on 24-Feb-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves Adult and unknown gender patient who had two temperature excursions 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.  On an unknown date, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE with unknown dosing lot UJ422AAA via unknown route in unknown administration site.  On an unknown date the patient had two temperature excursions (product temperature excursion issue) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (had two temperature excursions).  At time of reporting, the outcome was Unknown for the event had two temperature excursions.
ACCORDING TO PATIENT: PATIENT HAS HAVE SYMPTOMS OF SORE THROAT, HEADACHE, PAIN AT INJECTION SITES, SWOLLEN IN THE HANDS, STIFFNESS AT RIGHT SHOULDER AND HAND, PAIN LIKE NEEDLE PINCH, NO FEVER.
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age. The Registered Nurse reported that the patient developed cellulitis at the injection site after receiving PNEUMOVAX 23 (Lot#, dose/frequency, route and duration were unspecified) on an unknown date. No treatment information was reported. The outcome was unknown. Additional information has been requested.
Horrible infection in my thumb; losing my thumb nail; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular, administered in Arm Left on 07Apr2021 (Batch/Lot Number: EP6955, at 60 years old) as DOSE 1, SINGLE for covid-19 immunisation. No Medical history. No concomitant medications. On 07Apr2021, patient got a horrible infection in his thumb had to see doctor and have drained. The first infection was in his right thumb and patient is still losing his thumb nail. The outcome of the events was recovering. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No Known Allergies. Vaccination facility information available. Device Date: 29May2021. Treatment: Yes; Drain infection prescribed sulfamethoxazole.  Follow up attempts are completed. No further information is expected.
Around 9 hours after immunizations, this infants parent noticed a fever that continued to increase to 105 F. The patient began vomiting and having tremors and possible convulsions. At 9:00 PM, the patient was taken to the ER, he had IV's started and was treated with antibiotics. He was released after 3 hours.
Information has been received from a pharmacist referring to a 63 year old female patient. Concurrent condition and medical history were not reported. The patient had no drug reactions or allergies. On 03-FEB-2105 the patient was vaccinated with a dose of ZOSTAVAX (strength 19400 PFU) (lot no. K016325, expiration date 24-DEC-2015, dose and route were unknown) (reported as routine administration). Concomitant therapies were not reported. On 04-FEB-2015, the patient experienced tingling down her arm and hand. No treatment was given for the adverse event. No lab diagnostic studies were performed. The patient did not seek for medical attention. There was no significant disability of hospitalization. The outcome of the event was reported as recovered/resolved on an unknown date in February 2015. Additional information has been requested.
NO ADVERSE EVENT OF THIS TIME.  PATIENT SHOULD HAVE RECEIVED FLUZONE QUADRAVALENT INSTEAD OF HD.
Patient was given 12-adult dose of the vaccination for the first dose (patient was 10 years old at the time of administration), no symptoms or issues were reported and the mistake was discovered when the patient's father was trying to schedule the second dose of the vaccine.
PATIENT STATES ACHE IN ARM, LUMP WITH A DIMPLE IN THE MIDDLE, HURTS TO TOUCH.
headache; body aches; left arm pain at injection site; Fever of 99; This is a spontaneous report from a contactable consumer (Patient). A 74-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: ER8736), via an unspecified route of administration, administered in Arm Left on 06May2021 11:45 (at the age of 74-year-old) as dose 2, single for COVID-19 immunisation. Medical history included supraventricular tachycardia PSVT, Osteoporosis, PreDiabetes, osteoporosis, glucose tolerance impaired, known allergies-Shellfish, contrast dye, Paramenobenzoic acid (PAPA). Patient was not pregnant at time of vaccination. Historical vaccine received was first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EW0151), via an unspecified route of administration, administered in Arm Left on 13Apr2021 12:30 PM as dose 1, single for COVID-19 immunisation. Concomitant medications included verapamil (VERAPAMIL) taken for an unspecified indication. Patient did not receive other vaccine in four weeks of vaccination. Patient received other medications as Verapamil, vitamins in two weeks of vaccination. The patient experienced fever of 99 on 07May2021 18:30, on an unspecified date headache, body aches, left arm pain at injection site. Patient was not diagnosed with COVID, prior vaccination. Events were reported as non- serious. Lab test included body temperature: 99. No treatment received for the events. The patient recovered from fever of 99. The outcome for the other events was unknown.  No follow-up attempts are possible. No further information is expected.
After injection, patient cannot lift her left arm. It hurts when she tries to lift it. Patient went see her doctor. She might need an MRI.
psoriasis; This is a spontaneous report from a contactable consumer (parent). A male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on 07Apr2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The reporter stated that their son received the first dose of BNT162B2 on 07Apr2021 and was supposed to receive an adalimumab (HUMIRA) shot for his psoriasis on that Friday, 09Apr2021, but was told that the two were not good with each other. The patient's skin doctor said to give the patient the adalimumab, and the primary care physician told them the patient should wait 14 days. The reporter was not sure what to do and inquired if the patient should get the adalimumab shot. She reported that the patient had now (as of 13Apr2021) missed a dose of the adalimumab. The clinical outcome of psoriasis was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
pain on injection; This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received Rabies NVS (RabAvert) (batch number SWQG26CA, expiry date 30th June 2022) for prophylaxis.   In March 2019, the patient received RabAvert (intramuscular). In March 2019, immediately after receiving RabAvert, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to RabAvert.  Additional details were provided as follows: The reporter was a buyer for the hospital. In early March 2019, the patient went to the emergency room (ER) and received a dose of RabAvert. The patient experienced pain on injection and was not able to tolerate receiving the full injection due to the pain. The patient left the ER.
This spontaneous report as received from a healthcare worker refers to a 6 months old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 05-OCT-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally. The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Adult patient received pediatric dose of Engerix-B; Adult patient received pediatric dose of Engerix-B; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 73-year-old male patient who received HBV (Engerix B pediatric) (batch number DD7K7, expiry date 31-MAR-2024) for prophylaxis.   On 28-JUL-2023, the patient received Engerix B pediatric .5 ml. On 28-JUL-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Adult patient received pediatric dose of Engerix-B) and adult use of a child product (Verbatim: Adult patient received pediatric dose of Engerix-B). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 28-JUL-2023 The reporter was a clinical coordinator. The reporter stated that the patient did not had an adverse reaction. The adult patient was administered a pediatric dose of Engerix-B, which led to underdose and adult use of a child product. The reporter did consent to follow up.
This is a spontaneous report from a contactable consumer, the patient. A 29-year-old, male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8737) via an unspecified route in the left arm on 01Apr2021 at 10:30 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included lyme disease 15 years ago which resolved with 2 weeks doxycycline. The patient had no known allergies. The patient had no allergies to medications, food, or other products. The patient did not receive any other concomitant medications within  two weeks prior to the COVID-19 vaccine. The past drug history of the patient included doxycycline (MANUFACTURER UNKNOWN) started on an unknown date for lyme disease. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccination within four weeks prior to the COVID-19 vaccine. On 01Apr2021 at 14:00, the patient had intense pain in left bicep, near where it meets the elbow, felt like his muscle was literally tearing off his bone. He can flex his muscle with no pain. Extending his arm fully causes the intense pain. 6 days after the shot, the patient woke up with the pain spreading to his ribs close to his heart. There was no sign that the pain was decreasing or increasing, just spreading. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the event intense pain in left bicep was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
Pain in left shoulder muscle started the day after receiving flu immunization.  Pain is in all of the shoulder muscle.  Moving her arm causes it to feel like shooting pain.  She rates her pain an 8 on scale of 1 - 10 with 10 being the worst.
Extreme Fatigue , Blurry Vison, Inability to Focus/Concentrate - Brain Fog
nausea; heartburn; chills; nightmares; soreness at the back of her neck; headaches; seeing a blank shadow; This is a spontaneous report from a contactable consumer (patient). A female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Jan2021 11:00 AM at single dose for COVID-19 immunisation. Caller received the first dose of the Pfizer COVID vaccine yesterday (18Jan2021) at 11am. Last night, she started to experience nausea, heartburn, chills, nightmares, soreness at the back of her neck, headaches and seeing a blank shadow. She is concerned if these are normal side effects associated with the COVID-19 vaccine. Patient reported had a whole lot of things all night long, and wanted to see if they were normal, the side effects. Outcome of the events was unknown.   Information about Lot/Batch number has been requested.
initial - 20 minutes after shot - 1 quick shot of vertigo but I was already in the car. Next day - headache, tired, low grade fever lasted 1 day. On March 30 & 31 I would have massive nausea.  On 4/2 after dinner I started to have chest pain.  This lasted into the night and I had cold sweats, nausea, vertigo and went to the ER.  CTScan w/contrast was done, chest Xray, EKG was adnormal.  Was admitted to the cardiac unit for observation.  Was there 24 hours.  On 4/4, I was still having the chest pain, went to another cardiologist where I had another EKG, Stress test, blood work. Everything looked good, couldn't figure out why I was having chest pain.  Echo was scheduled. The night of 4/6 the vertigo increased drastically where I couldn't close my eyes and go to sleep, went to the dr on 4/7 and that is when it was thought that it was tied to the vaccine.  Was put on meclazine for the vertigo as needed.  It was then that the anxiety and depression started.  By body broke out in Hives, was put on allergy medicine to help with those.  Unexplained bruising was occurring on my legs.  Was put on a Mediterranean diet which is supposed to help with inflammation. Stopped drinking caffeine and alcohol. The vertigo, anxiety and depression continues.  I had an MRI of my brain to see if there was anything showing. Bloodwork was done. Started to experience breast pain, went to my dr, had a mammogram and ultrasound to see if anything was there.  Lymph nodes are still swollen, have to go back in 6 weeks. Went to an ENT for the vertigo and he found some of the crystals in my ears, I've never had that before. On 4/29 I had a hair appt where 1 minute after she put the hair dye on my hair, I experienced more vertigo.  Still experience the depression and anxiety, hoping that subsides very soon.
Site became warm to touch swollen and red hive like bumps - about the size of 4 fingers surrounding the sight.  Pt also ran a low fever.
Patient was observed by parents to have a seizure. Pt was taken to ER. This clinic referred pt. to Neuro clinic and ordered EEG.
Patient stated that she felt nauseated almost immediately after the injection followed by ringing in the ears and dizziness.  Patient was scared and reported sweating  and shaking.  Patient was given diphenhydramine liquid to help with possible allergic reaction. Patient began to recover shortly after the diphenhydramine administered.
Red around rash on (L) thigh, hot to the touch. Parent gave TYLENOL and cool compresses - rash is subsiding.
Pt. C/O total body weakness (dropping things, couldn't grasp wrench to any strength x 24 hrs after receiving inj. on 3/20/17. It resolved after 24 hours.
vaccine was involved in a temperature excursion reached 28.2 degrees Fahrenheit for 2 hours and 29 minutes. and 30 degrees Fahrenheit for 6 hours and 11 minutes and administered to patient with no reported adverse event; Initial information received on 09-Sep-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to cases 2022SA377287(CLUSTER) and 2022SA377293(CLUSTER).  This case involves a 47 years old male patient who was administered Influenza quadrival A-B high dose HV vaccine [Fluzone high-dose quadrivalent] vaccine after temperature excursion reached 28.2 degrees Fahrenheit for 2 hours and 29 minutes. and 30 degrees Fahrenheit for 6 hours and 11 minutes.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 07-Sep-2022, the patient received 0.7 ml, once dose of suspect Influenza quadrival A-B high dose HV vaccine unknown formulation (lot UJ875AD, Exp date: 30-Jun-23) via intramuscular route in the left deltoid for immunization.  On 07-Sep-2022 (latency: same day), the patient developed a non-serious "vaccine was involved in a temperature excursion reached 28.2 degrees Fahrenheit for 2 hours and 29 minutes. and 30 degrees Fahrenheit for 6 hours and 11 minutes and administered to patient with no reported adverse event (poor quality product administered).  Action taken: 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.
Systemic: see comments below-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium, Additional Details: patient became faint, sweating, with decreased vision. He sat down on a chair, heart rate in 52-57/min, BP 100/56, rr 20, O2 sat 100%. Took about 10 minutes to fully recover, and all sympotms resolved, HR returned to 61-67/min.  He declines EMS, says he will follow- up with PCP regarding drop of heart rate.  His girlfriend picked him up and he went home.
My son got symptoms couple of days after bad wizen couldn?t breathe bad sore throat coughing uncontrollably and very very tired I took him to the medical facility on the 17th and his covid test was neg
This spontaneous report as received from a medical assistant refers to a 18 month old child patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 17-SEP-2018, the patient was vaccinated with improperly stored dose of VAQTA ped 0.5 ml vial (dose, frequency and route were not reported) (lot # R009953, expiry date: 12-JUN-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) for 3.5 hours for 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source.; Sender's Comments: US-009507513-1809USA002868: Original Case : 1809USA002868 US-009507513-1902USA009324: Original Case : 1902USA009323 US-009507513-1902USA009325: Original Case : 1902USA009323 US-009507513-1902USA009326: Original Case : 1902USA009323.
Information has been received from a health professional concerning a 23 year old white female who on 29-APR-2008, at 1:56 pm, was vaccinated in the left deltoid with a first dose of GARDASIL vaccine (yeast) (lot #659655/1486U). On the same day the patient experienced panic attack symptoms like heart racing and difficulty breathing. It was reported that the patient called the GARDASIL vaccine (yeast) hotline and no more vaccines were given to the patient. Additional information has been requested. The patient recovered on the saem day. This is a consolidation of two reports concerning the same patient. Additional information is not expected.
Antibody Titer for Mumps of 79.2; Antibody Titer for Rubella of 32; Antibody Titer for Measles of 1.75; This spontaneous report has been received from a physician referring to a 34-year-old male patient. The patient's pertinent medical history, drug reactions or allergies and concomitant medication were not provided.  On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status unknown) (M-M-R II) subcutaneous injection (route of administration, dose, lot number and expiration date were not provided) for prophylaxis.  On unknown dates, his suspect vaccine antibody titers was tested with antibody titer for measles of '1.75', antibody titer for rubella of '32' and antibody titer for mumps of '79.2' (all units not provided) (antibody test abnormal, rubella antibody positive, mumps antibody test positive). At time of reporting, the reporter was unable to confirm if the patient was previously administered measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status unknown) (M-M-R II) and was also unable to confirm if the patient's suspect vaccine dose series was interrupted prior to or at current call time. The outcome of the events, the causality assessment between suspect vaccine and the events were not reported. No additional adverse event (AE) or product quality complaint (PQC) was reported. No further information was provided.  This is one of two reports from the same reporter (link# US-009507513-2302USA004000).; Sender's Comments:  US-009507513-2302USA004000:case number 02334107
Pt. received ZOSTAVAX SQ of inner side, lower left arm 2" x 3" rash appeared at injection site 2 days later. Dr. recommended ice and BENADRYL cream and to consult with pharmacy on 6/24/14 due to concern of injection site. Pharmacy consulted with manufacturer who stated CDC does not show any safety or efficiency concerns in SQ locations outside of deltoid.