chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case, initially received from other health professional (nurse) on 02-Oct-2018, concerning a female patient of an unknown age. The patient had not medical history. The patient did not receive any concomitant medications. Since an unspecified date, an opened multi dose vial (MDV) of FLUCELVAX QIV vaccine was left out of the refrigerator overnight and was exposed to room temperature of 73F for 16 hours, which was first excursion (explicitly coded as incorrect product storage). On 02-Oct-2018, the patient was administered FLUCELVAX QIV (dose: 0.5 ml, route of administration: intramuscular, batch number: 252229, expiry date: 31-May-2019 and anatomical location: not reported) which underwent temperature excursion (explicitly coded as drug administration error). The reporter assessed the case as non-serious.
Severe headaches, loss of vision with a beginning diagnosis of optical neurosis, continued headache and increased loss of vision In right eye after receiving steroids in hospital.
Information has been received from a consumer referring her 12 year old healthy daughter. The patient had no drug reactions or allergies. There was no concomitant medication. On 22-MAY-2015, the patient was vaccinated with first dose of unidentified Merck HPV vaccine (it was unspecified if it was GARDASIL or GARDASIL 9, lot number, dose and route were unknown). On an unknown date in 2015 (reported as "a few days later), the patient complained of waking with a very stiff neck and it was painful off and on. Then "for the next 3 or so weeks", the patient was experiencing different pain in her knees and feet. She was diagnosed with rheumatoid arthritis. The symptoms was so bad that the doctor had to drain her knees because there was a lot of fluid there. But the pain was still continued and the patient was referred to arthritis clinic nearby where she continued aggressive treatment for the arthritis. In approximately June 2016 (reported as "about 2 months ago"), the patient was feeling relief of the arthritis and she could be "an active teenager again". At the time of report, the patient had received all 3 dose of unidentified Merck HPV vaccine. The outcome of rheumatoid arthritis was recovering. The causality between the events and suspect therapy was unknown. Upon internal review, the event rheumatoid arthritis was considered to be medically significant. This is one of two reports received from the same reporter. Additional information has been requested.
One hour after the shot I had hives from the shot site to my wrist, stomach, and hives on my ankles.; This is a spontaneous report from a contactable consumer, the patient. A 63-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 03Apr2021 at 18:45 (at the age of 63-years-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19 on an unknown date. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) for an unknown indication from an unspecified date. The patient previously received  Ibuprofen (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced allergy. Prior to the vaccination, 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 vaccines within 4 weeks prior to the COVID vaccine. On 03Apr2021 at 19:45, one hour after the vaccination, the patient experienced hives from the shot site to her wrist, stomach, and hives on her ankles, that lasted for 4 hours. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the event hives from the shot site to her wrist, stomach, and hives on her ankles was recovered on 03Apr2021 at 23:45.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Systemic: Rash (other than injection site)-Medium; Lasted 4 days
severe local rxn to pneumovax fever & vomiting problem secondary to rxn;Ibuprofen, ice applications;
PATIENT PASSED OUT WITH EYES OPEN.  SHE COULDN'T SEE ANYTHING FOR A FEW SECONDS.  SHE CAME TO AND THEN ABOUT A MINUTE LATER, IT HAPPENED AGAIN.  SHE WAS COMPLETELY PALE BUT CAME TO WITHIN A COUPLE OF SECONDS AND THEN FELT BETTER.  WE DID CALL PARAMEDICS, WHO CHECKED HER HEART RATE AND BLOOD SUGAR.  THEY DID NOT TRANSPORT HER.
Vesicular lesions at site of injection left thigh, truncal rash. Both 10 days after immunization. Tylenol - observation - comfort measures.
Information was received on 13-OCT-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX vaccine on or about 10-OCT-2014 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 22-DEC-2016, the patient was treated at a clinic, for the onset of a severe vesicular rash accompanied by weakened immune systems, which was diagnosed as severe herpes zoster, or shingles. The patient has been prescribed VALTREX for management of her painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering and other damages. Additional information has been requested.
flu; Initial information received on 16-Oct-2021 regarding an unsolicited valid Social Media non-serious case received from a consumer or non-healthcare professional via social media.  This case is linked to cases 2021SA349452(Cluster).  This case involves female patient who experienced flu (influenza) while receiving vaccine INFLUENZA VACCINE.  The patient's past medical treatment, vaccination, concomitant medication and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event (flu).  The event outcome was unknown for influenza.  There will be no information available on the batch number for this case.
On 12/06/2022 I started feeling shortness of breath and swollen extremities. I was referred 12/30/2022 to a Pulmonologist and was prescribed an inhaler. I also have an upcoming Cardiologist appointment on 01/20/2023.
Patient called that night stating her right arm was very sore, she was unable to make a fist, deltoid immunization site was red and very hot. She also complained of nausea and headache. She stated that her arm was immediately hot and sore after her shots but she went to play Ultimate frisbee. During this game she became nauseous. She was advised to take 600 Ibuprofen if stomach could tolerate it, put hot compresses on arm and rest. A nurse called her back an hour later - her nausea was gone, still had a headache and arm was a little better. She could then make a fist but could not lift her arm above her head. She stated the heat helped a lot. She agreed to call if things get worse.
Chronic fatigue; A warm, red lump where injection was administered; A warm, red lump where injection was administered; A warm, red lump where injection was administered; hypertension; sleep apnea; pre-diabetic; This is a spontaneous report from a contactable Nurse. A 71-year-old female patient received pneumococcal 13-val conj vac (DIPHT CRM197 PROTEIN) (PREVNAR 13) on unknown date at single dose via unknown route of administration for immunization. Medical history was not reported. Concomitant medications were not reported. Patient experienced chronic fatigue and a warm, red lump where injection was administered; hypertension, sleep apnea and pre-diabetic. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/ batch number cannot be obtained.
First dose 3/13/21: next day feeling "not normal".  Difficult to describe. Usual side effects - tired, slight headache, slight nausea Second dose 4/3/21: Less usual side effects - essentially no problems ***First booster shot 12/15/2021: Next morning "intense hyperactivity - lasted 12 hours".  Left hand shook Uncontrolled - lasted ~2minutes. Intense and extremely loud periodic ringing in ears - happened 4 times. each episode lasting 10-15 minutes  ****Since the first booster December 15, 2021 have experienced continuous tinnitus, varying degrees, day to day. Worse at night when it is quiet.****
Pt had (L) arm shaking at approx 3 PM on 1/15, then at 9:30 PM (L) arm, (L) leg shaking. Went to ER, and had generalized tonic clonic sz lasting 2 min. Pt was admitted. Now taking TRILEPTAL 120 mg qd.
Redness, blisters around sites of injection with pain in the arm. Inform to see provider or go to ER. Patient is not concern to go to provider or ER. Told her if symptoms worsening go to ER.
30th, I woke up with tired, sore throat, headache - continued to January 2 and I had  gotten worse with a severe cough; fever; body aches and I called employee health line and  they had me get a test for COVID and it was positive result on January 3. I did not have any treatment. I had most of the symptoms for two weeks and cough lasted for a month. I was recovered from the symptoms before getting second dose of vaccine which was January 19th.
12/22/21 Chief Complaint: Visit CC: see ehr.        pt states she has been   feeling "sick" dizzy, cought for about a  week.        Diarrhea for over   a week.   Patient is a 50 year old FEMALE who is being admitted to the Hospital. This patient meets inpatient  level of care because  Hypoxia 2/2 to COVID requiring oxygen  supplementaion  pt arrived from ER @ 2000 via wheel chair, pt has a diagnosis of COVID (+) and  hypoxia, pt able to make most needs known, vtatl signs with in normal limits, no  fever, received first dose of Remdesiver in ER, wanted benadryl for insomnia.  Dropplet precautions    12/26/21 Patient discharged from FCU following Covid hypoxia
HEADACHE HARD, WARM MASS AT INJECTIION SITE PATIENT REPORTS NO FEVER. PATIENT INSTRUCTED TO CONTACT PRIMARY CARE PHYSICIAN.
The pt experienced a fever of 100.7 at 10:00 PM on 5/25/01. The pt was taken to the ER. All blood work was normal. The pt returned home on 5/29/01. No problems are evident now.
Parent noticed swollen and red arm at the site of Infanrix, 2.5x4.5.
Information has been received from a registered nurse concerning a 13-month-old (previously reported as 13-month-old) who on 02-AUG-2007 was vaccinated subcutaneously in the left arm with a first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (Lot # 655346/1324F). Concomitant vaccines administered on 02-AUG-2007 intramuscularly in the right vastus lateralis (RVL) included a third dose of Hib conj vaccine (OMPC) (MSD) (lot # 655547/0076U) and a fourth intramuscular dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) administered in the left vastus lateralis (LVL). On the 02-AUG-2007 10 minutes post vaccination the patient developed wheal approximately 1cm x 1cm at the injection site. It was reported the patient did not receive any follow-up and was not treated. Nurse stated "she has never seen such a reaction before". On 02-AUG-2007 the patient recovered. Lot check has been requested. This is one of several reports from the same source. The records of testing prior to release of lot 655346/1324F have been rechecked and found to be satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released by the regulatory agency. Additional information is not expected.
total body pruritic started about 6 hours after administration: per pt, started from feet, then spread to legs, lower back, sides, then forearms. he took two Benadryl and it subsided while he slept (so exact duration unknown). he did use a dose of sildenafil the night prior to getting the vaccine.
1:30pm: Red, raised rash on abdomen and back. No other symptoms. Pediatrician notified - no treatment recommended. Rash noted after H1N1 vaccine given. May have been present before injection.
Fever, vomiting, dizziness for 24 hours and swelling and redness at site of vaccine that was approximately 3"x7" and warm at site.
The day after the vaccine 10/27/2021 I had rapid heartrate, extreme headache, temp of 102.1 And then that that night I began to feel better around 8pm. However, I was weak for 3 more days. I then had blood in my urine and was instructed buy my doctor to go to the ER on 11/01/2021. They diagnosed me with a UTI and gave me an antibiotic. It has now been a few days and I am feeling better. There is no more blood in my urine as of today 11/02/2021.
fever of 101°F-102°F for 3-4hours; feeling really sick; high temperature; chills; felt really tired; shivering; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ILLNESS (feeling really sick), PYREXIA (high temperature), CHILLS (chills), FATIGUE (felt really tired) and CHILLS (shivering) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced ILLNESS (feeling really sick). 10-Mar-2021, the patient experienced PYREXIA (high temperature), CHILLS (chills), FATIGUE (felt really tired) and CHILLS (shivering). On an unknown date, the patient experienced PYREXIA (fever of 101°F-102°F for 3-4hours). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 13-Mar-2021, CHILLS (chills), FATIGUE (felt really tired) and CHILLS (shivering) outcome was unknown. At the time of the report, ILLNESS (feeling really sick), PYREXIA (high temperature) and PYREXIA (fever of 101°F-102°F for 3-4hours) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case pertains to patient 2. Cases will be crosslinked. This patient (Patient 2) called a doctor and done blood work. The patient took Tylenol for treatment and the patient will see a doctor. concomitant medication include High blood pressure medication.
Large red swollen circle around injection site,  hardness around injection site, low grade fever, body aches, chills, and very tired.
Moderna Bivalent PeeWee  Lot#216K22A 0.25ml (12.5mcg) administered IM to pt.  This is Moderna Peewee Bivalent Dark pink cap with yellow border.  Pt should have received Moderna Bivalent 0.25ml blue cap and gray border 0.25ml (25mcg) per updated guidance.  Attempt to notify mother. Left v/m. Awaiting call back.  New card with correct lot # sent to address on file.
12/26/21 presents to EC ED for "LLQ abdominal pain". "with no significant PMHx"
A report was received from a healthcare professional on 10/20/2003 concerning a 68 year old female vaccinee who received expired Fluvirin on 10/20/2003. On 20 October 2003 the vaccinee received expired Fluvirin.  The vaccinee did not complain of any adverse event. There was insufficient information to determine the reporter's causality assessment. Follow up pending. Update 1. 11/19/2003. A follow up report was received from a healthcare professional indicating that the vaccinee received 0.5ml of Fluvirin on 10/20/2003. No follow up pending.
was supposed to be given Boostrix dose yesterday 26Jul2023, but was administered a dose of Kinrix instead; was supposed to be given Boostrix dose yesterday 26Jul2023, but was administered a dose of Kinrix instead; was supposed to be given Boostrix dose yesterday 26Jul2023, but was administered a dose of Kinrix instead; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old female patient who received DTPa-IPV (Kinrix) (batch number 7D2Y4, expiry date 22-AUG-2025) for prophylaxis.   Previously administered products included DTaP (had 5 prior DTaP doses).   On 26-JUL-2023, the patient received Kinrix. On 26-JUL-2023, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: was supposed to be given Boostrix dose yesterday 26Jul2023, but was administered a dose of Kinrix instead), inappropriate schedule of vaccine administered (Verbatim: was supposed to be given Boostrix dose yesterday 26Jul2023, but was administered a dose of Kinrix instead) and inappropriate age at vaccine administration (Verbatim: was supposed to be given Boostrix dose yesterday 26Jul2023, but was administered a dose of Kinrix instead). The outcome of the wrong vaccine administered, inappropriate schedule of vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 27-Jul-2023 Pediatric office reported that the patient had 5 prior DTaP doses, not counting one day before the reporting day dose.  The Vaccine Administration Facility was the same as Primary Reporter. The reporter gave permission for follow-up.   The patient was supposed to be given Boostrix dose one day before the reporting day, but was administered a dose of Kinrix instead at an inappropriate age, which led to wrong vaccine administered, inappropriate age at vaccine administration and inappropriate schedule of vaccine administered.
Death Narrative:  Death on 02/10/2021. 2nd dose 28 days prior to serious event. Patient was admitted to facility for ALS and was on mechanical ventilation at time of death. No indications that death was related to the vaccine.
disturbance to menstrual cycle/cycle began on 01Oct2021 to 04Oct2021, and the menstrual bleeding begins again on 16Oct2021; disturbance to menstrual cycle/cycle began on 01Oct2021 to 04Oct2021, and the menstrual bleeding begins again on 16Oct2021; severe suicidal ideation; first dose: 06Apr2021, second dose: 14Sep2021; This is a spontaneous report from a contactable consumer (patient). A 30-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown as unable to locate or read the details), via an unspecified route of administration, administered in arm left on 14Sep2021 as dose 2, single for covid-19 immunization. Medical history included ADHD, clinical depression, and allergies: almonds. The patient was previously vaccinated with the first dose of BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE, lot number unknown as unable to locate or read the details) administered in the arm left on 06Apr2021 for covid-19 immunization at 29-years old and experienced heavy, elongated cycle in addition to 2 weeks of heightened PMS symptoms. Concomitant medication included sertraline hydrochloride (ZOLOFT) taken for an unspecified indication, start and stop date were not reported. The second dose was administered in a pharmacy or drug store. No other vaccines were received within 4 weeks prior to the covid-19 vaccine. Prior to vaccination, the patient was not patient diagnosed with covid-19. The second dose caused severe disturbance to menstrual cycle. Cycle began on 01Oct2021 to 04Oct2021, and the menstrual bleeding begins again on 16Oct2021. Severe suicidal ideation for 2 weeks after completion of first menstrual cycle post-administration - suicidal ideation daily on 04Oct2021 (reported as between 04Oct2021 and 14Oct2021). Both events resulted in doctor or other healthcare professional office/clinic visit. Treatment received for the aforementioned adverse events included talk therapy and medicinal adjustment. The patient had a negative covid-19 nasal swab on 15Oct2021. The outcome of the events was reported as unknown. The events suicidal ideation and disturbance to menstrual cycle was reported as serious due to life-threatening.  The lot number for BNT162b2 was not provided and will be requested during follow-up.
Twins arrived home told mother they felt dizzy, and took a nap. At 1 AM, mother checked on daughters and they had fever. Tylenol given. By 6 AM, both girls had facial swelling, reported itchy feeling in mouth/lips. One twin's R jaw was swollen and red. Other eyes were swollen nearly shut and red, facial swelling around cheeks and lips. Taken to Hospital and treated, one twin with IV steroids. Both girls were released by 8 PM on 12/06/2014.
Patient was inadvertently given 0.3mls of Pfizer and 0.2 mls of Janssen from the same syringe at the same time.  There were no adverse events that I am aware of.  Patient waited 15 minutes after dose with no side effects.  Attempts to contact her have been unsuccessful via phone and MyChart.
DONOR STATES SYMPTOMS BEGAN 3/23/14 MORNING WITH SWELLING AND PAIN TO LEFT ARM AT INJECTION SITE, SORENESS TO ENTIRE BODY, AND SMALL AMOUNT OF VOMITING THROUGHOUT THE DAY. AS OF 12:20 PM 3/24/15 DONOR HAS FEVER OF 102.0.