chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse regarding unspecified patients of unknown age and gender. Information regarding the pertinent medical histories, drug reactions or allergies and concomitant therapies were not provided. On unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 injection (lot # M011840, Expiration date 01-FEB-2018; lot # L037554, Expiration date 25-DEC-2017; lot # L026602, Expiration date 19-OCT-2017; lot # L024993, Expiration date 17-OCT-2017) (dosing details not known). The administered doses experienced a temperature excursion of 49.7 degree Fahrenheit for 8 hours. The call was because of a data logger. There was no previous temperature excursions. No adverse effects reported. This is one of the two reports received from the same reporter. Additional information has been requested.
Dev't of quarter-sized red spot at injection site on (L) arm. Thurs/Fri (11/3-11/4) Dev't swollen lump at injection site. Lump decreased in size from 11/3-11/4, was warm to touch. Sat (11/5), lump small sized site of injection still red, site is also itchy.
a 19 month old patient was administered Menactra by mistake instead of ActHIB; a 19 month old patient was administered Menactra by mistake instead of ActHIB; Initial information received on 09-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 19 month old patient who received a dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] by mistake instead of HIB (PRP/T) VACCINE [ACT-HIB] batch, expiry date via unknown route and unknown site of administration.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to wrong vaccine administered and Inappropriate age at vaccine administration.  It was unknown whether the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.
Possible extreme and chronic fatigue arising a few weeks after second dose; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW1050) via an unspecified route of administration in the left arm on 02May2021 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to sulfa and unspecified medical history, which the patient declined to provide. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient received any medication within two weeks of vaccination. It was unknown whether the patient received any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the right arm on 07Apr2021 (at the age of 38-years-old) as a single dose for COVID-19 immunisation and received erythromycin (MANUFACTURER UNKNOWN) for an unknown indication on an unknown date and experienced drug allergy. On an unknown date in 2021, a few weeks after second dose of Pfizer COVID vaccine, the patient experienced possible extreme and chronic fatigue. On 13Apr2021 and 09Jun2021, the patient underwent COVID-19 test via nasal swab and the result was negative. On 29Jul2021, the patient underwent COVID-19 test via nasal swab and the result was unknown. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the event extreme and chronic fatigue arising a few weeks after second dose was not resolved at the time of this report.
Status epilepticus with generalized seizure for 45-60 minutes, with intermittent seizures even after versed administration by EMS. Required intubation due to respiratory distress and worsening mental status, possibly secondary to versed. Also possible aspiration pneumonia due to seizure. Observed on continuous EEG overnight without clinical or subclinical seizures. Urinalysis was not concerning for UTI. Given 1 dose of Keppra and then discontinued due to lack of seizures on EEG. Was extubated the next day 01/14/2020 and transferred to the floor. However on 01/15/2020 developed respiratory distress likely secondary to bronchiolitis and/or pneumonia and was transferred back to ICU for increased respiratory support. Still hospitalized in ICU at this time.
Narrative:  Patient received J&J vaccine on 5/28/2021. He reported hand tingling ~2 weeks after receiving vaccination. Tingling progressed to bilateral upper extremity weakness. On 9/22, patient presented to the ED at MC and reported leg weakness. NIF was -40. Patient denied difficulty breathing. MRI head and c-spine were negative for acute pathology. Neurological work up was negative for acute pathology. GBS suspected. Patient was given IVIG 0.5g/kg x 4 days.
This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unspecified dates, the patients were vaccinated with doses of improperly stored M-M-R II lot # M029230 with expiration date on 08-JUN-2018 (albumin status, dose and route of administration were not reported). The doses of vaccine underwent a temperature excursion of 9 to 25 degrees Celsius for 32 minutes. Digital data logger was used to record the excursion. The doses of vaccine did not undergo any previous temperature excursions. No adverse effects were reported. A properly stored sterile diluent (lot number and expiration date were not reported) was used to reconstitute the doses of M-M-R II. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1705USA011196.
Patient developed cutaneous  large depigmented patches on the extremities and head. Onset was two weeks following second Moderna vaccination. Biopsy confirmed diagnosis of vitiligo. Patient reports patches progressed for several months. At time of dermatology visit, depigmentation was no longer progressing, but the patches had not re-pigmented.
Pt recv vax on 10/2/98; post vax pt exp sore throat, cough & not feeling well (10/98); tx=Amoxicillin
Miscarriage.  Not sure of my exact date of conception, but it fell between my first dose(Moderna10/21/21) and 2nd dose (Moderna 11/22/21).  Experienced known standard vaccine side effects, achy, fever, chills for about 12 hrs with first dose and the same for second dose but slightly longer, maybe 2.5 days of not feeling well.    I noticed I missed my period  after my 2nd vaccine, got an at home pregnancy test and discovered I was pregnant.  Had my first Dr. visit for a blood test and general screening. (No ultrasound).  The next Dr visit, Jan 25th, was for my 11 week screening, due date mid Aug 2022, came back with no heart beat and Dr said baby looked small maybe 6 week mark.  I was given pills for a forced labor to help remove the miscarriage.    I think there could have been a connection between vaccines and this miscarriage.  I have a healthy 1.2yr old and not much family history of this.  I understand this could be unrelated, but given the timing felt I should report it.
7/19 patient presented to ER and was admitted for generalized edema, elevated BNP, tachycardia, DM, and anxiety.    Acute CHF, cardiomyopathy, and apical mural thrombus.    Patient was diuresed, placed on heparin drip and anticoagulants, insulin adjusted.   Echo performed.  Labs.
Headache, Arthralgia, HA, JOINT PAIN, HYPERSENSITIVITY Narrative:
SWOLLEN PAINFUL LYMPH NODE UNDER ARMPIT ON RIGHT SIDE; SWOLLEN PAINFUL LYMPH NODE UNDER ARMPIT ON RIGHT SIDE; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: ewu62) via an unspecified route of administration in the right arm on 07Apr2021 at 12:00 PM (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient included hypothyroidism, penicillin allergy and allergy to antibiotic (CECHLOR). The concomitant medications included levothyroxine sodium (SYNTHROID), ascorbic acid (VITAMIN C), vitamin B12  (MANUFACTURER UNKNOWN) and Biotin (MANUFACTURER UNKNOWN); all from an unknown date and for an unknown indication. The patient had known allergies to medications include penicillin and cechlor. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: er2613) via an unspecified route of administration in the right arm on 17Mar2021 at 12:30 PM (at the age of 59-years-old) for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Apr2021 at 06:00, after 2 days of vaccination, the patient experienced swollen painful lymph node under armpit on right side. No therapeutic measures were taken for the reported events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event swollen painful lymph node under the armpit on the right side was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
12JUN diarrhea same day p/vax;13JUn fever, greater than 104 per mom next day febrile sz taken to hosp ER, 1 sz observed in ER:home w/fever instructions;14JUN not eating, rash (red dots) head to toe;
Injection site itching and mild swelling and rash in near perfect triangle. 3" x 3" in size.
In Mar2023 started like allergies and sneezing constantly and it was frustrating. Then there were heavier symptoms like a cold and I felt the congestion in my chest. Z-pak that was 10year old and I took it. I called my doctor on 7MAR2023.  I have given a fresh prescription of Z-pak. It took a long time to clear my chest and I coughed a lot like pneumonia symptoms. I was sick for over 3 weeks. I tested negative for COVID-19.
Tested positive for Covid; Dry cough; Red mark on arm; chills; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid), COUGH (Dry cough), CHILLS (chills) and ERYTHEMA (Red mark on arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced COUGH (Dry cough), CHILLS (chills) and ERYTHEMA (Red mark on arm). On 26-Jan-2021, the patient experienced COVID-19 (Tested positive for Covid). At the time of the report, COVID-19 (Tested positive for Covid), COUGH (Dry cough), CHILLS (chills) and ERYTHEMA (Red mark on arm) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information was provided. No relevant concomitant medications reported.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 85-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "allergies" (unspecified if ongoing); "htn" (unspecified if ongoing). Concomitant medication(s) included: COLD RELIEF, start date: 02Jun2022, stop date: 04Jun2022, also reported as, other medication in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included anti viral Paxlovid started on 03Jun2022 and stopped on 07Jun2022. Clinical course reported as, patient symptoms went away after about day 4 of paxlovid and returned again on about a week later still testing positive on COVID test now day ten. Patient received no treatment for symptoms and not recovered from symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Monday morning I drove to my job and suddenly began to feel nausea, dizziness, and drained of energy. I thought it was dehydration so I drank triple the amount of normal water intake to rule that out. I also tried to stay seated as much as allowed which I felt the same in any position sitting, standing, outside, or inside. 3 days went by and still felt the same and could not get rid of the symptoms. Called my family doctor to discuss what happened and they told me to take allergy medication. I did so for the recommended amount of days on the package and symptoms worsened not relieving the effects. The symptoms continued to persist for a total of 14 days before beginning to feel normal again.
After receiving last vaccine patient experienced a hypotonic hypo responsive reaction. After which she vomited several times. Patient was given juice and monitored for 15 minutes before being walked to the car by the nurse.
Patient received PREVNAR 13 on Monday 11/2/15. Next day patient developed a rash on LUE (injection site). Patient had on and off symptoms of chills, sweats, dizziness, nausea and diarrhea throughout the week. When patient arrived to clinic on  11/7/2015 she presented with symptoms of LUE arm pain and swelling from shoulder to elbow surrounding 3/4 of arm circumference, warm to touch, dizziness, SOB, jaw pain, discomfort with moving head left, right, up and down, throat tingling and tightness. Vitals were stable and patient was not in respiratory distress. EMS called for transport to hospital and 50mg IM BENADRYL given. Patient transferred to local ED.
After the 2nd Pfizer vaccine I started getting a ringing in my ears.  Went to Dr. for the ringing and found out I had hyper tension (high blood pressure), I have never had any history of high blood pressure or the ring in the ear.  The Dr has put me on blood pressure medication but the ring in the ears still continues.
12/20/2020 had the 1st covid19 Pfizer vaccine, left arm. no rash on the area of the injection site.  Abdominal rash started, which was maculopapular and itchy. continued  on abdomen but slightly had improved over the month, so went ahead and got covid19 second vaccine, 1/20/2021.  Later rash within 1-2 days, then spreading to chest and to thigh area, and recurring on abdomen.  Eventually went to allergist, had increased zyrtec to 40mg po daily, however, persistent rash of which they were not sure if related to vaccine as it is Pfizer and not Moderna, and symptomatic treatment with steroid cream and continue Zyrtec.   but site of injection, left deltoid remains rash free.  still having issues with the rash, 1/30/2021.
Guillain-Barre syndrome; other zoster-related conditions; Information has been received from an attorney regarding a case in litigation, concerning a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.  In on about 01-JAN-2016, the patient received a dose of Zoster Vaccine Live (ZOSTAVAX) (dosage, route, anatomical location, lot # and expiration date were not provided) for the long-term prevention of shingles and zoster-related conditions, at a clinic.   On unspecified date, the patient was treated by healthcare providers for Guillain-Barre Syndrome and other zoster-related conditions (Ill-defined disorder). As a direct and proximate result of patient's use of the vaccine, she had and would continue to suffer ongoing injuries, including but not limited to medical care and treatment for these injuries, medical losses and costs include care for hospitalization, monitoring treatment, medications and supplies. At the time of the report, the patient was not recovered from the adverse events. The reporter considered Guillain-Barre Syndrome and zoster-related conditions to be related to Zoster Vaccine Live (ZOSTAVAX) vaccine.   Upon internal review, the event of Guillain-Barre syndrome was considered medically significant.
Just getting over the Shingles. Got the shot/ suspected vaccination failure; Just getting over the Shingles.; the pain was unbearable/ non ending pain; could not sleep; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and insomnia. On an unknown date, the outcome of the vaccination failure, pain and insomnia were unknown and the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the vaccination failure, shingles, pain and insomnia to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was unknown. The patient got the shot couple years ago, after seeing what shingles did to a couple of his/her friends and the patient was just getting over the shingles. The doctor said that, the patient could get the shingles again as the patient painfully found out and without the shot, shingles would have been worse. The patient stated he/she was thankful to get the shot then, cause the pain was unbearable. The patient stated he/she could not sleep and experienced non ending pain and his/her right arm was (unspecified). The patient prayed to never get shingles again and recommended to get the Shingles shot.  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Patient the with a mild  axonal sensory neuropathy confirmed by electrophysiological evaluation with an onset at the time of her 1st injection with worsening leading to hospitalization at a local hospital after the 2nd dose were symptoms were exaggerated symptoms have since improved but continue.  Her symptomatology  is worsened by onset of chronic fatigue, widespread pain and sleep disturbance.
Patient tested positive for Covid-19 on 1/22/21 and died on 2/8/22
This study case was received from the investigator on 13 August 2012. A 34-year-old male subject received an injection of ACAM2000 (lot number not reported) on 05 April 2012 and a dose of anthrax vaccine (manufacturer and lot number not reported) on 02 April 2012. The subject had an abnormal ECG and echocardiogram on 09 April 2012. On 12 April 2012, Troponin I was abnormal at 00.31 and the subject had an abnormal MRI of the heart. On 17 April 2012, the subject was diagnosed with non-specific myocarditis. The subject had no significant medical history. The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance study. Documents held by sender: None.
headache, fever of 99.8,  nausea, vomiting, increased bowel movement but not diarrhea, lightheaded, muscle aches and very sore arm self treating. ( it's only 6 hours since sx began)
Initially presented with weakness/fatigue. He was found to have abnormal liver enzymes with  AST/ALT in the 900s, T bili of 10, creatinine of 1.7.  CK was elevated >13K. Patient overall worsening and anuric requiring possible hemodialysis for worsening renal function. Overall picture most suggestive of rhabdomyolysis. Unclear etiolgy but can't rule out a vaccine reaction.
Rash with a bump underneath at the injection site that occurred 8 days after injection. Rash decreased after taking hydroxazine, bump was still present at time of this reporting.
VACCINE ADMINISTERED BEYOND THE TWO HOUR RECOMMENDED STORAGE WINDOW AT ROOM TEMPERATURE; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a 20 year old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 17-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 17-AUG-2021, the patient experienced vaccine administered beyond the two hour recommended storage window at room temperature. On 17-AUG-2021, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine administered beyond the two hour recommended storage window at room temperature and incorrect product storage was not reported. This report was non-serious.
Patient became very nauseous & put head between knees while trying to get it under control while sitting & ended up tipping forward & falling & too weak/dizzy to get up so spent night on floor, slept all evening & night. Was shaky & weak & said bones hurt. Next day started getting better. Wanted us to be sure to report this.
Pain, Myalgia Information has been received from a health professional concerning her husband who on 22-DEC-2005 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot #651330/1048P). On 22-DEC-2005, the patient developed achy deep muscle soreness. Unspecified medical attention was sought and the patient was treated with acetaminophen (Tylenol) and ice. At the time of the report the patient had not recovered. A product quality complaint was no involved. Additional information has been requested.
Information has been received from a physician concerning a female with a history of "passing out" while having her blood drawn in the past who on 13-AUG-2008 was vaccinated with the first dose of GARDASIL. After receiving the first dose, the patient "passed out". No injuries noted. The outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.