chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from an office manager refers to 2 unspecified patients of unknown demographics. On 15-AUG-2013, the two patients were vaccinated with a dose of GARDASIL (lot # J002641, expiration date 10-DEC-2015) that underwent unsupported temperature excursions. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
PATIENT IS A NURSE AND ADMITS TO RECEIVING 2 DOSES OF MODERNA AT ANOTHER PROVIDER THEN RECEIVING 2 DOSES OF PFIZER.  PATIENT DID NOT DISCLOSE THE FACT  RECEIVED 2 DOSES PRIOR. AND PATIENT IS VERY HAPPY RECEIVING 4 DOSES AND WANTED TO KNOW WHY THEIR 4 DOSES ARE NOT SHOWING UP ON SCHEDULER DETAILS OR THE APP.
Information has been received from a physician concerning a 75 white female with urinary incontinence, diabetes, sleeplessness and penicillin, codeine, Ambien allergies who on approximately 05-AUG-2007 (or 06-AUG-2007) was vaccinated IM with a single dose of Zostavax (Oka/Merck). Concomitant therapy included oxybutynin (02-AUG-2007 to 05-AUG-2007), Glucotrol XL (September 2006) and lorazepam (September 2006). On 06-AUG-2007, about 24 hours after vaccination the patient felt like she had achyness around the thorax and felt like she was going to get a shingles rash. It was reported that the patient felt achyness thoughout, had fever (on 07-AUG-2007), malaise and fatigue (on 06-AUG-2007) for 7 days and then felt ok. At the time of report the patient had recovered. The patient's experience was considered to be disabling by the reporter. Additional information has been requested.
The pt experienced respiratory distress and fever. Onset from 8-12 hours post vax. The pt was hospitalized for 24 hours. Treated with albuterol. Diagnosed with Viral Respiratory Infection with RAD
Mom reports child c/o respiratory difficulty and nervous 15 minutes after receiving vaccines and went to ER for treatment. Reports child on prednisone now.
L arm SQ area above elbow from pneumonia shot on Wednesday afternoon- by Thursday morning area became sore - swollen to the size of a quarter -reddened - had violent shivering episodes - Friday at dinnertime noticed it was getting bigger-shivering continued - had trouble moving her arm due to the pain - took Motrin and Darvocet but did not take away pain.  Saturday morning awoke and went directly to the ER approx. 11am - the hospital completed blood work - Pt stated she was told she had an infection - a CT scan was completed and IV pain medication was started - CT scan showed no abscess - started on IV antibiotics - was not admitted - Given Vicodin and a PO antibiotic - Was unable to sleep because of pain. Sunday she called her family physician and stated it was worse - PCP told her to go to hospital for admission immediately. Pt was in hospital for 4 days on IV antibiotics and pain medications - diagnosed with cellulitis.  Released to home on Wednesday evening with Vicodin and Bactrim BID. Swelling has decreased - pain has decreased "a little" - Will follow up with physician tomorrow. 2/8/08-records received for DOS 2/3-2/06/08-Presented to ED with C/O left arm pain and swelling, pain in left hand. PE: left upper extremity erythema and duration located in triceps region, minimal fluctuance with discomfort on palpation. DX: Left upper extremity cellulitis.
Shingles out break/ shingles under her; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included myelodysplasia, decreased immune responsiveness, myelofibrosis and herpes simplex type i.   On 18th March 2019, the patient received the 1st dose of Shingrix. On 14th May 2019, 57 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose in the left arm. The patient had a history of a decreased immune system, myelofibrosis, mylodysplacia and HSV1 (herpes simplex type I).  The patient experienced a shingles out break under her breast and on her back. The patient did not receive dose 1 at the reporter's facilities and therefore, the reporter could not provide lot number or expiration date for dose 1. However, the patient planned to continue follow-up with her physician on an unknown date and she consented to follow up. The case US2019116923 was found to be duplicate of case US2019118478. Hence case US2019118478 would be deleted and all the information of this case will be added in case US2019116923 which is case of record for this patient.
Swelling in both hands, severe. Began around 1:00 1:30am on 7/13/06. Improving but conditions still exists as of 7/13/06 11:00am.
Patient was seen in the ED 12/29/21 and discharged with COVID-19. Patient returned for care 1/1/22 and discharged for COVID 19. Patient was admitted on 1/4/22 for acute respiratory failure and still hospitalized. Pt. is a 83 y.o. female with a past medical history of mixed anxiety and depressive disorder, migraines, obstructive sleep apnea, mixed urge and stress incontinence, hypertension, GERD, CKD stage 3 who presented to the emergency department due to worsening of shortness of breath and cough.  Patient started experiencing nasal congestion sore throat and cough along with shortness of breadth 1 week ago after she had an exposure from a family member.  She also has been experiencing diarrhea along with urinary urgency frequency and dysuria that started few days ago.  She was prescribed Ceftin for urinary tract infection but she was not able to pick up the prescription and eventually only took 1 dose of antibiotic prior to this presentation for her urinary tract infection.  Patient continues to have rigors chills fatigue.   In the emergency department patient was hemodynamically stable.  Due to hypoxia was placed on 2 L of oxygen.  AST and ALT were elevated at 80 and 41. Procalcitonin was high at 3.29. UA positive for urinary tract infection.  Cultures consistent with E coli due to elevated D-dimer patient also underwent CT angiogram which was negative for PE.  Patient was started on Decadron in the emergency department due to concern for acute hypoxic respiratory failure secondary to COVID and admitted for further management of COVID pneumonia and urinary tract infection.
Pfizer 3/14/21, 4/11/21, 11/15/21. Positive on 8/30/22
Initial report received on 31 DECEMBER 2013 (Pregnancy report) from an investigator. A 26-year-old female subject had vaccine exposure before pregnancy. The subject had received first intramuscular dose of IMOVAX in the left thigh on 25 JUNE 2013 (batch number not reported). The subject's current pregnancy history with risk factors (e.g. alcohol, tobacco or recreational drugs) was not reported. The last menstrual period date was 11 SEPTEMBER 2013. The mother's (subject's) health status was not reported. The father's health status was not reported. The father's age was 27 years at the time of report. The subject had two previous pregnancies. The subject had no births with congenital abnormality, 1 live birth without congenital abnormality, no pre-term birth, no elective abortions, one spontaneous abortion prior to 20 weeks gestation in JULY 2010 and no fetal death (>20 weeks gestation). She did not receive any treatment for infertility. The subject had no family history of congenital abnormalities. The subject had no maternal drug exposure. The subject had no relevant non-serious adverse event. The prenatal testing (including amniocentesis, alpha foetal protein, serologies, ultrasound, genetic screening and any other tests) was not reported. She had no reported pregnancy complications. Her estimate date of delivery was 18  JUNE 2014. The pregnancy was ongoing at the time of report. List of documents held by sender: none.  Unblinding information received on 20 DECEMBER 2013: The subject received INOVAX on 25 JUNE 2013. Follow up information received on 02 FEBRUARY 2014. The subject's current pregnant history included group B strep diagnosed on an unspecified date in JANUARY 2014 with 7 days of unknown antibiotic use. The mother (subject) was relatively healthy, other than bicuspid aortic valve (birth). The father's age was 27 years and health status was healthy. The subject had no reported pregnancy complications. Follow up information received on 03 FEBRUARY 2014. It was reported that the conception date was determined by ultrasound, and subject had regular menstrual cycle before pregnancy, pre-natal testing-ultrasounds, routine blood work, ultrasound dates as 13 NOVEMBER 2013, 11 DECEMBER 2013, regular heartbeats, another was scheduled on 05 FEBRUARY 2014.
After receiving nasal H1N1 vaccine at 3:15 PM, SP 500758P, experienced lightheadedness and warmth. VS taken and stable, given OJ, client admitted she had not eaten since breakfast. Wt 135, T 98.4, P 82, B/P 110/71.
Injection site reaction with heat, redness, and swelling plus headache and fatigue. Panic attacks reported 9 days after vaccine administration.
This case was received from a health professional on 18 April 2008. Seriousness Criteria: Other-Medically Significant. A 15-year-old female patient, with a history of type I diabetes and sulfa allergy, received an intramuscular left arm injection of MENACTRA (lot number U2548AA) and an intramuscular right arm injection of GARDASIL (Merck, lot number 1757U) on 04 March 2008. The patient was pregnant at the time of vaccination, and date of last menstrual period was 07 December 2007. At the time of the report, the patient had not experienced any adverse effects. Follow-up information received on 27 May 2008 from a clinic. Per the reporter, the patient was not seen at their facility. The name of the facility where the patient was evaluated was provided. No other medical information was received. Follow-up information received on 08 September 2008 from a healthcare professional. It was confirmed that the patient had no adverse effects following vaccination and that the date of her last menstrual period was 07 December 2007. The patient's estimated date of delivery was reported to be 18 September 2008. Her obstetrical history included no previous pregnancies. The patient's health during pregnancy and risk factors were not known. Follow-up information was received from the health professional on 27 October 2008. Based on new information received, the case was determined to meet serious criteria. Seriousness Criteria: Other-Medically Significant. The patient underwent an ultrasound on 18 August 2008 and a fetal stress test on 28 August 2008; results of both tests were reported as normal. Pregnancy complications included pre-eclampsia, failure to descend, and non-reassuring fetal status. A male infant was born on 29 August 2008 via C-section at 37 weeks gestation. Birth weight was 7 pounds 12 ounces, and birth length was 21.75 inches. Apgar scores were 8/10 at one minute and 9/10 at five minutes, and the infant had no congenital anomalies. He was subsequently adopted, and no information regarding the infant or adoptive parents was available.
Patient had a blister like bubble at the site of the injection. Patient did not have any other symptoms besides the blister like reaction. It is now getting a little bit bigger. She never had reactions to vaccines before and does not have any other allergies. Patient is being followed by her primary care provider and was suggested to wait until Thursday to reasses.
This spontaneous report was received from a registered nurse referring to a 16-year-old male patient. The patient's medical history and concurrent condition were not reported. He had no illness at the time of vaccination. His concomitant therapies included an unidentified Merck HPV vaccine, RECOMBIVAX HB, hepatitis a virus vaccine (unspecified), poliovirus vaccine inactivated (unspecified) and VACCIN TD. On 04-OCT-2016, the patient was vaccinated with an expired dose of M-M-R II (rHA, lot # K016153, expiration date 24-SEP-2016, exact dose was not reported), subcutaneously, in the right arm. No adverse effects were reported. A safety report was run and it was stated that the vaccine was safe and effective even though expired. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received. Sender's Comments: US-009507513-1610USA002517.
Admitted to hospital on 10/14/2021. This is an obese 45-year-old gentleman with a known history of prior  perirectal and perianal abscess x 6 in the past, several times requiring I and  D, last episode being almost 2 years ago.  The patient says that he has had  at least 2 colonoscopies in the past, the last one being more than 2 years ago  and that he has been ruled out for having any inflammatory bowel disease,  like Crohn disease or ulcerative colitis.  No family history of IBD as well.   Comes to the emergency room complaining of rectal pain going on for about 3  days now, which was worsening.  CT of the abdomen and pelvis shows a  perirectal abscess.  Dr., the surgeon, was called and saw the patient  in the ER, but during his rectal examination the patient had significant pain  so he wants Dr. not to see him again, so another Dr. will take the  patient for examination under anesthesia and possible I and D or surgical  intervention.  The patient will be kept n.p.o.  The patient is fully immunized  against COVID-19, but incidentally his COVID-19 test came back as positive  and on a CT lung windows, he has bilateral ground-glass opacities, but he is  currently saturating 100 to 99% on room air.  Denies any fever, chills, cough,  chest pain, or shortness of breath.  No loss of taste or smell.  He says at  work he wears the mask, but none of his customers do.  He will be admitted as  an inpatient for at least 2-3 days until we get his cultures back.He was started on IV antibiotics with IV Levaquin and Flagyl,and analgesics.   Incidentally patient also tested positive to COVID 19 however he denies any respiratory symptoms except muscle aches and pains. He is not hypoxic. Chest x-ray was unremarkable however the chest abdomen did capture the lower portion of the lungs with showed some ground-glass opacities on the right side.   He underwent rectal exam under anesthesia with rigid proctoscopy, incisional drainage of ischio-rectal abscess by MD on 10/15/21. Clinically he has done well. Surgical and blood cultures still pending . He was cleared for discharge on 10/16/21 by surgery service, and will complete 7 days of oral antibiotics (Levaquin and Flagyl), will follow up[ with MD in 2 weeks as swell as his PCP. Prescription for Norco 5/325 mg (#20) was provided.
SORE THROAT Narrative:  HAVING INTERMITTENT SORE THROATS THAT SHE AWAKENS WITH AND IT IS GONE IN A FEW HOURS
Site of injection became red and itchy with in 30 min or less. Over next four days pt describes pain as if someone punched her and on incident of it feeling a sharp pain only at site.
Chills starting around 10:30 PM, joined shortly after by an increasingly painful headache. Alternating between chills and being overheated on and off all night, while headache became worse. Had to take ibuprofen at 7:30 AM after not being able to sleep, and was able to sleep. Woke up at 1 PM and had to take another ibuprofen for the headache. Chills were gone, but was overheated and sweating for an hour or two. Had to take another ibuprofen at night, but headache wasn't too much worse. Headaches were gone upon waking up at 9 AM on Sunday.  Experienced lymph node swelling in armpit of arm that got the vaccination. Tried to do pushups, but became too painful. I had also experienced the lymph node swelling after my first vaccination 28 days before my second one. About a week after, and they always felt minorly swollen up until the time of my second vaccination. I didn't know they were caused by the vaccine until after the second vaccination.  Currently 1:20 AM on Monday, and I have been experiencing redness and itching in a large patch around the vaccination site all day.
I got a rash on my arms and legs for several days. They would go away as I slept and in the daytime and return in the evenings.
administered only the liquid portion/without reconstituting with accompanying antigen; administered only the liquid portion/without reconstituting with accompanying antigen; This case was reported by a pharmacist via sales rep and described the occurrence of inappropriate preparation of medication in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. It was reported that, the temporary medical assistants did not follow instructions for Shingrix and administered only the liquid portion to several different patients without reconstituting with accompanying antigen, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not recall many details. The reporter agreed to follow up.
06 Jan 2021 @1336: Presented to ED about 15 minutes after vaccine with complaints of nausea, vomiting, chills, and chest tightness. During this visit, she received IV fluids, Benadryl and Zofran by mouth.
A non-serious spontaneous report of administration to 20-month-old was received from a registered pharmacist. Medical history and concomitant medications were not reported. On 08-Nov-2008, a 20-month-old child (gender not reported) received FluMist, There was no adverse event associated with third medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.
Around 2:00pm, I was feeling tired.  I went home to take a nap.  Upon arriving at home,, I started to feel light headed and the room began to spine,.  I realized I was about to pass out.  I made my last call to my daughter for help.  When she came home I was unresponsive.  She called 911  and started doing what the 911 operator was instructing her to do. I  came to for a few seconds and pasted out again.  I woke up with my sister pounding my chest area.  I passed out again and work to EMTs asking me questions.  I lost my bodily function when I passed out.  On the way to the  ambulance, I began to throw up.  I passed out again and woke up on February 14.  I say up work because I have no recollection of what happened to me after I got in the ambulance.  I was taken to Hospital.  They ran all types of tests.  I know my heart was elevated.    I ended up leaving the hospital on dialysis and a implanted defibrillator.  I have 1342 pages of medical records that I can share.
administered expired vaccination - with no reported adverse event; Initial information received on 12-Sep-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who administered expired vaccination - with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical treatment(s), vaccination(s) and family history were not provided. The patient had no medical history, concomitant disease or risk factor.    On an unknown date, the patient received an unknown dose of suspect INFLUENZA QUADRIVAL A-B VACCINE, prefilled syringe (strength: unknown) lot UT7378NA, UT7376JA via intramuscular route in unknown administration site as prophylactic vaccination.  On an unknown date the patient was administered expired vaccination - with no reported adverse event (expired product administered) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  There were no lab data/results available. The company suspect product was inappropriately used as per local Marketing authorization. Intentions were no.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  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.
ataxia; This spontaneous report was received from a physician via company representative and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date in September 2019 (reported as "about two weeks ago"), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. It was unknown by reporter which dose in the series was given. On 01-SEP-2019 (reported as two weeks ago), the patient experienced ataxia and was treated by an unspecified Neurologist. The patient did sought medical attention. The outcome of ataxia was unknown. The causality assessment between the event and suspect therapy was not provided.
diagnosed with COVID-19; diagnosed with COVID-19; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age (reported as 62 without unit) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on 16Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter requested information on the administration of the second dose of the COVID-19 vaccine to a patient. The patient received vaccine first dose 16Dec2020; she was diagnosed with COVID-19 on 18Dec2020; started taking the medication "Bamlanivimab" on 21Dec2020. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: There is not a reasonable possibility that reported "diagnosis with COVID-19" is related to BNT162B2 vaccine.  Event developed 2 days after vaccination.  The event is most likely intercurrent medical condition.
No additional AE reported; Caller is a nurse who reports GARDASIL 9 was administered to an 8 year old female patient on 10/11/2023.; This spontaneous report was received from a nurse referring to 8-year-old female patient. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies was not provided.  On 11-OCT-2023, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (lot #W031448 was valid for formulation pre-filled syringe, expiration date 12-FEB-2025, exact dose, route of administration and anatomical location were not provided) for prophylaxis (Inappropriate age at vaccine administration). No additional adverse event (AE) or product quality complaint (PQC) reported (No adverse event).