chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hospitalized 12/24/2021; COVID-19 positive 12/24/2021; fully vaccinated  Discharge Summary    Date of Admission: 12/24/2021, Hospital Day: 8 Date of Discharge: 12/31/2021   DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Diarrhea Panniculitis Weakness Hypotension, unspecified hypotension type Diarrhea, unspecified type  COVID-19  C. difficile colitis    HOSPITAL COURSE: 77 yo/ man with PMH of A fib on Xarelto, type II DM, HTN and recurrent C diff who was recently admitted from 12/7-12/11 with second episode of c diff colitis and have completed a 14 days course of po VAnco on 12/21 with plan to continue a slow taper every 7 days.    He tapered his oral vanco on schedule  from qid to tid and very quickly  developed worsening diarrhea to the point of incontinence and associated presyncopal episode. The last couple of days he has increasing fatigue, malaise, myalgias and dry cough. Due to worsening diarrhea and malaise and another presyncopal episode today, he called ambulance and came to the ED.  Labs in the ED with sodium of 129, Cr of 1.32, LA of 1.9, covid PCR positive, CXR with Patchy bilateral airspace disease, predominating in the periphery of both lungs but NOT requiring Oxygen.    Patient received monoclonal antibody for COVID on 12/25. His CRP  228  and Ddimer 1440 not a remdesivir nor decadron candidate on room air. Patient was already on NOAC. Upped his vanco po dose to qid with plans of very slow taper per his outpatient regime. His electrolytes and fluid imbalance and mild AKI addressed. C.difficile testing was negative, however. His diarrhea could be secondary to covid too. His oral vancomycin was held and diarrhea improved. He was discharged to SAR in stable and improved condition.
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. On an unknown dates, in 2014 (reported as "since October 2014") the patients were vaccinated with improperly stored PNEUMOVAX 23 (dose, route, lot# and expiration date were not reported). No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Covid-19 vaccine given 09/20/2021  Manufacturer and Lot number not provided for entering in Immunization Registry  Depending on vaccine manufacturer, could be under the minimum age for immunization  Has been requested to enter all COVID vaccines into IR. The teams responsible for screening and administering vaccines were/are all employees.   They is assisting with entering information into IR and VAERS.
This spontaneous report as received from a nurse practitioner refers to a 12 months old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. No information on patient's concomitant medication was provided. On 22-DEC-2014, the patient was vaccinated with the dose of LIQUID PEDVAXHIB lot # K000074 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). This is one of several reports from the same reporter. Additional information has been requested.
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 71-year-old, elderly patient of an unspecified gender. It was reported that, the FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 23-Oct-2018, the patient was administered FLUAD (TIV) [route of administration: intramuscular, anatomical location: left deltoid, batch number: 250795, expiry date: 30-Apr-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805423 was crossed linked to original cases 201804863 due to same reporter.
Herpes simplex virus; Ecchymosis on extremities; Bruising on arms and legs; Sores on lips; Headache when walking in the morning; This spontaneous case was reported by a consumer and describes the occurrence of HERPES SIMPLEX (Herpes simplex virus), ECCHYMOSIS (Ecchymosis on extremities), CONTUSION (Bruising on arms and legs), CHEILITIS (Sores on lips) and HEADACHE (Headache when walking in the morning) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for Lymphocytic lymphoma.    No Medical History information was reported.   On 05-Apr-2022, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2022, the patient experienced HERPES SIMPLEX (Herpes simplex virus), ECCHYMOSIS (Ecchymosis on extremities), CONTUSION (Bruising on arms and legs), CHEILITIS (Sores on lips) and HEADACHE (Headache when walking in the morning). At the time of the report, HERPES SIMPLEX (Herpes simplex virus) and ECCHYMOSIS (Ecchymosis on extremities) had not resolved, CONTUSION (Bruising on arms and legs) and CHEILITIS (Sores on lips) outcome was unknown and HEADACHE (Headache when walking in the morning) was resolving.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication were reported.  The reporters causality for the events of HERPES SIMPLEX VIRUS, HEADACHE WHEN WAKING IN THE MORNING and ECCHYMOSIS ON EXTREMETIES with IMBRUVICA(IBRUTINIB) was a reasonable possibility. The reporter's causality for the events of BRUISING ON ARMS AND LEGS and SORES ON LIPS was not provided.  No treatment medication were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Information has been received from a physician concerning an infant patient, who on an unspecified date was accidentally vaccinated with a dose of PNEUMOVAX 23 (Lot # not reported) which was not indicated for patients under two years of age when they were supposed to give PREVNAR 13. The physician said they got the numbers confused with the 23 and 13. Follow up information has been received from the physician concerning a 20 month old (gender unknown) patient, who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (Lot # not reported). There were no adverse reactions. This is one of several reports received from the same source. Additional information has been requested.
This spontaneous report was received from a medical assistant and refers to a 4-year-old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 11-APR-2016, the patient was vaccinated with an improperly stored dose of (wistar ra 27-3) M-M-R II lot # L013601 and expiration date 08-JAN-2016 (dose and route of administration were not reported). It was reported that the refrigerator was out of range. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (sore arm) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), HCTZ, LISINOPRIL, SERTRALINE, SIMVASTATIN, BIMATOPROST (LUMIGAN) and DORZOLAMIDE for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced INJECTION SITE PAIN (sore arm). On 17-Jan-2021, INJECTION SITE PAIN (sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-024349 (Patient Link).
Patient developed rash on face across the forehead and on the arms approximately 2 weeks after injection.
early in March I began experiencing excessive swelling of upper eyelids and feet/ankles.  This is continuing and is now 7 months.  Doctor does not know what is causing this, thinks the two are unrelated but there have been no other changes in my routines/etc and I am now thinking that it may be related to my having received the vaccine.  Eye doctors don't know what's causing it, dermatologists have no direct opinion as to exactly what may be causing this.  My next appointment  is with an endocrinologist.  So, as a last resort I'm reporting this as I concerned it may have started as result of vaccine and I cannot recall anything else.  I want to know ifi its possible and if anyone else has reported similar issue(s).
A non-serious spontaneous report of secondary transmission, fever, chills and malaise was received from a 35-year-old female physician concerning herself, subsequent to her child receiving FLUMIST. Medical history and concomitant medications were not reported. The patient's child received FLUMIST on 23-Oct-2008. On 26-Oct-2008 the mother of the child who received FLUMIST, who is a physician, stated she experienced symptoms of fever, chills and malaise. The mother stated that she understood that risk of transmission was very minimal. The mother stated that on 28-Oct-2008 symptoms lasted for approximately 30 hours and she was feeling better.
pain at injection site/ left arm; pain when raising arm; This is a spontaneous report from a contactable consumer reporting for herself.   A 27-year-old non-pregnant female patient received her first dose of BNT162B2 ((PFIZER-BIONTECH COVID-19 MRNA VACCINE),  lot number: 9266, via an unspecified route of administration, administered in left arm on 25Jan2021 at 08:45 (at the age of 27 years old) as a single dose for COVID-19 immunisation.  Medical history included asthma from an unknown date, blood triglycerides increased from an unknown date, and drug allergy to cephalosporins from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included montelukast sodium (SINGULAIR) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Six hours after vaccine administration, the patient experienced pain at injection site/ left arm on 25Jan2021, and pain when raising arm on 25Jan2021. The patient did not receive treatment for the events. The outcome of the events pain at injection site/ left arm, and pain when raising arm was recovered on 26Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Pt exp erythema & pain @ inject site w/in 24 hrs of immun; Also, pt had generalized myalgia & hives on the upper arm @ inject site; Tx DPH, Ephedrine & ice packs; Pt asymptomatic w/in 72 hrs p/immun;
Severe menstrual cramping with nausea and vomiting, heavy  bleeding, longer menstrual  period  at 8 days ( normal for me is 4 days). Break through bleeding the week prior. No ovulation following that menstrual period on October 21st,2021 according to ovulation testing of LH hormones.
tested positive for covid; A spontaneous report was received from a consumer concerning a 83-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tested positive for covid.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 8 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 031L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 18 Feb 2021, the patient experienced the event(s) tested positive for covid.. she is feeling good feeling and would like to know if she can take her second shot.  Treatment details included Robitussin.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), tested positive for covid was unknown.
Pt 22 y/o AF pregnant (6 mos) gestation. Pt reports shortness of breath and dizziness 1 to 1 1/2 hours after receiving vaccination in clinic. Pt called clinic from her home and reported symptoms to clinic RN on duty.
Day 1 achiness, Day 2 achiness in both shoulders andm right hip in AM by mid afternoon, nausea, vomiting and shakes and coldness Day 3 all symptoms gone until I got out of bed and I went from feeling fine to being barely able to walk from one end of my house 50 feet w/o total exhaustion setting in this lasted fro nearly 36 hours.  Most of strenght backon Day 5 but still some weariness.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 10-MAY-2010, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 08-FEB-2015, the patient was treated at a medical center for a blistering vesicular outbreak that was diagnosed as severe herpes zoster, or shingles. 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.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Batch/Lot number: unknown), on 04Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 28Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 27 years for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Beta blockers" (unspecified if ongoing); "Optical migraines" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Anemia" (unspecified if ongoing); "Eczema" (unspecified if ongoing); "Vitamin D and vitamin B12 deficiency" (unspecified if ongoing); "Vitamin D and vitamin B12 deficiency" (unspecified if ongoing); "IBS" (unspecified if ongoing); "constipation" (unspecified if ongoing); "acid reflux" (unspecified if ongoing); "nausea" (unspecified if ongoing); "abdominal pain" (unspecified if ongoing); "Postural orthostatic tachycardia" (unspecified if ongoing); "low blood pressure" (unspecified if ongoing); "dizziness" (unspecified if ongoing). Concomitant medication(s) included: XANAX; LEXAPRO; GABAPENTIN. Past drug history included: Neomycin, reaction(s): "Known allergies: neomycin"; Melatonin, reaction(s): "Known allergies: melatonin". The patient also received Birth control medication in 2 weeks product. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Sep2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Body temperature: (20Sep2022) 101.4 Fahrenheit; SARS-CoV-2 test: (20Sep2022) Positive; (25Sep2022) Negative; (29Sep2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: It was reported that patient positive on 20Sep2022 with 101.4 F fever, back pain, nausea, chills, sore throat, headache, dizziness, cough, postnasal drip, chest pain, increased heart rate, started Paxlovid on 20Sep2022 and completed full course 24Sep2022. Tested negative on 25Sep2022 and feeling better. Patient was tested positive 29Sep2022 with low grade fever, sore throat, back pain, nausea, postnasal drip.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I became feverish with warmth flowing within my body. Then chills and even, tasted the medicine in my mouth and nostrils. I didn't vomit, although I felt the slight urge.   I slept during the day and it helped.  The next day I was  fine. I thought the medicine was strong. This happened two weeks after the 1st dose.  I'm waiting for the 2nd dose in two weeks, and I'm thinking, is it safe to take after this happened?
this hosp employee recv vax & devel spider-like rash or bites on rt arm;these pruritic, bite-like marks then spread to lt arm, abd, upper thighs;
Pt vaccinated with TD & OPV returned from lab after having blood drawn & immunization given, child cold & clammy & pale. Drl Losoya examined child.
Extra dose administered; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Medical Information (Reference number- US-SANOFI-00479881) and transmitted to Sanofi on 17-Feb-2021  This case involves a patient (unspecified age and gender) who had administered QUADRIVALENT INFLUENZA VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot number and expiry date not reported) via unknown route in left deltoid for prophylactic vaccination (extra dose administered)  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was a case of an actual medication error due to extra dose administered (latency same day).  Caller said that patient administer FLUZONE HD on 27 Oct 2020 and then later it was administered again on the 16 Nov 2020. Caller wants to know if should be concerned or if there is going to be adverse effects.   At the time of report, 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 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.  There will be no information available on the batch number for this case.
anterior thigh red, swollen 24 hr p/inj; tx apply ice, DPH & APAP
After receiving HPV vaccination having a near syncopal episode and fall while checking out of the office. She initially complained of a headache but denied any neck pain. She was raised to a seated position a wheelchair and brought into an examination room. After receiving HPV vaccine #2 she was pale, diaphoretic, with a weak pulse. She was brought to a reclined position with improvement in color and strength in pulse. Water intake has been low on the 90° day. Patient observed for 15 minutes. She was placed in a supine position with elevation of her legs with resolution of her symptoms. She drank apple juice with complete return to normal baseline. Headache symptoms resolved. No cardiac findings on exam or neurologic findings. She is released to home and will monitor for any further symptoms. Recommend increasing fluid intake.
patient claims that by next day arm was swollen sore red and now as of 3 days later is warm to touch and more swollen and getting worse as days pass from the vaccine. We have not seen the localized reaction it was reported over the phone. Patient advised to seek medical attention and has not to this point. she also received fluzone hd in same arm on the same day
My daughter received two doses of the GARDASIL vaccine which has resulted in Thyroid disease, fainting, tingling, anxiety, sweating, dizziness, hair loss, low monocyte count, and low alkaline phosphatase count, Gluten intolerance, and gastrointestinal distress. She suffers from fatigue.
7/26/06, day 1, within 5 minutes of shots: passed out to side with eyes open and mouth clenched shut.  8/3/06, 8 days later, 3 red "pimple" spots appeared on right upper arm.  8/5/06, day 10, 3 spots = a mass full of heat.  Day 12, saw family physician.  Prescribed Keflex & Clarinex.  8/8/06, day 13, medicine helped mass by relieving the heat and size gradually.  8/10/06, day 15, saw infectious disease specialist.  8/3/06, day 8: tiredness, stiffness of joints, headaches.  Still have all these symptoms at day 19 8/14/06.  Pain in arm at site of injection (right arm) & heaviness in both arms (this has subsided).
~ 2 HRS AFTER RECEIVING THE SHOT ON 01/05/2021  I EXPERIENCE  HEADACHE AND SORENESS AND NUMBNESS ON THE INJECTED SIDE.  WHEN I GOT HOME I WASNT FEELING WELL AND STARTED TO EXPERIENCE CHILLS, WEAKNESS AND MY HEADACHE WORSEN.  TO THIS DATE IM EXPERIENCING THE FOLLOWING SYMPTOMS: HEADACHE, BODY PAIN, LOST OF TASTE AND SMELL, LOW GRADE FEVER AND SHOOTING PAIN ON MY R LOWER RIB CAGE.
Mild generalized rash, classic for chicken pox, onset approximately 12/25/2004.
noticed swelling to rt thigh @ about 1030AM; brought pt back, to be seen; ice pack to rt thigh x 24 hrs; APAP next 1-2 days;
Patient received the HPV and following 3 minutes later patient complained of lightheadedness. She was escorted to exam table to lie down. Patient stated started to feel better and remained for 10 minutes. BP was taken 113/64. Raised to sitting position, BP 97/75, BP 2 minutes later 116/74. Raised to standing position, walked 5 steps, BP 106/70. Patient stated feeling better and escorted to car. Explained to patient if reocurrance lie down.
About 15 minutes after vaccination, patient began to experience lightheadedness and numbness, tingling and itching to her face.  Vital signs showed tachycardia, but otherwise within normal limits.  Taken to ED and noted with a rash to  chest and neck.  Given Benadryl 50 mg IV, famotidine 20 mg IV and solumedrol 125 mg IV.  Symptoms resolved.  Discharged with Benadryl 25 mg PO TID PRN, famotidine 40 mg PO at HS and prednisone 60 mg daily x 3 days.
Patient had a bad headache on 10/5.  She couldn't sleep, and went to bed late, around 2:30AM.
NO REALLY ADVERSE EVENT, BUT TOLD BY REGIONAL PHARMACY MANAGER SINCE THE SECOND SHOT WAS MORE THAN 42 DAYS THAT THIS REPORT NEEDED TO BE FILLED OUT
This spontaneous report as received from a pharmacy technician refers to a 1-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 22-JAN-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA001558.