chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a non-healthcare professional on 28 October 2016. This case involves an 87-year-old male patient who was vaccinated with a dose of FLUZONE HD (Batch number: UI697AB, expiry date: 06 May 2017, dose and dose in series were not reported) intramuscularly in the right arm on 27 October 2016. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as no known allergies (NKA). Illness at the time of vaccination was reported as chronic kidney disease (CKD). Concomitant medications were not reported. Any other vaccinations within four weeks of vaccinations were also not reported. On 28 October 2016, one day following the vaccination, it was reported that the patient felt weak in legs. The patient was vaccinated with FLUZONE HD in last year. The patient required emergency room (ER)/ doctor visit. Laboratory investigations and corrective treatment were not reported. The outcome of event was reported as not recovered. List of documents held by sender: none.
Itchiness; knot; minor rash; swollen arm at injection site; WARNING: THE STUDY CONFIGURATION IS MISSING THE STUDY PHASE. PLEASE UPDATE THE STUDY PHASE AND RE-GENERATE THE NARRATIVE AGAIN.    This     The subject received mRNA-1273 (Moderna COVID-19 Vaccine). The report describes a case of PRURITUS (Itchiness), VACCINATION SITE INDURATION (knot), VACCINATION SITE RASH (minor rash) and VACCINATION SITE SWELLING (swollen arm at injection site).     No Medical History information was reported.  On an unknown date, the patient experienced PRURITUS (Itchiness), VACCINATION SITE INDURATION (knot), VACCINATION SITE RASH (minor rash) and VACCINATION SITE SWELLING (swollen arm at injection site). At the time of the report, PRURITUS (Itchiness), VACCINATION SITE INDURATION (knot), VACCINATION SITE RASH (minor rash) and VACCINATION SITE SWELLING (swollen arm at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Treatment included ice and heat.
Started to feel dizzy; nauseous in evening received shot; This is a spontaneous report from a contactable consumer (patient herself). A 76-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot/Batch number: unknown), via an unspecified route of administration on the left arm 13Feb2021 at 2:15pm as a SINGLE DOSE for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. COVID prior vaccination was none. Since the vaccination, patient had not been tested for COVID-19. COVID tested post vaccination was none. Patient other vaccines within 2 weeks prior to the COVID vaccine included tamsulosin hydrochloride (FLOMAX), ondansetron (ZOFRAN), furosemide, oxycontin and oxycodone. The patient's medical history included bladder issues, celiac disease and allergy (reported as known allergies Yes 17 rxs). On 13Feb2021 at 11pm, the patient started to feel dizzy and nauseous in the evening received shot. The patient reported that the symptoms got progressively more pronounced. It was reported that patient did not receive any treatment for events. The outcome of the events was not resolved.
Blood clot inner  left leg 3 inches above ankle; blood clot cylindrical in shape  1 inch long 1/2 inch diameter
Had a period that has lasted a full month into my next menstrual cycle. I'm on birth control and bled right through my birth control.
This spontaneous report was received from a pharmacist referring to two unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with ZOSTAVAX, 19400 PFU, for prophylaxis, (Lot#, expiry date, dose, frequency and route of administration were unknown). ZOSTAVAX might have been improperly stored. No adverse effects reported. No product quality complaint (PQC) was involved. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Narrative has been updated. Sender's Comments: MERCK 1608USA003112:Mfr number.
Given flu shot at school clinic. 1 hour later experienced numbness to left side of face, headache, nausea. Taken to MD, did not feel it was related to flu vaccine.
shingles; Information has been received regarding a case in litigation concerning a male patient of unknown age. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not provided.  On an unspecified date in 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) as long-term prevention of shingles and/or zoster-related conditions (dose, vaccine schedule, route of administration, site of administration, lot number and expiration date were not provided).  On an unspecified date in 2015, subsequent to zoster vaccine live (ZOSTAVAX) vaccination, the patient experienced shingles (herpes zoster). The patient received treatment and was suffering ongoing injuries, mental and physical pain and suffering; medical care and treatment for those injuries; significant medical and related expenses as a result of these injuries, including medical losses and costs include care for hospitalization (on an unknown date), physician care, monitoring, treatment, medications, supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death; aggravations of pre-existing conditions and activation of latent conditions; and other losses and damages. At the time of the report, the patient had not recovered from herpes zoster.  The causality assessment between zoster vaccine live (ZOSTAVAX) and herpes zoster was considered related.
Was working on a deck and began feeling tingling in both hands. More so in left, concentrating in pinky. Patient report no PMhx. Patient reports pinky has continued to loss of motor control in pinky. Numbness has subsided. Patient reports decreased grip strength. Reports it has improved since Saturday when this first began. Right hand was tingling as well but no loss of motor control or decrease in strength.
Patient returned to vaccine clinic at 11 AM and reported that he was dizzy with associated chest pain and shortness of breath.
01/06/2022  History of Present Illness  The patient presents with upper respiratory symptoms. 73 year old female who recently tested positive for COVID-19 presents for worsening cough and shortness of breath that started prior to arrival. Risk factors consist of age.  Associated symptoms: shortness of breath, cough, denies chest pain, denies abdominal pain, denies nausea, denies vomiting, denies fever, denies chills, denies headache, denies dizziness and denies back pain.
Pt presented to ED complaining of cough and shortness of breath.  Patient's symptoms started on Friday 1/7.  His had some fever, generalized body aches, sore throat, shortness of breath.  He tested positive for COVID-19 on 01/10/2021. Patient's acute hypoxemic respiratory failure was secondary to COVID-19 and likely superimposed bacterial pneumonia.  Patient received 2 days of Remdesivir, 3 days of doxy, 3 days of Rocephin while in the hospital.  Due to his bilateral central serous core urine output the patient is to strictly avoid corticosteroids.  Patient remained stable on oxygen and was able to go home with it.  Although he had elevated inflammatory markers due to covid his D-dimer was within normal limits.   Patient was incidentally noted to have bilateral renal cysts and hepatic steatosis.     Patient remained hemodynamically stable throughout hospital stay and was discharged in stable condition.
Swelling and redness at injection site, hot to the touch, 8 cm inflammation, with tightness and decreased range of motion, without lymphadenopathy.
bright red and pink; was sick for 2 days; joints and bones ached; Fever; joints and bones ached; back ache; This is a spontaneous report from a contactable consumer (parent). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 06May2021 18:30 (at the age of 45 years old) as dose 2, single for COVID-19 immunisation. Medical history included underactive thyroid. No investigation assessment. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE) taken for thyroid disorder from an unspecified start date and ongoing. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on Apr2021 (at the age of 45 years old) as single for COVID-19 immunisation and experienced sore arm. The patient experienced fever, joints and bones ached, back ache, bright red and pink, was sick for 2 days on 06May2021. Reported as, reporter mentioned daughter who had the shot and was sick for 2 days. This was with the second vaccination, she had the Pfizer. All of her symptoms, fever, joints and bones aching, back ache and being bright red and pink, lasted 2 days. Outcome of all the events were recovered on May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I had J&J vaccine around 12:30 on 4/12/2021.  No issues at all until 11 p.m., started with sudden onset high fever (103), shaking chills, mild short-lived nausea, and immediate thumping splitting headache and very severe body aches and joint pain.  In bed until 12 noon the next day  feeling terrible.  On couch rest of day with fever fluctuating from 100.3 to 101.1. Went to bed 4/13/2021 with 101.1 fever, woke up 5-6 times drenched in sweat (fever trying to break?) and then was able to get out of bed, fever resolved.  Still achy and puny on 4/14/2021 but much better.  I took NO medications during the side effects/adverse events from the J&J vaccine.  I do have significant left arm pain at the injection site still on 4/14 but there was no redness, warmth, or rash at the site, arm looks completely normal.    Very typical flu like reaction.
This spontaneous report was received from a physician via a company representative referring to a female patient of unknown age. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. In an unspecified date in 2017 (also reported as "about 1 year ago"), the patient was vaccinated with GARDASIL 9, intramuscularly, for prophylaxis (dose, lot # and expiration date were not reported). It was stated that immediately after received the vaccine the patient experienced syncope. Additionally, the patient fell forward off the examination table at the time of the syncope. On an unspecified date, the patient went to her physician office and a facial x-ray and another unspecified test were performed and they were normal. On an unknown date, the patient experienced headaches. At the time of reporting, the outcome of syncope and fall were unknown. The outcome of headaches was reported as not recovered. The causality assessment between the events and GARDASIL 9 was not provided.
2/9  red itchy rash , sore arm for 3 Day 2/16. Hives for 3 days , chills on the third day 2/23.  Red, itchy rash for 3 days 3/4. Hives lasting for 5 days
the patient technically got half a Menactra dose because the patient received 0.5 mL of the diluted solution/no AE; accidentally diluted Menactra with the sterile diluent that was used with the MMR and Varicella/no AE; Initial information was received on 02-Aug-2021 regarding an unsolicited valid  non-serious case received from a Nurse via the [Global Medical Information (GMI) under reference-00706608].  This case involves a 12 year-old male patient who accidentally got half of the  MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (0.5 mL of the diluted solution) which was diluted with the sterile diluent that was used with the MMR and Varicella (underdose) (product preparation error).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for prophylactic vaccination.  On 31-Jul-2021, the patient received 0.5 mL (of diluted vaccine) [once; standard] dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6952AA and expiry date 09-Jun-2022)  via an intramuscular route in the right deltoid for prophylactic vaccination.  It was a case of an actual medication error due to vaccine underdose (latency was on same day).  It was a also a case of inappropriate reconstitution technique.  It was reported that "NP asking if they need to repeat the MENACTRA dose. NP states that the patient technically got half a MENACTRA dose because the patient received 0.5 mL of the diluted solution (MENACTRA). NP asking if they re-administer the dose if it would be another full dose or if they would give a half of a dose. NP asking if there are certain potential side effects to watch out for since the patient will be receiving a dose and a half total".  The patient was fine and there was no type of adverse event.  outcome of the event was unknown.  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.
Body coveted with itchy painful rash. Biopsy revealed Bullous pemphigoid. Still have it after 1.5 years
This subject is a two year old female, who expired due to asphyxiation while enrolled in a comparative post marketing safety study of Daptacel (Diphtheria and tetanus toxoids and acellular pertussis vaccine absorbed) administered with other recommended vaccines according to the standard of care at 2, 4, and 6 months of age in infants and as a booster to toddlers. The subject received four dosed of the study vaccine. The last dose prior to the event was given on 11/14/2003. Other vaccines administered on that day included a dose of ACTHIB, lot number W1452 (manufacturer lot number UA873AA), a dose of MMR lot number 0131N, a dose of Prevenar lot number 493505, a dose of VZV lot number 0344N. The routes and sites of administration were not provided. The subject presented to the ER in full code for probable aspiration of food. The subject subsequently deteriorated and resuscitation was unsuccessful. The subject expired due to asphyxiation 319 days post immunization. The coroners office determined that the cause of death was a bean in the subjects trachea. Autopsy results were not been requested. The event of asphyxiation was reported by the investigator as unrelated to the study vaccine. Further information is not anticipated, this case is considered closed. 3/7/06 Autopsy report received which states COD as asphyxia secondary to bean lodged in mid trachea./ss
swollen lymph nodes; nose bleeds; This is a spontaneous report from a contactable consumer, the patient. A 21-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration on 21Apr2021 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient was not reported. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration on 21Mar2021 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Apr2021, the patient experienced swollen lymph nodes and nose bleeds. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event(s). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events of swollen lymph nodes and nose bleeds were unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
10/16/18 -mother noticed easily bruising and disproportionate bruising and bloody noses that took 20 minutes to clot. Took pt to PCP. Bruising stated in the beginning of 7th grade school year sometime in early August. Pt had no other symptoms that mother noticed. CBC showed platelets of 5,000.   10/16-18 / 2018 Hospitalized and given IVIG treatment. 11/2018 -Diagnosed with ITP (idiopathic thrombocytopenia purpura) after bone marrow biopsy.
Initial feeling of vaccine through my veins.  Then heart tightness on first day.  Also pains near left chest near arm pit.   In the last 30 days heart palpitations, fluttering and sharper pains.  Uncomfortable to sleep or rest laying down.  Getting progressively worse.  Now some left arm numbness.
G47.33 OBSTRUCTIVE SLEEP APNEA 5/1/2023 NARCOTIC OVERDOSE, INTENTIONAL SELF HARM, INIT
Approximately two weeks post vaccination, the pt experienced acute demyelinating encephalomyelitis.  The pt deteriorated rapidly and died.  The cause of death was encephalomyelitis.  An autopsy was performed, but the brain was liquified.
Nurse calling to report VARIVAX was administered to patient while it had a temperature excursion. Exact date of administration not provided. Patient is asymptomatic. No additional AE. No PQC. Names of vaccines involved (including lot/exp) VARIVAX W03; no additional ae; This spontaneous report was received from Other Health Professional and refers to a patient of unknown gender and age.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 1 dose, lot #W032370, expiration date: 10-OCT-2024, administered for prophylaxis (strength, and route of administration were not provided).  On an unknown date, nurse was calling to report that varicella virus vaccine live (oka/merck) (VARIVAX) was administered to patient while it had a temperature excursion. Exact date of administration not provided. Temperature excursion was 24.4 degree F for 5 hours and 51 minutes. Patient is asymptomatic. No additional AE. No PQC.
Moderna COVID-19 Vaccine EUA  Side effects kicked in around 10 hrs after the vaccination Severe body pain for over 20 hrs Pain reduced down after 24 hrs Had fever over night for a couple of hours Sweating, feeling hot and cold for a couple of hours Arm received vaccination still in pain after 48 hrs Loss of appetite for over 24 hrs
5/13/11 2AM States noted onset of hives & RUQ stomach pains & not feeling well. Temp 102.2 at 5AM. 10:45AM c/o Rt upper quadrant pain, chills, joint pain.
Syncopal event about 10-15 minutes after shots given. Does have known diagnosis of vasovagal syncope. Monitored her for about 2.5 hr. since she was dizzy, pale, nauseated. She finally slept for approximately 30 min. and felt better.
I got Bronchitis and Laryngitis while I was traveling and arrived back home on the 28th of August. I took a COVID-19 test and it was negative. After a few days I had started to begin to feel worse and by 09/02/2022 I had a positive COVID-19 test. By 09/04/2022 I was very sick and had to speak with my physician since I was wheezing and coughing. I had a telemedicine appointment and was prescribed PAXLOVID, and inhaler, and cough syrup. I started taking them right away and I was sick for around 8 days. I was sick with a cough, sore throat, wheezing, and headache however I had a headache that persisted towards two weeks afterwards. After that I started to feel much better.
Pt reports to primary care clinic complaining of loss of tissue at injection site for wellbaby vaccines. Mother states last set of vaccines was Feb/Mar and 4 were received - IPOL, Comvax, Prevnar and Varivax. The loss of tissue has been progressive per patient. Patient info not available, only age.
THE PATIENT CALLED AND SAID THAT HIS TREMORS HAVE WORSENED, SIGNIFICANTLY.  HE STATES THAT HE USUALLY HAS TREMORS, BUT HE WAS BARELY ABLE TO FEED HIMSELF TODAY.
PATIENT FAINTED WITHIN 2 MINUTES OF RECEIVING THE VACCINE, SWEATING.  EMS ARRIVED BY THAT TIME PATIENT WAS CONSCIOUS.  DURING THEIR ASSESSMENT, PATIENT FAINTED AGAIN
Menstrual cycles are extremely heavier; Menstrual cycles are extremely heavier, painful and irregular.; Menstrual cycles are extremely heavier, painful and irregular.; Menstrual cycles are every 2 weeks; This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old, non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021(at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported.  Prior to the vaccination, the patient was not 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 four weeks prior to the vaccination.  On an unknown date in 2021, the patient's menstrual cycles are extremely heavier,  painful, irregular and had menstrual cycles every 2 weeks. The patient did not receive any treatment for the reported events. The clinical outcome of the events extremely heavier, painful, irregular and menstrual cycles every 2 weeks were unknown at the time of this report.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information is expected.
Sore arm; Pregnant patient received Moderna vaccine; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PREGNANCY (Pregnant patient received Moderna vaccine) and PAIN IN EXTREMITY (Sore arm) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 02-Aug-2021. On 17-Mar-2021, the patient experienced PREGNANCY (Pregnant patient received Moderna vaccine). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PREGNANCY (Pregnant patient received Moderna vaccine) and PAIN IN EXTREMITY (Sore arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment medications were provided