chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I was hospitalized on April 1 for pyosalpinx of unknown origin (not STD related). Symptoms included fever, chills, fatigue, soreness, abdominal and back pain, and headaches. I was hospitalized for four days, and on IV antibiotics for three of those days, followed by two weeks of oral antibiotics.
Pt's mother emailed stating that her son's left arm was red, swollen and hot to the touch. Pt had a temperature of 99.0.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 2:36 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 2:36 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 78.78.  Concomitant products were not provided.  On 27-Oct-2021, Excursion time was 09 AM and 10 AM, temperature was 29 and 32 respectively, total doses given for the day was 116, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 29-Sep-2021 and 05-Oct-2021, vial was moved to clinic on 27-Oct-2021. 6 vials were sent to clinic. Vaccine BUD date were 29-Oct-2021 and 04-Nov-2021.  On 27-Oct-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 41, 9 AM: 29, 10 AM: 32, 11 AM: 43, 12 AM: 43, 1PM: 43, 2 PM: 46, 3 PM: 46, 4 PM: 46 and 5 PM: 45.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  Treatment medications were not reported.
Patient presented to the pharmacy 9/19/19 with a sore left arm. She said it hurt to move it and that the pain woke her up in the middle of the night. The injection sites appeared normal, but there were two small red bumps on the inside of the patients arm that appeared to be a rash. Patient was told to try ice, benadryl, and alternate ibuprofen and tylenol. Patient presented back to the pharmacy 9/19/19, she said the arm was still very sore and the rash had enlarged and spread. She was instructed to follow up with her doctor at this point.
1 week after injection developed 3"x2" red raised and itchy hive at injection site
Around 10/06/23 the patient got her flu shot and pneumonia shot (she didn't know the specific form or manufacturer). During that week and thereafter the color of her stool changed to yellow. The color is now changing back to normal.  She did report having a loss of appetite for the last 3 to 4 weeks.
Roughly  12 hours after receiving dose number 2, I started to have body aches, general malaise, a headache, eye pane, and left ear pain.   Around midnight, I started to experience severe chills along with the body aches. I woke up around 4:30 a.m. with a fever, 38.8?C orally.  All other symptoms continued as well.
pt recv vax 6JUL98 310PM & grandma stated pt told her that did not feel good;pt appeared very pale w/clammy arms & warm head;pt taken to exam room HR 72, BP 64/40 @ 315PM;02 mask placed;321PM HR 96, BP 86/50 color improved;
The vial was initially stored in the refrigerator on 20-Aug-2022 and was administered on 19-Sep-2022; The vial undergo 1st temperature excursion; No adverse event; Administered with vaccine stored in the fridge for 32 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with vaccine stored in the fridge for 32 days), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 20-Aug-2022 and was administered on 19-Sep-2022), PRODUCT TEMPERATURE EXCURSION ISSUE (The vial undergo 1st temperature excursion) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 053B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Sep-2022 at 3:00 PM, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 19-Sep-2022 at 3:00 PM,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with vaccine stored in the fridge for 32 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 20-Aug-2022 and was administered on 19-Sep-2022), PRODUCT TEMPERATURE EXCURSION ISSUE (The vial undergo 1st temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered with vaccine stored in the fridge for 32 days), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 20-Aug-2022 and was administered on 19-Sep-2022), PRODUCT TEMPERATURE EXCURSION ISSUE (The vial undergo 1st temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered with vaccine stored in the fridge for 32 days), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 20-Aug-2022 and was administered on 19-Sep-2022) and PRODUCT TEMPERATURE EXCURSION ISSUE (The vial undergo 1st temperature excursion).    No concomitant product use was provided.  Patient was administered one dose of the Moderna monovalent vaccine which had been in the refrigerator for 32 days and administrated on 19-Sep-2022 at 3:00 PM.   The vial size was 5.5ml. The vial was initially stored in the refrigerator on 20-Aug-2022. The vial undergo 1st temperature excursion.  No treatment medication was provided.
heart condition; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 17 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "heart condition".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A dose of Hepatitis B vaccine (ENGERIX-B) 10mcg/0.5mL was administered to a newborn by nurse and when nurse removed the syringe from the baby's injection site, found the needle still halfway in the injection site. It was prefilled syringe from manufacturer, the needle was separated from the syringe.
Large red, warm area on both thighs where vaccines were administered, lasted around 5-7 days ,no fever, no treatment
1 1/2 inch by 1 1/2 inch circle below injection site that is warm, red, and swollen.  Skin is not shiny or taut.  Bruised at injection site. Phone call to MD and told to mark borders and apply ice.
Headache & Myalgia Narrative: brain fog as well.. IV zofran, NS drip, dc'd w/ oral ondansetron
INR 3.8 on 8/10/15. Dose decreased. Pt given PREVNAR 13 8/11/2015. Patient developed left arm swollen and rash. Seen in clinic 8/17/15 INR 1.8.
Swelling of the lips, and parts of the area around the mouth. Still experiencing dry, chapped skin around the lips and mouth. Went to physician and dermatologist but still has symptoms from January. Already took steroid pack. Has an appointment with allergist next week.
Approximately 4 hours after receiving shot experienced minimal arm discomfort with some fatigue, mild body aches.  Later in the evening increased body aches, headache, fatigue, upper back shoulder on left side to the neck pain with a feeling of stiffness and ringing in the ears.  No fever.  Unable to lay on left side at all.  Took Ibuprofen 600 mg to get some relief and just slept.  Next day started feeling some relief later in the afternoon/evening.  Next day, just minimal soreness of left upper arm.
Basically, I felt like flu like symptoms. I had no energy, slept 16 hours at a time for about 10 days to 2 weeks and a horrible headache. I also tested positive with Covid August 23rd, I had tightness in my chest, horrible cough, my sinus were dry, debilitating fatigue, I had some breathing treatments and steroids and an antibiotic.
56 year old gentleman with only medical history being COVID-19 infection in October. Admitted on 4/13/2021 for a cerebral vascular accident due to thrombosis of right posterior cerebral artery hemorrhagic conversion (I63.331). Has left-sided weakness.  Patient also tested positive by PCR (Panther Aptima) on 4/14/2021.
Patient started feeling pain in the right hip he had replaced 2 years ago. He states that the only thing different he has done recently was getting the two vaccines. He stated that it starts in the top of his hip and will radiate down into his leg. He stated that he has never had a reaction to a vaccine, but thought it may be what is causing his hip pain.
Shot administered @ 0645, symptoms Started @ 0730 N/V, abdominal cramps, sweating, Pt. was given Benadryl @ 0734, was evaluated @ 0745 by RN and again @ 0756. Pt was transported to clinic.
Redness at sight, fever, fatigue, body aches, and increase swelling, and headaches.
left arm was sore; felt that his temperature was high / temperature was actually lower than that as it was 88.2 degrees Fahrenheit; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (left arm was sore) and BODY TEMPERATURE INCREASED (felt that his temperature was high / temperature was actually lower than that as it was 88.2 degrees Fahrenheit) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN, TORASEMIDE (TORSEMIDE), POTASSIUM CHLORIDE (KLOR-CON), CLOPIDOGREL BESYLATE (CLOPIDOGREL [CLOPIDOGREL BESYLATE]), LISINOPRIL DIHYDRATE (LISINOPRIL [LISINOPRIL DIHYDRATE]), METOPROLOL, APIXABAN (ELIQUIS) and LEVOTHYROXINE for an unknown indication.    On 11-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (left arm was sore) and BODY TEMPERATURE INCREASED (felt that his temperature was high / temperature was actually lower than that as it was 88.2 degrees Fahrenheit). At the time of the report, MYALGIA (left arm was sore) and BODY TEMPERATURE INCREASED (felt that his temperature was high / temperature was actually lower than that as it was 88.2 degrees Fahrenheit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 88.2 (Low) 88.2 degrees Fahrenheit.         No treatment medications were reported.   This case was linked to MOD-2021-318247 (Patient Link).
Pt recvd vax & exp numbness of fingers & neck pain; 5 days post vax exp aching painful discomfort of the lt side of neck, lt arm & shoulder; cervical spondylosis w/lt sided c6 radiculopathy; brachial plexopathy;pericapsulitis of lt shoulder
Patient was administered one dose of Pfizer Bivalent and should have received Pfizer Initial Monovalent
I got really sick; all the symptoms of COVID-19 besides cough and loss of small fatigue, fever 99.9, chills, nausea, loss of appetite. Tightness in chest when I ended my work day. I started to feel a little better the next day after I woke up. My period is now 15 days late. I have not gotten my period following the 2nd dose of the vaccination.
Unable to breath within 27 minutes, coded, rushed to emergency after crash cart medical trestment
This study case was received from the investigator in the trial on 04 December 2012. A 24-year-old male subject received an injection of ACAM2000 (lot number not reported) on 19 July 2012. Medical history and laboratory/diagnostic testing were unavailable. On 26 July 2012, the subject was diagnosed with chest pain, unspecified. 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 (data mining, non-interventional) study. Documents held by sender: None.
Information has been received from a health professional concerning a 12 month old female with a history of ear infections who on 06-Feb-2006 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (lot #649756/0381R). Concomitant vaccination included a dose of varicella virus vaccine live (lot #651280/0803R) and a dose of pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (Prevnar). During a 27-Feb-2006 office visit the patient's mother reported that the patient had decreased appetite, fever, otitis media and weight loss. She was prescribed (Zithromax). An office visit on 02-Mar-2006 showed ear and nose drainage, perforated eardrum and weight loss. She was prescribed ceftriaxone sodium (Rocephin). On 03-Mar-2006 the patient had ear pain and received ceftriaxone sodium (Rocephin) and Cefdinir (OMNICEF). On 07-Mar-2006 the patient was weak, constipated and was admitted to the hospital. Her glucose was 349 and she was diagnosed with diabetes. She was receiving insulin. AT the time of the report, the patient had not recovered. There was no product quality complaint involved. The patient's event were considered to be other important medical events (OMIC). Additional information has been requested.
Within a couple of weeks both legs began swelling.  Initial diagnosis on April 23, 2021 was cellulitis.  After much testing and scans she eventually got diagnosed with lymphedema.  She  was being treated for that when she contracted Covid, was admitted to the Hospital and died within a week of admitance on October 24, 2021
I had really bad body aches, headache, nausea, fatigue and very sore arm after my last Moderna booster.
I took out vaccine, Prevnar 13 & Prevnar 20 are placed side by side.  Gave syringe to another employee, she verified that it was correct.  She was in training, did not realize it was the 20 instead of the 13.  It was administered, no reactions at that time.  It was not found incorrect until it was placed in the computer system and the NDC did not match.
Information has been received from a physician concerning 3 patients who on unspecified dates were vaccinated with doses of Zostavax (Oka/Merck) instead of Varivax (Oka/Merck) (MSD).  There were no known symptoms reported.  The incident was "due to human error". There was no further information provided.  There was no product quality complaint involved.  Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report.  Additional information will be provided if available. 12/21/07 This is in follow-up to report(s) previously submitted on 9/24/2007. Information has been received from a physician and registered nurse concerning a patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Oka/Merck) instead of VARIVAX (Oka/Merck) (MSD). There were no known symptoms reported. The incident was "due to human error". There was no further information provided. There was no product quality complaint involved. This is one of several reports from the same source. Additional information is not expected.
23 year old healthy active male s/p first dose of Pfizer COVID vaccine fell forward off chair from sitting position, loss of consciousness x 30 seconds, forehead and face hit floor. Once returned to consciousness AOx4, but diaphoretic. BP 110/58 HR 50 RR 20 SpO2 98%. 1 inch laceration noted on bridge of nose and small abrasion noted on forehead.
Local cellulitis (3 cm) at inject site with pain / redness 24 hrs post injection.
1 - 10 min post injection - SOB/pale, bilateral wheeze. 2 - albuterol rescue inhaler x 2 - poor result 3 - 11:25 o2 via mask/albuterol neb x 1/ 911 to hosp  1/21/10 = TC "panic" attack re: parent. No problems residual pt. recovered
Patient had uncontrollable shaking and fever the day after being vaccinated. The patient was admitted to the ER 2 days later. The ER did confirm that patient had another infection going on which they were treated for, but the patient was concerned that since this happened so shortly after being vaccinated it could be related. They wanted to report it  in case any of the symptoms were not only related to the infection, but also the vaccination. Patient no longer is experiencing a fever and the symptoms of shaking have become minimal.
administered the 5th dose to a patient earlier than the schedule with no reported adverse event; Initial information received on 27-Apr-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves an unknown age and unknown gender patient who got administered the 5th dose to a patient earlier than the schedule with no reported adverse event while receiving vaccine diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect diphtheria-15/tetanus/5 ac pertussis vaccine Suspension for injection lot number not reported via unknown route in unknown administration site (dose, frequency, route, strength and expiration date: not provided) for prophylactic vaccination.  On an unknown date the patient got administered the 5th dose to a patient earlier than the schedule with no reported adverse event (inappropriate schedule of product administration) (latency- same day) following the administration of diphtheria-15/tetanus/5 ac pertussis vaccine.  Action taken- not applicable.  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.
The first of March I was taking out the trash I receive shortness of breath though it was because of my heart so I went to a heart doctor and we weren't getting anywhere early January while I was outside my heart rate went 128 and I called 911 and went to the hospital they did basic test spent 1 hour doing and test then waited in the waiting room for 7 hours then ended up going home and nothing was confirmed other the symptoms. I got a call from the doctor and she ask me if I can come back to the doctor and still didn't end up seeing anybody. So I went to The HCF and they did EKG and X-ray. I'm still having accelerated heart-rate.
she is still experiencing injection site swelling; she still has a red round spot that feels like a lump; This is spontaneous report from a contactable consumer (patient). A 76-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration, on 20Apr2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medication were not reported. It was reported that patient presented all the symptoms mentioned in the fact sheet the day after the administration that was on an unknown date in Apr2021. Reportedly, most of them went away after a day but she is still experiencing injection site swelling and she still has a red round spot that feels like a lump. The patient would like to know if putting a warm cloth on it will help. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a physician concerning a patient who was vaccinated with the first dose of GARDASIL. After the vaccination, the patient was diagnosed with Lupus. The physician felt that lupus was not related to therapy with GARDASIL. The patient's outcome was unknown. It was unspecified if the patient sought medical attention. Upon internal review, lupus was determined to be an other important medical event. Additional information has been requested.
Pt's mom states pt had reaction for flu vaccine; fever 103.1, heart palpitation fast, blood pressure high, also vomiting.
Strong metallic taste in mouth, stool, gas all smell like metal.  Six weeks from first administration of vaccine and two weeks after second administration it is still present.
Cold and shivering  Persisting High fever , over 18 hours  Headache and facial/jaw ache Hyper tiredness
devel hives @ injs ite of lt leg 24hr p/vax;hives spread to rest of leg then  trunk & face;phoned MD who instructed parent to give DPH;
pt recv vax 10MAY95 & 22MAY95 pt devel chicken pox on head, arm, chest, & back according to the pt's mom; No further details were provided;
High fever, 101-102 with malaise and fatigue for 36 hours beginning the night after vaccine given that morning.
Nursing my ten month old and the baby developed a 103 degree fever that lasted 4 days
I have had my menstrual cycle for over 2 months.  It is heavy, I am clotting, and I have spoken to my OBGYN several times and tried to remedy it.  I am on birth control.   They said that Everything inside looks good.