chrisvoncsefalvay/vaers-outcomes huggingface dataset:
@0825am, patient sitting in chair,, HEP A VACCINE was administered. Right after receiving HEP A VACCINE, noted patient went unresponsive. CODE BLUE was paged overhead. Put patient on a lying position with both legs elevated. Multiple staff rushed and came to help and assessed the patient. VS 134/61, 59 HR, 20 rr, 99% 02 sat at RA.   @0827AM, patient alert and verbally responsive. Patient stated "i'm fine ". No c/o pain or discomfort. No sob. Patient still remains in lying position with both legs elevated.   @0832am, patient alert and verbally responsive. No c/o pain or discomfort. No s/sx of resp distress. VS 129/7, 76 HR, 20 RR, 99% 02 SAT at RA. Advised patient to stay in the room for 15 more minutes to be monitored.   @0847am, patient stated he feels fine. No c/o pain or discomfort. No s/sx of resp distress. Advised patient to f/u with his PCC/COMMAND regarding the incident that happened today.
7 days following vaccination patient reported swelling to right lower extremity with pain and shortness of breath. 10 days post vaccine, patient admitted to hospital with pulmonary embolism as well as very large deep vein thrombosis.
Hepatitis A (Havrix) adult dose given instead of child dose.  f/u with patient no adverse reaction.
This spontaneous report was received from a registered nurse, referring to multiple unspecified patients of unknown age and gender. Information regarding the patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, patients were administrated improperly stored doses of ZOSTAVAX (lot # and expiration date were not reported). It was reported that the vaccine was exposed for 2800 hours at -1 C degree. No adverse effects were reported. It was reported that all the vaccines were back in range. The data logger was reported as yes. This is one of the several reports received from the same reporter. Additional information has been requested.
Information has been received from a physician and the mother of an 18 month old male with a history of many ear infections and a double hernia repair (at age 13 months) who on 09/22/1998 was vaccinated with the first dose of MMR II. The physician reported that the pt was a transfer into her practice. The pt was delivered by an emergency C-section for failure to progress after the mother was in labor for 36 hrs. The physician reported that when she first started to see the pt, shenoticed that the pt had behavior problems and a speech delay around 18 months of age (approximately March 1999). The pt was unable to say 8-10 words like he should be able to at the age of 18 months. The physician reported that the pt had multiple ear infections and referred him for audiology testing. It was reported that the testing was difficult because of pt's behavior. The pt was diagnosed with autism at 2 and a half years of age (in approximately January 2000). The physician reported that she saw the pt on 06/13/2002. He was vaccinated with the second dose of MMR II and that the pt attends a special school, receives speech therapy, and occupational therapy and was "doing much better." Upon internal review, autism was considered as an other medical event. Additional info has been requested.
Pain in left shoulder that has progressivly worsened. Today is 11/01/2015. I no longer have complete function of my left arm. Cannot raise it up. Will make an appointment to see a neurologist on Monday or as soon as I can.
Patient had several visits to the ED where she was subsequently hospitalized. The first occurred on 3/24/21 for 3 days, then on 4/1 for  4 days, and 4/10 for 3 days. These were all within  6 weeks of receiving COVID vaccination.
Muscle ache localized to the right arm, shoulder and neck. Significant tenderness in R deltoid (injection site).
HUGE ISSUES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 2021, the patient experienced huge issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of huge issues was not reported. This report was non-serious.
Post vax, the pt complained of extreme soreness in left arm at site of injection and under arm. No redness or swelling. No fever.
Client had "severe deep pain" in upper left arm. Not in shoulder nor in elbow.  Radiated from injection around the upper arm, across the arm pit, into the left pectoral  and breast area. Arm movement reported as painful and limited. Client had No redness. No swelling. No lymph node swelling. Also reported  self-treatment "like for a sore muscle" of movement, heat or cold for comfort without change in painfulness and limited range of movement for two weeks.  Client reported this has improved starting 12/11/2022.
DOE with reduced exercise capacity 1 week after Pfizer covid Vaccine #1, worsening.COVID vaccine on April 30 and May 25. Symptoms started in May. Diff includes PE, myositis, bronchospasm. Timing is suspicious for vaccine side effects. labs EKG CXR PFts  echo  CT angio neg 2021 - 2022 Started feeling better in Fall 2021 VO2 and exercise capacity not back to normal, plateaued. Moderna Bivalent vaccine Fall 2022 - felt very sick /achy/ huge axillary LN etc but no DOE. Still athletic.
She came home from school tired and fell asleep. Not typical behavior. When she woke up had a very bad headache and started chilling. Fell back to sleep. I took her temp at 530pm and it was 103'F. She said her eyes hurt were red and gave her 400mg ibuprofen. At 7 pm checked temp and still at 101.9. She was crying when awake complaining of pain and feeling bad from headache. Very lethargic. 840pm still sleeping.
Pain at injection site - began day after injection and lasted about 3 days Fever - began two days after injection and lasted about 2 days Headache - began day after injection and lasted about 3 days Fatigue - began day after injection and lasted about 3 days Sensation of dermal scratchiness over torso and legs (no visible rash) - began day after injection and lasted about 7 days
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Weakness-Mild, Additional Details: a female that came in with patient, was with him in vaccine waiting area. Hollered for help. We called 911 and pharmacist went to patient. Patient was helped to the ground from his chair and when asked his name he was able to respond. He had a pulse and was answering questions. Patient felt like he was clammy. We tried to take his blood pressure but got an error on the machine. EMS arrived quickly and checked his vitals and his blood sugar.
16 y/o female received immunizations 1/4/17. Several hours later noticed redness at back of left arm with tenderness. She took ibuprofen, ok since that time. No cold compress applied. Yesterday more swollen, improving today.
developed skin rash, flushing and mild throat tightness.  She has a history of similar events with various medications and flu vaccine
Site where given-warm, red and swollen-under L arm swollen- (axilla). Entire left arm is sore.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 15-OCT-2016, the patient received ZOSTAVAX for its intended purpose: the prevention of shingles (lot #, dose, and route # not provided). As a direct result of the vaccine, the patient suffered from a shingles outbreak, in addition to chronic pain, rash, and lesions to various parts of her body. The patient had her first shingles outbreaks on 01-JAN-2018 and was diagnosed with zoster ocular disease, causing her pain and loss of vision. As a direct result of the vaccine, the patient suffered and continues to suffer mental and emotional distress due to resulting physical limitations and serious of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of the events was considered not resolved. Causality assessment was related. The lawyer considered the shingles outbreak and zoster ocular disease to be disabling. Upon internal review, zoster ocular disease was considered to be medically significant. Additional information has been requested.
Chills, Body Aches, Temp 99.3, fatigue resolved within 48 hours from onset
Patient received vaccination in left arm.  Shot given in correct arm.  There was some bleeding, no pain.  Later that evening, patient's mother stated that the arm was warm, swollen, and itchy.
He had multiple skin infections mostly on his forehead and hip which he had 3 or 4 times. He was prescribed 3 different medications for them. This was when we found out he was allergic to sulfamethoxazole. The other two was clindamycin and doxycycline. He had done two courses of sulfamethoxazole and two courses of clindamycin. They did a culture to figure out what was going on and they noted it was a Mrsa infection. They finally figured the correct antibiotic was doxycycline and it did get better. This started at the end of September and was finally resolving by the end of November. He is still on the antibiotic to keep everything calm. The goal is to get him off the doxycycline before the end of this coming May 2023.
Patient developed face and periorbital swelling 3 days after receiving covid vaccine. Swelling continued next day, responding to antihistamine treatment
pt recv vax 6SEP95&devel hives under both arms&around trunk into the groin area;the hives were characterized as itchy,hard&hurt;tx by dermatologist however condition still exists;
We were in the car waiting for her sister to come out of her class when suddenly she started to bleed from her nose, confuse, right side of her face was numb, and later she was feeling pain in same area. I took her to the Hospital.
This spontaneous report was received from a medical assistant (clinical coordinator) and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On an unknown date in 2017, between 27-JUL-2017 and 03-AUG-2017, the patient was vaccinated with improperly stored dose of VARIVAX injection (lot # reported as N008077; expiration date: 09-MAR-2019; dose and route of administration were not reported). Concomitant therapy included properly stored sterile diluent (MERCK) injection. The reporter stated that the administered dose of VARIVAX was stored at temperature of -10.7 degrees Celsius for 2 hours 10 minutes. Data logger was used to detect temperature excursions. There were no previous temperature excursions reported. No adverse effects were reported. No product quality complaint was involved. This is one of seven reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA005837: US-009507513-1708USA005841: US-009507513-1708USA003358: US-009507513-1708USA005840: US-009507513-1708USA005836: US-009507513-1708USA005838.
Arm has feelings of numbness, even after the second shot, at the same facility on April  28th . Still numb as date of this report
This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. No concomitant therapies were reported. On 13-MAY-2015, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB (10mcg/1mL, 10X1DS/VTF) lot number K003533, expiration date of 07-FEB-2016 (route of administration was not reported), which was stored at -3.333 Celsius Degrees; for 472 hours, 1.1 Celsius degrees for 136 hours, 0 Celsius degrees for 32 hours, -1.1 Celsius degree for 1000 hours, -1.6 Celsius degrees for 24 hours, -2.2 Celsius degrees for 480 hours, -2.7 Celsius degrees for 208 hours and -0.5 Celsius degrees for 192 hours with lowest temperatures recorded of 26, 34, 32, 20, 29, 28, 27 and 31 Fahrenheit degrees respectively. The type storage was refrigerator. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
pt recvd vax;30 days later,foot pain,trouble walking;weakness progressed;by day 50 unable to walk;unable to crawl,dress,roll over in bed;EMG consistent w/ GBS or severe non neuropathy multiplex;
Fever, malaise, beginning approximately 12 hours after immunization. Duration approximately 36 hours with measure temperature up to 102.9 F.
Patient became extremely nauseous and dizzy 5-10 minutes after administration. After putting her feet up and drinking water her symptoms resolved.
pt became listless, turned pale, wouldn't wake up-when finally did just stared; devel low grade temp about 8PM; 930Pm sx began resolving;
Guillain-Barre type of thing; This spontaneous case was reported by a physician and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain-Barre type of thing) and LOSS OF CONTROL OF LEGS (loss control of the lower limbs) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 007H21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient reports back on 01DEC2020 he got Covid) on 01-Dec-2020, Weight bearing difficulty in December 2020, Movements abnormal in December 2020 and Hospitalization (Patient reported being hospitalized 3 times due to Covid). Concurrent medical conditions included Loss of control of legs since December 2020.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain-Barre type of thing) (seriousness criterion medically significant) and LOSS OF CONTROL OF LEGS (loss control of the lower limbs) (seriousness criterion medically significant). In February 2021, GUILLAIN-BARRE SYNDROME (Guillain-Barre type of thing) and LOSS OF CONTROL OF LEGS (loss control of the lower limbs) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included about 15 unspecified medications. No treatment was received for the side effects. Company Comment This case concerns an 89-year-old, male patient with relevant medical history of COVID-19, who experienced the unexpected event of Guillain-Barre syndrome (AESI). The event occurred on and unknown number of days after the first dose of mRNA-1273. The medical history of COVID-19 remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns an 89-year-old, male patient with relevant medical history of COVID-19, who experienced the unexpected event of Guillain-Barre syndrome (AESI). The event occurred on and unknown number of days after the first dose of mRNA-1273. The medical history of COVID-19 remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Information has been received from a physician concerning a female who was vaccinated with a dose of GARDASIL. Subsequently the patient experienced syncope. The patient sought medical attention in the physician's office. At the report time the outcome was unknown.  This is one of several reports receiving from the same source. Additional information has been requested.
headACHE and stomach tired since 1/12  1/26 lost vision right eye 30min headache was seen in er
This spontaneous report was received from a registered nurse refers to an unspecified patients of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 26-SEP-2016, unspecified patients were vaccinated with an unspecified number of improperly stored doses of M-M-R II, therapy type: rHA, lot # L028274 (expiry date: 28-JUL-2017), lot# L032181 (expiry date: 25-AUG-2017), lot# L036851 (expiry date: 23-SEP-2017), lot# L037356 (expiry date: 28-SEP-2017), lot# L047133 (expiry date: 24-NOV-2017) and lot# M004063 (expiry date: 25-JAN-2018). No adverse effects reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with VARIVAX (Merck). Dose, route, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. The nurse reported that improperly stored VARIVAX (Merck) (about 8 doses) were administered to patients (on an unknown date). No adverse effects reported. This is one of two reports from the same source. Additional information has been requested.
This spontaneous report was received from a female physician, who was also the patient. On an unknown date, while preparing the GARDASIL 9 lot # L014198, expiry date 05-AUG-2017, the stopper of the prefilled syringe had moved. When the stopper moved, the syringe spilled and had touched the patient's hand. No adverse effects were reported. A product quality complaint was filed. The outcome of the accidental exposure was unknown. Additional information has been requested.
nausea, lightheaded, sweating with chills, visual disturbances(bluish coloration to all), disoriented to place, time. Lasted approximately 10  minutes. no treatment was given after the effects wore off.
Pain, swelling injection site, swelling under arm lymph node, swelling down enter arm to wrist, pain in shoulder, elbow, movement exacerbates pain, painful to sleep on the side of the injection, knot where injection was given. This has been ongoing since it started, I went to the Urgent care today- 2/19/21- due to pain continuing and swelling continuing. The lymph area has subsided but arm is still swollen. Very painful and uncomfortable, taking Tylenol and ibuprofen every 6 hours to help with pain.
My daughter tested positive and we had been with her on Sunday. I had a scratchy throat and began to have a cough. The first test was negative and I tested the next day and was positive. I and my husband had a monoclonal infusion on that Friday. The symptoms got better by that Monday.
Pt presented to ER with fever of 99.5 deg. F. maculopapular rash in arm after 2 daysof receiving hep B vaccine.
This spontaneous report as received from a registered nurse refers to a 82 year old female patient. The patient's concurrent conditions and medical history were not reported. On 13-OCT-2015 at 11:45AM, the patient was vaccinated with ZOSTAVAX after temperature excursion (lot # L012475, left arm, subcutaneous, dose 1). No adverse event was reported in the patient after receiving ZOSTAVAX after a temperature excursion on 22-SEP-2015. This is one of several reports received from the same reporter (ZOSTAVAX was given between 22-SEP-2015 to 09-NOV-2015 after temperature excursion). Additional information is not expected as follow up already received (this was received as a follow up for the related master case).
For three days I had mild symptoms, that I thought was just a cold or allergies. I then developed a bad cough, high fever, I used a home COVID-19 test that came back positive. I called my doctor; we discussed my symptoms. He prescribed the Lagevrio that I will be taking the last pills today. I only have a runny nose now but I feel fine.
Internal Tremors had been happening for 2-3 months but got severely worse starting the night after the 3rd immunization. Internal Tremors were impacting ability to sleep and also affecting normal work and life during the day. Went to Primary Care Physician to see whether a diagnosis of Multiple Sclerosis would be a fit. Had two meetings with PCP and was referred to a Neurologist. Neurologist did not diagnose MS.  With next two vaccinations (12/2/2022, 10/25/2023), internal tremors got slightly worse for a small period of time, but over time I return to mostly "baseline".
This spontaneous report was received from 63 year old male patient, who was also a physician and refers to himself, via a company representative. On an unknown date, the patient was vaccinated with ZOSTAVAX subcutaneously (dose, frequency, lot # and expiration date were not reported) for prophylaxis. On an unknown date, approximately 13 to 15 days later, the patient experienced pruritus generalised which lasted for about ten days. The outcome of pruritus generalised was unknown. The relatedness between the event and ZOSTAVAX was not reported.
difficulty breathing; still encountering vision issues; vomiting; feels weak at the moment; little headache; confusion; stomach cramps; fatigued; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (difficulty breathing), VISUAL IMPAIRMENT (still encountering vision issues) and VOMITING (vomiting) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included COPD and Lupus erythematosus. Concomitant products included ALPRAZOLAM (XANAX), LISINOPRIL and EZETIMIBE (ZETIA) for an unknown indication.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Dec-2020, the patient experienced DYSPNOEA (difficulty breathing) (seriousness criterion hospitalization), VISUAL IMPAIRMENT (still encountering vision issues) (seriousness criterion hospitalization) and VOMITING (vomiting) (seriousness criterion hospitalization). On 27-Jan-2021, the patient experienced ASTHENIA (feels weak at the moment), HEADACHE (little headache), CONFUSIONAL STATE (confusion), ABDOMINAL PAIN UPPER (stomach cramps) and FATIGUE (fatigued). The patient was hospitalized on 31-Dec-2020 due to DYSPNOEA, VISUAL IMPAIRMENT and VOMITING. The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) at an unspecified dose and frequency; OXYGEN at an unspecified dose and frequency and MORPHINE at an unspecified dose and frequency. At the time of the report, DYSPNOEA (difficulty breathing), VISUAL IMPAIRMENT (still encountering vision issues), ASTHENIA (feels weak at the moment), HEADACHE (little headache), CONFUSIONAL STATE (confusion), ABDOMINAL PAIN UPPER (stomach cramps) and FATIGUE (fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       This case was linked to MOD-2021-020166 (Patient Link).
Bruising at the injection site and rash under the injection site that has not gone away since the vaccine was administered. Saturday morning the rash is brighter, itchy, raised and hot to the touch.