chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DEATH; This spontaneous report received from a health care professional concerned a 63-year-old female with an unspecified race and ethnic origin. The patient's height, and weight were not reported. On 30-DEC-2021, the patient was admitted to facility with COVID 19 unvaccinated status for nursing care due to her concurrent conditions which included epilepsy, atrial fibrillation, chronic obstructive pulmonary disease (COPD), iron deficiency anemia, cardiomyopathy, severe protein calorie malnutrition with adult failure to thrive, diabetes mellitus (DM) type II, constipation, contractures to both knees, peripheral vascular disease (PVD) with multiple venous stasis ulcers, neuromuscular bladder, postural kyphosis, hyperlipidemia, hypertension (HTN), gastroesophageal reflux disease (GERD), major depressive disorder, vitamin D Deficiency, history of brain cancer, and vascular dementia. She underwent pacemaker placement, gastrostomy tube (GT) placement for nutritional needs/medication administration and had history of clostridium difficile. On unspecified dates, the outbreak COVID 19 testing were performed which revealed negative tests on patient throughout course of stay.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213D21A and expiry: 11-APR-2022) 0.5 ml, 01 in total was administered on 12-JAN-2022 for prophylactic vaccination. No concomitant medications were reported. It was reported that her vital signs remained stable with her being afebrile throughout the process. Following vaccination with covid-19 vaccine ad26.cov2.s, on 13-JAN-2022 at approximately 10:20 hours, certified nursing assistants (CNAs) reported to Licensed practical nurse (LPA) that the patient was unresponsive and upon assessment, she was pronounced dead at 10:20 hours. It was unknown, if an autopsy was performed or not. On 13-JAN-2022 at 10:20 hours, the patient died from unknown cause. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0-20220124384-covid-19 vaccine ad26.cov2.s- death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Within 15 minutes extremely sharp pain up shoulder to back of neck, generalized sick feeling, 5 days after diarrhea, nausea, headache for 7 days, 9 days calf cramp in right leg with red spot in same spot, 2 days later nerve pain started then a week later nerve pain started in left leg.  It?s been 2-1/2 month still nerve pain in both legs, joint swelling and muscle spasms.  2-ER visits, Urgent Care visit, Dr visit, x-rays-cervical and lumbar, leg ultrasound, various multiple blood test ran all coming back normal.  Scheduled to see a neurologist
mom described pt as lethargic or drowsy w/onset 4 hrs p/vax & lasting throught the evening; No treatment;
This spontaneous report was received from a medical assistant and refers to seven patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were unspecified. On seven separate unspecified dates, the patients were vaccinated with improperly stored PEDVAXHIB lot # M032148 expiration date: 18-APR-2019 (dose, route of administration and anatomical location were not reported). Vaccine was stored in temperature between 9 to 25 degrees Celsius for 3 hours and 30 minutes. It also underwent previous temperature excursion (9 to 25 degrees Celsius) for 2 hours and 20 minutes. Digital data logger was used to detect temperature excursion. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA008487: US-009507513-1707USA000769: US-009507513-1707USA000767: US-009507513-1707USA000768: US-009507513-1707USA000794.
headache, body aches, cough, chest pain when deep breathing, was tested for COVID-19 on 1/04/2021 and it was Positive
1st dose. When I go the vaccine 5-10 minutes I started with a headache and nausea, they told me to sit down and I felt dizzy. When I got home, I had a severe headache and nausea and I had a high fever and called the doctor who recommended Motrin every 6 hours, the the pain did not go away and I began to vomit with nausea and permanent headache. 2nd dose, after 20 minutes I had a headache and upset stomach when I got home I had a fever and my arm and hand swelled. Then my face swelled and turned red and I had a severe headache, fever lasted 4 days (102). My face got big and red (like a monster) and around the cheekbones I had a rash . I had a lot of itching around the vaccine site. I still feel the itch and feel something under my skin. I still have fever. I'm taking Ibuprofen. The visit with the doctor was virtual.
FEELING CLAMMY; HEADACHE AT NIGHT; FEVER; This spontaneous report received from a patient concerned a 41 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 18-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced feeling clammy. On AUG-2021, the patient experienced headache at night. On AUG-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on AUG-2021, and the outcome of feeling clammy and headache at night was not reported. This report was non-serious.
Information has been received from a RN concerning a 7 yr old Caucasian male with no pre-existing allergies or medical conditions who on 06Apr99 was vaccinated SC in the left thigh with his first 0.5mL dose of varicella virus vaccine live (lot629254/1849H). There was no illness at the time of vaccination. On 05May05 the pt developed 30 to 35 lesions scattered over his body and no fever. The physician was contacted via telephone and the pt was diagnosed with varicella. The pt was treated with diphenhydramine hydrochloride (Benadryl) for itching and calamine (+) camphor (+) pramoxine hydrochloride (AVEENO). On 09May05, the pt returned to school but was sent home with 1-2 lesions that were not yet crusted over. As of 26May05, it was reported that he had recovered. No product quality complaint was involved. It was reported that the pt's brother was vaccinated with a dose of varicella virus vaccine live (lot649271/0652P) and developed chickenpox (WAES0505USA01382). Additional information is not expected.
17.5 year-old received first dose vaccine accidentally; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17.5 year-old received first dose vaccine accidentally) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17.5 year-old received first dose vaccine accidentally). On 14-Jan-2022, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17.5 year-old received first dose vaccine accidentally) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.   Reporter stated that she does not have any side effects.
pain in the arm of the injection; tendon ball on the left side of the neck, near de collar bone, two little balls on the left side of the neck, near de collar bone; Second dose administered over 35 days after the first one.; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (tendon ball on the left side of the neck, near de collar bone, two little balls on the left side of the neck, near de collar bone), INTENTIONAL PRODUCT USE ISSUE (Second dose administered over 35 days after the first one.) and VACCINATION SITE PAIN (pain in the arm of the injection) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jun-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Second dose administered over 35 days after the first one.). On 04-Jun-2021, the patient experienced AXILLARY MASS (tendon ball on the left side of the neck, near de collar bone, two little balls on the left side of the neck, near de collar bone). On an unknown date, the patient experienced VACCINATION SITE PAIN (pain in the arm of the injection). On 03-Jun-2021, INTENTIONAL PRODUCT USE ISSUE (Second dose administered over 35 days after the first one.) had resolved. At the time of the report, AXILLARY MASS (tendon ball on the left side of the neck, near de collar bone, two little balls on the left side of the neck, near de collar bone) and VACCINATION SITE PAIN (pain in the arm of the injection) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included medication for allergy occasionally. Treatment details was not reported by the reporter.
Left Deltoid, blood flow controlled by gauze compress. Bleeding stopped within minutes. Immediate onset of  swelling from injection site to the elbow. Injection site bruising, purple and black discoloration. Patient was monitored one on one for 20 minutes. On 9/17/2016 patient states the swelling has reduced and no c/o pain or discomfort in the arm.
Pt is a 52 y.o. male  with a PMHx of pancreatitis, alcohol abuse, DM2, and OSA who presented to the ED on 9/19 for AMS. Patient's family says he has been increasingly unresponsive over last 3 days.  Today, he was largely unresponsive, they were unable to wake him up, so they called EMS.  On arrival, EMS initial blood pressure 77/46 and he was hypoxic, so they needed to ventilate with bag-valve mask.  They gave 2 mg Narcan, to which he was minimally responsive, then brought to ED for further evaluation.   Upon arrival patient was found to acidotic with a VBG: 7.17/62/55/23, Creatinine 5.52, Anion Gap 24, Lactate 3.2, WBC 15.52. He was intubated in the ER upon arrival and given cefepime, flagyl and vancomycin. BP was 64/40 requiring initiation of a levophed drip. He was also found to be COVID-19 positive on this admit.   Acute hypoxic respiratory failure requiring mechanical ventilation (POA) COVID-19 (POA) Recent MRSA Pneumonia (POA) -  Currently on mechanical ventilation secondary to altered mental status and hypoxia PLAN: - The ventilator was adjusted to provide optimal PEEP, minimize FiO2, and lowest tidal volume to avoid lung injury, and to maintain adequate minute ventilation - Continue Albuterol nebs as needed - Cefepime, Flagyl and Vancomycin - Propofol and Dilaudid for ventilator tolerance - Spontaneous breathing trial daily when appropriate per ventilator separation protocol  RESP:  Symmetrical chest expansion; no retractions. Breath sounds diminished bilaterally.  On discharge:  COVID-19 pneumonia On dexamethasone x10 days from 9/20-9/29 No respiratory symptoms at present, except slight cough Satting 90-96% on 2L O2, which is his baseline  Discharge Disposition/Condition Disposition: Home with Home Health Condition: Stable (s/sx potential problems absent or manageable)
He received 1st dose at CVS per MCIR Moderna. Today he said it was Pfizer. It was explained to him the vaccine series is complete.
2 weeks following the vax, the pt "could not control his legs". The pt was holding on to a shopping cart and was unable to control the cart. He subsequently fell to the ground. He was hospitalized and is now "wheelchair bound". According to his wife, he has lost control of his bladder and bowels as well. He has also lost his "cognitive reasoning".
Can still see injection site...pin prick hole...rash just above the injection site. As of today rash still there 15 days after.
allergic reaction; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 38-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that after receiving the first dose of the vaccine, she experienced an allergic reaction on an unspecified date. She wanted to know if she should still receive the second dose despite this. Outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Body aching, temp 104F, injection site hot, swollen, red and softball-sized. (Pt unable to work for 4 days)
Child presented to the school nurse the day after receiving the vaccine with a rash and pruritus to torso and back of neck. School nurse also reported that child's cheeks were 'rosy.' Child was given diphenhydramine orally by the school nurse. On Monday 11/2/2009, school nurse reevaluated child and noted redness and some pruritus to bilateral upper arms, but stated that it seemed to be resolving. It is unknown if child was evaluated by a physician since the child's mother has not provided any paperwork to the school nurse's office regarding the incident. The school nurse stated that the child did not have any school absenses related to this event.
Two days after getting the vaccine I woke up with a fever and allergy hives on my upper forehead, scalp"inside head" neck and all of my back. I could not sleep with all the hives and felt so itchy. It has been a very horrible experience with not being able to sleep properly and feel the discomfort on my skin due to the vaccine. I went to pharmacy and told the pharmacist what had happened and she told me to take BENADRYL allergy pills. I did that but it did not work, I still had the allergy hives. I then called my doctor and told me to come in to see me for an appointment. I explained to my doctor my symptoms and my doctor concluded that I had a very severe allergy reaction to the vaccine.Then My doctor prescribed me two medications first one was Methylprednisolone 4mg dose and second was SARNA anti -itch lotion. The hives went away very slowly, I am still currently dealing with a mild itch on my skin and have no choice but to try and deal with it an still use the anti lotion.
Pt recvd 2nd dose of Hep B vax on 17JUN91 following a needle stick exposure; w/in 1 hrs of vax, pt exp blurred vision, nausea, vomiting, weakness, & inc BP; On the 2nd day pt was hospitalized w/chest pain; tx meds;
The patient received his first Pfizer COVID vaccine. He was ok upon injection and walked out of the booth fine. After about 2 minutes, he complained of "hearing sounding funny" and his eyes were blurry. He was lightheaded. He sat down for a couple of minutes. He still felt bad and returned to the vaccine booth to rest for a few more minutes. He laid his head down to rest. He then got very nauseated and vomitted twice and passed out. He was out for 30-45 seconds. After waking, he was clammy and pale. He recovered within 5-10 minutes and was ok to walk and talk. Parent refused ambulance service and patient was ok when he left 30 minutes post-vaccination.
On day 7 post Modena No. 1, patient developed erythematous pruritic rash that has progressed into large confluent patches.  Rash remains intensely pruritic.  It is blanchable.  Spares palms and soles.  No enanthem identified.  No associated fever.  Images are available in EMR  upon HIPPA compliant request.   Of note, patient has several furuncles in various stages of development and resolution and in 2010 had a similar presentation of a skin eruption associated with MRSA infection. As noted above patient is polypharmic with numerous medications although none were recently started on adjusted prior to symptoms aside from receiving the maternal vaccine.
pt recv vax 13JUN97 & 13OCT97 pt devel a rash vesicular crusted lesion on face & legs;17OCT97 pt was dx w/chickenpox;24OCT97 pt recovered;
Nausea; chills; severe headache; pain at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 74 years intramuscular, in left arm for covid-19 immunisation; pneumococcal vaccine (PNEUMOCOCCAL VACCINE), on 29Apr2022 as dose 2, single (Batch/Lot number: unknown), in left arm. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (First dose, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Second dose, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Third dose, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: NAUSEA (non-serious) with onset 29Apr2022, outcome "recovering"; CHILLS (non-serious) with onset 29Apr2022, outcome "recovering"; VACCINATION SITE PAIN (non-serious) with onset 29Apr2022, outcome "recovering", described as "pain at injection site"; HEADACHE (non-serious) with onset 29Apr2022, outcome "recovering", described as "severe headache". Therapeutic measures were not taken as a result of nausea, chills, headache, vaccination site pain. Additional information: The Facility where patient was administered the most recent COVID-19 vaccine was Unknown. It was Unknown if the patient receives any other vaccines within 4 weeks prior to the COVID vaccine and List of any other medications the patient received within 2 weeks of vaccination. It was Unknown that, the patient was diagnosed with COVID prior to vaccination and since the vaccination, the patient has been tested for COVID-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
She was visiting in another state the 2nd week of April 2021. She was complaining of a strange feeling in her throat. She could not describe the pain and said she was having headaches. She was explaining just experiencing pain. The next week May 4th she went to a different and was having headaches, she suddenly developed a severe bout of Vertigo, she was crawling. She noted that the vertigo and headaches was that they were not at the same time. Vertigo started subsiding when the headaches started coming. She went home to her home state, she had three urgent care visits, ENT and the vestibular rehab center, a cardiologist who put her on heart monitor for two weeks. Problem continues with headaches vertigo equilibrium issues sore throat earaches and numbness in feet and legs at times. She saw doctor in July, they did VNG testing and on the left side. She has been diagnosed with three Cancers: Diagnosed Follicular Lymphoma, Mucinous Adenocarcinoma, and Follicular Lymphoma. She is now going through 2 chemotherapy treatments. They are not treating the other two cancers. And she will be on these chemotherapies for as long as she lives. She is being treated for her Hyoid tumor and lung cancer to relieve symptoms; they are saying that's what's going to kill her. A board of Oncologists and facility and they have expressed that they have not seen anything like this. Radiation Oncologist at oncology facility agrees he has never seen anything like this. Dr. had basically stated to her and her husband that she has possibly 1 year to live.
arm has a very red rash; Arm very sore / arm hurts; feverish; This case was reported by a consumer and described the occurrence of red rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Zostavax (received in 2015) and Shingrix with an associated reaction of herpes zoster (received 1st dose in September 2018 on unknown date, refer case US2019AMR154665.).   In August 2019, the patient received the 1st dose of Shingrix. In August 2019, less than 2 weeks after receiving Shingrix, the patient experienced red rash, pain in arm and fever. On an unknown date, the outcome of the red rash, pain in arm and fever were not recovered/not resolved.   It was unknown if the reporter considered the red rash, pain in arm and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported at time of reporting. When the patient went to get the second Shingrix injection in January 2019, the patient was advised not to have it because of her my recent bout with the shingles. In July 2019, the patient talked to the pharmacist at her local pharmacy about Shingrix. They said since it had been over 6 months since the first injection. The patient would need to get the first dose again which patient did two weeks ago (August 2019) and the second injection in 2 to 6 months. After receiving the first dose the second time, the patient's arm had a very red rash, very sore and feverish and hurts. The patient read that these type of side effects should clear up in a few days yet patient still experiencing them after several weeks. The patient was confused as to whether should proceed with the second injection come October of 2019 considering the patient had 2 injections within a year, had shingles and now this reaction. The patient asked that what was there recommendation based on patient history as explained above.
When I woke up my ears were ringing and hurting. I could also feel a sharp pain behind my eyes. I experienced headaches. After about 3 days I contacted my doctor She advised she thinks I have TMJ. I was told to take Tylenol, Ibuprofen and also used Ice/heat. That seem to help a little. After about a month My neck stiffened up. I went to see an ENT and was also told that I have TMJ. In 04/2022 I had an MRI of my head and it was confirmed that the disk between my jaw and skull was deteriorating.
focal motor seizures five days post vax; EEG was consistent w/sz disorder; no prior hx of sz;
Per patients daughter, he developed Guillain Barre Syndrome. He fell ill on 12/26/2010, was admitted to Medical Center and passed away on 1/6/2011.
Shortly after receiving vaccine started feeling foggy. upper lip began to tingle,  felt numb, and starting swelling. Started having palpitation and having shortness of breath.
Injection site (L) thigh with raised firm nodule < 1mm. Inner distal thigh with edema and mild redness 8X4 cm edema and mild warmth present, non tender