chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt. came in on 10/01/18 to receive her flu shot. When in the room with the patient the patient expressed her concern about receiving the flu vaccine due to having an adverse reaction to the TDAP vaccination she received on 07/05/18. Patient stated that after receiving the TDAP vaccine in our clinic within the next couple of days an abscess had formed, she was running and fever and was disoriented for two days. Patient states that she used a drying salve to draw the puss from the abscess and has been getting better since the abscess has drained. After receiving this information I has one of our providers Dr. look at the healing abscess and assess if the patient should receive the flu vaccine. Dr. stated that she would be fine to receive the flu vaccine just on the other arm to avoid further irritation to the Right arm.
Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 21 year old female with cystic fibrosis carrier who on 02-DEC-2009 was vaccinated with the first dose of GARDASIL (lot # 683452/0671Y). On 21-NOV-2010, 41 weeks from LMP, the patient delivered a normal female infant with weight 3670, length 21, apgar score 7/9, head circumference 33.5. There were no congenital anomalies. On unspecified date, the infant experienced respiratory distress syndrome. At the time of the report, the outcome was unknown. The mother's experienced has been captured in WAES # 1005USA00540. Additional information has been requested.
Information regarding Flumist (2003-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a healthcare professional regarding a 49-year-old female patient who experienced pain in her eyeball, dizziness, unable to get out of bed, dry cough and nausea. At 49 years of age, the patient received a dose on 10-Dec-2003. Medical history: The patient has no relevant medical history. Product details: Indication for Flumist (2003-2004 Formula) was immunization. Product was administered on 10-Dec-2003. Dose regimen was 1 dose (intranasal). Concomitant therapy: Patient was not taking concomitant therapy. Event details: The patient experienced pain in her eyeball (eye pain) immediately after receiving Flumist on 10-Dec-2003. That same night the patient was dizzy (dizziness), unable to get out of bed (asthenia), and developed a dry cough (cough) and nausea (nausea). As of 15-Dec-2003, her dry cough and nausea persisted. No additional information was available at the date of this report.
This is a spontaneous report from a Pfizer sponsored program. A contactable 50-year-old female consumer (patient) of an unspecified race and ethnicity received, on 02Jan2017, at the age of 49 years, PREVNAR 13 single dose, for immunization. Relevant medical history and concomitant medications were unknown. The patient reported that her muscles were damaged in both arms and legs, on an unspecified date. Stairs were a challenge at time of this report and she barely lifted a bottle of water (her arms and legs were weak). The patient reported that she goes to the gym almost every day. She did 7,000 steps recently and was in bed a couple days after that. The patient was feeling a little depressed because she was such an active person. The patient had sepsis. Hospitalization was required and antibiotic therapy was received. The patient had residual lung scaring in one lung and experienced walking difficulty for about a week after getting out of hospital. Clinical outcome of the events was unknown at time of this report. No follow-up attempts possible. No further information expected.
She had been in her crib sleeping. Heard a cry from her room around 9 am. Entered her room to find her on her stomach in the crib, wide eyed, convulsing, blue in the face and gasping for air. Removed her from crib and convulsions ceased, still unresponsive, tight muscles, turned darker shade in the face and was still gasping. Shortly after went completely limp, no sign of life. Performed CPR and was able to get her breathing again. Went to the ER where blood tests and CT scan came back clear. Was told she had suffered a Grand Mal seizure. EEG several days later came back normal. Started noticing Myoclonics. Had another Grand Mal April 6 around noon, lasted around a minute. Had 2 more Grand Mals April 7. First around 10 seconds at 5am and the second lasted over 2 min around 6 pm. Drastic increase in Myoclonics after the Grand Mals. Was diagnosed as Epileptic and has since started anti convulsion medication. Myoclonics and possible absence seizures are still recurring.
Originally, I did not think that the skin issue that arose shortly after the vaccine was related because it was not located on the arm that I received the vaccine. All of the news I had read about skin reactions seemed to be at the injection site.  I developed a lesion (~ 2"x2")  on my right torso that I thought was something similar to ringworm as well as a red patch on my left forearm (~2"x2") that did not resemble ringworm, and another inside my right thigh. None of these lesions were hot, painful or itchy. I had been scheduled for a food allergy test to try and pinpoint a possible cause of my scalp psoriaisis which was due in April so I waited thinking the patch on my forearm might be some sort of food allergy. I treated the lesion on my torso with clotrimazole thinking it was ringworm but it did not help. My food allergy test was negative and I scheduled an appointment with a dermatologist/pathologist to examine my lesions. He collected a punch biopsy from my back rom a 4th lesion which I had not noticed. The findings/cells are suspicious for cutaneous T-Cell lymphoma although he states this cannot be 100% confirmed. I have no family history of cancer/lymphoma and no previous personal history. The dermatologist/specialist has not indicated that the vaccine was the cause of this event but I felt the need to report it. I am currently treating the lesions with  topical steroids and I did receive intralesional injections at the office visit. The lesions are little improved but remain painless.  Following my second vaccine/injection, I experienced Tmax of 102.3 approximately 24 hrs post vaccine but no other side effects. I did have a COVID antibody test done sometime late in 2020 because I wondered if my scalp issue might be related to having asymptomatic COVID because it started in March 2020. I did not have antibodies.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, pertinent medical histories and drug reactions or allergies were not provided. On unknown dates, the patients were administered improperly stored M-M-R II, lot # M028130 with expiration date on 03-JUN-2018 and lot # M042846 with expiration date on 21-OCT-2018 (doses and routes of administration were not reported). Sterile diluent (lot # and expiration date were unknown) was properly stored. Administered doses of vaccines underwent a temperature excursion from 47 degrees Fahrenheit to 77 degrees Fahrenheit (56.3 degrees Fahrenheit), which lasted for 3 hours and 51 minutes. There was no previous temperature excursion reported. A digital data logger was not involved in recording the excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007887: US-009507513-1709USA007886.
Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced RASH (Rash). The patient was treated with CORTISONE (topical) for Rash, at an unspecified dose and frequency. At the time of the report, RASH (Rash) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medication reported.
Got shingrix # 2 on left deltoid. Claims huge lipoma left shoulder chest wall after that
12/22/2020 - Fever - jumped up from 98.9 which is warm for me to 102.5 and that took me in to get tested. Four days of fever. Tylenol and Ibuprofen. Went in and got tested for COVID positive.
Dizzy, flushed, pulse 77, 64, respiratory rate 20, O2 sat 99-100%. BP 189/91, 179/93, and 158/92.
Diarrhea, STOMACH CRAMPS SORENESS AT INJECTION SITE Narrative:
On 10/3/01, Hep-B was given at school. The child felt ill and vomited approx. 15 minutes after the shot. He stated that he felt nauseated. Eyes were dilated, skin was pale, warm and dry. Approx. 10:00 AM, he went home with mom. At 13:45, his mother called and stated that he has a flat blotchy rash on his ears, legs and arms are tingly and has chest pain when lying down. The injection site is swollen and painful. She called the MD and he stated to let him know if he worsens. At 12:30, the child states that he feels much better. Rash is gone.
Large, red, warm, itchy, circular, raised area on arm at location of injection.  Became larger for subsequent 2 days.  On this 4 th day, the area is a little sore feeling, and the redness, itching, is reducing.  It is not itching anymore.
The father reports a 3" long x 4" wide area where vaccine was given to be red, swollen, hard to the touch, and warm. Advised to contact health department. Recommended ibuprofen and ice.
Resident showed signs of a stroke at 8:30am on 4/1/2021; transferred to hospital;  4/1/21 12:22 pm resident admitted to hospital with symptoms of stroke; UTI; and elevated cardiac enzymes
Information has been received from a nurse practitioner concerning a 17 year old female who on 30-Sep-2008 was vaccinated with the first dose of GARDASIL (Lot # 660618/0572X). Concomitant therapy included ethinyl estradiol/norgestimate (ORTO TRI-CYCLEN LO). On 03-OCT-2008, the patient experienced hives on her chest, arms, back and shoulders after receiving the first dose of GARDASIL. The patient's outcome was not reported. The patient sought medical attention by a phone call. Additional information has been requested.
Patient had instant numbness and cold feeling in the arm that received the shot. Patient was asked to wait 30 minutes post-vaccination for monitoring. Patient said the feeling had not gotten worse in that time period, and was released. Patient was asked to sign up for V-Safe to report his side effects. Patient was told to monitor their arm, and if it got worse to contact their doctor/health care provider or go to an emergency room if necessary. Patient  has reported no new symptoms, and his arm has been getting much better over the past few days, but still has a slight bit of numbness.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 02Oct2023 at 17:00 as dose 1, single (Batch/Lot number: unknown) at the age of 42 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1), for COVID-19 immunization; Covid-19 vaccine (Dose 2), for COVID-19 immunization; Covid-19 vaccine (Dose 3), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid for COVID 19 treatment from 03Oct2023 to 08Oct2023. The patient experienced Covid rebound at 04:00 PM on 15Oct2023. The final outcome was recovering.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
pt is a nonresponder p/receiving 4 doses of Engerix-B;
My eyes swelled shut for two days is extremely painful now the inside of my eye is so red you can't tell what color my eyes are and they are painful and super sensitive to any light
Severe facial burning , neck redness, 2 red spots around injection site that happened 30 minutes after she left facility
The pt experienced a hive which was seen 5 minutes post vax. The hive was the size o a dime. No there symptoms were noted. Benadryl was given for hives. Mom was given instructions to follow-up if symptoms worsened. Injection of varivax was given in the left leg, where hive opened. No other reaction. Benadryl was given.
No adverse event; 1st dose given on 16Feb2021 and 2nd dose on 27Oct2021; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose given on 16Feb2021 and 2nd dose on 27Oct2021) and NO ADVERSE EVENT (No adverse event) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Penicillin allergy, Sulfonamide allergy and Adhesive tape allergy.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose given on 16Feb2021 and 2nd dose on 27Oct2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose given on 16Feb2021 and 2nd dose on 27Oct2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose given on 16Feb2021 and 2nd dose on 27Oct2021).    No concomitant medication information was reported. On 01-Dec-2022, the patient received third dose of MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) with route of administration as unknown, dose as unknown and lot number as unknown. On 03-May-2023, received fourth dose of MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) with route of administration as unknown and vaccination site deltoid, dose as 0.5 and lot number as AS7173B. No treatment medication information was reported.   This case was linked to MOD-2023-724026 (Patient Link).
24 hours after receiving vax - Mom discovered papular rash on trunk and pt. was fussy. No fever. Seen Monday afternoon at Drs. office. Rash still present - no new symptoms.
12/13/22 I woke up with a headache, a runny nose and coughing up stuff. I have been very tired. I tested for COVID with a home test and it was positive. I had a telehealth with my doctor that same day. She gave me a prescription for PAXLOVID and had me take MUCINEX. I started taking it that day. I tested again on 12/19/2022 and it is still positive. Today my symptoms are gone except I am so tired.
A consumer report has been received. The report concerns a 6 year old. Female consumer, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on 22-Nov-2014. The patient experienced coughing, didn't feel like eating, flu like symptoms, felt sick, nasal congestion and nose dripping which started on 22-Nov-2014. The patient recovered from the event of coughing, didn't feel like eating, flu like symptoms, felt sick, nasal congestion and nose dripping on 02-Dec-2014. The report was considered to be non-serious.
For second dose - a fever of  101-101.5 persisted from hour 10 after the shot till hour 34 after the shot  For booster dose - a fever of 99.5-100 persisted from hour 12 after the shot till hour 26 after the shot  For booster does - delayed  Urticaria (hives) occurred at approximately hour 72 (3 days) after the shot and are still occurring at hour 115 (5 days) after the shot. Coverage begin on main trunk area and then spread to limbs. Has partially cleared in trunk still full coverage on limbs - approximately 80% of the body has had it at one time or another
Petechiae, bruising, blood in stool & urine. To ER at 10/4 0100. Platelet count 2000. Transfusions x 3 count rose to 5000 then fell to 1000. Methylprednisolone 60mg incr to 125mg BID. Transfusion x2 w subsequent hives. IVIG 90 g begun. Count to 8000. 10/5 26000 10/6 30000.
I think the vaccine triggered my migraines and arthritis. I had severe headache and joint pain for almost two weeks. My lymph nodes (armpits) were so swollen for about a week. My neurologist said they were getting many calls about severe headache. I think the vaccine just triggered it.
pt recvd vax 27JUL94 w/in 10 mins minor wheal flare over shot site; not known if secondary MMR or Dt; resolved w/in 1hr p/DPH; 24hrs later swelling lt axilla w/regional axillary adenopathy; tender; no erythema; rx DPH, Advil;
On May 10, 2000 the child developed an injection site reaction characterized by a 6 cm area of redness, tenderness, and swelling at the site of Acel-Imune administration. On May 11, 2000 she was seen by the physician and treated with Benadryl and augmentin.
Information has been received from the authors in a literature titled as stated below concerning an unknown gender 37 year old healthcare worker with MMR (manufacturer unknown) (route, lot# and dose were unknown) therapy for prophylaxis. In this retrospective study, the authors report an outbreak of measles, resulting in multiple labor-intensive exposure investigations with no further cases identified. Measles testing was arranged for suspect cases presenting with rash with some combination of fever (temperature, >101 Fahrenheit (F)), cough, coryza, or conjunctivitis. Oropharyngeal polymerase chain reaction (PCR) testing was performed for patients presenting within 3 days of rash onset, with urine PCR and measles serum immunoglobulin M (IgM) testing whenever possible. Patients presenting days 4-10 after rash onset had oropharyngeal and urine PCR testing, frequently with measles IgM testing as well. Patients with rash beginning more than 10 days post-exposure and measles IgM testing, with oropharyngeal and/or urine PCR testing on a case-by-case basis. Exposures were defined, per agency guidance, as persons sharing the same airspace with a measles patient within 4 days before or after rash onset or who were in these areas within 1 hour of an infectious measles case. Clinical information for suspected and confirmed cases was obtained from medical chart reviews and phone/in-person interviews. Acceptable evidence of immunity for those working in high-risk occupations (healthcare/daycare settings) was defined as written documentation of 2 MMR vaccine doses or positive measles serum IgG. Serology was performed for measles-specific IgM/IgG at agency or at the facilities where patients presented. All positive samples from community laboratories were confirmed by Health Agency, which used the measles virus IgM/IgG antibody test system. All measles viral RNA reverse transcription polymerase chain reaction (RT-PCR) virologic testing was performed at agency using RT-PCR assay with the following 3 gene targets: nucleoprotein (N3), hemagglutinin (HI), and fusion (FI). The agency performed measles genotype sequencing. Results: Among 22 confirmed measles cases, 5 secondary cases occurred in HCWs. Of these, 4 had direct contact with measles patients; none wore N95 respirations. Four HCWs had prior evidence of immunity and continued working after developing symptoms, resulting in 1014 exposures, but no transmission. Overall, 13 of 15 secondary case had face-to-face contact with measles patients, 8 with prior evidence of immunity. The patient developed measles despite evidence of prior immunity and documented the vaccine administration (vaccination failure). The outcome of the event was unknown. The reporter considered the event to be related MMR (manufacturer unknown). A copy of the published article is attached as further documentation of the patient's experience. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug allergies and concomitant medications were not reported. On unknown dates in August and December 2016 the patient was vaccinated with first and second dose of GARDASIL 9 (lot # and expiry date was not reported) for prophylaxis and no symptoms were reported (no adverse event). The pharmacist reported that the patient will be returning to the pharmacy on 24-MAY-2017 to receive third Dose of GARDASIL 9. The outcome of the events was unknown. There was no product quality complaint involved. Additional information has been requested.
Moderna COVID-19 Vaccine  No problems, just had a strange metallic taste in my mouth a little less than an hour later. I had eaten a mint before that, so might not have noticed if it started earlier.
I sat down and suddenly felt dizzy, high blood pressure, and fast heart rate. (136bpm)
So, I had flue like symptoms chills, body, sweats, join, paint, headaches, nausea and fatigue like crazy. Like feeling overall awful and that was the start as soon as I got it within the next 48 hours. The issue I've had since then that sent me to the UC was that I felt like I had a left ear infection. My left ear hurt which was on the same side that I had my shot on. Throbbing and painful and clogged left ear. I felt like I had an ear infection. A few days after that I found right behind my ear, I had a big swelling lymph node and that was before 07/01 and it is still there. I also have a large lymph node under my left armpit.  They've swollen and they're painful and that's ultimately why I went in because I was feeling sick with a lot of fatigue and not feeling good. Because of the ear and lymph nodes behind the ear I wanted to make sure nothing was wrong. When I went to the UC I let them know that I didn't know if it was because of the vaccine. They tested and said I had some kind of infection and they put me on Augmentin it was a 10-day dose twice a day and that's what I began to become allergic to since I was prescribed that. I've had every side effect from Augmentin that you can have. I've had extreme diarrhea, bloating, stomach cramps, joint pains, nausea, lack of appetite and lack of sleep. As of yesterday, the doctor said, "oh yeah you're having reaction to that", and she switched me to Keflex 4 times a day for 10 days. Six days after my follow, my white blood cell count actually went up. Even though I was on antibiotics my infection increased instead of getting better.
Pt fainted 10 min after receiving vaccine.He was talking to his friend who brought him in to the clinic when event happened.Pt fell from the chair, did not remember  what happened.Initial BP is elevated,HR elevated,pt was pale and clammy and diaphoretic,O2 100%.Pt monitored for 30 min BP and HR stabilized. Pt was comfortable going home.
PATIENT HAD RASH TWO DAYS AFTER VACCINATION OF RIGHT UNDERARM. SHE REPORTS PERSISTENT RASH. PRESENTS INTO CLINIC TODAY WITH HISTORY OF WORSENING RASH. PATIENT EVALUATED AND PROVIDED TOPICAL PRESCRIPTION CORTICOSTEROIDS AND ANTIHISTAMINE, WITH RECOMMENDAITON FOR RE-EVALUATION IN A WEEK WITH DERMATOLOGY/URGENT CARE.