chrisvoncsefalvay/vaers-outcomes huggingface dataset:
6 itchy spots between arm and right shoulder.; pain in right jaw; swelling on right side of face/ear; swelling on right side of face/ear; right eye swollen and leaking; right eye swollen and leaking; severe pain around my head (felt like rubber bands tightening); This is a spontaneous report from a contactable consumer, the patient. A 78-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 6201) via an unspecified route of administration in the right arm on 25Feb2021 at 11:00 as a single dose for COVID-19 immunisation. Medical history included 5 stents and allergy to penicillin. Concomitant medications included ASPIRIN 81, ATORVASTATIN, ezetimibe, LISINOPRIL, and primi. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 9809) via an unspecified route of administration in the right arm on 04Feb2021 at 10:30 as a single dose for COVID-19 immunisation and also experienced drug allergy to amoxicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in Mar2021, the patient experienced 6 itchy spots between arm and right shoulder, pain in right jaw, swelling on right side of face and ear, right eye swollen, and leaking and severe pain around head (which felt like rubber bands tightening). The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with unspecified medication. The clinical outcome of the events 6 itchy spots between arm and right shoulder, pain in right jaw, swelling on right side of face and ear, right eye swollen and leaking and severe pain around head (which felt like rubber bands tightening) were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Information had been received in a published article. This literature marketed report refers to male child patient (currently 16-year-old). The patient was born with intra-uterine growth retardation (birth weight: 1.296 kg) at 33-week gestation. A presumptive diagnosis of the Finnish type of CNS was made, since genetic testing was not commercially available when he was diagnosed, based on his early and severe presentation. After a 12-month stay in the Neonatal Intensive Care Unit, the was discharged on home infusions of intravenous albumin via a right subclavian catheter along with anticoagulation, thyroid-hormone replacement, angiotensin converting enzyme inhibitors and multiple mineral and dietary supplements. The patient had been slow in gaining weight and had a short stature. In an attempt to reduce his risk of infections, all routine childhood immunizations (IZ) were administered to him, contrary to practice often followed in centers with extensive experience caring for babies with CNS. The patient received his primary series of IZ starting at the age of 3 months. At this time, his renal function was normal and he was profoundly hypoalbuminemic (serum albumin varying from 1.2 to 2.4 gm/dL) due to his massive urine protein losses. Other laboratory analyses, demonstrated low antithrombin III on a functional assay, low levels of IgG and normal IgA and IgM levels. Approximately in 2002 (reported as 2 years of age), the patient was vaccinated with first dose of Varicella vaccine (manufacturer unknown) (dosing details were not reported), while he was still nephrotic (NS). The patient had not seroconverted with the 1st dose (vaccination failure), which was not uncommon in healthy children and even more common in children with NS. The patient was again vaccinated with varicella vaccine (manufacturer unknown) after 8 months of 1st dose. The outcome of vaccination failure was unknown. The reporter considered vaccination failure to be related to varicella vaccine (manufacturer unknown). Additional information has been requested.
Vibration in her left breast / feel like when the cell phone is on vibrate; feel like when the cell phone is on vibrate; This case was reported by a consumer via call center representative and described the occurrence of tremor in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in March 2020).   On 18th June 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 21st June 2020, 3 days after receiving Shingrix, the patient experienced tremor and feeling abnormal. On an unknown date, the outcome of the tremor and feeling abnormal were not recovered/not resolved.   It was unknown if the reporter considered the tremor and feeling abnormal to be related to Shingrix.  Additional case details were reported as follows: The patient received the 2nd dose of Shingrix in left arm. On 21st June 2020, the patient started having vibrations in her left breast.  The reporter described it felt like when the cell phone is on vibrate. The vibrations started as very infrequent and then after that they were occurring more frequently.  Now they had gotten worse. The reporter consent to follow up.
Diagnosed as serum sickness. Day after, redness, soreness. Scar tissue developed, became increasingly red, hot and sore. Few days later, felt flu like symptoms - headache, fever, petechia on feet, arms swollen. Fatigue.
Shingles rash on her upper right thigh; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 14th September 2019, 3 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The reporter stated the patient has a shingles rash on her upper right thigh 3 days after receiving the Shingrix vaccine. The reporter was transferred to medical information for additional assistance including whether the patient should receive the 2nd dose.
Fever, Chills, Aches for seven days. Headache, Fatigue, chest and neck tightness, low oxygen for six weeks. Fatigue and low oxygen continuing up to seven months and longer.  . .
Information has been received from a physician via a company representative concerning a patient who "10 years ago" in approximately 1996 was vaccinated with a dose of Pneumovax 23. Subsequently the patient experienced swollen arm where the injection site was. Additional information has been requested.
Patient was feeling dizzy and had a low blood pressure, looked very pale, he claimed to have blurry vision. After sitting for a while he started to feel better and blood pressure rose to his normal value. Patient stated that this type of reaction to a vaccine had happened before.
Patient admitted to hospital on 13/07/21, and to Intensive Care on 14/07/21 for nasal high flow oxygen. He received dexamethasone IV. He was intubated on 24/07/21 following deterioration that day, and was proned. On 26/07/21 he had a chest drain inserted for a pneumothorax, and his endotracheal tube was changed due to a kinked tube. He was also started on antibiotics and antifungals to cover for superimposed infection. He passed away on 27/07/21 following further deterioration and ST elevation on ECG.
pt recv vax 31OCT96 & devel local erythema, pruritis, & hives;eyes became puffy & c/o tongue felt swelled;feeling of fullness in throat, had hoarseness;denied SOB & no audible wheezing detected;given epi;adm to ICU for observation;
Came in for my daughters 2 month old shots November 1st 2019. She had three in the thighs and one orally. The next day she started throwing up her milk. At first it was just a few but now she?s throwing up her entire bottle.
Coughing, itchy mouth, swollen and tingling lips, swollen eyes, blocked nasal passages. Symptoms improved somewhat about one hour after taking Benadryl. Three doses of Benadryl required.
CHILLS IN THE MIDDLE OF THE NIGHT. MUSCLE ACHES ALL OVER BODY. SHARP SHOOTING PAIN IN BOTH LEGS AND RIGHT ARM. SKIN WAS SENSITIVE TO TOUCH. RASH ON RIGHT ARM NEAR INJECTION.  TOOK 800 MG IBUPROFEN EVERY 8 HOURS. STARTED FEELING BETTER NEXT DAY AT 8 AM.
Inconsolable crying for 12 hours, seizures, jerking, vomiting, loss of appetite, moaning.
PATIENT RECEIVED SECOND BOOSTER OF MODERNA COVID-19 MONOVALENT MISTAKENLY. PATIENT WAS CONTACTED AND NO ADVERSE REACTIONS WERE REPORTED. PATIENT WAS INFORMED SHE COULD RECEIVE THE BIVALENT BOOSTER IN TWO MONTHS.
I previously had COVID so I experienced all of my previous COVID symtoms the following day including fever (102), chills, dizziness, sweating, fatigue, joint pain, and diarrhea.  However, I had new symptoms. The first one was odd because I felt like my heart wanted to jump out of my chest. I sit at a desk so it was quite noticeable because I could feel it thumping while sitting. I  grabbed my oximeter to check my pulse and it was in the 120-130 range.  I saw my doctor the next day who did an EKG and referred me to the cardiologist. The cardiologist saw thickening of the lining of the heart on the X-ray and ordered a CT scan. The CT scan confirmed the pericarditis
no additional AE details; administered an expired dose of MMR-II; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. Concomitant medications included sterile diluent (STERILE DILUENT) (manufacturer unknown).   On 28-FEB-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant Human albumin (M-M-R II) 0.5 milliliter, lot #S036664, expiration date: 14-NOV-2021 (Expired product administered) (strength, dose number, site and route of administration were not provided) for prophylaxis.  No adverse events were reported (No adverse event).
The pt died 24 hours post vax. Autopsy pending. COD as per autopsy report was sepsis.
Pt developed itching on way home after receiving vaccine. At 10:44 PM on the night of receiving vax, pt presented to ER with hives. He was treated with Benadryl and Pediapred. He was discharged from ER at 11:15 the same night.
Within two weeks of the first Pfizer shot, I experienced significant joint pain in both shoulders, and more disconcertingly, significant pain and locking of the right knee. It continues today, though somewhat reduced in intensity. I assumed there was some significant structural issue with the knee, but an MRI indicates there is not. Furthermore, I have experienced pain on a periumbilical hernia, which I have had my entire life, but never experienced any pain from until approximately 2 weeks after the first vaccine dose. I can provide more detail if requested. To be clear, I don't know that any of this is causally connected to the COVID vaccine, but it is at least correlated, and these medical symptoms I have had are unprecedented and thus far unexplained.
Pt called this am stating she had localized reaction to Zostavax administration.  Pt states that her left arm is red and has a brown spot in the center of it, as of this am.  Pt denies any heat, swelling, or pain to arm at this time.  Pt received vaccine on 06/11/2007, arm has been red since administration.  Pt states she has taken Benadryl for itching and redness, without relief.  Instructed pt to try cool compress for 15 minute intervals.  Pt to come by Health Department for me to visualize arm.  Pt going out of town for 2 months, leaving tomorrow.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 90-year-old male patient received BNT162b2 (BNT162B2), on 27Oct2021 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 88 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 and treated with Paxlovid.  Additional information: The patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
08/25/22 presents to EC ED for "fever, cough". PMHx of "TAA, HTN, aortic valve replacement, depression, COPD, Alzheimer's"
pediatric dose was administered to an adult; pediatric dose was administered to an adult; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a adult female patient who received HBV (Engerix B pediatric) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric. On an unknown date, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 09-JAN-2023 Reporter's Comments: The reporter stated that a pediatric dose of Engerix B was administered to an adult patient.  The vaccine administration facility was the same as primary reporter. Additional Supportive Information: The adult patient received pediatric dose of Engerix B, which led to underdose and adult use of a child product.
Breakthrough bleeding/spotting menses; soreness at injection site; This is a spontaneous report from a contactable healthcare professional (patient). A 35-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL0142, expiry: unknown), via an unspecified route of administration in the left arm on 13Jan2021 at a single dose in a hospital for COVID-19 immunization.  Medical history included Alport's, alopecia areata and eczema. The patient has no known allergies. Concomitant medications included lisinopril and cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). The patient previously had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EK5730, expiry: unknown) on 23Dec2020 at 10:00 in the left arm for COVID-19 immunization and experienced fatigue, muscle aches, breakthrough bleeding/spotting menses within 12 hours of dose and soreness at injection site within 12 hours of dose. On an unspecified date, the patient experienced breakthrough bleeding/spotting menses within 12 hours of dose and soreness at injection site within 12 hours of dose (worst with first dose, mild with second dose). The patient was tested for Covid post vaccination via nasal swab using SARS-COV-2 BY PCR (2019-NCOV) on 30Dec2020 which was negative. The patient was also tested with SARS-COV-2 IGG (blood test) on 09Jun2020 which was negative as well. The events were not treated. The outcome of the events was unknown.
Patient is a 81 y.o. male patient of MD with history of Late stage dementia, CAD, HLD  presented to a local Hospital with fever, weakness, SOB, covid positive test .   Covid Virus infection  Weakness P/w fever, SOB, weakness, tested + for covid on 3/27/23 Initial VS 99.5-69-18-117/64 93-95% on room air  CXR trace atelectasis otherwise negative  LA normal AST mildly elevated to 56, other hepatic panel normal Troponin 27 UA negative for infection VBG 7.37/49  IV fluids given Foley placed Monitor for Hypoxia  PT/SS/OT Placement secured and transportation set up for this afternoon   Late stage Dementia with Behavior Disturbance  Follows with neurology Continue Aricept, Namenda and trazadone  Delirium precautions    CAD s/p CABG x 3 Cardiomyopathy HLD HTN Unable to assess for CP  Troponin normal EKG no ischemia  Resume Coreg, Asa,  Lisinopril  Allergies to all statins, do not carry crestor   Cardiac monitoring  Anemia Thrombocytopenia  Hgb 11.4, Plt 115 Both have chronicity but plts lower likely reactive
Information has been received from a physician concerning a 11 year old female who on 03-JAN-2002 was vaccinated with a dose of MMR II (route, site, dose and lot number not reported). On an unknown date, the patient was vaccinated with a second dose of MMR II (route, site, dose and lot number not reported). On 29-NOV-2009, the patient was vaccinated with a third dose of MMR II (lot number 664886/0776Y) (route, site, dose and lot number not reported). On 04-DEC-2009 the patient experienced mumps. (the date of diagnosis was reported as 06-DEC-2009). The patient had fever of 101.2 F and left parotitis. On 07-DEC-2009, the patient had the following lab tests: serum IgM <1:10, serum IgG 7.3 and serum amylase was 316. The patient was exposed to others with mumps and there were other reported cases in the same household. The outcome for mumps was not reported. No further information is available.
aches all over, glands hurt, really tired, localized pain where shot was given.  Felt like really bad 24 hour virus.  I was in bed all day
Patient had chest pain which was non-radiating and presented to the ED on August 7, 2011. Patient was admitted and referred to cardiology who diagnosed him with Myopericarditis on August 9, 2011.
the patient have not gotten sick since stopped taking the flu shot over 8 years ago; Initial information regarding this unsolicited valid non-serious social media case received from a consumer (patient) and transmitted to Sanofi on 12-Dec-2020.  This case involved a patient of unknown demographics who had not gotten sick since stopped taking the flu shot over 8 years ago (Illness), after receiving vaccine INFLUENZA VACCINE.  Relevant medical history, concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route on an unknown administration site for prophylactic vaccination.  On an unknown date, the patient have not gotten sick since stopped taking the flu shot over 8 years ago (Illness), unknown latency following the administration of INFLUENZA VACCINE.  Relevant laboratory test was not reported.  Final diagnosis was the patient have not gotten sick since stopped taking the flu shot over 8 years ago.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There would be no information available on batch number for this case.
PATIENT RECEIVED FIRST DOSE OF MODERNA AND THEN LATER THAT NIGHT BEGAN TO FEEL HER HEART RATE BECOMING IRREGULAR. SHE SAID IT CONTINUED TO WORSEN THROUGHOUT THE NIGHT AND EVEN HER LOPRESSOR DID NOT CALM IT DOWN. IT WAS NOT UNTIL THE NEXT DAY WHEN SHE TOOK SOME HOMEOPATHIC MEDICATIONS (PRO-AMINO ACIDS SUPPLEMENTS) THAT SHE FELT HER SYMPTOMS BECOME BETTER.
allergic reaction; This case was reported by a physician via other manufacturer and described the occurrence of allergic reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 5 days after receiving Shingrix, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient's full demographics were not provided. The patient declined to participate in the adverse event reporting. No additonal information was available.
overdue for second dose; 50+days; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (overdue for second dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (50+days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (overdue for second dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (50+days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (overdue for second dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine), the reporter did not provide any causality assessments.   Caller was unable to provide any adverse effect details . Caller was a healthcare provider and had a patient who was overdue for their second vaccine dose. Caller wants to know what they should do   This case was linked to US-MODERNATX, INC.-MOD-2021-090650 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-090650:cluster case for some contractors
On April 4, 8 days following receiving second dose I experienced an ocular migraine lasting approximately 30 minutes.  10 weeks later on June 13 I experienced another ocular migraine lasting approximately 30 minutes.  Prior to Apr 4 I had experienced ocular migraines only 3 times in my lifetime in 1997, 2016 and 2018. My symptoms included seeing a jagged wavy line of prism-like color in my peripheral vision that progressed to the loss of the right half of objects in my vision.
Patient experiencing pain in the arm (bursitis or frozen shoulder) but no treatment attained yet and still suffering from pain 5 months later.
A report has been received from a Health Professional (Registered Nurse) concerning a male patient. The relevant history, concurrent diseases and concomitant medications of patient were not reported. The patient had been receiving FLUMIST which was started on 09-OCT-2012. It was reported that patient experienced flu-like symptoms, cough, sore throat, chills, fever, headache and body ache which started during Dec-2012. It was too late for him to be treated with TAMIFLU, so the patient was treated symptomatically with TYLENOL, fluids and rest. Action taken with FLUMIST was not applicable. Outcome of all the reported events was unknown. The report was considered to be non-serious.
Red, hard inflamed area at injection site raised and about 1 1/2 inches diameter. Was painful and itchy for 7 days after injection. Took BENADRYL and MOTRIN.
Patient was seen for 2nd COVID vaccine on 8/9/21 and reported that 1 day after receiving the 1st dose he began with left sided chest pain that worsened with physical activity with radiation of pain to left side of back, back pain worsened with stretching and deep breathing, chest pain provoked some shortness of breath and lasted 7 days before symptoms subsided. No treatments were tried during that week. 8/9/21 was the first time that I heard of the incident.  No current symptoms of chest pain/heart palpitation/shortness of breath reported on 8/9/21 and heart sounds were normal on exam. No history of heart problems. 2nd Pfizer dose not given until patient gets clearance from cardiologist.
felt like i had covid again. fever 101.9  very sever body aches and headache and fatigue. lasted about 36 to 38 hours. currently no fever but still have body aches and fatigue