chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse effect; patient was administered adose of improperly stored varivax; This spontaneous report was received from a medical assistant regarding a patient of unknown demographics. Information on patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. On 19-AUG-2019, the patient was vaccinated with an improperly stored varicella virus vaccine live (VARIVAX) (lot # S004554, expiry date: 14-FEB-2021), dose details, route, strength of all the vaccines were unknown) for prophylaxis. The vaccine was stored at a temperature range of (-14 degree Celsius to -10 degree Celsius (-14.4 degree Celsius)) for time frame of 18 minutes. No previous temperature excursion involved. The digital data logger was involved. No adverse effects reported.
Patient had an approximately 15 second syncopal episode immediately after vaccine was injected.  Upon awakening vomited 30cc clear fluid.  Patient was given cool washcloth and assisted to lay down on exam table.  Patient was given saltine crackers and water approx 10 minutes after episode and monitored for a total of 30 minutes.  Patient was ambulatory and stated she did not feel lightheaded or dizzy when she left the facility.
approx 1hr p/vax mom & grandma reported pt to be moving arms & head quickly & appearing to be uncomfortable;this last about 30-45sec;since then pt has been sl fussy but otherwise nl;
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
pt recvd vax;exp tightness in chest, cough non productive w/in 2 hrs of vax; leg achiness,flushed; ?fever
Flu-like symptoms (chills, joint pain, low grade fever, fatigue), vertigo, tinnitus, moderate hearing loss.  Flu symptoms resolved within 24 hours but hearing loss remains. Using OTC hearing aid until I can schedule appointment with PC and ENT
After my vaccine, I developed itchiness sensation to my calves. One week later I developed red bumps the size of a dime. I went to see m PCP who prescribed a cortisone cream along with steroids. My red bumps are still present but slowly going away.
Central chest pressure & tightness, that moved across left shoulder. Clammy and cold sweat, feeling of dread. Lasted possibly 5 minutes. Other than these symptoms, only local muscle soreness at injection site.
Developed a mild case of Covid in December. Aches, sore throat, fatigue, cough, runny nose
This spontaneous report as received from a pharmacist refers to a newborn male patient of unknown age. On 31-OCT-2012 14:43, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During the 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Patient alleges after receiving vaccine she began to feel fatigue and joint pain, sore throat this continued until approximately 12/16/2011.  She saw her PCP 11/10, 3 times in December and was told it was viral and no treatment was given.
I had chills for 2 nights that cause my body to be feel rigid.  Then on Thursday I had chest pain on 2 occasions that lasted around an hour each time and on Friday I had to go to the ER. I was released on Saturday and I either have myocarditis or pericarditis.  I need more tests to be done
COULDN'T SLEEP; CHILLS; FEVER; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid-19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On 08-JUN-2021, the subject experienced couldn't sleep. On 08-JUN-2021, the subject experienced chills. On 08-JUN-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills and couldn't sleep was not reported. This report was non-serious.
very high temperature of 107F; This is a spontaneous report from a contactable consumer (patient's wife). This consumer reported same events for 2 patients. This is one of the 2 reports.   A 72-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Mar2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization.  Medical history and concomitant medications were not reported. It was stated that the vaccine made him sick as he had a very high temperature of 107F.  Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021268728 same drug and event, different patient
right upper arm sore; runny nose; She stated her face from under her eyes, around and under her nose, and her lips feel like they are sunburned; under eyes really red; under eyes swollen/puffy; under eyes really itchy; her lips, around and under nose swollen/puffy; lips and around and under nose really itchy; her lips , around and under her nose is really red; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (right upper arm sore), RHINORRHOEA (runny nose), BURNING SENSATION (She stated her face from under her eyes, around and under her nose, and her lips feel like they are sunburned), OCULAR HYPERAEMIA (under eyes really red) and EYE SWELLING (under eyes swollen/puffy) in a 53-year-old female patient who received mRNA-1273 (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Rosacea. Concurrent medical conditions included Drug allergy (Patient is allergic to sulfa and codeine.) and Drug allergy (codeine.). Concomitant products included VITAMINS NOS (DAILY MULTIVITAMIN) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PAIN IN EXTREMITY (right upper arm sore), RHINORRHOEA (runny nose), BURNING SENSATION (She stated her face from under her eyes, around and under her nose, and her lips feel like they are sunburned), OCULAR HYPERAEMIA (under eyes really red), EYE SWELLING (under eyes swollen/puffy), EYE PRURITUS (under eyes really itchy), SWELLING (her lips, around and under nose swollen/puffy), PRURITUS (lips and around and under nose really itchy) and ERYTHEMA (her lips , around and under her nose is really red). At the time of the report, PAIN IN EXTREMITY (right upper arm sore), RHINORRHOEA (runny nose), BURNING SENSATION (She stated her face from under her eyes, around and under her nose, and her lips feel like they are sunburned), OCULAR HYPERAEMIA (under eyes really red), EYE SWELLING (under eyes swollen/puffy), EYE PRURITUS (under eyes really itchy), SWELLING (her lips, around and under nose swollen/puffy), PRURITUS (lips and around and under nose really itchy) and ERYTHEMA (her lips , around and under her nose is really red) had not resolved.        The action taken with mRNA-1273 (Intramuscular) was unknown.       No Concomitant medications were reported. Treatment include Topical Hydrocortisone cream Blistex Ointment Vasoline Vicks vapoRub OKeeffes Lip Repair
9 days p/ vax pt devel papular vesicular rash w/more than 50 lesions. MD stated pt may have been exposed to natural chickenpox prior to vax
Fever, Body Aches, Chest Pain, Difficult Breathing - Occurred around 10am and progressively got worse throughout the day. Went to ER on 21 November around 3PM with difficulty breathing and chest pain, and what felt like rapid heart beats.
Case number PHEH2014US003828 is an initial spontaneous report received from a pharmacist on 24 Feb 20: This report refers to an 85-year-old male patient who was inadvertently vaccinated with MENVEO (batch number: unknown) intramuscularly at a dose of 0.5 ml on 07 May 2013. No adverse event was reported following this administration error.
Pt received vaccine in left deltoid IM, and reports still having swelling in arm with nodule at site of injection causing pain and difficulties sleeping. Pt will contact her physician to see if further medical care is needed.
Information has been received from a medical assistant concerning a multiple unspecified number of patients (ages and genders not reported) who on unknown dates were vaccinated with improperly stored doses of ROTATEQ (Batch and Lot No. L013202, exp. 27-JAN-2017) (dose, route and site not reported). No adverse effects were reported. This report is linked to MARRS 1601USA001940, 1601USA001941, 1601USA001942, 1601USA001943 and 1601USA000936 from the same reporter. Additional information had been requested.
near death; serious neurological problems; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date not reported), via an unspecified route of administration in an unspecified anatomical location, on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced near death and serious neurological problems on an unspecified date. The outcome of the events was reported as unknown.  Information on the lot/batch number has been requested.
This medically confirmed spontaneous report (initial receipt 01-Mar-2012) concerns a 50 year old female patient with no medically history. She was also not taking any concomitant medication. On 11-NOV-2011, the patient received a standard dose of AFLURIA (batch: N55906) by intramuscular injection. On 11-NOV-2011, the same day as vaccination, the patient's arm started hurting bad immediately after the administration and the pain continued. The patient lost mobility of her arm and experienced fairly severe pain in various arm positions. The pain did not resolve over time and the patient is currently undergoing physical therapy to resolve pain in her arm. The patient has not yet recovered.
Arm sore; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Feb-2021 and was forwarded to Moderna on 18-Feb-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (Arm sore) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN for an unknown indication.  On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm sore). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Arm sore) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-056485 (Patient Link).
Patient with rash that started after leaving the office. Lasted about a week and a half. Mom reports that patient had large red raised bumps all over her body that were itchy. Mom did not try any medications or take patient to seek medical assistance. Mother reported this event when she returned today 2/7/19 for the second step of the vaccine.
Erythema Multiforme. Ibuprofen 600 mg QID.
Moderna Dose 1 4/27/21 (008C21A); Moderna Dose 2 5/25/21 (024C21A); COVID Positive 1/26/22; 1/26/22: Patient is a 76-year-old male with a past medical history significant for type 2 diabetes with diabetic neuropathy, coronary artery disease, hypertension, peripheral vascular disease, CKD, history of tracheostomy. The patient presents to the ED today via EMS with new onset confusion that began this afternoon. The patient's accompanying symptoms include shortness of breath, and cough.  He denies any chest pain, nausea, vomiting, diarrhea or abdominal pain. The patient tested positive for COVID-19 yesterday at the facility.  The patient was on 3 L oxygen via nasal cannula with O2 saturations at 75% prior to arrival to ED.  since arrival patient's O2 saturations have improved to 92% on 2 L oxygen via nasal cannula.  The patient is vaccinated against COVID-19 and has received is booster vaccination as well. The patient's symptoms began 2 days ago and have worsened rapidly according to the nursing home.  He has not been taking any medications for relief of his symptoms.  The patient denies any alcohol abuse, illicit drug abuse or tobacco use. Upon arrival to ED patient's temperature is 99.3°, heart rate 106, respirations 20, pulse ox 99% on 2 L oxygen via nasal cannula, blood pressure 123/100. Patient's laboratory findings are significant for sodium 132, chloride 95, glucose 184, BUN 63, creatinine 2.73, proBNP 21134, troponin 4.22, WBC 11.81, hemoglobin 11.2, hematocrit 37.6. The patient was started on a heparin drip in the ED and received 750 mg IV Levaquin and 1 L IV normal saline. The patient was seen and examined at the bedside in the ED.  The patient is not oriented x4 per his baseline; however, he is able to answer some questions appropriately. I did have a discussion with the patient and the patient's wife over the phone in regards to his code status.  The patient does have a DNR/DNI with comfort measures only. The patient's wife states that he does not want any procedures done at all as these are his wishes. The patient is being admitted to the hospital for management of COVID-19 pneumonia, NSTEMI, Rule out PE, and dehydration. 1/31/22: Patient is a 76-year-old male history of chronic hypoxic respiratory failure on home oxygen 3 L at baseline admitted to hospital for acute hypoxic respiratory failure due to COVID-19 pneumonia patient was treated with supplemental oxygen, antibiotics and Decadron, hospitalization was complicated by acute kidney injury on CKD and elevated troponin, as time progressed patient improved with medical treatment, patient was evaluated by Cardiology, recommended medical therapy.  Patient will be discharged.
Information has been received from an NP concerning a 15 year old pregnant female who in early 4/02, was vaccinated with varicella virus vaccine live and concomitant suspect therapy MMRII. The NP reported that approx. 1 week after the vaccinations, the pt had a miscarriage. The NP also reported that the pt estimated the date of her last menstrual period to be 1/28/02. Additional information has been requested. Conflicting info has been received from a public health nurse. The nurse reported that the pt did not receive the varicella virus vaccine live, but, on 4/17/02, the pt did receive the first dose of MMR II (639518/0698L). The public health nurse also reported that the pt did receive the varicella virus vaccine live, the public health nurse did not give it and she had no further info. No further info is expected.
Fever-104, musccle aches, cold sweats, vomit, pain and redness where the shot was given  and swelling
Rheumatoid Arthritis flare up; This spontaneous case was reported by a physician and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid Arthritis flare up) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis flare up.    The patient's past medical history included Rheumatoid arthritis since an unknown date.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and UPADACITINIB (RINVOQ) (Oral) UNK dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid Arthritis flare up) (seriousness criterion medically significant). The patient was treated with METHYLPREDNISOLONE ACETATE (DEPOMEDROL) for Rheumatoid arthritis flare up, at an unspecified dose and frequency. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid Arthritis flare up) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products were not reported.  Very limited information regarding this event has been provided at this time. Further information will be requested.   This case was linked to US-MODERNATX, INC.-MOD-2021-197904 (E2B Linked Report).; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information will be requested. US-MODERNATX, INC.-MOD-2021-197904:Dose 1 Case
When I received the Pfizer-BioNTech COVID-19 I experienced soreness at injection site on the day of and the next day. I began having swollen lymph nodes 2 days after the injection and weakness in the upper arm and elbow area. I cannot lift my arm without discomfort.
Information has been received from a gynecologist, concerning a 21 year old female patient with history of pollinosis who was vaccinated with a third dose GARDASIL (Lot number 0277U, Batch number NG00020, injection route and site not reported) On 13-MAR-2008. On 28-MAR-2008, the patient developed gastrointestinal cramps with postprandial diarrhea for, the first time. She recurrently complained of abdominal cramps with diarrhoea. After one of these episodes, in September 2008, she went to the emergency room. Clinical examination, lab tests and abdominal sonography were without pathologies. Suspected diagnosis was enteritis. During months she had a weight loss of 5 kg of weight. Within a few months p.v. the patient also experienced generalized itching and an eczema on the right hand. The patient additionally complained of impaired memory, amnesic aphasia, concentration impairment, bad mood, aggression, listlessness, arthralgia, headache, pain and numbness in the whole left arm (from shoulder to fingertips) so that temporarily driving a car was not possible. Also, the patient experienced intermenstrual bleeding, sleeping disorder because of pain in legs, dizziness, feeling of weakness and near fainting, loss of appetite, sore throat with dizziness, feeling of weakness and near fainting, loss of appetite, sore throat with lymphadenopathy followed by ear pain and reduced hearing. In June 2008, the patient consulted a pneumologist because of frequent dyspnoea and unusual cough. Diagnosis of allergic bronchial asthma was diagnosed for the first time (long time history of pollinosis). Treatment with beclometasone and salbutamole inhalatives was started. The outcome was not reported. Upon internal review report considered medically significant. Other business partner numbers included: E2009-00384. Additional information has been requested.
About an hour after the shot, I felt some tingling in my face; that was followed by a few odd sensations, all of which are basically the same as when I have a flu shot.  Eight hours after the shot, I noticed that I was smelling smoke; my sense of smell started to do weird things an hour before (for example, smelling rotten food in the fridge), but this became clear when the smoke smell started.  Over the first 48 hours, my left arm was sore (sore to touch at 24 hours, gone at 48), and I had some mild flu symptoms (sore throat, stuffy nose, fatigue), plus some chest "tightness" which I have been feeling from time to time since March 2020.  The flu-like symptoms were all basically gone except the stuffy nose.  I still have a slight stuffy nose, and the strange smell issue.  I have been able to smell things fine all along, it's just overlaid with a smell that started as smoke or BBQ, and varies in strength; it's a bit like smelling dirt now.  It's always possible this is coincidental, but I wasn't exposed to smoke or anything that I think could cause my nose to go haywire.
6hrs p/vax pt began to exp sharp pain in back & arms, muscle spasms spots chills; this AM woke to feel some better but w/activity discomfort returns; lt deltoid pain/tenderness;
Initial information received on 15-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 11 years old male patient who received 0.5mL dose of vaccine MENACTRA lot U5833AA, expiration 25-Feb-2019 via unknown route in the right deltoid on 15-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HPV VACCINE for Immunisation; INFLUENZA VACCINE for Immunisation; and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for Immunisation. It was a case of actual medication error due to Expired vaccine used. It was reported that a patient received a dose of MENACTRA on 15-Mar-2019, that was expired on 25Feb2019. It was unknown if any adverse event was occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.