chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A non-serious spontaneous report of given expired FLUMIST was received from a health professional concerning a four-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 22-Jan-2012. On 23-Jan-2012, expired FLUMIST was administered to the patient. There was no adverse event associated with this medication error, therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
a 7 month old patient inadvertently received MMR and VARIVAX due to human error; This spontaneous report was received from a nurse and refers to a 7-month-old patient of unknown gender.      The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant therapies were not reported.   On 12-NOV-2020, the patient was inadvertently vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX)  (dose, frequency, route of administration, indication not reported; lot # T017682 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 21-MAY-2022)  and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (dose, frequency, route of administration, indication not reported; lot # S029455 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 19-SEP-2021) due to human error (Inappropriate age at vaccine administration). No further information was available.
Patient reported nausea, abdominal pain, headache, fever, chills, body ache. Severe side effects, specially body ache. When patient called she also reported feeling better than prior day.
Patient reports tachycardia randomly occurring.  This is occurring when patient is idle and not being active (ie while sleeping at night).  Reports several instances of this.  Patient has had this issue in the past but has been common since the vaccine.  Patient is on heart medication since he has had stents/previous heart attacks.
Aug/Sep 2020 tested positive for Covid. I had 102-103 temperature would come and go and it would get worst every 3 day. The cough lasted a long time. Nausea, diareahha - GI issues and fatigue .  after my 2nd ( and my 1stdose)dose at 3PM - chills and had fever 103;5, my arm hurt, cough and headache and really fatigue for 2 days and then it went away. Its like having Covid.  8Jan2021 - Tested positive for Covid  - Sneezing and throat hurt . felt like I had Omicron. I went to work. on Wednesday I thought I had strep throat/ it hurt when I swallowed  . 3rd Jan2022 . 5Jan2022 ER - negative and tested on 1/8/2022 positive.
Found out I was pregnant inbetween the first 2 doses. Developed gestational diabetes at 28 weeks with no prior family history of diabetes and no risk factors. Suddenly developed preeclampsia at 34 weeks and needed to be induced to delivery. Baby boy spent 22 days in NICU
WITHIN SEVERAL HOURS OF VACCINATION CHEEKS BECAME FLUSHED AND BLOOD PRESSURE BECAME ELEVATED
Pt received 2nd Moderna vaccine 4/20/21.  Developed a fever 101-104 eight hours after getting the vaccine.  Also experienced headache and body aches.  Next day felt better on 4/21/21.  On 4/22/21 pt woke up with red, itchy rash on chest, abdomen, back and arms.
Tiredness; 100F fever; This is a spontaneous report from a contactable consumer or other non-health care professional.    A 12-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0177) via intramuscularly, in left arm on 07Jun2021, at 17:15 (at the age of 12-years-old) as dose 2, single for covid-19 immunization. The patient medical history included seasonal allergies. There were no concomitant medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0179) via intramuscularly, in left arm on 15May2021 at 01:30 PM (at the age of 12-years-old) as dose 1, single for covid-19 immunization. Patient had not received any other vaccines within 4 weeks. Patient had not received any other medications in two weeks. Patient had not been diagnosed with COVID-19 prior to vaccination. patient had no Known allergies. On 08Jun2021 at 15:00, patient experienced tiredness and 100F fever. Therapeutic measures were taken as a result of the events and treatment included 200mg Advil, taken once. The patient underwent lab test and procedure which included SARS-CoV-2 test Negative (Nasal Swab) on an unspecified date in Aug2020, body temperature 100 Fahrenheit on 08Jun2021. Outcome of the events were recovering.  No follow-up attempts are possible. No further information is expected.
Patient received IM flu vaccine L deltoid region. System confirms inj site was 5cm superior and 3cm posterior to belly of deltoid muscle, 1cm below acromion, directly into subacrominal bursa. Pharmacist was tall and standing, patient was sitting. Pain and limited ROM same arm with onset over next 3hr, persistent over next 6wk and counting. No prior pain, injury, surgery or any problems with this shoulder. Patient presented to Sports Med physician 5wk after inj (10/24/2018) and was Dx'd with SIRVA - deltoid bursitis due to erroneous direct inj of vaccine into subacromial bursa. Clinical outcome TBD at this point, no improvement with pain or ROM at 5wk - difficulty or inability with ADL including dressing reaching for alarm clock, washing hands (repeated supination and pronation), exercise, etc. Pharmacy manager was informed of incident, they reported never having heard of SIRVA and were unable to confirm vaccine lot number due to blurry scanned file.
Heart palpitations, very fast heart rate as well as a pounding heart that lasted for 3 days and all throughout the night, approximately a week after my first dose of the vaccine. In addition to these symptoms, my left arm, fingers, and hand would start to feel numb.  Ever since the first episode, I've been having severe heart palpitations at least twice every month.  Never suffered from heart issues in the past.
Felt weak after vaccination, but left facility believing it was hypoglycemia to eat. Hours later had chills for 3-4 hours, and abdominal cramps and diarrhea for 3 days.
Chest pain, tachycardia, pain radiating to scapular and shoulder pain , fatigue and shortness of breath over day 2 after vaccine worsened by day 6 ended in urgent care-EKG with st and t waves changes. Referred to emergency room and admitted at cardiac cath. unit-required emergency.
Approximately 2.5 hours after immunization, patient developed a lump on left shoulder area. Within 30 minutes, patient developed numbness and tingling in left arm. Patient went to urgent care clinic. Patient symptoms were still present. Clinic sent her to emergency department. At the emergency department, symptoms were fully resolved by 19:58 on the same day.
Hallucinations, UrticariaPruritus & Diarrhea  Narrative:  Employee reports experiencing itching at injection site, headaches, diarrhea, and "wheals" or welts/hives. Reports using Benadryl for symptom relief. Has not fully recovered from event as of date of this report. Did not seek medical attention for symptoms as of date of this report.   Other Relevant History:
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: blister like bubble at injection
THE PATIENT ARRIVED FOR THEIR SHOT, PRESENTED THEIR COVID CARD AND FILLED OUT THE IMMUNIZATION  INTAKE FORM. THE SHOT WAS ENTERED INTO THE  PHARMACY SYSTEM AND ADJUDICATED TO INSURANCE. AFTER REVIEWING THE FORM AND COVID CARD, REVIEWING ANY QUESTIONS THE PATIENT HAS THE SHOT WAS PREPARED AND ADMINISTERED .   AT THE END OF THE WORK DAY WHEN ENTERING PATIENT INFO INTO VACCINE SYSTEM IT WAS DISCOVERED THAT THE PATIENT HAS ALREADY RECEIVED THE MODERNA BIVALENT BOOSTER ON 9/22/2022.  CALLS WERE PLACED TO MODERNA AND TO THE CDC FOR ADVISEMENT ON COUNSELING THE PATIENT. THE PATIENT WAS IMMEDIATELY NOTIFIED. NO ADVERSE SIDE EFFECTS NOTED AT THE TIME, NO ASE REPORTED SINCE THAT TIME.
Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to cases 2018SA292282, 2018SA292283 and 2018SA292285. This case involves a 25 years old female patient who was accidentally vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE (lot UJ038AA and Exp. Date 03-MAY-2019) via intramuscular route in the right deltoid on 18-Oct-2018. The patient's medical history and concomitant medications were not reported. No other vaccines given at the time. It was also an actual medication error case due to inappropriate age at vaccine administration and vaccination Overdose. No information about any adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
Patient developed febrile seizure at 12 midnight on 2/7/23.  Dad reports tactile fever at that time and jerking movements of arms and legs lasting  less than 1 min.  He was evaluated in the Emergency Dept and no focal source of infection was identified.  Dx home with dx of febrile seizure.  He continues to have fever at this time.
Glands on the left clavicle; Sore chest; Fever; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of MASS (Glands on the left clavicle), CHEST PAIN (Sore chest), PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 031B21A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine. Concomitant products included ACETAMINOPHEN for Migraine.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MASS (Glands on the left clavicle), CHEST PAIN (Sore chest), PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, MASS (Glands on the left clavicle), CHEST PAIN (Sore chest), PYREXIA (Fever), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment for the events taken with Ibuprofen.
This spontaneous report as received from a registered pharmacist concerning a 70 year old male patient with no known allergies. On 04-NOV-2014 the patient was vaccinated with a dose of PNEUMOVAX 23, 0.5 ml, intramuscular in the right arm (dose, lot # and expiration date not reported). Concomitant therapies included Influenza virus vaccine (unspecified administered in the left arm. On 05-NOV-2014, the patient developed redness, soreness and swelling from his right bicep to his right elbow. The right arm was not warm to touch. The patient sought medical attention called pharmacy. On unknown date in November 2014 the patient recovered from the adverse events. Additional information is not expected because the reporter cannot be contact.
fever of 105, loss of appetite, excessive drooling, hypertrophied tonsils, erythema of tympanic membranes all within 24 hrs of vaccinations
Severe headache,  fever, chills, exhaustion, body aches, no taste or smell. Monday right side of tongue swelled and lip. Called doctor and was told take benadryl which helped.  Next day left side of tongue swell and again benadryl helped. Dr. wanted me not to get 2nd moderna shot but to get the Johnson and Johnson  which I had appointment for this week until canceled
Patient received 4 month vaccines and had seizure x4 after receiving vaccines (10 hours later). (IPV, DTaP, HIB, Hep B and pneumococcal)
It started with a fever of about 102 degrees all night. The next day and half I had a lesser fever and chills. The 3rd day on a Monday I was calling my boss and when I looked at my computer, I noticed my vision was impaired in my right eye. When it didn't improve that's when I went to the doctor. She referred me to a Specialist (Eye Associates) who said I had sudden onset of wet macular degeneration. I then had a phone consultation with my Internalist who said I should report it to the CDC that the high fever could have kicked off the inflammatory condition in my right eye. The doctor also said the same thing. I'm now getting injection in my eye every few weeks that doesn't make it any better just keeps it from getting worse. I had COVID on Dec. 7, 2021, which was after my 2nd dose. I had a pretty high fever 101 but not as high as when I got the vaccine. Coughing, chills, muscle aches, brain fog. Fatigue and brain fog when on for a long time. And wasn't better till the end of January. A month after I got well my toes developed red painful spots- I got them first on my left foot and subsided a week later. Then got them on my right foot and that's subsided.
C/O dizzy, syncope x1,  less than 5 seconds, patient reports similar problem with all other vaccinations and injections. Father reports daughter ate dinner last night . Did not eat breakfast before coming to site. Patient alert and oriented x4 after incident.
Patient had a CVA (ischemic stroke) on 3/29/21 and was hospitalized for two days. Her signs/symptoms included sudden inability to form words, slow speaking, inability to write, inability to text/use cell phone, elevated blood pressure. She arrived to the hospital within 30 minutes of the start of symptoms and had a CT done that show no blood clot but an MRI about 12 hours later showed an ischemic area approximately the size of a quarter in her basal ganglia. After discharge from the hospital, she is following up with speech therapy, occupation therapy, and physical therapy. She was started on lisinopril, atorvastatin, plavix, and aspirin in the hospital and will continue those indefinitely.
This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a female patient who received BEXSERO. On 6th July 2016, the patient received the 1st dose of BEXSERO. In July 2016, less than a week after receiving BEXSERO, the patient experienced injection site swelling and injection site tenderness. In July 2016, the outcome of the injection site swelling was recovered/resolved. On an unknown date, the outcome of the injection site tenderness was not recovered/not resolved. It was unknown if the reporter considered the injection site swelling and injection site tenderness to be related to BEXSERO. Additional information was provided as follows: Age at vaccination was not reported. The nurse reported that the patient's swelling had gone down, but she was still having tenderness at the injection site. No further information was provided.
Information has been received from a physician concerning a 20 year old male with drug hypersensitivity to Vancomycin and a medical history of heart transplant, in "June 2004" who on an unknown date, was vaccinated with a dose of Varivax. Concomitant therapy included: prednisone, sirolimus, pantoprazole sodium (PROTONIX), Cyclosporin and diltiazem hydrochloride (CARDIZEM). It was reported that "the first week of May, the patient developed disseminated Zoster". The first signs were scalp discomfort and itching. The patient presented to the physician on 10-MAY-2007 the first day of hospitalization with zoster of the dermatome C-2 distribution that was right sided and several (5-6) ulcercerations on the right side of the tongue. The lesions were described as red, excoriated lesions, 3-4 mm in diameter. On the second day of hospitalization, 11-May-2007, the patient developed vesicles 1-2 mm in diameter described as papules in an erythematous base 1.5 to 2cm in diameter. The vesicles were spread bilaterally through out the anterior and posterior trunk and neck. The patient was treated with intravenous acyclovi (ZOVIRAX) and discharged from the hospital in the morning of 14-MAY-2007. The Flourescent antibody test was positive for varicella and positive culture of varicella. The patient status is recovering. No product quality complaint was involved. Additional information has been requested.
With the first vaccine, I had 8/10 pain in my upper left arm and shoulder accompanied with slight lymph node swelling and tenderness in my arm pit for 2 weeks
accidently vaccinated expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (accidently vaccinated expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (accidently vaccinated expired vaccine). On 22-Sep-2021, EXPIRED PRODUCT ADMINISTERED (accidently vaccinated expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information were used. No treatment was reported.
Caused diabetes, high hymagloban a1c count of 10.5 in a healthy, normal weight, young adult with no generic history. Side effects started post first shot and worsened post second.
Arm pain began and worsened over several hours. The pain was located from the elbow to the mid-upper arm area. Pushing and pulling movement of arm elevated the pain and had difficulty lifting arm. Continued over night. Began to improve the next day with ibuprofen and heating pad and ice. As of this report (3/28/19), it feels nearly back to normal with slight tightness.
pt says he developed a fever, was shaking with chills, and he had trouble sleeping.  He still has fatigue and headache but is feeling about 70% better today 4/8/2021.
I had my vaccination on 09/02/2022. I had blood work done in 12/2022 in which showed elevated white blood cells. I was referred to Oncologist who diagnosed me with Chronic Lymphocytic Leukemia. No goal treatment as it progresses 10 to 15 years.
I?ve been experiencing unusual menstrual changes since I received my J&J dose on April 8th.  A few weeks after the vaccine I was experiencing PMS symptoms (breast tenderness, hormone imbalance, breakouts, light cramping etc) and today I began what appears to be my first day.  I was menopausal & my last period was December 2018.  This is unusual.
Mom brought child to clinic on 4/21/10 with mult. red papules; appeared to be chicken pox. Addendum to report #E - 43216 outbreak started 4/17/10 (one day after vaccine administered) pt seen 4/28/10 and MD diagnosed chicken pox (resolved).
Broke out in rash and itching on Tuesday 1-18-2010 after  vaccine resolving by Friday. No treatment done.
Patient presented for third COVID19 vaccine. Patient had received Moderna for doses 1 and 2, however received Pfizer vaccine, in error.
Client was experiencing dizziness and nervousness upon entry to the clinic. Client got a little dizzy during injection. Client was monitored for 30 full minutes (rather than 15) and was given two juice boxes. Client reports not having eaten breakfast and felt that her blood sugar was low. Client declined EMS/other assessment. Client recovered and was able to discharge from the clinic of own volition.
headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No medical history was not provided by reporter.  Concomitant products included ATENOLOL, HYDROCHLOROTHIAZIDE, PRAVASTATIN and Trazadone for an unknown indication.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication include tylenol .
atient complained of not feeling well and dizziness. Patient appears pale and clammy but remains alert and ale to answer questions. @1338 BP 80/50, HR 68, SP02 97%, sitting in chair in lobby. Patient given water and cold towel.  Assisted to clinic immunization room via wheelchair, assisted to gurney, placed on supine position. @1345 BP 110/65, HR 95 SPO2 99%, states he is feeling better, no longer pale or clammy. @1350, patient assisted into a sitting position (legs up in gurney), denies dizziness, BP102/68 RR 22, HR 83, SP02 99%. @1355 patient assisted in sitting position with legs dangling down. BP 94/72, HR 83, SPO2 100%. No dizziness.@1400 Patient assisted to standing position, no dizziness and states that he feels good. Advised patient to continue hydrating well at home and contact primary if any other symptoms occur.
I had started having heart palpitations after getting my second dose of the vaccine I saw my doctor at the beginning of March which when I started tracking what was occurring. From March 1st to April 27th I documented every time I had these heart palpitations. They tended to occur late at night when I was relaxing and not being active. I would feel the palpitations and sometimes I would also be light headed or feel a lump in my throat. I did wear a heart monitor and we did some tests to see if we could find out what had caused this. There really was not much we could relate this other than that second dose of the Moderna vaccine.
ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN ACUTE DVT, UNSPECIFIED VEIN
ischemic stroke/treatment lisonopril HCTZ 20/25mg, atorvastatin 20mg, aspirin 1 X day, metoprolol ER 25 mg 2 X day.  Permanent.
Feeling unwell; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling unwell) in a male patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Feeling unwell). At the time of the report, MALAISE (Feeling unwell) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD21-087683, US-MODERNATX, INC.-MOD-2021-114220 (E2B Linked Report).; Sender's Comments:  MOD21-087683: US-MODERNATX, INC.-MOD-2021-114220: