chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 11/5/07 at approximately 11am I had a Grand Mal seizure for the first time in my life with no prior symptoms or signalment. I was taken to the emergency room at the University of Missouri Hospital. In the emergency room at 2:15pm I had another seizure, a complex partial with secondary generalization seizure. I had a MRI, CAT scan and EEG, all of which were negative. I was treated with Dilantin 100mg 3 times per day, but have been switched to carbamazepine (Tegretol) 300mg orally per day for at least 6 months. I had to stay in the hospital three additional days due to thrombophlepitis of my upper left arm where a cathether had been placed. I was treated with Ibuprofen and Bactrim DS tablet orally for the thrombophlepitis. 12/26/07-records received for DOS 11/10-11/11/07-DC DX: Seizure.Seen in ED on 11/5 and 11/6 for new onset of sezure. After visit to ED and subsequent DC she was found near the pharmacy hypersomnolent. In ED on 11/5/07 observed generalized tonic-clonic seizure. Developed pruritis, rash, left orbital swelling presumably from Vancomycin.  02/03/2010 Petite Mal Seizure 12/21/07.
Very high fever for 4 days, red swollen leg from the vaccine injection...roseola on the 4th day....for sure from varicella injection!!!!
Patient was given Pfizer vaccines for his 6 month booster shot and it should have been Moderna. He previously had Moderna for 1st and 2nd doses.
Information has been received from an RN concerning a 48 year old male with hypertension and gout who on 25AUG2003 was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine. There was no hx of any previous rxn to any other vaccination."  Concomitant medication "at the time of vaccination" included Allopurinol and hypertensive medications. On 25AUG2003, patient developed a "local injection site reaction large, fist size within 20 minutes of vaccination" also reported as "immediately developed an injection site reaction"). It was noted that the pt was not hospitalized, was treated with Benadryl and ice was applied. It was noted that he was observed for a half hour before being sent home. The reporter expressed concern about the particular lot of vaccine mentioned that the "second and third pt received lot #0873M". Medical attention was sought. There was no product quality complaint involved. It was noted that the pt recovered completely. The records of testing prior to release of this lot have been checked by AQ and found to be satisfactory. The reporter also mentioned two other pts who were vaccinated with pneumococcal 23v polysaccharide vaccine and experienced similar reactions. No further information is expected
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE HYPOXEMIC RESPIRATORY FAILURE RESPIRATORY FAILURE, UNSPECIFIED ACUITY
This spontaneous report as received from a nurse refers to patients (clients) of unknown age. On an unknown date, the patients were vaccinated with improperly stored VAQTA (strength, dose, route of administration and indication were unknown). No concomitant medications were reported. No adverse effects reported at the time of report. No product quality complaint was involved. The outcome of events was unknown. No further details provided. This report is linked to 1405USA009522, 1405USA010570, 1405USA010572 by the same reporter link. Additional information has been requested.
Narrative:  Patient with history of seizures was given his 1st dose of Moderna COVID- 19 vaccine toward the end of a stable dialysis treatment. 15 minutes post immunization, patient experienced hypotension and grand mal seizures. Hypotension resolved with saline administration. Oxygen via NC administered. EMS called due to ongoing seizure activity. Transported to hospital where he was admitted for an undisclosed diagnosis.
Approx. 1 hour after injection child had one episode of vomiting. Patient's mother brought child back to clinic. MD examined patient. No treatment given, no further vomiting.
Significant reaction; A spontaneous report was received from a healthcare professional concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an event, significant reaction/vaccination complication.  The patient's medical history was not provided. Concomitant medications reported were gabapentin for unknown indication.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event, significant reaction. Treatment details were not provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event significant reaction was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event a causal relationship cannot be excluded. Further information has been requested.
on 3/22/07 broke out in rash on right arms, upper chest and neck itchy. on 3/23/07-examined and very faint macular rash on arms, neck, upper trunk, not urticaria
NO ADVERSE REACTIONS. PATIENT GIVEN EXPIRED  VACCINATION (EXP DATE 9-21-21)
Pfizer Dose 1 3/17/21 (EN6205); Pfizer Dose 2 4/14/21 (EW0153); COVID Positive 3/8/22; 3/8/22: 82-year-old lady presented to the emergency room with complaint of generalized fatigue and shortness of breath with activity that started yesterday evening.  The patient reports having difficulty ambulating because of increasing shortness of breath.  She denies fever.  She denies cough.  The patient was treated for COVID 10 days ago and stated that after treatment she was feeling just all right with no issues. She denies diarrhea.  In the emergency room, she was noted to have a hemoglobin of 6.  She denies abdominal discomfort.  She stated that she was on dexamethasone, and she continued taking her Plavix as usual. 3/13/22: Patient is an 82-year-old female with a history of coronary artery disease with the hospital with a chief complaint of generalized fatigue and shortness of breath. On initial lab evaluation the patient's hemoglobin was found to be 6.8.  Patient was transfused with 2 units of blood. Gastroenterology team was consulted and patient had an upper endoscopy performed which revealed 2 ulcerations which were about 0.5 cm x 2 cm arm and the other one was 1.5 cm 1 cm long.  Both of these ulcers were found to be not moving and both were cauterized.  H pylori samples were taken.  H pylori is negative.  Patient's hemoglobin remained stable during her hospitalization.  Patient is to be discharged with Protonix 40 mg p.o. b.i.d. Patient was instructed not to take Plavix and dexamethasone.  It is okay to take aspirin should follow-up with primary care physician in 1 week.  Also the low-grade temp of 100.8° F recorded in the patient's chart but according to the nurses report the patient was wearing a few layers of blanket. Patient was discharged from the hospital in a hemodynamically stable state.  Patient will follow-up with PCP in 1 week.
Pt came into office 12/28/07 complaining of red spots to both lower legs for 3 weeks. At that time had bruises over shins. Blood work checked(CBC) in office. Pt came into office 1/3/08 still complaining of bruising to legs, swollen right ankle, and painful bumps along shin and some on palm of hand. Further lab work ordered.
Patient presented to the clinic for covid vaccine at approximately 2:20pm. She received her Pfizer #1 vaccine without incident. The patient was notified to wait 15 minutes in the waiting area for monitoring. While she was waiting she became pale, was heavily perspiring, and was vomiting. She was A+ O x3 during the event. She did not lose conciousness. Vitals were 100/60, HR 60, O2 99. She was moved to a lying position with her legs bent on the exam table. She began to feel better. Paitent was then sat up and monitored x 10 minutes. Patient was feeling better so she was moved to a chair in the waiting room and monitored for another 10 minutes. She left with her family without assistance. Patient verbalized she was feeling better.
Small, hard, red lump at the site of injection beginning a week after injection. Lump dissapaited over a week until it left a large, red leison in its place that has lasted another week. Injection site is red, itchy, and painful to the touch.
Patient experienced severe lightheadedness and flushing w/i a few minutes of administration of the two vaccines. She believes she may have momentarily passed out on the table on which she was resting her head. Her vital signs were stable per EMS (evaluated about 20 mins after onset of symptoms). Patient refused transport or further medical care, proceeded to shop in the store, and did return to the pharmacy about 20 min later to report that she felt fine at that time.
observed the patient sitting down head lowred looking uncomfortable, called a translater, patient felt dizzy nausiated and had blurry vision. I had him lay down with feet up bp 89/41/54 at 1:25pm , a few minutes later he said his visiion had improved and took some water. at 1:30 bp was 97/61 60  some improvement but felt worse a few min later 1:34 bp 94/59 60 and at 1:44 bp 97/69 57 he felt well enough to stand, walk around  at 1:49 he left with his freinds but confided to the translater that he was still nausated. (he had not eaten lunch yet) I avdvised that if he still felt bad that he should consider seeing a doctor. He and his friends then purchased some crackers and tylenol before leaving  the store.
The evening after my flu shot I noticed that the injection site had a quarter size hard warm lump. On 12/12/12, the lump had grown to the size of an egg. I have not had any previous reactions to any vaccines, including the flu shot. I reported this to my physician's office on Thursday, 12/13/12.
Received 2 month shots on 8/31/06:  Pediarix, Prevnar, Acthib, and Rotateq. Office visit on 9/5/06 presenting with fever of unknown origin.  Family stated fever as high as 102.3 rectally.  At time of visit temp was 100.3 rectally post tylenol.  LP and CBC performed in office.  Admitted to Hospital.  10/13/06 Received D/C Summary from hospital which reveals the primary Dx as meningitis, cardiac arrest & seizures.  Patient had neurologic devastation s/p cardiac arrest, family requested palliative care & comfort measures.  Patient expired on 10/8/06
<20 scattered pruritic lesions, some vesicular, others mostly papular, over the course of 14 days so far. Also c/o fever, headache, malaise, brief sore throat. Treated with acetaminophen and Benadryl.
Patient's mother stated this was the patients first vaccination and he she wanted kids to recieve Moderna which was administered. SUbesequent records review revealed the child had recieved Pfizer 5 to 11 (Lot FK 5127) on 11/4/2021 and 12/1/2021. Mom and phone as listed  No known adverse events
COVID Arm developed 24 hours after injection and lasted three days. The injection site was red, swollen and hot. The circumference of the area was about 2.5 inches out from the injection site.   12 days after the injection I woke up with an itchy scalp and neck. I took a Zyrtec thinking it was allergy related due to weather changes. Within a few hours I had hives on my wrist and back. I continue to deal with hives that come and go throughout the day and move to various parts of my body. They are intensely itchy and burning and times. On Sunday, Dec 19th I went to Urgent Care and received a steroid shot and prescription for Prednisone. I took the full five-day course of Prednisone which did not provide much relief.  I am currently on a regimen of Zyrtec 10mg (morning and night), Benadryl 50 mg (every 4-6 hours) and Pepcid 20mg (morning and night). It provides some relief but not complete.
1st dose on 10/11/2019 and 2nd dose has not been administered yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the first dose of Shingrix on 11th October 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 07-JUL-2022 Reporter's comment: The pharmacist reported that the patient (husband) had not been administered 2nd dose yet. The Vaccine administration facility was the same as primary reporter. The Healthcare Professional (HCP) did not had lot number or expiration date of Shingrix first dose. The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. This case was linked with case US2022103850 reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022103850:Same reporter
flu-like symptom; body aches; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult 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, less than 3 months after receiving Shingrix, the patient experienced influenza-like symptoms and general body pain. On an unknown date, the outcome of the influenza-like symptoms and general body pain were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms and general body pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination not reported. The patient received the first dose of the Shingrix vaccine about 2.5 months ago (she does not remember the dates) and she experienced body aches and flu-like symptom. The reporter consented to follow up. For further tolerance of 2nd dose refer case US2020AMR237568.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR237568:2nd dose
AN ASSOCIATE HAS A RASH AND ITCHING ALL OVER THE BODY ABOUT ONE HOUR AFTER ADMINISTERING THE VACCINES BOOSTRIX AND FLUARIX QUAD. THERE WAS NO PAIN OR ITCHING IN THE AREA OF VACCINE ADMINITRATION. 50 MG OF LIQUID BANOPHEN(DIPHENHYDRAMINE)WAS GIVEN ORALLY.
Around October the site started feeling tender; Around October the site started feeling bruised feeling; 3 inch redness, swelling, warmth, itching at site for around 5 days; 3 inch redness, swelling, warmth, itching at site for around 5 days; 3 inch redness, swelling, warmth, itching at site for around 5 days; 3 inch redness, swelling, warmth, itching at site for around 5 days; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191) via an unspecified route of administration in the left arm on 28Aug2021 at 13:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, chronic kidney disease (CKD), high cholesterol and fatty liver. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included losartan (MANUFACTURER UNKNOWN) and atorvastatin (MANUFACTURER UNKNOWN); both for an unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EF0191) via an unspecified route of administration in the left arm on 06Aug2021 at 13:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. On 28Aug2021, the patient experienced 3 inch redness, swelling, warmth, itching at site for around 5 days. On an unknown date in Oct2021, reported as around October, the site started feeling tender/bruised feeling. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events 3-inch redness, swelling, warmth, itching at site for around 5 days was resolved on 02Sep2021; while that of the events around October the site started feeling tender/bruised feeling was not resolved at the time of this report. No follow-up attempts are possible. No further information is expected.
pt recvd vax 6APR; 8APR swollen; fever seen 9APR 4 x 3 in hot-swollen, red area rt upper;
YF-VAX administered IM instead of Subcutaneous with no reported adverse event; Initial information received on 11-Jul-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient and Yellow Fever Vaccine [Yf-Vax] administered im (Intramuscularly) instead of subcutaneous with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect Yellow Fever Vaccine Solution for injection (lot number: UJ820AB, Expiry date: 28-May-2024) (with an unknown strength) via intramuscular route in unknown administration site for Immunization.  On an unknown date, the patient received Yellow Fever Vaccine -vax im (Intramuscularly) instead of subcutaneous with no reported adverse event (incorrect route of product administration) (latency: same day).  It was reported, reports YF-VAX administered IM instead of Subcutaneous. She would like to know if there are any anticipated side effects and if the pt needs to be re-immunized." The pharmacist states that she doesn't have time right now to provide additional AE information but if e-mails her a form with specific questions she would be happy to fill it out. This is all the additional information she provided at the time of her call.  Action taken: not applicable.  Outcome: Unknown   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 the 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.
Abnormal period cycle with incredibly light, frequent bleeding for 8 weeks, followed by abnormal, heavy cycles.
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 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Jan2021 as dose 1, single (Lot number: EN5318), on 16Feb2021 as dose 2, single (Lot number: EN5318), on 19Oct2021 as dose 3 (booster), single (Lot number: FF8839) and on 29Apr2022 as dose 4 (booster), single (Lot number: FJ4987) at the age of 60 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hodgkins Lymphoma", start date: 2008 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Report about COVID treatment yes. If vaccine received was reported as yes. Patient received Paxlovid treatment from 23Dec2022 to 27Dec2022 for Covid-19. No current illnesses.
pt devel urticarial rash on 10/20/99;rash progressed to erythema multiforme w/oral involvement;dx as Stevens-Johnson synd;
Report described chest pain in a 9 year old female who received hep A vaccine. This report was received from the vaccinee's mother and has not been verified by a physician or other healthcare professional. Allergies and medical history were not specified. On 10/19/2000, the vaccinee received the unspecified dose of typhoid vaccine. In the morning of 10/27/2000, the vaccinee received the unspecified dose of hep A vaccine and yellow fever vaccine. Reportedly, sometime later that afternoon, the pt experienced wheezing, chest pain, back pain, and hives. The physician prescribed her diphenhydramine hydrochloride (Benadryl). As of 03/02/2001, the outcome of the adverse events was unknown.
Patient received her 2nd dose of Moderna. After 15 minutes had passed (6:00ish) , she informed me that her heart was hurting. She had shooting pain in her heart( scale 1-10 ( most) she said like a 5. Asked her if she wanted me to call the paramedics, she said no. Patient was accompanied by mother and sister. Told pt to wait a little longer to see if pain went away.  Her prior dose did make her sick for two weeks didn't eat; sleep was not feeling good.  At around 6:36 pt felt better and said she was fine to go.
This spontaneous report was received from a other healthcare worker refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. The patient's concomitant medication included sterile diluent was used to reconstitute the PROQUAD. On 12-FEB-2018, the patient was vaccinated with improperly stored PROQUAD (dose, units, frequency and route was not reported) (lot # N022973 and expiration date: 01-FEB-2019) at the temperature from -14 degree Celsius (C) to -10 C for 15 minutes and -9 C to 8 C (-1.7 C) for 1 hour 8 minutes. No adverse effects were reported and no further information was provided. No product quality complaint was involved. The call was because of digital data logger. There was no previous temperature excursion.
Patient stated that the injection was fine but after about 20 minutes she complained of arm feeling heavy. She compared it to upper shoulder tension headache through her deltoid to the trapezius muscles. She did not have any nervous system symptoms or significant pain. Just that her arm felt much heavier than normal and tension in the neck & shoulders.
This spontaneous report was received from a healthcare professional who reported that in January 2014, 21 improperly stored doses of ROTATEQ, (oral, dose, batch and lot number not reported) were administered by a clinic to an unspecified number of patients (age and gender were not reported). No adverse effects were reported. This is one of several reports from the same source. Follow up information has been received on 17-MAR-2014. All telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 22-SEP-2014. Demographic details for each patient were provided. This report referred to a 5-months old male patient, with no known drug allergies and no illness at time of vaccination. The patient was vaccinated with the third dose of ROTATEQ (oral, batch/lot # J001254, expiration date 19-SEP-2014), on 27-FEB-2014 at 09:16 AM. It was reported that this dose was spoiled since the refrigerator was too cold (onset of event also reported as 27-FEB-2014 at 10:00 AM). Revaccination was declined. No adverse event was reported for the patient. Outcome was reported by the reporter as unknown. This is one of several reports from the same source. Additional information is not expected since all follow ups requested to complete the case were received.