chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician via a company representative concerning a 16 year old male patient with no pertinent medical history and no drug reactions or allergies. On 01-MAY-2013, the patient was vaccinated with the second dose of GARDASIL (lot number and expiry date reported as H014645 and 27-MAR-2015 respectively, dose unspecified), intramuscularly in an unspecified arm. Concomitant therapy included MENACTRA (lot number, expiry date, dose and route unspecified) injected at the same office visit on 01-MAY-2013 with GARDASIL. On 01-MAY-2013, the patient experienced a seizure in the car, five minutes after leaving the office. It was reported by the mother of the patient, ten minutes after having left the office with her two sons. It was unspecified if the patient sought any medical attention. It was unspecified if the patient was treated or if any laboratory tests were performed. The mother of the patient was instructed by an unspecified healthcare worker at the physician office to go to the emergency room of an unspecified hospital. When the physician office later contacted the unspecified hospital to see if the patient had sought treatment, there was no record that the patient had been to the hospital. It was reported that approximately on an unknown date in May 2013, the seizure had ended (duration unspecified). Upon internal review, seizure was considered as medically significant. This is one of the two reports from the same source. Additional information has been requested.
The following timeline starts a year prior to patient receiving the third dose of the GARDASIL Vaccine. This part pertains to headaches, tingling in hands, face and head, and fatigue. 1/29/12 started VYVANSE for ADHD. 7/20/12 received the first GARDASIL vaccine. 9/21/12 received the second GARDASIL vaccine. 1/23/13 PROAIR HFA prescribed. 1/23/13 Azithromycin prescribed. 1/23/13 Received the third GARDASIL vaccine. 2/14/13 Patient stopped taking VYVANSE about a month ago dur to the side effects and she didn't feel it was helping. Headaches started, tingling and fatigue. 2/15/13 started amphetamine for ADHD. Discontinued due to headaches, tingling and fatigue. 3/8/13 started methylphenidate for ADHD. Discontinued due to headaches, tingling and fatigue. 3/30/13 Diagnosed with Dysthymia Disorder. Still having headaches, tingling and fatigue. 11/22/13 started Bupropion for depression. Stopped after 2 months. Still having headaches, tingling and fatigue. 1/7/14 started seeing a new therapist. Started Neuro Biologic Advanced Neurotransmitter Support for ADHD. April of 2014 and an IEP was put in place at school to help with grades and stress. 9/9/14 Referred to institute and had MRI. Was told to take 200 mg of B2 to prevent headaches. Headaches continued and was told to increase to 400 mg of B2. Still having headaches-stopped B2. 10/14/14 seen another Dr. and was told to take Magnesium to prevent headaches. Still having headaches-stopped Magnesium. Tried peppermint oil to prevent headaches. Headaches continued-stopped using peppermint oil. 2/4/15 Started NEUROCORE to help with stress and anxiety. 3/14/15 Started chiropractor for neck and back pain. This timeline is for immune issue 4/24/14 Dermatologist prescribed doxycyc mono for staph infection. Condition worsened. 5/1/4 Dermatologist prescribed Levofloxacin. Condition worsened. 5/13/14 Infectious disease dr prescribed smz/tmp ds and mupirocin. Condition continued. 7/7/14 Infectious disease dr prescribed smz/tmp ds again. Condition continued. 10/8/14 Dermatologist prescribed ACTICLATE. 12/26/14 dermatologist diagnosed cyst to be surgically removed. 1/19/15 Plastic surgeon recommends surgically removing cyst.
I have a possible urinary tract infection. I contacted my doctor and was prescribed an antibiotic and an antifungal medication, but I do not recall the name. I am doing better, but still not one hundred percent.
No additional AE reported.; an expired dose of VAQTA was administered.; This spontaneous report was received from a nurse concerning a patient of unknown age. No concurrent condition, medical history, or concomitant therapy was reported.  On 15-DEC-2021, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) (0.5 mL, strength and route were unknown; lot # T013204 has been verified to be a valid lot number, expiration date reported and confirm upon internal validation as 03-DEC-2021) for prophylaxis (expired product administered). The product had not experienced temperature excursion. There was no adverse event.
The adverse event occurred out of nowhere.  On the night of 2/20/21, my mom noticed something at the injection site.  It wasn't until the morning of 2/21/21 that her arm started to bother her.   The injection area was swollen, and warm to the touch.   There was a red, itchy rash present at the injection site - which grew bigger as the days went on.   The rash was about maximum 4 inches wide.   My mom  used hydrocortisone cream, an ice pack, and Benadryl tablets to treat the rash. The rash went away after about 4 days.   She thinks this was the "COVID arm" that can happen with the Moderna vaccine.
18APR99 pt exp scalp itching (entire);20APR99 pt took DPH  for itching scalp this helped;also on thursday pt noticed tiny bump rash along hairline on face & on neck;21APR99 itching is less but cont;
I have no sense of smell, and taste.  I had a great sense of smell before the vaccine. Now I cannot smell anything
No adverse effects reported; patient inadvertently received a fourth dose of GARDASIL 9 as a medication error as the dose was intended for sister; patient inadvertently received a fourth dose of GARDASIL 9 as a medication error as the dose was intended for sister; patient inadvertently received a fourth dose of GARDASIL 9 as a medication error as the dose was intended for sister; This spontaneous report was received from a nurse and refers to a 17 year old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  In October 2013, the patient was vaccinated with their first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (dose, route and vaccination site were not provided), with a lot# reported "J009788" and expiration date 17-MAR-2016, for prophylaxis. In January January 2014,  the patient was vaccinated with their second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (dose, route and vaccination site were not provided), with a lot# reported "J009788" and expiration date 17-MAR-2016, for prophylaxis. In August 2015,  the patient was vaccinated with their third dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (dose, route and vaccination site were not provided), with a lot# reported as "L010587" and an expiration date of 03-NOV-2016, for prophylaxis.  On 02-MAY-2019, the patient inadvertently received a fourth dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route and vaccination site were not provided), with a lot# of R011630 and expiration date of 12-DEC-2020, for prophylaxis as a medication error as the dose was intended for sister that came in at same time for an office visit.  This is one of two reports form the same reporter.; Sender's Comments:  US-009507513-1905USA011241:
I started fever 100.8 the next morning after the second vaccine, then climbed  up to 101.2 in the afternoon. I also had attacking pain here and there, in joint, or muscles. It moves around every few seconds. I drank a lot of water and slept a lot. All symptom were gone by the evening.  And I felt my normal self.  But I started feeling a lump in the neck yesterday, feels like swollen lymph node.  When i touch it or swallow food I feel the pain.   Not sure if it is vaccine related. I feel it is. So I decided to report. Since it is Friday night now I couldn't check with my doctor till at least Monday.
Information has been received from a physician's office concerning a 37-month-old female who on 09/09/1999 was vaccinated with varicella virus vaccine live. On 09/17/01, the pt experienced chicken pox. Unspecified medical attention was sought. Additional infortmation has been requested.
This spontaneous report as received from a other health professional refers to a 15 month old patient. The medical history, concurrent conditions and concomitant medications were not reported. On 25-OCT-2016, the patient was vaccinated with improperly stored doses of VARIVAX lot # M027347, 01-JUN-2018 and M-M-R II, M032153 22-APR-2017. No adverse effects were reported. Additional information has been requested.
Fluzone HD Quadrivalent was inadvertently administered to a 64 year old patient, no AE; Fluzone HD Quadrivalent was inadvertently administered to a 64 year old patient, no AE; Initial information received on 17-Aug-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 64-year-old male patient who was inadvertently administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ443AA, expiry date: 30-Jun-2021) (product administered to patient of inappropriate age and overdose) on an unknown date as prophylactic vaccination.  Medical history, past medical treatment, vaccination, concomitant medications and family history were not provided.  This was an actual medication error case due to inappropriate age at vaccine administration and overdose (latency same day).  At the time of reporting, no adverse event was 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.
Patient said while receiving his shot that after his first dose, when he was waiting in waiting area he became very hot and had to rest on the floor.  In an attempt to avoid this feeling, I gave the patient a bottle of water and a can of ginger ale, which was cold.  At first he said that the cold ginger ale felt very good, but several minutes after the shot he said he was beginning to feel "heat" rise from his shoulders through his neck.  He asked if he could recline on the floor as he wanted to feel the cold on his back.  I stayed with the patient and talked to him while he was resting.  He stayed there for about 5 minutes and then said he was feeling better.
Swelling, redness, hot, sore. After 4 days it has improved but has not gone away fully yet.
My second vaccination was in April, by May the onset of psoriasis had begun. My hands and feet are showing no signs of improvement.
First dose soreness in arm (left); This is a spontaneous report from a contactable consumer reporting for herself. A 52-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN5318, expiration date not reported), via an unspecified route of administration, in Arm Left on an unknown date in Feb2021 (01:00 PM, as reported) (at the age of 52-years-old), as SINGLE DOSE for COVID-19 immunization. Medical history included high blood pressure, known allergies to sulfa. Concomitant medications included lisinopril; elderberry [sambucus nigra]; vitamin D NOS; ascorbic acid (VIT C). Patient did not receive other vaccines in four weeks of Covid vaccination. Patient was not diagnosed with COVID-19, prior vaccination. Patient has not been tested for COVID-19, post vaccination. On unknown date in Feb2021, the patient experienced first dose soreness in arm (left). Patient did not received treatment for adverse event. Outcome of the event was recovered approximately on unknown date in 2021 (that lasted more than two weeks, as reported).  No follow-up attempts are possible. No further information is expected.
Joint Aches, body aches, "Halo around lights"-day of vaccine. Following Am-joints aches, sore throat and hoarse voice.
24MAR96 pt's mom noticed quarter size redness on rt arm where pt had recv MMR;25MAR96 redness had inc to 5cm diameter circular w/some swelling;MD rx DPH;29MAR96 f/u arm completely better
Had #2 Pfizer 1/13 8am. At 12 noon noticed tingling and swelling/fullness in upper lip which persists. Slight lightheadeness with exertion, "bad HA," slight ST. During call patient looked in mirror and noted fullness in upper lip with new "cold sore" and lightly flushed forehead w/ flat, non-pruritic, red rash. Denies SOB, wheezing, swelling of tongue or throat. Denies dyphagia, eye swelling.  Instructed patient to see provider at clinic now (she is in clinic now) and be evaluated.
Red injection site; Sore right arm; Swollen injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red injection site), PAIN IN EXTREMITY (Sore right arm) and VACCINATION SITE SWELLING (Swollen injection site) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21-2A and 037A21B) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-May-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red injection site), PAIN IN EXTREMITY (Sore right arm) and VACCINATION SITE SWELLING (Swollen injection site). On 08-May-2021, VACCINATION SITE ERYTHEMA (Red injection site), PAIN IN EXTREMITY (Sore right arm) and VACCINATION SITE SWELLING (Swollen injection site) had resolved. Not Provided   Treatment information was provided i.e., Tylenol for pain     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-073215 (Patient Link).
Received vaccine at 5:05pm and waited allotted 15 minutes. Twenty minutes after receiving vaccine,  developed palpitations, chest pressure, feeling flushed and anxious, nausea, tingling on left side of body and face, elevated blood pressure, and slight dizziness while driving home. Was seen at ER a few hours later;  cardiac workup was done with CXR, bloodwork, EKG and heart monitoring and was treated with Benadryl IV. Was sent home for 2 days out of work and instructed to take Benadryl as needed.
2 weeks after vaccine pt developed increased anxiety, shortness of breath, fatigue and palpitations. She has associated chest pain and cannot complete her usual exercise routines.
MOM CALLED STATES PATIENT HAS BEEN EXPERIENCING HAIR LOSS AND PAIN TO LEGS PAST 2 WEEKS.  MOM STATES HAD READ ABOUT POSSIBLE S/S TO VACCINE. pATINE HAS ALSO BEEN DEPRESSED
Profound despair/hopelessness 4/23/22 9:00 am-1:00 pm Extreme Headache - 48 hours Fever/Chills - 24 hrs Heart Palpitations-12 hrs Extreme muscle/ligament pain-48 hrs
- Experiencing "Continuous Low Back Pain" all day and every day. The symptoms started after couple of days from getting vaccinated. - Experiencing increase in sensitivity to my existing food allergies.
pt recvd vax; brother had chicken pox; 2 wks later devel 20 generalized lesions;
As patient was in the upstairs lobby the check-in nurse caught that the patient received Moderna as their first dose on 03/21/2021. Patient is 16 years old and was returning today for their second dose. Check-in nurse alerted myself Nurse Co-Lead. Nurse Co-Lead elevated the situation to Clinical Operations Coordinator, whom verified and approved for patient to receive the second dose of Moderna according to CDC interim considerations. Nurse Co-Lead verified that patient received the first dose of Moderna at the health center and on the patient's immunization record. First 0.5 ML IM dose of Moderna lot #046A21A administered on 03/21/2021. Second 0.5 ML IM dose of Moderna lot #042B21A administered on 04/18/2021. Patient denied adverse reaction to both doses of Moderna, only slight soreness at vaccination site for first dose on 03/21/2021. Nurse Co-Lead then spoke to all Moderna vaccinators and ancillary staff assigned for 04/18/2021, I reiterated the correct age groups for both Moderna and Pfizer. Our vaccination sites have today's date for allowing to vaccinate to which age group and for which vaccine on the walls of each nursing station within the vaccinator's view. In addition, our reception desk inside the building and now outside check in table have these daily reminders visibly in front of them. Nurse Co-Lead spoke to the nurse specifically that administered the first dose of Moderna on 03/21/2021 and re-educated the medication rights and agreed to the methods in preventing this error in the future. Nurse Co-Lead spoke to Lead Ancillary to re-educate and reiterate her ancillary staff each day as well. Nurse Lead produced a new nurse station safety checklist that includes medication rights, correct age group for each vaccine, and verbal consent from patient, and the 3 contraindication questions for the vaccinator/nurse to hold the vaccine. Nurse Co-Lead spoke to lead registration table ancillary lead as well as the site manager that oversees the ancillary staff outside the building as initial check in staff. Nurse Co-Lead and Nurse Lead agreed to have end of day huddle to re-iterate today's captured vaccination error and methods to prevent in the future. Patient along with her legal Guardian verbally consented and agreed to complete Moderna series.
Initial unsolicited report received from a consumer on 06-Oct-2015. This case involves a 70 years old female patient who was vaccinated with a first dose of FLUZONE HD via intramuscular route (batch number, expiry date, site of administration were not reported) on 06-Oct-2015. The patient had no illness at time of vaccination. She was diabetic and had cardiac conditions. Concomitant medications were not reported. On 06-Oct-2015, in the evening, few hours post vaccination, the patient developed body aches, chills, felt hot (no temperature was taken) and her hands were shaking. The patient took two asprin as corrective treatment. Laboratory tests were not reported. The symptoms were resolving. The outcome was reported as unknown. Follow up information received from a consumer on 17 December 2015. No new information was provided. Follow-up information received from a consumer on 22 January 2016. It was reported that the patient had not recived any vaccine at my office and come for visist after vaccination. No new information received. List of documents held by sender: none.
09/26/2022 My symptoms started in the evening with sore throat, headache, fatigue, cough, and difficulty breathing it was so bad that my caregiver called the ambulance and I was admitted in the Hospital. I had a hip replacement surgery 08/01/2022 and I had infection on 09/16/2022. I was hospitalized on 09/26/2022 for COVID-19. I stayed in hospital for about 8 days all together with my hip replacement infection and COVID-19. In the hospital they prescribed me IV antibody for COVID-19 (Remdesivir) and also oral antibiotics (Rifampin) for hip replacement infection along with Ancef antibiotics.
hard time sleep, slept really badly; has sinus; has fever 99.6F; chills; nausea; achy around neck; headache; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (hard time sleep, slept really badly), SINUS DISORDER (has sinus), PYREXIA (has fever 99.6F), CHILLS (chills) and NAUSEA (nausea) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. H062E21A and 04R20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Chronic lymphocytic leukemia. Concomitant products included LEVOTHYROXINE and DOXAZOSIN for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, the patient experienced INSOMNIA (hard time sleep, slept really badly), SINUS DISORDER (has sinus), PYREXIA (has fever 99.6F), CHILLS (chills), NAUSEA (nausea), MYALGIA (achy around neck) and HEADACHE (headache). At the time of the report, INSOMNIA (hard time sleep, slept really badly), SINUS DISORDER (has sinus), PYREXIA (has fever 99.6F), CHILLS (chills), NAUSEA (nausea), MYALGIA (achy around neck) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.6 (Inconclusive) 99.6F.         No treatment medications were reported.  Case is non-serious (lack of evidence of seriousness for all the events from a regulatory or clinical standpoint) and does not include any AESI event after correcting the coding of the event initially captured as "hypersomnia" to a more specific one according to source document. In consequence, no CC is required for this case".   This case was linked to MOD-2021-367613, MOD-2021-367566 (Patient Link).
Unusually cold, very lethargic, achy(mostly in legs), generalized weakness within 12 hours of vaccination. The majority of these symptoms resolved by 11:00 PM EST on 1/28/21. Around this time head became stuffy with a headache. Headache and stuffy head are continuing to the present moment on 1/29/21. Some lethargy also noted.
A rash at the injection place. Does not itch and is not bumpy. I didn?t know it was there until I looked at it in the mirror. It still is there. When I googled it, it said that it happens with the Moderna and it?s not anything to worry about.
Angioedema lips, hoarseness/laryngitis. Epi - 0.3mg IM (R) deltoid 5.12 PM.
This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers 71 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F. And the same was administered to the patient. The reporter stated that the temperature was not monitored on 24-Oct-2017 and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event and reporter's comment. Amended narrative accordingly.
Fever began to raise about 30 hours after shot.   Fever spike peaked at around 9PM (33-34 hours after vaccine was injected), to 101.4 degrees.
Fever; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The reporter wanted to know how long will a fever from the Shingrix shot last. The reporter consented to follow up.