chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tODAY MOTHER CALLED TO REPORT THAT THE ABOVE CHILD WAS BROUGHT TO THE EMERGENCY ROOM DUE TO SWELLING FROM SHOULDER TO ELBOW, RIGHT UPPER ARM BIGGER THE LEFT, REDNESS, PAIN & TIGHTNESS OF THE SKIN OF THE RIGHT UPPER ARM HOURS AFTER VACCINE WAS ADMINISTERED. CALLER CLAIM CHILD WAS PLACED ON ANTIBIOTICS DUE TO 'INFECTION'. CHILD IS CURRENTLY AT HOME CARED FOR THE FAMILY. ALLEGEDLY UP AND ABOUT, ACTIVE BUT GUARDS HER ARMS.
Patient had syncopial episode at home, leading to fall. Patient became completely unresponsive and voided bowels during episode. Brought to ER.
Report chest pain that pain on day 1 post vaccination and progressively got worst. Treatment: Seen in the emergency room. Outcome:  Need to follow-up with primary care doctor and off 3 days of work before returning.
Sharp pain near the eyes and into the middle region of the brain then radiates to the rear portion of the brain near the occipital; trouble concentrating; nausea; Severe headaches have been increasing in frequency since the application of the vaccine; Initial information received on 07-Jun-2023 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 25 years old female patient who had sharp pain near the eyes and into the middle region of the brain then radiates to the rear portion of the brain near the occipital, trouble concentrating, severe headaches have been increasing in frequency since the application of the vaccine and nausea after receiving vaccine yellow fever vaccine [YF-VAX].  The patient's past medical treatment(s), vaccination(s) and family history were not provided. The patient had no medical history, concomitant disease or risk factor.  On 14-Apr-2023, the patient received an unknown dose of suspect yellow fever vaccine, solution for injection (batch number: 4928109157920; expiry date: unknown) via subcutaneous route in unknown administration site for precaution (Yellow fever immunization).  On 14-Apr-2023 the patient had non-serious severe headaches that have been increasing in frequency since the application of the vaccine (headache) (same day latency) following the administration of yellow fever vaccine.  On 18-Apr-2023 the patient had non-serious sharp pain near the eyes and into the middle region of the brain then radiates to the rear portion of the brain near the occipital (pain), trouble concentrating (disturbance in attention) and nausea (latency: 4 days) following the administration of yellow fever vaccine.  It was reported, Severe headaches have been increasing in frequency since the application of the vaccine on 14 Apr 2023. Sharp pain near the eyes and into the middle region of the brain then radiates to the rear portion of the brain near the occipital. Nausea and trouble concentrating are added side effects. I am traveling abroad for an extended period of time; so as a precaution, I got the yellow fever vaccine.  Patient did not experience any additional symptoms/events.  Action taken: not applicable.  There were no lab data/results available.  It was not reported if the patient received a corrective treatment for the events (Severe headaches have been increasing in frequency since the application of the vaccine, nausea, Sharp pain near the eyes and into the middle region of the brain then radiates to the rear portion of the brain near the occipital, trouble concentrating).  At time of reporting, the outcome was Not Recovered / Not Resolved for the events severe headaches have been increasing in frequency since the application of the vaccine, nausea, sharp pain near the eyes and into the middle region of the brain then radiates to the rear portion of the brain near the occipital and trouble concentrating.
Feels like the medicine gets stuck in his throat; Feels like having dry mouth; Vomited; Feels like he needs to throw up; A spontaneous report was received from caregiver on 31MAY2023 regarding a male patient of unknown age who "feels like the medicine gets stuck in his throat" (PT: Foreign body in throat), "feels like having dry mouth" (PT: Dry mouth), "feels like he needs to throw up" (PT: Nausea) and "vomited" (PT: Vomiting) following the administration of Vivotif (Typhoid vaccine live oral Ty21A; lot number: 3003823) as an immunization.  The patient's medical history, concomitant medications, or known allergies were not reported.  It was reported that the patient had a violent reaction to Vivotif. Reportedly, the patient vomited after taking the dose of Vivotif. Furthermore, it was reported that the patient felt like the medicine got stuck in his throat, was having a dry mouth, and felt like he needed to throw up.  The outcome of the reported events was unknown at the time of this report.  The action taken with Vivotif with respect to the reported events unknown.   No additional information was reported.  Company Comment: A patient took Vivotif for immunisation and felt like the medicine gets stuck in his throat (foreign body in throat), had dry mouth, felt like he needs to throw up (nausea), and vomited (vomiting). Considering the limited case information, the role of Vivotif cannot be ruled out, and the causality of foreign body in throat, dry mouth, nausea, and vomiting are assessed as possible given the time to onset. The case is considered serious due to the medical significance of the event foreign body in throat. Foreign body in throat and dry mouth is unlisted whereas nausea and vomiting are listed as per insert.; Sender's Comments: A patient took Vivotif for immunisation and felt like the medicine gets stuck in his throat (foreign body in throat), had dry mouth, felt like he needs to throw up (nausea), and vomited (vomiting). Considering the limited case information, the role of Vivotif cannot be ruled out, and the causality of foreign body in throat, dry mouth, nausea, and vomiting are assessed as possible given the time to onset. The case is considered serious due to the medical significance of the event foreign body in throat. Foreign body in throat and dry mouth is unlisted whereas nausea and vomiting are listed as per insert.
2 weeks after the 2nd vaccine my left neck near the collar bone was swollen, and no change as of 1/20/22. Also in Oct 2021 special blood test resulted in a rare autoimmune disease called cold agglutinin, possibly triggered by the vaccine. In the past I have no autoimmune diseases .
Woke up with a sore neck, when I pointed to the sore area I realized there was a large swollen lump. My doctor ordered a CBC and an ultrasound. The ultrasound showed 2 "nodules". I am awaiting a CT scan with contrast for further evaluation.
erythema; rubor; fatigue; fever; This spontaneous case was reported by an other health care professional and describes the occurrence of ERYTHEMA (erythema), INFLAMMATION (rubor), FATIGUE (fatigue) and PYREXIA (fever) in a female 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (erythema), INFLAMMATION (rubor), FATIGUE (fatigue) and PYREXIA (fever). At the time of the report, ERYTHEMA (erythema), INFLAMMATION (rubor), FATIGUE (fatigue) and PYREXIA (fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2022-476096 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2022: Non significant Follow-up received
PT C/O DIZZINESS, SOB, TIREDNESS, AND FACIAL FLUSHING. SHE STATES THAT THESE SYMPTOMS STARTED ABOUT FIVE MIN AFTER RECEIVING HER VACCINE. AFTER 10-15 MINUTES HER EYES STARTED TO FEEL HEAVY AND SHE NOTICED SHE WAS SQUINTING MORE. SHE HAS A Hx OF ANAPHYLAXIS AND BROUGHT HER EPI PENS IN CASE SHE NEEDED THEM, BUT THIS REACTION WAS NOT AN EARLY SIGN OF HER NORMAL ANAPHYLAXIS. SHE MENTIONED THAT SHE CONSUMED A MONSTER ENERGY DRINK THIS AM AND A PIECE OF TOAST. PT DENIED CP OR CHEST PRESSURE. BP 134/92 AND 138/93 SpO2 100% HR 71 AND 67 PT APPEARED IN MILD DISTRESS DUE TO A SENSE OF TIGHTENING WITHIN HER CHEST AND FATIGUE.  AFTER ALLOWING PATIENT TO SIT IN HER CAR FOR AN ADDITIONAL 15 MIN , GIVING HER COOL WATER, AND A SNACK , THE PATIENTS BREATHING IMPROVED 100% AND HER DIZZINESS/FATIGUE IMPROVED 70%.  AT THIS TIME PT WAS STABLE TO TRAVEL HOME (15 MIN) AND INSTRUCTED TO EAT AND REST FOR THE DAY. PT WAS NOT GIVEN MEDICATION.
Reported via our Adverse Event reporting system for the organization:  Patient was given a COVID-19 vaccine that was not diluted when drawn up. Thus wrong dose administered.   (no reaction within office after administration, no reported effects at this time)
body is very sore; severe chill rigors; couldn't get out of the bed because the rigors were so intense that legs would not support her; a slight fever; This is a spontaneous report from a contactable consumer reported for herself. A 75-years-old female patient (not pregnant) received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 30Jan2021 11:30 at single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included venlafaxine, levothyroxine, diclofenac, gabapentin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The historical vaccine included the 1st dose of BNT162B2 on 09Jan2021 11:30 AM for covid-19 immunization. Initially the patient noticed a slight fever 11 hours after vaccine on 31Jan2021. Then about 12 hours after her vaccine on 31Jan2021, she had severe chill rigors for about 2.5 hours. She couldn't get out of the bed because the rigors were so intense that her legs would not support her. On 31Jan2021 12:00 AM, (12 hours after the rigors), her entire body was very sore, feeling as if she had been run over by a truck. No treatment received for the adverse events. The events outcome was recovering. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. It was not reported as serious.  Information on the Lot/Batch number has been requested.
15:15 C/O feeling hot T: 97.7F, BP: 92/68 Given 3 glasses of water 15:45 BP 100/70, T 97.7F, HR 74 16:00 Denies any symptoms.  Released.
Itching, redness, heat, radiating outwards from injection site at left deltoid, reaching arm and face. Administered 50 mg diphenhydramine IM, reaction subsided. Patient was observed until 6 pm then cleared to return home.
24 hrs after being given the vaccine started with hives and vesicles on left arm then progressed. When seen on 10/12/10 had lesions on both arms, knees upper back & chest.
Pt c/o's skin felt tingly at site of injection. Bandaid removed and flushed, reddened skin seen in oblong pattern. Pt given Benadryl 25 mg po from Pharmacy 3:05.  Pt observed and moved to adjacent room. Pt complained feeling nervous. Pt given 25 mg Benadryl IM left deltoid from emergency box 3:20pm. Pt c/o's short of air. BS non labored rate 20 & hr 80 pt & husband request to leave to go to ER. They declined my offer to call ambulance. Pt ambulatory, measured area of redness less after IM ~7.5 cm x 4cm irregular wide dispersion of redness.
I began to get a rash across cheeks on face. It lasted for 6 weeks included body aches and fatigue.
Patient report a small red raised area at injection site the day of administration. The day following administration patient report a larger red area at site of injection (approximately 3 inches in diameter), temperature of 101 and general malaise. Adverse symptoms resolved by 2/19/18.
The baby got a rash the day after the vaccination.  Ten days later she got a fever.  Then a couple days later she got what appears to be full blown measles all over her entire body and genitals.  The physician commented she had never seen anything like it before.  The baby is usally quiet and easy, has been extremely lethargic, doesnt want to move sometimes, screams when left alone, wont sleep alone, doesnt have much of an appetite.  Her genitals are very sore and red. I know that you can get a couple of bumps here and there but not a complete body full of red clusters. I know the mmr was given, she was also given the chicken pox vaccine, and one other I cant recall.  Whatever vaccine is standard for 15 month visits.
I felt dizzy and lightheaded stepping out of the shower ( March 20, 2021 at around 10:00 am) and I fainted and landed on the floor. When I came to, I was able to use the toilet to pull myself up and sit on the toilet seat until I got back in control of myself. I was lucky- I only had a few black and blue marks on my right knee, but it had potential to be serious- head injuries etc. I am 70 years old and this is the only time in my life that I have fainted. Very scary and has caused some emotional stress for me.
Received Tdap 1/8/2008 to Left Deltoid IM. Approx 3 hr post vac passenger in car noted left upper arm muscle tightness with pain radiating down left arm (3-4/10), no site rx noted.  This persisted for next two days until day 3 she noted redness surrounding vac site @ 6cm. The next day (day 4) c/o nodule formation @ 4cm with redness 6cm and hot to touch. Still with pain now 10/10 like rt arm after breast surgery - worse with ROM. Denied any fever, numbness, tingling, weakness, coldness, axillary swelling, n/v. ROM triggered pain but could move. On Tylenol, Tramadol, Parafon forte, using ice to site w/some relief.   She called immun about day 4-5 and was advised wait 1 week as rx may resolve-to f/u if no better in clinic. She presented day 10 with continued s/s pain (4/10) on meds with resolving redness and nodule formation. Has noted small area bruising to inner lower upper arm by elbow with no known injury.  Felt sore spot washing 2 days ago when first seen.  C/o pain rotating left arm, lifting obj's, dressing self, and limited ROM arm due to pain..
THE PATIENT RECEIVE A HEP A PEDIATRIC DOSE AND IT SHOULD HAVE BEEN A HEP A FOR ADULTS.
02/25/2014 Moderate Anaphylactic Reaction Dr assessed pt et advised mom to give BENADRYL when home, can take asthma rescue meds if respiratory issues develop, or take to E.R. immediately.
Received wrong vaccine - monovalent instead of bivalent Pfizer covid booster Narrative: Patient presented to occ health for COVID bivalent booster. He was administered COVID Pfizer monovalent booster instead of COVID Pfizer bivalent vaccine.
Intermittent pain shoulder to wrist, left side, 2-3 times per day.
Infected with Covid-19; Infected with Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 05Apr2022 at 10:00 as dose 3 (booster), single (Lot number: FL3197) at the age of 50 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: NEXIUM [ESOMEPRAZOLE MAGNESIUM TRIHYDRATE]. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 16May2022 at 13:00, outcome "unknown", COVID-19 (medically significant) with onset 16May2022 at 13:00, outcome "recovered" and all described as "Infected with Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19May2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Clinical course: Patient had no covid prior to vaccination. Patient had no known allergies. Facility type vaccine was workplace clinic. Facility type vaccine was workplace clinic.  No follow-up attempts are possible. No further information is expected.
flu like symptoms; This is a spontaneous report from a Pfizer-sponsored program, Optum Xeljanz Program, received from a contactable healthcare professional and a non-contactable consumer (patient). A 42-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose for COVID-19 immunization and tofacitinib citrate (XELJANZ XR), via an unspecified route of administration from 01Sep2021 (Batch/Lot number was not reported) to an unspecified date at 11 mg for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient experienced very severe flu like symptoms on an unspecified date, following the second dose of bnt162b2 while on Xeljanz, with outcome of unknown. The action taken in response to the event for tofacitinib citrate was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I lost the hearing in my left ear; A 6 weeks later I came down with Covid; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS UNILATERAL (I lost the hearing in my left ear) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Patient did not provide any medical history, allergy, concomitant diseases and risk factor (including any previous COVID-19 diagnosis).     On an unknown date, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEAFNESS UNILATERAL (I lost the hearing in my left ear) (seriousness criterion medically significant) and COVID-19 (A 6 weeks later I came down with Covid). At the time of the report, DEAFNESS UNILATERAL (I lost the hearing in my left ear) and COVID-19 (A 6 weeks later I came down with Covid) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Within 24 hours of having 5th shot, patient lost the hearing in left ear. A 6 weeks later patient had Covid. Treatment medication was not reported. Patient was eligible for 6th Covid booster shot. Patient was planning vacation June and wanted to know benefits of getting another booster shot as patient was concerned about the risks.  Company comment- This spontaneous case concerns an adult patient of unknown gender and age with no medical history reported who experienced the serious unexpected (medically significant) event deafness unilateral along with the non-serious unexpected event COVID-19 within 24 hours to 6 weeks after a dose of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine, given as a fifth dose of COVID vaccine schedule, was administered. It was reported that within 24 hours of having the 5th shot patient lost the hearing in left ear. Six weeks later patient came down with COVID. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 16-May-2023: Non-significant follow up.
Patient was vaccinated with 1st dose of Jynneos at 09-Aug-22 and 25 days after with 2nd dose of Jynneos; Case reference number US-BN-2022-002597 is a spontaneous case report initially received on 02-Sep-2022 from a consumer via Agency (reference number: USBAV22-1448) and concerns an elderly male patient of unknown age.  The patient's relevant medical history and concomitant medications were not provided.  On 09-Aug-2022, the patient was vaccinated with the first dose of Jynneos vaccine (Smallpox and Monkeypox Vaccine, Live, Nonreplicating; batch number: FDP00016) at a dose reported as 0.5 mL, administered subcutaneously, at an unknown site for monkeypox prophylaxis.  On 03-Sep-2022, 25 days after the first Jynneos vaccination dose, the patient was vaccinated with the second dose of Jynneos (batch number: FDP00016) at a dose reported as 0.5 mL, administered subcutaneously, at an unknown site (explicitly coded as 'inappropriate schedule of product administration') and with co-suspects Moderna COVID-19 vaccine (elasomeran) and quadrivalent influenza vaccine (brand name unknown), both at an unknown dose, route or site of administration, and for unknown indication.  At the time of this report, it was unknown if the patient experienced any adverse event.  Additional information received on 20-Sep-2022 from Bavarian Nordic included local BN case ID.; Reporter's Comments: An adult male patient, received the first dose of Jynneos, 0.5 ml subcutaneously at an unknown site. 25 days later (which is considered inappropriate schedule of vaccine administered), the patient received the second dose of Jynneos, 0.5 ml subcutaneously at an unknown site. On the same day, the patient received two co-suspect vaccines - COVID-19 Moderna Bivalent vaccine (mRNA vaccine) and a quadrivalent flu vaccine (unknown brand). Further administration details were not available at the time of this report. It was unknown if the patient experienced any associated adverse events. Inappropriate schedule of vaccine administered is considered listed per company conventions. The patient's medical history and concomitant medications were unknown. The event is assessed as not related to Jynneos, but to human factor. The case is non-serious.; Sender's Comments: An adult male patient, received the first dose of Jynneos, 0.5 ml subcutaneously at an unknown site. 25 days later (which is considered inappropriate schedule of vaccine administered), the patient received the second dose of Jynneos, 0.5 ml subcutaneously at an unknown site. On the same day, the patient received two co-suspect vaccines - COVID-19 Moderna Bivalent vaccine (mRNA vaccine) and a quadrivalent flu vaccine (unknown brand). Further administration details were not available at the time of this report. It was unknown if the patient experienced any associated adverse events. Inappropriate schedule of vaccine administered is considered listed per company conventions. The patient's medical history and concomitant medications were unknown. The event is assessed as not related to Jynneos, but to human factor. The case is non-serious.
Typical "hives", raised reddened welts on abd & thigh within 24 hrs , very itchy. Took OTC Benadryl & it went away for several days & came back on 12/10 for over 1 wk, taking Benadryl, daily. Referred to MD.
he patient presents with 1 week hx of chest pain with palpitations, mid and upper back pain, lightheadedness, headache, nausea, and dark urine. Pt reports to have experienced similar symptoms in the past, was informed he required further liver and cardiac evaluation. Pt denies shortness of breath, vomiting, numbness, tingling, fevers, chills, bowel or bladder dysfunction, abdominal pain, and all other symptoms.  The onset was 1  weeks ago. Patient is still admitted at time of form submission.
Client is a 28 year old female who came in for a Pfizer booster. Client received a Pfizer pediatric (5-11 year old ) dose.
Fever to rectal temperature of 102.3 F.  Was admitted 10/1/07-10/3/07 for partial sepsis workup.  10/23/2007 Hospital F/U received from PCP.  No hospital records sent. Child was seen for a F/U for hospitalization to r/o sepsis.  Child developed a fever withing hours of receiving vax and seemed listless.  Rectal temp = 102.3'F upon admission. 11/05/2007 MR received for DOS 10/1-3/2007 for D/C DX: Immunization Related Fever.  Infant presented to ER with fever of 102.3'F, decreased energy, and decreased po intake following vax earlier in the day.PE WNL.  Returned to baseline by 10/3/07 and D/C.