chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Local reaction at injection site. Sore, swollen, red, painful to touch, warm to touch. Patient wanted to take benadryl. Advised to watch for serious reaction (trouble breathing or more severe swelling) and call 911 if this happens. Done at  1:25pm 5/6/18.
Varicella vaccine breakthrough. Diagnosed with varicella 9-13-07. 6 vesicles afebrile.
The patient presented to the ED with c/o SOB and was diagnosed with Covid-19 6 days prior to admission.  The patient was admitted for Covid-19 Was placed on bronchodilators and duo nebs.  The patient was treated with dexamethasone and remdesivir.  She developed left-sided weakness during hospitalization and hypertension urgency.  MRI showed a subacute infarct, several grouped early subacute lacunar infarcts of the right basal ganglia extending to the pericallosal parietal white matter.  The patient was transferred on 02/08/2022.  The patient expired at facility on 02/13/2022.
PATIENT HAS A HISTORY OF FAINTING AFTER VACCINATIONS, WAS AWARE AT THE TIME.  PATIENT AND PARENT GAVE CONSENT TO ADMINISTER VACCINES.  COVID VACCINE WAS ADMINISTERED FIRST THEN INFLUENZA AND SHORTLY AFTER PATIENT FAINTED IN CHAIR.  PATIENT GAINED CONSCIOUSNESS SHORTLY AFTER, SEEMED PALE, SWEATING AND SHAKING SLIGHTLY.  SYMPTOMS LASTED LESS THAN A MINUTE OR SO.  PATIENT REMAINED SEATED IN CHAIR FOR 15 MINUTES AND WAS GIVEN WATER. WAS ABLE TO LEAVE ON HIS OWN WITHOUT ANY ISSUES SHORTLT AFTER.
Needed to take flu shot (was forced by my employer). Allergy (severe to latex) pharmacist gave me the latex free shot within minutes I began itchiness at the site then from my waist up - my hands and neck became very red this lasted 2 days.
A report has been received from a health professional concerning a 3 year old male patient. The patient was receiving nasal FLUMIST started on 09-Nov-2012 and 13-Nov-2012. It was reported that the patient had flu like symptoms, fever of 103 F and tested positive for influenza A which started on 13-Nov-2012. Action taken with FLUMIST was unknown. The outcome of the event of flu like symptoms, fever of 103 F and tested positive for influenza A is unknown. Company physician reporter assessed the events flu like symptoms, fever of 103 F and tested positive for influenza A to be non-serious.
devel swelling >3cm @ site w/erythema, mod-marked swelling & tenderness of axillary nodes & marked generalized myalgia; was seen by local urgent care & given symptomatic treatment;
redness soreness & swelling w/tingling same day inject was given in lt deltoid; arm completely better by 12JUN93;
Patient stated that starting the day after receiving his Shingrix vaccine, he felt very ill and had extreme fatigue to the point where he needed assistance walking. He also had a low grade fever. The symptoms lasted about a week and then he recovered fully.
Pfizer adult vaccine was stored in our freezer past the stability date of 11/23/2021 and was administered to patient on 12/02/2021.
UNDERAGED AT TIME OF VACCINE. DOB LISTED AS 1/13/2009 ON CONSENT BUT database DOB IS 7/13/2009.
Seizures and developmentally delayed with 1st set of vaccines. Had a high temperature and death with 2nd set.
The evening of receiving my vaccine, I noticed I had some blood in my stool. I checked my blood pressure at home the next moment which read 190/114 which is extremely high for me. Being that I have AHUS and recently coming off ULTOMIRIS, I was concerned with the bloody stool. I went to the emergency room immediately. They took my blood pressure again which read 208/114. They did blood work and took a stool sample to check if I was having another attack; the results came back, and nothing was too far out of range/abnormal. The more time spent in the ER, my blood pressure began to gradually drop. They checked my blood pressure often as time passed overnight. They released me the next morning when my blood pressure dropped back to normal range. They informed me to go home and rest and continue monitoring my blood pressure. Over the last couple of days, it has gradually grown back to normal.
Sore are the day after. One week later a welt about 3 inches in diameter at the injection site. Raised, hard, red, slightly warm to the touch, painful to the touch. Lasted for about 2 days in that condition and  has been clearing up.
Fever 16 hours after vaccine, then possible staring episode last few seconds, but respond to name. Tmax 104.
Patient went home after receiving vaccination and  at around 6pm he starting shaking and lost balance. He called his health care dr and he instructed him to go to the er. He received multiple tests  and was admitted for observation
Received the 1st dose of Moderna vaccine subcutaneously; A spontaneous report was received from a HCP concerning a patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced the 1st dose of Moderna vaccine subcutaneously.  The patient's medical history was not provided. Concomitant product use was not provided.  The patient received their first of two planned doses of mRNA-1273 on an unknown date subcutaneously for prophylaxis of COVID-19 infection.   On an unknown date, a patient received the 1st dose of Moderna vaccine subcutaneously. Treatment for the event was not provided.    Action taken with mRNA-1273 in response to the event was not provided.   The event, received the 1st dose of Moderna vaccine subcutaneously, were considered resolved.; Reporter's Comments: This report refers to a case of incorrect route of product administration error for mRNA-1273. There were no reported AEs associated with this case.
WHILE SETTING AFTER GETTING THE SHOT, THE PATIENT STATED HER HANDS WERE NUMB AND NOT WORKING CORRECTLY, SHE FELT LIKE THROWING UP, THEN PATIENT GOT REAL SWEATY AND BEGAN WHEEZING.  WE WERE CONCERNED AND CALLED 911, WE BELIEVED IT WAS A PANIC ATTACK.  PATIENT WAS ASKED ABOUT PANIC ATTACKS AND   PATIENT STATED SHE HAS HAD PANIC ATTACKS BEFORE NOT THIS SEVERE.  WE FANNED HER, TALKED TO HER AND SHE CALLED HER BOYFRIEND AND AFTER ABOUT 15 MINUTES SHE RETURNED TO NORMAL BREATHING, NO MORE SWEATING.  EMS CHECKED HER OUT AND SHE LEFT LATER WITH HER BOYFRIEND.
On the day she received the vaccine she had lots of pain after she got home, then her arm was swollen, from injection site down to her elbow. She came to notify the pharmacy the next day, and her whole left upper arm looks red and feels hot, itching and tingling. We advised pt to take BENADRYL, and apply ice pack on the affected area. Also told her to take TYLENOL or ibuprofen if feel pain or fever. She has doctor appointment the next day so she will follow up with her doctor.
After 15 minutes of the receiving the vaccine, the patient came and said that he felt that his throat felt tight. He did not experience any shortness of breath or trouble breathing. EMS was called just to be sure that the patient was not experiencing an allergic reaction. Patient was not in distress and blood pressure was normal and could communicate fine.
no adverse effect; administered improperly stored vaccine; This spontaneous report was received from a medical assistant referring to refers to a 6-month-old female patient. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported.  On 23-SEP-2019, the patient was inadvertently administered improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # R026541 with expiration date: 11-JUL-2020) (strength, exact dose, route of administration and anatomical location were not reported) for prophylaxis. Administered dose of vaccine experienced a temperature excursion of 51.62 degrees Fahrenheit for 10 hours. It was reported that digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. There were no adverse effects reported. No product quality complaint (PQC) was involved.  This is one of the several reports received from the same reporter.
Fever to 38C and had 6.5cm X 11cm area of erythema overlying injection site. Axillary lymphadenopathy. ? infection versus vaccine reaction. Treated with antibiotics.
2 1/2 hours after flu vaccine developed temperature of 102, inconsolable, not her usual self.  Fever lasted till evening (9-10), then low grade 100-10 during the night.  No fever 24 hours later.  Gave Ibuprofen for fever reducer.
48 hours later, developed nausea, vomiting. 1 week after vaccination, developed hives.
6/23/08 at 0940 AM patient had 4 vaccination, DTaP, polio, MMR and Varicella. Patient was crying a little nervous but did really well during immunization at 10:15 am. Dad brought her to clinic with face flushed and red, pale, sweating, mild SOB. O2 administered BENADRYL x 2 PREDNISOLONE given PO, albuterol Tx O2 99%
8 minutes after receiving vaccine, I realized I was having trouble swallowing.   My heart rate rose quickly getting as high as 156 and staying in the 100-120 rate for almost 3 hours.   It would not stay down.   I also had trouble taking  adeep breaths.
After 6-10 minutes of the injection , I started having shooting pain from the injection site, through my left clavicle area to around the back of my neck. After 15 minutes those muscles described started tensing and my muscles in the back of my neck tightened to the point I can?t look left to right (turning motion). It?s now Almost 3 hours after and symptoms remain same.
Patient was inadvertently given 1ml of influenza vaccine instead of 0.5ml dose. Pt reported arm was red at injection site for a few days, but has now resolved.
Initial report received on 10 October 2006 from a health care professional.  A male patient (date of birth and age were not reported) had received a left deltoid, intra-muscular injection of FLUZONE SV '2006-'2007 USP, lot number unknown; and a left deltoid, intra-muscular injection of Pneumovax, manufacturer Merck, lot number not reported, on 09 October 2006.  Approximately five hours post-immunization, the patient developed redness and swelling approximately six inches below the arm pit to the elbow.  He denied any other symptoms or local reaction to the actual injection site.  He required medical evaluation, but diagnostics and treatments received were not reported.  At the time of this report, the recovery status of the patient was unknown.  Another patient at the same facility had the same type of reaction that is reported in case 2006-02657.  Follow-up information received on 17 November 2006 from a health care professional.  As per the reporter, it was "determined that it was not the flu shot, but the Pneumovax shot".  Further information is not anticipated.
flushing, dizziness, light headiness: vital signs taken, assessed, water given, pt stated she feel better, sent home.
After about 10-12 hours, injection site was sore to the touch.  In the morning (next day), it was still sore to the touch.
Swollen, red, itchy patch aprx 4 inches in diameter.  Very hot to the touch.  Gave her Benadryl and she used Benadryl Cream for itch
This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F(Fahrenheit)for a total of 135 hours. No adverse effects reported. Follow-up received. Certified Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding a 13 years old, female patient with no pertinent medical history reported. On 28-AUG-2012 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the right arm, dose not reported). On 02-NOV-2012 the patient received the second dose of GARDASIL (lot number and expiration date not reported) (intramuscular on the left arm, dose not reported). It was reported that the patient did not seek medical attention. This is one of the several reports from the same source. Additional information is not expected.
Left Arm Pain & Left Underarm Pain - started the day after I was given the Vaccine and still hasn?t stopped
Teen received the flu vaccine on  March 9, 2020. Mom stated the next day she complained of  back pain and 2 days after her legs were weak;  she was unable to balance herself. She was admitted to the hospital on 3/11/20 with Dx: Guillian Barre syndrome - discharged to home on 3/17/20.
Fever of 100 degrees (normal is 97.6 for me), chills, nausea and sinus type headache started around 11 PM and lasted all night.  Fever still present until mid-afternoon the next day but other symptoms were mostly gone by 11 Am on the 19th
She had a low grade fever, would not/could not smile for 2 days, cried most of those two days, she would not look at us in our eyes or even our faces, she would stare off, did not use her right arm for most of those two days, and her legs were very sore. No site redness and not hot to the touch.  I lost trust in her doctors office so I did not take her into the office!
Patient has sore left shoulder to the point where she moves the arm and gets extreme pain (in the area of injection). I inofrmed patient to ice area and exercise but it has limited help.
Reporter states pt did not seroconvert p/Engerix-B series; all injects were administered IM;
Patient called in and reported normal arm tenderness and soreness during the first 2 days after administration.  After that, the soreness has seemed to spread down toward the elbow and up through the shoulder.  Today is day 4 and the symptoms are still there.
No additional AE/no PQC.; Medical assistant reported GARDASIL 9 was accidentally administered to a 6-year-old patient.; This spontaneous report was received from a medical assistant and refers to a 6-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 28-SEP-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, first dose, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Inappropriate age at vaccine administration). No additional adverse event was reported.
PATIENT CAME IN FOR VACCINES 09/20/2022, RN ONLY ADMINISTERED DILUENT. HIB COMPONENT WAS NOT MIXED IN. PATIENTS MOTHER WAS INFORMED AND CORRECT VACCINATION WAS ADMINISTERED 04/04/2023.
4 days of symptoms and counting. Chills, fever, malaise, weakness, joint pain, overall body pain. Chills and fever started four hours after shot was administered. Next day, muscle/joint pain, continued high fever and chills. . My wife, same age, got the same Fluzone Highdose 10 minutes before me at the same location and no symptoms.
Had a fever for one day with the vaccine/ the both. My brother was sick with the fever for a day that all I know. Mild low fever for a day; My brother was sick with the fever for a day that all I know; This is a spontaneous report from a contactable consumer. A male patient (reporter's brother) of an unspecified age received first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE, and as DOSE 2, SINGLE for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The reporter who reported for brother (patient), stated, "I believe my brother, he also did a Pfizer and he had a fever for one day with the vaccine, on the second vaccine, the both. My brother was sick with the fever for a day that all I know. Mild low fever for a day but I don't know. They didn't tell me so, I don't know." The patient underwent lab tests and procedures which included body temperature which showed mild low on an unspecified date. The outcome of the events was recovered on an unspecified date in 2021.  Information about batch/lot number has been requested.
This case was reported by a physician via sales rep and described the occurrence of dizziness in a male patient who received BEXSERO. On an unknown date, the patient received the 2nd dose of BEXSERO. On an unknown date, unknown after receivinf BEXSERO, the patient experienced dizziness and tingling of extremity. On an unknown date, theo outcome of the dizziness and tingling of extremity were unknown. It was unknown if the reporter considered the dizziness and tingling of extremity to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient was complaining of tingling in his below his waist in his lower half of his body and legs. The patient also felt dizzy.
passed out 24 hours after the first shot; heartrate went to 99; freezing; chills off and on; Wiped out, Fatigue; freezing ,chills off and on; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out 24 hours after the first shot) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter.  Concomitant products included TRIAMCINOLONE ACETONIDE (NASACORT), FLUTICASONE PROPIONATE (FLOVENT), LISINOPRIL, ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) and PRAVASTATIN for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out 24 hours after the first shot) (seriousness criterion medically significant), HEART RATE INCREASED (heartrate went to 99), FEELING COLD (freezing; chills off and on) and CHILLS (freezing ,chills off and on). 30-Mar-2021, the patient experienced FATIGUE (Wiped out, Fatigue). On 30-Mar-2021, LOSS OF CONSCIOUSNESS (passed out 24 hours after the first shot) had resolved. On 06-Apr-2021, FEELING COLD (freezing; chills off and on) and CHILLS (freezing ,chills off and on) had resolved. At the time of the report, HEART RATE INCREASED (heartrate went to 99) outcome was unknown and FATIGUE (Wiped out, Fatigue) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: result not mentioned (Inconclusive) result not mentioned. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment included discontinuation of glipizide. Company comment: This case concerns an 87-year-old female with a serious unexpected event of loss of consciousness, and non-serious unexpected heart rate increased, feeling cold, and expected fatigue, chills. Based on 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.   This case was linked to MOD21-070319 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: No new information On 04-May-2021: Updated outcome of fatigue, added route of administration of suspect drug.; Sender's Comments: This case concerns an 87-year-old female with a serious unexpected event of loss of consciousness, and non-serious unexpected heart rate increased, feeling cold, and expected fatigue, chills. Based on 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.
Massive Blood Clot in the carotid Artery that blocked all blood flow to the brain
Initial unsolicited misuse report received from a nurse on 18-Nov-2015. This case involves 47-year-old female patient who was vaccinated with a second dose of FLUZONE Quadrivalent) (batch number- U5321FA and route was not reported) in right deltoid 22-Oct-2015 at 14:40 hours. Patient had no illness at the time of vaccination; patient did not receive any other vaccinations within 4 weeks prior to this vaccination. Patient had allergy to Epinephrine and Novacaine. Patient did not receive any concomitant medications. On 22-Oct-2015, 5 minutes after vaccination at 14:45 hours patient experienced jittery feeling, could not catch her breath and right deltoid pain. Also patient experienced left arm pain. Lab tests were not reported and patient ate "CAN04" (illegible) as treatment. On unspecified date, patient was recovered from the events feeling jittery, short of breath and pain at right deltoid region and was not recovered from the event left arm pain. Documents held by sender: none. Follow up information received from a physician on 01-Mar-2016. Corrective treatment was reported as candy (illegible in initial report). The outcome of the event left arm pain was reported as unknown.
Weakness, tiredness, increase in temperature, nausea, headache, joint pain, stomach ache, heartburn, vaccination site soreness
On January 21, 2021 at the Clinic, a PA was administering vaccinations during the morning for a four-hour shift, 8 AM to noon. At the end of her shift, she handed off her vaccines to another vaccinator. The PA had three doses of vaccine drawn up at that time, in syringes, on her desk. When the nurse inspected the syringes, she found 0.4mL of vaccine had been drawn into those syringes rather than the required 0.3mL. The nurse then alerted the APRN, who escalated the situation to the manager. The manager then contacted Quality.  The concern was that the PA had been vaccinating patients all morning with an inappropriate dose of vaccine, 0.4mL.  After thorough internal investigation, we found that the PA drew up 38 vaccine doses and administered 35 of them.  Additionally, based on vial usage for the day and total number of vaccines administered, we have concluded that it is highly unlikely that excess vaccine was administered. This was a near miss event and is being reported out of an abundance of caution.
large red feverish whelp affecting the entire upper arm surrounding the injection site. Soreness surround entire arm.
Pfizer on 4/8 and 4/29. Positive on 9/13
Fatigue and headache; Fatigue and headache; This is a spontaneous report from Pfizer-sponsored program and received from a contactable consumer or other non-health care professional. A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown) via an unknown route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. No patient identifiers were provided but the reporter has first hand knowledge of the patient and was reporting on a specific patient. After 36 hrs later husband feels fatigue and headache today on unknown date. Patient wife was asking if this was normal after 36 hrs. After getting the vaccine. Caller was asking if the symptoms of her husband experienced 38 hours after his second covid shot could be a side effect or it was something else. Caller reported that both she and her husband got their second vaccine shot on Saturday, states they had no side effects from it except soreness at the injection site. This morning she reports that her husband felt fatigued, had a headache, felt run down and asked that was the shot or something else. The outcome of the events was reported as unknown.  Information on the lot/batch number has been requested.  Follow-up (12MAY2021): Follow-up attempts completed. No further information expected.