chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects were reported; a 70 year old patient received a dose of PROQUAD; This spontaneous report was received from a vaccine coordinator and refers to a 70-year-old patient. No information regarding patient's concurrent conditions, past medical history, concomitant medications, drug reactions or allergies was provided. On 06-NOV-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (recombinant human albumin) one dose, injection, lot # S002490, expiration date 23-JUL-2020 (exact dose and route of administration were not provided) for prophylaxis. On 06-NOV-2019, the patient experienced product administered to patient of inappropriate age. No adverse effects was reported. The outcome of the event was unknown.
Headache, Itch/Rash symptoms around Elbows, Knees & Legs (started around 4 days after vaccination).
fretful x 1 hr p/vax called MD t99.8 R-100 R day #2; pt recvd DPH & APAP;
PATIENT RECIVED A PEDIATRIC DOSE OF HEPATITIS A VACCINE INSTEAD OF A ADULT DOSE. PROVIDER AND PATIENT NOTIFIED. PATIENT RECIVED CORRECT DOSE (ADULT DOSE) OF HEPATITIS A VACCINE. PATIENT HAS NO SIGNS OR SYMPTOMS CAUSED BY OCCURANCE. NO TREATMENT NEEDED.
No additional AEs; Caller reported vaccine administered after temperature excursions.  No additional information provided.  No additional AEs or PQC reported.       ?    Names of vaccines involved (including lot/exp) PROQUAD X011979  7/18/2024        ?    Temperatu; This spontaneous report was received from a nurse referring to a patient (unknown age/gender). The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 11-AUG-2023, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin [rHA]) (PROQUAD) injection, 0.5ml, lot #X011979, expiration date: 18-JUL-2024, administered intramuscularly (IM) for prophylaxis (strength was not provided)(Product storage error). The vaccines involved underwent temperature excursion at 18.3F with time frame 1 hour and 5 minutes. There was no previous temperature excursion. No additional adverse events (AEs) (No adverse event).
achiness, joint pain, fever reaching 102, headache and fatigue.  I felt like I had the flu
First 2 days - soreness at the injection site  Day 6 to current date which is day 8 -  swelling, itchy, and hardness at the injection site. About 3 inches in diameter.  Has not gone away yet.
Patient felt soreness after shot, & can't raise arm. Patient went to see MD & they said that a nerve was hit on.
Lethargic, apneic, pale->dusky, murmur audible X @ least 1 hr @ about 12 hrs /p inject, site swollen, red, hot, pt had low grade temp > 24 hrs /p injection, required 02 supplement X 8 hrs, Tylenol po X 3 doses
Redness, pain, swelling at site of injection. Bad headache, nausea.
Pt at well-baby office visit 10/08/15. Received Fluzone quadrivalent, preservative-free, 0.25 mL IM dose appropriately. About ~6 hours later, found unresponsive at home. Parents called 911. EMS arrived at ~22:15 and began CPR. Brought to the ED where CPR and ACLS continued. Death pronounced at ~22:50. Unclear by hospital summary whether sudden infant death or vaccine-related. Autopsy being conducted to provide further details.
Hypertension and headache within minutes of vaccination; symptoms resolved by 20-30 minutes
Lethargic after first shot; Bad Chills after first shot; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargic after first shot) and CHILLS (Bad Chills after first shot) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Dental abscess (Had dental abscess and visited the dentist.).   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jan-2021, the patient experienced LETHARGY (Lethargic after first shot) and CHILLS (Bad Chills after first shot). The patient was treated with AMOXICILLIN ongoing since an unknown date for Dental abscess, at a dose of 500 mg. On 18-Jan-2021, LETHARGY (Lethargic after first shot) and CHILLS (Bad Chills after first shot) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication  was provided by the reporter.  Patient had a history of dental problems that started way prior to the vaccination and added that dental problems have nothing to do with the vaccine. Also had a dental abscess and visited the dentist. Patient had a dental appointment on 10-NOV-2021, and has been using Amoxicillin 500mg for 1 week and will continue another week. Patient visited the pharmacy to get a booster dose of Moderna on Sunday. The Pharmacist told to wait because Amox500 may interfere with the vaccine efficacy.
swelling and tingling of tongue   VS  124/88 97 HR 100% RA SpO2
When injecting vaccine it just squirted everywhere very quickly. Patient did not get a full dose (1/2 lost) but declined another today, no AE; Fluid leaked at juncture of needle to syringe, no AE; Initial information received on 06-Nov-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves patient (unknown demography) who did not get a full dose (1/2 lost) while was getting injected with the INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] (underdose, lot number UT7058JA and expiration date and other dosing details not reported , prophylactic vaccination) as it just got squirted everywhere very quickly o an unknown date. But patient declined another vaccine. Also, the fluid leaked at juncture of needle to syringe (needle issue).  The patient's medical history and concomitant medications were not reported.   It was an actual medication error case due to vaccine underdose (same day latency). It was also a case of needle leak.   No adverse event reported at the time of reporting.   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 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.
Left arm soreness began the night of (approx. 5hrs after injection). Body aches began the next morning (approx. 7am). Fever and chills began at approx. 12:00pm and extended for several hours, getting to a maximum of 102.5. Chills continued until evening past 10:00pm. Accompanying headache lasted throughout the day. Ibuprofen was taken throughout the day to help with headache and body aches. Erythematous rash surrounding injection site was noted in the afternoon, eased by the application of OTC hydrocortisone cream.
C/O chest tightness. Pt breath sounds clear, pulse ox. 99% on room air.  BP 110/72, pulse 72, good capillary refill. Pt. took 2 puffs of her personal albutrerol inhaler used for asthma.  Pt. monitored for additional 20 minutes.  stated feels better and remains stable.
LOCALIZED REACTION AT 3 OF 4 INJECTION SITES. ONE ON RT ARM, 2 ON LEFT ARM. BRUISED APPEARANCE WITH SMALL RED SLIGHTLY RAISED BUMPS IN DARKENED AREA, APPROXIMATELY THE SIZE OF QUARTERS, STILL PRESENT AFTER 1 MONTH. OCCURED SEVERAL DAYS AFTER INJECTIONS, TREATED WITH NEOSPORIN , ALCOHOL & PEROXIDE-(PARENT REPORT) DR. NOTIFIED
Acute Hypoxic Hypercapnic Respiratory Failure  Other causes leading to the above:   1. Covid 19 Pneumonia  2. Shock - multifactorial   3. Acute kidney injury
After (about) 12 hours of getting the single J&J shot I experienced the following events as I got ready for bed: Fever, sweating, both testicles ached / were causing me pain for an extended period of time, shortness of breath, had trouble sleeping due to the adverse events.  It all started with the fever-like symptoms, then quickly evolved into the others. They all lasted for hours (around 5 hours) until I was able to finally fall asleep.  I woke up with a general sense of fatigue (probably from my lack of sleep/experiences), but also dizziness and some lingering pain in my testicles. After 2-3 days after my shot the symptoms faded away.  The only remaining symptom is a slight tightness of the chest, something that I would usually only feel during a highly stressful moment. But no chest tightness that I would categorize as "painful."
Patient falsified DOB when registering for vaccinations, stating the minor's DOB was 8/12/2002. Guardian  did not consent to the vaccinations. MN Department of Health verified with statistical records that the patients actual DOB is 8/12/2002 which made the vaccine a contraindication.  1st Moderna vaccination given: 02/01/2021 2nd Moderna vaccination given: 02/27/2021  No known adverse reactions noted.
did not get second dose due to side effects from first dose; blood clot in lung; Really bad back pain; breathing was difficult; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (blood clot in lung) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PULMONARY EMBOLISM (blood clot in lung) (seriousness criterion medically significant), BACK PAIN (Really bad back pain) and DYSPNOEA (breathing was difficult). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not get second dose due to side effects from first dose). The patient was treated with APIXABAN at an unspecified dose and frequency. At the time of the report, PULMONARY EMBOLISM (blood clot in lung), BACK PAIN (Really bad back pain), DYSPNOEA (breathing was difficult) and PRODUCT DOSE OMISSION ISSUE (did not get second dose due to side effects from first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products information was not provided. Patient experienced "really bad back pain" and "breathing was difficult". Went to see his doctor who then stated he had a blood clot in his lung. Caller stated he was then put on Eliquis and the doctor said he would have to take it for the rest of his life. Caller wanted to know if this was true or if he can eventually stop taking the Eliquis. He also wanted to know what caused him to get a blood clot.  Company comment: Very limited information regarding the events has been provided at this time.  Further information is expected.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information is expected.
Rash around vaccine site, approximately 4  X 2, slightly swollen and itchy.  It started 8 days after injection with just a couple of red spots, then grew to a patch.
Information has been received from a registered nurse concerning a female who on an unknown date, was vaccinated with GARDASIL (lot # not reported).  Within 5 minutes after vaccination, the patient experienced vomiting.  Unspecified medical attention was sought.  Additional information has been requested.
Pt recvd vax 24SEP91 @ 830AM & 3-6AM 25SEP unconsolable "screaming", t101.5, temp down 2hr p/initial dose of vax; crying again 5-7PM given DPH;
INMATE INSISTED HE HAD NOT HAD THE COVID-19 VACCINE PREVIOUSLY.  WAS GIVEN A SECOND DOSE OF THE JANSSEN VACCINE.   INCIDENT  DISCOVERED 3 HOURS LATER.  INMATE WAS EXAMINED AND MONITORED.  TEMP 97.4, BP 130/80, PULSE 76, RR 20.   INMATE DENIES HEADACHE, CHILLS, BODY ACHES, UPSET STOMACH, AND FATIGUE.  INMATES STATES THAT "HE FEELS FINE."  HE HAD NO REACTION TO HIS FIRST VACCINE, JENSSEN, WHICH WAS GIVEN 3/25/21.  DEPUTIES ARE MONITORING HIM FOR SYMPTOMS.
This spontaneous report was received from a registered pharmacist and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. From 02-DEC-2016 to 17-APR-2017, the patients were vaccinated with improperly stored doses of ZOSTAVAX lot # M039452, expiration date 19-DEC-2017 (dose and route of administration were not reported). The vaccines were reconstituted with correctly stored sterile diluent. There was no adverse effect reported. Product quality complaint was not involved. Administered doses of vaccines experienced the temperature excursion between 15 and 46 degrees Fahrenheit for 4 hours and 30 minutes. A Digital Data Logger was involved. There were no previous excursions reported. Additional information has been requested.
This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 15Feb2021 at 11:30 (Batch/Lot Number: EL9266) (at the age of 50-years-old) as 2nd dose, single for COVID-19 immunization. The vaccination facility type was nursing home. The patient's medical history was reported as none and concomitant medications were not reported. The patient had no known allergies. The patient was not pregnant at the time of vaccination. The patient had no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive any other vaccines within 4 weeks and other medication in two weeks. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ENS358) on 25Jan2021 at 03:30 PM via an unspecified route of administration, administered in left arm for COVID-19 vaccination. The patient reported that she was 2 years post-menopausal. She had a full period for 6 days starting the night of 15Feb2021 at 07:00 PM on the same day she received her second dose of COVID vaccine. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Treatment included pelvic and internal ultrasound and scheduled uterine (as reported). The outcome of the event was recovering. No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
16 hours after receiving immunizations started with irritability, crying, decreased appetite fussiness throughout day, lasted about 1 1/2 days then resolved after being given Motrin. 45 min nap.
Very painful - soon after shot. Got sore redness swelling hard, hot to touch. Felt like it was burning all the way home, rash. Very very uncomfortable, went back to get it checked. I was told to keep cool compress on it. TC 2 days later it was not better. I went back and ask to see the Dr. He wanted to give me steroid or a counteract shot I refused. Both at this I just wanted it to get better so I left I took Ibuprofen and wrapped a cool pack on it for 4 days. Yes it did get better. I sure don't want to go through that again.
FEVER ON 02/05/2021, HAVE RASH ON LEFT ARM AND SWOLLEN, BODY ACHES. I HAVE HIVES ON MY CHEST AREA AND SWOLLEN HANDS. SKIN IS VERY RED.
2" swelling since got vax then on 23OCT it got more red & swollen & moving down the arm; 24OCT 6" x 4" erythematous, sl warm non indurated area of upper arm; mild sz adenopathy; acute cellulitis; tx Cephalexin, DPH, ice;
Information has been received from a nurse practitioner for GARDASIL, a Pregnancy Registry product, concerning a 23 year old female with allergies to sulfa, MACROBID and a medical history of Attention Deficit Disorder, depression, anxiety and obesity who on unspecified date was vaccinated with the 1st and 2nd dose of GARDASIL. Concomitant therapy included EFFEXOR and NECON 1/35. The doses were administered at a different facility so the nurse practitioner did not have specific dates or lot numbers. The nurse practitioner  stated that the patient did not document if she received any concomitant vaccines when she received the GARDASIL. Subsequently, after two doses of GARDASIL, the patient became pregnant. Unspecified medical attention had been sought. The patient delivered her baby at 33 weeks on 20-Oct-2008. The patient told the nurse practitioner that the baby was "doing great". Dose 3 has not been administered yet. Dose 3 was due in April 2008 but was never administered. At the time of reporting, the patient status was "fine". Additional information has been requested.
urticaria; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (PRIMARY IMMUNIZATION SERIES COMPLETED, UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: URTICARIA (non-serious), outcome "unknown". Additional information: Patient reported developing urticaria after bivalent vaccine booster.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Right eyelid swelling; Right eyelid swelling and drooping/allergic reaction; Right eyelid swelling and drooping/allergic reaction; This is a spontaneous report from a contactable nurse, the patient. A 24-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3184) via an unspecified route of administration in the left arm on 05Sep2021 at 13:30 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19.  The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 06Sep2021 at 06:00, the patient experienced right eyelid swelling and drooping/allergic reaction. The events resulted in visit to emergency room/department or urgent care. Therapeutic measures were taken as a result of the reported events and included treatment with steroids (unspecified) and diphenhydramine (BENADRY). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events right eyelid swelling and drooping/ allergic reaction was unknown at the time of this report.
Headache continues so far 30 days  Sporadic Shortness of breath  No adverse events on shot 1 or 2
dermatographia; heartburn; intense itchiness; tingling; itching of mouth; itching of lips; itchy inner ear canal; broke out in fully body hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (broke out in fully body hives), MECHANICAL URTICARIA (dermatographia), DYSPEPSIA (heartburn), PRURITUS (intense itchiness) and PARAESTHESIA (tingling) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033F21A, 048B21A and 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included DROSPIRENONE, ETHINYLESTRADIOL BETADEX CLATHRATE (YAZ) for Birth control, AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced URTICARIA (broke out in fully body hives). On an unknown date, the patient experienced MECHANICAL URTICARIA (dermatographia), DYSPEPSIA (heartburn), PRURITUS (intense itchiness), PARAESTHESIA (tingling), ORAL PRURITUS (itching of mouth), LIP PRURITUS (itching of lips) and EAR PRURITUS (itchy inner ear canal). The patient was treated with PREDNISONE for Adverse event, at a dose of For 5 days of steroid and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 4x recommended dose level of allergy OTC medications. At the time of the report, URTICARIA (broke out in fully body hives) had not resolved and MECHANICAL URTICARIA (dermatographia), DYSPEPSIA (heartburn), PRURITUS (intense itchiness), PARAESTHESIA (tingling), ORAL PRURITUS (itching of mouth), LIP PRURITUS (itching of lips) and EAR PRURITUS (itchy inner ear canal) outcome was unknown.            Patient reported 10 days after receiving the booster she broke out in fully body hives and States the symptoms are still ongoing 50 days after booster dose. Patient also  reported that it feels like anaphylaxis but its not, it is a immune response. 1200 patients also reported same side effects.   This case was linked to MOD-2022-437613 (Patient Link).
Pt experienced swelling on the left arm around the injection site as well as red patches on her right chest and right jawline. Another swollen area on the left elbow that may have been a bug bite.  Treated with prednisone , bactrim, loratadine.
Lip swelling approx. 15 minutes after vaccination. MD assessed and dosed with Benadryl 25mg. Monitored for additional 45 minutes. Pt. stated has not gotten worse.
left eye swelling, foreign body sensation of left eye, left mouth weakness/numbness, bilateral numbness of feet, left sided paresthesias mouth has improved
Information has been received from a healthcare worker concerning a 13 year old patient of unknown gender. No current or historical conditions were reported. On 21-APR-2015 (reported as "yesterday"), the patient was vaccinated with improperly stored GARDASIL 0.5 ml, intramuscularly (lot # K001631, expiration date 06-NOV-2016) in unspecified site. It was the second dose of the GARDASIL series for the patient. No adverse effects reported. Additional information is not expected since reporter stated she did not want any adverse event follow correspondence.