chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Covid19 vaccine: vaccination today, pt was getting second dose of moderna when 10 minutes later she started experiencing palpitations, flushed face, lip swelling, lightheadedness. No respiratory distress. Pt given benadryl by medics. Pt had history of anaphylaxis to cat dander. Given epi in ED. Stable after 3h ED obs. Rpt VS without tachycardia/hypertension despite epi. DC with return precautions.
DEVELOPED ACHING/ FEVER ABOUT 24 HOURS AFTER ADMINISTRATION OF TDAP.  TEMP 102 DEGREES, 48 HOURS LATER.  BODAY ACHES LASTED ABOUT 3 DAYS.
Right upper lip numbness and tingling beginning within an hour of injection.  Right side of face numb within 6 hours but facial numbness and tingling resolved the next day.  Right upper lip mild numbness and tingling remains and is current.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 2:41 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021 at 2:41 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial moved from freezer to refrigerator on 19-Nov-2021, it was a day when the Moderna Covid-19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer/refrigerator, or maintained at room temperature. The reporter stated that total 70 vials were still in the ultra cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No Previous temperature excursions was reported.  Total 280 patients received Moderna Covid 19 stored at minus 82 degrees Fahrenheit. The patient was administered vaccine that was stored at temperature between minus 80 degree F to minus 84 degree F. No treatment medication information was provided.   This case was linked to MOD-2021-402935 (Patient Link).
Awakened by dizziness at 3:00am on Friday October 5. Dizziness and vomiting for 13 hours. Went to the emergency room at hospital. Dizziness lasted through October 7. with occasional dizzy spells the following week.
Patient received the Booster shot before 6 month from having the primary series of vaccine.; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the Booster shot before 6 month from having the primary series of vaccine.) in a 34-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the Booster shot before 6 month from having the primary series of vaccine.). On 08-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the Booster shot before 6 month from having the primary series of vaccine.) had resolved.        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.
Vertigo, dizziness, fast heartbeat,   Patient received 1st dose on 3.31.21 (afternoon).  On 4.1.21 - called nurse triage line and reported: "Patient reports having covid vaccine 3-31-21 and today experiencing vertigo and fast heart beat. Symptoms began around 5 PM today. Patient states she felt dizzy and had the "spins" x 2 to the point where she had to fit down or else she would have fallen. She was at the store while this took place but was able to walk herself to her car. Patient states she could feel her heart beating fast but felt like it was getting better as she was driving.  She denies feeling dizzy while driving in the car."  One 4.12.21 - called nurse triage line again - with persistent / increasing symptoms:  "has been experiencing dizziness ever since.    Everyday as she walks, she is dizzy to the point of having to stop and sit down.  She feels like she is going to pass out at times.  She states it almost feels like a low blood sugar or a panic attack.  Her glucose this morning is 255 and she states she is breathing rapidly and is weak.  She was referred to ED now."  4.12.21 - Emergency Department:  primary diagnosis - dizziness.  given a fluid bolus.  Worked up and discharged. Please drink plenty of fluids. Use the medications that have been prescribed as needed for dizziness or nausea. If your symptoms persist after 7 days, please follow up with her primary care physician.  Prescribed meclizine and ondansetron.
This spontaneous report was received from a certified medical assistant, referring to an unspecified number of patients of unknown age and gender. Information about patients' medical history, concurrent conditions and concomitant medication were not reported. On unspecified dates, the patients were administered doses of improperly stored PEDVAXHIB (lot # M014926, expiration date 17-FEB-2019; lot # M020102, expiration date 08-MAR-2019); which were exposed to temperature of 49F for 1 hour and 48 F for 1 additional hour. There was not previous temperature excursion and the call was because of a data logger. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Tonic/clonic type seizure lasting approximately 1 minute, followed by prolonged lethargy > 1 hour O2 administered at 2L within 5 minutes of seizure. EMR called after one hour when patient unable to wake up completely. Patient had 2nd seizure lasting 20 seconds when EMR presents. No loss of bowel or bladder control.
Patient was given a shot he walked out to the waiting room and while talking to his siblings he fell backwards and hit his head on the floor. Patient was alert when we got over to him.
CDC reports: 7 mo with a known sz disorder since 4 mo had sz & screaming episode following immunization, on Phenobarbital since age 4 months.
Throat tightness, numbness in the tongue. Benadryl 50mg PO. not getting better after one hour.
Arm swollen; Arm painful; Arm red; This case was reported by a consumer via interactive digital media and described the occurrence of swelling arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 2 days after receiving Shingles vaccine, the patient experienced swelling arm, pain in arm and erythema of extremities. On an unknown date, the outcome of the swelling arm, pain in arm and erythema of extremities were unknown.   It was unknown if the reporter considered the swelling arm, pain in arm and erythema of extremities to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient asked that was it normal for his/her arm to be swollen, painful and red 2 days after the second shot. The follow up would not possible, as no contact details were available.
Bilirubin level of 12 (jaundice); Bilirubin level of 12 (jaundice); Peeling & itching hands, feet; Peeling & itching hands, feet; faceSweats; lung pain with deep breaths; abdominal pain; lower back pain; disoriented; This is a spontaneous report from a Contactable Consumer. A 51-Year-old male patient received BNT162B2 (Pfizer Covid-19, Formulation: Solution for injection, Batch/Lot no: EW0153) first dose via unspecified route of administration, administered in left arm on 11Apr2021, as a single dose for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. Patient not had COVID prior vaccination. Patient not tested for COVID post vaccination. On unspecified date Bilirubin level of 12 (jaundice) Peeling & itching hands, feet, & face Sweats, lung pain with deep breaths, abdominal pain, lower back pain, disoriented. AE resulted in: Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event) hospitalized up to six days. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Golf ball Hard knot 2 days after. After a month grape sized knot still present still very tinder to touch but not hot like infected.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age. An unspecified number of doses of VARIVAX (lot#, expiration date, dose, route not reported) for vaccination that were improperly stored might have been administered between 03-SEP-2013 and 29-OCT-2013. No adverse event reported. Additional information is not expected.
pt had redness and swelling on right arm described as hives per the provider, kids Benadryl 12.5mg was given.
Headache; Muscle and body aches; Muscle and body aches; This is a spontaneous report received from contactable consumer, the patient. A 62-year-old adult male received the second dose of BNT162b2 (solution for injection; Lot EL3247expiry not provided) as a single dose via unspecified route in the left arm on 19Feb2021 at 12:00 (at 62-years-old) for COVID-19 immunisation. The patient reported no medical history and denied any allergies to medications, foods or other products. There were no concomitant medications reported. The patient previously received COVID-19 immunisation with the first dose of BNT162b2 (lot EL3247) in the left arm on 29Jan2021 at 12:30 (at 62-years-old). The patient denied receiving any other vaccination within four weeks prior to the COVID vaccine. The patient also denied being diagnosed with COVID prior to the vaccination. On 21Feb2021 at 08:00 the patient began to experience headache and muscle and body aches. The patient denied being tested for COVID since being vaccinated. There was no treatment received. The outcome of the events, headache and muscle and body aches was recovered on an unspecified date in Feb2021.
Developed swelling (L) arm - felt feverish, chills say swelling was "size of softball". Seen at medical center 10/13, ER 10/14 advised Ibuprofen/rest/ice.
high fever, dizziness, nausea, congestion and diffculty breathing, wheezing, extremely bad headache, like a bad migraine. Patient passed out while driving her car and crossed over the highway into oncoming traffic and was killed instantly.  Four different individuals have given us details of her being so sick that she couldn't even hold her head up.  11/11/04 Medical records received from PCP. Autopsy Report received on 11/22/2004 states pt expereinced blunt force injuries.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. No pertinent medical history was reported. On 21-MAY-2015, the patient was inadvertently vaccinated with one expired dose of GARDASIL (lot # H015555 and expiration date 13-APR-2015). No adverse effects were reported. Additional information has been requested.
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS; PRODUCT USE FOR UNAPPROVED COMBINATION; TThis spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not provided and it has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced wrong technique in product usage process, and product use for unapproved combination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the wrong technique in product usage process and product use for unapproved combination was not reported. This report was non-serious.
Information has been received from a physician, for GARDASIL, a Pregnancy Registry product, concerning a 15 year old female with asthma who was received her first dose of GARDASIL, 0.5ml, intramuscularly on 20-FEB-2009 (Lot # 661764/0650X), and the second dose on 22-APR-2009 (Lot # 661766/0652X).  The patient was now pregnant with the last menstrual period date of 22-FEB-2009 and the estimated delivery date of 29-NOV-2009.  The patient had a office visit to seek medical attention.  The outcome of the patient's pregnant was unknown.  Follow-up information has been received from a registered nurse who reported the patient experienced preeclampsia (no details provided).  Growth abnormality was revealed on ultrasound.  The patient was induced at "37 weeks and 5 days" on 13-NOV-2009 delivered an abnormal infant with no congenital anomaly and with low birth weight, 2338 gm.  Additional information has been received from the registered nurse, OB coordinator in a medicine practice.  The nurse reported the patient's ultra sound revealed intrauterine growth restriction (IUGR).  The patient had mild pre-eclampsia.  The patient was induced and delivered the infant.  The infant had a low birth weight.  The baby was normal with no problems other than a low birth weight.  The baby was being followed by another nurse practitioner who practiced in the same medicine office.  The nurse also reported the patient was received her first dose of GARDASIL on 20-FEB-2009 (Lot # 661766/0652X, also reported as 661764/0650X by the physician) and did not receive any concomitant vaccinations, and the second dose on 22-APR-2009 (Lot # 661766/0652X) and did not receive any concomitant vaccinations.  Follow-up information has been received from the registered nurse concerning the patient who on 22-APR-2009 at 16:50 was received her second dose of GARDASIL into her right deltoid.  The patient was pregnant at time of vaccine but was unaware of pregnancy.  The patient was around EGA 4 weeks and 2 days at the time of vaccination.  The patient delivered a healthy baby girl, weighing 5 pounds and 2 ounces with no problem.  The baby's experience had been captured in WAES # 0904USA04206B1.  Additional information is not expected.
pt c/o fever 24hr p/vax 102 & burning in arm 2hr p/vax;vomiting for 1 day 24hr started day of inj;
Pt states she has pain (chest) and then radiates to back and this occurs on and off since last month. Advise pt to see doctor and go to ER if cannot get hold of doctor.
Given chickenpox vaccine to left arm on 7-31-12 youth complaint sore left arm on 8-1-12 0900 left arm with 7 cm red raised induration over injection site. 1. Tx. warm compresses BID x 3 days. 2. BACTRIM DS 1 tab PO BID x 7 days.
This spontaneous report was received from an administrator of vaccine, referring to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with one dose of improperly stored ROTATEQ (lot# M045546 with expiration date 12-JUN-2018; route, dose unknown) for prophylaxis. No adverse effects were reported. The vaccines were exposed to temperature excursion of 32 up to 35 (33.8) degrees Fahrenheit for 34 minutes, 32 up to 35 (35) degrees Fahrenheit for 5 minutes, 47 up to 77 (47.6) degrees Fahrenheit for 3 hours and 27 minutes, 32 up to 35 (35) degrees Fahrenheit for 5 minutes, 47 up to 77 (49.1) degrees Fahrenheit for 23 hours and 50 minutes, 47 up to 77 (48.7) degrees Fahrenheit for 24 hours, 47 up to 77 (49.4) degrees Fahrenheit for 9 hours and 47 minutes. There were no previous temperature excursions.  Data logger was involved. No product quality complaint (PQC) was involved in this case. This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1801USA014621:
Wears glasses. Notice blurry vision in right eye.  Left eye is already blurry . Couldn't see even with glasses. Put warm compression on eye. Put drops in eye. Call eye doctor. Vision is still blurry. Can't read vaccine card. Eye doctor should get back to him today.
A report was received from a healthcare professional on 10/23/2003, concerning a 2 year old female vaccinee who inadvertently received the Fluvirin vaccine on 10/14/2003. On 10/14/2003 the vaccinee inadvertently received the Fluvirin vaccination.  At the time of the report no adverse event had occurred. There was insufficient information to determine the reporter's causality assessment. Update 1, 16 March 2004: Further information was received from a healthcare professional indicating that the vaccinee experienced no adverse events.
rash, raised red bump that is warm to touch and red  on my arm at the injection site, it has lasted for several days coming and going,  I have used Hydrocortisone cream at least 2x per day
high cholesterol; plaque in her arteries; chest pain; This spontaneous case was reported by a patient and describes the occurrence of HYPERLIPIDAEMIA (high cholesterol), ARTERIOSCLEROSIS (plaque in her arteries) and CHEST PAIN (chest pain) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 018B21A) for COVID-19 prophylaxis.     It was reported that patient had never diagnosed with COVID.  Concurrent medical conditions included Drug allergy (Salicylates aspirin.), Sulfonamide allergy (Sulfa drugs) and Incontinence. Concomitant products included OXYBUTYNIN for Incontinence.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced HYPERLIPIDAEMIA (high cholesterol), ARTERIOSCLEROSIS (plaque in her arteries) and CHEST PAIN (chest pain). The patient was treated with ATORVASTATIN ongoing since an unknown date for Cholesterol, at a dose of Atorvastatin (Lipitor). At the time of the report, HYPERLIPIDAEMIA (high cholesterol), ARTERIOSCLEROSIS (plaque in her arteries) and CHEST PAIN (chest pain) outcome was unknown.            It was reported that patient had never had COVID positive test. Patient had never had any acute and Chronic illnesses at the time of vaccination. No other vaccines given within one month prior to Moderna COVID-19 vaccine. It was reported that the patient had not experienced a similar event in the past.  The doctor said that this could be developing chest pain since she was young because of her dietary habits.  It was reported that the medicine for high cholesterol gave her feet pain and swelling in the feet.
About 2 hours after vaccination, pt noticed small raised bumps near her injection site and on opposite arm.
Redness and pain at injection site with 5x5cm indurated area that is painful. Started Benadryl over the counter 12/11/06.
This spontaneous report was received on 12-JAN-2017 from a medical assistant who reported that a one year-old female patient received routine vaccinations of VAQTA (Dose, route of administration, site of administration, Lot number and expiration date were not reported) and VARIVAX (Dose, route of administration, site of administration, Lot number and expiration date were not reported) (Reference MARRS # 1702USA006062). The exact date of vaccinations was not specified.  The female patient had a pertinent medical history of anemia. The female patient had no concomitant medications and no drug reactions/allergies. The medical assistant reported that the patient experienced redness and swelling at the injection site, followed by swelling of one eye after receiving unspecified doses of VAQTA and VARIVAX. Treatment of the events was unknown. The medical assistant reported that this occurred on an unspecified date a couple of months ago, and the patient is now fully recovered.  No additional information was available. Additional information has been requested. This is one of two reports for the same patient.
Patient had same reaction on first vaccination on 11/11/2020: left arm rash with swelling below injection site down to below elbow; pain upon touching arm/elbow; joint, back, and muscle pain; stomach cramping with diarrhea; headache and fever of 100.4; wheezing with cough
PATIENT FELT WEAK AND TIRED. HE SLEPT SEVERAL HOURS LATER THAN NORMAL.  HE REPORTS MEMORY LOSS THAT HAS CONTINUED THROUGH 7/30/21
From telephone contact received at AP on 10/02/2002, it was reported that an adult patient (no age or sex was provided) received TD ADS ADULT (Lot # U0525AA) on an unspecified date.  The  patient experienced general fatigue, flu-like signs and symptoms, headaches, and cellulitis at the site of injection at an unspecified date.  It is unknown whether the patient recovered from these adverse events.  There is also another patient from this facility with the same reactions that will also need a report filed.
Developed loss of skin pigmentation on chest and back. Appears similar to sudden onset vitiligo.
Information has been received from a physician concerning a 60 year old female who had a reaction to flu vaccine one year ago, and with codeine, sulfonamide and tetracycline allergies, and a history of hypertension, irritable bowel and rosacea who on 18-JUL-2007 was vaccinated intramuscularly in the left arm, with a single dose of Zostavax (Oka/Merck) (Lot#652966/0623F).  Concomitant therapy included amitriptyline hydrochloride (MSD), NEXIUM, COLESTID and ZIAC.  On 18-JUL-2007 the patient experienced injection site erythema, swelling and pain.  Medical attention was sought, and antihistamines (unspecified name) were ordered.  There were no labs performed.  As of 25-Jul-2007 the patient recovered.  There was no product quality complaint involved.
6NOV c/o sore throat, coughing, tired, highest t100.9, achy all over; 7NOV PCE x 1 wk;
Patient reported received Johnson and Johnson COVID-19 vaccine on 5/24/21 at a "nearby stand up clinic" came to our clinic with reports of "allergic reaction".  This provider treated patient with Benadryl 50 mg by mouth once and Solumedrol 125 mg IM X 1 Observed for 30 minutes without adverse reaction and requested patient to follow up with clinic that provided vaccine or go to nearest ER for further evaluation.