chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I woke up and noticed slight redness on my left arm; the redness and patch continued to spread throughout the day?warm, tender, itchy. I was given a low-dose oral steroid which did stop the reaction. By the following day, the swelling, redness, and other symptoms were gone.
migraines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MIGRAINE (non-serious), outcome "unknown", described as "migraines".  Additional information: Facility type Vaccine: Others. If other vaccine in four weeks: No. Other medications in two weeks: No. Patient have been having migraines at least once a week since I have gotten the vaccine. Asked a colleague who also had gotten Pfizer and they have the same effects.  Follow-up attempts completed. No further information is expected.
recently diagnosed with paroxysmal ventricular bigeminy; This spontaneous case was reported by a nurse and describes the occurrence of VENTRICULAR EXTRASYSTOLES (recently diagnosed with paroxysmal ventricular bigeminy) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 006M20A) for COVID-19 vaccination.     The patient's past medical history included Surgical procedure in November 2020.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VENTRICULAR EXTRASYSTOLES (recently diagnosed with paroxysmal ventricular bigeminy). At the time of the report, VENTRICULAR EXTRASYSTOLES (recently diagnosed with paroxysmal ventricular bigeminy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: normal (normal) normal. On an unknown date, Electrocardiogram: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided.  Company comment- This case concerns a 70-year-old, male patient with no relevant medical history, who experienced the unexpected non-serious AESI event of ventricular extrasystoles. The date of onset of the event was not reported. The patient received two doses of mRNA-1273 Moderna vaccine. The rechallenge was not applicable as the outcome of the event is unknown. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 06-Nov-2021: Follow-up received contains updated reporter, patient details, medical history, laboratory test details event verbatim and drug information.; Sender's Comments: This case concerns a 70-year-old, male patient with no relevant medical history, who experienced the unexpected non-serious AESI event of ventricular extrasystoles. The date of onset of the event was not reported. The patient received two doses of mRNA-1273 Moderna vaccine. The rechallenge was not applicable as the outcome of the event is unknown. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.
Shingles. Started one week after vaccination, treating with antivirals, not yet recovered.
DILUTED Pfizer BIONTECH COVID 19 WHICH SHOULDN'T BE DILUTED. ADMINISTERED 0.3 ML. CALLED PATIENT AND ASKED TO COME GAIN FOR THE CORRECT DOSE
SOB. poor p.o intake, diarrhea and vague abdominal pain. Hospitalization
Patient experienced syncope after Moderna Covid-19 immunization. She never lost consciousness but was lowered from her chair to lie down on the floor by administering pharmacist and technician. Store management brought her cushioned chair to be seated more comfortably. Eventually was able to walk and was driven home by roommate.
Bloody nose on March 20th - threw up blood clot.  Bloody nose again on March 21st, same clot formed.  lasted about 15 minutes each time.  Seeing my PC doctor today March 22nd.
"A mother reported that her 2 month old son received Rota Shield, DTAP, HIB, IPV and HEP-B vaccines on 5/13/99. On 5/26/99, the infant developed bloody, mucousy stools 'about the size of a dime or nickel' that lasted 3 to 4 days."
Pt has developed intractable partial complex sz's 5 days after vaccine which persist to present (4Mar05). Mother's sister developed "sz" after vaccination at 4 months of age (1962).
Shortly after receiving ZOSTAVAX, the patient suffered left sided numbness, weakness, dizziness, headaches and sings of syncope. The patient was diagnoses with transient cerebral ischemic attack; This initial spontaneous report was received from a lawyer on 13-FEB-2020, regarding a case in litigation and refers to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 02-FEB-2018, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for the routine health maintenance and for its intended purpose: the prevention of shingles (the dosage regimen information was not reported). Then, on an unspecified date, (reported as "shortly"), the patient suffered left sided numbness, weakness, dizziness, headaches and sings of syncope. The patient was diagnosed with transient cerebral ischemic attack. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccination, the patient's symptoms had resulted in physical limitations not present prior to using this vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live (ZOSTAVAX) vaccination, the patient sustained severe and permanent personal injuries, serious, progressive, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccination, the patient had suffered and incurred damages, including medical expenses, the loss of accumulations and other economic and non-economic damages. At the time of the report, the outcome of transient ischemic attack was not recovered. Upon internal review, transient ischemic attack was considered to be medically significant.
This spontaneous report as received from a nurse refers to a patient of unknown age. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On an unknown date the patient was vaccinated with improperly stored GARDASIL 9 (dosing details were not reported) (lot # N001533, expiry date: 16-OCT-2019) for prophylaxis which was stored at a temperature of 47 degree Fahrenheit to 77 degree Fahrenheit (incorrect product storage). No adverse effects were reported. The call was because of a data logger. No product quality complaint was involved.
Moderna Booster 0.25mL given to 10 year old child.   No signs of symptoms of allergic reaction noted.  No adverse reactions noted or reported by patient x 30 minutes.
Child received immunization 1 on 8-11-09 & mother reports on 8-12-09 in AM (L) thigh became red & inflamed a injection site. Child would not move leg very much throughout the day. This noon child was seen here in clinic - child was walking with difficulty & was with c/o. Mother states he feels better but leg remains red & warm area of redness 3 1/2 cm.
It was reported that patient experienced weakness; This spontaneous case was reported by an other health care professional and describes the occurrence of ASTHENIA (It was reported that patient experienced weakness) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis, Hypertension, Depression, Multiple sclerosis and Multiple sclerosis aggravated. Concomitant products included METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL), TAMSULOSIN, PHENAZOPYRIDINE HCL, BIOTIN, KERATIN, FLUOXETINE HYDROCHLORIDE (FLUXETINE), VITAMIN D3, METHENAMINE HIPPURATE, IBUPROFEN (ADVIL [IBUPROFEN]), ZOLPIDEM TARTRATE (AMBIEN), FAMPRIDINE (AMPYRA), CALCIUM, ALPRAZOLAM (XANAX) and RITUXIMAB (RITUXAN) for an unknown indication.   On 06-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (It was reported that patient experienced weakness). At the time of the report, ASTHENIA (It was reported that patient experienced weakness) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product included MCG-Keretin. No treatment medication reported by reporter.
Patient was on hospice for general debility for about 2 years.  Patient was eating 100% and propelling self in wheel chair while living in nursing home.  Received Covid vaccine #1 on 2/2/21 and #2 on 3/2/21.  No other significant events occurred until starting 4/7/21 when patient started vomiting food.  Then on 4/8/21 patient vomited large amount of coffee ground emesis.  Then on 4/9/21 patient expired.
Headache, Myalgia, Fever, injection site swelling and chills Narrative:
SWOLLEN THROAT; HEART RACING; HEADACHE; This spontaneous report received from a patient concerned a 51 year old female. The patient's weight was 220 kilograms, and height was 54 inches. The patient's past medical history included hormone replacement therapy, and concurrent conditions included thyroid disorder, anxiety, depression, arthritis, non smoker, and no alcohol use, and other pre-existing medical conditions included the patient had no known allergies or history of drug abuse or illicit drug usage. The patient received COVID-19 vaccine AD26.COV2.S (suspension for injection, intramuscular, batch number: Unknown) dose not reported, on 04-MAR-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. It was reported that the patient was on unspecified hormone replacement therapy medication, thyroid medication, a blood thinner ,antianxiety and antidepressant medications, pre diabetes medications, and arthritis medication. On 04-MAR-2021, the subject experienced swollen throat and heart racing and was admitted to emergency room. On 04-MAR-2021, the subject also experienced headache. No further information provided. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 04-MAR-2021, and had not recovered from swollen throat, and heart racing. The reporter assessed the events as related to COVID-19 vaccine AD26.COV2.S This report was serious (Hospitalization Caused / Prolonged) for swollen throat and heart racing.; Sender's Comments: Swollen throat, headache and heart racing . This event(s) is considered related. The event(s) has a compatible/suggestive temporal relationship. There are no other factors more likely to be associated with the event(s) than the drug.
Uproductive cougb/dry cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Uproductive cougb/dry cough) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced COUGH (Uproductive cougb/dry cough). At the time of the report, COUGH (Uproductive cougb/dry cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
sweat through fleece; hands aches; missed her menstrual cycle last month which was supposed to be on April 18; body aches; headache on left side; cold chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweat through fleece), PAIN IN EXTREMITY (hands aches), MENSTRUATION DELAYED (missed her menstrual cycle last month which was supposed to be on April 18), MYALGIA (body aches) and HEADACHE (headache on left side) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 020B21A) 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 DHEA, VITAMIN B12 NOS (VITAMIN B 12 [VITAMIN B12 NOS]), UBIDECARENONE (COQ-10) and FISH OIL 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 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (sweat through fleece), PAIN IN EXTREMITY (hands aches), MENSTRUATION DELAYED (missed her menstrual cycle last month which was supposed to be on April 18), MYALGIA (body aches), HEADACHE (headache on left side) and CHILLS (cold chills). At the time of the report, HYPERHIDROSIS (sweat through fleece), PAIN IN EXTREMITY (hands aches), MENSTRUATION DELAYED (missed her menstrual cycle last month which was supposed to be on April 18), MYALGIA (body aches), HEADACHE (headache on left side) and CHILLS (cold chills) outcome was unknown.            Concomitant included vitamins for fertility. No treatment was reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable. Patient is not sure if she is pregnant but have not seen doctor yet. patient also mentions of having a negative covid test
L thigh area red and swollen, hot to touch. Area of redness covers most of upper thigh and 3/4 of circumference. TX: antibiotics and BENADRYL for itching.
Admit for COVID pna. Fully vaccinated 3/2021. O2, steroids, rocephin. Improved to RA and was discharged home.
23MAR92 on the 21JAN92 approx 1 hr p/vax pt was "unable to move whole body w/eyes not responding lasted approx 8 (?) hrs; also had fever; baby limp p/immun; had nap, woke up & was limp & unresponsive until evening;
I got up in the morning. I was stuffy, coughing, a little light fever. I was like this for a day and a half. I also had a here and there cough. The 2nd day I was feeling this way,  I called my doctor to see if I could prescribed something for it. He gave me an anti viral to take for 5 days. I did test for covid and came back positive. Now a week later I returned to work and have no problems.
Patient received COVID Moderna booster dose on 12/2/21. On 12/3/21, approximately 36 hours from her dose, she developed tingling and pain in her left ear canal and on the side of her face. Ultimately evaluated in her primary care clinic on 12/8/21 and diagnosed with likely Ramsay-Hunt syndrome. She was subsequently reevaluated multiple times by her primary care office as well as ENT physicians and had a treatment regimen consisting of various use and timing of prednisone, gabapentin, amitriptyline and oxcarbamazepine. She has had mild relief with medications but continues to have profound, life-altering, pain in her ear canal and on her face consistent with post-herpetic neuralgia.
flu like symptoms; stomach pain; Body aches; fever; Chills; high pressure 166/103; Not able to stabilize high blood pressure; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (high pressure 166/103), BLOOD PRESSURE INADEQUATELY CONTROLLED (Not able to stabilize high blood pressure), INFLUENZA LIKE ILLNESS (flu like symptoms), ABDOMINAL PAIN UPPER (stomach pain) and PAIN (Body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension, Chronic gastritis and Seasonal allergy. Concomitant products included ACETAMINOPHEN for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced BLOOD PRESSURE INADEQUATELY CONTROLLED (Not able to stabilize high blood pressure) and FATIGUE (fatigue). On 10-Mar-2021, the patient experienced HYPERTENSION (high pressure 166/103), INFLUENZA LIKE ILLNESS (flu like symptoms), ABDOMINAL PAIN UPPER (stomach pain), PAIN (Body aches), PYREXIA (fever) and CHILLS (Chills). The patient was treated with CODEINE at a dose of 3800 mg. At the time of the report, HYPERTENSION (high pressure 166/103), BLOOD PRESSURE INADEQUATELY CONTROLLED (Not able to stabilize high blood pressure), INFLUENZA LIKE ILLNESS (flu like symptoms), ABDOMINAL PAIN UPPER (stomach pain), PAIN (Body aches), PYREXIA (fever), CHILLS (Chills) and FATIGUE (fatigue) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Blood pressure measurement: 166/103 (High) Patient had high pressure.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications taken by the patient included high blood medication.
I had my first Pfizer vaccine at 10:30 AM on 4/2/21.  By 4:30 PM that same day, I began to feel achy and very tired.  I lay down to try to rest but chills came on so strong by 9 PM, the only thing that helped relieve them was a very hot bath.  I also took two Acetaminophen after the bath and tried to rest.  Body aches made that difficult.  From Saturday 4/3 until now, I have not had chills or fever.  Body aches and extreme fatigue have continued.  Taking ibuprofen and acetaminophen have been taken every 4-6 hours to manage these negative symptoms.
The first thing was my arm started hurting. I started getting really lightheaded and I had a headache. My fever went 99- 104.1 degrees in two hours. My husband took me to the emergency room. It felt like a really bad case of the flu. The fever stayed at 102 degrees for about two days.
Rash, primarily on chest and stomach. Headaches, low grade fever, throat irritation began after first shot but didn't suspect any problems until the last shot when it became a full blown rash. Burning and itching sore throat.
Experience two large heart palpitations and what seemed stopped beating for a second, this was followed by tremendous pressure in my head, I thought I was experiencing a stroke.  I felt like I was going to black out and was having tightness in my chest , my wife took me to the E.R.  I had an EKG done and it not show any arrhythmia and CT scan of my head did not show any abnormality.  They scheduled me to follow up with cardiologist.  The whole week I experienced the following symptoms: Tightness and sharp pains in chest; Difficulty breathing, especially at night (had to sleep sitting up on couch one night and another night woke up with difficulty breathing , appeared to be the biggest problem when laying flat).  Would get out of breath walking up stairs; Moments I would get really light headed with a feeling like I could pass out; Symptoms last until the 4/16 , when they finally went away.  Follow up with Cardiologist, who scheduled an electrocardiogram and stress tests on 5/7.  The tests results showed that I had a healthy heart and no underlying conditions. I'm 49 and never have experienced any cardiac events. before or have a family history of cardiac disease. I have no known allergies either.
within 5 minutes of receiving the vaccine, patient experienced generalized itching and feeling of swelling in throat; given IM injection of diphenhydramine 50mg; within 5 minutes of receiving diphenhydramine symptoms resolved
Initial localized reaction lt arm then progressed to generalized rxn with fever, headache, chills and myalgia.  Begun on prednisone burst and taper 10/19/15 and resolved by 10/26/2015.
Patient in observation and reported increase in heart rate, chest tightness and difficulty breathing 30 minutes after injection. Patient remained stable, but reported worsening symptoms and was transported to ED for further evaluation
Saturday evening on right side between eye and nose, above eye, on forehead and in scalp started red and itchy used topical diphenhydamine the next morning the redness had become blistery. Started acyclovir Tuesday 1/29/19.
Approx 4 hours post-vaccination, employee states eyes swelled shut, face swelled, experienced difficulty swallowing and breathing. Employee states that she took Benadryl, fell asleep, woke this morning with some residual swelling to eyes and face. Seen by her PCP and given antihistamine x 7 days.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), first regimen (Batch/Lot number: unknown) at single (dose 4 (booster), single), second regimen (Batch/Lot number: unknown) at single (dose 3 (booster), single), third regimen (Batch/Lot number: unknown) at single (dose 2, single) and fourth regimen (Batch/Lot number: unknown) at single (dose 1, single) for COVID-19 immunisation. The patient's relevant medical history included: "type 2 diabetes" (unspecified if ongoing); "Shellfish allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Day 0, with symptoms; Negative, notes: Day 7, on 2 antigen tests, symptoms gone; Positive, notes: Day 8, on antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional infromation: On day 0, the patient tested positive for COVID with symptoms. The patient started Paxlovid. On day 7, the patient tested negative on 2 antigen tests, symptoms gone. On day 8, the patient tested positive on antigen test. On days 9,10 and 11, mild symptoms were reported.  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.