chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within a minute or so I noticed my tongue and throat tingling/burning.; Within a minute or so I noticed my tongue and throat tingling/burning.; Within a couple more minutes face started to itch all over.; asthma; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the right arm on 05Apr2021 at 10:45 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma chronic. The patient had known allergies to medications, food or other products (UNSPECIFIED). Concomitant medications included gliclazide (CLARITIN), fluticasone propionate (FLOVENT) and salbutamol (PROVENTIL) from an unknown date for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 10:45 within a minute or so, the patient experienced tongue and throat tingling/burning. Within a couple more minutes her face started to itch all over and this lasted for about 2.5 hours. The patient asthma kicked up for 24 hours. No therapeutic measures were taken as a result of reported events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event tongue and throat tingling/burning, face itch all over and asthma was recovered on 06Apr201.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient received second dose on Day 124 which is outside the recommended interval of 21-42 days. Patient expressed no side effects.
Vasovagal Syncope w/Subsequent Head Injury - Approximately 10 minutes after vaccination, the patient sustained sudden onset of lightheadedness and lost consciousness. Fell from  seated position in her chair to floor. Sustained contusion/abrasion injuries to left periorbital region. Appropriate clinical actions undertaken and IVF started. Patient stabilized and transferred to ER via EMS.
Severe injection site pain with redness and lump, flu-like tiredness, body aches, fatigue, feeling of fever but no fever, lack of appetite
5 - 10 sec clonic movement. No postictal state. MRI head neg EEG reg. No further episodes  Neuro eval P as to dx of seizure.
two grand mal seizures; migraine; under skull feels like it itches; persistent cough; body aches; chills; pain at vaccination site; extreme n/v; extreme n/v; This spontaneous case was reported by a consumer and describes the occurrence of GENERALISED TONIC-CLONIC SEIZURE (two grand mal seizures) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Seizures. Concomitant products included VALPROATE SEMISODIUM (DEPAKOTE), CARBAMAZEPINE (TEGRETOL), TRAZODONE and POTASSIUM GLUCONATE for an unknown indication.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced GENERALISED TONIC-CLONIC SEIZURE (two grand mal seizures) (seriousness criterion medically significant), MIGRAINE (migraine), PRURITUS (under skull feels like it itches), COUGH (persistent cough), MYALGIA (body aches), CHILLS (chills), VACCINATION SITE PAIN (pain at vaccination site), NAUSEA (extreme n/v) and VOMITING (extreme n/v). On 20-Apr-2021, VACCINATION SITE PAIN (pain at vaccination site) had resolved. At the time of the report, GENERALISED TONIC-CLONIC SEIZURE (two grand mal seizures), MIGRAINE (migraine), PRURITUS (under skull feels like it itches), COUGH (persistent cough), MYALGIA (body aches), CHILLS (chills), NAUSEA (extreme n/v) and VOMITING (extreme n/v) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication: Norco 10mg, Zofran 8mg, Tylenol, Motrin.  Company comment: 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. Patient's hx of seizures and conmeds of Depakote, tegretol, trazadone, and potassium gluconate are confounding factors that may play a possible contributory role to the event PT seizures. .; 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. Patient's hx of seizures and conmeds of Depakote, tegretol, trazadone, and potassium gluconate are confounding factors that may play a possible contributory role to the event PT seizures. .
This spontaneous report as received from a nurse refers to an infant patient (age reported as 41 and 43 weeks) of unknown gender. On 12-SEP-2014, the patient, older than 32 weeks of age, was vaccinated with third dose of ROTATEQ 2 ml, oral (lot number and expiration date were not provided). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
severe headache, neck stiffness, fever up to 102F, diffuse myalgias; symptoms started ~12 hr after 2nd dose and persisted for another ~48-60hr before resolving
blotchy red, itchy face, puffy swollen lips, redness and swelling to right deltoid area of immunization
Systemic: Dizziness / Lightheadness-Medium, Systemic: Hypotension-Mild
This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On 31-MAY-2018, the patient was vaccinated with an improperly stored GARDASIL 9 for prophylaxis, lot #N025428 and expiration date 19-JUN-2020 (strength, dose, frequency and route of administration were not reported). No adverse effect was reported. The temperature of excursion was reported as below 30°F (-40°F), during a time frame of 4 hours and 7 minutes. There was no previous temperature of excursion reported. A digital data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA003811: US-009507513-1806USA007090: US-009507513-1806USA007091: US-009507513-1806USA007092.
Monday Nov 1, 2021, I was vomiting, dizzy, and nauseous. I stayed at home next day, could not sleep, chest pain, and SOB. I went to the ER. While at ER, I had blood work that stated I had pulmonary embolism blood clot and low white blood cell count. That was ruled out but something triggered that. Was discharged from ER with a referral to cardiologist. I also went back to the ER due to fast heart rate above 170 and high blood pressure with numbness in my arm. I wanted to make sure I was not having a heart attack. While in ER, I received another EKG, chest x-ray, and blood work. I had went to cardiologist and had a stress test which I failed. More testing was done with echocardiogram, EKG, CTA, a cardiac MRI, and Holter monitor. I have mild palpitation and myocarditis determined from the EKG and echocardiogram. I just had a cardiac MRI today so no results yet.
After giving the vaccination, the  injection site bled. I applied light pressure with gauze and the bleeding stopped immediately. There was an immediate bump on the area at the injection site approximately the size of a marble. The patient did not complain of pain. The customer remained seated in our waiting room for approximately 15 minutes while I called Sanofi to report the incidence. At no time did the patient report any dizziness, shortness of breath, or distress. Patient was advised to apply ice if needed and to follow up with doctor if the injection site became more swollen or painful. Patient was advised to call 911 if signs of anaphylaxis.
Death I21.4 - Non-ST elevation (NSTEMI) myocardial infarction J18.9 - Pneumonia, unspecified organism N17.9 - Acute kidney failure, unspecified
Nausea, tightness in chest, chest pain, headache, transient pains throughout the body, shortness of breath
Narrative: Patient returned for second dose of Moderna vaccine 60 days after first dose of Moderna vaccine. Second dose administered outside of CDC time frame.
Chills Bone ache  Fatigue  Headache Sore throat  Nausea
Confusion; Vomiting; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Confusion), VOMITING (Vomiting), HEADACHE (Headache) and FATIGUE (Fatigue) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, the patient experienced CONFUSIONAL STATE (Confusion), VOMITING (Vomiting), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, CONFUSIONAL STATE (Confusion), VOMITING (Vomiting), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       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. Treatment medicines were not reported.
5 hours after vaccination, had severe vertigo, nausea and vomiting.  Went to emergency room.
Patient reported her left arm feeling "itchy" approximately 20 minutes after injection. No hives present. Benadryl 50mg was offered to the patient, she declined an ice pack.
Heart fluttering Abdominal pains  3 internal infections septic and hospitalized Kidney Cancer / surgery/ hospitalized
flu-like sx, swollen rt arm, nausea, diarrhea, warm @ site, h/a for 2-3 days;flu like illness-resolved;
approx 3mos p/vax pt exp lt sided numbness & went to ER;pt had tingling & numbness of face & leg; 3days later same sx in lt arm & rt foot;dx w/transient ischemic attack;treated w/plavix & heparin;
Patient was giventhe Janseen covid vaccine on 5/5.     Apparently the patient 6 days later was reportedly aggitated had hallucinations and trouble breathing.  The  patient proceeded to  lay down to rest.  The patient never awoke.
On 6/20/19 patient reported pain to the left arm that started the day after he received the Tdap vaccine. Denied pain with the injection. Some soreness on day 2 and 3. Since then pain has felt deeper and worse, like in the bone. Worse when lifting arm and hand. Difficult to sleep and sleep, Struggling at work. Pain throughout the day and night. Some numbness and warmth to the fingers.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 11-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date of refrigeration of lot was 7-May-2021.  No concomitant medication information was provided. No treatment information was provided.   This case was linked to MOD-2021-363790 (Patient Link).
4:00pm itching of right arm, head and face. 4:15pm 25mg Benadryl taken. itching continued in same spots and occasionally other parts of body. neck and face were red and blotchy. 8:30pm another 50mg of Benadryl taken because of uncontrollable itching. next morning oct 29th itching was gone. but severe pain started in entire body. palms of hands and bottom of feet were like broken glass was stuck in them. difficulty walking and touching things. by the end of the night I couldn't walk. next morning oct 29 upper body was better but from the waist down was still burning with pain and still felt like walking on glass. This is still continuing with no end in site. I called the doctor's office on November 1st. I was told to take Motrin and use and icy hot patch on my back. Nothing has been resolved.
1 of 4 linked same reporter cases (other related cases: 1210USA013663, 1210USA013664 and 1210USA013665). This spontaneous report as received from a pharmacist refers to unspecified number of patients who on unknown dates were vaccinated with GARDASIL. The patients might have been vaccinated with improperly stored GARDASIL but did not have any other information. No adverse effects reported at that time. The outcome of the event was unknown. Additional information is not expected.
diarrhea; red rash on the injection arm; injection arm hurts; nausea; A spontaneous report was received from a Consumer concerning a 76-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events red rash on the injection arm, injection arm hurts, nausea and diarrhea.  The patient's medical history include hypertension and chronic kidney disease. Concomitant medications reported were Blood pressure medication, Simvastatin, Pantoprazole, Vitamins, drugs used for unknown indication.  On 29 Jan 2021, prior to the onset of the events the patient received their last of two planned doses of mRNA-1273 (lot batch: 037R20A) for prophylaxis of COVID-19 infection.  On 29 Jan 2021, the patient experienced the events red rash on the injection arm. injection arm hurts, nausea and diarrhea.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, red rash on the injection arm, injection arm hurts, nausea and diarrhea was not reported.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
No adverse effect reported; inadvertently administered an expired dose of VARIVAX; Information has been received from a nurse referring to a patient of unknown age and gender. Concomitant medication included sterile diluent (Merck manufactured). Information about concurrent condition, drug reactions/allergies and medical history was not provided.  The reporter reported that on 27-JUN-2019, the patient was inadvertently administered an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # was N019127, expiration date was 22-JUN-2019, strength, dose and route were not reported) for prophylaxis (Expired product administered). No adverse effect was reported.
Side effects, (fever, chills,) didn't kick in until after 24 hours of the shot. I was taking a hot shower at 2pm and started to get chills, got in bed, turned up the heat and put on a sweat shirt. Fever did go down overnight after peaking at 101.3F. Chills went away. The reason I am writing you is that I thought the onset of the side effects happened after 24 hours instead of the 12-16hrs. normally expected.
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 44-year-old male patient received BNT162b2 (BNT162B2), on 23Feb2021 as dose 1, single (Lot number: EN6200), in left arm, on 18Mar2021 as dose 2, single (Lot number: ER2613), in left arm and on 24Nov2021 as dose 3 (booster), single (Lot number: FJ1620 or FJ2620) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Jun2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Jun2022) Positive, notes: Originally tested COVID positive (antigen) on 30Jun2022; (10Jul2022) Positive, notes: Retested positive for COVID on 10Jul2022 using home antigen test; (Jul2022) Positive, notes: I tested once more to confirm consistent negative test, I tested positive again; (Jul2022) negative, notes: After completion of paxlovid, received negative COVID result (antigen). Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: No known allergies. No other medication in 2 weeks. Originally tested COVID positive (antigen) on 30Jun2022. Initiated paxlovid treatment on 30Jun2022 and concluded complete dosing protocol at end of day on 04Jul2022. After completion of paxlovid, received negative COVID result (antigen). After completing the CDC recommendations for 5 days isolation and 5 days masking, patient tested once more to confirm consistent negative test, tested positive again. In speaking with the nurse practitioner ((email withheld), telehealth) this was identified as a rebound COVID case and that patient should report. Additionally, as patient was testing positive a second time, he was to restart the isolation/quarantine protocol. He was asymptomatic. Symptoms were minor during paxlovid treatment.
flu-like symptoms; runny nose; achy; fatigue; chills; This spontaneous case was reported by a nurse and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), RHINORRHOEA (runny nose), PAIN (achy), FATIGUE (fatigue) and CHILLS (chills) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced RHINORRHOEA (runny nose), PAIN (achy), FATIGUE (fatigue) and CHILLS (chills). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), RHINORRHOEA (runny nose), PAIN (achy), FATIGUE (fatigue) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided. .   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow up received: Contain Non significant information
PT sts he began to feel feverish within one hour of vaccine.  Over the next 36 hrs sts his highest self-assessed temprature was 102.4F.  Headaches, tiredness, and systemic body aches began within 24hrs of vaccine.  Sts he was going for a COVID test, not positive.  Discovered gall bladder issue shortly after vaccination, in treatment.
VERY LITTLE SYMPTOMS; This spontaneous report received from a patient 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,) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 2021, the subject experienced very little symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of very little symptoms was not reported. This report was non-serious.
COVID-19 Cough, body aches, fever and sinus congestion and pressure. I still have a cough and sinus pressure. Today is my 10th day of symptoms. I got the monoclonal antibody infusion on the 19th of July.
Chills and muscle fatigue starting around 10:30am 1/12. Grew more intense throughout the day and into the night.  Had a fever starting around 3pm 1/12. Stayed around 102 until it went down after 3am (I took Tylenol 8pm and 12am) Headache starting evening of 1/12. At one point started to feel a slight tightening/tickle in my chest when taking deep breaths.  Overall felt sick for about 17 hours and wasn't able to work or do much beyond laying around. After getting the second dose, the only side effect at first was soreness at injection site. It was surprising that I didn't start to experience other side effects until the next day. As I type this up the next morning, I'm feeling about back to normal, though sore from the chills. Slept for almost 11 hours. Temperature back to normal, no headache this morning.
Generally, it felt as if I was having a heart attack. Notable symptoms include: 1. Chest pain 2. Shortness of breath 3. Abnormal or rapid heartbeat 4. Fatigue 5. Swelling of legs 6. Headache
PATIENT WAS OBSERVED FROM 0938 - 0953 WITH NO DISTRESS OR COMPLAINTS,   PATIENT CALLED AT 1100 COMPLAINING OF NUMBNESS IN HAND AND FINGERS
Started as itchy splotches around ankles on 7th day after vaccine, each day more splotches on both leg, Took anti itch cream, after 11th day started taking  benadryl, after 13 day woke up with splotches over both legs, on left arm and a few on my back.  Went to ER. Diagnosis. Hives allergic reaction Prescribed Prednisone 50 mg  for 5 days
AT 10 MINUTES AFTER VACCINATION (4:20 PM), PATIENT REPORTED EXCESSIVE SALIVA PRODUCTION, WATERY EYES, AND TIGHTENING OF THROAT.  SHE SAID SHE WAS STILL ABLE TO BREATH HOWEVER.  I GAVE HER ONE TABLET OF 25MG DIPHENHYDRAMINE.  I ASKED HER TO STAY AN EXTRA 30 MINUTES FOR OBSERVATION.  ABOUT 10 MINUTES LATER, HER DAUGHTER REPORTED HER THROAT WAS CLOSING.  I INJECTED 0.3 MG EPIPEN INTO HER LEFT THIGH AND ASKED TECHNICIAN TO CALL EMERGENCY.  HER THROAT OPENED UP QUICKLY AND I GAVE HER WATER WHILE WE WAITED FOR EMS.  EMS CHECKED HER VITALS AND LEFT AT 5 PM.  I COUNSELED HER TO NOT GET THE 2ND PFIZER SHOT AND TO REPORT THE ALLERGY TO HER PCP.  ALSO, IF SHE WERE TO EXPERIENCE ANY SIMILAR SYMPTOMS GOING FORWARD TO CALL EMERGENCY.  PATIENT AND DAUGHTER WAITED FOR HER HUSBAND TO COME AND TAKE THEM HOME.
For the first time in my life, my period was less than its typical 26-35 days between cycles. My recent range has been 25-31 days between periods. My period starting on Sep. 30 was only 18 days after the first day of the prior period, which started on Sep. 12.  This is really unexpected and confusing, and it has never happened since I started menstruating at age 14. My next period began 21 days later, on Oct. 23, also very early.