chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a employee refers to a 14 year old patient of an unknown gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date in July-2017, the patient was vaccinated with first dose of GARDASIL 9 injection, for prophylaxis (lot#, expiry date, route and dosage details were not reported). On 25-JUL-2018, the patient was vaccinated with second dose of GARDASIL 9 injection, for prophylaxis (lot#, expiry date, route and dosage details were not reported). No adverse effects were reported. No product quality complaint (PQC) was involved.
Approximately 10 minutes after mother and child left the clinic the mother returned to lobby stating that her daughter had passed out in the car. Mother stated they were driving and patient was upright in front passenger seat on her cell phone when she suddenly slumped to the left side and was briefly unresponsive. When RN reached the car, patient was awake and pale in a semi-reclined position in the front passenger seat. Her seat was reclined fully. The air conditioning was on in car but it was extremely warm from being closed up in the summer heat while they were inside the clinic. All A/C vents were directed to patient. An ice pack was placed under her neck and on her forehead. Her feet were elevated on the dashboard. She was given peanut butter crackers to eat. She remained reclined in the car and was conscious throughout time attended by RN staff. After approximately 20 minutes, patient's color had returned and she felt better. Mother was comfortable to drive her home. She was advised to have her eat and take fluids and to continue to observe for any further issues. On 7/27/18, this RN called and spoke to her mother, who stated that patient had not experienced any further issues after they left the clinic the second time.  She stated that she did fine the rest of the day and was "doing great" on 7/27/18.
Arm pain/soreness lasted longer than usual week, has persisted through today's date from the Dec. 12 2018 shot. Is getting it looked at by orthopedist in coming week.
full generalized tonic clonic seizure; fever; troponins checked and they were elevated; 70-80 systolic on 06Jun2021; heart rate 160s on; This is a spontaneous report from a non-contactable consumer (patient). A 12-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0175), via an unspecified route of administration, in left arm on 05Jun2021 12:00 as dose 2, single for covid-19 immunisation. Medical history included history of autism, controlled seizures. The patient's concomitant medications were not reported. patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection Batch/Lot Number: EW0175), via an unspecified route of administration, in left arm on 15May2021 as dose 1, single for covid-19 immunisation. The patient underwent lab tests and procedures which included blood pressure measurement: 70-80 systolic on 06Jun2021, cardiac monitoring: unknown results on 06Jun2021, echocardiogram: unknown results on 06Jun2021, heart rate: 160s on 06Jun2021, neuropathy peripheral: unknown results on 06Jun2021, body temperature: 103.6 on 06Jun2021, troponin: elevated on 06Jun2021. On 06Jun2021 08:00. After shot done at 12 PM, next morning at 8 AM patient had full generalized tonic clonic seizure lasting 20-25 minutes, fever of 103.6. EMS was called, went to ER, fever eventually went down and got IV fluids due to HR in 160s and BP 70-80 systolic. After 2 hours, troponins checked, and they were elevated. Transferred to hospital for overnight observation and monitoring of troponins (peaked at midnight, then trended down). Echo was okay. Will follow up with neurology and cardiology. The outcome of the events was resolved on unknow date in 2021.  No follow-up attempts are possible. No further information is expected.
Itching; Hives; Redness; Begun to stutter; This is a spontaneous report received via COVAES from a contactable consumer (patient). A 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in left arm on 07Apr2021 02:00 PM (Batch/Lot Number: SN6206) as single dose for covid-19 immunisation. Patient is not pregnancy at time of vaccination. Medical history included known allergies to Dilaudid, Percocet, Eggs. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient experienced itching, redness and hives within 5 days of getting the first shot on 10Apr2021. Patient also have begun to stutter on 10Apr2021, but doctor did not think it was a side effect. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Treatment received for the adverse event including a shot to stop the itching and hives. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19 with nasal swab negative on 12Apr2021. The event outcome for all events was recovering.
arm is killing (hurting); she feels tired with chills; she feels tired with chills; temperature of 103.1 degrees Fahrenheit; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (arm is killing (hurting)), FATIGUE (she feels tired with chills), CHILLS (she feels tired with chills) and PYREXIA (temperature of 103.1 degrees Fahrenheit) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm is killing (hurting)), FATIGUE (she feels tired with chills), CHILLS (she feels tired with chills) and PYREXIA (temperature of 103.1 degrees Fahrenheit). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm is killing (hurting)), FATIGUE (she feels tired with chills), CHILLS (she feels tired with chills) and PYREXIA (temperature of 103.1 degrees Fahrenheit) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Body temperature: 103.1 (Inconclusive) 103.1.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient felt tired with chills and a temperature of 103.1 degrees Fahrenheit for which she took aspirin.
Dry and chapped lips; First injection stung a bit; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of CHAPPED LIPS (Dry and chapped lips), VACCINATION SITE PAIN (First injection stung a bit) and PYREXIA (Low grade fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21a) for COVID-19 vaccination.     Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) and OXYCODONE for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHAPPED LIPS (Dry and chapped lips), VACCINATION SITE PAIN (First injection stung a bit) and PYREXIA (Low grade fever). At the time of the report, CHAPPED LIPS (Dry and chapped lips) and VACCINATION SITE PAIN (First injection stung a bit) outcome was unknown and PYREXIA (Low grade fever) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications also included unspecified thyroid medication. No treatment information was provided.   This case was linked to MOD-2021-218718 (Patient Link).
Patient received her Pfizer booster. She had reported no symptoms until the end of her 15 min observation. She then shared she felt dizzy. She went very pale and needed to lay back. She was provided comfort care and vitals were stable. She declined offer for water. After 10 minutes she returned to her initial state of health. She was observed an additional 15 minutes before she left. She did voice that she felt safe to drive. She was encouraged to bring someone with her when she needs vaccinations in the future.
COVID-19 virus test positive/lost sense of taste and smell but that was it; COVID-19 virus test positive; Vaccination site pain/Sore arm; This is a solicited report from a Pfizer-sponsored program received from a non-contactable consumer (patient) based on information received by Pfizer from(Manufacturer Control number 21K-163-3938265-00).  A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular in 2021 (Lot number was not reported) at the age of 62-year-old as single dose and dose 2 via an unspecified route of administration in 2021 (Lot number was not reported) at the age of 62-year-old as single dose for COVID-19 Vaccination; risankizumab (SKYRIZI), via subcutaneous from an unspecified date, at unspecified dose for Moderate to severe chronic plaque psoriasis. The patient medical history and concomitant medications were not reported. The patient experienced vaccination site pain in Jan2021. It was reported that the patient with events of non-serious Covid positive and sore arm after Covid vaccine with risankizumab. There was no reported medical history. On an unknown date, the patient experienced Sore arm after Covid Vaccine. In Jan2021, the patient experienced Covid positive. In 2021, the Covid positive resolved. On an unknown date, Sore arm after Covid vaccine resolved. Covid-19 Vaccine was also considered suspect. In Jan2021, patient had covid positive and lost sense of taste and smell but that was it. In 2021, he took two doses of Pfizer vaccine. His arm was a little sore. They just heard that people that had covid could not get the vaccine because there were antibodies in their bone marrow. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer. The action taken in response to the events for risankizumab was unknown. The outcome of the events was recovered on an unspecified date in 2021. The reporter's causality for the event of Covid positive with Skyrizi(RISANKIZUMAB) was a reasonable possibility. The reporter's causality for the event of Sore arm after Covid vaccine was not provided.  The reporter's assessment of the causal relationship of the events with the suspect product BNT162B2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Information about lot/batch number has been requested.; Sender's Comments: Whatever the efficacy of a product, lack of effect can occur and it is an expected finding. Based on the limited information currently available in this case, this occurrence cannot be excluded. Vaccination site pain is possibly related due to a plausible temporal relationship.
Patient given Anthrax vaccine in spite of patient's report to vaccine clinic of an allergic reaction. Patient is active duty sailor and has to maintain readiness. Was given vaccine in keeping with instruction that requires administration if no documentation exists for adverse reaction.  Symptoms were fever, chills, sweats, cellulitis at injection site, and headache conitnuing through 2 days after administraiton.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 56-year-old male patient received BNT162b2 (BNT162B2), on 23Jul2022 at 13:00 as dose 4 (booster), single (Lot number: FP7150) at the age of 56 years, in left arm for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 24Jul2022 at 10:00, outcome "recovering", described as "General Fatigue"; VACCINATION SITE PAIN (non-serious) with onset 24Jul2022 at 10:00, outcome "recovering", described as "Injection Site Pain"; MYALGIA (non-serious) with onset 24Jul2022 at 10:00, outcome "recovering", described as "Muscle Soreness". Therapeutic measures were taken as a result of fatigue, vaccination site pain, myalgia. Additional information: The patient took 600 mg Ibuprofen as treatment for adverse events. There were no other vaccine in four weeks. There was no covid prior to vaccination. The patient was not tested for covid post vaccination.
12 days after the booster I developed dermatographia. My throat started to close up and my entire body itched and broke out into hives. Benadryl wouldn't bring much relieve other than for an hour or 2 and then consulted a dermatologist.  After the first round of low dose steroids it didn't help that much and have now been prescribed more, which I will start tomorrow.
Rash x1 week, develops water filled blister which then pops.  Several lesions on arms, trunk
Patient (employee) stated she starting having redness and swelling to vaccination site the evening of 8-26-13 when administered. Reported to Employee Health on 8-27-13 L upper extremity noted to be red and slightly warm to touch at vaccination site. Patient afebrile. No complaint of n/v voiced. Respers easy and unlabored. Patient stated with first vaccine of MMR series she had pain for a couple of days after vaccination but no other reactions. Patient does have medication allergies to PCN, Codeine, Benadryl and sulfa. Patient was educated to apply ice every 4 hours times 20 minutes and take OTC Ibuprofen 400mg for pain/inflammation and to return to employee health if symptoms worsened or did not improve. Patient was seen in business health services on 8-28-13 to be evaluated by physician. Physician prescribed ATB therapy for adverse reaction. Will continue to follow patient.
PT BROKE OUT IN HIVES ON FACE, LASTING FOR MORE THAN 1 DAY.
8/19/2021 @ 8:30 pm - chills and L arm pain.    Chills ended around 10:00 pm on 8/19/2021  L arm pain continues   8/20/2021 @ 7:30 am - muscle aches and chills.   Taken 600 mg ibuprofen and  650 mg Acetaminophen.  Once at 8:30 am and 4:30 pm.    Chills ended around 4:30 pm on 8/20/2021  Muscle aches and L arm pain continue
SWOLLEN FACE; RASH WENT DOWN THE BODY TO THE KNEES; NAUSEA; FEVER; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included poison ivy.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070, and expiry: 25-MAY-2021) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. Non-company suspect drugs included: amoxicillin/clavulanic acid ( form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported.  On APR-2021, the subject experienced rash went down the body to the knees. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced fever. Laboratory data included: Blood test (NR: not provided) High inflammatory markers present (markers unspecified), and COVID-19 virus test (NR: not provided) Negative. On 11-APR-2021, the subject experienced swollen face. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Normal. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from rash went down the body to the knees, and swollen face, and the outcome of nausea and fever was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
2nd vax 4/26/2021. Admitted to Hospital for unknown reasons. Case has been attempted 3x with no return phone call.
- felt like severe flu. Horrible headache, chills, myalgia. Could not get up. Felt horrible. Took several OTC and passed out for 12 hours. Extreme fatigue. Nausea.
0200 woke up with a fever around 100, body aches, chills, and swollen lymph node under the injection arm. Felt like a small potato. Between hour 24 - 48, only lymph node and injection site pain. Lymph node is the size of a small kiwi.
48 hours after Prevnar began running temperature 102. 72 hours after Prevnar had brief febrile seizure. Continue temperature: 103.9. PE: normal. Possible Roseola.
I had a slight head ache after the 30 minute waiting period that I had. Then On Thursday in the middle of the night, I started with the fever. It started with 99.5 and went up to 102.7 and went down to 100; all day. Also, bodyache from Thursday until Friday. By Friday morning, fever went down to normal.
pt had breathing problem, shallow breathing, heart racing, inconsolable cry;MD called about 1PM & told to give pt APAP;pt went into deep sleep form 5PM-10PM & was unable to awaken;MD called again told to take pt to ER-eval & said OK;
22OCT97 rt arm swelling/bruising w/sore hives;no distress;rx ice, motrin, DPH PRN;
Tinnitus was at a manageable level, like crickits in background, After the shot, a high pitch ringing started and it has not stopped. I will not take the 2nd shot due to not knowing  how worse the tinnitus might elevate. I have had tinnitus for approx 2.5 years ( with some hearing loss ), but I have been able to train my brain to handle this. The tinnitus is 24x7, non stop, only relief is when you actually get to sleep. It's been a bigger issue to deal with since I took the Moderna shot. Had I known it would have affected tinnitus, I would not have taken the 1st shot. My daughter advised me to google moderna/tinnitus. I did and read all the reports on that. I wish I had read that first. I looked at the list of side effects, tinnitus was not on the list, so it never occurred to me it would be an issue. It is a big issue when you deal with it everyday of your life.
4/7/21 at 7pm Felt faint a little breathing off. Sore throat 8pm and started to feel uncomfortable and trouble swallowing a little bit.. 10pm felt like lump in throat. 11pm more trouble swallowing and tongue swollen and throat felt swollen. 6am under chin tongue still felt swollen.  2:45pm 4/8 trouble swallowing and felt odd in mouth/throat. Soft palate and uvula swollen and throat felt swollen. 7pm felt faint and breathing off a little. 9:45pm Mouth still swollen. All of this with Benadryl and Motrin in me.
no adverse event; recieved dose five years after the first dose; This spontaneous report  was received from a consumer concerning to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.   On an unspecified date in 2015, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).   On 11-JUL-2020 , the patient received her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # 1614898 for prophylaxis, five years after the first dose (inappropriate schedule of product administration).  However, at the reporting time, the patient had not reported adverse events. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: 1614898; expirationdate: 15-NOV-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
itching at injection site; swelling at injection site; injection site warm to touch; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received bnt162b2 (BNT162B2 Formulation: Solution for injection, Batch/Lot number: EN6198, Expiry Date: 30Jun2021), on left arm at the age of 65, dose 2 via an unspecified route of administration on 20Feb2021 as single dose, dose 1 (Lot EL9266, Expiry: 31May2021) via an unspecified route of administration on 30Jan2021 as single dose for covid-19 immunization. Vaccination Facility was Physician Office Hospital. Medical history included diabetes for which patient takes unspecified high blood pressure medication. Concomitant medication was Januvia for diabetes. On 23Feb2021 the patient experienced itching at injection site, swelling at injection site, injection site warm to touch. It was reported should he seek further treatment or advice. The adverse events does not require physician office visit and emergency room visit. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. Patient was not administered any vaccine on same date of the suspect. Outcome of reaction/event at the time of last observation was not recovered/not resolved.
12 hours after receiving JNJ vaccine, experienced fever, chills, headache, sore throat, body aches (these symptoms resolved after 24 hours). 24 hours after, experienced hives on both arms, upper back and hips. Hives eventually were limited to only arms after 3 days. 7 days after experiencing on and off hives, I took an antihistamine until hives disappeared for longer than 24 hours.  Hives were not itchy, but large and warm to the touch. No single hive lasted for more than 24 hours.  They disappear and reappear randomly on my arms. Specially over veins. It has been over a month since my vaccine and I?m still experiencing these hives that appear and disappear at random. I?ve documented each hive outbreak with photos and currently undergoing blood tests trying to learn more about this issue.
After 12 hrs, I got stabbing chest pains and center left side of my chest; advil. From the nest day the pain happened once every hr. This lasted two or three days and became less and less painful. By the 24th it was gone. Went to my doctor 21st Feb 2021.
My arm swelled to my elbow - red and hot. That lasted for 4 days.    I had the chills for two days  I was exhausted for two days.  On the third day I had neck pain.  No fever
I became dizzy within an hour of the vaccine.  At times it feels like vertigo and others more like lightheaded.  Beginning today (4/2/21) I felt tachycardic and took my pulse ox which read 96 oxygen saturation and HR of 125.  I?m resting and have not felt severe enough symptoms to call my doctor.
No additional AEs; a 5 month old child received a dose of PNEUMOV AX 23; This spontaneous report was received from a other health professional refers to a 5-month-old patient of an unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 15-MAR-2021, the patient, at the age of 5 months, was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vial, 1 injection, lot # T024556 with expiration date of 08-JAN-2022 (route of administration was unknown) for prophylaxis. No adverse event was reported.