chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client c/o itchey throat, slight difficulty swallowing, became flushed and redness/splotchy on neck/chest. O2 sat at 100% on RA. Lungs clear, no stridor noted. Client declined SOB. Received Pfizer vaccine dose#2 about 10 min prior to symptom onset. Client declines similar symptoms after dose#1. Benadryl 50 mg given PO. Client evaluated by fireman from Fire Department. Symptoms decreasing by the time her husband arrived. She agreed to go to urgent care/ED to be evaluated. Client was advised to go to ED/urgent care and husband was there to drive. Client in no apparent distress when she left. O2 sat @100% on RA and pulse was 83.
She developed a fever, and on her left leg, she developed burning pain and tingling in the nerve going up her leg. Eruptions/bubbles are present along the nerve line. Doctor gave her Valtrex and gabapentin
Patient reacted to vaccine with red, itchy swollen area on arm.  Approximately 2 inches in diameter in center of larger paler red spot approximately 4x6" oval area.
Oval rash at site of injection, approximately 2 inches in diameter. Pt states the area, itches and burns and is warm to the touch.
Pt called this morning complianing of nausea, hot, stomach discomfort. She said she feels every sick and has aches at the injection site with redness and little swelling. Instructed her to take some Benadryl, use motrin and ice packs and call the doctor's office or pharmacy if the reaction gets worse.
Bad diarrhea; Chills; Fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Bad diarrhea), NAUSEA (Nausea), CHILLS (Chills) and FATIGUE (Fatigue) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced NAUSEA (Nausea). On 26-Feb-2021, the patient experienced DIARRHOEA (Bad diarrhea), CHILLS (Chills) and FATIGUE (Fatigue). At the time of the report, DIARRHOEA (Bad diarrhea), NAUSEA (Nausea), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient on BP medication and Aspirin
day after patient reported chills, aches, nausea. 2 days after patient reports redness, swelling and warmth to L) arm, took Benadryl and had minimal benefit. 3 days after patient reports to clinic redness is milder per patient and measures 11.2cm X 9.1cm, slight warmth. Marked outline and recommended patient keep an eye on area and contact clinic if it grows or pain/swelling worsens, recommended Tylenol and ice to help with discomfort.
EXTREME FUSSINESS AND 103 DEGREE FEVER 24 HOURS AFTER GIVEN. TREATED WITH MOTRIN.  CBC WITHIN NORMAL LIMITS AND NEGATIVE UA
patient had near syncope after  administration of COVID-19 vaccine. patient was assess by EMS and transported to local hospital. HR 87; BP 150/102; Resp 12 GCS 15
Patient was found down.  Diagnosed with COVID on 1/21 despite being double vaccinated.  Last known well was 1/27 @ 1730.  Patient was observed to have left side hemiplegia and right gaze preference.  Patient was intubated for respiratory failure despite CXR  being negative.  CT head (-), Cervical spine (-),  CT CAP (-), CT T/L (-).  Troponin and  WBC elevated.  Patient complaining of chest pain.  Angiogram showed partial occlusive embolus of right ICA terminus.    Embolectomy performed with complete TICI 3 recannulization.  EMBOLIC STROKE ETIOLOGY - UNKNOWN!
severe anxiety; Caller states she was shaking uncontrollably even in her voice; Caller states she was shaking uncontrollably even in her voice; just weird shaking that started on the inside out; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 07Apr2021 (Lot number: ER8732, Expiration Date: Jul2021) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing); "leg cramps" (unspecified if ongoing); "Overweight" (unspecified if ongoing), notes: Medical Conditions: Caller states she is healthy just a little overweight. Concomitant medication(s) included: OLMESARTAN taken for blood pressure abnormal; KLOR-CON taken for muscle spasms. Vaccination history included: Bnt162b2 (Pfizer COVID-19 Vaccine 1st dose , Location: Left Upper Arm, Time: Between 4:30-5:00pm , Lot number: EN6199, Expiry: Jun2021, 1st dose aside from a sore arm which she expects to be normal.), administration date: 16Mar2021, when the patient was 66 years old, for Covid-19 immunization, reaction(s): "sore arm"; Flu (Caller states she gets the Flu shot every year with no reactions). The patient was not received any vaccine Prior Vaccinations (within 4 weeks). The following information was reported: ANXIETY (non-serious), outcome "unknown", described as "severe anxiety"; NERVOUSNESS (non-serious) with onset 2021, outcome "recovered" (2021), described as "just weird shaking that started on the inside out"; DYSPHONIA (non-serious), outcome "unknown", TREMOR (non-serious) with onset 2021, outcome "recovered" (2021) and all described as "Caller states she was shaking uncontrollably even in her voice". The events "severe anxiety", "just weird shaking that started on the inside out", "caller states she was shaking uncontrollably even in her voice" and "caller states she was shaking uncontrollably even in her voice" were evaluated at the physician office visit. Therapeutic measures were taken as a result of anxiety, nervousness, dysphonia, tremor. No follow-up attempts are possible. No further information is expected.
Headache; Chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 31-Mar-2021 and was forwarded to Moderna on 01-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical History is reported).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache) and CHILLS (Chills). At the time of the report, HEADACHE (Headache) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Approx 1 month after Anthrax #3, developed muscle and joint pain (myalgia, arthralgia). Approx 6 weeks after Anthrax #3, developed testicular pain. Follow up: chronic myalgias, flu-like symptoms, fever, muscle aches, tiredness.
DX; chicken pox ( varicella). Sx; rash on torso, HA, tactile fever, neck ache, (rash type varicellaform). TX;supportive.
Tachycardia (HR120-150 normal 85) within 2 weeks.
Patient received PREVNAR 13 and influenza vaccines and 4 days later had reaction. Transferred by ambulance to ED. Flu-like symptoms.
Dizziness, headache, ear infection/fluid, dehydration, thirst, food sensitivity, stomach aches, intestinal issues, repeated vaginal infections, fatigue, skin infection, anxiety, sleep issues, overheats.
Treatment of COVID-19; Treatment of COVID-19; interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Batch/Lot number: unknown) and on 13Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 03Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "migraine" (unspecified if ongoing); "uti" (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 "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid was given for the treatment of COVID-19 through oral route with start date 04Aug2022 and stop date 08Aug2022,11 days after completing paxlovid on 18 Aug2022 patient experienced chest and head cold, Cough mild sore throat and stomach cramping. Vertigo, fatigue and outcome for these events was recovering.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information a contributory role of BNT162B2 to the reported events Covid-19 and Drug ineffective cannot be totally excluded as efficacy of a drug varies from individual to individual depending upon the immune status. As with any vaccine, vaccination with BNT162B2 may not protect all vaccine recipients, so the expectedness of covid-19 and drug ineffective is : expected. The case will be reassessed further upon receipt of additional information.
nauseous; a slight fever of 99.3 degrees F and 100.2 degree F; whole body aches; chills; fatigue; Sore left arm; Sore at injection site; Migraine intensity increased (had a headache already prior to 2nd injection); This is a spontaneous report from a contactable consumer (patient) reported for herself. A 29-year-old female patient (Non pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 05Apr2021 09:30 (Lot Number: EP6955) as single dose for covid-19 immunisation. Medical history included migraine headaches. The patient did not have COVID prior vaccination. No Known allergies. No COVID tested post vaccination. Concomitant medications included propranolol and Nurtec ODT (as needed). No other vaccine received in four weeks. The patient previously received the first dose of BNT162B2 via an unspecified route of administration, administered in Arm Left on 16Mar2021 12:30 (Lot Number: EP6955) as single dose for covid-19 immunisation. The consumer reported that headache was not an adverse event of the 1st dose of vaccine. She had woken up the morning of 05Apr with a headache. The patient experienced sore left arm and at injection site and migraine intensity increased (had a headache already prior to 2nd injection) on 05Apr2021 12:00. About 12 hours post the injection, she became nauseous, had a slight fever of 99.3 degrees F, whole body aches, chills, fatigue, and a constant migraine. Over the course of the following day (06Apr), these symptoms lessened but only some completely went away. Her highest fever was 100.2 degree F during the morning of 06Apr. The body aches, fatigue, and migraine continue through today (07Apr). Treatment included took already prescribed Nurtec for the migraine. The outcome of the events sore left arm and at injection site and migraine intensity increased was not recovered. The outcome of the others was unknown.   No follow-up attempts are needed. No further information is expected.
Probable cellulitis at site of immunization 2.5 inch in diameter.  Red, warm, taut
became clammy and pale in color initial b/p 91/63 and pulse 63  called MD for assessment  water oven and crackers  B/p 99/48  after siting for additial 30 minutes  bp/ 99/64  MD advised client to follow-up with doctor.
Pt admitted for right hip pain, but no acute fracture or dislocation. Pt is COVID positive with a mild cough that is nonproductive and some generalized body aches.
About 7 weeks after I got my 2nd vaccine, I developed shingles. I am 36 years old, do not smoke, do drugs, eat relatively healthy and exercise 3-5x a week both cardio and strength. I have not been any more stressed lately than in the past, nothing has changed in my life to cause major stress.   Moderna COVID?19 Vaccine EUA
pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant) in a 35-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 031L20A) for COVID-19 vaccination.     The patient's past medical history included Nicotine abuse from 2010 to 2018. Concurrent medical conditions included Hyperthyroidism since 2014. Concomitant products included LEVOTHYROXINE for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 03-Dec-2020 and the estimated date of delivery was 09-Sep-2021. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  sixth week of the pregnancy.  At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Dec-2021, Pregnancy test: positive (Positive) Positive. On an unknown date, Ultrasound scan: normal (normal) normal.         No Treatment information provided Previous pregnancy included 14 Apr 2008 and 13 Jul 2009 with live birth.; Reporter's Comments: levothyroxine 100 mcg .
PATIENT WAS GIVEN VACCINATION. HE GOT UP A FEW MINUTES LATER AND PASSED OUT. HE LOST CONSCIOUSNESS FOR APPROXIMATELY 3-5 SECONDS AND HIT HIS HEAD . AFTER  APPROXIMATELY 5 MINUTES PATIENT VOMITTED. SHORTLY AFTER HE WAS ALERT AND AWARE OF SURROUNDINGS. PATIENT FELT COMFORTABLE EXITING THE BUS AND WALKING TO HIS CAR ALONG WITH MEDICAL STAFF. MEDICAL STAFF ENCOURAGED ADDITIONAL MEDICAL ASSISTANCE FOR HEAD; PATIENT AND MOM DECLINED.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of an unknown refers to a patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # M041082 with an expiration date 04-APR-2018, lot# M042502 with an expiration date 17-APR-2018, lot# M046943 with an expiration date 27-MAY-2018 for prophylaxis (route of administration and anatomical location were not reported). No adverse effects were reported. The nurse confirmed that sterile diluent used for reconstitution of vaccine was stored at recommended temperature range. Administered doses of PROQUAD experienced the temperature excursion from 6 degrees Fahrenheit to 14 degrees Fahrenheit for 2 hours and 20 minutes. There was previous temperature excursion (no details were reported). A digital data logger was involved. Additional information has been requested.
body aches; fevers; nausea; This is Spontaneous report from a contactable consumer. A 30-year-old female patient received second dose BNT162B2, via an unspecified route of administration on 07Jan2021 at the 30 years old at single dose for COVID-19 immunization. The medical history and concomitant medications were not reported. The Historical Vaccine included BNT162B2 for COVID-19 immunization (dose number 1). The patient was a nurse and she and several of her colleagues received the second dose of COVID-19 vaccine on Thursday 07Jan2021. On Friday 08Jan2021, she and many of her colleagues woke up with body aches, fevers, and nausea. She said the side effects went away within 12- 24 hours. There was no treatment received for all the adverse events. The outcome of the event was recovered in Jan2021.  Information on lot/batch number has been requested.
This spontaneous report as received from a pharmacist (also reported as pharmacy manager) refers to a 67 year old female patient. The patient's medical history, concurrent condition and concomitant medications were not reported. On 03-MAR-2018, the patient was vaccinated with PNEUMOVAX 23 from lot N019983 expiry date 03-MAR-2019 for immunisation. On 03-MAR-2018, the patient experienced bruising and redness at the injection site and felt really hot on the underside of her arm (feeling hot).  No lab diagnostics/studies were performed. The outcome of injection site bruising, feeling hot and injection site erythema was reported as not recovered. Causality assessment was not provided by reporter.
PATIENT HAD TINGLING AND SWELLING IN THE LIPS THE SAME DAY AS RECEIVING THE COVID-19 VACCINE AND TOOK BENADRYL AND SYMPTOMS RESOLVED.  THE NEXT DAY, SATURDAY, THE PATIENT BROKE OUT IN HIVES IN THE TORSO AREA AND TOOK BENADRYL AGAIN AND THE SYMPTOMS RESOLVED.  THE PATIENT HAS NOT HAD ANY OTHER SYMPTOMS.
Sore Injection Site (After First Vaccine); Arm Hurts and never fully recovered after First Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore Injection Site (After First Vaccine)) and AXILLARY PAIN (Arm Hurts and never fully recovered after First Vaccine) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).  In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   In March 2021, the patient experienced VACCINATION SITE PAIN (Sore Injection Site (After First Vaccine)) and AXILLARY PAIN (Arm Hurts and never fully recovered after First Vaccine).   In March 2021, VACCINATION SITE PAIN (Sore Injection Site (After First Vaccine)) had resolved. At the time of the report, AXILLARY PAIN (Arm Hurts and never fully recovered after First Vaccine) had not resolved. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-076721 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076721:second dose
Physician ordered a TDAP instead of an HPV, patient had a TDAP last year.  The TDAP was administered as part of the orders. No harm done. Just an honest mistake.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 67-year-old male patient received bnt162b2 (BNT162B2), on 05Apr2021 as dose 2, single (Lot number: ER8737) at the age of 64 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Arterial hypertension" (unspecified if ongoing); "IBS" (unspecified if ongoing); "chronic prostatitis" (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 "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 Included: Paxlovid.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccine BNT162B2 in this patient cannot be completely excluded.
Severe pain in top of right arm. Could not move shoulder (5 hours later) to lift arm for a few hours. Started with ice packs and massaging shoulder to get some movement.  27 hours later can move arm up but pain in top arm and shoulder. Called doctor, alternating tylenol and motrin along with hot and cold packs.  Doctor said would schedule an appointment if not better on 8/14
Information has been received from a LPN concerning a pt who in approximately 2003 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (Lot # 645646/0068N). Subsequently in approximately 2003, the pt developed redness and edema at the injection site. Unspecified medical attention was sought, but prescription drug treatment was not required. A product quality complaint was not involved.  The reporter also mentioned a second pt who had a similar experience post vaccination with pneumococcal 23v polysaccharide vaccine (Lot # 647654/0865N) (WAES #0312USA00223).  Additional information has been requested.
The patient is a 28 y.o. male who presents to the Emergency Department with left sided body aches and 6/10 head pain that began approximately two weeks ago following the administration of the Johnson and Johnson COVID-19 vaccine. The patient is present with a chaperone at bedside who helps provide history and translates for the patient. Since the administration of the vaccine the patient states he's been experiencing these symptoms. The patient reports that he began experiencing his symptoms approximately 30 minutes following the vaccine administration and have worsened since onset. He reports that he took oral Tylenol yesterday with minimal relief. The patient states that movement and exertion exacerbate his symptoms and reports that he was not able to attend work today secondary to his pain. The patient denies any associated symptoms of fever, chills, nausea, vomiting, diarrhea, constipation, or any visual changes.
Pt. presented 3 days after vaccine given with a 3 x 3" raised red area on (R) upper arm.
One hour after returning home.Heaviness in limbs, unable to walk, shortness of breath, nausea,  heaviness in chest. PCP provided oxygen, steroid shot, shot for nausea in office. Observed until symptoms subsided. Released with Rx for steroids and anti nausea medications
This spontaneous report as received from a consumer (the patients daughter) refers to a female patient of unknown age. The patient's concomitant medication included acetaminophen(+)hydrocodone bitartrate and other unspecified medications. Her pertinent medical history included diabetes. The patient had no drug reactions or allergies. In approximately 2016, (reported as "last year") the patient was vaccinated with ZOSTAVAX (lot #, expiration date, dose and route of administration were not provided) for shingles prevention. On unknown date in 2016, (reported as right after the vaccine was given) the patient had a burning and itching sensation. On an unspecified date in approximately 2017, (reported as a year after receiving the ZOSTAVAX) the patient experienced the shingles. The reporter stated that on unknown date (reported as on Saturday) the patient had shingles on the right side of her body, back, chest and arms. The primary reporter also stated that the patient had shakes since an unspecified date. The outcome of shingles, shakes, itching and burning sensation was unknown. The relatedness between the events and ZOSTAVAX was not defined by reporter. The patient sought medical attention and got unspecified therapy for the reported adverse events.  No lab diagnostics were performed due to the events.
This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified patients of unknown age and unknown gender. On an unknown date, the unspecified patients were vaccinated with PNEUMOVAX 23 (dose, frequency, route and lot # were not reported) which were improperly stored. No adverse effects were reported. No product quality complaint was reported for PNEUMOVAX 23. This case is related to case # 1502USA000341 (same reporter link). Additional information has been requested.