chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache, Fever, BODY ACHES, CHILLS, INJECTION SITE PAIN, FATIGUE, LIGHTHEADEDNESS Narrative:
The night I started getting a headache and took TYLENOL, arm started getting sore and was feeling tired. Went to sleep woke up and body felt painful and ached. As day progressed and pain got worse and redness on arm spread from the injection site and grew bigger and pain from back of arm to shoulder to elbow.
Injection was given in left arm (possible too low). Caused swelling, redness that spread down the arm.
I had a fever, headache and just didn't feel for about three days after receiving the vaccine. I tested positive for COVID-19 on 03/22/2023. I had nausea, extreme body aches, diarrhea and fever. I called my doctor for advice. I decided not to take PAXLOVID and treat my symptoms with over-the-counter medication. As of today, I still have a cough.
Patient reports 2 minute episodes of numbness to hands and feet occurring every 5 minutes s/p receiving COVID-19 vaccine. She further reports associated heart pounding and difficulty breathing General ROS: (-) chills, fever, (-) unusual fatigue or weight loss ENT ROS: (-) nasal discharge,  (-) cough, (-) sore throat Respiratory ROS: (+) shortness of breath CV ROS: (-) chest pain, (+) heart pounding Gastrointestinal ROS:  (-) abdominal pain Genito-Urinary ROS: (-) dysuria Musculoskeletal ROS:  (-) joint/bone pain Neurological ROS: (-) headache, (+) numbness to hands and feet Dermatological ROS: (-) rash Psychiatric: ROS: (-) SI/HI, (-) psych hx  Patient improved her symptoms, discharged home
Dizziness; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 19Apr2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration on 19Mar2021 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Apr2021, the patient experienced dizziness and nausea. The events resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizziness and nausea were not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sudden onset of left shoulder pain that has progressively worsened for 3 months since being vaccinated.    On MRI found to have acute bursitis and suggestion of adhesive capsulitis
After the second dose, mild flu like symptoms that appeared approximately 12 hrs after the injection and lasted for approximately 24hrs; Pain at the site of injection for 48hrs; This is a spontaneous report from a non-contactable consumer (patient). A 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3247, Expiration date not reported), via an unspecified route of administration, administered in the right arm on 11Feb2021 10:00 (at the age of 37-years-old), as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3247, Expiration date not reported), via an unspecified route of administration, administered in the right arm on 20Jan2021 14:00 (at the age of 37-years-old), as dose 1, single for COVID-19 immunization and experienced Moderate pain at the site of injection that appeared 8hrs after the injection and lasted for 48hrs. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced after the second dose, mild flu like symptoms that appeared approximately 12 hrs after the injection and lasted for approximately 24hrs and pain at the site of injection for 48hrs on 11Feb2021 21:00. Patient did not receive treatment as a result of the events and events did not result to emergency room or physician office visit. The outcome of recovered of mild flu like symptoms was recovered on an unspecified date on Feb2021 and pain at the site of injection on 13Feb2021 21:00.  No follow-up attempts are possible. No further information is expected.
1 am - 3-17-10 T.C. from pt. has hard reddened area around injection site which is painful. Pt started noticing this around 8:30 am on the day after the shot. Discussed local reactions. Pt will take BENADRYL, ibuprofen and use ice on the area. To see Dr. if condition worsens. Denies trouble breathing. Denies hives or rash on any other part of her body. States she had trouble sleeping because her arm was sore. 17-10 - 3:30 pm - Pt. at work today and request this RN to stop by and look at her arm. There is a pinkish/red circular rash on back of (L) arm approx. 4 - 5 inches in diameter. Within this area there is an approx 2 inch oval hardened red area which pt states is painful and warm to touch. Pt denies any other symptoms and is still taking BENADRYL and ibuprofen. She has not seen a Dr. for this. Referred to Dr. and continue with BENADRYL and pain med. 3.18.10 - 10 am. T.C to pt. she states the rash is a little bigger but the site is less painful. She thinks it is getting  better. She does not want to see Dr. Pt is to call Dr. if symptoms worsen. Denies hives or rash else where. Denies trouble breathing.
MODERATE ITCHING FOLLOWING FIRST AND SECOND VACCINATIONS.  ITCHING LASTED 24 HOURS AFTER FIRST SHOT.   TREATED WITH BENADRYL.  ITCHING LASTED ABOUT 4 HOURS FOLLOWING SECOND SHOT.  TREATED WITH BENADRYL.   TINNITUS AND AUDITORY SENSITIVITY BEGAN WITHIN 6 HOURS OF THE FIRST INJECTION.  SUBSIDED BUT STILL PERSISTENT UP TO AND AFTER THE SECOND INJECTION.   TINNITUS HAS BECOME WORSE 10 DAYS AFTER SECOND INJECTION.  IT IS LOUDER AND MOSTLY IN LEFT EAR.  AUDITORY SENSITIVITY HAS BECOME WORSE ALSO.
Vertigo  and she is still experiencing it; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo  and she is still experiencing it) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ETHINYLESTRADIOL, NORETHISTERONE ACETATE (JUNEL) for an unknown indication.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VERTIGO (Vertigo  and she is still experiencing it). At the time of the report, VERTIGO (Vertigo  and she is still experiencing it) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
I had zero reaction to the injection, until 8 days later.  Yesterday my injection site, right upper arm, became red (about a 3 inch by 3 inch area), swollen, severe itching, hard area at entry site,  and warm to touch.  Benadryl and warm compresses did help, but still having the reaction today..    I am only reporting this for your benefit for Data purposes on possible delayed reactions.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a female patient of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 01 total administered on 26-MAR-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 an unspecified date in NOV-2021, the patient underwent laboratory test SARS-CoV-2 antibody test which showed no antibodies. Reportedly on the same day, her doctor said that she had no antibodies (confirmed immunological vaccine failure). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000202717.; Sender's Comments: V0: 20211139112-COVID-19 VACCINE AD26.COV2.S-Confirmed immunological vaccine failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Ache at site. Chills at bed time o/a 11:00 PM same day.  All symptoms gone by next morning.
Fully vaccinated patient admitted through ED for cough, weakness, and fever who tested detected for COVID.  Provider d/c note below:    "63yr old female with a history of HTN, T2DM, CLL, Anxiety who presented on 10/07 with hypoxia, cough, chills and found to be covid positive. She has since been managed for Acute Respiratory failure in the CCU and transferred to PCU yesterday. She however did not require intubation. Today she is off the high flow and now stable on 2L NC oxygen   Acute Hypoxic Respiratory Failure secondary to Covid Infection with questionable superimposed bacterial infection - Was initially managed in CCU though did not require intubation. She completed 10 day course of decadron and IV remdesivir and is currently on IV solumedrol day#10. She also received antibiotics course with azithromycin, ceftriaxone, eraxis, meropenenm vancomycin and zosyn. Latest procal was 0.09 and repeat chest xray 10/28 showed slightly improved bilateral airspace disease so no indication for continued antibiotics. Persistent leukocytosis is likely secondary to steroids. She has improved remarkably on supportive treatment and steroids and is now stable on NC oxygen. CTA negative for PE but due to elevated d-dimer had been on full dose lovenox. She remains stable even with ambulation and is being discharged home on 2L of NC oxygen to follow up with PCP. "
No adverse reactions while in office, patient was transported by Mom to hospital but patient was already being admitted to due to wheezing and age
Child's mother states child started crying, her color changed to "green" and child started vomiting then fell down to floor and started jerking for about "3 minutes". Mother states child then went to sleep for approximately 5 hours and when she got up she acted fine. Mother states a "little fever" did not measure.
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH (Rash all over the body) and ADVERSE REACTION (Bad reaction) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis. The patient's past medical history included Anemia. Concomitant products included PANTOPRAZOLE for Acid reflux (esophageal), AMLODIPINE for Blood pressure high, FOLIC ACID for Folic acid supplementation, FERROUS SULFATE for Iron supplementation, TRAMADOL for Pain, PREDNISONE and HYDROXYCHLOROQUINE for Rheumatoid arthritis, SUCRALFATE for Stomach discomfort, FOLINIC ACID for Vitamin supplementation. On 09-Apr-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced RASH (Rash all over the body) (seriousness criteria hospitalization). On an unknown date, the patient experienced ADVERSE REACTION (Bad reaction) (seriousness criteria hospitalization). The patient was hospitalized for 1 day due to ADVERSE REACTION and RASH. At the time of the report, RASH (Rash all over the body) was resolving and ADVERSE REACTION (Bad reaction) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information included acyclovir and dexamethasone. Company comment: Based on current available information and the temporal association between product and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product and the start date of the events a causal relationship cannot be excluded.
Arm was sore and continued to stay sore for over 8-10 weeks. Had limited mobility in arm.
During an OBGYN visit, blood work was ran to determine hormone levels for conception. Numbers (pre vaccine) showed mild case of PCOS. During my pelvic exams, nothing showed anything remarkable. During an abdominal and vaginal ultrasound done in April, just after the vaccine, there were newly forming fibroids found in my uterus and cervix. There were no indication of fibroids one month prior.
PATIENT STATES SHE TESTED POSITIVE ON NOVEMBER 20, 2020 AND AFTER RECEIVING VACCINATION FELT THE SAME SYMPTOMS SHE EXPERIENCED WHEN SICK. PATIENT STATES IT STARTED APPROXIMATELY 4 HOURS AFTER THE VACCINE AND SHE JUST DIDN'T FEEL WELL. PATIENT STATES SHE EXPERIENCED BODY ACHES, HEAD ACHE, AND EXTREME FATIGUE. PATIENT STATES THIS LASTED UNTIL NIGHT FALL ON THE 3RD DAY AFTER RECEIVING THE VACCINATION.
Mother noticed swelling, redness and warmth starting the following day. She called the clinic and was told to use cool compresses. It continued to worsen - child constantly scratching and area getting hard.
Patient was given a full dose (0.5 ml) of Moderna instead of half dose for booster
Patient is a 61 year old MALE who presents to clinic with a 4 day history of R upper arm pain/swelling which started after he received the Zostavax on Monday.  He notes that began to notice pruritis  yesterday.  He c/o a dry, sore throat.  He does not recall having any fevers or chills.
Sore Throat; All her Teeth Ache; Pain in the Ears; Cheeks hurt; Headache; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore Throat), TOOTHACHE (All her Teeth Ache), EAR PAIN (Pain in the Ears), PAIN (Cheeks hurt) and HEADACHE (Headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included Dental cavity.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (Sore Throat), TOOTHACHE (All her Teeth Ache), EAR PAIN (Pain in the Ears), PAIN (Cheeks hurt) and HEADACHE (Headache). On 07-Mar-2021, OROPHARYNGEAL PAIN (Sore Throat) had resolved. At the time of the report, TOOTHACHE (All her Teeth Ache), EAR PAIN (Pain in the Ears), PAIN (Cheeks hurt) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment information was provided   Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: NNI received
Patient self-observed lethargy, dark urine and jaundiced sclera on morning of 1/18.  Vomited 1X on 1/19 .  Went to out-patient urgent care in early afternoon of 1/19.  Sent to Hospital.  HCT @21% and hemoglobin of 7.3 upon admission. HCT 18.1% and hemo 6.2 on 1/20.  Warm COOMBS (+) with POS IgG Abs; HCT fell to 17.5% with hemoglob at 5.9 on 1/21. Idiopathic AHIA suspected.  Strong (good) RBC regenerative marrow response noted.  Normal WBC count.  High dose injectable corticosteroid given 1/20.  Transfused with 1 unit RBCs on 1/21.  Discharged on 1/22 PM with ORAL PRED 60 mg SID.  First recheck on 1/25 showed PCV @25.8% (hemo 8.5); 2nd recheck on 2/2 showed PCV @33.9% (hemo 11.5).
Called to report deep aching pain to RD area of arm starting 6/29/05 and progressed with relief obtained taking aspirin or Tylenol and exertion increases pain. Pain not as severe feels weakness and effort to lift right arm continues. To be evaluated by MD as suggest.
lower right side of leg on the shin there is a nodule it's a blood clot; a torn meniscus on her right lower leg; tenderness; Varicose veins; inside the knee in the tissues side of the knee cap I have 3 bruises there; 1st dose on 29Apr2021, 2nd dose on 25Jun2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administration date 25Jun2021 (Lot number: EW0182) at the age of 68 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Heart disorder" (unspecified if ongoing); "two stents in my heart" (unspecified if ongoing); "pre diabetic" (unspecified if ongoing). Family history included: "Stroke" (unspecified if ongoing), notes: Stroke runs in my family. Concomitant medication(s) included: METFORMIN taken for glucose tolerance impaired and medication for heart (unspecified). Vaccination history included: Bnt162b2 (1st dose, Lot number: EW0176, site of administration: left shoulder), administration date: 29Apr2021, when the patient was 68 years old, for Covid-19 Immunization. The following information was reported: THROMBOSIS (medically significant) with onset 03Aug2021, outcome "not recovered", described as "lower right side of leg on the shin there is a nodule it's a blood clot"; MENISCUS INJURY (non-serious) with onset 03Aug2021, outcome "not recovered", described as "a torn meniscus on her right lower leg"; TENDERNESS (non-serious) with onset 03Aug2021, outcome "not recovered", described as "tenderness"; VARICOSE VEIN (non-serious) with onset 03Aug2021, outcome "not recovered", described as "Varicose veins"; CONTUSION (non-serious) with onset 03Aug2021, outcome "not recovered", described as "inside the knee in the tissues side of the knee cap I have 3 bruises there"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 25Jun2021, outcome "unknown", described as "1st dose on 29Apr2021, 2nd dose on 25Jun2021". The events were evaluated at the physician office visit (seen the doctor twice). The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Aug2021) negative. Therapeutic measures were not taken as a result of thrombosis, meniscus injury, tenderness, varicose vein, contusion. No follow-up attempts are possible. No further information is expected.
Worsening of alopecia; Body aches; HA; Chills; Arm pain; Severe migraines; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Jan2021 07:30 (Lot number: F13246) at the age of 44 years as dose 2, single and administered in arm left, administration date 18Dec2020 07:30 (Lot number: EK5730) as dose 1, single for covid-19 immunisation. Relevant medical history included: "HTN" (unspecified if ongoing), notes: hypertension; "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "allergy induces asthma" (unspecified if ongoing), notes: allergy induces asthma; "endometriosis" (unspecified if ongoing); "migraines" (unspecified if ongoing); "alopecia areata" (unspecified if ongoing). Concomitant medication(s) included: LABETALOL; HYDROCHLOROTHIAZIDE; LEXAPRO; VYVANSE. Past drug history included: Known allergies; wellbutrin, reaction(s): "Known allergies; Wellbutrin", notes: Known allergies; Wellbutrin; Known allergies; ceftin, reaction(s): "Known allergies; Ceftin", notes: Known allergies; Ceftin.  The following information was reported: PAIN (non-serious) with onset Dec2020, outcome "not recovered", described as "Body aches"; HEADACHE (non-serious) with onset Dec2020, outcome "not recovered", described as "HA"; CHILLS (non-serious) with onset Dec2020, outcome "not recovered", described as "Chills"; PAIN IN EXTREMITY (non-serious) with onset Dec2020, outcome "not recovered", described as "Arm pain"; MIGRAINE (non-serious) with onset Dec2020, outcome "not recovered", described as "Severe migraines"; ALOPECIA (non-serious) with onset Jan2021, outcome "not recovered", described as "Worsening of alopecia". The events "body aches", "ha", "chills", "arm pain", "severe migraines" and "worsening of alopecia" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain, headache, chills, pain in extremity, migraine, alopecia.  Follow-up (01Feb2022): Follow-up attempts are completed. No further information is expected.
Got dizzy and been on n off, my throat did feel a lil swollen but i do have allergies.
Patient received the COVID shot, follow up labs showed spiked HbA1c and ALT
Itchy hives spreading on from arms to back, groin and buttocks-started after influenza vaccine given. No shortness of breath, seizure, or other symptoms.
felt it in my heart; This is a spontaneous report from a contactable consumer (patient) via COVID-19 Adverse Event Self-Reporting Solution (COVAES). A 57 years old non-pregnant female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EL9261) via an unspecified route, administered in Left Arm on 29Jan2021 at 09:15 AM (57-year-old at time of vaccination) as Dose 1, single for Covid-19 immunization. The patient's medical history included High blood pressure and rapid heart rate. Meds control it. The patient had no known allergies. The patient's concomitant medications were not reported. Facility type vaccine was reported as Administration facility. The patient had no covid prior vaccination. The patient was not Covid tested post vaccination. The patient had no other vaccine within four weeks of Covid-19 vaccination. On 30Jan2021 ay 09:15 AM, (it was reported that 20 minutes after vaccination), the patient had felt it in her heart. The patient had not received any treatment medications for the resulted events. The outcome of the event was recovered on an unknown date in 2021.   No follow-up attempts are possible. No further information was expected.
soon p/vax pt arrived in office c/o nausea (vomited x 1);was perspiring&said legs&arms were numb;lips appeared cyanotic;pulse 72 when nurse arrived;mom was called to suggest follow up by MD;