chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm, started to hurt in the afternoon treating it at home with cold pack, trying to avoid OTC medications
Patient had syncopal episode with decrease in BP to 77 systolic, recovered given water subsequent BP systolic 106.  Left without incident
Itchiness at site immediately 10/23/07 3am- itchiness entire body; tingling of face 10/24/07 and chin 1pm 10/24/07 - took Benadryl 25mg - 3pm called BOH advised to seek medical treatment; called PCP. Treated by phone; prescribed Hydrazaline QID
Tested positive for COVID-19 on 6/21/22.  Called doctor the next day and received paxlovid.  Finished paxlovid on 6/27/22.  Still have a slight cough.
PATIENT REPORTS APPROXIMATELY 5-10 MINUTES AFTER RECEIVING VACCINE TO LEFT ARM THAT "MY HEAD FELT WEIRD AND I GOT A PAIN TO MY LEFT EAR FOR A SPLIT SECOND."  SHE REPORTS IT CAME AND LEFT VERY QUICKLY.  UNABLE TO DESCRIBE WHAT THE HEAD FELT LIKE OTHER THAN WEIRD. REPORTED FEELING COMPLETELY NORMAL AFTER OCCURANCE
AREA AT INJECTION SITE STARTED TO GET RED AND WARM. NO ITCHING. WHEN SHE WAS SEEN BY US ON 3-26-13, THERE WAS AN APPROX 2 1/2CM INNER CIRCLE THAT WAS A DARKER RED AND AN APPROX 10CM OUTER CIRCLE THAT WAS IGHTER RED. WARM TO TOUCH AND SOME TNIGLING DOWN TOWARDS ELBOW.
Parent reports large football sized lump (larger than a baseball) on left thigh, hard to the touch, red, warm, painful, itches.  Afebrile.  Sent to Urgent Care.  Treated with Keflex in case the reaction was cellulitis.
EXTRACTION OF MODERNA VACCINE FROM VIAL WAS NOT CONSISTENT WITH MODERNA TECHNIQUE (I.E. MORE THAN 20 DOSES WERE DRAWN UP FROM THE 15ML VIAL).
ON THIRD DAY AFTER VACINE INJECTION I EXPERIENCED PASSING A KIDNEY STONE FOR THE FIRST TIME IN MY 88 YEARS. EXCURCIATING PAIN FOR 1 1/2 DAYS & IT CAME OUT. ON 1ST DAY AFTER SHOT, SOME INTERNAL ORGAN DISCOMFORT.
This spontaneous report as received from an office manager (who is also a female patient of unknown age) via a company representative, refers to herself. No concurrent conditions or medical history were provided. On 04-SEP-2014 (reported as "six weeks ago"), the patient was vaccinated with a dose of ZOSTAVAX injection administered in the arm (strength, dose, route of administration, indication, lot# and expiry date unspecified), in an unspecified pharmacy. No concomitant medications were reported. The consumer developed a large swollen area on the back of her arm at the site of injection on an unspecified date in 2014. She described the injection site as a large, 3 to 4 inch swelling that was hard to the touch at the back of her arm and it was very painful. She stated that it took two weeks to resolve on an unspecified date in 2014. The relatedness between the event and ZOSTAVAX was not reported. Additional information is not expected as the physician did not grant permission to contact him.
Vaccinee developed multiple maculopapular lesions on hands without pain, itching, vesicles or pustules.  No spread to other areas.  Probable Dx: erythema multiforme
Initial information has been received from a physician on 08-DEC-2006 concerning a 12 month old male with a history of eczema, who on 09-NOV-2006 was vaccinated with a 0.5 mL first dose of hepatitis A virus vaccine inactivated given IM. Additional suspect therapy included a 0.5 mL first dose of Proquad given SC. Concomitant therapy included alclometasone diproprionate (ACLOVATE) ointment as needed for eczema. The patient's mother had strep throat at the time of vaccination. On 15-NOV-2006, the patient developed upper respiratory infection symptoms (non-serious) with goopy eyes and fever of up to 104 degrees tympanic (non-serious). On 17-NOV-2006, the patient was diagnosed with a viral disease and conjunctivitis (non-serious). The patient received acetaminophen (TYLENOL) and ibuprofen (MOTRIN) as needed from 15-NOV-2006 through 18-NOV-2006 for the fever. The subject also received gentamicin sulfate (GENTAK) ophthalmic drops from 17-NOV-2006 through 22-NOV-2006 for treatment of conjunctivitis. All symptoms resolved on 22-NOV-2006. On 26-NOV-2006, the subject experienced right ear drainage and a red spot on his right cheek. On 28-NOV-2006, the symptoms continued and he was diagnosed with right otitis media with rupture of the tympanic membrane and cellulitis of the face. The patient was hospitalized on 28-NOV-2006 for treatment of his cellulitis and on-going ear infection. On 28-NOV-2006, the patient started a course of ampicilin/sulbactam (UNASYN) IV and ofloxacin (FLOXIN) otic drops. The patient also had CBC, ESR/CRF, blood culture and ear culture performed. On 30-NOV-2006, the patient was discharged from the hospital. The patient had excellent regression of cellulitis and his ear discharge was resolving as well. The subject was discharged on a course of clavulanate potassium-amoxicillin (AUGMENTIN) and polymyxin B sulfate-hydrocortisone-neomycin (CORTISPORIN) otic drops. On 07-DEC-2006, a follow-up visit reported the otitis media and cellulitis were resolved. The investigator considered all events to be related to the study medication. Further information has been requested.
death - reported to primary care provider today, March 3, 2022 as died on January 20, 2022.  Do not know circumstances surrounding the death.
partial seizure secondarily generalized lasting about 12 minutes 11/3/2009 hospital records from ED visits 6/15/2009 and 10/20/2009. Patient presented with seizure activity, apnea, loss of consciousness, decreased mental status. Tx: on 6/15/2009 Ativan, on 1/20/2009 no tx just observed, no repeat seizure activity.  PE no neuro deficits, advised increase dose of Keppra and f/up with PCP/Neurologist. DC  Dx seizure
hospitalized  3NOV98 & discharged 12NOV98 w/ dx of pneumonia & fever;
mom reported devel hives 7/22/99PM w/o breathing;hives recurred 7/22/99AM & was seen by MD;dx urticaria unk etiology & rx DPH;
Pt in 15 minute observation period c/o feeling dizzy and itchy. BP increased to 140/103. Sent to ED for further evaluation and observation.
This spontaneous report as received from Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. Since 17-OCT-2014 the patient were vaccinated with an improperly stored dose ROTATEQ oral (strength, dose and lot # were not reported). The vaccine was exposed to a supported temperature excursion on 17-OCT-2014. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 62 year old female patient. No information regarding the patient's medical history or concurrent conditions was provided. On 08-JUL-2015, the patient was vaccinated with a dose of ZOSTAVAX in her arm (strength reported as 19400 plaque-forming units (PFU); dose, frequency, route of administration, lot# and expiry date were not reported). There were no concomitant therapies reported. On 09-JUL-2015, the patient experienced "redness, pruritus and swelling down to the elbow of her arm", which occurred in the arm in which the patient received the ZOSTAVAX. The reported stated that the patient also developed a blister on the roof on her mouth and cold sores around her mouth after receiving ZOSTAVAX (on 09-JUL-2015). The patient sought medical attention (called the pharmacist on an unspecified date). No treatment was given for the events. The outcome of the events was unknown. The relatedness between ZOSTAVAX and the events was not provided. Additional information has been requested.
HAND STILL HURTS/ARM STILL PAINFUL; SEVERE HEADACHE; HAND SHAKING FOR A COUPLE OF DAYS; DECREASED BLOOD PRESSURE; SWOLLEN HAND/ARM STILL SWOLLEN; This spontaneous report received from a patient concerned an 89 year old male. 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 admin not reported, batch number: Unknown) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the patient experienced hand shaking for a couple of days. On 12-MAR-2021, the patient experienced decreased blood pressure. On 12-MAR-2021, the patient experienced swollen hand/arm still swollen. On 12-MAR-2021, the patient experienced severe headache. Laboratory data included: Blood pressure (NR: not provided) Blood pressure dropped. On an unspecified date, the patient experienced hand still hurts/arm still painful. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from hand shaking for a couple of days, decreased blood pressure on 15-MAR-2021, and severe headache on 14-MAR-2021, and had not recovered from swollen hand/arm still swollen, and hand still hurts/arm still painful. This report was non-serious. This case, from the same reporter is linked to 20210840400.
PT FALSELY REPORTED THAT THEY HAVE NEVER HAD A COVID VACCINE SHOT BEFORE ON THEIR CONSENT FORM AND VERBALLY PRIOR TO RECEIVING THE SHOT. UPON BILLING INSURANCE, IT CAME TO OUR ATTENTION THAT PATIENT HAS ALREADY COMPLETED THE COVID DOSE SERIES IN JANUARY AND FEBRUARY 2021 AT ANOTHER PHARMACY.
they gave 9 doses from 1 vial (lot # 044A21A ) on 2Sep2021 from a vial that expired 31Aug2021; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they gave 9 doses from 1 vial (lot # 044A21A ) on 2Sep2021 from a vial that expired 31Aug2021) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (they gave 9 doses from 1 vial (lot # 044A21A ) on 2Sep2021 from a vial that expired 31Aug2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (they gave 9 doses from 1 vial (lot # 044A21A ) on 2Sep2021 from a vial that expired 31Aug2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.
patient had completed wait time in the observation room and was at the main lobby door on her way out when she stated she was having trouble breathing. The concierge put the patient in a wheelchair and brought the patient to the emergency department. Nothing noted during the observation time.
CELLULITIS; Bacterial infection; SWELLING; ITCHING; burning; couldn't lift her arm; JOINT PAIN; dry cough; nausea; diarrhea after drinking milk; improvement in blood pressure; This is a spontaneous report from a contactable consumer and a nurse, based on information received by Pfizer from clinic  (manufacturer control number: EC-2021-090067) for BNT162B2.  A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route single dose for COVID-19 immunization on unknown date; lenvatinib mesilate (LENVIMA, Lot number: 1265576, Expiration date: 31Oct2023) oral 14mg (10mg/4mg) daily for malignant neoplasm of endometrium from 12Mar2021. Medical history included: metastatic uterine cancer (to left fallopian tube and lymph nodes), hyperlipidemia, thrombocytopenia; allergies: diphenhydramine hydrochloride (BENADRYL), sumatriptan succinate (IMITREX), hydrocodone bitartrate, paracetamol (NORCO). Concomitant medication included: magnesium, amlodipine; levothyroxine sodium; ondansetron; echinacea; paracetamol (TYLENOL); ascorbic acid (VITAMIN C); Vitamin D3; trazodone; prochlorperazine maleate; cyclobenzaprine; lidocaine hydrochloride, prilocaine hydrochloride (LIDOCAINE PRILOCAINE BIOGARAN); doxycyline hyclate. Patient had a bacterial infection, cellulitis in her arm that started 2 days after 1st vaccination. She had swelling, itching, burning and couldn't lift her arm; missed lenvatinib mesilate 1 day to see if pain was due to LENVIMA or the vaccine; stated some joint pain improved on the day off, but other symptoms persisted so she went to the urgent care and was put on antibiotics; also reported 'joints', dry cough, nausea, diarrhea after drinking milk; improvement in blood pressure. Action taken for lenvatinib mesilate was temporarily withdrawn on unknown date. Outcome of the events joint pain and blood pressure abnormal was resolving, outcome of the events dry cough, nausea, diarrhea after drinking milk was unknown; outcome of the other events was not resolved.   Information on the lot/batch number has been requested.
w/in 24hr p/vax pt exp ecchymosis @ inj site lasting 4-5 days w/small knot pea size lasting 10-12 days & cont to exp severe pruritus from rt shoulder to elbow w/o rash causing loss of sleep, severe pruritus w/scabbing & peeling of skin;
headache after getting second Shingrix shot; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the headache to be related to Shingrix.     Additional Information: GSK receipt date: 13-May-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient self reported this case. The patient had headache after getting the second Shingrix shot. The patient asked that he/she could take something for headache. Additional Supportive Information: Follow-up could be possible as no contact details were available.
Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Visual Changes/Disturbances-Medium
Bursitis and had been swollen; Hip problems; Back problems; This spontaneous case was reported by a consumer and describes the occurrence of BURSITIS (Bursitis and had been swollen), MUSCULOSKELETAL DISCOMFORT (Hip problems) and BACK DISORDER (Back problems) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   In 2021, the patient UPADACITINIB (RINVOQ) (Oral) dosage was changed to at an unspecified dose. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced BURSITIS (Bursitis and had been swollen), MUSCULOSKELETAL DISCOMFORT (Hip problems) and BACK DISORDER (Back problems). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, BURSITIS (Bursitis and had been swollen), MUSCULOSKELETAL DISCOMFORT (Hip problems) and BACK DISORDER (Back problems) was resolving.            Concomitant product use was not provided by the reporter.  The patient had experienced bursitis and had been swollen. Patient had been off of Rinvoq for two weeks because patient took the Booster shot. Patient was back on Rinvoq as of 29-Dec-2021.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's causality for the events of bursitis, hip problems and back problems with Rinvoq was a reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Patient noticed a burning sensation in his finger (left hand).  The sensation comes and goes.  He also notices his left upper arm hurts when he moves his arm towards the back.  He also noticed a white, slightly raised spot approximately 3 to 4 inches from his elbow (estimation).  He noticed the spot the same time as the burning sensation in his finger.
Injection site suddenly became itchy, red, and raised (swollen). Within a half hour it was no longer itchy, but remained slightly swollen for about 12-14 hours.
Headache, body aches for the first 24 hours. Took an ibuprofen the next day and feels okay.
6/25/21 Received vaccine. 6/26/21 Started feeling sick, unwell. Patient stated he almost fell over.  EMT's at game stated it was because his immune system was working in overdrive trying to create immunity to pneumovax and Covid.  On 6/27/21 in am, Patient went to hospital because his shoulder hurt. He was given some medication cocktail by hospital and went home same day. On 6/27/21 in pm the redness in his arm started and got worse and he started sweating really bad.  On 6/28/21 He started feeling better, but went to the clinic due to the rash. They gave him cephalexin 500 mg 1tid, but he only took it once or twice a day and didn't finish the course.  MD drew a line around rash and told him if rash expands beyond line, to come back in due to possible blood clot.  On 6/29/21 patient stated he felt better.   7/9/21 Patient states he has recovered.
Sinus infection; Attention deficit hyperactivity disorder; Problems in walking; Felt like garbage; Problems in washing or dressin/Some problems with performing usual activities; Pain/Aches; Discomfort; Back pain; Chills; Fever; This spontaneous case was reported by a physician and describes the occurrence of SINUSITIS (Sinus infection), ATTENTION DEFICIT HYPERACTIVITY DISORDER (Attention deficit hyperactivity disorder), GAIT DISTURBANCE (Problems in walking), FEELING ABNORMAL (Felt like garbage) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Problems in washing or dressin/Some problems with performing usual activities) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Vitamin D deficiency in August 2020, Ankylosing spondylitis and Shortness of breath. Concurrent medical conditions included Depression, Anxiety, Anemia, Asthma, Cough and Rheumatoid arthritis. Concomitant products included ADALIMUMAB (HUMIRA) from 12-Jan-2021 to 26-Jan-2021 for Ankylosing spondylitis, ESCITALOPRAM OXALATE (LEXAPRO) for Depression, VITAMIN D3 for Vitamin D deficiency, VORTIOXETINE HYDROBROMIDE (TRINTELLIX).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SINUSITIS (Sinus infection), ATTENTION DEFICIT HYPERACTIVITY DISORDER (Attention deficit hyperactivity disorder), GAIT DISTURBANCE (Problems in walking), FEELING ABNORMAL (Felt like garbage), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Problems in washing or dressin/Some problems with performing usual activities), PAIN (Pain/Aches), DISCOMFORT (Discomfort), BACK PAIN (Back pain), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, SINUSITIS (Sinus infection) had resolved, ATTENTION DEFICIT HYPERACTIVITY DISORDER (Attention deficit hyperactivity disorder), FEELING ABNORMAL (Felt like garbage), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown, GAIT DISTURBANCE (Problems in walking), PAIN (Pain/Aches), DISCOMFORT (Discomfort) and BACK PAIN (Back pain) was resolving and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Problems in washing or dressin/Some problems with performing usual activities) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided. the lab data reported was tuberculosis on unknown date and results. concomitant medication includes Antibitics.  Action taken with mRNA-1273 in response to the events was not Applicable.
Delayed local reaction 7 days after injection. Had redness, itching at injection site.  Resolved after about 5 days.
16:30 Problem : dizziness loss of hearing and vision, clammy & sweaty skin, SOB,   unsteady gait, feeling very hot.  27 year old male received first Moderna vaccine, Moderna lot# 012a21a, Exp. 08/17/21, to left deltoid. 16:32 patient began experiencing dizziness, loss of hearing and vision, clammy and sweaty skin, SOB, unsteady gait. 16:37 patients hearing and vision returned. VS: 77-100/60, O2 sats 99% room air. Encouraged deep breathing for SOB. Applied cool cloth to back of patient?s neck. Ice chips given. Offered bottle water and snack 16:45 staff assisted patient to observation table. Patient ambulated without any issues. 16:50 asked patient how was he feeling, patient states, ?he is feeling better and he is no longer experiencing any symptoms. Observed patient for an additional minute. Reassessed vitals: VS: 86- 106/62, O2 sats 97%, room air. 17:10 Patient left facility. No other complaints voiced.
Maculo papular rash on Bilat upper and lower extremities. Pruritic and bright red about 12 days from vaccine.
pt recv vax 22JUL97 & 29OCT97 pt exp sx of a viral infect & a rash on torso very few lesions & not vesicular;
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization/Death. Rec'd Pfizer BioNTech vaccine on 9/8/2021, 5/18/2021 and 2/10/2022. Presented to ED with c/o SOB and coughing. Pt was dx'ed w/covid-19 and admitted. Upon admission pt was tachycardic in 130s, sats 96% on 4L O2.BNP elevated 1700+, trops neg, creatinine, h/h, and wbc near baseline. CT ab pelv and chest: findings included large bilateral lower lung consolidations, atelectasis and small pleural effusions. Pt continued to decline despite treatment. Transitioned to comfort care  and changed to DNAR/AND. Admitted to inpatient hospice service, expired 10/21/22. Tx'd w/decadron and rifaximin.
This spontaneous prospective pregnancy report as received form a physician via company representative refers to an about 20 year old female patient. On 11-DEC-2012 the patient received a 0.5 ml dose of GARDASIL (lot# unspecified) subcutaneous injection (location unspecified) by mistake. No concomitant therapies. The patient was found to be pregnant with LMP (Last Menstrual Period) of 24-JUL-2012 (20 weeks as reported) while received a 0.5 ml dose of GARDASIL and EDD (estimated due date) of 30-APR-2013. Trimester(s) of exposure was the second. The patient was not supposed to receive the vaccine, she was at the healthcare center for an unspecified reason, presumably a check-up. There was another patient in the waiting room with the same name, she was the one who was supposed to receive GARDASIL. The patient in this event received the GARDASIL instead. No adverse effect was reported. No treatment was given for the event. Follow up information as received from the physician's nurse who reported that the baby boy was born full term on 26-APR-2013 with no complications. Baby was normal and healthy and there were not congenital anomalies. Additional information is not expected.