chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report has been received from a Health Professional concerning a 13 year old, male subject, who hadbeen receiving nasal FLUMIST Quadrivalent.  FLUMIST Quadrivalent started on an unknown date. The patient experienced administered expired FLUMIST Quadrivalent which started on 20-JAN-2015. At the time of reporting the event of patient had been administered expired FLUMIST Quadrivalent was improving. The report was considered to be non-serious.
Effects: started with headaches, then soreness in the upper arm. Then my veins in the left arm started to swollen and hurt. I am not completely numb on my left side, arm, legs, the pain is stronger too. Headaches.
On 2/15 At 9-10pm she noticed her entire body shaking as ?if she was having a seizure?. She states this lasted for about 10 seconds. No report of previous seizure disorder. No incontinence, shaking stopped. On Friday night feb 19th, she noted itching in her left eye, eye was swollen , almost shut and then the right eye also became swollen almost shut. Face was very puffy. She then placed cold compress an eyes and took Benadryl. Second dose was not administered today 03/08.
Rash on inner thighs, chest, back, on face & around right eye, low grade fever, blister/lesions on chin/face.
On spine just below hairline red raised rash with pimples, also on back left shoulder in two spots and front right shoulder. Treatment from dermatologist cream xerese 5%-1% and valacyclovir 1gm 1 tid x7 days.
pt recvd vax & 4 hrs after inject pt exp pain at inject site w/ some swelling; apap & cold cloth used; pt had pain at entire deltoid area of arm; was red, hard & very hot to touch; area  is now dull red 2x2 w/out tenderness;
Hit flush feeling in whole body first then lips started tingling and  skin went very red over body and rash.  Paramedics gave me a shot  of Benadryl.
Following vaccinations, the pt was crying, mother tried the bottle and pacifier, baby refused both. Mother placed the baby on the table to dress him and she noticed the baby was pale, diaphoretic, eyes closed and the baby had stopped crying and was limp. The color was ashen and bluish. 911 was immediately called. The infant then became floppy with left side circumoral cyanosis. Oxygen was applied. EMS arrived and administered their oxygen and then the infant began to cry and turned pink. The pt was transported to the hospital and then was released home that same evening.
Pt complained of arm/shoulder pain and bilateral hamstring (calf pain) started Tuesday AM after receiving TD booster on Monday afternoon. Went to see covering PCP who drew blood and give Rx for Celebrex after seeing. Worse the evening of 3/19/03. Seen by employee health and drove to MD and after normal lab results, was given Medrol Dosepak and Pepcid. To follow-up with PCP.
21y male received vaccinia in right deltoid on 19 nov 08.  Awoke at 0300 on 29 nov 08 complaining of dyspnea, dizziness, blurry vision, and right sided weakness & numbness.  Arm and leg felt like they were asleep.  Seen at Hospital ED. Per their d/c note, pt stable and felt to have possible soft tissue or skin infection s/p vacccinia given right supraclavicular LAD on exam.  No fever/chills or vital sign abnormalities.  Started on Keflex & Lortab for severe pain.  Follow-up appt at flight med on 1 Dec 08.  Patient's vitals all wnl.  Dizziness and visual complaints resolved.  Still c/o right sided hypesthesia and weakness.  Slight 4/5 strength noted in right grip and shoulder shrug.  SCM's 5/5 bilat however.  Decreased sensation to light touch on right side, but other modalities intact.  Face and cranial nerves unaffected.  Close f/u scheduled for this week.  Patient to take Motrin for pain, inflammation.  Will schedule neurology consult.
Cold sore area since got one 3 days after 1st dose 3 weeks ago- lip tingled for about an hr. 30? after I got shot #2. Day after had aches/pains/ fever of 101.1.
Patient described feelings of dizziness and itchiness following second dose of Janssen. Denied swelling of face, shortness of breath, airway swelling, hives, etc. Patient has had anaphylactic reactions in the past and denies that this felt that severe. Patient noted some tingling in her tongue, but no swelling noted. After giving patient some water, dizziness started to subside. Due to itching patient was given 25 mg oral benadryl and kept for over 30 minutes for monitoring. Patient's symptoms improved and stayed in the building another 20 minutes to accompany her children being vaccinated. No other complaints.
Congestion and cough began on 02/02, progressed to a fever by 02/06 and by 02/10 rash all over body and a knot on the side of his neck.
On 6/8/99, the pt received her first treatment with Lymerix.  Four hours later, the pt experienced a fever of 102, chills, and shaking.  Lymerix was discontinued. The most recent information received on 6/29/99 reports the chills and shaking lasted 1.5 hours.
Joint aches; had Arthritis before getting Shingrix and that it got worst; This case was reported by a physician via call center representative and described the occurrence of joint pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included arthritis (before getting Shingrix).   On 23rd September 2020, the patient received the 1st dose of Shingrix. In September 2020, 1 week after receiving Shingrix, the patient experienced joint pain and arthritis aggravated. The patient was treated with steroids nos (Steroids). On an unknown date, the outcome of the joint pain and arthritis aggravated were unknown.   The reporter considered the joint pain and arthritis aggravated to be unrelated to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Doctor reported that a patient received the 1st dose of Shingrix and 1 week later started to experienced joint aches.  Doctor also said that the patient already had Arthritis before getting Shingrix and that it got worst so after the side effects he started taking Steroids. Doctor did not want to reported the event because he did not think the symptoms were related. The reporter did not consent to follow-up.
This case was reported by a physician via a sales representative and described the occurrence of erythema multiforme in an adult subject of unspecified gender who was vaccinated with Twinrix (GlaxoSmithKline).  In 2008 the subject received unspecified dose of Twinrix at 1.0 ml.  At an unspecified time after vaccination with Twinrix, the subject experienced erythema multiforme and a systemic reaction.  This case was assessed as medically serious by GSK.  At the time of reporting the outcome of the events was unspecified.  The physician considered the events were probably related to vaccination with Twinrix.
24 hours after the injection I blacked out for several minutes. Felt very woozy the rest of the day. Some forgetfulness. Alright after 3 days.
I am not sure if it is related to her having the vaccine but pt started complains of cold sores in her mouth.
Right arm pain from site of injections down to fingertips, and up to neck. Pain rated 7/10.
No taste; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (No taste) 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 AGEUSIA (No taste). At the time of the report, AGEUSIA (No taste) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Hives on arms, legs, torso, neck. Treated with medrol dose pack. Slow resolution,
After the shot(s) were given, she went silent from crying, threw up and got down on the floor. She crawled to the corner, sat there and zoned out staring at the corner of the wall. She wouldn't respond to anybody calling her name, you could approach her and there was no response. Like she was frozen. Wouldn't respond to any verbal or physical stimuli. The nurse ran to get the doctor and he came in and just stood there. She finally "came to" but did not recognize me or her father or anything. I tried to pick her up and she would push herself away, crying as if she was scared of me. After everything had happened she finally "snapped" out of it, came to me and said I want to go. She had a high fever for 3-4 days straight. All she remembers is throwing up and that she got a shot. Nothing afterwards.
10/31/07 - Hive like rash on neck and upper chest.  No shortness of breath.  Rash lasted 3-4 weeks.  Applied OTC hydrocortisone cream which reduced itching.  Did not consult physician.  Still experiencing some itching.
Flu symptoms presented on April 20-23 - in bed for 3 days with achy muscles and joints.  The flu-like symptoms resolved by April 25.   The on May 2 - left little finger, right middle finger, and both wrists were swollen and painful, hot to the touch with a loss of full mobility.  Fatigue was also noticed.  Dr. ran blood work to rule out RA as mother has RA.  All tests came back negative except ANA was positive.  Rest, ice, vitamin C, zinc, extra fluids - treatment similar to treating flu or a cold.  Symptoms fully resolved by May 13, 2019.
TEMP EXCURSION; No additional AE reported; This spontaneous report was received from a Medical Assistant referring to a 2-month-old female patient. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On an unknown date after the vaccines temperature excursion of 47.9 degree Fahrenheit (F) for 47 minutes on 01-DEC-2022, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1892784, expiration date: 03-DEC-2023 orally; and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #W006596, expiration date: 11-OCT-2024, intramuscularly (IM) at left thigh (LT), both administered for prophylaxis (strength and dose were not provided) (product storage error). No additional adverse event (AE) was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA009088:
Per pt - first three days - fever, chills, sweating, achy resolved. Arm sore - shoulder joints tight and sore no redness or swelling - slowly getting better.
This spontaneous prospective report was received from a medical assistant and refers to a currently 16 year old female patient with none drug reactions or allergies. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL, intramuscular, lot number K010215, expiration date 05-MAY-2017, (dose and frequency were not reported). There was no concomitant medication reported. On an unknown date, the patient had a positive pregnancy test result (exposure during pregnancy). The last menstrual period (LMP) was reported as February 2016, the estimated date of delivery and the estimated date of conception were unknown. At the time of reporting, the pregnancy outcome was pending and the fetal outcome was unknown. Additional information is not expected because there was no consent for follow-up.
Six days post injection the injection site began to itch.  The itching was followed by a four inch in diameter hot, hard, welt which continued to increase in size.  Benadryl, Bactrim  & Zyrtec were ordered by the GP.
Pt received shingles, flu and pneumonia vaccine. Reported to a Minor Emergency Clinic one week later due to breaking out with red painful patches to right side of body. Patient also was seen at Dermatology Clinic one day later. Physician stated rash was due to vaccine administered. The Minor ER started patient on Valtrex 1gm t.i.d. The Dermatology clinic con't the Valtrex and also Tylenol or Ibuprofen for pain. Pt stated mother had a severe case of shingles which caused mother to have a stoke and decease.
wide spread rash in the entire body; This spontaneous case was reported by a physician and describes the occurrence of RASH (wide spread rash in the entire body) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (wide spread rash in the entire body). The patient was treated with TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE (GLUCOCORTICOID)) ongoing since an unknown date for Rash, at an unspecified dose and frequency. At the time of the report, RASH (wide spread rash in the entire body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication details was not reported by the reporter.
This spontaneous report as received from a medical assistant refers to a patient of unknown age. On 12-JUN-2013 the patient was subcutaneously vaccinated expired dose of ZOSTAVAX (lot # 0423AE,exp 02-APR-2013). No adverse effect reported. Additional information has been requested.
9:30pm- Muscle fatigue/soreness. 10:30pm- hands and feet extremely cold. Only way to get warm was hot water. 11pm-7:30am 4/4/21- fever, chills, repeat of hands and feet cold. 7:30-ongoing- Clammy skin, muscle weakness, exhaustion.
On his arm in area of vaccination he said he felt burning pain, muscle spasms and weakness intermittent (about 20 times daily). Physician was consulted by myself and PT made visit to office (phone consult physician said may be temporary nerve irritation). Symptoms stopped 2 months later.
1 week later developed strange scent in nose, smells like stale cigarette smoke. Have had this for a couple weeks now.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2, solution for injection), administered in arm left, administration date 17Nov2021 16:30 (Batch/Lot number: unknown) at the age of 50 years as dose 1, single for covid-19 immunisation; influenza vaccine (INFLUENZA), administered in arm, administration date 17Nov2021 (Batch/Lot number: unknown) as dose 1, single for immunisation; varicella zoster vaccine rge (cho) (SHINGRIX), administered in arm, administration date 17Nov2021 (Batch/Lot number: unknown) as dose 1, single for immunisation. The patient had no relevant medical history. Concomitant medication(s) included: METFORMIN; TERBINAFINE; PHENTERMINE; TRAZODONE. The following information was reported: PAROSMIA (non-serious) with onset 26Nov2021, outcome "not recovered", described as "1 week later developed strange scent in nose, smells like stale cigarette smoke. Have had this for a couple weeks now.". Therapeutic measures were not taken as a result of parosmia.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headaches15 days, dizziness 17 days( on going) "brain fog", 15 days, on going, just better, fatigue 10 days, getting better, poor focus and memory 17 days, better but on going, poor balance 18 days, on going and getting better
w/in 24 hrs post immun w/Tetramune & OPV pt exp apnea & was cyanotic; evaluated by ENT specialists; no findings; hospitalized on 10AUG93; p/ENT eval placed on apnea monitor for 24 hr observation in hosp;
Onset of fever approximately 6 hrs after vaccines and hives on face and neck first noted about 12-14 hrs after vaccine. Also with concurrent viral upper respiratory tract infection and iven one dose of pediatric Motrin for fever.
No Adverse Event; Caller reported expired dose of GARDASIL 9 was administered.   No other information provided.  No additional AEs or PQC reported.; This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 02-JUN-2023, the patient was vaccinated with expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # U007667, expiration date: 23-MAY-2023, 0.5 milliliter, intramuscular (anatomical location was not reported) for prophylaxis (expired product administered). No additional adverse event reported (no adverse event).
This spontaneous report as received from a healthcare worker refers to her mother: a 66 years old female patient with high blood pressure and allergies to penicillin and unspecified medications that contain sulfur. On 22-AUG-2015, the patient was vaccinated with ZOSTAVAX injection, 0.65 ml, subcutaneous (lot# and expiration date were not reported) for shingles prevention. Concomitant medication included unspecified high blood pressure medications. On an unspecified date in August 2015 (reported as "after receiving ZOSTAVAX"), the patient developed redness and itching at the injection site. The outcome of the adverse events was reported as not recovered. No lab diagnostics studies were performed, and no treatment was given for the adverse events. The patient did not seek medical attention. The causality between the adverse events and ZOSTAVAX was not provided. Additional information has been requested.
Information was received on 08-MAY-2017 from a licensed practical nurse regarding an 11 weeks old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 14-SEP-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. The licensed practical nurse did not know why the excursions occurred but there were no further temperature excursions. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012916: US-009507513-1705USA004967: US-009507513-1608USA012794: US-009507513-1705USA004973: US-009507513-1705USA004952: US-009507513-1705USA004965: US-009507513-1705USA004961: US-009507513-1705USA004962: US-009507513-1705USA004960.
On the end of the syringe opposite needle the lip of the syringe broke off and glass became imbedded in nurse's thumb. Did not affect patient. Nurse was seen by a provider.
Moderna covid-19 vaccine EUA.  Numbness mostly around injection site, tingling and heaviness of entire arm within 5-10 min of injection.  Benedryl was given and symptoms gradually improved within 20-30 minutes. Lightheaded and slight headache next day. Sore arm for 2 days.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 10-JAN-2017 at 16:42, the patient was vaccinated with an improperly stored VARIVAX (lot # M031969) for prophylaxis (expiration date, dose and route of administration were not reported). It was reported that the vaccine underwent previous temperature excursions, but the number of previous excursions, time frames and values of incorrect temperature were unknown. A digital data logger was used. No adverse effects were reported. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000414: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000454: US-009507513-1704USA000456: US-009507513-1704USA000457: US-009507513-1704USA000458.
12MAY95 mom reported welts/bumps that itch on neck & extremities; MD advised DPH & observe; 13MAY95 PC from mom pt w/red rash behind ears, under arms; no fever, no itching;
COLD; KNEE PAIN; NAUSEA; MILD FEVER; This spontaneous report received from a patient concerned a 29 year old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. 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 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On APR-2021, the subject experienced cold. On APR-2021, the subject experienced knee pain. On APR-2021, the subject experienced nausea. On APR-2021, the subject experienced mild fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, mild fever, cold and knee pain was not reported. This report was non-serious.
SEVERE MUSCLE SPASMS; SEVERE MUSCLE PAIN; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced severe muscle spasms, and severe muscle pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe muscle pain and severe muscle spasms was not reported. This report was non-serious.