chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient checked in to the observation room. A patient sitting adjacent reported he 'dropped his phone and was out' momentarily.  The patient did not fall and MD was alerted. Patient was red, flushed, clammy but alert. BP 73/42mmHg, HR 85, O2sat 97%, and RR 12. He was placed on a stretcher. He had no difficulty breathing or cutaneous symptoms. BP recovered to 120/75mmHg, HR 80, O2sat 96% and RR 12 within 15 minutes.  Pt felt well and was able to be discharged home.
This spontaneous report as received via a company representative from a physician refers to a female patient of unknown age. The patient was vaccinated with standard dose of GARDASIL (lot number, expiry date, route and site not reported) within the last 30 days approximately in March 2013. The patient developed a transient acne problem about 2 weeks after receiving her first dose with GARDASIL, within the last 30 days. The patient had not sought medical attention. No treatment was given for the event. The outcome of transient acne problem was unknown. Additional information has been requested.
tested positive for covid; tested positive; This is a spontaneous report from a Pfizer-sponsored program, Covax US Support from a contactable consumer (patient's parent). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter's son got the first dose of the vaccine and tested positive for COVID and wanted contact number to reschedule her son for second dose of the vaccine. The outcome of the events was unknown.  Information about the lot/batch number has been requested.
About 10 days after dose 6, started having heart palpitations and higher blood pressure in the mornings.
3/2/21  @ 3:45 pm - covid moderna shot #2 received in right arm.  3/3/21 -  3/5/21  Severe side effects experienced --  could not go to work or do normal activities.  Tired, fever, chills, sweating, nausea, vomiting, diarrhea, sore arm/muscle pain, headache, "covid arm". "Covid Arm" after dose 1 on left arm and again after dose 2 on right arm.  Note:  I am still recovering but answered "yes" to item 20 below; not back to normal yet.
Arm soreness, low fever next two days.  Two weeks after, I kept getting body ached, muscle weakness, tiredness, shortness of breath, excessive sweating, hot flashes?Dizzy, nausea.
16FEB99 influenza a per throat cult;cough, nasal congestion, sore throat;APAP, sudafed, augmentin;flu dx;
little bit of headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (little bit of headache) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included Injury (due to which he ended up gaining weight). Concurrent medical conditions included Blood pressure high. Concomitant products included TAMSULOSIN and PRAVASTATIN for an unknown indication.    On 21-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Dec-2020, the patient experienced HEADACHE (little bit of headache). On 21-Dec-2020, HEADACHE (little bit of headache) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product includes Water pill and blood pressure medications.  Treatment information was not provided.  Patient had mild headache which got better by closing his eyes. When he was in his 50s he had some injuries due to which he ended up gaining weight and became 250 lbs. Patient took second dose on the right dominant arm on 21-JAN-2021.   This case was linked to MOD-2021-292993 (Patient Link).
3"x3" patch of skin below injection site red, rashy, itchy and a bit swollen.  Also, site of injection bruised.  No treatment.
I received the vaccine on 01/06/2021 and had some arm pain. On 01/07/2021,  I had flank pain, a  mild headache. Then on  Friday night I had chest pain right underneath the right breast that would at times radiate into the neck. My pain continued all day Saturday and into Sunday morning, I went saw a Pulmonogist. After testing,  it was determined it was not cardiac and that it was muscular.  On 01/11/2021, I saw my Chiropractor that  made an adjustment in my back.  I also was a massage therapist. After seeing both, the symptoms eventually subsided.
Patient experianced Swollen arm with Red rash around injection site. She said her arm was sore and hurt when raising it. This occured day after injection. She reported tingling in arm also.  Able to raise arm now but site hurts still and lympe nodes still swollen.
This is a spontaneous report from a contactable physician via a Pfizer Sales Representative. A 98 years old female patient of unspecified ethnicity received PREVNAR 13 on unknown date at single dose. It was reported that on unknown date the patient experienced bronchospasm for which she got hospitalized. The physician thought that the PREVNAR 13 was not responsible for the bronchospasm and hospitalization. Follow-up (09Mar2015): Follow-up attempts completed. No further information expected.
4/9/22 PMH of depression, and anxiety present to the ED with c/o left sided chest tightness/cough worsening over the past week.
pt recvd vax 7JUL95 & post vax same day exp dizziness & fatigue;seen in ER on 17JUL95 & was found to have labyrinthitis;antivert was prescribed for the vax & pt began taking it on 19JUL95;
Administration error - gave second dose of Pfizer and not Moderna; patient is fine; no adverse issues at time of vax or after vax
Literally got measles--full body extreme rash Behavior change.  Became violent and irritable.
bleeding from the vaccine site; pain in arm; slight fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (bleeding from the vaccine site), VACCINATION SITE PAIN (pain in arm) and PYREXIA (slight fever) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COPD.    On 10-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE HAEMORRHAGE (bleeding from the vaccine site), VACCINATION SITE PAIN (pain in arm) and PYREXIA (slight fever). At the time of the report, VACCINATION SITE HAEMORRHAGE (bleeding from the vaccine site), VACCINATION SITE PAIN (pain in arm) and PYREXIA (slight fever) outcome was unknown. Not Provided          The patient is on inhaler for COPD. Action taken with mRNA-1273 in response to the event was not applicable. No treatment reported.   This case was linked to MOD-2021-083128 (E2B Linked Report).; Sender's Comments:  MOD-2021-083128:First Dose Case
Change in behavior, cold/ flu like symptoms, no sleep, decrease in appetite, lots of crying.
Pt received vaccines for planned trip. After unknown time interval, was fatigued and tired. Progressed to left sided weakness and numbness. Seen in ER and found to have brain tumor via brain MRI. Serum will be sent to CDC for yellow fever testing.  11/2/07 Received vax records.  Yellow fever UE818AA; Hep A/B AHAVB195AB; Typhoid A0394; Polio A0170; Flu 79719.  VAERS database will be updated w/same. Record faxed to CDC.  11/6/07 Reviewed pcp medical records which reveal patient experienced HA x a few days starting w/bright light in left eye & HTN.  at office visit of 10/15/07, no evidence HTN & exam WNL.  10/16 t/c to office after speaking w/travel clinic stated she was not supposed to get YF or polio vaccine due to hx of Sjogren syndrome.  Labs done on 10/16 WNL.  Seen in office 10/22 due to persistent HA.  Returned to travel clinic & referred for MRI of brain which revealed glioma of basal ganglion.  Referred to neurosurgeon. 11/13/07 Reviewed hospital ER medical records which reveal paient seen 10/24/2007 after being sent by travelers clinic for 13 days of vague neuro symptoms including left sided HA, feeling confusion & dopey, inability to perform normal activities, left side paresthesias, blurred vision, anorexia, N/V intermittently & fatigue.  Neuro consult obtained in ER. FINAL DX: Primary brain glioma.
Patient reported two weeks of pain and limited range of motion in arm and shoulder. Was seen by her PCP and treated with 6 days of prednisone - she reports improvement after first dose.
left Arm pain injection site heat/hot to the touch loss of range of motion in neck numbness in his left arm fingers
This spontaneous report was received from a pharmacist concerning 5 patients of unknown age and gender. Relevant medical history was not reported for any of the patients. The pharmacist stated the 5 patients had expired product administered, as they were inadvertently administered ZOSTAVAX, lot number J012660, with expiry date of 10-JAN-2015 (dose and route were not provided), between the dates of 11-JAN-2015 through 28-JAN-2015. Concomitant medications were not reported. No adverse effects were reported and there was no product quality complaint involved. Additional information has been requested.
As soon as I received the shot it hurt inside my arm. It has become progressively worse and really hurts to raise my arms over my head. I am constantly in pain.
15yr old female was administer Moderna vaccine .5mL instead of Pfizer vaccine. Vaccine Coordinator, Medical Provider, and LVN on site notified. Medical Provider contacted patient's mother the following day to inform her of  wrong vaccine administration. Per patient's mother stated she has side effects from vaccination of fever. No fatigue, headache, chills, body and joint aches. Has some pain in arm where she received the vaccine. No lethargy, eating and drinking okay
Day 1 and 2, extreme fatigue,  pain and aches in my hips and buttocks which subsided each day but lasted 4 days until Sunday 4/11/21.  Monday at 1 am I was woken up from a deep sleep by a severe twitching on the right side of my face, below my cheek bone pulling the corner of my mouth up. This lasted about 1 minute. Monday I felt a little numb in the area. By Tuesday, the 12th, I felt 90% back to normal regarding each of these side effects.
Erythematous maculopapular rash from scalp to toes, developing from ~2 days after immunizations.  Resolved with OTC BENADRYL 12.5mg Q 6 hours.  T. 99.2 P. 128 R. crying.
expired dose of VAQTA was administered to a patient; This spontaneous report was received from a licensed practical nurse and refers to a 15-year-old male patient. His concurrent conditions included migraine without aura and myopia of both eyes. The patient's concomitant therapies included propranolol and sumatriptan succinate. There was no information about the patient's pertinent medical history or drug reactions and allergies provided. The case concerns 1 patient and 1 combination product.  On 13-JUL-2015, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) (exact dose, injection site, route of administration, lot # and expiration date were not reported) for prophylaxis. On 14-JAN-2021, the patient was vaccinated with the second dose of hepatitis a vaccine, inactivated (VAQTA) prefilled syringe injection, 0.5 milliliter, via intramuscular route in the left deltoid, lot # S032359, expiration date 11-JAN-2021 for prophylaxis. The vaccine was purchased with private funds at private doctor's office/ hospital.  On 14-JAN-2021, the patient was in the physician's office for his annual physical, which required second hepatitis a vaccine, inactivated (VAQTA) vaccination. The vaccine was pulled from storage location and given to a physician (M.D.) to verify that correct vaccine was retrieved to administer, expiration date was not checked. Expired vaccine was sent back to distributor (McKesson). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S032359; expirationdate: 11-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: No; reasonfornoneval: 02 Device evaluation anticipated, but not yet begun; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Fever101 Deep body aches Chills Headache Slight Nausea Lasted approximately  30 hours.  When symptoms finished, was completely back to normal the next day.
Patient c/o swelling, pain, itching and tenderness to upper extremity. Other physician office Dx with cellulitis.
Extremely sore and swollen arm, extreme fatigue, chills, body aches, headache, nausea.  Treated with Tylenol extra  Symptoms most severe on day one after vaccination, continued on day two, now day three arm is still swollen and sore headache and stuffy nose. But much better than I have been the two previous days
Very badly aching, arm extremely sore (can barely move it), fever of 100, frequent bouts of sneezing.  Primarily bad muscle aches
tightness to touch, left arm pain. Evaluated by EMS-Refusal to transport.
This spontaneous report as received from a Registered Nurse refers to an unspecified number of patients. The nurse reported that an unspecified number of patients of an unspecified date received improperly stored ROTATEQ (lot No, dose and route of administration not provided). No adverse effects reported. Additional information has been requested.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's past medical history included cigarettes smoker, and concurrent conditions included birdshot uveitis, alcohol user, and seasonal allergy, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. the patient was not pregnant at the time of reporting . The patient experienced drug allergy when treated with ketamine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 on left deltoid for prophylactic vaccination. Concomitant medications included Cellcept (mycophenolate mofetil) for birdshot uveitis. On 2021, the subject experienced confirmed immunological vaccine failure. On 08-APR-2021, 4 weeks and 1 day later after getting the Janssen Covid-19 vaccine, she got tested (semi-quantitative antibody test); as per health care professional, the result stated she did not develop antibodies/immunity. HCP stated she never was diagnosed with Covid-19. HCP stated she reported/consulted the result of her laboratory exam to CDC. 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).; Sender's Comments: 20210443252-covid-19 vaccine ad26.cov2.s-confirmed immunological vaccination failure, Drug hypersensitivity. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabelled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: CONMEDS-OTHER SUSPECT DRUGS, SPECIAL SITUATIONS
Feeling horrible after 2nd shot; Fever 101F after 2nd shot; This spontaneous case was reported by a nurse and describes the occurrence of FEELING ABNORMAL (Feeling horrible after 2nd shot) and PYREXIA (Fever 101F after 2nd shot) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Type I diabetes mellitus. Concomitant products included INSULIN LISPRO PROTAMINE SUSPENSION (HUMALOG N) for Type I diabetes mellitus.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced FEELING ABNORMAL (Feeling horrible after 2nd shot) and PYREXIA (Fever 101F after 2nd shot). At the time of the report, FEELING ABNORMAL (Feeling horrible after 2nd shot) and PYREXIA (Fever 101F after 2nd shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Blood glucose: 400 mg/dl (High) could not get the BG to go under 400 mg/dL for 18 hours. On 09-Apr-2021, Body temperature: 101 (High) had a Fever 101F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment medications were reported.
pt recvd vax;fever 105;neck/back aches;excessive crying;acted delerious,desoriented,vax site sore;behaviour worse;devel sensory problems,eyes sight got bad;dx w/ ADD & brain damage;apap a/vax to prevent fever;devel fever w/in 1 hr;has CAPD;
VACCINE ADMINISTERED AFTER  TRANSPORTATION OF THE  PREFILLED SYRINGE OUTSIDE OF  THE ACCEPTABLE LIMIT; This spontaneous report received from a health care professional concerned multiple patients. 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced vaccine administered after transportation of the prefilled syringe outside of the acceptable limit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine administered after transportation of the prefilled syringe outside of the acceptable limit was not reported. This report was non-serious.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 84-year-old female patient who received SHINGRIX for prophylaxis. On 12th July 2018, the patient received the 1st dose of SHINGRIX. On 12th July 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm. In July 2018, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain and pain in arm were not recovered/not resolved. The reporter considered the injection site pain and pain in arm to be probably related to SHINGRIX. Additional information was reported as follows: The patient was the reporter's mother. The patient received her first SHINGRIX vaccination last night, to the date of reporting, in her left arm. The patient complained of pain in her right arm after the vaccination and complained of pain at the injection site in the morning of reporting day.
patient noted myalgias and fever later in the day, then headache and vertigo started the next day. Initial symptoms resolved in 3 days but vertigo ,rocking sensation remains. ENT consult has started prednisone therapy and ordered physical therapy. Audiogram is normal and VNG is pending
12 hrs p/vax pt fussy, temp to 107; seen @ hosp -workup including CBC, u/a, blood cultures all nl;
Information has been received from a physician concerning a 21 year old white female, with type 1 diabetes and depression, who was vaccinated with a first and second dose of RECOMBIVAX HB. On 25-JUL-2006 the patient was vaccinated with a pediatric dose of RECOMBIVAX HB. Concomitant  vaccine administered on 25-JUL-2006 included a pediatric dose of VAQTA. There was no illness at the time of vaccination. No product quality complaint was involved. No other information was provided. Follow-up information from the medical assistant indicated that in December 2006, at 4:00 p.m. the she was vaccinated with a dose in the thigh of RECOMBIVAX HB. It was reported that the she experienced burning for a moment or two, which then went away. It was noted that the she was fine after she washed it with water. Additional information has been requested.
Swollen/Sore lymph node in right armpit (same arm as injection was administered) occurred about 19 hours after injection and lasted until about 36 hours after injection.  Physician was NOT contacted.  Ibuprofen taken for pain.  Condition was resolved with no medical intervention.
Fever (38.4C), Chills, Fatigue, Myalgia, Headache
pt recv vax&day p/t106;pt put down to sleep-mom heard sound (wild) unbelievable sound&rise 6" off crib;foaming @ mouth,eyes rolling,personality changed,can't sit up,listlessness,regression,dx w/ADD;lost consciousness;hair fell out
This spontaneous report was received from a 45 years old pharmacist who was also a patient and refers to himself. No medical history and concurrent conditions of the patient were reported. On 10-NOV-2015 (reported as Tuesday), the pharmacist was reconstituted a dose of ZOSTAVAX vial of strength 19400 PFU (lot number: L024997 and expiry date: October 2016) for an unspecified patient without wearing gloves. No concomitant medications were reported. The patient began to experience itching on the chest later in the afternoon of the same day. The patient does not know if any droplets of the ZOSTAVAX solution splashed on him on 10-NOV-2015. The patient also reported that on the next day (on 11-NOV-2015) he developed "purple papules" on his chest. The patient did not sought for the medical attention and did not consulted the healthcare provider and the patient was not recovered from itching and purple papules. The outcome of accidental exposure to product was not reported. No product quality complaint (PQC) was filed. No additional information was provided. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 08-NOV-2012 10:46, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
fever; Chills; body aches; diarrhoea; Abdominal pain; This is a spontaneous report from a contactable nurse (Patient). A 30-years-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 08Jan2021 (Batch/Lot Number: EJ1685) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fever, chills, body aches, diarrhoea, abdominal pain on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test which was positive on 26Dec2020. The outcome of event was unknown.  Follow-up attempts completed. No further information expected.
Diag. Guillain Barre Syndrome. Remains in hospital since April 13, 2012.