chrisvoncsefalvay/vaers-outcomes huggingface dataset:
an expired Sanofi yellow fever vaccine was administered with no reported adverse event; Initial information received on 22-Jan-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a male patient who received an expired sanofi yellow fever vaccine was administered with no reported adverse event while receiving vaccine YELLOW FEVER VACCINE [YF-VAX].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 21-Jan-2022, the patient received a dose of suspect YELLOW FEVER VACCINE (formulation, strength: unknown) (lot number: not reported, expiry date: Sep 2020) (expired product administered) via an unknown route in unknown administration site for prophylactic vaccination.  It was reported that "After hours call received at 8:01pm on 21jan2022. Caller states that a patient received and expired dose of the yellow fever vaccine at a travel clinic today. "What do we do now? Do we need to take the patient to the ER(emergency room)?" After hours call returned at 8:21pm on 21jan2022. Caller states that he is the husband of the patient and he received an expired dose of the Yellow Fever vaccine. He was told that the protocol was for them to contact the manufacturer for guidance."  It was not reported if the patient received a corrective treatment for the event  At time of reporting, the outcome was Unknown for the event    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report as received from a register nurse refers to a 1 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 07-FEB-2014, the patient was vaccinated with first dose of ROTATEQ lot #J007283; expiration date: 27-SEP-2014 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F.  On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
Information has been received from a registered nurse referring to a patient of unknown age and gender. Patient's current conditions, medical history and concomitant medications was not provided. On 24-AUG-2016, dose and route were unknown) that was improperly stored. It was reported that the doses were administered following an excursion of 14F from 28-AUG-2015 to 17-NOV-2015. No adverse effects was reported. This is one of several reports received from the same source. Additional information has been requested.
Low grade fever developed at around 10:00PM April 22, 2021; the day of the injection. The fever went from under 100 degrees to 103 during the night and the dreams were bizarre. The 103 degree fever persisted until the afternoon of April 24, 2021. It was accompanied by a terrible headache that ended when the fever broke. There has been a lack of memory recall. I attributed this to the fever at first, but it is April 27th, 2021 and I am still having trouble with mental focus. It is not debilitating, but it is impairing  my ability to function normally.
2 days following vaccination patient experienced pain, numbness in right hand. persisted and pt went to see provider 12/16 at which time he received an rx to treat
This spontaneous report as received from a physician, via company representative, refers to a couple of patients of unknown age and gender (anonymous, exact number of patients unspecified). On unknown dates the patients were vaccinated with a dose of ZOSTAVAX (route, concentration, and lot number unknown) for shingles vaccination. On unknown dates the patient got shingles after receiving ZOSTAVAX. The patient's didn't seek for medical attention. The outcome of shingles after receiving ZOSTAVAX was unknown. Additional information has been requested.
Injection site heat and pain x 1-2 days, diarrhea on days 3 and 4 Narrative:
Allergic reaction; Something like a rash; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection; Batch/Lot Number, and Expiration Date not reported) via an unspecified route of administration on 04Mar2021, as dose 1, single for COVID-19 immunisation. Medical history included allergic a while ago to all food, especially salmon. The patient's concomitant medications were not reported. The patient experienced allergic reaction and something like a rash on an unspecified date in Mar2021. Patient stated she has an "allergic reaction", all over her body she has "something like a rash", it started a day and a half after the dose, on the chest and goes down to her thighs. She stated she was allergic a while ago to all food, especially salmon but she has not eaten it. She called her doctor who sent her some prescriptions to the pharmacy but she was asking is she would have a stronger reaction to the second dose as her second dose was scheduled for 01Apr2021. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt recvd 3 doses of Engerix-B on 23JAN91, 20FEB91 & 10JUL91; 31OCT91 post HBSAB was 6.6 which indicates low titer, immune status questionable;
Received vaccine at 13 15. At 1351 c/o mild chest pain. 1353 c/o throat fullness and anxiety; 1354 bp 148/81 HR 99 O2 sat 100% c/o difficulty swallowing, SOB and itching. Rapid response called.  Benadryl 50 mg IVP given at 1355. 1356 Solumedrol 125mg given IV; 1357 Epinephrine given; 1358 Pepcid 20 mg given. 1400 Normal saline 250 mg IV; 1415 transported by ambulance to local ER. In waiting area in local ER no attention. Came back to Hospital and admitted to observation
HEADACHE; ARM SORENESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN) .5 ml, administered on 06-MAR-2021 13:00 to Right Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced headache, and arm soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and arm soreness was not reported. This report was non-serious.
No additional AEs; less than the 6 month recommended minimum interval between doses; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. No concurrent condition, medical history, or concomitant therapy was reported.  On 21-FEB-2018, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) 0.5 mL (strength and route were unknown; lot # N012954 was not valid lot number, expiration date reported as 31-AUG-2018) for prophylaxis.  On 13-AUG-2018 , the patient was vaccinated with the second dose of hepatitis a vaccine, inactivated (VAQTA) 0.5 mL (strength and route were unknown; lot # R007388 has been verified to be a valid lot number, expiration date reported and confirm upon internal validation as 27-MAY-2019) for prophylaxis (it was less than the 6 month recommended minimum interval between doses; inappropriate schedule of product administration). No additional adverse event was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: devicelotnumber: R007388; expirationdate: 27-MAY-2019; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
I became achy and feverish flu like sysmptoms. Apporx 9:30pm at my residents Ibegan to experince chills, Fever, soreness and dizziness. Approx. 11:30pm I was experincing an extremely high temp. (106*)severe chills, dizziness, disorientation, rapid heart beat and vomiting. Throughout time line I was drinking water and taking 800ml of Ibuprofen. Approx 1:30am on 10/18/11 my Fever and symptoms started to reside. Temp dropped (104*) chills started to subside and Vomiting stopped. Approx 3:00am body temp was down (101*) chills almost gone and hot burning sensation disappeared too. Approx. 5:45am awoke after a couple of hours of sound sleep. Except for light headedness and feeling of being tired all sysmptoms had gone. Approx 7:00am on 10/18/11 I had only a bad headache and nasal stuffiness type feeling left. Approx 9:00am I called my Doctor reported reaction event and was advised to continue Tylenol or Ibuprofen. Approx 5:30pm on 10/18/11 all symptoms gone. Felt fine.
This spontaneous report as received from a physician refers to a patient of unknown age. On unknown dates the patient was vaccinated with three doses of GARDASIL (strength, dose, frequency and route unspecified). The result of a Papanicolaou smear (PAP smear) on an unspecified date was a negative PAP smear and Human papillomavirus (HPV) positive. The outcome of the event was unknown. Additional information has been requested.
vomiting starting 45 minutes after and for 3 days. Continual vertigo and balance problems since. never before significant before and increase fatique
Patient reported feeling dizzy immediately after receiving vaccine. Patient reported dizziness resolved within 15 minute in observation area. Patient went back to work area, and felt "very faint", tachycardia, dizzy and diaphoretic after 30 minutes. Patient placed a cool rag on face and symptoms resolved shortly after.
no other Advers ee event; 20 year old patient who received their first dose of GARDASIL 9/The customer said they administered the second dose of GARDASIL 9 a couple of days ago; This spontaneous report as received from a pharmacist refers to an adult  patient of unknown age and gender. There was no information about the patient's medical history, concurrent conditions or concomitant medication.  It was reported that the patient had 20 year patient  when received their first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) "a year ago or longer" , date unspecified for prophylaxis (dose, route of administration, lot number and expiration date were not reported).   The reporter said they administered the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) a couple of days ago, approximately in June 2021 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). No further information was provided by the customer.
Per patient via phone call: Soreness at the injection site, redness, warm to touch, redness 2 inch diameter.  Told patient to contact MD about localized reaction, usually MD after visit/consultation will prescribe a course of antibiotics. Patient can also use a compress for the area.
Left anterior thigh at upper proximal thigh 4cmX7cm area of erythema and warmth with swelling/firm and inflamed; non-tender. Immunization given 9/23/02 AM developed reaction 9/24/02.
p/vax pt reported pain @ inj site;pt was instructed to apply heat or ice to affected area & take APAP;pt recovered;
I have a red rash on my face, neck, and big welts on right cheek and under eyes, and on eyelids.  My eyelids and under my eyes are very dry.
Information has been received from a physician concerning a female (age unknown), who, on an unspecified date, was vaccinated with a first dose of Gardasil. Subsequently, the patient fainted. The patient sought unspecified medical attention. The patient recovered on an unspecified date. No product quality complaint was involved. Additional information has been requested.
My son was in the best health of his 16 year life.  No flare-ups in the last year.  One month prior to vaccine had colonoscopy and results were the best they'd ever been.  Zero indicators of inflammation from visual inspection and blood labs.  He was eating all the things he couldn't in years past and was fine. Two weeks after vaccine diarrhea began, but he didn't tell us. Three weeks after vaccine diarrhea had a lot of blood. Four weeks after vaccine he was curled up in the fetal position, sweating, shaking in abdominal pain.  Fever around 103 F.  He had *never* had any flare-up anywhere close to this.  This was, by far, the worst.  He went from 140 lbs to 115 lbs. He as admitted to the hospital 19 Nov (Friday) and discharged 21 Nov (Sunday).  He developed another condition--a large abscess near his anus.  It was incredibly painful and the pain radiated through his whole pelvic area, making it hard to even walk.  The day he entered the hospital it popped on its own and pain was immediately relieved.  Doctors confirmed it was not serious and simply needed to heal on its own.
Information has been received from a physician concerning a patient with a history of known exposure to "wildtype varicella" who was vaccinated subcutaneously with a 0.5ml dose of varicella virus vaccine live. Subsequently, the patient developed varicella, and was "briefly hospitalized". It was noted that the "doctors were certain that wildtype varicella was the infectious agent based on clinical studies." Unspecified medical attention was sought. Subsequently, the patient recovered. There was no product quality complaint involved. On 16JAN2004 it was reported by the nurse manager that she could not recall who the patient was and without a name or a date of birth it would be impossible to determine who the patient was in this report. No further information is expected.
Received hepatitis A vaccine and ACTHIB in bilat thigh. 12 hrs later called to report rash on bilat thighs - fine red rash - gone over night. Parent reported today to MD.
slight dizziness, hot, turned clammy, no rash, no SOB, tremor in one hand started on transport to ED. Became increase in dizziness, shaking all over, put on ED stretcher, rash on chest, very dizzy
1 hr p/vax pt devel an inject site react, 7" x 4" pnu-immune site); site was indurated, red, painful; pt was started on DPH, ice packs & steroid ointments; p/24 hrs the inject site was still indurated;
pt recv vax 22SEP97 approx 30-60min p/that time;pt started screaming p/nap;felt hot;10 second episode of tongue thrusting w/body tensing x8;mouth dragged open;eyes glassy;pt slept in car during transit;dx sz;
After receiving the injection at the county fairgrounds at 2:16 I was moving my arm to try and prevent future arm pain. About 14 minutes later my heart was racing with palpitations.   My skin felt like it was sunburned, but I was not flushed.  It was not itching.  I debated honking my horn to notify the volunteers but my breathing was still ok.   Heart slowed down after a few minutes. Skin continued to feel prickly. Decided to stay for 45 minutes to make sure I was ok to drive home.   It was not an anaphylactic reaction, but there was definitely a reaction.
Swelling, pain, redness at right upper arm for 2 days since given DTAP, MMR.  Getting worse, no anaphylaxis.
Information has been received from a pharmacist referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On 12-NOV-2015 the patient was vaccinated with an expired dose of PNEUMOVAX23 (lot # K005402, expiration date 07-NOV-2015; dose and route not reported). No adverse effects were reported. Additional information has been requested.
Early afternoon of date of administration complained of tiredness and went to bed.  The next day at about 6PM I received a call that he was confused and non responsive in bed, EMS called and he was transported to ER. Admitting diagnosis at admit was Delirium.  He remained inpatient at Hospital from 2/24/2021 and transferred to Hospice on 3/6/2021. His condition deteriorated while hospitalized. Transfer diagnosis was Dementia, A-Fib and Diabetes.
I was given the vaccine & within 30min.I began having trouble breathing.I used my Xopenex inhaler & took 25mg Benadryl PO.I was also given Epi 0.3mg SQ via Epi-Pen.The reaction continued to progress & I was taken to the ED.There I was given another dose of Epi,2 more Xopenex resp.treatments,120 mg Sol-U-Medrol IV & placed on Bi-Papp.I was also give 60mg of Prednisone PO & another 60mg PO to be taken today.I was released from the Ed 5.5hr.later.Today I remain unable to speak above a whisper.ED doctor notifed my primary MD & I notifed my Pulmonary MD today.
01/25/08 11:00 PM Couldn't breathe or talk at fist. Then c/o pain in chest - then all over. 11:06 Ambulance called. 11:35 Ambulance arrived. Transported to hospital. 09/08 Had problems with SOB to ER - "Test did not show anything" (info given by daughter). 2/12 /08-myocardial infarction per coroner's office.  no autopsy performed.   4/7/08-ER records received for DOS 1/26/08-cardiac arrest. Prounced 0054.
slight fever; joint pain all over; severe neck pain; armpit pain; teeth pain; hands got warm sensation; sweating with no fever; slept hard for 15 hours; severe chills; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0158) via an unspecified route of administration in the right arm on 08Apr2021 at 10:45 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism, asthma, blood pressure high and the patient was allergic to penicillin. Concomitant medications included metoprolol succinate (MANUFACTURER UNKNOWN) 25 mg and losartan (MANUFACTURER UNKNOWN) and potassium (MANUFACTURER UNKNOWN) all from an unknown date for an unknown indication. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep7534) via an unspecified route of administration in the right arm on 18Mar2021 at 11:00 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 02:30, the patient experienced severe chills. On the same day, two hours later at 04:30, the patient experienced slight fever, joint pain all over, severe neck pain, arm pit pain, teeth pain, hands got warm sensation, sweating with no fever and slept hard for 15 hours. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events severe chills, slight fever, joint pain all over, severe neck pain, arm pit pain, teeth pain, hands got warm sensation, sweating with no fever and slept hard for 15 hours was recovered on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
muscle aches and discomfort; muscle aches and discomfort; pain was at the injection site; This is a spontaneous report via a Pfizer-sponsored program from a contactable nurse (reporting for herself). A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0142, expiration date: 31Mar2021), intramuscular in the left arm  on 02Jan2021 at a single dose for COVID-19 immunization.  Medical history was reported none.  The patient's concomitant medications were not reported. The patient previously received the flu vaccine on unspecified date and experienced discomfort. On 02Jan2021, the patient experienced pain at injection site. On 03Jan2021, the patient experienced muscle aches and discomfort. The patient was scheduled for the second dose of the COVID-19 vaccine and reported that she took Aleve after she got the first vaccine and was wondering if she can take Aleve after the second one. She stated that it helped with the pain. She said that she was getting conflicting information and stated that she heard that there have been more symptoms associated with the second vaccine. She wanted to know if it was contraindicated for her to take the Aleve after getting the second dose. The patient described it as discomfort and stated that she gets it with the flu vaccine too. Aleve helped with the discomfort and the ache. She did not pre-medicate. She took it afterward. She stated that she took maybe 1-2 doses of the Aleve the next day and stated that by the end of the next day her pain was fine. The patient clarified pain was at the injection site and was achy. She said that she received the first vaccine on 02Jan2021 in the morning. She noticed the pain later in the day around midafternoon and said that it was gone by the next day. The outcome of the event pain at injection site was recovered on 03Jan2021 while outcome of muscle aches and discomfort was recovered on unspecified date in Jan2021.