chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a Nurse Practitioner concerning a 17 year old female who on an unknown date was vaccinated with a 0.5 ml dose of GARDASIL.  No lot number was provided.  Concomitant therapy included a dose of MENACTRA on the same day.  About 2 weeks after vaccination with GARDASIL the patient was hospitalized in the pediatric intensive care unit and was diagnosed with guillain-Barre syndrome.  At the time of report the patient was recovering.  Follow up information was received from a Medical Assistant on 01-SEP-2009 via telephone reported that a patient's mother had reported that she heard that a patient developed Guillain-Barre Syndrome 2 weeks after the patient received GARDASIL.  The Medical Assistant stated that the patient was treated at another hospital.  The patient was not a patient in Nurse Practitioner's office.  The health care professional contacted during telephone follow-up could not supply the following information:  patient name, date of birth, dates of vaccination/therapy, dose number (if applicable), lot number (if applicable), date of event, recovery status, healthcare provider name and contact information.  Attempts to verify the existence of identifiable patients have been unsuccessful.  The reporter considered guillain-barre syndrome to be immediately life-threatening.  Additional information has been requested.
Rash and itching developed on Rt upper arm where KINRIX and FLUZONE given.
Patient was sick in bed June 19 and 20th.  On June 24 he woke up with some pain and irritation over his right jaw and noted the right parotid gland be swollen.  He complains of fatigue joint aches right sided earache stiff neck.  Gland has continued to enlarge.
Initial report received from a healthcare professional on 22 OCTOBER 2014. A 74-year-old female patient, whose concomitant medication were not reported, had received intramuscularly a dose of FLUZONE HD, (batch number and cycle in series not reported) in left deltoid on 18-OCT-2014. On 19-OCT-2014, patient experienced red itchy eyes, tickle in throat, shortness of breath and headache. Patient denied illness at the time of vaccination and medical history. Corrective treatment was reported as BENADRYL (50 mg) and TYLENOL. Laboratory investigations were  not reported.  At the time of t his report, the outcome of the event was reported as recovered. Documents held by sender: none
Arthralgia, NauseaVomiting, Chills, Fatigue, Injection site pain/swelling Narrative:
Ocular Issue--had vision change at 9:30am on 2 /10/21, could not focus on his computer screne, esp right eye, central focus and had a right eye stabbing pain, patient has had 3 day migraines years ago with vomiting etc. On the day of hospital admission, 2-11-21 after a walk in the bright snow, then sex and a nap, patient was disoriented for 15 minutes, then it mostly resolved. But his memory was a bit off for the next 6 hours. It took him 3 tries to get his wife's name correct. Briefly he didn't know where he was and did not recognize his cat. So he went to the ER.
Pt went to stand and fainted hitting the floor face down.  @ 2:30PM pt was picked up by friend from the vaccination center.
(L) lateral upper thigh 13x13 cm, light eryth/purple circle rash with central sl darker purple area with pinpoint noted centrally. Mild warmth to touch. (-) hot (-) swelling.
Patient noted the day following vaccines to be stumbling and not acting right. Seen at urgent care on 6-17-17, returned to ER and had head CT on 6-18-17 and admitted to hospital 6-19-17 with abnormal head MRI with evidence of encephalitis, underwent lumbar puncture and then in ICU for 10 days. Dx of post-infectious ADEM [G04.01] as well as Go4.90 and R26.81. Underwent plasmapheresis while admitted
Patient was 17 years old at the time she received the Moderna COVID-19 vaccine and did not meet eligibility criteria. She reported no adverse reactions.
Fever started 11/12/2001 evening. On 11/14/2001 cried throughout nite/sleepless nite. Thigh swelling, redness left. loss of appetite 11/12/2001 through 11/14/2001.
Rash.  On body.    Cleavage      Spike in blood sugar.  248
Patient developed headache, fever, erythema and mild swelling @ injection site and chills with malaise by the evening of 4/9/18. Was seen in office on 4/10/18 for evaluation. Rest and fluids recommended. Toradol 60 mg IM given in office.
Pt did not develop "protective titers" p/3 inject of Engerix-B; "plan to revax pt; Reporter states the non-protective titers can be possibly disabling and/or life threatening "if the person contracts Hepatitis";
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 66-year-old male patient 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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  It was reported that there have been no power outages that would have impacted the Moderna vaccine. However, reporter reiterated that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger that caller was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. Reporter said that they were filling out a temperature excursion assessment with the State at this time and she was calling in to report the same to Moderna. Reporter confirmed that patients have been administered doses while the temperature excursion assessment has been ongoing.  It was reported that no adverse reactions were reported by any patients.  No treatment information was provided.
A few days after receiving the COVID-19 vaccine, my entire body began itching.  This continued for several days until my Pharmacist wife suggested I stop using the fragranced body wash I was using.  I began using non-fragranced soap and the itching stopped.  I then began using a different brand of fragranced body wash an my entire body has begun itching again.  I am now returning back to non-fragranced soap.  I anticipate that my itching will again cease in a few days.
Very weak; Scar tissue on right arm from shoulder operation that is now bothering them, is achy; All the general side effects except for the fever and the vomiting; weird taste on tongue; Rough patch on tongue; Very tired/tiredness; Queasy stomach; slight chills; Felt like a wave of flue symptoms going up and down their body/flu like symptoms; Could not sleep that night; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt like a wave of flue symptoms going up and down their body/flu like symptoms), INSOMNIA (Could not sleep that night), ASTHENIA (Very weak), VACCINATION SITE PAIN (Scar tissue on right arm from shoulder operation that is now bothering them, is achy) and VACCINATION COMPLICATION (All the general side effects except for the fever and the vomiting) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Shoulder operation. Concurrent medical conditions included Cancer.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt like a wave of flue symptoms going up and down their body/flu like symptoms) and INSOMNIA (Could not sleep that night). On an unknown date, the patient experienced ASTHENIA (Very weak), VACCINATION SITE PAIN (Scar tissue on right arm from shoulder operation that is now bothering them, is achy), VACCINATION COMPLICATION (All the general side effects except for the fever and the vomiting), TASTE DISORDER (weird taste on tongue), TONGUE ROUGH (Rough patch on tongue), FATIGUE (Very tired/tiredness), NAUSEA (Queasy stomach) and CHILLS (slight chills). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, INFLUENZA LIKE ILLNESS (Felt like a wave of flue symptoms going up and down their body/flu like symptoms), INSOMNIA (Could not sleep that night), ASTHENIA (Very weak), VACCINATION SITE PAIN (Scar tissue on right arm from shoulder operation that is now bothering them, is achy), VACCINATION COMPLICATION (All the general side effects except for the fever and the vomiting), TASTE DISORDER (weird taste on tongue), TONGUE ROUGH (Rough patch on tongue), FATIGUE (Very tired/tiredness), NAUSEA (Queasy stomach) and CHILLS (slight chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 97-98 (normal) 97-98°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided   Most recent FOLLOW-UP information incorporated above includes: On 05-Feb-2021: Follow-up information received on 05-Feb-2021 included new events and treatment medication On 02-Mar-2021: Follow-up information received on 02-Mar-2021 included new events and medical history.
I had a mild headache; it comes and goes; This is a spontaneous report from a contactable consumer(patient). A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3249) via an unspecified route of administration on 05Feb2021 (at the age of 65-years old) as DOSE 1, SINGLE for covid-19 immunisation. Patient Medical history included thyroid, Acid reflux. Concomitant medication included pantoprazole (PANTOPRAZOLE) taken for gastrooesophageal reflux disease, pravastatin (PRAVASTATIN), levothyroxine (LEVOTHYROXINE) taken for thyroid disorder. Patient had a mild headache for like 2 and half weeks and supposed to get another vaccine this Friday. Patient would like to postpone it because of the headache but can't get a hold of them and was wondering. Patient still experiencing the event it comes and goes and it is mild, patient have not taken Aspirin every day, it's just there. Patient have taken Tylenol couple of time but don't want to take that every day. The outcome of the event was not recovered.  Follow-up attempts completed. No further information expected.
OUTER ARM RED, SWOLLEN, HOT, ITCHY, AND VERY TENDER. AREA ENLARGED OVER 12/05 AND BEGAN TO IMPROVE IN AFTERNOON OF 12/06.
Patient is 32 y/o who received FLUMIST on Jan 18 and AVA#1, HepB, and Typhoid vaccinations on Jan 25th. Patient presented to ER with substernal chest pain/pressure radiating to left arm on 11 Feb. Pain lasted 45-60 minutes only. Pos fam hx for MI - GF had MI at age 30.
This spontaneous report as received from an other refers to a patient of unknown age. On an unknown date the patient was vaccinated with an improperly stored dose of ROTATEQ, oral for prophylaxis.  Concomitant therapies included sterile diluent(STERILE DILUENT). On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event was unknown. The reporter considered incorrect product storage and no adverse event to be not related to ROTATEQ.; Sender's Comments: US-009507513-1707USA010527: US-009507513-1707USA010532: US-009507513-1707USA010529: US-009507513-1707USA010530: US-009507513-1707USA010531: US-009507513-1707USA010451: US-009507513-1707USA010528:
Sore, itchy, sensation of enlarged 1/2 tennis ball like lump at injection site. Warm to the touch. As the reaction was resolving it traveled down arm to right above the elbow on left arm.
This is not a serious spontaneous case from a consumer in the USA involving right ear neurosensory drop. The reporter causality is not provided to FluMist. A consumer reported that an adult female patient received FluMist on 1/7/05, and immediately after experienced stuffiness, congestion, and headache. This progressed to right ear fullness which never went away. Progressively, her hearing worsened and stated that she hears sounds in her right ear like water dripping. She was treated with a few courses of antibiotics and steroids. She was evaluated by two different ENT specialists and an audiologist. On 3/23/05, sinoscopy showed some inflammation within the sinus itself. Tympanogram showed normal pressure on both ears. Audiogram showed neurosensory drop on the right side. An MRI performed on 3/29/05 showed no acute intracranial abnormality nor any evidence of mass effect or enhancing lesions in the gray or white matter. The patient has not yet recovered. The reporter causality is not provided. (OMIC).  A follow up report will be submitted in accordance w/ 21CFR600.80. 4/12/2007.
Intermittent dizziness/lightheadedness that didn't affect balance, pain at injection site and base of neck, fatigue and sleepiness, and diarrhea hourly for 7hrs after shot with urgency and sudden onset.
82yr old male presented to ED via ambulance.  Patient states that he has chest pain rating at a 10 on scale of 0-10.  Patient states that he was at the clinic yesterday and got the Covid booster shot and the pain started not too longer after that.  His pain resolved later yesterday and he began to have it again today roughly 30-45 minutes prior to calling the ambulance.  Patient is unable to describe pain, states that just right in the middle.  324mg of aspirin given enroute by ambulance along with 1 dose of nitro; no relief noted from patient.  Findings:   Mild in stent stenosis of LAD Moderate disease however no acute lesion identified    Plan -trend trop, medical therapy  -if high trend may consider r/p LHC   . ST elevation myocardial infarction (STEMI), unspecified artery (HCC)        ASSESSMENT/PLAN/DECISION MAKING: 1. ST elevation myocardial infarction (STEMI), unspecified artery (HCC)    - Administered TNK, pain control, drew labs - sent patient by air to another facility or cardiac cath
Nausea, chills, low fever 99.5, extreme body pain, loss of bladder control, weakness. Lasted from 4:00 pm on Thursday Oct 14 until Saturday, October Oct 16.  Weakness and sweating continues as of Sat Oct 16. Temp is now normal.  Minor pain at injection site. Treated with Advil over-the-counter.
30 min to 1 ht after getting flu shot, pt reported be sweaty for 1-2 min, being lightheaded, and weak (had to sit down), went to bed. Arm extremely sore, but resolved per pt.
Injection Site turned red, burning and itching on day 7. The evening of day 7 I developed body ache and head ache. Day 8 I had reduced flu like symtoms. Days 9-10 I had cold symptoms  - runny nose scratchy throat. Redness at the injection site still pink, but no more itching and burning.
PT. Jerked back and fell on the back of her head and hit the floor.  She was pale, LOC for several seconds and regained and was Alert and Oriented x3.  Pt's BP was low, and concern for head injury, was sent to local hospital for further evaluation.
Patient has been in remission for 2 years.  He was working at a pharmacy/store and was mandated to get the pfizer vaccine on 12/20/21.  We agreed for him not to get it but he liked his job as a pharmacy tech and did what he thought was the right thing.  He received the 2nd dose on 1/23/22.  On 2/9/22 he was scheduled for his normal 2 month visit for blood work they noticed a drop in platelets.  Dr advised us to go back in a week.  We go back platelts dropped some more.  She said come back in another week now hos platlets dropped more and so did his wbc.  She said one more week so we did everything dripping but no sign if the cancer so she scheduled him to have a BMB.  The results was that the cancer was 8% percent in his marrow and being his history they considered it a relapse now he needs more chemo and a bone marrow tranplant. This vaccine effects the immune system the main problem with his disease.  His dr or his job should of never mandated this. Bc now he is sick again.
Child received DTAP in RA along with MMR & IPV in LA on 3/5/02. returned to clinic on 3-7-2 with mother complaining of Redness approximately 70 mm and firm area approximately 40 mm where DTaP was given. Warm to touch and slight tenderness noted. Afebrile, tylenol was given for discomfort and cool compresses Qid
Sedation lasting two weeks with chronic, mononucleosis-type fatigue to present day (8 weeks) with some gradual improvement.
The patient described that right after the vaccination she had black spots in front of her eyes, chest tightness, staggering to walk. She still had these symptoms while she was in the store and the following day. She plans to see her dr for her regular appointment on Thursday 3/25,but is going to discuss the adverse events with him. She reported to me on Saturday 3/20/21 that she was feeling better.
I got an assigned order from RN BSN, signed order for Dtap, I questioned her on whether or not it was the right one to give. She said that yes due to the Dtap and Tdap having the same stuff in it. I drew it up administered to the patient and then when going to enter it into the system I realized then that it was not the right one. I notified my clinical supervisor. My supervisor contacted the patient to notify her and then called the pharmacy to make sure no harm would be done to the patient. She contacted the Health Department as well.
Swelling, redness, pain during movement, hot to touch. Decreased ROM. Fever. Nausea and vomiting.
She got her vaccine, and felt weak and disoriented to begin with and broke out into a sweat and does not remember much after that.  Vaguely remembered somebody asking her if she was okay.  She was sat down and felt like she was coming back.  She does not remember anything for the next 32 hours.  She vaguely remembers being in the car, knows that she was seeing double cars in front of her, felt like she was in a dream.  The traffic lights were like a film.  Her daughter said that she saw her in Knoxville which was 35 minutes from where she was supposed to be.  Then had a doctors appointment and was told that she was not her.  It then took her 4 hours to get home, which is normally a 45 minute drive.  She does not remember where she had gone.  She was very shaky inside and got home and went to bed.  She is still having that shaky inside feeling.  She went to bed and did not get up until Friday night when her grandchildren came to the house.  She got up and could not remember them being there and them playing, does not remember them leaving, and does not remember locking up her house.  She met her daughter on Saturday and told her what was going on and she told her to go back home.  She was shaky with her hands and spilled everything.  She cannot remember anything, and not able to tell distances.  She can remember of different times of slamming on her breaks and almost hitting things.  The drug store called and nobody knew where she was for the 32 hour period of time.  This fogginess is kind of going away now, but still has the real shaking inside like she's had too much caffeine.  She called her doctor and left a message for them to call her back.
Patient asked if any reactions to Flu vaccine in past, she reported, flu symptoms, denies any allergies to eggs. 30 minutes after reports headache, dizziness - went to ED.
No additional AEs.; The patient the received the first PNEUMOVAX 23 on 11/29/2016. The patient then received a second PNEUMOV AX 23 vaccination on 3/26/2021; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 29-NOV-2016, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (exact dose, injection site, route of administration, lot # and expiration date were not provided) for prophylaxis. On 26-MAR-2021, the patient was vaccinated with the second dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection in prefilled syringe, 0.5 milliliter, lot # T028093, expiration date 24-APR-2022 (injection site and route of administration were not provided) (Inappropriate schedule of vaccine administered). No additional adverse events were reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T028093; expirationdate: 24-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Patient presents to the hospital with constant left sided chest pain, intermittent left arm tingling,  nausea, vomiting, confusion and shortness of breath. Chest pain is worse with deep inspiration.  Tests ran include EKG/CXR, chest CT, and labs.  Admitted to hospital for observation work up. Serial EKG, serial troponin, CT head Patient was discharged AMA with cardiology and pulmonary consults. Medications on discharge: Aspirin 81, Spiriva, and albuterol HFA.  Symptoms likely a result of exacerbation of other disease processed, but cannot rule out contributory effects of the vaccine
I've had COVID before - back in October of 2020. I had loss of smell and taste almost immediately. It took several months for smell and taste to return, mostly returning by early January 2021. There were slight exceptions.  I received the vaccine on 2/22 and starting on 2/25-2/26, I noticed that my taste has altered significantly. Almost everything I eat tastes like smoke. I've had everything from eggs to steak to bread. Even drinking coffee or wine tastes like I am drinking a smokey liquid. I'm not sure why this is happening and it has not improved since.   Sense of smell continues to remain in okay condition.
It appeared to both me and the patient's mother that the patient had a short seizure about 5 minutes after vaccination with Menveo. The patient's mother is going to take her son to the ER for follow-up.
PATIENT RECEIVED VACCINE AROUND 9:50 am AND RETURNED 30 MINUTES LATER STATING THAT HIS FINGER ON HIS LEFT HAND WAS FEELING A BIT NUMB (WHICH IS THE SAME ARM WHERE THE VACCINE WAS ADMINISTERED...LEFT DELTOID).
RED, RAISED SWOLLEN AREA, NON-TENDER ON LEFT UPPER THIGH NO INGUINAL LYMPH NODES FELT. ORDERED PRELONE SYRUP AND TOPICAL HYDROCORTISONE BID.