chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Inadvertently, vaccine was not mixed with diluent prior to administration resulting in 3 times the recommended vaccine dose being administered. Error was realized approximately 4 hours after administration, parent was contacted at that time child had no signs or symptoms of adverse clinical response
itching, swelling and hivelike rash with bumps on face the 1st day.  next day, rash over face, neck, chest, upper arms.  worse with exposure to cold air.  resolved after warming about 15-20 min 1st day. 2nd day resolved with benadryl 25mg x 1.
A report has been received from a Pharmacist concerning a patient born on 06-Jan-1996, female subject, who had been receiving FLUMIST. FLUMIST started on an unknown date. The patient experienced administration of only a half dose of FLUMIST in one nostril. The outcome of the event of administration of only a half dose of FLUMIST in one nostril is unknown. The report was considered to be non-serious.
Breakthrough case admission after 2 vaccines  Pfizer 8/7/21 Lot# FA7484;  Pfizer 9/4/21 Lot# FC3184
Patient called on 09/20/2023 and described that the day  after receiving the Shingrix vaccine on 9/17/23 the area of the vaccine site was itchy and that went away. Then, a bump developed on her neck and 5 bumps around the the arm of where the vaccine was delivered. She will follow up with her primary care provider per my (Pharmacist) suggestion. No other symptoms. But bumps are still there. She also received a Flublok vaccine spaced apart. She was informed which was vaccine was above or below each other.  She said the itching was from the Shingrix vaccine area
Pain radiating to fingers within minutes of vaccination.  Only lasted a short while.  That evening I had a bad headache, followed by muscle pain, chills and fever.  By 9 pm, I also had nausea.  These symptoms continued and worsened by the next morning, November 10.  I had nausea all day, bouts of diarrhea and vomiting.  I could only have ice chips.  I was exhausted and it was hard to get out of bed.  By Thursday, November 11th,  I was still quite ill and with pain, exhaustion and nausea.  I couldn't eat.  After Thursday sleeping all day, Friday I started getting better.  I still had muscle pain and nausea coupled with tiredness throughout the w/e.  By Monday, Nov 15, I started to be able to resume a normal schedule.
This spontaneous report as received from a physician refers to a 12 year old female patient. The patient's pertinent medical history included eczema. The patient had no drug allergies. Concomitant medication was reported as none. On 12-MAY-2014 the patient was vaccinated with the 2nd dose of GARDASIL (strength and lot# not reported), 0.5 ml, intramuscularly. On 12-MAY-2014, the patient developed dizziness, blacked out and shaking shortly after receiving the scheduled second dose of GARDASIL. The patient was brought to the physician's office. No labs were performed. The physician had the patient took PEDIASURE and had patient sit up. The outcome of dizziness, blacked out and shaking was reported as recovered/resolved. Upon internal review, black out was considered to be medically significant. This is one of the several reports from the same source. Additional information has been requested.
Diagnosed with high blood pressure after receiving vaccine, even though I have been treated by a cardiologist for close to 12 years and have never had high blood pressure.  My primary care physician has since played down the idea that my condition is vaccine-related.
after vaccine child while sitting in chair rolled to the right side and slumped over side of chair and then had 20-30 second tonic clonic generalized seizure. incontinent of urine. appeared plae and pupils dilated. after event tired, briefly confused, and had no memory of seizure. returned quickly to baseline neurological statues.
AM after injections patient's arm was sore, red and warm to the touch. Symptoms worsened over time and she sought help at a medical walk in clinic where she was prescribed a MEDROL Dose pak and Cephalexin 500mg t.i.d x 10 days.
about 12 days after first dose, intense vomiting and diarrhea for 68 hours, which they ceased with no further issues. During the 68 hour period, all food and liquid resulted in symptoms within 30 minutes of consumption. No fever detected.
pt recvd vax; pt had apneic episode at 7pm; pt became cyanotic & unresponsive, limp x 1 min;
COVID-19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (COVID-19) in a 79-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AFF166B) for COVID-19 prophylaxis.     Concurrent medical conditions included COPD.    On 05-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2023, Body temperature: Mild.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.    The patient first shot was in 2021, had every booster and last booster was 05-Oct-2022. COVID-19 symptoms included Small cough, mild cold, Mild fever temperature.    No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-717379 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Mar-2023: Live Follow up : Upon duplicate search, it was identified that the case MOD-2023-717380 is a duplicate of case MOD-2023-717202.Hence Argus ID MOD-2023-717380 has been incorporated into case MOD-2023-717202 and we have added documents from case of deletion MOD-2023-717380 into retained case  MOD-2023-717202. Hence case MOD-2023-717380 sent for deletion. Primary reporter details added, suspect administration date, event onset date and narrative updated. On 27-Mar-2023: IRD of deletion case (From subordinate duplicate case).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-717379:Wife case
pt recv vax 22JUL96;PE was nl;had t103.4 ax temp p/vax;seen in office 23JUL w/poss ear infect (early) & MD presumed vaccine rxn;
Headache  102.7 temp Chills Teeth chattering Injection site reaction Fatigue Aches
Pruritus and macular rash on forearms and torso within 30 - 45 seconds of administration of Pneumovax - 23. Treated with Epinephrine and Benadryl.
mistakenly given fluzone hd with no reported adverse event; after the vaccine had been administered that she already received a flu shot from her doctor with no reported adverse event; Initial information received from country on 10-Nov-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves Elderly female patient who was mistakenly given Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent] with no reported adverse event as the patient came in to get COVID, Pneumonia and RSV vaccines and after the Vaccine had been administered that she already received a flu shot from her doctor   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of 0.7 ml of suspect Influenza Quadrival A-B High Dose Hv Vaccine (lot: U8138AA and expiry date: 30-Jun-2023) (strength and formulation unknown) in unknown administration site for Immunization along with co- suspect vaccines Pnemonia, RSV vaccine and COVID-19 vaccine  not produced by Sanofi Pasteur (strength, batch number, formulation, expiry date unknown) via unknown route in unknown administration site for prophylactic vaccination (Immunization) .  On an unknown date the patient developed a non-serious mistakenly given fluzone hd with no reported adverse event (wrong product administered) and after the vaccine had been administered that she already received a flu shot from her doctor with no reported adverse event (extra dose administered) (unknown latency).  It was reported that Caller stated that the patient was mistakenly given FLUZONE HD even though the technician verified which vaccines were being given and patient agreed. Caller stated that the patient stated after the vaccine had been administered that she already received a flu shot from her doctor on Tuesday, 07-Nov-2023 so patient has now received two flu vaccines. Pharmacist wants to know if there is anything that they should watch out for.  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 Directive and Module of the Practices. 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.
small rash; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of RASH (small rash) and HEADACHE (Headaches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (small rash) and HEADACHE (Headaches). At the time of the report, RASH (small rash) and HEADACHE (Headaches) outcome was unknown. Not Provided
Low fever, body aches, joint pain, diarrhea, headache, sore arm. Began within 3 hours of shot, lasted the rest of that day, night, and the next day. Still feeling weak and feverish at present time.
pancreatic cancer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PANCREATIC CARCINOMA (death), outcome "fatal", described as "pancreatic cancer". The patient date of death was Dec2020. The reported cause of death was pancreatic carcinoma. It was not reported if an autopsy was performed. Clinical course: The consumer family members were thankful recipients of the Pfizer Covid Vaccine and were very appreciative of teams diligent work at Pfizer. The consumer's personal journey made even more thankful because of help in lengthening husband's life while battling pancreatic cancer. He lost the battle in Dec2020, obviously missed him dearly.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: pancreatic cancer
Vaccine administered 3/14/06.  On 3/15/06 morning parents report that she had redness and pain in her Left arm.  By the following day redness had spread from shoulder to elbow in Right arm.  Arm was hot and hard to touch.
Several raised, hive like areas on arms and abdomen. Sm. papule in each raised area itchy.  Pt diagnosed with dermatitis and is responding to treatment.
Immediately following flu immunization, patient reported feeling dizzy, light headed, nauseated, throat feels like she has a cold, hot flush with injection.
Developed dizziness immediately before and also after the 3 vaccines listed below. Felt pre-syncopal and was assisted to bed. Orthostatic BPs 118/72 laying P 109, 114/69 P 102 sitting, Sao2 97%, no wheezing or urticaria, no erythrooderma able to ambulate normally 30-45 minutes later.
Patients who received expired doses of the Moderna COVID vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients who received expired doses of the Moderna COVID vaccine) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients who received expired doses of the Moderna COVID vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients who received expired doses of the Moderna COVID vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant Medications were provided by the Reporter  No Treatment Information were provided by the Reporter
injection arm was "a little" sore after getting the first dose.; This is a spontaneous report from a female consumer (patient herself) of unspecified age who received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 17Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's Medical history included tooth disorder, Was prescribed doxycycline antibiotic.The patient's concomitant medications were not reported.The patient experienced injection arm was "a little" sore after getting the first dose on Mar2021.The patient was due for second dose on 07Apr2021.She had  been to the dentist and was being treated for a dental infection and was prescribed doxycycline antibiotic. She wanted to know if this would interact with the second dose of the vaccine. Per response made to referred caller to discuss with health care professional and informed the caller that company cannot make treatment recomendatons. Reviewed contraindications with caller as per attached document CONS-who should not get the vaccine.The outcome of the event was unknown.  Information on lot/batch number has been requested.
Dizziness  Vision loss Fainting  Came to, drank water, ate banana, cold rags on face
Pain directly below injection site. Extremely tender to even gentle touch, feels like a very deep bruise, but no visible bruising. This has occurred after a week and a half of no side effects.
pt recvd vax & 6 days p/dose 2 exp flu-like sx 8MAY94;
Feeling dizziness off balance spot on arm where vaccination was given has a dark colored spot still on arm fingers on each hand smallest finger and finger next to it feels funny all day didn't start feeling any of this until Sunday 04/11/2021.
Same day of injection, patient spiked fever 102. injection site red and sore. She c/o nausea and joint pain. Ibuprofen did bring fever down and relieved joint pain.
Major redness, swelling, blister of entire upper left arm, appears to be at Tdap injection site but a SQ shot was also given near this site.
Vax given 3pm, began vomiting 8PM; Had watery persistent diarrhea next AM; no fever; Mom tried to resolve diarrhea at home. To MD 1-29-91 for unresolved diarrhea.  Given Donnagel supp, resolved in 3 days.
Patient started noticing sensations of tingling and numbness in the forearms (elbows down) and legs (calves down). Symptoms started 2 days ago. Symptoms most noticeable last night. Patient describes them as barely noticeable and says they do not limit her day to day activities or movement. No aggravating or remitting factors. Not associated with any changes in lifestyle or medications, other than stopping a keto diet 5 days ago. Patient was reporting for her second dose of vaccine. I declined to administer the vaccine today and advised her to call her PCP for follow up care.
This pt my brother received Zostavax and a flu vaccine on the same visit approx 7-10 days prior to developing a stroke. The stroke by MRI MRA was a complete occlusion of his R internal carotid artery with the MCA arterial distribution affected. Risk factors were hyperlipidemia but this was well controlled with statin Zocor 40 for years. No hypertension. No diabetes. Healthy life style, occasional daily cocktail, non smoker ever. Only prior medical history otherwise was a urethral stone two or three years ago. 02/27/07-records received and reviewed for DOS 11/5-11/8/06 DC DX: cerebrovascular accident secondary to carotid dissection on the right side. hyperlipidemia. Admitted with left sided facial droopiness. He had a right internal carotid artery dissection is hole.  He still has cognitive impairment (mild), R facial droop.  He wil never be able to believe Per 60 day follow up: Pt had a right internal carotid artery dissection. He had a large R MCA stroke. He has regained most use of left hand. He still has a large left lip droop. He has difficulty with speech, of math calculations and difficulty concentrating.
A male patient received vaccine on 6/11/08 and 6/13/08 patient come to doctor's office with complaints of fever, chills, muscle aches, along with symptoms diagnosed as cellulitis. Patient's whole left arm was swollen. Patient was given antibiotics to treat the adverse reaction. Follow up on 8/13/08: patient recovered.
Patient brought to Regional Medical Center on 11/05/2021 for c/o falls, generalized weakness, and back pain.  In the ED the patient had increased work of breathing. The patient was placed on BiPAP. CXR showed left lower lobe that was consistent with PNA. His Covid-19 test was positive. EKG revealed sinus tachycardia with nonspecific changes.  The patient was given Decadron. The patient was given vancomycin and cefepime. Patient was admitted to the ICU and required intubation. Patient self-extubated on 11/7, required CPR 2-3 min and re-intubated.  Patient again self extubated but was able to be maintained on BiPap and went to 2LNC. Patient improved with course of dexamethasone and baricitinib. He developed worsening mental status and on 11/25 required reintubation. Patient also developed shock again requiring vasopressor support. Palliative care was consulted and the patient was transitioned to comfort measures. The patient expired on 11/30/2021.
Pt presented to clinic 40 mins after vaccination, clutching his chest and reporting difficulty breathing. Pt given .3 ml of Epi and 50 mg/ml of BENADRYL.
fatigue; body aches; chills; joint pain; dizziness/dizzy spells; fever that spiked at 103 degrees.; headache; confusion; forgetting words/brain fog; forgetting words/brain fog; tingling in face/lips; shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 35-years-old non-pregnant female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9264), via an unspecified route of administration, administered in Arm Right on 15Feb2021 as dose 2, single for covid-19 immunisation. Medical history included soya allergy from an unknown date and unknown if ongoing. 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 had not received any other vaccine within 4 weeks. Patient was not pregnant at time of vaccination. Concomitant medication(s) included Flagyl taken for an unspecified indication, start and stop date were not reported. The patient received first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VAC-CINE, Lot number: EN5318) in right arm on 25Jan2021 at 03:15 (At the age of 35-year-old) for covid-19 immunisation with reaction Dizzy and a week later, intense dizzy, my ears felt clogged, I became sensitive to sound, allergies, Inflamed Eustachian tubes, Fluid in the ear. On 2021, the patient experienced shortness of breath, dizziness/dizzy spells, fever that spiked at 103 degrees, headache, confusion, forgetting words/brain fog, forgetting words/brain fog, tingling in face/lips. fatigue on, body aches, chills, joint pain on 16Feb2021. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The day after the second vaccine, she had fatigue, body aches, chills, joint pain, dizziness, headache, and a fever that spiked at 103 degrees. When she received the first vaccine, felt a bit dizzy and a week later, intense dizzy spells began taking place, especially after eating. her ears felt clogged and be-came sensitive to sound, and thought she was allergic to food. Went to an allergist and discovered allergies, inflamed Eustachian tubes, and fluid in the ear. Allergist recommended a neurologist based on my described symptoms. After second vaccine, dizzy spells have continued almost daily, coinciding with confusion, forgetting words/brain fog, tingling in face/lips, and shortness of breath. Not sure if this is from the vaccine, but these symptoms began a week after her first vaccine and have continued after the second. Patient received no treatment for the event. The patient underwent lab tests and procedures which included body temperature was result 103 degrees on 16Feb2021, color vision tests: unknown results on unspecified date, sars-cov-2 test result was negative on 31Mar2021. The outcome of, dizziness/dizzy spells, confusion, forgetting words/brain fog, forgetting words/brain fog, tingling in face/lips not recovered. shortness of breath, joint pain, chills, body aches, fatigue, fever that spiked at 103 degrees, headache, on was unknown.  No follow-up attempts are possible. No further information is expected.
Severe headaches started one month after second dose of Pfizer. Severe headaches continued until massive stroke April 29th 2022. Another stroke occurred on June 16th 2022 followed by another stroke July 22nd of 2022. He also had to have his gallbladder removed as it was so inflamed. Surgery for gallbladder removal was March of 2022.
Patient states her arm swelled up twice the size and ran a fever of 102 degrees Fahrenheit for 3 days.
Pfizer-BioNTech COVID-19 Vaccine  Patient was administered vaccine at 0951. Patient reports not feeling well. Got a rush of feeling very warm and shaky. Upon assessment patient is pale, diaphoretic and has a rapid bounding pulse. Moved patient to exam room where we assisted her to lay down. Hooked her up to vitals machine for a set of vitals. HR-140-150, BP 146/88, O2 100%, R-24. Upon patient laying down she started to complain of her throat feeling hot and tingly. She began to develop a blotchy rash first noted above BP cuff on right arm, but quickly spread up neck and down trunk. Assessed mouth and throat, no swelling of tongue or lips noted. Patient still c/o feeling hot and tingly on neck and all the way down to her legs. Blotchy rash had subsided. HR dropping to 80-90 and BP came down to 124/82. O2 remained 100% throughout.  Patient transferred to emergency department.
Upper lip swelling, ~12 hours after IM injection  Patient also on Lisinopril however
Per patient report: I wanted to report an adverse reaction to the flu shot.  This is the first time I have ever had any type of reaction and it is getting progressively worse.  Originally, I had a knot at the shot injection site which has completely gone away. I currently have ongoing pain in the arm from the injection location that radiates down to my fingers and into my shoulder creating both pain and loss of intermittent strength which I would classify as weakness.  I have no redness, swelling, heat at site of injection, fever, hives, fast heartrate, headache or fatigue - I have felt oddly nauseous at times and the pain is affecting my sleep as it wakes me up. The feeling begins as a cramp at the the injection site then travels up and down.  It has been two weeks.