chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3 hours after vaccine, he experienced acute symptoms - dizziness, lightheadedness (described as room spinning around), anxiety (not problematic before), profuse sweating, feeling of doom, nausea/wretching, pronounced shaking. called 911, taken by ambulance to ER, prior symptoms continued in varying intensity for the next 3 - 4 hours.  He was given IV fluids, antibiotics, then admitted to the hospital.  He had loss of balance, continued lightheadedness, loss of appetite. Hospitalized for 3 days. Went home with a walker (not used before). He gradually improved over a two week period.
The patient received his booster dose of Pfizer vaccine on 09/30/2021. His previous doses were received on 01/29/2021 and 02/19/2021 respectively, without incidence. On the evening of 09/30/2021, the client reports that he had a sore arm and went to bed. He failed to show up to work the next day and co-workers went to check on him at his residence as he lives alone. The patient was discovered in bed and acting very confused and unable to form rational sentences. He was immediately brought to the ER by a co-worker and a work-up was performed. At this time, he was also complaining about a severe headache and had profuse sweating. Imaging, EKG, and blood work were all performed and there was no notable abnormalities seen. He was later released from the hospital the same day, per his request. He notes that his headache has resolved but that he feels tired and fatigued. Also, he is still c/o abnormally profuse sweating.
While being vaccinated, child pushed needle out of arm with left hand after unknown amount of vaccine was injected.  Minimal bleeding noted.  Bandaid applied . POD LHD nurse notified.
At 7:00 pm on 9/13 I began to have body aches. I took ibuprofen and went to bed. I woke up at midnight with severe chills and body aches. I took my temperature it was 100.2. I took 1,500 mg of Tylenol. The chill and aches kept waking me up. I got severely drenched in sweat about 4:00 am. I woke up and had extreme soreness on my left arm. I could hardly raise it. My armpit was also tender. I looked in the mirror and noticed a bulge in my arm pit. My armpit is still tender today (9/15). 9/14 I took Tylenol 1,500mg every 4-6 hrs. I had chills and body aches intermittently through out the day. In the morning I had sweats and shortness of breath just doing daily tasks around the house. The night of 9/14 I felt extremely fatigued and went to bed at 8:30 pm. Today 9/15 I feel back to my usual self.
10" x 10" blistering site on skin with cellulitis; 10" x 10" blistering site on skin with cellulitis; This is a spontaneous report received from contactable reporter(s) (Nurse) from a sales representative.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, manufacturer unknown), for COVID-19 immunization. The following information was reported: CELLULITIS (medically significant), BLISTER (non-serious), outcome "unknown" and all described as "10" x 10" blistering site on skin with cellulitis".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Nausea and Vomiting starting about 30 minutes after Xakia received the vaccine. Lasting episodically through the night.
Woke up the next day with a low grade fever, H/A and diarrhea. His right upper arm had a red raised area 3 in wide and 8 inches long. It was also itching. His arm was painful and he could not lift it up. Mom gave him BENADRYL and TYLENOL. It was redder on Sunday but no itching. Mom called the office on Monday am to report it. It was resolving on its own.
Localized soreness, redness and swelling to site. Ibuprofen for pain
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE NON ST ELEVATION MI ACUTE CORONARY SYNDROME, UNSPECIFIED ACUTE HYPOXEMIC RESPIRATORY FAILURE CHRONIC HYPOXEMIC RESPIRATORY FAILURE ACUTE ON CHRONIC RESPIRATORY FAILURE CARDIOGENIC SHOCK 11/24/2022,  11/14/2022,  11/15/2022 -- RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Reporting a vaccine administration error: 193 people were given Moderna monovalent vaccine (lot numbers above) as a booster dose instead of Moderna bivalent vaccine in a series of vaccine community outreach events from 11/3/22 through 12/15/22 by a mobile vaccine team.  There were 11 locations where this happened.  No adverse events resulted that we are aware of.  The patients have all received letters and a phone call to inform them.  Patients can schedule for a bivalent booster 2 months from the monovalent booster.  Age range was 17 - 92 years old.  (the DOB above is a dummy date so that I could fill out the rest of the form).
Telephone call from mother who states Left arm is swollen 4" x 5" area, warm to touch and tightness.  States he has 4 raised solid bumps with no fluid approximately 0.5cm in size.  No fever, no pain, c/o itching only.  Mom will continue to give Tylenol and Benadryl prn and use warm moist compress alternating with ice.  To call with any changes or take to PCP if worsens.  Mother verbalized understanding.
Onset of COVID-19 virus. Positive result from at home rapid diagnostic test (Quidel); Onset of COVID-19 virus. Positive result from at home rapid diagnostic test (Quidel); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 45 year-old male patient received bnt162b2 (COMIRNATY), administration date 17Feb2021 (Lot number: EN6201) at the age of 44 years as dose 2, single and administration date 25Jan2021 (Lot number: EL9261) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Patient receive other vaccines within 4 weeks prior to the COVID vaccine: No. Prior to vaccination, the patient diagnosed with COVID-19: No. Since the vaccination, the patient been tested for COVID-19: Yes. The following information was reported: COVID-19 (medically significant) with onset 15Dec2021, outcome "not recovered", VACCINATION FAILURE (medically significant) with onset 15Dec2021, outcome "unknown" and all described as "Onset of COVID-19 virus. Positive result from at home rapid diagnostic test (Quidel)". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (15Dec2021) positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of covid-19.
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. No information regarding patients' medical history, concurrent conditions or concomitant therapies were provided. On unspecified dates improperly stored vaccines were administered to unspecified number of patients (doses, routes, and indications were not reported). No symptoms were reported. One dose of VAQTA lot # L015460, expiry date 20-JUL-2017 was administered, one dose of RECOMBIVAX HB lot #L027733 expiry date 13-SEP-2017 or lot # L040458 expiry date 04-FEB-2018 was administered and five doses of ROTATEQ were administered lot # L033549 expiry date 05-JUN-2017, lot # L027726 expiry date 10-MAY-2017, lot #L033545 expiry date 30-MAY-2017 were administered. The reporting nurse was not sure which lot numbers were administered but the lot numbers listed above were the ones possibly involved. It was reported that the vaccines were exposed to temperatures of 46.9 Fahrenheit degrees for 15 minutes and 34.9 Fahrenheit degrees for 2 hours. Additional information has been requested.
Profound fatigue lingering, sleep disturbances, Diarrhea, nausea, fainting feeling, intermittent high heart rate.  I?ve had post viral postural orthostatic tachycardia syndrome and you thousand 15 to 2016. And this feels like the same thing. I have not had a flare until I received the vaccine
Pt recvd 1st dose of vax on 7AUG92 & following vax pt devel diarrhea, hives, pruritus, red face & neck; presented to MD treated w/DPH;
Employee describes feeling swelling and numbness of mouth/lips/half way back on the tongue - like when you have been to dentist.
Information has been received from a physician concerning a college age female pt who was vaccinated SC with a dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot not reported). Subsequently the pt was tested and had a negative titer for mumps. The physician reported that the pt had the appropriate doses of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) as a child. Unspecified medical attention was sought. The physician reported that he would be re-vaccinating the pt. Additional information has been requested.
PATIENT REPORTED BACK TO PHARMACY THE DAY AFTER VACCINATION AT ~11AM. PATIENTS LEFT UPPER ARM WAS VERY SWOLLEN AND RED FROM THE DELTOID TO THE ELBOW.  DOES NOT REPORT PAIN. PATIENT STATES HARDNESS AND WARMNESS IN THE AREA.   RECOMMENDED THE PATIENT REPORT TO URGENT CARE OR EMERGENCY ROOM FOR EVALUATION. RECOMMENDED ICING THE AREA IN THE MEANTIME TO REDUCE SWELLING.   PATIENT STATES SHE MAY NOT BE ABLE TO SEEK MEDICAL EVALUATION DUE TO TAKING CARE OF A FAMILY MEMBER AT HOME.
NOT ABLE TO SLEEP/INSOMNIA; SHAKES; SORE ALL OVER BODY/SORENESS; SEVERE HEADACHE; This spontaneous report received from a consumer concerned a 48 year old female.  The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 24-MAR-2021 01:00 pm for prophylactic vaccination on left deltoid. No concomitant medications were reported.  On 24-MAR-2021, the subject experienced not able to sleep/insomnia. On 24-MAR-2021, the subject experienced shakes. On 24-MAR-2021, the subject experienced sore all over body/soreness. On 24-MAR-2021, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe headache, not able to sleep/insomnia, and sore all over body/soreness, and the outcome of shakes was not reported. This report was non-serious.
starting on 22OCT94 pt c/o chills, h/a, backache, cough which occurred again on 11, 18NOV; same sx appeared each time;
pt recv vax 22JUL98 & mom called next day states arm is swollen, red, hot to touch size of orange;upper arm very swollen, hard & hot to touch & redness down 1/2 of arm;swelling same but redness had spread;It was reported that a 4-year-old patient received TRIPEDIA vaccine on 22-JUN-1998 RA (deltoid). Reportedly Mom called next day - states (the patient's) arm is swollen, red, hot to touch - size of orange. Seen in office, upper arm very swollen, hard and hot to touch, reddness down 1/2 of arm. Put on KEFLEX 250 2 tsp. x 10 doses - seen next day swelling same, but reddness had spread, no temperature, put on ATANAX, office visits x 2. On 29-JUL-1998 redness gone - only slight swelling now. Reportedly the patient recovered from this experience. Follow-up #1 (18-Jul-2002): During internal auditing of all files it was deemed necessary to amend the report by updating the narrative vaccine date to 22-Jul-1998 as per original source document.
At 6 hours after, I felt very dizzy and had a headache. At hour 12 I have a fever of 100.7, severe body aches, Hips, and knees were the worst. Paid scale would be 8/10. at 16 hours  added fever was 102.5 , sever headache over the whole head,  at  hour 24 same. Hour 36 fever is down to 99.7 however, muscle paid have subsided and migraine is better. Pain scale 3/10
Immediately after the shot I could taste it, then a few hrs later my tongue felt thick, patchy, funny...The next day my tongue still felt the same and I noticed a small white patch on it. The third day my tongue still felt the same and it was purple-ish. I brushed it and it started bleeding. The fourth day it was covered in white.
Patient is fully vaccinated.  COVID + on 12/31/2021. Admitting dx: fall, closed hip fracture, COVID and hypomagnesemia.86 year old female presents to EMS secondary to right hip pain following a fall in her bathroom at some point last night. Elevated troponin, hematuria. A fib on coumadin.  She is status post ORIF.  COVID pneumonia, CXR: Interstitial congestive changes which may be acute and/or chronic.  treatment: remdesivir, steriods.  Transferred to rehab.
This spontaneous report as received from a physician via an issue of a magazine refers to unspecified patients of unknown age and gender. No medical history or concurrent conditions were reported. On unknown dates the patients were vaccinated with GARDASIL (lot number and frequency unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. It was reported that, the GARDASIL had absolutely no effect on cervical cancer (vaccination failure) and it had very many adverse effects which destroys lives and also even kills (adverse event) (life threatening and death). It was also reported that cases of Guillain-Barre syndrome, paralysis of the lower limbs, vaccine induced multiple sclerosis (MS) and vaccine induced encephalitis could be found whatever the vaccine. The outcome of many adverse effects which destroys lives and also even kills was reported as fatal. The outcome of the other events were unknown. Additional information has been requested.
Information has been received from a RN concerning a child who was vaccinated with varicella virus vaccine, live ( also mentioned in f/u information as "several children" had developed a rash subsequent to reviewing the vaccine). It was also reported that the vaccine was exposed to multiple temperature elevations beginning 04/01/04. There were reportedly temps as high as - 1.3C(29.66 F). Follow up information received from a health department RN reported that the vaccines were determined to be safe by a health dept immunization representative. It was noted that the immunization rep had determined that the varicella virus vaccine live was stored at the recommended temperatures and the problem was related to the thermometer and the placement of the thermometer, not the freezer. It was noted that no vaccine was discarded. No product quality complaint involved. The reporter mentioned the following varicella virus vaccine live lot numbers 647763/0191P, 641710/0452N, 647259/1137N, but did not specify the lot that was used to  vaccinate the child. Unspecified medical atterntion was sought. No additonal information is expected.
Headachy; Feverish; With achy muscles; Tiredness; This case was reported by a consumer and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd March 2021, the patient received the 2nd dose of Shingrix. On 23rd March 2021, 1 days after receiving Shingrix, the patient experienced headache, fever, muscle pain and tiredness. On an unknown date, the outcome of the headache, fever, muscle pain and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the headache, fever, muscle pain and tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The got second Shingrix shot on Monday. The felt a bit headachy, feverish with achy muscles and tiredness on Tuesday. Some of this was lingering, though milder. The patient wanted to know how long these symptoms last on average.
no adverse event; administered an impropery stored dose of PEDVAX HIB; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. Patient's pertinent medical history, concurrent conditions, past drugs, allergies and concomitant therapies were not reported. On 17-APR-2020, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength, dose and route were not reported) (lot number S023645 and expiration date 10-MAR-2022) for prophylaxis (product storage error). The temperature excursion was noted with a temperature of 51.5 Fahrenheit (F) for 45 minutes. There was no previous temperature excursion. No adverse effects were reported. The call was because of digital data logger. No product quality complaint was reported.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA002553:
no adverse event; A 9 week old female infant was inadvertently administered PNEUMOVAX 23; This spontaneous report was received from a medical assistant concerning a 9 week old female patient. No information was provided regarding the patient's pertinent medical history, concomitant medications or drug reactions/allergies. On 14-AUG-2019, the patient was inadvertently administered pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) in her left thigh (product administered to patient of inappropriate age), lot # S01224 expiration date 10-FEB-2021 for prophylaxis (strength, dose and route of administration were unknown). No adverse effects reported.
The patient's mother states that he complained of having an upset stomach in the evening of 3/17/2021.  In the middle of the night he had several episodes of nausea with vomiting.  It continued until the evening of 3/18/2021 and resolved.  The only other symptom reported was sore arms.
Pt recvd MR vax as a child; pt currently  exhibited a lack of response to mumps; no further details were provided;
CDC reports: 4 yo child developed fever 103, rash, diarrhea, vomiting & malaise following DTP/EIPV immun. Duration of illness 2 days.
administered FLUZONE HD QIV instead of the FLUZONE QIV with no reported adverse event; Initial information received on 26-Oct-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case is linked to cases 2022SA447057(CLUSTER) and 2022SA446385(CLUSTER).  This case involves a 39 years old male patient who was administered fluzone hd qiv (vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE) instead of the fluzone qiv with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 19-Oct-2022, the patient received a dose of 0.7 ml of  suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (formulation, strength: unknown) lot UT7729CA, Expiration date: 30-Jun-2023, via intramuscular route in the left deltoid as Immunization.  On 19-OCT-2022 the patient was administered fluzone hd qiv instead of the fluzone qiv with no reported adverse event (wrong product administered) same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Action taken was not applicable.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
Pt exp malaise & joint pain following vax w/Hep B; No further details were provided;
Adolescent received Tdap on March 06, 2006.  On morning of March 08, 2006 she was observed in school having uncontrolled movements of her left hand, a blank stare, and nearly fell over.  She did not lose consciousness.  No prior events.  She had a headache afterwards and said she had a mild headache that morning.  She was evaluated in the Emergency Department.  An EEG was done and was read by the neurologist as normal.  She regained full activity; neurologist noted some residual weakness in the left hand which resolved completely.
Patient had a stroke. It started out with left-sided weakness and a facial droop. He was unable to talk was taken to another hospital where he was then life flighted to Hospital. He was a 14 on the stroke scale and sent immediately to the procedure room for a thrombectomy. They injected TPA into his brain and were able to dissolve the clot.  His hospital day was four days and during it they discovered patient had a PFO. Patient has not had any symptoms or signs of a PFO and we firmly believe the Pfizer vaccine contributed to the clot formation and the subsequent stroke.
Patient had fever of 103.3 F. Mild headache and dizziness. Treatment: Administered 400 mg Ibuprofen PO. Outcome: Temp. 98.5 2 hours later.
2/18 started at 10 am and progressively got worst: fatigue/ tired/ to complete exhaustion at 2 pm. Diarrhea, body aches all over every part of my body except my head 2/19 woke up feeling better but had red petechiae on my left arm 2/21 noticed at 9 am red petechiae to bilateral lower legs / calfs/ ankles  No treatments
Tested negative for antibodies; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC PRODUCT INEFFECTIVE (Tested negative for antibodies) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure increased since 2008, Anxiety since 2008, ADHD since 2003 and Shoulder injury since 2008. Concomitant products included COLECALCIFEROL (ADDERA D3) for ADHD, LORAZEPAM (ATIVAN) for Anxiety, LISINOPRIL for Hypertension, TIZANIDINE for Injury.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced THERAPEUTIC PRODUCT INEFFECTIVE (Tested negative for antibodies). At the time of the report, THERAPEUTIC PRODUCT INEFFECTIVE (Tested negative for antibodies) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, SARS-CoV-2 antibody test: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.  This report refers to a case of therapeutic product ineffective for mRNA-1273, ( lot # not provided) with no associated AEs.   This case was linked to US-MODERNATX, INC.-MOD-2021-094824 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Concomitant medication information and historical condition was updated; Sender's Comments: This report refers to a case of therapeutic product ineffective for mRNA-1273, ( lot # not provided) with no associated AEs. US-MODERNATX, INC.-MOD-2021-094824:Wife Case