chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ADMINISTRATION ERROR:  She went to the  Stadium to receive her vaccine, and was on the bus where the nurses came on the bus to administer the vaccines.  First dose given on the left shoulder, and then as she turned around she was given another dose in her right arm mistakenly within 5-10 seconds of the first dose, and she screamed out no.  They called the paramedics, her mother said that the nurse who gave her the dose left the bus.  The bus was parked in the outer area under a tree at the  stadium because the tent areas were inside.  The paramedics came and they took her VS, and the driver called the clinic to let them know what had occurred, and  her PCP said that he wanted her to be taken straight to his clinic.  She did have a really bad headache at that time, which they did not think was anything for her to go to the hospital, but due to administration error was taken to his clinic.  As per patient rescue team were called and arrived, examined her, and advised to visit her PCP (per the bus driver).    The bus then took her to her PCP which was at Medical Center,  where she saw her PCP.  When her daughter got there she had just arrived 5-10 minutes earlier.  She was examined and the exam was pretty much clear other than the sterile strips seen on both deltoid areas.  ASSESSMENT:  Error in prescription, acute.  COMMENTS:  Administered two doses of Pfizer vaccine same day by Doctor (which he did not administer).  She denied any symptoms or reactions to the vaccine.    Daughter reports that she was having headaches and the doctor contacted the daughter twice and asked her how she was, and she kept telling him that she was still having the headaches, and he told her to take 2 500 mg of Tylenol and to take 250 mg of Advil.   She was dizzy, she wasn't eating, she was laying down a lot in bed with the headaches which lasted for about 6-7 days.  She did not sleep well for the first week.  Her left arm was really swollen, red and hot to the touch.  The other one was not as much of a reaction.   She is not very active and does not speak a lot, but seems back to herself and does not complain much.  As far as the daughter can tell she has overcome the reaction.    She got a reminder call today of her being scheduled for the 2nd vaccine tomorrow.
Initial information received on 27-Sep-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 68-years-old patient (gender not reported) who was vaccinated with a 0.5 ml dose of FLUZONE QUADRIVALENT (Batch number: UJ011AG and expiry date: 30-Jun-2019) via intramuscular route in the left deltoid on 25-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to incorrect product storage because the vaccines were in transit to long. It was unknown if any adverse event was occurred or not following the vaccination. 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 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. Documents held by sender: none.
This spontaneous report as received from a nurse refers to an unspecified number of patient of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with doses of M-M-R II injection (strength, dose, route of administration, indication, lot # and expiry date unspecified), that were improperly stored. No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Patient received Pfizer COVID vaccine 1/5/2021.  On 1/14/2021 developed cough and nasal congestion.  Positive for COVID.
3 near syncopal episodes; Arm soreness at injection site; Chills; muscle aches; This is Spontaneous report from a contactable Other Healthcare Professional reported for herself. A 49-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number=EL1283 via intramuscularly on 12Jan2021 10:30 at single dose Vaccine location: Right arm for covid-19 immunisation ,facility type vaccine: hospital. Medical history included hypertension and the first dose of BNT162B2 Lot number=EK5730 in Dec2020 10:00 Intramuscular, Vaccine location Right arm Facility type vaccine Hospital. Concomitant medication included hydrochlorothiazide (HYDROCHLOROTHIAZIDE) and multi-vitamin. On 12Jan2021 22:00 the patient experienced 3 near syncopal episodes, arm soreness at injection site, chills and muscle aches. No treatment received. The event outcome was recovered and action taken is not applicable.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the event near syncope cannot be 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.
Pfizer COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccine on 10/19/21 and 11/14/21. Covid + 2/08/22. Pt presented with worsening hypoxia in the setting of covid19 was on her 12th hospital admission. Pt was finally admitted with SOB with large pericardial effusion showing tamponade physiology. On 1/30/2022 had pericardiocentesis and removal of 750cc of fluid and a pericardial drain placed which was removed 2/4. Patient on 2/6 had an episode of hypoxia pulmonary  was consulted reviewed fulls and saw resolution of pneumothorax and patient was palced on HFNC and NRB however patient continued to require HFNC for a few days. On 2/10/22 rapid response was called for worsening hypoxia was transferred to ICU for intubation. Patient noted on 2/13 to have multiple episodes of unstable SVT vs Afib with RVR. Pt was transitioned to comfort care and expired 2/15/2022
Red, itchy spots on big toe and balls of feet showed up Friday, 03/20.  Treatment via anti itch cream and Benadryl starting 03/22
Injection site started to get red with a small area around it red as well. Red area continued to grow in diameter and was warm to the touch, hard, and sensitive. This all was noticed Saturday morning and continued through the day. Sunday night at bath time, dad noticed the area had grown to a red area around his right groin area, which promoted a visit to urgent care.
Initially an area of erythema of about 37mm presented with in 15 min of administration.  Three seperate raised areas were noted with in the area of erythema.  Provider advised client to take Benadryl.  07/29/09 Client reported having had a fever 2 days after the vaccination of 101 degrees with fever and "sweats" off and on there after and hives that covered body starting 07/29/09.  Consulted her provider who diagnosed as "Atypical Measles".  Client stated provider treated her with Benadryl injection and advised her to take oral Benadryl at home.
6 days after vaccination a large red area noted at vaccination site.  Roughly the size of a baseball.  Denies fever, states at times warm to touch.
(L) thigh red, warm, swollen. The reaction started on 11/19/07 right after immunizations were given but progressively worsened over the next 24 hours.
Left upper arm had 4" x 4" localized reaction to KINRIX vaccination. Red in color, warm to touch.
severe swelling in the arm; redness; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (severe swelling in the arm) and ERYTHEMA (redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (severe swelling in the arm) and ERYTHEMA (redness). At the time of the report, PERIPHERAL SWELLING (severe swelling in the arm) and ERYTHEMA (redness) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided. Patient reports that HCP recommended that the patient should not take the second vaccine.
3RD MODERNA COVID VACCINE DOSE GIVEN 12/16/21, #077C21B; 8/31/22 pt admitted to ED with cough, dyspnea; found to be hypoxic and positive for COVID; placed on O2 supplementation; given dexamethasone, remdesivir, heparin drip, ABX; dc'd to SNF (Senior Living Community); 9/12/22; pt. passed away in Hospice Care.
Patient inadvertently received MenB vaccine. Patient was not due for Men B, and just due for Meningococcal Conjugate. Men B was pulled from refrigerator and administered to patient. Patient received planned vaccines of Tdap, Meningococcal Conjugate and HPV. Patient was notified in person and mother was notified via phone. Updated system , VIS sheets, and a copy of signed vaccine consent sent home with patient. Patient experienced no symptoms and returned to class 15 minutes after vaccine administration. Snack and water eaten by student while waiting and ice pack applied to arms . Clinical supervisor notified, debriefing scheduled to discuss vaccine safety and administration techniques to prevent future adverse events.
death Narrative: Patient received his COVID #1 Moderna vaccine on 2/3/2021. On 2/9/21, he reported to our ER with severe upper back pain x 2 weeks, notes indicate that he fell 12/2020 and sustained a fracture to T5, he denied shortness of breath but did report a cough. He was given morphine 10mg IM x 1 dose, ondansetron 4mg SL x 1 dose and an outpatient RX for Norco and discharged. On 2/11/21, his wife reported that he fell out of bed and he was taken to a facility via EMS. No records from that visit are available. On 3/9/2021. it was reported that he passed away. No autopsy reports available. 34 days from time of vaccine to date of death.
From elbows to fingers like pins & needles, tops of my thumb went numb, progressive weakness, shoulders began to ache, from my right shoulder down to my elbow began to ache, from my right shoulder down to my elbow bean to ache, range of motion in right shoulder was painful.
High fevers (104.5), swollen and a red rash where injections were given. The right thigh has a large welt in the center of the rash. Headaches, back aches, tingly fingers, swollen tonsils, so much so they almost touched, high white blood counts, lack of appetite, wouldn't/won't drink, mild rash on is back and shoulders, sores in his mouth and nose, throwing up....I have pictures of the injection sites.
She reports muscle aches from time of vaccine. She states that Wednsday she noticed her palms were itchy. On Thursday morning she noticed all of her joints were very sore. She continued alternating Tylenol and Ibuprofen which was helping until last night. Last night joint pain became more severe and her hands started feeling tight. They do not appear swollen but feel so tight that she can't make a fist. She states all last night both of her arms felt numb and tingly when she would lay on them. She states when she sits up it improves but doesn't go away. She states today she feels the numb/tingly sensation in both arms from the elbow to the forearm. She denies any arm/leg drift or any confusion, slurred speech or facial droop. She has tried Tylenol, Aleve and Benadryl. Pt. states it feels like she has a pinched nerve somewhere.
Day 1- Feeling of blood rush all over body. Drove home and within 15 minutes of injection felt confused and body ache. That night within 1 hour, shaking, chills, sweating, disorientation. Bed rest for rest of day/night.    Day 2- Same symptoms and whole body felt ache. Loss of coordination and a near falling incident. Blood pressure felt low and had tunnel vision while sitting on couch. No Blood pressure test able to be taken at home. Bed rest for rest of day and night.   Day 3- Felt slightly better with less pain.   Day 4- Felt almost back to normal. Still pushing fluids and getting at least 10 hours of sleep every day.   Day 5- Feelings of fever/Body Ache/Chills again around noon. Spent rest of day in bed unable to leave.   Day 6- Felt better and went out to lunch with . Around noon I started feeling faint and saw a napkin fall off the table. I reached to grab it but it did not exist. At that time I nearly lost conciousness at the table. I continued to drink water and was driven home.
This spontaneous report was received from a certified medical assistant refers to a 23 year old female patient. The patient's medical history and concurrent conditions were not reported. When the patient was 16 years old (unknown date due to date of birth was not reported), the patient received her first two doses of GARDASIL (dose, route of administration and lot # were not reported). On 27-APR-2015, the patient was vaccinated in the physician's office with GARDASIL dose 3 (dose, route of administration and lot # were not reported). No adverse effects reported. Additional information has been requested.
I had PAC's and  fast heart rate after my first vaccine. I saw a cardiologist and nothing else was done. After my second does 09/05/21 Lot # FC3182. I again began having fast heart rate, shortness of breath, weight loss and more tremors than usual, I contacted my healthcare provider who ordered labs and testing. My TSH levels went from 3.01 in June of 2021 to <0.01 on the 27th of September.
4 year old male inadvertently received TUBERSOL via intramuscular injection instead of IPOL,no AE; 4 year old male inadvertently received TUBERSOL via intramuscular injection instead of IPOL,no AE; 4 year old male inadvertently received TUBERSOL via intramuscular injection instead of IPOL,no AE; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Regulatory authority (Reference number- 00361396) and transmitted to Sanofi on 17-Nov-2020.  This case involves 4 years old male patient inadvertently received 0.1ml dose of TUBERSOL (TUBERCULIN TEST) (batch number: C5735AA and expiry date: 28-Jul-2022) via intramuscular injection in left thigh for tuberculin test instead of IPV (VERO) [IPOL] via unknown route in unknown administration site for prophylactic vaccination on 16-Nov-2020 (product administered to patient of inappropriate age, wrong product administered, incorrect route of product administration)  Medical history, medical treatment(s), past vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE; MUMPS VACCINE; RUBELLA VACCINE; VARICELLA ZOSTER VACCINE for prophylactic vaccination and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DIPHTHERIA TETANUS ACELLULAR PERTUSSIS) for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate age at vaccine administration, wrong vaccine administered and drug administered via inappropriate route (latency same day).  At the time of report, no adverse event was reported.  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 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.  There will be no information available on the batch number for this case.
Fainting spells and seizures that began on March 27, and also occurred on April 2 and June 8.
Patient received the KINRIX vaccine (DTaP/IPV). This is only for the 5th dose of a vaccine series - ages 4 to 6 years of age. Patient is only 16 months.
A red welt on my arm around the injection site; Itchy; Hurts very badly to touch; Slightly warm; This is a spontaneous report from a contactable consumer (patient).   A 53-year-old patient of an unspecified gender received BNT162B2, (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485), via an unspecified route of administration, administered in left arm on 21Jul2021 (at the age of 53-years-old) as dose 1, single for COVID-19 immunisation  .  Medical history included heart disease, diabetic, hypothyroidism, gastroparesis from an unknown date. Patient has known allergies of adhesive tape - slightly. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Patient received unspecified medications. Patient reported that on 23Jul2021, patient had a red welt on arm around the injection site. It was about 2 inches in diameter. It was itchy and hurts very badly to touch. It was slightly warm. The patient underwent lab tests and procedures which included SARS-COV-2 test, where found positive on an unspecified date.  Since the vaccination, the patient had not tested for COVID-19. No treatment was received for the events. The outcome of the events was not recovered.
Janssen COVID-19 Vaccine EUA  About six hours after receiving the vaccine, I felt a sudden lack of energy followed by uncontrollable shivering. I developed a low-grade fever that persisted for three days. I treated the symptoms with over-the-counter medications. I did not see a doctor. The symptoms went away on the fourth day after receiving the shot.
Information has been received from a healthcare professional referring to a patient of unknown age and gender. Information about medical history, concurrent condition and concomitant medication was not reported. The patient received the first dose of VAQTA on 16-SEP-2014 and the second dose of VAQTA on 26-NOV-2014 (strength, dosage, frequency and route unspecified) (inappropriate schedule of vaccine administration). Additional information has been requested.
pt recv vax;swelling & pain at site of inject & HA & neck pain;started 24 hr later;no relief from advil;
slight tingling in hands and feet, off and on shortly after vaccination.  tingling and muscle tremor in left cheek 12 hours after vaccination
This spontaneous report as received from a medical assistant refers to a patient of unknown age and unknown gender. Pertinent medical history, drug reaction or allergies were not reported. On 15-AUG-2014 the patient was inadvertently vaccinated with expired M-M-R II, expiration date 09-AUG-2014 (strength, dose, dose number, route, anatomical location and lot number were unspecified). No concomitant therapies were reported. No adverse effects reported. The outcome of the event was unknown. Additional information has been requested.
On 1/27/2010, patient noticed soreness in the left deltoid muscle. On 1/28-1/29/2010, she started having more pain in her neck and upper shoulder. Over 1/30-1/31/2010, the pain became worse and she started having tingling in her arm and spinal pain. She saw previous orthopedic surgeon on 2/3/2010 as she thought it might be related to previous shoulder surgery. Dr. ordered x-rays and an MRI which found nothing wrong. She was referred to another Dr., an orthopedic specialist in neck and spine problems who prescribed 6 days of anti-inflammatories and steroids. Both doctors practice through the same Orthopedic Group. Patient was then referred to a neurologist who drew comprehensive panel of labs and performed an EMG. Dr. diagnosed patient with brachial neuritis and prescribed a "nerve" medication per patient report. Patient has a follow-up appointment on 2/19/2010. Patient reports she continues to have tingly feeling from mid shoulder to fingers and her shoulder muscles are extremely sore to the touch.
Extremely hungry; Headache; Pain and soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HUNGER (Extremely hungry), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain and soreness at the injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient never had COVID-19 test or diagnosis.  The patient's past medical history included Kidney stones, Intestinal inflammation and Surgery (Small Intestinal Inflammatory issues that needed surgery). Concurrent medical conditions included Sulfonamide allergy, Cancer (Cancer 3 times) and Muscle wasting.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced HUNGER (Extremely hungry), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain and soreness at the injection site). On 26-Feb-2021, HUNGER (Extremely hungry), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain and soreness at the injection site) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       It was reported that the patient had allergies to something but she does not remember. No concomitant medications were reported. No treatment  medications were reported.   This case was linked to MOD-2022-552309 (Patient Link).
Initial misuse report received from a healthcare professional on 13-Sep-2013. A 4 months old patient was administered with ADACEL instead of DAPTACEL. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Shot was administered in Doctor's office by a medical assistant and/or nurse. The shot was injected into the right shoulder, not into the right arm. Within 15 minutes after shot was administered, symptoms included heart palpitations, diarrhea, vomiting, dizziness, weakness and faintness. Within 12 hours of injection, pain emanating from right shoulder all the way down the arm to the fingers. Unable to sleep the first night due to discomfort from injection. Morning after, rash from right shoulder to right elbow, itchiness, swelling at site of injection and in right biceps/deltoid areas, bruising around injection site, numbness and pain - has received physical therapy to help regain motion in right shoulder/arm. Has taken pain killers including Gabapentin (300 mg X 3 times daily), Extra strength TYLENOL, Prednisone (10mg), CELEBREX, Methylprednisone (4mg dose pack).
Subsequent to receiving first and second doses of Lymerix the pt experienced pain in her hands and fingers. Outcome unresolved. Pt was treated with NSAIDS in June of 1999. In May, 2000 the pt received third dose of Lymerix. Subsequently the pain in her hands worsened. Physician evaluated her joint complaints and swollen fingers were documented on the exam. Reporter was unsure whether or not warm joints were documented. Lab work was done for arthritis (results unknown). Approximately 6/18/00, pts was diagnosed with rheumatoid arthritis. Pt was treated with Relafen and Plaquenil. The most recent information reports the outcome as ongoing.