chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT DEVELOPED FEVER THE NIGHT AFTER ADMINISTERING 1ST SET (PEDIARIX, HIB, PREVNAR, ROTATEQ). GIVEN DIAGNOSIS OF ACUTE OTITIS MEDIA AND GIVEN PRESCIPTION FOR AMOXICILLIN.  aFTER THE SECOND DOSE OF AMOXICILLIN, THE PATIENT DEVELOPED A RASH, AND WAS EVALUATED IN THE ER AND ADMITTED.  THE PATIENT WAS TREATED WITH AZITHROMYCIN IN THE ER.  ON ADMISSION, THE PATIENT WAS FOUND TO HAVE AN ELEVATED BAND COUND (27%) AND TREATED WITH CEFOTAXIME. BY DAY 3 OF THE ADMISSION, THE PATIENT WAS MUCH MORE FUSSY, AND THE RASH WAS THEN CONFLUENT OVER THE ENTIRE BODY, WITH ONLY SOME FACIAL SPARING.  HIS BAND COUNT ROSE TO 41%, AND HIS CRP ROSE FROM 164 TO 203 MG/L. ON DAY 2 OF ADMISSION THE TOTAL WBC COUNT DROPPED FROM 5.4 TO 3, BUT ROSE TO 9.6 THE FOLLOWING DAY.  INITIAL CHEMISTRIES WERE NORMAL. URINALYSIS AND MONO SCREEN WERE NEGATIVE.  THE PATIENT DEVELOPED PERSISTENT TACHYCARDIA, AND WAS FELT TO BE IN COMPENSATED SHOCK, AND TRANSFERRED TO THE ICU AT THE HOSPITAL, WHERE THE PATIENT IS CURRENTLY IN CRITICAL CONDITION, INTUBATED AND WITH SEVERE GENERALIZED SWELLING.  NONE OF THE WORK-UP DONE TO DATE HAS REVEALED THE CAUSE OF THE PATIENT'S CLINICAL PICTURE.  INFECTION IS CONSIDERED STRONGLY, BUT REACTION TO EITHER THE VACCINES OR ONE OF THE 3 INITIAL ANTIBIOTICS GIVEN IS ALSO CONSIDERED.  5/29/07 Received outlying hospital medical records which reveal on 4/6/08 patient experienced fever & a papule in diaper region.  Dx w/otitis media & tx w/antibiotics.  Developed increased fever, cough & raised macular rash & went to ER on 4/7.  CXR then revealed RLL infiltrate.  Admitted 4/7-4/9/07 w/dx compensated septic shock; possible allergic reaction to antibiotics or vaccines; & clinical sepsis.  Rash continued to develop & became confluent over entire body, sparring face.  Tachycardia to 200 at rest.  Patient was transferred to higher level of care. 6/5/07 Received 2nd hospital medical records which reveal patient experienced intermittent variable rash.  Received vax on 4/5.  On 4/6, seen by PCP & dx w/acute otitis media & started antibiotics.  On 4/7, rash appeared beginning in diaper area & spread over entire body.  Presented to ER on 4/7 w/rash & fever.  CXR at that time revealed RLL infiltrate. Started on additional antibiotics.  Rash worsened & became confluent sparing only face.  Developed shock & was transferred to higher level of care for PICU.  Initially intubated during that admission for resp distress.  Final dx for that admission: respiratory failure; systemic inflammatory response syndrome; thrombocytopenia; probable toxic shock syndrome; rash; fever of unknown origin; and shock.  Rash had resolved by d/c & echocardiogram done 4/23 r/o Kawasaki.  Re-admitted 4/29-5/1/07.  Had been d/c from hospital a few days prior to this admit for possible toxic shock vs SIRS.  Rheumatology consult done.  Rash resolved completely by d/c to home FINAL DX: unknown rash, resolved.
Do not have feelings of side effects BUT have blood labs that show side effects, being treated by hematologist.
CHIEF COMPLAINT:   Covid+ today, having nausea & PO intolerance 2/2 same. Pt drinking water, no solid PO intake since yesterday. Pt c/o fatigue.   HISTORY OF PRESENT ILLNESS:     Patient with known baseline cognitive changes resides in a group home is tested positive for COVID vaccinated against such.  Has some nausea and poor p.o. intake.  Patient reports feeling tired denies any vomiting diarrhea chest pain or shortness of breath.  She was found to be hypoxic upon arrival in the emergency department.  She is requesting a Dr. Pepper and a hamburger upon my interaction with her.
Information has been received from the husband of a 65 year old female with no known drug allergies and no pertinent medical history, who in approximately September 2006 ("Fall of 2006") was vaccinated with zoster vaccine live (Oka/Merck). Concomitant therapy included CRESTOR and an unspecified medicine to control blood pressure. On approximately 17-SEP-2007, the patient broke out with shingles on her abdomen and lower back. This caused her a great deal of pain, and blisters developed. The patient sought medical attention. No lab/diagnostic studies were performed. As of 08-OCT-2007, the blisters were crusting over and his wife was gradually getting better. Additional information has been requested.
dizzy 10min after;by 30min felt like passing out, BP elevated to 180/100, hands cold, heartbeat rapid;resolved in 1 1/2hr;past hx of rash rxn p/TD in 1970;5JUN95 f/u pt had infected cat bites lft forearm & rt thumb t98.4;was dizzy a/vax
Patient passed out and fell down. His caretakers sate him on the floor. He was cold and seat. He was given water then orange juice. He recovered in about 10 minutes.
A non-serious spontaneous report of administrated to 19-month-old male was received from a registered nurse concerning a 18-month-old male patient. On 06-Nov-2009, the patient received H1N1, Intranasal for an unknown indication. The patient had no relevant medical history and no concomitant medications. The patient was doing well and had no symptoms. There was no adverse event associated with this vaccination error; therefore, treatment and reporter causality assessments are not applicable, and the event was considered resolved. Additional information was received on 13-Nov-2009 and incorporated into the narrative: The patient's medical history, concomitant medication and current health status was added. The reporter's address was updated. The responsible physician name and address was updated in the respective tabs.
muscle around elbow is tender and painful.; difficult to straighten; This is a spontaneous report from a contactable nurse. A non-pregnant female patient of unknown age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine; Batch/Lot Number: unknown), via an unspecified route of administration on an unknown date in Mar2021 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history and concomitant medications were not reported. Prior to the vaccination, it was unknown that the patient was diagnosed with COVID-19. Since the vaccination, it was unknown that the patient had been tested for COVID-19. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. On an unknown date in Mar2021, the patient muscle around the elbow was tender, painful and difficult to straighten (muscle stiffness). It was unknown that the patient received any treatment for the adverse events. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the events was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained  Amendment: This follow-up report is being submitted to amend previously reported information: Patient's country, vaccination facility country, best doctor or health care professional information were added and event onset date for AE "Difficult to straighten" was added in events tab.
VACCINE GIVEN AFTER USE BY TIME. IT HAD BEEN SITTING AT ROOM TEMPERATURE FOR FOUR AND A HALF HOURS; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855191, and expiry: 11-APR-2022) dose was not reported, administered on 23-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 23-DEC-2021, the patient experienced vaccine given after use by time. it had been sitting at room temperature for four and a half hours, and out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine given after use by time. it had been sitting at room temperature for four and a half hours and out of specification product use was not reported. This report was non-serious.
First day after patient received vaccination his arm was sore. He did not look at it at the time. The next day his arm felt like it was on fire (red, inflamed down to elbow & black in the center). He put ice on it & waited for it to get better. It formed blister & pus. Patient popped blister to reduce pressure. He contacted the doctor even though he thought it's getting better, (on 6/21/11). Doctor asked him to come in & patient was given SEPTRA DS.
Redness at sight of injection spreading approximately 3 inches down back of arm with warm sensation and tenderness at sight of injection.
Severe bruising/bleeding on left leg from groin to below knee with numbness to three small toes.
12/22/2020 I woke up with really bad body aches, and didn't feel right I went to get covid tested  and it was positive. and went home and managed symptoms with tylenol and nyquil .  I had low grade fevers, congestion, dry cough, fatigue and diarrhea and progressed the week after. I didn't go to the ER I went to the nurse help site but they ran the test through the ER
She had her vaccines, and on the night of the 12th her daughter heard a thump and she found her sitting on the floor in her bedroom basically mumbling and unable to stand. She had fallen. She was mumbling incoherently. Her daughter could not get her up, they called her 911, she went to Hospital ER. In the ER they did a CT scan on her and blood work, and they gave her the medication with their consent for the stroke tPA and subsequently they admitted her to ICU with FU CT's and MRI's that demonstrated the stroke, not a hemorrhagic stroke.  She was in ICU for 5-6 days, and then she was moved to the stroke floor and she was discharged on 10/22/2023 to home.  They did not do in-patient rehab, they are doing rehab at home with home health.  She is slowly improving, still has aphasia, she has to have maximum assistance with activities of daily living, toiletering.  She can feed herself with medium assistance.  She is only walking minimal steps requiring maximum assistance.  She has only been up twice since she has been home.  She is having fairly slow to move and does not comprehend things very good.  She was having some issues prior to the stroke, but knew what she did not remember.  She was able to wash dishes, but they did not allow her to cook anymore. She was able to walk up and down 16 stairs to get in her bedroom, she exercised with her walker and was able to walk 15-20 minutes.  She was attending to all of her activities of daily living other than not cooking.  She has had a major set back since receiving the vaccines as she had the stroke.  They saw on the news that there was a link in people receiving the new COVID and the flu vaccine the risk of stroke over 65 years old.  They were not informed of that information and if they had known they would have deferred getting those vaccines a the same time.  They are not happy that information was not released to the public at the time she had the vaccine.  She would have had ample opportunity to ge taken back to get the vaccines at different times.  They saw that there was 20-35% increase of strokes, where others were miniscule, but it outweighed people not getting the vaccine that were not optical as she could have been taking back at another time to get the other vaccines.
Also received TDAP.  Heart rate notification (Apple Watch at 100+ beats/min during time of relative inactivity) several times on the 28th , 29th and 30th.  One time on 10/1/2021 but dog had jumped up on my lap (60 lbs).    Also experiencing shortness of breath which is apparent from minor exertion.  This also happened after COVID vaccine in January and February 2021 (Moderna).   Had a quadravalent flu shot in 2020 but it was not high-dose and did not have these issues.
Injected patient with FLUVIRIN Left Deltoid IM, patient bled and then arm swelled at injection site. No pain and stopped bleeding. Gave ice to apply to swollen area.
Patient received vaccine at 1025 and came to RN stating feeling dizzy,"needing some air." Took patient to side room and placed on monitor.O2 sat 97%, HR 86, BP 148/81. Patient sitting and offered water which he did drink. VS at 1050 O2 sat 98%, HR 68 and BP 137/81. Patient stating feeling better. VS at 1055 O2 sat 96%, HR 68 and BP 143/84. Patient stated comfortable to leave.
What preservative is used in Moderna vaccine? The only potential allergy listed is Polyethylene; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (What preservative is used in Moderna vaccine? The only potential allergy listed is Polyethylene) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALLERGY TO VACCINE (What preservative is used in Moderna vaccine? The only potential allergy listed is Polyethylene). At the time of the report, ALLERGY TO VACCINE (What preservative is used in Moderna vaccine? The only potential allergy listed is Polyethylene) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.
55 patients received a dose of a vial after 12 hours of initial puncture; Vial punctured 6/1/21, vial stored in refrigerator once punctured, in freezer prior to puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) and PRODUCT STORAGE ERROR (Vial punctured 6/1/21, vial stored in refrigerator once punctured, in freezer prior to puncture) in a 33-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A and 047C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT STORAGE ERROR (Vial punctured 6/1/21, vial stored in refrigerator once punctured, in freezer prior to puncture). On 03-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture). On 03-Sep-2021, EXPIRED PRODUCT ADMINISTERED (55 patients received a dose of a vial after 12 hours of initial puncture) and PRODUCT STORAGE ERROR (Vial punctured 6/1/21, vial stored in refrigerator once punctured, in freezer prior to puncture) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided. No treatment information was provided.  The vials were being used past the recommended 12 hour post puncture time.
near syncopal episode, abdominal cramps and nausea. called EMSA who arrived and took her to the hospital
Joint swelling; Swelling of fingers; 05Aug2021/28Sep2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). Other Case identifier(s): 22K-163-4361158-00 (Agency).  A 21-year-old male patient received BNT162b2 (BNT162B2), on 28Sep2021 as dose 2, single (Batch/Lot number: unknown) at the age of 21 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), as citrate free (Lot number: 1159098) subcutaneous for ankylosing spondylitis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Intramuscular), administration date: 05Aug2021, when the patient was 21-year-old, for Covid-19 Immunization, reaction(s): "Joint swelling", "swelling of fingers". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 28Sep2021, outcome "unknown", described as "05Aug2021/28Sep2021"; JOINT SWELLING (non-serious) with onset 28Sep2021, outcome "recovered" (29Sep2021); PERIPHERAL SWELLING (non-serious) with onset 28Sep2021, outcome "recovered" (29Sep2021), described as "Swelling of fingers". The action taken for adalimumab was unknown.  Additional information: The reported causality of the events as per reporter with Covid-19 vaccine was possible.  No Follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
2 air bubbles on my skin (left arm),on the injection site; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE VESICLES (2 air bubbles on my skin (left arm),on the injection site), HEADACHE (Headache) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Oct-2021, the patient experienced VACCINATION SITE VESICLES (2 air bubbles on my skin (left arm),on the injection site), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, VACCINATION SITE VESICLES (2 air bubbles on my skin (left arm),on the injection site), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.
I hear swishing sound/hissing sound in my right ear since the day I got my vaccine. The sound started in the evening of the day I got my vaccine.
This spontaneous report as received from a Healthcare worker reported that live (Merck) VARIVAX were expose to unspecified temperature conditions during a power failure for an unspecified period of time, were then administered to unspecified patients on unspecified dates. The indication, dose, route and lot # of the vaccine was not reported. No concomitant medications were reported. No adverse effect reported. At the report time the outcome of event was unknown. It was unknown if the patient sought medical attention. This is one of several reports received from the same source. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a multiple, unspecified number of patients of unknown age and gender. There was no information about the patients concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patients were vaccinated with an improperly stored doses of RECOMBIVAX HB (lot # L018501, exp. date: 22-JUN-2017 and lot# M000442, expiration date: 31-MAR-2018) (doses number and route were not reported). The doses of RECOMBIVAX HB were stored in 11.4 Celsius degree for 1 hour and 14 minutes. There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
feeling bad; Her temperature is 99.3 and 98.7.; body aches; doesn't feel good; Usually she can go to the gym and work out and stuff, but she cannot right now.; She cannot put a finger on it.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 (Lot number: EN6207, Expiration Date: Jun2021) at the age of 59 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "feeling bad"; BODY TEMPERATURE ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "Her temperature is 99.3 and 98.7."; PAIN (non-serious) with onset 2021, outcome "unknown", described as "body aches"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "doesn't feel good"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2021, outcome "unknown", described as "Usually she can go to the gym and work out and stuff, but she cannot right now."; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "She cannot put a finger on it.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: After getting first dose she got her second dose one this Friday. Probably two or 3 days after the vaccine, she first started feeling bad on and off. Some days were worst. They were on and off not improving persisting or worsening. Like Sunday she was feeling fine, and then that night, she started feeling bad. She never ran a fever. Today she came home from work. She started feeling bad again yesterday. Her temperature was 99.3 and 98.7. She did not feel like she has a fever, but she has body aches. She did not feel good. She did not have side effects other than feeling bad on and off after the vaccine. She has tried to take Claritin (lot: OKE2401A; expiration: May 2022) because she thought maybe it was the pollen, but the Claritin did not do anything. It was extra strength, antihistamine, pharmacy brand. She has not been taking it every day and not feeling well at all. Usually, she can go to the gym and work out and stuff, but she cannot right now. She did not feel good and cannot put a finger on it. The Tylenol seems to help and take the edge off.  No follow-up attempts are needed. No further information is expected.
Hospitalized 12/15/2021; COVID-19 positive 12/15/2021; fully vaccinated  BRIEF OVERVIEW: Discharge Provider: PRIVACY, MD Primary Care Provider: PRIVACY, MD Admission Date: 12/15/2021 Discharge Date: Dec 17, 2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute respiratory insufficiency  Pneumonia due to COVID-19 virus  COVID-19    HOSPITAL COURSE: Patient is a 29-year-old man with a past medical history of obesity who presented to the emergency department due to concerns for shortness of breath and was found to have COVID test positive.  He was started on Decadron during this admission along with remdesivir.  Patient initially was requiring 1-2 L of oxygen however this was eventually weaned off to room air and he was doing really well at rest on room air.  Patient was evaluated on the day of discharge by Pulmonary rehab who recommended 2 L of oxygen with activity.  Patient was discharged home on 7 day prescription of Decadron along with 2 L of oxygen.  Instructions were given to follow up with COVID at home program.  Pt returned to ED at local HCF on 12/27/2021 and being evaluated for PE.
Pt c/o hot flush and racing heart rate, BP was 132/78, P 86, R 18.  Pt denied SOB, throat tightness, swelling of lips or tongue, nausea.  HR was regular but became irregular after a few minutes.  Pt transported to emergency room for treatment.
CLIENT RECEIVED VACCINATION ON 9/17/09 AT 10AM. ON THE SAME DATE AT 10:15AM CLIENT STARTED HAVING BLURRED VISION. AT 10:20AM CLIENT FELT TONGUE WAS SWELLING AND NUMB. AT 10:30AM CLIENT FELT DIZZY. AT 10:40AM CLIENT WAS IN THE EMERGENCY ROOM. CLIENT RECEIEVED A DOSE OF THE EPI PEN, IV BENADRYL AND IV STERIODS. ON 9/18/09 AT 3PM CLIENT FELT FACE AND NECK BURNING, TONGUE CONTINUED TO BE NUMB AND CLIENT FOUND IT HARD TO SWALLOW AND ALSO HAD CHEST TIGHTNESS. CLIENT IS NOW UNDER AN ALLERGIST'S CARE. CLIENT STATES THAT SHE CONTINUES TO HAVE SYMPTOMS THAT APPEAR TO BECOME LESSER DAILY.