chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Husband verbalized that wife was very anxious about the process and vaccination and after receiving the vaccine she was texting and reading while he was driving and she felt dizzy,  She was evaluated by Rescue and at 1:35 pm was released to her home feeling good.
Vertigo came back stronger (After SECOND Shot); a little Sleepy; Afraid to go to bed at nights; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VERTIGO (Vertigo came back stronger (After SECOND Shot)), SOMNOLENCE (a little Sleepy) and FEELING ABNORMAL (Afraid to go to bed at nights) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 030L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced VERTIGO (Vertigo came back stronger (After SECOND Shot)) (seriousness criterion hospitalization), SOMNOLENCE (a little Sleepy) (seriousness criterion hospitalization) and FEELING ABNORMAL (Afraid to go to bed at nights) (seriousness criterion hospitalization). At the time of the report, VERTIGO (Vertigo came back stronger (After SECOND Shot)) had not resolved and SOMNOLENCE (a little Sleepy) and FEELING ABNORMAL (Afraid to go to bed at nights) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal (normal) Normal.         Concomitant product use was not reported. On an unspecified date, an EKG was performed (results not reported).The patient did not receive any treatment.  Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.   This case was linked to MOD-2021-066561 (Patient Link).; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Patient received 2 dose of the RSV (arexvy) on 9/25/2023 and on 10/05/2023 at the pharmacy.
Localized mild swelling. Redness, itching and hot to touch. Pt was given typhoid and anthrax IM in same arm.
Product preparation error; Wrong technique in product usage process; No additional AE reported.; Information has been received from a medical assistant concerning a 21 month old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 14-JUL-2021, the medical assistant added sterile diluent (lot number R033082, expiration date on 14-AUG-2021, dose 0.7 mL) to the hepatitis a vaccine, inactivated (VAQTA) vial (lot number T022333, expiration date on 11-DEC-2021, dose 0.5 mL) prior to administration for prophylaxis. Dose number, route of administration and anatomical location were not reported. She reported that they normally get the prefilled syringes but ordered the vials instead. She was not aware that she was not suppose to add diluent until after the product was administered (wrong technique in product usage process) (product preparation error). No adverse event. No product quality complaint. No additional information was reported.
Guillain Barre Syndrome. received treatmetn with IVIG. symptoms improved, discharged to rehabiliation center at time of form submissions.
Patient presented with warm and red right leg. The leg was swollen and the child was limping.  Fever of 101F. treatment: Keflex for 10 days and Tylenol as needed.
I got my vaccine on 1/26/2021 at 1:00 PM and at around 6:00 PM, I began having an adverse effect. I felt pressure behind my eyes and had trouble visually focusing. The eye pressure felt like a sinus cold, and the lack of visual focus felt kind of like eye strain from being on the computer for a long time. I also had a rash around both of my eyes that felt like I had had a reaction around my eyes from a topical treatment, and I hadn't put anything on my eyes. There were raised, scaly patches on the lids, and there was red, itchy skin around the eyes. I had a headache for a little while, but it went away by 1/27.  On 1/27, I still had the eye pressure, lack of visual focus, and itchy eyes. I sent a text to the doctor explaining the symptoms. By the evening of 1/27, I still had not heard from the doctor, so I took Benadryl to help with the itching, and it seemed to help. The symptoms began to diminish after taking the Benadryl, and they were completely gone after 5 days. The doctor sent me cream for the itchy eyes, but I ended up not needing it.
I immediately felt skin and eye itchy after I received the vaccines. Stayed in the waiting room for 30 mins, felt better. Next day skin  itch got worse. Specially around my eyes.Eye itchy, rubbing, pain, vision blurry,  puffiness, discharged, I bought some allergy drops but it didn?t get better. , on the 7 days after the vaccine, it was a Saturday, it got so much worse  that I could barely open up my eyes. So I went to  a clinic. The nurse practitioner gave me eyes drop for infection, it did not get better. She prescribed another eye drop, still not working. Now my eyes feel horrible,.
Information has been received from a registered nurse concerning a 27 year old female patient, with no known drug allergies, who on 01/28/2002 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation)(Lot # 639917/0742L).  Follow up information indicates that a second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation)(Lot # 644083/0877M) was given in the left arm on 02/03/2003.  There was no illness at the time of vaccination.  On 12/26/2002 (also reported as 01/02/2003) the patient's titer was negative for rubella and a lab report indicates a "failure to serconvert."  Lab report from 12/26/2002 included: Measles AB (IGG) 1.21, Mumps AB (IGG) 1.05 and Rubella AB (IGG) <OR=0.90.  Unspecified medical attention was sought.  In follow up information the reporter indicated that "we did not administer the vaccine and there is nothing new to report."  The patient was going to have another measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) administered and titer drawn.  It was reported that "we have no more information".  Additional information is not expected.
Maculopapular itchy rash; Maculopapular itchy rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULO-PAPULAR (Maculopapular itchy rash) and RASH PRURITIC (Maculopapular itchy rash) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced RASH MACULO-PAPULAR (Maculopapular itchy rash) and RASH PRURITIC (Maculopapular itchy rash). The patient was treated with BACITRACIN for Rash, at an unspecified dose and frequency. At the time of the report, RASH MACULO-PAPULAR (Maculopapular itchy rash) and RASH PRURITIC (Maculopapular itchy rash) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient's concomitant medications were not reported.   It was reported that the rash was as big as an orange on her vaccinated arm. The patient stated that the itchy rash went away after three and a half weeks.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Event Outcome was updated to recovered.
Patient was seen by me in our clinic. Client was to receive Twinrix, MMR and Varicella. When I pulled the vaccine to administer I pulled and administered Twinrix, ProQuad and Varicella.
11/12/ 21 Two hours after receiving the flu and covid-19 vaccines my daughter's face began to itch pretty severely. Upon examination, I found red hives clustered on her face, from the temple down to her jaw line on both sides of her face. I contacted her pediatrician's office after-hours and spoke with the doctor. The doctor suggested 10 ml of Benadryl and to monitor her breathing and watch for swelling of the mouth/tongue. I administered the medication and she fell asleep. I continued to monitor her throughout the night.  11/13/21 9:00 am-Her face seemed significantly better, only a couple  small, pale hives remained. My daughter stated that she was no longer itchy. 10:00 pm-Her face began to itch again. The same pattern of hives occurred again, so I administered another 10 ml of Benadryl.
PATIENT PRESENTED 15 MINUTES AFTER VACCINATION WITH DIZZINESS, PALLOR, TUNNEL VISION AND BLURRY "LIKE I'M GOING TO PASS OUT", LIGHTHEADEDNESS.  PATIENT IMMEDIATLEY PLACED IN SUPINE POSTION.   SHE STATED SHE FELT BETTER AFTER 10 MINUTES AND  SHE WAS GIVEN WATER AND A LOLLIPOP.  SHE STATED THAT SHE HAD NOT EATEN MUCH DURING THE DAY.  AFTER HYDRATION AND SOME SUGAR ON BOARD SHE WAS ABLE TO SIT UP WITHOUT ANY SYMTPOMS.  VSS THROUGHOUT.  VS TAKEN Q5' SAO2 94-97%, BP 126/80, HR 87, RR 18 AND UNLABORED.  LUNGS CLEAR.  AFTER 15 MINUTES SHE WAS ABLE TO STAND WITHOUT ISSUES AND AMBULATE INSIDE TO A TABLE WHERE HER EMPLOYER WAS BRINGING HER LUNCH.  NO FURTHER ISSUES.
Diaphoretic, tachycardic, muscle pain in leg, difficulty swallowing. Fluid bolus,  iv push of benadry & solumedrol. Later that night nausea.  Pepto helped alleviate
Initial misuse report received from a healthcare professional on 20 June 2013. A 6-months-old had received third dose of ACTHIB, reconstituted with sterile water. No adverse event was reported. List of documents held by sender: none.
pt recv 1 dose of varivax 3/31/98 & 4/18/98 devel early chickenpox on la, chest & back. also approx 12 red & itchy lesions.
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, thyroid, alcohol use (occasional wine), and non-smoker, and other pre-existing medical conditions included the patient had no known allergies and did not had drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 041AZ1A or 041A21A, expiry: Unknown) frequency one total, dose was not reported, administered on 09-APR-2021 in right deltoid for prophylactic vaccination. No concomitant medications were reported.  The consumer reported that on unspecified date, the patient experienced suspected immunological vaccine failure and reported that antibody test called Sars-cov2-spikeAK was given to the patient by her primary care physician which came back negative for antibodies. The consumer also reported that the patient did not had any other side effects. Laboratory data included: Sars-cov-2 antibody test (NR: not provided) Negative antibody test. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). The suspected product quality complaint has been confirmed to be voided based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20210452504-Covid-19 vaccine ad26.cov2.s-Suspected Immunological Vaccine Failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Mom states - Son received T-dap vaccine on Tues 5/14/13 pm - Son woke around 11:30 AM and called her complaining of fever and SOB - Mom went home to check son - temp 102 and still having SOB - told mom to take son to ED. 6/3/13 attempted to f/u several times after report on 5/15/13. Spoke with mother on 5/23/13. Mother assistant patient was taken to ER on 5/15/13 - Temp 103 degrees, was retained in ER for 5 hours until fever resolved, was administered IV flds Lab work negative. Mother assistant patient went to work after receiving Tdap vaccine on 5/14/13, became ill after cutting grass. No other f/u reported.
Patient with onset of itching and hives within 6 hours of injection.  Benedryl was recommended.
Additional information was received via medical records, alleging the patient experienced the additional events of autism, neurodevelopmental disorder and pervasive developmental disorder and provided vaccines administered dates and lot numbers. This case was considered medically important. Information regarding Hib-Titer was received from an attorney regarding a male patient who received a third dose on 27-Dec-1996 along a third dose of DTP. The patient mercury poisoning and learning disability. A legal complaint was received from an attorney alleging that a male child received a dose of Hib-Titer along with other childhood vaccines. According to the legal complaint the child was "perfectly normal and healthy at birth, developed normally and demonstrated social, cognitive, behavioral and physical age-appropriate skills." According to the legal complaint the child was exposed to "cumulative toxic levels "was caused to suffer serious and permanent neurological damage...to include past and future mental, intellectual, developmental and neurological incapacity and associated learning disabilities, disorders and impairments". Additionally, it is alleged the child developed Autism and neurodevelopmental disorder. In Feb-2000, the patient was diagnosed with Pervasive developmental disorder. The patient's outcome is unknown. No additional information was available at the time of this report.
Extreme swelling and redness, itchiness at vaccination location. Extreme joint aches, pains, weakness, tiredness stomach problems, possible skin infection. All the above lasted 4 weeks.
PATIENT STATED ARM WAS SWOLLEN, RED, HOT TO TOUCH AND PAINFUL 2 DAYS FOLLOWING ADMINISTRATION. SHE CALLED DR WHO TOLD HER TO REPORT IT TO THE PHARAMCY, SHE WAS NOT SEEN BY DR. PATIENT PRESENTED TO THE PHARMACY 4 DAYS FOLLOWING THE VACCINE WITH ~8 INCH RASH ON UPPER LEFT ARM, ARM SLIGHTLY SWOLLEN, AND PAINFUL. SHE HAD BEEN TAKING CLORTRIMATON.
Patient received a pediatric Pfizer dose, and should have received an adult dose.  This occurred at 14:20.  The patient left the facility showing no obvious reactions or signs of distress.
SERIOUS MEDICAL PROCEDURE FOR ULCERATIVE COLITIS; COULDN'T WALK FROM CAR TO JOB; ENDED IN EMERGENCY ROOM FOR CONSTIPATION; REACTIONS IN THROAT FOR WHICH EGD PROCEDURE IS SCHEDULED; I WAS ILL, LIKE I HAD COVID AGAIN, WAS ON COUCH ALL DAY, AND DOWN ALL WEEKEND; BATHROOM ISSUES WENT FROM LOOSE TO COULDN'T GO TO BATHROOM; LEGS, FEET, HAND, WRIST, FINGERS, LOWER BACK DOWN WAS NUMB; This spontaneous report received from a patient concerned a 64 year old  female of unspecified ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 infection, and other pre-existing medical conditions included: The patient had no bowel issues, no numbness issues, no physical ailments before shot. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 206A21A expiry: unknown) dose was not reported, 1 total, administered on 10-APR-2021 at 10 or 10:30 hours to left arm for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021 after vaccination by 17:00 hours patient experienced like she had covid 19 again, patient was on couch all the day and down all weekend and the patient had bathroom issues, couldn't walk from car to job, legs, feet, hand, wrist, fingers, lower back down was numb. This since 10-APR-2021 continued and symptoms worsened. The patient's bathroom issues went from loose to couldn't go to bathroom, she went to the physician's office and ended in Emergency Room for constipation, was referred to gastroenterologist. The patient has been under doctors care and had serious medical procedure for ulcerative colitis. Reactions in throat due to shot for which the patient has been scheduled for esophagogastroduodenoscopy procedure. Laboratory data (dates unspecified) included: Colonoscopy (NR: not provided) Unspecified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bathroom issues went from loose to couldn't go to bathroom, couldn't walk from car to job, and legs, feet, hand, wrist, fingers, lower back down was numb, and the outcome of ended in emergency room for constipation, serious medical procedure for ulcerative colitis, reactions in throat for which esophagogastroduodenoscopy procedure is scheduled and i was ill, like i had covid again, was on couch all day, and down all weekend was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210858787--Ulcerative colitis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Runny nose, coughing, sneezing, stuffy nose, with nasal pressure. Tested positive for Covid-19 4/9/22.
Hospitalized (10.18.21);  COVID-19 positive (10/15/21);  fully vaccinated  Admission Date: 10/18/2021 Discharge Date: 10/25/2021 10/25/2021   Admission Diagnosis: Pneumonia due to COVID-19 virus [U07.1, J12.82] COVID-19 [U07.1] Inpatient procedures: None Hospital Course: Patient is a 85 y.o. female with pmhx relevant for CLL, Parkinson's, Epilepsy (keppra), and hyperlipidemia, and was admitted for acute respiratory failure and pneumonia due to COVID-19. She was vaccinated in March and April of 2021 with Moderna. She was treated with dexamethasone and remdesivir as well as supportive measures. She improved nicely and was stable on room air for ~24 hours prior to discharge. PT/OT initially recommended SAR but she showed rapid improvement and is discharged with home health services including therapy, skilled nursing, and SLP. Chronic conditions were stable and medications unchanged at discharge. On admission CXR she was noted to have a lesion suspicious for multiple myeloma on right humerus, however this was not demonstrated on dedicated right humeral x-ray. Extensive laboratory evaluation was completed for MM and was reassuring. No monoclonal proteins were found on immunofixation of serum. kappa and lambda free light chains and ratio were wnl. 24 hr urine collection for UPEP was also a negative study.
Approximately 40 minutes post vax, the pt complained of something in her throat. she became cyanotic and heart rate was irregular. She was treated with epinephrine, Benadryl and nebulizer/albuterol. The pt recovered.
Blood clots resulting in many strokes, brain bleeding due to strokes resulting in crushing the Brain Stem, heart attacks and death
red huge swelling at the injection site; injection site pain; chills; headache; hot rash; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (red huge swelling at the injection site), INJECTION SITE PAIN (injection site pain), CHILLS (chills), HEADACHE (headache) and INJECTION SITE RASH (hot rash) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE SWELLING (red huge swelling at the injection site), INJECTION SITE PAIN (injection site pain), CHILLS (chills), HEADACHE (headache) and INJECTION SITE RASH (hot rash). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form once a day and NAPROXEN SODIUM (ALEVE) at a dose of 1 dosage form once a day. At the time of the report, INJECTION SITE SWELLING (red huge swelling at the injection site), INJECTION SITE PAIN (injection site pain), CHILLS (chills), HEADACHE (headache) and INJECTION SITE RASH (hot rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included medication for diabetes, blood pressure and neuropathy.
Debilitating migraines in a 10-year old lasting for a week after receiving LAIV along with tingling in hands and feet.
FEVER; MUSCLE ACHES; LOCAL SITE INJECTION PAIN; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced fever, muscle aches, local site injection pain, nausea, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, muscle aches, local site injection pain, nausea and headache was not reported. This report was non-serious.
Monday 10/21/13 received flu vaccine (sl. congestion) prior but no other symptoms. On 10/23/13 developed low grade fever. The next day started with rash, runny nose, seen office 10/24/13 and again 10/25/13 - blood work and modest lymphocytosis. Covered with BENADRYL and amoxicillin. Seen again 10/28/13. Dx with Gianotti-Crosti linked with influenza virus vaccine.
This spontaneous report as received from a licensed vocational nurse refers to a 2 month old male patient with no relevant medical history, concurrent condition, drug history, laboratory data or concomitant medication. On 06-JUL-2016, the patient was vaccinated with a 2 ml dose of ROTATEQ lot # L029615 with expiration date on 15-MAY-2017, orally; that was exposed to a temperature excursion. The nurse reported that after receiving the improperly stored vaccine, no adverse events had been reported and that as of 25-AUG-2016 it was unknown if the patient would continue the therapy with ROTATEQ. This is one of several reports received from the same reporter. Additional information has been requested.
Pt. inadvertently was administered 2 doses of the PCV-13 vaccine during the same visit.
congestion; I feel body aches; I experienced a severe headache for a day; This spontaneous case was reported by an other health care professional and describes the occurrence of NASAL CONGESTION (congestion), MYALGIA (I feel body aches) and HEADACHE (I experienced a severe headache for a day) 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 14-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2022, the patient experienced NASAL CONGESTION (congestion), MYALGIA (I feel body aches) and HEADACHE (I experienced a severe headache for a day). At the time of the report, NASAL CONGESTION (congestion) and MYALGIA (I feel body aches) had not resolved and HEADACHE (I experienced a severe headache for a day) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.