chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Parent entered a birthdate of 1/25/2009 for the patient at time of vaccination. On review it was found that their birthday was actually 9/25/2009. I spoke to the parent. The parent had entered an incorrect birthdate because they stated that they wanted their child to be vaccinated due to the presence of people at high risk of severe disease from COVID-19 in their home. No adverse effects noted.
Subsequent to receiving two doses of varicella virus vaccine live, the pt's laboratory values indicated that the pt failed to seroconvert.
Pt received DTaP #4, HIB #4, MMR #1, Prevnar #4, Varivax on 05/09/203. He was Dx with ITP on 05/25/2003 with a plt count =12K. This is a 1 year old white male who has had a rash for the past 5 days at home. Mom noticed yesterday that he had a bloody nose on a couple of occasions and mom has also noted that he has been very off balance for the past couple of days. She also noticed that he has had quite a few bruises lately. She felt they were from falling down. He has had no fevers, no significant cold symptoms and he has not been acting ill. His activity level, his eating and his sleeping behaviors have all been within normal limits. His past medical history is non contributory. He is on no medications, has no allergies, has no chronic medical problems. He did receive his 1 year immunizations a couple of weeks ago. Well developed, well nourished white male in no acute distress. Weight 22, temp 97,pulse 118, resp rate 24. HEENT- there is a purplish green black and blue mark on the patient's forehead. TM's are close. Throat is clear with some petechiae on the soft palate. Nares are clear without any obvious bleeding. Neck supple without lymphadenopathy. Lungs are clear to auscultation. Cardiovascular is without  murmurs. Regular rate and rhythm. Abdomen is round, no hepatosplenomegaly or masses noted to deep palpatation. Lymph nodes- there are no supraclavicular, axillary or inguinal nodes palpable. GU- tests are down bilaterally. Tanner Stage 1 male. Extremities and skin- the patient has multiple petechiae all over his skin. He has bruises on his chest. He has bruises on his upper arms and his back in varying stages. C & S- he is alert and oriented. He is playful and appropriately bonded to his parents. Lab- CBC shows a white count of 11.7, hemoglobin of 11.9, hematocrit of 34.9, platelet count of 12.000, 77% neutrophils, 14.8% lymphocytes, 8.1 % mid range and 1.7% absolute neutrophils.  This is a 1 year old white male who presents with thrombocytopenia. This may very well be ITP, could be the beginnings of leukemia.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 76-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: NEBIVOLOL, start date: 01Jan2016; LISINOPRIL, start date: 01Jan2017; MELATONIN, start date: 01Dec2021. Past drug history included: Tamiflu, reaction(s): "cardiac arrhythmia due to Tamiflu"; Tamiflu, reaction(s): "known allergies: Tamiflu". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 27Dec2022 to 31Dec2022.  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 temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug.
1/21/2022   Chief Complaint:  Abdominal pain   Source of Information:  Patient   History of Present Illness:  This is a 34y.o. female with a past medical history of sickle cell anemia, epilepsy, HSV, moyamoya disease, and blood clots presents with abdominal pain.  This started this morning after patient woke up.  Patient states that she was having blood in her urine since Saturday and the pain became severe today.  Patient states she had a similar episode in 2019 when she had a UTI and was hospitalized.  She denies any fevers at this time but experienced chills.  She also experienced some lightheadedness and dizziness.  The pain is increased when she tries to lie down and patient states she cannot get comfortable.  The pain starts in the periumbilical region, pelvic region then moved to her right side.  Patient states she has been able to eat and drink okay lately.  Patient states this is significantly different from her sickle cell crisis episodes.  Patient states that she follows with a doctor at Hospital for monthly transfusions for her sickle cell disease.  Her last transfusion was last week.  Patient denies tobacco, alcohol, illicit drug use.  She does use pain medications at times. In the ED, Vitals on arrival of T 100.2°F, BP 104/57, HR 107, RR 22, SpO2 98% on RA Labs remarkable for wbc 22, hgb 10.5 on CBC, BMP unremarkable.  CT A/P shows no acute intra-abdominal process, cholelithiasis, hepatomegaly and autosplenectomy.  US abdomen shows no fluid, gallbladder with hyperechoic foci but without wall thickening. US pelvis with transvaginal Doppler shows layering debris and simple right ovarian cyst measuring up to 3.3 cm. Patient received fentanyl 50 MCG X3, Toradol 30 mg, ceftriaxone, Zofran, normal saline bolus 1 L. Surgery and ID consulted.
A report received from a health care professional on 11/06/02, concerning a 2 year old male vaccinee who was administered Fluvirin. On 11/04/02, the vaccinee was administered 0.25 ml of Fluvirin vaccine. No adverse symptoms were reported. There was insufficient information to determine the reporter's causality assessment. Update (1) 12/31/02: An update report was received from a health care professional which indicated that the vaccinee did not experienced any adverse effects at the time of the report.
Tiredness (no energy) Headache Chills Fever 107 Injection site redness Nausea
Doses administered after more than 1 temperature excursion; Doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 1:49 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 1:49 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 30.64  On 03-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 210, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 03-Apr-2021. 20 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021.  On 03-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 38, 9 AM: 34, 10 AM: 38, 11 AM: 42, 12 AM: 41, 1PM: 41, 2 PM: 41, 3 PM: 40, 4 PM: 40 and 5 PM: 41.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Concomitant products were not reported. Treatment medications were not reported.
Pt was supposed to receive the monovalent covid 19 pfizer vaccine but instead received the bivalent vaccine. no adverse reactions.
large lump and redness at injection site, nausea, very bad muscle aches & pain, headache, chills.  This was my "booster" shot.  Much worse on side effects than second dose.  Will hope symptoms subside, if not; I will seek medical treatment.
patient who received 0.13 mL, 1/4 of a dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (patient who received 0.13 mL, 1/4 of a dose) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .13 ml. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (patient who received 0.13 mL, 1/4 of a dose). At the time of the report, INCORRECT DOSE ADMINISTERED (patient who received 0.13 mL, 1/4 of a dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication reported.  Treatment information not provided.
MIGRAINE; This spontaneous report received from a 55 year old female patient. The patient's height, and weight were not reported. The patient's past medical history included migraines, and concurrent conditions included penicillin allergy, environmental allergy, and seasonal allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802068, expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 12:00 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported.  On 09-MAR-2021 18:00, the patient experienced migraine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from migraine. This report was non-serious.
Immediately after the shot (10:29 am) , the patient's arm developed a round, swollen area around the injection site that turned into a hard knot. Within 5 minutes, the patient described feeling hot, dizzy, experiencing an elevated heart rate, and her arm was hurting (10:34 am). Over the next 10-20 minutes her symptoms did not improve, but she began to feel light-headed and stated multiple times that she may pass out; She also described having a dry mouth and tingling sensations in her arm (10:45 am). We monitored blood pressure every 5 minutes, asked the patient to lay on the floor, and fanned her. She refused an ambulance initially, but did ask for one ~30 minutes after vaccine administration. Patient refused an epi-pen.
No adverse effects; the patient received one dose of MMR-II inadvertently by the intramuscular route; This spontaneous report was received from a pharmacist referred to a male patient of an unknown age.    The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the pharmacist reported that "one week ago", on approximately 05-JUN-2019, the patient received one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II)(lot number and expiration date was unknown) inadvertently by the intramuscular instead of subcutaneous and no adverse effects was reported(incorrect route of product administration and no adverse event). No additional information provided and no PQC found.
Feeling sick; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling sick) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014N20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced MALAISE (Feeling sick). At the time of the report, MALAISE (Feeling sick) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported. Patient was tested positive for covid-19 and kept quarantine until 29-MAR-2021. Patient was scheduled for her second dose on 19 APR 2021.
The pt experienced hives the same night of vaccination. Benadryl was given. Hives subsided a little. Reappeared in AM and another dose of Benadryl was given. Pt also complained of hoarseness.
Three more patients "in the same boat" (it has been 15 weeks and they have not received their second dose); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Three more patients "in the same boat" (it has been 15 weeks and they have not received their second dose)) 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 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Three more patients "in the same boat" (it has been 15 weeks and they have not received their second dose)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Three more patients "in the same boat" (it has been 15 weeks and they have not received their second dose)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication use was not reported.   Treatment information was not reported.
diarrhea; chills; o2 saturation is at 91; This is a spontaneous report from a Pfizer sponsored program. A contactable male patient of unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number & Expiry date not reported) via unspecified route of administration on unspecified date as dose 1, single for COVID-19 Immunization. Patient medical history include he got his first dose last Friday prior to vaccination he fell on his knees four days ago. This Saturday he felt pain specifically joint pain and, on his knees, got bruises from the fall. Patients concomitant medications were not reported. On unspecified date, patient experienced diarrhea with chills, O2 saturation is at 91 percent, blood pressure is normal. Patient did not take any medications for events. Patient underwent lab test and procedures include Blood pressure measurement was normal and Oxygen saturation was 91% on unspecified date. Patient was asking if these are possible effects of the vaccine. The Outcome of all events was unknown.  Information about lot/batch number has been requested.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Admission Date: 3/5/2023 Discharge Date: 03/9/2023  PRESENTING PROBLEM: COVID-19    HOSPITAL COURSE: Patient  is a 92 y.o. male with past medical history significant for hypertension, glaucoma, coronary artery disease s/p CABG, prostate cancer, bladder cancer, basal cell carcinoma, squamous cell carcinoma who presented emergency department with complaints of generalized weakness and fatigue. He was having difficulty with ADL. In the ER found to have COVID-19 and admitted to medicine for further evaluation.    Initially oxygenation well on room air and no COVID treatment, but developed slight hypoxia and intermittently requiring oxygen. Therefore started on remdesivir and dexamethasone. UA checked with urinary symptoms and returned with enterococcus. He was given fosfomycin in the ER for treatment. He admitted to chronic frequency otherwise no symptoms.  He admitted to some right hand/grip weakness.  MRI brain and cervical spine was obtained with no acute abnormality and spinal cord with normal signal characteristics.  Overnight pulse oximetry study was done and patient was setup to wear 2 L nasal cannula with sleep and naps.  Overall patient felt well at discharge.  He was recommended follow up his primary care physician.  He was discharged home in stable condition.
On right arm - S/Q with Pneumovax. Redness in irregular pattern around injection site - partially circumferentially around arm. 4cm x 15 cm (circumference) more splotchy. Some local induration.
BP 104/84, HR 86, PO2 96%.  dizziness and nausea. Given water and bar. Pt is back to baseline , walked 10-15 , denies dizziness.
Narrative:  Patient has arm soreness in injection site. Resolved within 48 hours.   Other Relevant Hx:  Symptoms:  & arm pain Treatment:
Patient came in for booster dose of COVID-19 Vaccine Shot 09/29/2021. Patient was notified that Pfizer was the only vaccine approved at this time for a booster unless they had certain underlying conditions. Patient reported that 1st and 2nd doses were in fact Pfizer. Doses were >6months prior. No brand name was on card, only lot numbers. Patient fit eligibility for booster dose. Booster dose given 09/29/2021. When putting vaccine into the system it was found that she had had Moderna for the 1st 2 doses. No adverse reactions noted. Patient notified and will let us know if any adverse reactions. State notified of error.
Caller has received two Covid-19 AstraZeneca vaccines as well as both Pfizer Covid-19 vaccines; Caller has received two Covid-19 AstraZeneca vaccines as well as both Pfizer Covid-19 vaccines; Caller has received two Covid-19 AstraZeneca vaccines as well as both Pfizer Covid-19 vaccines; pain in her right arm; nausea; This is a spontaneous report from a contactable consumer. This female consumer(patient) reported for herself. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), dose 2 via an unspecified route of administration, administered in Arm left on an unspecified date as a single dose for covid-19 immunization. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) included covid-19 vaccine nrvv ad (chadox1 ncov-19) (COVID-19 VACCINE ASTRAZENECA) taken for covid-19 immunisation. The patient has received two covid-19 astrazeneca vaccines as well as both pfizer covid-19 vaccines. She had pain in her right arm, nausea on an unspecified date. Caller received her second Pfizer covid-19 vaccine in her left arm, but reports pain in her right arm. Caller is interested in clinical trials for individuals in her situation and would like to report experienced side effects. Outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Significant body aches, chills, cold sweat, nausea, low grade fever, feeling like I was going to pass out.
Information has been received from a licensed practical nurse concerning a 30 month old white female who on 13DEC2001 was vaccinated in the right arm with a first dose of varicella virus vaccine live. Concomitant therapy on 12DEC2001 included a first dose in the left arm of measles-mumps-rubella vaccine. On 24JUN2003 the patient developed a rash. Upon an office visit on 26JUN2003, it was noted that the patient had erythema papules with one pustule. The pustule was located on the patient's trunk. The papules were located on the patient's left leg, right forehead, and back and abdomen. It was also noted that the patient was in the hot tub and the physician was questioning the diagnosis of varicella breakthrough or hot tub folliculitis. The outcome was reported as recovered. The reporter also indicated that one other patient developed lesions after being vaccinated with a dose of varicella virus vaccine live. No further information is expected.
I received my 1st shot in 2019; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first shot in around 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 02-FEB-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient asked who would have the record of his/her first dose and stated that his/her healthcare professional wants the record. The patient questioned who keeps the records of who gets these shots. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The VAERS details was reported for 1st dose. Follow-up would not possible as no contact details were available.
Pt recvd a series of 3 Engerix-B vax 03MAY90, 06JUN90, & 11NOV90; 11MAR91 titer of ANTI-HBS was 5; 4th dose is planned p/pt returns to work;
3/21/22 AREA OF INJECTION SWOLLEN 3/23/22 INJECTION AREA BLISTERED UP
Severe nausea that led to vomiting. Intense muscle and joint pain. Uncontrollable chills, fever. Unable to sleep or eat.