chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20a) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Live full term birth) on 26-Mar-2019, Pregnancy (Live full term birth) on 24-Oct-2016 and Alcohol use. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 01-Jan-2015 to an unknown date for Pregnancy.    On 04-Jan-2021 at 7:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 02-Oct-2020 and the estimated date of delivery was 09-Jul-2021. On 04-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirteenth week of the pregnancy.  On 04-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jan-2020, Prenatal screening test: normal (normal) Normal. On 01-Jan-2020, Ultrasound scan: normal (normal) Normal.     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 treatment information was provided.  This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.  The estimated date of conception was unknown. The patient had no maternal history of subfertility and had established prenatal care. There was no complications or acute illness reported during tis pregnancy. Number of fetuses was reported as 1.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Greater than 35 days between doses of the Moderna Covid-19 vaccine; Greater than 35 days between doses of the Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Greater than 35 days between doses of the Moderna Covid-19 vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days between doses of the Moderna Covid-19 vaccine) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009DZ1A and 035C21A) for COVID-19 vaccination.     Concurrent medical conditions included Latex allergy.   On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days between doses of the Moderna Covid-19 vaccine). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Greater than 35 days between doses of the Moderna Covid-19 vaccine). On 05-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Greater than 35 days between doses of the Moderna Covid-19 vaccine) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Greater than 35 days between doses of the Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medications information was not reported. Treatment information was not provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-302041 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Follow-up received: Patient demoghraphics, medical history and dose two details were added; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-302041:Same reporter
Patient said she felt weak for 30 seconds and then passed out and them came to. This occurred 12 hours later. Didn't go to ER.
This spontaneous report as received from a registered nurse refers to a female patient of unknown age who an unspecified dates was vaccinated with, second 0.5 ml GARDASIL on unspecified date. A nurse, reported that a patient did not received his third dose of GARDASIL (route and lot # not reported) on time and at the time of the report the patient was in the office for receive it. No adverse effects reported. Additional information has been requested.
No Adverse event. Report only of vaccine given too early in error. Was in office - told what to watch for and follow up calls made. No adverse event noted.
2-19-2010 Notified by coroner that child had died today requesting copy of immunization record. No other information available.
This spontaneous report was received from a registered nurse refers to a patient of unknown demography. It was reported that the nurse reported to determine the temperature stability of VAQTA. The nurse reported that the VAQTA (dose, route and frequency was not reported) which was exposed to temperature outside the prescribing information which was not supported may have vaccinated to an unspecified number of patients on an unknown date. No adverse events were reported. No further information was provided. This case is linked to the case 1402USA004498 (same reporter link). Additional information has been requested.
I95.9 HYPOTENSION 1/7/2022 SECONDARY HYPERCOAGULABLE STATE DUE TO UNSPECIFIED ATRIAL FIBRILLATION J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 2/15/2022 SECONDARY HYPERCOAGULABLE STATE DUE TO UNSPECIFIED ATRIAL FIBRILLATION I95.9 HYPOTENSION 1/7/2022 CAD (CORONARY ARTERY DISEASE) WO ANGINA J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 2/15/2022 CAD (CORONARY ARTERY DISEASE) WO ANGINA I95.9 HYPOTENSION 1/7/2022 ABDOMINAL AORTIC DISSECTION    LATE EFFECT OF STROKE J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 2/15/2022 ABDOMINAL AORTIC DISSECTION    LATE EFFECT OF STROKE I95.9 HYPOTENSION 1/7/2022 ATRIAL FIBRILLATION, UNSPECIFIED J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 2/15/2022 ATRIAL FIBRILLATION, UNSPECIFIED
Breakthrough case admission after three doses  Moderna 2/8/212 Lot# 027L20;  Moderna 3/8/21 Lot# 010M20A;  Moderna 2/23/22 Lot# 083J21A
no adverse effect; The following 10 patients were administered the VAQTA Lot # S009943 that had undergone temperature excursion; This spontaneous report was received from an office manager concerning a 19-months-old female patient. The patient's concurrent conditions, medical history and drug reactions or allergies were not reported.  On 10-OCT-2019, hepatitis a vaccine, inactivated (VAQTA) experienced temperature excursion at -1.49ºC for a timeframe of three days. On 31-OCT-2019, hepatitis a vaccine, inactivated (VAQTA) experienced another temperature excursion at 11.49ºC for a timeframe of fifteen minutes. On 13-NOV-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) (lot # S009943 and expiration date: 26-JUL-2020) as prophylaxis (strength, route of administration and anatomical location were not reported) (incorrect product storage).There was no previous temperature excursion. The call was due to digital data logger.   No adverse effects were reported.  This is one of several cases received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; deviceage and unit: 0 ; malfunction: No; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-1911USA007567:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 62-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 01Apr2022 as dose 3 (booster), single (Lot number: FK9893), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history, no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 for which included PF-07321332, ritonavir (PAXLOVID) from 15Oct2022 to 19Oct2022.  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.
11/8--arm pain left side 2 hours after vaccine. Arm soreness going down--able to move arm.  Chills, fever--99.9 Nausea. Vomiting. decreased appetite. 4-5 days.  Increasing sleep.8 days.  Left sided headache. 1 day  ? Fatigue  No uri symptoms. Cough--mild.  Diarrhea.    Continue to monitor the next 1-2 weeks.
Started feeling fatigue, sinus pain; headache and congestion; Went to an urgent care and tested positive for COVID-19; Was prescribed PAXLOVID.
I was sick with a fever of 103 for 48 hours which I expected. What I didn't expect was a huge inflamed hot and red upper arm that started on Sunday and gradually spread to entirely around my left upper arm from top to bottom.
SIGNIFICANTLY ELEVATED TEMPERATURE (NOT SURE WHAT THE TEMPERATURE WAS); PAIN IN THE ENTIRE BODY (TEETH HURTS, HAIR AND HEAD HURTS, LAYING ON THE PILLOW, CRYING DUE TO THE PAIN); This spontaneous report received from a parent concerned a 25 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: Hashimoto's thyroiditis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1855194, expiry: UNKNOWN) dose was not reported, administered on 10-NOV-2021 16:00 for prophylactic vaccination. No concomitant medications were reported. On NOV-2021, treatment medications included: ibuprofen. On 10-NOV-2021, the patient experienced pain in the entire body (teeth hurts, hair and head hurts, laying on the pillow, crying due to the pain). On 11-NOV-2021, the patient experienced significantly elevated temperature (not sure what the temperature was). Laboratory data included: Body temperature (NR: not provided) Elevated. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in the entire body (teeth hurts, hair and head hurts, laying on the pillow, crying due to the pain) on NOV-2021, and had not recovered from significantly elevated temperature (not sure what the temperature was). This report was non-serious.
Provider drew 0.1cc of Typhoid instead of the PPD vaccination. The Typhoid was then administered to the Left Forearm of the patient where the PPD should have been placed. Pt had no reaction to the vaccination that was placed.
Nausea/vomiting, tmax 100.5, body aches, chills. Vomiting was severe, projectile
pt c/o lower extremity, arms, & wrist swelling for 3 days p/vax;took ASA;also c/o s/sx flu x 1wk;no medical tx was not reported until 6wk later;
A week after the 1st dose I got hypertension. I was evaluated at local Medical Center with high blood pressure and abnormal EKG. I was transported to alternate Hospital and left overnight. I was diagnosed with Tachycardia. In June I had an Ablation. In September the problems with hypertension escalated daily. I was diagnosed with Arterial Fibrillation.
Patient called to report waking up at 3am shivering from head to toe, along with a headache and being swollen at injection site. She also reports extreme thirst and drinking 5-6 bottles of water.
I received the injection with no complications immediately following.   I woke up at 4 am extremely dizzy.  Unable to walk a strait path due to dizziness.  After almost an hour I was able  to fall back a sleep but woke with same symptoms a few hours later that were persistent through out the day.  I contacted my PCP who called in medication Meclizine which did help with my symptoms.  I continued to experience symptoms for 6 days following vaccine.
This spontaneous report was received from a physician via a company representative referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 05-JAN-2015, the patient was vaccinated with a dose of improperly stored of GARDASIL (dose, concentration, route of administration were not provided) (lot # K002740, expiration date 06-AUG-2015). Concomitant medications were not reported. The vaccine had temperature excursions of 48 hours with a lowest recorded temperature of 32 Fahrenheit (F) (0 Celsius (C)). The storage criteria and the storage type were reported as "refrigerator (R)". The vaccine status was reported as "in excursion" No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
On 04/03/2000 the patient was seen by the physician for a headache and 2 papules on his right arm. On 04/04/2000 the patient was again examined by the physician and was seen in the ER on 04/05/2000 for a persistent headache and unsteady gait. It was reported that the was "stumbling" and "falling" and was "definitely ataxic". The patient's mother reported that for the last 3 weeks, the patient has had right arm tremors "when eating or excited" that extinguish when she holds his arm from a moment. Physical examination revealed a patient who has ataxia and is positive for right arm tremor. On 04/08/2000 the patient presented to the physician with a right ear infection. On 04/12/2000 it was noted that the patient was "still wobbly, but improving". On 04/18/2000 the patient still had right otitis media. It was noted that presecription drug therapy was not required for this partner. Follow up information received from a physician reported that on 04/18/2000 the patient recovered from his experience.
This spontaneous report as received from a pharmacist refers to a 46 years old male patient of unknown age. On 03-JUL-2013 the patient was vaccinated with VARIVAX (Merck) (H021386, expire date 30-NOV-2014). Concomitant therapies included terazosin hydrochloride (TERAZOSIN HYDROCHLORIDE). In July 2013 (exact date of development of the chicken pox was unspecified) the patient developed chicken pox with-in 7 days after receiving VARIVAX (Merck). The event outcome was unknown. Additional information has been requested.
Information has been received from a physician via a registered nurse (RN) from the poison control center concerning a 12-month-old male who on 12-SEP-2007 was vaccinated with a dose of Zostavax  (Oka/Merck) instead of Varivax (Oka/Merck).  The reporter stated that the vials looked similar.  Subsequently, the patient experienced no symptoms.  Unspecified medical attention was sought.  No product quality complaint was involved.  Follow-up information states that a relative called the poison control center to report the mix up of vaccinations and that the infant did receive a dose of Varivax (Oka/Merck) after receiving a dose of Zostavax (Oka/Merck).  Additional information has been requested.
2 days after the injection I had the redness at the site (to be expected) and a rash all over my upper torso.  The next day or so I had a severe headache.  Day 4 the rash intensified and started itching terribly.  I still have a rash on 12/8/2020 although it is much less itchy and red than before.
pt recv vax 16JAN97 & pt failed to seroconvert p/2 doses;
Started with high fever (103.6 degrees F)within 12 hr and fussy MOTRIN and TYLENOL for fever - resolved in 356 hrs. No seizure activity, shaking, or staring spells.
Brief 1 minute seizure - tonic clonic associated with fever.  No treatment except TYLENOL, MOTRIN for fever
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with doses of  improperly stored VAQTA, (dose, route of administration, injection site, lot number and expiration date were not reported). No adverse experiences were reported. This is one of several reports received from the same reporter.  Additional information has been requested.
Fever, chills, hot, body aches, headache. It felt like the worst flu ever. This happened the next day it was terrible. By the 2nd day I felt better. Slight headache no fever and just body aches.
The pt returned to the nurses desk where she had been immunized two days prior stating her arm was painful during the night and she noticed redness from the injection site to the elbow. Suggested treatment was analgesics and cold compresses.
chest pain, weakness, listlessness, & a sore lt arm are reported in a pt receiving fluogen vax;
Gave pt vaccine on Friday. Pt called me Monday & said she developed a small rash/lump around injection site. Said it was itchy and reddish/pink. Pt said it occurred Monday AM.
I wasn?t contacted to get the 3rd dose after receiving the first 2 and now I test positive for hpv
This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a adult patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving a SHINGRIX, the patient experienced shoulder pain. On an unknown date, the outcome of the shoulder pain was unknown. It was unknown if the reporter considered the shoulder pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient recently received his SHINGRIX vaccine and wanted to know how long the patient had to wait before the patient would receive cortisone shot for the pain in the patients shoulder. The patient did not want to do anything that would interfere with the effectiveness of the SHINGRIX. The patient was waiting to hear back soon.
COVID Vaccine Breakthrough Case  Pfizer Dose 1 12/28/21 (lot NA) Pfizer Dose 2 1/18/21 (lot NA) COVID Positive 12/1/21  12/1/21: Patient is a 91 year old female with PMH osteoporosis and vascular dementia who presented to the ED today for confusion and possible UTI.   She was seen earlier today in clinic at which point her daughter noted the patient was having cloudy, dark urine with confusion.  She has history of UTI in the past that had similar symptoms and required hospitalization.  She also noted cough with others in her home being ill about 1 week ago.  She was advised to go to the ED for futher evaluation.   Upon exam her daughter noted that cold symptoms started on Saturday including a productive cough and rhinorrhea.  On sunday she began to develop confusion and decreased appetite.  Since that time she notes patient has gradually declined.  She has had some diarrhea.  She has had some incontinence which is not typical for her. Denies use of any OTC medications.  Not on any medications at home.   In the ED: Patient arrived tachycardic at 95 bpm with otherwise stable vitals and afebrile.  Labs were notable for Na 125, K 3.0, normal WBC and lactic acid, negative troponin.  Urine studies notable for moderate leuk esterase, trace blood, and few bacteria.  Urine and blood cultures obtained and pending.  CXR indicated no acute cardiopulmonary processes.  Head CT negative for acute findings.  EKG showed normal sinus rhythm.  Patient was given 1g Ceftriaxone, KCl 20 mEq, NS 500 ml.   Surgical Hx: cholecystectomy  SH: former smoker, lives with daughter  FH: noncontributory  12/6/21: Patient is a 91 year old female with PMH osteoporosis and vascular dementia who initially presented to the ED for confusion for 4 days in the setting of cold symptoms and other sick contacts within the home.  She was saturating well on room air and was afebrile, however did test positive for COVID.  She also noted dark and cloudy urine similar to previous UTI's. Urine was notable for a UTI for which she was treated with a 3 day course of IV ceftriaxone.   Confusion was thought to be due to hyponatremia which was slowly corrected with free water restriction and NS boluses.  CT head indicated no acute findings.   Throughout her admission her sodium normalized and she remained asymptomatic with COVID.  She did not qualify for any treatments for COVID per protocol aside from anticoagulation for which she was treated with subcutaneous heparin.  She never required supplemental oxygen.  Her family was initially requesting SNF placement due to deconditioning however upon finding out that the patient would need to remain in the hospital until 10 days from the first positive test due to regulations at the nursing home they chose to have her discharge home to their care instead with COVID safe at home and VNA.  On day of discharge patient was unhappy, believing she would have to stay, however was not requiring any supplemental oxygen and remained asymptomatic.   IMPROVE VTE score at discharge was 1 so patient did not require any outpatient anticoagulation.
Flushing, Face Tingles, Hot Flashes feels like flushing of the face and upper body
Received vaccine mandated for continuing hospital employment, no history of VZV disease or vaccination Fever to 103 degrees, rash covering >90% of body surface, more severe on back, sides, legs and arms accompanied by systemic itching. Swelling of mouth, lips and throat. Self dispensed 75mg diphenhydramine, 1,000 mg acetaminophen pre arrival to Emergency Department. Stayed for 3 hours for observation, directed to report to Occupational Health the next day. ED gave a diagnosis code of adverse reaction to vaccine, initial encounter and allergic reaction to vaccine. Brief, much more mild recurrence of same exactly three weeks later, resolved with same OTC treatment.