chrisvoncsefalvay/vaers-outcomes huggingface dataset:
ED to Hosp-Admission Discharged  4/3/2021 - 4/10/2021 (7 days) Hospital  MD Last attending ? Treatment team Severe sepsis with acute organ dysfunction Principal problem Discharge Summary MD (Physician) ? ? Internal Medicine         HOSPITAL INPATIENT DISCHARGE SUMMARY HOSPITALIST GROUP .   Date: 4/10/2021 Admission Date: 4/3/2021 Length of stay: 6 Days PCP: MD Discharging provider: MD    Admission diagnosis:     Primary Admission Diagnosis    Hospital Problems          POA   * (Principal) Severe sepsis with acute organ dysfunction Yes       Left hip pain Yes       Primary osteoarthritis of left hip Yes       Intractable vomiting with nausea Yes       Acute metabolic encephalopathy Yes       COVID-19 virus infection Yes       Gastrointestinal hemorrhage with hematemesis No       Urinary tract infection associated with indwelling urethral catheter Yes                HPI: Admitted with severe left hip pain and altered mental status. patient with history of stroke Was also found to have Covid positive at the time of admission     Hospital Course:    Following issues were addressed during this hospitalization   Acute encephalopathy: At the time of admission Most likely secondary to gabapentin Held medication during this hospitalization and also stopped at the time of the discharge. Patient was started on this medication recently due to his left hip pain.   COVID-19 infection D-dimer was elevated at the time of presentation.  CT chest ruled out pulmonary embolism.  Ultrasound did not reveal any DVT. Patient did not qualify for any convalescent plasma remdesivir during this hospitalization as he is saturating well on room air.   Possible catheter associated urinary tract infection Patient with chronic indwelling Foley catheter. Urine culture grew Staphylococcus hemolyticus and Enterococcus faecalis faecalis. Patient was started on ampicillin during this hospitalization he completed the 5-day course.   Sepsis ruled out at the time of admission   Acute kidney injury present at the time of admission Suspect underlying chronic kidney disease Patient needs to follow-up with the PCP for the follow-up on the creatinine in 1 week.   Left hip pain Patient underwent extensive work-up during this hospitalization.  MRI of the left hip showed high-grade tear of the iliopsoas tendon.  Patient was seen by orthopedics recommending continued therapy and pain management.   Acute GI bleed, presented as coffee-ground emesis Acute on chronic anemia Iron deficiency anemia Underwent extensive work-up during this hospitalization.  CT angiogram of abdomen pelvis revealed suspected bleeding in the stomach.  Patient underwent EGD which showed severe esophagitis most likely cause of the bleed. Gastroenterology recommending continuing pantoprazole twice daily. Patient hemoglobin remained stable during this hospitalization. Biopsy did not reveal any H. pylori infection.   Patient was seen by PT OT during this hospitalization who recommended acute inpatient rehab.  But patient and family decided to take the patient home patient was discharged home in stable condition with home health.
menactra vaccine 0.5ml given through subcutaneous route/ no AE; Initial information regarding an unsolicited valid non serious case was received from pharmacist and consumer/ non-health professional .  This case involves a 20-year-old male patient who received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] via subcutaneous route (incorrect route of product administration ).  Patient medical history, past medical treatment, vaccination, family history and concomitant medication were not provided.  On an unknown date, the patient received a 0.5 mL dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [frequency: once, dose: 0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test, strength: 0.5 mL, lot U6745AA, expiry date: 06-Oct-2021] via subcutaneous route at an left tricep for prophylactic vaccination.  This was actual medication error case due to inappropriate route of vaccination (latency: same day).  The Reporter reported "MENACTRA vaccine was given to a patient using the subcutaneous route. patient age less than 1 year enter as 2month, 4month, etc. many pediatric vaccines need month for age 20 years old".  At the time of this report the patient was fine and had no adverse events after the vaccination.  At time of reporting, the outcome was unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
This spontaneous report as received from a other health professional (registered nurse) refers to unspecified number of patients of unknown age. Current conditions and medical history was not reported. On an unknown date, the unspecified number of patients were vaccinated with GARDASIL (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. On an unknown date unspecified number of patients received GARDASIL after being improperly stored. No adverse effects reported. Product quality complaint was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a physician concerning a 14 year old female who on 11-FEB-2008 was vaccinated IM in the arm with her first dose of GARDASIL (lot# not provided).  On 11-FEB-2008 the patient experienced "striders syndrome."  Her specific symptoms were wheezing and asthmatic response.  Subsequently, on an unspecified date, the patient recovered from the "striders syndrome."  The patient sought unspecified medical attention.  Additional information has been requested. This is in follow-up to report (s) previously submitted on 3/14/2008.  Information has been received from a physician concerning a 14 year old female who on 11-FEB-2008 was vaccinated IM in the right deltoid arm with her first dose of GARDASIL (lot# 659439/1267U).  On 11-FEB-2008 the patient experienced "striders syndrome."  Her specific symptoms were wheezing and asthmatic response.  Subsequently, on an unspecified date, the patient recovered from the the "striders syndrome."  The patient sought unspecified medical attention.  Follow up information received from a health professional stated that on 11-FEB-2008 the patient also received vaccination of hepatitis A virus vaccine inactivated (lot# 657840/0797U) administered in the left deltoid.  It was important that on 15-FEB-2008 the patient experienced a "croup-like syndrome with subjective feeling of mirway closure"  and sought unspecified medical attention at the emergency room.  It was reported that on an unspecified date the patient recovered from croup like syndrome with subjective feeling of airway closure.  No further information was available
SYMPTOMS OF A BLOOD CLOT; SICK FOR 5 DAYS; This spontaneous report received from a parent via social media concerned an adult male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient was previously treated with covid-19 vaccine from an unspecified manufacturer (form of admin, route of admin, and batch number were not reported, expiry: UNKNOWN), 1 in total, dose was not reported for prophylactic vaccination (Dose number in series 1). It was unknown whether patient had any adverse event following covid-19 vaccination (Dose number in series 1).  The patient received booster covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: UNKNOWN) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination (Dose number in series 2). 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, following covid-19 vaccine ad26.cov2.s vaccination (Dose number in series 2), the patient was sick for 5 days. It was reported that one month later the patient was immediately taken to emergency room, as the patient experienced symptoms of a blood clot (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sick for 5 days, and the outcome of symptoms of a blood clot was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211218623-covid-19 vaccine ad26.cov2.s-Blood clot symptoms. 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).
cough; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 24-Feb-2021 and was forwarded to Moderna on 24-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 17-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 COUGH (cough). At the time of the report, COUGH (cough) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. Concomitant information was not provided.   This case was linked to MOD-2021-024260 (E2B Linked Report).; Sender's Comments:  MOD-2021-024260:same reporter, different patient and event
mom reported sz #1 3hr p/vax;sz #2 occurred 48hr p/vax;was seen by PMD post sz #2;
15-20 min after receiving flu vaccination, patient reported lightheaded, metallic taste, shortness of breath, and diaphoresis.
Patient received IM Pfizer-BioNTech vaccine x 2 doses in December 2021. By early May she developed significant suprapubic pain with negative urine cultures and negative urinalysis. Cystoscopy with bladder biopsy was performed and she was diagnosed with eosinophilic cystitis in May 2022.
pt recv vax 14SEP92 & 25AUG95 pt lab results revealed the presence of meningitis;pt part of a post marketing surveillance program;
This spontaneous report as received from a doctor of pharmacy refers to a patient who was vaccinated with an improperly storage dose of ZOSTAVAX (lot # 672609/1733AA, expiration date 04-FEB-2013, dose not reported) on 25-MAY-2012. No other co-suspects were reported. No concomitant medications were reported. The doctor of pharmacy reported that one of the facilities that he was in charge of was recording the temperature of the storage unit of ZOSTAVAX as -5F. He reports that the recently discovered that the actual temperature of the storage unit was -5C. He did not know if the patient had experienced any adverse effects. This is one of several reports received from the same source. This report is cross referenced with the following MARRS #: 1210USA002918, 1210USA006055, 1210USA006056, 1210USA006057, 1210USA006058, 1210USA006059, 1210USA006060, 1210USA006061, 1210USA006062, 1210USA006063, 1210USA006064, 1210USA006065, 1210USA006066, 1210USA006067, 1210USA006068, 1210USA006069, 1210USA006070, 1210USA006072, 1210USA006073, 1210USA006074. Additional information is not expected.
She got 3 vaccines at the same time, grandmother reporter, her father took her for the vaccines as she was home schooled and they were putting her back in public school.  She went to the bathroom and came out and her face were flushed, and then started vomiting and then started having patches popping out on her hands.  She then started having trouble breathing, and grandmother called 9-1-1 and they told her it was a AE from the vaccine, and they told her to give her Tylenol and Motrin as she was running a fever as well.  As the days have progressed she has broken out on her, each side of her eye, lip.  She was still throwing up yesterday, has a low grade fever now.  She is still just not feeling well at all.  She was not taken to the ER as they said it was the flu and if she got worse to take her to UC.  Grandmother took her to the clinic to see what was going on, and she got to talk to the doctor and asked what she recommended.  They did not say much, said that there was no long term side effects for it and said that she would need more vaccines, give her Benadryl for the swelling.  Grandmother informed her that she would not be getting anymore vaccines.  She said they did not seem concerned and she does not trust her as she was given all three at the same time.  She felt that she just didn't care.  The swelling has gone down some, but everyday there is something new coming up with her face, hands, little bitty red patches/bumps on her face and her nose.  Something that popped up that looked like a sore on her nose, lips and on the corner of her eyes.  Grandmother said it's the weirdest thing she has ever seen.  When the nurse came in they looked at her face as she had sores, and she knew that she was having a reaction to one of the vaccines, and that's when the doctor came in.    The granddaughter has a nutritional appointment in the future, and wants to know if she is going to be OK.
Injection site reaction: Raised, red, hot itchy, x2 inches in diameter. Tried ice, did not help.
This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a male patient who received FLULAVAL QUADRIVALENT 2017-2018 season (batch number 354H9, expiry date unknown) for prophylaxis. On an unknown date, the patient received FLULAVAL QUADRIVALENT 2017-2018 season. On an unknown date, less than a year after receiving FLULAVAL QUADRIVALENT 2017-2018 season, the patient experienced injection site rash and fever. On an unknown date, the outcome of the injection site rash and fever were recovered/resolved. It was unknown if the reporter considered the injection site rash and fever to be related to FLULAVAL QUADRIVALENT 2017-2018 season. Additional details were reported as follows: This case was reported by the patient's mother. The patient received a flu shot last year and had a reaction on his arm at the injection site. The reporter called as a rash and said it was all around the injection site and down the arm as well. The rash was resolved after 4 days. She also reports that her son had a fever for 24-48 hours after the flu shot last year. This case was linked with case US2018GSK176589, reported by the same reporter for the same patient.
Slept for the most part 18hrs; Chills; Fatigue; Body aches; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Slept for the most part 18hrs), CHILLS (Chills), FATIGUE (Fatigue), MYALGIA (Body aches) and HEADACHE (Headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 002A21A) for COVID-19 vaccination. No Medical history is reported.  Concomitant products included OMEPRAZOLE from 12-Jan-2018 to an unknown date for Reflux esophagitis.On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced HYPERSOMNIA (Slept for the most part 18hrs), CHILLS (Chills), FATIGUE (Fatigue), MYALGIA (Body aches) and HEADACHE (Headache). On 26-Mar-2021, HYPERSOMNIA (Slept for the most part 18hrs), CHILLS (Chills), FATIGUE (Fatigue), MYALGIA (Body aches) and HEADACHE (Headache) had resolved. No treatment medications were provided. This case concerns a 79 year old female with no reported medial history, who experienced non-serious , unexpected AESI event of hypersomnia which occurred the day after vaccination with the 2nd dose of mRNA-1273 vaccine (Moderna Covid 19 Vaccine ) . This was also accompanied by other non-serious expected events. (chills, myalgia headache , fatigue). The re-challenge for this case is not applicable since the events happened after the 2nd dose and no more additional doses will be given. The benefit -risk relationship of mRNA-12763 vaccine (Moderna Covid 19 Vaccine ) is not affected by this report.This case was linked to MOD-2021-372887 (Patient Link). Sender's Comments: This case concerns a 79 year old female with no reported medial history, who experienced non-serious , unexpected AESI event of hypersomnia which occurred the day after vaccination with the 2nd dose of mRNA-1273 vaccine (Moderna Covid 19 Vaccine ) . This was also accompanied by other non-serious expected events. (chills, myalgia headache , fatigue). The re-challenge for this case is not applicable since the events happened after the 2nd dose and no more additional doses will be given. The benefit -risk relationship of mRNA-12763 vaccine (Moderna Covid 19 Vaccine ) is not affected by this report.
Pt recvd Engerix-B on 5SEP9 given in ER & w/in 5 min became pale, diaphoretic, eyes rolled back of head, pulse 54, BP 112/68; also head drew back & arm & leg went out stiff; dx vasal vagal rxn;
Shakes that feel like a seizure; Shakes that feel like a seizure; Choking; Side effects are minimal unless she got sun on her; sunlight made her sick; Nauseous; Light headed; Weak; Sweaty but chills; Sweaty but chills; Brain fog got really bad; This is a spontaneous report from a contactable consumer(patient). The 50-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 22Apr2021 16:00 (Lot Number: ER8736) as first dose, single for covid-19 immunization.  Medical history included Polycystic ovarian syndrome(PCOS), Neuropathy, disabled, asthma, allergies, beat kidney cancer, autoimmune deficiency, anemic, gastric bypass. Concomitant medications included hydrocodone 10-325, escitalopram oxalate (LEXAPRO) 20mg, omeprazole 20mg.  The patient had known allergies: tramadol, melamine, gabapentin.  The patient stated sunlight made her sick. Side effects are minimal unless she got sun on her. Even through window. She got nauseous, shakes that feel like a seizure, light headed, weak, choking, sweaty but chills. Brain fog got really bad. She had brain fog from it but to the point she forgot she was headed to the bathroom after sunlight touched her. She had been able to handle indirect sunlight until today. Now she can't have any sunlight touch her without a reaction. Direct or Indirect. Nothing helped. Just sundown. Once the sun went down, the side effects calmed down. Events occurred on 26Apr2021 14:30 with outcome of recovering. There was no treatment received. Since the vaccination, the patient had not been tested for COVID-19.Case was assessed as non-serious by reporter.
10 minutes after administration, patient experienced shortness of breath and  was given 1 dose of epinephrine on right thigh. patient was shaky and paramedics were called. Blood pressure checked and was 160/102.
Information has been received from a consumer concerning her 5 year old son with no medical history or allergies who was vaccinated with a dose of MMR II (lot number not available) 3 years ago (in March 2006). Concomitant medications included unspecified antibiotics. Shortly after receiving MMR II he was diagnosed with autism. Lab diagnostics studies included autism tests. He did not recover at the time of reporting. The patient was seen by several physicians for medical attention. Upon internal review, autism was determined to be an other important medical event. No further information is available.
Patient had a 4 month check-up at 9:30 in the morning on 07/06/2017, no problems were identified, received recommended vaccines. Patient's mother called the office in the afternoon and reported that the patient displayed "seizure-like activity". Was referred to the emergency department. Parents declined to have patient evaluated on 07/06/17 and 07/07/17. On 07/08/17 the patient was seen in the office. Mother described the event on 07/06/2017 as a "strange episode" in which he made a strange noise and moved abnormally, following the episode he was more sleepy than usual. Per parents, may have had another episode later that day. She had a video of the first episode which was viewed by the physician. Unable to determine from the video if episode was true seizure activity or benign myoclonus of infancy. Parents also reported that he had a rectal temperature of 100.4 on the evening of 07/06/17 and on the evening of 07/07/17.
Migraine with nausea, sensitivity to light and sound for 10 days that is only minimally lessened with 12-16 Motrin daily.  Had injection of Toradol and started imitrex this morning after going to my doctor, but still no change.
arm swelling; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 61-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received Shingrix. In October 2019, 2 hrs after receiving Shingrix, the patient experienced swelling arm. On an unknown date, the outcome of the swelling arm was unknown.   It was unknown if the reporter considered the swelling arm to be related to Shingrix.  Additional details were provided as follows: The patient took the shingles shot about 2 hours ago and arm felt like it was swelling.
Medial/ant, Right thigh erythema, swelling, no warmth, no joint involvement, about 5 x 10 cm.
After second shot ovulation tests showed I did not ovulate in the months of April (month of shot). Month after, ovulation hit peak but did not see "high fertility" as expected. On June 28th I had a positive pregnancy test. July 12 cramping and bleeding began HCG test performed to confirm pregnancy. On July 14 test repeated, HCG did not double as expected. July 15 transvaginal ultrasound performed, confirmed fetus in gestational sac, and heartbeat subchorionic hemorrhage identified. Repeat ultrasound on Jul 23, heart beat heard, hemorrhage grown larger. Additional ultrasound on Jul 26, still a heart beat hemorrhage had grown more. On July 29 severe cramping and bleeding began and a spontaneous abortion occurred and pregnancy was lost. July 30 ultrasound confirmed no fetus.
Red spots on both legs and extreme itching; Extreme itching; This is a spontaneous report from a contactable consumer. A non-pregnant female patient of unknown age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8733) via an unspecified route of administration in the arm right on 28Mar2021 at 00:00 as a single dose for COVID-19 immunisation. Medical history reported as heart. Prior to the vaccination the patient was not diagnosed with COVID-19. The patient received other medication within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine.  The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on an unknown date of 2021 as a single dose for COVID-19 immunisation. On 04Apr2021 at 00:00, 7 days after the vaccination, the patient experienced red spots on both legs and extreme itching. Therapeutic measures were not taken for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event red spots on both legs and extreme itching was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.