chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Upon arrival to the emergency department, patient was found to have acute hypoxemic respiratory failure.  Chest x-ray was concerning for mild left basilar infiltrate.  He was also noted to have leukocytosis, anemia, hypernatremia, hyperchloremia, uremia, and elevated troponin.  Renal function seems to be at baseline.   07/25/2021tested positive 7/28/2021 discharged 91-year-old male with past medical history of prostate cancer 30 years ago status post surgical removal, coronary artery disease, and stage 3 chronic kidney disease who is also a DNR presented to the emergency department with worsening weakness and confusion.  Patient is unable to provide any history himself.  Patient's daughter was contacted directly.  Per her reports, patient was his usual state of health until approximately few months ago when his wife died.  Patient has not been himself since then.  He was admitted approximately 1 month ago due to changes in mental status.  He was discharged and went to rehab facility.  Patient went home approximately 1.5 weeks ago and at that time, per the daughter's report, he was doing very well.  Patient was able to take care of himself for the most part.  Mental status was also intact.  After about 1-2 days, patient started having weakness, poor oral intake, and lack of interest in food.  Patient also had poor appetite.  During this time frame, patient had multiple episodes of chills along with cough and shortness of breath.  He also had nausea and vomiting along with diarrhea 5 days ago.  Patient only lives with his daughter.  Patient was accident for COVID-19 in April 2021.  Over the last 5-6 days, patient has had barely anything to eat and has been very weak.  This morning, he was unable to bear his own weight therefore, his daughter brought him to the emergency department for further evaluation.    Upon arrival to the emergency department, patient was found to have acute hypoxemic respiratory failure.  Chest x-ray was concerning for mild left basilar infiltrate.  He was also noted to have leukocytosis, anemia, hypernatremia, hyperchloremia, uremia, and elevated troponin.  Renal function seems to be at baseline.  Elevated troponin also seems to be lower than baseline.  EKG independently reviewed and negative for any ST elevations or depressions.  No new T-wave inversions noted.  Urinalysis negative.   Patient was discharged approximately 1 month ago after being presented with similar symptoms.  At that time, patient has metabolic encephalopathy was deemed of unclear etiology.  MRI brain was negative for any acute findings.  Carotid ultrasound was also negative.  Hemoglobin A1c was 5.3.  TSH was unremarkable.  Lipid panel was also negative.  Patient was evaluated by Neurology and his mental status changes were deemed most likely secondary to toxic metabolic encephalopathy.  There was no clear source of infection identified.  Chest x-ray and UA were negative.  Also negative for COVID-19.  CT abdomen was also negative.  During the hospitalization, patient did have an episode of aspiration pneumonia and was treated appropriately.  Modified barium swallow was recommended however, daughter refused at that time.
p/vax that evening felt itchy & congested;by evening facial swelling & redness;tx w/pred & zyrtec;
The patient has not received her 2nd dose as the location stopped administrating the vaccine.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (The patient has not received her 2nd dose as the location stopped administrating the vaccine.) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (The patient has not received her 2nd dose as the location stopped administrating the vaccine.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (The patient has not received her 2nd dose as the location stopped administrating the vaccine.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Four hours after getting the shot on 12/12/22 I felt unwell and upon awakening the following morning was desperately unwell with jaw and chest pain, and unsteadiness, which culminated in dizziness and passing out on the floor. While coming-to I was nauseous and vomiting. The Person who found me called for help and by the time the nurse arrived I was able to get up and into a chair though weak and shaky.  I am still somewhat weak today with heavy fatigue.
Patient was admitted to the hospital for COVID symptoms 7/15/2022- 7/21/2022,  Medications given included zinc sulfate 50mg PO daily, ascorbic acid 1000mg PO daily, cholecalcifero 25mcg PO daily.
March 22 - March 26 Heart rate was as high as 134 while  patient was just sitting
This spontaneous report was received from a nurse prescriber and refers to a patient of unknown age. The patient's pertinent medical history, drug reactions and allergies were not reported. Concomitant therapies were not provided. On 30-MAR-2016 the patient was vaccinated with GARDASIL for prophylaxis (dose, route of administration, lot# and expiration date were not reported). On 17-JUL-2017, the patient was vaccinated with GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported). No adverse effect was reported.
concerning the lot  O70H21A, that has an expiration date of 4/7/2022, patients at our facility that received this Moderna vaccine between 4/8/2022 and 12/15/2022.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (concerning the lot  O70H21A, that has an expiration date of 4/7/2022, patients at our facility that received this Moderna vaccine between 4/8/2022 and 12/15/2022.) and NO ADVERSE EVENT (No adverse event) in a 91-year-old female patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced NO ADVERSE EVENT (No adverse event). On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (concerning the lot  O70H21A, that has an expiration date of 4/7/2022, patients at our facility that received this Moderna vaccine between 4/8/2022 and 12/15/2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (concerning the lot  O70H21A, that has an expiration date of 4/7/2022, patients at our facility that received this Moderna vaccine between 4/8/2022 and 12/15/2022.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (concerning the lot  O70H21A, that has an expiration date of 4/7/2022, patients at our facility that received this Moderna vaccine between 4/8/2022 and 12/15/2022.).    No concomitant medication information was reported. Patient age was reported as 91year8months. No treatment information was reported.
36 year old female, employee with no significant past medical history who presented to UCC s/p receiving first dose of COVID-19 vaccine and immediately thereafter developing chills and hypertension. RRT called with notable vital signs: BP 158/111, HR 101, T 36.5C, SpO2 99-100% RA. Patient received IV Benadryl 50 mg once. Vitals stabilized after observation.
Information has been received from a healthcare worker referring to two unidentified patients of unknown age and gender. On unknown dates (range between 18-FEB-2015 to 30-MAR-2015) the patients were possibly vaccinated with one dose of improperly stored PROQUAD (Merck) (lot # K007799, expiration date 29-NOV-2015, dose and route were unknown). No adverse effects reported. This is one of several reports received from same source. Additional information has been requested.
Pt states flu shot was administered too low by the nurse, causing neck and arm pain, that has since resolved
This case was reported by a consumer and described the occurrence of not responsive in a 71-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline).  A physician or other health care professional has not verified this report.  Concurrent medical conditions included anxiety and premature ventricular contraction.  Concurrent medications included TOPROL XL, ZOLOFT, Omega 3 fish oil, Vitamin C, Vitamin E and Co q 10.  On 1 October 2008 at 10:00 the subject received a dose of FLULAVAL in the left arm.  On the night of 1 October 2008, less than one day after vaccination with FLULAVAL, the subjects husband reported that she was in bed making funny gurgling noises.  At that time, the subject was also unresponsive and her eyes were rolled back.  The subject awoke in an ambulance and was unsure how she got there.  She was taken to the emergency room and was admitted to the hospital.  Physicians performed a CAT scan and an MRI which were both negative.  An EEG was also performed, but the results were pending.  The subject was discharged the following day.  The physicians told the consumer that it appeared as if she might have experienced a seizure, but they weren't sure what the cause might have been.  One physician apparently questioned whether the event was a result of the subject receiving the FLULAVAL vaccine.  A sleep apnea study was planned at the time of reporting.  The outcome of the events was not reported.
Incorrect DOB  provided by caregiver during  12/2021 immunization.  During review by vaccine team on 6/27/22 when caregiver requested for correction, pt was not eligible at the time for COVID-19 vaccinations. No reactions reported  by caregiver.
Fever, red raised papular rash entire body, started 24-30 hours after shots, also seen at hospital.  Monitor keep child away from newborns/infants.
Developed erythema and edema left thigh about 24 hours after DTaP, IPV injection, no fever, Erythema and swelling resolved completely on 8/03/06.
pt recv vax 28DEC99 & restless that noc, fever 103 ax the next day, Thurs, Fri, Sat, Sun of that week had couple red blotches on face & glands were swollen;had ulcers in the mouth& bleeding;unable to eat this lasted for 1 1/2wk;resp illness
Chest pain, passing large amounts of menstrual blood and clots (not pregnant), and later, undetermined heart issues (ST anomaly on ekg and mild heart arrythmia).  After booster on 11/12/2021, heart rate is quite high continuously, and have chest pain.
This case was reported by a pharmacist via call center representative and described the occurrence of swelling of legs in a 67-year-old female patient who received SHINGRIX (batch number CH2X7, expiry date 25th April 2020). Concomitant products included CARTIA, RESTASIS, SEROQUEL, triamcinolone, WELLBUTRIN, RANEXA, clonazepam, Nitroglycerin patch and YUVAFEM. On 2nd May 2018 17:46, the patient received the 2nd dose of SHINGRIX (intramuscular). In May 2018, less than a week after receiving SHINGRIX, the patient experienced swelling of legs, facial swelling, tingling sensation and burning sensation. On an unknown date, the outcome of the swelling of legs, facial swelling, tingling sensation and burning sensation were not recovered/not resolved. It was unknown if the reporter considered the swelling of legs, facial swelling, tingling sensation and burning sensation to be related to SHINGRIX. Additional details were provided as follows: Concomitant product included PROAIR. The patient came to the pharmacy last night on 9th May 2018 with swelling in both legs and her face. She also had a burning or tingling sensation all over her body. Since last night 9th May 2018 the patient had not seen her doctor, but the pharmacist advised her to do so and she was supposed to contact the doctor today. The patient did not state when the swelling had started, just that it was after she received SHINGRIX. The patient came into the pharmacy riding a motorized cart, but she had done so in the past as well. The pharmacist said he left a message on the line last night, but I did not yet find a record in 360.
Broke out in hives on both thighs that persisted for 1 week and spread to stomach, chest, and both arms at peak of outbreak. Hives appeared on inner thighs 5/28/21 persisting intermittently until 6/3/21. Hives spread to upper thighs, hips, stomach, lower chest, and inner elbow crease on both arms on 6/2/21, predominantly in areas prone to sweating. Final outbreak was minor and isolated to inner thighs on 6/3/21. Hives *did not* appear at injection site. Hives would start appearing every afternoon around 3pm, would peak every night around 10pm, and would be completely gone every morning around 7am. Hives did not feel itchy or irritated.
On 4/14/22, patient was given first dose of Pfizer without being diluted prior to injection. 0.2ml of Cominarty vaccine was drawn by RN and administered by MA. At the time this report is being submitted, we have been unable to contact patient guardian for follow up on any adverse reactions. No adverse reaction occured at time of injection or during the 15 minute wait period.
10 y/o presented for COVID-19 vaccine. Adult formulation of Pfizer Covid-19 vaccine diluted in error with 1.3 cc of diluent and 0.2 cc administered to 10 y/o via IM injection in left deltoid. Error realized soon after child left clinic. Parent notified. Instructed to monitor for adverse events. 12/18/2021-F/U by phone, no problems reported.
Swollen and painful spot on my right leg. No bruise. Thought it was workout related but didn't bump it on anything. It seems to match description of a blood clot.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 at 16:00 as dose 5 (booster), single (Lot number: GH9701) at the age of 71 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 13Jan2021 at 14:00 as dose 1, single (Lot number: EL9263), in left arm, on 03Feb2021 at 12:00 as dose 2, single (Lot number: EL9263), in left arm, on 17Aug2021 at 12:00 as dose 3 (booster), single (Lot number: FA7485), in right arm and on 09Apr2022 at 16:00 as dose 4 (booster), single (Lot number: FK9893), in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 01May2023 to 06May2023.
I became very ill on Friday. I did not take my temperature but know it was high. I was sweating and had chills. My joints throughout my body ached. My head was pounding and felt like a migraine. I stayed in bed for a 24 hour + time period. I was taking ibuprofen and Excedrin migraine but it only helped the pain a little. I also had green stool for 2 days when using the bathroom.  It was the sickest I have felt in quite some time. I am feeling better as of today.
pain that worsened at injection site; pain that worsened at injection site; This is a spontaneous report from a non-contactable consumer (patient). A 43-year-old patient of an unspecified gender received BNT162B2 via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pain that worsened at injection site over time on an unspecified date with outcome of unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report was received from a nurse and refers to a 12 years old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 06-NOV-2017, the patient was vaccinated with the improperly stored doses of GARDASIL 9 (dose and route of administration were not reported) (lot # N020352 and expiration date: 10-APR-2010) for prophylaxis. There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit or colder for 30 minutes. Data logger was involved. There were no previous excursions reported. This is one of four reports received from the same reporter. Sender's Comments: US-009507513-1711USA011244: US-009507513-1711USA011245: US-009507513-1711USA011243.
Patient reported symptoms began 5 hours post-vaccination. She experienced extreme headache, throwing up, bloody nose, nausea, sweating, temperature of 101 degrees Fahrenheit. Symptoms lasted for 36 hours.
First symptom: Skin eruption left clavicle area follow by more eruptions in the following days under breast, behind ears, on the head, on the back, face, abdomen, armpits and groin.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2014, the patient was inoculated with the ZOSTAVAX vaccine by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster.  In 2015, she was treated by a physician for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles.  As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
We administered incorrectly Covid19 Pfizer as a booster instead of Covid19 Pfizer Bi-Valent as a booster...Pt  did not exhibit any adverse affects.
Transient global amnesia; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TRANSIENT GLOBAL AMNESIA (Transient global amnesia) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 023M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TRANSIENT GLOBAL AMNESIA (Transient global amnesia) (seriousness criteria hospitalization and disability). The patient was hospitalized from sometime in 2021 to sometime in 2021 due to TRANSIENT GLOBAL AMNESIA. At the time of the report, TRANSIENT GLOBAL AMNESIA (Transient global amnesia) was resolving. Not Provided          No concomitant medications were reported. Treatment information was not provided.  The patient was fine after first dose, but after second dose, the patient was hospitalized for 3 days and diagnosed with transient global amnesia. It was reported that patient was feeling better.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.
Child had apparent seizure approximately fifteen minutes after being given shot.  Has loss of consciousness followed by pallor and post ictal period.  Was sent to ED for further evaluation.  CT was done
Developed a 99.5°F fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Developed a 99.5°F fever) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), CARVEDILOL and EMPAGLIFLOZIN (JARDIANCE) for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PYREXIA (Developed a 99.5°F fever). At the time of the report, PYREXIA (Developed a 99.5°F fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, Body temperature: 99.5 (Inconclusive) 99.5 degree F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that the patient used other medications Tormcaide 20 mg, Glamoraite and yanubin 100mg. Treatment included Tylenol.
Information has been received from a physician referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date the patient was vaccinated with ROTATEQ (dose, lot# and expiration date unknown) orally for prophylaxis. On an unknown date after the vaccination, the patient experienced intussusception. The patient had sought for medical attention (type unknown). The outcome of intussusception was unknown. Upon internal review, intussusception was determined to be medically significant. Additional information is not expected because there was no consent for further contact.
Blisters on my jaw bone and swelling of the face. Immediately took benadryl and was fine thereafter
Patient's eyes rolled back. It looked like he was having a seizure for about 1 -2 minutes. but regained consciousness afterwards with no idea of what happened. We called 911 and they came and picked up the patient
I had severe rash from middle of my neck, my chest, tops of my breast, left arm was swollen and rash to elbow.
Janssen Covid 19 vaccine given at onsite employer vaccine clinic As documented on: 1025 client c/o bilateral itching upper arm and slight headache 5/10. Itchy and HA began after 15 min observation period. Denies SOB, no wheezing noted. no hives or rash noted. 1027 50mg of Benadryl administered for itching. BP 122/70 , HR 88 @ 1045 1058 142/72 RUA, HR 82.  Continued to c/o itching, no hives or rash visible. Reports slight improvement in HA, rating 5/10 pain level. Reports slight drowsiness, A&Ox3. 1110 Continued intermittent itching. Reporting worsening HA 7/10 frontal area. states he is unsure if HA has worsened because he is thinking about not itching. Mild nausea reported.  1124 BP148/82 HR 86, Reports continued mild nausea, upper extremity itching.  Patient went home at 1128am.
Mother of patient reported swelling of injection site. It started off as a golf ball size welt then got as big as a tennis ball. The following day the whole upper arm was affected.