chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID+ 12/9/22.  Vaccination Status - J&J x1  Attending Physician: MD Date of Admission: 12/9/2022, Hospital Day: 4 Date of Discharge: 12/12/2022   BRIEF OVERVIEW: Discharge Provider: MD Primary Care Provider at Discharge: MD       Active Hospital Problems   Diagnosis Date Noted POA ? GERD (gastroesophageal reflux disease) 12/10/2022 Yes ? HTN (hypertension) 06/09/2014 Yes ? History of ischemic cardiomyopathy 06/09/2014 Yes ? CAD (coronary artery disease)   Yes DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute on chronic respiratory failure with hypoxia [J96.21] Acute on chronic respiratory failure with hypoxemia [J96.21] COVID-19 [U07.1]   HOSPITAL COURSE: This is a pleasant 79-year-old man history of chronic obstructive pulmonary disease on 4 L baseline at night only, coronary artery disease, and ischemic cardiomyopathy ejection fraction 54% and hypertension who presented with worsening shortness of breaths secondary to COVID-19 infection.  He has required oxygen during the day which is not normal for him.  He did get vaccinated with the Johnson and Johnson vaccine but is overdue for his booster.  Chest x-ray was negative, EKG was also unremarkable.  Procalcitonin was trivial at 0.18.  He was given Rocephin and azithromycin emergency department and admitted to Internal Medicine for further management.  He completed his course with azithromycin while inpatient and received 4 doses of Rocephin.  He was transitioned to Ceftin at discharge for 1 more day.  He was weaned to room air and remained stable overnight off of oxygen.  He completed a course of remdesivir while inpatient.  He was discharged to complete a 10 day course of dexamethasone and Tessalon Perles p.r.n. for cough.  Pulmonary rehab was consulted for home oxygen with activity.  The patient, prior to admission, was using boost oxygen that he buys at the camping and hiking store for activity as he does not want along around a big oxygen tank.  Respiratory therapy is working on getting him a portable tank that he can wear around his shoulder when he goes grocery shopping.  He was educated that he will remain in isolation until 12/19/2022 and educated to wear mask and get boost in when he is out of isolation and symptom free.  He was discharged home in stable and improved condition.
Approx 3 min after immunizations felt dizzy, CVR clear, breathing WNL, no color changes. HR WNL & reg. VS monitoring q 5 min, stable Oxim 100%. RR 20's. Vision felt blurry, dizziness & blurry vision increasing. Doesn't feel better seated or supine or after given water. Observed x15 min. No changes so called ambulance.
Moderna vaccine drawn up at PUblic Health office at 830 am on 9/17/21 and given to nursing home to give 2nd dose to staff that needed it.  The staff needing it did not receive it until 500 am on 9/18/21. It was not refrigerated during this time. After the 2nd shot, patient did have body aches, blah feeling and tired for 1-2 days.
24 hours after injection left arm had warm, red swelling. Improved over several days, then worsened about 8 days after injection. Large, itchy, red, warm lump at injection site.
Patient is the 2 month. Mom received her 2nd Pfizer Covid vaccine on Friday 10/15/2021. Mom exclusively breastfeeds the Patient and on Sunday 10/17/2021 Patient presented with a rash on various parts of her body. She was seen in our office on 10/19/2021 and evaluated by a doctor. Patient's rash was described as small red papules on her trunk and back. Patient had not other cold symptoms or recent fevers. There have been no new changes to detergents or foods. Mother did test positive for COVID-19 on 9/20/21 but Patient was not tested at that time. There was no other clinical explanation for Patient's rash and since the vaccine mom has also had a significant drop in breast milk production.
Within 1 week of receiving COVID vaccine,I started having left leg pain that lasted until hospitalization. I?ve had sciatica before and thought it was this. After second COVID vaccine(03/02/2021),started getting shortness of breath  that continued to get worse. Finally, in mid-April, along with the shortness of breath and left leg pain, I started getting right,mid back pain that radiated to right chest and shoulder. On April 21,2021, I  could no longer tolerate the chest and back pain and drove myself to ER and Urgent Care. The Dr. ordered a CT Angio of chest and determined I had bilateral pulmonary embolism and sent me by ambulance to Hospital.
Swollen tenderness in the left arm, at the site of the injection. Patient had mild fever and was given Tylenol. Follow up on 01/06/06: Doctor's office confirmed that patient recovered.
This case was reported by a other health professional via sales rep and described the occurrence of generalized pruritus in a 77-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced generalized pruritus, joint pain and skin lesion. The patient was treated with MEDROL. On an unknown date, the outcome of the generalized pruritus, joint pain and skin lesion were unknown. It was unknown if the reporter considered the generalized pruritus, joint pain and skin lesion to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not provided. The patient received SHINGRIX at the pharmacy one month ago. The over the counter product did not work. The reporter agreed to follow from GlaxoSmithKline.
patient was administered Ipol vaccine after it was suppose to be dis guarded after temp excursion / no adverse event; Initial information received on 02-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.   This case involves a 8 years and 8 months old female patient who received 0.5 ml IPV (VERO) [IPOL] lot P1E701M (Expiry date 09-NOV-2020) via intramuscular route in the left arm.  Patient's medical history, treatments, family history were not reported.  No other vaccines were given  It was a actual medication error case due to incorrect product storage.  It was reported that patient was administered Ipol vaccine after it was suppose to be dis guarded after temp excursion.  At a time of reporting no adverse event reported.  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 Directive and Module VI of the 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.  List of documents held by sender: none.
Fever; Changes in body temperature (cold/hot); Chills; Headache; Runny nose; Pain teeth; Sore throat; Dose received: 3; This is a spontaneous report from a contactable reporter (other healthcare professional). The reporter is the patient.  A 15-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Jan2022 at 16:30 (Lot number: unknown) at the age of 15 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing) and "Multiple allergies" (unspecified if ongoing), notes: Other medical history: allergies. Concomitant medication included: PROGESTERONE taken for Birth control. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: unknown; Anatomical site: left arm; Administration time: 12:00), administration date: 15May2021, when the patient was 15 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: unknown; Anatomical site: left arm; Administration time: 15:00), administration date: 06Jun2021, when the patient was 15 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 10Jan2022 at 16:30, outcome "unknown", described as "Dose received: 3"; PYREXIA (non-serious) with onset 10Jan2022 at 21:00, outcome "not recovered", described as "Fever"; FEELING OF BODY TEMPERATURE CHANGE (non-serious) with onset 10Jan2022 at 21:00, outcome "not recovered", described as "Changes in body temperature (cold/hot)"; CHILLS (non-serious) with onset 10Jan2022 at 21:00, outcome "not recovered", described as "Chills"; HEADACHE (non-serious) with onset 10Jan2022 at 21:00, outcome "not recovered", described as "Headache"; RHINORRHOEA (non-serious) with onset 10Jan2022 at 21:00, outcome "not recovered", described as "Runny nose"; TOOTHACHE (non-serious) with onset 10Jan2022 at 21:00, outcome "not recovered", described as "Pain teeth"; OROPHARYNGEAL PAIN (non-serious) with onset 10Jan2022 at 21:00, outcome "not recovered", described as "Sore throat". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, feeling of body temperature change, chills, headache, rhinorrhoea, toothache and oropharyngeal pain.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment for the reported events included rest at home, fluids, Ibuprofen and Tylenol. Since the vaccination, the patient had been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Received vaccine on 29Oct2021 with an expiration date of 11Oct2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine on 29Oct2021 with an expiration date of 11Oct2021) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 ml. On 29-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine on 29Oct2021 with an expiration date of 11Oct2021). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received vaccine on 29Oct2021 with an expiration date of 11Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment details were reported.
I got the shot on 1/26/23.  Over the next 24-48 hours I experienced mild nausea, definite muscle aches, and a moderate headache.   I also noticed that for a short while (<1 hour) my lips felt a little thick, but not enough to alarm me.  Since the injection I have also developed a few small hives on my face and scalp.  The injection site developed a sore much like the shingles rash itself which scabbed over and is mostly healed now.   Since I have many allergies (I carry an epipen), I am not sure if these "itchies" were from the vaccine or something else in my environment.
COVID-19 Vaccine-Induced Liver Injury; This is a literature report.  A 46-year-old female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Alcohol use" (unspecified if ongoing), notes: 2-4 drinks/ per week; "Migraines" (unspecified if ongoing); "Obstructive sleep apnea" (unspecified if ongoing); "fever" (unspecified if ongoing); "fatigue" (unspecified if ongoing); "arthralgias" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; Unknown manufacturer), for Covid-19 immunisation. The following information was reported: LIVER INJURY (medically significant), 42 days after the suspect product(s) administration, outcome "unknown", described as "COVID-19 Vaccine-Induced Liver Injury". The patient underwent the following laboratory tests and procedures: Alanine aminotransferase: Return to baseline; Alanine aminotransferase: 57 IU/l; Antibody test: Unknown result; Antimitochondrial antibody: negative; Antinuclear antibody: negative; Aspartate aminotransferase: Return to baseline; Aspartate aminotransferase: 58 IU/l; Blood alkaline phosphatase: 147 IU/l; Blood bilirubin: 0.4 mg/dl; Body mass index: 27.4; ASMA: negative; Serum ferritin: 662 ng/ml.; Sender's Comments: Based on the given information , the possible contributory role of the suspect for the event liver injury cannot be excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202300089305 Same article;suspect;event and different patient;
Information has been received from a registered nurse concerning a 12 year old male patient who on 10/18/02 was vaccinated with a first dose of hepatitis B vaccine recombinant 10mcg. Concomitant medication was unknown. It was noted that the patient developed back pain, a low grade fever, nausea, dizziness, hypersensitivity to touch and had surgery to clear blocked ureter shortly after vaccination. Unspecified medical attention was sought. The outcome was unknown. Follow up information revealed that the mother of the child reported to the nurse manager that the child was continuing to run intermittant fevers but does not have them documented. The nurse reported that she instructed the mother of the child to maintain a log of the child's temperature's at 8am, 4pm and 8pm daily. Around the same time the child was vaccinated (date unknown but sometime in October 2002) the child was diagnosed with a UTI, and since that time was also diagnosed with hydronephrosis of the kidney and had surgery to clear a blocked ureter in December 2002. It was reported that the child no longer had a UTI and that the nurse had done balance tests on the child and they were all normal. The physicians did not feel that there was any connection between the symptoms, surgery and the hepatitis B recombinant, however, the mother is looking for a reason for her sons condition. Upon internal medical review, the blocked ureter and hydronephrosis were considered an other important medical event. No further information was provided.
A report was received from a health professional on 03 Apr 2001, concerning 5 patients of unknown demography, who received an overdose of Fluvirin vaccine or Pru-immune-23, on an unknown date.  On an unknown date, the patient inadvertently received a double dose of the Fluvirin vaccine and Pru-immune-23.  No adverse event was reported.  There was insufficient information to determine the reporter's, causality assesment.
pt recv vax 8JUL97 & 23JUL97 pt exp itching in groin area w/presence of bumps;subsequently pt was found to have bumps in rt axilla & buttocks-noted on presentation to clinic 28JUL97;1/2mm-1mm vesiculopapular, non-erythematous;pruritic lesio
COVID Positive breakthrough case, patient also had booster on 11/3/2021  Lot #076C21A
a few sore arms; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  An elderly male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "a few sore arms".  Additional information: Patient did have a relatively high opinion of Pfizer because his wife and him had received their Covid-19 shots and boosters from this company and they had practically no side effects to date apart from a few sore arms for a day or two.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300290946 same patient/AE, vaccine different dose;US-PFIZER INC-202300290947 same patient/AE, vaccine different dose;US-PFIZER INC-202300290948 same reporter/AE, different patient;US-PFIZER INC-202300290949 same reporter/AE, different patient;US-PFIZER INC-202300290950 same reporter/AE, different patient;
This is a spontaneous report from a contactable consumer (patient's wife). An 83-year-old male patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EN6203), at the age of 83, via an unspecified route of administration, on Mar 2, 2021, single dose, for COVID-19 immunisation. Medical history included type 2 diabetes mellitus from an unknown date and unknown if ongoing. There were unspecified concomitant medications. Historical vaccine included COVID-19 vaccine, dose 1 (manufacturer unknown), on an unknown date, for COVID-19 immunisation. Patient had the second vaccination yesterday and woke up this morning (Mar 3, 2021) with chills. His arm really hurts too. He took his temperature, he does not have a fever. He wondered if he should take some Tylenol or something for his chills. The outcome of events: unknown. No follow-up attempts possible. No further information expected.
Tinnitus; While patient was reporting their own AE; This spontaneous case was reported by a patient and describes the occurrence of TINNITUS (Tinnitus) and VACCINATION COMPLICATION (While patient was reporting their own AE) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Tinnitus) and VACCINATION COMPLICATION (While patient was reporting their own AE). At the time of the report, TINNITUS (Tinnitus) and VACCINATION COMPLICATION (While patient was reporting their own AE) outcome was unknown. Not Provided      The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. While patient was reporting own AE , the doctor mentioned that there were other patients that come in with tinnitus as well with the Moderna that want to rip the ear off. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-708656 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-708656:For other patients
Pt. is Type I diabetic, and takes Glipizide for diabetic control.  Reported on 08/05/2005 that glucose levels frequently are over 300.  Rec. follow up at that time.  On or around 08/22/2005, pt. fell on his porch and scrapped his knees, felt dizzy, and went to the ER near where he lives.  Blood glucose level was checked there, and was over 400.  Was given IVF and insulin (unknown if IV or sub-q).  Pt. stated he was in the ER for 4-5 hrs., and felt some better when he left.  Blood glucose levels since have been under 300.  Has an appt. on Oct. 6, 2005 to see his PCP for follow up for diabetes.  Pt. did not report any itching, swelling, difficulty breathing as a result of his HBV given on 08/05/2005.
Experienced lightheadedness and ringing in ears. Payed down and drank liquids. The symptoms have slowly subsided. I currently have some ringing in my ears but at a background level/volume.
I have a large red spot at the injection site that is hot to the touch and very firm; The spot is only slightly raised but very painful; a large red spot at the injection site that is hot to the touch; The day after the shot, it was about the size of a quarter. The day after that it was a bit larger than a half dollar. Since 3 days after the shot, it has been about the size of a baseball.; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: GW0161) via an unspecified route of administration in the left arm on 15Apr2021 at 18:45 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history included kidney stones, migraines, sulfa (sulfonamide allergy) and adhesive (adhesive tape allergy). The patient previously received bupropion hydrochloride (WELLBUTRIN) on an unknown date and for an unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included alprazolam (XANAX), trazodone (MANUFACTURER UNKNOWN), sertraline hydrochloride (ZOLOFT), duloxetine hydrochloride (CYMBALTA) and gabapentin (MANUFACTURER UNKNOWN); all started on unknown dates and for unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 23Mar2021 at 19:30 (at the age of 36-year-old) as a single dose for COVID-19 immunisation. On 16Apr2021 at 08:00 the patient experienced a large red spot at the injection site that was hot to the touch and was very firm. The day after the shot, it was about the size of a quarter. And again, the day after that it was a bit larger than a half dollar. 3 days after the shot, it has been about the size of a baseball. The spot is only slightly raised but very painful. It was reported that it looks very similar to like a COVID arm on online. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events.  Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events a large red spot at the injection site that is hot to the touch and very firm and spot is only slightly raised but very painful were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected
Due to needle disconnecting from the syringe, nurse reports lower-than-authorized dose volume was administered to the patient in her right arm. Per current CDC guidelines, nurse then administered the authorized dose of Moderna vaccine immediately in the opposite arm (left arm) than the first injection was administered. The following day (3/25), the patient reports mild soreness and swelling in both arms with the left arm being more sore than the right arm.