chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID+ 10/27/2022 BRIEF OVERVIEW: Discharge Provider: DO Primary Care Provider: DO Admission Date: 10/25/2022 Discharge Date: Nov 2, 2022   Active Hospital Problems   Diagnosis Date Noted POA ? Dilated cardiomyopathy  05/02/2022 Yes ? Chronic combined systolic and diastolic heart failure  04/08/2022 Yes ? Nephrostomy status  03/22/2022 Yes ? Lymphoma  03/22/2022 Yes ? Hydronephrosis 03/17/2022 Yes ? Type 2 diabetes mellitus with diabetic neuropathy  03/14/2022 Yes ? Retroperitoneal mass 03/14/2022 Yes ? Chronic kidney disease (CKD), stage IV (severe)  03/14/2022 Yes ? Paroxysmal atrial fibrillation  03/14/2022 Yes ? Subclinical hypothyroidism 03/12/2021 Yes ? Thoracic aortic aneurysm without rupture 05/22/2020 Yes ? Lymphadenopathy, retroperitoneal 04/21/2020 Yes ? At risk for falls 06/13/2017 Yes ? Persistent proteinuria associated with type 2 diabetes mellitus   03/22/2016 Yes ? History of prostate cancer 02/22/2012 Yes ? Hypertension 07/06/2010 Yes ? Type 2 diabetes 07/06/2010 Yes  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: COVID-19 virus infection [U07.1]   HOSPITAL COURSE: Patient is a 88 y.o. male with past medical history significant for CHFrEF (now 20%), PAF on Eliquis, HTN, CKD4, DM2, hydronephrosis status post right nephrostomy, who present to emergency department with a complaint of weakness and fall.  Patient developed generalized weakness, cold symptoms, and malaise and had a ground level fall after receiving his COVID-19 and flu vaccine.   Upon arrival at emergency department patient's vitals blood pressure 123/60, pulse 114, temperature 97.7°, O2 sat 98% on room air, respiration 18. Imaging CT of the head and cervical spine showed no acute intracranial process or fracture.  Chest x-ray showed mild left pleural effusion without evidence of infiltrate or opacity. EKG showed atrial fibrillation with heart rate at 117, as well as left anterior fascicular block.  Given patient's frequent fall and generalized weakness as well as COVID-19 infection that patient tested positive for, patient was admitted to general medicine for further management and PT OT and case manager will be consulted for placement.   Due to frequent falls patients eliquis was discontinued. Patient and son both agreed on this. Repeat ECHO did note decrease in EF from 40 to 21%. Patient was continued on his goal directed medical therapy of Toprol XL and lisinopril. No evidence of acute CHF. Recommend to follow up with Cardiology outpatient for repeat ECHO and optimization of medical therapy. This was communicated to his son who voiced understanding.    Orthopedics was consulted for mildly displaced R fibular fracture during his stay for which orthopedic surgery recommended conservative management with weight-bearing as tolerated. Outpatient ortho follow up in 1 week.   Patient discharged back to assisted living in stable condition. Discharge instructions reviewed with son over the phone.
didn't feel sick for a few days like the Flu shot often creates; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 05-Dec-2020. This case involves a patient of unknown demographics didn't feel sick for a few days like the Flu shot often create (Illness), while the patient received Influenza vaccine.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was unknown.  On an unknown date, the patients received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, the patient didn't feel sick for a few days like the Flu shot often create (Illness) unknown period of time after the administration of influenza vaccine.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.
I woke up the morning after the shot and my tongue was swollen. The next day I took Benadryl and after I got a prescription for prednisone and I ended I went to the ER and they gave me Benadryl and Pepcid. I still have some swelling in my tongue and a rash which reoccur. The rash is on the front of my tongue. The little glands turn red and sometimes travel down the sides of my tongue. I am taking two Pepcid and two Benadryl, and I am twelve weeks out. I have been trying to stretch the time out between medication, but the symptoms come back. If I eat spicy food, my tongue starts tingling. The rash still comes and goes. I have been advised not to get the second shot.
Missed second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. Treatment medication was not provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.
Headache/severe headache; Soreness of arm; Tiredness; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Feb-2021 and was forwarded to Moderna on 16-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of arm), FATIGUE (Tiredness) and HEADACHE (Headache/severe headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (Soreness of arm) and FATIGUE (Tiredness). On 14-Feb-2021, the patient experienced HEADACHE (Headache/severe headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 13-Feb-2021, PAIN IN EXTREMITY (Soreness of arm) and FATIGUE (Tiredness) had resolved. On 18-Feb-2021, HEADACHE (Headache/severe headache) had resolved.            No concomitant medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Follow up received on 27-APR-2021. Contact information updated. First dose details were reported. Event outcome and end date added to case. On 29-Jun-2021: Non-Significant followup appended.
Back pain; Pain between the shoulder blades three days later; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain) and ARTHRALGIA (Pain between the shoulder blades three days later) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (Back pain) and ARTHRALGIA (Pain between the shoulder blades three days later). At the time of the report, BACK PAIN (Back pain) and ARTHRALGIA (Pain between the shoulder blades three days later) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant history was not reported.   The treatment information was not provided.   Reporter did not allow further contact
Light numbness in her mouth; Tingling mouth; Burning mouth; Chest pain; Apettite lost; Sweating; Loss of balance; Ear pain; Pain in arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (Light numbness in her mouth), PARAESTHESIA ORAL (Tingling mouth), ORAL DISCOMFORT (Burning mouth), CHEST PAIN (Chest pain) and DECREASED APPETITE (Apettite lost) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0404C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021, the patient experienced HYPOAESTHESIA ORAL (Light numbness in her mouth), PARAESTHESIA ORAL (Tingling mouth), ORAL DISCOMFORT (Burning mouth), CHEST PAIN (Chest pain), DECREASED APPETITE (Apettite lost), HYPERHIDROSIS (Sweating), BALANCE DISORDER (Loss of balance), EAR PAIN (Ear pain), VACCINATION SITE PAIN (Pain in arm) and HEADACHE (Headache). The patient was treated with LORATADINE ongoing since an unknown date for Allergy, at a dose of 1 dosage form and IBUPROFEN ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, HYPOAESTHESIA ORAL (Light numbness in her mouth), PARAESTHESIA ORAL (Tingling mouth), ORAL DISCOMFORT (Burning mouth), CHEST PAIN (Chest pain), DECREASED APPETITE (Apettite lost), HYPERHIDROSIS (Sweating), BALANCE DISORDER (Loss of balance), EAR PAIN (Ear pain), VACCINATION SITE PAIN (Pain in arm) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by reporter.
This spontaneous report refers to a 76 years old male patient. The patient was vaccinated with, .65 ml ZOSTAVAX on 21-MAR-2010. No other suspect therapies were reported. Concomitant medications included gabapentin. On 29-NOV-2012 the patient experienced herpes zoster infection. The patient has a history of cancer but was in remission at the time of the vaccination. Patient was treated with Valacyclovir and ZOFRAN. The outcome of herpes zoster infection is unknown. The relatedness for herpes zoster infection is unknown for ZOSTAVAX. Additional information has been requested.
Vaccine was administered past the vial's Beyond Use Date of 05/16/2023 @ 11AM. Per manufacturer recommendations, clinic medical director to reach out to patient to schedule visit for re-administration of new dose.
Product storage error; Covid-19 vaccine that were given beyond the 30 day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Covid-19 vaccine that were given beyond the 30 day use by date) and PRODUCT STORAGE ERROR (Product storage error) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Covid-19 vaccine that were given beyond the 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Covid-19 vaccine that were given beyond the 30 day use by date) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient Ethnicity was reported.  Dose description included: Booster.    Vaccine went into 2 to 8 degree Celsius thaw state on about 24 Dec 2021. The vaccine was administered up until its manufacturing expiry date of 04 Apr 2022.  No concomitant medication was provided. No treatment medication was provided.
PT DOB 4/14/1992 recieved 1st dose of Pfizer vaccine today. Per Safety officer report to this writer: Pt stated he had a smoothie this morning. Pt has needle anxiety from other shots. Pt states blurred vision but after laying down, Pt states the blurred vision resolved. Pt was given juice. EMS arrived to evaluate Pt. After 10 min, Pt condition resolved further. Pt cleared by EMS and was asked to wait another 15 min. Pt waited another 15 min and ambulated out of facility with steady gait.  VSs per EMS 0918 BP 82/palp HR 56 O2 sat 99% on RA  VSs per EMA 0924 BP 102/palp HR 76 RR 14 O2 sat 100% on RA
Walked to the parking lot following the injection. Had a syncopal episode at their car about 6-9 minutes after her injection. Witnessed by MOC. Child fell striking her head on the ground. MOC states daughter's lips were blue and she was unresponsive. MOC started CPR and called emergency. Sent son inside to get me. When I arrived the girl was responsive with eyes open. She could answer simple questions correctly and follow commands. Hand grips were equilaterally strong. She could wiggle her toes bilaterally and her pupils appeared even and she could track with her eyes. Her complexion was pasty pale and a weak pulse was present. At that time emergency vehicles were there and she was transported by ambulance to the local hospital for further evaluation. 11/05/10 heard back from MOC today. She states pt is much better. She took her into her PCP today to double check everything and pt is back to normal.
I did not have an adverse reaction to the vaccine. On 10/29/2022, I went to the emergency room with vision issues in my left eye, dizziness, trouble speaking and talking. I was diagnosed as having a TIA (transient ischaemic attack).  I was referred to a neurologist. As of today, I am doing well.
pt had episode of vomiting, then was unresponsive for about 10 mins; no cyanosis, no sz activity, no fever, no irritability; 4 hr later, had period of unresponsiveness x 3min; pt was observed on monitor overnoc in house w/o recurrence;
Had flu vaccine 10/5/04 in AM. Arm ached the night of 10/5/04. Did not look at arm till afternoon of 10/6/04 and noticed large, raised area on upper arm. Area was warm and red. Areas was 4" in diameter from site. Swelling went down after 5 days, redness lasted 2 weeks. I saw site one week later and site appeared reddened 4" diameter/ location of site probable S/Q instead of IM/
Hard, red, and swollen area left deltoid-patient returned to have checked 08/22/2003.  Dr advised use cold pack and Benadryl and call if not better.
01/28/22 presents to ED for "cough and fatigue". PMHx of "COPD with chronic hypoxic resp failure, ESRD on HD MWF, myeloma"
This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the first vaccine a week ago. It was reported that the patient had a migraine today and wants to know if there's any side effects of any medication or reactions to migraine medication she is taking at onset of migraines only. She wanted to know if she could take it. The outcome of the event was unknown.
Patient had already completed primary series and initial booster, so should have received bivalent vaccine for booster. Was administered monovalent vaccine instead in error. Will return in 2 months for bivalent booster dose.
severe fatigue, nausea, vomiting, shakes and feeling hot.  Sx started approx 25 hours after 2nd vaccine and have carried into the next day.
Since 2 weeks after the shot, I've been experiencing tingling and numbness in my toes and fingers throughout the day.
Narrative: had lumps all over his chest and his axilla after receiving vaccine. he did not receive second dose as he was advised against it by his provider.
Reaction occurred after the second dose/she got really bad anxiety; This is spontaneous report from a contactable consumer (Patient). A 71-years-old female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Batch/Lot Number and expiration date was not reported) via an unspecified route of administration, as dose 2, single for COVID-19 immunization. The patient medical history included She is very addicted to the nicotine, and She took Chantix, got sick off of one of the pills was afraid to take this new Chantix. The patient concomitant medications were not reported. The patient previously received historical vaccine of first dose of BNT162B2 vaccine, on an unspecified date for COVID-19 immunization. On an unspecified date, Reaction occurred after the second dose/she got really bad anxiety. On an unspecified date, the patient experienced Reaction occurred after the second dose/she got really bad anxiety. The Caller stated she then did not took any more. She got a different prescription instead of the drug mart she previously went to. Was afraid to take this new CHANTIX.S he was now vaping again. She Stated she did take one of the new CHANTIX this morning while speaking with the  agent. She did not thought she will get sick on this new CHANTIX she started today. She did not knew if the previous CHANTIX was just old. She also had a reaction to the vaccine. Is not sure. She clarified she had both Pfizer COVID vaccines, first and second dose. Reaction occurred after the second dose. She was very addicted to the nicotine. She stated she was not vaping at the time she took the CHANTIX. Stated she was also on CHANTIX a year ago and did quit vaping. She really likes CHANTIX. She did not got side effects a year ago. All she got was colourful dreams, which did continue for a while after she stopped the CHANTIX. She had no nightmares. Clarified she got sick off of one of the pills: She got very bad headaches like never before. Felt sick to stomach even though she had eaten, which never happened before. Only thing that was different was she was taking the CHANTIX. She got scared and stopped taking it before Pfizer came out with the lot numbers. Began: Dec2020 or Jan2021, she had the COVID vaccine by then so she did not knew what caused it. She took CHANTIX in the beginning of August, stating it was an old prescription she got out of the drawer and that was what she got sick on. She clarified that got sick after taking CHANTIX in Jan2021. Then she got the new one, it had the same number, so it was the same product, and she just took it. Wanted to add, when she got the COVID vaccine, she got really bad anxiety. Takes Xanax at night to sleep, had take Xanax during the day, which is unusual for her. She usually takes 2 Xanax, but only took 1. She then woke up at 3AM and took one more Xanax, so she was taking her full dose. She was originally diagnosed and put on Xanax three times a day, but it is too much for her. So she cut it down to two Xanax at night. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
2 inch diameter at injection site; swelling, redness, tender for 3 days after; 2 inch diameter at injection site; swelling, redness, tender for 3 days after; 2 inch diameter at injection site; swelling, redness, tender for 3 days after; This is a spontaneous report from a contactable other health professional (patient).  A 40-years-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 17Dec2020 16: 30 at single dose on left arm for COVID-19 immunization in hospital. Medical history included attention deficit hyperactivity disorder (ADHD), idiopathic retinitis. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), gabapentin, naproxen sodium (ALEVE), ergocalciferol (VIT D), magnesium supplement and multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced 2 inch diameter at injection site; swelling, redness, tender for 3 days after, stated from 18Dec2020 12:00 PM. Then gone. No treatment received for the adverse events. The events outcome was recovered in Dec2020. No COVID prior vaccination, since the vaccination, the patient hadn't been tested for COVID-19. The seriousness was reported as no.  The information on the batch number has been requested.
SKIN PAIN; NERVE PAIN; RECURRENT PSORIASIS; CHEST HURTS; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: psoriasis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced skin pain, nerve pain, recurrent psoriasis, chest hurts, headache, and fatigue. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) tested twice it was negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, skin pain, nerve pain, fatigue, recurrent psoriasis and chest hurts was not reported. This report was non-serious.
Patient informed this writer that she had had COVID approximately 1 week after her initial vaccination. I informed the patient that she could then defer 90 days to receive her 2nd Moderna dose without any worry. She indicated she would rather receive the second Moderna dose today, for fear of getting COVID again. She was vaccinated. After vaccination was given, she informed this writer that she had in fact been hospitalized with COVID. This writer asked, "Did you receive monoclonal antibody during that hosp" She replied, "Yes." This writer informed the patient that she would need to contact Agency to report the incident, as the vaccination should have been deferred. No adverse event reported in the patient.
shingles; Information has been received from a lawyer regarding a case in litigation, concerning a male patient (pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided.   In or about September 2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) at a pharmacy, for routine health maintenance and for its intended purpose: the prevention of shingles (dose, route of administration, anatomical location, lot number and expiration date were not reported).   In or around April 2018, the pt presented to the physician, with a painful rash on his right leg, which was diagnosed as shingles. The shingles outbreak lasted approximately three months, causing severe pain and suffering. Symptoms resulted in physical limitations not present prior to vaccination and the pt experienced mental and emotional distress due to resulting physical limitations and seriousness of the condition. The pt suffered severe, serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Moreover, the pt had incurred and would continue to incur medical expenses and other economic harm.   The outcome of the event was considered to be not resolved. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Upon internal review, the event of shingles was considered to be disabling.