chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; 5 doses administered after expiration date. Doses administered today. Bivalent vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 doses administered after expiration date. Doses administered today. Bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Jun-2023, 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 16-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 doses administered after expiration date. Doses administered today. Bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 doses administered after expiration date. Doses administered today. Bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (5 doses administered after expiration date. Doses administered today. Bivalent vaccine).    Patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine was unknown. Dosage text was reported as unknown. Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter. This case contains information of 4th patient out of 5.   This case was linked to US-MODERNATX, INC.-MOD-2023-729599 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729599:Master case
Vaccine past beyond use date administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine past beyond use date administered) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy and Drug allergy.    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine past beyond use date administered). On 17-May-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine past beyond use date administered) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant information was not provided. Treatment information was not provided.   This case was linked to MOD21-091070 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Patient medical history was updated. Allergies to medication, food and others.; Sender's Comments:  MOD21-091070:same reporter different patient
Patient is a 77 y.o. male patient of PRIVATE, MD with history of recent PEA arrest with cardiogenic shock, NSTEMI, chronic HFpEF, PAF on Eliquis, CAD s/p PCI, s/p ICD, HTN, HLD,COPD with chronic hypoxemic respiratory failure on home 02 and recent intubation, DM2, GERD, Normocytic anemia, Nicotine Dependence, and weakness with deconditioning, who presents with worsening shortness of breath from baseline.    Acute on Chronic Respiratory Failure with hypoxia Acute COPD Exacerbation COVID-19 Infection Secondary to COPD and recent PEA CXR with no infiltrate, nodule, or effusion.  Chronic lung markings. Continuous pulse ox with nasal cannula oxygen.  Reviewed down to 2 L O2 which is his baseline Continue bronchodilators as ordered Vaccinated with booster Symptoms onset 12/13/2022, positive test date 12/15/2022 tested positive again on 12/21 ID recommendation noted.  Continue remdesivir for 5 days and Decadron for 10 days.  Monitor daily CMP Anticoagulation: Home Eliquis Consider discontinuation of isolation 12/23/22 after completion 10 days isolation from symptom onset 12/13   Acute on Chronic Systolic Congestive heart failure  Paroxysmal A. fib Recent ECHO from 11/2022 showed Moderately severe LV cavity enlargement with severe global systolic dysfunction; EF 15-20%. indeterminate study for diastolic function. IV lasix 40 twice daily discontinued, euvolemic on exam  Strict I&Os Fluid restriction Continue Eliquis Cardiology and palliative cardiology and palliative care following.  Recommendations noted.  Net IO Since Admission: -6,767.99 mL [12/30/22 0736]   Sepsis without organ dysfunction -resolved now Secondary to  COVID-19  & POA:  Presented with tachycardia and tachypnea. Hemodynamically stable, not requiring vasopressors received breathing treatments in ED Workup: COVID-19 positive, influenza A/B negative, and BC/UC pending Holding antibiotics given viral etiology at this time   DM2 Hold home oral medication, Diet Special; Diabetic, Cardiac; Carbohydrate Consistent 60g/meal (1500-2000 kCal equivalent) diet, sensitive SSI + BG checks ACHS, hypoglycemic protocol, and target BG 140-180  Chronic Anemia Secondary to anemia of chronic disease  Baseline hemoglobin 9.0 Admission hemoglobin 9.0 No signs of overt bleeding Trend CBC daily, and Q72h Type and screen if indicated Transfuse for hbg < 7   Other chronic medical conditions: Continue all home meds except stated above or contraindicated. ? Recent PEA arrest with cardiogenic shock ? NSTEMI ? CAD s/p PCI ? S/p ICD ? HTN ? HLD ? GERD ? Nicotine Dependence ? Weakness with deconditioning
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Oct2023 at 16:00 as dose 1, single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: moderna (DOSE 1, SINGLE at 04:00 PM, Batch/lot number: 013M20A, Anatomical location: Arm left), administration date: 04Feb2021, for COVID-19 immunization; moderna (DOSE 2, SINGLE at 03:45 PM, Batch/lot number: 031M20A, Anatomical location: Arm left), administration date: 08Mar2021, for COVID-19 immunization; moderna (DOSE 3 (BOOSTER), SINGLE at 02:30 PM, Batch/lot number: 045C21A, Anatomical location: Arm left), administration date: 25Oct2021, for COVID-19 immunization; moderna (DOSE 4 (BOOSTER), SINGLE, Batch/lot number: A5714nl, Anatomical location: Arm left), administration date: 04Sep2022, for COVID-19 immunization; bnt162b2 (DOSE 5 (BOOSTER), SINGLE at 02:00 AM, Batch/lot number: FT5682, Anatomical location: Arm left), administration date: 12May2022, for COVID-19 immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 03Nov2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Nov2023) positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient had no known allergies. Patient received Paxlovid treatment from 04Nov2023 to 09Nov2023. Patient experienced symptoms on 03Nov2023 and tested positive 04Nov2023.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300384752 same patient, different drug/AE;
Patient received the fourth dose of covid vaccine at health department on  03/16/22. Patient returned to nursing home. Nursing home called physician office at 11:49 am on 03/17/22, reporting "BP being low, she is pale, vomiting, and is confused." Patient sent to ER. Upon arrival to ER, according to chart, "Patient was brought to the emergency department by ambulance from the nursing home with altered mental status.  EMS reports that nursing home staff stated patient had been hallucinating and had had some facial drooping and was leaning towards the right with right-sided weakness.  EMS did not notice any facial drooping or right-sided weakness on their arrival but the patient was confused and hallucinating.  EMS describe intermittent consciousness with patient being unresponsive but arousable at times.  Upon arrival to the emergency department patient was awake but intermittently confused.  She did acknowledge she knew where she was at.  She denied any chest pain.  She stated she has chronic difficulty breathing.  She is able to move all asked remedies on command and stated she had pain in her feet all the time.  She was without any other complaints. Staff advised that she has intermittent problems with hallucinations over the last week or 2.  Review of her chart and after discussion with her primary care provider she does have a history of urinary tract infection with sepsis in the past and confusion and altered mental status associated with the past episode.  Patient also has a history of CVA in the past.  Patient also has history of some kind of neurologic disorder that caused quadriplegia which improved to just paraplegia." Patient diagnosed with sepsis, UTI, altered mental status, facial droop, hallucinations, elevated lactic and d-dimer, fever, and hypoxia.
HERPES ZOSTER; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 65 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or around 09-AUG-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a healthcare provider for herpes zoster at the emergency room. The outcome of the event herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
small redness at the injection site; small swelling at the injection site; nausea; pains in the arm that woke him up and prevented him from sleeping; pains in the arm that woke him up and prevented him from sleeping; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pains in the arm that woke him up and prevented him from sleeping), INSOMNIA (pains in the arm that woke him up and prevented him from sleeping), INJECTION SITE ERYTHEMA (small redness at the injection site), INJECTION SITE SWELLING (small swelling at the injection site) and NAUSEA (nausea) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   Concomitant medications were not reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.   On 25-Mar-2021, the patient experienced VACCINATION SITE PAIN (pains in the arm that woke him up and prevented him from sleeping) and NAUSEA (nausea). On an unknown date, the patient experienced INSOMNIA (pains in the arm that woke him up and prevented him from sleeping), INJECTION SITE ERYTHEMA (small redness at the injection site) and INJECTION SITE SWELLING (small swelling at the injection site).   At the time of the report, VACCINATION SITE PAIN (pains in the arm that woke him up and prevented him from sleeping) and NAUSEA (nausea) outcome was unknown.      No treatment medications are included.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Pain, swelling and itching at site within 8 hours. Temperature 99.9 (taking Advil around the clock for another problem) Hand felt numb but residing. on day three the area was 3 inches in diameter of redness and 2 inches of induration.  Employee states her mother said it looks like her shots when she was a child. Left Deltoid.
coughing with a "wheezy sounding cough; she felt "not so good in my chest"; pain in chest; mild allergic reaction; a lot of pressure and pain and tightness in my ears; a lot of pressure and pain and tightness in my ears; This is a spontaneous report from a contactable consumer (reporting for herself) via the medical information team. A 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: unknown), via an unspecified route of administration, administered in left arm on 03Mar2021 at 04:15 as single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. On 03Mar2021 at 17:00 (reported as 05:00PM), the patient experienced mild allergic reaction. The patient waited for 15 minutes before leaving. On the way home, the patient experienced a lot of pressure and pain and tightness in her ears. She stated that she felt "not so good in her chest". The patient took 2 Benadryl to help. At 18:00 (reported as 06:00PM), the patient developed pain in her chest and was coughing with a "wheezy sounding cough". Her doctor instructed her to go to the emergency room where she was told she was having a mild to moderate reaction and was administered Albuterol. She states that the next day she was still coughing, but by the day after that, she felt fine. She states she already spoke with her doctor who recommended she not get the second shot. At the emergency room, they checked her pulse oximetry for the blood oxygen level. She had an albuterol treatment for her breathing. They listened to her chest with a stethoscope. The outcome of the event coughing, she felt "not so good in my chest", and pain in chest was recovered on 05Mar2021 while the outcome of the other events was recovered on an unspecified date.  Information on the lot/batch number has been requested.
Developed ITP, currently in the hospital getting treated with dexamethasone 40 mg daily
Right under arm lymph node extremely swollen visible through the skin; Right under arm lymph node extremely swollen visible through the skin - the size of orange, painful for aprox 4 days;; Type 1 insulin dependent diabetic experienced veryhigh blood glucose readings begining day after second vaccine - over 250 mg/dL - and continuing through 5 days; This is a spontaneous report from a non-contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 23Apr2021 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included type 1 diabetic and COVID-19 (Prior to the vaccination, the patient was diagnosed with COVID-19). The patient received unspecified medication within two weeks of vaccination. The patient did not receive any other vaccine within four weeks prior to the COVID-19 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 02Apr2021 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. On 24Apr2021, the patient experienced right under arm lymph node extremely swollen visible through the skin - the size of orange, painful for approximately four days; type 1 insulin dependent diabetic experienced very high blood glucose readings began day after second vaccine over 250 mg/dL and was continued through five days. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. On 24Apr2021, the patient underwent blood glucose test and the result was 250 mg/dL. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event right under arm lymph node extremely swollen visible through the skin - the size of orange, painful for approximately four days and high blood glucose readings began day after second vaccine over 250 mg/dL was recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pain in arm immediately; unable to lift arm; went to see doctor who did a nerve study on her then sent her for an MRI on 10/24/2012. Placed her on Lyrica 50 mg TID for pain. MRI showed 2 pockets and fluid in arm and edema. She is to have another MRI on 11/06/2012 to reassess. Pt is still working as a nurse but only because pain is kept under control with the Lyrica.
Swelling, erythema, warmth & induration at vaccine site area involved 12 1/2 cm X 12 cm in size.  Received 2 vaccines in left deltoid HEP A #2 - MENACTRA.  Did not have reaction with HEP A #4.
Patient's arm swelled; warm; kind of red.; firm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Patient's arm swelled), FEELING HOT (warm), ERYTHEMA (kind of red.) and MUSCLE RIGIDITY (firm) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     Concomitant products included METFORMIN, AMLODIPINE, ASCORBIC ACID, ASPIRIN [ACETYLSALICYLIC ACID], BILBERRY [VACCINIUM MYRTILLUS], ENALAPRIL, GABAPENTIN, GINKGO BILOBA (GINGKO BILOBA), GLUCOSAMINE, HYDROCHLOROTHIAZIDE, SALMON OIL, METOPROLOL, SIMVASTATIN and LIPO FLAVONOID PLUS for an unknown indication.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Patient's arm swelled), FEELING HOT (warm), ERYTHEMA (kind of red.) and MUSCLE RIGIDITY (firm). At the time of the report, PERIPHERAL SWELLING (Patient's arm swelled), FEELING HOT (warm), ERYTHEMA (kind of red.) and MUSCLE RIGIDITY (firm) had resolved.            No treatment medication was reported. Patient had Moderna for the 1st and 2nd dose and did not have any reaction.  This case concerns a 79 year old female  with no reported medical history who experienced  , non-serious, unexpected events of peripheral swelling, feeling hot, erythema and muscle rigidity which occurred on an unknown date after vaccination with the 3rd  dose ( booster dose ) of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine ) . The re-challenge for this case is not applicable since the events occurred after the 3rd dose and no additional doses will be given and also the outcome of the events was unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 30-Nov-2021: Follow up received on 30-Nov-2021 contains updated the outcome from unknown to recovered and updated address of primary reporter.; Sender's Comments: This case concerns a 79 year old female  with no reported medical history who experienced  , non-serious, unexpected events of peripheral swelling, feeling hot, erythema and muscle rigidity which occurred on an unknown date after vaccination with the 3rd  dose ( booster dose ) of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine ) . The re-challenge for this case is not applicable since the events occurred after the 3rd dose and no additional doses will be given and also the outcome of the events was unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.
Mom called office on 4/1/2019 to report that child has a flesh colored marble sized lump at injection site. Lump is non tender, no C/O itchiness or drainage from area. Will monitor and follow-up as needed.
Mild coughing; Headaches here and there; Fever 101.6-103; This spontaneous case was reported by a nurse and describes the occurrence of COUGH (Mild coughing), PYREXIA (Fever 101.6-103) and HEADACHE (Headaches here and there) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Systemic lupus erythematosus.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jan-2021, the patient experienced PYREXIA (Fever 101.6-103). On 26-Jan-2021, the patient experienced COUGH (Mild coughing) and HEADACHE (Headaches here and there). At the time of the report, COUGH (Mild coughing), PYREXIA (Fever 101.6-103) and HEADACHE (Headaches here and there) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jan-2021, Body temperature: 101.6-103.2 High. On 26-Jan-2021, SARS-CoV-2 test: positive Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications and treatment medications were reported.   This case was linked to MOD-2021-029547 (Patient Link).
Fever, Chills, Muscle Aches, Runny Nose, New olfactory and taste disorder, Headache, Fatigue, Cough, Shortness of Breath, Diarrhea
1/4/21-Headache with aura started around noon progressing into the evening with extreme muscle and joint pain. Mostly from the calf to both feet with swelling. Fever started next day 1/5/21  till current 1/6/21. Highest temp 102 degrees. Painful to walk or stand. Nausea- no vomiting. Swollen shoulder at the injection site.
CHRONIC HYPOXEMIC RESPIRATORY FAILURE 4/15/2023 CHRONIC PAIN SYNDROME
This is a spontaneous report from a contactable consumer, patient. A 46-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3248), via an unspecified route of administration in the left arm on 23Mar2021 at 10:00 (age at vaccination was 46-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any known allergies. The concomitant medications included fesoterodine fumarate (TOVIAZ) and loratadine (CLARITIN) for an unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3248), via an unspecified route of administration in the left arm on 02Mar2021 at 10:00 (at the age of 46-years old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 23Mar2021 at 18:00, the patient experienced exhaustion. The patient did not receive any treatment for the reported event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of exhaustion was resolved on an unspecified date in Mar2021.   No follow-up attempts are needed. No further information expected.
Information has been received from a health professional concerning a male who was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. On 28-FEB-2006 the patient came to the health center with parotid swelling. labs were drawn and mumps was laboratory confirmed. unspecified medical attention was sought. no product quality complaint was involved. No other information was provided. Additional information has been requested.