chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Hospitalized 10/12/2021; COVID-19 positive 10/12/2021; fully vaccinated  Assessment/Plan    DIAGNOSIS at time of disposition: 1. Hypoxia  2. COVID-19  Current Discharge Medication List ED Disposition   Hospitalized MEDICAL DECISION MAKING Patient is a 69-year-old who presents to the emergency department today complaining of shortness of breath, chronic cough, and primarily fever.  Exam, patient is somewhat tachypneic.  He has some coarse breath sounds bilaterally.  He is hypoxic requiring supplemental oxygen. Patient did note that his wife was recently diagnosed with COVID-19.  This is high in differential.  Also, other etiologies of sepsis or on the differential.  Given this, I will obtain IV access, chest x-ray, complete blood count, CMP, blood cultures and lactic acid. Patient did require titration of oxygen level from secondary to hypoxia at 2 L. Chest x-ray came back overall reassuring.  Patient's COVID-19 test did come back positive.  I did order Decadron for this patient. Given hypoxia, patient will require admission.  I did discuss case with patient and hospitalist who are agreeable with this plan of care.  Patient has no further questions or concerns at this time. 10/13/2021 notes: ASSESSMENT / PLAN: Acute hypoxic respiratory failure COVID-19 pneumonia COPD exacerbation - continue steroids, decadron 6mg daily, remdesivir - pneumonia by clinical exam, rales, COVID-19, infiltrates often do not appear on CXR and can be seen with CT, no indication for CT here currently - scheduled breathing treatments - symbicort - needs COPD education, did not realize he had COPD or why he was on symbicort, never picked up his nebulizer machine - monitor oxygen closely given high risk of decompensation. 10/14/2021 note: ASSESSMENT / PLAN: Principal Problem:  Respiratory failure (HCC)  Acute hypoxic respiratory failure COVID-19 pneumonia COPD exacerbation -Symptom onset 10/10. Currently requiring 4L via NC - pneumonia by clinical exam, rales, COVID-19, infiltrates often do not appear on CXR and can be seen with CT, no indication for CT here currently -Decadron 6mg x10 days -Remdesivir - Albuterol INH q4hr - Dulera BID, Spiriva daily - needs COPD education, did not realize he had COPD or why he was on symbicort, never picked up his nebulizer machine. Will consult Pulm Rehab once closer to discharge - Continuous pulse ox - Daily labs  Transaminitis, improving -Likely related to COVID -CMP daily, especially while on remdesivir  Disposition: stable on 4L via NC. Continue steroids, remdesivir, and supportive care. Continue to wean O2. If able to wean further, can consider discharge in next 24-48hr with home O2
Dry skin has not changed (After first and second vaccine); Decreased WBC after first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DRY SKIN (Dry skin has not changed (After first and second vaccine)) and WHITE BLOOD CELL COUNT DECREASED (Decreased WBC after first vaccine) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoporosis since 2012 and Glaucoma (She had Glaucoma and uses latanoprost eye drops.). Concomitant products included LATANOPROST for Glaucoma, DENOSUMAB (PROLIA) for an unknown indication.    On 19-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced WHITE BLOOD CELL COUNT DECREASED (Decreased WBC after first vaccine). On 09-Aug-2021, the patient experienced DRY SKIN (Dry skin has not changed (After first and second vaccine)). At the time of the report, DRY SKIN (Dry skin has not changed (After first and second vaccine)) and WHITE BLOOD CELL COUNT DECREASED (Decreased WBC after first vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, White blood cell count (3.5-11): 4.4 (normal) WBC 4.4. On 14-Jul-2021, White blood cell count (3.5-11): 3.4 (Low) WBC decreased to 3.4.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided by the reporter.   This case was linked to MOD-2021-280551 (Patient Link).
Patient Summary: Patient is a 79-year-old female with a past medical history significant for hypertension, hyperlipidemia, type 2 diabetes mellitus, GERD, hypothyroidism and previous stroke versus TIA in 2016 who presented to the emergency department at Hospital on April 27 after receiving her second Covid vaccination and developing altered mental status.  She was evaluated in the emergency department by the neurology service and there was no evidence of stroke on imaging.  She was admitted to family medicine for continued monitoring and evaluation for infection.  Extensive work-up including echocardiogram, chest x-ray, MRI of the brain, blood cultures and all of her labs were nonrevealing.  Her cognition returned to baseline but she was noted to have weakness and unsteadiness.  Physical and Occupational Therapy evaluated the patient and recommended postacute rehabilitation in a skilled nursing facility.
Pt presented with itching and heaviness in chest 15 min after vaccine administered.  Pulse regular. Denies chest pain.  10cc liquid Benadryl given PO, 25 min later itching gone and chest heaviness decreased, 15 min later feeling much better with no itching and chest heaviness gone, VS stable.  Released 15 min later at 7pm to father and instructed to notify dr.     Pt called nurse hotline the next day (1/29/21) experiencing 102.5 fever, achy, hard time breathing, HA and chills,  appt with MD in3 days.  Given emergency protocol.
DVT to right popliteal vein; This is a spontaneous report from a contactable physician (patient). A 68-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140), intramuscularly, administered in left arm, on 29Dec2020 (at the age of 68-years-old) at 1st dose, single for COVID-19 immunisation. Medical history included type II diabetes and hypertension. The patient was not pregnant. No COVID prior vaccination and no COVID tested post vaccination. The patient had no known allergies. Other medications in two weeks included metoprolol, ramipril and metformin. No other vaccines were received in four weeks. The patient experienced deep vein thrombosis (DVT) to right popliteal vein on 15Mar2021. The event resulted in doctor or other healthcare professional office/clinic visit. Treatments were administered as a result of the event and included ELIQUIS, bed rest, legs elevated. The patient was recovering from the event.; Sender's Comments: Based on the temporal relationship, the association between the event deep vein thrombosis with BNT162b2 can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product 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.
Patient reports redness, swelling, and pain at injection site approximately 5 hours after receiving pneumococcal injection. Fever, chills - uncontrollable, night sweats. Myalgias still on day 3. Redness, swelling, severe pain at injection site still on day 3.
I got chills for about 4 hours. Then a few days later, it flared my eye virus up. I went to my eye doctor about it. They upped my medicine.
pt recv vax 26SEP97 Friday PM arm (deltoid area) swollen to size of a football muscle aches esp rt thigh;t104.2 w/Ibuprofen t101;seen by own MD 1OCT97 ATB given;
HOT FLASHES, AND THEN EXTEME DRYNESS IN NOSE OR MOUTH AND LATHARGIC, TIRED, RED, SWOLLEN, HOT AND PAINFUL AT INJECTION SITE. I'VE RECEIVED A FLU SHOT EVERY YEAR AND NOT HAD THIS REACTION BEFORE
patient only received 75% of first dose; Needle twisted off of the syringe while adminstrating; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (patient only received 75% of first dose) and NEEDLE ISSUE (Needle twisted off of the syringe while adminstrating) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046L21A) for COVID-19 vaccination.     Concomitant products included CODEINE and AMOXICILLIN for an unknown indication.    On 15-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2022, the patient experienced ACCIDENTAL UNDERDOSE (patient only received 75% of first dose) and NEEDLE ISSUE (Needle twisted off of the syringe while adminstrating). At the time of the report, ACCIDENTAL UNDERDOSE (patient only received 75% of first dose) and NEEDLE ISSUE (Needle twisted off of the syringe while adminstrating) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter stated that patient got administered with first dose of Moderna COVID-19 vaccine on 15-Feb-2022 where there was only 75 percent of the dose went into the patient due to the needle twisting out of the syringe. Patient was okay.  No treatment medications were reported.
Patient was given the Fluzone HD indicated for patients 65 years of age and older. The patient is only age 54 at time of administration.
Pain under left foot. Then it went to the right side. 2nd day it was severe.  Today it is a mild feeling but it is still there on the right side.
This spontaneous report was received from a medical assistant, refers to unspecified patients of unknown age and gender. No pertinent medical history was reported. On an unknown date, unspecified patients were administered VAQTA (strength, dose, route, lot# were not reported) which were exposed to temperatures of 10 degrees Celsius for 7 hours and 45 minutes. No adverse events were reported. This is one of the several reports from the same source. Additional information has been requested.
pt recvd vax 11AM recvd phone call 1550 describing elevated temp 104; sl swelling & ? labored breathing;
I have double beats and skip beats in my heart and ever since the vaccine, I have had heart beat problems. Went to doctors and they said I have Premature Ventricular Contractions and I have them often.
Systemic: Rash (other than injection site), Systemic: Hyperventilation without airway block from neck
No adverse effect was reported. Previous lot number AS7164B was taken for a Bivalent dose at check-in.
Within 24 hrs of applied, mother noticed inflammation over (L) deltoid area. Patient doing well. No tingling, numbness or weakness.
10 hours after vaccination, client noticed itching at injection site (left upper arm (deltoid)) and noticed severe redness "itchy". Was 6-7"x4". Experienced slight dysfunction for 1-2 days.
Currently presents a bruise with pain when touched in the area where the vaccine was placed. A little headache in the temple area.
Fully vaccinated, then shingles/Suspected vaccination failure; Two episode of shingles; This case was reported by a other health professional via call center representative and described the occurrence of vaccination failure in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On 27th October 2022, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 27-OCT-2022 Reporter's Comment: The reporter was medical assistant. The reporter reported that, patient experienced vaccine inefficacy twice after being fully vaccinated.  The reporter was unable to provide any adverse event information at this time.  The reporter consented to follow up with safety team. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Progressive development of a rare skin condition called pityroasis rubra pilaris which has been recalcitrant to multiple therapies
MAJOR FLU LIKE SYMPTOMS; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, and batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination.  The batch number is not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced major flu like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of major flu like symptoms was not reported. This report was non-serious.
Mom reports that there are "lumps" under the injection site, like the medicine pooled in the area under the injection.  This occurred with both injections.
Pt received Pediarix and Hib, then was inadvertently given IPOL all in one visit on 04/20/2005.
Vaccine administered 10/13/11, mother called 10/20 to report varicella type rash on face & neck (7 bumps), child was taken to medical center. Varicella type rash confirmed, child also had fever r/t strep throat. F/u on 10/24 with mother, child's rash very faint & doing well.
Received shots. Unsure it was right or left arm, but swelled up and turned red and purple. He went limp and was lethargic. Took him to the hospital; received IV antibiotics and instantly better. The ER record received on 4/5/04 states pharyngitis and dehydration.
RESIDENT WAS VACCINATED WITH FIRST DOSE OF MODERNA ON 6/23/22 AND WAS SCHEDULED TO RECEIVE HIS SECOND DOSE OF MODERNA AT THE CLINIC HELD AT LOCAL FACILITY ON 9/22/22 BY LOCAL PHARMACY. AT THE CLINIC, HE RECEIVED A PFIZER BIVALENT DOSE IN ERROR. THERE WAS NO ADVERSE REACTION NOTED. MEDICAL DIRECTOR WAS NOTIFIED AND RESIDENT WAS MONITORED ACCORDING TO FACILITY PROTOCOL.
No additional AE reported.; PROQUAD was administered on 08/24/2021 following a temperature excursion.; This spontaneous report was received from an office manager and refers to a patient of unspecified age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies.  On 24-AUG-2021, the patient was vaccinated with an improperly stored Measles, Mumps, Rubella, and Varicella (Oka-Merck) Virus Vaccine Live recombinant human albumin (rHA) (PROQUAD) (concentration, dose, vaccination scheme frequency, route, and anatomical site of administration were not reported; lot number U009260 was verified to be a valid lot number with an expiration date reported and established as 19-SEP-2022) for prophylaxis. It was reported that the administered vaccine experienced a temperature excursion of minus (-)10.7 degrees Celsius (°C) for a time frame of192 hours (product storage error). If there was any previous temperature excursion this information was not reported. No additional adverse event was provided.  This is one of two reports reported by the same reporter. Sender's Comments: US-009507513-2108USA007542.
Fast heart beat (100-135 bpm when sitting and not active).; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 34-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0162), via an unspecified route of administration, administered in the left arm on 20Mar2021 10:00 (at the age of 34-year-old) as dose 2, single for COVID-19 immunisation. The patient's medical history was not reported. Patient had no known allergies. Patient took birth control medication within 2 weeks of vaccination. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8727), via an unspecified route of administration, administered in the left arm on 20Mar2021 10:00 (at the age of 34-year-old) as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Apr2021, the patient experienced fast heartbeat (100-135 bpm when sitting and not active). Patient Had not gone to doctor but was thinking of going. The patient underwent lab tests and procedures which included heart rate increased: 100-135 bpm on 26Apr2021. No treatment received as a result of events. The reporter considered the event as non-serious. The outcome of the event was not recovered.
dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021 at 11:40 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Jan-2021 at 11:40 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of the patient was reported as 78.55.  No concomitant medications were reported.  On 12-Jan-2021, 3 vials were moved to clinic.  The vial was initially moved to the fridge on 08-Jan-2021 and proposed beyond use date was 07-Feb-2021. On the date of administration, at 08:00 A.M., the temperature recorded was 34 degree Fahrenheit and at 09:00 A.M., the temperature recorded was 34 degree Fahrenheit that has been reached by the vial. The vial was moved to clinic on 12-Jan-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  The healthcare professional (HCP) reported that, each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. The vial was stored in cooler storage during high-pace COVID-19 vaccination clinic at the time of excursion. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.  The occupation of reporter was reported as clinic manager.   This case was linked to MOD-2022-566976 (Patient Link).
In April I woke up in the middle of the night to write some on my school paper.  I was not able to write.  I got up again to write and I was still unable to write.  I called a friend, and I was not able to speak.  I saw my primary doctor about two weeks later and learned that I had a mini stroke.  I was prescribed several medications.  I had an event monitor and several tests that I cannot remember exactly.  I think I had a brain scan. I continue to have trouble enunciation and speech issues, concentration,
Vaccination was given in right thigh and developed a blistered rash from knee to hip, swelling, itching, and fever of 100.8 degrees F.
Sore arm; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 27Feb2021 at 15:00 (at the age of 71-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high and unspecified allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), hydrochlorothiazide/losartan potassium (LOSARTAN/HCTZ) and fexofenadine hydrochloride (ALLEGRA); all for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Feb2021, the patient experienced sore arm. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore arm was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore injection site arm) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore injection site arm). At the time of the report, VACCINATION SITE PAIN (Sore injection site arm) outcome was unknown.        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.   No relevant concomitant medications were provided. No treatment information was provided.   This case was linked to MOD-2021-339324 (Patient Link).
12/30 vaccine 1/1 about 12 started to feel fever, HA, fatigue, chills, body aches, night sweats.  101 at highest point for temp.  Took Ibuprofren. Doraflu from urgent care.
patient received 0.5ml dose instead of0.25ml of the 6 months through 11 year moderna covid vaccine