chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from nurse practitioner refers to a patient of an unknown age and gender. No medical history and concurrent conditions reported. On 16-JUN-2015, the patient was inadvertently administered with improperly stored, MMR II vaccine, lot # K002528, Expired date 18-FEB-2016, therapy type not provided, (dose, route, therapy type not reported). No adverse effects reported. No product quality complaint reported. This is one of several reports from the same source. Additional information has been requested.
Pt received Moderna vaccines on 01/12/21 and 02/09/21. Pt presented to the ED on 11/20/21 with complaints of AMS and decreased appetite. Pt was found to be COVID positive. Pt required 2L of nasal cannula.
One day post vax the pt developed an injection site reaction reaction characterized by redness, swelling and pain.
At 72 hr marl I began having nausea and intermittent vomiting.  Voming has subsided but nausea is persistent to the pint ive taken zofran many times.
This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EM9809), via unspecified route of administration on left arm on 03Feb2021 08:30 (at the age of 56-year-old) at single dose for Covid-19 immunization administered at Workplace clinic. The patient medical history included Atrial tachycardia and Meniere's disease. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EK4176), via unspecified route of administration on left arm on 19Jan2021 15:00 (at the age of 56-year-old) at single dose for Covid-19 immunization. Concomitant medication include Metoprolol, Pantoprazole, Crestor and Famotidine. Past drug events include Pyridium and Cleocin and experienced Allergy. The patient experienced, chemical taste and odor for 1st vaccine, right after administration for a minute or so 2nd vaccine, 30-45 minutes after which lasted at least 5 minutes on 09Feb2021 09:15. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any treatment for the event. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. The outcome of event was recovered.
No additional adverse effect reported; vaccine that underwent a temperature excursion was administered; This spontaneous report was received from a medical assistant referring to a patient on unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  It was reported that varicella virus vaccine live (oka/merck) (VARIVAX) (lot # T024283, expiration date was reported as 14-JUL-2022 but upon internal validation established as 15-JUL-2022; lot # T032930, expiration date was reported as 27-SEP-2022 but upon internal validation established as 28-SEP-2022) underwent a temperature excursion.  On 11-JUN-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose and route of administration were not reported) for prophylaxis. Information for which lots were given to patient not provided. The vaccine was exposed the temperature excursion 7.3 Fahrenheit (F) (between 6 to 14 F) for 10 minutes (product storage error). The data logger was involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2106USA004367: US-009507513-2106USA004368: US-009507513-2106USA004370: US-009507513-2106USA004372: US-009507513-2106USA004384: US-009507513-2106USA004356: US-009507513-2106USA004375: US-009507513-2106USA004376: US-009507513-2106USA004377: US-009507513-2106USA004366: US-009507513-2106USA004365:
3 days after vaccination patient developed a feeling of disorientation. Also developed nystagmus, and inability to hold his head still (bobbing) when at rest. A week later he developed dizziness, spinning.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Tinnitus-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: spoke with patient after recovery: patient states she started to feel light headed after vaccination. patient was seated when she fell over and fainted. patients was brought to lying position and legs raised. after awakening, patient felt, confused, had tinnitus, flushing, and very warm. was given water and fanned to cool down. patient states that she never has passed out before. after 15-20 minutes patient fully recovered and left with no further issues.
Left arm is swelled up; Left arm is red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Left arm is swelled up) and VACCINATION SITE ERYTHEMA (Left arm is red) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, the patient experienced VACCINATION SITE SWELLING (Left arm is swelled up) and VACCINATION SITE ERYTHEMA (Left arm is red). At the time of the report, VACCINATION SITE SWELLING (Left arm is swelled up) and VACCINATION SITE ERYTHEMA (Left arm is red) had not resolved.            No concomitant medications were provided. No treatment medications were reported.
Developed mild itching that turned into wide spread, severe itching and pain. Given benedryl and tylenol per peer RN recommendations. Improved, but ongoing
ATRIAL FIBRILLATION; This solicited report received from a patient: Janssen for XARELTO concerned a female of unspecified age, race and ethnic origin. 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, batch number: unknown, expiry: unknown) dose was not reported, 01 total, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medication included (ELIQUIS) apixaban for an unknown indication.  On unspecified date in JUL-2021, the patient was diagnosed with atrial fibrillation. The patient received (XARELTO) rivaroxaban (film-coated tablet, route of admin, and batch number were not reported, expiry: unknown) dose and frequency were not reported from JAN-2022 for an unspecified indication. On an unknown date in APR-2022 and JUN-2022, the patient again went into atrial fibrillation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable and action taken with rivaroxaban was not reported. The outcome of atrial fibrillation was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s and atrial fibrillation was related and between rivaroxaban and atrial fibrillation was not related.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220712003-covid-19 vaccine ad26.cov2.s -Atrial fibrillation. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered related.  20220712003-xarelto-Atrial fibrillation. The event(s) shows an incompatible temporal relationship. Therefore, this event(s) is considered not related.
Information has been received for the Pregnancy Registry for Gardasil from a physician concerning an 18 year old female patient with no pertinent medical history or drug reactions/allergies who on 27-AUG-2007 was vaccinated with a dose of Gardasil. There was no concomitant medications. The physician reported that the patient received Gardasil and became pregnant on an unspecified date. Her last menstrual period (LMP) was on 10-AUG-2007. The estimated delivery date would be 16-MAY-2008. Routine pregnancy panels laboratory tests were done. No result available. The physician reported that the fetus had acrenia and a therapeutic abortion was planned. No further information available. The outcome was unknown. In follow up telephone information it was reported by the medical assistant that patient was scheduled to be seen with a physician for the "abortion" on 13-NOV-2007. No further information was available at this time. Additional information has been requested.
Patient received her first dose of Moderna on 4/26/21. She would have been due for her second dose on 5/24/21 but her second dose was administered today (5/4/21) due to my oversight.      We had the patient wait for 30 minutes after her vaccine and she has not reported any negative signs or symptoms.
have experienced facial twitching that started in my eye and now progressed to my whole side of my face; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Sep2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1 Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2 Manufacturer Unknown), for Covid-19 immunization.  The following information was reported: MUSCLE TWITCHING (non-serious) with onset 2021, outcome "not recovered", described as "have experienced facial twitching that started in my eye and now progressed to my whole side of my face".  Additional information: The patient received booster for Covid back in Sep2021 and ever since then have experienced facial twitching that started in eye and now progressed to whole side of face. The patient didn't know to who should report this to or asking had any idea as to how long it would last. The patient just concerned as to whether would be ok to have another booster this was ever needed.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Rash to the upper arm a week after vaccination. A wheal of about 8in x 4in around the site of injection.
developed a rash similar to hives; developed a rash similar to hives; This is a spontaneous report from a contactable physician. A 17-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number and expiration date were not reported) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient medical history and concomitant medication were not reported. The patient developed a rash similar to hives in appearance is now being tested for vasculitis. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sore arm; This is a spontaneous report from a non-contactable consumer, the patient. A 43-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the  left arm on 21Feb2021 at 09:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included multi-vitamins (MANUFACTURER UNKNOWN) and probiotic (MANUFACTURER UNKNOWN); both for unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 22Feb2021, the patient experienced sore arm. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore arm was resolved on an unknown date in Feb2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous case reported by a pharmacist, describes the occurrence of vaccination site reaction (vaccination site reaction), tremor (tremor in the right arm), pyrexia (fever) and headache in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 028A21A) for COVID-19 immunization. No medical history reported. Concomitant products included losartan for an unknown indication. On Mar 7, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 4, 2021, received the second dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced vaccination site reaction (vaccination site reaction), tremor (tremor in the right arm), pyrexia (fever) and headache. At the time of the report, vaccination site reaction (vaccination site reaction), pyrexia (fever) and headache outcome: unknown; and tremor (tremor in the right arm): not resolved. The reporter did not provide any causality assessments or treatment information. Action taken with mRNA-1273 in response to events: not applicable.
Information has been received from the registered  nurse on 02-JAN-2014. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had been administered dose of GARDAIL on 30-APR-2013 (lot number: H011350; exp date: 21-FEB-2015) (dose, frequency, route and site of administration were not reported). No adverse event was reported. This is one of the reports from the same source. Additional information is not expected.
Feeling "flu-ish" Thought it was allergies. The next day, felt really sick. Flu-like symptoms. Took Covid test. It was negative. Issues with dyslexia came back. Having some memory issues. Memory fog. Memory lapses. Also having issues with knees and legs
0.2ml of undiluted covid19 pfizer 5-11 administered, no symptoms/signs to date.
flu; Initial information received on 09-Jan-2023 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional via social media.  This case involves a male patient of unknown age who had flu after receiving influenza vaccine.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.  On an unknown date in Nov-2022, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, formulation, lot number and expiry date - not reported) via unknown route in unknown administration site for influenza immunization.  On 01-Jan-2023, the patient had flu (influenza) (latency: 2 months approximately) following the administration of influenza vaccine.  Reportedly, My wife and I took the flu shot, nov 2022..caught the flu jan. 1st...still trying to get rid of it.  It was unknown if there were lab data/results available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
muscle trembling; mild pain at the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (muscle trembling) and VACCINATION SITE PAIN (mild pain at the site of the injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     The patient's past medical history included Cervical dystonia.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced MUSCLE TWITCHING (muscle trembling) and VACCINATION SITE PAIN (mild pain at the site of the injection). At the time of the report, MUSCLE TWITCHING (muscle trembling) and VACCINATION SITE PAIN (mild pain at the site of the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment related information was reported.  No concomitant medication was provided.
61 yo man w/PMH of HTN, HLD, pulmonary sarcoidosis, sarcoid CM s/p heart transplant (5/11, c/b RV dysfunction requiring ECMO and CRRT), CKD, recent admission (9/10-9/14 for AKI, concern for rejection), COVID + (11/26/21) after exposure on 11/24, presenting with fevers/chills, shortness of breath, weakness. S/p regeneron 12/1/21, transferred for further care.  Per chart review - febrile, tachycardic, hxpoxemic initially, LA initially 6.3, but cleared with IVFs.  Started on HFNC initially but able to de-escalate to regular NC.  Started decadron, remdesevir.  Continued on transplant meds.  Empiric coverage with CTX/Doxy. Hypoxic resp failure/Covid+ve PNA/Sepsis --Covid +11/26 with isolation to end 12/17 per ID --Decadron 6mg IV transitioned back to to prednisone 10 mg daily --s/p remdesivir therapy #Pancytopenia: probable covid related --Last received Zarxio 480mcg 12/8/2021 --WBC improved ANC currently stable --continue Valcyte - ýChange Pepcid to protonix --hold ASA --monitor platelets closely S/p orthotopic heart transplant 5/11/2021 for cardiac sarcoidosis.  - prograf/mmf/pred immunosuppression regimen.  --Celcept reduced given infection, will need to readjusted later --Continue Prograf and follow daily levels Goal trough 8-10 (6-12 months);ýlevel stable --Continue Cellcept 250 mg BID, Prednisone 10 mg dailyýýý -- Hydralazine 25 mg TID AKI with hyperkalemia --continue Patiromirý --continue to encourage PO fluid ýý Sarcoidosis - prednisone taper as above - repeat PET scan 6 months post transplant (~11/11/2021) - overdue; will do as outpatient - ACE levels q 3 months . ýNext in Jan ý
Prolonged hospitalization due to COVID-19. Post-op spinal surgery respiratory failure noted and then patient tested positive for COVID after wife tested positive.  Pt still on O2 but weaning down,
AT APPROXIMATELY 1:59PM 03/30/2021, PATIENT UNDER 15 MINUTE OBSERVATION STARTED TO DEVELOP LIGHT-HEADEDNESS AND DIZZINESS WITHOUT EVENT OR HISTORY OF SYNCOPE. PT UPON ASSESSMENT WAS AA&OX4, AIRWAY PATENT, BREATHING NORMAL AND NON-LABORED. PULSE STRONG AND REGULAR WITH ADEQUATE PERFUSION. PT SELF-ADMINISTERED 1L WATER ORALLY AND FELT IMPROVEMENT TO CONDITION, AND WALKED WITHOUT EVENT TO VEHICLE AND TO HYDRATE AS RECOMMENDED.  VITALS: 1400 (160/100, 87p, 18r, 97%) 1415 (132/60, 79p, 16R, 97%) 1427 (128/92, 78p, 18r, 97%)
get the flu when I take the shot; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 17-Oct-2020.  This case is linked to cases 2020SA294179, 2020SA294180, 2020SA294181, 2020SA294182, 2020SA294183, 2020SA294184, 2020SA294185, 2020SA294186, 2020SA294187, 2020SA294188, 2020SA294189, 2020SA294190, 2020SA294191, 2020SA294192, 2020SA294193, 2020SA294133 and 2020SA294195 (Cluster).  This case involves a male patient of unknown age who reported that he got the flu when he took the shot (influenza), while he received vaccine Influenza Vaccine.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medication.  On an unknown date, the patient 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 stated that he got the flu when he took the shot (influenza).  It was not reported if the patient received a corrective treatment.  Outcome of both the events were unknown, at the time of reporting.  There will be no information available on the batch number for this case.      The reporter assessed the causal relationship with suspect vaccine as related.
RHINORRHOEA/RUNNYNOSE; FATIGUE/TIREDNESS; FEELING HOT/FEELING OF WARMTH; FEELING COLD/CHILLINESS; FEELING ABNORMAL. Information regarding flumist 2003-2004 formula influenza virus vaccine, live intranasal solution frozen was received from a 31 year old female consumer who developed a runny nose. She also felt funny and uncomfortable as well as warm, chilly and tired, after exposure to a "sick" person. The patient received a dose on 19-Dec-2003. On 19-Dec-2003, the day of vaccination, the patient developed a runny nose which "lasted until the last few days." Then on 03-Jan-2004, she began to "feel a little funny, tired, warm, chilly and uncomfortable, " after being exposed to someone sick on 01-Jan-2004. No additional information was available at the time of this report.
Patient is a 69 y.o. female who presented to Hospital 2/18/2023 with shortness of breath     1.  Septic Shock - initial lactic acid was 4.2; has returned to normal - hypotension now resolved - known UTI- E.Coli - completed 5 days total of cefepime/ceftriaxone - 2/18: chest CT: Mild-to-moderate ground-glass opacities throughout the lungs, left greater than right consistent with atypical or viral pneumonia -(2/24) transferred out of ICU  - repeat labs OK; pulm signed off and patient transitioned to med/surg telemetry floor    2. Hypoxia    - was placed on bipap (2/20- improved and off bipap 2/21) Currently on room air - abnormal wide complex arrhythmia 2/19 and patient was cardioverted pacer interrogated revealing A.fib with RVR - on amiodarone and now transitioned to Xarelto - cardio followed -Continue Amioradone   3. COVID + (2/18)  - states got both vaccines and 2 boosters - initial CRP was 157 - on decadron and  also received remdesivir      4. UTI- e. coli - states had frequency at home - UA abnormal - urine cult sent - completed 5 days total of cefepime/ceftriaxone -Fluids (water) encouraged - urine amber in color still   5. Diab, type II - states sugar runs 130 at home - hosp gluc goal will be < 180. This is not being met; increased dose of NPH BID d/t stress hyperglycemia - A1C from Aug 2022 was 6.8   6. Elevated trop;      H/O TAVR 2019, perm pacer Dec 2022 - denies chest pain - follows with Dr.  - cardio recommends keeping magnesium >2; 2.1 today Hypothyroid due to thyroidectomy - Nov 2022 TSH 0.85 - states no recent change in thyroid dose - will cont with home dose here   8. OSA - has her own CPAP here   9. HTN, hyperlipidemia   10. Encephalopathy - resolved              - likely secondary to hypoxia/uti
Next day- fever spike, chills and body aches Since then every day I become achy and feverish at some point. It is generally in the late afternoon. Never had this before but it is every day.