chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient became lightheaded, sweaty, with a weak pulse immediately after receiving COVID-19 vaccination.
Patient had a delayed swelling and expanding rash at injection site  -- 8 days after vaccination
This spontaneous report was received from a registered nurse, referring to a an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions or concomitant medication were not reported. Since 01-JUN-2017, the patients may have been administered incorrect storage doses of M-M-R II (dosage information, route, lot number an expiration date were not informed) for prophylaxis. No adverse effects were reported. It was also informed: temperature/time: 49.8F for 30 minutes. There was no previous temperature excursion. "Data logger" was involved. The outcome was reported as: supported. This is one of several cases from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA004961: US-009507513-1706USA004962: US-009507513-1706USA003517.
I have had mild AFIB for years, minor short term less than 4 days perhaps once a year.  On February 28th I started a very symptomatic AFIB, breathless with little energy and stamina , it lasted 8 days which is double previous events.  It then subsided and recurred about 2 weeks later for 11 days.  Again a severe episode which prompted me to seek out medical help.  I just finished a cardiac ablation because of these episodes.  They were far more severe and  persistent than previous events.
extreme tiredness, headache, left side tingling/numbness (left arm to left jaw), dizziness and near syncope, body spasms, and left sided chest pain (worse with palpation)
I was diagnosed with cellulitis on my Left Arm and placed on antibiotics which resulted in a yeast infection and a return visit to urgent care and placed on an antifungal medication.  Due to my low grade fever and symptoms of fatigue underwent a covid 19 screen test which was negative
Largely, I was getting nasal drainage and congestion. I was prescribed decongestant medication. I also am experiencing major fatigue still. It's up and down, my energy levels. I also had a cough. The cough is not everyday.
Swelling of left leg (front and back) from knee to underwear. Area feels tight and warm. Tender to touch and unable to bear weight. Area of redness about the size of a quarter around the IPV injection site.
HIGHER FEVER ALL NIGHT; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced higher fever all night. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of higher fever all night was not reported. This report was non-serious.
I encountered a problem with a faulty BD Integra syringe. I inserted the needle into the muscle but as soon as I pressed the plunger the needle separated from the syringe and the contents of the syringe ran down the patient's arm. Before I administered the vaccine, I checked to make sure that the needle was screwed on tight. There was no adverse event because the vaccine was not administered.
no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 2-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided.   On 05-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 (strength, exact dose, dose #, anatomical location and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds on 01-JAN-2021. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported.  This is one of 33 reports from the same reporter (original case # 2102USA004059). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2102USA004059:
I tested positive for Covid today 08May2022; I tested positive for Covid today 08May2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08May2022, outcome "unknown" and all described as "I tested positive for Covid today 08May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08May2022) Positive, notes: tested positive for covid.  Clinical course: Patient Wants to report that Patient had tested positive for Covid today 08May2022. Patient was double vaccinated and boosted with Pfizer vaccine. Booster was on Dec2021. Currently Patient has no symptoms, just reporting the positive case.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt passed out, woke up and was white with low blood pressure but eventually gained color and blood pressure increased . was able to walk out of store with mom feeling better
skin the size of a dime is missing at vaccine injection area; It is still bleeding 4 hrs later; My 1st shot my arm burned; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SKIN EXFOLIATION (skin the size of a dime is missing at vaccine injection area), VACCINATION SITE HAEMORRHAGE (It is still bleeding 4 hrs later) and VACCINATION SITE PAIN (My 1st shot my arm burned) 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 SKIN EXFOLIATION (skin the size of a dime is missing at vaccine injection area), VACCINATION SITE HAEMORRHAGE (It is still bleeding 4 hrs later) and VACCINATION SITE PAIN (My 1st shot my arm burned). At the time of the report, SKIN EXFOLIATION (skin the size of a dime is missing at vaccine injection area), VACCINATION SITE HAEMORRHAGE (It is still bleeding 4 hrs later) and VACCINATION SITE PAIN (My 1st shot my arm burned) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided. No treatment information provided.   Reporter did not allow further contact
it's itching; it's like a bee hive; rash a little under the injection area; it's a big red area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (it's itching), VACCINATION SITE URTICARIA (it's like a bee hive), VACCINATION SITE RASH (rash a little under the injection area) and VACCINATION SITE ERYTHEMA (it's a big red area) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy. Concomitant products included VITAMINS NOS, VITAMIN D [VITAMIN D NOS] and CALCIUM for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (it's itching), VACCINATION SITE URTICARIA (it's like a bee hive), VACCINATION SITE RASH (rash a little under the injection area) and VACCINATION SITE ERYTHEMA (it's a big red area). At the time of the report, VACCINATION SITE PRURITUS (it's itching), VACCINATION SITE URTICARIA (it's like a bee hive), VACCINATION SITE RASH (rash a little under the injection area) and VACCINATION SITE ERYTHEMA (it's a big red area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Chills, Headache, Fever, Fatigue, Muscle Aches, Swelling and redness at injection site and loss of taste buds.
low blood pressure (9 days) (80/40's); blood pressure went up 190/98; lungs became congested/congestion; coughing up phlegm; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY CONGESTION (lungs became congested/congestion) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart attack (had a heart attack at 62 years old) and Lyme disease. Concomitant products included CLOPIDOGREL, ASPIRIN [ACETYLSALICYLIC ACID], CARVEDILOL, LISINOPRIL, SALBUTAMOL SULFATE (PROAIR HFA) and TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced PULMONARY CONGESTION (lungs became congested/congestion) (seriousness criterion medically significant) and PRODUCTIVE COUGH (coughing up phlegm). On an unknown date, the patient experienced BLOOD PRESSURE DECREASED (low blood pressure (9 days) (80/40's)) and BLOOD PRESSURE INCREASED (blood pressure went up 190/98). At the time of the report, PULMONARY CONGESTION (lungs became congested/congestion) had not resolved and PRODUCTIVE COUGH (coughing up phlegm), BLOOD PRESSURE DECREASED (low blood pressure (9 days) (80/40's)) and BLOOD PRESSURE INCREASED (blood pressure went up 190/98) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: decreased (Low) 80/40's and increased (High) 190/98.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication included statins drugs.  Treatment was not given.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Fatigue; Chills; This is a spontaneous report from a non-contactable consumer, the patient. An 80-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 04Mar2021 at 12:45 (at the age of 80-year-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient received unspecified medication taken for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Mar2021 at 22:00, the patient experienced fatigue and chills. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in Mar2021, the patient underwent SARS-CoV-2 test (nasal swab) and the result was negative. The events 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 reported events. The clinical outcome of the events fatigue and chills was not recovered 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.
Patch of warm erythema with central induration al L upper arm in area where Varicella vaccine administered.
No adverse event; Patient received the monovalent booster instead of the bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received the monovalent booster instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event) in an 18-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received the monovalent booster instead of the bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received the monovalent booster instead of the bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received the monovalent booster instead of the bivalent booster).    No concomitant medications were reported.  It was that moment they did not have the bivalent vaccine.   They received the bivalent vaccine on 04-Oct-2022.  No treatment medications were reported.  This case is for 2nd patient out of 5 patients.   This case was linked to PR-MODERNATX, INC.-MOD-2022-655231, PR-MODERNATX, INC.-MOD-2022-656480, PR-MODERNATX, INC.-MOD-2022-656483 (E2B Linked Report).; Sender's Comments:  PR-MODERNATX, INC.-MOD-2022-655231:Patient 1 PR-MODERNATX, INC.-MOD-2022-656480:Patient 4 PR-MODERNATX, INC.-MOD-2022-656483:Patient 5
Pt recvd 2nd dose of Engerix-B on 28MAY92 & 3 days later devel flu-like sx, nausea, diarrhea, vomiting, fever, joint & muscle pain over entire body; sx persisted on 2JUN92; als exp kidney inflammation;
PATIENT CALLED APPROX. 3.5 HOURS AFTER RECEIVING VACCINE DOSE AND SAID THROAT WAS VERY RED AND ITCHY AND IT HAD BEGUN SPREADING DOWN BOTH SIDES OF HER ARMS. DESCRIBED IT AS TO FEELING LIKE A SUNBURN AND VERY ITCHY. PATIENT WAS ADVISED TO GO TO URGENT CARE AND WAS GIVEN BENADRYL AND IS FEELING BETTER.
No adverse symptoms reported; The patient inadvertently received an expired dose of Pneumovax23; This spontaneous report was received from a registered nurse referring to a patient of unknown age and unknown gender. Information about pertinent medical history, drug reactions/allergies and concomitant medication was not reported.  On 01-JUL-2020 the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (1 dosage form, lot # R021045 with expiration date 14-APR-2020, route was not reported) for prophylaxis (expired product administered). No adverse symptoms reported.   combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: R021045; expirationdate: 14-APR-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Patient reported chills, high fever, body sores at 1;30 AM. Patient took ibuprofen and reported to be better and near 100%.
Severe gout flare on the ipsilateral side of the vaccine. Resulted in an ED evaluation.
Vial was first punctured on 14-Jul-2022 and was administered on 15-Jul-2022/ Vial stored in fridge post puncture; received doses from a vial first punctured the day before the date of administration; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received doses from a vial first punctured the day before the date of administration) and PRODUCT STORAGE ERROR (Vial was first punctured on 14-Jul-2022 and was administered on 15-Jul-2022/ Vial stored in fridge post puncture) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017b22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received doses from a vial first punctured the day before the date of administration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 14-Jul-2022 and was administered on 15-Jul-2022/ Vial stored in fridge post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received doses from a vial first punctured the day before the date of administration) and PRODUCT STORAGE ERROR (Vial was first punctured on 14-Jul-2022 and was administered on 15-Jul-2022/ Vial stored in fridge post puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. It was reported that 4 Patients received doses from a vial first punctured the day before the date of administration LOT 017b22a from the same vial. Date the vial was initially stored in the refrigerator was reported as 14Jul2022. Date and time of vial was first punctured was reported as 14 Jul 2022, time unknown estimation at 10:30 AM. Date and time of administration of vaccine was reported as 15Jul 2022 first administration 0:9 30 last administration 11:30. Vial did not undergo temperature excursions. Total amount of time the vial was exposed to room temperature range (8 degree celciu  to 25 degree celcius is equal to 46 degree celcius to 77 degree F) was between 10 minutes and 35 minutes. No Treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-614372, US-MODERNATX, INC.-MOD-2022-614373, US-MODERNATX, INC.-MOD-2022-614374 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-614372:Patient 2 US-MODERNATX, INC.-MOD-2022-614373:Patient 3 US-MODERNATX, INC.-MOD-2022-614374:Patient 4
this is a report of my personal experience I received the 2nd dose of the Moderna Covid Vaccine Wednesday January 20th at approximately 4:30pm Cox North. The injection was painful, the person administering the injection inserted the needle VERY slowly, and then pressed the plunger VERY slowly. However, other than injection site pain, I had no symptoms at that time. I then went home and went to bed for the evening at approximately 6:30pm. The following morning, Thursday January 21st, I woke up at 5am (normal time). Before getting up, my stomach felt "funny" mild nausea. When I stood up, I experienced weakness, mild lightheadedness, and nausea; and sat back down IMMEDIATELY. I then stood up to walk to the restroom with the intention to take Tums to settle my stomach. I walked approximately 12 feet, put one tums in my mouth and immediately passed out. (my partner reported that I was unconscious for approximately 2 full minutes). When I regained consciousness I was very disoriented. (did not know where I was, what day it was) I could not stand, and could not use my arms. My partner picked me up and physically put me back in bed. I was unable to roll over on my own. (he then called my supervisor to report the event. My supervisor called him back after speaking with the Nurse who advised "bed rest and hydration") I slept on and off for the next 5 hours. at which time I attempted to sit up. I was unable to remain upright, but could sit in a recliner at that time. I was unable to hold a bottle of water on my own until approximately 2pm. I had no headache, no fever, no nausea (after the initial 5am experience) but DID experience extreme muscle weakness until approximately 2pm Thursday January 21, 2021. (too weak to chew food) Friday January 22nd, I felt "fine", but still mild tiredness. ( I was told by our office manager that I should fill out an RL to report my experience)
Shingles shot (right arm) when I awoke the next morning, the arm was extremely sore.  Unable to move it (including combing hair, brushing teeth).  It was worse when I walked, as I could feel the skin on my arm move with each step.  This  lasted only 1 day.  Took TYLENOL for pain.  Mild ache the evening of vaccination.
Positive COVID-19 illness and test after fully vaccinated 4/25/2021.
This spontaneous report as received from a nurse practitioner refers to a 13 year old male patient. Patient's concurrent conditions and relevant medical history was reported as none. Drug reactions/allergies were none. On an unknown date in March 2014, the patient was vaccinated with GARDASIL (lot number, dose and route unspecified). Concomitant medications were none. On unknown date in April 2014 (reported as a month later) the patient experienced warts on knees and hands on the same side as injection which hurt. The patient sought medical attention by consulting doctor and dermatologist. Patient was treated with cryotherapy and unspecified acid. The outcome of warts on knees and hands was reported as recovering/resolving. The causality of the events with GARDASIL was not reported. Additional information has been requested.
31 yo F presented with gran mal seizure, bleeding tongue, bleeding forehead, and disorientation in a post-dictal state. Pt was combative while disoriented. Pt transported to treatment area and evaluated by EMS. Pt became cooperative over time. Has a history of seizures. Pt states that her doctor just changed her seizure medication last week. Pt care transferred to responding EMS unit and transported to local hospital emergency room for continued treatment.