chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She experienced hives on both legs,,face,Lips,all over her body; Itchiness on both legs.; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (She experienced hives on both legs,,face,Lips,all over her body) and PRURITUS (Itchiness on both legs.) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced URTICARIA (She experienced hives on both legs,,face,Lips,all over her body) and PRURITUS (Itchiness on both legs.). The patient was treated with PREDNISOLONE ongoing since an unknown date for Hives, at an unspecified dose and frequency; FAMOTIDINE (PEPCID AC) ongoing since an unknown date for Hives, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) ongoing since an unknown date for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (She experienced hives on both legs,,face,Lips,all over her body) and PRURITUS (Itchiness on both legs.) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment of the events included, prednisone, famotidine and diphenhydramine. On 01 Apr 2021, patient went to emergency room.
Information has been received from a nurse concerning her 1 year old male some who on 28Mar03 was vaccinated with  measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation), IM administration. There was no concomitant medication. On approximately 04Apr03, one week after receiving the vaccination, the pt developed a fever which lasted for 2 weeks off and on. The pt was treated with acetaminophen (Tylenol) and ibuprofen (Motrin). Subsequently, the pt recovered from fever. The pt sought unspecified medical attention. No product quality complaint involved. Additional information has been requested.
sore arm for 2-3 days; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received BNT162B2 (Pfizer BioNTech COVID-19 Vaccine, lot no. and expiry date were not reported), via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sore arm for 2-3 days. The outcome of the event was unknown.   No follow-up attempts are possible, information about batch number cannot be obtained.
Pt received flu vaccine on 12/03/2015 with no outstanding observations. Pt reported to pharmacy on 12/22 c/o continuing pain in vaccine administered arm. Pt did not report any swelling, redness, or itchiness in arm.
This report was received from the investigator of a trial on 06 May 2010. A 25 year-old male subject received ACAM2000 (lot number not reported) on 22 July 2009. Fourteen days after vaccination, the subject was diagnosed with non-specific myocarditis. Twenty-two days after vaccination, the diagnosis of acute myocarditis was reported. The subject had a history of elevated cholesterol, shortness of breath, asthma, eczema, headaches and psychiatric illness. On Day 14 (05 August 2009), the subject's Troponin I was 4.66 (abnormal). The subject had a normal echocardiogram on Day 15 (06 August 2009) and a normal electrocardiogram on Day 22 (13 August 2009). The outcome was not reported. Additional information will be requested from the investigator. Note: There is no reported causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: None.
Approximately 10 minutes post vaccine patient complained of dizziness, shortness of breath and diaphoresis.  Patient transported to ER for further evaluation.
mom c/o redness to rt leg by blotches w/swelling noted around inj site;MD saw pt on 24JUN97 instructed APAP & DPH;
This spontaneous report was received from a physician, via company representative, and refers to a patient of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant therapies were not reported. On 26-APR-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 10 PK-0.5 ml SD-PFS LLokwTip, lot # L002310, expiration date 08-JUL-2016, (route and anatomical location of administration were unspecified) which was improperly stored in refrigerator to temperatures excursion of 1.1 Celsius degrees for 920 hours and for 0 Celsius degrees for 168 hours with lowest temperature recorded of 32 and 34 Fahrenheit degrees respectively. No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Started with redness and Swelling. Turned greenish color and became a big lump. This is the second incident (second report) both times my baby had to have her legs cut open to drain abscess.
Chronic Myeloid Leukemia; Dose Number: 1, Date of start of drug: 21Feb2021 / Dose Number: 2, Date of start of drug: 21Feb2021; This is a spontaneous report from a contactable Nurse (patient). A 61-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EL9264) via an intramuscular route of administration in left arm on 21Feb2021 at 16:15 (age at vaccination 61-year-old) as dose 1, single and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EN6200) via an unspecified route of administration in left arm on 21Feb2021 (age at vaccination 61-year-old) as dose 2, single for Covid-19 immunization. Patients medical history included asthma and fuchs. Patient did not have any known allergies. Patients concomitant medications included Vitamin C [Ascorbic Acid], Vitamin D3 and multivitamins (ascorbic acid, biotin, calcium, choline bitartrate, chromium, copper, folic acid, inositol, iodine, iron, magnesium, manganese, molybdenum, nicotinamide, pantothenic acid, phosphorus, potassium, pyridoxine, retinol, riboflavin, selenium, thiamine, tocopherol, vitamin b12 nos, vitamin d nos, zinc) for unspecified indication and start and stop date was not reported. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for Covid-19.The patient had a routine CBC performed and her white blood cells (WBC) count was abnormally high, and she was diagnosed with chronic myeloid leukaemia On 29Jun2021 07:30. On 21Feb2021, patient took both doses and experienced overdose. Adverse event WBC increased and chronic myeloid leukaemia resulted into emergency room/department or urgent care. Patient was hospitalized for 4 days. Treatment included for adverse event WBC increased and chronic myeloid leukaemia was chemotherapy. The patient underwent lab tests and procedures which included full blood count: WBC count was abnormally high on jun2021, WBC count was abnormally high and was diagnosed with chronic myeloid leukaemia, since the vaccination, the patient had been tested for COVID-19. sars-cov-2 test: negative on 29Jun2021 nasal swab. The outcome of event was unknown.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event chronic myeloid leukaemia . The case will be reassessed once new information is available   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 presented to the emergency room on 10/23/2021 with cough and shortness of breath. He was found to be hypoxic and was admitted for further management. He was treated with remdesivir, dexamethasone, baricitinib, and supplemental oxygen. He condition worsened and he was transferred to the intensive care unit on 10/25/2021.  Patient was intubated on 10/29/2021. Patient's condition continued to worsen.  Patient had a pulselessness event on 11/5/2021 and code was called. Patient was unable to be resuscitated and he expired on 11/5/2021.
Initial case was received from a health care professional on 04 October 2013. A 70 year old patient (gender unknown) had medical history reported as negative R factor, received a dose of FLUZONE HD in left deltoid on 26 August 2013 (batch number U4714AA). Patient had not reported concomitant medication. It was reported that on 28 August 2013 patient experienced pain, redness and swelling at injected site. No corrective treatment was reported. At the time of report the outcome was unknown.
Janssen COVID-19 Vaccine EUA - Developed fatigue 24 hours later, and a fever.  Went as high as 101.1.  Went down to normal by Weds. morning, but was back up to 100.8 by 9 am.  Now at 12:00 its 100.1.  Otherwise feel fine.
Administration of expired moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired moderna vaccine) in a 42-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired moderna vaccine). On 10-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administration of expired moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported.
The morning after the vaccine, I woke up with dizzy spells and have had on and off every day since day of 1st vaccination
little bumps in skull both on the side and top of head were bleeding; upper left side of chest red spots; On upper left side of his chest he had red spots, they were itchy; little bumps up in skull both on the side and top of head; itchy rash left top of chest; This spontaneous case was reported by a consumer and describes the occurrence of SKIN HAEMORRHAGE (little bumps in skull both on the side and top of head were bleeding), RASH ERYTHEMATOUS (upper left side of chest red spots), PRURITUS (On upper left side of his chest he had red spots, they were itchy), RASH (little bumps up in skull both on the side and top of head) and RASH PRURITIC (itchy rash left top of chest) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), OCTREOTIDE ACETATE (SANDOSTATIN), LISINOPRIL, LEVOTHYROXINE and ACETAMINOPHEN for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 26-Jan-2021, the patient experienced SKIN HAEMORRHAGE (little bumps in skull both on the side and top of head were bleeding), RASH ERYTHEMATOUS (upper left side of chest red spots), PRURITUS (On upper left side of his chest he had red spots, they were itchy), RASH (little bumps up in skull both on the side and top of head) and RASH PRURITIC (itchy rash left top of chest).   The patient was treated with TRIAMCINOLONE (topical) for Rash, at an unspecified dose and frequency.   At the time of the report, SKIN HAEMORRHAGE (little bumps in skull both on the side and top of head were bleeding), PRURITUS (On upper left side of his chest he had red spots, they were itchy) and RASH (little bumps up in skull both on the side and top of head) outcome was unknown and RASH ERYTHEMATOUS (upper left side of chest red spots) and RASH PRURITIC (itchy rash left top of chest) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 09-Feb-2021: New event added and details updated, reporter information were added. Treatment drug information updated. On 22-Apr-2021: NNI updated. Patient declined to provide email address or provide any additional information.
day 2 after vaccine, pt reports injection site soreness and body aches in neck and shoulders Narrative:
Felt like I was losing my mind, panic attack and very irritated for about 4 hours
Wok up with large rash and hives on arm that was injected a week after the vaccine. Rash/hives spread to chest and down arm. Took Benadryl and rash went away after a couple days.
Gout after dose 1; This spontaneous case was reported by a consumer and describes the occurrence of GOUT (Gout after dose 1) in a male patient of an unknown age 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 GOUT (Gout after dose 1). The patient was treated with PREDNISONE ongoing since an unknown date for Gout, at an unspecified dose and frequency. At the time of the report, GOUT (Gout after dose 1) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided. Patient was taking Prednisone for treating Gout at the time of report.
pt recvd vax 5OCT94 & 15 mins later devel a half-dollar sized raised area by collarbone; also c/o aching in the arm pit; On 12OCT94 stated that whole arm ached; sx resolved in 4-5 days;
Congestion started soon aftrerward, by evening needed emergency inhaler, rapid heartbeat overnight for a few hours, asthma symptoms continue
Cytoquin storm; Severe inflammation in nerves; Severe inflammation in muscle; A spontaneous report was received from a healthcare professional concerning a female patient of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events cytokine storm, sever nerves inflammation (central nervous system inflammation) and severe muscle inflammation(myositis)  The patient's medical history was not reported.  Concomitant products information was not reported.  On unspecified date, prior to the onset of event the patient received their one of two planned doses of mRNA-1273 (batch number:unknown) for prophylaxis of COVID-19 infection.   On unspecified date after receiving vaccine the patient experienced the events cytokine storm, severe nerves and muscle inflammation.  Action taken with mRNA-1273 in response to the event was not provided.  Treatment information was not provided. On 26 Feb 2021 the outcome of the events cytokine storm, severe nerves and muscle inflammation was unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested
pt recvd vax 14OCT92 & w/in a few hrs of inject pt devel a red flush, warmth, t102 & erythema @ inject site; temp lasted for 2 & 1/2 days; No further details were provided;
Patient experienced pain at injection site after injection of Flu vaccine. Pain has not abated and still persists. Visited family physician on 1/6/17 and was told that possibly a nerve was hit and pain may persist for up to a year.
Pt given Hep A #1 and Varivax #1 on 3-2-07. Pt seen in our office 3-6-07 for temp 101.3 and rash at 1:30 pm. Dx post vaccine chicken pox rash. 3-6-07 temp 103.9R and rash allover. Mom took pt to hosp ER. Dx ear infection and viral rash.
Itchy rash on back, stomach, wrists, ankles. Appeared about 36 hours post shot.; This is a spontaneous report from a contactable consumer  A 43 -year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6200) on 19Feb2021 at 09:45 at single dose via an unspecified route of administration on right arm for COVID-19 immunization. Relevant medical history included migraines, depression, reynaud's syndrome, seasonal allergies, animal allergies and dust allergy. Concomitant medications included montelukast, escitalopram oxalate (LEXAPRO), trazodone, levocetirizine dihydrochloride (XYZAL). On 20Feb2021 at 17:00 the patient experienced itchy rash on back, stomach, wrists, ankles, appeared about 36 hours post shot. At the time of the reporting the patient had not yet recovered from the event    Follow-up attempts are completed. No further information is expected.
5. Brief History and Hospital Course:  Patient is a/an 79 y.o. female with a past history significant for HTN, HLD, and DM who presented to facility on 3/9/2021 with complaints of severe 8/10 right jaw pain lasting 3 minutes. EKG with new left BBB and troponin mildly elevated 8-17-35-26. She was seen by Cardiology and determined to have NSTEMI and taken for cardiac cath with drug eluting stent placed to LAD. Echo was also ordered with evidence of murmur. Cavity size is normal. Wall thickness is normal. Systolic function is normal. The estimated ejection fraction is 55%. Dyssynchronous interventricular septal motion, likely related to conduction abnormality/bundle branch block. Grade I diastolic dysfunction. Annulus is severely calcified. Severely calcified and restricted opening of posterior mitral leaflet. Mild mitral valve stenosis at the max.  She remained stable post stent placement. She remained on dual antiplatelet therapy
Admit Date: 10/17/22   Discharge Date: 10/20/22   Discharge Condition: Stable    Discharge Diagnosis:   Covid 19 Infection Dyspnea Hypokalemia Hypomagnesemia  Essential Hypertension Obesity
Swelling, pain snd rash around injection site. Shoulder pain, stiff neck and headaches
I had a gout attack. I am a vegetarian now and did not have any alcohol to drink 3 days prior to the vaccine. I often drink a glass of wine with my evening meal, but had not done this for 3 days prior to vaccine or since.
No adverse event; Patient received first dose on 19-Mar-2021 and second dose on 31-Mar-2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 19-Mar-2021 and second dose on 31-Mar-2021) and NO ADVERSE EVENT (No adverse event) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A214 and 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (Sulfur allergy) and Arthritis. Concomitant products included METFORMIN, SITAGLIPTIN PHOSPHATE (JANUVIA) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 19-Mar-2021 and second dose on 31-Mar-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 19-Mar-2021 and second dose on 31-Mar-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Patient concomitant medication included arthritis medication.  No treatment information provided.   This case was linked to MOD-2022-651942, MOD-2022-651944 (Patient Link).
One day post vax, pt complained of swollen glands to neck, axilla and groin. Pt also complained of malaise and headache.
Redness on left arm starting on 1/24/2021. Itchy. Warm.
This case was reported by a healthcare professional via a sales representative and described the occurrence of injection site rash in a subject of unspecified age and gender who was vaccinated with Fluarix for prophylaxis. The subject has previous problems with the flu vaccine. It was unknown what type of problems the subject experienced or to which flu vaccine. In November 2006 the subject received an unspecified dose of Fluarix (.5 ml, unknown). In November 2006, at an unspecified time after vaccination with Fluarix, the subject experienced injection site rash and shortness of breath. The subject was seen in the emergency department. The sales representative believed that Fluarix was administered one to two days ago. He did not know if the subject was hospitalized as a result of the events was unspecified. Follow up was received from the reporting healthcare professional on 29 November 2006. The subject is a 48 year old female. On an unspecified date in November 2006, the subject received a dose of Fluarix. Approximately one to two hours later, the subject experienced injection site rash and shortness of breath. The subject was seen in an emergency department, but was not admitted to the hospital. The events resolved on an unspecified date in November 2006. The healthcare professional considered the events to possibly be related to vaccination to Fluarix and also to the preservative in Fluarix.
He thinks it might be worse than a UTI; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (He thinks it might be worse than a UTI) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 20-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced IMMUNISATION REACTION (He thinks it might be worse than a UTI). At the time of the report, IMMUNISATION REACTION (He thinks it might be worse than a UTI) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Patient got the Spikevax 12+. The patient states he thinks he has to go to the hospital. He is supposed to get a UTI test tomorrow. He thinks it's getting worse.
Severe fatigue for 4 days; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Severe fatigue for 4 days) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (Severe fatigue for 4 days). At the time of the report, FATIGUE (Severe fatigue for 4 days) had resolved. Not Provided          No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-066531 (Patient Link).