chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Myocarditis; This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Myocarditis) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: Myocarditis associated with mRNA COVID-19 vaccination. Radiology. 2021:211430     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS (Myocarditis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Magnetic resonance imaging heart: abnormal (abnormal) Late Gadolinium Enhancement (LGE): epicardial left ventricular(LV) inferior basal wall, lateral wall mid ventricle, anterolateral wall apical.T2w signal abnormality in corresponding locations as LGE. Pericardial enhancement and borderline effusion. Left Ventricular Ejection Fraction(LVEF) was 57%, Right Ventricular Ejection Fraction (RVEF) was 54%. Ipsilateral axillary lymphadenopathy.. On an unknown date, Angiocardiogram: negative (Negative) Negative. On an unknown date, Brain natriuretic peptide: 38 pg/ml (normal) 38 pg/ml. On an unknown date, Electrocardiogram: abnormal (abnormal) Nonspecific T-wave abnormality anterolateral leads, RSR' pattern in V1. On an unknown date, Magnetic resonance imaging: negative (Negative) Negative. On an unknown date, Troponin I: 4.00ng/ml (abnormal) Troponin-I at peak was 4.00ng/ml.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDITIS (Myocarditis) to be possibly related.    No concomitant medication was provided by the reporter.  Patients was hospitalized due to acute onset of chest pain with diagnosis of acute myocarditis. Patient had received their second dose of mRNA-1273 three days before onset of chest pain. Patient had following symptoms after vaccination subjective mild fever, chills, malaise, chest pain and dyspnea. COVID-19 test was negative for 4 patients out of 5 patients.  No treatment medication information was provided by the reporter.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to MOD-2021-293277 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Covid Arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid Arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported.     On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE REACTION (Covid Arm). At the time of the report, VACCINATION SITE REACTION (Covid Arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant or treatment medications provided.
Patient previously received Moderna vaccine on 6/23/2021. Patiwnt mistakenly given Pfizer vaccine 21 days later. No immediate adverse reactions noted by patient who was informed of administration error.
pt exp severe diarrhea w/flu vax last; pt ate eggs 24 hrs following vax; pt has no h/o allergies to eggs;
COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 58-year-old male patient received BNT162b2 (BNT162B2), on 07Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 57 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "cardiac murmur" (unspecified if ongoing); "overweight" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) negative; (24May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 19May2022 to 23May2022 via oral route. Clinical course: It was unknown whether patient received other medication in 2weeks or not. Patient had rebound COVID after Paxlovid. Symptoms completely resolved, multiple days of negative tests, today return of symptoms and positive test (24May2022). The patient had no Known drug allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on reported information, causal association of event drug ineffective, covid-19 with BNT162b2 cannot be excluded. However, response to vaccine can vary in individuals.
No adverse event; HCP stated they had 12 patients from 6 months to 5 years not previously vaccinated, and accidentally they administered 2 doses 1 month apart (0.25 mL); This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP stated they had 12 patients from 6 months to 5 years not previously vaccinated, and accidentally they administered 2 doses 1 month apart (0.25 mL)) and NO ADVERSE EVENT (No adverse event) in an 11-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     Patient's relevant medical history/conditions, allergy, concomitant diseases and risk factor were unknown.    On 29-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 27-Jul-2023, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 27-Jul-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (HCP stated they had 12 patients from 6 months to 5 years not previously vaccinated, and accidentally they administered 2 doses 1 month apart (0.25 mL)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (HCP stated they had 12 patients from 6 months to 5 years not previously vaccinated, and accidentally they administered 2 doses 1 month apart (0.25 mL)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (HCP stated they had 12 patients from 6 months to 5 years not previously vaccinated, and accidentally they administered 2 doses 1 month apart (0.25 mL)).    Patient did not received other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter. This case contains information about 2nd patient out of 12.   This case was linked to US-MODERNATX, INC.-MOD-2023-737216 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737216:Master Case (Patient 1)
This case was reported by a pharmacist and described the occurrence of drug dose administered interval too long in a 46-year-old male patient who received TWINRIX ADULT. Previously administered products included TWINRIX (3 doses of accelerated schedule 1 and 1/2 years ago). On an unknown date, the patient received the 4th dose of TWINRIX adult. On an unknown date, an unknown time after receiving TWINRIX adult, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.
w/in 1 few minutes p/HIB/DTP/OPV pt exp inject site reaction @ the HIBTITER site which included a 3cm x 2cm lump & maculo-papular rash; tx w/ice pack; pt observed for 1 hr; next day had resolved but leg was bruised; pt also irritable;
Patient developed petechial rash following the MMRV and influenza and hepatitis B Vaccines on 3/19/15. Patient was admitted to the hospital and labs showed thrombocytopenia, likely cause ITP.
He is uncomfortable when he moves the left arm; Swollen Lymph node under left armpit and it is getting worst. The lymph node swelling is getting worst and it became significant on 07NOV2021; This spontaneous case was reported by a nurse and describes the occurrence of LIMB DISCOMFORT (He is uncomfortable when he moves the left arm) and VACCINATION SITE LYMPHADENOPATHY (Swollen Lymph node under left armpit and it is getting worst. The lymph node swelling is getting worst and it became significant on 07NOV2021) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024F21A, 012L20A and 029K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Nov-2021, the patient experienced VACCINATION SITE LYMPHADENOPATHY (Swollen Lymph node under left armpit and it is getting worst. The lymph node swelling is getting worst and it became significant on 07NOV2021). On 08-Nov-2021, the patient experienced LIMB DISCOMFORT (He is uncomfortable when he moves the left arm). At the time of the report, LIMB DISCOMFORT (He is uncomfortable when he moves the left arm) and VACCINATION SITE LYMPHADENOPATHY (Swollen Lymph node under left armpit and it is getting worst. The lymph node swelling is getting worst and it became significant on 07NOV2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided.
Deformed macular rash to face, trunk, few on extremities. No exanthem, no lymphadenpathy. Fever of 101 degrees for 2 days.
pt recv vax DEC95 & APR96 pt was exposed to chicken pox;pt exp modified chicken pox;
Received Pfizer vaccine on 3/6/21, 3/26/21, and 1/14/22. COVID positive on 2/14/22. Presented to ER on 2/15/22. Admitted on 2/15/22. He had some associated shortness of breath. CT angiogram was done and showed pneumonia.  There was some overlap between lingering COVID-19 type pneumonia and community-acquired pneumonia. Secondary to his comorbidities he was admitted to the hospital and started on broad-spectrum antibiotics. Over the next 2 and half days his condition improved. Initially he had some shortness of breath, dizziness, and fever and those resolved. He never was hypoxic. Pancultures were negative. He was discharged in stable condition. Received ceftriaxone and azithromycin during visit. Discharged on 3/3/22
Wrong vaccines given to patient (was not supposed to get the Hep A or the Hib).
Information has been received from a licensed visiting nurse concerning a patient who in January 1997 was vaccinated with 1 dose of varicella virus vaccine live. On 07/06/2000 the patient developed itchy lesions on her torso and mostly over the face. It was noted that the patient was afebrile. Unspecified medical attention was sought. Additional information has been requested.
Initial report was received from a health care professional on 09 February 2011. An unidentified female patient with a history of being Rh negative had received FLUZONE (lot number, route, site and exact date of administration not reported) "in December" and an unspecified amount of time later "in February" was "retested and was found to be Rh positive. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: none.
Over 3 day weekend, use bandages slides off. Reaction occurs progressively starting around original vaccination point to upper arm. Exam reveals clustered vesicles/papules covering deltoid, spreading towards next.
feels like she has a droopy face; migraines; This is a spontaneous report from a contactable consumer (patient) received from a Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of historical vaccine, bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on an unspecified date as dose 1, single for Covid-19 immunization. It was reported that she received her both doses and she feels like she had a droopy face and had migraines on an unspecified date. She had seen the doctor for a treatment and she stated that they were not going to fix this and she wants to know if Pfizer offers assistance with payments or treatment. The outcome of events was unknown.  Follow-up attempts completed. No further information expected.
Feb 3, 2021.  Five days after first vaccination, had severe dizziness upon awakening.  Could barely stand up.  Dizziness and lightheadedness has persisted on and off for almost two months.  Felt much better for about 3 weeks and then it re-occurred and continues to this day (5/3/21).  On the evening of 4/29/21, actually passed out and hit the floor incurring head laceration.  Epley procedures have had no effect.  Doctors have not found cause.  Cardiologist has me starting on a monitor, but I'm sure that's not the issue.  Dizziness comes and goes and is not always present.  Have never experienced these symptoms before.  No history of vestibular problems.  Very distressing.
Information has been received from a consumer concerning her 65 year old husband with an allergic reaction to sulfa drugs and no pertinent medical history who on 08-SEP-2008 was vaccinated IM with PNEUMOVAX (lot # 659487/1960U) 0.5mL/single dose.  Concomitant therapy included influenza virus vaccine (unspecified).  On 09-SEP-2008 the patient developed a "streaking rash" that went around both arms and on the skin of his testicles after receiving PNEUMOVAX.  The patient sought unspecified medical attention.  The reporter had no additional information.  At the time of the report the patient had not recovered from "streaking rash" that went around both arms and on the skin of his testicles.  Additional information has been requested.
Day/evening 1: Tired just didn't fell good. night 1 through day 3: congested sinuses, intense sinus pressure,  head ache, achy, felt really sick likely as bad as many people get actual flu, diarrhea, running nose, post nasal drip, ear congestion in sinuses, uncomfortable throat, trouble paying attention, nausea,  tired, irritable Day 4 started feeling better.  Day 5 solid poop Day 6 (today), feeling a lot better. Sinises are almost clear, much less pressure in head, very little post nasal drip, much less headache, still having a lot of trouble paying attention to people talking to me while trying to listen to them. People are still irritating me more than normal.
Temperature 104.0, headache, stomach ache, chills - 0400 Headache started earlier in the night approx 0200
Patient was administered Pfizer vaccine at the age of 11 years 9 months.  Current guideline were given for the approval of use in 12+.
Patient started feeling tingling sensation on her throat and numbness on her lips. BLS activated. Patient received 0.3 mg IM of epi and 50 mg IM of Benadryl. 1408: 163/92 HR 102 02sat 100% on room air. Patient denies SOB. Pt awake and alert. 1412: 144/80 98 100% RA. Patient stated that throat feels better post meds with tingling on the lips.  Tx to the ED
Vaccine @11:00, @11:10 experienced  numb lips, mouth, chest, tightness,  vs taken , HR 110's, Sats 99-100% after 20 min, symtoms non unimproved.  sent To are RN accompay RN W/C. Family notified.  Monitored by RN from form 1110 to 1150. Patient transported to ED for chest tightNess, denied Chest pain, and numbness of lips. Denied difficulty breathing or tightness in throat while transporting to ED by RN. Respirations even & unlabored. Talkative - skin warm & dry. Report called to  ED charge RN prior to transporting.  On arrival to ED patient roomed with beside  reprot given to ED paramedic. Report  given to ED charge & to ED Providir Dr.
BLOODY EYE (EYE WITH BUSTED  BLOOD, WHITE  PART OF RIGHT EYE WAS RED); This spontaneous report received from a patient concerned a 30 year old male. 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 was not reported, administered on 21-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 24-OCT-2021, the patient experienced bloody eye (eye with busted blood, white part of right eye was red). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bloody eye (eye with busted blood, white part of right eye was red) was not reported. This report was non-serious.
Severe nausea, vomiting, diarrhea. Cramping diarrhea lasting several more days - Rx with antidiarrhea med for 2 doses.
Covid 19; Covid 19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 34-year-old female patient (pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and on 31Aug2021 as dose 2, single (Batch/Lot number: unknown) at the age of 33 years for covid-19 immunisation. The patient's relevant medical history included: "Nickel" (unspecified if ongoing). Date of last menstrual period: 20Mar2022. The patient is expected to deliver a baby(s) on 25Dec2022. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid 19". Therapeutic measures were not taken as a result of drug ineffective, covid-19.. Clinical course of the events: vaccine received: Yes. Other medication in 2weeks: No. Known allergies: Nickel. Other medical history: None.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events: "Drug ineffective", "COVID-19" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
On 12/15 she was admitted for fever and dyspnea found to have COVID and completed a course of remdesivir and steroid burst, never developing hypoxia. She is vaccinated for COVID and had received her booster.  Over the last week, she developed increased dyspnea and lower extremity edema, productive cough (yellow sputum), and congestion with first-time fever 99.8° this morning which caused her to go to the ED.
Headache, bodyache, some nausea. 4/10/09.  Advised TYLENOL 500 mg 2 tabs P.O. Q6 PRN.
Fever; Chills; Muscle spasms; Joint pain; Profuse sweating; Tiredness; Pain at injection site; Lymphadenopathy; Dose received: 3; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old non-pregnant female patient received third (BOOSTER) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8027) via intramuscular route of administration in the left arm on 22Nov2021 at 08:30 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and allergy to penicillin. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not take any concomitant medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via intramuscular route of administration in the left arm on 24Apr2021 at 15:00 (at the age of 21-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via intramuscular route of administration in the right arm on 15May2021 at 15:15 (at the age of 21-years-old), both as a single dose for COVID-19 immunisation. On 22Nov2021 at 12:00, the patient experienced fever, chills, muscle spasms, joint pain, profuse sweating, tiredness, pain at injection site and lymphadenopathy. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, chills, muscle spasms, joint pain, profuse sweating, tiredness, pain at injection site and lymphadenopathy was unknown at the time of this report.
his fever today is 101.8 F; This is a spontaneous report received from a other health care professional. A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 11Mar2021 (at the age of 57-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter stated, "My husband and I both had a Covid vaccine shot on the 11Mar2021, and he was having a reaction, but she was okay, and he has like underlying conditions so she just wondering if she should be concerned because his fever today was 101.8 F". Height and weight for the patient, reporter stated, he was about 5'9, 5'10 and 230 pounds probably. For further probing, reporter mentioned, "I did tell you my story after I get my questions answered about the vaccine that if I need to worry or take him to the doctor or what?". The patient underwent lab tests and procedures which included fever was 101.8 Fahrenheit on an unknown date. The outcome of the event was unknown.  No follow up activities are needed; No further information is expected.
Large local reaction involving (L) arm upper arm with redness, swelling, pruritus 2 days after injection
Headache and fever of 101F which started within 48 hours. Temperature was over 103.2F on day 5 (4/16/02). Complained of general body aches, neck pain, splenic tenderness, not enlarged.