chrisvoncsefalvay/vaers-outcomes huggingface dataset:
visibly swollen, painful lymphnode under armpit of left arm; visibly swollen, painful lymphnode under armpit of left arm; achy; diarrhea; soar arm, muscle; soar arm, muscle; possible lymphoma pain under arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Oct2021 12:30 (Lot number: FE3590) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Antiphosolipid syndrome" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "depression" (unspecified if ongoing); "overweight" (unspecified if ongoing); "Known allergy: Latex sensitivity" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; LIOTHYRONINE; WELLBUTRIN. Past drug history included: Known allergies= cephalosporins, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (prev dose product=COVID 19, prev dose brand=Pfizer, prev dose brand unknown=False, prev dose lot number= EN6208, prev dose lot unknown=False, prev dose administration date=20Mar2021 , prev dose administration date=11:30 AM, prev dose dose number=2 , prev dose vaccine location=Left arm), administration date: 20Mar2021, when the patient was 47 years old, for covid-19 Immunization; Bnt162b2 (prev dose product=COVID 19, prev dose brand=Pfizer, prev dose brand unknown=False, prev dose lot number= EN6198, prev dose lot unknown=False, prev dose administration date=27Feb2021 , prev dose administration time=12:30 PM, prev dose dose number=1 , prev dose vaccine location=Left arm), administration date: 27Feb2021, when the patient was 47 years old, for covid-19 Immunization. The following information was reported: PAIN (non-serious) with onset 10Oct2021, outcome "not recovered", described as "achy"; DIARRHOEA (non-serious) with onset 10Oct2021, outcome "not recovered", described as "diarrhea"; PAIN IN EXTREMITY (non-serious), MYALGIA (non-serious) all with onset 10Oct2021, outcome "not recovered" and all described as "soar arm, muscle"; LYMPH NODE PAIN (non-serious) with onset 10Oct2021, outcome "not recovered", described as "possible lymphoma pain under arm"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 11Oct2021, outcome "not recovered" and all described as "visibly swollen, painful lymphnode under armpit of left arm". Therapeutic measures were not taken as a result of pain, diarrhoea, pain in extremity, myalgia, lymph node pain, lymphadenopathy, lymph node pain.  Additional information: Facility type vaccine was pharmacy or drug Store. No other vaccine in four weeks. No covid prior vaccination. Covid was not tested post vaccination. Patient was not received treatment for AE.  No follow-up attempts are possible. No further information is expected.
vaccine was frozen rather than placed in the refrigerator. dose was given to patient. no symptoms reported. revaccination offered
Patient was given a booster dose out of expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was given a booster dose out of expired vial) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was given a booster dose out of expired vial). On 17-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patient was given a booster dose out of expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that dose vial mentioned that the vial didn't undergo any temperature excursions.  No treatment details were reported.  This is a spontaneous case concerning a 40-year-old, female patient with no relevant medical history, who experienced the non serious event of expired product administered for mRNA-1273 vaccine (lot number 041C21A). The event expired product administered occurred right after the third dose of mRNA-1273 vaccine administration, the administered mRNA-1273 vaccine was 16 days past expiration date (Date of mRNA-1273 vaccine administration: 17 November 2021, expiration date of administered mRNA-1273 vaccine: 1 November 2021). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 40-year-old, female patient with no relevant medical history, who experienced the non serious event of expired product administered for mRNA-1273 vaccine (lot number 041C21A). The event expired product administered occurred right after the third dose of mRNA-1273 vaccine administration, the administered mRNA-1273 vaccine was 16 days past expiration date (Date of mRNA-1273 vaccine administration: 17 November 2021, expiration date of administered mRNA-1273 vaccine: 1 November 2021). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Pt began to feel dizzy.  Pt was layed down to relax. Shortly after that the pt began to have hives. Pt was given Zyrtec. Symptoms resolved. Pt went home
Multiple papules on abdomen, back, neck and upper and lower extremities.  Some are crusted.  Symptoms for 2 days.  Low grade fever for 1 day prior to rash with stomach ache.
Tenderness in arm, then a rash on the arm, aches all thru the left arm down to the wrist. swelling of the underarm and the side of breast and hotness to the upper arm.
ROTARIX/oral vaccine, administered IM. Mild fussiness, low grade temp.
Had fever. Temp max at 102.3 degrees Fahrenheit. Febrile seizure lasting about 2 minutes (rolling of eyeballs, cyanosis of lips, stiffening of extremities).
07/28/21 serious chest pain and now off and on continuous  07/31/21 body rash off and on continuous
Allergic conjunctivitis of both eyes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24May2021 (Lot number: EW0171) as dose 1, single and administered in arm left, administration date 14Jun2021 (Lot number: EW0217) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Yes" (unspecified if ongoing), notes: Other medical history: Yes; "known allergies - Sulfa" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: CONJUNCTIVITIS ALLERGIC (non-serious) with onset 04Jun2021, outcome "not recovered", described as "Allergic conjunctivitis of both eyes". The event "allergic conjunctivitis of both eyes" was evaluated at the physician office visit. Therapeutic measures were taken as a result of conjunctivitis allergic. Additional Information: Facility where the most recent COVID-19 vaccine administered was Pharmacy or Drug Store. Patient age at vaccination was 63 years. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received medications within 2 weeks of vaccination. Prior to vaccination, the patient was  not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Device Date : 29Sep2021  No follow-up attempts are possible. No further information is expected.
Pharmacist drew up vaccine of Covid-19 Pfizer Pediatric age 5-11 without diluting the vial and immunizing technician administered.  Left message for patient parent on 03/21/22 3:42 pm and 03/22/22 2:40 pm to check on patient.  Physician notified at Pediatrics Office, spoke with employee at office and noted in patient chart.
This spontaneous report was received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown dates, an unspecified number of patients were vaccinated with unknown number of doses of RECOMBIVAX HB, (strength, dose, route, anatomical location, lot number and expiration date were not reported), which were improperly stored. No adverse effects were reported and no product quality complaint (PQC) was involved. Follow up information was received from a certified medical assistant during a phone call on 25-MAR-2015. The certified medical assistant was unavailable at the time of the call. The call was transferred to the manager who indicated that RECOMBIVAX HB the lot # H020605 with expiration date: 31-MAR-2015 (also reported as 13-MAR-2015) and indicated that the patient identification information was not readily available at the time of the call. Additionally, the reporter indicated that there had been no reports of adverse events following the administration of RECOMBIVAX HB vaccine. The office was in the process of contacting the patients for revaccination. The correspondence process was reviewed and telephone number was provided should information become available. This is one of several reports received from the same reporter. Additional information has been requested.
Symptoms include flushed/itchy face, red patches on face, numb tongue, no fever
9/3/21 Patient started to have a bad skin rash all over the body about 1 week after receiving 2nd dose of Pfizer COVID vaccine, her arms, trunk and legs were all swelling, which brought her to ER on 9/7/21, where she was given Deltasone 50mg, Singulair 10mg, Benadryl 50mg for 5 days; her condition got better while she's on medications but the rash came back on 9/15/21 with puffy swollen arms and rash all over trunk, and she went to ER again where the doctor changed her meds to Prednisone 20mg daily and Atarax 25mg TID; She also started taking corn starch mixed w/ water as suggested by a friend, which seemed working  for her; On 9/16/21 when she stops by the pharmacy, her rash got much better, and we suggested her to finish her prednisone 20mg and apply topical hydrocortisone as needed and follow up with us.
Narrative: COVID infections following completion of COVID vaccine series 02/10/21 COVID vaccine dose #1 03/03/21 COVID vaccine dose #2 07/28/21 Pt presents to screening reporting cough and headache x2 days; COVID POSITIVE 07/29/21 Pt reports mild headache 07/30/21 Pt reports fever, headache, cough, sore throat related to cough and headache x2 days; COVID POSITIVE 07/29/21 Pt reports mild headache 07/30/21 Pt reports fever, headache, cough, sore throat related to cough, and problem sleeping; rx given for cepacol, dextromethorphan/guaifenesin, melatonin 07/31/21 Pt reports improving symptoms 08/01/21 Pt reports fever, headache, and sore throat have been resolved; reports slight cough 08/04/21 Pt reports burning sensation in nares but is stable 08/05/21 Clinically resolved
c/o pain, soreness, nausea w/h/a describes pain in lt arm;some kind of nervous like;also wiping eyes w/tissue;referred to pvt MD ASA;
received 2 doses of Havrix (pediatric) 11 days apart---redness and edema at injection site
56 YO F with poorly controlled DM/HTN, HL, HCV, depression with self mutilation, presented to the emergency room with fever and altered mental status. Per family, on 09/13 the pt was in regular state of health, presented to the clinic for prescription refills of amitriptyline, gabapentin and trazodone. She then took an unkown quantity of pills throughout the day and slept for the remainder of the day. She woke up the following day abruptly with altered mental status, confusion, agitation, talking to inanimate objects, so the family called EMS. In the ED the patient had low back pain, fever to 40.4 C, tachycardia, PO2=88. CXR  showed perihilar infiltrate and increased interstitial markings. Leucocytosis to 17.7. An LP was performed and later the pt was found to obtunded with increased CO2, so she was intubated. She was then admitted to the medical ICU. Where she improved and then walked out AMA today (2 days later). The patient told the medical resident that she had received 2 flu shots prior to the event. The local pharmacy has a record of giving 1 Flu vaccine to her on 09/13 (lot 111776P, exp 03/31/2011/Novartis/Fluvirin).
Patient developed palpitations, lightheadedness, with heart rate in the 140's on 2-23-21.  Echocardiogram revealed pericardial effusion.  She also developed petechiae and mild transaminitis around this time, but the petechiae and transaminitis resolved quickly.  Pericardial effusion did resolve per repeat echo.  Of note, she tested positive for COVID infection on 8-7-21.  She has experienced numerous episodes of palpitations between April 2021 and April 2022.  Cardiology visit on 4-18-22 revealed diffuse ST segment depressions on EKG.  The cardiologist diagnosed her with myopericarditis.
administered expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired vaccine) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered expired vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported . No treatment medication was reported .
Left deltoid muscle swelling within 24 hrs of vaccine, measures 5x4cm.
Red Rash that covers my upper left arm from just below the shoulder to just above my elbow.  The rash is hot to the touch.
red, like a blood vessel had broken; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR HYPERAEMIA (red, like a blood vessel had broken) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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 OCULAR HYPERAEMIA (red, like a blood vessel had broken). At the time of the report, OCULAR HYPERAEMIA (red, like a blood vessel had broken) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.   This case was linked to MOD-2021-025085 (E2B Linked Report).; Sender's Comments:  MOD-2021-025085:
This is a spontaneous report from a contactable Medical assistant on behalf of the physician received via a Pfizer sales representative, and from a contactable nurse. A 18-year-old female patient of an unspecified ethnicity received a second dose of TRUMENBA (Batch/Lot# M37314, Exp date Apr2017), intramuscular in left deltoid, at 0.5 ml single, on 03May2016. The patient's medical history and concomitant medications were none. Previously the patient received first dose of TRUMENBA on 16Dec2015. The patient experienced swollen left arm from upper arm to just above elbow on 03May2016 with outcome of recovered on 09May2016, pruritus of lateral left arm and elbow on 03May2016 with outcome of not recovered and 2 inch margin of redness surrounding the vaccination site on 03May2016 with outcome of recovered. The patient was seen by a physician 6 days after vaccination and described the adverse events. At the time of the visit, her left arm was slightly swollen from the upper arm to just above the elbow. The erythema was no longer present, but the arm was very itchy. The day of administration the patient has a 2 inch margin of redness surrounding the vaccine site, which spread down the arm, and progressed to swelling and pruritus over 2-3 days. Therapeutic measures were not taken as a result of swollen arm. The nurse considered that the Pfizer product had a causal effect to the adverse events. Follow-up (13Jun2016): New information received from a contactable nurse includes: patient's age, nurse causality assessment, TRUMENBA details, vaccine history, concomitant/relevant history details, events updated, treatment detail. Follow-up (05Aug2016): Follow-up attempts are completed. No further information is expected.
didn't feel well; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (didn't feel well) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 024C21A) 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) (unknown route) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (didn't feel well). At the time of the report, MALAISE (didn't feel well) outcome was unknown.            This case was linked to MOD-2021-163656 (Patient Link).
History 59-year young lady with history of COPD coronary artery disease CHF  was evaluated at a local hospital  and transferred  with diagnosis of pneumonia.  Patient O2 sat was in the 70s she was placed on CPAP.  In route patient complained of chest pain abdominal pain and back pain subsequently had a cardiorespiratory arrest.  Patient was being bagged after ET intubation in the field by EMS with chest compressions.  Breath sounds well equal on arrival.  Glucose was greater than 100 on fingerstick. Providers were initially able to obtain a pulse with return of spontaneous circulation but blood pressure was at best 50 systolic.  Patient was begun on an epinephrine infusion and norepinephrine ordered.  The patient then deteriorated into  V-tach,  All additional heroic measures failed and the patient expired.
12OCT95 pt called to report vaxed 5OCT95;only sl tenderness @ site of inj;7OCT95 noted numbness on tongue lack of sensation but could move in all directions;9OCT95 eyelid somewhat drooped-eye waters;12OCT95 mouth/lip sensation dec
One week after Varivax administered, the pt began developing varicella type rash which by the next day was almost confluent on both anterior chins and right upper arm and more scattered right chest. Placed on Acyclover 200 mg QID x 5 days.
Fever, chills, dizziness, all began 23 hours after 2nd dose, subsided 12 hours later at 10 pm
2hr post vax severe dizziness occurred-BP inc;SOB, h/a;
Patient received his Covid-19 vaccine almost 3 weeks ago and reported a mild headache post vaccination, but the headache only lasted a few days. He then received a Typhoid vaccine about 7 days ago and states he has had headaches daily. He is one who suffers from migraines and these headaches are different. They are not severe or cause impairment.
fell off my horse; I started having dizziness about every afternoon for 4 weeks; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Nov2021 at 09:00 as dose 3 (booster), single (Lot number: EW0176) at the age of 62 years intramuscular for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), as single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Meniere's disease" (unspecified if ongoing), notes: other medical history: Meniere's disease; "known allergies: Sulfa drugs" (unspecified if ongoing), notes: known allergies: Sulfa drugs. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: ER8733, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM, Route of Administration: Intramuscular), administration date: 08Apr2021, when the patient was 62-year-old, for Covid-19 immunization, reaction(s): "I am sure this started in May 2021 that I had the 1st vertigo episode.", "dizziness"; BNT162b2 (Dose Number: 1, Batch/Lot No: EN6207, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM, Route of Administration: Intramuscular), administration date: 18Mar2021, when the patient was 61-year-old, for Covid-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 16Nov2021, outcome "not recovered", described as "I started having dizziness about every afternoon for 4 weeks"; FALL (non-serious) with onset Jun2022, outcome "not recovered", described as "fell off my horse". The events "i started having dizziness about every afternoon for 4 weeks" and "fell off my horse" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: On May2021, patient had the 1st vertigo episode. Then went 6 months with vertigo or dizziness. In Nov2021, patient had the covid vaccine and flu vaccine and that afternoon, started having dizziness about every afternoon for 4 weeks. Then in Dec, started 7 months feeling normal. In Jun2022, patient fell off a horse and started seeing a neurologist b/c she started having dizziness every p.m. July-Sept was fine. Then after 08Sep booster, after 36 hours on 10Sep, patient woke up at 1 am and the room was spinning.
Patient stated his back started started hurting approximately 10 days ago.  The pain then went to his knee.  He stated that  a spot on the side of his knee is hard, swollen and warm to the touch.  Adivised him to seek immediate medical attention.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose01/06/21 2nd dose01/27/21 Diagnosed covid positive:08/20/21 Symptom onset:08/13/21 Exposure: Symptoms:SOB,fatigue,COUGH, loss of smell/taste, runny nose,HA