chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vaccine was given on 1/28/2021.  The patient reported to the Medical Center ED on 2/7/2021 with complaints of worsening bilateral lower extremities pain, swelling, numbness L>R leg for about a week. He reports significant purple discoloration of his legs, "purple spots on lower legs", pain in bilateral legs worse with rest and standing still and associated DOE. Denied chest pain, abd pain, palpitations, fever, chills, NVDC, sick contacts, recent trauma/falls/injury. Denies regular use of NSAIDs, antiplatelet meds or chronic anticoagulation, clotting or bleeding disorders, history of DVT or PE. Patient was seen here by the ED staff on 2/3/2021 after a syncopal event at home where he described feeling light
COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4411272-00.  A 58-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk, (cf), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", SUSPECTED COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". The action taken for adalimumab was unknown.  Additional information: It was unknown if patient was enrolled in a covid-19 vaccine trial.  The reporter considered "covid-19" related to BNT162b2. The reporter's causality for the event(s) of COVID with Humira (Adalimumab) was no reasonable possibility.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a possible contributory role of suspect drug cannot be excluded for the reported events.
Through quality checks it was discovered that the patient likely did not receive a full dose. Patient notified that it is recommended that they are re-vaccinated. Patient returned for repeat dose on 12/3/2021.
Child completed HPV/Gardasil series as follows 3/9/07;05/16/07;08/21/08  As of 5/2009 reported epsodes of syncope. Symptoms reported with episodes were acute confusion with loss of consciousness lasting between 30 to 60 minutes. Child reports episodes when she feels anxious or anxiety.  11/5/2009 and 11/9/2009 ED records for 5/26/2009 and Cardio/Neuro consult notes from 6/15 and 6/17/2009. Patient with c/o's syncope, mental confusion and loss of consciousness. Cardio evaluation norm, Neuro evaluation norm. DC DX Syncope Vasovagal Tx'd with Florinef  11/9/09:  Neurology Consultation received for dates of service 6/17/09 to 10/28/09:  Dx:  Pseudoseizures. Assessment:  Presents with episodes of syncope following hyperventilation, followed by periods of unconsciousness of 30 to 60 minutes during which she is unresponsive to painful stimuli.  A recovery period of 20 to 30 minutes has been marked by extensor posturing of her legs and confusion as she becomes more responsive.   11/17 and 11/18 Medical records and ICD9 codes received.  DOS 11/3-11/4. Final DX: Pseudoseizures w/anxiety component, altered mental status C/O of syncopal episode. Dizzy, HA, palpitations, nausea. LOC. Also cardiac consult 10/8/09.  Not neurally-mediated syncope. Non cardiac. Concerns for conversion reaction. ICD9 codes: 7880.970.39, 780.4, 7
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Oct2022 at 11:00 as dose 5 (booster), single (Lot number: GJ2524), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Atrial Fibrulation" (unspecified if ongoing); "Sulfa drugs" (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 "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Positive, notes: Covid test was strongly  positive again in 3 days after end of treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Interchange of vaccine products; COVID 19; COVID 19; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 4 (booster), single (Lot number: GH9702) at the age of 61 years, in left arm for COVID-19 immunization; elasomeran (MODERNA COVID-19 VACCINE), on 11Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 11Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 20Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for COVID-19 immunization. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Sjogrens'" (unspecified if ongoing); "Hashimoto's" (unspecified if ongoing); "NHL", stop date: 2007, notes: in remission since 2007; "Primary Immune Deficiency", start date: 2015 (unspecified if ongoing), notes: on IVIG. Concomitant medications included: ESTRADIOL, start date: 01Jan2008; PROGESTERONE, start date: 01Jan2008; ADVAIR, start date: 01Jan2015; MONTELUKAST, start date: 01Jan2015; BLOOD PLASMA, start date: 01Jan2016. Past drug history included: Vicodin, reaction(s): "known allergies: Vicodin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 12Sep2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: COVID-19 Test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. As COVID 19 Treatment, patient received Paxlovid from 26Sep2022 to 01Oct2022.
Severe headache began on 3/5/21.  Headache continued off and on for a week and still has headache to day.
Fatigue began 4 hours after vaccine, followed by body aches, headache, difficulty in  doing daily tasks. Twelve hours after vaccine, body aches caused sleep interference. During the night, 12 to 20 hours after vaccine: nausea, mild fever, and mild chills, each of which resolved quickly. Headache, body ache, fatigue continued and resolved appropriately 36 hours after vaccine. This was 2nd dose, 6 months after 1st, which caused no adverse effects other than soreness at site.
This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Administered in biceps), SKIN REACTION (it was a delayed hypersensitive reaction (the injection site raised and started to be hot, red, a little itchy and swollen, being 2 inches in diameter.), FATIGUE (little tired), CHILLS (little cold) and VACCINATION SITE PAIN (Pain on her arm) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 immunisation. The patient's past medical history included No adverse event (No reported medical history). Concomitant products included ESCITALOPRAM (LEXAPRO) for an unknown indication. On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced FATIGUE (little tired), CHILLS (little cold) and VACCINATION SITE PAIN (Pain on her arm). On 15-Jan-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Administered in biceps) and SKIN REACTION (it was a delayed hypersensitive reaction (the injection site raised and started to be hot, red, a little itchy and swollen, being 2 inches in diameter.). The patient was treated with Wound care (kept the site with ice) for Skin reaction. On 11-Jan-2021, FATIGUE (little tired), CHILLS (little cold) and VACCINATION SITE PAIN (Pain on her arm) had resolved. On 15-Jan-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Administered in biceps) had resolved. At the time of the report, SKIN REACTION (it was a delayed hypersensitive reaction (the injection site raised and started to be hot, red, a little itchy and swollen, being 2 inches in diameter.) outcome was unknown. 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. Treatment included, Benadryl + hydrocortisone cream + ibuprofen + ice (For the symptoms that started on 15Jan2021 she took on 16jan2021 Benadryl and a Hydrocortisone cream, and kept the site with ice. This case was linked to MOD-2021-005636 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2021: New event and urgent care visit; 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. MOD-2021-005636:Cross linked
My arm right away was sore and kinda numb while still in the store after the shot. My neck became more sore that evening.  Sunday my neck was swollen and hurt to turn. My glands are swollen in my clavicle and up the neck. I felt fatigued all day.  Monday my breast is sore on that same side, the glands are sure down my side by my breast.  I have some soreness in my neck but better.
Swelling and pain went away; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Swelling and pain went away) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 010A21A) for COVID-19 vaccination.     The patient's past medical history included Joint pain (Joint pain in the past) and Joint swelling (Joint swelling in the past). Concurrent medical conditions included Osteoarthritis, Psoriatic arthritis and Alopecia. Concomitant products included METHOTREXATE for an unknown indication.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Swelling and pain went away). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Swelling and pain went away) outcome was unknown.            After 2 days receiving the vaccine The swelling and pain went away. No treatment information details were reported.   This case was linked to MOD-2021-079053, MOD-2022-496958, MOD-2022-496962 (Patient Link).
Golf ball size, red, itchy, hot.  Took 1 Benadryl, Lasted 2 days.
Patient began having pain 24 hours after the vaccine was given and then broke out in vesicular rash along T1 dermatome line on the left. Rash progressed over several days.
testing positive after first covid vaccine dose/Positive test for COVID/tested positive; testing positive after first covid vaccine dose/Positive test for COVID/tested positive; This is a spontaneous report.  A contactable nurse reported that a 73-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3248, Expiration date: unknown), via an unspecified route of administration in left arm at the age of 73-year-year on 22Jan2021 at 11:30 am at a single dose for COVID-19 immunisation. The patient's medical history included high blood pressure, prostate cancer, and prediabetic. Concomitant medications were not reported. Prior vaccinations (within 4 weeks) were none. It was reported that the patient got the first dose on 22Jan2021. He is due for the second dose on the 12Feb2021 but last week he had positive test for COVID. He tested positive on 04Feb2021. The patient underwent lab tests and procedures which included PCR test on 04Feb2021: positive (PCR test done for positive COVID results). No treatment was given for the event positive test for COVID. The outcome of the event was unknown.
arthritis in left foot; This spontaneous case was reported by a patient and describes the occurrence of ARTHRITIS (arthritis in left foot) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced ARTHRITIS (arthritis in left foot). The patient was treated with PREDNISONE ongoing since an unknown date for Arthritis, at an unspecified dose and frequency. At the time of the report, ARTHRITIS (arthritis in left foot) had not resolved.        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 medications reported. Treatment included Prednisone
Received 0.5ml Moderna instead of 0.25ml booster dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (Received 0.5ml Moderna instead of 0.25ml booster dose) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012h21b) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (Received 0.5ml Moderna instead of 0.25ml booster dose). On 19-Nov-2021, ACCIDENTAL OVERDOSE (Received 0.5ml Moderna instead of 0.25ml booster dose) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant Medications were provided by the reporter.  No Treatment Information were provided by the reporter.
Patient states Saturday 4/17/21 he noticed "normal Pfizer symptoms" of fever, chills, "shakes," muscle pains, especially in joints including shoulder and back, they got better after several hours, except that about midnight Saturday he still had the back pain, in the upper back, noticed severe chest pain in front and back, it hurt "with every heart beat," "like a heart attack," sometimes would have "attacks," sometimes better, sometimes worse, and it hurt in chest to breath, took Nyquil about 3am, was able to go to sleep, Sunday-Monday it was "pretty bad," but came in "attacks," sometimes it felt worse than others. Monday chest still hurt, went to urgent care, had EKG and scan, went home and did some school, that evening chest pain was severe "I froze," went to ER, was diagnosed with pericarditis. given an IV and Toradol. Was discharged home from ER with OTC Ibuprofen 200mg, to take 8 times a day. Patient states it is getting better, still continues to have some pain, taking ibuprofen daily at this point.
Covid-19- I tested positive on August 16, 2022 I wasn't feeling well I had a fever of 102.0 I had cough and congestion, runny nose, with muscle aches and body aches. I was taking the anti-viral medication in an IV for my symptoms.
One day post vaccination the pt developed swelling and redness from the elbow to the shoulder. The pt sought unspecified medical attention.
On January 7th, 2022, 11 days after the flu and COVID vaccines were administered; I began to notice an uncontrollable itch in my groin area as well as shoulders and head.  The itch became more severe throughout the day and hives began to appear along with rashes.  These were at various locations on my body.  I began to develop an uncontrollable itch and pain in the palms of my hands.  Later that day I took a benadryl tablet which alleviated some of the itchiness.  By that evening I noticed distinct hives developing around the outside of my face, jawline, temple, shoulders and neck.  My eyes began to swell.  The next day, January 8th, 2022, I visited the local urgent care facility.  My body and face still covered in hives and rash.  My jaw and neck began to swell at this point from my temples down.  I was given a COVID rapid test which was NEGATIVE.  The physician felt this was a result of a delayed reaction from the vaccine.  I was prescribed a methylprednisolone dosepak (6 days, series of 4mg tablets) and began taking Zyrtec for the itch.  after  2 days taking the prescribed medication I began to notice less rash and hives.  The swelling began to subside after the second day and the itching is almost irrelevant.  At this time (January 10th, 2022) I am noticing sporadic rash activity in different parts of my body but with very limited duration.  The itchiness is almost completely gone and the swelling around my jam and neck is 90% resolved.
cellulitis; swollen glands; muscle aches; fever 102 degrees; left biceps swelling; pain; redness; neck stiffness; elevated WBC; throat ache; chills; high fever; body aches; groin pain and swelling; groin pain and swelling; fatigue; This is a spontaneous report from a contactable consumer or other non hcp (patient).  A 16-years-old male patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 08May2021 as single dose for covid-19 immunization. (Vaccination facility: Public Health Clinic). Medical history included eczema, myositis during childhood from an unknown date and unknown if ongoing, Allergies to medications, food, or other products: All nuts from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient not receive any other medications within 2 weeks of vaccination. Patient previously received first dose of bnt162b2 in left arm on 16Apr2021 for covid-19 immunization. Patient was not diagnosed with COVID-19 Prior to vaccination. It was reported on 31May2021 04:30 PM he had high fever, chills and body aches. Tested for COVID rapid and PCR came out negative. Then a week after he started c/o groin pain and swelling followed by throat ache and swollen glands. It lasted for few days. As He c/o fatigue and neck stiffness he took to urgent care on June 12th 8;30 pm and did the blood work and found to have elevated WBC. Sent him home requesting to hydrate and take fluids. On 15Jun2021 morning he had muscle aches and left biceps swelling, pain and redness as well as fever 102 degrees. Took him to the doctor and they suspected cellulitis and started on 10 days dose of Cephalexin. The swelling started going down within 24 hrs. He is still on antibiotics. Slowly feeling better. Adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 01Jun2021 (test name: Rapid and PCR, test type: Nasal Swab), Body temperature measurement: fever 102 degrees on 15Jun2021. Therapeutic measures were taken as a result of cellulitis, high fever, chills, body aches, groin pain and swelling, groin pain and swelling, throat ache, swollen glands, fatigue, neck stiffness, muscle aches, left biceps swelling, pain, redness, fever 102 degrees. The outcome for the event was reported as resolving.    Information regarding the lot/batch number has been requested.
patient had flu like symptoms; no energy; itching at the injection site; The caller had soreness/ soreness at the injection site; redness/ redness at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA LIKE ILLNESS (patient had flu like symptoms), ASTHENIA (no energy), VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE PAIN (The caller had soreness/ soreness at the injection site) and VACCINATION SITE ERYTHEMA (redness/ redness at the injection site) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (patient had flu like symptoms), ASTHENIA (no energy), VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE PAIN (The caller had soreness/ soreness at the injection site) and VACCINATION SITE ERYTHEMA (redness/ redness at the injection site). At the time of the report, INFLUENZA LIKE ILLNESS (patient had flu like symptoms) and ASTHENIA (no energy) had resolved and VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE PAIN (The caller had soreness/ soreness at the injection site) and VACCINATION SITE ERYTHEMA (redness/ redness at the injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Flu-like symptoms lasted for 6 to 8 hours. Reporter stated that her busy life might have contributed to the no energy. No treatment details were reported.   This case was linked to MOD-2022-567475, MOD-2022-568117, MOD-2022-568134, MOD-2022-568154, MOD-2022-568158 (Patient Link).
skin lesion - information has been received from a registered nurse concerning a 5 year old black male patient with a history of cutaneous fungal disease who on 24 apr 1998 was vaccinated with a second dose of varricella virus vaccine live in the left arm.  concomitant therapy included amoxicillin trihydrate (+) clavulanate potassium (Augmentin).  On 11 apr 2000 the patient presented with more than 100 lesions.  half of which were on his face.  there were also lesions on his back and stomach.  the patient did not have a fever.  follow up information from a registered nurse indicated that the patient was prescribed sulfadiazine silver salt (silvadene) cream.  Subsequently, the patient recovered.
Fever greater than 101.5 degrees, runny nose, cough, lethargy, trouble breathing and sleeplessness. Runny nose and cough have lasted more than 2 weeks.