chrisvoncsefalvay/vaers-outcomes huggingface dataset:
body aches; horrible headache; joint aches; all tired; chills; 3rd dose given and not immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), HEADACHE (horrible headache), ARTHRALGIA (joint aches), FATIGUE (all tired) and CHILLS (chills) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced OFF LABEL USE (3rd dose given and not immunocompromised). On an unknown date, the patient experienced PAIN (body aches), HEADACHE (horrible headache), ARTHRALGIA (joint aches), FATIGUE (all tired) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 22-Oct-2021, OFF LABEL USE (3rd dose given and not immunocompromised) had resolved. At the time of the report, PAIN (body aches), HEADACHE (horrible headache), ARTHRALGIA (joint aches), FATIGUE (all tired) and CHILLS (chills) outcome was unknown.            No concomitant medications were reported.   This case was linked to MOD-2021-268326, MOD-2021-364583 (Patient Link).
DISORIENTED AND SLOW IN MOVEMENTS DIFFICULTY IN GETTING DRSS DIFICULT IN COORDINATION CHANGE IN PERSONALITY ,AND NOT HERSELF. ALL THIS AFTER THE VACCINE .  SHE IS NOT HERSELF
morning of 20APR was aching all over alittle nauseated; by about 5PM on 20APR started to itch all over; trunk of body & arms became very reddened & rash appeared also in groin area; inc temp, sore throat, some coughing; was shaky;
Fatigue, Shortness of breath, Atrial fibrillation, Tachycardia, elevated BNP, possible CHF.
sick really bad; Vomiting; Bad headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick really bad), VOMITING (Vomiting) and HEADACHE (Bad headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 ILLNESS (sick really bad), VOMITING (Vomiting) and HEADACHE (Bad headache). At the time of the report, ILLNESS (sick really bad), VOMITING (Vomiting) and HEADACHE (Bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided by the reporter no treatment information reported by the reporter   Reporter did not allow further contact
High fever 104 degrees, chills, bad headache about 10 hrs after vaccine. No redness or swelling at vaccine site treated with ROCEPHIN, then oral antibiotics (? viral illness).
dizzy since getting 1st / shot 2 weeks ago; This case was reported by a consumer via interactive digital media and described the occurrence of dizziness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was unknown.   It was unknown if the reporter considered the dizziness to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient received  1st Shingrix and  since then experienced dizziness. The reporter asked how long should this last.
I was exposed to COVID-19, my wife was positive. On July 4, 2022 I started feeling nauseous that evening so the next morning I took a home COVID-19 test that came back positive. My temperature came back positive, I had a telehealth visit with my primary care physician who prescribed PAXLOVID that I started taking immediately. I was also taking MUCINEX for the congestion. I started feeling good within three days. This past Saturday I had a pain in the back of my head. I went to my chiropractor and got no relief. I now have diarrhea and have changed nothing in my eating habit and I am now wondering if these are side effects of COVID-19 or PAXLOVID.
Intramuscular inflammation, burning joints, muscular spasm s.  Now 10/5/21, still occurring since 9/9/21 (two days after vaccine). Taking meloxicam, flexiril, massage and chiropractic care per recommendation of orthopedic and trying trigger point injections in the near future.
Patient was admitted to the Medical Center on 01/07/2022 under care of hospitalist service Dr. after an fall.
A 40-year-old nurse/health professional reported a non-serious spontaneous report of metallic taste in mouth while administering H1N1 and headache concerning herself, subsequent to H1N1, Intranasal vaccine. Neither medical history nor concomitant medications was reported for this patient. The patient herself did not receive H1N1, Intranasal vaccine. On 05-Nov-2009, while administering H1N1 to several patients, she experienced metallic taste in her mouth and in addition she experienced headache for about ten hours after that. The outcome of the headache is resolved and the outcome of metallic taste was not recovered.
This prospective pregnancy case was reported by a nurse and described the occurrence of vaccine exposure during pregnancy in a 24-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). The subject's past medical history was not reported. No concurrent medication was reported. On 25 June 2014, the subject received an unspecified dose of BOOSTRIX (0.5 ml, intramuscular, unknown injection site). Her last menstrual period was on 28 October 2013 and estimated date of delivery was on 4 August 2014. The subject was exposed to the vaccine at 34 weeks and 2 days gestation. No adverse event was reported. At the time of reporting, the pregnancy was still ongoing. The nurse reported another case of vaccination with BOOSTRIX during pregnancy. See case A1078835A. Follow-up information received on 20 October 2014 from the nurse: The patient gave birth to a male infant at 38 weeks gestation by vaginal delivery. Birth weight was 6 lbs and APGAR scores at 1 minute and 5 minutes were 08 and 09. VAERS details were provided.
1st day-Sore arm.  2nd day-Severe headache.  8th day-Arm itchy, tender to touch, small red dot.  9th Day-Red dot increased to 3" ,hot to touch, swollen
Received Varivax 9/22/04. Developed fever, lesions 10/2/04. Seen at clinic 10/5 with clinical varicella. Received acyclovir secondary underlying chromosomal problem.
Red, raised, blanching, well-defined patch of urticaria over left deltoid muscle, tender to light palpation. Gradually increased in diameter to 11cm in longest dimension at time of first assessment. Patient given Tylenol 650mg PO x1, loratadine 10mg PO x1.
p/vax pt sought medical treatment for a varicella like rash;pt presented w/ pruritic rash & a low grade temp lasting a few days;rash was noted as erythematous papules w/blistering;exp breakthrough case of chickenpox;
Slight fever, 99.4, (ordinarily I run lower than normal), severe body aches, and chills.
10/29/21 - Vaccine administered, 10/31/21 - pain in arm at shot area, miscarriage around 12pm (didn't move much during miscarriage), 11/1/21 - inability to move arm and shooting pain noticed first thing in the morning.
had covid; had covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "had covid". Clinical course: Patient just recently got covid virus, and she asked when she could get the fifth shot. Patient also stated that she got the four doses of Pfizer covid 19 vaccine. Patient stated she had 2 covid vaccines and 2 boosters. She recently had covid and wanted to know when she could get the fifth dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PULMONARY EMBOLISM, UNSPECIFIED. 8/16/2021 ACTINIC KERATOSIS  ACUTE HYPOXEMIC RESPIRATORY FAILURE 8/16/2021 ACTINIC KERATOSIS
Swollen lymph nodes; headache; fatigue; body aches; pain at injection site; Booster; 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 female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Dec2021 12:00 (Batch/Lot number: unknown) at the age of 73 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High BP" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: LIPITOR; VENLAFAXINE HCL; TRAZODONE; BUSPAR. Past drug history included: Codeine, reaction(s): "Known allergies: codeine". Vaccination history included: Bnt162b2 (Dose: 1, dose administration time=03:30 PM, dose vaccine location=Left arm, lot unknown reason=Not available/provided to reporter at the time of report completion), administration date: 09Feb2021, when the patient was 72 years old, for Covid-19 Immunization; Bnt162b2 (Dose: 2, dose administration time=01:00 PM, dose vaccine location=Left arm, lot unknown reason=Not available/provided to reporter at the time of report completion), administration date: 30Mar2021, when the patient was 72 years old, for Covid-19 Immunization, reaction(s): "Inappropriate schedule of vaccine administered". The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021 12:00, outcome "unknown", described as "Booster"; LYMPHADENOPATHY (non-serious) with onset 15Dec2021 16:00, outcome "recovering", described as "Swollen lymph nodes"; HEADACHE (non-serious) with onset 15Dec2021 16:00, outcome "recovering", described as "headache"; FATIGUE (non-serious) with onset 15Dec2021 16:00, outcome "recovering", described as "fatigue"; PAIN (non-serious) with onset 15Dec2021 16:00, outcome "recovering", described as "body aches"; VACCINATION SITE PAIN (non-serious) with onset 15Dec2021 16:00, outcome "recovering", described as "pain at injection site". Therapeutic measures were not taken as a result of lymphadenopathy, headache, fatigue, pain, vaccination site pain.  Additional information: Patient did not had Covid prior to vaccination and Covid was not tested post vaccination. other vaccine in four weeks was none.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Itchy, red rash on arm near injection site appeared 8 days after injection.  Still there after 3 days
painful; black eye; at the time of the shot she felt "off-centered; itchy; This spontaneous case was reported by a patient and describes the occurrence of PAIN (painful), EYE CONTUSION (black eye), FEELING ABNORMAL (at the time of the shot she felt "off-centered) and PRURITUS (itchy) in a 79-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pneumococcal vaccine. Past adverse reactions to the above products included No adverse event with Pneumococcal vaccine.    On 28-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In October 2023, the patient experienced PRURITUS (itchy). On 28-Oct-2023, the patient experienced PAIN (painful), EYE CONTUSION (black eye) and FEELING ABNORMAL (at the time of the shot she felt "off-centered). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PAIN (painful), EYE CONTUSION (black eye), FEELING ABNORMAL (at the time of the shot she felt "off-centered) and PRURITUS (itchy) had not resolved.            It was reported that patient had received other vaccines four weeks prior to Covid-19.  Concomitant product use was not provided by the reporter.  Patient receives total of five doses of mdoerna covid-19 vaccine, previous four doses were first dose on 12-Jan-2021 (Lot number-013L20A), second dose on 09-Feb-2021(Lot number- 030M20A), third dose on 27-Oct-2021 (Lot number- 012F21A), fourth dose on 18-Apr-2022 (Lot number- 057M21A).  It was reported that 30 minutes after receiving the most recent dose of the vaccine she noted her eyelid started to turn black. This spot was slightly painful, and at the time of the shot she felt off-centered. It got worse over the weekend, moving to her eye and her face. She talked to a pharmacist who recommended she take an antihistamine, so she took a Zyrtec. At the time of report black eye as it was still ongoing today, but was also itchy.
Stomach/fever 99 after 2 1/2 weeks, (wheezing). Serious lung (lungs filled w/fluid-heart same, diarrhea, dizziness, racing heart, serious fatigue and weakness, horrible pain-trouble walking and talking-hoarseness, headache, eyes and trouble breathing w/mucous. No sleep, pain!!  12/04/09 ED records for DOS 11/10/09. DX Acute bronchitis   Pt c/o distress, pain, anxious, SOB, chest pain, and back pain. On physical exam: Neuro: wnl; rash red, urticaria under B breasts. Tx: decadron. Pt improved and discharged home with Tylenol and antibiotics.  12/04/09 ED records for DOS 11/27/09 DX: Flu like symptoms. Pt presented with fever, cough, and sputum, headaches. Pt improved and discharged home.
This spontaneous report as received from an unknown age female pharmacist refers to herself. Information about concurrent conditions, concomitant medication and medical history was not provided. On an unspecified date, the pharmacist was vaccinated by a fellow colleague with a dose of ZOSTAVAX (lot#, dose and frequency were not provided), intramuscularly rather than subcutaneously. The pharmacist also reported that since receipt of the ZOSTAVAX, the site was painful and "stingy" (date unspecified). The outcome of the events was not provided. Additional information has been requested.
Interchange of vaccine product; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine product) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Sep-2021, the patient received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine product). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine product) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product information was provided. No treatment information was provided.
Very sore arm, starting a couple hours after the injection. So sore for 4 days I could hardly raise my arm to get dressed, although it was gradually getting better. However, it is still sore after 2 weeks when I raise the arm! This is not right!
Patient received Vaxelis instead of getting varicella. Patients mother was notified, manufacture , and safety report from office was completed.
Patient is stating it is tender in that area and it started about 4 days after. He still states it is a little tender still.
Information has been received on 02-JAN-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 28-DEC-2012, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. In 18-FEB-2016, the patient was treated by a physician at a hospital for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is not recovered. The causality of the events is related. Additional information has been requested.
Headache, Myalgia, Fever, Chills, Weakness Narrative:
On 3/19/21, presented to ED with new right facial droop and numbness. CT head negative, neurology consult and thought to be Bell's Palsy. Discharged home on Solumedrol 5 day pack.  Patient noted asymmetry in her taste sensation and then started to have R sided facial pain, followed by R sided facial droop. On 3/23/21, brain MRI showed no acute infarction, intracranial hemorrhage or mass lesion, very minimal asymmetric enhancement of the labyrinthine segment of the right facial nerve as compared to the left side.
While seated after shot, patient fell on his back hit head against the wall (hollow) opened eyes. Immediately after 45 seconds came back.
Dizziness; Metallic taste; Metallic smell in mouth and nose; Eyes feels warm; Injection site pain; This is a spontaneous report from a non-contactable consumer, the patient. A 41-year-old male patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204), via an unspecified route of administration on left arm, on 23Mar2021 at 09:45 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, patient has not tested for COVID-19. On an unknown date, the patient had experienced dizziness, weird metallic taste, metallic smell in mouth and nose, warmness in eyes and injection site pain. No therapeutic measures were taken as a result of adverse events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events dizziness, metallic taste, metallic smell in mouth and nose, warmness in eyes and injection site pain was unknown.   No follow-up attempts are needed. No further information is expected.
Patient is fully vaccinated.  COVID positve on 12/26/2021 at ED visit. 21yo female presents with COVID concern. She reports multiple exposure to COVID including her boyfriend who she lives with. States onset of shortness of breath and chest pain that is worse with inspiration since yesterday. The sharp pain comes and go and has not had pain like this before. She also states that she has a frontal headache which is somewhat similar to her previous headaches. Had 1 episode of vomiting which has now resolved. CTA was negative for PE. U/S duplex was negative for DVTs bilaterally.EKG was negative for acute ischemia.Vitals within normal limits on arrival. No hypoxia or respiratory distress. Pt discharged from ED. Given information for monoclonal antibodies.
Pt states after Gardasil IM had redness, itching swelling x 2wks.
Patient is a 75 y/o female who presented with complaints of shortness of breath and generalized weakness. Patient has a past medical history of COPD with oxygen dependency, pulmonary embolism, atrial fibrillation on chronic anticoagulation, lung cancer s/p radiation and chemo, and hypertension. Patient was hospitalized here in December 2021 with COPD exacerbation and discharged on 5L O2 with instructions to reestablish care with Pulmonology. Patient reports she had weaned back down to 2-3L O2 since that admission. She has not followed up in Pulmonology clinic. She reports she did have routine PET scan at Facility within the past couple of months which showed no recurrence per her report. Per Dr.s 1st it appears she was on prednisone taper in April however she does not recall this. Nevertheless, patient reports increased shortness of breath and cough over the past two days. She has thick sputum production. No fevers. She has not required increased O2 requirements. She reports generalized feeling of unwell and weakness. She denies any sick contacts. Reports she has received COVID19 vaccine X2, no booster. Patient also reports right hip pain for the past two days. Denies any injuries or falls.   In the emergency department patient is normotensive,HR 110s, EKG with sinus tachycardia. SpO2 on home oxygen 93%. CXR with right upper and lower lobe scarring. No acute process. Routine CBC with WBC 5.09 with 83% granulocytes. Chemistry significant fro Na 124, blucose110. COVID positive. UA with positive nitrites and 5-10 leukocyte esterase. Patient received IV ceftriaxone and IV toradol in the ED. Hospitalist asked to admit.  PT REMAINS INPATIENT AT THIS TIME.
Beginning in mid-March, I began to experience psoriasis or eczema like symptoms for the first time in my life. This initially began on my neck, then appeared on my chest and upper eyelids. I?ve seen a dermatologist and they are unsure of the cause only that it?s inflammatory. I was treated with topical tacrolimus, and have had some relief but the itchy, flaking, and redness around my eyes persists most prominently. The chest and neck have mostly cleared up. I?ve also experience significant fatigue.
Patient presented to the ED for low oxygen saturation and confusion on 4/5/21. He presented to the ED on 4/5/21 and was subsequently hospitalized for acute respiratory failure with hypoxia. He presented to the ED on 4/28/21 and was subsequently hospitalized for pneumonia. These visits are within 6 weeks of receiving COVID vaccination.
FEVER 104.3, REDNESS, HEAT AND SWELLING 1-2 INCHES AROUND INJECTION SITE.
3x4 cm mass-tender behind right ear. Ultrasound showed collection of enlarged lymph nodes.