chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Could not keep his balance; Fell down; Hit his head; Dizziness after 2nd booster; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (Could not keep his balance), FALL (Fell down), HEAD INJURY (Hit his head) and DIZZINESS (Dizziness after 2nd booster) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067H21A, 013A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-May-2022, the patient experienced BALANCE DISORDER (Could not keep his balance), FALL (Fell down), HEAD INJURY (Hit his head) and DIZZINESS (Dizziness after 2nd booster). On 14-May-2022, BALANCE DISORDER (Could not keep his balance), FALL (Fell down), HEAD INJURY (Hit his head) and DIZZINESS (Dizziness after 2nd booster) had resolved.            No relevant concomitant medications were reported.  The patient had received First booster dose of Moderna vaccine on 26OCT2021. The patient had received Second booster dose of Moderna vaccine on 13MAY2022  Patient wife called EMS and the ambulance came. Everything was fine so they did not transport patient to the hospital. Patient also mentioned that he did not report his adverse event to VAERS.  No treatment information was provided.
received DTap (Daptacel) in place of Tdap (Adacel); Initial information received on 30-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 23 years old male patient who DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 30-Apr-2019, the patient received a  dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5206AA via intramuscular route in the left arm.  It was of actual medication error due to Wrong vaccine administered..  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Severe, Error: Infection / Cellulitis (diagnosed by MD)
Patient had prolonged period that normally lasts just a few days but it lasted 14 days.
I broke out in hives, was especially bad on August 14. Had never had hives previously. It covered my entire torso, much of my face and some of my legs.
Saturday, 20Mar2021 was when I had noticed the same adverse event (joint pain) on my left foot after I had received the 2nd dose of Pfizer vaccine on Thursday, 18Mar2021; Another flare up (worse than 1st time) occurred after the 2nd vaccine shot - within 2 days; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN6199), via an unspecified route, administered in Left Arm on 18Mar2021 (48-year-old at vaccination) as Dose 2, Single for COVID-19 immunization. Facility type vaccine was reported as Workplace clinic. The patient's medical history was concomitant medications within two weeks was reported as none. No known allergies. The patient had not received any other vaccine within four weeks to prior vaccination. The patient was not diagnosed with COVID prior vaccination. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN 5318), via an unspecified route, administered in Left Arm on 24Feb2021 at 3:30 PM as Dose 1, Single for COVID-19 immunization. Left foot joint pain (gout) several days after receiving 1st vaccine shot. Another flare up (worse than 1st time) occurred after the 2nd vaccine shot - within 2 days. On 20Mar2021 at 12:00 (Saturday), the patient experienced the same adverse event joint pain on his left foot. The patient underwent lab test and procedure which included X-ray left foot: unknown results. Post vaccination the patient was not tested for COVID. The patient was prescribed Colchicine for resulted events. Clinical outcome of the events was reported as not recovered. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
chills; muscle ache; fever; Slight Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), MYALGIA (muscle ache), PYREXIA (fever) and HEADACHE (Slight Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills), MYALGIA (muscle ache), PYREXIA (fever) and HEADACHE (Slight Headache). At the time of the report, CHILLS (chills), MYALGIA (muscle ache), PYREXIA (fever) and HEADACHE (Slight Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication reported.  No treatment information was provided.
Pt given GARDASIL vaccine about 15 minutes later.  Pt had light headiness and dizzy, pale and nausea.
high pitched cry starting 4-6 hrs p/DTP/OPV/HIB also had persistent crying; t101;
Left side of face froze up/Bell's palsy; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (batch/lot number and expiry date not reported) as 1ST DOSE, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced left side of face froze up/Bell's palsy on an unspecified date.  The patient underwent lab tests and procedures which included test in the emergency room: unknown result on 24Apr2021. Therapeutic measures were taken as a result of left side of face froze up/Bell's palsy (unspecified medication). The patient has not recovered from the event.   Information on the lot/batch number has been requested.
2hrs p/vax pt became very pale & was limp-lasting approx 30-45mins
got a rash around his entire right side of his upper body from just above the waste line to his shoulder; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A male patient in his 20's received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunization. The following information was reported: RASH (non-serious), outcome "unknown", described as "got a rash around his entire right side of his upper body from just above the waste line to his shoulder". Therapeutic measures were taken as a result of rash.  Additional information: The patient received his Pfizer BioNTech COVID 19 vaccine booster and got a rash around his entire right side of his upper body from just above the waste line to his shoulder. The patient took Benadryl. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
?Pt received vaccine that was stored improperly. Vaccine was moved from ultra-cold freezer to freezer on 6/17/21. According to Pfizer, vaccine stored in the freezer after day 17 is considered improperly stored, and the pt will need to be re-vaccinated.?   Pt received replacement dose on 7/21/21
Breakthrough case admission after 2 vaccines  Moderna 2/4/21 lot# 007M20A;  Moderna 3/4/21 Lot# 023M20A
Received the vaccine from nurse. Left after appropriate wait time. Started having trouble breathing 45 minutes after injection. Stopped at healthcare. Nurses adminstered epi pen and addressed doctor. Doctor unsure if issues were coming from vaccine since epi pen given and didnt see patient presenting with symptoms. Gave oral benadryl also and went home. Patient states mom told her she reacted to a flu shot similarly once but not every time she received it. Patient feels she should pretreat with benadryl next time and receive her second dose.
Expired dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021 at 12:23 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose). On 18-Oct-2021 at 12:23 PM, EXPIRED PRODUCT ADMINISTERED (Expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment details not provided 19 doses of Moderna lot number 009C21A, Expiry Date 10-15-2021 were administered to 19 patients on 10-18-2021.  16 patients received 0.25 ml booster dose and 3 patients received 0.5 ml full dose.   This case was linked to MOD-2021-355973 (Patient Link).
arm pain; bursitis; hit a nerve in his arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101211084 (Pfizer).  A 49 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01May2021 (Lot number: EW0162, Expiration Date: 31Jul2021) at the age of 49 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE: 1, Lot: EP7533, Expiration 31Jul2021, both injections were in the left arm.), administration date: 10Apr2021, when the patient was 49 years old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 01May2021, outcome "not recovered", described as "arm pain"; BURSITIS (non-serious) with onset 2021, outcome "unknown", described as "bursitis"; NERVE INJURY (non-serious) with onset 2021, outcome "unknown", described as "hit a nerve in his arm". The events "arm pain", "bursitis" and "hit a nerve in his arm" were evaluated at the physician office visit. Therapeutic measures were taken as a result of pain in extremity, bursitis, nerve injury.  Additional information: Patient stated he did not experience bothersome side effects after his first dose, but after his second dose he experienced arm pain that has persisted for greater than 2.5 months and radiates to the bone and into the upper muscle of the arm into his back. Patient stated his doctor diagnosed him with bursitis and informed him this could be due to injection technique, and the needle could have hit a nerve in his arm. Patient asking if this was a known side effect from the Pfizer BioNTech Covid-19 Vaccine or if this was likely to be caused by poor injection technique. Patient asking, since people seem to have stronger reactions to the second dose of the vaccine, if the second dose of the Pfizer BioNTech Covid-19 Vaccine was stronger or different than the first dose. He waited the time that he thought would be normal for most people of hurting for about 3-4 days to a week. It kept getting worse. It hurt the same day. It never stopped hurting after that. Six weeks later he went to the doctor, and it could have worsened into that bursitis feeling. It was pain when you wake up. He felt like vaccine shot was a menace some days and other days it was stiffness, and the bursitis pushes through. They recommend physical therapy.   No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from the patient's mother and refers to a 1 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was taken for her 1 year booster shot and received doses of both PROQUAD (Merck) (lot #, dose and route were not provided) and M-M-R II (lot #, dose and route were not provided) vaccines. The reporter stated the provider informed her that there should not be any real cause for concerns. No adverse effect was reported. Additional information has been requested.
Area around vaccine was red, raised and warm. Advised to administer Zyrtec, use cold compress and hydrocortison cream.
Had 1st shot 3/10/21; Had 2md shot 4/8/21; Loud tinnitus started 1 week after 2nd shot; some days it is SCREAMING in my ears; some day less so, but always present; went to ENT; had hearing test; they suggested hearing aids, which I declined.
Redness, swelling and warmth to touch. Large hard area at DTaP site left arm. DR RX Keflex 250 3/4 tsp QID x 7 D.
A bivalent Moderna booster indicated for patients aged 6-11 years was inadvertently given to the patient.
Discharge Provider:  Primary Care Provider:  DO Admission Date: 4/14/2023 Discharge Date: Apr 20, 2023  PRESENTING PROBLEM: NSTEMI (non-ST elevated myocardial infarction) (HCC)    HOSPITAL COURSE: 93-year-old female with a known history of hyperlipidemia, anxiety disorder, reflux presented to the Emergency Room 04/14/2023 with a week's worth of shortness of breath that had been progressing.  Was found to be hypoxic in the emergency room requiring 3 L nasal cannula oxygen.  Normally on room air at home.  The patient tested positive for COVID and was started on remdesivir and dexamethasone. Troponins were elevated and cardiology consultation recommended transfer for echocardiogram and cardiology management.  Elevated troponins 154 with repeat 139. Patient denied chest pain, but did have intermittent shortness of breath and cough.  Chest x-ray was read as findings of CHF, bibasilar airspace disease and small pleural effusions, and proBNP was greater than 7000. Patient with improvement in her breathing with treatment for COVID. Cardiology consulted for elevated troponins and EKG changes, thought could be myocarditis related to COVID, recommended no further invasive evaluation.   She also underwent a neurological workup for facial paresthesia. CT head without contrast showed no acute, CTA head and neck revealed no acute intracranial large vessel occlusion but severe short-segment atherosclerotic narrowing of the left anterior cerebral artery A2 segment and some minimal carotid artery disease. Parotid mass measuring 1.9 cm on the left. Has had this worked up and seen ENT 11/2022. Neurology consulted and patient underwent a brain MRI which revealed the left superior cerebellar artery appears to contact and bow the left cisternal trigeminal nerve near the root of entry zone, left anterior inferior cerebellar artery appears to exert mild mass effect upon left cranial nerve. Neurology recommended starting carbamazepine and will follow-up outpatient in clinic
Patient received Pfizer vaccine 25 days earlier than recommended guidelines. Dose administered at 4 months and 5 days.
Feeling of swelling in throat, and strange feeling in face, which happened at first vaccine.  This was same reaction I received when starting allergy shots years ago (for grass, trees, etc. ) Reaction did not progress  after the  first vaccine,  but persisted with headache for four hours.  This time, while driving home, face felt like cement, throat felt full like I could barely swallow.  Intensity subsided about 20 minutes later and I was able to drink, so I assumed it was okay.  I  had bad headache for 2 days. On day 2, noticed welts below and on sides of injection sights, which were painful to the touch.  Today, they look like hives.  I was not concerned about the headaches, but the strange feeling in my face and throat were concerning.  I"ve never had painful hives after any vaccination.
CHEST PAIN; CHEST PRESSURE; This spontaneous report received from a consumer concerned a 58 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-APR-2021, the subject experienced chest pain. On 19-APR-2021, the subject experienced chest pressure. Laboratory data included: Blood test (NR: not provided) Normal, and EKG (NR: not provided) Normal. Laboratory data (dates unspecified) included: Stress test (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chest pain, and chest pressure. This report was non-serious.; Sender's Comments: MAC not required as per standard procedure as case was assessed as non-serious.
Information has been received from a registered nurse concerning a female with unspecified pertinent medical history and unspecified allergies reactions who on an unspecified date, was vaccinated SQ with a dose of ZOSTAVAX (Merck) (Lot number not reported). On an unspecified date, the patient developed hives all over her body after vaccination with ZOSTAVAX (Merck). The patient was given steroid injection at health care professional office. It was unspecified whether lab diagnostic studies performed. Upon the report time, the patient was not recovered. Hives all over her body after vaccination with ZOSTAVAX (Merck) was considered to be significant disability or incapacity by the reporter. Additional information has been requested.
Itchy rash on injected arm around elbow; This is a spontaneous report from a contactable consumer (patient). An 86-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), at age 86 years old, via an unspecified route of administration, administered in the right arm, on 02Mar2021 12:00 (Batch/lot number unknown), at age 86 years old, as dose 2, single, for COVID-19 immunisaiton, at a hospital. Relevant medical history included type 2 diabetes from an unknown date, not reported if ongoing or not. The patient has no known allergies. The patient did not have COVID-19 prior vaccination and was not tested for COVID-19 post vaccination. Concomitant medications included warfarin, metoprolol, lisinopril, insulin lispro (HUMALOG) and insulin detemir (LEVEMIR), all taken for unspecified indications, start and stop dates not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection), administered in the right arm, on 09Feb2021 12:00 (Batch/lot number unknown), at age 86 years old, as dose 1, single, for COVID-19 immunisation. The patient did not receive over vaccines in four weeks. On 08Mar2021, the patient had an itchy rash on the injected arm around the elbow. The patient was not given treatment for the event. The patient was recovering from the event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Body ache, rash, headaches, joint pain 4 days after cellulitis injected in the arm
Upon administration plunger came out of vaccine device, child moved suddenly causing needle to withdraw and superficial scrape against child upper LT thigh leaving 3cm arc scratch on thigh which required first aid and readmin of vaccine.
My baby was vaccinated on the upper thigh and a few days after she developed hard lumps that was very obvious on the vaccinated area. We went to another doctor, and at clinic, the doctor did not make any official record; and she just ignored our concern.
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Consulted with the local Dept. of Health and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Local Healthcare is working on a compliance improvement plan and has been reinstated vaccination privileges.
This spontaneous report as received from a health professional refers to unspecified number of patients of unknown age and gender. Since on unknown dates, the patients had been vaccinated with unspecified doses of VARIVAX (route, lot # and expiration date were not provided). It was reported that the vaccines underwent supported defrost cycling. No adverse effects reported. Additional information has been requested.