chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Incidental diagnosis of rheumatoid arthritis,; current treatment with Orencia IV q month; pain and swelling in thumbs, wrists starting November 2021 and persistent to present time.
Racing heart beat. Talked to pt 850am on 9-30-11; she's fine; BP & HR back to normal.
pt recv vax as a prophylactic measure p/an outbreak of Hep A in geographical area;approx 6,000 doses were given; 21 days post vax pt presented w/sx of hep A & inc IGM & IGG values;ER or MD visit required;
Narrative: COVID infection following COVID vaccine series 01/01 Pfizer, dose #1 02/01, Pfizer, dose #2 10/03 COVID swab, result: detected 10/03 pt cc: exposure: unknown 10/04 clinically resolved
Cellulitis over smallpox vaccination site, approximately 5cm in diameter. Also with lymphatic streaking. Now on Keflex.
NO WHEEL OBSERVED AFTER DOSE ADMINISTERED. INTRADERMAL DOSE REPEATED 2-3 INCHES FROM PREVIOUS DOSE. WHEEL OBSERVED AFTER DOSE REPEATED.
An hour after the vaccine I started to develop dizziness and lightheadedness and mild nausea while walking. After laying down i still had the symptoms. Ate a bowl of cereal and took a 2 hr nap. Symptoms we still persistent after waking. I spoke with a tele doc from my insurance were she recommended I go to the ER if symptoms got worse or I develop new ones. After a night sleep, slight nausea is still present but no more dizziness.
Severe H/A's on 1st & 2nd vaccine.  Rash on back ~8 spots on middle/left side of back on 12/9/07 - extremely painful/blisters/itchy.
Pt cam in to office c/o rash on body 10/17/06 had a reaction to immunization on 10/12/06.
Mom concerned about the vaccine (TDAP) that is required for client to attend 7th grade. Afraid of SE. Was told not to immunize due to Hx.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. Patient medical history was not reported. On 02-DEC-2014 date the patient was vaccinated with expired ZOSTAVAX, of dose 0.65 ml via subcutaneous route (frequency reported as once). Expiration date for the ZOSTAVAX was reported as JULY-2014. No adverse events were reported. The outcome of the events was unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
8/2/2021 I had bloodwork done and my blood sugar was elevated for the first time. This eventually went up and I was diagnosed with Pre-Diabetes. I am not on medication but am trying to control with diet and exercise.
tested covid positive 5/3/21; fully covid vaccinated as of 4/21/21
Patient states the evening following her vaccinations she experienced "every flu symptom imaginable." She states she was nauseous, had chills and a fever, and even had to miss work the following day. She didn't start to feel better until 2 days later.
From initial information received on 31/May/2005 from a registered nurse regarding an adverse event occurring in the USA, it was reported that a cluster of ten five year old patients (individual patient information not provided) received a dose of DAPTACEL, lot number C2221AA, on unspecified dates. The routes and sites of administration were not reported. An unspecified amount of time following vaccination, all of the patients experienced swelling and redness from the shoulder to the elbow. All of the patients recovered from these events.
Patient hospitalized due to breakthrough covid-19 infection from 7/29/21 to 7/30/21. Patient completed the Pfizer vaccine series in April. Below is copied from patient notes:  Patient is a 24 y.o. female with a history of diabetes mellitus presented to the ED c/o shortness of breath, a non productive cough, loose non bloody stools, decreased appetite, chest pain, myalgias, arthralgias, headaches, and fatigue x 5 days. CXR showing bilateral airspace opacities. ECG SR with T wave inversions in III and AVF. Temp 100.3, mid 80s SpO2 on ambulation. K+ 3.2, glucose 245, AG 18, beta hydroxybutyrate 5.4. Pt given IVF and dexamethasone in ED.    Sepsis due to COVID-19: - pt not requiring oxygen  -Meeting sepsis criteria absed on fever, tachycardia and positive COVID 19 test - COVID-19 order set initiated  -Sepsis order set started, check LA - hold further dexamethasone as patient is not on supplemental oxygen  - anticoagulation with Loveonx 40mg SQ QD - supportive care with Tylenol for fevers, DuoNebs p.r.n., and dextromethorphan/guaifensin  -Consider remdesevir in the future for borderline benefit if AKI, transaminitis> 3ULN or >10 days from onset of symptoms, or if requires oxygen later on   Hyperglycemia  Type 2 diabetes mellitus, uncontrolled  - AG 18, beta hydroxybutyrate w mild elevation  - hold metformin  - add low dose sliding scale  - A1c    Hypokalemia  - replete, recheck in am  - check magnesium level    Obesity, BMI of> 40 -would benefit from lifestyles modifications regarding low fat diet, weight loss and daily excercise -F/U OPD with PCP
I received my 2nd dose of Moderna at 12:20 on 4/8/21. Starting at 11:30 p.m. that same day, I began to have severe chills, followed by fever in 101-102 degree range and full body aches.  At approximately 3:30 AM the next day (4/9/21), I vomited and came close to losing consciousness.  Fever and aches continued until I began to treat with Extra-Strength Tylenol at 9:00 AM on 4/9/21, which helped to ameliorate symptoms, although temperature stayed above normal and both aches returned as soon as Tylenol wore off.  I continued to use maximum dose of Tylenol through that day (3000 mg over 24 hours).  By the morning of 4/10, I had mild fever (100 - 101 degrees) and a persistent headache, but no more body aches.  I continued to treat with Tylenol through that day.  By 10 p.m. on 4/10, my symptoms had all resolved.   I should note that I would have begun treatment with Tylenol sooner, but I had seen conflicting information about whether Tylenol use after the vaccine injection would inhibit the immune response.
on 20APR93 pt recvd vax & had grand mal sz to hosp via ambulance lab done x-ray; lab work chest, x-ray showed pneumonia w/pluarie thickening; t104.9 @ hosp;
Sunday, headache began to form. The, what appeared to be bite marks, found on right leg. Monday, day long headache. Tuesday, horrible headache, nausea, night sweats, chills. ER diagnosed it as reaction from spider bite. Wednesday, headaches, more bumps. Thursday, headaches, nausea. Friday, headaches, more bumps on right leg, itching on right leg, ringing in right ear. Contacted doctor on Friday with pictures, and he diagnosed it as shingles.
Patient was given the primary series instead of the bivalent booster. The patient has had no adverse effects from this.
Pain in tooth at site of filling received one month prior to vaccine, pain felt like the pain post filling and went away with OTC pain medicine and did not return the next day
strong headache, bad teeth chattering chills, nausea, aches, possible sinus drainage, cough - lasted from Friday night one week after shot until Sunday afternoon.  Only reporting for your information.
26 hours after vaccination booster. Surface pain and ache on right side upper rib cage on right side (vaccination was in right arm). Simular to if i had bruised my rib cage, but no mark or swelling. Pain radiates away from center in decreasing levels up to 10 inches away from center area.
AFTER VACCINE ADMINISTRATION PATIENT REPORTS DOUBLE VISION, CHEST PAIN AND BREATHING DIFFICULTIES.
Hives developed in the arm in which the vaccine was administered. Pt took 25 mg of diphenhydramine. Pt also started to feel tingling sensations on her tongue.
This case was reported by a nurse via other manufacturer and described the occurrence of therapy non-responder in a patient who received ENGERIX B. Co-suspect products included ENGERIX B and ENGERIX B. On an unknown date, the patient received 1st dose of ENGERIX B, the 2nd dose of ENGERIX B and the 3rd dose of ENGERIX B. On an unknown date, an unknown time after receiving ENGERIX B, ENGERIX B and ENGERIX B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown. It was unknown if the reporter consider they therapy non-responder to be related to ENGERIX B, ENGERIX B and ENGERIX B. Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that, on unknown dates, an unspecified patient received 3 doses of ENGERIX B. On an unknown date, after receiving 3 doses of ENGERIX B, the patient had titer drawn, and the titers came back as not immune, which led to not responding to therapy. No further information was provided.
My left arm felt numb the first two days. The third day my hand felt numb and then my whole left side of my body felt numb. It has been numb ever since.
Ongoing shoulder pain at the injection site (L deltoid). Pain travelled up to the shoulder and has been ongoing for several months since the injection. Patient has x-rays done on the shoulder and has been seeing physical therapy for the pain. The pain is still not resolved despite current treatment plan and will further discuss with PCM.
My baby lost eye contact for three days and capacity for varied expression.  Once smiling and interacting went to vacant and distant.  Reaction time slowed or was stunted
Initial information received on 10-Sep-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 9 months old patient who was vaccinated with a 0.5 ml single dose of FLUZONE QUADRIVALENT (lot number: UT5897MA; expiry date: 30-Jun-2018) (route and site of administration was not reported) on 10-Sep-2018. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patients concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) on the same day (dates not reported). It was a case of actual medication error due to expired vaccine used. It was not reported whether the patient experienced any adverse events or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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 athorization 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
Redness and itching noted after injection. Advised to take PO Benadryl once home. Patient has a history of itching after vaccinations
My tongue swelled up. My face swelled I had problem breathing. I had a severe headache. My blood pressure went up to 181/119
This spontaneous report as received from a healthcare worker refers to unspecified patients of unknown age and gender. The patients pertinent medical history and concurrent conditions were not reported. No previous drug allergies were reported. On an unknown date the patients was vaccinated with improperly stored (Merck) VARIVAX (strength, dose, frequency and route were not reported) lot # L023594 with an expiry date of 26-JUN-2017. No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint. This is one of the two reports from the same reporter. Additional information has been requested.
Client administered 0.3 mL Pfizer COVID19 vaccine via IM to left arm at apx  1525.  At apx 1545 client verbalized complaint of tingling sensation to lips and face. Client denied any difficulty breathing. Client administered 50mg of Diphenhydramine via IM to right arm at apx 1546.  1547 BP= 117/70; HR = 98bpm; RR = 18; temp = 97.2.  Client verbalized tingling sensation lessening at apx 1550.  1552 BP = 113/69; HR = 92; RR = 15; temp = 97.2 At 16:00 client verbalized tingling sensation had completely subsided.  Client denied any difficulty breathing. Client declined transport to ED and instead called friend to pick her up as she was too drowsy to drive per Dr.
Inadvertent administration of dose of ROTATEQ two weeks after the previous dose; No adverse effects reported; This spontaneous report was received from a pharmacy intern and refers to a 32 week old premature patient. No information regarding the patient's medical history, concurrent conditions, concomitant medications, drug allergies and reactions was provided.  On an unknown date, the patient was vaccinated with a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (exact dose, dose number, lot # and expiration date was not provided) for prophylaxis. On an unknown date, reported as two weeks later, the patient was inadvertently vaccinated with another dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (exact dose, dose number, lot # and expiration date was not provided) for prophylaxis as opposed to the recommended regimen. No adverse effects were reported.
doses administered past the published expiry date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported.  No treatment information was provided by the reporter.
swollen axillary and clavicular lymph nodes; This spontaneous case was reported by a patient and describes the occurrence of LYMPHADENOPATHY (swollen axillary and clavicular lymph nodes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 LYMPHADENOPATHY (swollen axillary and clavicular lymph nodes). At the time of the report, LYMPHADENOPATHY (swollen axillary and clavicular lymph nodes) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant medications were provided by the reporter.  No treatment information was provided by the reporter.
Mild tingling in the body, mild lightheadedness, mild nausea, brief heat and tingling of lips, face, and ears, mild swelling of the upper lip
ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 21 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 201A21A, expiry: 21/SEP/2021) 0.5 ml, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced administered expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211002617.
Vaccine is labeled for use in patients 2 years and older. Patient is 2 months old. Failed to read packaging appropriately.
On 10/18/2021 I had appendicitis attack and had to get an appendectomy. Because my appendix had burst, I was in the hospital for 2 nights.
Fever 103F. (R) arm swelling and bacterial superinfection/cellulitis.
uncontrollable high blood pressure; cardiac arrest; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP; patient's husband).  A 52 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) 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 number unknown), administration date: 2021, for COVID-19 immunization. The following information was reported: CARDIAC ARREST (death, medically significant) with onset Dec2021, outcome "fatal", described as "cardiac arrest"; HYPERTENSION (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "uncontrollable high blood pressure". The patient was hospitalized for hypertension (start date: 2021). The patient underwent the following laboratory tests and procedures: blood pressure measurement: high, notes: uncontrollable high blood pressure. The patient date of death was Dec2021. The reported cause of death was cardiac arrest. It was not reported if an autopsy was performed. The reporter specified that shortly after taking the 2nd dose of covid vaccine, his wife developed uncontrollable high blood pressure. The patient was 52 years old and in perfect health before the vaccine. His wife was admitted into hospital, where she worked helped people for 31 years. She was released both times once they dropped her blood pressures. One week before Christmas, his wife had another high blood pressure event, and went into cardiac arrest on our way to the hospital and died.  The lot number for bnt162b2 was not provided and will be requested during follow-up.; Reported Cause(s) of Death: went into cardiac arrest on our way to hospital, and died.
Patient received a Pfizer vaccine on 9/16/2021, then received a Moderna vaccine on 10/7/2021. There was a vaccine mismatch.
chills, muscle cramps and aches, joint/bone aching, nausea but no actual vomiting, fever of 102, dizziness/faint feeling
leg swelling; crying; redness of the left leg; This is a spontaneous report received from contactable reporter(s) (Other HCP). Other Case identifier(s): 20220422000219.  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 20Apr2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL), on 20Apr2022 as dose number unknown, single (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CRYING (non-serious) with onset 20Apr2022, outcome "recovered"; PERIPHERAL SWELLING (non-serious) with onset 20Apr2022, outcome "recovered", described as "leg swelling"; ERYTHEMA (non-serious) with onset 20Apr2022, outcome "recovered", described as "redness of the left leg".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Dizzy/ light headed; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy/ light headed) 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 DIZZINESS (Dizzy/ light headed). At the time of the report, DIZZINESS (Dizzy/ light headed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.
extreme mental fog/ could hardly hold a conversation... could not put together words for a sentence; extreme fatigue; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received BNT162B2, via an unspecified route of administration, administered in arm left on 09Apr2021 11:00 (Batch/Lot Number: ER8729) at the age of 60 years old, as dose 2, single for COVID-19 immunisation. Medical history included Chronic kidney disease, gastroparesis, arthritis, known allergies: penicillin, sulfa and bactrum. There were no concomitant medications. No other vaccine in four weeks. No other medications in two weeks. The patient previously took first dose of BNT162B2 (Batch/Lot Number: EN6199) administered in arm left on 12Mar2021 09:00 for COVID-19 immunisation and experienced no problems. No COVID prior vaccination. Not COVID tested post vaccination. On 10Apr2021 17:00 (on the 2nd day of second dose), the patient had extreme fatigue for 4 days with continued fatigue, now almost 4 months later. Also had extreme mental fog for 4 days in which he could hardly hold a conversation as he could not put together words for a sentence. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient recovered with lasting effects. No treatment for adverse events. Outcome of events was recovered with sequelae.  Follow-up attempts are completed. No further information is expected.
Pt received vaccine at approximately 4:50pm, however later that night she started to experience swelling of the eyes and face, and she also developed hives over most of her body with itchiness.
Headache, Myalgia, Fever, NauseaVomiting,  left arm pain, chills, flu-like feeling Narrative:
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Lot number: EL9261), in left arm, on 09Feb2021 as dose 2, single (Lot number: EL9264), in left arm, on 01Oct2021 as dose 3 (booster), single (Lot number: 30135BA), in left arm and on 11Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 80 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LATANOPROST, start date: 11Apr2022. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of suspected covid-19.
Local reaction: swelling, redness, warm to touch; 5 cm in diameter - left arm.
Vigorous take with axillary adenopathy and numerous follicular based pustular lesions mainly present on neck and trunk 12 days post smallpox vaccination.  Patient afebrile and not systemically ill.
Information has been received from a certified medical assistant referring to an unspecified number of patients of unknown age and gender. There was no information about the patients medical history and concurrent condition. On an unspecified date in September 2016, On an unspecified date in September 2015, (manufacturer unknown) (reported as PEXVAXHIB)(lot# L009649, expiration date: 29-NOV-2017) was improperly exposed to 49 degrees Fahrenheit for 1.5 hours. Then, on unspecified dates after this, these patients each received a dose of improperly exposed (Manufacturer unknown) (reported as PEDVAXHIB) (lot# L009649, expiration date 29-NOV-2017, route and dose unknown). No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.