chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fatigued; Patient experienced sore arm; Hotness; Pressure in the head at night; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Patient experienced sore arm), FEELING HOT (Hotness), HEAD DISCOMFORT (Pressure in the head at night) and FATIGUE (Fatigued) in a 49-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 (No reported medical history).    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (Patient experienced sore arm), FEELING HOT (Hotness) and HEAD DISCOMFORT (Pressure in the head at night). On 19-Mar-2021, the patient experienced FATIGUE (Fatigued). On 19-Mar-2021, PAIN IN EXTREMITY (Patient experienced sore arm), FEELING HOT (Hotness) and HEAD DISCOMFORT (Pressure in the head at night) had resolved. On 20-Mar-2021, FATIGUE (Fatigued) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment information included paracetamol.    This case was linked to US-MODERNATX, INC.-MOD-2021-058032, US-MODERNATX, INC.-MOD-2021-057976, US-MODERNATX, INC.-MOD-2021-059170 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-058032: US-MODERNATX, INC.-MOD-2021-057976: US-MODERNATX, INC.-MOD-2021-059170:
soreness of the arm after getting administered Prevnar 13; This is a spontaneous report from contactable pharmacist. This pharmacist reported same events for three patients. This is 2nd of three reports.   A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration from an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced soreness of the arm after getting administered the suspected vaccine on an unspecified date. The outcome of the event was unknown.   ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019548921 same reporter/drug/event, different patient;US-PFIZER INC-2019548928 same reporter/drug/event, different patient
Child dose of Pfizer given to a 12-year-old instead of the full adult dose. No adverse effects or symptoms reported.
pain in the injection site, fever 103 (started at about 3 PM 03/06/2021 from 99F,  then  increased to 100, 102, 103 by midnight, decreased to 99 at 2 AM on 03/7/2021), chills, headache, weakness
No AEs; RN called to report temperature excursion that occurred on 7/12/2022. Caller states that 100 doses of PROQUAD and 94 doses of VARIVAX were administered since 7/12/2022 from mobile unit to children in community. No further information provided. No add; This spontaneous report was received from a nurse and refers a child of unknown gender. The patients' concurrent conditions, medical history, allergies and concomitant therapies were not reported.  On 12-JUL-2022, 40 doses of the vaccine varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U029621with expiration date 20-SEP-2023) underwent a temperature excursion during storage.   On an unknown date, the patient was one of 40 patients vaccinated with vaccine varicella virus vaccine live (oka/merck) (VARIVAX) (lot # U029621, expiration date 20-SEP-2023) 0.5 milliliter once, administered as prophylaxis (dose regimen details were not provided).   No adverse event was reported. No further information was reported.  This is one of several reports received from the same reporter.
Hospitalized (11.28.21);  COVID-19 positive (11.28.21); fully vaccinated  Admission Date: 11/28/2021 Discharge Date:  12/02/2021 Admission Diagnosis: AKI (acute kidney injury) Non-traumatic rhabdomyolysis Pneumonia due to COVID-19 virus Discharge Diagnosis:  AKI (acute kidney injury) Non-traumatic rhabdomyolysis  Pneumonia due to COVID-19 virus  Hospital Course: Patient is a 62 y.o. female with pmhx relevant for hypothyroidism, hyperlipidemia, obesity and arthritis who presented secondary to a chief complaint of severe fatigue.  She was vaccinated for COVID-19 and had no sick contacts.  She complained of worsening fatigue for 2 weeks prior to admission.  She was unable to get up from the floor after a fall.  She laid on the ground for 22 hours without moving.  Family brought her to the emergency department.  She admitted to decreased intake prior to admission.  In the emergency department, she was positive for COVID-19.  She had mild hypoxia and was placed on 2 L nasal cannula.  Chest x-ray showed left lower lobe opacity.  BMP showed a creatinine of 1.39 which was AKI.  She had an elevated CPK of 4300 from immobilization.  White count was 12000. Procalcitonin was mildly elevated.  She was treated with IV Rocephin and azithromycin for a 5 day course due to community-acquired pneumonia on top of COVID-19.  She was treated with fluids initially.  Her CPK and creatinine improved. She did receive dexamethasone for five days, discontinued at discharge. She is not a candidate for remdesivir due to time from onset of symptoms. PT/OT recommended skilled nursing facility at discharge however patient is adamant in her refusal to consider this despite discussion of risks/benefits. Husband works from home and is able to help care for her. Evaluated by pulmonary rehab and discharged with home oxygen 2L with exertion as well as home healthcare services.  Initial UA with RBC's however repeat one day prior to discharge without any hematuria.  Recommendations: CT head was performed due to a fall with possible head trauma.  There was no bleed or stroke noted.  There was concern for ventriculomegaly that was asymmetric.  MRI of the brain was ordered to further evaluate this which showed prominent lateral and third ventriculomegaly concerning for possible obstructing web / aqueductal stenosis vs hydrocephalus. She had no associated neurologic symptoms and this should be further evaluated as outpatient.   She had fairly significant hypokalemia which was repleted and I recommend repeat BMP in 1-2 weeks. Magnesium was also repleted.
This case was reported by a other health professional via sales rep and described the occurrence of injection site induration in a male patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced injection site induration, injection site erythema, myalgia, injection site warmth, headache and felt faint. On an unknown date, the outcome of the injection site induration, injection site erythema, myalgia, injection site warmth, headache and felt faint were unknown. It was unknown if the reporter considered the injection site induration, injection site erythema, myalgia, injection site warmth, headache and felt faint to be related to BEXSERO. Additional details were provided as follows: At the time of the call, patient specifics and lot number were not available. The male patient had a baseball sized induration, erythema, myalgia, headache, felt faint, and the injection site was warm to the touch. GlaxoSmithKline representative was given info from the medical assistant, who would give a call early next week to provide specific information about patients and vaccine lot. She told the representative that she felt that the female and the male with the more mild adverse events aligned with what was in the patient information. This was one of 3 cases reported by same reporter.
Initial report received from a healthcare professional on 08 OCTOBER 2014. A 69-year-old female patient, whose medical history and concomitant medications were not reported, had received an intramuscular dose of FLUZONE HD (batch number U5023BA, expiration date, dose in series not reported) in to the deltoid left on 06 OCTOBER 2014. The patient had experienced swelling about a 5 inch diameter, 6-8 inches below the injection site, redness about 5 inch diameter, 6-8 inches below the injection site, warm to touch and bruising at the injection site on 07 OCTOBER 2014. The patient's had no illness at the time of vaccination, and pre-existing diagnosed allergies and birth defects were no known drug allergy. The patient had no laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome of the events was not resolved. List of documents held by sender: none. Follow-up information received from a healthcare professional on 23 JAN 2015. Expiry date of vaccine FLUZONE HD was reported as 27-APR-2015. Any other vaccination within 4 weeks prior was reported as none. Documents held by sender: none.
Massive Hair loss and patchy bald spots.  Was diagnosed with Alopecia Areata by my dermatologist when I went in 2 weeks after my shot.
Typical post flu shot symptoms, but started severe dull pain in back and chest, never ceasing, develop a rash on chest, few days later diagnost: shingles. Never have had chicken pox. 5 weeks later still sufering from pain. Rash has cleared up.
Vaccine administered at 823am; at 0831, patient reported feeling warm and that her throat felt like it was swelling.  0834 pt placed on VSS monitor; 911 called; 0843  Pt was given epi pen 0845/0850 VS repeated;  0851 ambulance arrived and pt taken to ED
Dizziness & Right sudden sensorineural hearing loss - profound - still undergoing treatment, minimal recovery of hearing thus far. Dizziness Symptoms started within 2-3 days after 2nd Pfizer COVID vaccine.
cried out, found by babysitter to be pale in color around mouth, hands were blue, foaming @ mouth, unresponsive to verbal & touch stimuli;skin cool & clammy, eyes rolled backing head;911 called;
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 16-OCT-2017, the patients were vaccinated with doses of improperly stored M-M-R II lot # N002337, expiration date 20-JAN-2019 (dose and route of administration were not reported) for prophylaxis. On 16-OCT-2017, the patients were vaccinated with doses of improperly stored VAQTA lot # N017094, expiration date 31-AUG-2018 (dose and route of administration were not reported) for prophylaxis. On 16-OCT-2017, the patients were vaccinated with doses of improperly stored RECOMBIVAX HB lot # N020613, expiration date 05-MAY-2020 (dose and route of administration were not reported) for prophylaxis. On 16-OCT-2017, the patients were vaccinated with doses of improperly stored LIQUID PEDVAXHIB lot # N007749, expiration date 29-NOV-2019 and lot # N000238, expiration date on 25-OCT-2019 (dose and route of administration were not reported) for prophylaxis. On 16-OCT-2017, the patients were vaccinated with doses of improperly stored ROTATEQ orally, lot # N005617, expiration date 03-OCT-2018 (dose was not reported) for prophylaxis. The M-M-R II vaccines were reconstituted with properly stored sterile diluent (lot# and expiration date were not reported) There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between 9 and 25 degrees Celsius for 1 hour and 12 minutes. Data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1710USA008187:
Arm hurt so much; This is a spontaneous report from a contactable other healthcare professional(patient). A 45-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, batch/lot number was not reported), via an unspecified route, administered in arm left on 13Feb2021 16:00 (at the age of 44-years-old) as dose 1, single for covid-19 immunization. Patient medical history included gastritis from an unknown date and unknown if ongoing. Concomitant medication included estradiol taken for an unspecified indication, start and stop date were not reported. The patient was not pregnant at time of vaccination. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in 2021, the patient arm was hurted so much. The patient received acetaminophen and Alka-Seltzer as a treatment. The outcome of event was recovering.   Follow-up attempts are completed. No further information is expected.
Patient stated that she was on a blood thinner.  After administering her HD flu shot, she bled a bit from injection site, then quickly developed a knot approximately the size of a nickel. The bleeding stopped quickly and the knot stopped growing.  I monitored the patient for about 20-25 minutes and she felt fine, no itching, dizziness, shortness of breath, etc that would indicate allergic reaction.  She has recieved this vaccine and others in the past without any issue. She did not want to take 2 benadryl as a precaution due to her daily schedule.  I sent her with 2 tablets just in case any other allergic symptom did arise, and instructed the person she was with to seek medical attention if appropriate.  I suspect that a small vessel was hit, and with the blood thinner the knot arised.  I also counseled her on the fact that she is like to experience much bruising.
This spontaneous report as received from a registered nurse refers to a patient of unknown gender and age. On 18-AUG-2014, the patient was vaccinated with a dose of VAQTA, 0.5 ml, intramuscular injection (dose number, lot/batch number, expiration date and indication were not reported) that was improperly stored. No adverse events were reported.  No product quality complaint (PQC) involved. This is one of several reports from the same source. Additional information has been requested.
wanted to know that if there is a leeway from 3weeks to 5 weeks on the second dose; This case has been considered invalid as there is no event experienced by the patient under BNT162B2.  This is a spontaneous report from a contactable consumer or other non healthcare professional. A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient wanted to know that if there is a leeway from 3weeks to 5 weeks on the second dose of vaccination leading to off label use on an unspecified date with outcome of unknown.    No follow-up attempts are possible. No further information is expected.
hands were tingling; her heart was racing; This is a spontaneous report from a contactable consumer (mother). A 42-years-old female patient received first dose of BNT162B2 (COMIRNATY, solution for injection, lot number: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced tingling in hands and her heart was racing on an unspecified date. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
received /hepatitis B vaccine in 2000 / Engerix-B on 07-Aug-2020 / didn´t receive any other doses after that; received a dose of hepatitis B vaccine in 2000 / received / Engerix-B on 07-Aug-2020; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 19-year-old female patient who received HBV (Engerix B) (batch number 4CL44, expiry date unknown) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Hepatitis B vaccine (might have received a dose of hepatitis B vaccine in 2000).   On 7th August 2020, the patient received the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, the patient received the 3rd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 7th August 2020, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device and not applicable after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the drug dose administration interval too long and incomplete course of vaccination were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: The age at the vaccination was not reported for the 2nd dose. The age at the vaccination was not applicable for 3rd dose. The patient received 2nd dose of Engerix B at an interval longer than the recommended which led to lengthening of vaccination schedule.  Till the time of reporting the patient did not received 3rd dose of Engerix B which led to incomplete course of vaccination. The reporter did not consent to follow up.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. Since 19-JAN-2015 the patients were vaccinated with VAQTA (dose: 0.5 ml, administered intramuscularly) which were improperly stored. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Site: Redness at Injection Site-Mild, Systemic: Lymph Node Swelling-Medium, Additional Details: Patient's grandmother claims pharmacist gave flu and covid shots less than an inch apart which caused lymph node swelling. Believes shots are now ineffective.
Received at ER at 2 am on June 6, 2021, then transferred to another ER at 9 am on June 6, 2021. Released from hospital at 4 pm that day with diagnosis of myocarditis.
Information has been received from a physician concerning a 63 year old female who on 16-AUG-2008 was vaccinated with ZOSTAVAX (lot number not provided) 0.65 mL. Concomitant therapy included aspirin. A day after receiving ZOSTAVAX, on 17-AUG-2008, the patient experienced soreness, fatigue and a headache. She had a "mild stiff neck" and high blood pressure (150/90). As of 22-AUG-2008, the patient had not recovered. The patient sought unspecified medical attention. There was no product quality complaint. Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/24/2008. Information has been received from a physician concerning a 63 year old female who on 16-AUG-2008 at 08/:21 was vaccinated with ZOSTAVAX (lot #659672/0294X) 0.65 mL. A day after receiving ZOSTAVAX (Oka/Merck), on 17-AUG-2008, the patient experienced soreness, fatigue and a headache. On 18-AUG-2008, 48 hours after receiving ZOSTAVAX (Oka/Merck), she had a "mild stiff neck", high blood pressure (150/90), achy muscles, worsening headache in left eye/temples and 2 inches diameter erythema at injection site. On approximately 30-AUG-2008, the patient had recovered. The patient sought unspecified medical attention. There was no product quality complaint. Additional information is not expected.
Hoarseness at 02:00 PM and continuing; cough beginning at 3:00 PM; lip swelling beginning at 08:00 PM; treated by urgent care physician (reporting) at 08:45 PM.
Patient presented with sudden onset of pleuritic chest pain and elevated D dimer. Clinically suspect PE
5 days after shot, lt arm started to itch, I noticed it was red, it spread and hot to the touch, Went to urgent care Thursday,  Feb.18, 2021, the doctor gave me Benadryl and Famotiodine, and outlined the redness and told me to go to urgent care if it gets worse, it got worse, I went to urgent care, he gave me steroid to put on for the itch. It is itchy and is still spreading.  I will call the doctor tomorrow and see what I should do next.
Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient regained consciousness in about 20 seconds after lying him on his back with leg elevated.
A non-serious spontaneous report of administration to a 23-month-old was received from a nurse.  The patient received FLUMIST on 06-Nov-2008.  There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 10:00 as dose 5 (booster), single (Lot number: GH9694), in right arm and on 13Aug2023 at 12:15 as dose 6 (booster), single (Lot number: A57643E) at the age of 70 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 10Feb2021 at 15:00 as dose 1, single (Lot number: 01M20A), in left arm, on 10Mar2021 at 15:00 as dose 2, single (Lot number: 048A21A), in left arm, on 21Oct2021 at 13:00 as dose 3 (booster), single (Lot number: 011F21A), in left arm and on 05Jul2022 as dose 4 (booster), single (Lot number: 017B22A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Coronary artery disease" (unspecified if ongoing); "type 2 diabetes" (unspecified if ongoing); "nephrotic syndrome" (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 "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.
Flushing of my face and neck, chills, fever, 99.8 has gone up .4 in the last 10 minutes. No treatment, currently having symptoms.
This is an instance of breakthrough COVID-19 after which death occurred.   The individual was vaccinated with the Moderna product on 01/21/2021, 02/18/2021, and 11/03/2021. They tested positive for COVID-19 on 05/16/2022 at the nursing home at which they were a resident, after developing a cough. The individual was treated with Paxlovid. They experienced an acute myocardial infarction and died on 06/05/2022. I see no indication the individual was hospitalized related to this illness.
pt recvd vax 31OCT95 PM had localized rxn severe, by 1NOV95 AM; deltoid & inner aspect of upper arm red, hot, edematous 5x7 inches
Urticaria - pt woke up 2/9/11 with rash. No other symptoms. No medications.
Insomnia, chills, fever, pain at injection site, lymph node swelling under right arm