chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Urinary infection; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Urinary infection) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (Urinary infection). At the time of the report, URINARY TRACT INFECTION (Urinary infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
PATIENT RECEIVED THE VACCINE AFTER THE 30 DAY WINDOW FOR STORAGE IN A REFRIGERATOR (NOT IN A FREEZER) HAD ENDED
2nd vaccine on Tuesday.  Wednesday started to have symptom: fatigue, chill and fever.  Today 12/14/2021 only fatigue.
with covid Dx (during) Dec2021; with covid Dx (during) Dec2021; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 21Feb2021 at 19:00 as dose 1, single (Lot number: EZ9266), in left arm, on 19Mar2021 at 09:00 as dose 2, 30 ug single (Lot number: EN6207), in left arm and on 23Oct2021 at 11:00 as dose 3 (booster), single (Lot number: FF2593), in right arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Seasonal asthma" (ongoing); "Vaginal atrophy" (ongoing); "OSA Mild with CPAP occasional use", start date: 01Jan2012, stop date: 01Jan2020, notes: Pertinent Details: Borderline; "OSA Mild with CPAP occasional use", start date: 01Jan2012, stop date: 01Jan2020; "Urethral Fascia sling repeat removal", start date: 22Oct2019, stop date: 22Oct2019, notes: Pertinent Details: Sling Broken in muscle; "Sling Broken in muscle", start date: 22Oct2019, stop date: 22Oct2019; "Asthma" (ongoing); "Rheum arthritis" (unspecified if ongoing); "sjogrens" (unspecified if ongoing); "Raynards" (unspecified if ongoing). Concomitant medication(s) included: ADVAIR resp inhalation taken for asthma, start date: 2019 (ongoing); ATROVENT HFA resp inhalation taken for asthma, start date: 2019 (ongoing); PROAIR HFA resp inhalation taken for asthma, start date: 2019 (ongoing); ALBUTEROL HFA resp inhalation taken for asthma, start date: 2019 (ongoing); ESTRACE VAGINAL topical taken for atrophic vulvovaginitis, start date: 2015 (ongoing). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2021, outcome "not recovered" and all described as "with covid Dx (during) Dec2021". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: I also had a booster in Oct2021; with covid Dx (during) Dec2021; The episode 27Dec2022 lasted until 07Jan2023 with paxlovid; (1st dose, 2nd dose and 3rd dose) Vaccine administered at private location was reported as No.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300020988 same patient, different vaccine dose/event;
Site: Itching at Injection Site-Mild, Systemic: Nausea-Mild; symptoms lasted 1 day
12 hours after the injection, I developed hives - first on my legs, then encompassing my entire body.  I've had two ER visits and been given Prednisone, as well as anti-histamines.   The hives are now subsiding during the daytime, but return at night and early morning.  As of today, 9/14/21, I still have hives.   Very itchy!!
chills; high fever of 100.3.; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and PYREXIA (high fever of 100.3.) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Leukemia lymphocytic chronic and COVID-19 in December 2020.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced CHILLS (chills) and PYREXIA (high fever of 100.3.). At the time of the report, CHILLS (chills) and PYREXIA (high fever of 100.3.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment and concomitant medications were not provided by reporter.   This case was linked to MOD-2021-017163 (Patient Link).
Left sided weakness, headache, chills, hypertension (normally hypotensive), bradycardia.
Severe shoulder and arm pain initially. Arm pain subsided and shoulder pain still persists. Never had shoulder pain prior to this vaccine.
No adverse event; 5 patients were administered an expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 patients were administered an expired vaccine) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 041H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (5 patients were administered an expired vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 patients were administered an expired vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (5 patients were administered an expired vaccine).    No concomitant medication  was provided. No treatment medication were provided. This case contain information of 5th patient out of 5th reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-728837 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728837:Master Case
PT went into cardiac Afib, monitored and put on blood thinner, potassium, and change in blood pressure medication. Still being monitored.
Narrative:  ACMC, Covid +, J&J, CLL, chemo, weakness, fatigue, SOB, dry cough, pneumonia, hypoglycemia, dehydrated. Decadron, doxy, ceftriaxone and remdesivir. Took downward course during inpt stay.
2 hours after immunization, itching and swelling, pain below injection site. Pt went to express care. Prescribed doxycycline 100mg and KEFLEX 500. Had ultrasound to rule out clot?
This infant had red blotches on her cheeks, swollen eyes (lids & around) red, (right cheek - quarter to nickel size) one blotch on right arm quarter size.
Pt dx with systemic vasculitis, unknown etiology. pt had headaches, double vision, vomiting and abdominal pain. FU indicates most symptoms are resolving (according to mother). Child continues to complain of pains in back, chest, and abdomen. He is under care of psychologist who is helping him deal with illness, symptoms, and affect on lifestyle (missed a month in school). He is to have FU MRT in June 2000 then FU with neurologist. Was hospitalized twice.
Initial report received from a healthcare provider on 17/May/2006. A 23 year odl male patient, with no pre existing medicla history, had recieved a subcutaneous, right extremity, second dose injection of JE VAX, lot number EJN221A, on 08/May/02006. On the same day, he developed headache, fatigue, and dizziness which lasted for one to two days. Two days later, he developed a red rash generalized throughout his body and tingling in his hands and feet. The patient ha drecieved prior vaccinations on 01/May/2006 which included a subcutaneous, right extremity, first dose injection of JE VAX, lot number EJN221A, and a second dose injection of Hepatitis A vaccine, lot number AHAVB106. the patient had also recieved the follwoing vaccinations within four weeks of the 08/May/2006 vacciantion (date of these vaccinations was not specified. an injection of YF VAX, lot number UE664AB, and in injection of Typhim VI, lto number Z0479-2. Routes and sites of administration were not provided. At the time of this report, the patient had recovered. Follow up information recieved on 05/Jun/2006 from a health care professional JE VAX (second dose) was adminiastered in the right arm, JE VAX (first dose) was administered in the right arm, YF Vax was administered subcutaneously in the right arm, Typhim VI was administered in the left deltoid, and Hepatitis A vaccine was administered in the right deltoid. Other medications which had included Ataral was amended to Adderall (as needed).
dizziness that started slowly and then continued to increase for three weeks after the 2nd dose on March 29, 2021. Now dizzy for about 85% or 90% of the entire day.
Swollen lymph nodes. After about a week after the 2nd vaccine I developed pain in the joints in the back of my head. The pain is now persisting for over a week. No specific treatment except using Voltaren 2.32% gel.
This is a spontaneous report from a contactable consumer (patient).  A 55-year-old male patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, batch/lot# not reported), via an unspecified route of administration, on Feb 25, 2021, single dose, for COVID-19 immunization. Medical history included joint injury about 20-30 years ago and minor arthritis.     The patient's concomitant medications not reported. Patient experienced a little soreness in the arm the next day after the second dose, but otherwise was fine. On Mar 3, 2021, he experienced joint pain and swelling of his knee. He says he has minor arthritis. And this joint pain and swelling of the knee has caused him to limp on Mar 4, 2021. He stated, he did not twist or do anything to it. It is swollen and he is in a great deal of pain. He says he is trying to figure out if this could be associated with the vaccine or if it is something different. He just wanted to see if there has been other people going through what he is going through or if there is anything he can do. He was treated with Tylenol; with outcome of unknown. No follow-up attempts possible. Information about lot/batch number cannot been obtained.
48 HOURS AFTER INJECTIONS, PATIENT STARTED WITH ABSENCE SEIZURES  DIAGNOSED WITH EEG
little fatigue; body aches; cold and cough; cold and cough; light headed; This is a spontaneous report from a contactable consumer. A 14-year-old male patient received BNT162B2 (BNT162B2, Solution for injection, PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0186), dose 1 via an unspecified route of administration on 15May2021 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced little fatigue, body aches, slowly developed cold and cough, Light-headed all on 16May2021. It was reported that patient was fine and okay on the day of vaccination. The seriousness of the events was not reported. Therapeutic measures were taken as a result of events fatigue, body aches included pain killers Advil (200mg). The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Initial report received from a consumer on 08 Jul 2010: on 06 Jul 2010, this patient received only the 0.5 ml intramuscular dose of the diluent portion of MENVEO (batch number: 100003, 100005). No adverse effects were noted following this administration.
pain all over; muscle aches; freezing but have a fever accompanied with chills; Fatigue; freezing but have a fever accompanied with chills, low grade fever; pain in the arm of the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain all over), VACCINATION SITE PAIN (pain in the arm of the injection site), MYALGIA (muscle aches), CHILLS (freezing but have a fever accompanied with chills) and PYREXIA (freezing but have a fever accompanied with chills, low grade fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE PAIN (pain in the arm of the injection site) and PYREXIA (freezing but have a fever accompanied with chills, low grade fever). On an unknown date, the patient experienced PAIN (pain all over), MYALGIA (muscle aches), CHILLS (freezing but have a fever accompanied with chills) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Fever, Chills, Myalgia and Pain, at an unspecified dose and frequency. At the time of the report, PAIN (pain all over), VACCINATION SITE PAIN (pain in the arm of the injection site), MYALGIA (muscle aches), CHILLS (freezing but have a fever accompanied with chills), PYREXIA (freezing but have a fever accompanied with chills, low grade fever) and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, Body temperature: 100.8 °F (High) 100.8 and 101 °F (High) 101.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.
Patient presents to Hospital as a transfer from Hospital for PNA, hypoxia and anemia.  Patient states went to outside hospital d/t worsening SOB.  She was diagnosed with COVID 19 on 8/24/2021.  The patient was admitted to hospital.  CT scan showed viral PNA.  She was in respiratory failure and required oxygen.  Transfused with PRBC. She was given steroids.  Patient began refusing all medications, palliative care consulted.  Patient was transitioned to hospice and expired on 8/30/2021.
Vaccine was received in refrigerator on 03/07/2022 in appropriate temperature (2-8 Celsius).; Patient received Moderna vaccine Booster on 04/08/2022. Vaccine was given beyond use date.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna vaccine Booster on 04/08/2022. Vaccine was given beyond use date.) and PRODUCT STORAGE ERROR (Vaccine was received in refrigerator on 03/07/2022 in appropriate temperature (2-8 Celsius).) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046L21A, 032M20A and 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 08-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna vaccine Booster on 04/08/2022. Vaccine was given beyond use date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was received in refrigerator on 03/07/2022 in appropriate temperature (2-8 Celsius).). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna vaccine Booster on 04/08/2022. Vaccine was given beyond use date.) and PRODUCT STORAGE ERROR (Vaccine was received in refrigerator on 03/07/2022 in appropriate temperature (2-8 Celsius).) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (Patient received Moderna vaccine Booster on 04/08/2022. Vaccine was given beyond use date.) and PRODUCT STORAGE ERROR (Vaccine was received in refrigerator on 03/07/2022 in appropriate temperature (2-8 Celsius).) to be not related.    Race of the patient was given No concomitant medications were reported  The reporter reported that they had refrigerated some vials of moderna covid-19 vaccine more than 30days. Reporter would like to know if the vaccine is still viable 30 days after the vaccine had been in the fridge. Reporter further stated  that it was stored between 2 and 8 Celsius degrees.  Dose was administered after 30 day use by date or after manufacture date of expiry. Lot number  046L21A No of doses or vials: 9 doses. Date the vial was initially stored in the refrigerator 07-Mar-2022. The vial had not undergone any temperature excursions.  No treatment medications were reported
These all things that I had done in my arm has started making me feel tingle in my left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARAESTHESIA (non-serious), outcome "unknown", described as "These all things that I had done in my arm has started making me feel tingle in my left arm".  Additional information: This is to be in the record and the patient saw someone who put the vaccine in' (not clear), The patient tried to find put if this was put in the patient without being authorizing it. So, was there anyway to know that you were given the vaccine, the patient didn't want to had it done, so the patient don't know if they put it without me knowing about it. the patient went to emergency room and they had the patient 'arm' (not clear) check and the patient don't know about this vaccine." (consumer was not sure if consumer got the vaccine and name of vaccine was not clarified further, hence suspect captured as Unspecified Vaccine).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Received Flu shot and pneumonia shot shortly before discharge.  I felt pain when the pneumonia shot was administered and within a day or two the pain got worse and I am still in pain in my left arm. Pain is severe most of the time; I have difficulty sleeping due to the pain.  I have difficulty moving arm; especially when I am showering I can't move my arm across my body to wash my right side.  I can not sleep on my left side as the pain gets worse.
Patient became lightheaded, diaphoretic and passed out minutes after receiving vaccine.  Woke within seconds.  Patient was evaluated by medical professional.  BP normal and all symptoms resolved with 10minutes.  Kept in nurses offices for approx 45 minutes for observation and was released to his care.
At approx 2:30am I woke up experience severe chills.  I began taking Tylenol at this time, and continued to take it every 4 hours throughout the day.  I ran a temp of 100.9, experienced severe fatigue, tooth/jaw pain, terrible HA, and palpitations, approx every 30seconds - 2 minutes throughout the day.  Symptoms resolved the following day.  I did have almost all of these symptoms following dose 1 as well.
Within seconds of getting vaccine, felt nauseous and headache.  Within a minute, dizzy, extremely pale, nauseated and felt like she needed to vomit. She was excited to get this vaccine and has never had a reaction to any vaccine to include her allergy
ear infection; sinus infection; This is a spontaneous report from a contactable pharmacist (patient) received via the Pfizer Sales Representative. A female patient of unspecified age received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at a single dose for immunization. Medical history included cochlear implants. Concomitant medications were not reported. The patient, who had cochlear implants, reported that she got an ear infection and then a sinus infection after her pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein). The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt felt lightheaded and passed out for a few seconds 3-4 minutes after vaccination
Awoke with chills and very hot. Walked to bathroom to take Advil. Took 600mg Advil became nauseous and dizzy, sat down and became more dizzy and had loss of vision. Then laid down and a very moments later was able to sit back up. Was very sweaty and with tinnitus which lasted about 10 minutes and then Resolved itself.
Dose 1 given at 11:01 and at about 11:16 AM father alerted us that his son was rubbing his face and scratching his neck.  Face swollen with swelling of bilateral eyelids, upper lip swollen and visible hives on face and neck.  Mouth was OK and no wheezes heard.  Benadryl was offered at 11:25 and after about 10-15min the swelling of the eyelids and lip subsided and most of the facial hives gone and only a few remaining hives on neck.  Observed until 11:45 and given instructions on when to return. Also, family has epipens at home for the preexisting tree nut allergy
The pt was vaccinated w/ three vaccine into the Right deltoid on 10/17/16. Erythema, swelling began yesterday 10/19/16. Better today (was eval today). Afebrile.
Patient experienced anaphylaxis(Epipen used) from Pfizer 1st dose possibly due to the allergy from syringe. Patient received 2nd dose of Pfizer based on her provider's recommendation. She showed signs of troubled breathing within 30 minutes of administration. 2 Epipen were given while waiting for medics. Patient was taken to ER for observation then released the same day.
Moderna vaccines on 3/19/21, 4/16/21 COVID 19 by PCR positive on 12/3/21 Admitted to the Hospital 12/9-12/15/21 with mitral valve infective endocarditis, per notes:  Mild COVID-19 infection without evidence of pulmonary infiltrates, hypoxia or respiratory distress, treated elsewhere with 4 days of dexamethasone plus remdesivir.
abdominal pain; nausea; high blood pressure; This is a spontaneous report from a contactable consumer. A 93-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration on 22Dec2020 at a single dose for COVID-19 immunization. Medical history included diabetic and irritable bowel. The patient's concomitant medications were not reported. The patient received the COVID vaccine and had abdominal pain, nausea and high blood pressure within 12 to 18 hours of vaccine received. The events lead to nursing home to emergency room and admitted to hospital. The patient was hospitalized due to events since 23Dec2020. Outcome of the events was recovering.
Information has been received from a consumer concerning her 6 year old daughter who was vaccinated with varicella virus vaccine live at approximately one year old. Subsequently the patient experienced chicken pox. It was reported as a mild itchy chicken pox rash on her face two weeks prior to her sister (WAESE 0311USA00633). She had no other symptoms. The outcome was not known. The patient's sister (WAES 0311USA0633) also experienced chicken pox after vaccination with varicella virus vaccine live. This reporter also indicated that a first grade child (WAES 0311USA01817) experienced chicken pox after vaccination with varicella virus vaccine live. Additional information is not expected.
When giving intradermal needle not inserted far enough into the skin, when given dose. Vaccine went on the skin not into the patient.