chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose from vials beyond 30-day use by date) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose from vials beyond 30-day use by date). On 28-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Patient received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided. The date of Refrigeration was on 07-MAY-2021.   This case was linked to MOD-2021-363754 (Patient Link).
Patient complains of arm and shoulder pain. She also has trouble sleeping and sometimes feels a little nausea accompanied with the pain. Pt had symptoms for 24 days now. Doctor gave her MOBIC 15 mg 1 tablet only for the pain on 10/18/11. Pt states its hard to life her arms above shoulders.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 01/12/21Lot#EL3248 2nd dose 02/02/21,lot#EN5318 Diagnosed covid positive:08/07/21 Symptom onset:08/05/21 Exposure:Home Symptoms:SOB, fatigue,ABD pain,nausea/vomiting,chills,headache,back pain,chest pain
Information has been received from a nurse concerning a 70 year old female with a history of glaucoma, Hashimoto's thyroiditis, goeta osteopenia, colonic polyp and RLS-osteoarthritis who on 24-OCT-2007 was vaccinated intramuscularly in the left deltoid muscle with the 1st dose of PNEUMOVAX 23 (lot#658555/0964U).  The patient was concomitantly vaccinated with a influenza virus vaccine (unspecified) on the same day the PNEUMOVAX 23 vaccine was given.  The patient was concomitantly taking glucosamine hydrochloride, chondroitin, calcium (unspecified), vitamins (unspecified), folic acid, timolol maleate (manufacturer unknown), metronadizole, sulfacetamide sodium and EVISTA.  On 24-OCT-2007, post vaccination, the patient could not raise her arm, developed shaking chills, headache, redness and swelling of the left arm and nausea.  No diagnostic lab test were performed.  The patient sought unspecified medical attention and recovered on 25-Oct-2007.  No additional information is expected.
Fever, diarrhea, diagnosis of intussusception.  6/1/07 Received vax record from CDC.  VAERS database updated.  8/7/07 Received hospital medical records which reveal patient experienced fever, vomiting & bloody stools.  Abdominal x-ray in ER revealed IS.  Admitted 5/15-5/18/07 & IS reduced by gastrograffin enema.  Also diagnosed w/UTI.  Progressed well & d/c to home on oral antibiotics for UTI. FINAL DX: Intussusception, s/p reduction by enema; fever; & UTI.
Next morning and continued still chemical taste in mouth,  nothing tastes good. Taste like chemicals or metal in my mouth. Altered taste
Began 2 days after injections: dizzy, lightheaded, body aches, chills, fever (101.5) today 10/9/07. C/O lightheaded and headache.
Patient passed out 5 minutes after vaccination. States she has vasovagal syndrome and has passed out before after procedures.
Began on 10/18 as normal side effects (cough, runny nose).  Slowly progressed into more severe symptoms during the next few days.  As of 10/21/09, symptoms include difficulty breathing accompanied by a cough as well as fatigue.
Pt recvd 3 doses of Engerix-B vax 18DEC89, 18JAN90 & 2JUL90 & 31OCT91 HBSAB titer (Anti-HBS) was tested & reported neg; booster doses given 4NOV91 & 4DEC91; also treated w/HBIG 4NOV91;
Information has been received from a registered nurse concerning a 13 year old female who on 06-AUG-2008 was vaccinated with the first dose of GARDASIL {0.5 ml, left arm, lot number not reported} via IM route, and VARIVAX (MSD) (dose, route not reported) and hepatitis A virus vaccine (unspecified0 (manufacturer not known) ( dose, route not reported) received in the right arm. Immediately following the injections the patient's left arm became numb and she felt dizzy and "almost passed out." The patient was observed for 10 minutes in the office and recovered fully and was discharged home. The nurse mentioned that the physician believed this to be a syncopal episode. No lab diagnostics studies was performed. Additional information has been requested.
Approximately 6 x 18 cm area of mild erythema underside of upper arm where given, decreased appetite, somnolence.
Case number PHEH2015US017711, is an initial spontaneous report from a consumer (patient's parent) received on 09 Sep 2015. This report refers to a 16 years old female patient. Medical history and concomitant medications were not reported. Her vaccination history included administration of meningitis vaccine (manufacturer and batch number unknown) in 2004 and her last vaccination of any kind was in 2010. She was vaccinated with MENVEO (batch number: A14089, expiry date: 30 Nov 2015) at a dose of 0.5 ml into left arm on 14 Jul 2015. In Jul 2015 the patient was nervous, crying, felt sick to her stomach and was almost suicidal. Further the patient also had anxiety, irritability, chest pain and was upset. The patient was taken to the emergency room (ER) for treatment on 19 Jul 2015 and released. Blood test indicated low platelet levels which were fine previously. The patient now sees a doctor 3 or 4 times per week and an intravenous immunoglobulin (IVIG) was being considered. Outcome of crying, nervous, stomach discomfort and almost suicidal was reported as not recovered. Outcome of the other events were not reported. Seriousness and causality of the events were not reported. Seriousness assessment of "almost suicidal" was upgraded based on the NVS-IMS list.
This is a 40y.o. male Unvaccinated for cough in 19 tested positive 11/16/21.  Initially he was having fever and nonproductive cough.  Over the last couple days he began experiencing increasing shortness of breath. In ED he was afebrile, tachycardic, tachypneic and spO2 91%. Patient was placed on 4L NC with improvement. All labs and imaging were reviewed. Labs significant for hyperglycemia without history of diabetes. D-dimer within normal limits, troponin negative. CXR shows changes related to COVID-19. Patients treatment was initiated in the ED with IV decadron as he is requiring supplemental oxygen. ID consult ordered
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 23-JUN-2015 the patient was vaccinated with oral, ROTATEQ (dose was not reported, route of vaccination defaulted to oral, lot # K016314 with expiration date: 05-JUN-2016) which was improperly stored. No adverse symptoms reported. This is one of several reports from the same reporter. Additional information has been requested.
Initial report was received from a health care professional on 28 October 2011. An 11-year-old female patient had received a FLUZONE Intradermal in left deltoid, lot number U4178AA and MENACTRA in right deltoid, lot number U4241AA on 24 October 2011. On 27 October 2011, 3 days after vaccination the patient was seen in the doctor office for swelling at the right deltoid in which radiates down to the mid arm. The patient also complained of pain. No further informational was available at the time of the report. The patient outcome was unknown. Follow-up information was received from a healthcare professional on 20 January 2012. The patient outcome was reported as recovered/resolved. Documents held by sender: none.
12 hours after injection I had a fever at 105 for one night, the next 24 hours I had a fever at 102, the next 24 hours I had a fever at 99; Overall soreness, dizziness, nausea, loss of appetite, lethargic.; Overall soreness, dizziness, nausea, loss of appetite, lethargic.; Overall soreness, dizziness, nausea, loss of appetite, lethargic.; Overall soreness, dizziness, nausea, loss of appetite, lethargic.; Overall soreness, dizziness, nausea, loss of appetite, lethargic.; This is a spontaneous report from a contactable consumer (patient). A 43-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number: EW0191, Expiry date: unknown) (age at the time of vaccination was 43 years), via unspecified route of administration, administered in Arm Left on 27May2021 at 12:15 as dose 2, single for COVID-19 immunization. The patient's medical history was none. The patient's concomitant medication was not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EW0185), via an unspecified route of administration, administered in Arm Left on 06May2021 at 12:15 as dose 1, single for COVID-19 immunization. On 27May2021 at 00:15, the patient had typical symptoms of fever, overall soreness, dizziness, nausea, loss of appetite and lethargic. No treatment received. The patient underwent lab tests and procedures, which included Fever: 105 on 27May2021, 102 0n 28May2021, 99 on 29May2021. The outcome of the events was resolving.  Follow-up attempts were completed. No further information was expected.
Dad found child in her crib face down and when he picked her up her eyes were rolled back.  Child also had temperature 101.  Called ambulance to take child to hospital.
Discharge Provider: DO Primary Care Provider at Discharge: MD Admission Date: 9/4/2023 Discharge Date:  9/06/2023  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Hyponatremia [E87.1] Generalized weakness [R53.1] Urinary tract infection associated with indwelling urethral catheter, subsequent encounter [T83.511D, N39.0] COVID-19 [U07.1]   HOSPITAL COURSE: Patient is a an 83-year-old male with a history of hypothyroidism, dyslipidemia, hypertension, seizures, CVA and urinary retention with chronic indwelling catheter who presented to Emergency Department for a fall.  Patient fell out of bed the night prior and hit his head on the nightstand.  He denies LOC and is not anticoagulated.  This was an unwitnessed fall.  Patient lives at a memory care center and when his family came to visit him the day of arrival they noticed he was not interacting as his normal self.  Patient was alert and oriented upon exam x4 and very pleasant. Patient was seen in ED on 8/29 and diagnosed with urinary tract infection and sent home on cefuroxime. UC with Enterococcus faecalis.  He was admitted and discharged on 8/19  for seizure and Neurology recommended that his Depakote dose be increased. He denies fever, chills, nausea, or vomiting.  He does complain of productive cough for the past few days.  On arrival to the ED, his vital signs were stable.  Labs significant for hyponatremia.  Sodium 122. Viral PCR panel positive for COVID-19.  UA with infection.  CXR negative. head CT negative for acute findings, there is encephalomalacia from prior infarct.  Patient received a L of IV normal saline and a dose of fosfomycin.  Patient accepted to Hospital Service for management of hyponatremia.  Patient is admitted and slowly improved over the next 2 days.  He had persistent cognitive deficits which are likely his baseline.  He tolerated antibiotic therapy.  His sodium stabilized.  Arrangements were made for him to return to the memory care center given his worsening cognitive function.  He was seen on day of discharge stable and discharged back follow-up outpatient with primary care provider and urologist.   35 minutes were spent discharging this patient over 50% was in coordination of care and face-to-face counseling with family
Severe neck spasm and paralyzed hemidiaphragm/right diaphram.    My right diaphragm is elevated pressing on my right lung causing SOB with any activity.  Had several CTs and MRI to determine this.
patient developed a rash around 6 weeks post 2nd COVID Vaccine.  5/11/21 was diagnosed with granuloma annulare. Provider unsure if related to covid vaccine
I have begun having numerous outbreaks of Herpes Virus which I have never had before.  They are severe.   I did not know what they were and struggled through them for months before getting diagnosed and treated.   I am married with only 1 partner for 6 years and never had this viral outbreak prior to the vaccine.
Due to age, patient was to have 0.25ml of vaccination. Patient was given 0.5ml of flu vaccine. No known reaction.
Skin itchy; Skin inflamed; HANDS SWOLLEN; COUGH; NAUSEA; FATIGUE; SKIN IRRITATION; LOW GRADE TEMP; INJECTION SITE SORENESS; MUSCLE ACHES; HEADACHE; This spontaneous report received from a patient concerned a 53 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included high blood pressure, and non allergic sinusitis, and allergy to codeine and black mold. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 04-MAR-2021 10:00 to Left Arm for prophylactic vaccination. No concomitant medications were reported.  On 04-MAR-2021, the patient experienced headache, muscle aches, skin irritation left like skin itchy and skin inflamed but no rash, low grade temperature 99.9, injection site soreness.  On 05-MAR-2021, the patient experienced nausea. On 05-MAR-2021, the patient experienced fatigue and cough. On 06-MAR-2021, the patient experienced hands swollen. Treatment medications (dates unspecified) included: paracetamol for headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea, and cough on 06-MAR-2021, was recovering from headache, muscle aches, fatigue, and skin irritation, had not recovered from low grade temp, injection site soreness, and hands swollen, and the outcome of skin itchy and skin inflamed was not reported. This report was non-serious.
12 year old received Moderna lot number 076c21a; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received Moderna lot number 076c21a) in a 12-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21a) for COVID-19 vaccination.     No Medical History information was reported.  On 28-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received Moderna lot number 076c21a). On 28-Oct-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received Moderna lot number 076c21a) had resolved.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medication were provided.
Very mild, but noticeable headaches; This is a spontaneous report from a non-contactable consumer (patient). A 67-year-old male patient received first single doseof BNT162B2 (Pfizer, Solution for injection, lot number: EL9263, exp date not reported), via an unspecified route of administration (vaccine location: left arm) on 25Jan2021 13:00 for COVID-19 immunization. The patient was 67-years-old at the time of vaccination. Facility type vaccine: Health Clinic facility. Medical history included hypertension. The patient had no known allergies. The patient did not have Covid prior vaccination. Concomitant medications/ other medications in two weeks included valsartan and levothyroxine sodium (SYNTHROID). There were no other vaccine given in four weeks. On 30Jan2021, the patient experienced very mild, but noticeable headaches beginning 5-7 days after the first vaccination and continue until day 14. No treatment was given for the event. Patient was not covid tested post vaccination. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Patient complained of nausea and vomiting; swelling, pain, and inflammation at injection site, and headache.
I received the flu shot and Covid booster at 38 weeks pregnant. Within 5 hours of the vaccines, I had a fever, chills and body aches. Those went away about 24 hours after (and are the same side effects I have had every time). Sunday morning so 36 hours later approximately, I had complete and total facial paralysis on one side, shortness of breath, shaking, headache. Went to emergency room and was diagnosed with Bell?s Palsy. Because I was having the weird sense of taste symptom the day before the vaccine, I have no idea if the vaccine played a roll. It?s possible it did not. Or maybe I was sick with something and the vaccine put my body in overdrive.
This spontaneous report was received from a physician, via a company representative, concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 16-DEC-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 with lot # L007720 expiration date: 08-JUL-2018, 0.5 ml (route and anatomical location of administration were not reported). On unspecified dates, the PNEUMOVAX 23 vaccine had five temperature excursions of 0 Celsius Degrees (32 Fahrenheit) for 168 hours, 0.55 Celsius degrees (33 Fahrenheit) for 128 hours, -1.11 Celsius degrees (30 Fahrenheit) for 264 hours, -1.66 Celsius Degrees (29 Fahrenheit) for 256 hours, and -0.55 Celsius Degrees (31 Fahrenheit) for 368 hours, respectively. The vaccine status was reported as "in excursion" and the type of excursion and storage criteria were reported as "refrigerator (R)". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
patient was administered an expired dose of Menactra with no reported adverse event; Initial information received on 09-Jun-2022 regarding an unsolicited valid non-serious case received from another health professional.  This case involves a 25-year-old female patient who was administered an expired dose of menactra with no reported adverse event while receiving vaccine meningococcal a-c-y-w135 (d conj) vaccine [Menactra].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Measles Vaccine, Mumps Vaccine, Rubella Vaccine (MMR) for Prophylactic vaccination.  On 08-Jun-2022, the patient received a 0.5 ml dose of suspect meningococcal a-c-y-w135 (d conj) vaccine lot U6951AA expiration date 06-Jun-2022 via intramuscular route in the left deltoid for prophylactic vaccination. The patient was administered an expired dose of menactra with no reported adverse event (expired product administered).  Action taken: Not applicable  Outcome: Unknown      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 the guidelines. 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.
The day after the shot pain in her chest, "pain in her heart"; The day after the shot pain in her chest, "pain in her heart" and arm which lasted 2 days; This spontaneous case was reported by a consumer and describes the occurrence of ANGINA PECTORIS (The day after the shot pain in her chest, "pain in her heart") in an 80-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.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included CARVEDILOL, AMLODIPINE, ISOSORBIDE and METFORMIN for an unknown indication.    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 ANGINA PECTORIS (The day after the shot pain in her chest, "pain in her heart") (seriousness criterion medically significant) and PAIN IN EXTREMITY (The day after the shot pain in her chest, "pain in her heart" and arm which lasted 2 days). At the time of the report, ANGINA PECTORIS (The day after the shot pain in her chest, "pain in her heart") and PAIN IN EXTREMITY (The day after the shot pain in her chest, "pain in her heart" and arm which lasted 2 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that these events occurred even before receiving the vaccine every once in a while. Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
GARDASIL 9 was improperly stored and administered to a patient.; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. There was no information regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies.    On 03-MAY-2021, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # 1687290 and expiration date of 06-SEP-2022 verified as valid, for prophylaxis (dose, frequency, route of administration and anatomical location were not provided). The vaccine was exposed to multiple temperature excursions that started on 09-MAR-2021 and  was improperly stored at 34.5 Fahrenheit degrees (product storage error) for 3.5 hours, which was detected by digital data logger. By reporting time, it was unknown the total time of temperature excursions.   This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: 1687290; expirationdate: 06-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2105USA002270: US-009507513-2105USA002246: US-009507513-2105USA002232:01924937