chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a male who on "25-JAN-2008" was vaccinated with a 2 mL first dose of ROTATEQ, oral. On "12-FEB-2008" the patient experienced fulminating hepatitis and GI bleed. The patient was hospitalized (no details provided). Laboratory evaluations were performed to the patient. The patient sought medical attention. Fulminating hepatitis and GI bleed were considered to be immediately life-threatening. Additional information has been requested.  1/27/09 Received hospital medical records of 2/12-3/23/2008. FINAL DX: Hepatitis; GI bleed; coagulopathy; renal insufficiency; acidosis; resp failure; HTN. Records reveal patient experienced respiratory distress, decreased LOC.  Had fever & URI s/s day before admission.  Developed emesis & bloody diarrhea on day of admit.   PICU & mechanical ventilation, feeding tube insertion.  Surg, ID, GI, Nephro consults done.  Exp lap done 2/12 revealed petechiae throughout bowel but no obstrution or perforation.  GI consult felt s/s most c/w adenovirus infection but all c/s neg.  Tx w/pressors, antibiotics & antivirals until c/s all neg.  Abnormal coags tx w/multiple FFP infusions.  BP was labile & nephro consult done Rocky hospital course & ultimately recovered, D/C to home on regular diet & RA.
Right upper arm (bicep area) became swollen, very sore and very red about 9:00 PM. Took 2 Tylenol and went to bed about 10:00 PM, had chills and ran temperature. Woke up about 1:00 AM and took temperature with Infrared thermometer, 100 degrees at forehead and 103 at arm.  Took 2 Tylenol and went back to bed.  By Thursday, Sep 3 arm was better but still not 100%.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 29-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  Vials stored in the refrigerator on 21-Sep-2021. No temperature excursions and no adverse event were noted.  No treatment information was provided.
I started feeling really tired (couldn't move type tired). I called off worked for few days. On the 1/7 noticed right of my face was drooping about 10 days couldn't smile and wiggle both ears.For me to talk it was very difficult due to right side of my face being so weak. I went to walk in clinic was diagnosed with Bell's Palsy. As of today I still couldn't lift my eyebrow (right) and smile still slightly cooked.
After the injection I have noticed a problem with slurred speech. I have had an MRI with and without contrast and a CT Scan with and without contrast of my head and neck. Three neurologists have determined that there are no significant findings with these scans.  No signs of a stroke.  No shuffling of feet, no loss of strength in arms or legs.  Just slurring of words. I went to the Emergency Room thinking I may have had a stroke.
Tender arm, nausea, vertigo, tired for two days. Extreme menstrual period bleeding for 3 weeks, one week off then bleeding again for two weeks. One month off then bleeding heavy for two weeks. One month off then bleeding for over two weeks, etc. Still happening irregularly with extreme bleeding and painful cramping. Was put on iron pills now.
Achy; Sore arm; Chills; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achy), PAIN IN EXTREMITY (Sore arm), CHILLS (Chills) and MYALGIA (Muscle pain) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 20-Feb-2021, the patient experienced PAIN (Achy), PAIN IN EXTREMITY (Sore arm), CHILLS (Chills) and MYALGIA (Muscle pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Achy), PAIN IN EXTREMITY (Sore arm), CHILLS (Chills) and MYALGIA (Muscle pain) outcome was unknown.
pt recvd vax 4APR94 starting 14APR94 t100 & then 15APR94 rash appeared & t100, rash flat macular 2-5mm circles & ovals on chest, back, arms & legs; cleared in 2 days;
8cm erythematous indurated; one central papule but no vesicles.  Today 4cm erythematous induration.  Benadryl and warm compresses.
13 days after the second dose i started getting hives really bad. Everytime I drink it eat anything dairy it gets worse. I was out on steroids and the only thing that helps is just cutting dairy from my diet. I was never allergic to food before this.
123 days post first Shot scheduling for second shot now; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (123 days post first Shot scheduling for second shot now) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (123 days post first Shot scheduling for second shot now). At the time of the report, PRODUCT DOSE OMISSION ISSUE (123 days post first Shot scheduling for second shot now) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Information has been received from a 70 year old female with high cholesterol, hypertension, glaucoma,and penicillin allergy who on 14-OCT-2005 was vaccinated with pneumococcal 23v polysaccharide vaccine (0.5 ml), subcutaneously.  Concomitant therapy included atorvastatin calcium (LIPITOR), valsartan ( DIOVAN), amlodipine besylate (NORVASC) and atenolol.  On 14-OCT-2005, "later that night" the patient experienced severe pain in the region of the injection and red blotches on arm.  The next day she had a rash on her chest.  On 16-OCT-2005 the rash had spread to her lower abdomen.  The patient was reportedly recovering.  There were no relevant diagnostic test of laboratory data.
Had a dull ache at the injection site a month later. Can move arm fine but has on-off pain (left arm).
Fever, Diarrhea, ABDOMINAL PAIN, ARM PAIN, DIAPHORESIS Narrative:
DYSPNEA,CLEARING OF THROAT, TICKLE/SCRATCHY THROAT.
Vaccine administered 3/30/21. On 4/1/21, rash developed on buttocks right of tailbone. Feelings of fatigue, generally unwell. Originally misdiagnosed as HSV-2 outbreak on 4/3/21. Prescribed Acyclovir. Neurological issues including numbness and tingling in legs, buttocks, and arms/hands, as well as continued fatigue/feeling unwell. On 4/12/21 discontinued acyclovir, and on 4/13/21 developed diarrhea, insomnia, agitation, stomach cramping, and tremors/shaking in legs, back, and shoulders. Visit to emergency room on 4/16/21 for diarrhea and shaking. Administered 1 L fluids; various test performed including chest XRay, EKG, and blood labs. All looked normal.  On 4/16/21 follow up visit with Primary Care Provider diagnosed with shingles. Restarted acyclovir on 4/14/21 and instructed to continue by PCP. As of 4/21/21 symptoms have improved on acyclovir, but not resolved. Continued tingling in backs of legs. Fatigue and feeling unwell continues.
Patient was admitted to hospital on 2/20 with a diagosis of pulmonary embolism.
Nurse calling from HCP office to report that a dose of ROTATEQ was given on 12/1/2020 and had expired on 11/26/2020.; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.   On 01-DEC-2020, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), administered by oral route, as prophylaxis (formulation, strength and vaccination scheme were not provided; lot number S005876, which has been verified to be valid, expiration date reported as 26-NOV-2020, but upon internal review was established as 25-NOV-2020). The vaccine administered did no experience previous temperature excursion.
Left shoulder superclavicular swelling 3.5 x 2.5 inches. Tender to touch. No redness. Seen by physician who believes patient has a "seroma from the way the vaccine is administered". Instructed to apply heat and call if it becomes worse.
Patient was sitting in Observation c/o feeling weakness in bilateral legs. States she has a history of Myasthenia Gravis and pseudo-seizures.  Able to take several steps to chair steadily. Sat for a while then states legs feel much better.
1 day after injection pt. developed redness, pain, and swelling at injection site. Went to Dr. got an antibiotic still has some pain at site.
Tightness to neck, Flushing, Warm  Pepcid 10mg x1  Benadryl 25mg x2
pallor, circumoral cyanosis, breath holding, spontaneous recovery day p/shot;felt warm;
ATYPICAL PNEUMONIA, MICROPLASMA IN UPPER HALF OF RIGHT LUNG.
Soreness at the injection site, headache, fatigue.  The soreness appeared first, then the rest appeared about 6 hours later
48 patients received an expired vaccine; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine). On 16-Nov-2021, EXPIRED PRODUCT ADMINISTERED (48 patients received an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   The reporter reported that they had received the vaccine on 18-Oct-2021 and on the same day, the vial was stored in the refrigerator. The reporter did not realize that the vial was expired 07-Nov-2021. The reporter also reported that, it was unknown if this was the patient's first, second or booster doses. The vial did not undergo any temperature excursions.  No treatment information was provided by the reporter.
Heart Attack, 100% blockage with blood clot.  I had to have three stents put in, but survived.  I was in hospital for 2 days,
Pt describes feeling "hot" the day after receiving the vaccine and redness is observed at the site of injection. Pt states he's feeling better since the reaction 2 days ago.
Arm pain, hard to lift arm. Low blood pressure noted later that day / next day - started resolving following day. (Noted in PREVNAR 13 arm).
Patient was receiving Gardasil vaccine in office. Vaccine given, when the nurse withdrew the vaccine the needle detached and remained in the patients arm. The nurse was able to remove the needle without harm to patient or herself.   Needle used: BD SafetyGlide Needle 25Gx5/8 Ref 305901. Lot 1343388 exp 11/30/2026
Fever; chills; body ache; Swollen lymph nodes in face, back, underarm, collarbone; counting- lymph nodes have swollen knots that are very painful to the touch; burning sensation in arm of injection; This is a spontaneous report received from a contactable consumer (patient). A 35-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 20Mar2021 09:00 AM, at the age of 35 years old, as single dose for Covid-19 immunisation. Medical history included allergies to Food Dyes. The patient's concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 administered on 27Feb2021 01:00 PM in Left arm. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and patient received other medications within 2 weeks of vaccination. The patient experienced fever, chills, body ache approximately 48 hours. Extremely Swollen lymph nodes in face, back, underarm, collarbone 4 days and counting- lymph nodes have swollen knots that are very painful to the touch, burning sensation in arm of injection, 3 days after injection. All symptoms occurred on 20Mar2021 07:00 PM after 2nd dose. No treatment received. The patient was not diagnosed with COVID-19 prior to vaccination, and has not been tested for COVID-19 since the vaccination. Events outcome were recovering.  The information on the lot/batch number has been requested.
Pt presented to the ER 1/21/21 for a syncopal episode, approximately 36 hours after injection. She reported fatigue and dizziness the evening of 1/20/21, then had a syncopal episode and incontinence of diarrhea at that time. She also had hypotension that was corrected with IVF, lowest BP was 60/45 at 0200 on 1/21/21.
Initial report was received 31 May 2012 from a health care professional which involved a cluster of approximately 17 patients (six elderly patients, two adolescent patients and approximately nine unidentified patient(s) who tested PCR positive for influenza A/H3 since January. This case captures information for six elderly patients. The two adolescent patients have been captured in case number 2012-05659 and the approximately nine unidentified patients have been captured in case number 2012-05660. A cluster of six elderly patients had received FLUZONE, lot number UH454AC (route, site and dates of administration not reported), and an unspecified amount of time later, the patients tested PCR positive for influenza A/H3 at the state laboratory. Outcomes were not reported. No additional information was provided at the time of the report. Documents held by sender: None.
1/13/2014-PAIN, SWELLING AND REDNESS AT INJECTION SIGHT. 1/13/2014-1/17/2014- PAIN PERSISTS DOWN ARM EVEN WITH DAILY MODERATE EXERCISE AND MASSAGE. 1/17/2014- 4:00 PM SWOLLEN LYMPH NODE PAINFUL AND GROWING. CONTACTED DRS OFFICE TO INQUIRE ABOUT APPROPRIATE ACTIONS TO TAKE.
This spontaneous report was received from a Registered Nurse and refers to an unspecified number of patients of unknown age and gender. Medical history and concomitant medications were unknown. Since 05-JAN-2016, an unspecified number of patients were vaccinated with doses of VAQTA lot # K018181 expiration date 04-JUN-2017 (route, dose and anatomical location were not reported), which were exposed to temperatures outside of the recommended range. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 5 (booster), single (Lot number: GJ2524) at the age of 63 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Clindamycin, reaction(s): "Known allergies: clindamycin"; Sentra, reaction(s): "Known allergies: Sentra". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jul2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19, patient was treated with Paxlovid from 12Jul2023 to 17Jul2023.
This spontaneous report as received from a licensed vocational nurse (LVN) refers to a 7 month old female patient. Patient's medical history included vaccination on 25-APR-2014 with the first dose of ROTATEQ (2 ml, orally, lot # J002785, expiration date: 02-AUG-2014), first dose of DTaPHBIP (default manufacturer GlaxoSmithKline reported as "GSK) (0.5 ml, left thigh, lot # E4T92), first dose of HIB (unspecified carrier) (default manufacturer: Sanofi reported as "AVP") (0.5 ml, right thigh, lot # UH969AA) and with first dose of PCV13 (default manufacturer: Pfizer reported as "PFI") (0.5 ml, right thigh, lot # G77643), and on 25-JUN-2014 with second dose of ROTATEQ (2 ml, orally, lot # J004875, expiration date: 17-OCT-2014), second dose of DTaPHBIP (GSK) (0.5 ml, left thigh, lot # 2J534), second dose of HIB (AVP) (0.5 ml, right thigh, lot # UH969AA), and second dose of PCV13 (PFI) (0.5 ml, right thigh, lot # H17300). Patient had no history of chickenpox. On 15-SEP-2014, the patient was vaccinated with third dose of ROTATEQ (2 ml, lot # J004875, expiration date: 17-OCT-2014, orally) which was incorrectly stored. Concomitant therapies included third dose of DTaPHBIP, HIB (unspecified carrier) and PCV13. No adverse symptoms were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
pt recv vax 1/27/98 & 3/5/98 pt was found to be preg & urine preg test;pt exp streptococcal pharyngitis & was treated w/PCN;this report is part of preg registry;
Itching left arm - elbow to wrist and inside of forearm is bright red and warm; both ankles red and swollen. These symptoms started on 10/28/03, 13 days after flu shot. Treated with 2cc Kenalog in RD on 10/28/03; on 10/29 given Diprolene 0.1% cream tid to area.
PATIENT FELT DIZZY FOR FEW MINUTES AND THEN SHE FAINTED AND REGAINED CONSCIOUSNESS ON AND OFF AND WAS SWEATING. WE CALLED 911 AND ASKED FOR EMS AS SOON AS POSSIBLE. SHE WAS BREATHING WELL WITH NO RESPITORY DISTRESS.
Child w/approx 3 inches in diameter red indurated area on lt leg @ inject site; No reports of fever, n/v, or sz; no treatment was done;
subarachnoid hemorrhages; This is a spontaneous report from a contactable consumer (patient self). A 68-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3248), via an unspecified route of administration (location: left arm) on 16Feb2021 at age of 68-year-old at single dose for COVID-19 immunisation. Medical history included polymyalgia rheumatica. No known allergies. Facility type vaccine was pharmacy or drug store. No other vaccine received within four weeks. No COVID prior vaccination. Concomitant medications included alendronate sodium (FOSAMAX), prednisone, methotrexate and hydroxychloroquine. The patient experienced subarachnoid hemorrhages on 23Feb2021 and sent to emergency neurosurgery on the same day for 2 subarachnoid hemorrhages. The event resulted in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). The patient was admitted into neurosurgery on unknown date and received treatment (unspecified). The patient was hospitalized for 9 days. COVID test (nasal swab) post vaccination on 23Feb2021 resulted negative. The outcome of event was recovering.
Patient had headache, fever, fatigue, and GI issues. Then after 48 hours her thigh to her knee went numb. She went to the ER and they checked for blood clots, but she did not have any blood cloths. The area is still numb and tingling.
no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 21-NOV-2018,  the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose, lot # R000554 with expiration date 08-JAN-2020 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010301: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010321: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373: