chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received vaccine 01/19/09 (Monday) and report ear ache and cold sores on 01/23/09. Patient treated as such but returned to MD office and diagnosed with shingles on 02/09/09. Patient presents with lesions on left lip and left ear.
Previously healthy female presented with a 3 cm "soft nodule" at the site of of previous injection in left thigh. She had received the Pediarix combination vaccine in the left thigh, and PCV-13 in her right thigh on 6/8/11.  The mass increased in size by 10/26/11  to 4x5 cm.  MRI noted "fluid filled subcutaneous mass".  On 2/29/12, the mass had decreased to 3 1/2 x 3 and the child received DTaP in left arm, and Pedvax in right arm, MMR in right thigh.  On 3/22/12 the child had masses in both arms at injection sites.  The mass in thigh was continuing to decrease in size.  No fever, never appeared to be painful or pruritic, no drainage, and never erythematous.   THIS CASE WAS EVALUATED BY THE CISA CCCR WORKING GROUP AND THIS IS THE SUBSEQUENT VAERS REPORT BECAUSE WE WERE UNCERTAIN IF THE PROVIDER EVER REPORTED THIS CASE.
Increased redness/muscle pain/swelling around bicep/inner arm x 3-5 days after shot. Sl. improvement on Day 6. No neuro change's; no end compartment.
Initial information received on 17-Sep-2018 regarding an unsolicited valid non-serious case received from a other health professional, Pharmacist. This case involves a 71 years old male patient who received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No Concomitant medication received. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number UJ006AB in left arm intramuscularly. It was a case of actual medication error due to vaccine underdose. Patient didn't get an adequate dose of the FLUZONE HD because there was leakage after the injection. No reaction reported. 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
No additional adverse effects reported; an improperly stored PROQUAD was administered to a patient; Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.       On 23-MAR-2020, the patient was administered an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA)) (PROQUAD) (strength, dose detail and route were unknown; lot # S023652 and expiration date 26-JAN-2021) for prophylaxis. The vaccine was exposed to temperature excursion at minus 12.15 degrees Celsius for 3 hours (incorrect product storage). There was no previous temperature excursion. The call was due to digital data logger. No additional adverse effects were reported.
Patient admitted with SOB and edema.  Found to be COVID-19 positive >14 days post vaccination.
C/O DIZZINESS, FEELING PASS OUT, HYDRATE AND SNACK OFFERED. SYMPTOMS IMPROVED, REFUSED TRANSPORT, HOME WITH MOM
Head congestion/Sinuses; Sore throat; Chest congestion; Coughing
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. On 03-AUG-2015, the patient was vaccinated with one of the improperly stored VARIVAX (Merck) lots L002215-exp. date 21-JAN-2017; L001332-exp. date 13-JAN-2017, L005300-exp. date 17-FEB-2017 (dose and route of administration not provided). No adverse effects or PQC were reported. Additional information has been requested.
10 days p/MMR pt started w/hives/rash went to clinic 18FEB; late evening on 18FEB pt went to ER & was treated for severe hives; On 19FEB pt reported back to clinic is on Atarax & improving;
It happen over night (Dec 16th 2008), my baby wake up, fussy, did not wanna eat, start vomiting yelow liquid, got pale, went to doc. and told us it could be stomach flu, came home, that night things did not get better, he was not holding anythig in his tummy, and in the morning (Dec 17th 2008) was very dehydrated, had a black pasty, bloody stool, went back to doc office, then to ER and after that we went to another hospital where he had an intussusception surgery (Dec 18th 2008), he recoverd well and now he is doing fine, however before we were able to find out what the problem was......It was the most terrifying 24hrs of our lives.  1/27/09 Received hospital medical records of 12/18-12/22/2008. FINAL DX: Ileoileal intussusception, s/p exp lap, bowel resection & ileoileostomy anastamosis, appendectomy. Records reveal patient experienced vomiting x 2 days, dark stool, lethargy & weight loss.  Seen at outlying ER & transfered to higher level of care after attempts to reduce w/BE were unsuccessful.  Attempts to reduce in hospital also unsuccessful & taken to OR.  Progressed well & d/c to home.  2/2/09 Received PCP medical records of 10/20/2008-01/23/2009 which reveal patient experienced good health on 10/20/08.  RTC on 12/16 for irritability, diet refusal, vomiting, pale.  Dx as probable viral infection.  RTC 1/23/09 s/p IS surgery in good health w/surgical scar healing.
The patient reported approximately 36 hours post-vax tightness in her throat, difficulty breathing and swallowing. The patient denied fever, hives, rash, dizziness, nausea, or sensory changes. The patient went to an urgent care center where she was found to be alert and oriented, right upper arm area with warmth, tenderness at the injection site, tonsils mildly enlarged with erythema, nose clear, neck supple, no adenopathy, and no cardiac or respiratory abnormalities. Patients gait was normal, BP 120/72, HR 64, R 16, T 99.3. The patient was treated with Prednisone and Benadryl.
headache; fatigue; muscle aches; joint pain; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (reported as Age: 59; Unit: Unknown) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration on 07Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced headache, fatigue, muscle aches, and joint pain on an unspecified date in Jan2021. The patient was still experiencing muscle aches and joint pains 5-7 out of 10 currently. She reached out to healthcare professional and vaccination clinic which referred her to Pfizer. She was wondering if it was okay to be experiencing side effects that long. The outcome of the events muscle aches and joint pain was not recovered while the outcome of the events headache and fatigue was unknown.   Information on the lot/batch number has been requested.
Pt described feeling SHOB and chest tightness/pain five minutes after receiving the COVID-19 Moderna #1 injection, pt was given 02 nasal cannula at 2 Liters, vital signs obtained, and ECG performed, pt was then transported by ambulance to nearest hospital after explaining to provider that she has recent history of seeing provider in for "holes in her heart and fainting spells". Pt denied history of myocarditis and pericarditis when questioned prior to vaccine administration.
Day 1-5- Migraine nausea and vomiting Day 4- Day Menses 7 days early 14 days- Body aches and extreme fatigue Day 3-14 Constipation and diarrhea Day 7-14- Body odor and bad taste in mouth Day 14-21 Abdominal pain
About 2hrs after getting vaccine, arm became red, swollen, and described itching at site of vaccine, pain to move. Applied ice that evening. Mom states dad reported a fever but no meds given.
Dizzy/hot/hypotensive Fainted Took approx 60min to recover enough to leave clinic.
temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; No further AE; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported. On 25-AUG-2020, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # R021636 was confirmed to be valid with expiration date 12-MAY-2021(exact dose, route of administration, anatomical location were not reported) for prophylaxis.  The temperature excursion was below 2 Celsius degrees (C) (1.1 C) for 27 hours and 45 minutes and above 9 C for 1 hour and 15 minutes (29 hours cumulative). The digital data logger was involved. No adverse effects were reported.  This is one of two 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: R021636; expirationdate: 12-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:
Information has been received from a registered nurse concerning a female patient who in 2006 was vaccinated with her first dose of GARDASIL. Subsequently, she was vaccinated with her second dose of GARDASIL (yeast). Subsequently, she developed a blister at the injection site.  Medical attention was sought.  The patient's outcome was unknown.  Additional information has been requested. Follow up information indicated that the patient was being treated with an unspecified vaccine, and not GARDASIL as previously reported. Therefore, WAES #0609USA00391 is being deleted from our files on GARDASIL. This report was previously sent to PLA V501 on 14-SEP-2006.
Information has been received from a registered nurse concerning a 56 year old female patient. The patient's medical history included 2 prior episodes of shingles (unspecified dates and lengths of time). On an unknown date the patient was vaccinated with her first dose of ZOSTAVAX (lot#, dose, route and duration were unspecified). Unspecified concomitant medication was taken. The patient experienced swelling, redness, tingling, and itching at the injection site immediately after receiving the ZOSTAVAX vaccine while already in the physician's office. The patient did not seek medical attention, as she was already in the physician's office when her reactions occurred. No lab diagnostics studies were performed and no treatment was given for the events. Since that unspecified date, the patient had called the physician's office to let them know she was still experiencing the itching and tingling. It was unspecified how long the swelling and redness lasted. The itching and tingling still remained with the patient as of 27-APR-2015. Additional information has been requested.
Redness on injection site, swelling from lateral side of thigh to medial with increasing induration. Mother refused CBC.
Chills, severe headache, body ache, malaise. Recommend ibuprofen and tylenol. Testing for symptoms lasting longer than 24 hours
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 03-DEC-2012, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 16-OCT-2016, the patient was treated at a hospital for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Patient ID:   80 y.o.    Admit Date:  8/8/2022   Discharge Date:   8/11/2022   Discharge Diagnosis:  Principal Problem:   Acute systolic heart failure Active Problems:   NSTEMI (non-ST elevated myocardial infarction)   COVID-19 virus infection   Type 2 diabetes mellitus with stage 3 chronic kidney disease, with long-term current use of insulin   Stage 3a chronic kidney disease     Hospital Course:  80 year old male with dementia was admitted for CHF and MI. He also tested (+) for Covid-19 infection but did not require Remdesivir therapy. Cardiology saw him and started him on Amiodarone. TTE show moderate global hypokinesis of the left ventricle with 30-35% LVEF. He was also diuresed. Renal function remained stable. He will be discharged home today for follow up with cardiology. Patient educated on appropriate level of care post-discharge.    Physical Exam on the day of discharge: Last Recorded Vital Signs: Temp: 97.4 °F (36.3 °C) Heart Rate (Monitor): 87 Pulse: 77 BP: 115/74 Respirations: 18 SpO2: 99 % O2 Flow Rate (l/min): 0 l/min General Appearance: no distress  Eyes: PERRLA ENT: moist mucus membranes, no adenopathy Lungs: clear to auscultation bilaterally  Heart: regular rate and rhythm Abdomen: soft, non-tender  Skin: No rashes or lesions  Extremities: full ROM Neuro: alert   Consults:  IP CONSULT TO HEART FAILURE NURSE IP CONSULT TO DIETARY IP CONSULT TO SOCIAL WORK IP CONSULT TO CARDIOLOGY IP CONSULT TO HEART FAILURE NURSE   Significant Diagnostic Studies:   TTE, CXR   Operations: none   Disposition:  Home with HH   Discharge Condition:  Fair
Per patient initially the first couple of days he experienced normal superficial discomfort in the arm and shoulder-but then on June 5th he began to feel the pain  deeper in the arm. The pain continued to persist and according to him it was a level 10. He did go to the physician's office to get examined and per patient, MD stated it was bursitis  and it would take time to heal. I did speak with him on 7/12/21 and he mentioned the pain is gradually getting better.
Information has been received from a health professional concerning a female pt who was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (lot 637345/1449K). Subsequently, the pt experienced significant body aches, a large area of erythema, redness and pain (at least 3" X 3"). Unspecified medical attention was sought. It was reported that 2 other pts (WAES 0202USA00635 and 0202USA00633) had similar experiences following exposure to pneumococcal vaccine 23 polyvalent. Additional information has been requested.
First, the hot flashes disappeared.  Then I could sleep through the night.  Then my energy and mental focus returned and I even lost a couple of pounds of fat.  Basically, the second shot reversed menopause.  While this sounds glorious (and it was) I have hormone receptor positive breast cancer so getting my hormones back drives up my chances of more cancer considerably.  My break from menopause lasted between three and four months, complete with monthly two-day periods.  I  reported this to my oncologist, who would only respond ?that hasn?t been reported?.
doses were administered post excursion; had a temperature excursion. 9 doses were administered post excursion; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses were administered post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (had a temperature excursion. 9 doses were administered post excursion) and NO ADVERSE EVENT (no adverse event) in an infant patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS1903B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses were administered post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (had a temperature excursion. 9 doses were administered post excursion) and NO ADVERSE EVENT (no adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (doses were administered post excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (had a temperature excursion. 9 doses were administered post excursion) 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 assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (doses were administered post excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (had a temperature excursion. 9 doses were administered post excursion).    Concomitant products were not reported.  It was reported that 9 doses were administrated post temperature excursion. The storage condition at the time of excursion was reported as frozen. Lot number and expiration dates were provided as AR9236B: Exp: 22Aug2023, AS1903B: Exp: 14Jun2023, AS7170B: Exp: 09Jun2023. The maximum or minimum temperature reached was -2 to -18 C. The excursion duration was reported as 2 hours.   Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2023: Live Follow up significant Information received event added and narrative updated.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, past medical history and concomitant therapies were not reported. On an unknown date since 03-JUN-2015, the patients were vaccinated with improperly stored dose of oral, ROTATEQ (lot # L004453 exp. date 27-MAY-2016) (dose and frequency were not provided). No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient presented with history of bloody streaks in stool, twice in the past 1 hour.  He has been fussy and colicky (but he has always been like this).  No vomiting or diarrhea.  Exclusively breastfeed.
This spontaneous report was received from a pharmacist and refers to a 18 year old healthy and normal male patient. The patient has none concurrent conditions, medical history or concomitant medications. Merck Sterile diluent was used. On 23-MAY-2018, the patient was vaccinated with his first dose of VARIVAX (lot # M038226 with expiration date 07-SEP-2018), subcutaneously for school purposes (dose not reported). On 06-JUN-2018, the parents reported the pharmacist that the patient developed chickenpox on an unspecified time post vaccination (varicella). The pharmacist prescribed the patient acyclovir (manufacturer unknown) as treatment. No laboratory diagnostic studies were performed. The outcome of varicella and the causal relationship between varicella and therapy with VARIVAX was not reported.
Abdominal Pain leading to a diagnoses of small kidney stone, treated by prescription of tamsulosin and proper hydration.
8/31/21 pt had a positive COVID test at Hospital; was treated with dexamethasone, remdesivir; transferred; admitted with acute on chronic hypoxic respiratory failure; MICU; placed on ABX and BiPAP; shock; Atrial Fibrillation with RVR; acute renal failure; family transitioned pt to comfort care and pt expired in the hospital
patient states that she was short of breath after receiving the vaccine. Patient airway was assessed for airway, breathing and circulation. vital signs were checked accordingly. She was encouraged on good breathing exercises. Vital signs were checked accordingly. She was discharged home by self  in stable condition at 10:15AM.
PT c/o low-grade temp 100.2 at time of visit on 3/25/12, Nausea, Dizziness, Pain at injection same, myalagia, weakness.
Initial information received on 20-Aug-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to case 2018SA232895 (Sibling/ same reporter). This case involves an eight-year-old male patient who experienced discomfort, redness and inappropriate route of vaccination, while she received vaccine ADACEL. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapy taken. On 13-Aug-2018, the patient received a 0.5 ml once first dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U5872AA via subcutaneous route in the left arm. On an unknown date, the patient developed a non-serious little bit of redness (erythema) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. On an unknown date, the patient developed a non-serious discomfort following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. On an unknown date, the patient developed a non-serious it appears that it was a sc injection (incorrect route of drug administration) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. On an unknown date, the patient developed a non-serious gave adacel to two patients at a site too low to be in the deltoid (product administered at inappropriate site) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. It was also a case of actual medication error due to inappropriate route of vaccination and vaccine administered at inappropriate site. No Lab data was reported. Final diagnosis was gave adacel to two patients at a site too low to be in the deltoid, it appears that it was a subcutaneous injection, discomfort and little bit of redness. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for little bit of redness and as Unknown for discomfort. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by the sender: None.
Dark pink oval patch (2X3 inches) at the sight of the vaccine 8 days after vaccine. No fever, no pain just tickes
Patient came to the pharmacy and presented a yellow bruise and a pink/red rash with a scab in the middle. This was located on his lower arm, but not in the deltoid area. The patient reported that the rash appeared over the last few days and he has never experienced this type of reaction after being vaccinated.