chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt recvd MMR approx 1-2min later, pt stated felt as though was goint to faint x 2; no complete lose of consciousness noted; pt given coke to drink w/BP monitored; BP upon leaving 122/86;
2 days following vaccine, the patient reported a red rash developing on his lower right back. The rash continued to spread. 8 days post vaccine the rash covered his right trunk, front and back. His healthcare provider treated him for shingles initially and he took an antiviral.
Left hip pain started day one after vaccination.  Gone in day two after vaccination. Recurred on day seven after vaccination and persisting. No history of hip pain prior to vaccination.
Patient reported a high temperature (>100), swelling, warmth and redness at injection site.
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown age and gender. Information regarding concurrent conditions and pertinent medical history was not provided. Between 13-AUG-2014 and 15-AUG-2014, an unspecified number of patients had been administered PNEUMOVAX23 (dose, route and frequency were not provided), which was improperly stored and not supported. Concomitant medications were not provided. No adverse effect was reported. Additional information has been requested.
The injection was given, it is red and swollen; the injection was given, it is red and swollen; A spontaneous report was received from a consumer who is a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced redness and swelling at the vaccine site injection.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 17-Jan-2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 25-Jan-2021, the patient experienced redness and swelling at the vaccine site injection.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, redness and swelling at the vaccine site injection was not reported.; Reporter'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.
On day 8 hard lump the size of palm developed over vaccine site as well as a red spotty rash on top of lump. The next day the hard lump turned into the size of a hand and there was a red circle fully red inside with a defined edge over this lump. Went to doctor was told they don?t know what it was maybe to be safe gave her antibiotics in case it was cellulitis and that is all she was given. Seems to be going down but still a small lump
Patient presented to scheduled appointment et acknowledged being nervous. Denied contraindications and history of reaction to vaccines. Vaccine prepared and administered. Adolescent states "I don't feel well, I need to lie down." Encouraged her to keep talking to me and to concentrate on breathing. Reports feeling better and requested a drink of water. Assisted her off exam table and retrieved a glass of water while patient sat with mom. Time of vaccine administration until time pt left clinic lasted 10 minutes.
Fever 101.4; Tired; Headache; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 16Apr2021 at 02:45 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high and cholesterol high. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), metoprolol (MANUFACTURER UNKNOWN), citalopram (MANUFACTURER UNKNOWN) and potassium (MANUFACTURER UNKNOWN) all from an unknown date for an unspecified indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Since the vaccination, the patient had not been tested for COVID-19. On 17Apr2021 at 09:00, the patient experienced fever 101.4, tired, headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. On 17Apr2021, the patient underwent Body temperature and the result was 101.4 (UNSPECIFIED UNITS). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever 101.4, tired, headache was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Nasal Swab: Positive; Nasal Swab: Positive; hair loss; This is a spontaneous report from a contactable consumer (patient) reporting herself. A 50-year-old non pregnant female patient received BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 via an unspecified route of administration, administered in left arm on 07Apr2021 08:15 (at the age of 50-years-old) (Batch/Lot Number: EW0162) as dose 2, single and dose 1 via an unspecified route of administration, administered in left arm on 17Mar2021 08:15 (at the age of 50-years-old) (Batch/Lot Number: ER8727) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. The patient previously experienced known allergies: Penicillin. The patient experienced ongoing hair loss from an unspecified date in Jun2021. The patient was tested positive for Covid-19 which was confirmed by the nasal swab test. The patient was exposed to vaccination failure scenario. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received other medications within 2 weeks to the COVID vaccine. The patient was not diagnosed with covid-19 prior to vaccination. Therapeutic measures were taken as a result of hair loss; Prescription shampoo. The patient visited physician office for the treatment for hair loss. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 13Aug2021 post vaccination. The outcome of the hair loss was not recovered. The outcome of all the other event was unknown.  Follow-up attempts are completed. No further information is expected.
Fever, aches, nausea, diarrhea, sore throat, headache
Small lump Lt upper arm at injection site noted soon after vaccination 4-3-09.  Presented for care on 5-1-09 with 2d history increasing size of lump and pain at site.  Tx with Bactrim DS #14 and warm compresses.  Saw PMD 5-6-09 who changed her antibiotic and scheduled her for drainage of infected abscess at site 5-11-09
Idiopathic thrombocytopenia Purpura   12/2/08 Reviewed hospital medical records of 11/13-11/15/2008 & 11/17-11/19/2008. FINAL DX: idiopathic thrombocytopenic purpura Records reveal patient experienced bruising & full body petechiae.  Har URI s/s x 2 days & gastroenteritis 10 days prior.  Seen by PCP, CBC revealed thrombocytopenia & admitted.  Tx w/Win Rho.  Improved & d/c to home w/serial labs by PCP.  Seen in Heme/Onc clinic 11/17 & readmitted for plts 15K.  Tx w/IVIG x 2.  Plts improved to 46K & d/c to home w/clinic f/u.
This spontaneous report as received from a physician to a patient of unknown age and gender. Pertinent medical history and drug reactions or allergies were unspecified. On 16-JUN-2014 (reported as "today") the patient was vaccinated with an improperly stored VAQTA (strength, dose, route, dose number and lot number were not reported). Concomitant medication was unspecified. No adverse events reported at the time of this report. The outcome of the event was unknown. This is one of several reports received from the same reporter. The physician also reported that on an unknown date another patient was vaccinated with improperly stored M-M-R II (see MARRS 1406USA008465). Additional information is not expected.
flu-like symptoms - cough, fever, migraine, achy & sore muscle injection site warm to touch and extremely sensitive to any touch, large hard lump
Patient is a 95y.o. female it was a history of CHF, advanced dementia, A. Fib not on any anticoagulation, recent community-acquired pneumonia who was brought into the emergency room by EMS for complaints of generalized weakness, decreased appetite and failure to thrive and hypoxia.             On examination patient does have advanced dementia, very poor historian patient is alert did not answer any questions limited history available secondary to her status per EMS note at the facility patient wasn't eating and drinking for the past 1 week and noted to have oxygen saturation of 81% place the patient on oxygen and brought her to the emergency room for evaluation and management. ED course sodium-164 hypernatremia, potassium hypokalemic-2.6, hyperchloremic-114, CO2-38, elevated BUN/creatinine creatinine view and 30, creatinine 0.78, pro calcitonin plasma-0.06, lactic acid-1.7, WBC-11.0, hemoglobin-11.3, platelet-330, covid-positive, patient fully vaccinated with the 2 doses of  Vaccine  in March.chest x-ray-no improvement from previous improving bilateral patchy airspace opacities, probably small pleural effusion,   Past Medical History:
Patient called the pharmacy today to report significant shoulder pain in her left arm from her flu shot given over two weeks ago. She stated her right arm is very painful and when she touches her shoulder she feels "a lump." Patient is not having any other symptoms other than significant shoulder pain.
Information has been received from a health professional concerning a 9 month old patient who was vaccinated with a third dose of ROTATEQ. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Patient vaccinated approximately 2:10 and left observation area after 15 minutes. She returned to observation @2:35pm complaining of rash, redness, and itching on right inner arm, opposite arm of injection site. Patient states bitten by mosquito earlier and noticed some itching on right arm, after leaving observation she developed a rash, redness, and itching on right arm. Obtained vitals signs and administered 25mg of benadryl by mouth. Continuedto observe until 3:05pm, symptoms decreased significantly. No acute distess noted. Advised to seek medical attention for worsening/returning symptoms.
Information has been received from a 25 year old female who on 18-FEB-2009 was vaccinated with her first dose of GARDASIL and the patient had not had her period although she was due on 27-FEB-2009. A pregnancy test was negative. She also experienced on 18-FEB-2009, heartburn since vaccination and stated her arm was sore after vaccination. The patient's symptoms still persisted. The patient sought unspecified medical attention. Additional information is not expected.
Slight Pain at injection site, Swelling at injection site, Redness, Itchy on injection site; Slight Pain at injection site, Swelling at injection site, Redness, Itchy on injection site; Slight Pain at injection site, Swelling at injection site, Redness, Itchy on injection site; Slight Pain at injection site, Swelling at injection site, Redness, Itchy on injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of INJECTION SITE PRURITUS (Slight Pain at injection site, Swelling at injection site, Redness, Itchy on injection site), INJECTION SITE PAIN (Slight Pain at injection site, Swelling at injection site, Redness, Itchy on injection site), INJECTION SITE ERYTHEMA (Slight Pain at injection site, Swelling at injection site, Redness, Itchy on injection site) and INJECTION SITE SWELLING (Slight Pain at injection site, Swelling at injection site, Redness, Itchy on injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no historical condition was reported).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PRURITUS (Slight Pain at injection site, Swelling at injection site, Redness, Itchy on injection site), INJECTION SITE PAIN (Slight Pain at injection site, Swelling at injection site, Redness, Itchy on injection site), INJECTION SITE ERYTHEMA (Slight Pain at injection site, Swelling at injection site, Redness, Itchy on injection site) and INJECTION SITE SWELLING (Slight Pain at injection site, Swelling at injection site, Redness, Itchy on injection site). At the time of the report, INJECTION SITE PRURITUS (Slight Pain at injection site, Swelling at injection site, Redness, Itchy on injection site), INJECTION SITE PAIN (Slight Pain at injection site, Swelling at injection site, Redness, Itchy on injection site), INJECTION SITE ERYTHEMA (Slight Pain at injection site, Swelling at injection site, Redness, Itchy on injection site) and INJECTION SITE SWELLING (Slight Pain at injection site, Swelling at injection site, Redness, Itchy on injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; 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.
Explosive diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old unknown gender patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 10Apr2021 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not take any concomitant medication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021, at 06:15 the patient experienced explosive diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event explosive diarrhea was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Cystic outbreak all throughout my body, need to be biopsied, one over my heart Erratic behavior reported by family Potential heart failure due to heart condition
Can't move right arm. Numbness down arm. Pressure deep in axilla. Can't lift arm above head-still 2 days later. Supportive care.
Temp 100.4,dry cough, headache, body aches, fatigue, runny nose started 1-2-20 started dexamethasone, zpack Pepcid vit c vit d zinc aspirin
PT STATED THAT SHE FELT A PAIN IN HER LEFT ARM AT SIGHT OF INJECTION WHICH TRAVELED UP THE OUTSIDE OF HER NECK.  SHE STATED THAT SHE STILL CONTINUES TO HAVE THIS PAIN AT TIMES.  SHE STATED THAT HER INJECTION ARE FELT VERY HEAVY AND LETHARGIC FOR THE DAYS AFTER THE INJECTION AND THAT SHE HAS TIGHTNESS IN THE SAME SIDE IN HER CHEST. SHE FEELS PAIN RADIATE DOWN HER LEFT ARM AS WELL.  DID NOT FEEL ANY OF THIS UNTIL SHE WAS GIVEN THE INJECTION. PATIENT INTENDS TO MAKE A DOCTOR VISIT.
Patient required hospitalization due to breakthrough infection. He received Pfizer vaccine second dose in series on 06/03/21. Hospitalized from 08/01/21 - 08/04/21. Below is copied from discharge summary:   Patient is a 81 y.o. with a PMH of HTN, HLD, PVD who presented with generalized weakness for the last several days and postural dizziness. Patient denies having any complaints at the time of interview and would like to go home. Collateral information gathered from ED and daughter. Apparently patient is poorly compliant with medications at home, but is prescribed some antihypertensive meds. Otherwise is usually in good health and recently saw his PCP. Received both doses of COVID vaccine, but is found to be COVID + and with new oxygen requirement in the ED  Pt discharged. Transported via wheelchair downstairs to daughter. Pt belongings sent with pt. Discharge instructions given and pt states to understand. IV removed.
This spontaneous report was received from a consumer concerning his grandmother (patient) of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route, frequency and lot # unspecified). No concomitant medications were reported. Consumer stated that his grandmother got shingles vaccine but got shingles last Thursday (Approximately on 01-OCT-2015). Patient sought medical attention. The outcome of the event was unknown. Causality assessment was not reported. Additional information has been requested.
A report was received from a health care professional on 10/30/03, concerning an unspecified number of vaccinees under 4 years of age who inadvertently received Fluvirin on an unspecified date. No adverse effects had occurred at the time of report. There was insufficient information to determine the reporter's causality assessment. Update 1, 12/01/03: Follow up information received from a health care professional indicated that a 14 month old male vaccinee inadvertently received Fluvirin on 10/23/03 and had not experienced any adverse event at the time of the report. No follow up pending, all information received. Cross reference with: PJP200300957, PJP200400013, PJP200400014, PJP200400015, PJP200400016, PJP200400017, PJP200400018, PJP200400019, PJP200400021, PJP200400022, PJP200400023, PJP200400024.
A few days after the second vaccine began to experience malaise symptoms in the early evening hours continuing throughout the night with low grade fever, headache.   ~ 3 weeks later continues to experience the same with night  sweats.
Shaking, chills, fever over 101 degrees for approximately 14 hours. Vomited 4 times. Woke up next morning with migraine headache but no fever. Pains in muscles all over body for the next 24 hours. Total time sick was approximately 48 hours.
Welts and hand swelling. Diphenhydramine 25 mg QID PO.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   The nurse reported that, on 06-AUG-2016, the patient received an improperly stored VARIVAX (Lot #: M008171; Expiration date: 16-FEB-2018) for prophylaxis (Dose, route and anatomical location were not reported). No adverse effects reported. Temperature/Time frame: >-15°C but <-10°C (>5°F but < 14°F) excursion reported for 46 hours 10 minutes (worst case) Previous temperature excursion:   >-15°C but <-10°C (>5°F but < 14°F) excursion reported for 133 hours and 30 minutes (worst case) The call was not because of a "data logger". There was no Product Quality Complaint (PQC) involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA005376:
34 y.o. female now on admission day 39 for ischemic necrosis of small bowel due to unclear etiology.  Now status post ex lap and small bowel resection secondary to the ischemia and necrotic small bowel.  Neg for malignancy and clotting disorders.  Developed leak and went back to the OR again and was found to have an anastomotic leak with a large amount of feculent contamination and a contained large abscess cavity walled off by omentum and necrotic small bowel.  She was left in discontinuity with the plans to return to the operating room for second look with anastomosis.  Returned to the OR on 5/13 for abdominal washout, small bowel anastomosis, repair of perforation, placement of drains, complex midline fascial closure with vicryl mesh, wound vac to skin/abscess cavity in RLQ.  She has since been extubated (5/18), started on ice chips but is now NPO due to increasing output from her fistula. She has 3 drains putting out succus. (high output SB fistula leak).  Residual bowel estimated to be 120cm and surgery avoiding further SB resection as this would be unlikely to be compatible with life. Avycaz for CRE.
approx 36 hrs p/vax pt woke up @ 3PM w/red & swollen eyes; mom took pt to ER; dx: bilateral eye redness & swelling secondary to MMR vax; cannot r/o acute bilateral conjunctivitis;
Patient developed a round, 1-2 inch diameter, raised, rash that she described as warm and itchy. She said that it had increased in size from 11/3 to 11/5. She was advised to treat with Benadryl, Motrin and ice on 11/5 and to report back if any worse over the weekend.
administration of Menquadfi post excursion without adverse event; Initial information received on 10-Mar-2023 regarding an unsolicited valid non-serious case received via health professional. Number: 01527689.  This case involves 11 years old male patient to whom Meningococcal A-C-Y-W135 (T CONJ) Vaccine [Menquadfi] post excursion without adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This case is linked to cases 2023SA082367, 2023SA082373, 2023SA082418, 2023SA082416, 2023SA082675, 2023SA082382, 2023SA082953 and 2023SA081681.   On 11-Jan-2023, the patient received suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) vaccine Solution for injection at dose 0.5ml once (lot: U7449AB, expiry date: 23-Sep-2024) via intramuscular route in unknown administration site for immunization after the excursion, with no reported adverse event (poor quality product administered) at same day latency.  Action taken with MENINGOCOCCAL VACCINE (MENQUADFI) was not applicable.  No corrective treatment was received for the event.  At time of reporting, the outcome was Unknown for the event poor quality product administered.  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 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.