chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patients were given FLUBLOK QUADRIVALENT rather than the intended FLUZONE QUADRIVALENT, no AE; Initial information was received on 15-Sep-2020 regarding an unsolicited valid non-serious case.  This case involves 140 patients who were given INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] rather than the intended INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (wrong product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   Between 08-Sep-2020 to 10-Sep-2020, the patients received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot QFAA2002, expiry date: 18-May-2021, strength: standard) once via intramuscular route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to wrong vaccine administered.  The nurse reports that the medical center ordered flu vaccines for both patients and staff. Both Flublok and Fluzone Quadrivalent were ordered. The plan was to administer the Fluzone Quadrivalent to staff and some patients and Flublok to other patients. But when flu vaccine administration began on 08-Sep-2020, Flublok was given to staff rather than the intended Fluzone. The discrepancy was discovered on 10-Sep-2020, when it was noted that the lot of the vaccine being administered was different from the one on pre-filled-out release forms for those vaccines. Between 08-Sep-2020 to 10-Sep-2020, 140 staff members (out of 3400 team members) had received the Flublok instead of the intended Fluzone.   At the time of report, the patients had no adverse event (AE) symptoms.  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.
Patient received covid-19 vaccine at the age of 15 years and 10 months. This vaccine is indicated for patients 16 years of age and older
Enlargement of lymph node; This is a spontaneous report received from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number; EN6199) via an unspecified route of administration in the left arm on 09Mar2021 at 16:00 (age at vaccination 37-years-old) as a single first dose for COVID-19 immunisation.  Medical history and Concomitant medications were not reported. Allergies to medications, food, or other products reported as None. 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 4 weeks prior to the vaccination. On 15Mar2021 at 12:00, the patient experienced enlargement of lymph node, one pea-sized swollen lymph node appeared on left clavicle (same arm where shot was given) and another nodule appeared on 16Mar2021.The patient did not receive any treatment for the event. The clinical outcome of the enlargement of lymph node was recovering. No follow-up attempts are needed. No further information is expected.
headache, itchy/burning eyes, muscle aches, bone pain, cold chills/hot flashes, insomnia, diarrhea, pain in testicals, and nausea
itchy rashes all over my body; itchy rashes all over my body; the back of my tongue felt thick and tingled; the back of my tongue felt thick and tingled; difficult to swallow; wheezing; At the site of injection was red, warm, itchy, and raised; At the site of injection was red, warm, itchy, and raised; At the site of injection was red, warm, itchy, and raised; At the site of injection was red, warm, itchy, and raised; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 37 years old non-pregnant female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA Vaccine, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration in Left Arm on 25Feb2021 (at the age of 37-year-old) as Dose 1, single for covid-19 immunization. Facility type vaccination was reported as Other. The patient was non-pregnant at time of vaccination. The patient's medical history included thyroid and asthma. The patient had no known allergies. The patient had received other medications within two weeks of vaccination. Patient was neither diagnosed for covid prior to vaccination nor tested for Covid post vaccination. The patient had not received any other vaccine within four weeks prior to vaccination. On 25Feb2021 (30 minutes after receiving the dose 1 vaccination), the patient experienced itchy rashes all over the body, the back of her tongue felt thick and tingled, it was difficult to swallow, and she was wheezing. At the site of injection was red, warm, itchy and raised. This was lasted in 2 days. These events resulted in doctor or other healthcare professional office/clinic visit. The patient was prescribed steroid pack and OTC Benadryl for resulted events. The outcome of all the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. Information about lot or batch number cannot be obtained.
Information has been received from a physician concerning a 15 year old female who on an unspecified date was vaccinated with a first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). In October 2007, "about a week ago", the patient was vaccinated with a second doses of HPV rL1 6 11 16 18 VLP vaccine (yeast) 0.5 ml IM. Concomitant therapy included influenza virus vaccine (unspecified) also given on the same date in October 2007. In October 2007, about 24 hours after being vaccinated, the patient developed a headache, dizziness, and vomiting and was hospitalized.  At the time of reporting, the patient had not recovered. The physician felt that the events were disabling. Additional information has been requested.  03/03/2008 MR received for DOS 11/8-11/2007 with DX: Headache Disorder, Intractable Migraine. Pt presented with 2 1/2 week hx of throbbing headache in the forehead, bitemporal, and occipital areas which began 1 day s/p flu and Gardasil vax.  H/A associated with nausea, dizziness, light and noise sensitivity.  Occasionally wakes from sleep with pain. Previous ER visit with normal diagnostics.  PE WNL.
complaints  of general malaise, headache, cough, congestion, and sneezing all symptoms  started a day ago
?Moderna COVID?19 Vaccine EUA? -  Flu like symptoms including body aches, muscle pains, joint pains, red/blotchy face, minor itchy ness, tired, fatigue , pain at the injection site, left arm pain, feeling of swollen hands/joints
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. It was reported that no treatment was given on the patient.
Information has been received from a healthcare student concerning a male patient who on 07-JAN-2009 was vaccinated with ZOSTAVAX (Oka/Merck).  The patient developed a "blood blister" on the lip after receiving ZOSTAVAX (Oka/Merck).  The patient spoke with pharmacist for medical attention.  No further information is available.
After administering last immunization, Tdap, Meningococcal, HPV and Flu shot, approx. 1 minute later patient convulsed and made snorting noise lasting approx. 15sec. Grandmother states patients father does the same thing after injections. Grandmother states patient does not have history of seizures or family history. Patients skin cool and clammy and could not keep eyes open for 15 seconds. Patient aware of surroundings, but drowsy for 3 minutes. Normal respirations, pulse. Offered to call ambulance transfer to ED. Declined by grandmother. Advised grandmother to seek further medical attention if needed. Assisted patient to personal vehicle in wheel chair, Patient stable and alert when leaving health unit. Grandmother states she was taking patient to ED. 1600 TC from patient grandmother stating patient was seen in ER and released, ER stated patient had vasovagal reaction from immunizations.
Information has been received from a physician concerning a 4 year old normal, healthy male with no significant medical history including no prior chicken pox and no immunosuppression who on 4/26/03 was vaccinated with varicella virus vaccine live (lot # 644569/1158M). On 6/15/04 the patient presented to the emergency room with what initially was diagnosed as poison ivy on his face. The child presented with unilateral lesions on the left side of his face, around the left eye and into the left side of scalp. It was reported that other than the lesions, the child was asymptomatic, he did not have any pain or itching. A lesion specimen was DFA positive. The final diagnosis was herpes zoster. The patient was also diagnosed with periorbital cellulitis. The patient was treated with acyclovir. The patient was admitted to the hospital and was discharged on 6/17/04. There was no product quality complaint involved. Additional information has been requested. Follow Up: information received from a health professional on 15JUL2004 reported taht on 17JUN2004, an adequate specimen was obtained from a vesicle lesion for VZV identification. The specimen was sent to the laboratory on 21JUN2004 and arrived in the laboratory on 23UN2004. The results reported taht VZV DNA was amplified and the VZV strain identified was wild type strain. There was no globin DNA amplified. Additional information has been requested. Follow up information was received from a physician who reported that on 05JUN2004 the pt developed herpes zoster left VI (periorbital/ scalp) 50-100 lesions and left periorbital cellulitis which lasted approximately three weeks. It was noted that the pt had a maximum temperature of 102 degrees F and pain intesity quanitified as a 3-4 on a scale of one through ten. The physician also reported that the pt did not develop a rash at the site of injection or elsewhere within 42 days of varicella virus vaccine live administrtion, he had not a hx of chickenpox and had not had a recent exposure to chickenpox or herpes zoster. It was also noted that the pt had not  had adverse events following prior vaccinations. On 15JUN2004 a direct fluorescent antibody was positive and the specimen for PCR was positive for WT. On 15JUN2004 a vesicle speciment was tested for Herpes simplexDFA and the Herpes Simplex virus antigen was negative,no virus was isolated. Also, on 15JUN2004, Varicella antibody was 7.78 and Varicella IGM was 1.26. The physician indicated a photgraph of the rash was taken. No additional information has been requested.
Janssen COVID vaccine EUA: Fully vaccinated patient presented on 080221 with sore throat, body aches, and chills.
I did not have an adverse event after receiving the vaccine. I started not feeling well on 11/11/2022, I had congestion and productive cough with a yellow and green color. We had plans to travel so I saw my doctor on 11/12/2022 and again on 11/15/2022. I was tested for COVID-19, and it was negative on 11/15/2022. I was diagnosed with a sinus infection and got the prescription ZITHROMAX.
positive for her COVID test; positive for her COVID test; she came in contact with somebody who was COVID positive; This is a spontaneous report from a contactable consumer (patient) via medical information team. A female patient of an unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection) via unspecified route of administration on 15Mar2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient mentioned that she received the first dose of the vaccine on 15Mar2021. On 26Mar2021, she came in contact with somebody who was COVID positive. On 31Mar2021 she came in positive for her COVID test, but on 01Apr2021 her PCR test came back negative. Patient was scheduled to receive her second dose on 05Apr2021 and would like to find out whether she will need to reschedule. It was reported that people who have a Negative COVID Diagnosis would reasonably receive their vaccine as scheduled, but patient would need to confirm her status with her doctor. The outcome of the events was unknown.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Pt experienced a quarter size circle on chest, rash on chest, excessive crying, lack of appetite, non-alert, extremely thirsty and auxilary temp of 100.6
Both a tiny yellow bruise on the injection site and a dime-sized oval swollen lump about three inches below injection site appeared almost a week after the injection. Swelling flattened to rash but enlarged to two inch red area over next couple if days. Redness and swelling gone after 3-4 days but still have small dime sized hard lump under skin where rash was 4 weeks later. Bruise healed like a normal bruise over a few days.
Slight headache for about 20 minutes ,then developed to a full migrane.  Took one Excedrin migrane pill  at 12:05 pm( 01/04/2021). Migrane relieved  slightly .
Public health nurse administered vaccine. The hub of the needle was loose and an unknown amount of vaccine ran down the recipient's arm. Followed up with recipient the following day 2/7/2021. Recipient verbalized arm was sore from the vaccine.
State Immunization Registry was not updated by staff after MMR #1 and Pentacel #2 were given on April 17, 2015 - patient returned to the office today for immunization update and both MMR and Pentacel were given based off of the un-updated IR listing.
Information has been received from a physician concerning a 7 year old white female who on 6/16/95 was vaccinated with varicella virus vaccine live. On 1/16/00, the pt developed chickenpox. Additional information has been requested.
LEG CRAMPS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included hospitalization.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced leg cramps. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from leg cramps. This report was non-serious.
Severe arthritis in sight hip leading to total hip replacement. 60 Day follow up states pt has not recovered. Pt had to have right hip replaced because of sever arthritis. Very limited physically and can't do many things physically that could before. the pain from arthritis started shortly after received the vaccine and pt attributed it to Lymerix vaccine. Annual follow up on 02/06/04: "Pt has not recovered from adverse events. Total hip replacement 06/11/02, many physical activities that I previoiusly performed, I cannot do after the surgery.
pt recvd vax & 5 hrs p/vax exp itching, burning upper torso which oozed & blistered; sx were treated w/DPH & shot of steroids;
Woke up in the middle of night/early Thursday am-did not feel well. Nauseous. Index finger on hand of arm of injection site was blistered. Thursday/Friday still nauseous/diarrhea.
Information has been received from a registered nurse concerning a female "65 years or older", who in October 2007, was vaccinated intramuscularly with a 0.5mL dose of PNEUMOVAX vaccine.  Subsequently, the patient developed swelling that encompassed most of the upper outer arm.  The area was red and very painful.  The patient sought unspecified medical attention.  At the time of the report, the outcome of the patient was unknown.  No product quality complaint was involved.  Additional information has been requested.
pt recvd vax; swelling; stiffness of fingers, toes, wrists, knees;
Arm Pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Pain) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm Pain). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at an unspecified dose and frequency. On 14-Mar-2021, PAIN IN EXTREMITY (Arm Pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   This case was linked to MOD-2021-106996 (Patient Link).
Inconsolable crying x 72hrs started 4 hrs after vaccination. 07/19/06-records received from hospital. Chief Complaint: per mother "we are here because of crying: Prior to admission, medicated with Tylenol for bit of fever. Cried throughout night and on into the next day after immunization. Mother indicated child appeared constipated. PMH: 34 week gestational age,11 day hospitalization after birth for prematurity, NG feedings for a time.  Physical Exam: Temp 99 (R), pulse 160, inconsolable crying during entire exam. Impression: fever by palpation per history, continuous crying per parents' history. Plan: admit treat with Ampicillin and Ceftriaxone for 48 hours. No DC summary available or dictated.
Within 12 hours started with sore arm which last until felt like I got punched in the arm where shot was giving very much fatigue. Lasting a good week. Red at shot site, warm little swelling not bad fever 102 for a week shivering, headache. My Right that when I did have Shingles the spots that had flared up those spots bruised off and on for some time like how the shingles felt strange but it did happen. Min stomach pain. I didn't send this form in when I got the paperwork was waiting for my left arm to stop hurting before I filed this. Planning on second shot at 6 month as recommended from CDC when returned my call.
HEADACHE; RIGHT EYELID SWELLING; This spontaneous report received from a parent concerned a 33 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included gluten intolerant, and allergy to antibiotics.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 04-APR-2021, the subject experienced right eyelid swelling. On 08-JUN-2021, Laboratory data included: MRI (NR: not provided) No tumors. On 16-JUN-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right eyelid swelling, and headache. This report was non-serious.
Continued to monitor patient & she left by ambulance to hospital. - BP did lower to 156/98
Information has been received from a registered nurse concerning a medical assistant who had been administering ZOSTAVAX (Merck) for the past 3-4 weeks. At the time of reporting the patient was experiencing chickenpox. The outcome of the medical assistant's chickenpox was not reported. Additional information has been requested.
Lethargic, Fever started that night lasted till Monday 9/10/18- high of 100.9, sweating, headache, body aches, I still have heaviness in my chest, cough, hoarseness. Lethargy is improved and body aches.
Patient noticed blistering and swelling at injection site the day after the vaccine was given. She did not seek medical attention. Patient applied ABREVA to the site of RxN and took BENADRYL. Patient does have known Hx of herpes and feels that's what was the cause.
rash hive-like on torso and upper and lower extremities bilaterally, sparing the face, palms and soles
A few minutes after the vaccine, patient fell down, heart rate increased, was breathing really fast and sweating.  No swelling or difficulty breathing recognized. This went on for about 15mins until the paramedics came and got him.  Patient was helped to lay down in a relax position and no treatment was administered.
Per mom, one to two hours after receiving vaccines the patient developed tachycardia, hypotension and non-bloody vomiting and diarrhea. Mom was notified that his vitals were abnormal when he presented for his specialist appointment one to two hours after being vaccinated. Mom took him home after that appointment and gave him some Benadryl. PCP was not notified until the following morning when he presented for parental concerns for a possible vaccine reaction. At that time, he had a fever of 100.6 associated with tachycardia. Blood pressure and remaining vitals were normal. No further vomiting or diarrhea, but still gagging intermittently per mom. Patient was given some ibuprofen for the fever and Zofran. He was monitored for 1-2 hours. He remained stable so he was discharged home.
Patient began to have redness, swelling in right arm 20hrs post vaccination.  Patient also had itching of the scalp, both arms and legs and swollen lymph nodes of the underarm on the right side.
Given standard dose flu vaccine in error.  Patient is over 65.  I decided it would be best clinically to also administer the adjuvant flu vaccine for >65.
Swollen red sore arm for over one week. Chills fatigue   Nausea headache body aches
Initial information received on 18-Oct-2018 regarding an unsolicited valid non-serious case received from an other healthcare professional. This case involves a 4 months old patient received both vaccines PENTACEL and HIB Vaccine. (batch number, expiry date, dose, dose in series, route and site of administration were not reported for both the vaccine). The patients past medical history, medical treatments, vaccinations and family history were not provided. Concomitant medication was not reported. It is an actual medication case error due to extra dose administered. It was not reported that if any adverse event was experienced or not. 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 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. List of documents held by sender: none.
After receiving the vaccine shortly after the patient felt dizzy and became pale. We called 911 and in the meantime I kept talking to the patient and gave him water. He didn't show signs/symptoms of anaphylaxis. EMS arrived and took over the scene. They did an EKG, took his blood pressure and did a glucose test. Patient refused to go to the hospital and said his wife will take him if he feels worse.