chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she gave an expired Kinrix vaccine to a patient; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number Yz97n, expiry date 26th August 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st August 2022, the patient received the 1st dose of Kinrix (intramuscular) .5 ml and Kinrix Pre-Filled Syringe Device. On 31st August 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 31-AUG-2022 The nurse stated that she gave an expired Kinrix vaccine to a patient. She did not report that the patient was experiencing any side effects. The reporter did not consent to follow-up. Additional supportive information: The patient had received an expired dose of Kinrix, which led to expired vaccine used.
patient exhibits symptoms of syncope and orthostatic hypotension after receiving first shot of moderna vaccine. patient experienced shortness of breath and tachycardic (HR: 134 bpm).  Patient also complained of bilateral tingling/ numbness in upper arm, and nausea. To relieve symptoms patient was placed in supine position with legs elevated. Patient was transported to Hospital.
No symptoms at or shortly after vaccine given in clinic. Patient with chills and HA at home and was taken to the ED where patient was Dx with reaction to vaccines.
I developed seasonal allergies for the first time ever Headache, redness in the eyes, sneezing and fatigue almost 10 days after the second dose of vaccine
Diffuse macular papular rash (urticarial) about 10 days post vaccination.
Expired vaccine used; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received 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 EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    Concomitant medication was not provided. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 Vaccine. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:MASTER CASE
Patient was getting the influenza vaccine and had stated how she gets nervous prior to immunizations, but did not exhibit any symptoms besides general uneasiness prior to administration. After vaccine administration, patient soon turned a pale color and loss consciousness. Patient regained consciousness a few seconds later. I, the pharmacist at the immunization booth, along with staff, the pharmacist that was in the pharmacy at the time, attended to the patient. Patient then passed out twice more while still sitting down in the chair, in the care of both me and staff. EMS had already been called at this time, and until their arrival both staff and I cared for the patient.  We gave the patient water and took blood pressure to assess the patient's status as best we could before arrival of EMS.
headache; intense itching at the injection site; redness approximately 2cm; bruising developed; This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (headache), INJECTION SITE PRURITUS (intense itching at the injection site), INJECTION SITE ERYTHEMA (redness approximately 2cm) and VACCINATION SITE ERYTHEMA (bruising developed) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache), INJECTION SITE PRURITUS (intense itching at the injection site), INJECTION SITE ERYTHEMA (redness approximately 2cm) and VACCINATION SITE ERYTHEMA (bruising developed). At the time of the report, HEADACHE (headache), INJECTION SITE PRURITUS (intense itching at the injection site), INJECTION SITE ERYTHEMA (redness approximately 2cm) and VACCINATION SITE ERYTHEMA (bruising developed) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment and concomitant medications included by reporter.
had the newest shingles vaccine and still got them/suspected vaccination failure; serious pain; still got them; 2nd nerve block; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), pain (serious criteria other: serious as per the reporter), shingles and nerve block. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the pain and nerve block were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, pain, shingles and nerve block to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had the newest Shingles vaccine and still got the shingles. The patient was in the 3rd week of serious pain and the fixing to got his/her 2nd nerve block. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting.
This spontaneous report was received from a nurse via company representative regarding an elderly male patient over the age of 65 years. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (lot#, expiration date, route of administration and dosing details were not reported) for prophylaxis. On an unknown date the patient experienced an unspecified severe reaction to PNEUMOVAX 23 (adverse event). The outcome of adverse event was unknown. Causality assessment was not provided by the reporter. This is one of the report received from the same reporter.
A report has been received from a Health Professional concerning a 5 year old, male subject who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on 01-DEC-2014. It was reported that the patient had administered expired FLUMIST Quadrivalent which started on 01-DEC-2014. The outcome of the event of expired FLUMIST was unknown. The report was considered to be non-serious.
Some aching in back thighs and legs; little numbness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ANAESTHESIA (little numbness at injection site) and PAIN IN EXTREMITY (Some aching in back thighs and legs) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Arthritis. Concomitant products included CALTRATE + D PLUS, AMLODIPINE, OMEPRAZOLE, LOSARTAN, HYDROCHLOROTHIAZIDE, METOPROLOL, SIMVASTATIN and SERTRALINE for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE ANAESTHESIA (little numbness at injection site). On 07-Feb-2021, the patient experienced PAIN IN EXTREMITY (Some aching in back thighs and legs). On 06-Feb-2021, VACCINATION SITE ANAESTHESIA (little numbness at injection site) had resolved. At the time of the report, PAIN IN EXTREMITY (Some aching in back thighs and legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications Caltrate, Amlodipine, Omeprazole, Losartan, Hydrochlorothiazide, Metoprolol, Simvastatin, Sertraline. Treatment
headache, nausea, chills for brief period of time, muscle ache, fatigue  Took Tylenol, as suggested by pharmacy, after approx 12 hrs which relieved the headache and nausea. Fatigue and reduced aches lasted approx 24 hrs.
Pt was arrived due to missing dialysis and having volume overload and uremia secondary to noncompliance and hemodialysis. The pt was tested for COVID despite being asymptomatic and was positive.
4 year old child received Fluzone 0.25ml rather than indicated 0.5ml as a medication error/No AE; 4 year old child received Fluzone in in the left vastus lateralis/No AE; Initial information received on 17-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 4 years old patient who received 0.25 mL dose instead of 0.5 mL dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] lot UT6647JA, expiry date 30-06-2020 via intramuscular route in the left vastus lateralis on 09-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to vaccine underdose and vaccine administered at inappropriate site.  At the time of report no adverse event was 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.
poss of seizures;EEG-irregular waves on rt hemisphere is the possibility of seizures;
Moderate severe headache, chills, muscle aches and muscle spasms/cramps.  Severe enough to keep me in bed the following day.
10 days after smallpox vaccination patient with myalgias, neck ache, chest discomfort.  Admitted with EKG changes, grey zone troponins, elevated c-reactive protein.  Symptoms decreased after approximately 3-4 days. 03/21/08-records received for DOS 2/12-2/15/08-DC DX: Pericarditis. Resolving cellulitis at vaccine site.  Admitted with 3 days of flu like symptoms to include fatigue, generalized muscle aches, congestion, diaphoresia, fevers, headache and chest pressure, lightheadedness and presyncope, hand tingling. Mild blurred vision and photo/phono phobia. Erythema right shoulder at site of vaccination.
Patient presented to emergency department on 11/2/2021 with cough, shortness of breath, and fever. She test positive for COVID-19 on 10/26/2021. She was treated with dexamethasone and remdesivir. She was discharged home on 11/6/2021.
pt exp palpitations, fatigue & a low-grade fever following vax w/Engrerix-B;
The patient had fever, chills, body aches, and headaches; The patient had fever, chills, body aches, and headaches; The patient had fever, chills, body aches, and headaches; The patient had fever, chills, body aches, and headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 06Oct2023 at 22:00 as dose 1, single (Lot number: HG2282) at the age of 31 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine inact split 4v (FLUZONE QUADRIVALENT), on 06Oct2023 as dose number unknown, single (Lot number: UT8076JA) for influenza immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ROBITUSSIN [MENTHOL]; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; CLARITIN [CLARITHROMYCIN]; BIOTIN. Vaccination history included: Covid-19 vaccine (DOSE 1; Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 4 (BOOSTER); Manufacturer Unknown), for COVID-19 immunization. The following information was reported: PAIN (non-serious), PYREXIA (non-serious), CHILLS (non-serious), HEADACHE (non-serious) all with onset 07Oct2023, outcome "recovered" (Oct2023) and all described as "The patient had fever, chills, body aches, and headaches". Therapeutic measures were not taken as a result of pain, pyrexia, chills, headache.  Additional information: Concomitant medications (or Other medications in two weeks) also included Womens Multivitamin, Stress Relief Gummies, Vitamin D Gummies. Patient had no known allergies. No COVID prior vaccination. Not tested for COVID post vaccination. Facility type vaccine was Pharmacy or Drug Store. No other vaccines received within four weeks.
Information has been received from a Nurse practitioner and the patient's grandmother, for GARDASIL, a Pregnancy Registry Product, concerning a 15 year old female patient with no pertinent medical history, drug reactions or allergies reported, who on 05-APR-2011 was vaccinated with her first dose of GARDASIL (Lot #: 667866/1437Z, Exp: 25-FEB-2013) (Dose and route not reported). Concomitant therapy included a dose of MENACTRA (lot #, dose and route not reported). The nurse reported that the patient received the first dose of GARDASIL and then was found to be pregnant. The patient performed a pregnancy test at home on 05-APR-2011, prior to receiving the first dose of GARDASIL. The office discovered the pregnancy on 05-APR-2011, when they performed a pregnancy test in the office (for another procedure) after the patient received the first dose of GARDASIL. The grandmother reported that while her granddaughter was in the clinic on 05-APR-2011, she had a urine pregnancy test before the first dose of GARDASIL. No adverse event reported. Home and office (unspecified type) pregnancy tests were performed with positive results and unspecified blood tests (results not provided). Follow-up information was received from the patient's grandmother who stated that on an unspecified date in April 2011, the patient's pregnancy had miscarried. Upon the internal review, miscarriage was determined to be an other important medical event. Additional information has been requested.
A 68 year old patient was vaccinated with MENACTRA, no AE; Initial information regarding an unsolicited valid non-serious case was received from other health professional via consumer/non-health care professional via Medical Information (Reference number- 00763830) and transmitted to Sanofi on 10-Sep-2021.  This case involves a 68-year-old female patient who was vaccinated with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] [Product administered to patient of inappropriate age].  The patient had ongoing medical history of Basal cell carcinoma.   Past vaccination(s) and family history were not provided.  Concomitant medications included ECULIZUMAB (SOLIRIS); and RUXOLITINIB PHOSPHATE (JAKAFI).  On 06-May-2016, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to inappropriate age at vaccine administration (latency same day).  No adverse event was reported.  It was reported "Registered pharmacist (RPh) Intern has questions regarding MENACTRA and a patient who had received an injection on 5/6/2016 and is also being treated for Basal Cell Carcinoma. The pharmacy intern states that she is aware of what it says in the Principal Investigator (PI) but she is making sure on what the procedure is for this patient because it has been more than 5 years and she is on chemotherapy. The pharmacy intern states that the patient is being treated for basal cell carcinoma and they are on Soliris and Jakafi. She states that the last time they received Menactra was on 05/06/16"  She was asked for the lot number for the Menactra the patient received on 05/06/16 but she did not have this information so the rest of the questions on the Management of Adverse Events and Product Technical Complaints and for the Pasteur adverse event (AE) Reporting were not asked   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.  There will be no information available on the batch number for this case.
Very bad headache, dizziness, fever, vomiting, diarrhea, body aches, chills, hot flashes. They started the morning after vaccine and got worse through the day when I woke up the next day I was feeling somewhat better, the headache had subsided but still ran low grade temperature and diarrhea. By that evening the symptoms were almost completely gone.
No additional AE details were provided; a patient that was administered a dose of PROQUAD that was involved in a supported temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unspecified age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 02-SEP-2022 the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human Albumin (rHA) (PROQUAD) 0.5 milliliter, lot #U039259, expiration date: 09-JUN-2023, (anatomical location was not provided) administered subcutaneously as prophylaxis (Product storage error).  The improperly stored dose underwent a temperature excursion of 12.1 degrees Fahrenheit (F) for 12 hours without previous excursions. No adverse events were reported.
Information has been received from a Registered Nurse concerning a 24 year old female who on 10-NOV-2009 was vaccinated IM with a first dose of GARDASIL (lot number: 663552/1350Y). The nurse told that the patient called at the office and stated that she experienced a high fever of 101 with chills and aches on 12-NOV-2009. The patient reported that the symptoms resolved within 24 hours of onset (on 13-NOV-2009). The patient sought medical attention at the physician's office. Follow up information has been received from Registered Nurse who reported that 24 year old female patient who on 10-NOV-2009 was vaccinated with a first dose of GARDASIL (lot number: 663552/1350Y) in the left deltoid. On 13-NOV-2009 " (also reported by Registered Nurse as on 12-NOV-2009)", the patient complained of temperature of 101 with chills. As of 13-NOV-2009, she was feeling better. It was reported that she felt it may be due to GARDASIL but today. On 16-NOV-2009, a telephone follow up to the patient who reported that she was feeling better and the symptoms were developed into a cold. Additional information is no expected.
flu like symptoms--aches, chills, headache, fatigue, followed by red rash over left chest area, with itching Treated with benadryl with little effect.  Received Rx for dosepack Prednisone. Also applied cortizone OTC to rash area.  Flu like symptoms abated wtihin 36 hours; rash improving more slowly.
Five days after receiving my Pfizer booster, I developed a herpes zoster lesion on my left upper arm  approximately the size of a silver dollar; symptoms of itching, redness, swelling, and blisters.   I applied acyclovir ointment 5% topically and it is slowly getting better.  This has been a chronic site of herpes zoster in the past and usually only erupts about once per year.  This lesion has now erupted after my first, second, and third dose of Pfizer so know that there must be a connection to the Pfizer vaccine.  Also, this third dose reaction appears worse in size and intensity even though I have received both doses of Shingrix in 2019.  I would like to know what the health implications are?  Is the Pfizer vaccine making my Shingrix vaccine null and void?  Do I need to get vaccinated again with Shingrix?  How is this affecting my immunity against Covid-19?  Is my body able to produce antibodies against Covid-19 as it is supposed to do?
Patient received the second dose of the Moderna COVID-19 vaccine more than 35 days after the first dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose of the Moderna COVID-19 vaccine more than 35 days after the first dose.) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 009D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose of the Moderna COVID-19 vaccine more than 35 days after the first dose.). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the second dose of the Moderna COVID-19 vaccine more than 35 days after the first dose.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and 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.