chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccine was administered to a 15 year old patient today with no reported adverse event; Initial information received on 17-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 years old female patient who was administered with Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Prophylactic vaccination; HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) for Prophylactic vaccination; and VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (VARIVAX [VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK)]) for Prophylactic vaccination.  On 17-Jul-2023, the patient received 0.5 ml dose of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (lot number: C5969AD, Expiry date: 17-Feb-2023) (Strength: Unknown) via intramuscular route in the right arm for immunization.  On 17-Jul-2023, the 15 years old patient was administered to a 15 year old patient with Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine with no reported adverse event (product administered to patient of inappropriate age) (Latency: same day).  It was reported, Medical Assistant reported that the wrong vaccine was administered to a 15 year old patient today. Caller would like to know how to proceed. Product: DAPTACEL. This situation is reported as a medical error due to the administration of DAPTACEL to a patient of an age that is not indicated for use with this product.   Action taken: not applicable.  Outcome: Unknown   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 guidelines. 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 reports have "bad" headaches "on and off" since recieving vaccine. Patient verbalized that headache are not normal for her. Provider was consulted and patient was told to go to the nearest emergency room right away. Patient stated that she would be able to go tomorrow. Patient encourage to go today but still refused.
This is a spontaneous report obtained from a contactable pharmacist. A 73 year old male patient of an unspecified ethnicity received, on 11Oct2016, the second dose of PREVNAR 13, (Lot. M51193, Expiration date: May2017, NDC number: 00005197102) intramuscularly, in the right arm, 0.5 ml, single dose, for immunization. Relevant medical history was unknown. Concomitant medication included influenza vaccine (Manufacturer: Sanofi), received on same date of Pfizer vaccine, in the right arm. The patient previously received one other dose of PREVNAR 13 for immunization, on an unspecified date. On an unspecified date, the patient experienced sore arm and his body was achy. Clinical outcome of the events was unknown at time of this report.
The patient came into the health department on 5-10-2021 to schedule an appointment for a COVID vaccine. The clerical staff checked GRITS and there was not a COVID vaccine entered into GRITS. The patient was scheduled for 5-11-21. The patient was given what I thought was her first COVID vaccine on 5-11-21. The patient checked no that she had not had a COVID vaccine on the consent form.  After entering the vaccine into GRITS, it was discovered that this was the second COVID vaccine. The first COVID vaccine was given on 4-30-21 and was not entered into the system until 5-10-21 at 9:59.  The first vaccine was given by MGCC Pharmacy. I called the patient and the sister stated that she had been incarcerated in Pulaski County on 4-30-21 and the sister was unaware that she had gotten the first vaccine. Advised that the patient did not need another COVID vaccine at this time.
Fluzone High Dose on 06nov2019 and another today in the same site left arm, no AE; Initial information received on 26-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 67 years old male patient who was vaccinated with a 0.5 mL dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ301AA, expiry date: 24-Jun-2020 via intramuscular route in the left arm on 06-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to extra dose administered. It was reported that the patient received a Fluzone High Dose on 06nov2019 and another today.  At the time of reporting, 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 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.
Diffuse maculopapular rash 6 days after administration of MMR and varicella. No itch. No fever. No other symptoms
None stated 4/4/08-records received for DOS 2/7/08-DC DX: Seizure. Influenza A. Seen in ED for left sided twitching then right sided twitching, eye fluttering. Temp 101.6. Tonic clonic seizure activity  1/21/2010 Chronic recurrent seizures. Pt has not been seen since 1/17/08. Pt did see a neurologist for seizures.
chest tighened on first dose, history of cardiomyopathy, second dose has same feeling, does not feel like angina
An 82 year old female patient with a medical history of no known allergies developed slight dizziness and felt very much fatigued approximately 1-2 days after the influenza vaccine and Pneumovax administration on an unspecified date. The patient was not recovered at the time of the report.
Information has been received from a physician concerning a 13 year old female with attention deficit disorder and no history of drug reactions or allergies who on 11-APR-2008 was vaccinated with the first dose of GARDASIL (LOT#: 659962/1740U) and on 16-JUN-2008 was vaccinated with the second dose of GARDASIL (LOT#: 660389/1968U). Concomitant therapy included oral birth control and ADDERALL. One week after the second vaccine (on approximately 23-JUN-2008) the patient developed joint pain that continued to get worse. She was not able to bath herself. She developed short term memory loss and blurred vision. The patient saw her primary physician and the physician ordered a magnetic resonance imaging (MRI) that revealed a cerebral vascular accident (CVA). The patient was hospitalized. Further diagnosis revealed the patient had lupus and antiphospholipid syndrome. As of 11-AUG-2008 the patient was recovering. Additional information has been requested.  08/25/2008 MR received from PCP from 6/13/08 to 8/7/08. Pt presented 6/13/08 for well check with normal exam and no c/o.  Some recent weight loss due to increased activity while training for an athletic event. Seen again 7/1/08 with c/o 3 wk hx of arthalgias, myalgias, weight loss and fatigue. Pt reports poor memory. Subjective fever past weekend as well as swelling of R ankle.  Recent ?tick bite. Seen again 7/10/08 with persistant arthralgias, fatigue, muscle aches and loss of vigor. Currently with night sweats and increased transaminases.  Rheumatology consult 8/7/08 with DX:  SLE characterized by a midbrain stroke and positive labs.  On anticoagulants for the CVA. MD reports sx started after 2nd Gardasil dose. PE (+) for several areas of bruising, otherwise WNL. 9/10/2008 MR received for DOS 7/29-8/01/2008 with D/C DX:  Antiphospholipid syndrome.  Positive ANA, questionable reactive vs true Systemic Lupus Erythematosus.  Ischemic stroke.  Pituitary adenoma as an incidental finding on MRI. Pt presented with 5 week hx of myalgias, one week hx of vision changes as well as fatigue, arthralgias, fevers, personality changes, decreased energy, and slowed speech. Recent onset blurry vision, dizziness, loss of peripheral vision, short-term memory loss and weight loss. Sx noted after receipt of Gardasil vax. PE (+) for ankle edema, DTRs 3/4, slightly unsteady gait.  Ischemic stroke of unknown etiology found on MRI as well as pituitary adenoma.  Neuro consult  PE (+) for nystagmus, internal left strabismus, and tonsillar hypertrophy. Pt also reports bilateral calf pain. Tx with anticoagulation and d/c or oral contraceptive with sx resolving by d/c. To f/u with rheumatology and neurosurgery as outpt.
The patient received flu shot first, then Covid 19 shot. Patient fainted/slumped in chair after covid shot. Patient recovered quickly.
Patient received vaccine (HPV) 2nd dose during pregnancy.  Reported to Merck 6/17/08.
The patient suffered herpes zoster and postherpetic neuralgia; The patient suffered herpes zoster and postherpetic neuralgia; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. The pt's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unspecified date, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving zoster vaccine live (ZOSTAVAX), the pt suffered herpes zoster and postherpetic neuralgia. As a result of these symptoms, the pt was seen and treated by medical providers and was still under their care. It was also specified that the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of herpes zoster and postherpetic neuralgia was unknown. The events were considered to be related to zoster vaccine live (ZOSTAVAX) vaccination.  The events were considered to be disabling due to serious, permanent and incurable injuries.
DEATH; ADVERSE REACTION; This spontaneous report received from a consumer via social media via a company representative concerned a 29-year-old male of unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported)1 total, dose, start therapy date were not reported for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  It was reported that ""The Johnson and Johnson vaccine contributed to the death of my grandson only 29 adverse reaction to a mandated vaccine to keep his new job." On an unspecified date, the patient died from unknown cause of death. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse reaction was not reported. This report was serious (Death).; Sender's Comments: V0 20211234915- COVID-19 VACCINE AD26.COV2.S-Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Fatigue, not so much hot flashes, I started coughing and I started hacking. It was like a dry cough, and I can normally get a few sentences out and I start coughing. I feel like I have bumps on the back of my throat because I can't speak. I went to see my doctor 2 days ago because it's been a week, I haven't eaten anything, so she decided to test me, and it came back as something Viral. She ended up prescribing me Benzonatate 100MG 3 times daily and if I didn't feel any better within 10 days to go see my primary care physician.
Started showing signs of having a stroke. Went to hospital and admitted as Stroke Alert. After further tests it was determined I had Bell's Palsy.
This spontaneous report as received from a healthcare worker (medical assistant, M.A.) refers to an unknown number of patients of unknown age and gender. Pertinent medical history and drug reactions or allergies were not specified. On an unknown date, the patients were vaccinated with doses of GARDASIL (unknown dose in series, 0.5 ml, subcutaneously administered) that were stored at 34.7 Fahrenheit (F) for 36 hours. Affected lots included: lot number H021861, expiration date 09-OCT-2015; lot number H020901, expiration date 05-JUL-2015, lot number J013277, expiration date 06-AUG-2015 (reported as 05-AUG-2015) and lot number reported as J015375, expiration date 09-APR-2016. Concomitant medications were not specified. No adverse effects were reported. Lot number J015375 is an invalid lot number for GARDASIL. This is one of several reports received from the same reporter. Additional information has been requested.
Additional dose (0.5mL) was administered to patient who only qualified for Booster dose (0.25mL) due to confusion regarding new booster dose that was authorized the day prior.  Patient was notified the following  Monday (10/25/2021) of the dose mistake and reported that she had not experienced any symptoms over the weekend and was feeling fine.
covid vaccine breakthrough case  dose 1 Moderna 2/26/21 no lot number given dose 2 Moderna 3/25/21 no lot number given
In 11/2021 I began having dry eyes, dry throat and itching in the throat as well. I use eye drops but even with the eye drops my eyes were still getting dry. I called my eye doctor and went in for an appointment. He told me both eyes were extremely dry. Normally my eyes don't react this way to the change in season. He put me on a new eye drop that is working better but my eyes are still a bit dry. Also, I normally don't have headaches but all of the sudden I am getting intermittent headaches. I experienced this after the first two Covid shots as well.
Severe Headache on day of injection (5/20/2021)  and then  nausea, increased water intake and frequent urination (07/08/2021) then  vomiting, dizziness and severe dehydration starting (07/23/2021). Hospitalized with Diabetic Ketoacidosis.  Diagnosed with Type 1 Diabetes due to unknown  causes. Permanent damage to pancreas unable to produce insulin; will require insulin therapy for Type 1 diabetes for life.
Could not function correctly; Headache; Body aches; Chills; They had to go to sleep; He felt really exhausted and drained.; This is a spontaneous report from a contactable consumer or other non-Healthcare professional. A 46-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiry date: unknown) via an unspecified route of administration, administered in left arm on 19Apr2021 at 11:30 am (age at vaccination was 46 years) as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. Medical history included blood pressure. The patient did not have any family medical history relevant to adverse events. Concomitant medications included lisinopril (40 mg, taking for quite some time, 3 or 4 years) taken for blood pressure and nifedipine (30 mg, taking for same amount of time as Lisinopril) taken for blood pressure. The facility where the most recent COVID-19 vaccine was administered was other. The vaccine was not administered at Military Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other additional vaccines were administered on same date of the Pfizer Suspect. On an unknown date, the patient could not function correctly and experienced headache, body aches and chills. The caller and his wife had both doses of the Pfizer vaccine. After the first dose, both could not function correctly. The caller explained that both he and his wife could not function correctly the day after both shots. They had to go to sleep. He said that the headache, body aches and chills started the same day as the shot after both shots. The caller reported that he took Advil and he was sleeping. The patient did not have physician office or emergency room visit due to the events. No relevant tests were done. The outcome of the events could not function correctly, headache, body aches and chills was resolved on an unknown date in 2021. The outcome of the events they had to go to sleep and he felt really exhausted and drained was unknown.
MOM PHONED ON 11/01/2010 AND REPORTED TO RN, APRN, CPNP THAT PATIENT STARTED VOMITING, DIARRHEA AND FEVER UP TO 104 LAST NIGHT.  NO VOMITING 11/01/2010 BUT STILL DIARRHEA AND FEVER UP TO 103. ON 11/02/2010 RN CALLED MOM AND WAS TOLD PATIENT WAS ADMITTED TO MEDICAL CENTER ON 11/01/2010 WITH 1.RIGHT PERIHILAR PNEUMONIA 2.HISTORY OF BRONCHOSPASM AND 3.VOMITING AND DIARRHEA (WILL FAX HOSPITAL NOTES)
No additional AE; temperature excursion for VARlVAX; This spontaneous report was received from a registered nurse (conflicting information as the reporter's title was reported as medical assitant) referring to a 52-week-old patient of unknown gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 14-SEP-2021, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot number U015682, expiration date 18-MAY-2023 (dose and route of administration not provided) for prophylaxis. No adverse event was reported.         The vaccine experienced a temeprature excursion on 07-SEP-2021 of 4 degrees Celsius (°C) for 20 minutes and on 09-SEP-2021 for the same temperature and duration. The vaccine experienced a previous temeprature excursion of 4°C for 7 hours and 30 minutes; Sender's Comments:  US-009507513-2109USA005628:
Patient had completed her 15 minutes in recovery area and upon rising to exit the area, became dizzy, unsteady and needed to sit back down.  Patient informed the recovery Nurse, had not eaten anything yet today.  Initial VS check,  1330: B/P 158/100, HR: 71, O2 Sat 96%, recheck at 1349: 142/82, HR: 68, O2 Sat 98%, provided with simple snacks, maintained in recovery area for add'l 15 minutes, stable, 911 not activated, dc from recovery area, stable, AAOx4, left recovery area ambulating freely.
29-year-old male chief complaint of fevers chills body aches and back pain after Johnson & Johnson vaccine.  On arrival vital signs stable.  On exam patient with no meningismus no focal neurologic deficits.  Suspect vaccine reaction.  Counseled patient on taking supportive medications and follow up with primary care physician.  Patient in agreement with plan.
Headache, Sedation, Myalgia, Arthralgia, UrticariaPruritus, Diarrhea, NauseaVomiting, chills and fatigue. arm with injection was stiff. also reports flu like symptoms. Narrative:
Patient got BOOSTRIX 4/10 and came in 4/11 to show his arm is red, swollen to the touch. Told him to ice it and take ibuprofen.
pt vomiting on 5, 7 & 14 DEC98;pt recv vax 15DEC98 &  19DEC98 mom reported that pt was vomiting;MD instructed mom to take pt to ER;dx of intussusception was made & pt underwent surgery on 20DEC98;
Pt given SHINGRIX at 10:20am. Pt. advised due to 1st dose of she should stay in clinic. Checked with PA. at 10:27am. Pt. reported lightheaded, weakness and was diaphoretic. Vital signs monitored closely.
aching in should & upper arm began immed tingling for neck down to fingers the next day followed by persistent pain from scapula down lateral lt arm to thumb;
Severe abdominal cramps, diarrhea, nausea, dry heaves, fever over 102
12/28/2021 @ 08:25 AM: Numbness of left arm and tingling on fingers.  Was kept in observation in observation room and assessed in the urgent care. Feeling better and resolved on same day.
Ever since the 1st hot I developed a superficial blood clot in the left calf with pain. The same thing is happening again after the third shot- but this time the throbbing pain and numbness occurs most of the day instead of just at night. I have had several ultrasounds.  After the ultrasound on my left calf at Urgent Care my left hand felt like it was going to explode - but they did not find a clot in the leg. When I had an ultrasound at Health center the pain in my groin left but my left ankle and left calf felt like it was getting worse - they did not find a clot in my left calf.  When I had an ultrasound at Health on my left arm and left calf - they did not find a clot.  Since the 3rd shot my left calf is pain and numb, I have lightheadedness like the time I passed out from the 2nd shot, and I have loss of vision. I have had my eyes checked and also seen ophthalmologist - nothing wrong with my eyes. I also have memory loss. Today I couldn't remember how to drive to my bank.
Local injection site soreness (within 1 hour of administration); fever/chills, fatigue, and myalgias (approximately 7 hours following injection). Improved with acetaminophen and ibuprofen. Fever/chills resolved within 12 hours of onset. Myalgias and fatigue resolved within 48 hours of onset.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s). The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Oct2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 68 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN, start date: Apr2020; METAFORT, start date: Aug2020. Past drug history included: Emycin, reaction(s): "known allergies: Emycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Dec2022, latency 10 days after the suspect product(s) administration, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors, however a contributory role of the suspect drug to the reported events DRUG INEFFECTIVE and COVID-19 be ruled out.,Linked Report(s) : US-PFIZER INC-202300002128 Same patient, different product and event;
(R) deltoid sore, (R) arm mild-moderate edema. Fever at 100-101 deg. F, inappetence, HA, dry mouth, generalized discomfort. Breathing not affected. No tachycardia.