chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administration of QUADRACEL to a patient that is 10 years old (with no reported adverse event); Initial information received on 24-Apr-2023 regarding an unsolicited valid  non-serious case received via other health professional.  This case involves a 10 years old male patient who was administred  quadracel (with no reported adverse event)  The patient's past medical history, medical treatment(s), concomitant(s) and family history were not provided.    On 06-Apr-2023, the patient received suspect diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine Suspension for injection at dose of 0.5 ml (lot U756AA, Expiry date: 08-Nov-2024) (strength: unknown) via intramuscular route in the right deltoid for prophylactic vaccination (immunization).  On 06-Apr-2023 the patient was given quadracel to a patient that is 10 years old (product administered to patient of inappropriate age) (same day latency) (with no reported adverse event)  Action taken was not applicable.  At time of reporting, the outcome was 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 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.
Flare up; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Flare up) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced CONDITION AGGRAVATED (Flare up). At the time of the report, CONDITION AGGRAVATED (Flare up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided. No treatment information mentioned.  On an unknown date, patient experienced a flare up post taking the booster dose.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
The vaccine was maintained at proper refrigeration temperatures, but for longer than 31 days.  7/29/21 was day 31 at refrigeration temps and vaccine was given on 8/16/21.  No adverse events have been reported by patient.  Error discovered on 8/16/21.
The patient came to the pharmacy on 5/8/19 to receive his first dose of the SHINGRIX vaccine. On 7/15/19 the patient contacted the pharmacy and spoke with the pharmacist intern about experiencing an adverse reaction to the vaccine 4 days after it was administered. The patient said that he had extreme difficulty with breathing and decided to seek treatment at the emergency room.
he felt hurt, with pain; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 56 year-old male patient received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset Nov2021, outcome "recovered" (2021), described as "he felt hurt, with pain"; PYREXIA (non-serious) with onset Nov2021, outcome "recovered" (2021), described as "fever". The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient given DTaP instead of Tdap. I spoke with patient who is aware of error. She had a swollen red arm the day after the immunization. It is feeling a little better today (6/26/06).
I had no adverse events from the vaccine itself. I had a post-vaccine case of COVID19. The COVID infection was concurrent with a then two-week old cold. I was treated with Paxlovid and subsequently with antibiotics. It was impossible to distinguish which symptoms were precipitated by COVID and the cold.
Pain in shoulder that has not improved over 2 months later, decreased range of motion of the left arm/shoulder. Difficulties carrying out normal tasks that I use the left arm for.
Systemic: Exhaustion / Lethargy-Mild, Systemic: seizure-Mild, Systemic: Seizure-Mild, Additional Details: immediately after administratn, patient had a seizure. His hands,arms, and legs had uncontrolled jerking movements.  The occurence lasted approximately 1 minute.  Afterwards, patient was alert and indicated that he was very tired and was sweating.  Patient was seated on a chair; his head did not hit anything.  911 was called and emergency response personnel was at the premise within 5 to 10 minutes.  Patient was taken to hospital.  Patient stated to EMS that he did not lose consciousness.
Fever 101.0 degrees, body ache, decrease energy, sciatica, sore at injection site. Never had a reaction to  the Influenzas Vaccine. Will see HCP in the am if signs and symptoms worsen.
This case was reported by a consumer and described the occurrence of tiredness in a 65-year-old male subject who was vaccinated with influenza virus vaccine (Fluarix, GlaxoSmithKline) for prophylaxis. A physician or other health care professional has not verified this report. Concurrent medical conditions included diabetes and hypertension. Concurrent medications included Diabetes medication and Antihypertensive (Hypertension med). On 13 October 2007 at 13:15 the subject received unspecified dose of Fluarix (.5 ml, unknown). On 14 October 2007, 1 day after vaccination with Fluarix, the subject experienced tiredness. on 14 October 2007, the event was resolved.
Information has been received from a physician referring to his sister. There was no concurrent condition or medical history reported. On an unknown date the patient was vaccinated with ZOSTAVAX (dosage, strength, route and lot # unknown). There was no concomitant medication reported. On an unknown date, after receiving ZOSTAVAX the patient developed shingles. At the time of the report (28-DEC-2015), it was unknown if the patient continued to receive ZOSTAVAX and the outcome of the shingles was unknown. Additional information has been requested.
C/O dizziness.  BP 77/64, pulse 74, O2 Sat 100% on RA.  Encouraged to stay for additional Observation & agreed. Sat in chair with feet elevated & had water to drink. Symptoms resolved, BP 88/62, Pulse 77,  & O2 sat 100%. Encouraged to follow up with ER, Urgent Care, & Primary Physician. Verbalized Understanding. Awake, Alert, & Oriented.
I've never had an issue with my hands. I had a hand pain that was really severe. I was misdiagnosed by the first doctor, and they did a nerve conducting study. They thought it was a hand string, and they told me stop taking the muscle relaxers. I can't hold cold drink because my hands start to hurt. It prevented me with being able to write. I was prescribed 800mg Ibuprofen I couldn't take the pain, then I was given Gabapentin I had to stop my treatment due to being pregnant.  They haven't diagnosed me with anything, Nov 22nd. to discuss the ENG that they submitted.
Circular rash with a circumference of 7inches to the right tricep. Tender, itchy, warm to touch with redness.
I was chilling so badly that I began to shake. This lasted several hours. I had a fever that lasted several days. I had a great deal of fatigue and it seemed to be difficult to breathe for a while.
Pt walked from pt room to lobby, she then fell to the floor. she momentarily lost consciousness, when I came around the corner she was already regaining consciousness and was alert and  oriented X 3.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 01-OCT-2015, the patient was inoculated with ZOSTAVAX vaccine (Dose, route of administration, site of administration, Lot number and expiration date were not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 27-JUN-2016, the patient was treated by a physician at a dermatology office for a vesicular outbreak, which was diagnosed as herpes zoster or shingles.  As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, he has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
This case was reported by a nurse via sales rep and described the occurrence of dizziness in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was unknown. It was unknown if the reporter considered the dizziness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced dizziness about a month ago from the time of reporting. The dizziness resolved after a day. The healthcare professional did not have any other information and didn't have additional time to talk. The healthcare professional was opened to follow up on this adverse event. The patient complained of unusual dizziness next morning.
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 03-DEC-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L024264, expiration date: 01-JUL-2017) (incorrect product storage). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
01/05/22 presents to ED for "shortness of breath and generalized weakness". PMHx of "afib, htn, COPD not on home o2, Afib on eliquis, prior PE, colectomy with ostomy"
pt called p/inj 24hr later approx w/a silver dollar sized knot on arm that was red w/hot & painful radiating under arm;symptomatically tx w/Ibuprofen et ice;
mild disease/ cold-like symptoms; 5 of our employees tested positive for breakthrough infections/ all 5 were vaccinated with the same lot # of Moderna; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (5 of our employees tested positive for breakthrough infections/ all 5 were vaccinated with the same lot # of Moderna) and NASOPHARYNGITIS (mild disease/ cold-like symptoms) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Jul-2021, the patient experienced COVID-19 (5 of our employees tested positive for breakthrough infections/ all 5 were vaccinated with the same lot # of Moderna). On an unknown date, the patient experienced NASOPHARYNGITIS (mild disease/ cold-like symptoms). At the time of the report, COVID-19 (5 of our employees tested positive for breakthrough infections/ all 5 were vaccinated with the same lot # of Moderna) and NASOPHARYNGITIS (mild disease/ cold-like symptoms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter.   This case was linked to MOD-2021-270723, MOD-2021-270623 (Patient Link).
Patient developed acute chest pain 2 days after administration of the 2nd dose of the COVID vaccine. Contacted PCP on the third day post vaccination. PCP directed him to be seen in the ED. Patient noted to have ST elevation on ECG with elevated cardiac enzymes (CKMB and troponin) thus was admitted to the PICU. Echocardiogram showed normal cardiac function. Troponin level increased further following admission, however CKMB started to trend down. Remained hemodynamically stable and did not require any significant interventions (IVIG, vasopressors, ECMO, steroids, etc). Chest pain resolved on admission to PICU.
Started having severe migraines with Autoimmune Lupus diagnosed after reporting tinnitus, chest pressure, migraines, joint pains, and extreme fatigue with ear fullness, blurred vision and vestibular and hemiplegic migraines.  These events continue daily and do not subside unless given a steroid pack. Can only do steroid pack every three months. Symptoms above occur daily and have prohibited me from working through most of 2021.
Re-immunization 11:00 am on 9/15. By evening, the pt's arm from elbow to shoulder was red, hot, swollen, and painful all the way down to fingers. Medical intervention-Prednisone.
Patient described to this PHN fever, chills, very sore arm starting  the night after receiving the injection.  Soreness in arm continued for 3 weeks, on and off.  Sometimes it felt like deep bone pain, she described as excruciating.  Sometimes woke her at night.  Did not occur every day.  Some arm swelling.   The injection was given at where she works.   This PHN did not give the vaccine, but patient called to inform of reaction.  We were going to complete this form together, but patient decided she'd do herself.  I am not certain she will, so am sending the info I was told.  She received 2nd injection 3/1/2021.  Side effects seem less vigorous, by report, so far this time.
Information had been received on 10-MAY-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient (age unknown) was inoculated with ZOSTAVAX on or about 12-SEP-2013 at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles (dosage and lot#/expiration not reported). The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 28-AUG-2014, patient was treated by a physician assistant for a painful rash that was diagnosed as shingles. Patient had been prescribed valacyclovir (VALTREX) to manage her persistent symptoms and outbreaks. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Stroke; Heart Failure; Ill defined-disorder; This spontaneous report was received from a lawyer and refers to a patient of currently 78 year-old of unknown gender concerning a case in litigation. The patient's concurrent condition's, medical history, historical drugs and concomitant medications were not reported.  In 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route, lot number and expiration date were not reported) for long-term prevention of shingles and zoster-related conditions.  On an unknown date, the patient experienced stroke (cerebrovascular accident), heart failure and other zoster related conditions (ill-defined disorder), the patient was treated with unspecified therapies.      The outcome of cerebrovascular accident, ill-defined disorder and cardiac failure was unknown.     The reporter considered cerebrovascular accident, ill-defined disorder and cardiac failure to be related to Zoster Vaccine Live (ZOSTAVAX).     Upon internal review, the events of heart failure and stroke was considered medically significant.
pt recv vax 29SEP97 & 3OCT97 pt exp fever of 101;pt was treated w/one dose of motrin;
Swelling in feet beginning several hours after vaccine was admin.   Continued thru ought that day 4/30/21 until completely subsided this morning (5/2/21) upon awakening.
Dolor de piernas, calambre en piernas, falló al levantarme para caminar, en la pierna derecha en la parte de atrás se me formo un chichón el cual me dolio, hace unos días tuve mi periodo, regularmente soy una persona que sangra bastante, esta vez fue muy distinta, pude estar bastante horas con una misma toalla yabque cada vez que iba al baño estaba limpia, pero al secarme es donde se podía apreciar la sangre, como que no me bajo bien la sangre, nunca me había ocurrido algo similar.
Lack of Response - Information has been received from a health care professional concerning a 25 year old male medical student with dust.  Mite leather, and mold allergies who on 31 Jul 1997 and 08 Oct 1997 was vaccinted with the first (17073 invalid lot number ) and second dose (lot 620626/1400d) of varicella virus vaccine live in the left and right upper arm respectively.  Concomitant therapy included methlphenidate (ritalin).  On 13 Apr 2000 lab work indicated a negative titer.  On 12 May 200 the patient received a third dose of varicella virus vaccine live 632375/1340J
Patient received MMR vaccine 4/22/15. Developed fever x 3 days (101-104 degrees), Koplik spots and rash on body 7 days after vaccine.
This case was reported by a consumer and described the occurrence of sore muscles in a 24 year old female pt who received Twinrix. The reporter is the pt. A physician or other health care professional has not verified this report. This pt experienced local injection site soreness following receipt of prior immunizations. On 2/8/05, the pt received the 3rd dose of Twinrix in the left arm. At an unspecified time following the 3rd dose of Twinrix, on 2/8/05, the pt experienced sore muscles. The following day, on 2/9/05, the pt experienced diarrhea, nausea and exhaustion. The pt was seen at a physician's office. The events had improved as of the time of initial reporting, 2/10/05.
Information has been received from a health professional concerning a patient who was vaccinated with a second dose of Gardasil.  Subsequently the patient experienced pain in the arm radiating into the fingers.  It was an intense pain that could last through the day.  This occurred in three to five girls in the practice.  It was unknown whether medical attention was sought.  The patient's outcome was unknown.  No product quality complaint was involved.  Additional information has been requested.
No other AE reported; GARDASIL 9 has been administered since the temperature excursion; This spontaneous report was received from a Agent referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.     On 30-DEC-2020, the patient was vaccinated with improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # S010729 with expiration date 01-DEC-2021, lot # 1637648 with expiration date 19-JUN-2022; dose and route were not reported) for prophylaxis (product storage error). The administered doses experienced a temperature excursion of 32.9 Fahrenheit (F) for 24 minutes and 34F for 16 hours. It was not applicable if there was previous temperature excursion. A "data logger" was involved. No product to retrieve. No product quality complaint (PQC) reported. No other adverse event reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S010729; expirationdate: 01-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Information has been received from a Registered Nurse referring to a 12 month old patient of unknown gender. Information about patient's concurrent conditions and medical history was not reported. On 20-JUN-2015 the patient was vaccinated with a dose of improperly stored PEDVAXHIB (route not reported, lot # reported as K025004, dose 0.5 (unit not provided). Concomitant medications were not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
12 year-old patient was given a dose of Moderna COVID-19 vaccine  Patient has had NO side effects, adverse effects, or issues following vaccination
I have been extremely tired. I now have Like a Brain Fog , I can?t remember simple things. I can?t Function the way I used to. My arm is still sore and I?m just tired all the time.
In late May 2022 I began to have nausea and gastrointestinal issues. I tested positive for COVID-19 on June 8, 2022. The gastrointestinal issues have continued. In the middle of the night, it wakes me up. I have lots of gas pains. I have up to eight bowel movements per day. Before COVID-19 I had a bowel movement every other day. It is not considered diarrhea. Usually by 8:00AM in the morning I am good.
The day before I was exposed to COVID-19. 11/26/2022 on that afternoon I had a tiredness, a drippy nose and a cough. I had gotten a sore throat on day five. I started developing laryngitis. They cough only lasted a couple of days. I isolated for an extra four days. I tested at home the next day and it was positive. I called my PCP on that same day and asked for the prescription for PAXLOVID. It was fine, only thing is I had the metal taste in my mouth, it was every day. As soon as I stopped taking it went away.
Hives on arms and legs, not responding to allergy medication and have been continuous for 4 days.