chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt recvd 3 doses of Engerix-B vax on 23NOV90, 26DEC90 & 29MAY91 & 7OCT91 it was determined that pts titwer was neg p/3 doses of Engerix-B vax;
Client was given the imms, then shortly after, c/o dizziness. Had x2 episodes of tremors/seizures. 911 called on second seizure. Vital signs normal. EMS released client to Mom's care when stable.
On day 1-3 fatigue and injection site soreness On day 11 large itchy hot welt around injection site
Patient's arm was red and she stated that it was tender. Her physician said to keep an eye on it - no other treatment at this time.
Fluarix dispensed and administered to newborn in error. Newborn should have received Engerix-B. Products look very similiar-especially when outer packaging is removed. Medication error.
This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 29-AUG-2016, the patient received an improperly stored dose of VARIVAX injection (lot # M004328 with expiration date at 26-JAN-2018; dose and route of administration were not reported). The administered dose of vaccine was exposed to a temperature of -3.5 degrees Celsius (C) for 1 hour and 6 minutes. No previous temperature excursion was reported. Data logger was used to track the temperature. No symptoms were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments:  US-009507513-1610USA011133:
She was hoarse and hives - She lost her voice I was very scare so I took her to her doctor.
Chills; Fever; Fatigued; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Fatigued) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Fatigued). At the time of the report, CHILLS (Chills), PYREXIA (Fever) and FATIGUE (Fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported Treatment received in response to the event was not reported.
sore arm; big round circle; swollwn enlarged lymph node; delay in getting second shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), VACCINATION COMPLICATION (big round circle), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (delay in getting second shot) and LYMPHADENOPATHY (swollwn enlarged lymph node) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051F21A, 052L20A and 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (delay in getting second shot). In December 2021, the patient experienced PAIN IN EXTREMITY (sore arm), VACCINATION COMPLICATION (big round circle) and LYMPHADENOPATHY (swollwn enlarged lymph node). On 10-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (delay in getting second shot) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm), VACCINATION COMPLICATION (big round circle) and LYMPHADENOPATHY (swollwn enlarged lymph node) was resolving.            No concomitant medication was reported by the reporter. No treatment was reported by the reporter.
Side effect of heart beat 100 plus; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE (Side effect of heart beat 100 plus) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEART RATE (Side effect of heart beat 100 plus). At the time of the report, HEART RATE (Side effect of heart beat 100 plus) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 100+ (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information not provided. Concomitant medication not reported.
Partially Frozen Vaccine Administered to 3 Patients; A spontaneous report was received from a HCP concerning three patients who received Moderna's COVID-19 vaccine (mRNA-1273) and 3 doses of vaccine were administered from a vial which was then observed to contain partially frozen vaccine.   The patients' medical history was not provided. No relevant concomitant medications were reported.     On unknown date, three patients  received their first of two planned doses of mRNA-1273 (lot/batch: unknown)  for prophylaxis of COVID-19 infection.   On unknown date, 3 doses of vaccine were administered from a vial which was then observed to contain partially frozen vaccine. No treatment information was provided.    Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the events were  resolved.; Reporter's Comments: This report refers to a case of Out of Specification Product Use for mRNA-1273 (lot# not provided) with no associated AEs.
patient received concentrated dose, when cycle count was done this was discovered - no adverse outcome, patient is symptom free
the 1st shot in march should i just start over; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (the 1st shot in march should i just start over) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported.    In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (the 1st shot in march should i just start over). At the time of the report, PRODUCT DOSE OMISSION ISSUE (the 1st shot in march should i just start over) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No Concomitant medications were reported. No Treatment information was reported.
Case number PHEH2013US013483, is an initial spontaneous report from a consumer (patient) received on 19 Jun 2013. This report refers to a 78-year-old female patient. Concomitant medication included metoprolol at a dose of 100 mg. She was on treatment with DIOVAN for three to four years (see case: PHEH2013US013443). The patient reported that her body was very sensitive (unspecified). She was vaccinated with an influenza vaccine (manufacturer and batch number: unknown) on an unspecified date. The patient reported that after vaccination (on an unknown date) she nearly died. Outcome, seriousness, and causality were not reported.
Pentacel was administered separately(just the DTaP-IPV portion) and then a second combined dose was administered later / no AE; Initial information received on 22-Jan-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a six months old female patient who received DTaP-IPV portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (Pentacel ) (0.5 mL dose, Carton- UJ083AAA, expiry date: 13-Oct-2020, DTaP-IPV - UJ104AA, Exp: 13-Oct-2020) via intramuscular route in right thigh for prophylactic vaccination on 22-Jan-2020.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR), INFLUENZA VACCINE (INFLUENZA) and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE).  It was a case of actual medication error due to Wrong technique in product usage process.  It was reported that dose of Pentacel was administered separately (just the DTaP-IPV portion) and then a second combined dose (Carton- UJ056AAA, expiry date 24-Oct-2020, Hib - UJ056AA, Expiry date 27-Oct-2020, DTaP-IPV - UJ6257AA, Expiry date 27-Oct-2020) was administered later.  At a time of reporting no adverse event 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.
Hospitalized 11/6/2021; COVID-19 positive 11/5/2021; fully vaccinated  BRIEF OVERVIEW: Admission Date: 11/6/2021 Discharge Date: 11/9/2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute respiratory failure with hypoxia Acute hypoxemic respiratory failure due to COVID-19 COVID-19   HOSPITAL COURSE: 56 yo male presented to the ER with the complaint of fatigue and hypoxia. He had 7 days of symptoms to include high fever, cough and loss of smell. He was vaccinated against covid earlier this summer. A home test was positive on Nov 5 and he monitored his symptoms with a pulse oximeter. In the ER his CXR noted minimal LLL infiltrates and he was hypoxic to 88%. He was admitted for the treatment and management of covid pneumonia. He was started on dexamethasone and remdesivir. His inflammatory markers have remained low and stable. Over the course of his hospital stay he has noted clinical improvement and has been afebrile. He continues to require supplemental oxygen and will discharge home with this. He will complete a 10 day course of dexamethasone.
localized rash, uticaria,  itching, tenderness at site, axilla LAD at arm of injection site. headache
sharp back pain with numbness of both legs difficult of breathing high blood pressure of 171/120 no fever called emergency and paramedics came : pt did not receive any treatment or medication  but all the symptoms resolved after 20 minutes  and bp was normal pt wanted to go home by herself
Had severe chills the evening of the shot.  By mid-day the next day, had initial shingles symptoms.  Rapidly developed into full-blown shingles rash on right side of body from bottom of foot to upper buttocks. Still have shingles rash that is diminishing.
Woke up at 3:00 AM 4/24 - Headaches, sick to stomach, shaking entire body - dizzy, had to hold on. 5:30 lay down and fell to floor within 1 hr shaken stop but weak beaten strange.
Pt developed an 8 cm area of erythema, swelling and tenderness on left deltoid region.
Extremely emotional.  Could not stop crying for 2 days.  My period came 10 days earlier than expected and was heaviest in past 2 years.
Sore muscles (24 hours after injection), headache (1 days after injection), malaise(1 days after injection), hives/body rash (occurred 6-7 days after injection and has lasted 7 days from onset)
My initial reaction was headache, body aches,  and brain fog, lasted about a day and half. Then about a week later i started just itching on my for arms and torso.  I have little bumps and they itch. It comes and goes.
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 70 year-old male patient received bnt162b2 (BNT162B2), administration date Apr2021 (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 IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021514881 same reporter/drug,event, different patient
Have had a severe cold, congestion, sinuses, etc.  fever chills controlled by tylenol / advil.  Took 3 covid home tests all negative... saw PA after cold was getting better... Never had a cold this long or this bad and wondered if impacted by vaccine effects on immune system.  Am still recovering but still have a lot in my head (sounds like a bad cold still)... coughing is much less both day and night.
This is a 42-year-old male patient with past medical history of hypertension presented to the emergency department today with complaints of nausea, vomiting, diarrhea over the last 5 days.  Patient also noted having a nonproductive cough.  Denies any fever, chills, chest pain, shortness of breath.  Patient notes he got his 2nd CoVID vaccination on the 9th.  Imaging done in the emergency department showed Left midlung infiltrates and probably also in the middle lobe.  Patient's labs sodium 136, potassium 4.2, BUN 21, creatinine 2.87, glucose 154.  Patient was started on IV antibiotics in the emergency department.
PATIENT FULLY VACCINATED TESTED POSTIVE FOR COVID 9/5/2021 AND ADMITTED TO THE HOSPITAL.
Information has been received from a physician via company representative referring to a 13 year old female patient. Information about medical history and concurrent condition was unspecified. On 14-SEP-2015 the patient was vaccinated with first dose of GARDASIL 9 (lot number, dose and route were unknown) for prevention of HPV. In January 2015, the patient received an unspecified influenza virus vaccine (unspecified). In January 2016, the patient started to "work out" and lose weight. The patient was seen by an unspecified hematologist on an unspecified date and it was found that she had a low platelet count and mononucleosis. Unspecified blood tests were performed. The outcome and causality of the events was unknown. Additional information is not expected because the reporter did not want to be contacted.
head was foggy; Throwing Up; So Nauseas; headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (head was foggy), VOMITING (Throwing Up), NAUSEA (So Nauseas) and HEADACHE (headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension. Concomitant products included LISINOPRIL for Hypertension.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced FEELING ABNORMAL (head was foggy), VOMITING (Throwing Up), NAUSEA (So Nauseas) and HEADACHE (headache). On 01-Mar-2021, FEELING ABNORMAL (head was foggy), VOMITING (Throwing Up), NAUSEA (So Nauseas) and HEADACHE (headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: increased (High) increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Updated contact number, concurrent medical condition, concomitant medication, added  new events, outcome of the event changed from unknown to recovered.
Site: Redness at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: FAINTED AND SCAR ON FACE-Mild, Additional Details: PATIENT SEATED AT SEAT 5 FELL AFTER FAINTING AND INJURED ON HIS FACE WITH BRUICE ON RIGHT SIDE AFTER HITTING GROUND WITH HIS GLASSES. PATIENT GOT CONSCIOUSNESS IMMEDIATELY AFTER. OFFERED MEDICAL HELP AND ATTENTION. GAVE WATER TO DRINK. HE WAS MONITORED FOR 30 MINUTES AND LEFT PHARMACY HIMSELF.
Thought that I was having a stroke. Was unable to control mouth movement. Right side of face was starting to sag. Went to urgent care following morning and was dx with Bell's Palsy.
This spontaneous report has been received from a healthcare worker via Company Representative concerning unspecified number of patients of unknown age and gender. Patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with doses of GARDASIL 9 (strength, frequency, route, lot # and Exp. date not reported) outside the recommended time frame. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Patient stated that her arm was okay initialy and a few weeks after she received the vaccination a bump started to appear (unsure when appeared). Pt stated it did not hurt but it itched and looked bad. She did not seek medical attention In January Pt stated it looked bigger/uglier, but did not hurt or itch and was to have an apt with the doctor. Pt cancelled apt for January and is not to be seen until March. Recommend pt seeks medical attention.
WE HAVE THIS TD FOR ALL ADULT PATIENT OVER 18 YEARS OLD.
Mother reported that child developed a red, hot, swollen,left arm extending from shoulder to elbow.  Immunization given 8/16/04 at approximately 1:30 p.m. Child was very uncooperative and required 2 adults to restrain for immunization. Mother reports onset began at 5 p.m. on 8/17/04.  Mother reported it pediatricians office 8/18/04, who instructed her to use Motrin, ice, Benadryl and cortisone cream and to notify them if no improvement later in day.  Mother felt there was no improvement and took child to physician later that day and felt reaction was related to immunization.  Mother and physician are requesting that the office visit be paid by Vaccine Injury Compensation Fund.
Viral symptoms developed on 5/5/21. Diagnosed with COVID on nasal swab on 5/6/2021, despite being fully vaccinated.
This spontaneous report as received from a pharmacist, as part of a marketing research program conducted, refers to an 86 years old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose 1; dose, route of administration, lot # and expiration date were not reported). On an unknown date, the patient experienced injection site reaction and a square rash. The reporter stated that she/he believed age to the factor and that she/he never gave it to the oldest patients. The outcome of the adverse events was reported as recovering. The relatedness between the adverse events and the vaccination with ZOSTAVAX was not reported. Additional information has been requested.
All administration of vaccine was done properly, however, patient soon developed sudden syncope.  Had patient sit in upright chair, legs not crossed, had BP readings done (113/68, HR 67), patient states light headiness and dizzy. Patient had to be in administered chair for 10 minutes before transitioning to another post vaccination chair to be monitor for additional 20 minutes. Patient regained consciousness within a few minutes and was cleared to leave facility after patient was properly monitored in facility.
first dose on 08/18/2021, dose 2 on 1/5/2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 28-year-old female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B (received 1st dose on 18th August 2021, with batch number xa4dd).   On 5th January 2022, the patient received the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 5th January 2022, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long 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 details were provided as follows: The patient received 2nd dose of Engerix-B later than the recommended schedule, which led to lengthening of vaccination schedule. The reporter enquired if revaccination was needed. The reporter consented to follow up.
Nurse notified MD day after injection that she realized she only injected patient with diluent and not powder when giving Menveo.  Patient's mother was notified.  Called GSK and was told since he received CWY strains, no further doses needed to correct error - mother was notified but also told she could choose to have him revaccinated in 6 months to receive the A strain.   Our vaccine protocols within the office were rereviewed with all staff.
Difficulty swallowing, tingling and burning on tongue and lips. Epi was given prior to coming to the ER. Patient also took 50 mg benadryl by mouth one hour prior to arrival.
This spontaneous report was received from an office manager and refers to an unknown number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (lot# L046508, expiration date: 17-MAY-2017; lot# M033209, expiration date: 09-JAN-2018 and lot# M031941, expiration date: 27-DEC-2017). No adverse effects were reported. Temperature excursion details: Temperature: >-10 degree C but <8 degree C Time frame: 190.5 hours Previous temperature excursion? No Digital data logger was involved. This is one of two reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA002359.
Patient reported at her second dose appt 8 days after 1st dose her left arm before red, not itchy, but sore to touch. she took tylenol and it lasted for 7 days
requested medical records and never received them; pt had a positive COVID test on 8/5/21; per death certificate, pt died in the hospice facility with COVID 19 being the cause of death
I started having  body aches, arm soreness and a headache about 15 hours after I got my 2nd vaccine. My symptoms lasted about 12 hours and I feel completely fine now.
MEMBER EXPERIENCED SWOLLEN, RED, ITCHY, BURNING SENSATION LOCALIZED AT THE INJECTIONS SITE FOLLOWING VACCINATION.
On injection, but before administration of vaccine, patien complained of severe shooting pain at site of injection. Also shooting pain to left forearm. Vaccine not administered in left arm. Injection given in right deltoid without pain.
Immediately after GARDASIL was administered today around 12:30 PM, client fainted and convulsed for approximately 3 seconds. He immediately recovered consciousness and appeared confused for a very short time. Questions about name, time and place were asked which he accurately answered. He complained of pain at the site of injections and lower extremities. BP and HR were taken WNL and patient was observed for approximately 1/2 hour. Patient went home verbalizing that he feels well and he appeared fine just like before injection. It is very important to note that his sister received a 3 dose of GARDASIL and hour earlier and surprisingly the same reaction occurred. Adverse event also completed for her.