chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received 2 doses of the product FLUZONE QIV NP in a span of 5 weeks with no adverse event; Initial information was received on 01-Dec-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 16 years old male patient who stated received 2 doses of the product fluzone qiv np in a span of 5 weeks with no adverse event after receiving influenza quadrival A-B vaccine [Fluzone QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 29-Nov-2022, the patient received 0.5 ml dose of suspect influenza quadrival A-B vaccine (Suspension for injection) (lot: UT7701LA, expiry date: 30-Jun-2023, strength: standard frequency: total) via intramuscular route in right deltoid for Immunization.  On 29-Nov-2022 the patient developed a non-serious event of event patient received 2 doses of the product fluzone qiv np in a span of 5 weeks with no adverse event (extra dose administered) (Latency: same day) following the administration of influenza quadrival A-B vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  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.  Additional information was received on 02-Dec-2022 from other health professional: Classification, Therapy start date, frequency, Dose, Location, Route, New event (extra dose administered) were updated. Text amended accordingly.
I had chills, headache, and was nauseous all day but around 630 I passed out and smacked my face when getting out of the shower.
Three days post vax pt developed loose stools.  On the third and fourth days post onset the pt passed gross blood in his stool. Stool culture and culture for Ecoli were negative.
severe abdominal pain; clay colored stool; tea colored urine; a intensely burning, exploding headache; productive cough; This is a spontaneous report from a contactable Nurse (Patient).  A 66-years-old non pregnant female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EKT231), via an unspecified route of administration, administered in Arm Left on 24Dec2020 14:15 (age at vaccination: 66-year-old) as single dose for covid-19 immunization. (vaccination facility: Hospital). The patient medical history was not reported. Concomitant medication included losartan (LOSARTAN) taken for an unspecified indication, start and stop date were not reported, metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported, dulaglutide (TRULICITY) taken for an unspecified indication, start and stop date were not reported, vitamin d3 (VITAMIN D3) taken for an unspecified indication, start and stop date were not reported. patient did not receive other vaccine in four weeks. Patient also took second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration, administered in Left deltoid on 14Jan2021 as single dose for covid-19 immunization. No covid prior vaccination. No known allergies. It was reported that on 29Dec2020 06:30 PM 5 days after, severe abdominal pain, clay colored stool, tea colored urine and intensely burning, exploding headache, productive cough. patient tested nasal swab positive for covid-19 post vaccination on 29Jan2021. Patient was not received any treatment for events. The patient underwent lab tests and procedures which included sars-cov-2 test: positive (Nasal Swab) on 29Jan2021. Outcome for the event was reported as Resolved with Sequel on unspecified date.   Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Pain in shoulder/upper arm with injection that persists (2 weeks). Pain on int rotation, abduction.
suspected vaccination failure; Shingles in January 25, 2021; Drug dose administration interval too long; This case was reported by a physician via sales rep and described the occurrence of suspected vaccination failure in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In June 2018, the patient received the 2nd dose of Shingrix. In November 2017, the patient received the 1st dose of Shingrix. In June 2018, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure, shingles and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix, more than the recommended interval, which led to lengthening of vaccination schedule.  The physician stated that, the patient came to the practice with shingles on 25th January 2021.  This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles and time to onset were unknown
Patient reports that he had joint pain and body aches x 4 days after the second dose of Moderna Vaccine which have since resolved.  He also complains that since the second dose, he "feels off balance" few minutes at a time few times a day without any dizziness, HA, visual complaints or fever which seem to be persisting. He also feels that his energy is lower that he cannot complete his usual exercises. Also reports cold sweats after working out that he cannot continue. This patient used to do 500 push up almost daily and apparently now can only do <200! Neuro exam is negative during his clinic visit on 3/17/2021
Swelling on right side face; Swelling on right side face and right side ear lobe; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EC3180) via an unspecified route of administration in the right arm on 06Aug2021 at 18:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included two premature baby. The patient had known allergy to sulfa antibiotics. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 21Aug2021 at 08:00, the patient experienced swelling on right side face and right-side ear lobe. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events and the patient had an appointment for biopsy. The clinical outcome of the events swelling on right side face and swelling on right side ear lobe was not recovered at the time of this report.
Patient voiced @ 1359, that her R arm was itching, opposite to vaccinated arm.  Also stated that it felt warm to touch.  V/S BP-114/82, P-95, O2-99. Patient stated she felt fine @ 1405.  Benadryl 25mg given via staff to take home.  Patient left observation @ 1410.
5 to 10 minutes after receiving the vaccine,  said she felt nauseous and light-headed.  About 5 minutes after that she slumped in her chair and began vomiting.  She was non-responsive, vomiting and shaking.  We called 911 and kept her upright, allowing her to vomit while waiting on ambulance.  When they arrived she was still vomiting but becoming aware of her surroundings.  She was taken to Hospital and given fluids and Zofran and sent home about 7pm.  Today she is feeling much better.
Unsure if complete dose was given; Vaccine squirted out from  patient's arm; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 50-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number BM9ZY, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th October 2021, the patient received Fluarix Quadrivalent 2021-2022 season (intramuscular) .5 ml and Fluarix Tetra Pre-Filled Syringe Device. On 12th October 2021, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced incomplete dose administered and exposure via skin contact. On an unknown date, the outcome of the incomplete dose administered and exposure via skin contact were 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 pharmacist reported that while administration of Fluarix vaccine some of the vaccine squirted out of patient's arm and pharmacist was unsure if complete dose was received, which led to incomplete dose administered and exposure via skin contact. The pharmacist enquired if patient needed another dose. The pharmacist was warm transferred to medical information for guidance. The pharmacist stated that this patient was to get another dose of the vaccine.
On January 7 (approximately 1 week after getting the first dose of the Moderna vaccine), I experienced itching, hives, redness, and swelling at the injection site. None of these symptoms appeared immediately after getting the injection, and only first appeared on January 7. The symptoms subsided after 3 days and multiple doses of benadryl.
Patient hospitalized for fever thought to be related to 2nd dose of covid vaccine. See hospital a/p from H&P.  Assessment/Plan: Fever, myalgias and headache, I think this is all secondary to his recent Covid vaccine yesterday, dose 2.  I would anticipate his symptoms should resolve over the next 24 to 48 hours.  He was started on vancomycin in the emergency room given history of MRSA.  We will continue for now, though I think less likely secondary infection.  He is on Cipro for SBP prophylaxis.  He does not seem to have significant ascites.  I think bacterial peritonitis is less likely.   End-stage renal disease on hemodialysis.  I spoke with individual.  Plan is to dialyze him here today.   Cirrhosis -he was evaluated by the transplant center at Hospital on February 25.  His meld was 25 at that time.   History of type 2 diabetes.  His last hemoglobin A1c's have been all 5.  Can remove that from his problem list.
8 year patient given Pfizer dose,. Mom reports patient say arm hurts and patient tired.  Today she reports mild headache and patient is warm t touch.  She will check temperature.
Information has been received from a medical assistant regarding a 2 years-old patient of unknown gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported. On 17-DEC-2018, the patient was vaccinated with improperly stored VARIVAX injection, lot number R017768 with expiration date in 21-JUN-2020, which was reconstituted with properly stored sterile diluent (DILUENT MRK) (strength, dose, route of administration and anatomical location not reported), for prophylaxis. The VARIVAX was stored at a temperature range of -9 degrees Celsius (°C) to 8°C for the time frame of 70 hours and 45 minutes, and another range of 9°C to 25°C (17.7C) for the time frame of 34 hours and 30 minutes . There was no previous temperature excursion and the call was because of a data logger. No adverse effects were reported.
Redness at injection site, red hives on back, arms, hands burning sensation developed in the evening and got worse.  Patient did take Claritin and Benadryl for symptoms.  Doing well now.
This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 32-year-old female patient who received FLUARIX QUADRIVALENT. On 13th October 2016, the patient received the 1st dose of FLUARIX QUADRIVALENT (intramuscular) .5 ml. In October 2016, less than a month after receiving FLUARIX QUADRIVALENT, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. This case was not associated with any medication error. This case has been linked with US2016GSK160436, reported by same reporter.
On 4/21/21  client received 2nd dose of Moderna, the vaccine was given one day before the minimal interval of 24days.
I have been having abnormal more frequent periods since March of 2021. This is new for me. I have always had irregular periods. Now my periods are more frequent.
Patient came for booster shot on a very busy day.  Patient had 2 previous pfizer shots but requested moderna for the booster.  Shot was given to patient with no problems.  Patients age was missed at the time of vaccination.
given the adult dose of the Fluzone Quadrivalent instead of the kids dose/no AE; given the adult dose of the Fluzone Quadrivalent instead of the kids dose/no AE; Initial information received on 03-Feb-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1 years old male patient who received adult dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (VACCINE lot UT6695LA via unknown route) instead of pediatric dose on an unknown date.  The patient medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was of actual medication error due to inappropriate dose of vaccine administered and overdose.  It was unknown whether adverse event was experienced or not.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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.
Pt states experienced severe fatigue, fever over 100, shortness of breath, muscle aches, says was bedridden and unable to lift arm for 4 days
Completely lost hearing in her right ear; Pulsatile tinnitus/ringing is coming from my left ear/pulsating in my left ear; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS UNILATERAL (Completely lost hearing in her right ear) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006821A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Tinnitus.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced TINNITUS (Pulsatile tinnitus/ringing is coming from my left ear/pulsating in my left ear). On an unknown date, the patient experienced DEAFNESS UNILATERAL (Completely lost hearing in her right ear) (seriousness criterion medically significant). At the time of the report, DEAFNESS UNILATERAL (Completely lost hearing in her right ear) and TINNITUS (Pulsatile tinnitus/ringing is coming from my left ear/pulsating in my left ear) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2021, Magnetic resonance imaging: normal (normal) MRI Fine.         Concomitant medication use information was not provided by reporter. Treatment medication use information was not provided by reporter.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient received undiluted pediatric dose .2ml Patient notified.  No reactions or side effects. Patient scheduled for full booster in 8 weeks per CDC guidelines.
Developed shortness of breath and fatigue.  Discovered that I had pulmonary emboli.
Up to 6 hours of high pitched cry with 1st and 2nd DTap. No other neurologic sequelae.
she started vomiting few minutes after she got the vaccine and she was dizzy. she waited 20 minutes until she felt better the, left with her mother
pt recvd vax;abdo discomfort; N/V;later rash on face, on back;severe HA, spiking T; some joint pain, hard, enlarged abd;swollen glands rt side of neck;
Three hours after receiving immunization started to have body aches and chills, Temp rose to 101 F, developed profound sense of exhaustion and drowsiness.  Had immediate tingling down entire arm, questions whether injection may have gone IV versus IM  Area at injection site caused no symptoms, no hardness, inflammation, or heat
Expired vials were used to provide 38 doses of the Moderna Covid-19 Vaccine; Sore arm; Some identified common side effects after the vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vials were used to provide 38 doses of the Moderna Covid-19 Vaccine), PAIN IN EXTREMITY (Sore arm) and VACCINATION COMPLICATION (Some identified common side effects after the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vials were used to provide 38 doses of the Moderna Covid-19 Vaccine). In November 2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and VACCINATION COMPLICATION (Some identified common side effects after the vaccine). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vials were used to provide 38 doses of the Moderna Covid-19 Vaccine) had resolved. In November 2021, PAIN IN EXTREMITY (Sore arm) and VACCINATION COMPLICATION (Some identified common side effects after the vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided Some of patient received booster dose on 1-Nov-2021, 05-Nov-2021, 11-Nov-2021 and 12-Nov-2021. No vial went any temperature excursions.   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Non significant follow up received on 19-nov-2021 and new reporter information added
drip of the medication on the patient's arm  / no AE; drip of the medication on the patient's arm, Vaccine leaking/no AE; leaking from Luer-Lok adapter area where the needle connects to the syringe / no AE; Initial information received on 07-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 65 years old female patient who had an incomplete vaccination of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ288AB, Expiry date unknown) via intramuscular route in the left deltoid on 02-Nov-2019.  It was an actual medication error case due to vaccine underdose and syringe leak.  It was also a case of Exposure via skin contact.  It was reported that she noticed a drip of the medication on the patients arm.  Vaccine leaking from the Luer Lok adapter area where the needle connects to the syringe.  At the time of reporting no adverse reaction 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.
Initial solicited case was received from the investigator in a trial on 23 July 2015. This case involves a 21-year-old male who developed unspecified disease of pericardium during the study participation. The subject had a significant medical history of elevated cholesterol. On 09 June 2015, 20 days after receiving a dose of ACAM2000 (lot number, route and site of administration not reported), a dose of Anthrax vaccine (manufacturer, lot number, route and site of administration not reported) and a dose of Typhoid VICPS (manufacturer, lot number, route and site of administration not reported) on 20 May 2015, the subject developed unspecified disease of pericardium. On 31 May 2015, the subject's troponin I result was abnormal, the highest value was 32.48 and electrocardiogram (ECG) was abnormal. Echocardiogram performed on 31 May 2015 was abnormal. The subject's MRI (brain), MRI (spinal cord), MRI (heart) and Lumbar puncture were not performed. The subject's outcome was not reported. Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Relationship of the investigation product as per Company: associated. Documents held by sender: None.
Patient became lightheaded and dizzy about 4 minutes after shot. Layed down on floor. I SOB, lost consciousness for about 50 seconds paramedics came and stayed about 3 or 4 minutes and left. He sat up for a while on floor then moved to chair and was ok. Spent about 20 or 30 minutes in store.
Pt seemed well without nervousness. Given Tdap, Menactra and HPV #1. 3-4 min. later standing at front desk waiting and lost consciousness, hit head and back. BP - 110/60, P = 100. Started responding 2-3 min. later. Pale, diaphoretic. Taken TO ER 20 min later. Called 5 hrs later - client ok. Went to school next day.
This spontaneous report was received from a Registered Nurse who was a male patient of unknown age. On unknown dates the patient had 4 or 5 doses of unspecified Hepatitis B vaccines (manufacturer unknown) dose, route and indication was not specified). All of which the patient failed to seroconvert. The outcome of event was unknown. Causality assessment was not provided. This is one of several reports from the same reporter. Additional information has been requested.
Axillary lymphadenopathy on the side of injection. No localized reaction at injection site. She has malaise, fatigue.