chrisvoncsefalvay/vaers-outcomes huggingface dataset:
metastatic prostate cancer; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 07-Dec-2021 and was forwarded to Moderna on 07-Dec-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PROSTATE CANCER METASTATIC (metastatic prostate cancer) in an 80-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced PROSTATE CANCER METASTATIC (metastatic prostate cancer) (seriousness criterion medically significant). At the time of the report, PROSTATE CANCER METASTATIC (metastatic prostate cancer) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: negative (Negative) Negative.         Patient was taking lot of medications (names not mentioned) including chemotherapy. It was reported that antibody test showed they were almost no existent and HCP assumed it was because of the chemotherapy. No treatment medication was provided COMPANY COMMENT: This is a regulatory case concerning a 80-year-old patient with no clinical history who experienced the unexpected event of  PROSTATE CANCER METASTATIC  The event occurred unknown days after the first dose of mRNA-1273. The rechallenge was not applicable since only information about third dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.    Most recent FOLLOW-UP information incorporated above includes: On 07-Dec-2021: Non Significant follow-up appended; Sender's Comments: COMPANY COMMENT: This is a regulatory case concerning a 80-year-old patient with no clinical history who experienced the unexpected event of PROSTATE CANCER METASTATIC  The event occurred unknown days after the first dose of mRNA-1273. The rechallenge was not applicable since only information about third dose was disclosed The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
I had a rash from the second vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of RASH (I had a rash from the second vaccine) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (I had a rash from the second vaccine). At the time of the report, RASH (I had a rash from the second vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Patient had all three doses of Moderna. Patient never had any adverse reaction to anything.  No treatment details were provided.   This case was linked to MOD-2022-472019 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Feb-2022: Follow-up received include no new information.
SWEATS; HOT/COLD; SHIVERING; FEVER LIKE SYMPTOMS; NAUSEA; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. 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 not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination.  The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. No concomitant medications were reported. On an unspecified date, the patient experienced sweats, hot/cold, shivering, fever like symptoms, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweats, hot/cold, shivering, fever like symptoms, and nausea. This report was non-serious.
This spontaneous report was received from a 60 year old male patient referring to himself. The patient's current conditions included degenerative joint and back disease, and arthritis. The patient's drug reactions/allergies included unspecified reaction to barium. The patient's medical history was not reported. On 25-SEP-2015, the patient was vaccinated with ZOSTAVAX injection (strength, dose, frequency, route and lot number were not reported). Concomitant therapies included influenza virus vaccine (unspecified) taken on 17-SEP-2015. After receiving ZOSTAVAX injection, on an unknown date in 2015 the patient experienced headache, nausea, difficulty breathing and swallowing, pain and redness at the injection site, exhaustion, and muscle and joint pain. Some days the adverse reactions weaken, but then they come back. On 21-OCT-2015, the patient had dental work and he had a greater sensitivity to the procedure than usual. The patient sought medical attention and visited primary care physician. The patient was given treatment with unspecified course of antibiotics. Product quality complaint (PQC) was not involved. No further information was provided. The outcome of events was unknown. The reporter did not provide the causal relationship between the events and suspect therapy. Additional information is not expected as no contact details were provided.
Patient reported chest pressure/pain rated 8/10 and dizziness at 14:07. Patient was breathing and talking. Patient stated her vision was going in and out. Patient offered EMS. EMS activated. Vitals assessed: BP 126/80 mmHg, HR 50 bpm, 94% SpO2. Patient stated she wanted water. Patient given water. EMS arrived  and assumed care at approximately 14:15. Patient transported via ambulance. Patient left facility at approximately 14:25.
Initial unsolicited report received from a physician via other company (Pfizer) on 19 August 2016. Manufacturer Report Number: 2016394959. This case involves a female patient (age not reported) who was vaccinated with a dose of TETANUS AND DIPHTHERIA TOXOID (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's medical history and Concomitant medications were not reported. On an unknown date, following the vaccination, the patient had swelling.  Severity was reported as severe. The patient's laboratory data and corrective treatment was not reported. The outcome of event was not reported. List of documents held by sender: none.
received Pfizer vaccines on 1/4/21, 1/25/21 Tested positive for COVID by PCR on 9/29/21 Admitted to hospital on  10/8/21 with SOB, DOE, weakness. Received Monoclonal antibodies on 9/30/21. underlying rheumatoid arthritis
This spontaneous report as received from medical assistant refers to 3 patients of unknown age. Pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 (dosage regimen were not reported) lot # M005714, expiry date 07-OCT-2017 for prophylaxis. No adverse effects were reported. The outcome of incorrect product storage and no adverse event were unknown. No further information was available. Additional information has been requested.
Fever; nausea; sore arm; This is a spontaneous report from a non-contactable consumer (patient). A 61-year-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) on an unspecified date, at single dose, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history included known allergies to sulfur. The patient had not experienced Covid-19 prior vaccination. Concomitant medications were unknown. On an unspecified date, the patient experienced fever, nausea and sore arm. Post the vaccination, the patient has not been tested for COVID-19. Clinical outcome of the adverse events was unknown at time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt claims he woke up at 3 am and couldn't move for awhile and he had slurred speech. His wife is a nurse, so he called her at work. They determined on their own that it was from the flu shot. Did not seek dr care.
Exacerbated asthma symptoms; Difficulty during exercise and deep breathing after 3rd Pfizer booster received Oct2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 22 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: DYSPNOEA EXERTIONAL (medically significant) with onset Oct2022, outcome "recovering", described as "Difficulty during exercise and deep breathing after 3rd Pfizer booster received Oct2022"; ASTHMA (medically significant) with onset Oct2022, outcome "recovering", described as "Exacerbated asthma symptoms". The events "exacerbated asthma symptoms" and "difficulty during exercise and deep breathing after 3rd pfizer booster received oct2022" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of asthma, dyspnoea exertional. Clinical course: No Known allergies. No Covid prior vaccination. Since the vaccination, has the patient been tested for COVID-19. Exacerbated asthma symptoms. Previously no difficulty during exercise, deep breathing. Difficulty during exercise and deep breathing after 3rd Pfizer booster received Oct2022. Symptoms controlled with alvesco, but have not resolved. Treatment included Ciclesonide.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
pt vax pt c/o weakness, dizziness, nausea, blurred vision & dec hearing in rt ear; pt alert, oriented x 3; no ataxia; ear & eye, BP, pulse, chest & heart auscultation-WNL;
was reconstituted with saline; received one vial of the vaccine which was reconstituted with saline; This non-serious case was reported by a consumer via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 26-SEP-2023, the patient received Menveo (intramuscular, left deltoid). On 26-SEP-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: was reconstituted with saline) and inappropriate dose of vaccine administered (Verbatim: received one vial of the vaccine which was reconstituted with saline).  The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 27-SEP-2023 Father of the patient reported that the patient received a Menveo (2-vial formulation) vaccine at the local health department yesterday (day before reporting). The Health Department contacted the reporter on reporting day to inform that his son (patient) received one vial of the vaccine which was reconstituted with saline. He did not receive the 2nd vial of vaccine. The patient received only one vial of Menveo reconstituted with saline, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
This spontaneous case, initially received from other healthcare professional on 08-Oct-2018, concerns a 46-year-old, adult, male patient. The patient had no medical history. The patient did not receive any concomitant medications. Since an unspecified date, FLUCELVAX QIVc vaccine underwent first temperature excursion, probably at 30.9 Fahrenheit for approximately 08 hours (reported as worst-care scenario was 8 hours). On 04-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252659 and expiry date: 31-May-2019] which underwent temperature excursion. At the time of this report, no adverse event was reported. The reporter assessed this case as non-serious. This case 201804345 was cross-linked to case 201804346 due to same reporter.
Manufacturer/Syringe malfunction. Despite tightening of syringe to needle for vaccination, partial Moderna dose leaked at needle and syringe connection point during vaccination. Pt received remaining dose as needle in pt during leakage. Per CDC guidelines, Provider  reports pt received greater than half of the dose and no additional dose given.  Pt tolerated vaccine with no additional concerns.
After dose 1 mild GI upset, loose bowel movements, that lasted 2.5 weeks. 2 days after second dose, extreme diarreah and pain for 24 hours. Fatigue for 7 days,  mental foginess, for 2 days sensitivity to light for 24 hrs. All symptoms began 2 days after vaccine administered. Took pepto bismal,  ate a bland diet for 3 days  after 24 hrs of upset. It stopped the upset. Now no bowel movement for 5 days.
Pharmacy did not take Pfizer vaccine out of freezer after 14 days of being between -25 and -15 degrees C. Was instructed by corporate office to administer another dose to be sure of effectiveness of vaccine.
Patient reported excessive swelling of feet and the hand of the arm injected. Swelling resolved in feet by 3/17, but hand was still swollen on 3/17.
This spontaneous report as received from a medical assistant via Center, refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 09-MAY-2018, the patient was vaccinated with PROQUAD injection (Strength, anatomical location, route, lot # and expiry date were not reported) for prophylaxis. Other suspect therapies included VARIVAX and diluents for reconstitution of PROQUAD and VARIVAX. On the same day, during the same office visit, the patient was vaccinated with PROQUAD and VARIVAX. It was unknown if the patient experienced a reaction after being provided PROQUAD and VARIVAX during the same office visit on the same day. As of 09-MAY-2018, it was unknown if the patient would receive future doses of PROQUAD or VARIVAX.
Extremely irritable, fever of 101.6 at 8:30pm, felt warm for several hours before. Contacted doctor, was told to go to ER. Had fast shallow breathing around 9:30pm for 2ish hours. ER ran blood and urine, looked normal, confirmed vaccine reaction. Left ER at 1am on 10/25/18. At 9am 10/25 fever was at 100.5. At 9pm 10/25, fever was at 100.0. Follow up with doctor scheduled for 10/26.
Pt recvd vax & exp numbness on rt side of face, trouble closing eye & asymmetric mouth; went to ER; dx w/Bell's Palsy; 10AUG92 seen by MD w/Pred;
Priori adjuvant therapy: Subepithelial bevacizumab, HPV vaccination; Priori adjuvant therapy: Subepithelial bevacizumab, HPV vaccination;   This literature marketed report has been received from authors of published article as stated above, referring to a 47 years old female patient who had hypertension, pancytopenia and systemic lupus erythematosus(SLE).   On an unknown date, the patient received HPV vaccination(hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(strength, dose, frequency, route, lot # and expiration date were not reported) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL)(strength, dose, frequency, route, lot # and expiration date were not reported) as prior adjuvant medical therapy for severe recurrent respiratory papillomatosis (RRP)(product use in unapproved indication and product origin unknown).The disease of recurrent respiratory papillomatosis (RRP) distribution included supraglottic, glottic, subglottic, cervical and thoracic trachea, pulmonary.  A copy of the published article is attached as further documentation of the patient's experience.
Narrative: Symptoms: Myalgia & SORENESS AT INJECTION SITE Treatment:
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and unknown gender. The patient's pertinent medical history was not provided. On 18-JUN-2015, the patient was vaccinated with a dose of both RECOMBIVAX HB and PEDIARIX. No known adverse effects were reported. Additional information has been requested.
5/17/21 received Pfizer vaccine in right arm.  5/18/21 woke up with large, tender knot on right deltoid at injection site.  Denies chest pain, shortness of breath, leg pain, rash, or other adverse reaction.
Non stop headache, severe  joint and body aches, swelling of left arm, injection site swelling has spread and now on 3rd day swelling has spread all  over below  upper left left arm, arm,  hand and fingers numbness, fingers swollen as well.
12 hours following vaccination experienced fatigue, chills, body aches, and fever of 100.3 (t max) that lasted 24 hours.
Mother states rash all over body including soles and palms after itching onset night of 1/10.
Sore arm day after 2nd shot; Red knot on arm day after 2nd shot; Red knot on arm day after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm day after 2nd shot), ERYTHEMA (Red knot on arm day after 2nd shot) and INJECTION SITE NODULE (Red knot on arm day after 2nd shot) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002a21a and 030l2la) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE, METOPROLOL, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE/HYDROCHLOROTHIAZIDE), PREDNISONE, ACETYLSALICYLIC ACID (BABY ASPIRIN), SITAGLIPTIN PHOSPHATE (JANUVIA [SITAGLIPTIN PHOSPHATE]), GABAPENTIN and PARACETAMOL (TYLENOL) for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm day after 2nd shot). 06-Mar-2021, the patient experienced ERYTHEMA (Red knot on arm day after 2nd shot) and INJECTION SITE NODULE (Red knot on arm day after 2nd shot). At the time of the report, PAIN IN EXTREMITY (Sore arm day after 2nd shot), ERYTHEMA (Red knot on arm day after 2nd shot) and INJECTION SITE NODULE (Red knot on arm day after 2nd shot) outcome was unknown.            Treatment medication include Tylenol twice per day and noticed arm pain was more when the Tylenol started wearing off.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was Not applicable.   Reporter did not allow further contact
Pt was anxious post vaccine and reported to observer that she felt dizzy and nervous.  BP, HR and SP02 was WNL.
Covid19 breakthrough.  Vaccinated with Janssen on 3/31/21.  Pt presents with c/o fevers, nausea, vomiting, diarrhea, fatigue, SOB for past 5 days.  Pt felt so unwell that she did not complete her peritoneal dialysis for those days and wore her home oxygen.  Pt received steroids.
No other adverse event reported; A patient received a dose of Gardasil 9 that underwent a temperature excursion; This spontaneous report was received from a medical assistant referring to a 14-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant therapies and drug reaction or allergies was provided.  On 26-JAN-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (product storage error) injection, lot number reported and validated as T026954, expiration date reported and validated as 13-APR-2022 (dose, route of administration, anatomical site of vaccination, and vaccination scheme frequency were not reported)  as prophylaxis.   The vaccine underwent a temperature excursion on an unspecified date. The vaccine was stored at 47.3 degrees Fahrenheit (F) and 35.2 F for 30 minutes and 48 minutes respectively. There was not a previous temperature excursion. The call was due to a digital data logger.  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); devicelotnumber: T026954; expirationdate: 13-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Felt weak; Was not hungry; Bad chills; Fever; Aching all over; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Felt weak), DECREASED APPETITE (Was not hungry), CHILLS (Bad chills), PYREXIA (Fever) and MYALGIA (Aching all over) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure, Cholesterol and Prostate adenoma.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced ASTHENIA (Felt weak), DECREASED APPETITE (Was not hungry), CHILLS (Bad chills), PYREXIA (Fever) and MYALGIA (Aching all over). At the time of the report, ASTHENIA (Felt weak), DECREASED APPETITE (Was not hungry), CHILLS (Bad chills), PYREXIA (Fever) and MYALGIA (Aching all over) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included blood pressure pill, cholesterol pill, prostate pill were reported. Treatment details was not reported by the reporter.
temperature excursion of Tenivac at an unknown extreme temperature, for a cumulative time of 10 minutes due to being prepared and then finding out the patient did not need the dose because of handling error/No AE; Initial information received on 02-Oct-2019 regarding an unsolicited valid non-serious case received from an other health care professional.  This case involves a patient of unknown demographics.  This case involves a temperature excursion of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] at an unknown extreme temperature, for a cumulative time of 10 minutes due to being prepared and then finding out the patient did not need the dose excursion was due to handling error (lot number: U6187AA and expiry date: 06-Feb-2021).  It was a potential medication error due to incorrect product storage.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization 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.  List of documents held by sender: none.