chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to 2018SA292670 (same reporter). This case involves a 71-year-old male patient who was vaccinated with the dose of FLUZONE HIGH DOSE lot UJ042AB exp date: 19-May-2019, via intramuscular route in the left deltoid on 18-Oct-2018 which was administered prior to realizing a 1 day shipping excursion had occurred with the product, delayed Transit Vaccine Stability. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines administered. It is an actual medication error case due to incorrect product storage. No reaction 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. List of documents held by sender: none.
administered two booster doses after the expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered two booster doses after the expiration date) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022J21A, 053E21A, 038A21A and 022M20A) for COVID-19 vaccination.     It was reported that patient was not diagnosed with/tested positive for COVID-19. It was reported that patient did not have any acute illnesses at time of vaccination.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 25-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 25-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered two booster doses after the expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered two booster doses after the expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product information was not reported. The vial was initially stored in refrigerator on 18-Apr-2022. The vial did not undergo any temperature excursions. Patient received expired second booster dose. It was stated that no adverse reaction was reported by the patient after receiving the vaccine and after 15 minutes of standard post-vaccination observation.  Treatment information was not provided.
No other AE reported; administered GARDASIL 9 during a temperature excursion; This spontaneous report was received from a medical assistant and refers to a 14-year-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 16-FEB-2021, the hpv rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) vaccines experienced the temperature excursion of 11 degrees Celsius for 10 hours.    On 02-MAR-2021, the patient was vaccinated with improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter, lot # T007035, expiration date 01-MAY-2022 (route of administration and anatomical location were not provided) for prophylaxis. The vaccine was administered by the certified and trained medical assistant and was paid for with  Vaccines for Children (VFC) funds. There was no previous temperature excursion. Digital data logger was involved. The vaccine was not available for return/evaluation. There was no other adverse event reported. At the time of reporting, the patient had not experienced cellulitis, erythema or swelling at the site of the injection.  This is one of several reports received from the same reporter. 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: T007035; expirationdate: 01-MAY-2022; deviceage and unit: 0 ; operatorofdevice: Medical Assistant; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2103USA001535: US-009507513-2103USA001532: US-009507513-2103USA001526:
SORE NECK AND HEADACHE THE NIGHT OF THE VACCINE; STABBING PAINS IN HEAD AND EARS FOR THE NEXT FIVE DAYS ALONG WITH FATIGUE, A MILD TO MODERATE FEVER, CHILLS, AND SENSITIVE SKIN OVER ENTIRE BODY; GENERAL BODY ACHES STARTED ON 05/11/2010 AND EVERY MORNING WOKE UP WITH VERY SORE NECK AND BACK MUSCLES; STABBING HEAD AND EAR PAIN CEASED ON 5/15 BUT ALL OTHER EVENTS PERSISTED UNTIL 5/21.
There are new lesions; rash being a delayed reaction and lasting for 4 weeks; Rash initially on her anterior chest and rash is still spreading to other parts; This spontaneous case was reported by a health care professional and describes the occurrence of WOUND (There are new lesions), SKIN REACTION (rash being a delayed reaction and lasting for 4 weeks) and RASH (Rash initially on her anterior chest and rash is still spreading to other parts) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced RASH (Rash initially on her anterior chest and rash is still spreading to other parts). On an unknown date, the patient experienced WOUND (There are new lesions) and SKIN REACTION (rash being a delayed reaction and lasting for 4 weeks). At the time of the report, WOUND (There are new lesions) and RASH (Rash initially on her anterior chest and rash is still spreading to other parts) had not resolved and SKIN REACTION (rash being a delayed reaction and lasting for 4 weeks) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information included topical steroid. She responded to topical steroid, but the rash is still spreading to other parts and there are new legions over the 4 weeks. They are not itchy.   Company comment 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.
Early Booster. Client received 2nd Dose out of state less than 5 months prior.
Pt stated she had diarrhea, chills, slight temp, vomiting. Symptoms for 24 hrs.
This spontaneous report was received from a pharmacist and refers to multiple unspecified patients of unknown age and gender. There were no medical history and concurrent conditions reported for the patients. On an unknown date, the unspecified patients were vaccinated with improperly stored doses of VAQTA (dose, frequency, route, lot # and expiration date were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of two cases from the same reporter. Additional information has been requested.
Temperature excursions during a period of 33 weeks on 2021/The vial was put into cooler, sometimes there was a period 1hr or 1.5hr approximately, when temperature data logger registered 34 or 35 F; Dose administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/Each time vial was put into cooler, sometimes there was a period 1 hr or 1.5hr approximately, when temperature data logger registered 34 or 35°F) and POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursion) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 9:12 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 9:12 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/Each time vial was put into cooler, sometimes there was a period 1 hr or 1.5hr approximately, when temperature data logger registered 34 or 35°F). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursions during a period of 33 weeks on 2021/Each time vial was put into cooler, sometimes there was a period 1 hr or 1.5hr approximately, when temperature data logger registered 34 or 35°F) and POOR QUALITY PRODUCT ADMINISTERED (Dose administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial was initially moved to the fridge on 29-Sep-2021 and proposed beyond use date was 29-Oct-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. On the date of administration, at 08:00 A.M., the temperature recorded was 41 degree Fahrenheit  at 09:00 A.M., the temperature recorded was 29 degree Fahrenheit and at 10:00 A.M., the temperature recorded was 32 degree Fahrenheit that has been reached by the vial. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. The vial was not in a frozen state at the time of vaccine administration. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. No treatment information was provided.
shoulders was hurting a little; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 5 patients. This is 3rd of 5th reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as Dose number Unknown, Single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported on an unspecified date that if Consumer didn't get a reaction that means the shot was not effective and was not working, was that true? As per consumer there was 5 of us and none of us had reactions, only our shoulders were hurting a little but we had not fever. The outcome of event was unknown.  Information on Lot/Batch number has been requested.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021171051 same drug/AE, different patient.;US-PFIZER INC-2021171050 same drug/AE, different patient.;US-PFIZER INC-2021171048 same drug/AE, different patient.;US-PFIZER INC-2021130494 same drug/AE, different patient.;US-PFIZER INC-2021171050 same drug/AE, different patient.
Staff from a senior living facility called me stating the patient was actively dying and presented with high fever unsure of specific symptoms. I told staff if the patient is dying taking him to urgent care, and she said that he is in hospice.
Delayed rash and swelling. Hot to the touch; also lymph node swelling under the right arm.
At approximately 0906 staff immediately began to cough and c/o itchy throat, and itching throughout the body.  O2 given at 3 L via nasal cannula. 0910 Cetirizine 10 mg PO. 0915 Benadryl 50 mg given PO.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On 07-OCT-2014, an unspecified number of patients were vaccinated with improperly stored PEDVAXHIB lot # J014279, expiration date: 16-SEP-2016 (dose and route of administration were not reported). No symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
This case was reported by a other health professional via call center representative and described the occurrence of cough in a 4-year-old male patient who received KINRIX (batch number T325H, expiry date 17th February 2017). On 24th February 2017, the patient received KINRIX. On 24th February 2017, unknown after receiving KINRIX, the patient experienced expired vaccine used. On 17th March 2017, the patient experienced cough and fever. On an unknown date, the outcome of the cough, fever and expired vaccine used were unknown. The reporter considered the cough, fever and expired vaccine used to be unrelated to KINRIX. Additional details were provided as follows: This case was previously reported to Doctor. This case was reported by a Certified Medical Assistant. The call was transferred from Vaccines Service Center. The patient received KINRIX on right thigh, which was already expired on 17th February 2017. On 17th March 2017, 3 weeks after the vaccination, the patient experienced fever and cough. This case was linked with US2017044474, reported by the same reporter.
Recieved the Pfizer-Biontech Covid-19 vaccination on Dec 26th 2020, and had no major adverse reaction to vaccine except for mild soreness and heat around injection site and intense fatigue for three days after. Symptoms went away after the 4th day. Two weeks later on Jan 5th 2021, i began to notice an intense itching, burning, and swelling at the injection site. Pain and soreness in arm made it difficult to do my job and seem to just get worse. Upon the next morning of Jan 6th 2021, pain remained but itching had gone down, but intense burning, soreness and massive redness around injection site remained and seemed to be getting worse. Pain remains and redness has not gone down, arm is very tender near site and lifting and moving arm is very stiff and sore. Feeling of lump or stiffness on injection site comes and goes and feeling of heavy and sore muscles move from upper left arm down to elbow and extend to hand; making movement and function slowed or slightly numb. Stiffness in arm and intense heat at injection site makes it uncomfortable to move or use arm. Cold tingling sensation on occasion and stiffness in elbow joint. Slight dizziness and fatigue follow with pain in arm. Was informed to see a physician on Jan 6th, 2021 who said to fill out vaccination adverse event report and to keep an eye on arm. If pain or symptoms become worse to return.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 14-DEC-2015, the patient was inoculated with ZOSTAVAX at a medical facility 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 15-AUG-2016, the patient was treated by a physician at a medical facility for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, 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, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Patient made aware of receiving third booster dose of Pfizer earlier than  due date of  3/23/2022. Patient observed for 15 minutes and  no signs and symptoms or adverse effects noted.
Patient's own description: "within 2 days of administration, it first affected my shoulder and shoulder blade area, causing stiffness and limited range of motion for my arm (including a clicking sound during some motions). The side of my torso was also a bit stiff. By day 3, the stiffness spread to my upper and lower back after a sharp but brief pain in my back. The stiffness in my upper back also spread to my neck.    After 3 weeks (and a few chiropractic sessions), my shoulder has loosened and I am close to returning to a full range of motion in my shoulder again. However, my neck remains problematic with stiffness and limited range of motion. This has caused some difficulties when driving, with me sometimes needing to turn my entire body instead of just my neck. "
mom recv vax 18APR97 & 21MAY97 & prev tested for varicella antibody & was negative;pregnancy confirmed LMP 21MAY98;mom delivered @ 38wk nl infant 4lb, 14oz;lab eval revealed infant had elevated bilirubin p/birth;
stayed sick all winter long, couple of times even hospitalised; Initial information was received on 06-Dec-2020 regarding an unsolicited valid serious social media case from a non-healthcare professional (son/daughter of the patient) via social media .  This case is linked to the case 2020SA350795 (mother of reporter, wife of patient).  This case involved a male patient of an unknown age who stayed sick all winter long and couple of times was even hospitalized (Illness), after receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by an unknown manufacturer (lot number and expiry date were not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  it was reported that the reporter's mother used to get the flu shot every year and would get deathly ill and stepfather of the reporter stayed sick all winter long, a couple of times was even hospitalized (Illness) following administration of INFLUENZA VACCINE (unknown date and latency, serious event).   The patient was already died at the time of reporting, the cause of death was not reported   After the patient's death, reporter's mother stop taking something that made her sick and she never got sick with the cold and flu again and lived another 15 years.  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Information on the batch number was requested.; Sender's Comments: This case involved a patient of an unknown age and gender who presented with illness after vaccination with INFLUENZA VACCINE. Time to onset is unknown. Although, medical history, concomitant medications, additional information on investigations ruling out other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
My initial symptoms were sneezing and runny nose, which continued for probably two days. I didn't feel sick, though. I thought it was just allergies. On the third day, I took a COVID-19 test and got a positive result. On the fourth day, I called the doctor's office and asked if I should have PAXLOVID. They prescribed me PAXLOVID, which I took for five days. They had me stop taking simvastatin while I took the PAXLOVID on account of contraindications; I ceased taking the simvastatin for ten days. I felt fine, and I never had any other symptoms aside from the sneezing and runny nose.
I was exposed to Covid-19 4 days after and tested + 9 days after dose #1; I was exposed to Covid-19 4 days after and tested + 9 days after dose #1; I was exposed to Covid-19 4 days after and tested + 9 days after dose #1; This is a spontaneous report from a contactable female nurse (patient) via Pfizer sponsored program.  A female patient of an unspecified age received bnt162b2 (BNT162B2) on 26Dec2020 at single dose for Covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient was exposed to Covid-19 4 days after on 30Dec2020 and tested + 9 days after dose #1 on 04Jan2021.  The outcome of events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given. Case will be reevaluated based on follow-up information
Late in the day of the shot on 01/21/2021, site on arm began to hurt and got worse in the increasing 2 days. Red very warm rash began at the injection site and spread to the size of a soft ball.  Today, 01/25, the site is still red and swollen but not as poinful. Temperature is normal.      Along with the affected infection site from 01/21, had a series of fevers ranging from 99.9 - 100.9. Usual body temperature is 97.6. Along with this,   severe body aches, fatigue, malaise, deep depression and bed stay for 2 1/2 days.  Took Tylenol. Today, 01/25/21  at 11:27AM, temperature is 98.3.
Information has been received from an occupational health registered nurse concerning a 21 year old black female patient care assistant with no allergies, no history of chicken pox and no medical history on 07JAN2004 was vaccinated subcutaneously in the left arm with a 0.5ml first dose of varicella virus vaccine live. There was no concomitant medication. On the night of 20JAN2004 the patient stated her temp was as high as 104F. On 21JAN2004 the patient was seen in the office with a fever of 101.2F and a sore, swollen, hard and slightly red, 2-3 diameter area (silver dollar size) around the injection site. There were no lesions at the time of report. The patient was advised to take acetaminophen (Tylenol) for an elevated temperature and discomfort, apply warm compresses to her left upper arm for discomfort and was then sent home. She was instructed not to return to work until she was afebrile. No diagnostic lab tests were performed. On 22JAN2004 the patient reported to the occupational health clinic prior to work. She was afebrile, there was no rash or redness and there was a "little" soreness. It was reported that the patient had recovered. No product quality complaint was involved. No further information is expected.
3 1/2wk p/vax devel pain, weakness & swelling in upper extremities;has trouble sleeping & weakness in the lower extremities;has problems getting up;seen by internist & neurologist (demyelinating disease;neuro feels this is secondary to GBS;