chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 60 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with MRNA 1273 (Dose Number in Series 1) (Moderna vaccine, route of administration, dose, batch number 039B21A,expiry 02-OCT-2021 (first shot) and received the second dose on 12-MAY-2021 (batch number 022C21A, expiry 23-DEC-2021 (second shot). The patient had a reaction to both the shots.(dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2)(suspension for injection, intramuscular, batch number:213D21A, expiry: UNKNOWN) dose not reported, 1 total administered on 15-DEC-2021 to the left arm for prophylactic vaccination. No concomitant medications were reported. On 10-FEB-2022, the patient experienced confirmed clinical vaccination failure, and confirmed covid-19 infection. (Dose number in series 2). The patient did two rapid tests at home, one was negative and one was positive. As per the advice of her doctor she got tested again at the county testing site on 10-FEB-2022 for a Covid test, and they contacted her back with a positive test result. They had done a rapid test and a PCR (polymerase chain reaction) test. The patient did not specify any symptoms but reported that she does not have a fever. The patient also enquired if there was a problem with asthma and the Janssen booster. Laboratory data included: On 10-FEB-2022, COVID-19 PCR (polymerase chain reaction) test (NR: not provided) positive, and COVID-19 rapid POC test (NR: not provided) positive. Laboratory data (dates unspecified) included: COVID-19 rapid POC test (NR: not provided) positive, negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed clinical vaccination failure and confirmed covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report is associated with a product quality complaint number 90000217187.; Sender's Comments: V0:20220230227-COVID-19 VACCINE AD26.COV2.S-Confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. In 2012, the patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) at a medical facility/office, (by an unspecified health care professional), for routine adult health maintenance and the intended purpose for the prevention of shingles. The vaccine did not prevent shingles as intended. The patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine is intended to prevent. During 2013, the patient was treated at the medical facility/office (by an unspecified healthcare professional), for a vesicular outbreak, which was diagnosed as shingles and Ramsey Hunt Syndrome, a neurological disorder secondary to zoster infections. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, she has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Upon internal review, Ramsey Hunt Syndrome was determined to be a medically significant event. Additional information has been requested.
Information has been received from a medical assistant, referring a patient of unknown age and gender. Information on medical history, concomitant medications and drug allergies was not provided. On an unknown date, the patient was vaccinated with a dose of improperly stored VARIVAX (lot# M038858, expire date: 14-SEP-2018) for prophylaxis (dose and route of administration were not reported). The temperature of storage for VARIVAX was above -10 Celsius and below 8 Celsius for 1 hour and 2 minutes (2 excursions). A data logger was involved. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1702USA011638: US-009507513-1706USA000480: US-009507513-1706USA000481: US-009507513-1706USA000482: US-009507513-1703USA002284: US-009507513-1706USA000487: US-009507513-1706USA000488: US-009507513-1706USA000489: US-009507513-1706USA000490: US-009507513-1706USA000492:
A non-serious spontaneous report of testing positive for influenza type A has been received from a health professional concerning a 13-year-old male, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 28-Aug-2011. On 31-Aug-2011, the patient experienced fever, chills, nausea and vomiting. On 06-Sep-2011, the patient tested positive for influenza type A. The outcome of the event was unknown.
Information has been received from a physician through the Pregnancy Registry for GARDASIL concerning an 18 year old female with a history of deep vein thrombosis at the age of 15 and no drug allergies, who in the middle of September 2007 was vaccinated intramuscularly in the left arm with the first dose of GARDASIL.   The patient was vaccinated with a second dose of GARDASIL approximately from the middle to the end of November 2007.  There was no concomitant medication.  Subsequently, the patient was pregnant.  The patient sought medical attention from her primary care physician.  A urine pregnancy test was performed and was positive.  The patient's last menstrual period was 12-NOV-2007 and her estimated delivery date was 18-AUG-2008.  The patient contacted the physician for OB/GYN care.  No problems were reported.  At the time of the report, the outcome of the patient was unknown.  No product quality complaint was involved.  Follow-up information was received from a nurse practitioner and patient who reported that the patient delivered a normal healthy baby on 12-AUG-2008.  The nurse practitioner reported that during the pregnancy the patient had a routine pregnancy ultrasound on 04-APR-2008, 23-JUN-2008 and 22-JUL-2008 and the results were normal.  On 29-MAY-2008, the patient had a glucose screen and was normal.  In further follow up, the patient reported that the baby was female and weighed 7 pounds, was 20 inches, the APGAR score was 8/9 and head circumference was 32.  The infant was normal, with no congenital anomalies and there were no other complications.  The patient had no complications during the pregnancy and labor/delivery.  Infection during the pregnancy included  a "staff" infection.  The medications used during her pregnancy were LOVENOX, 40mg, daily (January to July 2008) and HEPARIN, 20mg, twice daily (July to August 2008) for the treatment of deep  vein thrombosis.  No further information is available.
Sweaty palms; Pain on right shoulder; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an intramuscular route of administration in the right arm on 25Mar2021 at 11:45 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. The patient did not had any relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. Concomitant medication was not reported. On 25Mar2021, after vaccination, the patient experienced sweaty palms and pain on right shoulder. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events sweaty palms and pain on right shoulder was recovered on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 27-year-old female patient 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) .25 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible 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. No Treatment information was reported.  It was reported that there have been no power outages that would have impacted the Moderna vaccine. However, reporter reiterated that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger that caller was unable to download for the months of Dec2021, Jan2022 and Feb2022. Reporter said that they are filling out a temperature excursion assessment with the State at this time and she was calling in to report the same to Moderna.  Reporter confirmed that patients have been administered doses while the temperature excursion assessment has been ongoing. It was reported that no adverse reactions were reported by any patients.
Fever, "almost as bad as when I had COVID infection"; This is a spontaneous report from a contactable consumer. An unspecified age of non-pregnant female patient received first dose of 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 a single dose for COVID-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced Fever, almost as bad as when she had COVID infection. It was unknown whether the patient had received any treatment for the event. It was unknown whether If COVID tested post vaccination. The outcome of the event was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
(L) shoulder pain that started 1-2 days after vaccine. Treatment, rest, ice, heat. States it is a dull act that flares with excessive use.
This 43-year-old female presents to the emergency department for evaluation of headache. Pt states that she has had HA ongoing since Sunday. She was seen here for same then. States that since that time she feels that the HA has gotten worse and has developed loss of sense of taste and smell. States that she feels crackling in her sinus and is concerned for CSF leak secondary to coughing/choking episode the other day. Also reports post nasal drip. No fevers, chills, nausea, vomiting, chest pain, SOB, dizziness, lightheadedness, states that she has pressure behind her eyes but has no vision changes. States that she has no other concerns at this time. She has not had any recent head injury. No recent travel or procedure. She is otherwise at her baseline state of health. HA called 10/10 throbbing while sitting or standing and 7/10 with laying flat.  Reports loss of taste and smell since last visit to ED  Patient had CT negative for acute intracranial findings on 8/1/21 and is concerned for worsening sx. She is scheduled for neurology follow up on Friday.    Will obtain COVID test due to loss of taste and smell.  COVID test + All labs and imaging studies have been reviewed and results have been discussed with patient/family.    Diagnosis: Covid    PLAN: 1. tylenol 2. fluids 3. Follow up with PCP  Continue to monitor for new and worsening symptoms.    Patient/family understand that this is a provisional diagnosis that can and may change. If symptoms worsen or fail to improve or new symptoms arise, patient should seek re-evaluation either here or with PCP. All questions are answered and patient/family is agreeable to plan of care.
Body aches; joint pain; severe headache; This is a spontaneous report from a non-contactable consumer, the patient. A 51-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: El3247), via an unspecified route of administration in the left arm on 23Mar2021 at 12:00 (at an age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. The patient previously took his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on an unspecified anatomical site on an unknown date as a single dose for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date in Mar2021, the patient experienced body aches, joint pain, severe headache. The clinical outcome of body aches, joint pain, severe headache was unknown at the time of report.   No follow-up attempts are possible; information about lot number cannot be obtained.
Dose administered to patient from a vial punctured more than 24 hours ago; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to patient from a vial punctured more than 24 hours ago) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) and CITALOPRAM for an unknown indication.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to patient from a vial punctured more than 24 hours ago). On 10-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered to patient from a vial punctured more than 24 hours ago) had resolved.        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.
Patient reports still having arm pain and is also having difficulty moving arm. Recommended she reach out to PCP - waiting to hear back if she did that.
pt recv vax & area of inj sore, red, warm 11FEB98;area was itching, also 11FEB98 area 15cm x 15cm red, raised w/pinpoint;pt put cold compression 11FEB98;
The following day, noted increased fever, increased rash to chest & arms (red pimples). 3-5 days later, decreased speech, clumsiness, huge dilated pupils, loss of eye contact, constipation, diarrhea, severe anxiety PDD insomnia, cerebral dysfunction, forgetfulness.  8/4/09 Medical records received DOS 6/23/08 to 6/23/09 Assessment: Autism Spectrum Disorder. Parental concerns for child include impulse control, attention, diet, following commands, social, poor language fluency. ASD behaviours. Biting at school. Yeast infection. Clostridia infection. Enterobacter cloacae infection.
a 6 month old patient was inadvertently administered a Kinrix; administered a Kinrix dose on 8/31/23 in the Left Thigh, instead of the intended Pentacel; kinrix received as 2nd dose of Dtap; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old female patient who received DTPa-IPV (Kinrix) (batch number T343J, expiry date 25-JAN-2025) for prophylaxis.   Previously administered products included Pentacel vaccine (received first dose on an unknown date).   On 31-AUG-2023, the patient received Kinrix (left thigh). On 31-AUG-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: a 6 month old patient was inadvertently administered a Kinrix), wrong vaccine administered (Verbatim: administered a Kinrix dose on 8/31/23 in the Left Thigh, instead of the intended Pentacel) and inappropriate schedule of vaccine administered (Verbatim: kinrix received as 2nd dose of Dtap).  The outcome of the inappropriate age at vaccine administration, wrong vaccine administered and inappropriate schedule of vaccine administered 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 Information: GSK receipt date: 13-Sept-2023 Medical assistant called to inquired that how to proceed. Did not consent to follow-up. Kinrix was inadvertently administered as Dtap 2nd dose to a patient instead of Pentacel at an inappropriate age, which led to inappropriate age at vaccine administration, wrong vaccine administered and inappropriate schedule of vaccine administered.
This spontaneous case was reported by a consumer and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), IMMUNISATION REACTION (Vaccination adverse reaction) and INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 59-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis. The patient's past medical history included Rheumatoid arthritis. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) UNK Citrate free. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up), IMMUNISATION REACTION (Vaccination adverse reaction) and INFLUENZA LIKE ILLNESS (Flu like symptoms). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up) had not resolved and IMMUNISATION REACTION (Vaccination adverse reaction) and INFLUENZA LIKE ILLNESS (Flu like symptoms) outcome was unknown. Concomitant medications were not reported. On unknown date, Patient experienced Rheumatoid arthritis flare up on right ankle. No treatment information was provided. Company Comment: This is a spontaneous case concerning a 59-year-old male patient with medical history of rheumatoid arthritis, who experienced the unexpected, non-serious adverse event of special interest of Rheumatoid arthritis (Rheumatoid arthritis flare up on right ankle), on unknown date after receiving a dose of mRNA-1273 vaccine. Date of vaccination, onset date of the event, clinical course and diagnostic tests were not provided in the case. The outcome of the event was unknown at the time of the report. The patient is receiving Adalimumab daily for rheumatoid arthritis. Medical history of rheumatoid arthritis remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This is a spontaneous case concerning a 59-year-old male patient with medical history of rheumatoid arthritis, who experienced the unexpected, non-serious adverse event of special interest of Rheumatoid arthritis (Rheumatoid arthritis flare up on right ankle), on unknown date after receiving a dose of mRNA-1273 vaccine. Date of vaccination, onset date of the event, clinical course and diagnostic tests were not provided in the case. The outcome of the event was unknown at the time of the report. The patient is receiving Adalimumab daily for rheumatoid arthritis. Medical history of rheumatoid arthritis remains a risk factor for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Information has been received from a certified medical assistant concerning a female patient of unknown age. Pertinent medical history or drug allergies/drug reactions were not reported. On an unspecified dates, the patient was vaccinated with the first, second and third dose of hepatitis b vaccine (manufacturer unknown), (lot number, expiration date, dose, strength, frequency and dose were not reported). Concomitant medication was not reported. It was reported that on an unknown date, the patient had titers drawn and the results came back negative for hepatitis B. The reporter also stated that a fourth dose of hepatitis B vaccine (manufacturer unknown) was administered on an unspecified date. At the time of reporting, the outcome of the hepatitis B surface antibody negative was unknown. Additional information is not expected since no permission for follow up was given.
decent reaction; feeling miserable; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (decent reaction) and FEELING ABNORMAL (feeling miserable) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder and Blood pressure abnormal. Concomitant products included THYROID (ARMOUR THYROID) for an unknown indication.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (decent reaction) and FEELING ABNORMAL (feeling miserable). At the time of the report, VACCINATION COMPLICATION (decent reaction) and FEELING ABNORMAL (feeling miserable) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications included blood pressure medication.   This case was linked to MOD-2021-410138, MOD-2021-410145 (Patient Link).
Bell's Palsy. Started with ear pain and then tongue numbness. Went to ER with just ear pain and tongue numbness and at the time you could just start to see the weakness in the facial muscles. It got much worse over the next couple of days.