chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse via a company representative refers to a currently 21 year old female patient. On an unknown date when the patient was 13 or 14 years old she was vaccinated with the full series of GARDASIL (dose, frequency, lot number and expiration date not reported) for immunization. There was no concomitant medication reported. The reporting nurse from a physician's office stated that someone she knew personally, stated that the patient after completing the series of GARDASIL tested positive for HPV. The nurse could not specify which strain she tested positive for. The outcome of the event was unknown. Additional information has been requested.
Described flushing on her face, took her own blood sugars = 62, then ate, came up to 300. Described eye swelling. Stayed for full 30 min after vaccine.  All symptoms went away and counseled to f/u with PCP or go to ED if urgent symptoms returned.
11/18/2021 2019 Novel Corona virus RNA detected Hospitalized 11/21/21 DX with Pneumonia
Case number PHEH2014US020800 is an initial spontaneous report received from a health care professional on 13 OCT 2014. This report refers to a patient of unknown identifiers. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN 2014/2015 (batch number: 1411501) intramuscularly at a dose of 0.5 ml on unspecified date. It was reported that the patient experienced intestinal issues. The outcome of the event was reported as unknown. The seriousness and causality of the event were not reported. No additional details available.
Patient reports ~10 minutes post vaccine becoming sweaty, experiencing blurry vision, and muffled hearing. Writers assessment at 12 minutes , no longer diaphoretic, reports clear vision, slight headache,  still slightly muffled hearing. Report no past medical history or allergies, and states last meal was ~20 hours ago. Assessment at 20 minutes - patient reports ?weak neck?, continued headache, vision/hearing returned to normal. Provided with education to seek care of physician if conditions continue or worsen,  left site with boyfriend.
Patient came in for a re-check appointment. I usually quickly assess last office visits, vital signs, & then assess immunization status before taking a patient back. In the exam room I confirm needed immunizations with the patients verbally. Patient informed me she could not remember the last time she had a tetanus booster. I had her fill out the immunization Questionnaire form & I administered the TDaP before the provider went in to see her. After provider went in to see her. After I documented the vaccine in EMR I clicked on the EMR Immunization Report & to my horrid surprise, I saw she had a TDaP about 3.5 years ago. I'm not sure when the immunization assessment failure. I might have just opened the EMR immunization section which does not show all the immunizations (like TDaP) at a glance though normally I open the Immunization Report section which does show the whole record at a glance. Practice: Community Health Center Product: Tdap, ADACEL Dose: 0.5 mL EMR: XXXXX, unable to see full shot record on the imms home page. The page must be opened to see the full vaccine record.
completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose:01/07/2021pfizer, 2nd dose:01/28/21 Pfizer, Diagnosed covid positive:04/06/21 Exposure:unknown Symptoms:Cough,sore throat,SOB,Fatigue,muscle aches,ADB pain,runny nose, headache.
Patient received injection approximately 16:00. At 19:30 began to experience pain in left arm. It worsened through the night and she came to doctor's office in morning complaining of severe pain (rated 10 on a 0-10 scale). Unable to move arms. Still in hospital 10/23/2006.  Hospital record received from PCP which reveals that the patient was admitted to the hospital 1 day following pneumovax with c/o severe (10-11/10 ) Left arm pain at the injection site.  Hospitalization was to R/O MI or acute cardiac event.     Admitting and Discharge Diagnosis was the same: "Left shoulder pain secondary to Pneumovax injection."  Has had and will continue PT.  F/U visits to PCP of 10/30/2006 and 11/13/2006 with following Assessment:  Reaction to pneumonia vaccine in left shoulder improving at present time.
Painful rash that would randomly appear on both hands, arms, neck, and back of scalp. Each day after injection, the rash would appear more throughout the day and each flare up would be worse in appearance and pain.
I know more than one person that took the shingles shot only to get shingles a month or two later / Suspect vaccination failure; I know more than one person that took the shingles shot only to get shingles a month or two later; your immune system is weakened; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, between 1 and 3 months after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and decreased immune responsiveness. On an unknown date, the outcome of the vaccination failure, shingles and decreased immune responsiveness were unknown.   The reporter considered the vaccination failure, shingles and decreased immune responsiveness to be related to Shingles vaccine.  Additional details were provided as follows:  The age at vaccination was not applicable for this report. The reporter stated that shingles were something you got after you took the shot and your immune system was weakened. The reporter know more than one person that took the shingles shot only to get shingles a month or two later. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not be possible, as no contact details were available.
Information has been received from a licensed practical nurse concerning a patient who was vaccinated with a dose of VARIVAX (Merck).  The patient developed rash at the injection site after receive the VARIVAX (Merck).  Follow up information received on 08-MAY-2009 from the licensed practical nurse stating that this was the patient's second dose of VARIVAX (Merck).  She did not remember the patient so she was unable to provide further information.  The LPN stated that this was over a period of time and did not believe that the other patients involved (WAES 0905USA00016 and 0905USA00489) were vaccinated with the same vaccine lot number.  This is one of three reports from the same source.  Additional information has been requested.
- Local reaction - red, hot, swollen, - 6 cm diameter, tender.  - Myalgias, low grade fever, cough.
Sever diarrhea began on 11/5/2021.  Has been almost daily since then, lasts for 3 to 5 hours, normal Imodium and Pepto Bismol provide little help.  GI prescribed Hysocyamine.  Does not help.   Stool testing has been completed with all negative results.  She has never had diarrhea this severe.
This spontaneous report as received from a registered nurse refers to an unknown age and gender patient. Pertinent medical history, drug allergies or reactions were not reported. On 12-SEP-2013, the patient was vaccinated with GARDASIL dose 1, 0.5 ml, intramuscular (lot # was not reported). Late on 10-FEB-2014, the patient was vaccinated with GARDASIL dose 2, 0.5 ml, intramuscular (lot # was not reported). Concomitant medication was not reported. No adverse effects reported. Additional information is not expected.
This case was reported by a healthcare professional and described the occurrence of injection site pain in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On 7 October 2011 at 15:00 the subject received a dose of FLULAVAL (details unknown). On an unspecified date in October 2011, less than one week after vaccination with FLULAVAL, the subject experienced injection site pain. At the time of reporting the outcome of the event was unspecified. The healthcare professional reported that 5 subjects had received FLULAVAL and had experienced injection site pain. This is case 4 of 5 (see case IDs A0949586A, A0949593A, A0949594A, A0949596A for details of the other reports).
This spontaneous report as received from a pharmacy technician refers to a 4-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 02-MAR-2018 the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA001558.
PATIENT STATED HER ARM BECAME HOT AND PAINFUL FOR 3 DAYS BUT STOPPED; HOWEVER, SHE STATED THAT THE FOLLOWING MORNING AFTER RECEIVING THE VACCINE SHE DEVELOPED "SMALL BUMP, RASH" ON HER ARM AND BODY BUT AT FIRST SHE THOUGHT THEY WERE DUE TO INSECT BITES. PATIENT DID GO SEE HER PRIMARY CARE DOCTOR TODAY 12/20/19 BECAUSE SHE STILL HAS THE RASH AND STATED DR. CONFIRMED SHE CURRENTLY HAS SHINGLES AND WAS PRESCRIBED VALTREX 1 GRAM TO BE TAKEN 1 TABLET BY MOUTH THREE TIMES PER DAY FOR 7 DAYS.
After 5 minutes of receiving the dose patient fainted and fell from a chair  he was cold and clammy, and sweating
Patient was given shots with no problem. She was a little nervous but did not cry after injections. She sat up and mom noticed she was not alert, she asked her what was wrong and she didn't respond. Patient was limp and was laid down. Immediately she starting urinating. Eyes were open but fixed. Patient was not responding. Her rt leg was twitching during the event. Event lasted less than 1 minute. After regaining consciousness she responded to basic questions but remained pale. She laid down for 10-15 minutes then someone carried her to the bathroom. After coming back patient looked drowsy and felt like she had to vomit. She again turned very pale. Mom held her over the garbage can but did not vomit. Patient complained of just wanting to go to sleep. Also said she felt dizzy after the shots but was not dizzy anymore. EMS called.
Narrative: Patient reported to primary care provider on 9/15/22 experienced a vaccine SE one year ago when received moderna vaccine. Patient received one dose of moderna on 9/20/21; then reported to provider one year later experienced lower leg numbness / tingling within 15 minutes after receiving the vaccine. Patient refuses additional COVID vaccinations and did not seek medical care after experiencing the potential SE a year ago; resolved.
vaccine expired on 08/31/2021 and vaccine was administered on 09/07/2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine expired on 08/31/2021 and vaccine was administered on 09/07/2021) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Asthma, Hyperlipidemia, Chronic kidney disease, Prediabetes and Allergy to antibiotic (Allergy to Bactrim). Concomitant products included SALBUTAMOL SULFATE (PROAIR HFA), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR), OMEPRAZOLE, NIFEDIPINE and SIMVASTATIN for an unknown indication.    On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine expired on 08/31/2021 and vaccine was administered on 09/07/2021). On 10-Sep-2021, EXPIRED PRODUCT ADMINISTERED (vaccine expired on 08/31/2021 and vaccine was administered on 09/07/2021) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details was not reported by the reporter.
transient ischemic attack  I was working and felt unusually exhausted, lost vision in my right eye for over an hour, and called my boyfriend to tell him I wasn't feeling well and that I would try to make it through my work shift. I then called him back 4 minutes later and failed to form words, and also could not type words. I felt like I was going to faint and have no recollection of 10 minutes during that time. I had to leave work to go to the emergency room.  I had a massive headache for 3 days following my TIA.
The patient presented to a mass vaccine event for a first dose. On review of patient records in state immunization registry during an appointment several weeks after receiving what was believed to be their 2nd dose , it was determined that the patient received 3 doses of the Pfizer vaccine, with the 1st and 2nd doses being 2 days apart. They received their 1st dose at a different facility on 2/24/21 and then a 2nd dose at local Health Center on 2/26/21. They came back to receive what was intended to be their 2nd dose on 4/10/21, but this was then their 3rd dose.
This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen Left Arm) and CHILLS (Chills) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced PERIPHERAL SWELLING (Swollen Left Arm) and CHILLS (Chills). On 29-Jan-2021, PERIPHERAL SWELLING (Swollen Left Arm) and CHILLS (Chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2021-034135 (Patient Link).
pt recv vax & 2-7 days post vax pt exp flu-like sx, nausea, h/a & gen malaise;pt was seen by MD;tx unk;
Soreness in his arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Soreness in his arm) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A, 032L20A and 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness in his arm). At the time of the report, VACCINATION SITE PAIN (Soreness in his arm) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Antibody test: 110 (Low) S test showing a count of 110. In December 2021, Antibody test: 83.9 (Low) S antibody count dropped to 83.9.. In December 2021, Blood test: not reported Results were not reported. On 18-Dec-2021, Antibody test: not reported Anti SARS CoV N and S tests Results were not reported.. On an unknown date, Antibody test: 85 Retested and count was 85.         No concomitant information was reported. No treatment information was reported.  Patient stated that he was not sure whether it was possible that the booster created absolutely no S antibodies and failed to trigger an immune response in the patient.  Patient was enrolled in an antibody study undertaken by [school] by utilizing (unspecified) tests.These tests were done by a Laboratory.   This case was linked to MOD-2021-417990 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Dec-2021: Added reporter occupation as other health professional, Lab tests, event outcome as recovered. On 23-Dec-2021: Updated reporter occupation as patient and Updated lab data- Antibody count updated
BLOOD IN STOOL; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2. s (suspension for injection, route of admin not reported, batch number: unknown, and expiry date: unknown) dose was not reported, 1 in total administered on 06-MAY-2021, around 14:00 for prophylactic vaccination. The batch number was not reported. The company is unable to perform the follow up to request batch number. No concomitant medications were reported.  On 07-MAY-2021, the patient had blood in stools in the morning and later on day of reporting. The patient had visited physician office for blood in stool. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood in stool. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210516537-covid-19 vaccine ad26.cov2. s-blood in stool. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Improper storage of product in use; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication, previous drug reactions, and allergies were not reported.      On 15-MAR-2021, the patient was vaccinated with one Hepatitis A Vaccine, Inactivated (VAQTA) (lot number T014589, which has been verified to be valid, the expiration date was reported and validated as 25-OCT-2021), as prophylaxis (dose, dose number, route of administration, and anatomical site of vaccination were not provided).  The suspect vaccine was exposed to a temperature of 0 hours 30 minutes and 0 seconds (product storage error), as recorded by digital data logger. Additionally, a previous temperature excursion was reported of 46.4 degrees F for a time frame of 0 hours 30 minutes and 0 seconds. The reporter stated all the patients were asymptomatic.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T014589; expirationdate: 25-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2104USA001297:
Extreme fatigue for 5 days could not stay awake fatigue for a further 3 weeks.
Moderna Vaccine was administered after the beyond use date of 30 days at refrigerated  temperature. BUD 10/01/2021
This spontaneous report as received from a pharmacy technician refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 31-AUG-2015, the patient was vaccinated with an expired dose of RECOMBIVAX HB, lot # J014232, expiration date 29-AUG-2015, (dose, route of administration and injection site were not reported). No adverse effects were reported. Additional information has been requested.
son then husband sick but neg Ag tests then she had Mod to severe ST fever myalgias congestion starting 31May2022 + PCR 02Jun2022; son then husband sick but neg Ag tests then she had Mod to severe ST fever myalgias congestion starting 31May2022 + PCR 02Jun2022; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 34-year-old female patient received BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EL3247), on 24Feb2021 as dose 2, single (Lot number: EL3247) and on 02Nov2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 34 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 31May2022, outcome "unknown" and all described as "son then husband sick but neg Ag tests then she had Mod to severe ST fever myalgias congestion starting 31May2022 + PCR 02Jun2022". The patient underwent the following laboratory tests and procedures: Polymerase chain reaction: (02Jun2022) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The reporter stated that the patient son then husband was sick but negative Ag tests then she (patient) had moderate to severe ST fever, myalgias, and congestion starting 31May2022 + PCR 02Jun2022. It was unknown whether treatment was received by the patient. No Covid prior vaccination, was Covid tested post vaccination. Covid test type post vaccination was nasal swab, test name was PCR, and results were positive.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to the reported events Vaccination failure   ,covid 19 cannot be completely excluded based on temporal association.
Experienced several minutes of dysphasia at 6:30 PM after waking up from a nap. I knew my words weren't making sense.  Went to ER and put on stroke observation - no further symptoms. Diagnosed as a TIA with not brain damage.
Patient received Moderna COVID-19 vaccine on 6/22/21 at approximately 6pm.  Returned to pharmacy on 6/28/21 to report the following.  On Wednesday 6/23/21 at 5:30am patient has a fever. Then Thursday 12:00am patient reports tongue swelling, patient took 25mg of diphenhydramine and swelling subsided.
redness; Itching; Heat; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (redness), INJECTION SITE PRURITUS (Itching) and INJECTION SITE WARMTH (Heat) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event reported).    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (redness), INJECTION SITE PRURITUS (Itching) and INJECTION SITE WARMTH (Heat). At the time of the report, INJECTION SITE ERYTHEMA (redness), INJECTION SITE PRURITUS (Itching) and INJECTION SITE WARMTH (Heat) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.   Reporter did not allow further contact; 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.