chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PY1 student administed vaccine into patients right deltoid IM. The vaccine was running down the patients arm and she had removed the needle from the patient's arm. The syringe still had vaccine in it. Patient received less than 1/2 of the vaccine. I proceeded to call the manufactuer Moderna to find out what to do. They sent me information that stated it the patient received less than 1/2 of the dose to revaccinate immediately in the opposite arm. I proceeded to then revaccinate with full dose in the left deltoid IM. I followed up with the patient the following day 5-4-2021 and she said she was fine and having no side effects from the vaccine other than her arm was a little sore.
Sore arm day one. muscle and joint pain in lower body. Extreme fatigue. swelling in hands and ankle that is still present.
Puss shooting out after 10 days from date of vaccination. Wound infected, redness around injection site.
Patient has pain in arm radiating from collarbone to elbow in left arm. Is unable to use arm. No redness or swelling. Advised to see doctor.
Headache, Arthralgia, Fever, NauseaVomiting, high grade fever of 103. F; chills Narrative:
Raised red area in belly for 2 days.  Itchy was seen 04/05/2006.  Patient started on acyclovir, zyrtec.
Severe hives after 2nd set of immunizations lasted 4-5 days. Spread out next time.
Myalgia, Fever, Diarrhea, NauseaVomiting, right arm pain last night then body aches, diarrhea, chills, vomiting Narrative:  Other Relevant History:
This spontaneous report was received from a physician via an online article and refers to a 20-year-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a first dose of GARDASIL (route of administration, lot# and expiration date were not provided) for prophylaxis. On an unknown date, reported as within four months after her first GARDASIL shot, the patient developed symptoms of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease. The reporter stated that disease progressed very fast(the disease progressed more quickly than typical for young ALS patients). She died on an unknown date in August 2008 (reported as last August), reported as 28 months later (also reported as 13 months later), at the age of 22 years old. The cause of death was reported as amyotrophic lateral sclerosis (ALS). An autopsy was performed. The autopsy results showed that the patient's spinal cord was so inflammatory(also reported as distinct immunological features), very different that normally seen in ALS (as reported). The reporter considered amyotrophic lateral sclerosis to be related to GARDASIL. The physician reported that both the timing of the symptoms and autopsy results "suggest a link between" the vaccine and the fatal cases of amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease. She also stated that with only two confirmed cases, they did not know for sure if it was coincidence or if they were connected to the vaccine. The pathology features all supported a temporal association between the illness and vaccination. The relatedness between the spinal cord inflammatory and GARDASIL was not provided. Upon internal review, the amyotrophic lateral sclerosis and spinal cord inflammatory (disorder) were considered to be medically significant. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1812USA000380: US-009507513-1811USA012613: Reported Cause(s) of Death: amyotrophic lateral sclerosis; Autopsy-determined Cause(s) of Death: spinal cord was so inflammatory. That is very different from what we normally see in ALS.
This spontaneous report has been received from a medical assistant referring to a 16 year old patient (gender not reported). No information was provided regarding the patient's medical history, concurrent conditions, drug reaction/allergy history or concomitant medications. On an unknown date, the patient was vaccinated with PROQUAD, lot # R024017, expiration date 19-FEB-2020 subcutaneously in the right arm for prophylaxis, and a dose of VARIVAX, lot # R026547, expiration date 17-SEP-2020, subcutaneously in the left arm for prophylaxis (strength, dose and frequency were not provided for either of the therapies). No adverse events were provided.
Developed urticaria to entire body on 9/5/21.  Given Allegra by mother.  Taken to ER on 9/6/21 due to sensation of tightness in throat, given Benadryl and Prednisone.  Taken back to ER on 9/7/21 for recurrence of symptoms, prescribed 5 days of prednisone and Epipen, but was not given epinephrine.  Described some lip swelling during the event along with urticaria.  No vomiting or respiratory symptoms apart from sensation in throat.
Received vaccine FLULAVAL IIV midmorning. Within 2-3 hours developed fever, chills and severe headache with severe nausea which lasted approx 30 hours. Max fever 101. Telephone report by pt to immunization healthcare provider.
Hyposmia (limited smell)  or Anosmia (absence of smell) began approximately during the first two weeks of October 2016.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive, notes: Still test positive at day 15. Therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No Adverse Event; 01-OCT-2021-Dose 1,19-NOV-2021-Dose 2; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (01-OCT-2021-Dose 1,19-NOV-2021-Dose 2) and NO ADVERSE EVENT (No Adverse Event) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   On 01-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On 19-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (01-OCT-2021-Dose 1,19-NOV-2021-Dose 2). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (01-OCT-2021-Dose 1,19-NOV-2021-Dose 2) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.            No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medications were reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-621582 (Patient Link).
Started as diaper rash within hours of receiving vaccinations. Started small, about size of dime, and spread to testicles, covering surrounding genitals, in folds of thighs. Bright red, with bumps at edge of rash. Treated with A and D ointment, DESITIN, and AQUAPHOR diaper rash cream with no relief. Taken to doctor 03/01/2017, prescribed Nystatin cream and KEFLEX for possible bacterial infection.
Forgetfulness; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of MEMORY IMPAIRMENT (Forgetfulness) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Psoriasis.    No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Jul-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 1 dosage form. On 15-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced MEMORY IMPAIRMENT (Forgetfulness). At the time of the report, MEMORY IMPAIRMENT (Forgetfulness) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.  The reporter assessed the event of forgetfulness as possibly related to Moderna vaccine and as not reasonably possible with Skyrizi.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Patient complained of scratchy throat. Swelling and redness at injection site. Low grade fever.
Hemmoriged and passed many clots from my reared. Lost a lot of blood. Fainted and threw up. Was in ICU for 2 nights. Had 2 blood transfusions. They clamped area where polyp was removed on March 30th.
No addtional AE; finger flange broke off and the patient was unable to receive the full dose of GARDASIL 9.; finger flange broke off and the patient was unable to receive the full dose of GARDASIL 9.; This spontaneous report was received from a nurse who was reporting on patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant therapies provided.  On an unknown date, the patient was vaccinated with dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, anatomical location and strength were not provided; lot number T025370 for prophylaxis was confirmed to be valid, expiration 01-DEC-2022) for prophylaxis.  During the vaccination the finger flange has broke off and the patient was unable to receive the full dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (syringe broken, incomplete dose administered). The patient has received about three quarter of the vaccine. There were no additional adverse events reported. The nurse kept syringe aside and would send its picture. 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: T025370; expirationdate: 01-DEC-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
This spontaneous report as received from a 50 year old male patient reporting on himself with none pertinent medical history and none reaction/allergies. On 27-MAR-2013 the patient was vaccinated with ZOSTAVAX 19400 PFU (Lot # and exp date not provided) intramuscularly in the tricep (dose not provided). No other co suspects were reported. No concomitant therapy was reported. On 28-MAR-2013, the patient did not seek medical attention. Lab diagnostics were not performed. The outcome of the patient developed joint pain and rash around the injection site was reported as not recovered/not resolved. Additional information has been requested.
had both shingrix vaccines in 2019, got shingles 10 days ago/ Suspected vaccination failure; shingles; 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 (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In October 2021, more than a year after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: This case was reported by the patient. The age at vaccination was not reported. In 2019, the patient received both the doses of Shingrix vaccine and 10 days before the date of reporting, the patient experienced shingles. The patient stated that he/she was at the tail end or middle of a shingles break out. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles was unknown.
Hot to touch at injection site; Swelling at injection site; Very red at injection site; Difficulty breathing which lasted less than a minute; Tightness of breath; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot to touch at injection site), VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE ERYTHEMA (Very red at injection site), DYSPNOEA (Difficulty breathing which lasted less than a minute) and CHEST DISCOMFORT (Tightness of breath) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Heart valve replacement.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hot to touch at injection site), VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE ERYTHEMA (Very red at injection site), DYSPNOEA (Difficulty breathing which lasted less than a minute) and CHEST DISCOMFORT (Tightness of breath). At the time of the report, VACCINATION SITE WARMTH (Hot to touch at injection site), VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE ERYTHEMA (Very red at injection site), DYSPNOEA (Difficulty breathing which lasted less than a minute) and CHEST DISCOMFORT (Tightness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included medications for heart valve replacement. No treatment medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: follow-up received Patient declined further follow-up
received vaccine 8/26/2021 - unknown time - unknown location but IM injection - started having nausea and vomiting 8/27/2021 AM and high fever of 103.2F orally
13 hours after injection woke with sore arm; Intense chills; Shaking; Nausea; Vomiting; Mild headache; Tired; Dehydrated; This is a spontaneous report from a non-contactable consumer, the patient. A 43-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0170) via an unspecified route of administration in the left arm on 20Apr2021 at 10:45 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included hemophilia, gastroesophageal reflux disease (gerd), irritable bowel syndrome (ibs), Barrett's esophagus, incontinentia pigmenti, ehlers-danlos syndrome (hEds) and sulfonamide allergy (sulfa). Prior to the vaccination, it was unknown whether the patient was diagnosed with COVID-19. Concomitant medications included celecoxib (CELEBREX), octocog alfa (KOVALTRY), pantoprazole (MANUFACTURER UNKNOWN) and thyroid (MANUFACTURER UNKNOWN), all taken for unknown indication from unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8732), via an unspecified route of administration in the left arm on 20Mar2021, at 10:00, (at the age of 43-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the vaccination. On 20Apr2021 at 00:15, 13 hours after injection the patient woke with sore arm followed by intense chills, shaking, nausea, vomiting, mild headache. Next morning on 21Apr2021, the patient was super tired and unable to keep down liquids or medicines (including TYLENOL) and became dehydrated. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. It was unknown whether therapeutic measures were taken as a result of the reported events. The clinical outcome of the event 13 hours after injection woke with sore arm, intense chills, shaking, nausea, vomiting, mild headache, tired and dehydrated were not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
About 20 min after shot patient felt lightheaded, an hour later chills/backaches, he then vomited 5-6 times and sweating profusely, he then blacked out for a few seconds. Then fell asleep for hours. Tried eating but vomited back up. Has not eaten since.
Patient came in today 9/27 and said she had pain and redness in her left arm.  Other than that, she feels fine.
Congested, felt tired, nausea by morning and vomited x1 after waking. Did not seek any treatment. Reports feeling better at 4:30PM on 01/05/2017.
she had problems with her gallbladder; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported for herself that A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient has a scheduled second dose due on 22Apr2021. She found out that she had problems with her gallbladder, and asked if she can still get the second dose tomorrow. Outcome of event was unknown.   No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Sore arm/Hers was kind of at the injection site; Her entire arm was radiating with pain, more intense; Pain that was under ear extending to palm of hand; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "Sore arm/Hers was kind of at the injection site"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Her entire arm was radiating with pain, more intense"; EAR PAIN (non-serious), outcome "recovered", described as "Pain that was under ear extending to palm of hand".  Additional Information: The patient had a sore arm just after her vaccination. She stated that it was the Pfizer Covid-19 vaccine because her, her husband, and children all did their first dose and have not done their second dose yet. The patient clarified that her sore arm was at the injection site. The next day, when she woke up, she had pain that was under her ear and it extended all the way to the palm of her hand. Her entire arm was radiating with pain, more intense than she ever felt with the tetanus. The very next day, nothing, zero. She thought she would get up in horrible pain and did not-it was just gone.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient complains of fever of 100 degrees, migraine headache, chills, total body muscle spasms, & trouble standing. Symptoms started 3-30-11 and resolved by 4-2-2011. No treatment.
herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 72 years old female patient (pt). There was no information about the pt's concurrent conditions, concomitant therapies or medical history provided.   On or about 16-APR-2014, the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, lot number and expiration date were not reported) as prescribed and/or administered by a healthcare provider, for the long-term prevention of shingles and herpes Zoster related conditions. On an unknown date, subsequent to the zoster vaccine live (ZOSTAVAX) inoculation, the pt experienced shingles (herpes zoster). The pt was treated by a healthcare due to herpes zoster. It was reported that the pt would continue suffer ongoing injuries, losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the herpes zoster was not reported. The reporter considered the herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
Patient reports significant itching and pain at the vaccine site given 1 year ago on 10-4-13. Now 1 year later she still has a raised, red somewhat itchy bump approx 3/4 x 1 cm.
I felt sick; also had tube side effects for 3 weeks and was just in bed; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced sickness (Verbatim: I felt sick) and bedridden (Verbatim: also had tube side effects for 3 weeks and was just in bed). The outcome of the sickness and bedridden were not reported.   It was unknown if the reporter considered the sickness and bedridden to be related to Shingles vaccine.     It was unknown if the company considered the sickness and bedridden to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 09-JUN-2023 This case was reported by patient via interactive digital media. The patient reported that he or she received Shingles vaccine and the day after the vaccine he/she felt sick. Patient also states that he/she also had tube side effects for 3 weeks and was just in bed. Follow up was not possible, as no contact details were available.