chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Three unspecified patients between the ages of 12 through 14 years experienced syncope after receiving GARDASIL 9 vaccine/ the patient passed out/ black out for a couple of seconds; This spontaneous report was received from a nurse via company representative concerning 3 adolescent patients between the ages of 12 through 14 years old of unknown gender. Information regarding the patients' pertinent medical history, concomitant medications or drug reactions/allergies was unknown by reporter. On an unspecified day in July 2019 (reported as in the last couple of days), the patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection as recommended by age (strength and route of administration was not provided; dose, lot number and date of expiration were unknown by reporter). On that day, the patients experienced syncope after receiving hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).  The nurse reported that, for one patient, this was the second dose administered and the patient tolerated the first dose just fine. For the other two patients it was unspecified which dose was administered. One patient was sitting down. When the patient stood up, the patient passed out for a couple of seconds. The patient was asked to stay seated for "15 minutes", but it could not be clarified if the patient tried to stand prior to waiting 15 minutes. The other two patients were "laying down on a table and blacked out for a couple of seconds" (syncope). One patient was asked if they had eaten anything that day and the patient replied (s)he had not eaten anything that day. It was unspecified if the other two patients had eaten anything that day.  The patients sought medical attention, and all three patients were in the healthcare provider's office. However they did not receive treatment for the adverse event. It was unknown by reporter if laboratory diagnostics/studies were performed. It was reported that therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not discontinued.  On the same date as the injection, the patients recovered from the syncope event. The causal relationship between the event and therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided. Upon internal review the event syncope was considered to be medically significant.
Flare up / Loss of remission of psoriatic arthitis lasting approximately 2 monnths. Inflammation moved to shoulder joints around vaccination site (left shoulder) glenohumeral and acromioclavicular joints.  Then to right acromioclavicular joint.  Then each Achilles tendon was affected unilaterally separately.  Then enthesis of quadriceps and patellar tendon and illiotibial band enthesis at right knee.  Medical burden included sports medicine evaluation + physical therapy appointments for multiple points of enthesitis at right knee. Loss of remission / flare of psoriatic arthritis lasted at least 2 months. Product: Flublok Quadrivalent PF, Lot # UJ931AA, NDC: 49281-0722-10.
Patient passed out after vaccination and started shaking in a "seizure" like manner.  Client quickly recovered.
presenting for generalized weakness in the setting of known active COVID infection.  She reports that her symptoms started with a decreased appetite Sunday.  When she went to dialysis on Monday she just "didn't feel right", she was more weak than usual and knew something was wrong.  The generalized weakness has progressed over the last two days.
7 hrs after Flu shot developed 102 degrees F fever. Severe aches and pains. 36 hour duration of symptoms.
Thyroid nodule; Night sweats; Dry eyes; Pain; This spontaneous case was reported by a consumer and describes the occurrence of THYROID MASS (Thyroid nodule), NIGHT SWEATS (Night sweats), DRY EYE (Dry eyes) and PAIN (Pain) in a 61-year-old male 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) (Intramuscular) 1 dosage form. In 2021, the patient experienced THYROID MASS (Thyroid nodule), NIGHT SWEATS (Night sweats), DRY EYE (Dry eyes) and PAIN (Pain). At the time of the report, THYROID MASS (Thyroid nodule), NIGHT SWEATS (Night sweats), DRY EYE (Dry eyes) and PAIN (Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the events of THYROID NODULE, NIGHT SWEATS, DRY EYES and PAIN was not provided for Humira. 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.
Information has been received from a health professional concerning a 5 year old male with no known drug allergies and no pertinent medical history who on 06-NOV-2007, was vaccinated with a second 0.5 cc subcutaneous dose of VARIVAX (Oka/Merck) (lot# 658424/1181U).  There was no concomitant medication.  On 30-JAN-2008, the patient, developed breakthrough chickenpox with vesicles on unspecified areas.  No laboratory studies were done.  His vaccination history included on 14-JAN-2004, a first dose of VARIVAX (Oka/Merck).  It was indicated that at the time of this report, the patient was recovering.  A product quality complaint was not reported.  This report is one of two reports from the same source.  Additional information has been requested.
first dose three weeks ago, just got a mild case of them; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 3 weeks after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the dose of Shingles 3 weeks prior to the report and just got the a mild case of Shingles. As per the patient, it was not fun but could not imagine if he/she did not have the 1st dose.
Patient received vaccine with no apparent issue - sat in our waiting area per request for anticipated 15 minute + stay - Approximately 5 minutes after vaccination patient began to experience dizziness - elevated legs with chair with patient in sitting position - a minute later patient became unresponsive and appeared to have fainted/lost consciousness.  Activated 911 system with local fire department and with patient not responsive - lifted patient from chair and placed on floor with cushion for head and elevated legs slightly - the patient had a pulse and was breathing the entire time and when able to communicate informed us she has a POTS condition - at this time EMT services arrived and stayed with patient for approximately 15 - 20 minutes talking the entire time - no transport to hospital - no drugs administered - patient may have followed up with walk-in/ER services but did not require transport and was released by EMT services
Pt passed out on floor. He was dizzy for 30 seconds or 40 secs. EMS came and he had pulse OK. EMS took him to hospital.
Vaccination site pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
Vertigo, tinnitus, nausea, rash on left-side of face, swollen left eye and pain in left underarm.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter (consumer). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 OMI BA.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 4 (booster), single (Lot number: Gh9694), in left arm and on 15Mar2023 as dose 5 (booster), single (Lot number: AJ6743) at the age of 69 years, in left arm for COVID-19 immunisation; COVID-19 VACCINE (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Breast cancer", stop date: 2020, notes: Cancer free for 3 years; "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing). Concomitant medication included: ARIMIDEX, start date: Oct2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Apr2023) Negative; (12Apr2023) Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19. Clinical course: The patient took Paxlovid from 01Apr2023 to 06Apr2023 for treatment of COVID-19. She tested positive for COVID on 12Apr2023 after completing five days of Paxlovid and testing negative on 07Apr2023.
PT returned to clinic 11/16 with complaints of redness, swelling with pain at injection site. This began on 11/16 .Pt had fever on 11/16 .None on day of visits. seen by Dr. Documented tricep area 10 cm erythematous skin, tender warm with induration. ORdered Keflex 500 mg 1 capsule 4 x a day for 10 days. to follow up with pcp in 1 week. If worsening symptoms to return to clinic.
Patient was given a flucelvax 0.25mg instead of the fluzone .5mg. We didn not have any state fluzone in stock at the time and that is why Dr. decided to have the child receive .25 of the flucelvax. I called the CDC and spoke to staff on 10/31/2019 he stated it was not harmful and often times can be ignored. Not a live vaccine. Patient does need to return for the fluzone .5mg because last year was her first dose but she only received one dose instead of two. Mom was notified baby was fine, no side effects and will bring her in for the fluzone.
Pyoderma Gangrenosum to Right leg Started in the end of May, 2021 had to take high doses of Prednisone for 4- 5 months and it took that long for leg to heal. Was hospitalized for couple of weeks for this.
Patient reports dizziness, ringing in ear (briefly), blurred vision, stiffness in arm and feeling faint when standing up. No treatment was administered.
This case was reported by a nurse via sales rep and described the occurrence of general body pain in a female patient who received SHINGRIX. On 18th May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 18th May 2018, several hours after receiving SHINGRIX, the patient experienced general body pain and fever. On 21st May 2018, the outcome of the general body pain and fever were recovered/resolved. The reporter considered the general body pain and fever to be probably related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported, however patient was in the mid 50s. The patient received the vaccine during the day and developed severe body aches and fever that night. The patient's body temperature was recorded as 104 degree F over the weekend. The patient could not do anything over the weekend (incapacitated). The effects resolved in 3 to 4 days. This case was linked to the case US2018091579, reported by the same reporter for the husband.
This case was reported by a pharmacist via Merck and described the occurrence of rash in a subject of unspecified age and gender who was vaccinated with FLULAVAL (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced rash. A pharmacist reported that the subject developed a rash after possibly receiving FLULAVAL. At the time of the report no other information was available. At the time of reporting the outcome of the event was unspecified.
After the 2nd dose of the Modera Vaccine 3 hours later.  Intense pain associated with Trigeminal Neuralgia that had been in remission for 12 years.  It was thought the condition would lessen but it has not.
On 12/5/99, started having chills, heaviness in chest, fever 101 & cough. Went to urgent care & received an antibiotic injection & Rx for oral antibiotic. Now feels better but still is not 100%.
administered expired vaccine. vaccine expired on 11/1/2021- administered 4 days past expiration on 11/5/21. patient reports no symptoms post vaccine
Tested positive for COVID; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (parent) reporting for the patient (son).  A 19-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in deltoid left on 01Apr2021 (Lot Number: ER8737) as 1ST DOSE, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. It was reported that the patient tested positive for COVID on 11Apr2021. The patient did not receive any treatment for the event. The event did not result in emergency room/department visit and physician office visit. The patient underwent COVID-19 test with positive result on 11Apr2021. The patient is scheduled for the second dose 1 day shy of 7 weeks from getting the first which later on clarified the appointment had to be rescheduled for the second dose of the vaccine. The outcome of the event was recovered in Apr2021.
Pt vaccinated with Measles Vaccine experienced rash  11 days; also had sore throat, acthing, nausea and swollen glands which were still present 15 days days after receiving vaccin.
Pt states became ill on about 3NOV91 & was dx w/pneumonia on xray; rx w/ATB; Pt is well now; reporting because "the form says report any illness w/in 4 wks;
pain in her ear; buzzing in her ear; Warm sensation inside her head; This spontaneous case was reported by a consumer and describes the occurrence of   in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient presented to hospital 5/23 with altered mental status. Pt COVID positive upon admission. He was started on antibiotics. 5/25 No s/s of acute distress or discomfort upon assessment. Blood cultures also came back positive for gram-positive bacteremia and was seen by Infectious Disease.  Pt completed a course of IV antibiotic therapy during her hospitalization. Maintained on vancomycin Rocephin and Zithromax, and treated empirically for COVID-19.  Symptoms improved overall.  On 06/03/2022, pt was re-evaluated and felt to be stable for discharge with home care.
Patient called reporting that she has swelling on arm where injection was intense redness rash like and welting. She said this started today but she got immunization on  9/8/21. She reports no throat itching, throat swelling, or shortness of breath just substantial irritation in the area where immunization was given
Headache, chills and nausea and vaccination site soreness. Headache and vaccination site soreness started at 10pm. Around 2:30 am woke up with chills and nausea. Vomited once.  Nausea went away and had chills for a couple more hours.  Felt better when woke up at 6:00am with the exception of headache and tiredness. Headache lasted most of the day. by second day no headache and vaccination site soreness stopped by 3 day.
Patient with diabetes received GARDASIL 9 and then had poorly controlled blood sugars; This spontaneous report has been received from a nurse, regarding to an 18-year-old female patient. The patient's concurrent conditions included Diabetes mellitus. Her pertinent medical history, concomitant medications, and previous drug reactions or allergies were unknown by reporter.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, route of administration, anatomical site of injection, lot number and expiration date were not reported).  On an unspecified date in September 2022, the patient experienced had poorly controlled blood sugars (diabetes mellitus inadequate control). The outcome of blood glucose abnormal as well as the causal relationship between the event and the suspect vaccine were unknown. Additionally, it was reported that the patient's mother informed that the endocrinologist had told them not get with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) because it could elevate blood sugars.
Fainted; Vomiting; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainted) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No Reported Medical event).    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced SYNCOPE (Fainted) (seriousness criterion medically significant), VOMITING (Vomiting) and NAUSEA (Nausea). At the time of the report, SYNCOPE (Fainted), VOMITING (Vomiting) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.; Sender's Comments: This case concerns a 22-year-old female with a serious unexpected event of syncope and nonserious expected nausea and vomiting. Event onset 3 days after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
10002424:ANGIOEDEMA - Patient received the Moderna Covid bivalent booster on 12/14/22. Approximately 2 hours later she began experiencing tongue and throat swelling, and chest tightness. She was administered 0.3 mg IM epinephrine in urgent care and was transferred to the local ER. She was given 50 mg diphenhydramine en route to the ER by EMS, and Solu-Medrol in the ER. Upon evaluation in the ER she did not have any tongue swelling and was not experiencing any respiratory distress. She was observed for 2 hours and then discharged. Patient had previously received three doses of the Moderna monovalent vaccine with no reactions.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Seasonal" (unspecified if ongoing), notes: Known allergies: Seasonal. Concomitant medication(s) included: FLONASE [FLUTICASONE PROPIONATE]. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: Heart rate: (27May2022) low heart rate (48-52), notes: occurred for 4 hours, 2 hours after taking the 3rd and 4th doses. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical course Paxaloid was taken for covid-19 and adverse events noticed Chest pain with low heart rate (48-52) occurred for 4 hours, 2 hours after taking the 3rd and 4th doses.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This spontaneous report as received from a healthcare worker refers to a 1 year old patient. On 07-MAR-2014 the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX (lot #, expiration date and route unspecified). accidentally instead of (Oka/Merck) VARIVAX. No adverse effect reported. Additional information has been requested.
got tested again for COVID-19 infection on the 29th at work and on the 30th, his results came as positive; This is a spontaneous report from a contactable consumer or other non hcp.   A 48-years-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 28Jun2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications was not reported. It was reported that, the caller is calling on behalf of her husband who received the first dose of the Pfizer covid vaccine on 28Jun2021. The patient is being tested for covid weekly and on 25Jun2021 he was tested for covid and on 26Jun2021 it resulted negative. After the first dose the patient was tested on 29Jun2021 and then on 30Jun2021 his covid test resulted as positive on 30Jun2021 with outcome of unknown. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 26Jun2021   sars-cov-2 test: positive on 30Jun2021.  Follow up(30Jul2021), This is a follow up spontaneous report from Pfizer sponsored program COVAX US Support. A contactable reporter reported information included.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
pt devel pneumonia 2 wks p/vax; had recvd flu vax 3 wks a/pnu-imune; pt had a previous bout w/pneumonia 6 months prior to pnu-imune;
patient developed blisters following second moderna vaccine. followed by that, she was dx with shingles on 5/8
Red rash near site of the injection.  Rash has been present for 2 weeks post vaccination.