chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she has tested positive for HPV despite being vaccinated with GARDASIL; tested positive for HPV despite being vaccinated with GARDASIL; This spontaneous report was received from a nurse practitioner via company representative and refers to a female patient. The patient's historical conditions included being sexually molested at age of 5-year-old. There was no information about the patient's concurrent conditions or concomitant therapies provided.  On an unknown date (at age of 11-year-old), the patient was vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) or HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported). Vaccine was administered for prophylaxis.   On an unknown dates, she was informed by her obstetrician-gynecologist (OB/GYN) that she had tested positive for human papillomavirus (HPV) despite being vaccinated with Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) or HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (vaccination failure). The reported did not know which HPV type the patient was testes positive for. It was reported that she sought medical attention. It was unknown whether the patient received any treatment for the events. The outcome of the events was reported not recovered.  The causality assessment was not provided.
Janssen COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Janssen Vaccine on 3/11/2021. Presented to ED on 8/25/2021 with a 9-10 day history of coughing, fevers, diarrhea, fatigue, hypoxia, myalgiam and chills. She was started on Dexamethasone on 8/26 and continued this through her hospital course.  Eventually her oxygen requirements escalated and she required intubation on 8/27/21 due to persistent significant hypoxia despite maximum non-invasive interventions. A trialysis catheter was also placed for her and nephrology was consulted due to urgent need for dialysis as her kidney function continued to deteriorate since admission. Renal ultrasound did not show any hydronephrosis or obstructive processes.  On 8/27 she had 3L removed via HD. She required paralytics, sedation, and pain control while on the ventilator. On 8/27/21, her code status was changed to DNAR/COT. Eventually, she developed septic shock and was found later to be bacteremic (GPC in clusters) with a positive MRSA PCR nares. The culture did not have a final result by the time of her passing. She was started on broad spectrum antibiotics on 8/30 at the time of her becoming more septic.  On 8/31, the patient's MAPs and oxygen saturations continued to decrease despite maximal therapy (including four vasopressors). The patient passed away at 0630 on 8/31/21.
got the vaccine, had shingles / 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 (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The age at vaccination was not reported. The patient got the vaccine and then had singles months later. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required. This case has been linked with US2021AMR205456 and US2021AMR205468 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR205456:Same reporter US-GLAXOSMITHKLINE-US2021AMR205468:Same reporter
Dizzines/vertigo.  Continue to feel unsteady.  Increased sensitivity to computer work, ongoing. Increased sense of overwhelm with normal activities.  I am a mental health provider.  I have had to cancel clients all week due to symptoms.
Got pain like pin prick. Is that how shingles strts?; This case was reported by a consumer via interactive digital media and described the occurrence of prick pain feeling in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In January 2022, the patient received Shingles vaccine. In January 2022, less than a week after receiving Shingles vaccine, the patient experienced prick pain feeling. In January 2022, the outcome of the prick pain feeling was recovered/resolved.   It was unknown if the reporter considered the prick pain feeling to be related to Shingles vaccine.  Additional details were reported as follows: The patient self-reported this case. The age at vaccination was not reported. The reporter asked could get Shingles from shot and said, it was a 4 days before in January 2022. The patient reported he/she had pain like pin prick on the side of his/her stomach earlier which was lasted for about a minute.  The follow-up would not possible as no contact details were available.
Approx 3 hours after vaccinated c/o chest bain starting in her back then slowly wrapping around to the front, Throat tightening, swelling of eyes and lips, difficulty breathing lasted about 10 hours, required ER transport and CT for L renal Colic
received 2 doses, one month apart; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 32-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number X4G4C, expiry date 30th November 2024) for prophylaxis.   Concomitant products included DIPHTHERIA VACCINE TOXOID + PERTUSSIS VACCINE ACELLULAR + TETANUS VACCINE TOXOID (BOOSTRIX).   On 14th November 2022, the patient received the 2nd dose of Boostrix. On 14th November 2022, unknown after receiving Boostrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 14-Nov-2022 Reporter's comment: No symptoms was reported. The reporter consented to follow-up. Additional supportive information: The patient accidentally received 2nd dose of Boostrix, which led to extra dose administered.
Staff member had administered expired IPOL to a patient with no reported adverse event; Initial information was received on 08-Oct-2021 regarding an unsolicited valid non-serious case received from an other health professional via consumer via phone under (Information Inquiry Number: 00804220).  This case involves a 14-years old female patient who was administered with an expired dose of IPV (VERO) [IPOL] with no adverse event (expired product administered).  The patient's medical history, past medical treatments, vaccinations and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for Prophylactic vaccination.  On 05-Oct-2021, the patient received a 0.5 ml dose of suspect IPV (VERO) lot number: R1S973M via and expiry date: 03-Oct-2021 via intramuscular route in the left arm for Prophylactic vaccination.  It was case of an actual medication error due to expired vaccine used (latency: same day).  It was reported "The caller stated that a staff member had administered expired IPOL to a patient. The caller would like to know how to proceed regarding the patient."   At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Father describes generalized rash resemble erythema matiforma lesion all over body itchy - treated with Benadryl and baking soda bath.
Chills, headache, muscle and joint pain, fatique, fever for one day and 2 nights
Client reports swelling shortly after receiving PNEUMOVAX. Client went to ER following day; was admitted with cellulitis.
About five hours after vaccination, pt had severe itching and hives started to form. Continued to get worse and symptoms lasted for 10 days.
Guest complains of injection side pain and soreness months after the injection, says is having pain in her arm and can't do daily tasks without residual pain in left arm. Guest received shot on 9/6/18 and reported to pharmacy on 11/3/18. Pharmacist spoke with guest on 11/5/18, guest had said she had seen her primary care doctor and was told to take anti-inflammatory medications and pain still hasn't resolved 2 months after shot. Advised patient to reach out to get medical help for pain, and that we will conduct research regarding possible incident. Guest says "was reading online about someone who received flu-shot too high in the arm and had some injury and inflammation in arm, don't know if the pain and symptoms are in my head, but the pain is worse". Will be escalating to do further research per pharmacy protocol.
received a dose that had expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received HBV (Engerix B) (batch number N234J, expiry date 21st January 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 26th January 2022, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 26th January 2022, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was unknown. Medical assistant reported that a patient received an expired dose of Engerix B, which led to expired vaccine used. The Vaccine Administration Facility was the same as Primary Reporter. The reporter did not consent to follow-up.
Rash on both arms, chest and face. Used over the counter allergy meds and creams.
After patient recieved booster dose of Moderna, patient complained of dizziness and then fainted. Patient regained consciousness after a few moments, but was disoriented, pale, sweating, and nausated. Stayed & monitored patient until all symptoms resolved and patient was able to leave on his own accord. Patient did not require any additional medical assistance.
COVID-19 TEST POSITIVE; This spontaneous report received from a patient via a company representative concerned a 64 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 11-JAN-2022, the patient experienced covid-19 test positive. Laboratory data included: COVID-19 antigen test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from covid-19 test positive. This report was non-serious. This report was associated with product quality complaint: 90000211582 and 90000211583.
About 10 minutes after vaccination patient reported feeling hot and itchiness on right side of face. Also had hive on  right jaw line. No shortness of breath. Patient was evaluated by EMS who advised IM benadryl which patient refused. relative brought patient oral benadryl.  The itchiness and hot flash resolved after 10-15 minutes.
This case was reported by a nurse via call center representative and described the occurrence of flu symptoms in a adult female patient who received SHINGRIX for prophylaxis. On 13th June 2018, the patient received SHINGRIX. On 13th June 2018, 4 hrs after receiving SHINGRIX the patient experienced flu symptoms, general body pain, joint pain and mobility decreased. In June 2018, the patient experienced frustration and emotional distress. On an unknown date, the outcome of the flu symptoms, general body pain and joint pain were unchanged and the outcome of the mobility decreased, frustration and emotional distress were not recovered/not resolved. The reporter considered the flu symptoms, general body pain and joint pain to be related to SHINGRIX. It was unknown if the reporter considered the mobility decreased, frustration and emotional distress to be related to SHINGRIX. Additional details were provided as follows: This case was reported by nurse for herself. The age at vaccination was not reported. Four hours after receiving SHINGRIX, the patient horrible flu symptoms (without fever) including body aches and joint pain. The patient could not lift her arm. The symptoms worsened over the past 24 hours. Less than a week, after receiving SHINGRIX, the patient experienced distress and frustration. The reporter had some difficulty obtaining information due to distress and frustration and did not have lot or expiry for vaccine administered.
BOTH SHOULDERS HURT. HEAD AND BODY FELT HEAVY COULD NOT GET UP. LEFT ARM SWOLLEN, RED AND PAINFUL FOR 5 DAYS
Fever and chills started all of the sudden around 5:15 pm on day of vaccination (3/8). Fever and chills have continued  through say and evening of 3/9.
the vaccine "squirted out" instead of going through the needle with no AE; Initial information received on 08-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age female patient whose vaccine "squirted out" instead of going through the needle (needle issue) with no adverse event, while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot UJ471AB and expiration date 30-Jun-2020] via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE to an employee and the vaccine "squirted out" instead of going through the needle (needle issue) with no adverse event.   Final diagnosis was needle issue.   Relevant laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Not Applicable.
Second covid vaccine booster shot was only half dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (Second covid vaccine booster shot was only half dose) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL UNDERDOSE (Second covid vaccine booster shot was only half dose). At the time of the report, ACCIDENTAL UNDERDOSE (Second covid vaccine booster shot was only half dose) outcome was unknown.            Patient was taking Humira (Adalimumab), from an unknown date, subcutaneous, ongoing, for moderate to severe Rheumatoid Arthritis. It was reported that on 11 may 2022, the patient experienced misfire pen/ injection went in but after pulling the pen off the skin there was a small pool of medication left behind with the Humira.  It was unknown if patient was enrolled in a COVID-19 Vaccine trial. No treatment medications were reported.
sick as a dog with a fever; sick as a dog with a fever; headache; couldn't get out of bed; The patient got an equivalent of 6 doses of very concentrated mRna vaccine.; patient received 0.3 mls of undiluted vaccine; This is a spontaneous report from a contactable pharmacist via from a Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: En6199; Expiration Date: 30Jun2021) via an unspecified route of administration on 05Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received 0.3 ml of undiluted vaccine. Patient receiving a full undiluted vial of the covid-19 vaccine, patient received 6 doses of the vaccine, States that one of his pharmacists did not dilute the vial, and drew a dose and gave it to a patient; so the patient received 0.3mL of undiluted vaccine. The patient got an equivalent of 6 doses of very concentrated mRna vaccine. On 06Mar2021, she was sick as a dog with a fever, headache, and she couldn't get out of bed. She was not on any other medication and confirmed she had no other vaccines 4 weeks prior to receiving the Covid vaccine. The reporter also confirmed that the dose drawn was .3mL and not the full .45ml in the undiluted vial. No Prior vaccinations. The outcome of event was recovered on unspecified date 2021  No follow up attempts are possible. No further information is expected.
On Day 11, I woke up with my arm again inflamed at injection site.  Elevated, hot to touch.  For 3 days after my Moderna shot my arm at injection site was hot, inflammed and sore.
Dizziness, sweaty, blurred vision approx 2 mins after getting vaccine. Brought over to medical.  Patient was alert, pale and diaphoretic.  Patient was given water, crackers, alert and talkative, feeling much better. Patient sent home  Past Medical Hx Had presyncope episodes with vaccine/blood draws in the past No recent illness and ate today
Malaised, lethargic, sweating, chills mild fever, nausea and headache.
Temp inc to 103(r) p/shot given taken to ER given med for fever; Mom states she had given APAP x2 before taken to ER;
Patient passed out about 5 minutes after vaccine administration. He was caught by his dad, came to pretty quick, and was no longer dizzy. Called EMS just incase.
Headache, Myalgia & Arthralgia Narrative:  Severe migraine unable to work for 2 d,  painful arm of injection site,body aches and fatigue   Other Relevant History:
13:49: Pfzier Vaccine administered to Left Deltoid 13:55: patient complained of tongue "thickening"  13:56: patient complained of shortness of breath and concerned with taking Benadryl 13:58: patient complained of drowsiness. 911 called 14:00: patient complained of chest pain BP 135/98, P104, PO2 96 14:03: BP 125/100 P 94 PO2 92   14:05: PT states I cant lift my legs 14:06: PT tolerated sips of water. Benadryl 25 mg PO given BP 122/86 P98 PO2 94
Left shoulder erythema slightly warm to touch approximately 7 cm starting 6 days after vaccination.
Pt was seen on 11/8/10 due to spreading papular then papulo-vesicular & crusting on some lesions noted since yesterday p.m. Pt is alert, active & playful. No fever noted; w/mild cough & cold; incidentally, he has mild paronychia on (L) thumb & dry rough skin on trunk from eczema.
Weekend of 8/12/06 mom noted patient to be walking "like a Frankenstein"-jerking and robotic movements. Falling over when walking and standing. Sent to Neurology diagnosed with Acute cerebellar ataxia. U/A, VMA and catecholamines tested. 9/13/06-Records received from Hospital Oncology Consultation 8/24/06-new onset opsoclonus, polymyoclonus with high index of suspicion for neuroblastoma.. 8/31/06-presume opsoclonus and polymyoclonus and mildly low IgG 247.  Recommendation: IgG therapy and consider rituximab therapy in future. HX Present Illness: Previously health 16 month old with progressive onset of ataxia complicated by eye movement abnormalities . Significant problems with gait over last several weeks increasing number of falls and clumsiness. CNS evaluation normal as well as spinal fluid.  ACTH therapy for initiation of treatment of OMS syndrome. PE: HEENT otherwise unremarkable except for bilateral lateral nystagmus and upgoing eye movements that are random. Wide based gait with some significant ataxia upon standing and will fall quickly and wobble when walking. She does not have a predilection for falling left or right and does have truncal ataxia. Also has episodic myoclonic jerks. DTR and Babinski normal.
Dry mouth; Weight gain; This spontaneous case was reported by a patient and describes the occurrence of DRY MOUTH (Dry mouth) and WEIGHT INCREASED (Weight gain) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced DRY MOUTH (Dry mouth) and WEIGHT INCREASED (Weight gain). At the time of the report, DRY MOUTH (Dry mouth) and WEIGHT INCREASED (Weight gain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant  medication and treatment medications were reported. .   Most recent FOLLOW-UP information incorporated above includes: On 19-Jul-2021: Non-Significant follow up. Contact information updated.
Pt. received Pfizer Dose 1. At 12:32, after 3 minutes in observation, pt. complained of chest pain, shortness of breath, headache, dizziness, nausea and soreness on the arm. VS were taken and within normal limit. Provided water, cracker and ice packs were applied. Pt. was placed on the floor with legs elevated. Encouraged pt to do deep breathing and emotional support provided. Observation was extended. At 1:10 pm, pt stated that shortness of breath and chest pain were resolved. Pt. was placed in sitting position and stated that chest pain and shortness of breath returned. Chest pain described as sharp pain with 10/10 and pt. also and having abdominal pain with 10/10. At 1:42 pm, 911 was activated. EMS arrived at 1:57 pm. Pt awake and alert, left the building via wheelchair, accompanied by 2 transporters, pt's cousin and 2 children.
Patient had several ED visits and was admitted to the hospital, all within 6 weeks of receiving COVID vaccination. ED visits 3/5/21, 3/18/21, and admissions on 3/22/21.