chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse concerning a female who on an unspecified date was vaccinated with the second dose of GARDASIL. The nurse reported that "right after receiving the second dose" the patient came back to the clinic because she saw a crystallized mass come out from the surface of the injection site. Nurse reported that the patient did not report this kind of issue when she got the first dose of GARDASIL vaccine. Additional information has been requested.
77 year old gentleman who presented to the emergency room with altered mental status; he was found on the floor at home; his stepsister found him after he did not show up for an appointment with a client yesterday; he also missed several other appointments so his family went to check on him; he says that he took a medication but cannot tell me which one; he is not able to answer questions;  He tested positive for COVID on admission screening.
Started on 8-28 with tingling in toes, and pain in neck. The tingling turned to numbness, which began ascending through the body. The numbness took over the extremities, and there was excruciating pain (not muscular) in upper/mid back that made sleeping impossible. At this point legs could not support the weight of whole body. Doctor visit, and Neurologist visit on Friday September 4th- both could not make a diagnosis. On Saturday (9-5) left side of the face began to drop (eyes and mouth), made talking and eating more difficult. On Sunday evening went to ER and was immediately admitted. An MRI was conducted the night of the 6th, and was diagnosed with the Guillain Barre Syndrome on Monday, September 7th 2020.
While I was overseas awaiting to go north into another country, I was advised by my supervisor at that time, that I was required to take the Anthrax vaccine shots before entering the country and reporting to my job location. I then took the first shot in Sept 22, 2003 and the 2nd October 08, 2003. Due to the ill effects these vaccines caused I quit taking the vaccines. Before I took these Anthrax vaccinations, my blood pressure was under control with 3 good EKG readings prior to the Anthrax vaccinations.  I am now experiencing the following adverse effects;  uncontrollable high blood pressure, atrial fibrillation, high cholesterol, memory loss, insomnia, muscle and joint pain, increased hypertension. Patient continues with atrial fibrillation, high blood pressure and abnormal high cholesterol.  BioPort Corp. has no further information on this case. In the event that additional relevant medical information is received a follow-up report will be submitted.
Within 24 hours of my 2nd Pfizer shot, I had some moderate level dizziness, lightheadedness and brain fog.  Then on May 8th, I woke with debilitating vertigo. I was unable to walk without help, and over the next two weeks, I had severe dizziness, brain fog, cognitive decline, and was unable to work, drive or watch my kids. After about two weeks, I noticed I was experiencing ringing in my ears, which I learned was tinnitus. The tinnitus has steadily increased in volume/intensity, and now I have insomnia because the noise is so bad.  The vertigo, dizziness and brain fog have since gone away, but the tinnitus has not. I strongly believe that my tinnitus is related to the covid vaccine.
Case number PHEH2013US023798 is an initial spontaneous report received from a pharmacist on 11 NOV 2013. This report refers to a 33-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with a dose of FLUVIRIN 2013/2014 (batch number: 1309601) intramuscularly in the arm on 17 OCT 2013. It was reported that she received only a part of the dose as some of the vaccine ran down her arm during administration. No adverse event was reported following the maladministration.
Dose 2 administered 2 April 2021.   Patient has been experiencing episodes of spontaneous urticaria diffusely across body starting in July 2021. Will also have joint pain and fatigue. Most episodes respond to antihistamines and resolve within 24-48 hours, but some episodes with last 5-7 days. Patient has required steroids for prolonged episodes. Patient currently takes fexofenadine 180 mg BID, and when she has a flare, will also take Pepcid 20 mg qd and Benadryl or Hydroxyzine as needed.
Patient had localized swelling reaction from vaccine in Left arm, 30mm, redness at site, no pain, no itching and no burning  noted at site of injection.  No other symptoms noted. No other signs or symptoms, 15mm induration.
Daughter rec'd vaccine on 2/17 and she lost her voice and was unable to speak, she's had an underlying issue. She stayed for 30-45 minutes and started coughing and then lost her voice, her throat started itching and she could not speak she was very hoarse, her skin turned real dark and she went to the hospital, they gave her an EPI pen, Prednisone 40mg for 4 days, Albuteral was given, Solumedrol and Peptin, and benedryl, Ivciartin, She continues to have a deep hoarseness.
Patient was administered all three doses of GARDASIL 9 and then presented to the clinic with genital warts; Information has been received from a physician via company representative, concerning a 16-years old male patient. The patient's medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were unknown by the reporter.    On unknown dates, the patient was vaccinated with all three doses of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, route of administration, anatomical location, lot number and expiration date were unknown) for prophylaxis.  On approximately 12-JUL-2019, the patient experienced genital warts. The patient went to the physician's office and an unspecified treatment was given to the patient. The outcome of the genital warts was unknown at the time of this report.   The causal relationship between the genital warts and the therapy with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) was not provided.
a sore arm/arm soreness; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is 1st of 2 reports.  A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Jan2021 to Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Jan2021, the patient experienced a sore arm/arm soreness. The outcome of the event was unknown.  Information about lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021101539 Same reporter, drug and event, different patient
pt recv vax 24SEP96 & NOV96 pt was exposed to a pt w/chickenpox;17DEC96 pt devel chickenpox;pt recovered;
patients were administered from an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients were administered from an expired vaccine) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients were administered from an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients were administered from an expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided.  The vaccine was initially stored in the refrigerator on 04-Nov-2021. 50 different doses were administered and the date of administration for some vaccines were on 05-Nov-2021 and the other doses were administered on 12-Nov-2021. The vaccine did not undergo any temperature excursions. No adverse event was reported for the patient.
Patient presents 2 days after her vaccination with redness below the injection site, swelling, and pain.
Headache; On 07-FEB-2023, this serious, initial non-interventional study safety report was received from a consumer was received by Regulatory Authority on 07-FEB-2023.  An individual of an unspecified race, age and sex was vaccinated with intramuscular Covid-19 Vaccine (Recombinant and Adjuvanted) 10 ug/mL suspect Covid-19 vaccine unspecified dose on an unspecified date.  No medical history was reported.  No concomitant medications were reported.  On an unspecified date, after vaccination, the individual experienced headache (PT: Headache) (Serious: Hospitalization). It was reported the individual was admitted to an intensive care unit (ICU) because of symptoms related to the COVID-19 vaccine for 2 nights.   At the time of reporting, the event outcome of Headache was unknown.  The reporter assessed the causality between vaccine and reported events: Headache as not reported.  Lot number was not provided in the report.; Sender's Comments: This individual of an unspecified age and sex experienced: Headache after vaccination with Covid-19 Vaccine (Recombinant, Adjuvanted) 10 ug/mL. The event Headache was reported as serious. Considering the current knowledge of the vaccine, the causal relationship between Covid-19 Vaccine (Recombinant and Adjuvanted) and Headache was assessed as related.
Client was waiting his shot time when he fell from his chair hitting his left shoulder and face. He appeared to have seizure activity. He became responsive very quickly and was oriented. 911 was called and he was transported to emergency department. He was able to walk to the ambulance.
Child received 0.5 cc of vaccine that was labelled in the Moderna vial as "single-dose vial". Child should only have had 0.25 cc.
Soreness and weakness of affected arm, fatigue, body aches, nausea, diarrhea
5/24/99 lt upper arm swollen, warm, tender, induration 5x3;
Hives around mouth with pruritis on forearms, legs bilaterally, denies fever. Symptoms occurred 4 days after vaccination. No treatment given.
Pt states she experienced increasing pain in shoulder where vaccine was administered. Severe pain & "frozen shoulder" still & is seeing an orthopedist for tx.
Patient received Pfizer Covid-19 vaccine in ED.  Nurse received vaccine vial from Pharmacy, she reconstituted it, drew up entire contents of vial and noted to administer 2.1ml IM.  She did scan the vial and EHR indicated dose due was 30mcg/0.3ml.  Patient discharged.  After few hours in discussion with colleagues regarding vaccine, she realized she gave too much to patient.   Nurse was not aware it was a multiple dose vial. Risk management and physician tried to reach patient multiple times, left message with grandmother and sent letter to patient to address provided.  No return calls from patient or family.
Patient complained of fever and chills on 4/18. Patient continued to have symptoms, suspected to be acute frontal sinusitis. On 4/21, patient complained of bilateral leg heaviness, felt weighed down, difficult to walk, no weakness, swelling, or redness. Patient elevated legs and felt better on 4/22. Patient later presented to the ED with acute mental status changes. Patient fell at home and had a seizure according to family. Patient is currently intubated and critically ill.
No additional AEs, no PQCs; Medical Assistant called in to report a temperature excursion. ROTATEQ was administered; This spontaneous report has been received from a medical assistance regarding a patient of unknown age and gender. Patient's pertinent medical history, drug reactions and allergies and concomitant medication were unknown by reporter.  On an unknown date, the patient was vaccinated with an improper storage dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ), oral liquid, administered orally, (strength, dose, frequency, and indication were not reported; lot number 1892784 was validated as a valid number and expiration date was reported and established as 03-DEC-2023) (improper storage of product in use). The excursion occurred with a temperature of 46.4 Farenheit (F) for 5 minutes. There was a previous temperature excursion reported for 47.9 F for 47 minutes. No additional adverse event provided.  There was no additional adverse events reported (no adverse event).
Lower back discomfort/mild joint pain Mild injection site pain Large swelling/redness at site for a week Mild/moderate loss of bladder control Vertigo/nausea Lethargy Chills/fever 102.9 Congestion/cough Headache Unwell for about 24 hours
A mother reported that her daughter received Acel-Imune vaccine between 1996 and 1997, when she was an infant. Subsequent to each immunization, she developed a high pitch scream and "high" fever. In the summer of 2002, she was diagnosed with autism. The child has completely white hair with a piece of jet black hair scattered here and there. The mother thinks thimerosol in the vaccine is to blame for her daughter's condition. This case was considered serious since these events were considered medically important in this case. The mother also reported that twin brothers of the pt experienced similar events following immunizations. See related cases HQ4066704SEP2002, HQ4066804SEP2002, HQ4067004SEP2002, HQ4067104SEP2002, HQ3981728AUG2002 and HQ4066604SEP2002. No additional information was available as of the date of this report.
symptoms started 2-20-07 at 7pm.  1st noticed bumps on arms. She now has hives on her abdomen, face, neck and arms.  She also felt faint at times.
Immediately hurt worse than any flu shot I have had in the past. About one minute later when trying to leave the store I felt like I was going to pass out, face turns bright red, nauseous, weak, trouble breathing, chest pain, heart racing. Made it back to the pharmacist where she had me sit for about 10 minutes until I felt well enough to walk and drive home. About one hour later my lips turned numb, another 20-30 minutes later my left hand turned numb and a fever spiked. I felt extreme fatigue and just slept the rest of the day. Woke up the next day and my hand and lips were still numb. It comes a goes. Fever spiked again 24 hours after the vaccine and got a headache.  Now I?m about 28 hours after the vaccine and lips are numb but hand is not. Fever controlled with Tylenol. If the numbness persists over a week I will go to a doctor.
I have a painful bump by my collarbone.  I am assuming this is my lymph node reacting to the vaccine.
(R) arm developed red splotches which are warm to the touch. Arm is swollen.
Information has been received from a consumer concerning his wife with no medical history or drugs allergies, who on 24-AUG-2009 was vaccinated with a first dose of GARDASIL. On 24-OCT-2009 the patient received a second dose of GARDASIL. There was no concomitant medication. The patient was 6 days late for her menses. At the time of this report no pregnancy testing or laboratories were done. The patient did not seek medical attention. The patient had not recovered. Additional information is not expected.
This spontaneous report was received from a medial assistant via a company representative, referring to a 20 year old female, patient who was his/her niece. The patient's pertinent medical history, concurrent conditions, drug reactions, allergies or concomitant medication were unknown by the reporter. On an unknown date in approximately April 2015 (reported as "3 years ago"), the patient was vaccinated with a dose of GARDASIL 9 (route, dosage information, lot number and expiration date were not informed) for prophylaxis, at an unspecified facility. On an unknown date, after an unspecified amount of time following the dose of GARDASIL 9, the patient suffered an unspecified amount of paralysis. The medical assistant explained that the adverse event was reported at the time. It was unknown if laboratory diagnostics or studies were performed or if the patient sought medical attention and the reporter stated in addition that, the patient was not treated at the facility. The outcome of paralysis was unknown. The causality assessment between paralysis and therapy with GARDASIL 9 was not provided. Upon internal review the event paralysis was determined to be medically significant.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 12:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 12:00 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 34.10.  Concomitant medication of the patient was not reported.  Batch number 044B21A underwent temperature excursion on 15-Apr-2021 with temperature of 34 degrees Fahrenheit at 09:00 AM. These vials were moved to fridge on 06-Apr-2021 and beyond use date for the vials was reported as 09-May-2021. The vaccines moved to clinic on 15-Apr-2021. Storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination. Vials were only punctured right before administration. Vaccines were not frozen at time of administration and prior to administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. The reporter reported that, no data logger reports were available and fisher brand traceable temperature monitor was used to record hourly temperatures.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-566976 (Patient Link).
Complained of throat itchiness approximately 17 minutes after vaccination was administered. Seconds later, started having sensation of throat tightness and began coughing. Onsite clinician administered 0.3 mg epi pen to left outer thigh at 10:16 am. Patient refused 911 and Ambulance.  She left vaccination site at 10:19 am and was transported to nearest Emergency Room by her friend who is an EMT.  Patient left before vitals could be collected. She was discharged shortly after arrival to emergency department and was able to return to work on the same day.
Shortness of breath after covid; Tired; Fever of 102.6F; Could not sleep; Really freezing; Shivering; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath after covid), INSOMNIA (Could not sleep), FEELING COLD (Really freezing), CHILLS (Shivering) and FATIGUE (Tired) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 pneumonia (Has been struggling on walks after having COVID due to shortness of breath) in 2020 and Shortness of breath. Concurrent medical conditions included Chronic sinusitis and Lung scarring. Concomitant products included ALBUTEROL [SALBUTAMOL], ATORVASTATIN CALCIUM (STATIN [ATORVASTATIN CALCIUM]) and ESTRADIOL (ESTROGEN) for an unknown indication.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced INSOMNIA (Could not sleep), FEELING COLD (Really freezing) and CHILLS (Shivering). On 01-Apr-2021, the patient experienced PYREXIA (Fever of 102.6F). On 02-Apr-2021, the patient experienced FATIGUE (Tired). On an unknown date, the patient experienced DYSPNOEA (Shortness of breath after covid). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 2 dosage form. At the time of the report, DYSPNOEA (Shortness of breath after covid), INSOMNIA (Could not sleep), FEELING COLD (Really freezing), CHILLS (Shivering), FATIGUE (Tired) and PYREXIA (Fever of 102.6F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Body temperature: 102.6 (High) Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other concomitant products include BP medications.   This case was linked to MOD-2021-098685 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow-up information received contains non-significant information. On 29-Jun-2021: Follow-up information received contains non-significant information.
swollen lymphnodes; stomach discomfort; felt so bad the day after; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 24Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose1 manufacturer unknown.), for Covid-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swollen lymphnodes"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "stomach discomfort"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "felt so bad the day after". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report has been received from a registered nurse, concerning an unspecified patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not provided. On an unknown date in 2015, the patient was vaccinated with the first dose of GARDASIL (also reported as GARDASIL 4) and then, on an unknown date in 2016 (reported as administered late), the patient was vaccinated with the second dose of GARDASIL 9 (dose, route of administration, lot number and expiration date were not provided for both vaccines) for prophylaxis. No adverse effects were reported. There was no product quality complaint involved.