chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient blacked out, twice, and had to go to the Emergency Room; Patient's EKG test results presented Brugada; This spontaneous case was reported by a physician and describes the occurrence of LOSS OF CONSCIOUSNESS (Patient blacked out, twice, and had to go to the Emergency Room) and BRUGADA SYNDROME (Patient's EKG test results presented Brugada) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 16-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Oct-2021, the patient experienced LOSS OF CONSCIOUSNESS (Patient blacked out, twice, and had to go to the Emergency Room) (seriousness criterion medically significant) and BRUGADA SYNDROME (Patient's EKG test results presented Brugada) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Patient blacked out, twice, and had to go to the Emergency Room) and BRUGADA SYNDROME (Patient's EKG test results presented Brugada) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Oct-2021, Electrocardiogram: abnormal (abnormal) results presented Brugada.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication listed. No treatment information provided.  Company Comment : This case concerns a 56-year-old male patient with no reported medical history who experienced the unexpected event of loss of consciousness and Brugada syndrome. The event occurred 1day after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine).  The rechallenge was nunknoen as details pertaining to second dose was not disclosed. Causality assessment with product use was not provided by the reporter.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  The event was assessed as serious per regulatory authority reporting.  Both events are important medical events; Sender's Comments: This case concerns a 56-year-old male patient with no reported medical history who experienced the unexpected event of loss of consciousness and Brugada syndrome. The event occurred 1day after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine).  The rechallenge was nunknoen as details pertaining to second dose was not disclosed. Causality assessment with product use was not provided by the reporter.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  The event was assessed as serious per regulatory authority reporting.  Both events are important medical events
Extreme fatigue and lethargy, body aches, chills, fever, minor shoulder pain at injection site.
Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding a female pt who experienced fever of 103 deg. F.  The pt received a dose on an unspecified date.  Relevant medical history was not provided.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on an unspecified date.  Dose regimen was 1 dose (IN).  Concomitant medications were not reported.  The pt experienced fever of 103 deg. F (pyrexia).  No additional information was available at the time of this report.
ON 10/25/2021 RASH ON VACCINATION SITE HARD RED NO ITCHING DISAPPEAR IN 2 DAYS ON 10/27/2021 AWAKEN WITH PARTIAL REDNESS OF LEFT EYE WITH SLIGHT ITCHING NO OTHER SYMPTOMS
Adverse event contacted by V-safe was that I was unable to perform my job duties the day after the vaccine. Symptoms included left arm pain, back pain, aches/chills starting at midnight on 1/6/21 into 1/7/21. Headache lasted all day, slept intermittently all day, low energy and extreme fatigue. Was 13 weeks pregnant at the time of the vaccine.
Information has been received from a physician concerning a 25 year old female with headache and contraception who on 14-MAY-2007 at 3:30 pm was vaccinated with the first dose of Gardasil, 0.5 mL, IM.  Concomitant therapy included vitamins (unspecified), desogestrel/ethinyl estradiol (KARIVA) and ibuprofen.  On 14-MAY-2007, the patient reported a rash appeared on her abdomen and back around 9 pm and spread overnight to her arms and legs.  The patient had no fever or chills.  The patient did not go to work on 15-MAY-2007.  The patient called the physician's office the next day to report the event.  The patient was instructed to take loratadine (CLARITIN) during the day and diphenhydramine hydrochloride (BENADRYL) during the night.  The patient was also instructed to soak in lukewarm water with baking soda.  On 17-MAY-2007, the patient reported that she continued to have some pruritis but the erythema had resolved.  The patient reported that she continued to have a few "bumps" but claims to be much better.  The patient continued with the loratadine during the day and diphenhydramine hydrochloride at night, and taking the lukewarm soaks with baking soda.  The patient stated that she will continue with the soaks as they offer relief from the itching.  The patient has not missed any more time from work due to this condition.  Additional information has been requested.
PT was only given 0.25ml instead of 0.5ml that she should have gotten for the booster dose.
No additional AE; patient was administered a vaccine that was improperly stored; This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 24-OCT-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) subcutaneous injection, 0.5 ml/once, lot number W024973, expiration date: 05-FEB-2024, administered for prophylaxis (strength, and route of administration were not provided). It was reported that before the administration the vaccine has been improperly stored (temperature: 18.3 Fahrenheit (F), time frame: 2 hours 16 minutes; previous temperature excursion: 11.7 F, 1 hour 48 minutes) (product storage error). No additional adverse event was reported (no adverse event).  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2211USA001529: US-009507513-2211USA001622:
No Adverse Event; gave the patient 0.3mL of Moderna Covid-19 Vaccine, Bivalent, instead of 0.5mL.; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (gave the patient 0.3mL of Moderna Covid-19 Vaccine, Bivalent, instead of 0.5mL.) and NO ADVERSE EVENT (No Adverse Event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .3 milliliter. On 02-Nov-2022, the patient experienced ACCIDENTAL UNDERDOSE (gave the patient 0.3mL of Moderna Covid-19 Vaccine, Bivalent, instead of 0.5mL.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, ACCIDENTAL UNDERDOSE (gave the patient 0.3mL of Moderna Covid-19 Vaccine, Bivalent, instead of 0.5mL.) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (gave the patient 0.3mL of Moderna Covid-19 Vaccine, Bivalent, instead of 0.5mL.).    No concomitant medication details was reported. No treatment medication details was reported. It was reported that HCP travelled to different counties and used to giving the Pfizer, which was 0.3mL.   Reporter did not allow further contact
SOB., NAUSEA, MILD COUGH, INTERMITTENT DIARRHEA
severe vertigo; dizziness; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm  on 29Mar2021 at 12:15 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. The patient received other vaccine within 4 weeks of vaccination which included  varicella zoster vaccine (MANUFACTURER UNKNOWN) on 10Mar2021 for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 10Apr2021 at 04:00, the patient experienced severe vertigo and dizziness. On 07Apr2021, 14Apr2021 and on 21Apr2021, the patient underwent lab test and procedures which included COVID-19 virus test (Dxterity)  and the results were negative. Therapeutic measures were not taken as a result of the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. The clinical outcome of the event severe vertigo and dizziness was resolved on 14Apr2021.   No follow-up attempts are needed. No further information is expected.
Patient had an injection site reaction w/some dermatitis and pain near site. Occurred the nite after injection and pain treated at hospital.
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.   The patient's past medical history included chickenpox (as a child).   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 was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles, but it was very mild and resolved quickly. The patient was glad to get the Shingles vaccine. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
1/5/22:  full body aches, temperature 1/6/22: slight body ache  1/7/22: left armpit hurt for 2 days   Itchy rash 1/12/22 :  rash on right hip 1/13/22:  rash on left hip 1/14/22: rash on left and right forearms 1/15/22:   rash on the front of my left and right thighs 1/16/22- 1/26/22 present day: rash continues to spread on body.  right ankle, behind left & right knees, left & right upper arms,  scattered areas of bumps on lower legs.  new areas continue to pop up on forearms, and hips.  Dermatologist appt via telehealth diagnosed as Dermatitis.  recommended cerave lotion and prescribed Clobetasol Propionate.  zyrtech and benadryl also recommended but does not relieve the itching.
Around noon on 4/10, 5 days after shot, I started feeling a buzzing sensation in my right arm, as if my cell phone was vibrating. This persisted around 48 hours, stopping sometime around noon 4/12. A web search led me to issues with nerve damage and the further down the rabbit hole I went, possibly Parkinson?s disease. This is a degenerative brain disorder.   I scheduled appointment with my internist ASAP for May, the soonest I could get in. I also cold called a Neurologist office and they advised me to first see the internist. When I got up today and saw the issues with the J and J vax, and the rare instance blood clots in the brain, I thought my experience of 48 hours of some kind of nerve damage(?) or stimulation could be relevant or at least reported to someone.
pt recv vax 11AM & 1145 stated pt had shakes but no temp reviewed again w/mom all side effect possibilities & reminded to give APAP told to take to hosp if conditions worsens-pt to ER w/t104 dx w/ ear infect & was dehydrated;
Within 24 hours swelling R arm redness 10X11.5cm. Follow-up appointment 1 week. Treatment: Prednisone Rx.
Four generalized clonic-tonic seizures 7 days after administration of MMR II and Varivax.
Sore/Itchy throat - 25mg Benadryl IM. Relief 8 minutes post Benadryl
Fevers over 101.5 started after 24 hours of administration of vaccine, aching all over body with joints also affected, tonsil swelling also noted for three days, night sweats and diaphoresis during feverish episode.
Within about two-four minutes of getting the shot, my throat felt "fuzzy" and I got lightheaded/dizzy.  I thought that I was going to pass out, but I did not.  Both symptoms passed quickly, after about 30 seconds or so.
This case was reported by a other health professional via sales rep and described the occurrence of fatigue in a 65-year-old female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On 26th April 2018, less than a year after receiving SHINGRIX, the patient experienced fatigue and malaise. On an unknown date, the patient experienced fever. On an unknown date, the outcome of the fatigue, malaise and fever were unknown. It was unknown if the reporter considered the fatigue, malaise and fever to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was approximately 65 years old. The patient experienced severe fatigue, general malaise and fever. The patient was on bed for 3 days. This case was linked to the case US2018GSK080274, reported by the same reporter.
Immediate headache, 101 fever, chills, profuse sweating, lethargy.
feeling a little not too well; blood sugar a little high; This is a spontaneous report received from a contactable consumer (reporter wife). A 68-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection /Batch/lot number: unknown) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's relevant medical history and concomitant medications was not reported. It was reported that the patients had taken COVID-vaccine that but he was feeling a little not too well in the morning since he had his blood sugar a little high (400 mg/dl) and she wanted to know if it was recommended to get or not to get the vaccine today the patient want to take second dose or not. Outcome of the events was unknown.  Follow-up information on the lot/batch number has been requested.
Arm and chest numbness within first hour, resolved within first 24 hours Itching arms and torso, lasted for first 48 hours Headache, intense paid behind the eyes and temples, first 96 hours acetaminophen, next 96 hours alternating acetaminophen and ibuprofen. Tongue swelling, lasted for first 36 hours.
Covid booster shot was given in shoulder joint (bursa) instead of deltoid muscle.  Obviously high injection site 1/2 finger width below acromion process.  Pain, heat, swelling to shoulder joint progressively getting worse over past 5 days, no pain in deltoid muscle.
Localized shingles dermatitis of the left back of knee with neuropathic pain along length of the S1 dermatome, including dorsal upper leg and into lateral left foot.
Pt felt warm 1230 Friday afternoon 11OCT91; mom gave APAP; pt continued to feel hot 104.1 R; mom gave sponge bath; temp down 101 mom took pt to ER; temp was 104; admitted to hosp; dx bronchitis;
The feeling is different than what she had before; Period advanced/Usually has period every 30-35 days. This time it started in 19 days.; Dizziness; Short of breath; This is a spontaneous report from a contactable consumer (patient). A 26-years-old female patient received bnt162b2 (PFIZER COVID 19 VACCINE, Batch/Lot Number: ER8729; Expiration Date: 31Jul2021), via an unspecified route of administration, administered in Arm Left on 28Apr2021 (26-years-old) as 2nd dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Vaccination Facility Type: Stadium at college campus. The patient took first dose of bnt162b2 (Lot: EP7534, Expiration: 30Jun2021) on 07Apr2021, administered in the left arm for COVID-19 Immunization. Patient received the second dose of the Pfizer Covid-19 vaccine on 28Apr2021. Shortly afterwards, her period advanced on 08May2021. Usually she has her period around every 30-35 days. This time it started in 19 days. She is unsure if it is really a period or abnormal bleeding. The feeling is different than what she had before. Today is the 6th day of bleeding. She is unsure how long it will last. She does not have health insurance. She is asking if she should purchase health insurance. If she continues to bleed she may have to go to the doctor. She was asking if there was anything that can protect her. She will be moving at the end of the month because she graduated. She provides the address of a friend. She also experienced dizziness on 30Apr2021 (or 03May 2021) which lasted 20-30 minutes, she had to lay down and rest at the time, she felt good now; and she also experienced shortness of breath from 30Apr2021 (or 03May2021) which lasted a few minutes, unsure if related because she was working in the sunshine in the garden. She thinks she maybe was exposed to Atrazine while in the garden. She is unsure if this was related or not. She pulled weeds up where this had been spray a month ago. The half life of chemical is half of a year. She asked if she goes for a screening or clinic for any diagnosis or treatment for breathing will Pfizer be able to help with the cost of expenses? The outcome of the event period advanced/usually has period every 30-35 days. this time it started in 19 days was not recovered, dizziness and short of breath was recovered on 30Apr2021, while other event was unknown.
Pain in shoulder at injection site, especially when exercising, when lying down, and upon exertion. Pain in arm is staying the same and not getting better. Wakes me up and keeps me up occasionally.
no adverse event; HCP called to report that a patient was inadvertently given 4 doses of GARDASIL 9. She was given her first dose on 05/30/2019 at the age of 21 years old. The series was started over after not realizing the first dose was already given so the patient; This spontaneous report has been received from a physician concerning to a 25-years-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.  On 30-MAY-2019, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, route of administration, anatomical location, lot# and expiration date were not provided). On 02-MAY-2022, the patient was vaccinated with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, route of administration, anatomical location, lot# and expiration date were not provided) (it was thought that this was the first dose). On 30-SEP-2022, the patient was vaccinated with the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, route of administration, anatomical location, lot# and expiration date were not provided) and on 20-FEB-2023, the patient was inadvertently vaccinated with a fourth dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (strength, dose, route of administration, anatomical location, lot# and expiration date were not provided) (extra dose administered). No adverse event was reported. No further information was provided.
patient got vaccine. stated doesn't get faint with needles but a few minutes after moved to waiting chair he passed out. his his face off of the floor/wall and broke his tooth and cut his lip. called 911 and patient was taken to hospital by ambulance.
Broke out in red bumps all over body. Progressively worsened and itch.  They are still present from head to toe. Dr. didn't request to see patient, just treating with 2.5% hydrocortisone ointment.
Patient experienced syncope within minutes of receiving the vaccines. Patient was seated, ambulance was called,   they continued to feel dizzy and weak, went with ambulance to continue monitoring.
Expired Dose Administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 79-year-old female patient who received HAB (Twinrix adult) (batch number J477Y, expiry date 20-MAY-2023) for prophylaxis.   On 06-JUN-2023, the patient received the 1st dose of Twinrix adult. On 06-JUN-2023, an unknown time after receiving Twinrix adult, the patient experienced expired vaccine used (Verbatim: Expired Dose Administered). 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 Information: GSK Receipt Date: 06-JUN-2023 The reporter reported that they are wondering if the patient need to restart the series. The reporter reported that the vaccine administration facility was the same as primary reporter. The reporter did consent to follow up via postal. The patient received a Twinrix adult which was already expired, which led to expired vaccine used.
Patient received a Pfizer Monovalent booster instead of a bivalent booster. Patient has been informed of the vaccine administration error. Reports no adverse reaction to the vaccine.
Headache, Myalgia, Arthralgia, LEFT AXILLARY LYMPHADENOPATHY  Narrative: EMPLOYEE HEALTH PROVIDER SPOKE WITH EMPLOYEE CONCERNING SYMPTOMS WITHOUT OFFICIAL OFFICE/CLINIC VISIT.
pain at injection site; trouble moving arm that she received the injection in; This spontaneous report was received from a female patient of unknown age, who was reporting on herself. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 20-OCT-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), 1 dose at administration, intramuscularly for prevention of pneumonia (exact dose, anatomical location, lot # and expiry date were not provided).   On the same day, the patient returned to the pharmacy due to feeling pain at injection site. She was also having trouble moving arm that she received the injection in. The patient did not sought medical attention.  The outcome of the events was unknown. The relatedness between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
03/26/08 PRESENTED TO HOSPITAL W/ VOMITING, PALE IN COLOR, AND BRIGHT RED BLOOD IN DIAPER. LAB WORK AND IV'S DONE PRIOR TO TRANSFER TO HOSPITAL. 6/19/08-records received for DOS 3/26/08-presented to ED with C/O blood in stool, low grade fever, vomiting. Assessment: abdominal pain, vomiting, rectal bleeding. Transferred. 6/24/08-records received for DOS 3/26-3/27/08- DX: Intussusception. Vomiting began day prior to admission. Surgery laparotomy reduction of intussusception.