chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dizziness, fatigue,  generalized and local (left ankle, right knee, left wrist), joint pain, muscle weakness, syncope, near syncope, brain fog, short term memory loss, headache, neck pain back pain, ataxia, photophobia., sensitivity to loud noises, at one point, difficulty swallowing.
This case was considered medically important (OMIC). Information regarding Flumist nasal solution was received from an attorney regarding a patient who experienced Guillain Barre. The patient received vaccine on an unspecified date. Relevant medical history was not provided. Indication for Flumist was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Concomitant medications were not reported. An attorney reported that a patient experienced GBS following receipt of Flumist. The attorney declined to provide any further information due to potential litigation; no lawsuit has been filed. The attorney stated that if improperly shipped and stored Flumist had been administered to a patient, then interstate commerce could be involved if a patient got sick. The attorney mentioned, "there is a bill in Congress which lists influenza as covered for compensation, which is an attempt by your company to limit liability towards problems like this." No additional information was available at the time of this report.
Light-headed 12:35 bp 157/101 hr 83 rr 12 L arm 12:48 bp 171/105 hr 89 rr 12 R arm States BP is usually high "160 over something" Had water and felt better. Left at 12:57
Right arm swollen, (sharp) pain in muscle that feels like it is expanding at site of injection.
Patient reported a fever and tingling to his face in the morning on 12/17/20. EHS followed up with him at 11:30 am on 12/17. He reported that the fever had resolved, and he was no longer having tingling to his face. He denied paralysis to his face, shortness of breath, and chest pain.
Skin began breaking out. After the second vaccine, , I had to go to a dermatologist and then a gastroenterologist. Received 2 shots of Kenalog at the Dermatologist; Had a endoscopy and was found to have gastritis and ephosogitis and inflammation of the stomach.
Redness with swelling and pain in right upper arm developed 5-6 hours after the shot. Went to ER on 9/13/2019  given Decadron 10 mg oral once and discharged. Symptoms resolved over 2 days. Father did not want to bring child for follow up as he was better.
The symptoms I had which started in April, were that I was out of breath with exercise, tightness in my chest, sensitivity to heat, a high resting heart rate. I experienced some heart palpitations along with frequent bowel movements. The symptoms came on gradually. I went to the doctor in June 2022. My pulse rate was high at the time of this visit. It was around 112 sitting. I was scheduled to have an ultrasound of my thyroid. The ultrasound was completed on June 09th of 2022 which determined heterogeneous thyroid gland with no discreet nodules. I went to see an endocrine specialist. I had bloodwork done again on 06/23/2022 and was diagnosed with graves' disease. I was put on beta blockers as well as methimazole. I have seen an endocrine specialist 3 times and they have adjusted my medication as needed. I am no longer on the beta blockers. I did experience some weight gain, but I am no longer experiencing the initial symptoms. I have not recovered as I am still having to take medications for my symptoms.
The next morning after my shot. I was nauseas and took Tylenol to help with the pain in my arm from the shot around 6 am. Around 11 am, my neck was very itchy and I was itching it. Around 230 pm, I went to the bathroom and noticed I had hives all over my neck and chest. When I came home from work, I took a look in the mirror and noticed the hive spread to my face and back. I took an oatmeal bath which helped a bit with the itching. I took Benadryl when I got out of the bath and went to take a nap. When I woke up some of the swelling went down on my neck. Hives are still bright red on my back and have spread to my legs and lower torso and I am extremely itchy and uncomfortable right now around 10:00 pm.
flu like symptoms headache for 48 hours, then extreme muscle weakness, fatigue, brain fog, continuing to current day 10, symptoms getting worse from day 2 to current day, 15 year old daughter is non functioning, exhausted, not able to got to school, activities, was normal high functioning athlete honors student before vaccine given
Hives covering most of my body about 3 hours after the flu shot. I took two Benadryl when I first noticed the hives followed by two more when I went to bed. I awoke at 2am and took two more. By morning the hives were not as red, but still noticeable. I took 2 more Benadryl at breakfast and by noon, there was no sign of hives on my body.
Information has been received from a certified medical assistant concerning a 22 year old female allergic reaction to LEVAQUIN who on 17-NOV-2008 and 11-JAN-2009 was intramuscularly vaccinated with a first and second doses of GARDASIL (both lots #0702X), respectively.  There was no concomitant medication.  On 18-JAN-2009 the patient developed left arm pain and swelling and difficulty moving her left arm after receiving her second dose of GARDASIL.  The patient also experienced tingling in her left hand.  The patient sought medical attention via an office visit.  She did not recover at time of reporting.  The patient's left arm pain and swelling and difficulty moving her left arm and tingling in her left hand were considered to be disability.  Additional information has been requested.
Information has been received from a registered nurse referring to a patient of unknown age and gender. On an unknown date, the patient was inadvertently administered expired PROQUAD (lot # K025765, expiration date 08-JUN-2016, subcutaneous). No adverse effects were reported. There was no product quality issue (PQC) involved. Additional information has been requested.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: No other medication in 2 weeks. No known allergies. Anti viral details: product=COVID 19 Treatment, brand=Paxlovid , treatment start date=12Nov2022, treatment stop date=16Nov2022, indication=Treatment of COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a pharmacy technician refers to a 1 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 09-FEB-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
Received an e-mail vaccine error message 6/17/16 from our management company for our EMR for date of service 4/4/16 vaccines. After reviewing patient immunization history in our EMR and Child Profile. All 3 vaccines were administered 31 months ahead of schedule for this patient. Staff member was contacted but currently out of the office until 6/20/16. E-mail was sent to staff member to contact me about this incident when she returns. Incident also reported to practitioner's supervisor, who was involved in the event.
Patient was experiencing itchiness around the site of injection for 5+ days. Placed anti itch cream on site daily at least BOD x 5 days.
Constipation; Muscle pain; Stomach cramps; Flu like symptoms; Chills; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach cramps), CONSTIPATION (Constipation) and INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 26-Mar-2021, the patient experienced CHILLS (Chills) and DIARRHOEA (Diarrhea). On 22-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach cramps) and INFLUENZA LIKE ILLNESS (Flu like symptoms). On an unknown date, the patient experienced CONSTIPATION (Constipation) and MYALGIA (Muscle pain). At the time of the report, CHILLS (Chills), DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach cramps), CONSTIPATION (Constipation), INFLUENZA LIKE ILLNESS (Flu like symptoms) and MYALGIA (Muscle pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.     Reporter did not allow further contact
I noticed within 3 or 4 days, that the location of the shot on my left shoulder developed a noticeable indent in my shoulder muscle.   The indent is only about the size of a dime, however, there is a visible recession in the muscle where the injection occurred.  I am unsure how quickly the indent occurred, but I noticed it maybe 4 days later.   It is as if the muscle below the injection shot dissolved away and just left a hollow indent about a millimeter or two in depth. I did report this to the injection site nurses upon getting my second follow up vaccine. They verbalized easily being able to notice the indentation from 5 feet away.
lightheadedness, dizzy, felt like she was going to fall; shaky; Afib started up again (heart was racing); arm hurts; head hurt; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (lightheadedness, dizzy, felt like she was going to fall), NERVOUSNESS (shaky), PALPITATIONS (Afib started up again (heart was racing)), PAIN IN EXTREMITY (arm hurts) and HEADACHE (head hurt) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced DIZZINESS (lightheadedness, dizzy, felt like she was going to fall), NERVOUSNESS (shaky), PALPITATIONS (Afib started up again (heart was racing)), PAIN IN EXTREMITY (arm hurts) and HEADACHE (head hurt). At the time of the report, DIZZINESS (lightheadedness, dizzy, felt like she was going to fall), NERVOUSNESS (shaky), PALPITATIONS (Afib started up again (heart was racing)), PAIN IN EXTREMITY (arm hurts) and HEADACHE (head hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment medication included acetaminophen.
Patient received YF vaccine Sept 11th and noted onset several hours late of hives and itchy. Seen 9/18/2013 in f/u due hx continuous itching.
Received dose from vial punctured days before; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from vial punctured days before) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from vial punctured days before). On 29-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Received dose from vial punctured days before) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter reported number of doses/vials was 1 vial, 1 dose. Date the vial was initially stored in the refrigerator was 03 Sep 2021. Date and time vial was first punctured was 07 Sep 2021 at 3.20pm. The vial did not under gone to temperature excursion.  No concomitant medications were mentioned. No treatment details were reported.
Called in by Father, stated school nurse called that daughter face was swollen. Father instructed to take daughter to ER.
Patient had a tingly face and lips 10 minutes after dose, same as last time.  Last time resolved after 45 mins and a workout.  Feels same, refused ambulance evaluations.
tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable consumer (patient) via medical information team.   A patient of unspecified age and gender received bnt162b2 (Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date on Apr2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 (Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The reporter stated that the patient had both Pfizer vaccines on an unspecified date in Mar2021 and Apr2021. The patient had tested positive for Covid on 01Sep2021 and had been quarantined for the past 2 weeks. The patient was wondering when or if the patient could get the booster and if the patient still should get it. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 01Sep2021 (have been quarantined for the past 2 weeks). The outcome of the event was unknown.  The lot number for [BNT162B2] was not requested and will be requested during follow up.
Smallpox vaccine 3/18/03; Take read 3/24/03.  Abdominal pain started around 12:00 pm 3/26/03; Went home early from work; Off Thursday; Returned to work 3/28/03; Right side pain; Referred to ER 11:00 am; Surgery 3/28/03; Returned home 3/29/03; Feeling much better 3/31/03.
No adverse event. Pt said  he never got covid vaccine and nothing was listed. Pt had J and J  covid19 in March.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 12-JAN-2011, the patient was inoculated with ZOSTAVAX by a healthcare provider to obtain permanent prevention and protection against shingles and zoster-related injuries (dose, route, and lot # not provided). On an unknown date, the patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of patient's injuries. The patient was treated by a physician for shingles on or about 16-APR-2012. The lawyer reported that as a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death- aggravation of preexisting conditions and activation- of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
Feb 15 just two small places about 2 inches below site. Feb 17 Hives spread from injection site to elbow with swelling and itching. Lasting until March 1, 2021. Swelling and hives subsided but not completely gone. Lines of what appeared to be hives at angles started on inside of arm, appeared on upper right leg and  and back. They were gone by March 9. Arm continued to itch for another week.
pt recv vax 30JUN98 & later the same day pt devel hives all over body;tx w/DPH & calamine lotion;
Early period after just having one two weeks prior. Heavy bleeding and cramping with large blood clots.
This spontaneous report was received from a consumer of unknown age and gender who is also an administrator, via a company representative, referring to her/himself. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 26-FEB-2018, the patient was vaccinated with ZOSTAVAX 194000 plaque forming unites (PFU), lot # N025703 with expiration date 16-DEC-2018, for prophylaxis (dose and route of administration were not reported). On an unspecified date in 2018, the patient experienced the following symptoms: hard, indurated (induration), warm to touch center (feeling hot), surrounded by oedema that wrapped about half way around the arm (oedema peripheral). It was irritated (skin irritation) but not painful. No other symptoms were reported. The patient stated that the center was a little larger at the time of reporting than the day before. The outcome of the events was unknown. The causality assessment between the events and ZOSTAVAX was not provided.
Sedation, Myalgia, Fever, chills, fatigue, body aches Narrative:
This spontaneous report as received from an office administrator refers to an unspecified number of patients of unknown ages and genders. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified dates starting in February 2015, the patients were vaccinated with an unspecified number of doses of GARDASIL (lot # J009243, exp. date 23-APR-2016) (route, dose and dose number were not provided). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of two reports received from the same reporter (MARRS # 1509USA003613). Additional information has been requested.
PATIENT PRESENTED TO ER ON 12/17/2021 WITH RESPIRATORY FAILURE. REPORTEDLY HAD 3 DAY HISTORY OF FATIGUE, CONFUSION. EMS CALLED, FOUND PT UNRESPONSIVE WITH O2 SATURATION OF 40%. PT INTUBATED, TRANSPORTED TO ER, ADMITTED TO ICU. IN ADDITION TO +COVID LABS, BLOOD AND RESPIRATORY CULTURES FROM 12/17 ALSO POSITIVE FOR MRSA. PATIENT UNABLE TO WEAN OFF MECHANICAL VENTILATION, INCREASING O2 REQUIREMENTS, NEEDED PRESSORS. 12/25/2021 PT HEART RHYTHM PROGRESSED TO ASYSTOLE, PRONOUNCED DEAD 0935.
At site started   red rash arm and legs.   hive like , face red,   welts on legs.
24 hors post vax, pt developed muscle aches, fever of 101 and pain in skin all over which lasted about 24 hours.
General tiredness; body aches; chills; sore injection site; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration in the left arm on 19Jan2021 at 17:45 (at the age of 60-years-old) as a single dose for COVID-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing; high cholesterol from an unknown date and unknown if ongoing; occasional atrial fibrillation (AFIB) from an unknown date and unknown if ongoing; and pre-diabetes from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not have allergies to food or other products. Concomitant medications included dabigatran etexilate mesilate (PRADAXA); ezetimibe, simvastatin (VYTORIN); propafenone (manufacturer unknown); escitalopram (manufacturer unknown); and metformin (manufacturer unknown); all from unknown dates for unknown indications and unknown if ongoing. The patient previously took amoxicillin sodium, clavulanate potassium (AUGMENTIN) for an unknown indication and experienced nausea. On 20Jan2021 at 07:30 the patient experienced general tiredness, body aches, chills, and sore injection site. The patient did not receive treatment for the events. The clinical outcome for the events was not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
13 min post vaccine pt became unresponsive to verbal and uncomfortable stimuli.  Pt slumping in chair with right side facial drooping .  Pt began to respond in approx 3 minutes with confusion and not recalling events of prior 3 min.  Pt with max assist placed in wheelchair and paramedics called.  RR. Low teens  B/P 150/88  Per family pt had same episode yesterday
This spontaneous report as received from a nurse refers to an 8 months old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.