chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Emergency room HPI Patient is a 91 y.o. male who presents from nursing home with positive coronavirus a and flu A positive tests.  Test was done yesterday.  Patient sent to ER because of low oxygen saturation.  Patient unable to answer or respond to questions.  No fever or chills, no cough or shortness of breath and no complaint of pain when patient was moved around. Oxygen saturation on presentation was 89% on room air and went up to 93% on 4 L of oxygen  admission: HPI:   Patient is a 91 y.o. male with a history of severe dementia and severe COPD.  He currently resides at Rehab.  He had a routine coronavirus (COVID-19) test yesterday that was positive.  Then, today he started having increasing oxygen requirement.  He was not responding to his typical breathing treatments or oxygen and so they sent him in.  In the ER he was found to be in some respiratory distress and did require increased oxygen concentration.  Once they got him calm down, his oxygen saturation state over 90% with 4 L.  His ABG did show an oxygen  Saturation of 86% on 4 L. The patient reportedly had coronavirus (COVID-19) several months ago, but then did test positive for both coronavirus (COVID-19) and influenza on rapid testing at the nursing home yesterday.  The patient is being admitted due to his increasing oxygen requirement and respiratory distress
Moderna COVID-19 Vaccine EUA  Day 1 just local injection site pain, no treatment. Day 2 local injection site pain, body aches x 24 hours, chills x 24 hour. No treatment.
Headache, shortness of breath, loss of hearing, fever of 100.5 F, bodyaches, chest tightness, swelling of my face
Syringe was inserted into left arm without medication. Syringe did not contain air or vaccine. Syringe was withdrawn without injecting anything.  Bleeding occurred.
Began vomiting in evening 12/6/04. Continued to Wed 12/8/04 taken to ER No IV, No hospitalization. Not dehydrated per ER, taking Pedialyte and fluids. Improved Thurs okay by Fri.
Fatigue; Fever; Headache; COVID-19; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID-19), FATIGUE (Fatigue), PYREXIA (Fever) and HEADACHE (Headache) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced FATIGUE (Fatigue), PYREXIA (Fever) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19), FATIGUE (Fatigue), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: the patient experienced fever.     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.   Concomitant product use was not provided by the reporter.
Hard and sore at shot site.  Still, after almost 5 months, it continues -- with or without, but mostly with movement.  ON a scale of 1-10, pain is about a 6.  Never has gone away.  I treat it with a THC/CBD salve and/or take 2 Tylenol at night (when pain is more pronounced) or both.
Fatigue, headache, nausea, bodyaches, no appetite - Tylenol, sleep and fluids for symptoms - lasted 24 hours
Developed silver dollar- sized "burn" lesion at injection site.  Immediately developed atrial fibrillation. Was sick for 3 weeks. After 2nd vaccination, developed a noticeable decline in mental awareness.  Had ischemic stroke in 2023.
he got the second vaccine and on 08Mar2022 when he went back to the eye specialist, he can't read with that eye nothing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old male patient received bnt162b2 (BNT162B2), administration date 23Feb2022 (Lot number: FM0698) at the age of 50 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Batch/Lot number: FK9896), administration date: 24Jan2022, when the patient was 50 years old, for COVID-19 immunization, reaction(s): "eye stroke". The following information was reported: VISUAL IMPAIRMENT (non-serious) with onset 08Mar2022, outcome "not recovered", described as "he got the second vaccine and on 08Mar2022 when he went back to the eye specialist, he can't read with that eye nothing". The event "he got the second vaccine and on 08mar2022 when he went back to the eye specialist, he can't read with that eye nothing" was evaluated at the physician office visit. Therapeutic measures were taken as a result of visual impairment.  Additional information: The caller stated that he got the Pfizer vaccine, thinks he had some bad things, stated he got the first vaccine 24Jan2022 and on 10Feb2022 when he went to the eye doctor, they said he had an eye stroke, stated the doctor took a picture, told him he had an eye stroke, stated at that time he could read the biggest letters and then on 23Feb2022 he got the second vaccine and on 08Mar2022 when he went back to the eye specialist, he couldn't read with that eye nothing. He stated his right eye was affected. The caller stated that the doctor said this could be due to the vaccines. It was persisting and the doctor told him that he would not get back his vision, stated that it could turn into glaucoma. Gave him a shot, some medicine, details unknown.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200461909 same patient and drug, different event separated in time
On January 6, 2023, I noticed I had congestion and a little bit of a headache.  I tested positive on same day.  .I then had a fever.  The next day I called doctor and received Paxlovid.  I began the five day dosage and my symptoms subsided.  I did get a rash on my right arm.  I called the nurses line.  I began taking Benadryl for possible allergic reaction.  I was almost completely better by Monday night.  I completed Paxlovid on that Wednesday.  As of today, I don't feel any symptoms but have a slight runny and occasional cough.
Confusion, Headache, Myalgia, Arthralgia, SkinRash, CoughWheeze, Rash, UrticariaPruritus, NauseaVomiting Narrative:  Employee reports he was so ill he thought he was going to die. He is very fearful of getting second vaccination. He currently is refusing to get it.
Chest pain. Been 30 days; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 67-years-old non pregnant female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 07Feb2021 12:00 AM (Age at vaccination: 67-years-old) as single dose for covid-19 immunization. Medical history included Factor V, allergies to Sulpha all from an unknown date and unknown if ongoing. Concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 in arm right on 17Jan2021 12:00 AM (Age at vaccination: 67-years-old) for covid-19 immunization, patient previously took cipro [ciprofloxacin] and experienced drug hypersensitivity. Patient did not receive other vaccine in four weeks. Patient was not diagnosed with covid prior to vaccination. On 08Feb2021 12:00 AM patient experienced Chest pain. Been 30 days. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. Patient did not receive any treatment for the events. Patient was tested for covid since the vaccination. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 10Feb2021. The outcome for the event was reported as not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This is a spontaneous report from a contactable consumer (patient). A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), intramuscular in left arm (also reported as left leg; pending clarification), on 04Aug2021 at 10:00 AM (at the age of 44 years), as dose 1, single, for COVID-19 immunization. The patient's medical history included atrial fibrillation (AFib) from 2016 and had an ablation to fix it in 2016. The patient's concomitant medications included lisinopril, carvedilol, omeprazole (PROTONIX), atorvastatin calcium (LIPITOR), and magnesium chloride (SLO-MAG). The patient previously took cyproheptadine hydrochloride (CYPRO), metronidazole (FLAGYL), and codeine and experienced allergies. The patient was not diagnosed with COVID-19 prior vaccination. The vaccine was administered in a pharmacy or drugstore facility. On 07Aug2021 at 01:00 PM, the patient experienced heart palpitations and chest pains. The events resulted in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care visit. No treatment was administered for the events. The patient considered the events as non-serious. On 25Aug2021 at 10:00 AM, the patient received the second dose of BNT162B2, intramuscular in left arm. Since the vaccination, the patient has not been tested for COVID-19. The patient had not recovered from the events. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Patient developed a fever of 101 degrees the evening after vaccination was administered.  She stated the fever lasted for one and a half days.  Her upper arm also became swollen and red.  She stated her upper arm felt really hot and sensitive to touch.  Patient came in 3 days later and showed me her arm.  The red/swollen site is not where injection site was.  It as on the inside of her upper arm, and not where the deltoid muscle is where the vaccination was administered.
I noticed that like my periods got weird that I have not had a period; I noticed that like my periods got weird that I have not had a period; This is a spontaneous report from a contactable consumer reported for herself. A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left, at the age of 35 years, on 02Apr2021 (Batch/Lot Number: ER8735) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included allergies to sweet potato and banana from an unknown date and unknown if ongoing. Concomitant medications included polycarbophil calcium (FIBER) taken for an unspecified indication, start and stop date were not reported and vitamins. The patient previously took wellbutrin, methocarbamol and ceclor and experienced drug hypersensitivity. On 21Apr2021, the patient stated, "So, I think I need to report something that isn't the first effect and the other thing I don't know if it is not, so I got my first Covid Vaccine the Pfizer on 02Apr2021 and I noticed that like my periods got weird that I have not had a period and I am normally, completely regular then I got my 2nd Vaccine that past Saturday and I got it on my left side of my body and my lip swelled up on left side and then I got a rash but the rash is going away and swelling going down but I thought I need to report that." The patient underwent lab tests and procedures which included body height: 5 foot 8 inches, pregnancy test: not pregnant, sars-cov-2 test: negative and weight: it must be between 180-185; all on unspecified dates. The outcome of the events was not recovered.
Patient fainted about 2 minutes after vaccination after standing up for about 30 seconds.  Patient recovered quickly, brought patient Apple juice and grand parent  brought up some food.  Patient states she hadn't eaten since lunch time.
This spontaneous report as received from a physician's assistant refers to a patient of unknown age and gender. On 02-NOV-2015, the patient was vaccinated with an improperly stored dose of MMR II (lot # K024036 exp date 26-NOV-2016) (dose and route not reported). The temperature excursion was 53.8 F for 10.75 hours from 17-AUG-2015 to 06-NOV-2015. No adverse event was reported. This is one of several reports received from the same source. Additional information is not expected as all follow up information to complete the case was received.
Local reaction surrounding site. Erythematous rash from left elbow up on left shoulder (distal surface only). Skin warm to touch in some areas. Tx: Benadryl allergy 25mg tsp every 4-6 hours PRN rash. No systemic effects noted.
Approximately 5 days after my second shot I began to have an increase in joint symptoms (redness, warmth, stiffness, swelling, pain). After 7 days it became a full-blown flare with between 30 and 35 joints affected (all joints of the hands, the spine, the knees, hips and joints in the ankles and feet). I also developed a lupus rash on face, low grade fever, sore throat and overall feeling of exhaustion. All are typical symptoms of a flare.
patient was mistakenly given FLUZONE HD when she was supposed to be getting a pneumonia vaccine the same patient had already received FLUZONE HD  with no adverse event; patient was mistakenly given FLUZONE HD when she was supposed to be getting a pneumonia vaccine with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a Pharmacist via Call Center via the agency (Reference number- 00356259) and transmitted to Sanofi on 12-Nov-2020.  This case involves a 65 year old female patient was mistakenly given INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] when she was supposed to be getting a pneumonia vaccine the same patient had already received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] with no adverse event (Extra dose administered and Wrong product administered).  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   It was a actual medication error due to Extra dose administered and Wrong product administered.  On 27-Sep-2020 she also received a first dose of the INFLUENZA QUADRIVAL A-B VACCINE (batch number: unknown) via an unknown route in an unknown administration site for prophylactic vaccination.  On 11-Nov-2020, patient went to go get a Pneumonia vaccine, however the clinic was filled with patients that were getting the INFLUENZA QUADRIVAL A-B VACCINE and the person administering the vaccine did not check the consent form and patient administered the INFLUENZA QUADRIVAL A-B VACCINE prefilled syringe (batch number: UT7081KA Expiration date: 30-Jun-2021 Strength Standard via an intramuscular route in an unknown administration site) in error (Extra dose administered and Wrong product administered).  The patient has not exhibited any adverse event as a result of the Extra dose administered and Wrong product administered.   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 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.
Patient reports feeling nauseated and lightheaded. Patient vs 106/87, 79, blood sugar 120, 97 oxygen. Water provides to patient. She states she feels better. Pt discharge home.
Got COVID; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Got COVID) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Got COVID). At the time of the report, COVID-19 (Got COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided.
Shingrix administrered to a patient but reconstituted with sterile water instead of using the proper adjuvant; Shingrix administrered to a patient but reconstituted with sterile water instead of using the proper adjuvant; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number ZM749, expiry date 22-AUG-2025) for prophylaxis.   On 25-JUL-2023, the patient received Shingrix. On 25-JUL-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Shingrix administrered to a patient but reconstituted with sterile water instead of using the proper adjuvant) and inappropriate dose of vaccine administered (Verbatim: Shingrix administrered to a patient but reconstituted with sterile water instead of using the proper adjuvant). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 26-JUL-2023 The reporter was the medical assistant. The Shingrix vaccine reconstituted with sterile water instead of the GlaxoSmithKline supplied diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow up.
A report has been received from a Health Professional concerning a 46 year old , male subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on 10-DEC-2014. The nurse reported that the patient was administered with expired FLUMIST Quadrivalent which started on 10-DEC-2014. The outcome of the event of expired FLUMIST Quadrivalent administered is unknown. The report was considered to be non-serious.
My daughter developed a rash on her trunk area on the morning or February 17th.  As the day went on, the rash progressed to her neck, behind her ears, scalp, diaper area and face.  The rash became more severe and at its worst point the whole area was almost entirely bright red.  Baby was very irritated by rash.  Rash was gone in about 36 hours.  Did not visit Dr's office as it was a Friday night/Sat morning.
patient not feeling good; was throwing up; patient's joint hurt; fever last night; This spontaneous case was reported by an other caregiver and describes the occurrence of FEELING ABNORMAL (patient not feeling good), VOMITING (was throwing up), ARTHRALGIA (patient's joint hurt) and PYREXIA (fever last night) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced FEELING ABNORMAL (patient not feeling good), VOMITING (was throwing up), ARTHRALGIA (patient's joint hurt) and PYREXIA (fever last night). At the time of the report, FEELING ABNORMAL (patient not feeling good), VOMITING (was throwing up), ARTHRALGIA (patient's joint hurt) and PYREXIA (fever last night) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  Concomitant medication not provided.  Treatment information not provided.  Caregiver reported that patient was not feeling good and was throwing up. She was unsure if it was an allergic reaction but stated that patient's joints hurt, may have had a fever last night
had arm pain for 1 day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (had arm pain for 1 day) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (had arm pain for 1 day). At the time of the report, PAIN IN EXTREMITY (had arm pain for 1 day) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment medication information was not reported.   This case was linked to MOD-2022-474275 (Patient Link).
Partial paralysis of bilateral arms that resovled in aprox 3 hours. Severe neck stiffness, bilateral arm weakness and pain remaining at this time. Has recently tried Flexeril and Naproxen for related pain. Has been evaluated multiple times and no further treatment available.
Massive swelling (entire arm) redness, very warm to the touch, fussiness. Treated with rest, cold compress, ibuprofen.
I woke up without a voice; This spontaneous case was reported by a consumer and describes the occurrence of APHONIA (I woke up without a voice) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced APHONIA (I woke up without a voice). At the time of the report, APHONIA (I woke up without a voice) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.
6cm in diameter circle of erythema, induration and swelling to R thigh around injection site
After Vaccine, patient complained that she was very hot and started to feel light headed. She stated she feels like she is starting to see black and might pass out. She asked the PASR for some cold water. Her husband asked if we could provide a cold compress in which we did and she applied it to her forehead and back neck. She stated she was starting to feel better but Emergency Response was activated as a precaution. The medical response personnel checked the patient's blood pressure and noticed it was very low (no specific measurement given). She then advised the patient to go to the ER and security along with the medic response personnel helped the patient to the ER.