chrisvoncsefalvay/vaers-outcomes huggingface dataset:
delirium; does not remember anything from that time; she was talking to her father who had died 10 years before; vomited while she was on her couch; Initial information received on 05-Aug-2021 regarding an unsolicited valid serious case received from a consumer/non-Healthcare professional via Medical Information (Reference number 00711987).  This case involves 81-year-old female patient who experienced delirium, vomited while she was on her couch (vomiting), does not remember anything from that time (memory impairment) and she was talking to her father who had died 10 years before (abnormal behaviour) after receiving INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past vaccination(s) included FLUZONE HIGH-DOSE QUADRIVALENT and experienced no issues.  The patient's medical history included urticaria.  The patient's past medical treatment(s) and family history were not provided.  Concomitant medications included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) and FAMOTIDINE (PEPCID [FAMOTIDINE]) for Urticaria.  On 29-Sep-2020, the patient received dose of 0.7ml suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ483AA and expiry date: 30-Jun-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  On 29-Sep-2020, the patient developed a serious delirium (lasted two days) on the same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE. This event was assessed as medically significant.  On 29-Sep-2020, the patient developed a non-serious vomited while she was on her couch (vomiting), does not remember anything from that time (memory impairment) and she was talking to her father who had died 10 years before (abnormal behaviour) on the same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  It was reported that, patient had a reaction to last year's (2020-2021) Fluzone High-Dose Quadrivalent vaccine, and wanted to know the ingredients so that patient and her doctor could compare them to the ingredients in the Covid-19 vaccine.  Relevant laboratory tests were not reported.  It was not reported if the patient received any corrective treatment for all the events.  At time of reporting, the outcome was resolved on an unknown date for the events.; Sender's Comments: This case involves an 81-year-old female patient who had delirium, vomiting, memory impairment and abnormal behavior after receiving FLUZONE HIGH-DOSE QUADRIVALENT. The time to onset is compatible. There is no further information regarding patient's medical condition at time of vaccination, history and laboratory tests ruling out alternate etiologies. Based upon the reported information, the role of a vaccine cannot be assessed.
BP remained higher than normal; This is a spontaneous report received from a contactable consumer (reported on herself) in response to non-HCP letter sent.  An 82-year-old female consumer received second dose of BNT162B2 (Solution for injection, Lot number: EM9809 Expiry date: 30Jun2021) via an intramuscular route 19Feb2021 02:00 pm, as a single dose for Covid-19 immunization. Medical history was not reported. The patient was not on any concomitant medications. There was no history of other prior vaccination. The patient received first dose of BNT162B2 (Solution for injection, Lot number: EL9262 expiry date: 31May2021) via an intramuscular route on 28Jan2021 12:40 pm, as a single dose for Covid-19 immunization. On an unknown date, after vaccination, the patient experienced that blood pressure (BP) reminded higher than normal/ High BP. The patient received treatment with Losartan and Hydroxyzine. The outcome of the event of BP) reminded higher than normal/High BP was reported as not resolved.     No follow up attempts were possible. No further information was expected.
Seen in the ED for nausea, bloody diarrhea.  Possible intussusception.   Patient transferred to hospital.
Information has been received from a consumer concerning his wife a 72 year old female patient with fibromyalgia and a history of pacemaker and no known drug allergies, who on 24-JUN-2009 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot not reported). Concomitant therapy include "other medication". On 26-JUN-2009 the patient developed shingles. His wife started with a rash above the left eye that was also itching. His wife was very tired and weak and slept a lot. Wife had no strength. The left eye was swollen and she can hardly open it and had to put in drops continually. His wife was seeing an ophthalmologist every day because of the ophthalmologist concerns about the eye. His wife had pain. One day his wife fainted and she was taken to the emergency room. She was checked with an an electrocardiogram, computed axial tomography scan and blood work which were all negative. At the time of reporting, the patient's symptoms persisted. Follow up information has been received from a consumer concerning his wife who on 24-JUN-2009 received a dose of ZOSTAVAX (Merck) (Lot # not reported) and on 26-JUN-2009 was diagnosed with shingles. She developed a rash above her left eye and forehead and then her eye became infected causing her almost complete lost of sight in that eye. She was going daily for many consecutive weeks to the ophthalmologist. As of 27-SEP-2009, her vision had improved. She was in constant pain, very weak and extremely tired. One time she fainted and he had to take her to the emergency room. At the time of this reporting it was reported that the patient had not recovered. Upon internal review almost complete loss of sight in the left eye was considered to be an other important medical event. Additional information is not available.
rash all over body from head to toe.  It is especially bad on legs, groin, back, arms and wrist.  Went to PCP Dr. on 5/18/2021 and was prescribed prednisone.  Went back 5/19/2021 was given a methylprednisolone pack.  This helped clear up the rash but after the medicine was completed the rash came back by 5/27/2021.  Went back to work and feels like the heat made the symptoms worse.
Itching, swelling, pain on 10/17/01 (Benadryl given) red and tender to the touch 10/18/01, Keflex given on 10/18/2001 - 10/24/2001.
High fever over 105 (had phone visit with Urgent Care) that lasted for 2 days with Tylenol and Ibuprofen, intolerable headache, extreme muscle cramps, hallucinations, bone pain, very elevated bp. This was filled by 3 days of continuing fevers between 102-104, with heart palpitations, trouble sustaining breaths, problems with forming thoughts, extreme fatigue  during this time I was evaluated and tested for covid and other viruses which all came back negative. Sent home. I followed up with these issues to my nutrition doctor and was referred to cardiologist where I have had ekg, echo, and am turning in a halter monitor. I still find that I fatigue easier, lose my breath easily, have more rapid pulse, and elevated bp. I also still have brain fog. And an increase in migraine headaches.
feeling really tired; feeling run down; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (feeling really tired) and ASTHENIA (feeling run down) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010821A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LISINOPRIL, CARVEDILOL, MONTELUKAST, ROSUVASTATIN, SALBUTAMOL (ALBUTEROL HFA), TIOTROPIUM BROMIDE (SPIRIVA) and BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced FATIGUE (feeling really tired) and ASTHENIA (feeling run down). At the time of the report, FATIGUE (feeling really tired) and ASTHENIA (feeling run down) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021:  Patient denied to fill ADR and denied for further follow up. No further follow up required.
Moderna Covid-19 vaccine. Severe muscle/joint pain starting 5 hours after administration and persisting for 48 hours and counting.  Loss of functional mobility in left arm,  severely decreased ROM and moderate-severe pain causing stress, inability to sleep, inability to work.
Mom states swelling where shot was given IM left leg redness, hard, hot to touch, fever of 103. Mom is giving Tylenol and Motrin. Grabs at her head and screams says it hurts.
two days later she developed slight numbness in her legs; like her skin feels weird on both legs; developing grogginess; feeling tired; head felt dizzy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 42 year-old female patient received bnt162b2 (BNT162B2), administration date 26Aug2021 (Lot number: EW0173) at the age of 42 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: HYPOAESTHESIA (non-serious) with onset 28Aug2021, outcome "not recovered", described as "two days later she developed slight numbness in her legs"; SKIN DISCOMFORT (non-serious) with onset 28Aug2021, outcome "not recovered", described as "like her skin feels weird on both legs"; SOMNOLENCE (non-serious) with onset 28Aug2021, outcome "recovered" (2021), described as "developing grogginess"; FATIGUE (non-serious) with onset 28Aug2021, outcome "recovered" (2021), described as "feeling tired"; DIZZINESS (non-serious) with onset 28Aug2021, outcome "recovered" (2021), described as "head felt dizzy".  Additional information: Reporter Details: She works in the emergency room and runs the registration department but was not one of the HCPs listed by this agency. Declined mailing address. she was usually very healthy. She takes vitamins and stuff and she is not one to complain. She doesn't get sick and she also doesn't see her doctor on a regular basis.  No follow-up attempts are possible. No further information is expected.
EXTREME SORENESS AT INJECTION SITE, LEFT ARM WEAKNESS, FEELING OF BEING TOO HOT, SWEATING,  RED AREA THE SIZE OF A SOFTBALL, 36 HOURS HOURS COULD NOT EVEN TOUCH THE AREA DUE TO EXTREME SENSITIVITY AND PAIN, SWELLING , 48 HOURS LATER AREA IS STILL RED, SWOLLEN AND SKIN IS EXTREMELY HOT, STILL SORE TO THE TOUCH.
the patient feels a little achy; Arm ache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm ache) and MYALGIA (the patient feels a little achy) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Back pain and Inflammation. Concomitant products included CELECOXIB (CELOXIB) for Antiinflammatory therapy, DIAZEPAM (VALIUM) for Back pain.    On 08-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced PAIN IN EXTREMITY (Arm ache). On an unknown date, the patient experienced MYALGIA (the patient feels a little achy). At the time of the report, PAIN IN EXTREMITY (Arm ache) and MYALGIA (the patient feels a little achy) outcome was unknown.            No treatment details were reported.
Within 10-15 minutes of injection, patient became hot and flushed all over. Took benadryl 25mg PO and symptoms subsided.
Patient came in for Pfizer booster. It was discovered after given, patient is not 18 until March 2022 (3 months away). Booster given too soon.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Biaxin, reaction(s): "Drug Allergy"; Naproxen, reaction(s): "Drug Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient had known allergies: a few others. Treatment start date: 29Apr2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300176519 Same patient, different event/drug;
Rash and soreness at the site of injection. Body aches and pains, nausea.
Patient felt lightheaded and fainted briefly. Pt came too and was aware of her location and what she was doing and what happened immediately before she fainted. No further issues.
9/9/09 at 6 PM started screaming and grabbing at rt. leg, at 12:30 AM noticed swelling of fist size on rt. leg from above shot to below knee. 9/9/09 not eating or drinking, cry all day, sat and stared without talking, fever of 102 and given Tylenol. 9/10/09 still not eating, clingy, wimpered all day, scream when rt. leg touched, not sleeping.  9/11/09 swelling down some but bruised, not eating, not walking much but if does then limps.  to Dr. in afternoon.
she was paralyzed in her legs; Her husband had to carry her to bathroom throughout the day; couldn't walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 24Nov2021 15:00 (Batch/Lot number: unknown) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Multiple sclerosis" (unspecified if ongoing), notes: treated by Ocrevus; "COVID virus", start date: Oct2021 (unspecified if ongoing), notes: hospitalized for three days. There were no concomitant medications. The following information was reported: MONOPLEGIA (medically significant) with onset 25Nov2021, outcome "recovering", described as "she was paralyzed in her legs"; MOBILITY DECREASED (non-serious) with onset 25Nov2021, outcome "recovering", described as "Her husband had to carry her to bathroom throughout the day"; GAIT DISTURBANCE (non-serious) with onset 25Nov2021, outcome "recovering", described as "couldn't walk". Therapeutic measures were not taken as a result of monoplegia, mobility decreased, gait disturbance. Clinical course: The second shot she has not got yet, Second shot scheduled on 14Dec2021. She is not sure if she should get the second vaccine, but then that would mean she is not fully vaccinated. She specified her doctor recommended her to get the Moderna COVID 19 vaccines as her second dose. Patient received her first dose last Wednesday at 15:00 and was paralyzed in her leg the next morning. She specified it took hours to take the feeling out and now she can walk.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Pain in needle strike area for 3 months. Very concerned. On  yesterday my neck was stiff and painful, the pain  spread down to the vaccine stick Decided to contact CDC.  Using  hot pad and a cold pad.  Tylenol Extra Strength, it does not get to the stick area. The pain feels like it?s in my flesh, not ny bones. A feeling I?ve never felt before.
5 hours after injection I felt chilled and shivered on and off the rest of the evening. The next morning I awoke with a mild fever, fatigue and shivering also no appetite for the entire day that night around 9:00pm I started uncontrollably shaking for about I hour and felt very chilled. The third morning I felt much better just slightly fatigued.
Td vaccine 7/18/07 urticaria left deltoid 1 week after Td vaccine resolved by 7/30/07 with PO Cimetidine and PO Benadryl.
Hands are cold/hands frozen/knee cold/feet frozen; vascular inflammation; Sweating cold; Fever; Body aches; Throw up; Trembling; Tingling in hands/feet; Numbness in hands; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Trembling), PARAESTHESIA (Tingling in hands/feet), HYPOAESTHESIA (Numbness in hands), PERIPHERAL COLDNESS (Hands are cold/hands frozen/knee cold/feet frozen) and INFLAMMATION (vascular inflammation) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Pneumonia and had done antibody testing.) in July 2021. Concurrent medical conditions included Blood pressure. Concomitant products included METOPROLOL for Blood pressure.    On 31-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Nov-2021, the patient experienced TREMOR (Trembling), PARAESTHESIA (Tingling in hands/feet), HYPOAESTHESIA (Numbness in hands), PYREXIA (Fever), MYALGIA (Body aches) and VOMITING (Throw up). On 03-Nov-2021, the patient experienced PERIPHERAL COLDNESS (Hands are cold/hands frozen/knee cold/feet frozen), INFLAMMATION (vascular inflammation) and COLD SWEAT (Sweating cold). At the time of the report, TREMOR (Trembling), PARAESTHESIA (Tingling in hands/feet), HYPOAESTHESIA (Numbness in hands), PERIPHERAL COLDNESS (Hands are cold/hands frozen/knee cold/feet frozen), INFLAMMATION (vascular inflammation), COLD SWEAT (Sweating cold), PYREXIA (Fever), MYALGIA (Body aches) and VOMITING (Throw up) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Nov-2021, Body temperature: 95.9 (Low) Decreases (95.9).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details were not provided.
On Feb 14, 1999 the pt developed chickenpox. On June 2, 1999 the pt was diag with shingles. The shingles developed on the left mediothoracic area following the chest wall line. The pt maximum temp during herpes zoster was 98.6F. The pt did not have other systemic symptoms. On a scale of one through ten, ten being the worse, the pt was quantified as a 2.
Site: Pain at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Additional Details: pale face
After receiving the flu with Pneumovac shots, approximately 36 hrs I began having severe foot and ankle pain and swelling, was bed ridden, could not walk or stand because of pain and swelling. Had chills, no appetite. Went to ER, gave pain shot started on Neurontin. Had visiting nurse. Still have home PT 2xwk. Still after 1 mo having foot pain and swelling.  Follow up on 12/03/03: "My PCP would have that info."
I experienced heart failure due to Myocarditis and had to be rushed to the hospital. I was administered IV fluids, blood thinner, and medication to help with the inflammation of my heart. I am currently under the care of a Cardiologist and still have symptoms that need to be treated until further notice.
Got Covid 19 after receiving the Moderna Covid 19 vaccine; She got Covid19 and was not able to receive the vaccine; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Got Covid 19 after receiving the Moderna Covid 19 vaccine) and INCOMPLETE COURSE OF VACCINATION (She got Covid19 and was not able to receive the vaccine) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041JC1A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (Chocolate).    On 07-Dec-2021, 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 19 after receiving the Moderna Covid 19 vaccine) and INCOMPLETE COURSE OF VACCINATION (She got Covid19 and was not able to receive the vaccine). The patient was treated with PARACETAMOL (TYLENOL) for COVID-19, at an unspecified dose and frequency and ASPIRIN [ACETYLSALICYLIC ACID] for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (Got Covid 19 after receiving the Moderna Covid 19 vaccine) and INCOMPLETE COURSE OF VACCINATION (She got Covid19 and was not able to receive the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient does not take any concomitant medication  Company comment-This spontaneous case concerns a female patient aged 53 years, with no relevant medical history reported, who experienced the non-serious unexpected AESI of COVID-19 on an unknown date after first dose of mRNA-1273 vaccine. Additionally Incomplete course of vaccination was noted. She had covid before receiving the second dose of vaccine and missed the second dose. She was treated with Tylenol and Aspirin. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient aged 53 years, with no relevant medical history reported, who experienced the non-serious unexpected AESI of COVID-19 on an unknown date after first dose of mRNA-1273 vaccine. Additionally Incomplete course of vaccination was noted. She had covid before receiving the second dose of vaccine and missed the second dose. She was treated with Tylenol and Aspirin. The current pandemic situation of COVID 19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
If I had a minor reaction to the first dose will the second be worse; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (If I had a minor reaction to the first dose will the second be worse) 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 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 VACCINATION COMPLICATION (If I had a minor reaction to the first dose will the second be worse). At the time of the report, VACCINATION COMPLICATION (If I had a minor reaction to the first dose will the second be worse) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   No treatment medications were reported.   Reporter did not allow further contact
Nine days after receiving first Moderna shot I broke out with rash on injection site.   That evening I experienced extreme abdominal, back, underarm pain and bloating.   It was enough to double over and almost pass out.  Pain has continued on still.   I called my gastroenterologist a few days after.  We had a telehealth call.   I?ve had ultrasounds, endoscopys, mris, ct scans, blood work.  No diagnosis as yet.  I have malnutrition and extreme weight loss.
The child developed a generalized, itching rash on 11/2/08 at night.  Vaccines given on 10/31/08.