chrisvoncsefalvay/vaers-outcomes huggingface dataset:
migraine with aura/Headache/migraine/numbness and tingle in her mouth and tongue; Her taste bud feels off; This spontaneous case was reported by a patient and describes the occurrence of MIGRAINE WITH AURA (migraine with aura/Headache/migraine/numbness and tingle in her mouth and tongue) and AGEUSIA (Her taste bud feels off) in a 70-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8058856) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 in November 2022. Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine (1st dose 077M20A) on 27-Jan-2021, Moderna COVID-19 vaccine (2nd dose 001A21A) on 24-Feb-2021 and Moderna COVID-19 vaccine (3rd dose 033F21A) on 18-Oct-2021. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 vaccine, Moderna COVID-19 vaccine and Moderna COVID-19 vaccine.    On 21-Oct-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In 2023, the patient experienced MIGRAINE WITH AURA (migraine with aura/Headache/migraine/numbness and tingle in her mouth and tongue) and AGEUSIA (Her taste bud feels off). At the time of the report, MIGRAINE WITH AURA (migraine with aura/Headache/migraine/numbness and tingle in her mouth and tongue) and AGEUSIA (Her taste bud feels off) had not resolved.            Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medication was reported.  Caller stated they got the 2023 COVID-19 vaccine she had very strange symptoms. No treatment information was reported.  Company Comment: This is a Spontaneous case reported by a patient, concerning a 70-year-old female patient, with no relevant medical history, who experienced the unexpected and non-serious AESI of Ageusia, which occurred within the first 2 weeks after SPIKEVAX 2023-2024 vaccine, administered as fourth dose within COVID-19 vaccination schedule. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event had not resolved. The benefit-risk relationship of SPIKEVAX 2023-2024 vaccine is not affected by this report.
On the second day of the vaccine, I experienced a severe headache, muscle pain in both of my legs, and a mild fever, on Wednesday I felt better, but on thursday I began to have a mild headache with shooting pain to the back of my head near my right ear and it has been painful ever since.
Dizziness, Headache, Fever, NauseaVomiting, chills; sweating; shortness of breath; dry heaves  Narrative:
Warm erythematous non-pruritic 38mm x 63mm patch on  anteriolateral aspect of left deltoid. First noticed this morning (1/22/21)
Tested positive for covid-19; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media on 02-Dec-2020.  This case involves a patient of unknown demographics who got tested positive for coronavirus disease 2019 (COVID-19) after patient received Influenza vaccine.  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On an unknown date, the patients received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via unknown route in unknown administration site as prophylactic vaccination.  On an unknown date, the patient got tested positive for COVID-19 (COVID-19) after got influenza vaccine.    It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown, at the time of reporting.  There will be no information available on the batch number for this case.
This spontaneous report as received from a physician refers to a 6 month old female patient. On 05-MAR-2013 the patient was vaccinated with her first dose of ROTATEQ (oral, Lot#, dose/frequency and duration were unspecified). On 08-MAR-2013, patient suffered intussusception. Patient was seen at Hospital for an unspecified length of time. Therapy with ROTATEQ, oral was discontinued. The patient was now recovered. The causality between intussusception to ROTATEQ, Oral was unknown. Additional information has been requested.
This spontaneous report as received from a 74 year old female patient reporting on herself. The patient's concurrent conditions included arthritis, osteoporosis and drug reactions/allergy to aspirin, KEFLEX, DILANTIN, sulfa and TERRAMYCIN. Historical drug included aspirin, KEFLEX, DILANTIN, sulfa and TERRAMYCIN. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX in the left arm (dose, route, lot number and expiration date were not provided). Concomitant therapy included unspecified thyroid and cholesterol medications. On an unknown date, the patient experienced loss of appetite, nausea, and intermittent fever. The patient also reported that she experienced erythema and pain in her extremities reported as "redness underneath top layer of her skin and red shiny, painful sores on her arms and legs". The patient reported that the pharmacist provided Nortriptyline as a treatment for the adverse events, however she ceased the treatment since nortriptyline made her "sick". At the time of the report, the outcome of loss of appetite, nausea, pyrexia, intermittent fever, pain in extremities and erythema was reported as not recovered/not resolved. The primary reported considered loss of appetite, nausea, pyrexia, intermittent fever, pain in extremities and erythema as other important medical events as these events required intervention to prevent serious criteria. The patient sought medical attention. No product quality complaint was involved. Additional information has been requested.
I developed a rash on my arm, I was told it was a normal reaction and the will clear off in a couple of weeks, but I still have the rash as of today 6/9/2021.
PAIN LOWER BACK PULSATING TO LEGS; MUSCLES FEEL WEAK CONTRIBUTED TO BACK ISSUES; SOMETHING LIKE SPASMS; LEGS AND THIGHS FEEL LIKE THEY PULSATE WHEN STOOD UP; DIFFICULT TO WALK/PAINFUL TO WALK; DIFFICULTY TO KEEP BALANCE; MUSCLE WEAKNESS CONTRIBUTING TO MORE NERVE CONDITIONS; PAIN IN TOES/PAIN IN ARMS AND LEGS; PAIN IN BICEP OF ARMS WHICH FEELS LIKE IT'S PULSATING AND BOUNCING AROUND; NERVE PAIN LEGS AND ARMS (NERVE PAIN GETTING WORSE AND SPREADING); This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: cholesterol, penicillin allergy, alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. Concomitant medications included rosuvastatin for cholesterol. On 16-APR-2021, the patient experienced nerve pain legs and arms (nerve pain getting worse and spreading). On an unspecified date, the patient experienced pain lower back pulsating to legs, muscles feel weak contributed to back issues, something like spasms, legs and thighs feel like they pulsate when stood up, difficult to walk/painful to walk, difficulty to keep balance, muscle weakness contributing to more nerve conditions, pain in toes/pain in arms and legs, and pain in bicep of arms which feels like it's pulsating and bouncing around. Treatment medications (dates unspecified) included: paracetamol, and gabapentin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nerve pain legs and arms (nerve pain getting worse and spreading), pain in toes/pain in arms and legs, pain in bicep of arms which feels like it's pulsating and bouncing around, pain lower back pulsating to legs, muscle weakness contributing to more nerve conditions, muscles feel weak contributed to back issues, something like spasms, legs and thighs feel like they pulsate when stood up, difficult to walk/painful to walk, and difficulty to keep balance. This report was non-serious.
Every time I get a glutenated feeling.   Migraine light sensitivity and noise.   Sets off my asthma.    Benadryl calms it.   Usually it's a flush feeling in the arm.  The nurse Saud that not normal so I am reporting the cumulative.    It could be I am sensitive or allergic to a component but it passes within 24hrs and Benadryl if it gets bad enough.
10/15/15 Pt had syncopal episode approx 3 min after vaccine administered. Pt became hypotensive, 70/50; 2 min later 80/60. Pulse decreased 56; 2 min later P 80. Pulse Ox. 99. Pt was lethargic and weak for 5-10 min.
Pts mother reported diarrhea, went to a hospital, admitted by 2-4 days, was discharged, also fussy. DC Summary for DOS 08/04-08/07/2006 DC DX: Acute Gastroenteritis with dehydration. Metabolic acidosis. Admitted with c/o diarrhea, cranky and stomach bloating. Sick for past 5 days with diarrhea and fever. No HX of bloody stool.  PE: temp 98.3, Heart Rate 144 and respirations 30, remainder of exam WNL. RX with IV fluids and Pedialyte. DC home. Per 60 day follow up: He is no longer a patient of the physician who reported him.
Initial report received on 10 September 2012 from the Investigator participating in a post-marketing study under the reference number M5A16 which involved a case of misuse (inappropriate schedule of vaccine administered). A case of pertussis disease in a two-year old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3657AA received on 22 September 2010, lot number C3793AA received on 19 November 2010 and lot number C4115AA received on 27 January 2012 (routes and sites of administration not reported). The subject developed a paroxysmal cough without a whoop on 18 July 2012, approximately five months after the last dose. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing for PCR was not reported. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 02 August 2012 for five days. The subject was not hospitalized. At the time of final contact on 07 August 2012, the subject's cough was still persisting. The duration of the cough was reported at that time 20 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Hospitalized;  COVID-19 positive (after being fully vaccinated - him and wife)      Admission Date: 8/27/2021 Admitting Diagnoses: Principal Problem:   ESRD needing dialysis (HCC)   COVID-19 infection Active Problems:   Aortic stenosis   CAD (coronary artery disease)   S/P 5 v CABG 1998   Kidney Transplant   Hypertension   Dyslipidemia   Hypothyroidism   Chronic gout without tophus  Details of Hospital Stay PRESENTING PROBLEM: ESRD needing dialysis (HCC)   HOSPITAL COURSE: 8-year-old male with end-stage renal disease on hemodialysis, renal transplant.  Patient tested positive for COVID on 08/26 and was unable to dialyze on that day because his schedule had to be switch from T THS to MWF because of his COVID.  The next day, he also missed his dialysis because of diarrhea from COVID.  He therefore presented to the emergency department to have dialysis done.  He did not have any hypoxia on admission.  He underwent dialysis today and was uneventful.  Patient was discharged home.  Patient was advised that he is on day 8 of his COVID illness and is therefore still at risk of developing COVID pneumonia and hypoxia.  Patient is the primary caretaker of his wife who has dementia and also has COVID.  Patient was advised to make arrangements to care for his wife in case he needs to be admitted for COVID pneumonia.  He was advised to watch out for shortness of breath.  Dialysis nurse will checked his oxygen saturation on Monday, 8/30, during his dialysis session.
9 yo child given an adolescent dose of Pfizer. NO adverse reaction after 30 minutes. Will call mothet otmorrow to see how child is.
Left leg red, swollen to size of softball, warm to touch. Patient has no complaint of pain. No problems with walking on leg. Advised to apply warm cloth to area and give Tylenol as needed for fever. Advised to call doctor if any other problems arise.
Within less than 12 hours of receiving my vaccine, I started feeling tired and had chills, and a headache that lasted on and off for about 24 -30 hours. I took some acetaminophen for the headache and slept off the side effects.
Headache, Fever, RespDepression, Diarrhea, chills, sob (went to ED to be seen) Narrative:
Patient complained of having low blood pressure and feeling "down". Patients legs were elevated. Patient was given water & Power Ade. Medics were notified. Medics arrived and vitals were taken. Her initial blood pressure was 97/36, heart rate of 56, oxygen saturation on room air was 97. Her blood sugar was 125.  Five minutes later  after consuming both the Power Ade and water patient reported she felt better. Vitals were rechecked. Her blood pressure was 125/75, heart rate 74, oxygen saturation was 98 on room air. Patient advised to stay hydrated and to eat. She verbalized understanding. Patient left without further incident in stable condition.
Follow-up information from the physician's office provided lab results and event outcome (pt recovered).  Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a nurse regarding an 8 year old male pt who experienced a fever of 100.7 deg. F. and a sore throat.  The pt received a dose on 12/20/03.  The pt had no relevant medical history. Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/20/03.  Dose regimen was 0.5mL (IN).  Pt was not taking concomitant therapy.  On 12/21/03, 36 hours post-immunization, the child experienced a fever of 100.7 deg. F. and a sore throat.  On 12/22/03, he was seen by the physician.  Results of a "rapid strep test" and throat culture were negative.  On 12/24/03, the mother was called with the lab results.  The nurse reported that the child had no further problems.
black bubbles; shingles; red spots begin to surface on the thigh/Just bigger red spots; red spot became bigger I thought it was rash, pain persists; red spots begin to surface on the thigh; Back pain; Thigh pain; This is a spontaneous report from a contactable consumer or other non hcp (patient) and physician. A 28-year-old male patient received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 15May2021 at 08:30 AM (at the age of 28-year-old) as dose 2, single for COVID-19 immunization. The patient medical history included known allergies: possibly lutein from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 17Apr2021 at 11:00 AM (at the age of 28-year-old) as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccine in four weeks. The patient did not receive any other medications in two weeks. Patient was not diagnosed with COVID prior vaccination. Patient had not been COVID tested post vaccination. The patient experienced back pain, thigh pain on an unspecified date in 2021; red spots begin to surface on the thigh on 16May2021; red spot became bigger I thought it was rash, pain persists on 17May2021; red spots begin to surface on the thigh/just bigger red spots on 18May2021; black bubbles, shingles on 20May2021. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Adverse event: On 13May2021 (3 Weeks after first covid vaccine shot), I started to feel skin pain on the area above right kneecap. Then I felt nerve pain on the same side of leg. 14May2021 I couldn't sit down as I felt occasional lumbar pain. I even went to Orthopaedics and they said no trouble found. Skin pain spreaded through the whole body. 15May2021 I had second shot of Pfizer, still back pain and thigh pain. 16May2021 I saw red spots begin to surface on the thigh. 17May2021red spot became bigger I thought it was rash, pain persists. 18May2021the red spots looks out of control, I scheduled the next available appointment for primary care (2days later) 19May2021Just bigger red spots every time I take off my pants. 20May2021 black bubbles appeared in the morning, and I got to finally go to appointment at noon, diagnosed as shingles. The patient received unspecified treatment for the event shingles. Outcome of all the events was recovering.  Follow-up: Follow-up attempts completed. No further information expected.
Pfizer Monovalent vaccine given. Clinic thought we would stop giving these when the new orders came out and not right away on September 1st.  Only one given inadvertently.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Other-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Vomiting-Mild, Additional Details: Patient was responsive after the shot. Collapse during 15 mins wait. Unresponsive and brother claimed patient has no allergic reaction. Gave epipen on right thigh, patient became responsive right away. Call 911.
Received first shot and about half went in her as the syringe was not properly attached; Received first shot and about half went in her as the syringe was not properly attached; A spontaneous report was received from a consumer, concerning herself, a female patient of unspecified age, who received first shot of Moderna's COVID-19 vaccine and about half went in her as the syringe was not properly attached.  There was no medical history provided. There were no concomitant medications provided.  On an unspecified date, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (lot number unknown) for prophylaxis of COVID-19 infection.   On an unspecified date, the patient received her first shot of vaccine and as the syringe was not properly attached, only about half of the vaccine went in her. Patient also stated that she was not sure how much of vaccine had went into her. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome for the event received first shot and about half went in her as the syringe was not properly attached was considered to be resolved on an unspecified date.; Reporter's Comments: This concerns a female patient of unknown age who received the first of two planned doses of mRNA-1273 (lot number unknown) for prophylaxis of COVID-19 infection and reported the syringe was not properly attached and only about half of the vaccine went in her. There were no reported adverse events of the syringe was not properly attached and only about half of the vaccine went in her.
#1 - rash on rt arm around injection site - lasted 3 days.  Started 7 days from injection #2 - Fever (101), tired, joint aches, rash on rt arm around injection site - all following day
Began with headache, turned into a migraine, body aches, stick neck, sore throat, pain in chest and ears, very tired, lasted 4+ days.
Patient received full 0.5ml dose, not 0.25ml. Pt is not immunocompromised.
Started with fatigue, at 3:45 acetaminophen was given in childrens 80mg tablet by mouth. at 6:15 child was crying with a severe headache, and fever of 103.2. Went to urgent care and saw physician at 6:45pm. Ibuprofen suspension by mouth was administered fever was 103.1. Child complained of nausea, dizziness, mid abdominal pain, pain and red swollen lump appox 1.5 and mild dehydration inches in diameter at injection site. at 7:26pm fever was 102.9 Referred to ER.  During ride to ER child started vomiting. Arrived at ER at 8:30, dizziness, disorientation, vomiting, listness, fatigue, pain in arm, severe headache, dehydration persisted. Child was rehysrated, Tylenol suppositories, Toradol, anti nausea medication.
had pain in the back of my shoulder; had paint in the back of my neck; stiffness; arm pain; Headache; soreness/I have pain where i received the injection.; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A female patient of an unspecified age received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number FA7485, expiration date unspecified), via an unspecified route of administration on 02Aug2021 DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took tylenol and experienced nausea. On 02Aug2021, the patient experienced arm pain, headache along with pain/soreness at the injection site with stiffness. On 03Aug2021, the patient developed pain in the back of shoulder and neck. The patient was treated for the events with Excedrin but it did not work. The outcome of the events was reported as unknown at the time of report.  No follow-up attempts are possible. No further information is expected.
No other issues or concerns noted.; Nurse calling to report that a patient received an expired dose of PMEUMOVAX 23.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, drug reaction or allergies, pertinent medical history and concomitant therapies were not reported.     On 01-FEB-2023, the patient received an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), lot # U026796, expiration date 28-JAN-2023, for prophylaxis (dose and route were not reported) (expired product administered). Nurse did not know if the product had a previous temperature excursion. No other issues or concerns noted.
Inflammation , night sweats, back pain, fever, fainting, lungs filled with fluid, fluid around heart
Headache ,whole body ache , back pain ,low grade temperature 99.2 since yesterday
Chills (no fever) within 24 hours of the Janssen vaccination, lethargic, no appetite. Very dizzy and lightheaded on day 5 and day 6 after the Janssen vaccination with continued lethargy and loss of appetite  for approximately 3 weeks. Heavy nosebleed in left side of nostril with large blood clots for 1.5 hours approximately 3 weeks after the Janssen vaccination
After patient received vaccines, went to the waiting room to wait for 15 minutes while guardian made follow-up appointment and she fainted.  Patient was pale, drank some water, and gave patient some crackers.  Checked patient's blood pressure at 94/60.  Patient stated she was feeling dizzy when she fainted.  Patient's color came back and she stated she felt better.
Present to healthcare system on 5-19-07 with Abdominal pain. Pt had a bloody mucus stool during ER visit. Barium enema study was positive for intussusception-Was Reduced and observed overnight.  06/11/2007 MR received for o/n hospitalization 5/19-20/2007 for Intussusception. Infant developed intermittant acute abdominal pain on 5/18/2007.  Pain continued and on 5/19/07 infant passed a large bloody, mucusy, stool in the ED. Intussusception which was reduced per radiologist by air contrast Barium Enema. DX:  Intussusception-reduced.
Redness and swelling in Right upper arm area since she received the immunization. Instructed to use Benadryl and cold packs. Follow up if symptoms worsen.