chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Systemic: Seizure-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: HE SEIZED WHILE WAITING. HE FELL DOWN THE CHAIR AND HIT HIS HEAD. THERE WAS A LACERATION ABOVE HIS RIGHT EYEBROW. HE SAT DOWN ON A CHAIR ABOUT 15 MIN AFTER SEIZING AND PROCEEDED TO VOMIT IN A BAG. CONCERNED, HIS PARENTS DECIDED TO TAKE HIM TO ER.
No symptoms reported; patient received unspecified doses of PEDVAXHIB and ROTATEQ on 20-FEB-2020 that had been improperly stored; This spontaneous report was received from a registered nurse and refers to a 4 month old patient, of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs, drug reactions and allergies was not provided.  On 20-FEB-2020, the patient was vaccinated with improperly stored doses of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # S000352, expiration date on 17-OCT-2021 (dose, route and anatomical location were not provided); and rotavirus vaccine, live, oral, pentavalent(ROTATEQ) orally, lot # R033256, expiration date on 23-JUN-2020, both for prophylaxis. The vaccines were exposed to a temperature of 49.5 degree fahrenheit during 30 minutes. There was a previous temperature excursion of 49.1 degree fahrenheit during 1 hour and 48.6 degree fahrenheit during 1.5 hours. It was reported that digital data logger was involved. No symptoms were reported.
I woke up at 3 am that Sunday with large (quarter sized) blood clots in my urine. I had lower abdominal discomfort.  As the day progressed I began to have lower back pain, cramps and spasms and felt generalized aching. I had burning in my urethra area when voiding. I felt fatigued. I went to urgent care on Sunday when they opened and there they did a urine dipstick and treated me for a UTI. I was started on Ciprofloxacin and phenazopyridien. On Monday I was feeling better. I had very small blood clots in my urine still and mild burning and fatigue. By Tuesday I felt almost completely back to normal with only mild fatigue.
patient c/o mouth dryness, slight headache, and slight upset stomach. Provided water to patient. patient seen by Dr.  Monitored patient for additional 30 minutes. After 30 minute observation patient felt better and no longer had symptoms. Patient was sent home and was advised to eat breakfast. patient verbalized understood and agreed.
Sore throat ,body aches to point of believing dieing, severe fatigue,  headache on 1st dose ,2nd dose severe body aches and fatigue   no fevers
Significant Menstrual period changes. (Typically VERY normal , regular cycle and no other explanations. Not currently sexually active)
pt received pneumovac on 06/15/04 to L Deltoid at 7AM.On 06/16/04 7am pt noted to have redness and swelling to L deltoid.MD notified ordered Topicort bid and Benedryl 25mg po prn.
pt recv vax 8DEC97 & herpes zoster c8 distribution rt arm & axilla 20NOV98;dx shingles (herpes zoster) 25NOV98
Swollen and red at site. Gave 2 tsp BENADRYL.
Pfizer vaccine was administered outside of facility- reported by patient  ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 10/14/2021 NAUSEA AND VOMITING ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 10/14/2021 FEMALE INFLAMMATORY BREAST CANCER, UNSPECIFIED SITE OF RIGHT BREAST
I was short of breath, dizzy, cough, phelgm running down my throat but I didn't feel like I was sick. I took a home COVID-19 test that came back positive. I went to the local Urgent Care, they prescribed me prednisone that did help me to feel better. I have recovered from COVID-19 but now I have different virus,
Patient's daughter feels as though some of the vaccine was not injected into deltoid therefore did not receive adequate dosing.
11/24: sore throat next day, then decreased appetite 48 hours later had temp of 103.3F. 11/29: still having weakness, tired: no energy
This spontaneous report was received from a pharmacy technician refers to a 63-year-old male patient. Concurrent conditions included allergy to drugs such as simvastatin (manufacturer unknown) and cholestyramine. Patient experienced both allergies and unspecified adverse events (AE's) with cholestyramine in the past. On 06-OCT-2012 the patient was vaccinated with PNEUMOVAX 23 (lot # H010661), expiration date unknown) intramuscularly. No concomitant medications were reported. The reporter mentioned a patient received PNEUMOVAX 23 approximately on 06-OCT-2012 and developed fever. It was unknown if this was the 1st dose or 2nd dose of PNEUMOVAX 23. Patient sought medical attention for the event but how he sought it was unknown. The outcome of the reported event was unknown. No further information is available. This is one of the two reports from the same reporter. Additional information has been requested.
fever; sore arm; headache; fatigue; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer sales representative. A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history  and concomitant medications were not reported. The patient had the following symptoms after vaccination: some fever, sore arm, slight mild headache and fatigue. The outcome of the events was unknown.  No follow-up attempts are possible; Information about batch/lot number cannot be obtained. No further information is expected.
Pt did fine for 5 days then begin itching around inject site; became nauseated w/arm edematous, reddened, feverish & the size of a softball; redness extended into the shoulder w/pain;
Tightness in throat, dry mouth and tongue. Evaluated be EMS- Refusal to transport.
I received a Shingles vaccine on Friday, Jan. 27, 2013, at my doctor's office. The next day my hands were both numb as if LANACAINE had been applied. A sharp pain in my right arm began shortly afterwards. The pain got progressively worse and travelled to a sharp pain in the area between my shoulder blades. It got so bad that I went to the emergency room. They sent me home with pain medication, saying it was a reaction to the vaccine. I spent the next 7 days in bed in agony as the pain moved to the outside of my legs and around my rib cage. I could not sleep as I couldn't get comfortable. My only comfort was numerous hot whirlpool baths. I was given Gabapentin and finally started getting some relief. People should be warned about these life altering reactions to the vaccine.
Information has been received from a nurse concerning a 15 year old female patient with no medical history who in July 2007 "about 2 months ago" , was vaccinated IM with a first 0.5ml dose of GARDASIL (lot # 658556/1060U). On 15-AUG-2007, the patient also received the first dose of Hepatitis A vaccine (Lot# AHAVB106BA). It was reported within minutes. There was no concomitant medication. It was reported that the patient passed out about 5 to 10 seconds after vaccination. Unspecified medical attention was sought. She was aroused shortly and had no complications. No laboratory diagnostic studies were performed. That same day, the patient recovered. No product quality complaint was involved. Additional information has been requested.  No further information is available.
patient was concerned that the evening of the vaccination her arm got really red and swollen. She had swelling up to the neck area and said she was in pain. She also had a fever  and never had any reaction to any vaccines before- explained that redness and swelling at injection site are normal for vaccination but will document for them since they were concerned - not all the way recovered yet still some swelling in the neck
Moderna COVID- 19 Vaccine: Approximately five minutes after receiving vaccine reported dizziness, lightheadedness, "weird taste" in mouth,  sensation of throat closing , and throat itching. Diphenhydramine 25 mg orally was administered and vital signs were:  blood pressure- 158/96 mmHg,  pulse - 88 beats per minute, oxygen saturation - 96% on room air. Patient reported throat swelling was worsening. and sensation of throat closing comes and goes. Another diphenhydramine 25 mg dose orally was administered and repeat vital signs were blood pressure - 183/91 mmHg, pulse 98 beats per minute, oxygen saturation 94% on room air. Patient was transported to the emergency department where they arrived in no acute distress. On physical exam no rash, diaphoresis, respiratory distress, or swelling of the uvula or pharynx were noted. After being observed repeat vital signs were blood pressure 125/90 mmHg, pulse 82 beats per minute, repiratory rate 16 breaths per minute, and oxygen saturation 94% on room air. No hypotension, loss of consciousness, or gastrointestinal symptoms developed. Patient diagnosed with allergic reaction, provider stated did not suspect anaphylaxis, prescribed prednisone and diphenhydramine, and patient was discharged to home stable. On follow-up visit with primary care provider the following day, patient noted to have residual throat itchiness and lightheadedness but no other symptoms and is taking prednisone and diphenhydramine as prescribed. Vital signs: blood pressure 110/68 mmHg, pulse 83 beats per minute, temperature 36.8 degrees Celcius, oxygen saturation 97% on room air.
Broke out in rash 5 days ago started on back and spread to stomach; seen immediate care 06/08 and this office 06/09 Dx: shingles.
Pt given immunizations. Mother standing outside doorway holding sibling. After 1st shot pt began to cry and continued to cry throughout the duration of shots. Immediately pt was given to Mom to comfort. Within 5 minutes mom states "Oh my gosh" "His color don't look right!" Something is wrong with my baby!" Mom immediately handed baby to the nurse.
Patient came to vaccination clinic - stated that he needed 2nd dose of Pfizer. Writer verified that he needed Pfizer (he did not have his vaccination card). Writer administered Pfizer vaccine. When entering into WIR today, we found that he had first dose Moderna.
No symptoms o additional adverse effects reported; patient inadvertently received expired first dose in VAQTA immunization series; Information has been received from office manager regarding a 61-years-old patient of unknown gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 08-JUN-2020, the patient was vaccinated with a expired first dose of hepatitis a vaccine, inactivated (VAQTA) for prophylaxis (lot number: S001832 with expiration date 12-MAY-2020) (strength, frequency and anatomical location were not reported) (expired vaccine used).   No symptoms or additional adverse effects reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: S001832; expirationdate: 12-MAY-2020; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Developed a headache and a low grade fever (~99.1-99.3 degrees) 3 days after the shot.  Headache subsided after2-3 days, fever lasted for ~3 days.
Brain fog; This is a spontaneous report from a non-contactable consumer, the patient. A 39-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 04Apr2021 (at the age of 39-year-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient had no known allergies to medications, food, or other products. The patient did not receive any medication within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021, the patient experienced brain fog. Event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event brain fog was recovering at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Got flu shot on 9/25/19, went home & started developing rashes on neck then spread to chest & breasts. 0 difficulty w/breathing, no SOB, no confusion or numbness, no tingling on face/extremities, no fever or chills. Advised to go to ER but pt, she is fine at that time so will Follow up with PCP.
Small, visible muscle twitches on calves and thighs, occasionally  on my back. Happens constantly while sitting or lying down, but not while walking or exercising. Never experienced this prior to vaccine. Not accompanied by pain, visible bruising or discolorations.
Chest pain started 1 day after vaccine, resolved, and then returned one week later. Patient did not report to healthcare provider. Patient returned on 7/7 for 2nd vaccine, reported symptoms after 1st vaccine and 2nd vaccine was NOT given.   Workup started, see below item 19. Pending echo and appt with cardiology.  Advised to strenuous exercise until cleared by cardiology. Advised COVID-19 vaccinations are contraindicated for patient until further notice. Letter provided, waiving him from 2nd vaccine.
suspected COVID-19; suspected COVID-19; Fatigue; Body aches; Headache; chills; The initial case was missing the following minimum criteria: no adverse event. Upon receipt of follow-up information on 04Jan2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable healthcare professional, the patient, from a Pfizer sponsored program IBCC (Inbound Call Center for HCPs).  A 32-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730), intramuscular in the left deltoid on 15Dec2020 at 21:00 (at the age of 32-years-old) as a single dose for COVID-19 immunization. Medical history included ongoing hypertension from 2009 and COVID-19 from 10Jun2020 to an unknown date in 2020.  Ongoing concomitant medications included fosinopril (MANUFACTURER UNKNOWN) taken for hypertension from 2017. The patient did not receive any other vaccines on the same day as the BNT162B2 vaccine.  On 19Dec2020, shy of about 96 hours of getting the vaccine, the patient experienced fatigue, body aches, headache and chills. He did not have any fever. The patient stated that he recovered from the fatigue, body aches, headache and chills by 19Dec2020. The patient was fine from 19Dec2020 until 01Jan2021. On 28Dec2020, the patient had a COVID-19 PCR test that came back negative. On 01Jan2021, the patient suspected that he had COVID-19. He had a fever of 103.1 degrees Fahrenheit, body aches, chills like he was freezing to death, fatigue, diarrhea; however, he did not have nausea or loss of taste or smell. He had swollen lymph nodes, but no sore throat and his oxygen saturation was okay in Jan2021.  He was also having chest pain but it was more like intercoastal pain. He stated that these current symptoms were significantly worse than the ones he had just after getting the vaccine and felt more like the symptoms he had when he had COVID-19 before on 10Jun2020 (positive IgG for COVID-19-tested in 2020). The patient had a COVID nasal swab (PCR) done at an urgent care (physician's office) on 02Jan2020 or 03Jan2020 and was awaiting the results. The clinical outcome of the suspected COVID-19 was not recovered.; Sender's Comments: A causal association between reported suspected COVID-19 cannot be excluded.
Fever; This non-serious case was reported by a physician and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced fever (Verbatim: Fever). The outcome of the fever was not reported.   The reporter considered the fever to be related to Shingrix.     The company considered the fever to be related to Shingrix.   Additional Information: GSK Receipt date: 11-JUL-2023 The reporter did not consent to follow up.
lymphadenitis L axilla. Nausea, dizziness, fatigue.  supportive care at home. Required doctor visit.
patient complains of blurred vision since the day of/after receiving vaccine, recommended seeking medical attention/primary care provider
Woke up with a racing heart and dizzy feeling.  Felt as if i would faint and could not drive   This continued for about four hours. Overall tired feeling the rest of the day.  I am a very healthy male and just had a full physical a few months prior with a heart scan that was normal
Woke up with Severe Facial and neck swelling and red blotchy sore and itchy patches over shoulders and trunk of body
Pt given immun for college entrance; That evening pt exp h/a, inc temp; Sunday 16JUN91 exp nausea, muscle weakness & shakes, lasting 5 min; Also seen for sinus & chest congestion;
Within 2-3 minutes of patient getting Moderna COVID vaccine, patient experienced dizziness, felt room was spinning, felt hot.  Patient observed and encouraged to take deep breaths.  Dizziness did not improve.  Patient said she felt sensation of vaccine running through her body, was increasingly restless.  No hives, itching, trouble swallowing or shortness of breath evident in Vaccine Observation area.  Over concern of patient?s condition devolving, ED called (Fast Track first), and then ED Charge nurse notified. Patient transported to ED in a wheelchair, accompanied by CMA.  Patient seen by ED Provider   Hives became evident in ED.  Solumedrol 125mg IV given and 1000ml NS.  Patient?s condition improved. Discharged from ED at 3:58pm on 1/16/21.
large area of erythema 9x12 w/area in center 3.5 x 6.5 of purple lt gluteus;
This spontaneous case was reported by a patient and describes the occurrence of CHEST PAIN (extreme burning in chest cardio area), VACCINATION SITE MOVEMENT IMPAIRMENT (hands, elbows, fingers, shoulders locked after waking up) and VACCINATION SITE PAIN (deep burning pain in the site of injection (right arm)) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21E and 022C21A) for COVID-19 vaccination. Concurrent medical conditions included Anxiety disorder (No recent change in status such as improvement or worsening) and Legal blindness, (No recent change in status such as improvement or worsening) since 2003. Concomitant products included MIRTAZAPINE, VITAMIN C [ASCORBIC ACID] and VITAMIN D [VITAMIN D NOS] for an unknown indication. On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-May-2021, the patient experienced VACCINATION SITE PAIN (deep burning pain in the site of injection (right arm)). On 08-May-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHEST PAIN (extreme burning in chest cardio area) and VACCINATION SITE MOVEMENT IMPAIRMENT (hands, elbows, fingers, shoulders locked after waking up). The patient was treated with DICLOFENAC for Burning sensation, at an unspecified dose and frequency. At the time of the report, CHEST PAIN (extreme burning in chest cardio area) was resolving, VACCINATION SITE MOVEMENT IMPAIRMENT (hands, elbows, fingers, shoulders locked after waking up) had resolved and VACCINATION SITE PAIN (deep burning pain in the site of injection (right arm)) had not resolved. The patient had no allergies. He never had COVID positive test or diagnosis. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Concomitant product also included BENZODIAZEPINE for anxiety disorder. When patient tried to lift weight to do exercise, burning pain in injection site (right arm) was getting worse. Three days after the 1st dose, after waking up every day he felt that his hands, elbows, fingers, and shoulders were locked, this was happening for about 8 to 9 months. Patient treated his symptoms with Diclofenac, because it helped him with burning symptoms. The outcome of event extreme burning in chest cardio area was reported as residual effects, 95 percent better and the symptoms had been improved.
Unable to walk without assistance. To ER, stayed in hospital 8 days, with 5 plasmapheresis. Then in rehab hospital 28 days and currently in skilled nursing facility for 23 days. Still unable to walk or use hands and arms. Diagnosed with Guillain Barre Syndrome.
15 minutes after receiving vaccines, patient vomited. About an hour later, broke out in an itchy rash all over body. 2 tsp BENADRYL was administered and rash resolved.
No additional adverse event reported; improperly stored administered PROQUAD; This spontaneous report was received from a registered nurse referring to a 4 year-old-patient of unknown gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 24-FEB-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) 0.5 milliliter, lot number T023919, expiration date 09-JAN-2022 (route of administration was not provided) for prophylaxis.  The vaccine underwent a temperature excursion of -5.2 degrees Celsius (°C) for 15 minutes. There were no previous temperature excursions. The call was due to digital data logger.
A very itchy rash has flared on my body 2 days after receiving first dose of Pfizer vaccine.
started within 12 hours and lasted 2 1/2 days - 101 fever, headache, muscle ache, pain, nausea, loss of appetite, insomnia - These also happened with the 1st dose, but not nearly this bad and only lasted 12 hours. The first dose was June 1st 2020
vaccination 11/29 Admitted 12/1 from ED with cellulitis L deltoid, with deep space fluid collection ?phlegmon on CT