chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received from a consumer on 09-Dec-2013. A 83 year old male received influenza USP trivial A-B sub virion vaccine (lot # and expiration date unknown) on 23-Oct-2013. Within 24 hours of vaccination, on 24-Oct-2013, the patient had double vision. The event was ongoing at the time of the report. Documents held by sender: none.   Follow-up information was received on 18 February 2014: It was reported that the patient had additional symptoms. He was often falling down, initially he was sleeping for 15 hours a night but now sleeping only for 8 hours. He had seen his physician which sent him for a "brain scan with dye". The physician told him the scan was negative. He had persistent double division that was frustrating to him. The patient told that his single eye vision was intact, referring to which when he covers one eye, he could see normally. The physician also prescribed a one week course of Ciprofloxacin (Cipro) and some eye drops, neither of which resolved the double vision or the falling down.   Follow up information received from consumer on 25 February 2014: The patient had received a first dose of vaccine intramuscularly in the left arm. It was reported that prior to the vaccine the patient had a good eye exam. The next day after the vaccine the patient had double vision and were sleeping for 15 hours a day. The physician gave him CIPRO as corrective treatment. The patient, then went for 2 brain scans which "showed nothing". The patient had blood tests that "showed nothing". The was now sleeping only 20 hours a day. The dog licked his eyes and his vision improved for a few hours after that. Every time the dog licks his eyes the vision improved for a few hours. On an unspecified date, the patient had recovered from events.
BRUISING AT SITE OF INJECTION, APPROX 1.5 INCH IN DIAMETER
Initial report was received on 28 September 2009 from a health care professional. A 59-year-old male patient with a history of diabetes and high blood pressure had received an injection of FLUZONE SV 2009-2010, lot number U3184AA, (route and site of administration not reported) on 08 September 2009 and an unspecified amount of time later that same day, he developed higher blood sugar levels in the evening. According to the reporter, levels were "higher than usually are; running about 240". The patient had been taking ADACAN, "Metformin: and "Novalog" concomitantly and he had no concurrent illness and no known allergies. At the time of the report, the patient had not reported to their health care provider and their recovery status was unknown. Documents held by sender: None
Patient had a brief event that is likely a brief motor focal seizure in the middle of the day about ten seconds in front  of the class in reading group eyes deviated was briefly unresponsive no family or personal history of seizures  no other trigger
Patient experienced body weakness, headache, soreness, used ibuprofen to relieve symptoms.
Urinary tract infection; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Urinary tract infection) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (Urinary tract infection). At the time of the report, URINARY TRACT INFECTION (Urinary tract infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
(L) leg inflammatory reaction; c/o itching at injection site; occurred within 24 hrs after initial vaccination.
No adverse event; Patient was given a 0.25 mL of Moderna Bivalent Booster dose / Invalid Bivalent Dose Administered; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Patient was given a 0.25 mL of Moderna Bivalent Booster dose / Invalid Bivalent Dose Administered) and NO ADVERSE EVENT (No adverse event) in a 59-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was unknown that patient had any allergies to medication, food and other products. It was unknown patient ever been diagnosed or tested positive for COVID-19. It was patient had any acute illness or any chronic long-standing health conditions at the time of vaccination.     On 15-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 15-Sep-2022, the patient experienced ACCIDENTAL UNDERDOSE (Patient was given a 0.25 mL of Moderna Bivalent Booster dose / Invalid Bivalent Dose Administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Patient was given a 0.25 mL of Moderna Bivalent Booster dose / Invalid Bivalent Dose Administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Patient was given a 0.25 mL of Moderna Bivalent Booster dose / Invalid Bivalent Dose Administered).    No prescriptions, over the counter medications, dietary supplements or herbal medicines being taken at the time of vaccination and or at the time of adverse event.   It was reported that the patient was given a 0.25 mL of Moderna Bivalent Booster dose on 15-Sep-2022. Patient denied having distress at the time of call. Patient denied having to go to the emergency room  or primary care provider. Informed the patient according to Moderna the recommendation was to re vaccinate with full dose in 8 weeks from 15-Sep-2022. However, the patient would like to be re vaccinated.   Treatment medications were not reported.
Discharge Provider: MD  Primary Care Provider : ANP   Procedures to be scheduled by PCP: None   Results/Procedures requiring PCP followup: None   Admission Date: 9/22/2022 Discharge Date: 09/26/2022   Admitting Diagnoses: Community acquired pneumonia of left lower lobe of lung  PRESENTING PROBLEM:  Pneumonia [J18.9] UTI (urinary tract infection) [N39.0] Community acquired pneumonia of left lower lobe of lung [J18.9]   HOSPITAL COURSE: Patient is a 65 y.o. female who presented to hospital emergency department with complaints of cough.  Patient has past medical history of hypertension, hyperlipidemia, chronic obstructive pulmonary disease, depression, type 2 diabetes, GERD, essential tremors, neurogenic bladder, and she is wheelchair bound. Patient states that she has had a cough for approximately 1 week.  Denies fever or chills, but states that it has been productive and she has been experiencing shortness of breath and wheezing.  She presented to the emergency department for further evaluation.  In the emergency department, patient was hypoxic and with desaturation to the 80s.  She required supplemental oxygen at a rate of 2 liters/minute via nasal cannula.  Additionally, she was hypertensive, however, other vital signs were stable.  Complete blood count was unremarkable.  CMP showed hyperglycemia and hypokalemia.  Patient did not have lactic acidosis.  COVID-19 was negative.  Chest x-ray showed increased atelectasis and infiltrate in the left lung base.  Suspect left lower lobe pneumonia.  Patient has been transferred and admitted to Hospital for further evaluation management of left lower lobe pneumonia.   Patient had a film array performed which came back COVID positive.  Since she was not hypoxic she was not offered any COVID specific therapies.  D dimer was elevated so a CT angio was performed showing right sided pulmonary emboli.  Lower extremity dopplers showed left sided proximal and right sided distal DVT.  She was started on lovenox and transitioned to eliquis.  She was not felt to be a candidate for thrombectomy.  Echo showed normal cardiac function.  She completed a 5 day course of antibiotics for pneumonia.  Her urine did grow proteus but this was felt to be colonization, not infection.  On the day of discharge she was doing well and discharged home with home care in stable condition.  She will follow up with her PCP in one week.  It is anticipated she will have life long anticoagulation.
FATIGUE; This spontaneous report received from a patient concerned a male of unspecified age (reporting on himself). The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on an unspecified site in 27-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 31-MAR-2021, the patient experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue. This report was non-serious.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2012, the patient was inoculated with ZOSTAVAX at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. In 2015, the patient was treated by a doctor of osteopathic medicine (D.O.) for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient had suffered significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related.
This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates since 11-FEB-2016, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # L033343, expiration date: 13-SEP-2017; dose and route were not provided). The vaccine underwent a temperature excursion in range between 30 degrees Fahrenheit and 53.2 degrees Fahrenheit for undetermined amount of time, which was detected by a data logger. There was no previous temperature excursion. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
I took shingle shot on Aug-15; by Aug. 27 I had twitch in eyelid and lip also I felt tingle in left breast area. I described tingle like "cell phone vibration, bee buzzing or sensation when arm goes numb". I went to immediate care center, as soon as I said left breast area, doctor sent me to ER for test (thought it could be heart related). However, I did not think this was a heart issue and after 5 hours, doctor there did not find anything wrong. I counted about 25 times the tingle occurred and subsided within few minutes. Doctor saw chigger bit under my arm and suggested it could be shingles. Tingling stopped about Sept. 10. On Nov. 11, I had second shingle shot; I have experienced a few tingles, but  not as often or strong as before. I was wondering if this could be side effect from shot.
Color purple,enylis syncope, lethargic, diminished response to voice, bradycardic, cap refill 4 secs. Laid down with legs raised, ice pack, blow by 02. Rescue called <10 min.
Had stuffy/runny nose. Felt tired. Upset stomach. Headache. Dizzy
1. Cease of cooing/screaming/"talking"  2. Cries no longer a strong vocals; instead it's now a low grunt 3. Constantly has feces in diaper from the pressure of the low grunts  4. Extreme diaper rash; raw skin 5. Loss of fine motor skills 6. Loss of erections 7. No longer able to swallow solid foods.  Now pushes food out with tongue instead of swallowing. 8. Eczema rash all over torso
Information has been received from a physician concerning a 9 year old male who was vaccinated with a dose of varicella virus vaccine live. The physician reported that on 10/26/03, the pt developed chickenpox characterized by about 35 lesions. Unspecified medical attention was sought, but treatment was not required. At the time of this report, the pt was recovering with sequalae (unspecified).  The physician also reported that the pt's two brothers also developed chickenpox after being vaccinated with varicella virus vaccine live (WAES #'s 0311USA00327 & 0311USA02058).  Additional information has been requested.
very high BP,  High resting pulse all day (felt like heart was going to come out of my chest)
Sore arm; Muscle tenderness; Achiness; Tired; This is a spontaneous report from a contactable healthcare professional, the patient. A 43-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3184) via an unspecified route of administration in the left arm on 03Sep2021 at 17:30 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety, borderline anemia and COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19. The patient received unspecified concomitant medications. On 03Sep2021 at 18:00, the patient experienced sore arm, muscle tenderness, achiness and was tired. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events sore arm, muscle tenderness, achiness and tired were resolved on an unknown date in Sep2021.
Portions of the left side of my face became numb and while some of the numbness faded, there is still less sensation in parts of my face and still feels a bit numb
Very tired. The tiredness had been progressing over time, but iron deficiency showed up in test results.  I?m taking iron pills and had one iron infusion.  Researched and found others had this condition after having vaccine.  Iron retested this week. Video Dr appt. next week to determine course of action.
Patient reported tingly tongue and became slightly numb. Later reported burn in throat. Pt also reported mild hot flash about 30 minutes after administration.
Grand Mal sz w/approx 5sec apnea to ER-t105.6 w/BOM; Given Rocephin & septra- ?viral synd;
Pt had an anaphylactic reaction 40min after immz where administered. Pt presented with hives all over body and was in moderate resp distress. Pt was immediately give Epi Jr and shortly after symptoms began to subside, 911 was called and pt was transported to the hospital for further care.
Patient had overall muscle aches and chills for 3 days after the vaccination. No fever.
101.8, at 5 am, took ibuprofen 400 mg, fever rose to 103.5 by 11:00, took acetaminophen 1000 mg. Continued Fever rise at  4 pm 104.2 with onset of controlled diarrhea. Took ibuprofen 800 mg, 10 mg cetirizine and sat outside in winter weather for 10 minutes. Fever reduced to 102 remainder of the afternoon and evening with another dose of acetaminophen 1000 mg, followed by 400 mg ibuprofen at bedtime. No fever the following morning, persistent loose stools and headache relieved by ibuprofen 400 mg TID. Headache and intermittent loose stool still present on 1/30/21
Flublock Quadrivalent was administered to a 13 years old female patient/no AE; Initial information received on 07-Oct-2019 regarding an unsolicited valid non-serious case received from a physician.  This case was linked to 2019SA279974 (same reporter).  This case involves a 13 years old female patient who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Patient was not on any concomitant therapy.   On 04-Oct-2019, the patient received a 0.5 ml single dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1929 via intramuscular route in the left deltoid.   It was of actual medication error case due to Inappropriate age at vaccine administration (Product administered to patient of inappropriate age).  It was unknown whether any adverse event was noted or not.  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.
My period came a week early, even though Im on birth control.; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 03May2021 at 13:00 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included severe anxiety, autism, post-traumatic stress disorder (PTSD), premenstrual dysphoric disorder (PMDD) and allergy to scallops. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included medication for birth control (unspecified) from unknown date and unknown if ongoing, desvenlafaxine succinate monohydrate (reported as generic: PRISTIQ) and drospirenone, ethinylestradiol betadex clathrate (reported as generic: YAZ), both for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 03May2021 at 18:00, the patients period came a week early, even though she was on birth control. The event did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event period came a week early, even though she was on birth control was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.
Patient came to the vaccine clinic today and inadvertently received a 22 mcg dose of the Pfizer COVID-19 vaccine. I spoke to dad via phone who did not report any unusual symptoms during the 15 min observation period. I counseled them to monitor patient for the next 7 days and report any unusual symptoms to her pediatrician or if more serious to go to the ED.
Received the shot in 2010 - in Aug. 2012 I came down with shingles - and still have some effects and pain in December-the shot did not prevent the shingles or shorted duration. I feel the shot is overpriced as it is not that effective.
Information has been received, for the Pregnancy Registry for GARDASIL, from a nurse concerning a 24 year old female who on 05-OCT-2007 was vaccinated intramuscularly with her first dose of GARDASIL. Subsequently, the patient found out she was pregnant (LMP = 15-SEP-2007). According to the reporter, it is believed that the patient was about 5 to 8 days pregnant at the time of vaccination. The patient sought unspecified medical attention. No further information was provided. Follow-up information was received on 04-NOV-2008 via phone call from a person of a doctor's office indicating that the patient was given the vaccine elsewhere and she came in for one prenatal visit and returned stating she had terminated the pregnancy elsewhere. The reporter could not confirm the gestational age at the time of the pregnancy termination. The patient later moved to another state and they have no further information to provide. Upon internal review, pregnancy termination was determined to be an other important medical event. Additional information is not expected.
This spontaneous report was received from a healthcare worker and refers to a currently 4 year old patient of unknown gender. The patient's concurrent conditions, past medical history were not reported. On an unspecified date, the patient was vaccinated with an improperly stored M-M-R II (lot # K024035, expiry date 26-NOV-2016, dose, strength, vaccination site, dose number unspecified). Concomitant medications were not provided. No adverse effects were reported. Product quality complaint (PQC) was not reported. On 26-JAN-2016, a phone call was placed to the physician. The physician was unavailable  at the time of call. The phone call was transferred to the Certified Medical Assistant (CMA). The C.M.A was unable to place specific lot numbers for each of the reported vaccines that experienced a temperature excursion; M-M-R II, ROTATEQ and VAQTA, with the information already supplied for patient identifiers, date of birth and date of vaccination, at this time. The C.M.A will need to review the records. This is one of the several reports received from the same reporter. Additional information has been requested.
Red, Swollen, Hot, Itchy Injection Site Reaction- lasted about a week  Swollen eyelid area, hives around eyes, watering and itchy eyes- had these eye problems which started about a month upon receiving vaccine and are still ongoing (have never had these symptoms prior to the CVD vaccine)
compliant of back pain and stomach problems occurring 8/23, resolved today.  came in today with injection site irritation and welps around injection site
Immediately after receiving injection experience intense pain at injection site, continuing.  Injection was given immediately below shoulder bone in area of Deltoid muscle.  Saw doctor twice and received steroid injections for the pain which continues but is getting better.