chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Systemic: Seizure-Medium, Additional Details: Patient had seizure shortly after vaccine, seizure lasted for approximately 30 seconds, paramedics were called and took patient to the hospital.
Patient felt dizzy/faint after receiving first dose of Pfizer covid vaccine. Pharmacist went out to her, she took a few sips of water and vomited into the garbage from the pharmacy. She didn't appear to be having an allergic reaction or signs of anaphylaxis, so no epipen or Benadryl was administered. She stated she never had a reaction to a vaccine before. She felt weak so I stayed with her, asked he if she wanted an ambulance.Patient refuse medical treatment and she just wanted me to call her sister which I did. Patient started to feel better as we waited for her sister.
7/12/21 er @ hospital: 69 y.o. female who presents with increasing shortness of breath.  Patient reports increasing shortness of breath for the past 3 days.  She denies any runny nose or sinus congestion.  Patient does report a dry cough but states it is no different from her typical COPD cough.  Patient denies any chest pain or palpitations.  However, patient on bedside monitor is in AFib with RVR.  Patient does voice a history of intermittent atrial fibrillation.  Patient denies any current palpitations, chest pain, or edema.   Of note, patient reports she sustained a stroke approximately 6 weeks ago.  Patient reports she experienced left-sided weakness.  She reports that left-sided weakness has since returned to completely normal.  She did not seek medical care for her stroke at the time of the stroke.  (pt is a retired nurse)  Transferred to another healthcare facility where she remains admitted as of 7/13/21
neck tightness; This is a spontaneous report from a contactable Pharmacist (patient) via Medical  Information Team. A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration on 13Feb2021 as first dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient experienced neck tightness, denied any issues with breathing. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021283574 Same pt/drug, different dose
26 years old pregnant patient recieved Fluzone Quadrivalent, no AE; while needle in the patients arm, pushed the plunger, and liquid leaked where the needle meets the syringe, no AE; vaccine leaked while injecting, patient received partial dose, no AE; Initial information received on 24-Sep-2019 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves a 26 years old female patient who was pregnant and received partial dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot UJ212AB, Exp. Date 30-Jun-2020) via intramuscular route in the left deltoid, on 24-Sep-2019 .  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The patient was exposed to INFLUENZA QUADRIVAL A-B VACCINE at 8 weeks of pregnancy, during first pregnancy trimester for INFLUENZA QUADRIVAL A-B VACCINE. The date of last menstrual period was reported as 29-Jul-2019. The estimated due date is 13-May-2020. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to vaccine underdose.  It was a case of vaccine exposure during pregnancy, syringe leak.  It was reported that vaccine leaked while injecting the patient with pre-filled 0.5 mL syringe. When asked how nurse connected the needle to syringe, she stated she twisted needle. She stated it appeared normal until pushing the plunger while needle in patients arm. Patient received partial dose, caller stated liquid leaking from multiple areas around syringe where needle meets syringe.  At the time of reporting, no adverse reactions were reported.  Additionally, at time of reporting, the outcome of the pregnancy was unknown.  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.  List of documents held by sender: none.
Local redness, pain, swelling began after ~12 hours. Flu-like symptoms (serious myalgia, fatigue, 101-degree fever, chills) began ~24 hours after injection, lasted 48 hours, resolved completely.
Initial report received on 11 September 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a 3-year-old male subject was identified by the investigator based on review of data form the Electronic Disease Surveillance (EDS) electronic database. The subject had received 3 doses of PENTACEL (lot numbers not reported) on 07 January 2009, 04 March 2009 and 12 May 2009, and one dose of TRIPEDIA, lot number U2470BA on 22 February 2010 (routes and sites of administration not reported). The subject developed cough and cold-like symptoms on 26 July 2012, approximately 29 months after the last dose. On 28 July 2012, the subject developed a paroxysmal cough with a whoop. The subject also experienced apnea and sleep disturbance. Laboratory testing included positive PCR on 29 July 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 31 July 2012 for five days. The subject was not hospitalized. At the time of final contact on 07 September 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 43 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
According to parents, patient's DOB is 8/20/2010 making their child 11. The child received the adult/adolescent dose of Pfizer due to the parents stating the incorrect birth date so child could be vaccinated, since pediatric doses were not available at the time. The child reported no adverse events but this is being reported due to the parents misrepresenting his age.
More than 35 days after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (More than 35 days after 1st dose) 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 19-Mar-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 INTENTIONAL PRODUCT USE ISSUE (More than 35 days after 1st dose). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (More than 35 days after 1st dose) outcome was unknown.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  It was reported that due to surgery the patient missed the second dosage. No concomitant or treatment medication has been reported.
Information has been received from a nurse concerning a patient who was vaccinated with a dose of Pneumovax 23 (lot #654593/0358F). Subsequently, the patient developed redness, swelling, and pain at the injection site. The patient's outcome was unknown. A review of the Laboratory Information Management System data revealed that the lot conformed to all required testing at the time of product release. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
The patient came in for a Pfizer Covid Booster, but the pharmacy gave Flublok instead. However, the patient hasn't gotten Flu shot for the year 2022. So the patient got both shots today 11-4-22 FluBlok and Pfizer Bivalent Booster. No reaction has been seen yet.
I tested positive for COVID 19 on 10/06/2022. My symptoms were a slightly scratchy throat, a very runny nose, a fever over 100 degrees for about 16 hours, a headache, an ear infection, and I lost my sense of smell after a few days of having the previously listed symptoms.
thinks the vaccine has been her "fountain of youth."; month after second dose, hair is 3 feet long; month after second dose, hair is black; Moderna covid-19 vaccine the first in JUN/2021 and the second in DEC/2021; This spontaneous case was reported by a consumer and describes the occurrence of HAIR GROWTH ABNORMAL (month after second dose, hair is 3 feet long), HAIR COLOUR CHANGES (month after second dose, hair is black), THERAPEUTIC RESPONSE UNEXPECTED (thinks the vaccine has been her "fountain of youth.") and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna covid-19 vaccine the first in JUN/2021 and the second in DEC/2021) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In December 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In December 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna covid-19 vaccine the first in JUN/2021 and the second in DEC/2021). In January 2022, the patient experienced HAIR GROWTH ABNORMAL (month after second dose, hair is 3 feet long) and HAIR COLOUR CHANGES (month after second dose, hair is black). On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (thinks the vaccine has been her "fountain of youth."). In December 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna covid-19 vaccine the first in JUN/2021 and the second in DEC/2021) had resolved. At the time of the report, HAIR GROWTH ABNORMAL (month after second dose, hair is 3 feet long), HAIR COLOUR CHANGES (month after second dose, hair is black) and THERAPEUTIC RESPONSE UNEXPECTED (thinks the vaccine has been her "fountain of youth.") outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2022-473560 (Patient Link).
Case number PHEH2015US001680, is an initial spontaneous report from a pharmacist received on 20 Jan 2015. This report refers to an 18-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was administered only MenCYW-135 liquid component of MENVEO (batch number: X14044) without being reconstituted with MenA intramuscularly on 12 Jan 2015. No adverse event was reported following the administration error (inappropriate preparation of medication).
Hive that is very itchy about 4 inches in diameter, hot at the site, itchy all over body. Upper posterior arm.
p/vax pt began having chills, fever, flushed warm to touch, (did not check temp) had taken APAP;site of pneumovax inj began to swell, redness & very painful from shoulder to elbow;heart racing & chest pain;
pt recv vax by noon, first itchy, watery eyes, congestion & cough;felt miserable in afternoon;
This spontaneous case reported by a patient, describes the occurrence of cough (coughing starting-up), diarrhea, injection site pain (sore arm) and fatigue (tiredness) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Mar 4, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced cough (coughing starting-up), diarrhea, injection site pain (sore arm) and fatigue  (tiredness). At the time of the report, cough (coughing starting-up), diarrhea, injection site pain (sore arm) and fatigue (tiredness) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information reported.
No idea if it is related, but the doctor said to report it just in case. I got my booster on 11/27 and got a severe reaction to something on 12/7. I got hives everywhere, extreme itching
Chest pain starting 1 week after Moderna booster dose. The quality is a ?pressure? at baseline that becomes more severe and sharp when he lays flat. At baseline it is 3/10. No other associated symptoms. Initial diagnostic evaluation for this issue to included an EKG, CXR, troponin, ESR, CRP, TSH, and a battery of rheumatologic labs and has revealed an enlarged cardiac silhouette on CXR and an elevated CRP. All other studies have been normal. Cardiology visit on 2-19-2022 revealed trace pericardial effusion, which may be a normal benign finding, otherwise normal. EF 65%. The EKG demonstrated sinus tachycardia to 102bpm with diffuse PR segment depression but was otherwise normal. Cardiac physical exam demonstrated a normal S1 and S2 with a friction rub suggestive of pericarditis. Lab abnormalities (elevated CRP), symptoms, exam, and EKG consistent with acute pericarditis in temporal association to Moderna booster dose.
pt recvd vax & exp convuls & stopped breathing; grand mal sz attributed to DPT; pt hospitlaized 3-5 days & released on Phenobarbital; dx w/learning disability; pt is mentally regressed (slurred speech & 10 word vocabulary);
PATIENT WAS TIRED AND SORE AT SIGHT OF SHOT A COUPLE OF DAYS AFTER SHOT HE WAS DEHYDRATED AND HAD LOW BLOOD PRESSURE SO WEAK HE COULDN'T STAND NOT LIKE HIM AT ALL HE USUALLY IS VERY OUTGOING.  CALLED 911 RUSHED TO HOSPITAL. ALL TESTS WERE TAKEN EVERYTHING IS NEGATIVE. SENT TO A REHAB FACILITY AT ADMISSIONS HAD TROULE BREATHING CALLED 911 BACK TO HOSPITAL. ADMITTED INTO ICU SAID HE HAS SWELLING ON THE BRAIN RAN EVERY TEST POSSIBLE NEGATIVE FOR EVERYTHING. DOCTOR HAS TREATED HIM FOR ANYTHING HE THINKS COULD BE WRONG. DISCHARGED TO A LONG TERM ACUTE CARE TO SEE IF ANY IMPROVEMENT FOR 25 DAYS. NO DIAGNOSIS OF WHY THIS IS HAPPENING. ONLY THING THAT MAKES SENSE IS THAT EFFECTS OF VACCINE.
Vaginal bleeding 6 hours after vaccination. The last menstruation period ended on 5/22/21. Taking birth control which makes period very regular. Was not projected to get my next period until 6/15/21.
no additional AE; patient was given a dose of GARDASIL 9 after the dose was stored improperly; This spontaneous report was received from a medical assistance and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported.  On 06-MAY-2023, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, "0.5ml/ series", (lot #W004648, expiration date: 06-OCT-2024 and lot# 1775827 with expiration date 27-JUN-2023; it was not reported which one of lot# was administered to the patient) (strength, dose#, route and anatomical site of vaccination were not provided) for prophylaxis (product storage error). On 2nd May of unknown year, for suspect vaccines, the temperature excursion was 34 Fahrenheit for 7 hours, and on 6th May on an unknown year was 33.72 Fahrenheit for 6 hours. It was not reported if the suspect vaccines underwent previous temperature excursion. No additional adverse event (AE) was reported (no adverse event).
Symptoms: patient complained of feeling like her "throat was closing up" 20 minutes after  injection patient started coughing and gagging in office, vital signs taken and reported to provider who advise patient to high point of care. Patient wheelchaired to emergency department. Patient was given methylPREDNISolone sod succ (Solu-MEDROL) Inj 125 mg ,diphenhydrAMINE (BENADRYL) 50mg/mL Inj 50 mg ONCE , famotidine (PEPCID) Inj 20 mg, monitored with normal vital signs and sent home with  epiNEPHrine (EPIPEN 2-PAK) 0.3mg/0.3mL Kit (2 Pens), and prednISONE (DELTASONE) 20mg Tab prescription. Patient returned to emergency department on 12/06/17 Care Timeline  0041   Arrived 0054   Sodium Chloride 2000 mL 0102   RaNITidine HCl 50 mg 0106   DiphenhydrAMINE HCl 25 mg 0110   MethylPREDNISolone Sodium Succ 125 mg 0801   Discharged
^ hours after injection my arm was aching.  Then Head ache set in by 7pm. pain with neck and head and fever progressed quickly. by 9pm it was 103.7     By 11:00pm my fever was 105.4.    By midnight it was 105.9  I took Vicks NyQuil because it was the only pain med that had Tylenol in it.  Fever reduced to 105.4  by 2:30 am fever was at 104.5  and I felt safe to try and sleep and not die.  A nurse friend was telling me to go to the emergency room.   I applied and Ice pack to my splitting headache and eyeballs felt like they were going to pop out.  also Icepack to neck.  ate a popsicle.  I hydrated emencely before the shot and All day with the shot.  I kept moving my arm and it was fine after a few hours.  THE FEVER SITUATION WAS QUITE FEARFUL AND STRESSFULL.  My throat felt a "little" tightening.  I swallowed every few minutes to make sure it did not progress.  I had Benadryl on hand just in case.  I slept from 3:00am until 9:30 am.  My morning fever was between 103.7 and 104.5   It was 102.4 at 3:00pm  it is 8:45 pm  and my temp is 202.2 now.  head ache is at 50% of yesterday.
Patient with pericarditis starting 14 days after 2nd covid vaccine with small but detectable tropI responding to nsaids however continue chest pain and SOB and failure to taper without discomfort while on Colchicine 0.6mg once a day for 2 months resulted in transitioning therapy to steroids currently on 15mg to taper to 10mg , 7.5mg, 5mg, 2.5 mg. Her taper extends by 2.5mg q30 days until complete with plan to wean off by mid fall then start return to exercise as tolerated and eventual duty. A CMR was performed without evidence of overt myocarditis however her etiology at this point is suggesting of covid19 vaccine induced perimyocarditis although idiopathic cannot be excluded.
Patient received vaccine 4/28/2021 and was admitted to the hospital on 8/28/2021 (presented to the ED 8/27/21).
Intense headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 34 year-old female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Intense headache".  Additional Information: The patient received her first dose of the vaccine in (place name) or (place name) on either Friday 05Mar or Friday 12Mar. Reporter was not sure of the exact date but recall her appointment being a Friday in the last week or two.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021377195 same patient, different dose/AE
Moderna COVID-19 Vaccine EUA I experienced chills and a low grade fever (99.6) almost exactly 24 hours after receiving the vaccine. The symptoms persisted for a couple of hours so I took two Tylenol and went to bed early. There were no adverse symptoms when I woke up the next day.
Patient stated that she had hives and a rash on her right arm. Patient took benadryl and tylenol and it went away a little bit and is getting better.
Started experiencing neck pain and stiffness shortly after receiving the vaccine.  Moving my neck from left to right, or up and down has been hard t o do because of the pain.
Initial unsolicited report received from a non-healthcare professional on 18 May 2018. This case involves a patient who was vaccinated with ADACEL (batch number, expiry date, route and site of administration were not reported) instead of DTap vaccine on an unspecified date. It was a case of actual medication error due as product use in unapproved population, Inappropriate age at vaccine administration and Wrong vaccine administered as patient received Tdap vaccine when should had received Dtap vaccine. It was unknown if any adverse event was occurred. 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. Documents held by sender: none.
Prolonged vaginal bleeding after 2nd shot/ Period extended to 11 days after 2nd shot; Fever 101 F after 2nd shot; Body aches after 2nd shot; Nausea after 2nd shot; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Prolonged vaginal bleeding after 2nd shot/ Period extended to 11 days after 2nd shot), PYREXIA (Fever 101 F after 2nd shot), MYALGIA (Body aches after 2nd shot) and NAUSEA (Nausea after 2nd shot) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced HEAVY MENSTRUAL BLEEDING (Prolonged vaginal bleeding after 2nd shot/ Period extended to 11 days after 2nd shot) and NAUSEA (Nausea after 2nd shot). 01-Nov-2021, the patient experienced PYREXIA (Fever 101 F after 2nd shot) and MYALGIA (Body aches after 2nd shot). On 04-Nov-2021, PYREXIA (Fever 101 F after 2nd shot), MYALGIA (Body aches after 2nd shot) and NAUSEA (Nausea after 2nd shot) had resolved. On 11-Nov-2021, HEAVY MENSTRUAL BLEEDING (Prolonged vaginal bleeding after 2nd shot/ Period extended to 11 days after 2nd shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 f (High) 101 F.         No concomitant medications were reported. Treatment information was not provided.  This case concerns a 23 year-old, female patient with no relevant medical history, with maternal exposure during breastfeeding, who experienced the non serious unexpected event of Heavy menstrual bleeding. The event occurred after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable, as the event was reported exclusively after the second dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-375543 (Patient Link). Sender's Comments: This case concerns a 23 year-old, female patient with no relevant medical history, with maternal exposure during breastfeeding, who experienced the non serious unexpected event of Heavy menstrual bleeding. The event occurred after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable, as the event was reported exclusively after the second dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Upon going to bed I started getting vertigo like room was spinning.  thislasted in the evening for about 4 days. It appeared to have stopped ad then after taking second dose the same thing occured. I am not sure if this is related to the vaccine or not but seemed suspicious that it occured again after second injection