chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Upon 2nd dose of Gardasil 9 my son went out to the car to leave and passed out while attempting to get into car and drive away.  Had lump on head from fall in parking lot and was sick rest of day with throwing up several times.   Upon 3rd dose of Gardasil 9, I attended appointment.  30 seconds after the 3rd injection of Gardasil 9 he passed out and was unresponsive.  His blood pressure dropped to 60/40 and shallow respiration rate.  Spent 45 minutes in office under supervision of healthcare provider until blood pressure and blood oxygen level returned to acceptable levels.  My son then had a debilitating headache and spent rest of day in bed.  I am reporting this several years after the fact,  I believe that this should have been reported by my PCP but not sure if that is the case.  If my son would have driven away and passed out after leaving it could have resulted in a fatality which needs to be reported as an adverse reaction.
Patient is a 89 y.o. female patient of the MD with history of CAD s/p CABG, chronic diastolic CHF, GERD, hypertension, chronic lower extremity pain presented to the Hospital with fever, sore throat, shortness of breath and cough admitted for acute respiratory failure secondary to CHF and COVID-19 infection  Acute hypoxic respiratory failure-resolved Not on O2 at home, requiring 4 L of oxygen Shortness of breath secondary to acute on chronic CHF and COVID-19 Chest x-ray-worsening pulmonary edema and bilateral pleural effusions On IV diuretics and steroids as mentioned below Pul toilette   Acute on chronic diastolic CHF, uncompensaed CAD, s/p CABG Last echo 2/16/2023-EF 60% with grade 2 diastolic dysfunction Not on cardiac meds (patient and family does not like polypharmacy) On Lasix 10 mg as needed at home, started on Lasix 20 mg IV twice daily>changed to oral today Cardio followed and signed off,resume f/u as instructed C/w lasix 20mg daily on discharge OP Cardio fu as instructed   Covid-19 Virus Infection Date of onset of symptoms: 3/12 Symptoms present on admission: Sore throat, cough, low-grade fevers Date of covid positive test: 3/14 Vaccination status: vaccinated Imaging: Chest x-ray-pulmonary edema Oxygen requirements on admission: 4 L Current oxygen requirements: 4 L> RA Medical therapy: steroids years her EKG Consultants following: E consult to ID for Paxlovid, started on 3/15, stop on discharge Anticipated special isolation end date: 3/22  F/u with your PCP for updating your vaccination per current CDC guidelines.    Hypertension Not on meds at assisted living On amlodipine and lasix, continue on discharge Hold coreg due to bradycardia OP PCP f/u with BP log as instructed   Sinus bradycardia-resolved Stopped Coreg Stable vitals   Chronic leg cramps-stable Recent lower extremity venous Doppler negative for DVT
redness, swelling, tenderness (size of baseball) w/in 24hrs p/inj; one streak from site;resolving by 3OCT95;redness gone, sl lump;
Patient woke up that morning with rash on top of head.  Rash had spread by morning of 10/25/2014.
Patient report to have been in A-fib for three days after receiving first dose of vaccine; Throat closure; Felt like anaphylaxis; A spontaneous report was received from a consumer who was a 53-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who developed atrial fibrillation and an anaphylactic reaction.    The patient's medical history included heart failure and allergies to butter and NSAIDS.  Products known to have been used by the patient, within two weeks prior to the event, included metoprolol, diltiazem, apixaban, lisinopril and loratadine.    The patient received their first of two planned doses of mRNA-1273 (Batch number: 040A21A) on 11 Mar 2021 in the left arm for prophylaxis of COVID-19 infection.   On 11 Mar 2021, the patient reported that he experienced a moderate reaction; throat closure (not complete).  He stated that it felt like anaphylaxis.  He also reported having a numb tongue. He reported that the reaction was not immediate and that  it started about four hours after the vaccine.    Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the event, atrial fibrillation, was considered recovered/resolved. The outcome of the event, anaphylactic reaction, was considered recovering/resolving.; Reporter's Comments: This case concerns a 53-year-old male who experienced a serious anaphylactic reaction with serious unexpected event of atrial fibrillation and throat closure.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Atrial fibrillation resolved, and anaphylaxis resolving. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patient is fully vaccinated, then later hospitalized and died four days later due to Covid related causes.  Patient was resident of long-term care facility
First dose / on 10Nov2019 / Second dose had not been given at time of call; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received from 10th November 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter mentioned that, vaccine information was not available at time of call and patient information was shared limitedly. The reporter also mentioned that, 2nd dose was not been given at the time of call. The reporter consented to follow up.
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe
cold symptoms; sore arm; sneezing; runny nose; cough; headache; low energy; extreme fatigue; easily out of breath; vision problems; brain fog; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Aug2021 11:00 (Lot number: FA7485) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroid" (unspecified if ongoing), notes: Hypothyroid. Concomitant medication(s) included: NP THYROID; VITAMIN C [ASCORBIC ACID]; VITAMIN D3; VITAMIN B12 [CYANOCOBALAMIN]; MAGNESIUM; TURMERIC [CURCUMA LONGA]. The following information was reported: NASOPHARYNGITIS (non-serious) with onset Aug2021, outcome "unknown", described as "cold symptoms"; PAIN IN EXTREMITY (non-serious) with onset Aug2021, outcome "unknown", described as "sore arm"; SNEEZING (non-serious) with onset Aug2021, outcome "unknown", described as "sneezing"; RHINORRHOEA (non-serious) with onset Aug2021, outcome "unknown", described as "runny nose"; COUGH (non-serious) with onset Aug2021, outcome "unknown", described as "cough"; HEADACHE (non-serious) with onset Aug2021, outcome "unknown", described as "headache"; ASTHENIA (non-serious) with onset Aug2021, outcome "unknown", described as "low energy"; FATIGUE (non-serious) with onset Aug2021, outcome "unknown", described as "extreme fatigue"; DYSPNOEA (non-serious) with onset Aug2021, outcome "unknown", described as "easily out of breath"; VISUAL IMPAIRMENT (non-serious) with onset Aug2021, outcome "unknown", described as "vision problems"; FEELING ABNORMAL (non-serious) with onset Aug2021, outcome "unknown", described as "brain fog". Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. After the first dose, the patient had cold symptoms, a sore arm, sneezing, runny nose, cough, headache, low energy. Between the first and second dose, the patient started extreme fatigue and becoming easily out of breath. The patient also noticed some vision problems and brain fog. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Device date was reported as 23Oct2021.  Follow-up attempts are completed. No further information is expected.
BODY ACHES; LOW GRADE FEVER; VERY TIRED; This spontaneous report received from a parent concerned a 19 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcoholic, and non smoker. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 204A21A,expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-MAY-2021, the subject experienced tiredness. On 25-MAY-2021, the subject experienced low grade fever. On 25-MAY-2021, the subject experienced body aches. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient recovered from tiredness on MAY-2021, and low grade fever, and body aches on 25-MAY-2021. This report was non-serious.
pt recv vax 12JUN97 & 10JUL97 pt exp swollen parotids on the rt side of the face w/loss of the angle of the jaw, malaise, low grade fever, mild post auricular erythema & ear pain;swelling went down into anterior neck;
10d. s/p vaccination experienced chest pain, palpations, dyspneaè ER è Discharged to home
feeling yucky; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 54-year-old female patient received BNT162b2 (BNT162B2), on 15Apr2021 as dose 1, single (Lot number: ER8731) at the age of 54 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "feeling yucky".  Additional information: Had three or 4 other injections prior and had no other side effects other than feeling yucky for a day but never had rashes. Clarified injections as all Pfizer COVID-19 Vaccines.
Client inadvertently admin'd HepB- peds dose. Brought client back from waiting room to inform them and admin adult HepB dose
R periorbital swelling, labial swelling, little to no respiratory discomfort reported.
Symptoms, started 11 hours after the injection. Fever 101 deg; shaking chills; no localized reaction; no parathesias. Severe headache.
a little tired; her arm is a little sore; This is a spontaneous report from a contactable consumer (patient) from a Pfizer Sponsored Program. A 75-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at the night of 05Feb2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was a little tired and her arm was a little sore on an unspecified date. The event outcome was unknown.  Information on the lot/batch number has been requested.
Pt. said had immediate muscle pain once given & though the acute pn. lessened, she still has sharp muscle pain with use. She is currently using CELEBREX 200 BID x2 weeks for the pain.
This patient was here for her 2nd Novavax vaccination but was accidentally given a Pfizer-BioNTech bivalent vaccination, instead.
Painful, red, swollen area around the injection site. Symptoms started the day after injection given. Patient visited MD who gave antibiotics for possible Staph infection.
On 02/05/2021, 8 days after receiving his vaccine, the patient developed an oral lesion on his right upper lip. It caused tingling of lip with blistering sore. He was asymptomatic when he presented back to the clinic on 03/04/2021, but by description it sounded consistent with HSV-1. He declines prior history of eruption and no confirmed exposure, but acknowledges possible exposure from past kissing contacts (last contact in 2003) or by sharing beverage cups (most recently in November 2020).
No side effects until  abruptly at 30 hours after the dose I had the most severe episode of very loud tinnitus and vertigo. Resolved after 150 minutes.  Interestingly, 8 days after the first dose (lot number EL 3247) had a similar but slightly milder reaction that lasted 24 hours. I do have Meniere?s with intermittent episodes like this for many years, but these two events were profoundly more severe than any in the past.
I woke up this morning & my blood sugar was 350.  It started raising around 2:30 am.  I am on an insulin pump & have given myself numerous doses of insulin, but i can't get my blood sugar to get below mid 300s.
Red arm from shoulder to elbow; 103 fever; pain  could not touch arm; ongoing headache; tired and weak.  Some symptoms lasted up to 2 weeks. Severe symptoms 4 days. Tiredness and arm itching now. Color of arm now lt pink.
pt passed out & then went into a sz for approx 10 sec w/all 4 extremities involved;
Case number PHEH2015US019855, is an initial spontaneous report received from a pharmacist on 02 OCT 2015. This report refers to a 46 year old male patient. Historical conditions and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN 2015/2016 (batch number: 1514801) intramuscularly at a dose of 0.5 ml on 02 OCT 2015. The pharmacist reported that the vaccine FLUVIRIN that had reached 52 degree for 30 minutes was administered to the patient. No adverse event was reported following the medication error (incorrect storage of drug).
high sed rate, joint pain, numbness of arms, legs & back;ANA positive, arthralgia;have been treated for lyme disease & lupus;hosp for alk phos 163, triglycerides 1357;anti inflammatory drugs;Annual follow-up dated 10/30/00 provided no additional data.
Started getting really cold and shivering around 11:30 pm woke up around 12:00 am shivering uncontrollably tried to sip on some water and then got really sick and threw up. Was really tired and weak and shaky all day the next day .
Redness, slight swelling, itching  on/around injection site started early morning of Feb. 24, 2021 or possibly during sleep on  Feb 23/24.  Applied cold compresses during the day.    Itching and swelling stopped 2/25; slight redness still apparent 3/1/2021;
This is a spontaneous report from a nurse. A 71-year-old female patient received PREVNAR 13 (lot# J20343, Exp. date: 11Mar2016, NDC # unknown) intramuscular on left deltoid at 0.5 ml, single on 11Mar2015 at 9:49 am. Medical history included ongoing hypertension, migraine and depression all from 05Oct2012, shoulder pain, cholesterol problem, sleep disorder. She was not sure whether she had Osteoporosis/Osteopenia. Concomitant medication included trazodone from 2014 at 50mg one at bedtime (as needed) for sleep, paroxetine from 05Oct2012 at 20mg daily for anxiety and depression, NEURONTIN tablet from 05Oct2012 at 300 mg, 3 times a day for neuropathy, MOBIC 7.5 mg daily, as needed for anti inflammatory pain for shoulder, losartan/HCTZ tablet from 28Mar2013 at 50mg/12.5mg one a day for blood pressure, fish oil 2000 mg, 1x/day for cholesterol, EPIPEN as needed for allergy to shellfish, Multivitamins, CENTRUM vitamin once a day supplement for wellness, calcium once a day supplement for wellness, Vitamin D daily, ACTONEL tablet from 10Jan2015 at 35mg daily for osteoporosis/osteopenia. On 11Mar2015 at 10:00am patient started to have severe nausea, dizziness and arm pain at site of injection which intensified to the point that she could barely move her arm. Arm became very swollen and red: she had swelling and redness of deltoid muscle and it was bright red. Patient felt fatigued and got migraine. She also reported fever to office. Patient's temperature at doctor's office was 99. On 16Mar2015 patient visited the doctor's office and antibiotics for cellulitis were given. Arm appeared less red than when it first started. Nausea was better. The patient recovered from all the events on unknown date. Follow-up (21Apr2015): New information received from a contactable nurse includes: vaccination and event details, events updated, concomitants.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 15-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment information was provided.
Administered an expired vaccine to a patient. Vaccine had been moved to the fridge 71 days ago and was incorrectly labeled.
Heart Palpitations, Irregular Heart Beat and Angina was felt within 2-days after receiving the vaccine. Mild symptoms continue to persist for months, resulting in the Patient seeking medical attention. Patient was diagnosed with a Complete Right Bundle Block by Cardiologist.
Information has been received from a physician concerning a 64 year old male with no pertinent medical history, drug reactions or allergies who on 05-FEB-2008 was vaccinated with 0.65 ml of ZOSTAVAX.  There was no concomitant medication.  Ten days post vaccination, on approximately 15-FEB-2008, the patient developed shingles.  At the time of reporting the patient had not yet recovered.  Unspecified medical attention was sought.  There was no product quality complaint.  No further information was provided.  The patient was enrolled in the VZVIP program: the Varicella Zoster Virus Identification Program enables biological samples to be analyzed by PCR to identify if VZV is present and if it is present to identify if it is associated with the wild-type VZV strain or with the OKA/Merck vaccine VZV strain.  Additional information is not expected. This is in follow-up to report(s) previously submitted on 3/26/2008. Information has been received from a physician concerning a 64 year old male with no pertinent medical history, drug reactions or allergies who on 05-FEB-2008 was vaccinated with0.65 ml of ZOSTAVAX (Merck). There was no concomitant medication. Two days post vaccination, on approximately 15-FEB-2008, the patient developed shingles. At the time of reporting the patient had not yet recovered. Unspecified medical attention was sought. There was no product quality complaint. No further information was provided. The patient was enroled in teh VZVIP program, the Varicella Zoster Virus Identification Program enables biological samples to be analyzed by PCR to indetify if VZV is present and if it is present and if it is present to identify if it is associated with the wild-type VZV strain or with the the Merck vaccine VZV strain. Follow up information was received from the consumer who reported that he still had shingles and that neither LYRICA nor VALTREX helped get rid of his shingles pain. The consumer also reported that his wife was vaccinated on 05-FEB-2008 with ZOSTAVAX (Merck), and has had itchiness and a burning sensation at the injections site ever since she was vaccinated (WAES # 0804USA01392). Additional information has been requested. Product quality complaint, No further information was provided. The patient was enrolled in the VZVIP program the VARICELLA ZOSTER Virs Identification program enables biological samples to be analyzed by PCR the identify if VZV is present and if it is present and if it is present to identify if it is associated with the wild-type VZV strain or with the Merck vaccine VZV strain. Additional informationis not expected.
Pt went to ER 4 days after immunizations with abdominal pain, LFT's elevated. U/A suspicious of UTI. Pt had been treated for vaginitis on 10/11/07. On 10/15/07 when seen in the ER, pt was diagnosed with hepatitis and UTI. Labs from 10/11/07 were normal. Concerned elevation was secondary to vaccine. Repeated labs 10/25/07 - all normal.
Narrative:  She relates having developed urticaria s/p the initial vaccination. In brief: *Started over b/l wrists and medial b/l LE with minimal extension over b/l medial knees about 1x wk after vaccination *Persisted almost continuously for a week *Areas were very itchy, no other common adverse effects experienced *Went to ER, where she was treated with zyrtec x1 dose - which causes her to feel excessively drowsy *After that week, she has continued to have intermittent pruritic urticaria *Frequency of episodes has slowly decreased as time progresses since vaccination *She has been applying topical benadryl with some relief *Denies new environmental exposures including plants, pets/dander, detergents.  No recent new medications or OTC drugs *Lesions described as red, bumpy,  <1cm and not fluid filled NO lesions noted on exam. Discussed the following plan: *Reviewed risk vx benefit of 2nd vaccination. Noted that reaction could continue and potentially be more prolonged or worsened *Make f/u appt with personal PCP in ~7-10 days *If hives re-occur: can do trial OTC antihistamine for about a week that is non- sedating for her vs one that may be more sedating for her, but recommended at nighttime *Ok to continue topical benadryl. Might add low dose topical steroid, as short a course as possible *Consider discussion regarding short damage course of oral steroids with PCP during f/u if issue persists despite above interventions
She's been having a "severe case of gas and bloating"; She's been having a "severe case of gas and bloating"; This is a spontaneous report receivec from a contactable consumer (patient). This 54-years-old female received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Batch/ Lot Number and expiry date were not provided) via an unspecified route of administration on 16Apr2021 (at the age of 54-years-old) as a single dose for covid-19 immunisation. Patient's medical history and concomitant medication were not reported. In Apr2021, patient had severe case of gas and bloating. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Case is Instructor at Community College.  Nursing student gave case Fluad High Dose instead of Fluarix.  No adverse reactions or complications occurred after vaccination.  Case is aware of error.
Immediate fatigue and malaise.  Nausea and vomiting by the next day, which persistent for 2 weeks.  Now has higher pitched voice and dyspnea, presumably from laryngeal irritation.