chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received from a health care professional on 12 September 2011. A 55-year-old male patient received a left deltoid intramuscular injection of FLUZONE No Preservative 2011-2012, sanofi pasteur Inc. lot number UH475AA, on 01 September 2011 at 2:00 PM. The patient had no medical history, took no concomitant medications, had no illness at the time of vaccination and had no other vaccines within 4 weeks of FLUZONE. On 06 September 2011, the patient developed "flu like symptoms" with a temperature of 102.8, general aches and pains, headache, and dizziness. The patient was evaluated by a physician on 08 September 2011 and diagnosed with "flu syndrome". The patient returned to work on 12 September 2011. The outcome was reported as recovered. Documents held by sender: None.
This spontaneous report as received from a pharmacist refers to at least 2 adult patients of unknown age and gender (however, there might have been as many as 48 adult patients who actually received a dose of PROQUAD. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 07-AUG-2016, the adult patients were vaccinated with a dose of PROQUAD subcutaneously. There was no known adverse effects. Additional information has been requested.
Dizziness, Headache, Myalgia, Fever, chills Narrative: fever and chills x48 hours, myalgia x5-6 days, headache x1 week, dizziness x2 weeks
On Sunday afternoon while driving my car I randomly had a nose bleed. Just prior to my nose bleeding my head got really hot and than the nose bleed started. I was able to control the bleed and after about 2 to 3 minutes the bleeding stop. It's been a little over an hour since the incident and I have not any more nose bleeds.
Fever 103 degrees orally, severe lethargy, anorexia. No local reaction at injection site. Fever continued x 24 hours.  Lethargy and anorexia x 5-7 days.
Patient was given vaccine in 11-5-08. She had soreness of upper extremities before ZOSTAVAX was given. Over the last 6 weeks, she has complained of her left shoulder being numb. She was using Diclofenac Gel on shoulder for pains. Saw Dr. 12/16/08, confirmed Shingles.
Sore arm, but with this dose I had a red bump at injection site that started the size of a pea and as of the evening of 1/21/21 it is the size of a quarter, red hot and hard lump, it?s been itchy on and off since last night. I did not have anything other than a sore are with the first dose.
Patient was vaccinated with Pfizer at 1100 (R deltoid) then vaccinated with HPV at 1105. (R deltoid) Patient sat down in the waiting area and began feeling nauseous at approximately 1113. Patient was given an emesis bag and remained AAOx3 the entire time. vitals upon reaction at 1115 were: BP: 103/73, P: 95, O2: 100%.  Patient was observed playing video games on his phone at 1125. Patient did not vomit and stated he felt better at 1130. Patient left vaccination site under his own power along side his mother with no observable signs of distress or impairment.
Patient complained of severe itching for three days, "like if had hot water poured on him". He informed me of this when it was time for the second injection, therefore no treatment was done.
This spontaneous report was received from a health care worker referring to an 11 year old female patient. No medical history was reported. Approximately on 25-DEC-2015, the patient was vaccinated with a dose of improperly stored GARDASIL 9, dose, route and frequency: unknown, lot number: L016429, expiry date: 09-AUG-2017). No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
1st one before covid, then unable to get the 2nd one; This case was reported by a consumer via call center representative and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on January 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.       Additional Information: GSK Receipt Date: 06-JUL-2022 Reporter's Comments: The patient received the 1st shot before Covid and then unable to get the second shot.The reporter said It was January 2020 and in March everything was shut down. The patient asked if he/she protected from shingles as he/she only received 1 dose.
patient received her doses at 0, 2, and 3 months instead of the recommended 0, 2, and 6 months; No additional AE's were reported; This spontaneous report has been received from a physician via Company representative concerning a 17-year-old female patient (also reported as her by reporter). Her concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On an unspecified date, the patient was vaccinated with a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) administered as prophylaxis (dosage regimen, route of administration, lot number and expiration date were not provided). According to the reporter the patient was administered HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) outside recommended dosing schedule, the patient received her doses at 0, 2 and 3 months instead of the recommended 0, 2 and 6 months (Inappropriate schedule of product administration). No additional adverse events were provided (No adverse event).
Dry mouth progressively getting worse since the first dose. Symptoms were minor at first and have gotten significantly worse over the last 5 months. Starting in July my taste buds have felt burned and I have lost the ability to taste normally.
Beginning approximately 1 minute after receiving the vaccine, I became light headed, started sweating, and experienced a tingling sensation in my arms and legs. No treatment was given. I returned to normal after approximately 10 minutes.
Both knees began to ache and turn stiff; Both knees began to ache and turn stiff; Can hardly stand up; His knees became puffy, pink, swollen, and warm; His knees became puffy, pink, swollen, and warm; His knees became puffy, pink, swollen, and warm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 24Jan2021 as dose 1, single (Lot number: EN5318) at the age of 67 years for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure" (ongoing). Concomitant medication(s) included: TOPROL XL taken for blood pressure measurement (ongoing); LIPITOR (ongoing); HYDROCHLOROTHIAZIDE;SPIRONOLACTONE. Vaccination history included: Flu shot (He gets a Flu shot every year.), for Immunization.  The following information was reported: ARTHRALGIA (non-serious), JOINT STIFFNESS (non-serious) all with onset 2021, outcome "not recovered" and all described as "Both knees began to ache and turn stiff"; DYSSTASIA (non-serious) with onset 2021, outcome "not recovered", described as "Can hardly stand up"; JOINT SWELLING (non-serious), JOINT WARMTH (non-serious), ERYTHEMA (non-serious) all with onset 2021, outcome "not recovered" and all described as "His knees became puffy, pink, swollen, and warm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of arthralgia, joint stiffness.  Additional information: The patient Prior Vaccinations (within 4 weeks): none. If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): None. Relevant Tests: None.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300053948 Same patient/vaccine/event, different dose;
1. Hypotension - patient's usual blood pressure is about 106/68 - 2 blood pressure readings around 14:00 on the same day was 86/54 and 84/56 - no treatment provided 2. Lethargic 3. Injection site soreness
Patient C/O numbness to left side of arm and face. Pt denies SOB, difficulty swallowing, swelling of throat, dizziness, no presence of rash, hives. Facial movement and expression symmetrical. Equal bilateral hand grip strength. Per provider monitor patient for 30 min for change in vitals or worsening of symptoms.  10:15 patient vital signs BP 110/64 HR 66 RR 16 SPO2 95% Still no change to c/o but symptoms not worsening.  10:35 patient vitals BP 108/66 HR 60 RR 16 SPO2 fluctuating between 92-96% advised patient to keep taking deep breaths. Patient reports some improvement in symptoms just feeling tired.  10:45 Patient sent home informed to monitor for any changes in symptoms at home, follow up with her PCP recommended if symptoms do not improve within 48 hours. Patient stated she already has an appointment with PCP in 2 days. ER precautions provided, Pt verbalized understanding. Patient left vaccination site with no signs of distress noted
Within 24 hours of the 2nd COVID-19 vaccine, I developed a rash around my abdomen and hips. This initially was treated with topically steriods and oral antihistamines, at normal doses. The rash became itchy and spread up my trunk and down my legs and  presented as urticaria within 2 weeks of the 2nd vaccine.  Within 4 weeks of the 2nd injection, I developed 2 episodes of facial angioedema of the eyes and lips, one of which necessitated an emergency room visit (3/9/21). I continue to be under the surveillance of an allergist and continue to wean antihistamine use and other acute allergic reaction medications. I continue to have transient facial swelling of my lips randomly that require additional antihistamine use to manage.
Patient reported onset of slight headache immediately following vaccine injection. Resolved at time of dc after 30 min obs.
thought it was a kidney infection no infection in urine sample but, passing blood thru my kidneys; pain in my right groin; still feel pressure; pain; This is a spontaneous report from a non-contactable consumer (patient) .  This  51-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 28Aug2021 11:15 (Batch/Lot number was not reported) as DOSE SINGLE for covid-19 immunisation  .  Medical history included Aspirin allergy, abdominal discomfort sensitive in stomach , tomatoes and oranges allergy and high acid food can't tolerate.     The patient's concomitant medications were not reported. Facility type vaccine: Pharmacy or Drug Store. No other vaccine in four weeks.The clinical course was reported as follows: the patient started having some pain in my right groin. Went to my dr thought it was a kidney infection no infection in urine sample but, passing blood thru my kidneys so, will probably have to see urologist still feel pressure and pain. Not taking the second shot.Onset date of the events was on 31Aug2021.The adverse event result in Doctor or other healthcare professional office/clinic visit.The outcome of the events was not reovered.Additional information :no Covid prior vaccination. No Covid tested post vaccination. No follow-up attempts are possible. No further information is expected.
OFFICE NOTE FROM AUGUST 2021: 22 year old female with a history of infantile autism . Patient is present with her brother and daughter. The patient was diagnosed with autism at 3 years old. She was diagnosed because milestones were delayed, patient was not very social, she was delivered through C-section. No complications with birth. The patient graduated from high school and can read and write at a 2nd or 3rd grade level according to Family. She can dress, but needs help with bathing herself. Changes before seizure are denied. She was vaccinated on April 2nd. The mom heard a noise in the night described as a "choking" and jerking, tongue biting, urinary incontinence was seen. There has been no seizure-like activity since. She has not been put on any medication. The day of the seizure she had sleep difficulties and she was fatigued. Since there, there has been no change in behavior and is sleeping well. Patient did not go to the hospital but ambulance came and checked on her. No aura is reported. Seizure was not around menstrual cycle, no family history of seizure.  OFFICE NOTE FROM JANUARY 2022: Patient is a pleasant 23 year old female with history of seizure, here today for a follow up.         Brother reports patient is still getting seizures, had 3 in December and 1 last week. Mother reports it only happens at night, when she is sleeping. I. Mother is having to sleep with patient to monitor for seizures and is not getting much sleep.         Hydration is reportedly good. Other than seizures, patient sleeps well, though does have sleep study scheduled for next week
Within 20 minutes developed pain in left arm. Now have weakness in hand grip and left arm, and pain that continues for many years since this vaccination.  Ultrasound and electronic stimulation were tried and beneficial. Medical records state hypertension, tendon disorder. msv
Rash all over the body, itchy. Lasted until 11/11 morning (about 60 hours), then cleared. Did not see a doctor. Used OTC anti-histamine medication (4 times).
2nd Pfizer booster (initial vaccine was JJ&J single dose). Normal side-effects during first day after injection, including sore arm, headache, fatigue, mild nausea, and slightly elevated heart rate.  One day after injection (~27 hours) vasovagal syncope; unconscious 1-2 minutes with full recovery with 10-15 minutes; evaluated by EMTs immediately after syncope event. Otherwise athletically fit and healthy.
Patient fainted after vaccine. Patient was placed on cushions with feet elevated for further evaluation. Set of VS taken . Neuro checks done q15 for three times. Neuro checks WNL. PT offered juice and granola bar, pt recovered quickly, observed for an additional 30 mins before released home.
stiffness of muscle; Neck pain same side as shot from Jaw to Collar bone every time I eat or drink anything; Uncomfortable feeling in neck; This is a spontaneous report from a contactable consumer or other non hcp(patient). A 45-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration, administered in left arm on 13May2021 (at the age of 45-years-old) as single dose for covid-19 immunization. The patient's medical history included penicillin allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 16May2021, the patient experienced neck pain same side as shot from jaw to collar bone every time she eats or drink anything, uncomfortable feeling in neck and stiffness of muscle. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the adverse events. The outcome of the events was not recovered, still continues after 5 weeks passed the last vaccine.  Information about batch/lot number has been requested.
While administering the 1st dose of the Moderna vaccine in pt's right deltoid, the syringe detached from the needle.  An unknown amount of vaccine was administered to patient and  an unknown amount of vaccine was sprayed in my eyes.
Red swollen arm myalgias followed by eyelid swelling and dry, burning feeling of face.
onset of nausea, vomiting & diarrhea w/in 30-45 mins p/vax, followed by nervousness, tremors & diaphoresis; temp inc 103 & to ER; various labs & IV's initiated in Er; d/c to home w/rx for Pred & DPH;
Fever 101.0 F for two days, chills, extreme fatigue, shortness of breath
Hives - treated with Benadryl oral and epinephrine 1:1000, 0.5 mg IM. After 10 minutes, she had significant improvement in her symptoms, though some persistent urticaria yet (they are fading more anteriorly than posteriorly). This dose was repeated with essential resolution of her symptoms.
Sore arm, moderate fatigue, slight dizziness, lasting about 24 hrs.
Next morning from 0600, pain in left arm around vaccine injection. Dry throat, diarrhea  and fatigue all day Thursday.  Today Friday, I feel fine other than still dry throat.
muscle aches; low grade of fever; This case was reported by a consumer via call center representative and described the occurrence of myalgia in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th February 2020, the patient received the 1st dose of Shingrix. On 14th February 2020, 2 days after receiving Shingrix, the patient experienced myalgia and fever. On 16th February 2020, the outcome of the myalgia and fever were recovered/resolved.   It was unknown if the reporter considered the myalgia and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but it could be 52 or 53 years. The patient received Shingrix in right arm and had muscle aches and low grade fever.
The vaccine expired on 03-May-2022 and vaccine administered on 04-MAY-2022; Moderna COVID-19 vaccine that expired on 3MAY2022 was administered to 3 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine that expired on 3MAY2022 was administered to 3 patients) and PRODUCT STORAGE ERROR (The vaccine expired on 03-May-2022 and vaccine administered on 04-MAY-2022) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A, 038K20A and 038K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine that expired on 3MAY2022 was administered to 3 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine expired on 03-May-2022 and vaccine administered on 04-MAY-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine that expired on 3MAY2022 was administered to 3 patients) and PRODUCT STORAGE ERROR (The vaccine expired on 03-May-2022 and vaccine administered on 04-MAY-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The vial was initially stored in the refrigerator :21-Apr-2022. The vial didn't undergone any temperature excursion. No treatment medications was reported.
Random spotting about an hour after vaccine was given , lasting 4-5 days. Cycle wasn't  scheduled to began  until 1¹/² weeks later and it's regular so it begins on schedule. Moderate left arm cramping began 4 days after vaccine, in index finger and continued up forearm. Cramping lasted about 5mins and remained sore for 3 days afterwards.
General weakness 10 minutes after injection. Checked BP 30 minutes after injection 120/75. Pt. still felt weak/tired. Rash Began to develop 1 Hr After injection. EpiPen Refused. Ambulance Called. Pick Pt. UP 70-75 minutes after injection.
Case number PHEH2015US026935, is an initial spontaneous report  received from a nurse on 22 Dec 2015. This report refers to a 22 years old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN (batch number: 1514501 and expiry date: May 2016) in left deltoid on 16 Oct 2015. It was reported that before administration the FLUVIRIN had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information was provided. Follow up information received from the nurse on 26 Jan 2016: Reporter comment updated.
Severe bell's palsy; twitch on affected side of face when stressed; This is a spontaneous report received from a contactable reporter) (Consumer). The reporter is the patient.  A 33-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Apr2021 as dose 1, single (Lot number: ER8737) at the age of 33 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "anxiety/depression" (unspecified if ongoing); "anxiety/depression" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "dust allergy" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN; CONCERTA; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; BENADRYL; IBUPROFEN. The following information was reported: BELL'S PALSY (hospitalization, medically significant) with onset 17Apr2021 at 10:00, outcome "recovered with sequelae", described as "Severe bell's palsy"; MUSCLE TWITCHING (hospitalization) with onset 17Apr2021 at 10:00, outcome "recovered with sequelae", described as "twitch on affected side of face when stressed". The patient was hospitalized for bell's palsy, muscle twitching (hospitalization duration: 1 day(s)). The events "severe bell's palsy" and "twitch on affected side of face when stressed" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: covid tested post vaccination. Therapeutic measures were taken as a result of bell's palsy, muscle twitching. Clinical course: Patient had no known allergies; no other vaccine in four weeks. It was unknown if patient experienced covid prior vaccination. Patient experienced severe bell's palsy was 9 months before recovering with lasting twitch on affected side of face when stressed. Treatment included steroids, antiviral medication. Patient recovered with lasting effects. Patient also received dose 2 (Lot number: EW0175) on 06May2021 in right arm.   Follow-up attempts are completed. No further information is expected.
Chest pain/tightness, short of breath, and feeling like my heart is racing since a couple days after receiving vaccine. Hard to breathe when laying down
BREAKTHROUGH COVID: PT FULLY VACCINATED AND BOOSTED WITH JANSSEN VACCINE Patient was positive for covid 19. Pt was admitted with fever, right flank pain, vomitting.  Acute cholecystitis on CT abd/pelvis and HIDA scan, and AKI. REQUIRED ICU  S/P cholecystostomy drainage, fluid culture grew Klebsiella, Diabetes ,Leukocytosis, Hypoxia .Continue Zosyn for now. No particular Rx indicated for Covid 19.
Vaccine administered after expiration date of 03/16/2013. No adverse events occurred as of today.
Awakened from sleep with extreme nausea and vomiting which lasted for approximately 30 minutes.
12/3/21 patient given Covid-19 vaccine second dose. Patient went to ER on 12/5/21 for hives all over body, they put her on hydralazine and five days of steroid. Patient then seen in PCP office 12/10/21 and told to take hydroxyzine for next few days and to call office if hives return, the hives have come and gone over last few days, since yesterday no more hives and patient doing well. ER advised not to get the Covid-19 booster vaccine.
I received smallpox on 06-13-15. Infected at left arm. Left arm sore.