chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 04/27/05- Child developed fever. Fell to the floor, eyes rolled back and became limp/unresponsive x 30-60 seconds. EMS called to scene and child normal exam by then.
It was reported that a 1 month old infant pt received a Tripedia vaccination on 5/7/01. Reportedly, that same day, the pt presented with a high-pitched scream, his left upper thigh was red and swollen greater than 10mm. Refused feeding, his temperature with Tylenol was 99.3F. His right thigh was 6.5" and his left thigh was 7".
right arm swelling from elbow to shoulder with pain heaviness sensation Narrative:  Other Relevant History:
8 days after the first vaccine dose, I had itching, swelling, redness, and warmth at injection site on my right upper arm when I woke up in the morning. This is the first day I have had these symptoms.  The swelling and redness is about 4 inches in diameter and is very firm.  The symptoms have stayed the same all day and the swelling has not gone down yet.  I haven?t taken any medication for it or gone to a doctor yet.
Narrative:  SEVERE DIZZINESS AND WEAKNESS  FOR 6 HOURS AFTER VACCINE.
After vaccine I lost my sense of smell and have not gained it back. After vaccine I was diagnosed with heart failure and currently taking medication daily.
Patient came in on 7/14/21 complaining of mumbnes in his left side of neck shoulder an arm
trouble hearing out of left ear; complete loss of vision for short periods of time; trouble walking; extremely dizzy; vertigo; Initial information received on 20-Sep-2019 regarding an unsolicited valid serious case received from a nurse.  This case involves a 82 years old female patient who experienced trouble hearing out of left ear (hypoacusis), complete loss of vision for short periods of time (blindness), trouble walking (gait disturbance), extremely dizzy (dizziness) and vertigo (vertigo), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 12-Sep-2019 at 2:09 pm, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ221AB and Exp. Date 01-Apr-2020 via intramuscular route in the left deltoid.  On 13-Sep-2019 at night around 3 am, the patient developed a serious trouble hearing out of left ear (hypoacusis), complete loss of vision for short periods of time (blindness), trouble walking (gait disturbance), extremely dizzy (dizziness) 12 hours 51 minutes following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. patient was diagnosed with vertigo. The patient was hospitalized on the same day these events occurred and discharged on 14-Sep-2019 (hospitalization duration 1 day). She was told to go to emergency room.  Other relevant tests not reported.    Final diagnosis was vertigo, hypoacusis, blindness, gait disturbance and dizziness.  It was not reported if the patient received a corrective treatment.  The patient was recovering from all the events.  List of documents held by sender: none.; Sender's Comments: This case involves a 82 years old female patient who developed vertigo, hypoacusis, blindness, gait disturbance and dizziness after vaccination with FLUZONE HIGH DOSE. Time to onset was compatible. However, patient's medical condition at the time of vaccination and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of vaccine cannot be assessed.
rash across her back; This case was reported by a consumer via call center representative and described the occurrence of rash in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th November 2022, the patient received the 1st dose of Shingrix. In November 2022, less than a week after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 15-NOV-2022 Reporter's comment: The patient self-reported this case. The patient received dose of Shingrix vaccine and now she was experiencing a rash across her back. The reporter consented to follow-up.
Patient stated she felt some pain in her back at first, then when down to her left leg. She stated her left leg has been hurting since the first shot. She felt muscle pain and sensitive to the touch to he left leg. She was advise to seek medical treatment for a doctor.
I started to have GI problems. 01/30/2022 I took a rapid test and it was negative for COVID symptoms contributed to progress. I retested on 02/03/2022 tested positive for COVID.
I had a cough, a little tightness with breathing; so it felt like bronchitis.
On 11/29 began feeling lightheaded in the morning, was becoming increasingly dizzy, fainted. When woke up from fainting, could not control bowels, and low motor skills. Taken to ER, had an EKG done in ambulance and hospital, both negative, Doppler done on left left (because of previous knee surgery, checking for blood clot).  No medication administered, urine tests and blood tests. Nothing unusual. Still experiencing extreme fatigue and weakness. Planning to do a follow-up with primary care provider and neurologist.
COVID; COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 86-year-old patient received COVID-19 Vaccine - Manufacturer Unknown, as dose number unknown (booster), single (Batch/Lot number: unknown), as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID". The patient reported that the patient received the vaccines at privacy, then 2 boosters. Then, the patient got COVID. For behtelovimab infusion, the patient fell out of the chair, had fractured hip then underwent bone surgery and rehab and received another vaccine on 23Jan. The patient had fatigue, diarrhea, brain fog, etc. Granted that the patient was 86 but had none of this and other health issues prior.   The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
fatigue; chills; arm soreness; This is a spontaneous report from a contactable pharmacist. This 34-year-old female pharmacist (patient) reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via intramuscular on left arm on 18Dec2020 at 12:45 PM at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine administered was hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Medical history and concomitant medications were not reported. It was reported patient had no other vaccine in four weeks; she had oral contraceptive in two weeks. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced fatigue, chills, arm soreness on 18Dec2020 at 03:00 PM. No treatment was received. Outcome of events was recovered in Dec2020.
This  was reported to this writer. The patient lost consciousness immediately after the injection. Laid on floor by daughter. There was no head trauma.  EMS was called and assumed care. Patient's legs were elevated. Laid on floor for 10 minutes. Conscious and able to answer questions from EMTs, with daughter interpreting. Patient was eventually assisted to a wheelchair and wheeled into the observation area. There was leg weakness with transfer.  While in the post vaccination observation area, patient was talking, drinking water.  Appeared stable. 15 minutes from EMT arrival, they left.  Patient able to stand and walk with stable gait 45 minutes following the incident.  Taken home by daughter.
Severe Ringing in the ears. Doctor prescribed antibiotics just in case there was an infection. He has not had any sickness with in the last year., including the common cold. The antibiotics have not helped the ringing ears at all after 4 days. We are hoping this goes away but so far there is no improvement. He has been unable to work while this is going on.
On day 1 & 2 after initially receiving vaccination, expected tenderness and induration at site. No itching or redness noted. Initial induration completely resolved by day 3. Today, on day 7, induration 2.5cm in diameter noted with moderate itching and slight redness noted. Advised to use hydrocortizone 2.5% to relieve itching by coworker. Unable to restart antihistamine treatment at this time. I attribute this adverse effect to my latex sensitivity as most multidose vials have latex stoppers and the person who drew up the vaccine did not change needle tips between drawing up the vaccine and administering the vaccine.
This spontaneous report was received from a healthcare worker refers to a 12 months old patient of unknown gender. On 30-DEC-2014, patient was vaccinated with an improperly stored dose of M-M-R II (lot# J016232, Expiry: 19-DEC-2015, dose number 1) (dose and route was unknown). No adverse effects reported. This is one of the several reports linked with the same reporter link. No further information was available. Additional information has been requested.
Starting 11/2 going into 11/3 had  jaw pain radiating to ears.   This escalated mildly over the course of the week. On Saturday, November 6, there was an increase in the discomfort with a small area of numbness on the L side of the tongue. On Sunday, November 7, I awoke with full facial paralysis on the L hand side of my face. I rushed to the ER with concerns of a stroke and was diagnosed with Bell's Palsy. I have followed a Prednisone Taper (Starting with 60mg daily) and a 7 day course of Valcyclovir.  Today, I have progressed remarkably and have mild facial weakness on the left hand side. Today is my last day of prednisone. I am being followed by my PCP for recovery of this diagnosis.
Decreased po, fever up to 101, stomach ache. Mouth had salt water taste in mouth, body aches.
1/11/2021, Monday 0800- received vaccine L arm 0845- felt like her B/P was going up, that ended at 0930. 0900- headache began 0930- began feeling nauseated and dizzy 10:00- began feeling very lethargic Went home from work early today.
sick; allergy reaction; Initial information was received on 23-Nov-2020 regarding an unsolicited valid serious case from a non-health care professional (patient) via social media.  This case involves an adult patient with an unknown demographics who was sick (illness), and had allergy reaction (hypersensitivity), while received influenza vaccine.  The patient's medical history, past medical treatment, vaccination, family history and concomitant medication were not reported.   On an unknown date, the patient received a dose of suspect influenza vaccine (produced by unknown manufacturer) (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, the patient was sick (illness) and had allergy reaction (hypersensitivity).  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case. No further relevant information was reported.
After the first dose: pressure in ears, After second dose: marked increase in ear pressures, thought it was hearing loss, but after hearing test, did not lose any hearing. Experienced dizziness. More frequent ear pressure in car.
This spontaneous report as received from a pharmacist refers to a 67 year old female patient with asthma who is allergic to penicillin. Approximately on 09-MAR-2015, reported as 3 weeks ago, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose, anatomical location, route, lot number and expiration date not reported). Concomitant therapies included: SYMBICORT, unspecified albuterol inhaler, meloxicam (manufacturer unknown) and simvastatin (manufacturer unknown). On 25-MAR-2015, the patient was prescribed prednisone (manufacturer unknown), by an unspecified physician, for the treatment of asthma. The pharmacist stated that the asthma is an existing condition and stated that the prednisone may have been prescribed for an exacerbation of asthma symptoms. Outcome of asthma was unknown at the time of the report. Additional information has been requested.
extreme fatigue, extreme migraine, dizzyness, nausea, diarrhea, cant smell certain things, burning sensation throughout body no fever, increase in blood pressure
Information has been received from the mother of a 18 year old female consumer who in late December 2006, was vaccinated 0.5 mL IM with her first dose of Gardasil. The patient came down with mononucleosis on 15-FEB-2007. Unspecified Blood work was performed. The patient was reported as recovered on 19-FEB-2007. No further information is available.
pt immunized w/ pnu-immune 23JAN95;w/in 24hrs devel inj site rxn consisting of swelling,erythema & pruritus;rxn approx 6 inches long;tx w/Atarax/Advil;not seen by MD;pt has been immunized w/pnu-immune approx 10yrs ago
First 30 min post-vaccine: flushing and lightheaded, self limiting. 1.5 hours post-vaccine: vertigo x10 minutes, palpitations, chest tightness. Palpitations were brief and at rest. BP 172/110, HR 95, O2 Sat 99% on RA. 2.5 hours post-vaccine: chest tightness has remained constant with mild restrictive sensation on full inhale, vertigo returned but briefer in duration, BP 173/100, HR 85, Temperature 98.5F, O2 Sat 97% with decrease during conversation. 3 hours post-vaccine: lightheaded with constant chest tightness, BP 168/110, HR 88, O2 Sat 98% on RA, 6 hours post-vaccine: symptoms resolved, BP 148/100, injection site burns and sore to touch.
Pt developed transient global amnesia-memory loss x 12 hrs after the vaccine. fully recovered.  11/27/07 Reviewed hospital medical records which reveal patient experienced acute onset of memory loss & recall for only events that happened 10/20.  Admitted 10/20-10/21/2007.  Memory returned approx 6-10 hours from initial onset & within 24 hours of admit was completely back to normal. FINAL DX: memory loss, transient, probably secondary to transient global amnesia. 12/21/07 Reviewed pcp medical records which consisted of H&P from hospitalization 10/20/07.  No new information.
Patient to receive Shingrix shot but was given COVID19 shot by mistake. No harm was caused to patient and the patient was given the shingrix vaccine the same day on 6/9/21.
Scaling pruritic maculopapular rash. 250mg SOLU-MEDROL.
pt recv vax & devel flu-like sx characterized by fever,malaise,deep body/muscle aches,h/a,nausea;this is one of three patients who exp above rxn @ this site;
Administration of an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a 56-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED. At the time of the report, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.    No treatment medications were reported.  This case concerns a 56-year-old, female patient, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred on unknown date after unspecified dose of Moderna vaccine. The benefit-risk relationship of Moderna vaccine is not affected by this report.   This case was linked to MOD-2021-375393 (Patient Link). This case concerns a 56-year-old, female patient, with no known medical history, who experienced the non-serious event of expired product administered. The event occurred  on unknown date after unspecified dose of Moderna vaccine. The benefit-risk relationship of Moderna vaccine is not affected by this report.
Approx. 12 hours after injection pt C/O visual disturbance, Facial and (R) arm parasthesia with headache. Went to sleep - all symptoms were resolved in the morning except for 3-4/10 throbbing headache.
This  75 year old   female received the Pfizer Covid shot on  3/29/21    and went to the ED on  4/9/21     and was admitted  on 4/9/21 with the following diagnoses listed below. I63.9 - Acute CVA (cerebrovascular accident) R56.9 - Unspecified convulsions
Information has been received from a consumer concerning her 17 year old daughter who on 02-JUN-2008 was vaccinated with a first dose 0.5 mL of GARDASIL. Concomitant therapy included tuberculin purified protein derivative and meningococcal vaccine (manufacturer unknown). The mother reported that on 02-JUN-2008 her daughter fainted after she was vaccinated with her first dose of GARDASIL. She also developed itching on her hand and soreness at the injection site. The patient sought unspecified medical attention. The patient's blood pressure was obtained (results not reported). A telephone call was placed to the doctor's office to obtain more information. At this time no additional information was available. The patient was recovering. The reporter considered the events syncope, patient experienced itching on her hand and soreness at the injection site to be disabling. Additional information has been requested.
pregnant females that were given the invalid Adacel, no side effects observed; caused by Human Error, The Excursion was Negative 40 degrees C and 22.7 degrees C/ There were no side effects observed; Initial information received on 06-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case ID: 2019SA250873 and 2019SA250874 (same reporter).  This case involves a 22 year old female pregnant patient who was exposed to a second dose vaccine of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (dosage form: Prefilled Syringe) lot U6273AA via intramuscular route in the left arm on 20-Aug-2019.  Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported administered invalid Adacel occurred at unknown gestation period. The date of last menstrual period was reported as 28-Jan-2019. The estimated due date is 28-Oct-2019. The patient previous pregnancy was not reported.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is a case of vaccine exposure during pregnancy. It was reported that excursion was caused by Human Error, The Excursion was Negative 40 degrees C and 22.7 degrees C/ There were no side effects observed. Incorrect product storage.  It was reported that the patient had no adverse event following the vaccination.  Additionally, at time of reporting, the outcome of the pregnancy is 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.
No AEs were reported for any patient; HCP stated they accidentally administered 9 doses of Moderna COVID-19 Vaccine Bivalent after the expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 9 doses of Moderna COVID-19 Vaccine Bivalent after the expiration date) and NO ADVERSE EVENT (No AEs were reported for any patient) in a 72-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 052D22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetes.    On 24-May-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 24-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 9 doses of Moderna COVID-19 Vaccine Bivalent after the expiration date). On an unknown date, the patient experienced NO ADVERSE EVENT (No AEs were reported for any patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 9 doses of Moderna COVID-19 Vaccine Bivalent after the expiration date) and NO ADVERSE EVENT (No AEs were reported for any patient) 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 AEs were reported for any patient) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 9 doses of Moderna COVID-19 Vaccine Bivalent after the expiration date).    Patient had no known relevant medical history, allergy, concomitant diseases and risk factor. No concomitant information was reported. Suspect product dosage text was reported as unknown. The 2.5ml vial was thawed directly from the freezer each time they needed to administer a dose. The vial did not underwent temperature excursions. No treatment information was provided. This case is reported for patient 1 out of 9 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-729367, US-MODERNATX, INC.-MOD-2023-729360, US-MODERNATX, INC.-MOD-2023-729381, US-MODERNATX, INC.-MOD-2023-729363, US-MODERNATX, INC.-MOD-2023-729366, US-MODERNATX, INC.-MOD-2023-729365, US-MODERNATX, INC.-MOD-2023-729359 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-729367:Patient 9th US-MODERNATX, INC.-MOD-2023-729381:Patient 8th US-MODERNATX, INC.-MOD-2023-729360:Patient 6th US-MODERNATX, INC.-MOD-2023-729366:Patient 3rd US-MODERNATX, INC.-MOD-2023-729363:Patient 2nd US-MODERNATX, INC.-MOD-2023-729365:Patient 5th US-MODERNATX, INC.-MOD-2023-729359:Patient 4th
Palpitations started a couple days after receiving the first dose of the vaccine. Then about a week later the dizziness, lightheadedness. Checked my pulse a couple weeks after feeling funny and it was 44. Went into the urgent care clinic and had an EKG performed which showed PVCs. Also had a positive D-Dimer of 1.9. Had a referral to cardiology where a heart monitor was placed. Results of heart monitor show PVCs occurring sporadically and together, explaining the way I have been feeling. Now have a plan to get a cardiac MRI to check out the function of my heart, Heart rate still skips around and will drop into the 40s at times and get as high as 120 after climbing stairs. Resting heart rate is now in the mid 50s when it used to be 70s-80s.