chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician referring to 14 anonymous patients of unknown age and gender. Patients' concurrent conditions, concomitant medication and medical history were not provided. On unknown dates between 12-APR-2015 and 30-JUN-2015, the 14 patients were vaccinated with expired GARDASIL (lot # H016238, expiry date 11-APR-2015, dose and route were not provided). The physician reported that the GARDASIL had previous temperature excursions on unknown dates and was unable to provide the excursion details at this time. No adverse symptoms were reported. The physician called back on 09-JUL-2015 and provided the names of 14 patients administered improperly stored and expired doses of GARDASIL. Physician did not specify what dose in the GARDASIL series was administered to each patient. One of the patients was administered the vaccine on 15-JUN-2015. This is one of several reports received from the same reporter. Additional information has been requested.
Could not lift left arm, extreme pain in left arm, had neck stiffness and pain, also weakness, chills and fever.
Information has been received on 27-OCT-2016 from a female patient's mother, who was also a registered nurse, regarding her daughter (age unknown) who received (Wistar RA 27-3) M-M-R II subcutaneous (date not reported). The patient's mother reported to a field employee that the patient developed a "rash" 14 days after vaccination of (Wistar RA 27-3) M-M-R II (date not reported). The patient developed "hives on her back that traveled to legs and head: (date not reported) and the "hives continued for 12 hours and resolved". Patient sought medical attention with an office visit. Patient's present status was recovered. No other adverse information was reported. Additional information has been requested.
UPON GETTING UP THE NEXT DAY AFTER VACCINE I WAS NAUSEATED, THIS CONTINUED FOR AROUND 5 DAYS NO FEVER, I THEN DEVELOPED PAIN IN MY NECK AND ARMS WITH PAIN IN BOTH OF MY LEGS ON 11-16-09 WITH TIREDNESS. AS OF TODAY I CONTINUE TO HAVE BURNING IN MY LEGS AND SLIGHT WEAKNESS WITH EXERTION BUT THE PAIN  IN MY ARMS IS ALMOST GONE.
pt stated@ site of inj pain, tender;throbbing descending down arm to fingers, diarrhea & nausea x 24hrs; seen by MD
Next morning - fever 102 - 103, severe body aches x 24 hrs, red/blotchy rash around inj. site.
A little over 24 hours after the shot  suddenly I felt weak, brain foggy, my face was hot and extreme exhaustion.  I am not a napper but took a 1 1/2 nap.  Went back to bed and had chills and sweats all night.  I took Advil but it did not help.  The next morning my joints were achy but the fever symptoms were gone.  Took more Advil and this time it seemed to help a bit.  Was excessively tired the whole weekend.  Had the shot on a Thursday.
Systemic: Abdominal Pain-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Chills-Severe, Systemic: Diarrhea-Severe, Systemic: cannot move-Severe, Systemic: Hypertension-Medium, Systemic: Vomiting-Severe, Systemic: Weakness-Severe
Numbness in upper - last a few minutes to a few hours. Has been daily since since first occurred.
MMR given on 06/24/2005 as required by school.  On 06/26/2005 began having severe left arm/shoulder pain.  Seen in clinic on 06/27/2005.  Tender anterior shoulder, pain with abduction.  Instructed to take NSAID he already had at home.
Developed nose bleed around 8am, took 18 minutes to completely stop (held pressure x8 min, then clot dislodged, held pressure again x10 min). Got lightheaded, heart rate increased to 120 bpm, felt palpitations, got I-watch and took EKG. Then felt stronger palpitations, had to sit down, 2nd EKG read 172bpm. 911 called, felt very dizzy, laid down in floor with legs up, pursed lip breathing. Ambulance arrived and had SBP of 100. HR in ambulance on way to hospital was around 120.
hitting himself in the head.; became increasingly fussy; night terrors; a knot on his leg at the injection site; Initial information received on 22-May-2023 along with live follow-up received on same day both were processed together regarding an unsolicited valid serious case received from a consumer/non-hcp.  This case involves a 22 months old male patient who experienced hitting himself in the head, became increasingly fussy, night terrors and a knot on his leg at the injection site after receiving vaccine diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel].  The patient had family history of vaccination reactions The patient's past medical history, treatment(s), vaccination(s) were not provided.   On an unknown date in February 2023, the patient received an unknown dose (dose 1) of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (Suspension for injection) (lot number; expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination (immunization). On 28-Apr-2023 he also received a dose 2 of the same vaccine (lot number; expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination (immunization). Information regarding batch number was requested in the case.  On an unknown date in May-2023 the patient experienced night terrors (sleep terror) and a knot on his leg at the injection site (vaccination site mass) (latency: few days approximately).  On an unknown date the patient was hitting himself in the head. (intentional self-injury) and became increasingly fussy (irritability postvaccinal) (unknown latency).  Reportedly, the patient's mother questioned what she was doing with the information she was providing on her son; she was worried that her telling the details of his reaction would prevent him from receiving other doses of DTAP. She reports she has checked with Hospital, and they told her he needs to have a dose every 2 months until, caller questioning if they delay the 3rd dose is there a possibility that he will not produce sufficient antibodies.   Action taken was not applicable.  It was not reported if the patient received a corrective treatment for all the events.  At time of reporting, the outcome was Unknown for all the events.  The event hitting himself in the head was assessed as medically significant.; Sender's Comments: Sanofi company comment for information received on 24-May-2023: This case involves a 22 months old male patient who experienced hitting himself in the head, became increasingly fussy, night terrors and a knot on his leg at the injection site after receiving vaccine diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel]. Further information regarding concurrent condition during vaccination, previous vaccination, tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based on the data provided, the role of vaccine(s) cannot be assessed.
pain/ discomfort in L arm @ inj site, red, swollen, fatique/ malaise Narrative:
She began to have full body urticaria, facial and lip swelling, fever, diarrhea, nausea, and vomiting 5 days after receiving dose 1 of Moderna COVID vaccine. She reports at that time she was experiencing dizziness, but denies syncope. She was given Solu-Medrol 125mg IM and this helped.
Muscle aches on left side of my body, started in hip and then down the back of the leg and my left foot feels like it is asleep; Muscle aches on left side of my body, started in hip and then down the back of the leg and my left foot feels like it is asleep; Soreness on left arm at injection site.; I have been cold today; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167) via an unspecified route of administration in the left arm on 26Apr2021 at 15:15 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included meniere's disease, chronic migraine and known allergies to sensitivity to steroids- acne reaction. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included hydrochlorothiazide/triamterene (TRIAMTERENE HCTZ) 37.5-25 MG for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0163) via an unspecified route of administration in the left arm on 05Apr2021 at 15:15 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. On 26Apr2021 at 16:45, the patient experienced muscle aches on left side of her body, started in hip and then down the back of the leg and her left foot felt like it was asleep, soreness on left arm at injection site and the patient had been cold that day. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events muscle aches on left side of her body, started in hip and then down the back of the leg and her left foot felt like it was asleep, soreness on left arm at injection site and had been cold that day was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Localized inflammation left deltoid site of DTaP inoculation. Fever 101 degrees F on 11/10/01 @ 7:00 pm. went to ED 11/10/01 and 11/13/01
Red, rashy, swollen from site to fingertips, heat present, painful patient did not seek treatment from physician because she had upcoming appointment.  It was at that time she showed her physician her arm.  Physician said to notify us of the reaction.
This spontaneous report as received from a currently 42 year old male patient refers to himself. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route of administration were not reported). On an unknown date, 24 hours after vaccination the patient noticed he had a pink spot and started to become sore and warm on the site of vaccination. The outcome of events was unknown. Relatedness between events and vaccination with ZOSTAVAX was not reported. Additional information is not expected, because reporter's details were not provided.
Half dose of 0.25ml administered instead of 0.5.  Vaccinating staff returning to immediately provide additional 0.25.
COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable consumer, the patient. A 47-years-old non-pregnant female patient received BNT162B2 (Lot Number: emu199) via an unspecified route of administration, administered in Left arm, on 13Mar2021 at 13:00 as dose 1, single (age at vaccination: 47 years) and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: ew0150), via an unspecified route of administration, administered in Left arm on 04Apr2021 at 14:00 as dose 2, single (age at vaccination: 47 years) for COVID-19 immunization. Medical history included known allergies to sulfa drugs from an unknown date and unknown if ongoing. Concomitant medication included valaciclovir hydrochloride (VALTREX); bupropion hydrochloride (WELLBUTRIN); berberine; magnesium; menaquinone-7 (K2) and fish oil, oenothera biennis oil, tocopheryl acetate (OMEGA 3 & 6), all taken for unspecified indications, start and stop dates were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated that, on 07Jul2021, she contracted COVID and COVID-19 confirmed by positive COVID-19 test on 10Jul2021. Reportedly, the patient was not diagnosed with COVID-19, prior to vaccination and since the vaccination, had been tested for COVID-19 via Nasal Swab on 19Jun2021 and 01Jul2021, both with negative results. There was no corrective treatment. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
PATIENT HAS THE FIRST SHINGRIX ON 5/9/23, AND PATIENT CALLED BACK TODAY 5/17/23 STATING HE HAVE A ITCHY RASH ON THE CHEST, BACK, SIDE AREA, PT STATED IT STARTED SEVERAL DAYS AFTER THE VACCINE. PATIENT WAS ADVISE TO CONTACT DOCTOR.
weakness; shortness of breath; dizziness; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient).  A male patient of an unspecified age received bnt162b2 (COVID 19 VACCINE), dose 1 via an unspecified route of administration on 03Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient experienced severe weakness, shortness of breath, and dizziness immediately after taking the shot on 03Apr2021 with outcome of unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt was waiting in parking lot after receiving injection.  Notified attendant that she was experiencing sensation of right facial "fullness" .  RN's x 2 arrived at pt's car to assess and monitor.  Denied shortness of breath or any other adverse symptoms.  Vital signs taken - see below.  Pt reported to RN that she had "forgotten to report" alleric response to shellfish.  Benadryl 25 mg administered po and RN continued to monitor.  Pr reported no further progression of swelling and was allowed to leave lot after 20 minutes.  Stated she was going to her grandmother's house and would take another 25 mg of Benadryl on arrival there.  RN instructed to seek medical attention immediately (ED or call 911) if sx progress.
sore arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 18-Feb-2021 and was forwarded to Moderna on 18-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     The patient's past medical history included Sleep apnea, Hypertension, Hyperthyroidism and Pacemaker insertion (cardiac). Concurrent medical conditions included Seasonal allergy and Drug allergy (certain prostate medication (unsure)). Concomitant products included RIVAROXABAN (XARELTO), LOSARTAN, AMLODIPINE and METOPROLOL for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   This case was linked to MODERNATX, INC.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Follow up included no new information as the follow up document contains information about wife.; Sender's Comments:  MODERNATX, INC.
5/22/19 - AM, well child visit - Dtap administered  5/22/19 - PM - ER for Temp 105, febrile seizure 5/25/19 - Admitted to hospital. Seizure-like activity. 30 hr EEG - normal. Discharged 5/26/19 6/6/19 - PCP office visit.
pt immunized 25MAR93 @ clinic; 26MAR broke out w/red bumps; it was worse on the face; pt seen by MD;
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 50-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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The reporter stated that their facility had not been able to download the digital data logger, they had been put on hold by the state at the moment. There had been no power outages that would have impacted the Moderna vaccine.  It was reported that, the facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. The reporter did not have any questions and wanted to report this to Moderna.  The reporter stated that no adverse reactions were reported by any patients.  No treatment medications were reported.
My supervisor, BSN  received a call from client's family member at 10:52 AM on February 3, 2020, stating client had and episode of a  seizure.  BSN asked client's family member if she was having any difficulty with breathing.  Family member answered no, she is alert now.   BSN directed family member to take client to the ER STAT.  If needed  call 911.  Family member stated they were taking client to ER now. Family member stated that client was doing ok but was  worn out.
Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from other health professional. This case is linked to case 2018SA298495, 2018SA298512, 2018SA298536, 2018SA298512, 2018SA298593, 2018SA298603, 2018SA298611, 2018SA298622, 2018SA298631, 2018SA298644, 2018SA298649, 2018SA297575, 2018SA298692, 2018SA298695, 2018SA298701 (same reporter). This case involves a patient (age and gender not reported) who was vaccinated with a 5 ml dose of FLUZONE HIGH DOSE lot U1995AB, expiry date: 20-Jun-2019 (frequency once, Suspension for injection in pre-filled syringe) via intramuscular route in unknown site on an unknown date (reported as during the period 01Oct2018 to 08Oct2018). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccine was given. It is an actual medication error case due to incorrect product storage and overdose. It was reported that temperature report of the refrigerator showed that the FLUZONE HD was frozen at some time and were injected to 15 patients. It was unknown whether the patient experienced any adverse reaction after vaccination. 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.
The patient (minor) was brought to the pharmacy by her father to get her 2nd dose of Covid Vaccine. After reviewing the PQCF form, the pharmacist administered 0.3ml of the Pfizer Vaccine Adult to the patient. Patient was asked to remain in the recovery area for 15 minutes. While waiting, patient's father reported to technician that his daughter had fainted. Pharmacist was notified , and she went immediately to assist the patient.  Patient was observed to be conscious, pale, sweating, and dizzy. I immediately loosened patients clothing, and placed patient in reclining position. A cool, damp compress was applied to her face and neck. Her pulse was taken manually and recorded as 62.  Patient was kept under close observation until she recovered fully, took about 10 minutes.  She was given some water to drink, and her blood pressure checked and observed to be normal, 105/70  before she was released.  Patients parent was advised to seek medical attention if necessary.
Patient had swollen lymphnodes the size of baseballs the next days and her kidney function decreased after getting the 1st dose.
This spontaneous report as received from a Medical Assistant refers to an adult patient of unknown age and gender who on 04-JUN-2015 was vaccinated with an improperly stored dose of GARDASIL lot #K006960 (exp date, dose and route of administration not provided). According to the reporter the vaccine dose administered underwent a temperature excursion for 63 hours. This is one of several reports from the same reporter. Additional information is not expected as all correspondence was received. Product and narrative were updated.
Heart fluttering for 7 days after than vertigo and jumpy/blurry vision from day 4 post vaccination through today-day 15
I have always had low grade tinnitus and migraine related visual issues, so this could be a completely a coincidence. However I feel the need to report it just in case. On the night of May 29, I had begun to hear a low noticeable hum in my right ear and a feeling of fullness. This humming disappeared and returned on Tuesday, June 1st 2021, and then continued on and became worse upon waking up on Wednesday June 2nd, 2021. I am scheduling follow ups with an ENT specialist in order to understand the root cause.
the 1st one she had a little headache, the 2nd one it got worse; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 immunization, reaction(s): "Headache".  The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "the 1st one she had a little headache, the 2nd one it got worse".  Additional information: Patient wanted to report that she got 3 Pfizer Covid vaccines, the 1st one she had a little headache, the 2nd one it got worse.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.