chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Since the vaccination patient has been very clingy, fussy, difficulty staying asleep, a mild temperature, and has had difficulty feeding her.
Nausea after breakfast immediately followed by Syncope then Vomiting while unconscious. Brought to ER. Released after tests and observation.
The 17-year-old patient was accidentally given the Moderna vaccine a month prior by , but was advised to get her second dose anyway to finish the series. The  nurse who gave her this injection (second for the patient) did not realize that the patient was underage because the clinic was exclusively for second-dose recipients and the patient did not volunteer her age. The administration error was discovered post-vaccination.
VOMITING; This spontaneous report received from a pharmacist concerned a 24 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A and expiry: 23-JUN-2021) dose was not reported, administered on 03-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-JUN-2021, the subject experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting on 03-JUN-2021. This report was non-serious.
Headache, muscle aches, chills, fatigue, stomach pain. Lasted one day.
The next day I had nose bleeds for more than 8 hours, it was random nose bleeds.  My son end up having to leave school because it was happening at anytime without a warning; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 at 15:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 16 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Lactose intolerant" (unspecified if ongoing), notes: Lactose intolerant, mild egg allergies and caffeine allergy; "mild egg allergies" (unspecified if ongoing), notes: Lactose intolerant, mild egg allergies and caffeine allergy; "caffeine allergy" (unspecified if ongoing), notes: Lactose intolerant, mild egg allergies and caffeine allergy. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1; Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2; Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3; Manufacturer unknown), for COVID-19 immunization. The following information was reported: EPISTAXIS (medically significant) with onset 06Oct2022 at 06:00, outcome "recovered" (Oct2022), described as "The next day I had nose bleeds for more than 8 hours, it was random nose bleeds.  My son end up having to leave school because it was happening at anytime without a warning". Therapeutic measures were not taken as a result of epistaxis.  Additional information: Patient had no covid prior to vaccination and not tested covid post vaccination. Other medical history reported as not applicable.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Developed rash on L arm & body cluster on abd. Red pimples 8-27-09.
On 5/17/12 pt. received Tdap (L) arm; within 24 hours developed redness/vesicles around injection site; increased redness; discomfort; 6 3/4 x 5 1/2 inches diameter redness.
Red sore arm with the bump  22 hours after the shot he went from a normal temperature to chills and 103.4 instantly temperature headache aches pains
Red welt that is growing, warm, and painful. Majority of inner forearm is pink.  Two days post and borders are expanding.
Patient received immunizations. Immediately following immunizations patient became lightheaded, sweaty, pale, nauseated, and felt like he could faint. Ammonia inhalant opened and held underneath nose. Patient states this did help. At approximately 2:00 pm, patient began complaining of sharp chest pain and numbness of left arm. Mom states teen has history of chest pain and numbness of left arm in the past. States patient is seen by cardiologist and that they think he may have a valve problem with heart. Instructed by nursing director to contact patient's MD. Contacted Dr. and was instructed to call 911 for any concerns. Dr. states that teen does have a minor valve issue that showed up on echocardiogram. 911 contacted at approximately 2:10 pm and notified of the above. Teen transported to hospital.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 16-SEP-2015, the patient was vaccinated with an improperly stored dose GARDASIL (lot # K014191, expiration date 10-MAY-2017). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time of the first time was 56 hours with the lowest recorded temperature of 34 Fahrenheit degree (the highest recorded temperature was not reported). The storage criteria and the type of excursion for the vaccine was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Itching and burning raised rash on hands, wrists, injection site. Tx: Benadryl, cold compress
severe tenderness in the arm/my arm was slightly sore for a day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (severe tenderness in the arm/my arm was slightly sore for a day) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (severe tenderness in the arm/my arm was slightly sore for a day). On 06-Feb-2021, PAIN IN EXTREMITY (severe tenderness in the arm/my arm was slightly sore for a day) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications reported.  Treatment medications was not provided by the reporter   This case was linked to MOD-2021-037864 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Follow-up received updated patient details, suspect dosage details, event details and outcome.
This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153) via an unspecified route of administration in the left arm on 11Apr2021 at 15:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive concomitant medications. On 13Apr2021, the patient experienced 5 days early menstrual cycle. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event early menstrual cycle was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.
Pt c/o itchy throat and tingling tongue within 10 minutes of receiving flu shot. Observed for additional 30 minutes;  no progression of reaction noted.
A nurse reported that a female employee of a clinic received flu shield vaccine on 11/16/2001. On 11/16/2001, she developed an injection site reaction characterized by pain. The reporter noted that the employee may be allergic to thimerosal. No additional info was available as of the date of this report.
patient was scheduled on nurse visit and Medical Assistant looked at note in chart for order to give vaccines. Medical assistant  misread the providers previous note as the note for current visit and inadvertently gave repeat of previous vaccines.  Patient received Tdap, varicella on 7/27/23 and again on 8/5/23. In addition patient did receive HPV which was correct as ordered. No adverse reaction has occurred at this time and provider disclosed information with patient and family.
Rash, swelling and erythema at site of injection.  Mild nausea and tactile fever
pain at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 58-year-old male patient who received Herpes zoster (Shingrix) (batch number MX2LT, expiry date 29th May 2021) and (batch number 42D4K, expiry date 29th May 2021) for prophylaxis.   On 19th February 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the dose was an unknown dose. On 19th February 2019, immediately after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left deltoid. It was reported that the patient experienced pain at the injection site when he received Shingrix and at the time of reporting the patient still had pain at the injection site.
Patient made the mistake telling the pharmacy the wrong  scheduled date on her second dose and was administered the second dose one day earlier than it should be
Arm swollen, hot to touch, fever, headache, malaise, difficulty moving right arm.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patient was vaccinated with the first, the second and the third dose of GARDASIL (dose, route of administration, injection site, lot# and expiration date were not reported). On an unknown date, the patient was inadvertently administered a 4th dose of GARDASIL 9 (dose, route of administration, injection site, lot# and expiration date were not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Bells Palsy; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bells Palsy) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (Bells Palsy) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (Bells Palsy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication listed.   No treatment information provided.  Company comment: This case concerns a patient of unknown age and gender, with no previous relevant medical history reported, who experienced the unexpected event of Bell´s palsy. The event occurred on an unknown number of days after the first dose of mRNA-1273. The rechallenge was unknown since the outcome of the event is unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.; Sender's Comments: This case concerns a patient of unknown age and gender, with no previous relevant medical history reported, who experienced the unexpected event of Bell´s palsy. The event occurred on an unknown number of days after the first dose of mRNA-1273. The rechallenge was unknown since the outcome of the event is unknown. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.
swelling of the throat; This is a spontaneous report from a contactable pharmacist. A 20-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0217, Expiration date: Unknown), via intramuscular route of administration in Left arm on 02Jun2021 at 16:00 as dose 1, single (at the age of 20-years-old) for COVID-19 immunization. It was unknown if the patient received any medications in four weeks of vaccination. The patient's medical history included asthma and pollen allergy from an unknown date and unknown if ongoing. The patient's concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]) taken for an unspecified indication in two weeks of vaccination. It was reported that the patient received his vaccination around 4:00 PM and then he waited for 15 minutes post-vaccination. On 02Jun2021, after going home, the patient experienced swelling of the throat around 20 minutes after they left the pharmacy. The patient and his mother then proceeded with the Emergency room visit. The outcome of the event was recovered on an unspecified date 2021.   Follow-up attempts are completed. No further information is expected.
Swollen, red, itchy arm for 5 days, asthma attack, nausea, hives
14 year old is excellent health now with Over 1 year of fatigue dizziness headaches due to POTS diagnosis following approximately 30d post vaccine administration # 2. Heart rate excessive with standing then sometimes normal...Multiple visits to MDs over 1 year. Cardiologist neurologist chiropractic psychological help due to chronic illness. Several trials of medications. Missed consecutive school days due to severe symptoms. Unable to participate in sports and activities due to symptoms.
Low grade fever (100°),  Muscle aches, tiredness, extreme thirst, tinnitus
First 3 Pfizer and 4 th Moderna. Mildly sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (First 3 Pfizer and 4 th Moderna. Mildly sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form and third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (First 3 Pfizer and 4 th Moderna. Mildly sore arm). At the time of the report, PAIN IN EXTREMITY (First 3 Pfizer and 4 th Moderna. Mildly sore arm) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Initial information received on 26-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 73 years old female patient who experienced hives all over her body, while she received INFLUENZA VACCINE. The patients past medical history, concomitant medication and family history were not provided. The patient did not have an allergy to bird products. On an unknown date, the patient received injection of suspect INFLUENZA VACCINE produced by unknown manufacturer, lot number, expiry date and dose not reported via unknown route in unknown administration site four years ago. On an unknown date, the patient developed a non-serious hives all over her body (urticaria) with unknown latency following the administration of INFLUENZA VACCINE. Lab data was not provided. Final diagnosis was hives all over her body. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for hives all over her body. List of documents held by sender- none.
14 years old received an infanrix dose; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 14-year-old patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 1-Nov-2022 Reporter's comment: The reporter consented to follow-up. The case was linked with case US2022158126 reported by same reporter. Additional supportive information: The patient received an Infanrix dose at inappropriate age, which led inappropriate age at vaccine administration.; Sender's Comments:  US-GSK-US2022158126:same reporter
patient had received an expired dose of ACT-HIB with no reported AE; Initial information was regarding an unsolicited valid non serious case was received from a other healthcare professional via Medical Information (MI) (Reference number- 00806513) and transmitted to Sanofi on 11-Oct-2021.  This case involves a one-month-old female patient who was vaccinated with the expired HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DAPTACEL) for Immunisation.  On an unknown date, the patient received a first dose (0.25 mL to 2 mL) of suspect HIB (PRP/T) VACCINE (lot UJ359AAA, expiry date 11-Jul-2021) via intramuscular route in the left thigh for prophylactic vaccination.  Relevant laboratory test results included: Tuberculin test - On an unknown date: Inconclusive  It was an actual medication error due to expired vaccine used. (latency: same day).  It was reported "patient had received an expired dose of ACT-HIB".  At time of reporting, no adverse event reported.  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 the 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.
Information has been received from a physician assistant concerning a patient (age and gender not reported) who on an unknown date was vaccinated intramuscularly with a 0.5 mL dose of Pneumovax 23 (Lot# 651321/1036P). Subsequently, within 48 hours of vaccination, the patient developed swelling, redness, warmth and severe soreness around the injection site. The patient had also developed a fever of 101F. The reporter indicated that the patient was treated with anti-inflammatory medication for relief of symptoms. At the time of the report, the patient had recovered. The physician assistant requested a lot check. The reporter considered the patient's experience an other important medical event. The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory. The lot complies with the standards of the Center for Biologics and Research and was released. Additional information has been requested.
Prolonged sleep; difficulty waking pt, lethargic reported only when due for 2nd set of immun;
Pfizer COVID Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccine on 3/3/21 and 4/9/21. Covid+ 2/5/22. Admitted to hospital  2/15/22 - 2/16/22 d/c'd home on O2. Presented to ED 2/25/22 satting  64% on 4L of O2. O2 needs cont'd to escalate, requiring intubation. ADmitted for acute resp failure 2/2 Covid PNA. Labs remarkable for BS 234, Na 128, lactate 3.2, WBC 18.1, and D-dimer 2.06. CXR w/bilateral patchy airspace opacities c/w multifocal PNA. Transitioned to DNR/COT. Course c/b AKI and hypotenisve shock. Tx'd with vancomycin, cefepime, tocilizumab, steroids, and levaquin. Pt expired 3/8/22.
HYPOTENSION 8/24/2022 HYPONATREMIA  CHRONIC HYPOXEMIC RESPIRATORY FAILURE 11/3/2022 HYPONATREMIA  HYPOXIA 8/30/2022 HYPONATREMIA  HYPOTENSION 8/24/2022 CANCER METASTATIC TO LIVER  CHRONIC HYPOXEMIC RESPIRATORY FAILURE 11/3/2022 CANCER METASTATIC TO LIVER  HYPOXIA 8/30/2022 CANCER METASTATIC TO LIVER  HYPOTENSION 8/24/2022 ANAL CANCER, UNSPECIFIED SITE  CHRONIC HYPOXEMIC RESPIRATORY FAILURE 11/3/2022 ANAL CANCER, UNSPECIFIED SITE  HYPOXIA 8/30/2022 ANAL CANCER, UNSPECIFIED SITE  HYPOTENSION 8/24/2022 ANAL CANCER, UNSPECIFIED SITE  CHRONIC HYPOXEMIC RESPIRATORY FAILURE 11/3/2022 ANAL CANCER, UNSPECIFIED SITE  HYPOXIA 8/30/2022 ANAL CANCER, UNSPECIFIED SITE
Mom states pt had muscle pain, soreness, and jitteriness on entire R side of body 2-3 hrs after vaccine and lasted 2-3 days. Pt received vaccine in L arm.
Left hand in pain. Took ibuprofen as recommended by the Pharmacist. Pain has not gone away as of 9/13/2021.
Screaming RxN on 2/12/07 after immun. Mom states lasted 1 hr and 45 mins
Fever 103, severe chills, anxiety, nausea, pain in right flank. Swelling of ankles, left knee pain in joints. Numbness in all fingers in both hands. Taken by ambulance to hospital. Was release at 12:00 AM the following morning.
Patient received 2nd dose of pfizer 1033, Patient c/o dizziness and lightheadedness at 1043. Patient directed to lay down, offered water, vital signs taken. Symptoms improved. Patient went home at 1103
RTC: 10:154 wheezing, rash, itchiness, coughing. 10:20 : epinephrine 2 mg IM. 10:30 BP 85/53, P140. Pox 97. 10:35 Decade on 12mg IM. 10:40 Atravent by nebulizer, discharged home.