chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a patient that was given an expired dose of last year's formula of FLUZONE HIGH-DOSE with no adverse event; Initial information received on 23-Sep-2020 regarding an unsolicited valid non-serious case received from an other health care professional.  This case involves a 65 years old female patient who received a 0.5 ml once dose of an expired vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] Single-dose, prefilled syringe (lot: UJ311AB, expiry date: 30-Jun-2020), via unknown route and site, on 23-Sep-2020. (Expired product administered)  The patient's medical history, medical treatments, vaccinations and family history were not provided.  Concomitant medications were not reported.  It was an actual medication error due to expired vaccine used. It was reported that a patient was given an expired dose of Fluzone High-Dose. It was last year's formula of Fluzone High-Dose. (latency: on the same day)  At the time of reporting, the patient had no adverse event.  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.
Within 6 hours she developed right arm pain, generalized myalgias, temp to 104, headache and nausea. Emergency Room that day. WBC 16,600, ESR 6. Blood culture- negative. Antibiotics given and she has recovered.
doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 11:56 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 11:56 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  The excursion time on initial supply was 2P, temperature was 35, vaccine was not frozen prior to administration. Vaccine moved to fridge on 08-Jan-2021 and moved to clinic on 11-Jan-2021. 9 vials were sent to the clinic. BUD date was 07-Feb-2021. Vials only punctured right before administration.  Vial was stored on cooler 1 , on 11-Jan-2021, Excursion duration At 9 AM: 34, 10 AM: 37, 11 AM: 37, 12 AM: 35, 1PM : 36, 2 PM : 37, 3 PM: 37.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
A 15 and ½ year old received the vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Sep-2021 and was forwarded to Moderna on 09-Sep-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 15 and ½ year old received the vaccine) in a 15-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 15 and ½ year old received the vaccine). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 15 and ½ year old received the vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.
headaches; kinda unwell; difficulty in finishing sentences; feeling drugged; This is a spontaneous report from a contact physician (patient) from a Pfizer-sponsored program Pfizer First Connect. A female patient of unspecified age received the 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. After taking the Covid-19 vaccine, she's experiencing headaches, kinda unwell, difficulty in finishing sentences, and feeling drugged. Outcome of events was unknown.   Information on the lot/batch number has been requested.
low grade fever post 2nd dose of Pfizer covid vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose), for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "low grade fever post 2nd dose of Pfizer covid vaccine". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Flu like symptoms of chilling/sweating/muscle aches/headache/nausea/dry heaves. In bed for 24 hours. Today (6/19/2019) out of bed but eating toast and water. Weak and entire body sore
Vertigo, dizziness began and was treated with Meclizine 25.  Vertigo/dizziness, vomiting, difficult walking continued for about 3 hours until after taking meclizine.  Meclizine resulting in sleeping upon the next day symptoms were gone.  Similar events occurred after the second vaccination which was received on 04/13/21.  Meclizine was taken and the symptoms were gone.  However, balance issues, fullness in ears and ear ringing occurred.  ENT visit resulted in detection of hearing loss and tinnitus.  As of 3/22/2022 tinnitus is present in both ears and is continuous.
1105--pt c/o nausea (no vomiting), shortness of breath, chest tightness, diaphoretic, c/o jaw pain, shaky---Assessed by Dr and had pt drink 4 cups of water. 1115--BP 119/77 P 83 R 20; feeling very tired, less chest pain, less nauseated, jaw pain gone, still a little shaky. 1130--BP 120/75 P 80--feeling some pressure in forehead, sore neck, seeing bubbles, nausea and pain gone. 1135--ambulated in hall, steady on feet, bubbles going away. 1140--left clinic, going home.
Immediate ache at vaccination site.  By 6:15, upper arm around injection site to three inch diameter was red and swollen.  On 9/9 redness had moved downward toward elbow; by evening on 9/9 redness extended into chest wall.  On 9/10 injection site has less redness but redness continues toward elbow and into chest wall.  No itching.  Pain occurs when elbow is raised to shoulder height.
Developed papular/vesicules directly distal to injection site - to middle of forearm - LD scabs by day #7.
this is the 2nd booster shot, i received in left arm, the next 2 1/2 days my hurt at a pain level of 8+, also had dizziness, constant bowel movement extreem  weakness flu like symptoms, very light headed. overall body aches never had this type of reaction with other 3 doses. was very weird, especially have the injection site hurting for 2 1/2 days had a hard time moving my arm, i am better now, just thought you would like to know this.
Entire upper arm swollen, erythematous, tender and painful on right arm. Pt. has hx of latex allergy.
She was admitted at hospital on 8/8/21 due to altered mental status, fever, and SOB. Upon the initial evaluation, her chest xray showed possible pneumonia, and she was required to be on oxygen. She was discharged home on 8/11/21. She was readmitted on 8/23/21 due to AMS. She is discharged home on 8/27/21. Total of hospital days is 9 at Hospital.
Swollen, painful arm. Inability to move arm very much. Muscles feel like they are "seizing"  Treatment: ibuprofen, ice packs   Outcome: currently still extremely sore (3days after shot)
patient received quadracel instead of the pentacel with no reported adverse event; patient received quadracel at a age of 2 years with no reported adverse event; Initial information was received on 30-Aug-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 2 years old male patient who received quadracel instead of the pentacel with no reported adverse event and patient received quadracel at age of 2 years with no reported adverse event Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/IPV (MRC5) Vaccine [Quadracel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Measles Vaccine, Mumps Vaccine, Rubella Vaccine (MMR) for Prophylactic vaccination; and HIB Vaccine CONJ (TET TOX) (ACTHIB) for Prophylactic vaccination.  On 22-Aug-2022, the patient received 0.5 ml dose of Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/IPV (MRC5) Vaccine (frequency: once; strength: standard; batch/lot number: C5862BA; expiration date: 01-Apr-2023) via intramuscular route in the left thigh for Immunization.  On 22-AUG-2022, same day, it was reported that the patient received quadracel instead of the pentacel (wrong product administered) and patient was 2 years old (product administered to patient of inappropriate age) following the administration of Diphtheria-15/Tetanus/5 Hybrid Ac Pertussis/IPV (MRC5) Vaccine.  No adverse event was reported.  Seriousness criteria: non-serious  Action taken: not applicable  Outcome: unknown for both events  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 guidelines. 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.
pain beginning in arm pit, increasing in severity over days. Today, increased to pain from hip to upper trapezius muscle, down arm and into left breast. After a few hours, pain radiating under rib cage. skin sensitivity almost like a burning sensation with clothes touching, as well as tingling in left arm.
Pt vaccinated with DTP developed sore arm 5 days after injection because abscessed required incision & drainage grew Group A Beta Strep inspite of Amoxicillin Administered orally.
Swollen and sore lymph node on side of injection. Anxiety with chest tightness and shortness of breath
Patient came to staff and said she was "very hot and itching all over", very shaky.  Nurses visibly saw patient's skin angry red and patient scratching all over. Vitals were checked, ABC's were done. Gave patient an injection of Benadryl 50mg IM right arm. Covid vaccine given in left arm.  Had a nurse sit with her for another 30min. patient reported the itchiness and redness was resolving after 10 min, by 25min the symptoms returned and pt started to clear her throat. She denied any throat fullness or cough, vitals were checked 4 times, stable. Epi-pen was administered and 911 was called. Patient was alert and oriented x 4, no SOB or respiratory distress reported.
Pain/ hurting/hurt when moving a certain way; Discomfort; This case was reported by a nurse via call center representative and described the occurrence of pain in a 44-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number 3DE4L, expiry date 30th June 2020) for prophylaxis.   On 16th October 2019, the patient received Fluarix Quadrivalent 2019-2020 season. On 6th November 2019, 21 days after receiving Fluarix Quadrivalent 2019-2020 season and an unknown time after starting ibuprofen, the patient experienced pain. In November 2019, the patient experienced movement disorder and discomfort. The patient was treated with ibuprofen and paracetamol (Tylenol). On an unknown date, the outcome of the pain, movement disorder and discomfort were not recovered/not resolved.   It was unknown if the reporter considered the pain, movement disorder and discomfort to be related to Fluarix Quadrivalent 2019-2020 season.  Additional case details were reported as follows: The patient received Fluarix Quadrivalent 2019-2020 season in her right arm. The patient explained that, she was still in a lot of pain with no bruising or swelling but it hurt when moving a certain way. The patient was instructed by her primary care physician to rotate between Ibuprofen and Tylenol but she still had discomfort. The reporter consented to follow up. This case has been linked with case US2019209098, reported by the same reporter.
The pt developed a pale complexion followed by tensing of muscles, purple lips, eyes rolled back into head, convulsions (these episodes together lasted less than 1 minute). Treatment was oxygen administered when pt fell into deep sleep.
8 red dots appeared vertically on arm under injection site; Fatigue; bruised immediately after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (bruised immediately after vaccination), VACCINATION SITE ERYTHEMA (8 red dots appeared vertically on arm under injection site) and FATIGUE (Fatigue) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 26-Jan-2021, the patient experienced VACCINATION SITE BRUISING (bruised immediately after vaccination). On 27-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (8 red dots appeared vertically on arm under injection site) and FATIGUE (Fatigue). At the time of the report, VACCINATION SITE BRUISING (bruised immediately after vaccination), VACCINATION SITE ERYTHEMA (8 red dots appeared vertically on arm under injection site) and FATIGUE (Fatigue) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Fever around 100; Achy joints; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever around 100) and ARTHRALGIA (Achy joints) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A.) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced PYREXIA (Fever around 100) and ARTHRALGIA (Achy joints). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 20-Apr-2021, PYREXIA (Fever around 100) and ARTHRALGIA (Achy joints) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Apr-2021, Body temperature: 100 (Inconclusive) fever around 100.         No concomitant medications were provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-083367 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-083367:
This spontaneous report was received from Registered Nurse who reported that on unspecified dates a unknown number of patients (ages and gender not reported) were vaccinated with a dose of VAQTA (dose and site not reported) which were improperly stored. No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Follow up information has been received on 28-OCT-2014 from Registered Nurse reported that 3 patients of 2 years old with unknown gender were vaccinated with VAQTA (2 doses) (lot # J005010 and expiration date was 23-OCT-2015) (dose and route were not reported) which were improperly stored. This is one of the several reports from the same source. Additional information has been requested.
Patient got vaccinated, left facility, and then returned because her blood pressure dropped and she began having difficulty breathing. She was loaded into an ambulance and administered oxygen for 2-3 minutes on the way to  Hospital. Her blood glucose and EKG results came back normal, and she was discharged the same day. Patient mentioned during a follow-up call with Hospital staff on 5/13/21 that she had 3 similar but less severe breathing episodes between vaccination and 5/4. She did not visit a care facility and reports feeling fine since. Hospital staff referred her to a private provider and advised her to visit an ER or urgent care facility if she experiences another episode.
The patient received LAIV on 3 Dec 2015 (lot# FK2037) and 6-8 hours later developed facial edema, severe pruritus to eyes, especially lids, rhinitis, conjunctivitis, flushing to face and lips, minor wheezing and urticaria to her chest. She had generalized pruritus. They deny dyspnea, chest pain, nausea or emesis. She was seen in ER and given oral steroids, BENADRYL, and antiinflammatories. They report she has continued to have intermittent episodes typically 2-3 times per week, managed with BENADRYL. She had such severe pruritus she 'pulled all her eyelashes and some of her brows out.' She has recurrent headaches and has a neurology referral. She had one episode of similar dermatology symptoms after body wash and shampoo brands were changed. She also has increased temperatures, with a high of 100, although had a cold that day. She has continued increased nasal blockage. She has continued increased ear pain. She was referred for allergy evaluation for alternate etiologies, as delayed timing, identification of an alternate trigger and continued recurrence do not support the LAIV as causal, although may have exacerbated conjunctival symptoms.
Dizziness, nausea, irregular HR. EKC revealed AF. Drank full glass of red wine at 2 AM on the day of the vaccine. Went to the ED
29 year old female patient was administered expired dose of TENIVAC, with no adverse event; Initial information received on 27-Apr-2021 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 29 year old female patient who was administered expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (expired product administered).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On 26-Apr-2021, the patient received a 0.5 ml booster dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot U6265AA and expiry date: 19-Apr-2021) (Frequency: Once) via an intramuscular route at an the deltoid NOS (not otherwise specified) for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency on same day).  It was also reported that this case was placed in proxy as there was no one available during the time of the attempted transfer. A call back is needed for assistance. The caller stated that her previous call was disconnected and is calling back because she wanted to know if there is any data supporting the use of expired TENIVAC. The caller stated that the product expired last week and was administered today. The caller would like to know if the patient must be revaccinated. The TENIVAC was given in the deltoid, but they not sure if it was left or right deltoid. No further information was provided.  At the time of report no adverse event was 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.
THE PATIENT WAS UNDER THE AGE OF 18 AND RECEIVED THE BIVALENT MODERNA BOOSTER. SHE RECEIVED PFIZER FOR HER PRIMARY SERIES. SHE ALSO RECEIVED AN INFLUENZA VACCINATION THE SAME DAY (AFLURIA PF QUAD 0.5ML IN HER LEFT ARM). NO HARM CAME TO THE PATIENT.  THE NURSE CALLED HER THE NEXT DAY AND PATIENT'S MOTHER REPORTED NO SIDE EFFECTS.
02/01/2022 - 55-year-old woman with history of schizophrenia, chronic urinary retention  requiring Foley catheter, seizure disorder presents with headache and chest pain.  Initial vital signs significant for oxygen saturation 89% and tachycardia to 125.  Oxygenation improved to mid 90s with 2 L by nasal cannula. EKG shows sinus  tachycardia with rate 105, normal axis, normal intervals, no ST elevations or  depressions, initial troponin negative. Chest x-ray without evidence of  pneumonia. Labs show no leukocytosis, hemoglobin normal not suggestive of acute  blood loss, slight LFT elevation but at baseline, normal bilirubin and lipase,  normal lactate not suggestive of sepsis, urinalysis not strongly suggestive of  infection and low suspicion in absence of symptoms. D-dimer is elevated to 1.96.  Covid swab is positive.  Patient's tachycardia did improve with fluids, making  suspicion for pulmonary embolism and lower so CT was deferred.  Patient requires  admission given her hypoxia and will be started on remdesivir and dexamethasone.  02/01/2022 - Patient arrived to floor from ED at 1605. Transferred self to bed from w/c. O2  saturation 92%RA. Patient placed on oxygen 1L/NC. Admission assessment completed.  Patient received Remdesivir, and evening dose of Phenobarbital, Keppra, and  Potassium 40 mEq now dose at 1730.  02/06/2022 - Patient discharged from facility following covid-19/hypoxia
Erythematous patch at right upper arm, non tender Benadryl and Tylenol.