chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Site pain after vaccination; The vaccine administered was exposed to 32F for max of 6 hours; The vaccine administered was exposed to 32F for max of 6 hours; This spontaneous case was received on 06-Mar-2021 from a pharmacist via Communications (reference number: SEQW21-00914) with additional information (being processed together) received on 11-Mar-2021 and concerned a 24-year-old, male patient.  The patient had no relevant medical history and was not taking any concomitant medications.   On an unspecified date, the Flucelvax Quadrivalent multidose vial (influenza vaccine, subunit influenza virus vaccine polyvalent) reached 32 degrees Fahrenheit (F) for maximum six hours (explicitly coded as 'Product storage error temperature too low'). There was another excursion at 35.5 F, but it was confirmed that the temperature was under the range of recommended storage conditions. The batch number was not reported.   On 05-Mar-2021, after temperature excursion, the patient was vaccinated with Flucelvax Quadrivalent (dose: 0.5 ml, route of administration: intramuscular and anatomical location: deltoid) for influenza prophylaxis (explicitly coded as 'Product administration error').  On the same day, after receiving Flucelvax Quadrivalent, the patient experienced site pain. No treatment measures were taken.  At the time of initial reporting on 06-Mar-2021, the patient had not recovered from the event of 'vaccination site pain'.   The reporter did not provide causality assessment.  The reporter assessed the case as non-serious.  Company comment: The event of 'vaccination site pain' is assessed as related to Flucelvax Quadrivalent. The events of 'product storage error temperature too low' and 'product administration error' are considered as not related to Flucelvax Quadrivalent.; Sender's Comments: The event of 'vaccination site pain' is assessed as related to Flucelvax Quadrivalent. The events of 'product storage error temperature too low' and 'product administration error' are considered as not related to Flucelvax Quadrivalent.
Patient administered Fluzone QIV with no reported adverse event; Initial information received on 08-Sep-2022 regarding an unsolicited valid non-serious case received via health professional.  This case involves a 26-year-old female patient who was exposed to vaccine Influenza Quadrival A-B Vaccine [Fluzone Quadrivalent] in context of patient administered fluzone qiv with no reported adverse event. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known at 22 weeks, during second pregnancy trimester.  The date of last menstrual period was reported as 12-Apr-2022. The estimated due date is 17-Jan-2023. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 07-Sep-2022, the regnant patient received suspect Fluzone Quadrivalent vaccine at unknown dose (lot UT7682KA) via intramuscular route in unknown administration site for prophylactic vaccination with no reported adverse event (exposure during pregnancy) same day latency.  Action taken: Not applicable.  At time of reporting, the outcome was Unknown for the event patient administered fluzone qiv with no reported adverse event. Additionally, at time of reporting, the pregnancy is still ongoing.
Pt was hospitalized due to positive COVID 19  and hypoxia from 2/2/21 and 2/5/21. Pt had a 4 day history of weakness, abdominal pain, and shortness of breath. Pt tested positive for COVID 19 and was hypoxic requiring hospitalization. Pt was treated with Remdesivir and Dexamethasone in hospital and weaned off oxygen at discharge. Py had CT of chest showing groundglass opacity. Pt had received her first Moderna COVID 19 vaccine previously on 1/26/21.
Woke up extremely nauseous at 4 in the morning the morning after and vomited multiple times. Still nauseous now. Otherwise, intense chills, weakness.
The patient received half of the dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (The patient received half of the dose) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (The patient received half of the dose). At the time of the report, ACCIDENTAL UNDERDOSE (The patient received half of the dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant Concomitant Medications were reported. No Treatment Information Provided.
48 hours temp range 98.2 - 104 decreasing with tylenol-ibuprofen.  Rash presents neck and ear area. 1-29-04 2:30 pm flat to macular-red-spreading to trunk by 5 pm - 1-30-04 3 am emesis x1-rash to face-by 10am 1-30-04 rash fading-to Dr. -1-29-04 lungs CTA-fluid on ears rx zithromax.
1116 - c/o throat tightness, given Benadryl 25mg PO, VS 139/85, 104, 95, 18 1120 - VS 125/78, 98, 96, throat tightness improving at this time 1131 - talking, laughing VS 131/76, 97, 96, 16 1139 - VS 125/76, 94, 96, 16, No SOB observed 1148 - VS 120/80, 89, 97, 16, No acute distress noted 1151 - D/C to home. NAD observed.
Dad calling clinic on 11/5/2021 stating child had a nose bleed 10/6-10/18 after receiving vaccine. Dad just watched at home. Child NOT evaluated by us during symptoms
No symptoms reported; 5 year old patient received unspecified dose in PROQUAD innnunization series that was improperly stored; This spontaneous report was received from a licensed practical nurse, concerning a 5-year-old patient of unknown gender. The patient's past drug and pertinent medical history, as well as the concomitant medications and drug reaction or allergies, were not provided.  On 13-MAR-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA) (PROQUAD) for prophylaxis (product storage error) (lot number S003866  has been verified to be a valid lot number, expiration date reported as 08-AUG-2020, but upon internal validation, it was established 08-AUG-2024) (concentration, route of administration, frequency of vaccination scheme and anatomical location of vaccination were not reported).  The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin (rHA) (PROQUAD) underwent a temperature excursion at 38.1 degrees Fahrenheit for a time frame of 20.7 hours as recorded by the data logger. There were no other temperature excursions previously.  The diluent used was properly stored.   No symptoms were reported.
Patient states that the 2nd night after having gotten the shot he had extreme muscle weakness (in the middle of the night) and had trouble being able to stand / walk  (concerned he may be having a stroke based on symptoms). He contacted the Dr via phone the next morning, but he did not have any other stroke symptoms and the symptoms have since resolved.
Upper and lower arm are red / very red; Blister inside the upper arm; Redness at the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 11th September 2019, 2 days after receiving Shingrix, the patient experienced injection site erythema. On 15th September 2019, the patient experienced erythema of extremities and blister. On an unknown date, the outcome of the injection site erythema, erythema of extremities and blister were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, erythema of extremities and blister to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine on unknown arm. About 5 days later the patient visited the pharmacy and there was redness at the injection site.  The patient said the redness started about 2 days after getting the vaccine.  The patient was instructed to put an icepack on the redness.  The patient was at the pharmacy again on day before reporting and 6 days after receiving Shingrix his upper and lower arm are red and there was a blister at the injection site. It was not itchy or painful, but very red. Upon call back to healthcare professional on day of reporting, they stated that the blister was not at the injection site on arm but inside the upper arm. The reporter consented to follow up. In the document outcome of events was reported as recovering, but its mentioned as not recovered, so kept as reported.
Peripheral Neuropathy.  No history of diabetes or cancer treatment chemotherapy that would cause this.
Information has been received from a physician concerning a 4 yr old male with asthma and respiratory allergies who on 30Aug04 at 15:00 was vaccinated SC with a first 0.5 dose of varicella virus vaccine live (lot647528/1242N). There was no illness at the time of vaccination. On 30Aug04, one hr post vaccination, the pt developed hives and an itchy throat (also reported as one half post vaccination). Unspecified medical attention was sought. No laboratory or diagnostic tests were performed. The pt took diphenhydramine hydrochloride (Benadryl) and albuterol inhaler and improved.  Later that same day, the pt recovered from hives and itchy throat. No product quality complaint was involved. The physician considered the hives and itchy throat to be other important medical events (OMIC). It was also reported that the pt had an adverse event following vaccination with  measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3)  (WAES0509USA03077). Additional information is not expected.
Patient diagnosed with COVID-19 6/20/2022. Admitted through ER locally, on 6/26/2022. Patient died 6/26/2022 at 1800 per hospital report.
Information has been received from a pharmacist referring to unspecified numbers of patients with unknown age and gender. There was no information about the patients' medical history and concurrent condition. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (dose, lot# and route unknown). There was no information about concomitant therapy. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Narrative:  Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. PMH significant for malignant neoplasm of lung, pvd, carotid artery stenosis, hyperlipidemia, coronary atherosclerosis, HTN. Pt presented to ED on 4/19/21 with CC of SOB x 3 days. Received antibiotics for multifocal pneumonia, tested negative for covid. He was found to have worsening leukocytosis, renal function and hypoxia on 4/24. Was intubated with vasopressors and septic but did not improve. Was extubated. Deceased 5/1/2021.
Terrible headache; Tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tired) and HEADACHE (Terrible headache) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Tired). On 19-Mar-2021, the patient experienced HEADACHE (Terrible headache). At the time of the report, FATIGUE (Tired) and HEADACHE (Terrible headache) outcome was unknown. Not Provided          Concomitant product information was not provided. Had a terrible headache after using Fluticasone propionate.(Aller-flo). During the follow up Patient said he had both shots and is "happy with it."   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow up information received on 24 May 2021 does not contain any new information.
MOTHER BROUGHT PATIENT ON MONDAY WITH BUMPS AND REDNESS TO LEFT THIGH WHERE VACCINE WHERE ADMINISTRED. MOM DENIES FEVER OR ITCHINESS.
Nausea, diarrhea, dizziness, rash on hand, muscle soreness in arms, arm pain at site of administration, and blurry vision. Still having blurry vision and diarrhea after 3 days
I received the first vaccine without a single side effect. However, the evening after receiving my second dose, I began to get chills, a fever of 101.7, and night sweats. The next morning I woke up to two rashes on my chest. I continued to experience chills, a fever of 102, and the rash now covers my entire body, including my face. The rash is painful, itchy, and bumpy. This is day two. I have swollen lymph nodes in my neck. The urgent care I saw today told me to watch my throat to make sure it doesn't close up.
Pt stated he felt short of breath, shaky and had a fast heart rate at about 1 minute after the vaccine was administered. Initial blood pressure was 168/108 with a HR of 112, lung sounds were clear in all fields. Pt was laid down on a stretcher and assessed immediately after the incident. Subsequent vitals were BP 148/94, HR 108, LS clear. Before leaving pt stated he felt better. Advised to seek emergency medical treatment if symptoms returned or worsened. Pt's wife drove him home.
No adverse event; Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in an 88-year-old female patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    Patient's age was reported 88 years 8 months.  No concomitant medications were reported.  The reporter informed that, the expired Moderna vaccine was administered to the patient between 08-Apr-2022 to 15-Dec-2022.  No treatment medications were reported.
Left side of my face went numb, left side of arm went numb, cramps bath of my legs, headache, nausea 1st evening after covid shot. 2nd day so very tired, very nauseous and headache. The next two days i could not even get out of bed. I was beyond tired, horrid headaches, my left leg would feel asleep my stomach hurt so bad. Nothing would ease headaches just a constant headache. my left arm would feel odd achy then my heart would feel sore and my chest. It was a very odd feeling. Then on Monday i felt just so overwhelmingly tired. I never sleep during day and i fell sound asleep.I have not felt completely well since the 1st shot. I get nauseous spells , headaches and so tired i can't hold my eyes open and sometimes my  the area btw my arm where i got shot and heart just feel sore and my heart skips. I am due to get 2nd shot in 3 days 2/18 and I'm not sure my body is could handle another reaction like that. I got shot in my left arm on 1/27/2022
administered Engerix Recalled  lot; administered Engerix Recalled  lot; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B pediatric) (batch number CP23D, expiry date December 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric 10 mcg .5 ml and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The medical assistant reported that, the patient administered Engerix B recalled Lot number back in June 2021 through July 2021, which led to recalled drug administered and drug dispensing error. The medical assistant unable to provide patients details. The reporter did not consent to follow up. This case was 1 of 70 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021223559:Same reporter US-GLAXOSMITHKLINE-US2021AMR224766:Same reporter
Patient developed headaches 2 days after receiving the vaccine.  Headaches have been every other day and associated with nausea.  Headaches occasionally wake her up at night and pain can be up to a 7 out of 10.  No associated neurologic symptoms.  Headaches have not improved over time.  No previous headaches prior to the vaccine.
Approximately 10 minutes after receiving the vaccine pt reported flushed area near chest.  Denied itching or dyspnea.  Speech clear. md notified and requested patient take benadryl 25mg oral now - given to patient. patient is under observation for 1 hour of time.
Administered high on shoulders, likely into subacromial bursae leading to likely SIRVA.
I contacted staff at pharmacy to make an appointment for a #13 pneumococcal vaccine prior to my visit on Friday, June 12.  I stated my health condition and she indicated I did not need an appointment. On June 12, I arrived at pharmacy just prior to 9:00 a.m. Person was one of the pharmacy staff members I greeted as they arrived to work.    When the pharmacy opened, I approached the counter and asked staff for the pneumococcal vaccine shot.  Staff, who appeared to be training a male employee, asked why I needed the vaccine.  I explained to staff that we previously spoke on the phone at which time I provided her with my information and confirmed my insurance was covering this vaccine.  She said the only way insurance would cover this for my age was if I had ?a disease? and asked me in front of other customers if I had ?a disease?. Despite being uncomfortable answering her question in front of other customers, I answered ?yes?. She then asked ?which disease?? and I responded despite being uncomfortable with other customers present.  While she and I completed billing documents she often turned to the trainee as he posed several questions including ?Who normally gives the vaccines??  After completing documents, I was asked to wait by a small private area. A few minutes later, the hesitant young man directed me to a small room where he would give me the vaccine.  Since he seemed unsure, I asked him to verify which vaccine he was administering.  He confirmed and proceeded with the shot on my left shoulder.  I became aware of sharp pain while entering my vehicle and noticed that the Band-Aid provided by the pharmacy was placed unusually high on my shoulder. Due to the pain in my shoulder, I limited activity hoping it would resolve in a couple of days. Since the pain did not resolve, I researched and based on the injection site, I fear this vaccine was not properly administered.  It is evident that this young man was improperly trained.  He administered the vaccine at an incorrect site and it appears an improper sized needle was used based on the fact that I weigh less than 100 lbs.    Presently I still have pain and limited range of motion on my left arm.  I have a future appointment with a neurologist.
Since 10/19/15, pt c/o having cough, diarrhea, Lt arm pain, back pain, achy and fatigue. Pt was given DEPO-MEDROL 60mg IM, codeine-guaifenesin, albuterol inhaler at appt on 10/22/15. On 10/19/15 pt received knee injection of MARCAINE and KENALOG.
administered the Adacel (Tdap) prefilled syringe instead of DTaP today with no reported adverse event; Initial information received from United States on 20-Jan-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 5 years old male patient who was administered the adacel (tdap) prefilled syringe instead of dtap today with no reported adverse event while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 20-Jan-2022, the patient received a  dose (0.5 ml 1X (once) prefilled syringe ) of suspect diphtheria-2/tetanus/5 ac pertussis vaccine lot: U7187AA, expiry date: 28-Sep-2023 via intramuscular route in unknown administration site for immunization.  On 20-JAN-2022 the patient developed a non-serious administered the adacel (tdap) prefilled syringe instead of dtap today with no reported adverse event (wrong product administered) same day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was reported, Pharmacist stated that a male patient, who she believes was 5 years old, was inadvertently administered intramuscularly the Adacel (Tdap) prefilled syringe instead of DTaP today (20 Jan 2022).  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the event (administered the Adacel (Tdap) prefilled syringe instead of DTaP today with no reported adverse event).  At time of reporting, the outcome was Unknown for the event administered the adacel (tdap) prefilled syringe instead of dtap today with no reported 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 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.