chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided. The vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration. The vials did not undergo any temperature excursions.
SORENESS AT INJECTION SITE  FEVER AND SORENESS LASTED  THREE DAYS
gave her/adjuvant suspension/did not reconstitute the vial of lyophilized gE antigen; gave her/adjuvant suspension/did not reconstitute the vial of lyophilized gE antigen; This case was reported by a consumer via call center representative and described the occurrence of inappropriate reconstitution technique in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate reconstitution technique and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate reconstitution technique and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The case was reported by the husband of the patient. The age at vaccination was not reported. The husband reported that they only gave her a single-dose vial of adjuvant suspension component and did not reconstitute the vial of lyophilized gE antigen component, which led to inappropriate reconstitution technique and inappropriate dose of vaccine administered. No further information was reported. The reporter consented to follow up.
patient complained of feeling pressure on her tongue when swallowing post vaccine. Patient given PO diphenhydramine and felt better
Not enough room to list all. Lost range of motion "slippy shoulder". "Crunchy" in joint, felt like slush in joint. Painful moving. Wakes me up I can no longer work at my career of 21 years as a dancer.
2 hours after shot started to get hives and itchy on certain parts of the body, also had some difficultly breathing for 24 hours. After 24 hours, breathing was better but hives and itchy on right upper thigh, left and right arm/hand, and left side of torso and chest. After 48 hours from shot, there has been no improvement in reaction.
This patient is a 56 y.o. female presenting to the emergency department with a chief complaint of a possible reaction to the COVID vaccine onset 2 days ago. The patient states that she has had a fever, chills, adenopathy, and body aches since her vaccination. Her highest recorded temperature was 101F, and she has been taking Tylenol. She states that her biggest concern is the adenopathy under her right armpit which is painful to touch. She denies any masses. She saw her PCP on 12/24 and had blood work done, which showed an elevated white count of 17.
This is 91-year-old male who was admitted due to COVID-19 pneumonia on 9/6 and progressively worsening.  was admitted after he had noticed weakness and fall as well as shortness of breath. Initially required 3 to 4 L oxygen by nasal cannula. He was given steroids oxygen and breathing treatment. He progressively worsened and required up to 15 L oxygen by nasal cannula. He also had agitation and soft restraints were placed. He was placed on high flow oxygen with 100% FiO2, 55 L/min as his hypoxia worsened. Family eventually decided to switch him to comfort care only. Patient was seen by palliative care. He met inpatient GIP criteria. He does not have good oral intake. He is somnolent.
Right sided facial drooping and edema 8 days after Moderna #1. Sought care - prescribed Valtrex 1 gram TID for 7 days and Prednisone 60mg Q day x 7 days. She recently established care with new PCP. She has not seen PCP yet and has a virtual visit scheduled for sometime in June. Patient informs me she has not completely recovered  from this event and she can not completely shut right eye.
Bilat thighs developed lg oval area reddened with small white pustules lasting several days.
Stroke(s) 40 days after 3rd booster, second stroke 60 days hospitalized after 3rd booster.. Clot in thymus
Appeared to be a raised, swollen, red area on the thigh right where the vaccine was injected.  You can still see the "pinhole" where the needle entered the skin.  Area was approximately 2 1/2 inches long and about 1- 1 1/2 inches wide.  Child said it hurt, was sore to the touch.  Very inflamed.  Took child to physician on Monday, 11/14 where she was diagnosed with a skin infection and put on antibiotics.  Now a gland in her groin is also swollen, reported this to physician today, 11/16.
Dose administered after 30-day Use By Date; Vial reached a maximum temperature of 15C for 1 hour & 43 minutes; Vial stored in refrigerator on 04-Apr-2022 and administered on 08-Jul-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT TEMPERATURE EXCURSION ISSUE (Vial reached a maximum temperature of 15C for 1 hour & 43 minutes) and PRODUCT STORAGE ERROR (Vial stored in refrigerator on 04-Apr-2022 and administered on 08-Jul-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 065K21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Apr-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vial reached a maximum temperature of 15C for 1 hour & 43 minutes) and PRODUCT STORAGE ERROR (Vial stored in refrigerator on 04-Apr-2022 and administered on 08-Jul-2022). On 08-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT TEMPERATURE EXCURSION ISSUE (Vial reached a maximum temperature of 15C for 1 hour & 43 minutes) and PRODUCT STORAGE ERROR (Vial stored in refrigerator on 04-Apr-2022 and administered on 08-Jul-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Vial was initially stored in the refrigerator on 4-Apr-2022.  On 4-Apr-2022 after the vial was placed in the refrigerator to thaw, the refrigerator was left open and the vial reached a maximum temperature of 15C for 1 hour & 43 minutes. The Excursion tool was used at that time which gave the results involving the 24 cumulative time frame.  At the time of excursion storage condition was refrigerated.  The vial was stored in fridge currently.  Any vaccine state change after visual inspection was not sure.  One vial was impacted.  No treatment information was provided.
symptomatic with cough on 12/27/22. Positive test on 12/28/22. Transferred from Facility to Facility on 12/29/22.
Pt. received a dose of influenza vaccine (flucelvax) and approx. 5 min after she developed some vision changes. Pt stated it seemed like there was a bright part and black area around it and it was fading and freezing for a bit. The incident lasted approx. 6 min per the pt. Pt denied any lasting or residual adverse effects and her vision has returned to normal.
Fever; chills; soreness at injection spot; body and joint aches; body and joint aches; headache; nausea; eye ache and watery; eye ache and watery; This is a spontaneous report received from a non-contactable consumer (patient). A 42-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 9267, expiry date: unknown), via an unspecified route of administration in the left arm, on 13Feb2021 09:30, at single dose, for COVID-19 immunization, at the hospital. There were no medical history and concomitant medications.  The patient has no allergies to medications, food, or other products and was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 9261, expiry date: unknown) received at 42 years of age, via an unspecified route of administration in the left arm, on 23Jan2021 09:30, at single dose, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2 vaccine. On 13Feb2021 at 18:00, the patient experienced fever, chills, soreness at injection spot, body and joint aches, headache, nausea, and eye ache and watery. No treatment was given for the events. The patient recovered on an unspecified date in Feb2021. The reporter assessed the events as non-serious.  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information regarding the patients' pertinent medical history, concurrent conditions, concomitant and historical drugs were not provided. On 18-JAN-2019, two patients were vaccinated with improperly stored doses (also capture in 1901USA010528) of VARIVAX Lot # R022116, expiration date 02-AUG-2020, subcutaneously (strength, dose, dose number, and anatomical location were not provided) for prophylaxis. The sterile Diluent used to reconstitute the VARIVAX was stored properly. The vaccines were exposed to a temperature of 15 Fahrenheit degrees to 46 Fahrenheit degrees (18.9 Fahrenheit degrees) for 30 minutes. There was a previous temperature excursion from 15 Fahrenheit degrees to 46 Fahrenheit degrees (16.7 Fahrenheit degrees) for 30 minutes, 15 Fahrenheit degrees to 46 Fahrenheit degrees (23.3 Fahrenheit degrees) for 50 minutes, 6 Fahrenheit degrees to 14 Fahrenheit degrees for 30 minutes, 15 Fahrenheit degrees to 46 Fahrenheit degrees for 30 minutes, and 15 Fahrenheit degrees to 46 Fahrenheit degrees (25 Fahrenheit degrees) for 50 minutes. It was reported that digital data logger was involved. No adverse effects were reported. This is one of two cases reported, received from the same reporter. Sender's Comments: US-009507513-1901USA010528: Same reporter Link.
Expired vaccine used; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter.  No treatment medication was provided.
Ulcerative Colitis; This is a spontaneous report from a contactable consumer (Patient, reported for self). A 54-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0158, Expiration date: Not reported), via an unspecified route of administration, administered in Arm Left on 20Apr2021 at 12:15 (at the age of 54-years-old) as dose 2, single for COVID-19 immunization. The patient past Medical history included autoimmune hemolytic anemia (Auto immune hemolytic anemia when I was in my 20s)from an unspecified date and unknown if ongoing and known allergies includes seafood allergy (shell fish). The patient had earlier received first dose of BNT162B2 on 23Mar2021; lot number: EN6198; as single for COVID-19 immunization. The patient's concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. The patient has not received other medications in 2 weeks of vaccination. On 21Apr2021 at 18:00, 1-2 days after the 2nd dose of Pfizer COVID vaccine the patient experienced diarrhea and has lasted for over 8 weeks. Sometimes very sever and bloody. Patient had a colonoscopy last week and was diagnosed with Ulcerative Colitis and never had any digestive issues prior to the 2nd vaccine. However, did have prior auto immune problems. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests which included colonoscopy: Ulcerative colitis on an unspecified date. The patient had been tested for COVID-19 post vaccination on 29May2021, [COVID test type: Nasal Swab] COVID-19 test result was Negative. The patient was treated with Colonoscopy and now on steroids. The event outcome was reported as Unknown. Device Date : 12Jun2021
This spontaneous report was received from a health care worker referring to an unspecified number of patients of unknown ages and genders. Information regarding medical history or concurrent conditions were not informed. On an unknown date, the patients were vaccinated with improperly stored doses of PEDVAXHIB (which had the lot # reported as M006709, expiration date 05-DEC-2018, lot # L042258, expiration date 18-AUG-2018, lot # L014428 expiration date 12-MAR-2018, lot # L038502, expiration date 16-AUG-2018) (dose, route and anatomical site of vaccination were not provided. Information regarding concomitant medication was not reported. No adverse effects were reported. And there was not product quality complaint involved. This is one of several cases from the same reporter. Additional information has been requested.
TEMPERATURE EXCURSION, vaccine was stored in freezer longer than manufactures recommendation. PATIENT DID NOT HAVE ANY ADVERSE REACTION TO THE VACCINE
Vertigo; Dizzy; Lightheaded; Get really bad; Feels uneasy; A spontaneous report was received from a consumer, a 78-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273), and who experienced vertigo, dizzy (dizziness), lightheaded (dizziness), get really bad (malaise), and feels uneasy (malaise).   The patient's medical history was not provided. Concomitant medication use was not provided.   On 25 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 012M20A) for prophylaxis of COVID-19 infection.   On 1 Feb 2021, the patient started to "get really bad". The room was spinning (vertigo) and she was also dizzy and lightheaded.  On 02 Feb 2021, the patient still had the same symptoms. It was reported that the patient was evaluated and spent one day in the hospital.  On 10 Feb 2021, the patient reported that every once in a while, she is lightheaded and feels uneasy. Treatment for the event included meclizine.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, vertigo, dizzy, and get really bad, was unknown. The outcome of events of lightheaded and feels uneasy was not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
1/12/2021 fever 101.2 body aches chills fatigue still continue yesterday diarrhea symptoms lasted x2 days 11/20/2021 noted left arm with inches all around with bright red patches redness lt arm around injection site. Denies pain  Taking Tylenol
Mother called 09/12/2005 claims child has had vomiting since he received immunization on 08/29/2005. He developed a rash 3 days ago, Red with a pinpoint look, No oozing or pruritus. Called mom later in the day 4:02 pm no vomiting this day no increase in rash. Mom told to take child to PMD 09/19/2005 mom took child to ER no TX given. Resolved on its own.
Began with rash maculopapular 4-15-14 arm, leg, torso and face (12-13 lesions) no vesicles.
Patient found unresponsive in chair and incontinent of urine. Returned to consciousness and oriented to surroundings. Patient still lethargic EMS took patient vital signs. Patient vomited. Wife was notified. Patient transported to emergency room via ambulance.
Pt received vaccine 2/12/03, today 2/14/03 presented at clinic with inflammation on lt deltoid approx 2" in diameter. Slightly raised bump at site of injection. Mom states child moved around at time of injection. Dr evaluated child and gave mom reassurance, suggested ice packs, Advil, and call PRN.
Information has been received from a registered nurse concerning a female (age not reported) who on 10/30/06 was vaccainted with HPV vaccine. Subsequently, the pt experienced redness in her face and had vomited. The pt sought unspecified medical attention. At the time of this report, the pt was recovering from the event. Additional information has been requested.
The patient's past medical history included Alcohol use (Prior use-twice monthly). Concurrent medical conditions included Migraine (Migraine with Aura), Anxiety and Allergic asthma. Concomitant products included ONDANSETRON (ZOFRAN MELT) for Nausea, DOXYLAMINE SUCCINATE (UNISOM 2), VITAMIN B6, VITAMIN D NOS and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 01-May-2020 and the estimated date of delivery was 16-Feb-2021. On 09-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  forty-fourth week of the pregnancy. The delivery occurred  on 17-Feb-2021, which was reported as Full-term. For neonate 1, the birth weight was 3390 grams (7lbs 8oz). The outcome was reported as Term Birth NOS. Length of the baby was 51 cm and head circumference was 33 cm. On 09-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-May-2020, Pregnancy test: positive (Positive) positive. In February 2021, Ultrasound scan: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 01 Mar 2017 and 15 Sep 2019 patient had  stillbirth. On 30 Jan 2018 and 17 Feb 2021 patient had full term birth. The estimated due date of conception was 14 May 2020. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow up information was received and the patient demographics, past medical history, pregnancy information were updated.
Patient informed the RN that she had a reaction to the Bexsero vaccine given to her. Patient said that she developed a rash at the injection site and went to urgent care as it was ?getting bigger on her skin?. Urgent care gave her an ?antibiotic pill? and it?s healed but she still has a ?black dot at the site?.
Diareah, Severe pain, weakening, almost fainted. Happen once a day, Thursday night, Friday, and Saturday. On Tuesday, loose bowels, no pain.
Information has been received from a 61 year old female who on 12-JUN-2007 was vaccinated with a dose of Zostavax (Oka/Merck).  Concomitant therapy included alendronate sodium (MSD), vitamin D (unspecified), BUSPAR and LEXAPRO.  On 12-JUN-2007 within a couple of hours the patient experienced pain and redness at injection site, within an hour or two after that she experienced vomiting, diarrhea and fever.  These symptoms lasted about 2 days, the patient recovered.  No medical attention was sought.  No product quality complaint.  No further information is available.
Blister type spot on left arm, where medical tape ended. Chest pains, feels like an odd heartbeat.
Pt. in observation at 11:50, had a syncope episode and fell out of the chair on his right side.  11:51 Staff called paramedic. Episode lasted for approximate 2 minutes. Placed pt. in supine position, BP 102/68. Pt awaken, alert and oriented. He was concern about what happen. He obtained a bruise under his right eye skin remained intact. Cold compresses applied to back of neck and forehead. Place on stretcher in upright position. Left knee also has a small bruise. Paramedic arrived at12:08, pt. was fully responsive and was able to answer all questions. EKG done, B/P standing 102/59both was normal.  Pt declined to go out to hospital. Observation continued until family member was able to take him home. No further complication observed. 1:03 came to take him home.
14MAR97 w/in 20min of vax pt states felt feverish, nauseated & eyes hurt, h/a, neckache, backache that evening;joints hurt, arm hurt @ inj site;temp 98 or 99 per pt lat arm was weak & throbbing;
On Ipol, patient was administered an expired dose of IPOL with no reported adverse event; Initial information received on 29-Jul-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 17 years old female patient who was administered an expired dose of IPV (VERO) (IPOL) with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Prophylactic vaccination.  On 27-Jul-2022, the patient received suspect IPV (VERO) at a dose of 0.5 ml (lot T1D48, expiry date: 25-Jul-2022) via intramuscular route in the left deltoid for immunisation.  On 27-Jul-2022 the patient was administered an expired dose of ipol with no reported adverse event (expired product administered)(same day latency).  Action taken: Not applicable.  Outcome: Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.
Dad reports sleepiness immediately following vaccines. He then reports him being very irritable and refusing to go to sleep that night. The following morning he that he was at his usual activity level.
dTap and Menningococcal shots given at 2:00pm Monday, August 20.  Nausea began at ~9:30pm and he vomited at 11:00pm that evening.  Tuesday began with headache, fever (extreme hot/sweaty to shivers/cold), sore throat w/slightly swollen lymph nodes, exhaustion and no appetite; Tuesday mid-night woke up with very wet bedsheets and pillow case (from sweating); Wednesday began with stiff neck, continued sore throat, swollen lymph nodes, headache, fever, still no appetite; and significant left earache.  Thursday (today) fever gone, but sore throat, swollen lymph nodes and increased mucous.  Did eat small amount of breakfast.  Seems to be recovering!
Narrative:   Other Relevant Hx:  Symptoms: Diarrhea  Treatment