chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant refers to unspecified patients of unknown age and gender. No relevant medical history of the patients was reported. On 19-MAY-2014, the patients were vaccinated with 2 doses of VAQTA (strength, route of administration, lot number and expiration dates were not reported). No concomitant medications were reported. It was reported that on an unknown date, these vaccine doses had reached a low temperature of 32.9 Fahrenheit for 9.5 hours and were supported. No adverse effects were reported. There was no product quality complaint involved. The outcome was unknown. This case is linked to Case # 1405USA011843, Case # 1405USA014112, Case # 1405USA014113 via the same reporter link. Additional information has been requested.
migraine that lasted more than five hours, accompanied by confusion, and extreme lethargy. Lethargy, feeling faint, chills, and weakness continued for over 24 hours. Extreme fatigue and mental fogginess still persistent, impeding all day-to-day activities.
pt recv vax & the same day devel a fever of 101.5; by the following day had completely recovered; reporting nurse felt that there was a problem w/this particular lot;
Pleasant 74-year-old female with past medical history significant for vasculitis on Rituximab presents to the ED for evaluation of known Covid-19 and increasing shortness of breath. Patient has completed a Covid-19 vaccine series with a booster. She was in her normal state of health until this past Wednesday, January 5th when she felt "off". This caused her to get tested for Covid-19 which was positive. She began experiencing shortness of breath on 1/9 and presented to the ED at Mercy Berryville for evaluation. At this time her oxygen saturations were acceptable on room air and she was sent home. She returned to the same ED yesterday on 1/10 with worsening shortness of breath and was found to require 2L of oxygen v.
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On 22-JUL-2015 the patient was vaccinated with an improperly stored dose of oral, ROTATEQ (lot # K009745, expiry date 17-FEB-2016, dose and dose number were unspecified) orally. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Swollen gums/Blisters; Jaw pain, poping, locking, chewing, opening mouth and yawning problem; Fatigue; Fever; Chills; Headache; Swollen glands; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLISTER (Swollen gums/Blisters), TEMPOROMANDIBULAR JOINT SYNDROME (Jaw pain, poping, locking, chewing, opening mouth and yawning problem), FATIGUE (Fatigue), PYREXIA (Fever) and CHILLS (Chills) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 0088B21-21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced BLISTER (Swollen gums/Blisters), FATIGUE (Fatigue), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and LYMPHADENOPATHY (Swollen glands). 30-Apr-2021, the patient experienced TEMPOROMANDIBULAR JOINT SYNDROME (Jaw pain, poping, locking, chewing, opening mouth and yawning problem). The patient was treated with Manual therapy (got mouthguard) for Temporomandibular joint syndrome. On 07-May-2021, BLISTER (Swollen gums/Blisters), FATIGUE (Fatigue), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and LYMPHADENOPATHY (Swollen glands) had resolved. At the time of the report, TEMPOROMANDIBULAR JOINT SYNDROME (Jaw pain, poping, locking, chewing, opening mouth and yawning problem) had not resolved.            No concomitant medication was reported by reporter.  No treatment medication was reported by reporter.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  Jaw pain started after two days of vaccination. Patient's primary doctor and dentist told her that might be TMJ.   This case was linked to MOD-2021-068490 (Patient Link).
Patient states that he got redness at injection site, and a small scar developed at the flu injection site. The patient states states the injection site has stayed red for the last 3 years, and that his dermatologist has been monitoring it for last couple of years. Patient also states that the area now has tested positive for basal cell carcinoma and has been directed to have the area surgically removed.
Stayed in bed; migraine; Painful swelling; Body aches; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Stayed in bed), MIGRAINE (migraine), SWELLING (Painful swelling), PAIN (Body aches) and CHILLS (Chills) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) UNK dosage form. On 24-Jan-2021, the patient experienced ASTHENIA (Stayed in bed), MIGRAINE (migraine), SWELLING (Painful swelling), PAIN (Body aches), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, ASTHENIA (Stayed in bed), MIGRAINE (migraine), SWELLING (Painful swelling), PAIN (Body aches), CHILLS (Chills) and NAUSEA (Nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: TCR Attached-NNI
Information has been received from a registered pharmacist concerning a 57 year old male patient with chest pain who on 14-AUG-2010 was vaccinated with a dose of PNEUMOVAX 23 and on 10-SEP-2010, the patient received a dose of PNEUMOVAX 23 (lot numbers not reported).  The pharmacist reported that the patient, who was in the hospital for chest pain, received a dose of the PNEUMOVAX 23 on 10-SEP-2010.  His effected arm began to swell, and six hours after receiving the injection patient was ordered to have a computed axial tomography (CT scan) to evaluate the extremity.  The CT scan revealed subcutaneous edema, and after further history collection from the patient, it was discovered that he had received a PNEUMOVAX 23 vaccine dose on 14-AUG-2010.  The patient received treatment with steroids and BENADRYL over the next four days, and the swelling resolved.  No residual effects were reported.  The pharmacy director reported that the patient left the hospital without any adverse effects to his arm.  Subcutaneous edema was considered to be disabling by the reporter.  Additional information has been requested.
9JUN92 used APAP & cool compress as ordered; start walking on ball of rt foot during evening; took to ER MD not worry about it cont APAP-very fussy, limping, fever; dec solid & fluid intake; inc sleep, rash around inject site (R);
My left arm felt heavy and painful. Having a hard time raising my arm. I have pain that radiates to my back. I am taking tylenol 500 mg for the pain.
Numbness of the arms and legs. Vascular problems in legs. Mental fog, loss of balance.
This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 12-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA66AA, expiry date 31st October 2021) for prophylaxis. Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis. On 30th November 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 30th November 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 details were provided as follows: The age at vaccination was not reported. The patient came in to pharmacy for school shots Bexsero. After the dose was administered, pharmacist noticed the dose had expired, which led to expired vaccine used. The reporter consented to follow up.
Dose number 3; Fever; Nausea; This is a spontaneous report from a non-contactable reporter (other healthcare professional).   A 55-year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 12Jan2022 (Lot number: FD7218) as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid 19 vaccine (DOSE 1, MANUFACTURER UNKNOWN, Lot Number: Unknown, Route of Administration: unspecified), for COVID-19 immunisation and Covid 19 vaccine (DOSE 2, MANUFACTURER UNKNOWN, Lot Number: Unknown, Route of Administration: unspecified), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 12Jan2022, outcome "unknown", described as "Dose number: 3"; PYREXIA (non-serious) with onset an unknown date in Jan2022, outcome "unknown", described as "Fever"; NAUSEA (non-serious) with onset an unknown date in Jan2022, outcome "unknown", described as "Nausea".   No follow-up attempts are possible. No further information is expected.
My Father was ill for approx 3-4 days after first vaccine with fatigue and some minor chest pressure, this start approx 3 days after injection and had made a complete recover, he then recieved his 2nd vaccine shot and again 3-4 days later he again stated began having severe fatigue and mobility issues, ( he stated his legs felt  like jello ) ,  no chest pains and no breathing issues were associated. 3 days  later  he was still feeling the same with symptoms and on the 4 day he was found deceased in his home.
Information had been received on 19-APR-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient (age unknown) was inoculated with ZOSTAVAX on or about 11-DEC-2014 at a hospital, as recommended for routine adult health maintenance for the prevention of shingles (dosage and lot#/expiration not reported). The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster (onset not reported). On or about 20-APR-2016, patient was treated at a hospital for an ongoing painful rash which was diagnosed as shingles. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Per ER record obtained from Hospital ER the patient presented to the ER in a post ictal state.
Developed Shingles  3wks after vaccine.  Not sure if directly related but thought it should be reported in case  others seen.
Felt pretty sick; 104 degree fever for 2 days felt like he had the flu; 104 degree fever for 2 days felt like he had the flu; Still pretty tired; This is a spontaneous report via a Pfizer-sponsored program, received from a contactable consumer (patient, reported for self).  A male patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as unknown, single for COVID-19 immunization. Medical history included atrial fibrillation from an unknown date and unknown if ongoing. Concomitant medications includes, blood thinner taken for Atrial fibrillation from an unspecified date and unknown if ongoing.   On an unspecified date, the patient experienced 104 degree fever for two days felt like he had the flu. The patient was progressively getting better still pretty tired and felt pretty sick. Patient enquired if the blood thinner make something bad happen. The patient takes Blood thinner for AFIB. On an unknown date, the patient underwent lab tests and procedures which included body temperature: 104 degree. Patient enquired if Blood thinner for AFIB should he take it or no. The outcome of event still pretty tired was unknown and rest events were recovering.  Information about batch/lot number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
ACUTE RESPIRATORY FAILURE 1/31/2021 DIASTOLIC HEART FAILURE, ACUTE ON CHRONIC ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 2/8/2021 DIASTOLIC HEART FAILURE, ACUTE ON CHRONIC HYPOXIA 2/8/2021 DIASTOLIC HEART FAILURE, ACUTE ON CHRONIC
I had severe-shivering, joint and muscle pain throughout the night. I also had a headache and a nausea tword morning. By about 2:00pm I was feeling mostly better. The injection site redness, swelling and pain went on for over 3 days. I couldn't sleep on that arm because of the pain.
Date the vial was initially stored in the refrigerator 15Jul2022 and date of administration of vaccine 15-jul-2022; temperature excursions; poor quality drug administered; vaccinated someone two days after the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccinated someone two days after the expiration date), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator 15Jul2022 and date of administration of vaccine 15-jul-2022), PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (poor quality drug administered) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccinated someone two days after the expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator 15Jul2022 and date of administration of vaccine 15-jul-2022), PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (poor quality drug administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccinated someone two days after the expiration date), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator 15Jul2022 and date of administration of vaccine 15-jul-2022), PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (poor quality drug administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The caller asked vaccinated someone two days after the expiration date. Number of doses/vials: 4 doses (2 boosters and 2 second boosters). The vial undergone temperature excursions. No treatment medication was reported.
About 28 hours after vaccination, client had swelling in same arm from wrist down in flat part of hand and very slight swelling in same area on Left hand. Swelling appears to be getting better.
Three different hospitalizations with sepsis; Difficulties to urinate; prostate growth; This spontaneous case was reported by a consumer and describes the occurrence of SEPSIS (Three different hospitalizations with sepsis) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, 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 experienced SEPSIS (Three different hospitalizations with sepsis) (seriousness criteria hospitalization and medically significant), DYSURIA (Difficulties to urinate) and PROSTATOMEGALY (prostate growth). The patient was treated with LEVOFLOXACIN (intravenous) on 10-Aug-2021 for Sepsis, at a dose of 200 mg and Surgery for Prostatomegaly. At the time of the report, SEPSIS (Three different hospitalizations with sepsis), DYSURIA (Difficulties to urinate) and PROSTATOMEGALY (prostate growth) outcome was unknown.            Concomitant product use was not provided by the reporter.  On 29-Jun-2021 patient had an elective surgery on his prospate (because it had grown and caused him difficulties to urinate) and after that had three different hospitalizations with sepsis and has been on IV antibiotics.  Is schedule to get the third dose of the Moderna COVID-19 vaccine on 28Aug2021 and wants the booster to do the best job it can. Wants to know if the antibiotics can interfere in any way. Caller does not think the vaccine is related at all with the surgery/antibiotic treatment and was not really interested in providing further information to report the AE.  Company Comment Based on reporter's causality and events being a possible complication of elective surgery described after 4 months of vaccination, the events are assessed as unlikely related to mRNA-1273.; Sender's Comments: Based on reporter's causality and events being a possible complication of elective surgery described after 4 months of vaccination, the events are assessed as unlikely related to mRNA-1273.
I felt fatigue even the day of the second vaccine.  Then about 2 days after I had a severe and sudden bout of plantar facsitis, then increase in other arthritis symptoms.  Then a week after I suffered a stomach virus.  Then latter that same week for two days I experienced severe right leg pain.  Then developed cluster rashes on the whole right leg.  Went to Urgent care since we are  wintering out of state.  Was diagnosed with Shingles which I have never had and hope to never have again.  The blisters are improving but the pain remains.  I very strongly feel this is ALL due to the second dose of this vaccine.       I certainly feel the second dose of this vaccine should not be given for at least 6 months.
1/11/22 pt brought to ED due to decreased alertness, poor oral intake, respiratory distress; had a positive COVID test on 1//4/22; given dexamethasone in hospital; pt required intubation and sedation; transferred to CCU; was able to be extubated; dysphagia worsened and platelets were too low for feeding tube placement; started on TPN; pt experienced rapid A Fib and worsened, rapid response called; intubated again; able to be extubated the following day; developed significant hemoptysis and there was concern for aspiration; pt declined another intubation; decided on comfort measures and was transferred to inpatient hospice unit where he passed away
D-tap - HIB combo given before 15 months of age. Noside effects reported.
woke w/ arm pain the following day which resolved, 12/28 arm pain, swollen, gland axillary/post neck, eval PCP; inc redness by 1/1/21, seen in ED, RX for cellulitis
Pt received a third dose of the Shingrix vaccine. Pt contacted after the injection was given and Pt reports no ill effects from getting a third dose of the vaccine.
Heaviness in right thigh the same night but that disappeared Woke up on Thursday w cramping foot, leg, thigh and left side of face Still tingling
pt recvd vax;father states pt had fever & sz like activity p/ 12jun95; to er on 13jun95 & was told sz was from fever caused by immun;
Second flu shot was given at 8:30 am on 10/30/2023. No symptoms
faint reddness to sides of face, blotch to lt cheek & scattered lacy pink/red rash to upper chest;occured 1hr 45mins p/vax;tx w/DPH;rash resolved w/in an hr
TINGLING IN THE CHEST ABOUT 1/2 HOUR AFTER SHOT, FEELING OF SWOLLEN LIPS STARTING ABOUT 2HRS AFTER SHOT LASTING ABOUT 4 HOURS..THEN TONGUE AND FACE FELT TINGLING ..TONGUE FELT SWOLLEN  METAL TASTE IN MOUTH AND A VERY FUZZY FEELING FOR THE DAY OF AND DAY AFTER SHOT WENT TO WALK IN CLINIC AT 620 PM ON 4/3. RECOMMENDED  BENEDRYL  RATHER THAN STEROID METAL TASTE  AND FEELING OF SWOLLEN TONGUE SUBSIDING....FACE TINGLE REMAINS ON 4/6/21
Dose administered after 30-day use by date or after manufacturer date of expiry; 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 or after manufacturer date of expiry) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  Health care professional (HCP) administered expired vaccine to 450 patients, after the manufacture date of expiration.Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 102 doses. Dates of administration of vaccine were reported as 25-Oct-21, 26-Oct-21, 27-Oct-21 and 29-Oct-21. The vial did not undergo any temperature excursions.  No treatment information was provided   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live follow-up received on 08-Jun-22, non-significant information reporter details added.
3 patients reported on the document who received ROTATEQ after an excursion was reported/Temperature 48F Time frame 17 minutes; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, current conditions, previous drug reactions and allergies and concomitant medications were not reported.   On 01-JUL-2020, at the age of 4-months-old, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), administered at a dose of 2 milliliters, by oral route (formulation, strength, vaccination scheme were not reported; lot number S004400, which has been verified to be valid, expiration date was not reported, but upon internal review was established as 14-NOV-2020) as prophylaxis. The vaccine administered experienced a temperature excursion of 48 degrees Fahrenheit for a time frame of 17 minutes, as recorded by a data logger (product storage error). There was no previous temperature excursion.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA006635: US-009507513-2009USA007900: US-009507513-2009USA007901: