chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No signs of symptoms have been reported; Improper storage of product in use; This spontaneous report was received from a registered nurse concerning a 9-month-old male patient.      The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 27-JUL-2021, a temperature excursion occurred due to power outage. Temperature excursion was reported as follows: temperature -0.5 Celcius degrees (C) (1 hour 30 minutes) and 13.6 C (1 hour 40 minutes); time frame 2 hours 10 minutes (cumulative). There was no other previous temperature excursion. It was reported that there was miscommunication when reporting high/low reading of temperature, and initially, the site received clearance to use vaccines on 28-JUL-2021. On 29-JUL-2021, the patient was vaccinated with the third dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscularly in the left thigh (lot # T033149, expiration date 19-NOV-2022) for prophylaxis (product storage error) at the private doctor's office/hospital. On that date, temperature readings were corrected which changed outcome, but the vaccine had already been administered. No signs or symptoms were reported and no treatment was administered. The patient's physician was notified and the patient would have the vaccine repeated later. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck. devicelotnumber: T033149; expirationdate: 19-NOV-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2107USA008895: US-009507513-2107USA008894:
high fever post vax;t104-106.6 in PM; to ER alert, sl irritable;tx Ibuprofen
Moderna COVID-19 Vaccine EUA 01/05/21 started itching on injection site,  01/06/21 @07:20am noticed redness and hot to touch on injection site, @08:30  started with pain and right arm feeling heavy with swelling. @ 11:05 am noticed injection site swollen (like a large welt and hot to touch). Currently at 4:48 pm injection site still swollen (RED) and hot to touch. Right arm has pain and heaviness.
After 24 hours of receiving DTAP and IPV in the left deltoid, a red rash with blisters and warmness to the skin 4 1/2" wide by 5" tall appeared. The mom gave Tylenol. Per clinic, the doctor advised Benadryl 1 tsp every 6 hours and Tylenol every 4 hours, and apply cool compress to the area.
p/vax pt T102; to ER; T105; lips turned blue, hands & feet blue, eyes rolling in head, shaking; hosp for a week; still having sz;Annual follow-up states the child has not recovered.
Had chills, body aches, and low grade fever  starting approximately 14 hours after vaccination.  Symptoms continued off/on  for  approx. 16 hours. Treated with Tylenol and Ibuprofen without any further issues.  Arm was quite sore also for a day and a half.
Onset of what was later diagnosed as Multiple Sclerosis or another demylinating disorder. Began with numbness and muscle weakness on lower left side of body, including left buttock, leg, and foot. Onset was 06/26/2007. Rectum, tailbone area, and toes of right foot also went numb within 10 days after initial symptoms. Patient presented in mid-July with *no rectal tone* and was unable to defecate normally for nearly 2 weeks. Following an MRI of the brain (on 07/20/2007), which showed several lesions, was formally diagnosed with Multiple Sclerosis "or another demylinating disorder." 10/22/07-records received for DOS 7/16-7/22/07-DX:Multiple Sclerosis.On 6/27/07-suddenly awoke with insidious onset of left lower extremity numbness, symptoms distributed from hip to foot, felt lower extremity was heavy. Seen in ER no motor dysfunction seen in ER on 6/29/07-with weakness, referred to PCP-seen by PCP 7/3/07-decreased sensation on left buttock area, descreased sensation left side of genitals and rectum. 7/8/07-some dysfunction with defecation, unable to complete defaction. Sitting causes pain. MRI of spine no focal disk herniation or central canal stenosis. Neurology consults 7/19/07-left lower limb numbness for 1 month. Impression: first presentation of demyelination, syndrome is most keeping with Multiple Sclerosis.
This spontaneous report was received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored (temperature excursion was 48 Fahrenheit, time frame 20 minutes, because of data logger) RECOMBIVAX HB injection, lot # L029361, expiry date 14-AUG-2017, (dose, frequency and route of administration were not reported). Previous temperature excursion was reported as no. No adverse effects reported. The outcome of events was unknown. No product quality complaint (PQC) was involved. No further information was provided. Additional information has been requested.
Metallic taste that started 5 minutes following vaccine and is still present 25 hours later. *Pregnant- due 5/23/21
patient experienced chills, low grade fever, pain in arm, sore in mouth/on lip that lasted about 48 hours. Patient did not seek treatment and states she is completely better.
This spontaneous report as received from a Registered Nurse regarding a 12 year old Adolescent patient of unknown gender. There was no information about concurrent condition, historical medication and concomitant medication. On 29-OCT-2018, the patient was vaccinated with improperly stored PROQUAD for prophylaxis (product storage error). Vaccine was stored out of range at -6 degrees for an approximate time of 15 minutes. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1902USA001085.
This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 27-SEP-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L035127, expiration date:14-SEP-2017, as prophylaxis (Strength and dose were not reported), which experienced a temperature excursion between 14 and 46 Fahrenheit degrees for 3 hours. There were no previous temperature excursions reported. Digital data logger was involved. No adverse effects were reported. A product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA000452: US-009507513-1702USA003692: US-009507513-1702USA003693: US-009507513-1702USA003694: US-009507513-1702USA003695: US-009507513-1702USA003696.
A moderately pruritic  mildly erythemic body rash on limbs  both arms , inner thighs and scalp.  A few petechiae seen  on upper forearms, maybe from scratching  lasting  2 weeks.  Self-treated with OTC topical steroid cream Hydrocortisone 1%.
NSTEMI . ED visit to hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On 29-AUG-20114 the patient was vaccinated with the second dose of VAQTA (injection strength: 25/0.5(units were not reported), 0.5 ml, lot # and expiry date were not reported). which was early as first dose of VAQTA was given on 09-MAY-2014. No symptom was reported. Additional information has been requested.
Admission Date: 5/11/2022 Discharge Date: 05/30/2022  PRESENTING PROBLEM: Generalized weakness Acute kidney injury (nontraumatic) Multiple falls Laceration of multiple sites of lower extremity, unspecified laterality, initial encounter Hypotension due to hypovolemia Septic shock   HOSPITAL COURSE: Patient is a 61 year old female who presented to the ED with complaints of frequently falling and had sustained another fall prior to admission in which she denied striking her head or losing consciousness but did suffer lacerations to her left upper thigh and bilateral medial calves which were sutured in the ED. She had been discharged the previous day from rehab in which she had reported to being stronger but endorsed that she was not back to her baseline.  After admission she became hypotensive despite fluid resuscitation, requiring vasopressors to maintain blood pressure. She was treated for septic shock with organ dysfunction. Labs did reveal an intermediate c diff result on 5/12 but subsequent c diff PCR was negative. Source of infection was unclear but she did receive a 7 day course of Zosyn with concern for colitis.   She did have significant third spacing on admission felt to be due to poor nutrition status with low albumin. Dietary did speak with her and did discuss proper nutritional goals. We have started her on marinol to improve appetite.   During her stay she did have significant coagulopathy felt secondary to liver dysfunction and did receive 3 units of FFP. She also did receive 2 units of PRBCs during this hospital stay.   Physical therapy did consult when she stabilized and felt patient would benefit from rehab. Unfortunately, a covid 19 screen was done which was positive; although, she did not have any respiratory symptoms. Due to being positive COVID 19 placement was difficult which caused a prolonged hospital stay. With continued physical therapy the patient's mobility did improve and it was felt that patient could be safely discharged home with family and home physical therapy on 5/29. Patient also expressed eagerness to go home and was agreeable with the plan. She is ambulating in the room independently including feeding, dressing and going to the restroom. We will arrange for home health.    We are discharging her on potassium supplementation but would recommend a BMP including magnesium to be checked in the next 5-7 days.     Patient is being discharged in stable condition and was agreeable with discharge plans.
13 hours after my injection I fainted and fell. After getting up I fainted and fell again. I also had the typical symptoms of arm pain, sweating and weakness before fainting. After fainting I had the above plus chills and muscle spasms and was unable to get up for about 20 minutes.
Initial case received from a physician on 14 July 2010. A 16-year-old female patient received a right arm injection of MENACTRA (lot number U34400AA) and a left arm injection of GARDASIL (Merck, lot not reported) on 13 July 2010. The patient had a history of ADHD (attention deficit/hyperactivity disorder) and depression, and 8 months prior to vaccination had suffered a head trauma with symptoms involving the right side. Concomitant medications included PRISTIQ, VYVANSE, and PAMELOR. On 14 July 2010, the morning after vaccination, the patient woke up with swelling of the right side including right-sided facial swelling and right arm swelling; right-sided weakness; and lower back pain. The patient noted that she had pain when trying to get up to walk, and that she "hurt all over". She was seen by her physician on 14 July 2010. Outcome was unknown at the time of the report.
Weak/tired coming and going; Aches and pain coming and going; Weak/tired coming and going; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weak/tired coming and going), MYALGIA (Aches and pain coming and going) and FATIGUE (Weak/tired coming and going) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Urinary infection.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced ASTHENIA (Weak/tired coming and going), MYALGIA (Aches and pain coming and going) and FATIGUE (Weak/tired coming and going). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. On 28-Jan-2021, ASTHENIA (Weak/tired coming and going) and FATIGUE (Weak/tired coming and going) was resolving. At the time of the report, MYALGIA (Aches and pain coming and going) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included blood pressure and cholesterol pills and antibiotics (urine infection). Treatment included some kind of "liquid".
Information has been received from a consumer concerning a co-worker who on 13-OCT-2008, the patient was revaccinated with PNEUMOVAX. Concomitant therapy included Influenza virus vaccine (name and manufacturer unspecified). On 13-OCT-2008 the patient experienced high fever, pain in lymph nodes her left side hurt, high injection site heat, extreme pain and heaviness in her arm, malaise, not feeling good, achiness after getting revaccinated and cellulitis. The patient had symptoms by the afternoon. At the time of the report, the patient was feeling better but not recovered. This is one of several reports received from the same source. No additional information is expected.
pneumonia; flu; was given the high dose; Initial information was received on 12-Dec-2020 regarding an unsolicited valid serious social media case received from a consumer (Patient).  This case involved a 60 year old patient who developed pneumonia, flu (Influenza) and for whom was given the high dose (Extra dose administered) was reported, while patient received INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiration date not reported via unknown route at unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed pneumonia, flu (Influenza), 2 days following the administration of INFLUENZA VACCINE.  Seriousness criteria was assessed as hospitalization (caused or prolonged) for events flu and pneumonia.  It was also the case of actual medication error due to extra dose administered.  Patient reported that had trouble with lungs.  No relevant laboratory data was reported.  It was not reported if the patient received any corrective treatment.  The event outcome was unknown for pneumonia and flu at the time of reporting.  There will be no information available on the batch number for this case.  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 Disclaimer: 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.; Sender's Comments: This case concerns an 60 year old patient who developed pneumonia, flu and was given the high dose was reported after vaccination with INFLUENZA VACCINE. It was unknown if the time to onset is compatible. Howerver, concomitant medications, patient's medical condition and laboratory tests ruling out alternate etiologies. Based upon the reported information, the role of vaccine cannot be assessed.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 at 14:00 as dose 5 (booster), single (Lot number: FJ7145B) at the age of 67 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Mar2022 at 15:00 as dose 4 (booster), single (Lot number: Fm0698), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: two negative tests on day 9 and 10; Negative, notes: two negative tests on day 9 and 10; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 (PAXLOVID from 08Dec2022 to 12Dec2022). Reporter considered the event non-serious.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out.
The day of my vaccine and the following day my arm was very sore. It went away. 7-8 days after receiving my  first dose my arm became sore at the injection site, warm to the touch and itchy. I just started today on the advice of my physician to take Tylenol, use cold compresses and Hydrocortisone cream. It's helping to take the edge off of the itch but my arm is still very warm.
This spontaneous report as received from a pharmacy technician refers to a 4 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 06-APR-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
first dose she had severe pains in the left side of her neck; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 77 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Feb2021 11:00 (Lot number: EN6202) at the age of 77 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Swine flu vaccine (Couldn't use her legs), for she couldn't use her legs. The following information was reported: NECK PAIN (non-serious) with onset Feb2021, outcome "not recovered", described as "first dose she had severe pains in the left side of her neck".  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had a terrible reaction to the Swine flu vaccine years ago and she couldn't use her legs, has no product information for this vaccine she had the reaction to. States she is otherwise very healthy, states she has never drank or smoked and exercises and eats healthy.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200510888 Same patient and product, different dose;US-PFIZER INC-202200510889 Same patient and product, different dose
Expired vaccine was stored and then administered/Vial refrigirated after expiry; 606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine was stored and then administered/Vial refrigirated after expiry) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine was stored and then administered/Vial refrigirated after expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) and PRODUCT STORAGE ERROR (Expired vaccine was stored and then administered/Vial refrigirated after expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. No treatment information were given. No adverse event reported. Date place in refrigerator was 26th October 2021.
Information has been received from a registered nurse concerning a 46 year old female patient who on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (lot # not provided).  It was reported that the patient was seen in the office on 25-SEP-2009 with complaints of cold symptoms with a cough.  The patient also complained that the arm where she received the vaccine was sore and swollen and she had trouble moving her arm.  The registered nurse was not sure where the patient received the vaccine.  It was unknown if the patient recovered.  The health care professional contacted during telephone follow-up could not supply the following information:  dates of vaccination/therapy, dose number (if applicable), lot number (if applicable), date of event and hospital name (if applicable).  Additional information has been requested.  This is one of several reports from the same source.
There was fluid found in the cap of the 3ml syringe and the vaccinator suspected that less than 1/2 of the 0.5ml dose was administered.  The patient and family member were alerted immediately.Moderna was contacted and case created, and we were advised to call the patient back ASAP for vaccine admin of 0.5 ml in the opposite arm.  The patient is scheduled to return on 3/11/21 for vaccination.
Leg that received vaccine became too painful to stand on.  Pain seems to originate in heel or ankle. Stands only on her toes on affected leg.
No additional AE reported; Patient was administered expired MMRII; Expired / Administered Vaccine; This spontaneous report was received from healthcare business professional and refers to a patient of unknown gender and age. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported.  On 31-MAR-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live) (recombinant Human albumin (rHA)) (M-M-R II), lot #T010650 was confirmed to be valid, expiration date: 26-MAR-2022, (strength, dose, route and site of administration were not provided) (expired product administered). No additional adverse event was reported (no adverse event)